FOI 25.26 0594 Decision Documents

November 2019 — Drafted by Technical Advisory Team

Item: [Prostheses for NDIS participants who have had a previous

amputation and a subsequent change in prosthetic needs; |

Paper Type: For discussion & confirmation of reasonable and necessary considerations for prosthetic supports

Sponsor: TAT Executive Leadership

Draft resolution: Discuss the proposed NDIS position for 3 x specific prosthetic

1.2.

1.3.

1.4.

scenarios that involve the health/disability interface in a way not consistently and/or previously defined and agree to the associated funding and service delivery implications.

Purpose

For participant’s who have undergone a previous surgical amputation procedure and now have a change in circumstance, there are three common scenanios relating to funding

and provision of prosthetic supports that are causing service delivery delays and require

Commented [DA1]: The following things need to be considered in the email out: Getting actuarial data on lower limb numbers so we can calculate the financial risk. Decide on the scenario 3 position i.e. option 1 capacity building or option 2 health responsibility. Note the 17 pages document is intended to comprehnaisvley outline the position and rationale and that a short ELT smmary paper will be drfted once agreement reached. Once agreed, need to discuss with AOPA. eAlso need to condsider if a literature review examining BAP and high end compnents is required to substantiate position and mitigate counterarguments.

2. Participants undergoing bone-anchored (osseo-integrated)’ prosthesis surgery;
3. Participants who have never used a prosthesis or not used one for an extended period of time now requesting a prosthesis (requiring trials and rehabilitation).

These are discussed further in item 4: ‘Three Prosthetic Scenarios’ and

individually in Items 5, 6 & 7.

The purpose of this paper is to:

1.3.1. Identify and discuss the funding and service delivery interface issues participants with prostheses are currently experiencing whilst transitioning through post-surgery rehabilitation with the aim of reaching functional stability and using a definitive prosthesis.

1.3.2. Seek approval on a NDIA policy position on the funding of prosthetic supports for NDIS participants during these three specific scenanos; particularly how participants will receive NDIS funded prosthetic-related supports and care during the rehabilitation time period. This will significantly improve participant experience and streamline access to definitive prostheses.

1.3.3. Establish a pathway forward for how this prosthetic position, once endorsed internally, will be progressed and communicated to relevant stakeholders: NDIA delegates, Artificial Limb Schemes (ALS) and state and territory health departments.

Note: for the purpose of this document, an interim prosthesis corresponds to a prosthesis used during the rehabilitation phase and a definitive prosthesis corresponds with the prosthesis to be used during the maintenance phase. See Attachment A for full interim versus definitive definition agreed with The Australian Orthotic Prosthetic Association (AOPA).

Background

Generally, prosthetic limbs will be connected to the participant using the prosthesis via either a custom made socket which fits the residual limb, or a bone-anchored implant

inserted during surgery and a complementary adapter, which j joins the implant to the

1 Note: Bone anchored prosthesis are also commonly referred to as Osseo-integrated prosthesis.

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2.2.

2.3.

3.2.

3.3.

3.4.

2.5. |For reference, the average cost of a...|

other parts of the prosthesis. Regardless of the way the prosthesis attaches to the

person, below the socket or adapter, there are a number of other tailored components

(such as a knee and a foot) that assist in performing functional tasks and provide

compatible cosmesis.

2.1.1. See Attachment B for images of a standard socket prosthesis and bone anchored prosthesis and components.

To date, a NDIS participant requiring a prosthetic limb has had this funded by the NDIS

once the Prosthetist and rehabilitation team are confident that their current full functional

potential has been established. NDIS funding would be for prostheses required to pursue

an individual’s functional goals. At this time it is expected that the custom made socket

not require replacement during the first 12 months of their plan.

Generally, with prostheses that include a custom made socket, a participant would be

considered suitable for NDIS funding when:

2.3.1. Swelling and oedema has stabilised to a point where socket fit remains stable;

2.3.2. Participant, Prosthetist and Rehabilitation team are confident that a socket replacement (due to swelling/oedema) will not be required by the participant for the first 12 months of their plan;

2.3.3. Their functional classification/potential (K-level) has been established and their prosthetic componentry requirements for the foreseeable future have been clearly established.

2.4. The funding boundaries for bone anchored prostheses have not been firmly established.

This is explained further in scenario 2 below.

Issues with Current Funding and Service Delivery Situation

Prior to the NDIS, the way people received supported rehabilitation as they transitioned from post-surgery, fo using an intenm prosthesis, to using a definitive prosthesis, occurred differently in each state and territory. This is due to variances in funding and service delivery mechanisms, definitions of ‘interim’ and’ definitive’, and different professional guidance outlining an amputee’s rehabilitative transition to a definitive prosthesis.

Also, it has been identified that the Artificial Limb Schemes (ALS’s) - which are the state and territory based government schemes that fund, regulate and provide artificial limbs to eligible Australians (notably Australians who do not receive prosthetic maintenance through NDIS) - is delivered and funded differently across each jurisdiction. Many of the historical ALS orthotic/prosthetic providers in each jurisdiction are also NDIS providers. As with other health supports, each state and territory health system administers funds related to prosthetic rehabilitation in different ways. ALS and state and territory health departments argue that funding that was previously set aside for replacement sockets has transitioned to the NDIS.

This is important because whatever funding position NDIA adopt, will have varying ‘gap’ implications across each jurisdiction. If health funding is not available for a specific phase of rehabilitation or prosthetic component, then an NDIS participant may be left with no prosthesis during a critical period. It also highlights why ALS regulators and providers need to be part of the communication strategy for this funding position; if all stakeholders are not in agreeance, we may find that NDIS will continue to request funding from the NDIS for supports that are outside the scope of NDIS responsibility and participants will be left with no way of achieving their required daily functional tasks.

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xx2

• -[ Commented [DAZ]: Jackie to add in standard costs

November 2019 — Drafted by Technical Advisory Team

3.5. _ The timeframes for transition from a rehabilitative phase to a maintenance phase will be different for each individual and will depend greatly on the type of prosthesis required. In general, as early phases of a person’s prosthetic related care is provided by the health system and/or ALS and ongoing support is the responsibility of the NDIS, these supports and services will need to be provided in a collaborative manner. This collaborative approach has not yet been established.

4. Three Prosthetic Scenarios

5. For each of these three scenarios the following information is provided: 41.1. standard prosthetic pathway; 41.2. reasonable and necessary decision making — interpretation of s34.1.f; 41.3. issues;

6. benefits; 41.5. risks to participant and scheme; and

7. anideal case example.

8. Reasonable and necessary decision making has been developed in line with current guidance and legislative requirements.

4.2.1. See Attachment C full the summary of these guidance and legislative requirements relating to prosthetics.

| 5. Scenario 1 — Minor Revision Surgery

5.1. | Standard Prosthetic Pathway

5.2. Amputation > prolonged use of prosthesis > minor revision surgery > stabilisation and healing of limb > plan > fitting of socket to previous prosthetic parts > potential replacement of socket required within 12 month period

5.3. _ Note: this scenario only applies to minor revision surgery and does not include revision

where the level of amputation changes |e. below knee to above knee amputation

surgery.

54 Issue

5.5. | Some NDIS participants have an established definitive prosthesis and due to change in

circumstances are now having revision surgery at the same level of amputation. This change in circumstance may be due to:

5.5.1. Redundant tissue needing to be removed from the amputated limb to make wearing a prosthesis easier and more comfortable

5.5.2. Adjustment to the placement, length or otherwise of nerves and/or other vessels to enable increased comfort

5.5.3. In children related to adjustment of the growth plate to accommodate more appropriate prosthetic componentry in the future

5.5.4. There may be other reasons for minor surgery identified by medical personnel, these examples are not exhaustive.

5.6. The key issue is that 34.1.f indicates the NDIS will not be responsible for funding

services and therapies provided after a recent medical or surgent event, yet post-surgery anew prosthetic socket is likely required and whilst health pay for wound management

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ndis:

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5.7. 5.8.

5.9.

5.10. 5.11.

5.12.

5.13.

5.14.

5.15.

5.16. 5.17.

5.18. 5.19.

there is opinion among prosthetic providers and ALS’s that in this situation, there is typically no aim of improving functional status and the socket will be used well into the maintenance phase, therefore prosthetic costs are not considered health responsibility. Reasonable and Necessary Decision Making — Interpretation of s34.1.f

{34.1.f of the NDIS Act 2013 is not considered to be met in the following circumstance for

the following reasons:

5.8.1. If a socket is required now and there is likely to be further volume change to the participant’s residual limb and the socket will not last 12 months;

5.8.2. It is deemed that time-limited rehabilitation to enable the residual limb to once again arrive at a stable volume is required;

5.8.3. The prosthetist and participant should work together with the health sector to continually monitor and adjust the situation and request NDIS funds when a stable volume has been attained and a new socket is envisaged to last a 12 month period.

NDIS funding the socket replacement is considered reasonable and necessary in the

following circumstances for the following reasons:

5.9.1. Where the new socket to be funded will be used for at least the next 12 months;

5.9.2. Given that the participant has been successfully using a definitive prosthesis, the surgery is minor, only the socket requires replacement and no functional improvement is aimed for, it is considered 34.1.f is met in relation to socket costs;

5.9.3. The NDIS participant can lodge change of circumstance with their NDIS planner and the planner can allow for a socket replacement in the 12 month plan period, with the expectation that this will be a definitive socket used on an ongoing basis,

that is, only one socket replacement will be required ina 12 month plan period| = _ -

Benefits

NDIS can be assured that participants are receiving a streamlined service and their time without use of a prosthesis and therefore performing functional tasks independently or as they usually do is limited

NDIS can be assured that no additional costs related to additional core supports will be required due to a participant being unable to use their prosthesis longer than planned; potentially offsetting the cost of the socket required

Risks to participant:

If NDIS processes are not swift, then the participant will not be able to get a socket at the optimal time they require post surgery

If the NDIS fund the first socket and the Prosthetist has incorrectly assessed the situation and the participant requires a second socket in a 12 month plan period, the participant will likely be left with no one taking responsibility for funding a replacement socket at this point in time

Risks to NDIS:

NDIS is seen as creating a gap with state based services and leaving a participant they have been paying for without a prosthesis.

Ideal case example

The participant has an established definitive prosthesis and is functioning at a high level with their prosthesis. The participant is able to conduct all their required and desired functional activities with the prosthesis. However, over time since the initial amputation they have lost weight and muscle bulk within the residuum (amputated limb) as is typical

Commented [DA3]: Jackie — Kate’s comments were to

change the order of these paragraphs (which | have done)

and to clarify that ‘ the prosthetist must ensure that the socket is going to last 12 months for it to be soncisdered definitive’. And tat if it does not last 12 months it would be considered a failed script and the prosthetist would need to fund replacement costs.

Will need you to clarify

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5.20.

5.21.

when you are unable to exercise these muscles and they are constricted by a socket for significant periods of time. This has resulted in the participant having a large amount of redundant (floppy) tissue in the residuum. This tissue makes it hard for the participant to get their prosthesis on and off, limits the types of prosthetic liners they can use to hold their leg on and is uncomfortable for them when the tissue moves during their activity. It also makes it harder for the participant to control the prosthesis as well as they could if this tissue were not moving around. The issue is taking a lot of time with their Prosthetist to work around in their current prosthesis. The participant has been advised that surgery is the only remaining solution to improve this situation.

The participant undergoes surgery and their wound management occurs in conjunction with the health system. The participant requires crutches and wheelchair post surgery as they are unable to walk with the prosthesis. The participant already has this AT (wheelchair & crutches) as a backup plan to their prosthesis for days/times when they can’t wear it. The Prosthetist provides the participant with a shrinker as soon as wound healing allows to ensure the swelling in their residual limb is minimised. This shrinker is funded by the health system.

When the wound has healed and the limb is ready to use a prosthesis again the prosthetist assesses the amount of swelling in the residuum and the size of the residuum as compared to the previous prosthesis and assesses whether the participant is likely to require one or two sockets in the next 12 month plan period. If there is any doubt the socket will not last 12 months the initial socket is funded by health. The prosthetist and participant should not request funds from the NDIS until the residual limb volume is stable and the socket can be assured to last more than 12 months.

Scenario 2 — Bone-anchored prosthesis

6.1. 6.2.

6.3.

6.4.

6.5. 6.6.

6.7.

6.8.

Standard Prosthetic Pathway

Bone anchored prosthesis surgery > initial loading (with surgical team) > fitting of ‘light training prosthesis — limited gait training only (typically return to local prosthetic and physiotherapy team as outpatient within this phase) > fitting of prosthesis for gait training with crutches (unknown if this prosthesis will meet ongoing needs or not at this time, may become definitive prosthesis) > if required, definitive prosthesis provided

Note: This is based on the most commonly performed type of surgery currently occurring in Australia. There are different methods available, some require 2 sets of surgery with time between which vanes greatly in length from weeks to months prior to prosthetic rehabilitation beginning.

Note: this reasonable and necessary consideration for this bone-anchored scenario only applies to lower limbs, but may to upper limbs in the future. Considerations for upper limbs are separate due to differences in weight bearing rehabilitation requirements. Issue and participant experience

Some NDIS participants who have previously undergone an amputation and use either a wheelchair or definitive prosthesis for mobility, may now choose to have a bone anchored prosthesis inserted

Typically people choose to undergo this procedure if they have difficulty utilising a more traditional prosthetic socket for a vanety of reasons, however, anecdotally it is reported people who are successfully using a prosthesis are also choosing to undergo this procedure for a vanety of envisaged benefits associated with removal of the need for a prosthetic socket

This change in circumstance involves surgery to insert the implant and a rehabilitation phase while the implant wound heals and the person begins to function with a prosthesis.

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6.9.

6.10.

6.11.

6.12.

6.13.

6.14.

6.15.

6.16.

The initial rehabilitation period for bone-anchored prostheses usually involves healing and weight bearing on something connected to the inserted implant but not on a prosthesis they can walk on.

Surgery is typically not covered by the Medicare system and is conducted within the private sector (self-funded or funded via Private health insurance); in some cases rehabilitation associated with the surgery appears to be limited to the initial loading stage only and then the participant is discharged to continue rehabilitation with their local prosthetist and physiotherapist.

Bone anchored prostheses are a relatively new procedure and the rehabilitation process and responsibilities for prosthesis provision following this surgery are unclear.

This gap created by a surgery that no group has ever funded, presents an added layer of complexity surrounding the responsibility for the provision of rehabilitation and the provision of the required light training prosthesis and maintenance prosthesis.

The next phase of rehabilitation is to walk on a prosthesis. In some areas this is called a ‘light prosthesis’ and may or may not reflect the same type of prosthesis the person has used before (and therefore already has available to them) or will need to use to meet their functional requirements in the future. In some cases the participant is referred to their prosthetist in the community by the surgical team with no prosthesis to begin walking on and the prosthetist is not eligible to access prosthetic componentry funded by health for rehabilitation purposes. As the participant is registered with the NDIS, the prosthetist requests prosthetic funding from the NDIS.

To walk, the participant does not require a prosthetic socket, instead an adapter which ‘clicks on’ to the implant is used to connect the person to the other required prosthetic components. This adapter should not need to change and could be used ongoing into the maintenance penod without needing to be replaced. */f alignment is not correct or on occasion this may need to change if the prosthetist chooses the wrong adapter for the other parts required ongoing.

All other prosthetic components which are required for the prosthesis to be walked on (e.g. foot, knee and/or hip depending on amputation level) given to someone during rehabilitation, could potentially be used ongoing in the maintenance period as well, however, given the participant needs to use crutches for at least a 3 month period to ensure safety of the implant and gait training will occur over this time, it is difficult to immediately confirm what the most cost effective or reasonable and necessary level of componentry required will be for the individual’s functional requirements. However, it is possible that what is provided at this point in time may meet the person’s functional requirements as they transition into the maintenance phase. It is noted this aspect is not unique to BAP implants and is consistent with all prostheses irrelevant of the way they attach to the person.

After the light prosthesis has been utilised, where required, a further change in componentry will occur to ensure the prosthesis entails what the prosthetist envisages the participant will need into the future.

The key issues are:

6.16.1. Post-surgery, the participant is not always linked with a prosthetic service in a manner in which they can access health funded rehabilitative services because

surgery is often occurring privately.| ee __-- { Commented [DA4]: FY! added this in

6.16.2. Due to the process of a ‘light prosthesis’ and then a further prosthesis sometimes being required, it is not clear at what stage a rehabilitation or maintenance prosthesis is in use (doesn’t fit the traditionally used terms of interim and definitive).

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6.17.

6.18. 6.19.

6.20.

6.21.

6.22.

6.23.

6.16.3. In most regions there is no established process to integrate these participants post-surgery into the traditional health sector prosthetic rehabilitation processes and this appears to be occurring differently in different regions and differently between participant’s in the same regions in some circumstances.

6.16.4. At the time NDIS prosthetic funding is being requested, rehabilitation to the point of walking on a prosthesis and confirming that implant surgery has been successful has not always been completed

6.16.5. In some situations, state and territory health systems are not facilitating the type of componentry that will enable the opportunity for functional success and therefore NDIS is being requested to fund componentry that is envisaged will be used long term, however, suitable levels of evidence that this componentry meets reasonable and necessary and that the surgery has been successful is not yet available.

To date, NDIS has been delaying requests for prosthetic funding during the interim period

stating that participant’s need to complete rehabilitation to a point where they have been

walking on a prosthesis to enable planners to determine that the implant will continue to be used and which components meet reasonable and necessary criteria, as per any other prosthetic rehabilitation situation. The key reason for prosthethic rehabilitation is to identify what type of componentry a person requires on the definitive prosthesis. This reduces the risk of funded parts not being used and/or requiring premature replacement

Reasonable and Necessary Decision Making — Interpretation of s34.1.f

As per Schedule 1 of the NDIS (Supports for Participants) Rules 2013: Considerations relating to whether supports are most appropriately funded through the NDIS; The NDIS is not responsible for funding time-limited, goal-oriented services and therapies provided after a recent medical or surgical event, with the aim of improving the persons functional status, including rehabilitation or post-acute care.

\It should be noted that the DRC announcement for the NDIS to fund disabilty related

health supports did not change this. |The health system will continue to be responsible for__ -

time-limited goal-onentated serviced and therapies including rehabilaition. See Attachment C.

Post BAP (Ol) surgery, the allied health intervention required to assist the participant to walk with a prosthesis so that the implant can be utilised is considered time-limited, goal onented therapy after a surgical event with the aim being to improve the person’s ability to walk either at all or to a higher level.

It is therefore expected that the health sector facilitate the therapy which is required to occur until such a time occurs that there is evidence that the use of the implant for walking will be successful into the foreseeable future and that the prosthetic componentry required for the definitive prosthesis can be determined against reasonable and necessary cniteria_

Componentry required to facilitate this therapy is generally considered the responsibility of health or the individual to facilitate; however, these exceptions exist for the following reasons:

6.23.1. |If a request is made to use NDIS funding for the adapter/connector which clicks

onto the implant to connect to the prosthetic componentry, despite the person still undergoing rehabilitation then NDIS planners can agree to release funds as this componentry will be utilised as a part of the definitive prosthesis. It is expected this adapter will be used into the maintenance phase for at least the length of the

twoyearwarrantyperiod.|  —s—“—ssSSSsSsSsSsi /

6.23.2. If componentry to enable the participant pursuit of their goals is not facilitated by health in terms of purchasing costs, then trials of varying componentry are

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• { Commented [DAS]: FY! - added this in. Commented [DA6]: Jackie — Kate suggested we add in something about us expecting that mechanical units be trailled.

Also briefly discussed the assessment criteria for an BAP> AOPA have Ol fact sheet that ets into this assessment criteria a bit.

https://www.. org. ments/item,

will leave up to you if you want to include any of this info

November 2019 — Drafted by Technical Advisory Team

6.24. 6.25.

6.26.

6.27. 6.28.

6.29.

6.30.

6.31.

6.32.

6.33. 6.34.

6.35.

expected to be conducted so that suitable clinical evidence can be submitted of the outcomes of using such componentry to enable R&N decision making by the NDIS in relation to the participant’s definitive prosthesis.

Benefits

If NDIS were to facilitate trials and fund the definitive prosthesis components during the rehabilitation phase - a whole of system saving would occur if the participant were provided with the prosthesis they require into the maintenance period during the rehabilitation phase, that is, the health sector would potentially not have to buy a prosthetic knee or foot that would then be replaced before the end of its useful life by the NDIS to meet participant need and the NDIS would benefit from therapy being provided by the health sector in relation to the required components for future use, saving on allied health capacity building hours within participant’s plans

Where health sector rehabilitation is provided, in the current market the required allied health practitioner skills would be easier for participants to access; the NDIS would not purchase prostheses that are not utilised into the future; this would maintain consistency with what occurs when people have their initial amputation; wound management can be integrated to other care being provided;

Risks to participant:

In some regions the prosthetic rehabilitation service providers funded by health are not NDIS registered and therefore are not aware of the stipulated interface between health and NDIS and do not work within the reasonable and necessary framework

In some regions the prosthetic rehabilitation service providers funded by health do not possess the skills and knowledge required to assist a participant who has undergone BAP surgery and/or requires certain technology in their prosthetic components for successful functional outcomes

Private health surgeons appear to be communicating with participants and prosthetists rather than health sector rehabilitation staff and therefore delays accessing health funded rehabilitation are likely if this is required

Where participants are not referred into a health funded rehabilitation program and aim to utilise componentry they already have and work with their prosthetist in the community, no funding for the labour costs associated with the prosthetists work and required trialling of prosthetic components will be available

In some situations bone anchored prostheses are beginning to be inserted at the time of initial amputation, there is a risk that the decision made here will be applied to all scenano’s where this surgery occurs (as opposed to only when it is follow-up surgery), depending on the solution agreed upon, this could increase costs for the NDIS and create an inequity between those who do and don’t have bone anchored prosthesis surgery at the time of amputation

Risks to NDIS:

Multiple examples exist to demonstrate that in order to facilitate trials and streamline processes prosthetists require increased education relating to the NDIS’s expectations in this area and a deeper understanding of reasonable and necessary legislation, otherwise tnals of components which are not R&N will be conducted and trials of the most cost effective options will not necessarily occur first. It needs to be communicated that NDIS tnals of prosthetic componentry are not isolated to these scenarios and are expected to be occurring for all individuals who require a prosthesis funded by the NDIS which is of higher cost than what they are currently utilising.

If scenario 2 or 3 does not require involvement from either public or private rehabilitation there is a risk NDIS pay for a prosthesis and it is not utilised in the long term.

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6.36.

6.37.

6.38.

6.39. 6.40.

6.41.

If tals of componentry were to be facilitated in these situations in order to inform definitive prosthesis componentry selection and for purchase to occur through the NDIS rather than health, it may follow that this process would be utilised for all people who require a prosthesis that are to transition to the NDIS.

Only fa limited number of major components when considering knee and foot units are available for trial from suppliers at this point in time and these are usually higher cost

options, therefore if a trial rather than purchase had to occur this limits the components available, this is a risk to optimal outcomes for the participant and a risk to the NDIS that

only high cost options become feasible for providers to choose from|_ ===

Trial costs will increase due to weekly rental arrangements of some componentry if fast ‘, decision making regarding buying components does not occur. \

lldealcaseexample|  —s—“—i‘“‘“‘“<—isti‘i‘itiststSS \

The participant is a 48 year old who has an above knee amputation and has been using a ‘

definitive prosthesis to date. However, due to limitations with their comfort and function A

using their current prosthesis, the participant is having Ol surgery next month. Following

the planned surgery the participant receives prosthetic rehabilitation within the health

system to:

6.40.1. Ensure that the surgery is successful and suitable healing around the implant occurs to ensure the definitive prosthesis will be usable and tolerated by the participant

6.40.2. Inform the type of prosthesis required to allow the participant to pursue their goals

The participant’s treating Prosthetist and rehabilitation team then provide the NDIS

planner with all the relevant information required……

Scenario 3 — Congenital or old amputation with no previous prosthesis use |

7.1. 7.2.

7.3. TA.

Standard Prosthetic Pathway

Limb stable = initial consultation and plan 3 first fitting of socket > interim trial of structural components > once fit, comfort and function established definitive prosthetic provided

Issue and participant experience

Participant has not wom a prosthesis ever, or for an extended period of time, and are now choosing to use a prosthesis (this only applies to a new standard socket prosthesis, No surgery is involved). The choice not to use a prosthesis before may be due to not successfully completing prosthetic rehabilitation previously, or personal preferences i.e. prosthesis was not required or was painful, new technology has now identified an appropriate option for them which was not previously available.

\As with bone anchored prosthesis cases, there is not a clearly stated and consistent pathway for these participants to access rehabilitation, interim and definitive prostheses,

particularly where trials of more costly componentry may be required to determine the ___ appropriate type of definitive componentry.

The key issue for this cohort is that they have likely not been linked in with any prosthetic service to date and have not received support through a prosthetic rehabilitation or tral phase relevant to their current situation. This means that NDIS planners are not able to make a decision in line with reasonable and necessary criteria as to the level of funding that is appropriate for a definitive prosthesis.

In addition, as per the above scenario there is no evidence that the participant will indeed tolerate and utilise a prosthesis into the maintenance phase or that it will be effective and

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Commented [0J7]: Usually prosthetists have ones on their shelf that they can try on people that they have bought previously and for whatever reason didn’t provide… can it be expected that people providing rehab have these options available for trial?

Commented [DA7R2]: | think we had to make a change |

here but | didn’t get it down???

Commented [0J9]: This will need to be adjusted in relation to what is decided regarding trial information above

-1!can do some research but at this point in time | am not

sure that there is a problem with the states and territories not accepting these people back for rehabilition — we have pushed back on this before and my understanding is people got an interim in the state scheme — problem will be in relation to when needs are not met by componentry in health system and facilitating trials etc.

November 2019 — Drafted by Technical Advisory Team

beneficial toward pursuing their goals. Whilst the participant will not have undergone surgery, the participant will likely require a socket replacement within the first 12 month plan period as when a residual limb is subject to the pressures of a prosthesis (or any new pressure) it will shink

7.8. Todate, the NDIS have stated that trials need to occur to ensure the participant will tolerate and utilise a prosthesis into the maintenance phase and to gain the evidence required to demonstrate that any prosthetic recommendations meet reasonable and necessary criteria. However, it has been stated in some cases that this needs to occur through the health system and in others that the participant has choice and control as to whether to access these trials in the health system or utilise Capacity Building funds from their plan to conduct these trials with allied health professionals they are already linked within the community.

79. Reasonable and Necessary Decision Making — Interpretation of s34.1.f (2 pathways being considered for this cohort)

7.10. Two funding pathways are presented for consideration:

status ~~] Commguted (DATO: eee dee epson 1er2i

7.11. |The facilitation of a prosthesis to improve function is considered the responsibility of the preferable,

NDIS as the provision of these services are not occurring post medical or surgical intervention nor related to the persons health status, the need is instead tnqgered by a change in the participant’s circumstances which now indicates that use of a prosthesis would potentially be effective and beneficial in enabling goal pursuit and functional participation.

7.12. Therefore, is it a NDIS responsibility to fund the necessary capacity building hours and componentry trials which will enable further determination as to whether a prosthesis will enable the functional improvements envisaged and subsequently the reasonable and necessary level of funding required for definitive componentry.

7.13. The participant should be afforded choice and control as to whether they receive these

services within a multidisciplinary program within a hospital as an outpatient or access

the allied health professionals they need in the community, === __ – 7 Commented [DA11]: Jackie — kate had said we need to (2) Health responsbility: add in something about the need for outcome measures for trials to participants can provide that their prosethtic is 7.14. The funding of a prosthesis is not the responsibility of the NDIS for the following reasons: working???

7.14.1. The need for a new prosthesis is considered a mainstream health support due to the time-limited, impermanent nature of the interim trial phase.

7.14.2. This trial phase is not appropriately funded by the NDIS as the participant’s support needs are not definitive and there is no evidence that a prosthesis will be tolerated and successfully utilised to improve function in social and economic participation.

7.14.3. In this scenanio, the participant is required to engage with allied health professionals through a multidisciplinary program within a hospital as an outpatient for the trial of interim socket and componentry solutions.

7.15. Benefits 7.16. Affords choice and control depending on which pathway is chosen… 7.17. Risks to participant:

7.18. Need to engage with the health sector in a way they haven’t for a long time, may not have access to the nght people and/or skills and may interrupt the service provision they are currently receiving from providers in the community with their NDIS funds

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7.19. 7.20.

7.21. 7.22.

7.23.

8.2. 8.3.

8.4.

8.5. 8.6.

8.7.

8.8. 8.9.

8.10.

8.11.

8.12.

Risks to NDIS: Participant’s avoid health sector rehabilitation following initial amputation and wait until they can receive funds to conduct this with their preferred community providers.

It has been four years since the NDIS participant has had an above knee amputation as a result of an accident. During this time, the participant has opted not to have a prosthetic leg because they have had unresolved nerve pain from surgery making the use of a prosthesis painful. The participant now requires a prosthesis, which the NDIS will fund. However, the participant also requires some rehabilitation and training to learn to use the prosthesis and have it fitted correctly.

Secondary considerations to three scenarios

There are other risks associated with ongoing prosthetic costs that may need to be considered as an addendum to these three scenarios:

Consumables for bone-anchored prosthetics

What party is responsible for ongoing consumables costs associated with Ol prosthetics and at what phase of care? For example, consumable (bushing, lock screws, tape sleeve) at the time of the implant, and any element that requires surgical or medical intervention to replace/repair are likely to be more appropriately funded by health.

While, the NDIS would fund all ongoing replacement parts, components or consumables for the Ol prosthetic because the participant would not be able to utilise the assistive technology without the consumables to go with it.

Other prosthetic consumables

Participants will likely require other prosthetic related consumables such as limb socks/sheaths, skin products, silicone liners and foot shells to ensure high quality skin condition and the prevention of skin issues. These are not everyday living costs and are required directly because of the prosthesis.

As such, the NDIS is the most appropnate provider of ancillary costs related to consumables for definitive prosthetic limbs. The amounts, type and style will need to meet all reasonable and necessary criteria in section 34 of the NDIS Act.

Replacement sockets for children who are still growing

Some NDIS participants who are children will likely require more than 12 montly replacement of sockets to allow for growth and to ensure that the socket fits properly.

The risk is this position in relation to one socket per plan period post surgery being

communicated without clear guidance as to when more than one socket is appropriate,

means children may be without necessary NDIS funds to maintain their prosthetic

function simply due to growth which is not considered relevant to the

rehabilitation/maintenance phases of prosthetic care.

The NDIS is the most appropriate provider of this support when related to a definitive

prosthetic limb and it is considered reasonable given the age of the child and considering

that their prosthetic needs may change as they grow.

The ideal scanerio for this cohort is that:

8.12.1.Delegates put in participant plans funding for one limb and a replacement socket plus CB hours in a 12 month plan. The following year the Prosthetist would need

to ask for what the participant support needs are as some participants will need a new limb, while others may not.

Prosthetic supports for NDIS participants who have had a previous amputation and have a change in prosthetic support needs xx.11

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=~ | Commented [DA12]: Case example will be finished once

we decide on option 1 caapcity building or option 2 health system responsiblity

November 2019 — Drafted by Technical Advisory Team

8.12.2. Generally, at a minimum two socket replacements in a year would be reasonable where there is no new limb. However, this is difficult to substantiate as support

needs are very individual and why prosthetics are by quote.| = - ~~ Commented [DA13]: Jackie - your previous comment

was an ideal scenario for this chort. | treid to addd in to the

doc. Can you please review and delte if not approrpaite to

9. Impact include.
10. The positions outlined in the attachment will improve: 9.1.1. Consistency of funding decisions being made about prosthetic supports when participants have a change in support needs. 9.1.2. The participants’ experience with the NDIS, so that the participant receives the

supports they require, in a timely manner, from appropriate service system. 9.1.3. Certainty for planner and partners in maki jate decisions and providing clear advice.

92. Clarifying these funding and service deliveg ane ics will potentially reduce NDIS costs associated with defing eti i may actually obtain the correct components and de

93. Recommendations 10.1. Agree to the reasonable ané ssa ide and implied funding as outlined i ios TORNDSppartici »have had a previous amputation

10.2.

11. ibili PPS Ne — -~ | Commented [DA14]: Guessing from what Jackie and |

have discussed what the process would be.

11.1. . : anagem “Scheme Policy Branch (SPB) for internal

11.2 , ( tea ati ialSe to decide whether this agreed funding i i i al Guidance, or if it needs to be shared extemally.

113. If thelpesiti 1s guidance only: am will liaise with Access and Planning Strategy Branch and to develop new comprehensive practice guidance on

11.6. It may need to go to:

11.6.1. The NDIA Policy Committee (NPC)

11.6.2. The Senior Official’s Working Group (SOWG) Health Sub-group for state and 11.7. Engagement with NDIA Comms Team to develop a communication pan so that all relevant stakeholders are informed. 11.8. TAT, SPB and ATHM team will liaise with Access and Planning Strategy Branch and on prosthetics.

Prosthetic supports for NDIS participants who have had a previous amputation and have a change in prosthetic support needs xx.12

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Attachments

Attachment A: _ Definition of interim versus definitive prosthesis Attachment B: Images of socket prosthesis and bone anchored prostheses Attachment C: Relevant guidance and legislation (for reference)

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November 2019 — Drafted by Technical Advisory Team

Attachment A – ~ Commented [DA15]: Add in definiiton }

Definition of Interim versus Definitive Prosthetics === —s—s—‘—s—sSS | Commented [DA16]: | have edited Ash's old document

In 2017 the AOPA (peak body) prepared a paper for the NDIA and provided a suggested slightly to make it fit within this doc’s purpose. definition (paraphrased below):

e The NDIA do not stipulate a time frame in relation to a participant moving from utilising an interim prosthesis to a definitive prosthesis, as this will vary with each individual and will be dependent on vanous medical, health and rehabilitation factors.

e A participant is considered suitable for a definitive prosthesis supported by the NDIA when:

o The amputated residual limb volume has stabilised to a point where a new prosthetic socket is unlikely to be required within the following six months

o When the participant, prosthetist and rehabilitation team feel that the participant’s full potential has been reached in the rehabilitation setting

In their paper, the AOPA also state some other points for consideration:

e Currently, the transition from interim to definitive prosthetic treatment occurs differently in each state and territory due to variances in:

o Definition o Funding mechanisms e These differences will likely mean that a national definition will have differing unintended consequences for participants in different locations.

Definition Recommendation

The NDIA is in agreeance with the AOPA that putting a stated time frame on the transition from interim to definitive (eg. 30 days, 6 months, etc) would have risks and issues that may have unintended negative consequences for both participants and the scheme.

A more appropriate definition is suggested below:

A participant is considered suitable for a definitive prosthesis (NDIS-funded) when the participant, prosthetist and rehabilitation team are confident that the participant’s full functional potential has been reached, and they are unlikely to require socket replacement across the first 12 months of their plan.

Some further guidance may need to accompany this definition: e Functional potential has been reached:

o Participant, Prosthetist and Rehab team confident that function has stabilised, functional classification/potential (K-level) has been established, and there will be no further changes in future

e Unlikely to require socket replacement across the first 12 months of their plan: o Swelling and oedema has stabilised to a point where socket fit remains stable

o Participant, Prosthetist and Rehab team confident that a socket replacement (due to swelling/oedema) will not be required by the participant for the first 12 months of their plan

e Plan build: o May require a ‘stepped approach’ to fund items in a plan

= Fund reusable components (knee, foot, pylon) once functional potential has been reached — as a stated support

Prosthetic supports for NDIS participants who have had a previous amputation and have a change in prosthetic support needs x.x.14

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November 2019 — Drafted by Technical Advisory Team = Fund socket, adaptors, cosmetic cover once swelling/oedema has stabilised — as a stated support. e Liaison with health sector: o Each state has different guidance for an amputee’s transition to definitive, which may lead to a funding gap if a state-based health funding is ended by a set date

(as opposed to reaching functional potential as NDIS requires). Scheme transition will be required to liaise with the Health sector to discuss this.

co The timing of access to the scheme is essential to the successful implementation of this guidance

Prosthetic supports for NDIS participants who have had a previous amputation and have a change in prosthetic support needs xx.15

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Attachment B___ - { Commented [DA17]: Jackie to add In pictures

Image 1:XXXXX?

Image 2: XXX?

? Add in image location reference

3

Prosthetic supports for NDIS participants who have had a previous amputation and have a change in prosthetic support needs xx.16

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Attachment C

Disabilty Related Health Supports Policy

The DRHS policy provides that disability-related health supports will be most appropriately funded by the NDIS where the supports are:

o directly related to the participant’s ongoing functional impairment; and o required on an ongoing (regular) basis.

The health system will continue to be responsible for the diagnosis and clinical treatment of health conditions (acute/post-acute care), chronic health conditions not related to a participant’s disability, palliative care, other activities that aim to improve the health status of Australians or funding time-limited, goal-oriented services and therapies, including rehabilitation and post-acute care.

The NDIS Act 2013 Section 34(f)

In accordance with section 34(1)(f) of the NDIS Act, the NDIA needs to determine whether a disability-related health support for a participant is most appropnately funded or provided by the NDIS.

The NDIS Rules 2013 Schedule 1: Considerations relating to whether supports are most appropriately funded through the NDIS indicates the following:

o 7.5 The NDIS will not be responsible for

o (c) funding time-limited, goal-oriented services and therapies:

o. (il) provided after a recent medical or surgical event, with the aim of improving the person’s functional status, including rehabilitation or post-acute care

Council of Australian Governments — Applied Principles and Table of Supports

o NDIS: Prosthetics, orthoses and specialist hearing and vision supports (excluding surgical services) where these supports directly relate to a person’s permanent impairment

o Other systems [health]: Rehabilitative health services where the purpose is to restore or increase functioning through time limited, recovery oriented episodes of care, evidence based supports and interim prosthetics, following either medical treatment or the acquisition of a disability (excluding early interventions). When a participant is receiving time limited rehabilitation services through the health system, the NDIS will continue to fund any ongoing ‘maintenance’ allied health or other therapies the person requires and that are unrelated to the health system’s program of

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Attachment D

November 2019 — Drafted by Technical Advisory Team

8. Prosthetic limbs Prosthetic (artificial) limbs are devices that provide a portion of functions normally provided by natural arms and legs. They are often used when there is absence of part or all of a limb, for example due to an accident or birth defect, and help to improve function and quality of life. Prosthetic limbs consist of a custom made socket which fits the residual limb and a terminal

device made up of different components that assist in performing functional tasks and providing compatible cosmesis.

Prosthetic limbs vary considerably in their sophistication by virtue of their complexity, cost, and specialisation and due to the varying levels of function they provide. For example, a prosthetic limb may be a simple device that is functionally efficient, or an enhanced limb that is configured to have an appearance and functional performance that is similar to that of a natural limb.

The NDIA must be satisfied, amongst other matters, that the funding of a prosthetic limb represents value for money in that the costs of the support are reasonable relative to both the benefits achieved and costs of altemative support (section 34(1)(c)).

In considering whether a proposed prosthetic limb represents value for money, the NDIA will consider whether.

e _ the total labour and associated costs, including the number of hours and hourly rate of the Prosthetist, represents value for money in the participant’s local market; and

e the cost of componentry proposed represents value for money when compared to the cost of similar prosthetic components that would meet the participant’s functional needs and goals.

The NDIA will generally fund definitive limbs only where they are specified (prescribed) by health professionals who are designated and accredited lied (where applicable) by the artificial limb service in the state or territory where the participant resides

For upper and lower limbs, the specifications should propose the minimum level or grade of socket materials, componentry and coverings required that relate to:

e the participant’s weight; e the participant’s goals and aspirations; e the ability to use, put on and remove the limb; e the ability to care for the limb; and e the medical needs, that is, residual limb shape, fixed deformity to be accommodated, skin integrity and alignment-elevant co-morbidities. In addition the necessity for a particular level of componentry should relate to factors that include:

e _ the participant’s expected or known functional level (based on standard measures such as the K classification);

e functional needs related to the environment of use, for example typical floor surfaces and gradients, the use of stairs, the amount of time walking, typical terrain if used outside, expected impacts; and

e the impact of actual or expected vocational demands on limb type.

Generally, the NDIA will fund:

e entry level or standard grade prostheses for participants up to K2 classification and will consider higher prosthesis for people up to K3 and K4 classification;

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• repairs, maintenance, minor and major adjustments to prosthetic limbs (or prosthetic limbs funded by other systems prior to the participant joining the NDIS);

. ancillary costs related to prosthetic limbs such as residual limb socks and sheaths (typically 6 per year);

* limbs extemal to|Osseo integratedimplants; and = ssi —

Commented [DA18]: If we are going with ‘bone anchored’ the current OG will need to be updated.

e upper limb myoelectric prostheses where the participant is either a biateral amputee or has contralateral overuse syndrome which prevents the use of body powered prosthetics and where there is demonstrated commitment and success using a training device.

Generally, the NDIA will not fund: « repairs due to damage resulting from use of a limb outside of recommended use and care guidelines; e more than one prosthetic limb (i.e. a spare prosthetic limb), unless reasonable and

necessary to do so having regard to any vocational demands or other relevant considerations (for a second limb for recreational use, recreational supports; and e ForK4 level, C-legs and computerised components unless reasonable and necessary to

do so having regard to the functional benefits expected to be achieved and whether such benefits can be achieved in other ways.

Limbs will be replaced at typical replacement intervals unless more frequent replacement is

warranted. Typical replacement penods are 3 years for most adults and, as needed, due to

growth for children under 18 years of age (typically no more than bi-annually).

The NDIA may consider whether more frequent replacement is warranted on the basis of the

participant’s needs.

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Position Paper: Ocular Prosthesis as a Disability Related Health

Support

The contents of this document are OFFICIAL

Purpose of paper:

This position paper has been developed to clarify National Disability Insurance Agency (NDIA) delegate decision making regarding the provision of an ocular prosthesis as a disability related health support (DRHS). Specifically:

a) Is it appropriate for the National Disability Insurance Scheme (NDIS) to fund an ocular prosthesis under the DRHS policy?

b) Is this assistive technology likely to meet the reasonable and necessary support criteria, as outlined in the ND/IS Act 2013 and NDIS (Supports for Participants) 2013?

This position applies to all components utilised (conformer, prosthetic eye, orbital implant) in the rehabilitation of the orbit following evisceration, enucleation or exenteration, and cases of non-painful blind eye due to phthisis bulbi or microphthalmia which would benefit from a scleral shell.

Description of support or intervention and potential benefit

Every part of the human body holds significance and function; however, the face is particularly unique. It is principally how individuals are recognised and what is recalled when the person is absent. The face communicates perceptions, intensity of emotion, awareness, and ideas. Eyes in particular convey understanding and insight, and have an important role in non-verbal communication and self-expression.

The loss or absence of an eye may be caused due to a congenital defect, irreparable trauma, tumour, painful blind eye, sympathetic ophthalmia or the need for histological confirmation of a suspected diagnosis [1].

After the loss of an eye, if a prosthetic eye is not soon fitted then the eye socket will begin to close in on itself and the eyelid will droop and not function properly [2]. Ocular prostheses meet an aesthetic or cosmetic need but are also functional in that their presence prevents possible complications like ulcers, infections, tissue retraction, severe orbital defects, and also the fallen eyebrows, eyelids and forehead that can occur in cavities without eyeballs [3-5]. They also restore lacrimal dynamics and help the tear-glands partially recover their natural position [4, 6, 7].

In addition to the anatomical benefits, the provision of an ocular prosthesis has been shown to significantly reduce; e Anxiety and depression

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e Preoccupation with hiding the effected eye e Fear and insecurity e Feelings of shame and shyness

And improve; e Psychosocial awareness e Personal relationships

e Comfort/pain levels

Targeted cohorts

In the context of the NDIS, this support may be of assistance to any participant who has undergone a surgical procedure such as: e Evisceration - where the contents of the globe are removed leaving the sclera intact e Enucleation - most common, where the entire eyeball is removed after severing the muscles and the optic nerve e Exenteration - where the entire contents of the orbit including the eyelids and the surrounding tissues are removed

Or, in cases where the use of a scleral shell is an appropriate option, such as a non painful blind eye due to phthisis bulbi or microphthalmia with no useful vision.

Associated risks

Based on current quotes, the cost of an ocular prosthesis can range between $1,900 and $2,150. It could be argued that the cost of this support may have an impact on scheme sustainability. However, the number of participants requiring an ocular prosthesis is extremely low. The most recent national eye health survey estimated that 0.21% of the population are bilaterally blind and 1.9% are unilaterally blind [8]. Whilst not reported, only a small percentage of blind eyes will end up requiring enucleation, evisceration or exenteration.

In addition, the lifespan of an ocular prosthesis is considerable. There is general consensus that the life-time of a prosthetic eye is between two and six years, however, this is dependent on the patient’s age, occupation, care of the prosthesis and the materials used to make the prosthesis [4, 9, 10].

There are no risks associated with providing the support. Conversely, there is a risk of developing post-enucleation socket syndrome if the support is not provided. The symptoms of this include:

e Enophthalmos (posterior displacement of orbital contents)

e Deep upper eyelid sulcus

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e Ptosis (droopy upper lid) e Laxity of the lower lid

Overview of literature

A full review and evaluation of available research can be found in Appendix A.

Application under NDIS law, guidance and policy

An NDIS funded support must meet all the reasonable and necessary (R&N) criteria set out in section 34 of the National Disability Insurance Scheme Act 2013 (NDIS Act) and NDIS (Supports for Participants) Rules 2013 (Supports for Participants Rules).

When considering the primary purpose or benefit of a prosthetic eye (to support ocular function and facilitate social and economic participation), the support meets all necessary criteria for a Disability Related Health Support.

Recommendations

Participants of all ages requiring a prosthetic eye following evisceration, enucleation or exenteration should be provided with the support under the NIDS.

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Appendix A — Literature Review

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James, To determine the Observational - Cross sectional 62% were female and 81% were white Low/Moderate

Jenkinson [11] | psychosocial and survey Exploratory, cross-

appearance-related 98 participants attending For 79% of participants, the eyes were their main sectional, and with a concerns of a sample of ophthalmic outpatient clinics in area of concern in regards to their appearance. modest sample size. ophthalmic patients by either London, Bristol, Sheffield or measuring a range of Bradford. The DAS24, anxiety, and depression mean scores psychological, social, and were within the normal range. However, standard demographic factors. Outcome measure deviations and ranges indicate that the variation in e Hospital Anxiety and scores between participants was considerable with

Depression Scale (HADS) | some patients experiencing considerable levels of

e Appearance-related social | generalized anxiety.

anxiety and social avoidance, as measured Significant negative correlation was found between by the Derriford age and the DAS24 (P<0.01) and salience (p 0.03), Appearance Scale with older participants experiencing less distress and (DAS24) dysfunction, as a result of their appearance and e Physical Appearance considered appearance to be less important.

Discrepancy

Questionnaire (PADQ) Female participants were found to experience e Valence of Appearance greater levels of general anxiety, reported higher scale (CARVAL) levels of distress and dysfunction in relation to their e — Salience of Appearance appearance, placed more value on their appearance, scale (CARSAL) compared their appearance more often with others Sm lowa-Netierlands and evaluated their appearance more negatively.

Comparison Orientation

measures (INCOM)

McBain, Ezra | To explore the Observational - Cross sectional Completed questionnaires were received by 39 Low/Moderate

{12] psychological impact of survey patients (18 female, 46%) living with an artificial eye

or cosmetic shell and determine the relationship between psychological well-being and clinical and psychosocial factors.

Participants recruited from ocular prosthesis clinic of Moorfields Eye Hospital, UK.

Outcome measure

e Hospital Anxiety and

Depression Scale (HADS)

e Appearance-related social anxiety and social avoidance, as measured by the Derriford

Appearance Scale

(DAS24)

37 (95%) indicated that the appearance of their eyes caused them some concern.

18% (n = 7) of the patients were experiencing clinical depression and 18% (n = 7) clinical anxiety 21% (n = 8) of patients reported considerable levels of social anxiety and avoidance in relation to their appearance.

Exploratory, cross sectional, and with a modest sample size.

Over 40% of the sample failed to return a completed questionnaire, potentially biasing the results of the study.

Cross-sectional nature of this investigation precludes an examination of how individuals change over time and adjust to their prosthesis

Clarke,

Rumsey [13]

To establish the extent and type of psychosocial distress in this patient population (ocular disfigurement), and to explore the extent to which patients’ needs are currently met.

Observational - Cross sectional survey

Consecutive outpatient attenders from three different outpatient eye clinics

Outcome measure

e Hospital Anxiety &

Depression Scale (HADS)

e Derriford Appearance

Scale-Short Form

measuring appearance related concerns and social avoidance;

e World Health

Organisation Quality of

153 participants across 3 clinics (results presented per clinic, not cumulative)

10-45% ‘case’ levels of anxiety 3-18% exhibited ‘case’ levels of depression 16-45% experienced considerable levels of appearance-related distress and social avoidance

e 21-72% of participants scored below normative levels for QoL

Low/Moderate

Exploratory, cross-sectional study. Large variation between clinics and unclear as to why this was.

Life Scale-Short Form

(WHOQoL Bref).

Song, Oh [14] | To evaluate patient Observational - Cross sectional 56 males (71.8%) Low

satisfaction with ocular survey

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prosthesis after evisceration or enucleation and to determine which variables were correlated to their satisfaction in order to find out how to increase patient satisfaction?

78 consecutive patients from Korea University Hospital. Satisfaction survey developed by authors

The overall rate of satisfaction with ocular prosthesis was 71.8%. The variables significantly correlated to patient satisfaction were economic status (p <0.01),

other people’s response (p <0.01), and insertion of motility coupling post or motility peg (p 0.03).

Exploratory, cross-sectional study. No mention of how survey was developed or whether it went through an internal validation process.

Wang, Zhang

[15]

To investigate the psychosocial benefits of hydroxyapatite orbital implant insertion and prosthesis wearing in this patient population

Observational - Cross sectional survey

e Hospital Anxiety and

Depression Scale (HADS)

e Derriford Appearance

Scale-Short Form (DAS24)

e World Health

Organization Quality of

Life Scale-Short Form

36 patients (36 eyes), 28 men and 8 women Post-treatment scores for anxiety and depression are lower than pre-treatment scores (p < 0.05). Indicating that the negative emotions (anxiety and depression) due to anophthalmia improved significantly after orbital implant insertion and prosthesis wearing.

Anxiety about one’s appearance was lower post treatment than pre-treatment scores (p < 0.05)

All QoL domains improved post-treatment

Low/Moderate

Small sample size but used validated tools. Further research is needed to validate these results.

Pine, de Terte

[16]

To investigate the concerns of prosthetic eye wearers to determine which concern (appearance, discharge experience, or visual perception) is more important than the others and to report on the reasons given for these concerns.

Observational - Cross sectional survey

Participants were over 16 years old and had worn an ocular prosthesis for more than 2 years.

29 questions and five psychological

scales across four main categories (demographics, concerns, feelings and problems, psychological scales)

The questionnaire was completed by 217 participants (40% response rate).

No significant differences in levels of concern for discharge, visual perception, and appearance during the initial period following eye loss or after at least 2 years.

The older participants were when they lost their eye, the lower was their current concern about appearance (p = 0.007), and the greater was their initial concern about visual perception (p = 0.003).

Females were more concerned about current discharge and appearance compared to males.

Low

Exploratory, cross-sectional study. No mention of how survey was developed or whether it went through an internal validation process.

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Some participants were “fine with their appearance” (17%) because they were either happy that the prosthesis matched their companion eye (“An excellent match, so not a lot of people realised it was prosthetic”) or believed their prosthetic eye improved their appearance (“Appearance has never been an issue in fact a great change from my previously damaged eye”).

Goiato, dos To assess the improvement | Observational - Cross sectional 40 respondents Low

Santos [17] in psychosocial awareness | survey Exploratory, cross-sectional

of anophthalmic patients Inclusion criteria: Minimum of 2 Feelings of shame, shyness, preoccupation with study with small sample.

wearing ocular prostheses _| years wearing ocular prosthesis hiding it, sadness, insecurity and fear were Survey not validated

and its relationship with (uni or bilaterally); eye loss significant for improvement in psychosocial demographic resultant from pathology or awareness (i.e. after prosthesis wear) characteristics, factors of trauma; and patients aged 10-90 loss/treatment, social years. 16 female patients, 12 (75%) presented activity, and relationship Questionnaire used in this study improvement in psychosocial awareness in between professional and has not been validated comparison to 8 (33.3%) of the 24 male patients. An patient association between gender and improvement in

The improvement in psychosocial | psychosocial awareness was observed (P = 0.01).

awareness was assessed by

comparing the perception of some | Positive influence of the prostheses on personal

feelings reported in the period of | relationships, 12 (30.0%) patients reported a

eye loss and currently. negative answer and 28 (70.0%) a positive one (P = 0.006). All the patients declared that they were depressed after the loss of their eye. Patients reported that the depression was overcome by wearing ocular prostheses Anophthalmic patients wearing an ocular prosthesis has significant improvement in psychosocial awareness after rehabilitation.

Ahn, Lee [18] | To evaluate the health- Observational - Cross sectional 134 anophthalmic patients and 48 healthy Low/Moderate

related quality of life and

survey

volunteers (age and gender matched)

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emotional status of anophthalmic patients.

Short-Form 36-Item Health Survey

(SF-36) was used to assess the e quality of life

Hospital Anxiety and Depression

Scale (HADS) was

used to evaluate the degree of anxiety and depression

Anophthalmic patients scored lower in all categories (body pain, general health perception, mental health, physical functioning, role function-emotional, function physical, vitality, social functioning) of SF-36 compared with controls.

Married females and participants with children had lower QoL, particularly in regards to physical quality

There were significant negative correlations between all SF-36 scores and participant self-evaluations on whether they had negative feelings regarding their social interpersonal relationships as a result of wearing prostheses.

Those who scored higher on the HADS anxiety and depression scales tended to evade social interrelations significantly.

Exploratory, cross-sectional study with moderate sample size. Used validated tools, however, further research is needed to validate these results.

Pine, de Terte

[19]

To explore the feelings of prosthetic eye wearers.

Observational - Cross sectional survey

Participants had worn an ocular prosthesis for at least 2 years and were aged 16 years or above. Questionnaire included 29 questions and 5 psychological scales across 4 main categories (demographics, concerns, feelings and problems, psychological

scales). e Depression Anxiety and Stress Scale (DASS 21) e Social Appearance and Anxiety Scale (SAAS) °

217 anophthalmic respondents (40% response rate)

Participants initially experienced strong negative feelings, which decreased over time while positive feelings increased. Participants who lost their eye due to an accident, as opposed to a medical condition, were younger and initially had stronger negative feelings.

Younger participants (especially adolescents) initially had stronger negative feelings, but at least two years later, eye loss at any age produced similar (much reduced) negative feelings.

Greater appearance, visual perception and discharge concerns led to stronger negative feelings.

Low/Moderate

Exploratory, cross-sectional study with good sample size. Unclear how questionnaire was developed.

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e Social Support

Questionnaire (SSQ)

e General Self-Efficacy Scale

(GSE)

e Likert scales assessing feelings of acceptance. Questionnaire used in this study has not been validated

e = Allresults reported above had a p-value of <0.05.

e No differences between genders

Pine and Pine

[20]

Explores the role of appearance, mucoid discharge, visual perception and functional problems as indicators for depression, anxiety and stress amongst prosthetic eye wearers

Observational - Cross sectional survey

Participants had worn an ocular prosthesis for at least 2 years and were aged 16 years or above. Questionnaire included 29 questions and 5 psychological scales across 4 main categories (demographics, concerns, feelings and problems, psychological

scales).

e Depression Anxiety and Stress Scale (DASS 21)

e = Social Appearance and

Anxiety Scale (SAAS)

e Social Support

Questionnaire (SSQ)

e General Self-Efficacy Scale

(GSE)

e Likert scales assessing feelings of acceptance. Questionnaire used in this study has not been validated

217 anophthalmic respondents (40% response rate) Mean scores for depression, anxiety, and stress fell within the accepted normal ranges

e 11% of participants experienced moderate depression, 7% severe or extremely severe

e 10% moderately anxious and 7% severe or extremely severely anxious

e 5% moderately stressed, 7% severely or extremely severely stressed

Depression was significantly positively correlated with appearance anxiety (p =.012) and negatively correlated with feeling accepted by social group (p <.001), number of social supports (p =.043), satisfaction with that support (p =.003), current age (p =.004), and years since eye loss (p =.034).

Anxiety had a significantly positive relationship with discharge concern (p =.011), visual perception concern (p =.004) and appearance anxiety (p =.001), and was significantly negatively correlated with feeling accepted by society (p =.041), and current age (p =.009).

Stress was positively correlated with appearance concern (p =.006) and appearance anxiety (p =.006),

and negatively correlated with current age (p <.001).

Low/Moderate

Exploratory, cross-sectional study with good sample size. Unclear how questionnaire was developed.

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Pine, De Terte

[21]

To explore the impact of eye loss and prosthetic eye wear on recreational, occupational and social areas of functioning

Observational - Cross sectional survey

Participants had worn an ocular prosthesis for at least 2 years and were aged 16 years or above.

217 anophthalmic respondents (40% response rate) Participants with recreational difficulties reported significantly stronger negative feelings (M = .70, SD =

92. than those without difficulties (M = .41, SD = .79, p< 0.001). Those with recreational problems

Low/Moderate

Exploratory, cross-sectional study with good sample size. Unclear how questionnaire was

Questionnaire included 29 were also significantly more concerned about their developed. questions and 5 psychological appearance and visual perception. scales across 4 main categories Prosthetic eye wearers who reported experiencing

(demographics, concerns, feelings | social problems had significantly stronger negative

and problems, psychological feelings (M = .91, SD = 1.01) than those without (M = scales). .32, SD = .67, p< 0.001). Those with social difficulties e Depression Anxiety and also had significantly higher discharge, appearance Stress Scale (DASS 21) and visual perception concerns than those without ¢ Social Appearance and Prosthetic eye wearers who have experienced Anxiety Scale (SAAS) employment problems reported having significantly ¢ Social Support stronger negative emotions (M = .83, SD = .97) than Questionnaire (SSQ) those with no employment problems (M = .39, SD =

© General Self-Efficacy Scale | -74, p< 0.001). They were also significantly more

(GSE) concerned about appearance and visual perception e Likert scales assessing than those without employment problems. feelings of acceptance. Questionnaire used in this study has not been validated

Korani, Pine The aims are to: (a) identify | Observational - Cross sectional 90 participants Low/Moderate

[22]

the concerns of experienced prosthetic eye wearers in representative areas of India; (b) investigate how they change over time; (c) study how some demographic characteristics influence concerns; and (d) compare prosthetic eye concerns in India versus Germany and New Zealand.

survey

Multi centre: Mumbai, Bengaluru

and Delhi.

Aged from 18 to 65 years, with experience of at least two years of wearing a prosthetic eye.

The questionnaire had four sections. e Section A captured demographic information

At the time of eye loss, the five main concerns of participants were: e health of the remaining eye change in appearance comfort colour of the prosthesis movement of the prosthesis

However, after at least two years these concerns were significantly reduced (p < 0.05).

Exploratory, cross-sectional study with good sample size. Unclear how questionnaire was developed.

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e Section B captured levels of concern using a numerical interval rating scale.

e Section C captured the level of each concern about prosthetic eye wear using the same numerical interval rating scale.

e Section D captured the experience of participants with respect to watering, crusting and discharge, associated with wear of their prosthetic eye.

The main present-day concern was watering, crusting and discharge, which was experienced by 81.1% of the participants, 55.5% of them on a daily basis.

Compared with other demographic groups, blue collar workers had higher odds of being concerned about the health of the remaining eye and least odds about prosthesis motility.

Homemakers had higher odds of being concerned about wearing comfort and students had higher odds of being concerned about wearing comfort, appearance and health of the remaining eye.

Avisar, Norris

[23]

To evaluate the use and safety of temporary, cosmetic, painted prostheses as an alternative to clear conformers immediately post removal of eye or socket surgery in children and adults.

Observational study — Cross sectional survey and retrospective audit

Inclusion criteria

(i) an enucleation or an evisceration with or without primary or secondary orbital implant, (ii) an orbital implant exchange or (iii) a socket reconstruction and in addition, received a stock, painted, temporary prosthesis

Qutcome measures

(i) Prosthesis related complications as reported from a clinical notes review, (ii) cost of manufacture and finally (iii) patient reported

54 participants (22 females, 32 males, mean age 18.6 years, range 6 days—82 years)

All adult patients were comfortable with the printed prostheses, nine patients were comfortable ‘most of the time’ and seven patients were comfortable ‘all the time’.

Overall, 46 (88%) returned to normal activities within 2 weeks.

11 adults (68.7%) and all children (100%) did not wear any patch/dark glasses after surgery. Two adults (12.5%) used dark glasses and three adults (18.7%) used a patch until a permanent prosthesis was available because of unsatisfactory appearance. 26 patients (50%) felt that the permanent prostheses had better movement and comfort compared with the temporary stock prosthesis. The remaining patients felt that same degree of comfort and movement was present in both prostheses. All

Low/Moderate

Exploratory, cross-sectional study with modest sample size. Unclear how questionnaire was developed. Patient files were reviewed which is likely to lead to less recall bias.

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acceptance of the cosmetic prostheses using a questionnaire.

patients felt colour match was better with their permanent prosthesis.

Overall, 90% of respondents expressed a definite preference towards the painted shell over a clear shell

Heindl, To investigate anxiety and Observational - Cross sectional 295 participants Moderate Trester [24] depression levels in survey Mean age of 62.54 + 16.77 years (range, 18-95 Exploratory, cross-sectional

prosthetic eye—wearing Inclusion criteria were age over 18, | years). study with big sample size.

patients using standardized | wearing cryolite glass prosthetic 198 of 295 (67.1%) had no symptoms, while 31 Used validated tools.

psychometric instruments, | eyes patients (10.5%) had only depression symptoms, 26

to define factors associated patients (8.8%) had only anxiety symptoms, and 40 with these psychological Standardized three-section patients (13.6%) had both depression and anxiety diseases, and to identify a questionnaire symptoms. potential healthcare gap. Section 1 - requested general There seems to be a significant underdiagnosing for demographic data both depression and anxiety disorders (p < 0.001, Section 2 - patients were asked respectively). about their history and treatment of already diagnosed active Higher anxiety scores were significantly associated depression and anxiety-related with higher patient health questionnaire scores, disorders. lower appearance related social function, lower Section 3 - six standardized and mental health functioning, and female gender (p <

established questionnaires for the | 0.021, respectively).

psychometric evaluation of

depression, anxiety, health-related | Higher patient health questionnaire scores were

quality of life, vision-related significantly associated with lower physical and

quality of life, appearance-related | mental health functioning, higher educational

psychological distress, and degree, and non-traumatic eye loss (p <0.038, appearance-related social respectively). interactions.

Knowles [25] | To collect data on the Thesis 71 respondents Low

psychological and social Observational - Cross sectional Non-peer reviewed. impact of eye loss survey At time of eye loss Reasonable sample size.

Exclusions criteria were:

1. Patients under the age of 18 at the time of study.

50.7% experienced extreme feelings of anger whilst 18.3% were ambivalent, possibly due to their young age at the time of loss

Only descriptive statistics used.

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2. Patients who declined to give consent to be involved in the study.

3. Indigenous Australian patients.

4. Patients with serious socket complications.

Questionnaire developed and trialled using patients suffering eye loss

Visual analogue scale of 0-10 and/or on short structured interviews, different methods used based on varying circumstances.

54.9% experienced extreme sorrow

38% report experiencing extreme denial, 40.8% reported feeling a very high level of acceptance

44.3% reported feeling extreme frustration, whilst only 21.4% experienced a high level of relief

Participants emotion when received first prosthesis 52.1% reported feelings of extreme happiness. 21.1% reported emotions of extreme sadness.

29.6% reported extreme feelings of sorrow, whilst 52.1% reported extreme emotions of relief.

42.3% reported feeling ‘healed’. 30.1% reported feeling somewhere in between dysfunctional and ‘healed’, but the majority of this middle group trended slightly towards the ‘healed’ side of the visual analogue scale of emotion.

Current prosthesis

40.8% felt they look extremely attractive with their prosthesis. 38% felt an improvement in their appearance whilst wearing their prosthesis.

36.8% feeling that others described them as looking ‘normal’. 42.6% say others describe them as looking excellent.

77.5% reported feeling extremely unattractive without their prosthesis in.

71.8% reported feeling extremely uncomfortable without their prosthesis in.

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57.7% of participants reported feeling extremely insecure whilst not wearing their prosthesis

80.3% stated that they did not believe their prosthesis was purely of cosmetic/aesthetic value to them.

When asked whether their prosthesis contributed to their appearance, 77.5% responded that they believed it made them look much better.

76.1% of respondents stated that their prostheses contributed greatly to their self-esteem.

67.6% responded that their prosthesis contributed to their psychological health in a major way

60.6% stated that their prosthesis made them feel much better about social acceptance

Shapira,

Worrell [26]

To compare the unique experiences related to artificial eye (AE) versus cosmetic shell (CS) wear.

Observational - Cross sectional survey

National survey delivered across AO sites.

Patients who were 18 years of age or older.

37 items questionnaire was constructed by a panel consisting of experienced maxillofacial prosthetists and oculoplastic specialists

1198 respondents 951 (79.4%) respondents wore an ‘artificial eye’, while 238 (19.9%) wore a ‘cosmetic shell’.

Comfort

Relatively high in both AE and CS respondents, with an average score of 80.4+0.73 vs 81.41+1.45 (p=0.51, respectively).

Appearance

Appearance of the eye was ranked higher by CS

respondents compared with AE respondents (p=0.032), with a greater proportion reporting appearance to be excellent by CS respondents (44.5% vs 38.7%).

Prosthesis motility

Moderate

Exploratory, cross-sectional study. Lack of examination data to verify objective measures.

Questionnaire developed by panel of experts.

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Prosthesis motility was rated significantly superior in CS (p<0.0001). At least good motility was reported by 64.7% of AE respondents vs 79.0% of CS respondents

Adjusting to prosthesis wear Self-reported length of time that has taken to adjust

to wearing the prosthesis was slightly shorter among AE respondents; however, the difference was not statistically significant (p=0.17).

Hatamleh,

Alnazzawi

[27]

To evaluate patient satisfaction with ocular prosthetics and association and cross tabulation of various aetiological variables with their satisfaction. The complaints of anophthalmic patients and the ways of wearing and managing their ocular prosthesis were also evaluated.

Observational - Cross sectional survey

Patient satisfaction was assessed through 8 closed-end statements. The statements reflect various aspects concerning patients views on prosthesis comfort and appearance; patient’s expectations, self-esteem and perception; and cooperation with ocularist.

Each statement had 3 options of agree, moderately agree, and disagree.

The ocular prosthetic services provided were also rated as “poor,” “average,” “good,” “very

good,” and “excellent.”

126 respondents

Very high satisfaction rate with their ocular prosthetics (comfortable to wear; looks realistic; meets all their expectations, enhances their self esteem, integration into society, and how people perceive them).

Artificial eye wearers exhibited statistically significantly higher percentage of agreement in the 6 statements when compared with cosmetic shell wearers (P<0.05).

Having an eye replacement that covers the defect is associated with high satisfaction among patients regardless of ocular prosthetic type (P>0.05)

No differences between gender, age or work status (working, unemployed or retired)

Low

Exploratory, cross-sectional study, small sample. No mention of how survey was developed or whether it went through an internal validation process.

Page 34 of 119

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5. Cevik P, Dilber E, Eraslan O. Different Techniques in Fabrication of Ocular Prosthesis. Journal of Craniofacial Surgery [Internet]. 2012; 23(6). Available from: https://journals.lww.com/jcraniofacialsurgery/Fulltext/2012/11000/Different_ Techniques in Fabric ation of Ocular.48.aspx.

6. Goiato MC, de Caxias FP, dos Santos DM. Quality of life living with ocular prosthesis. Expert Review of Ophthalmology [Internet]. 2018 2018/07/04; 13(4):[187-9 pp.]. Available from: https://doi.org/10.1080/17469899.2018.1503534.

7. Goiato MC, Mancuso DN, Sundefeld MLMM, Da Motta Gabriel MB, Murakawa AC, Guiotti AM. Aesthetic and functional ocular rehabilitation. Oral Oncology Extra [Internet]. 2005 2005/09/01/; 41(8):[162-4 pp.]. Available from: http://www.sciencedirect.com/science/article/pii/S1741940905000294.

8. Foreman J, Xie J, Keel S, Ang GS, Lee PY, Bourne R, et al. Prevalence and Causes of Unilateral

Vision Impairment and Unilateral Blindness in Australia: The National Eye Health Survey. JAMA

Ophthalmol [Internet]. 2018; 136(3):[240-8 pp.]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885895/.

9. Akman A, Irkeg M, Orhan M, Erdener U. Effect of lodoxamide on tear leukotriene levels in giant papillary conjunctivitis associated with ocular prosthesis. Ocular Immunology and Inflammation [Internet]. 1998 1998/01/01; 6(3):[179-84 pp.]. Available from: https://doi.org/10.1076/ocii.6.3.179.4042.

10. Pine KR, Sloan B, Stewart J, Jacobs RJ. The response of the anophthalmic socket to prosthetic eye wear. Clinical and Experimental Optometry [Internet]. 2013 2013/07/01; 96(4):[388-93 pp.]. Available from: https://doi.org/10.1111/cxo.12004.

11. James H, Jenkinson E, Harrad R, Ezra DG, Newman S, members of the Appearance Research C. Appearance concerns in ophthalmic patients. Eye [Internet]. 2011 2011/08/01; 25(8):[1039-44 pp.]. Available from: https://doi.org/10.1038/eye.2011.116.

12. McBain HB, Ezra DG, Rose GE, Newman SP. The Psychosocial Impact of Living with an Ocular Prosthesis. Orbit [Internet]. 2014 2014/02/01; 33(1):[39-44 pp.]. Available from: https://doi.org/10.3109/01676830.2013.851251.

13. Clarke A, Rumsey N, Collin JRO, Wyn-Williams M. Psychosocial distress associated with disfiguring eye conditions. Eye [Internet]. 2003 2003/01/01; 17(1):[35-40 pp.]. Available from: https://doi.org/10.1038/sj.eye.6700234.

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14. Song J-S, Oh J, Baek SH. A survey of satisfaction in anophthalmic patients wearing ocular prosthesis. Graefe’s Archive for Clinical and Experimental Ophthalmology [Internet]. 2006 2006/03/01; 244(3):[330-5 pp.]. Available from: https://doi.org/10.1007/s00417-005-0037-0.

15. Wang J, Zhang H, Chen W, Li G. The Psychosocial Benefits of Secondary Hydroxyapatite

Orbital Implant Insertion and Prosthesis Wearing for Patients With Anophthalmia. Ophthalmic Plastic

& Reconstructive Surgery [Internet]. 2012; 28(5). Available from: [https://journals.|ww.com/op-rs/Fulltext/2012/09000/ThePsychosocialBenefitsofSecondary.2.aspx](https://journals.|ww.com/op-rs/Fulltext/2012/09000/ThePsychosocialBenefitsofSecondary.2.aspx).

16. Pine NS, de Terte |, Pine KR. An investigation into discharge, visual perception, and

appearance concerns of prosthetic eye wearers. Orbit [Internet]. 2017 2017/11/02; 36(6):[401-6 pp.]. Available from: https://doi.org/10.1080/01676830.2017.1337201.

17. Goiato MC, dos Santos DM, Bannwart LC, Moreno A, Pesqueira AA, Haddad MF, et al. Psychosocial impact on anophthalmic patients wearing ocular prosthesis. International Journal of Oral and Maxillofacial Surgery [Internet]. 2013 2013/01/01/; 42(1):[113-9 pp.]. Available from: http://www.sciencedirect.com/science/article/pii/S0901502712002585.

18. Ahn JM, Lee SY, Yoon JS. Health-Related Quality of Life and Emotional Status of Anophthalmic Patients in Korea. American Journal of Ophthalmology [Internet]. 2010 2010/06/01/; 149(6):[1005-11.e1 pp.]. Available from: http://www.sciencedirect.com/science/article/pii/S0002939409009775.

    19. Pine N, de Terte |, Pine K. Time heals: an investigation into how anophthalmic patients feel

about eye loss and wearing a prosthetic eye. J Ophthalmol Vis Sci [Internet]. 2017; 2(2):[1018 p.]. Available from:

https://www.researchgate.net/profile/Keith Pine/publication/317184064 Time Heals An Investig ation into How Anophthalmic Patients Feel about Eye Loss and Wearing a Prosthetic Eye/lin ks/592bb4deaca27295a80b957b/Time-Heals-An-Investigation-into-How-Anophthalmic-Patients Feel-about-Eye-Loss-and-Wearing-a-Prosthetic-Eye.pdf.

20. Pine NS, Pine KR. Depression, Anxiety and Stress Indicators for Prosthetic Eye Wearers. Clin Ophthalmol [Internet]. 2020; 14:[1715-23 pp.]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320898/.

21. Pine N, De Terte I, Pine K. The impact of eye loss and prosthetic eye wear on recreational, occupational and social areas of functioning. Journal Ophthalmology & Visual Science [Internet]. 2017; 2(1):[1016 p.]. Available from:

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and Prosthetic Eye Wear_on Recreational Occupational and Social Areas of Functioning/links

[592bd97aaca27295a80c10fe/The-Impact-of-Eye-Loss-and-Prosthetic-Eye-Wear-on-Recreational

Occupational-and-Social-Areas-of-Functioning.pdf.

22. Korani H, Pine KR, Sood M, Vyas A. Concerns regarding Indian prosthetic eye wearers. Clinical and Experimental Optometry [Internet]. n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/cxo.13076.

    23. Avisar |, Norris JH, Quinn S, Allan D, McCalla M, Dugdale D, et al. Temporary cosmetic

painted prostheses in anophthalmic surgery: an alternative to early postoperative clear conformers. Eye [Internet]. 2011 2011/11/01; 25(11):[1418-22 pp.]. Available from: https://doi.org/10.1038/eye.2011.179.

24. Heind| LM, Trester M, Guo Y, Zwiener F, Sadat N, Pine NS, et al. Anxiety and depression in

patients wearing prosthetic eyes. Graefe’s Archive for Clinical and Experimental Ophthalmology [Internet]. 2020 2020/09/01. Available from: https://doi.org/10.1007/s00417-020-04908-0.

25. Knowles PT. The outcome of ocular prosthetic (artificial eye) reconstruction 2018.
26. Shapira Y, Worrell E, Ullrich K, Litwin A, Malhotra R. UK National Artificial Eye Questionnaire study: comparisons between cosmetic shell and artificial eye users. Part 1: demographics, comfort and satisfaction. British Journal of Ophthalmology [Internet]. 2020:[bjophthalmol-2020-317015 pp.]. Available from: https://bjo.bmj.com/content/bjophthalmol/early/2020/09/05/bjophthalmol-2020

317015.full.pdf.

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27. Hatamleh MM, Alnazzawi AA, Abbariki M, Alqudah N, Cook AE. Survey of Ocular Prosthetics Rehabilitation in the United Kingdom, Part 2: Anophthalmic Patients’ Satisfaction and Acceptance. Journal of Craniofacial Surgery [Internet]. 2017; 28(5). Available from: https://journals.lww.com/jcraniofacialsurgery/Fulltext/2017/07000/Survey of Ocular Prosthetics

Rehabilitation in _the.39.aspx.

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Research – Cost effectiveness of external powered (myoelectric) upper limb prosthesis compared to body powered

Population = children aged 2-6 with upper limb amputation(s).

Questions: Is it likely cost effective in the long term for children to use external powered (myoelectric) compared to body-powered prostheses?

Specific questions/considerations raised for further investigation during this advice which will likely assist answering the research question include but are likely not limited to:

Is it still cost effective if a second prosthesis for recreation activities is required?

Brief What is typical pricing for this age group for external powered prosthesis?

How do the long term impacts of overuse injuries play into cost effectiveness at this age?

What are the likely key functional participation advantages and disadvantages?

What are the rates of and reasons for acceptance and rejection of myoelectric prostheses compared to body powered prostheses in children?

Does the evidence and answers to any of these questions vary between children with unilateral or bilateral and trans-radial (below elbow) or trans humeral (above elbow) amputations / limb deficiencies?

Date 03/08/2021

Requester(s) s47F-Personal Privacy - Senior Technical Advisor (TAB/AAT)

Researcher s47F-Personal Privacy - Research Team Leader (TAB)

Cleared N/A

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of these matters.

The contents of this document are OFFICIAL

Research – Cost Effectiveness of external powered devices compared to body powered for children Page 1 of 23

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1 Contents

2 Summary ……………………………………………………………………………………………………………………….. 2

3 Introduction …………………………………………………………………………………………………………………… 4

4 Active V Passive Prosthesis ………………………………………………………………………………………………. 5

4.1 Passive Prostheses …………………………………………………………………………………………………… 5

4.2 Active Prostheses …………………………………………………………………………………………………….. 5

4.2.1 Body powered devices ………………………………………………………………………………………. 5

4.2.2 Myoelectric devices ………………………………………………………………………………………….. 6

5 Cost of Prosthesis ……………………………………………………………………………………………………………. 7

6 Acceptance of myoelectric devices for children ………………………………………………………………….. 8

6.1 Upper Limb Prosthetic Fitting and Brain Development …………………………………………………. 9

6.1.1 Brain and Grasp Development ……………………………………………………………………………. 9

6.1.2 Fitting Progression Based on Brain Development ……………………………………………….. 10

6.2 Studies investigating acceptance of myoelectric devices …………………………………………….. 11

6.2.1 Recreational Devices ……………………………………………………………………………………….. 12

7 Factors leading to prosthesis abandonment …………………………………………………………………….. 19

7.1 Level of Limb Loss ………………………………………………………………………………………………….. 19

7.2 Origin of Limb Absence …………………………………………………………………………………………… 19

7.3 Bilateral Limb Absence ……………………………………………………………………………………………. 19

7.4 Fitting time frame ………………………………………………………………………………………………….. 19

7.5 Age of rejection ……………………………………………………………………………………………………… 20

7.6 Established Need and Importance of Factors …………………………………………………………….. 20

7.7 Prosthesis Technology ……………………………………………………………………………………………. 20

8 References …………………………………………………………………………………………………………………… 21

2 Summary

• The question of cost effectiveness is difficult to determine due to the lack of clear pricing for body powered and myoelectric prosthetic devices. Furthermore, the peer reviewed literature investigating these devices in children is sparse and of low quality.

• This report provides information on timing of device prescription, factors leading to device abandonment and advantages/disadvantages of each device in an attempt to

Research – Cost Effectiveness of external powered devices compared to body powered for children Page 2 of 23

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determine whether providing the higher cost myoelectric device is better in the long term.

• It is important to consider the functional and cosmetic needs of the patient, as well as the motivation of the child and family. Although there are various predictors of device abandonment, one predictor that stands out is that early prosthetic fitting of a unilateral transradial limb deficiency is a strong indicator of a child’s continued wear of a prosthesis later in life, whereas fitting a child at an older age is more likely to result in a rejection of the prosthesis. o Device abandonment is costly, no matter what type of device has been prescribed.

• There are few studies investigating prosthesis for recreation. They conclude that prosthetic adaptations are expensive and must be weighed individually by the family in light of children’s fleeting interest in individual hobbies.

• Unable to determine the impact that overuse injuries have on cost effectiveness. However, several reports have suggested that younger children have difficulty with body powered devices due to lack of strength, lack of excursion ability, and lack of understanding of the cause and effect of the movements required to produce active grasp which can lead to pain and discomfort.

• Please refer to Section 6 for overview on acceptance rates for myoelectric and body powered prosthesis.

• Children with above elbow tended to wear their prosthesis for more hours of the day (8 hours) compared to below elbow (5 hours).

• Level and origin of limb loss o Level of limb absence was a primary predisposing factor in prosthesis acceptance. Individuals with limb absence proximal to the elbow (high level) or to the wrist (low level) are more likely to reject the device than were those with transradial limb absence (P = 0.001). o Rejection rates for individuals with congenital limb absence were greater for low-level (63%) or high-level (65%) limb absence and less for transradial (21%) (P = 0.02). For acquired limb absence, prostheses were rejected by 0% of individuals with low-level amputations, 16% with transradial, and 39% with high level amputations (P = 0.001).

• Bilateral limb absence o Rejection rates for bilateral and unilateral limb absence do not differ significantly, irrespective of level of limb absence. Rejection rates for unilateral and bilateral limb absence were comparable in individuals with acquired amputations. o Individuals with congenital, bilateral limb absence had significantly higher rates of rejection (75%) in comparison with those with unilateral limb absence (28%) (P < 0.004).

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3 Introduction

In very young children upper limb deficiency is mainly caused by malformations. Upper limb deficient children can be provided with three types of prosthesis: cosmetic (passive device), body-powered and myoelectric prosthesis (active devices).

Prostheses have been shown to contribute to social acceptance and certain special activities, however, there is still considerable controversy regarding the daily living benefits of adapting an upper limb prosthesis in children, particularly in unilateral amputations below the elbow, since the levels of function and quality of life observed are very close to normal [1].

An infant with an upper-limb loss or absence presents parents with uncertainty regarding how the deficiency will impact the child’s ability to function physically and psychosocially in life. The decision about if and when to fit a prosthesis needs to be made and requires analysis of many factors, including, but not limited to [2]:

• Level of limb loss
• Developmental stage of the child
• Opinions of the prosthetist and therapist
• Commitment of the parents
• Advantages and disadvantages of age appropriate prosthetic devices.
• Long-term physical effects of upper-limb absence. Whether the use of a prosthesis will prevent issues relating to chronic pain and overuse syndrome (also called cumulative trauma disorder or repetitive stress injury).

Young children can be successful with incorporating prostheses into their daily activities if provided with multiple, properly fitting, and up-to-date prosthetic options [2, 3]. A thorough analysis of all factors is necessary by the care team and caregivers to determine which device would be of most benefit to a child [2]. Fitting a child early and enforcing a consistent wearing schedule with parent and therapeutic follow-through contributes to functional prosthetic success. Along with functional prosthetic success comes an enhanced ability for a child to participate in age-appropriate activities that may lead to positive self-esteem and a positive quality of life [4]. In addition, using an upper-limb prosthetic device may help a wearer to use proper body mechanics during activities. Proper body mechanics may reduce orthopedic changes in the spine and upper-body joints and reduce the potential for soft tissue overuse injuries in the future [5].

Compared to lower limb amputation, there is not a common consensus in the literature regarding the appropriate time and device to implement for upper limb amputees. It is difficult to compare studies, as they analyse various deficiency levels, differing prosthetic device types, and other incomparable variables. In addition, assorted outcome measures are used, and success is defined differently in each study [2, 6]. In many cases, the sample sizes are small, inclusion criteria varies, the effectiveness and comfort of the socket is unknown, and there is no indication of whether or not upper-limb prosthetic training was provided [7].

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4 Active V Passive Prosthesis

4.1 Passive Prostheses

Passive prosthetic devices (PPD) are employed when physical appearance and comfort are of the greatest priority [8]. Despite the functional limitations, passive devices remain a popular choice for users [8].

Passive prosthetic devices are relatively inexpensive and have an aesthetically pleasing cosmetic appearance. The functionality of PPD is limited to primitive actions such as pushing, pulling and carrying objects [8]. However, they are commonly worn in social situations as they increase the confidence of the user. Approximately one in three amputees use a passive prosthesis in some capacity [8]. The device is usually recommended for patients who have recently undergone amputation. On familiarisation with it, users typically advance onto using active prostheses [9].

4.2 Active Prostheses

The primary difference between active and passive prosthetic devices is that active devices can generate power [9]. Active prostheses can be further classified into body powered and myoelectric devices. Each presents advantages and disadvantages. A combination of passive and active prosthetic devices is often used to meet the needs of amputees.

4.2.1 Body powered devices

Body powered upper extremity prostheses are controlled using a harness which is connected via a cable to elsewhere on the patient’s body, such as the healthy shoulder. The working shoulder is manoeuvred in distinct movements to control the prosthesis. A standard body powered upper extremity prosthesis features a socket, wrist, control cable, harness and a terminal device (see Figure 1) [10].

Advantage

• The hooks are highly practical for a wide variety of activities.

• Robust: Suitable for extensive, heavy-duty activities when compared to myoelectric prostheses because they are less susceptible to damage in volatile conditions such as corrosive and wet environments.

• No batteries or alternative power sources needed.

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• Offers ‘intuitive control of the prosthetic device as well as force feedback via the cable tensioning’

• Relatively low cost in comparison to myoelectric devices.

Disadvantages

• The activation forces required are often large and can be physically overwhelming for some users, leading to issues such as fatigue and discomfort.

• If a hand is utilised as the terminal device, the prosthesis is generally mechanically inefficient, as they are relatively heavy, and most hands do not provide enough pinch force to complete mundane tasks.

• Many users prefer the terminal device to be a hook when using a body powered prosthesis due to their improved functionality and ease of use. Despite this, hooks do not provide the user with an authentic appearance and therefore are not satisfactory for a large percentage of users.

In a study conducted in 2012, it was found that the use of body powered devices has reduced over time - 30% of those interviewed used a body powered device, with myoelectric being the most prevalent prosthesis among adult amputees [11].

Figure 1. Example body powered device.

4.2.2 Myoelectric devices

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Myoelectric upper extremity prostheses are powered through the use of electric motors with an external power source. The movement of the joint is controlled through muscle activity from the remaining limb. ‘Electromyographic (EMG) signals from the limb stump are detected by surface electrodes, amplified and then processed by a controller to drive battery-powered motors that move the hand, wrist or elbow’ [9].

Advantages

• Enhanced cosmetic appearance. o This is a deciding factor for many users on which device they wish to use. An individual’s social-psychological requirements are of top priority. Devices that do not restore a lifelike appearance for the user are commonly rejected. o Myoelectric prostheses are the standard for Western countries, with around 90% of patients using it as their primary device [12].

• Greater range of motion

• More natural control: Myoelectric devices operate in a physiologically natural manner. When a transradial prosthesis is employed, the muscles which are used to open and close the myoelectric hand are identical to the muscles used in the natural hand. o Users have reported perceived sensory feedback

• Grip strength of the myoelectric device is typically several times larger than that of a body-powered prosthesis.

• Increased comfort

• User needs less compensatory motion to execute ADLs

Disadvantages

• Cost of myoelectric devices is a barrier that limits user access, especially in countries without appropriate health care coverage. In countries such as the USA, an advanced myoelectric upper prosthesis with a functional terminal device can cost around $75,000 [13].

• The battery needs to be recharged daily, and can become damaged from environmental factors such as water and dirt [9, 10].

• Maintenance and repair costs for the devices are generally higher than alternatives [10].

• Difficulty when managing simultaneous movements and few degrees of freedom. 5 Cost of Prosthesis

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Research into the cost effectiveness of various prosthetic devices does not exist. Precise pricing for myoelectric and body powered devices are difficult to locate and only ranges are supplied online.

The James N. Kirby Foundation states that the current cost of a myoelectric arm is $12,000 and young children will generally outgrow their prosthesis within 12 months.

In comparison, the Medical Centre Orthotics and Prosthetics website (which is American) states that without insurance, you can expect to pay around $5,000 for a cosmetic prosthetic, up to $10,000 for a functional prosthetic with a hook, and between $20,000 to $100,000 for the latest myoelectric arm technology.

The US Department of Veterans Affairs in 2010 provides some detail about myoelectric prosthetics based on the level of limb loss:

• Partial loss of hand: $18,703
• Loss up to the middle of the lower arm: $20, 329
• Loss up to the middle of the upper arm: $59,664
• Loss up to the shoulder: $61,655 In the paper by Resnik, Meucci [14], the costs for myoelectric and microprocessor prosthetic devices are substantially higher than those for body powered devices. Prices can be seen below and are based on 2011 pricing.

6 Acceptance of myoelectric devices for children

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There still exists a disagreement in the community regarding right age and device to fit a child. Usually, a child is initially fitted with a passive, cosmetic prosthesis as soon as being able to sit in stable position. With a passive device, a child learns to use both hands, which supports brain development. A next step is transition from passive to an active device. Some experts believe that the child should receive a body-powered prosthesis when they are able to stand and grasp an object or when the child starts with kindergarten. The progression to the myoelectric prosthesis usually takes place at the age of ten or when the child has fully accepted active prostheses [15]. Other experts believe that children should be fitted as soon as possible with a myoelectric prosthesis [2].

6.1 Upper Limb Prosthetic Fitting and Brain Development

It has been proposed that fitting an infant with an upper-limb prosthetic device both affects and is affected by brain development. The clinical approach and the corresponding results cited in the literature strongly suggest that early paediatric fittings are appropriate [1, 2, 16, 17]. Therefore, timing of fitting and device type should correspond with the appropriate developing activity in a child’s brain.

6.1.1 Brain and Grasp Development It is during the first 3 years of life that a child’s brain is most plastic, when neuronal connections which affect the child for life are created [2]. If a necessary experience does not occur during a critical time in development, the loss may not be able to be regained in the future [2]. The ability to grasp with a hand is a progression that begins at birth and continues to develop as a child matures. The capacity to use the hands together in a bimanual way develops at around 7 months of age, with skilful use beginning at 13 months [2].

To develop bimanual upper-limb neuronal connections, it is important for the child to utilize both upper limbs. When a child is missing a hand or a portion of an upper limb, the upper limb is not utilised as much as the intact upper limb due to decreased length and an inability to grasp or pinch on the deficient side [2]. In accordance with the brain development theories, this leads to the possibility that there may be less information from the limb being processed by the brain for establishing neuronal connections [2].

In a study of how a prosthesis is represented in the brain, van den Heiligenberg, Orlov [18] concluded that the “neurophysiological embodiment of artificial limbs depends on prosthesis usage in everyday life” and “prosthesis usage also shapes large-scale brain reorganization.” Aymerich-Franch and Ganesh [19] propose that having a functional artificial limb assists in the embodiment of a prosthetic device such that the user feels that the prosthesis is part of the body. To capture the critical periods in development when a child’s brain circuitry is being shaped, a prosthetic fitting protocol should include early introduction of an active grasp prosthesis [2]. This allows grasp on the limb deficient side of the body for promotion of bimanual upper-limb use and assistance with achieving developmental milestones facilitated by participation in age appropriate activities.

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6.1.2 Fitting Progression Based on Brain Development

The opinion piece by Kannenberg [12] has proposed the following prosthetic fitting progression for paediatric patients based on brain development considerations.

6 months

• As a child is learning to sit up and build strength and coordination with the upper limbs, the child should be fit with a passive prosthesis with a semi-flexible, passive hand attachment. This allows the child to become accustomed to wearing a prosthesis and to begin to explore upper-limb prosthetic movement in the environment.

12-18 months: Transition from passive to active prosthesis

• Body powered systems are not recommended as children of this age are unable to efficiently operate the device. o Shaperman, Leblanc [4] objectively studied limb-deficient children’s body strength in comparison to the strength required to efficiently operate a body powered prosthesis and concluded that infants and preschool age children are unable to produce the necessary force to produce sustained, effective grip. o Hichert, Vardy [20] found that even adults have difficulty operating a body powered prosthesis without fatigue, discomfort, or pain. It would be expected that a young child may also experience the same negative consequences from attempting to operate a body-powered prosthesis. o Shaperman [21] concluded that children are unable to demonstrate full control of a body-powered prosthesis until 28 to 37 months. Because a child often cannot understand or accomplish control of the body-powered terminal device until at least 28 months [21] due to lack of strength,[4] lack of excursion ability, and lack of understanding of the cause and effect of the movements required to produce active grasp.

• In contrast, myoelectric prostheses have been fitted successfully since the 1980s on children as young as 1 year old [15, 22]. The reason a young child is able to control and use a myoelectric prosthesis is that it taps into normal physiological movement and neurological pathways that the brain is developing at this age.

2-3 years – control strategy transition

• A transition from single-site to dual-site myoelectric control is made based on a clinician’s clinical judgment. The change occurs when the clinician determines that a child’s communication skills and attention span have developed enough for the child to understand control instructions from the clinician.

• A body-powered prosthesis can be introduced at this age, if desired, since the child should have the aptitude to understand the movements required to control a body powered prosthesis.

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3 years – Introduction of activity specific prosthetic devices

• Because the myoelectric prosthesis cannot be worn during sport activities a child would benefit from being fitted with an activity-specific “sports” prosthesis. An activity-specific prosthesis often allows interchanging of terminal devices for different activities.

6.2 Studies investigating acceptance of myoelectric devices

The literature investigating myoelectric devices in children is sparse and mainly consists of retrospective reviews or cross sectional studies which often introduce high levels of bias. The findings of the studies located are conflicting, with some concluding that myoelectric devices are favourable, and others suggesting that the more simple designs are preferred.

The study by Egermann, Kasten [1] found that:

• 76% of children successfully used the myoelectric prosthesis

• Children fitted between two and four years of age (n=23) showed a higher average time of daily use compared to the older subgroup (four to six years [n=18])

• Children amputated above elbow wore prosthesis more than 8h per day, while children with amputation below elbow wore prosthesis more than 5h per day

• Developmental reediness to use myoelectric prosthesis is at 2 years of age Participants in the study by Baron, Clarke [5] overwhelming preferred the myoelectric prosthesis when performing functional tasks. They also developed a strict selection criteria which included:

• Child and family are highly motivated to participate in the myoelectric hand study.

• Child has a functional or cosmetic need that can be met by the myoelectric hand.

• Child is of an appropriate size for the myoelectric hands available.

• Child has two suitable electrode sites.

• Child has an appropriate length residual limb.

• Child has a consistent wearing pattern if currently wearing a prosthesis.

• Child can make the required visits for training and evaluation.

• Child and family are conscientious about maintaining current prosthesis.

• Child will restrain him/herself when activities may cause damage to the myoelectric hand.

• Child is able to wear an intimately fitting socket without a prosthetic sock.

• Child does not object to having restricted range of motion at the elbow. In contrast, Crandall and Tomhave [3] investigated the use of multiple devices and found that:

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• 44% of patients selected a simple cosmetic ‘passive hand’ as their prosthesis of choice

• 41% of patients selected the conventional prosthesis using a voluntary closing terminal device

• 15% selected the myoelectric device as their primary prosthesis Kruger and Fishman [23] recruited 120 children with below-elbow amputation and compared cosmetically identical myoelectric and body powered hands after wearing each for 3 months. They found that 78% chose the myoelectric hand and 22% chose the body powered after the initial 3 month study.

At 2 year follow up, only 44% wore the myoelectric and 33% used a body powered hand or hook, and 23% became non wearers.

Only 30% of participants aged <8 years and 0% aged <5 years demonstrated any active prosthetic prehension. These findings suggest that prescription of a prosthesis, especially a myoelectric, for infants and pre-school children in anticipation of active prehension use is questionable.

Full study results can be found in Table 1.

6.2.1 Recreational Devices

A single study investigating the usefulness of recreational devices found that 9 of 15 recreational terminal devices prescribed improved performance [24]. However, they were primarily adaptions that were compulsory for participation such as weight lifting and violin bows. Only 4/9 successful recreational terminal devices were still in use at an average follow up of 3.9 years because the patients had lost inters tint he activity. Prosthetic adaptations are seen as expensive and must be weighed individually by the family in light of children’s fleeting interest in individual hobbies.

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Table 1.

Egermann,

Kasten [1]

To evaluate the acceptance of myoelectric prostheses in preschool children and to examine factors related to successful use of upper extremity prostheses.

Retrospective Review

<6 years of age Consecutively recruited

All subjects suffered from a unilateral congenital upper limb transverse deficiency or traumatic upper limb amputation, but showed regular development of motor function.

Excluded

e Bilateral amputations e Additional handicaps e Mental retardation

To be fitted with a myoelectric prosthesis all patients had to fulfil the following inclusion criteria:

1. The child communicates well and follows instructions from strangers.

2. There is bi-manual handling and proactive interest in an artificial limb.

3. The family setting must support the child in using the myoelectric device.

Questionnaire about acceptance and use of prosthetic devices during daily life.

41 children

76% of the study group appeared to be successfully using the prosthetic device.

The actual mean time of daily use was 5.8+4.1 hours per day (range, O—14 hrs).

24% of the subjects were categorised as rejecters of the myoelectric device.

Children fitted between two and four years of age (n=23) showed a higher average time of daily use compared to the older subgroup (four to six years [n=18]), although the level of significance was not reached.

The level of amputation significantly influences the daily wearing time (p=0.04). Above elbow amputees, although low in number, demonstrated a higher wearing time than children with below elbow amputations.

Children who had a body-powered active device prior to myoelectric prosthesis show a tendency towards higher wearing time compared to patients with a passive device

only.

Frequent skin irritation was associated with a trend toa higher daily wearing time.

Level: IV

Quality: Low

The outcome of this study indicates that the use of the myoelectric prosthesis is not related to the age of the child.

Most patients demonstrated developmental for myoelectric prosthesis as early as two years of age.

The more important selection criteria is activity and the temperament of the child, i.e. a calm child interested in doing handicrafts or similar playing activities reliant on bimanual handling.

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Successful use of the prosthetic device was defined by a mean daily wearing time of more The myoelectric prosthesis was preferentially used for than two hours. playing and in the kindergarten, and half of the study group preferred not to use the prosthesis playing outside.

Overall, the families were satisfied with the appearance and function of the prosthesis, whereas the susceptibility for breakdown and the weight of the prosthesis were rated less than good. There was consensus that the battery life span was too short.

To compare myoelectric                                           78% chose the myoelectric hand and 22% chose the         Level: IV

Kruger and Cross Sectional Study

versus body-powered hand                                               body powered after the initial 3 month study.               Quality: Low

Fishman [23] devices. 120 children with below-elbow amputation

compared cosmetically identical myoelectric and   78 participants appeared for follow up review. At 2 year   The findings suggest that

body powered hands after wearing each for 3      follow up, only 44% wore the myoelectric and 33% used    prescription of a

months.                                     a body powered hand or hook, and 23% became non       prosthesis, especially a

wearers. myoelectric, for infants and pre-school children 80% of children aged >8 years used active prosthetic in anticipation of active prehension for both myoelectric and body powered prehension use is prostheses. Comparatively, only 30% aged <8 years and questionable. 0% aged <5 years demonstrated any active prosthetic prehension.

Level: IV

Baron, Clarke    Study goals                    Prospective Observational                    14 participants

Quality: Moderate

[5]

• establish criteria for           Selection criteria                               Nine were fit with the Otto Bock hand and five with the

selection of candidates.                                                        Systemteknik #1 hand.                                     This study has

•  Child and family are highly motivated to               • identify maintenance needs                                                                                                                      successfully established

participate in the myoelectric hand study.                unique to the myoelectric                                                                      All of the participants were unilateral congenital upper     the feasibility and

•  Child has a functional or cosmetic need that                      fittings for children.                                                                                               limb amputees.                                            functional benefits of

can be met by the myoelectric hand.                                                                                     fitting children with               • evaluate the functional

•  Child is of an appropriate size for the                   potential of myoelectric                                                                                    11 children had below elbow deficiencies, and three had   myoelectric hands.

myoelectric hands available.                hands for children.                                                                   wrist disarticulation deficiencies.

•  Child has two suitable electrode sites.               • develop evaluation, fitting

and training techniques         •  Child has an appropriate length residual limb.  Age of subjects at the time of the myoelectric fitting

appropriate for different age    •  Child has a consistent wearing pattern if       ranged from 3 years and three months to 17 years of

groups.                             currently wearing a prosthesis.                 age.

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• evaluate the attitudes of • Child can make the required visits for

children and their parents           training and evaluation.                 Two of the participants were male and 12 were female.

toward the myoelectric         •  Child and family are conscientious about

prosthesis with regards to its       maintaining current prosthesis.              12 of the participants had been fitted with a prosthesis

functional and cosmetic         •  Child will restrain him/herself when activities   before the age of 2.

potentials. may cause damage to the myoelectric hand.

•  Child is able to wear an intimately fitting       Based on a total of 22 fittings, the average socket life

socket without a prosthetic sock. was found to be 15.4 months, the median was 14

•  Child does not object to having restricted      months.

range of motion at the elbow. Interest in cosmetic aspects of the myoelectric fitting The following operational definitions were used were also higher for females and also influenced the to apply these criteria. sample.

• Approximate size: sound hand is the same size or slightly larger than available The overwhelming preference was for use of the myoelectric hand. Myoelectric prosthesis when performing functional

  • Consistent wearing pattern: wears prosthesis tasks.

regularly for certain activities or periods of The major reasons given for wanting to try the the day.

•  Required number of visits: regular visits to      myoelectric hand were:

•  Cosmesis (40%)                                                                    facility and/or therapy training facility until

•  Freedom from the restrictions of a harness (40%)                                                       prosthesis is completed and child has

achieved developmentally appropriate         •  Curiosity in new advances or better function (20%)

functional use of the prosthesis.

•  Appropriate length residual limb: the        60% of the respondents felt the myoelectric prosthesis

residual limb must be long enough to met their original expectations. Reasons most often accommodate the electrode sites given for the prosthesis not meeting expectations comfortably within the socket and short included disappointment in cosmesis and function. enough to keep the overall length of the finished prosthesis no longer than is cosmetically acceptable to the child and family.

Attitudes toward change in prosthetic fitting questionnaire

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11 children prescribed a myoelectric prosthesis before Level: IV

Datta and      To describe the experience of   Cross Sectional Study

the age of 3.5 (routinely provided 3.5-6 years). Average Quality: Low Ibbotson [25] using powered prosthetic Unilateral congenital upper limb transverse age of 20.6 months hands in very young children deficiency Introduction of a At the review, 72.7% of these children appeared to be powered prosthesis at a

Prior to prescription of powered prosthesis, 7                                                                                                          successfully using these powered prostheses and          younger age is a suitable

were wearing passive cosmetic prosthesis and 4                                                                                                parents were satisfied with the prosthesis.                  alternative to using a

were wearing body powered grippers. body powered prosthesis Children has demonstrated developmental while waiting to reach an readiness. older age.

Questionnaire administered to gauge parents This is a small study with opinion at time of review. no group comparisons, therefore, results needs to be interpreted with caution.

To retrospectively analyse all                                             25 female and 9 male individuals.                            Level: IV

Retrospective Review

of our unilateral below-elbow                                             The average age when first seen was 2.8 years. The         Quality: Low

Crandall and    amputees in a busy paediatric   Patients who used only one prosthesis were not    average age at follow-up was 15.7 years. Not all patients

Tomhave [3]    amputation centre who were   included in this study.                            returned their questionnaire.                         The authors conclude

documented to have used that frequently the most

multiple prosthetic devices.      Files of 34 unilateral below-elbow amputees who   Patient list was gathered over a period of 3 years.           functional prosthesis

used multiple prostheses were reviewed. selected in the long term Twenty-six of the 29 patients responding indicated that is the simplest in design. Questionnaire posted to eligible patients. they currently were using a prosthesis.

All patients were fitted with a passive hand. Ninety seven percent were fitted with body-powered devices and 82% with myoelectric prostheses. Data indicated that the body-powered prosthesis with the voluntary closing terminal device generated the most functional responses in all 22 activities.

15 patients (44%) selected a simple cosmetic “passive hand” as their prosthesis of choice. In long-term follow up 14 patients (41%) continued as multiple users.

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Fourteen patients (41%) selected the conventional prosthesis using a voluntary closing terminal device as the prosthesis of choice. Only five patients (15%) selected the myoelectric device as their primary prosthesis.

Level: IV

Dabaghi-       To determine the prognostic    Cross Sectional Study                         Sample of 67 patients was obtained

Quality: Moderate

Richerand, factors of a satisfactory

Participants who used body activation upper           •   8 were excluded due to a poor use of the

Haces-García functional outcome in

limb prostheses during the period between                   prosthesis (<2 h/day)                            Better function among

[7] patients using upper

January 1991 and June 2008.                         •   2 were excluded due to rejection of usage for    those patients who used                  extremity prosthetics with a

over 6 months the prosthesis for a proximal third forearm All the patients were amputated at least at the

•   8 could not be located to apply the DASH         longer period per day,                stump, and above, level of       level of proximal forearm.

questionnaire                                   leading to a lower rate of                 amputation.

All patients underwent: rejection. Final study sample was comprised by 49 patients.

•    Psychological evaluation                                                               Upper limb prostheses                                                                                                •   37 (75.5%) had a proximal forearm stump

•    Pre-prosthetic training for 2 months                                                          not only generate a                                                                                                •   5 (10.2%) a trans-humeral stump

•    Prosthetic training for a mean period                                                                 functional gain, but also                                                                                                •   7 (14.2%) were disjointed at the shoulder.

of 4 months promote social

A total of 36 (73.4%) had a congenital aetiology and 13     adaptation and feeling of                                         Use of the prosthesis was defined as usage for at

(16.6%) had a traumatic aetiology.                         normality, nevertheless,                                                       least 2 h/day.

a large proportion of Mean age of the sample was 11.5 years, with a minimum Disability arm shoulder hand (DASH) scale was children and parents age of 3 and a maximum age of 18 years. used to assess the function of the upper limb report discouraging

prosthesis.                                        Level of amputation was found not to be significant in      functional results.

predicting a functional result (P = .7287.). Independent variables analysed to determine the functional prognosis were: Traumatic cases were more likely to obtain poor results

•    Level of amputation                        in relation to level of function (P = .0383).

•   Age at the start of using the prosthesis    Prosthesis use before the age of 6 more commonly

•    Aetiology leading to the use of the        results in good outcomes (P = .0031). Higher failure rate

prosthesis after the age of 6.

• Number of hours of usage per day. Those who used their prosthesis >6 hrs per day are more likely to have a good result, compared to those who use their prosthesis <6 hrs (P <.0001).

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To assess the usefulness of Ages of the children ranged from 4 to 16 years, with a Level: IV

Walker, Retrospective Review & Follow-up Survey

recreational terminal devices                                        mean of 10.1 years. There were 2 females and 9 males.     Quality: Low

Coburn [24]

for children with upper        20 recreational terminal devices were prescribed    All patients had functional elbows. Amputation levels

extremity amputations who     to 15 children with upper extremity             were at the proximal third forearm in 4 patients, middle    Prosthetic adaptations

wish to pursue sporting and     amputations.                                         third forearm in 3 patients, wrist level in 2 patients, and    are expensive and must

musical hobbies.                                                                           partial hand without prehension in 2 patients. Ten of the   be weighed individually

4 patients who could not be located and whose    11 patients had congenital deficiencies. One patient’s      by the family in light of

chart information was insufficient were           amputation occurred after a traumatic injury.               children’s fleeting

excluded, leaving a study population of 11 interest in individual

children with 15 recreational terminal devices.     Devices provided at no cost.                              hobbies.

Participants and parents were asked:

•   To rate their prosthesis use for            Five of the 11 patients did require construction of a

everyday activities as never, part time, prosthesis specifically for the recreational device or full time. because they did not routinely wear a prosthesis or their

•  Who instructed them in the use of the    existing myoelectric prosthesis would not accommodate

special recreational terminal device the recreational adaptation.

• Whether they practiced with it at home after the training sessions and, if 9 of 15 recreational terminal devices prescribed so, how long. improved performance. However, they primarily were

  • If they used the recreational terminal the adaptations for weight lifting and violin bows, where

their use was obligatory for participation. device in any game or performance and to rate whether or not it improved, worsened, or had no effect on their Only 4 of the 9 successful recreational terminal devices performance. were still in use at average follow-up of

•      If they still used the recreational          3.9 years because patients had lost interest in the

activity or had designed something that worked better. terminal device and, if not, why not.

Selection criterion was a child having trouble participating in a desired activity.

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7 Factors leading to prosthesis abandonment

Prosthetic usage rates vary substantially, with rates ranging from 39% to 81% in studies from the Northern Hemisphere [11]. The stated predictors of prosthetic device rejection or acceptance are varied [10, 16, 17]. One predictor that stands out is that early prosthetic fitting of a unilateral transradial limb deficiency is a strong indicator of a child’s continued wear of a prosthesis later in life, whereas fitting a child at an older age is more likely to result in a rejection of the prosthesis [2].

A survey by Biddiss and Chau [16] investigated prosthesis use and abandonment in 242 participants above the age of 12.

7.1 Level of Limb Loss Level of limb absence was a primary predisposing factor in prosthesis acceptance. Individuals with limb absence proximal to the elbow (high level) or to the wrist (low level) were more likely to reject the device than were those with transradial limb absence (P = 0.001).

7.2 Origin of Limb Absence Rejection rates for individuals with congenital limb absence were greater for low-level (63%) or high-level (65%) limb absence and less for transradial (21%) (P = 0.02). For acquired limb absence, prostheses were rejected by 0% of individuals with low-level amputations, 16% with transradial, and 39% with high level amputations (P = 0.001).

7.3 Bilateral Limb Absence

Rejection rates for bilateral and unilateral limb absence did not differ significantly, irrespective of level of limb absence. Rejection rates for unilateral and bilateral limb absence were comparable in individuals with acquired amputations. However, individuals with congenital, bilateral limb absence had significantly higher rates of rejection (75%) in comparison with those with unilateral limb absence (28%) (P < 0.004).

7.4 Fitting time frame The fitting time frame emerged as an important factor in prosthesis acceptance for individuals with congenital limb absence. Prosthesis rejecters were fitted within a median of 3.9 years, with an interquartile range (IQR) of 2– 6.6 years, whereas frequent wearers were fitted more quickly, within 11 months (IQR: 5 moths to 1.5 years).

A similar trend was apparent for individuals with acquired limb absence. Rejecters were fitted at a median 6 months after amputation, with an IQR of 3 months to 1 years, whereas wearers were fitted within a median of 3 months (IQR: 2–5 months).

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7.5 Age of rejection No differences in prosthesis rejection were observed between adults and children with congenital limb absence, irrespective of gender or level of limb absence. The mean age of prosthesis rejecters and frequent wearers was also not significantly different. However, when grouped by different life stages, significant differences in rates of rejection were observed (P = 0.02), irrespective of origin of limb absence. Rejection rates peaked markedly in three age groups, from 4 to 10 years, from 24 to 35 years, and for those greater than 65 yrs. These differences are likely related to lifestyle and functional needs.

A cross sectional study by Huizing, Reinders-Messelink [26] evaluated whether prosthetic fitting before the age of one year was associated with better outcomes in children with unilateral congenital below-elbow deficiency compared to children fitted after the age of one. A total of 20 participants aged 6 to 21 years of age were included. The results showed that early prosthetic fitting seems to have a limited impact on prosthesis use during later stages of life no matter the device type.

7.6 Established Need and Importance of Factors Perceived need varied significantly for frequent wearers and prosthesis rejecters (P = 0.001), with median ratings of 6 and 1 for wearers and rejecters, respectively. No difference in perceived need was observed between users of different prosthesis types.

Prosthesis rejecters discontinue use largely because of a lack of functional need, discomfort, and impediment to sensory feedback. However, no evidence found to suggest any difference between devices types and level of abandonment.

7.7 Prosthesis Technology

Prosthesis rejecters were significantly less satisfied with all aspects of prosthesis design, including appearance (P = 0.014), comfort (P = 0.001), function (P = 0.001), ease of control (P = 0.001), reliability (P = 0.001), and cost (P = 0.034). Of prosthesis rejecters, 74% stated that they might reconsider prosthesis use if technological improvements were made at a reasonable cost.

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8 References

1. Egermann M, Kasten P, Thomsen M. Myoelectric hand prostheses in very young children.
   

International Orthopaedics [Internet]. 2009 2009/08/01; 33(4):[1101-5 pp.]. Available from: https://doi.org/10.1007/s00264-008-0615-y.

2.  Peterson JK, Prigge P. Early Upper-Limb Prosthetic Fitting and Brain Development:
   

Considerations for Success. JPO: Journal of Prosthetics and Orthotics [Internet]. 2020; 32(4). Available from: https://journals.lww.com/jpojournal/Fulltext/2020/10000/EarlyUpperLimbProstheticFittingandBrain.4.aspx.

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satisfactory functional result in patients with unilateral amputations of the upper limb above the wrist that use an upper limb prosthesis. Revista Española de Cirugía Ortopédica y Traumatología (English Edition) [Internet]. 2015 2015/09/01/; 59(5):[343-7 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S1988885615000541.

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review. Prosthetics and Orthotics International [Internet]. 2017 2018/02/01; 42(1):[66-74 pp.]. Available from: https://doi.org/10.1177/0309364617691622.

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prosthesis for improved user suitability. Journal of Orthopaedics [Internet]. 2021 2021/01/01/; 23:[88-96 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S0972978X20303615.

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Perspective. JPO: Journal of Prosthetics and Orthotics [Internet]. 2017; 29(4S). Available from: https://journals.lww.com/jpojournal/Fulltext/2017/10001/MyoelectricversusBodyPoweredUpperLimb.5.aspx.

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acquired major upper-limb amputees: patterns of wear, prosthetic skills and the actual use of prostheses in activities of daily life. Disability and Rehabilitation: Assistive Technology [Internet].

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of Continued Prosthetic Wear in Children With Upper Extremity Prostheses. JPO: Journal of

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20. Hichert M, Vardy AN, Plettenburg D. Fatigue-free operation of most body-powered
    

prostheses not feasible for majority of users with trans-radial deficiency. Prosthetics and Orthotics International [Internet]. 2017 2018/02/01; 42(1):[84-92 pp.]. Available from: https://doi.org/10.1177/0309364617708651.

21. Shaperman J. Early learning of hook operation. Inter-Clinic Info Bull October [Internet]. 1975; 14:[11-8 pp.]. Available from: https://cdnadmin.artofliving.org/index.php/membership/newsletters-journals/icib–jacpoc-volumes-1961-1989/volume-14/number-9-10/early-learning-of-hook-operation.

22. Brenner CD. Electronic Limbs for Infants and Pre-School Children. JPO: Journal of Prosthetics and Orthotics [Internet]. 1992; 4(4). Available from: https://journals.lww.com/jpojournal/Fulltext/1992/07000/ElectronicLimbsforInfantsandPreSchool.6.aspx.

23. Kruger LM, Fishman S. Myoelectric and body-powered prostheses. J Pediatr Orthop [Internet]. 1993 1993 Jan-Feb; 13(1):[68-75 pp.]. Available from: http://europepmc.org/abstract/MED/8416358

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24. Walker JL, Coburn TR, Cottle W, Burke C, Talwalkar VR. Recreational Terminal Devices for Children With Upper Extremity Amputations. Journal of Pediatric Orthopaedics [Internet]. 2008; 28(2). Available from: https://journals.lww.com/pedorthopaedics/Fulltext/2008/03000/RecreationalTerminalDevicesforChildrenWith.26.aspx.

25. Datta D, Ibbotson V. Powered prosthetic hands in very young children. Prosthetics and Orthotics International [Internet]. 1998 1998/01/01; 22(2):[150-4 pp.]. Available from: https://www.tandfonline.com/doi/abs/10.3109/03093649809164477.

26. Huizing K, Reinders-Messelink H, Maathuis C, Hadders-Algra M, van der Sluis CK. Age at First
    

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OFFICIAL For Internal Use Only

Microprocessor knee prostheses

The content of this document is OFFICIAL.

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared

external to the Branch. These are for internal TAB use only and are intended to assist our

advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates

require further information on access or planning matters, they are to call the TAPS line for

advice.

The Research Team are unable to ensure that the information listed below provides an

accurate & up-to-date snapshot of these matters

Research question: Is it considered best practice and likely cost effective for people with lower limb amputations, either through or above the knee, to be fitted with a microprocessor knee unit instead of a mechanical knee unit when costs non directly related to the prosthesis are considered including quality of life, reduction of health and falls related costs, improved economic participation, improved independence with decreased carer support, improved social and recreational participation?

Original publishing date: 18/11/2021

Review date: 13/10/2022

Requestor: s47F-Personal Privacy

Endorsed by: s47F-Personal Privacy

Researcher:s47F-Personal Privacy

Cleared by: s47F-Personal Privacy

Review date: 13/10/2023

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Microprocessor knee prostheses ………………………………………………………………………………….. 1

1. Summary ………………………………………………………………………………………………………. 2
2. Outcomes of microprocessor knee compared to non-microprocessor knee prosthesis 2 2.1 Mobility and activities of daily living ………………………………………………………………… 3

2.2 Use, abandonment and satisfaction ……………………………………………………………….. 4

2.3 Falls …………………………………………………………………………………………………………… 5

2.4 Health and quality of life ……………………………………………………………………………….. 6

3. Cost-effectiveness ………………………………………………………………………………………….. 6
4. International service systems ……………………………………………………………………………. 7
5. References ……………………………………………………………………………………………………. 8
6. Summary Government funding of microprocessor-controlled knees (MPKs) varies between countries and different regions within countries (5. International service systems). However, MPKs are shown to be cost-effective within USA and several European health systems. No Australian cost effectiveness studies were found. While MPKs are still more expensive to purchase and repair than non-MPKs (4. Cost-effectiveness), there are significant health and functional benefits of MPK use.

There is substantial evidence that MPKs have increased clinical benefits compared to non MPKs, reducing the incidence of falls and potentially reducing the likelihood of developing osteoarthritis (3.3 Falls and 3.4 Health and quality of life). MPK use correlates with user satisfaction, well-being (3.2 Use, abandonment and satisfaction), increased physical activity, improved function mobility and completion of activities of daily living (3.1 Mobility and activities of daily living). Despite recommendations from UK’s National Health Service (NHS), there is insufficient evidence that MPKs are more beneficial for users at higher activity levels.

While studies are generally consistent regarding the positive outcomes of MPK use, there are some quality issues in many of the included studies, such as small and non-representative samples, risk of bias, lack of masking, heterogeneity of methods and measures, and use of non-validated measures, which make meta-analysis difficult and limits interpretation of findings.

2. Outcomes of microprocessor knee compared to non- microprocessor knee prosthesis

People who have a trans-femoral amputation, hip or knee disarticulation may choose to be fitted with a prosthetic leg. A health professional will prescribe a prosthetic leg consisting of a knee, ankle and foot. The two most common types of knee prostheses are mechanical (non

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microprocessor) knees (non-MPK) and microprocessor-controlled knees (MPK). An MPK is an artificial knee joint that includes a built-in computer that controls the swing and position of the knee based on real-time data of the user’s gait, whereas a non-MPK is mechanical knee joint with no computerised components.

2.1 Mobility and activities of daily living

MPK use can improve users’ mobility including walking speed, gait quality, balance and ability to navigate uneven terrain (Hahn et al, 2021; Mileusnic et al, 2021;). Wurdeman et al (2020) found significantly improved mobility in MPK users compared to non-MPK users as measured by the Prosthetic Limb Users’ Survey of Mobility.

Many researchers use the Medicare functional classification level (MFCL) to classify a prosthesis user’s activity level (refer to Table 1 – Medicare Functional Classification Level). There is some evidence that MPK use can allow a prosthesis user classified as K2 on the Medicare functional classification level (MFCL) to perform at a level expected of K3 users (Kahle et al, 2008; Kannenberg et al, 2014; Jayaraman et al, 2021; Hahn et al, 2021). However, there may be quality issues with this evidence, including small sample sizes, lack of controls and risk of bias. Most of the subjects of included studies are younger males with unilateral transfemoral amputations (Balk et al, 2018). The position of the US Lower Limb Prosthetic Workgroup is instructive on this point:

The Workgroup was divided on the quality and strength of the literature pertaining to microprocessor knees (MPKs) for beneficiaries who ambulate at the K2 level. Some argued that the individual articles noted in the literature which discuss this topic, do adequately demonstrate that those who utilize their prosthesis at the K2 level might improve their functional abilities (e.g., walking speed on level and unlevel ground; ramp descent speed, falls, etc.) with MPK technology. Others argued that the studies comprising this literature were significantly flawed (e.g., small sample sizes, attrition, confounders such as training differences, sole use of laboratory studies, significant conflict of interests, etc.). Those arguing the limitations of these studies are aware that these findings may not agree with the conclusions of other federal agencies.

Therefore, the Workgroup acknowledges an amputee functioning at the K2 level may benefit from MPK technology. However, as a population, these individuals cannot be categorically defined for policy purposes (Centers for Medicare & Medicaid Services, 2017, p.10).

This conclusion is supported by Balk et al (2018), who find the evidence base is insufficient to determine characteristics of prosthesis users which would allow clinicians to predict whether MPKs would be beneficial or not.

MPK use is also associated with improved performance in activities of daily living including carrying objects, avoiding obstacles and toileting (Hahn et al, 2021; Mileusnic et al, 2021).

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Table 1 — Medicare Functional Classification Levels

Source: Balk et al, 2018

Level Description

KO Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility

K1 Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator.

K2 Has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.

K3 Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

K4 Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

2.2 Use, abandonment and satisfaction

MPKs users report higher rates of well-being and satisfaction with their prosthesis compared to non-MPK users (Hahn et al, 2021; Mileusnic et al, 2021; Thibaut et al, 2022). A study of 450 MPK users showed no statistically significant difference in satisfaction or well-being between 4 different MPK models (Cambell et al, 2020). Higher reported prosthesis satisfaction rates are likely to translate into increased physical activity and participation in activities of daily living (Kaufman et al, 2008; Gerzeli et al, 2009; Highsmith et al, 2010; Sawyers & Hafner, 2013; Kannenberg et al, 2014).

Balk et al (2018) find low level evidence that 11-22% of lower limb prosthesis users abandon their prosthesis after 1 year. People with transfemoral amputations are twice as likely to abandon their prosthesis compared with people with transtibial amputations. There is low level evidence that 24 — 29% of lower limb prosthesis users restrict their prosthesis use to only indoor activities within the first year. The authors note this evidence is taken from studies

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which are mostly older and which show inconsistent results. Good quality information relating current rates on rejection, abandonment or non-use for MPK versus non-MPK prostheses could not be sourced. One 2010 study of US veterans found that of 109 participants with transfemoral amputations, 44 users rejected their myoelectric or microprocessor-controlled prostheses compared to 136 users of mechanical prostheses (Gailey et al, 2010). This provides some indication that rejection rates are higher for non-MPK prostheses. However, this data should not be relied on as the data does not represent the current state of MPK technology. Also, the study does not define the term ‘rejection’, so it is not entirely clear what is being measured.

2.3 Falls

Falls are common in lower limb prosthesis users. As many 50% of lower limb amputees fall at least once per year (Palumbo et al, 2022). Above knee prosthesis users have a higher risk of falling than below knee prosthesis users (McGrath et al, 2022). Fear of falling is a major risk factor in reduction in physical activity, mobility and quality of life (Highsmith et al, 2010; Miller et al. 2001).

There is consistent evidence that MPKs contribute to a reduction in falls. People with MPKs are less likely to have falls causing minor, major or fatal injuries compared to users of non MPKs (Kahle et al, 2008; Highsmith et al, 2010; Liu et al, 2017; Chen et al, 2018; Kuhlmann et al, 2020; Kuhlmann et al, 2022). In a study of 1486 hospitalizations of 815 individuals, MPK use was associated with the least frequent falls (Palumbo et al, 2022). In one recent study, 315 lower limb prosthesis users were asked about trips, stumbles and falls in a 4-week period. In this study, 71 non-MPK users reported trips or stumbles compared to 16 MPK users, while 37 non-MPK users reported falls compared to 3 MPK users (McGrath et al, 2022).

The benefit in falls reduction is likely to be true for both lower and higher activity prosthesis users. A 2014 systematic review showed MPK use can reduce falls in level K2 prosthesis users by as much as 80% (Kannenberg et al, 2014). Other studies show MPK-use can reduce the number of falls for users assessed at K2 or higher by between 63% and 85% (Kahle et al, 2008; Hahn et al, 2021; Mileusnic et al, 2021; Kuhlman et al, 2020; Kuhlman et al, 2022). Reductions in the incidences of falls are thought to be because MPKs improve gait and balance compared to non-MPKs (Kaufman et al, 2007; Kaufman et al, 2012).

There may be a difference in falls reduction for different models of MPK, though the evidence is not conclusive (Thibaut et al, 2022). In a study of 602 prosthesis users, Campbell et al (2020) found Orion and C-Leg MPKs outperformed Rheo and Plié MPKs. Other studies also suggest stability of C-Leg against other MPK models (Palumbo et al, 2022).

While studies consistently show correlation between MPK use and falls reduction, there are some quality issues with studies that indicate findings should be interpreted with a degree of caution. Quality issues include lack of masking and heterogeneity of methods and measures (Hahn et al, 2021).

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2.4 Health and quality of life

Lower limb amputation negatively affects quality of life (Thibaut et al, 2022). Users of MPKs report increased quality of life compared to users of non-MPKs (Kuhlman et al, 2020; Hahn et al, 2021; Kuhlman et al, 2022). MPK use can improve general health outcomes (Kuhlman et al, 2022). Studies have shown improvements in health-related quality of life of between 16% and 38% (Kuhlman et al, 2020). Demonstrated benefits such as reduction in falls, fear of falling, and increased physical activity level and independence with activities of daily living have been shown to predict increased quality of life (Kuhlmann et al, 2022; Ernstsson et al, 2021; Highsmith et al, 2010; Miller et al. 2001). Some research from approximately 2015-2016 shows that the Genium MPK improves quality of life to a greater extent than other models. However, due to recent improvements in MPK technology, the current Genium may now be more like other models than it was when this evidence was collected (Balk et al, 2018; Mileusnic et al, 2021; Thibaut et al, 2022).

2.4.1 Osteoarthritis

Improved gait provided by a MPK may lead to reduced degenerative changes such as osteoarthritis (Chen et al, 2018; Liu et al, 2017; Kaufman et al, 2012). Individuals with lower limb amputations are significantly more likely than the general population to develop osteoarthritis (Gailey et al, 2008), with 27% prevalence of osteoarthritis in the intact knee and 14% prevalence in the intact hip (Struyf et al, 2009). This is thought to result from an increase in forces experienced on the intact limb due to alterations in gait (Kaufman et al, 2012, Struyf et al, 2009). It is theorised that improvements to gait are provided by MPKs, and therefore a decrease in forces absorbed by the intact limb, could lead to reduced degenerative changes such as osteoarthritis (Chen et al, 2018; Liu et al, 2017; Kaufman et al, 2007; Kaufman et al, 2012; Mileusnic et al, 2021).

A computer simulation study which compared the incidence of osteoarthritis between users of non-MPKs and MPKs found that over a 10-year period the MPKs resulted in 16 fewer instances of arthritis per 100 people (Chen et al, 2018). It is important to note that this study was a computer simulation which assumed that MPKs would reduce the prevalence of arthritis from 20% to 14% based on expert opinion and previous research on forces exposed on the prosthetic knee of people with lower limp amputations (Kaufman et al, 2007). Observational or experimental studies directly comparing the incidence of osteoarthritis in people with non MPKs and MPKs could not be sourced for this current research.

3. Cost-effectiveness Studies over the last 20 years have consistently showed that MPKs are cost-effective when considering quality adjusted life years (QALYs) (Brodtkorb et al, 2008; Gerzeli et al, 2009; Seelen et al, 2009; Highsmith et al, 2010; Liu et al, 2017; Chen et al, 2018; Kuhlmann et al, 2020; Kuhlmann et al 2022). A standard method for evaluating the cost-effectiveness for a new medical technology is to calculate the incremental cost per QALY gained, referred to as the

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incremental cost-effectiveness ratio (ICER). This approach is based on estimating the relationship between health costs and health outcomes (Hutubessy et al, 2003).

While the cost of purchasing and repairing MPKs is higher than for non-MPKs, there is evidence that MPKs are cost-effective based on the clinical benefits, reductions in health care costs, reductions in the costs of caregiving, and increased economic participation (Brodtkorb et al, 2008; Gerzeli et al, 2009; Seelen et al, 2009; Highsmith et al, 2010; Liu et al, 2017; Chen et al, 2018; Kuhlmann et al, 2020; Kuhlmann et al 2022). Early studies found the largest cost saving in the area of economic productivity (Gerzeli et al, 2009; Seelen et al, 2009), however these did not estimate falls-related medical costs (Kuhlmann et al, 2022). More recent studies have found significant cost savings, avoidance of injury and fewer deaths due to the reduction in falls (Chen et al, 2018; Kuhlmann et al, 2020; Kuhlmann et al, 2022). In Kulhmann et al’s 2020 study, it was found 97% of the costs related to MPK use were due to the purchase and maintenance of the prosthesis itself. Whereas for non-MPK use, 25% of the costs were falls related medical costs. In Kuhlmann et al’s 2022 study, it was found 88% of the costs associated with MPK use were related to purchase and maintenance of the prosthesis while almost half of the costs related to non-MPK use were due to falls-related medical costs.

It should be noted there is a risk of bias due to conflict of interest regarding the two cost effectiveness studies from Kuhlmann et al as both studies were co-authored by employees of Ottobock, an MPK provider.

Cost-effectiveness studies based on the Australian healthcare or disability services system could not be sourced.

4. International service systems In 2016, the United Kingdom’s NHS reviewed evidence comparing the clinical benefits and costs of MPKs and non-MPKs, and concluded that there is sufficient evidence to support routine commissioning of MPKs. MPKs are now provided under the NHS through Specialised Prosthetic/Amputee Rehabilitation Centres for patients who meet the following criteria:

• trans-femoral amputation, hip or knee disarticulation
• MFCL K3 activity level
• SIGAM D or above mobility level
• Patient must demonstrate: − commitment to prosthetic rehabilitation through active participation with the

therapy team − adequate strength and balance to be able to activate the knee unit − requirement of MPK as the main day to day prosthesis − cognitive reasoning to master control, operation and care of the device

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− sufficient cardiovascular abilities to meet the fitness demands of ambulating

outdoors with free knee

• Patients must meet one of the following criteria: − clinical presentation of unstable gait evidenced as history of frequent falls,

stumbles, or near misses − risk of injury from a fall is very high due to a co-existing medical condition − the reduced energy requirements for walking would allow the user to improve

mobility and environmental obstacle negotiation (NHS England, 2016).

The United States of America, like the UK, also limit prosthetic devices based on the MFCL. Some private insurers may cover the full cost of the prosthesis, but within the Medicare system patients pay up to 20% of the cost of the device which incentivises patients to choose a lower cost device (Chen et al, 2018). The Centers for Medicare & Medicaid Services’ Lower Limb Prosthetic Workgroup Consensus Document states that consideration should be given to prosthetic users with K2 classification level (Centers for Medicare & Medicaid Services, 2017). However, information confirming whether this consensus statement has been implemented in US funding services could not be found.

While the UK and US limit MPK funding for people with a certain activity level, Kanenberg et al (2014) note that several European healthcare systems (Germany, Austria, the Netherlands, Italy, France) allow trial fittings to confirm whether a person benefits from an MPK. In Germany for instance, “mobility grade is not a limiting factor for component selection” (Hahn et al, 2021, p.2). In Sweden, each health care region receives a budget for prosthetic devices and services and decide whether a patient will receive an MPK on a case-by-case basis (Kuhlmann et al, 2022).

In contrast, most regions in India do not fund microprocessor knees for transfemoral amputees (Lakkireddy et al, 2022). Canadian coverage varies by province, with some provinces providing no coverage for microprocessor knees and others offering subsidies of $6,000 – $20,000 (Howard et al, 2020).

5. References Abouhossein, A., Awad, M. I., Maqbool, H. F., Crisp, C., Stewart, T. D., Messenger, N., Richardson, R. C., Dehghani-Sanij, A. A., & Bradley, D. (2019). Foot trajectories and loading rates in a transfemoral amputee for six different commercial prosthetic knees: An indication of adaptability. Medical Engineering & Physics, 68, 46–56. https://doi.org/10.1016/j.medengphy.2019.03.014

Balk EM, Gazula A, Markozannes G, Kimmel HJ, Saldanha IJ, Resnik LJ, Trikalinos TA.

(2018). Lower Limb Prostheses: Measurement Instruments, Comparison of Component

Effects by Subgroups, and Long-Term Outcomes. Comparative Effectiveness Review

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No. 213. AHRQ Publication No.18-EHC017-EF. Rockville, MD: Agency for Healthcare

Research and Quality. https://doi.org/10.23970/AHRQEPCCER213

Brodtkorb, T.-H., Henriksson, M., Johannesen-Munk, K., & Thidell, F. (2008). Cost effectiveness of C-leg compared with non-microprocessor-controlled knees: a modeling approach. Archives of Physical Medicine and Rehabilitation, 89(1), 24–30. https://doi.org/10.1016/j.apmr.2007.07.049

Campbell, J. H., Stevens, P. M., & Wurdeman, S. R. (2020). OASIS 1: Retrospective analysis of four different microprocessor knee types. Journal of Rehabilitation and Assistive Technologies Engineering, 7, 2055668320968476. https://doi.org/10.1177/2055668320968476

Center for Medicare and Medicaid Services. (2017). Lower Limb Prosthetic Workgroup

Consensus Document. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/LLP Cons ensus Document.pdf

Chen, C., Hanson, M., Chaturvedi, R., Mattke, S., Hillestad, R., & Liu, H. H. (2018). Economic benefits of microprocessor controlled prosthetic knees: a modeling study. Journal of Neuroengineering and Rehabilitation, 15(Suppl 1), 62. https://doi.org/10.1186/s12984 018-0405-8

Edney, L. C., Haji Ali Afzali, H., Cheng, T. C., & Karnon, J. (2018). Estimating the reference incremental cost-effectiveness ratio for the Australian health system. PharmacoEconomics, 36(2), 239–252. https://doi.org/10.1007/s40273-017-0585-2

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Gailey, R., McFarland, L. V., Cooper, R. A., Czerniecki, J., Gambel, J. M., Hubbard, S., Maynard, C., Smith, D. G., Raya, M., & Reiber, G. E. (2010). Unilateral lower-limb loss: prosthetic device use and functional outcomes in servicemembers from Vietnam war and OIF/OEF conflicts. Journal of Rehabilitation Research and Development, 47(4), 317–331. https://doi.org/10.1682/jrrd.2009.04.0039

Gerzeli, S., Torbica, A., & Fattore, G. (2009). Cost utility analysis of knee prosthesis with complete microprocessor control (C-leg) compared with mechanical technology in trans femoral amputees. The European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care, 10(1), 47–55. https://doi.org/10.1007/s10198-008 0102-9

Hahn, A., Bueschges, S., Prager, M., & Kannenberg, A. (2021). The effect of microprocessor controlled exo-prosthetic knees on limited community ambulators: systematic review

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377. https://doi.org/10.3109/03093646.2010.520054 Howard, C., Saraswat, D. K., McLeod, G., Yeung, A., Jeong, D., & Lam, J. (2020). Canada’s prosthetic coverage: A review of provincial prosthetic policy. Canadian Prosthetics & Orthotics Journal, 2(2). https://doi.org/10.33137/cpoj.v2i2.33489

Hutubessy, R., Chisholm, D., & Edejer, T. T.-T. (2003). Generalized cost-effectiveness analysis for national-level priority-setting in the health sector. Cost Effectiveness and Resource Allocation, 1(1), 8. https://doi.org/10.1186/1478-7547-1-8

Jayaraman, C., Mummidisetty, C. K., Albert, M. V., Lipschutz, R., Hoppe-Ludwig, S., Mathur, G., & Jayaraman, A. (2021). Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial. Journal of Neuroengineering and Rehabilitation, 18(1), 88. https://doi.org/10.1186/s12984-021-00879-3

Kahle, J. T., Highsmith, M. J., & Hubbard, S. L. (2008). Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference. Journal of Rehabilitation Research and Development, 45(1), 1–14. https://doi.org/10.1682/jrrd.2007.04.0054

Kannenberg, A., Zacharias, B., & Pröbsting, E. (2014). Benefits of microprocessor-controlled prosthetic knees to limited community ambulators: systematic review. Journal of Rehabilitation Research and Development, 51(10), 1469–1496. https://doi.org/10.1682/JRRD.2014.05.0118

Kaufman, K. R., Levine, J. A., Brey, R. H., Iverson, B. K., McCrady, S. K., Padgett, D. J., & Joyner, M. J. (2007). Gait and balance of transfemoral amputees using passive mechanical and microprocessor-controlled prosthetic knees. Gait & Posture, 26(4), 489–493. https://doi.org/10.1016/j.gaitpost.2007.07.011

Kaufman, Kenton R., Frittoli, S., & Frigo, C. A. (2012). Gait asymmetry of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees. Clinical Biomechanics (Bristol, Avon), 27(5), 460–465. https://doi.org/10.1016/j.clinbiomech.2011.11.011

Kaufman, Kenton R., Levine, J. A., Brey, R. H., McCrady, S. K., Padgett, D. J., & Joyner, M. J. (2008). Energy expenditure and activity of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees. Archives of Physical Medicine and Rehabilitation, 89(7), 1380–1385. https://doi.org/10.1016/j.apmr.2007.11.053

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Kuhlmann, A., Krüger, H., Seidinger, S., & Hahn, A. (2020). Cost-effectiveness and budget impact of the microprocessor-controlled knee C-Leg in transfemoral amputees with and without diabetes mellitus. The European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care, 21(3), 437–449. https://doi.org/10.1007/s10198 019-01138-y

Kuhlmann, A., Hagberg, K., Kamrad, I., Ramstrand, N., Seidinger, S., & Berg, H. (2022). The Kenevo microprocessor-controlled prosthetic knee compared with non-microprocessor controlled knees in individuals older than 65 years in Sweden: A cost-effectiveness and budget-impact analysis. Prosthetics and Orthotics International, Published Ahead of Print. https://doi.org/10.1097/PXR.0000000000000138

Lakkireddy M, Taduri G, Kandakatla M, et al. State-sponsored institute-based provision of advanced artificial limbs for rehabilitation of amputees. Journal of Orthopaedics, Trauma and Rehabilitation, 29(2). doi:10.1177/22104917221123340

Li, S., Cao, W., Yu, H., Meng, Q., & Chen, W. (2019). Physiological parameters analysis of transfemoral amputees with different prosthetic knees. Acta of Bioengineering and Biomechanics, 21(3), 135–142.

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Advanced Transfemoral Prosthetics. Santa Monica: RAND Corporation

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McGrath, M., Gray, L. A., Rek, B., Davies, K. C., Savage, Z., McLean, J., Stenson, A., & Zahedi, S. (2022). Can microprocessor knees reduce the disparity in trips and falls risks between above and below knee prosthesis users? PloS One, 17(9), e0271315. https://doi.org/10.1371/journal.pone.0271315

Miller, W. C., Speechley, M., & Deathe, B. (2001). The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Archives of Physical Medicine and Rehabilitation, 82(8), 1031–1037. https://doi.org/10.1053/apmr.2001.24295

Mileusnic, M. P., Rettinger, L., Highsmith, M. J., & Hahn, A. (2021). Benefits of the Genium microprocessor controlled prosthetic knee on ambulation, mobility, activities of daily living and quality of life: a systematic literature review. Disability and Rehabilitation: Assistive Technology, 16(5), 453–464. https://doi.org/10.1080/17483107.2019.1648570

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Equipment- Prosthetics. (2016). Clinical Commissioning Policy: Microprocessor

Controlled Prosthetic Knees. NHS England. Available at

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Palumbo, P., Randi, P., Moscato, S., Davalli, A., & Chiari, L. (2022). Degree of safety against falls provided by 4 different prosthetic knee types in people with transfemoral amputation: A retrospective observational study. Physical Therapy, 102(4). https://doi.org/10.1093/ptj/pzab310

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Seelen, H. A. M., Hemmen, B., Schmeets, A. J., Ament, A. J. H. A., & Evers, S. M. A. A. (2009). Costs and consequences of a prosthesis with an electronically stance and swing phase controlled knee joint. Technology and Disability, 21(1–2), 25–34. https://doi.org/10.3233/tad-2009-0269

Struyf, P. A., van Heugten, C. M., Hitters, M. W., & Smeets, R. J. (2009). The prevalence of osteoarthritis of the intact hip and knee among traumatic leg amputees. Archives of Physical Medicine and Rehabilitation, 90(3), 440–446. https://doi.org/10.1016/j.apmr.2008.08.220

Thibaut, A., Beaudart, C., Maertens DE Noordhout, B., Geers, S., Kaux, J.-F., & Pelzer, D. (2022). Impact of microprocessor prosthetic knee on mobility and quality of life in patients with lower limb amputation: a systematic review of the literature. European Journal of Physical and Rehabilitation Medicine, 58(3), 452–461. https://doi.org/10.23736/S1973-9087.22.07238-0

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Cost effectiveness of upper limb myoelectric prostheses

The content of this document is OFFICIAL.

Please note:

The research and literature reviews collated by our TAB Research Team are not to be

shared external to the Branch. These are for internal TAB use only and are intended to

assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If

Delegates require further information on access or planning matters, they are to call the

TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an

accurate & up-to-date snapshot of these matters

Research question: Considering costs not directly related to the prosthesis including quality of life, reduction of health including overuse injury related costs, improved economic participation, improved independence with decreased carer support, improved social and recreational participation, is it best practice and likely cost effective for people with upper limb amputations to be fitted with a myoelectric prosthesis instead of a body powered prosthesis?

Date: 11/08/2022

Requestor: s47F-Personal Privacy

Endorsed by (EL1 or above): s47F-Personal Privacy

Researcher: s47F-Personal Privacy

Cleared by: s47F-Personal Privacy

Review date: 11/8/2024

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1. Contents Cost effectiveness of upper limb myoelectric prostheses …………………………………………………. 1

2. Contents ……………………………………………………………………………………………………….. 2

3. Summary ………………………………………………………………………………………………………. 2

4. Non-use or rejection of upper limb prostheses ……………………………………………………. 3

5. Independence ………………………………………………………………………………………………… 4

6. Social and community participation ……………………………………………………………………. 4

7. Economic participation …………………………………………………………………………………….. 5

8. Health effects …………………………………………………………………………………………………. 6

9. Quality of life ………………………………………………………………………………………………….. 8

10. References ……………………………………………………………………………………………………. 9

11. Summary With existing evidence, it is not possible to say whether body-powered or myoelectric upper limb prostheses are more cost-effective in general. The best evidence suggests that body powered and myoelectric prostheses are suited to different activities and preferred for different reasons. The recommended prosthesis type will likely depend on the user’s goals and circumstances.

There is some evidence that prosthesis use reduces disability and improves economic and social participation, health and quality of life. However, the evidence is less clear regarding prosthesis type. There is no clear evidence that myoelectric or body-powered prostheses are functionally better overall for social participation, work-related tasks or daily activities, though evidence suggests that users may prefer one or another device type for various reasons. Often myoelectric prostheses are preferred for lighter tasks and for social participation, while body powered prostheses are preferred for heavier functional tasks.

Existing cost-analysis comparing myoelectric and body-powered prostheses suggests that despite difference in initial cost of the device, overall health costs even out over 4 years. However, this analysis is based on a single state in USA and may not reflect costs in the Australian healthcare system.

Note: other TAB research papers consider cost effectiveness of prostheses. RES 202 Cost effectiveness of external powered (myoelectric) compared to body powered prostheses investigates this question for children aged 2 – 6 years. RES 219 Prostheses for people with transfemoral amputations compares mechanical and microprocessor knees.

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3. Non-use or rejection of upper limb prostheses Rejection or abandonment of upper-limb prostheses needs to be factored into any cost effectiveness analysis of body-powered versus myoelectric prostheses (Efanov et al, 2022). However, there is a lack of firm evidence relating to the rejection of upper limb prostheses (Carey et al, 2015; Carey et al, 2017; Smail et al, 2020; Salminger et al, 2022a).

In their 2015 and 2017 systematic reviews, Carey et al attempted to assess the evidence for the claim “Proportion of rejections are not different between BP or MYO prostheses.” (Carey et al, 2015, p.255; Carey et al, 2017). The authors found studies showing higher rates of rejection for both body-powered and myoelectric prostheses. They therefore determined there was insufficient evidence to judge which style of prosthesis has a higher rejection rate.

The largest body of evidence on rejection rates is from a 2007 study by Biddis and Chau. They found:

Mean rejection rates of 45% and 35% were observed in the literature for body-powered and electric prostheses respectively in pediatric populations. Significantly lower rates of rejection for both body-powered (26%) and electric (23%) devices were observed in adult populations while the average incidence of non-wear was similar for pediatric (16%) and adult (20%) populations (Biddiss & Chau, 2007, p.236).

According to this study, mean rejection rates were slightly higher for body-powered prostheses than myoelectric prostheses for both adults and children. However, many studies also note that the range is broad (Biddiss & Chau, 2007; Carey et al, 2015; Smail et al, 2020; Salminger et al, 2022a). Biddiss and Chau found reported rejection rates of between 16% and 66% for body-powered prostheses and between 0% and 75% for myoelectric prostheses (Biddis & Chau, 2007).

Biddiss and Chau’s study continues to be cited and in fact the bulk of evidence of rejection rates comes from older papers which may no longer be relevant. There have been considerable advances in myoelectric prosthetic technology in both comfort and function, which may affect rejection rates (Smail et al, 2020). However, there is some evidence that advances in technology do not have the expected effect on rejection rates. While prospective prosthesis users tend to cite comfort and function as the main reasons for rejection (Smail et al, 2020), it has not been shown that improvements in these areas have resulted in an increase in device acceptance (Salminger et al, 2022; Jones et al, 2021; Walker et al, 2020; Yamamoto et al, 2019). As early as 2007, Biddiss and Chau noted that rejection rates do not appear to decrease with time. More recently, Salminger et al (2022) found rejection rate of 44% in a population of mostly myoelectric prosthesis users and Resnick et al (2019 & 2020a) found 33% of their veteran sample of unilateral amputees (n = 776) did not use prostheses. These estimates are higher than Biddiss and Chau’s mean rejection rates though we should keep in mind the limitations of those estimates. In contrast, Yamamoto et al (2019) found a 9% rejection rate in a population of 174 people. Most non-users in this study (10 out of 16) had tried body-powered prostheses. Only 4 had tried myoelectric prostheses. Resnick et al’s

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survey of USA veterans supports the higher incidence of rejection of body-powered prostheses. They found that of 379 people who had ever stopped using a prosthesis, twice as many people had rejected body-powered prostheses compared to myoelectric prostheses (Resnick et al, 2019; Resnick et al, 2020a).

With the available evidence, we do not have a reliable estimate of rates of rejection or abandonment of upper limb prostheses in general, of body-powered prostheses or of myoelectric prostheses. Nor can we assume that technological advances will reduce the rates of rejection.

4. Independence Resnick et al (2022) asked 108 upper limb prosthesis users if they require help with activities of daily living. Only 18 said they do require help. Of that 18, only slightly more were users of body-powered prostheses (n = 10). The same team had previously found no difference between myoelectric and body-powered prosthesis users in perceived difficulty with activities, likelihood of needing assistance with activities of daily living (ADL), self-reported disability or health-related quality of life (Resnick et al, 2020b). The low proportion of prosthesis users requiring support with ADLs may be explained by rehabilitation therapy after injury, including pre-prosthetic training and prosthetic training focussing on achieving independence with self care activities (National Academies, 2017; Carey et al, 2017; Carey et al, 2015; Major et al, 2014).

With moderate level of confidence, Carey et al support the claim that, “Depending on functional needs, control scheme familiarity and user preference, either BP prostheses with conventional hook or MYO are advantageous compared with each other or other alternatives” (Carey et al, 2015, p.255). There is no clear evidence that myoelectric or body-powered prostheses are functionally better overall for promoting independence or completing daily activities, though evidence suggests that users may prefer one or another device type for various reasons. Myoelectric prostheses are likely better suited for lighter work, and body powered prostheses are likely better suited for heavier work or multiple different types of activity (Davis & Onge, 2017; Carey et al, 2015).

5. Social and community participation Upper limb loss can affect social relationships and community participation (Shue et al, 2021; Kristjansdottir et al, 2020; National Academies, 2017). Prosthetic use is thought to promote social engagement and participation is social activities by masking the upper limb loss (Kristjansdottir et al, 2020; Walker et al, 2020). Among active prostheses, myoelectric is generally preferred over body-powered for a more realistic look (Smail et al, 2021; Uellendahl, 2017; Carey et al, 2015).

Qualitative studies show participants have different attitudes to prosthesis use. Some note that prosthesis use can facilitate social interaction by allowing people with upper limb absence to

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‘fit-in’ in social situations (Kerver et al, 2021; Kerver et al, 2020; Kristjansdottir et al, 2020) or by prompting benign curiosity and conversation from others (Jones et al, 2021; Davis & Onge, 2017). Some people prefer a prosthesis which does not resemble an anatomical arm/hand in order to defy or challenge social expectations. Some are also more comfortable socially without a prosthesis (Jones et al, 2021; Walker et al, 2020).

There is also evidence in the literature that social and community participation among people with upper limb prostheses is not well understood. Most studies depend on self-reported surveys or non-validated measures (Resnick et al, 2021; Chadwell et al, 2020). Resnick et al (2021) note that most psychosocial measures used are designed for lower limb amputation and are not sensitive to the unique factors related to upper limb absence. Chadwell et al (2020) propose sensors which attach to a prosthetic limb to track actual use and movements, which would give a better picture of real community participation of people with upper limb prostheses.

Prosthesis use appears to affect feelings of social integration. Some studies suggest myoelectric prostheses are preferred for social participation due to a more ‘realistic’ appearance and due to body-powered prosthesis harnesses damaging clothing. However, these attitudes are not universal and I was unable to find social participation estimates. Further research is required to understand actual social participation among upper limb prosthesis users.

6. Economic participation A handful of studies track economic participation for people with upper limb prostheses. In their cost analysis comparing transplantation with myoelectric prosthesis use in Canada, Efanov et al (2022) found one study of 12 people showing return to work for 80% of study participants who received myoelectric prostheses. This return to work estimate for myoelectric prosthesis users should be compared to Salminger et al (2022) who found 86% of their 25 survey respondents returned to work regardless of type of prosthesis. In contrast, in a population of 808 USA veterans, only 13% were employed at the time of the survey, though 63% were employed full time or part time at some point after their amputation (Resnick et al, 2019). Variation in estimates is likely due to differences in study populations.

It is more difficult to judge whether prosthesis use is responsible for users’ return to work. Survey respondents in several studies indicated that both cosmesis and function facilitated their return to work (Kristjansdottir et al, 2020; Kerver et al, 2020; Yamamoto et al, 2019). In contrast, Salminger et al (2022) found no significant correlation between employment and prosthesis acceptance and note that just under 43% of respondents used their prosthesis during work or household tasks. An earlier study of 21 people found only 9 people used their prosthesis at work, an identical percentage to the Salminger et al study (Postema et al, 2016). In Yamamoto et al’s 174 person study, 52% used their prosthesis at work. Walker et al (2020) found that 12 of their 18 survey respondents judged prosthesis use to have no impact on their

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capacity to work. Of the remaining 6 respondents, only 2 noted a positive impact, while 4 noted a negative impact.

Comparing employment rates of myoelectric versus body powered prosthesis users, Yamamoto et al (2019) found that 65% of respondents with myoelectric prostheses were employed compared to 51% of passive prosthesis users and 48% of body-powered prosthesis users. Postema et al (2016) found that employed prosthesis users were more likely to use a myoelectric prosthesis. Three times as many workers used myoelectric prostheses compared to body-powered prostheses. They also found people with upper limb absence were employed at roughly the same rate as the control group, though prosthesis users were more likely to be employed than people with upper limb absence who did not use a prosthesis. Importantly, work productivity did not differ greatly between people with upper limb absence and the control group.

Body-powered prostheses are often preferred for physically demanding work while myoelectric prostheses are often preferred for cosmesis or to facilitate social integration in the workplace (Smail et al, 2021; Kerver et al, 2020; Uellendahl, 2017; Carey et al, 2015).

Economic participation estimates for people with upper limb loss range from 13% to 86% depending on population. Further research is required to reliably judge employment rates for people using different prosthesis types. This is likely to vary by jurisdiction considering different disability related training and employment schemes.

7. Health effects It is hypothesised that myoelectric prosthesis use lowers the risk of overuse injury by reducing compensatory movements. There is some evidence that this is true in comparison to non prosthesis use (Chadwell et al, 2019; Wanamaker et al, 2019; Burger and Vidmar, 2015). There is less reliable evidence comparing risk of overuse injuries between myoelectric and body-powered prostheses.

In their study of 65 people with upper limb loss, Burger and Vidmar found 33% of users of body-powered prostheses experienced carpal tunnel syndrome compared to 0% of the myoelectric prosthesis uses. No other overuse injury was associated with prosthesis type (Burger & Vidmar, 2015). On the other hand, Engdahl et al (2022) found that compensatory movements did not differ significantly with prosthesis type. While they did not investigate overuse injuries specifically, this finding casts doubt on the connection between prosthesis type and overuse injury due to increase in compensatory movements. Both studies depend on small sample sizes and further research is necessary to draw solid conclusions.

Limb loss can lead to increased symptoms of depression, anxiety and other mental health conditions (Resnick et al, 2021; Shue et al, 2021; Luza et al, 2020; Kannenberg, 2017). Body image anxiety is reported to be worse in upper compared to lower limb loss (Resnick et al, 2021). Prosthetic use may reduce symptoms of depression although this has only been shown in relation to lower limb prosthesis use (Shue et al, 2021).

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Resnick et al (2022) did not detect differences in mental health outcomes by device type for their sample of 127 veterans with upper limb loss. These results are similar to their 2020 report that shows only a slightly improved mental component summary score for myoelectric prosthesis users (Resnick et al, 2020a). Results are complicated by participants in the 2022 survey rating their overall mental health better than age-matched norms contrary to other studies (Resnick et al, 2021; Shue et al, 2021; Resnick et al, 2020a; Luza et al, 2020; Johansen et al, 2015).

Wanamaker et al (2020) looked into insurance claims for 133 upper limb amputees. For hand amputees, average total insurance claims relating to mental health were greater for myoelectrical prosthesis users. For below elbow amputees, claims were roughly equal among device types. For above elbow amputees, claims were significantly greater for body-powered prosthesis users.

Chronic pain, including phantom pain, is often associated with upper limb loss (National Academies, 2017; Johansen et al, 2017). With a low level of confidence, Carey et al (2015) supports the claim that regular use of a myoelectric prosthesis reduces phantom limb pain. They note that studies differ but the higher quality study supports the reduction in phantom pain. However, it is not clear whether the results were obtained in comparison with body powered prostheses or no prosthesis use.

In Wanamaker et al’s insurance claim study (2020), the average total insurance claims relating to pain management tracked the results for mental health claims reported above: claims for hand amputees were greater for myoelectric prosthesis users; claims for below elbow amputees were roughly equal across prosthesis types; and claims for above elbow amputees were greater for body-powered prosthesis users.

Resnick et al (2020a) assessed health related quality of life of 808 veterans using QuickDASH and SF-36. Cosmetic prosthesis users were significantly worse off according to the QuickDASH, had better physical health and worse mental health (according to mental and physical components of SF-36) compared to body-powered and myoelectric prosthesis users. Myoelectric and body-powered prosthesis users had similar scores on the QuickDASH while body-powered prosthesis users had slightly worse physical and mental health compared to myoelectric prosthesis users. Regression modelling of the same data showed no significant difference in health related quality of life between body-powered and myoelectric prosthesis users (Resnick et al, 2020b).

Importantly, Wanamaker et al conclude that overall health care costs for each type of prosthesis even out over 4 years despite higher initial outlay for myoelectric prosthesis (Wanamaker et al, 2020).

Further evidence is required to resolve whether the type of prosthesis used affects likelihood of overuse injury, chronic pain, or mental health. Larger population studies find no significant difference in health related quality of life between users of body-powered versus myoelectric prostheses.

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8. Quality of life Limb loss is reported to reduce quality of life, while prosthesis use is reported to improve quality of life of people with limb loss (Shue et al, 2022; Yamamoto et al, 2019; Johansen et al, 2017; Kannenberg, 2017). There is an occasional assumption in the literature that improvements in function would necessarily result in improvements in quality of life (Hashim et al, 2017). However, there are also reasons to reject this assumption, including the fact that technological improvements do not seem to affect prosthesis rejection rates (Salminger et al, 2022; Jones et al, 2021; Walker et al, 2020; Yamamoto et al, 2019).

In their study of 174 patients with upper limb loss, Yamamoto et al (2019) find highest quality of life in cosmetic prosthesis users. This is measured by the EQ-5D, a validated self-reported survey designed for the general population. Myoelectric prosthesis users scored higher than body-powered users. However, the difference in mean EQ-5D utility score between users of all three prosthesis types is only slight and is within the margin of error. There is a 0.006 difference between myoelectric and body-powered prosthesis users.

Efanov et al refer to a 2018 study into quality adjusted life years (QALY) of myoelectric versus body-powered prostheses:

The authors found body-powered prosthetics to be the most cost-effective option, which increased QALYs by 14.45 at a cost of $281,795 over a lifetime (ICUR of $19,501/QALY, corresponding to the acceptability threshold of less than $50,000/QALY). In comparison, myoelectric prostheses, and upper extremity VCA produced ICURs of $75,895/QALY and $780,061/QALY, respectively. However, when myoelectric devices cost less than $31,000, they became the preferred strategy of treatment (Efanov et al, 2022, p.155).

While this indicates the cost-effectiveness of body-powered over myoelectric prostheses, there are a few reasons to be cautious of these results. Firstly, the study referred to is a conference abstract and detailed methodology was not supplied. Secondly, the footnote in Efanov et al appears to be incorrect, referring to a different paper than the one described. Thirdly, other evidence suggests body-powered and myoelectric prostheses are suited to different purposes and it may not be possible to compare the effect on quality of life abstracted from individual circumstances (e.g. level of limb loss, cause of limb loss, type of work or other interests etc.) (Yamamoto et al, 2017).

There is some evidence that prosthesis use for people with upper limb loss improves quality of life. However when comparing use of myoelectric and body-powered prostheses, the evidence is less clear.

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9. References Biddiss, E. A., & Chau, T. T. (2007). Upper limb prosthesis use and abandonment: a survey of the last 25 years: A survey of the last 25 years. Prosthetics and Orthotics International, 31(3), 236–257. https://doi.org/10.1080/03093640600994581

Burger, H., & Vidmar, G. (2016). A survey of overuse problems in patients with acquired or congenital upper limb deficiency. Prosthetics and Orthotics International, 40(4), 497–

502. https://doi.org/10.1177/0309364615584658 Carey, S. L., Lura, D. J., Highsmith, M. J., CP, & FAAOP. (2015). Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. Journal of Rehabilitation Research and Development, 52(3), 247–262. https://doi.org/10.1682/JRRD.2014.08.0192

Carey, S. L., Stevens, P. M., & Highsmith, M. J. (2017). Differences in myoelectric and body powered upper-limb prostheses: Systematic literature review update 2013–2016: Systematic literature review update 2013-2016. Journal of Prosthetics and Orthotics: JPO, 29(4S), P17–P20. https://doi.org/10.1097/jpo.0000000000000152

Chadwell, A., Kenney, L., Granat, M., Thies, S., Galpin, A., & Head, J. (2019). Upper limb activity of twenty myoelectric prosthesis users and twenty healthy anatomically intact adults. Scientific Data, 6(1), 199. https://doi.org/10.1038/s41597-019-0211-6

Chadwell, A., Diment, L., Micó-Amigo, M., Morgado Ramírez, D. Z., Dickinson, A., Granat, M., Kenney, L., Kheng, S., Sobuh, M., Ssekitoleko, R., & Worsley, P. (2020). Technology for monitoring everyday prosthesis use: a systematic review. Journal of Neuroengineering and Rehabilitation, 17(1), 93. https://doi.org/10.1186/s12984-020 00711-4

Davis, C., & St. Onge, M. (2017). Myoelectric and body-powered upper-limb prostheses: The users’ perspective: The users’ perspective. Journal of Prosthetics and Orthotics: JPO, 29(4S), P30–P34. https://doi.org/10.1097/jpo.0000000000000155

Efanov, J. I., Tchiloemba, B., Izadpanah, A., Harris, P. G., & Danino, M. A. (2022). A review of utilities and costs of treating upper extremity amputations with vascularized composite allotransplantation versus myoelectric prostheses in Canada. JPRAS Open, 32, 150–

160. https://doi.org/10.1016/j.jpra.2022.03.003 Engdahl, S. M., Lee, C., & Gates, D. H. (2022). A comparison of compensatory movements between body-powered and myoelectric prosthesis users during activities of daily living. Clinical Biomechanics (Bristol, Avon), 97(105713), 105713. https://doi.org/10.1016/j.clinbiomech.2022.105713

Hashim, N. A., Abd Razak, N. A., Abu Osman, N. A., & Gholizadeh, H. (2018). Improvement on upper limb body-powered prostheses (1921-2016): A systematic review.

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Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine, 232(1), 3–11. https://doi.org/10.1177/0954411917744585

Johansen, H., Østlie, K., Andersen, L. Ø., & Rand-Hendriksen, S. (2016). Health-related quality of life in adults with congenital unilateral upper limb deficiency in Norway. A cross-sectional study. Disability and Rehabilitation, 38(23), 2305–2314. https://doi.org/10.3109/09638288.2015.1129450

Jones, H., Dupan, S., Dyson, M., Krasoulis, A., Kenney, L. P. J., Donovan-Hall, M., Memarzadeh, K., Day, S., Coutinho, M., & Nazarpour, K. (2021). Co-creation and user perspectives for upper limb prosthetics. Frontiers in Neurorobotics, 15, 689717. https://doi.org/10.3389/fnbot.2021.689717

Kannenberg, A. (2017). Active upper-limb prostheses: The international perspective: The international perspective. Journal of Prosthetics and Orthotics: JPO, 29(4S), P57–P62. https://doi.org/10.1097/jpo.0000000000000158

Kerver, N., van Twillert, S., Maas, B., & van der Sluis, C. K. (2020). User-relevant factors determining prosthesis choice in persons with major unilateral upper limb defects: A meta-synthesis of qualitative literature and focus group results. PloS One, 15(6), e0234342. https://doi.org/10.1371/journal.pone.0234342

Kerver, N., van der Sluis, C. K., van Twillert, S., & Krabbe, P. F. M. (2021). Towards assessing the preferred usage features of upper limb prostheses: most important items regarding prosthesis use in people with major unilateral upper limb absence-a Dutch national survey. Disability and Rehabilitation, 1–12. https://doi.org/10.1080/09638288.2021.1988734

Kristjansdottir, F., Dahlin, L. B., Rosberg, H.-E., & Carlsson, I. K. (2020). Social participation in persons with upper limb amputation receiving an esthetic prosthesis. Journal of Hand Therapy: Official Journal of the American Society of Hand Therapists, 33(4), 520–527. https://doi.org/10.1016/j.jht.2019.03.010

Luza, L. P., Ferreira, E. G., Minsky, R. C., Pires, G. K. W., & da Silva, R. (2020). Psychosocial and physical adjustments and prosthesis satisfaction in amputees: a systematic review of observational studies. Disability and Rehabilitation. Assistive Technology, 15(5), 582–589. https://doi.org/10.1080/17483107.2019.1602853

Major, M. J., Stine, R. L., Heckathorne, C. W., Fatone, S., & Gard, S. A. (2014). Comparison of range-of-motion and variability in upper body movements between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks. Journal of Neuroengineering and Rehabilitation, 11(1), 132. https://doi.org/10.1186/1743-0003 11-132

National Academies of Sciences Engineering and Medicine, Health and Medicine Division, &

Board on Health Care Services. (2017). Upper Extremity Prostheses. In The promise of

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assistive technology to enhance activity and work participation (J. L. Flaubert, C. M. Spicer, & A. M. Jette, Eds.). National Academies Press, pp.100-163

Postema, S. G., Bongers, R. M., Brouwers, M. A., Burger, H., Norling-Hermansson, L. M., Reneman, M. F., Dijkstra, P. U., & van der Sluis, C. K. (2016). Upper limb absence: Predictors of work participation and work productivity. Archives of Physical Medicine and Rehabilitation, 97(6), 892–899. https://doi.org/10.1016/j.apmr.2015.12.022

Resnik, L., Ekerholm, S., Borgia, M., & Clark, M. A. (2019). A national study of Veterans with major upper limb amputation: Survey methods, participants, and summary findings. PloS One, 14(3), e0213578. https://doi.org/10.1371/journal.pone.0213578

Resnik, L. J., Borgia, M. L., & Clark, M. A. (2020a). A national survey of prosthesis use in veterans with major upper limb amputation: Comparisons by gender. PM & R: The Journal of Injury, Function, and Rehabilitation, 12(11), 1086–1098. https://doi.org/10.1002/pmrj.12351

Resnik, L., Borgia, M., & Clark, M. (2020b). Function and quality of life of unilateral major upper limb amputees: Effect of prosthesis use and type. Archives of Physical Medicine and Rehabilitation, 101(8), 1396–1406. https://doi.org/10.1016/j.apmr.2020.04.003

Resnik, L. J., Borgia, M. L., Clark, M. A., Graczyk, E., Segil, J., & Ni, P. (2021). Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users. PloS One, 16(12), e0261865. https://doi.org/10.1371/journal.pone.0261865

Resnik, L., Borgia, M., Cancio, J., Heckman, J., Highsmith, J., Levy, C., Phillips, S., & Webster, J. (2022). Dexterity, activity performance, disability, quality of life, and independence in upper limb Veteran prosthesis users: a normative study. Disability and Rehabilitation, 44(11), 2470–2481. https://doi.org/10.1080/09638288.2020.1829106

Salminger, S., Stino, H., Pichler, L. H., Gstoettner, C., Sturma, A., Mayer, J. A., Szivak, M., & Aszmann, O. C. (2022a). Current rates of prosthetic usage in upper-limb amputees have innovations had an impact on device acceptance? Disability and Rehabilitation, 44(14), 3708–3713. https://doi.org/10.1080/09638288.2020.1866684

Salminger, S., Gstoettner, C., Sturma, A., Mayer, J. A., Papst, H., & Aszmann, O. C. (2022b). Actual prosthetic usage in relation to functional outcomes and wearing time in individuals with below-elbow amputation. Prosthetics and Orthotics International, Publish Ahead of Print. https://doi.org/10.1097/PXR.0000000000000137

Smail, L. C., Neal, C., Wilkins, C., & Packham, T. L. (2021). Comfort and function remain key factors in upper limb prosthetic abandonment: findings of a scoping review. Disability and Rehabilitation. Assistive Technology, 16(8), 821–830. https://doi.org/10.1080/17483107.2020.1738567

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Uellendahl, J. (2017). Myoelectric versus body-powered upper-limb prostheses: A clinical perspective: A clinical perspective. Journal of Prosthetics and Orthotics: JPO, 29(4S), P25–P29. https://doi.org/10.1097/jpo.0000000000000151

Walker, M. J., Goddard, E., Stephens-Fripp, B., & Alici, G. (2020). Towards including end users in the design of prosthetic hands: Ethical analysis of a survey of Australians with upper-limb difference. Science and Engineering Ethics, 26(2), 981–1007. https://doi.org/10.1007/s11948-019-00168-2

Wanamaker, A. B., Whelan, L. R., Farley, J., & Chaudhari, A. M. (2019). Biomechanical analysis of users of multi-articulating externally powered prostheses with and without their device. Prosthetics and Orthotics International, 43(6), 618–628. https://doi.org/10.1177/0309364619871185

Wanamaker, A. B., Andridge, R. R., & Chaudhari, A. M. W. (2020). Costs associated with lower- and upper-limb amputation over the first 4 years with a prosthesis. Journal of Prosthetics and Orthotics: JPO, 32(2), 81–92. https://doi.org/10.1097/jpo.0000000000000310

Yamamoto, M., Chung, K. C., Sterbenz, J., Shauver, M. J., Tanaka, H., Nakamura, T., Oba, J., Chin, T., & Hirata, H. (2019). Cross-sectional international multicenter study on quality of life and reasons for abandonment of upper limb prostheses. Plastic and Reconstructive Surgery. Global Open, 7(5), e2205. https://doi.org/10.1097/gox.0000000000002205

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ndis’ Simptezresponse

For Internal Use Only

Non-limb external prostheses

The content of this document is OFFICIAL.

Research question: Are there any functional benefits to non-limb external prostheses? Date: 30/08/2022

Requestor: “Tm ?nas

Endorsed by:

Researcher: (Erase wand Cleared by: H7F-Pasonal Pie

Review date: n/a

1. Contents Non-limb external prostheses ……………. ccc cece cecceeecceececccccceeceeeeeeeceececeeeeeeseeeeceeeeeeeesaeseeeseeeeeeeeeees 1

2. COMPENES oo cece ee ee eee ceenee eee eeee eects eeeeeueaeeaeeeeeceeeeseeeeeaeeeeeeeeeeeeeeeneeseeeeeeeeess 1

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2.4 Breast ……. eee cece cc ceeeeeeee cece eee eeeeeeeeeeeeeeeeeeeeeeeeseeeeeaeeeeeeeeeeseeeneeeneeeseeeeeseeteeeeneeeeees 2

3. REPEFENCES ooo. eee e cece eee cc cee ec cceeceeeeeceeeeeceeeeeceeeeceeeeeceeeeeceeeeeeeeeeeeeeeeeeeeeeceeeeceeeeeeeeeeeeees 2 30-08-2022 Non-limb prostheses Page 1 of 3

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OFFICIAL For Internal Use Only

2. External non-limb prostheses Research supporting outcomes of facial and other non-limb prostheses is developing. Outcomes measures are generally patient-reported though clinical measures such as infection rates are sometimes used (Jablonski et al, 2021).

2.1 Nasal

Two papers from Becker et al (2016 & 2017) show patients are overall satisfied with both the appearance and function of their nasal prostheses. How stable the prosthesis is during everyday activities may affect performance of those activities. Some evidence indicates that appearance of a nasal prosthesis is comparable to nasal reconstruction. However, this differs between patient self-report and clinician report. Patient’s tend to rate the appearance of their nasal prosthesis higher than plastic surgeons.

2.2 Auricle

Generally, an auricle reconstruction is preferred to using a prosthesis (Ronde et al, 2021a; Ronde et al, 2021b). In a 2017 study, Akter et al found 61 participants preferred auricle reconstruction while only 2 preferred a prosthesis (Ronde et al, 2021a). One study shows an improvement in quality of life and self-esteem for patients receiving auricular prosthesis (Kievit et al, 2013).

2.3 Hair

While hair loss may not have significant implications for physical health, living with a disease which causes hair loss can have an impact on psycho-social functioning and participation in activities. Wearing a wig is a coping strategy for people with alopecia (Montgomery et al, 2017; Weffort et al, 2020). Montgomery et al found 65% of respondents in their study said they would not feel confident to leave the house without a wig (Montgomery et al, 2017).

2.4 Breast

A prosthetic breast may be worn for cosmetic reasons, to improve socialising and self confidence and to improve body balance (Jetha et al, 2017) and can affect quality of life (Hojan, 2020). Evidence that an external breast prosthesis affects balance and posture is inconsistent (Hojan and Manikowska, 2017; Hojan, 2020).

3. References Becker, C., Becker, A. M., Dahlem, K. K. K., Offergeld, C., & Pfeiffer, J. (2017). Aesthetic and functional outcomes in patients with a nasal prosthesis. International Journal of Oral and Maxillofacial Surgery, 46(11), 1446–1450. https://doi.org/10.1016/j.ijom.2017.04.024

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Becker, Christoph, Becker, A. M., & Pfeiffer, J. (2016). Health-related quality of life in patients with nasal prosthesis. Journal of Cranio-Maxillo-Facial Surgery: Official Publication of the European Association for Cranio-Maxillo-Facial Surgery, 44(1), 75–79. https://doi.org/10.1016/j.jcms.2015.10.028

Hojan, K., & Manikowska, F. (2017). Can the weight of an external breast prosthesis influence trunk biomechanics during functional movement in postmastectomy women? BioMed Research International, 2017, 1–9. https://doi.org/10.1155/2017/9867694

Hojan, K. (2020). Does the weight of an external breast prosthesis play an important role for women who undergone mastectomy? Reports of Practical Oncology and Radiotherapy:

Journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation

Oncology, 25(4), 574–578. https://doi.org/10.1016/j.rpor.2020.04.015

Jablonski, R. Y., Veale, B. J., Coward, T. J., Keeling, A. J., Bojke, C., Pavitt, S. H., & Nattress,

B. R. (2021). Outcome measures in facial prosthesis research: A systematic review. The Journal of Prosthetic Dentistry, 126(6), 805–815. https://doi.org/10.1016/j.prosdent.2020.09.010

Jetha, Z. A., Gul, R. B., & Lalani, S. (2017). Women experiences of using external breast prosthesis after mastectomy. Asia-Pacific Journal of Oncology Nursing, 4(3), 250–258. https://doi.org/10.4103/apjon.apjon 25 17

Kievit, H., Verhage-Damen, G. W. J. A., Ingels, K. J., Mylanus, E. A. M., & Hol, M. K. S. (2013). Long-term quality of life assessment in patients with auricular prostheses. The Journal of Craniofacial Surgery, 24(2), 392–397. https://doi.org/10.1097/SCS.0b013e31827fef2c

Montgomery, K., White, C., & Thompson, A. (2017). A mixed methods survey of social anxiety, anxiety, depression and wig use in alopecia. BMJ Open, 7(4), e015468. https://doi.org/10.1136/bmjopen-2016-015468

Ronde, E. M., Esposito, M., Lin, Y., van Etten-Jamaludin, F. S., Bulstrode, N. W., & Breugem,

C. C. (2021a). Long-term aesthetics, patient-reported outcomes, and auricular sensitivity after microtia reconstruction: A systematic review. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS, 74(12), 3213–3234. https://doi.org/10.1016/j.bjps.2021.08.004

Ronde, E. M., Esposito, M., Lin, Y., van Etten-Jamaludin, F. S., Bulstrode, N. W., & Breugem,

C. C. (2021b). Long-term complications of microtia reconstruction: A systematic review. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS, 74(12), 3235–3250. https://doi.org/10.1016/j.bjps.2021.08.001

Weffort, F., Sales Martins, S., Plata, G. T., Duraes, C. T., & Melo, D. F. (2021). Do you know how to recommend a wig to your patient? Journal of Cosmetic Dermatology, 20(3), 724–728. https://doi.org/10.1111/jocd.13602

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Research - Prosthetic Eyes Update

We now need to progress the possibility of prosthetic eye being included under DRHS funding. So we will put a position forward within the Agency. In doing this we would like a your team to undertake some further research around

e The health role that prosthetic eyes perform

e Prevalence

e Further expansion on the mental health / social aspect of having a

prosthesis

Brief e Costing

e Any differences of one eye vs two eyes? (Maybe for the social aspect??)

Update

ls there a Medicare item number for ocular prosthesis? Literature on paediatric population Mainstream services, i.e. hospitals that fund ocular prosthesis or co-fund.

Date 16/07/2021 SATE Personal PY (Director — TAB)

Requester i ond (Assistant Director — TAB) Vision Team — a ie Priacy o47F-Fersonal Paes SA7F-Personal Privacy Researcher i = (Research Team Leader — TAB)

The contents of this document are OFFICIAL

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of

these matters.

Contents

SUIMIMALY ….eseceeceseseceeeseeesecceceeeensnececeeeeeeeseseeeeceusueeseseeeceeeeeeueuececeueaeaseeseseeeeeeseeeseseceuees seeueaeaeeuanseeeeneaeees 2

Role of prosthetic eyes in OCUlar FUNCTION ………cecsssececsseceeesssseeeesseceeceesaececeesaaececsuaeeeecesaeeeeesuaaeceseeeeaaeess 5 Prosthetic Eye …….ccsssccccssssccessssceecessececeeeeeeeesneecsesaaeceeseaaeceeeseaeeceesueeecessnaeceeaaeeeceesaeesens ceeesaeeeseseaaeeeens 6 Scleral Shell/Cosmetic Shell ……cccccccccsssscecsssscssccscceseccscecsecscsecececesececeeeseeceueeeccessecceceeaseseeaueecusaseneasens 7 COMFOFMEL …..cscseccccecessessseceececeeeessnseeeceeceeseeauaeeeeeeceeseaacaeeeseeeeceueasecececeeuusaneeeeceeeeauanseece ceasaeeeeeseeeeesaaaes 7

Research - Prosthetic Eyes Update Page | 1

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Prevalence …………………………………………………………………………………………………………………………….. 8

The social, emotional and physical impact of living with a prosthetic eye …………………………………….. 9

Depression, anxiety and health related quality of life ……………………………………………………………… 9

What effect does receiving a prosthesis have on the patient? …………………………………………………. 9

Gender differences …………………………………………………………………………………………………………… 11

Age and time since injury …………………………………………………………………………………………………… 11

Concerns of patients …………………………………………………………………………………………………………. 11

Prosthesis type …………………………………………………………………………………………………………………. 12

Recreation, occupational and social areas of functioning ………………………………………………………. 13

Costing ……………………………………………………………………………………………………………………………….. 13

Longevity of the ocular prosthesis ………………………………………………………………………………………. 14

Difference between unilateral and bilateral eye loss ………………………………………………………………… 14

References ………………………………………………………………………………………………………………………….. 29

Summary

• Studies which investigate the social and emotional aspect of eye loss and rehabilitation with a prosthetic eye are observational, cross sectionals surveys. These studies clearly show that patients with a prosthetic eye have: o High levels of depression, anxiety and stress – which often improve over time o Top concerns are about appearance (both how they see themselves and how others perceive them), discharge from the eye and motility of the prosthesis

• Following rehabilitation with a prosthetic eye there are significant improvements in self-esteem, psychological health, social acceptance and appearance o More than 80% of patients in one study stated that they did not believe their prosthesis was purely of cosmetic or aesthetic value to them.

• Ocular prostheses meet an aesthetic or cosmetic need but are also functional in that their presence prevents possible complications like: o ulcers, infections, tissue retraction, severe orbital defects, and also the fallen eyebrows, eyelids and forehead that can occur in cavities without eyeballs o They also restore lacrimal dynamics and help the tear-glands partially recover their natural position

• Research in this area is based on the patients perspective, rather than what society’s expectations are.

• In Australia, there is evidence of public hospitals providing funding for prosthetic eyes. Therefore, this support is likely the responsibility of health rather than the NDIA.

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Medicare reimbursement of ocular prosthesis

Ocular prosthesis are not listed on the Medicare Benefits Schedule (MBS) or the Prosthesis List provided by the Department of Health for private health insurers [1]. Ocular prosthesis would fall under products not eligible such as:

• External prostheses, like prosthetic limbs or external breast prostheses
• Surgically implanted devices, not purposely designed for replacing an anatomical body part, or combat a pathological or modulate a physiological process, such as some cosmetic implants.

Funding for prosthetic eyes

Information on the funding of prosthetic eyes through the health system is often not publically accessible. The ACT and Tasmania do state that they provide funding for the support, whereas NSW make it clear that they do not. After speaking to contacts in WA and VIC I was able to verbally confirm that funding does exist through Fremantle Hospital and the Royal Victorian Eye and Ear Hospital. Tasmania is the only state to specifically exclude school aged patients.

State         Funded       Details

(Yes/No)

ACT            Yes            1. Canberra Hospital and Health Services funds the purchase of

the first prosthetic eye, irrespective of where the biological eye was removed.

2. Replacement is funded if the prosthetic eye is more than 5 years old, or is clinically unsatisfactory e.g. irritating, poor fit.

3. Funding is provided only if the remaining biologic eye has been examined within the last 2 years, and clinical information about that examination has been provided along with the request for a prosthetic eye.

   NSW No Funding guidelines states that Prosthetic devices for parts of the

body other than limbs - e.g. Breast, wig, nose, ear, digit, eye, etc. are excluded.

QLD            Yes         Spoke to Director of Ophthalmology at Queensland children’s

hospital. The hospital funds prosthetic eyes for children and the same is done for adult patients through Royal Brisbane and Women’s Hospital.

Research - Prosthetic Eyes Update                                                                          Page | 3

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VIC Yes Royal Victorian Eye and Ear Hospital have a funding scheme.

Eligibility and need for replacement prosthesis is determined by the Ophthalmologist.

SA             Unclear       In a Master’s Thesis by Peter Knowles (with is an ocularist) he

states that some individuals referred through the public system do not pay for their prosthesis. Those eligible for Public treatment is as defined by the SA Department of Health, usually relating to age, pensioner or employments status with no cost incurred.

WA            Yes         Cannot find anything online, however, received information from

a contact in Perth who sent me a photo of guidelines at

Fremantle Hospital

Eligibility

1. Public hospital patients who have had an enucleation/evisceration surgery through Fremantle hospital

2. Public Patients who have had an initial assessment in relation to the fitting of a cosmetic cap performed through Fremantle hospital.

3. Public patients who have had post-operative or anophthalmic orbital management performed in Fremantle hospital prior to recommended referral from Artificial Eye Services.

4. Public patients genuinely requiring late assessment/management of an anophthalmic orbit with a view to active interventions prior to further ocular prosthesis services. Those who don’t the criteria will have to self-fund their prosthesis. However, there may be exceptions for public patients in genuine financial need.

   TAS Yes Pay up to 70% of cost or a maximum of $379.95 per eye for non-

school aged patients. This is under the State-wide Spectacles and Intra Ocular Assistance Scheme.

NT             Unclear      Can’t find any information online.

Literature on Paediatric Population

The paediatric anophthalmic socket, whether congenital or acquired, poses a different set of challenges than that of the adult because of the integral relation of volume replacement and normal orbital growth [2].

At 3 months of age, a child’s face is only approximately 40% the size of the adult face, and by 2 years of age, the face reaches 70% of the adult size [3]. By 5.5 years of age, the paediatric face is approximately 90% of the adult dimensions. Generally, in a child younger

Research - Prosthetic Eyes Update                                                                          Page | 4

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than 5 years requires an implant that can increase in size [3]. A large fixed-sized orbital implant can be placed in children older than 5 years of age [2].

A thesis by Chinnery [4] explored the artificial eye process in children with a diagnosis of retinoblastoma. The study found that those with poor coping mechanisms are more prone to adjustment and acceptance difficulties. How they react to trauma was found to be essential in how participants cope with having an artificial eye fitted [4].

The fitting process and comfort significantly effects the psychosocial wellbeing of the child. Service cuts, lack of training guidelines and the process being time consuming contributed to participant’s feelings of a stressful and at times, traumatic experience [4].

In addition, social dimension scores, school dimension scores, and total scores for the Pediatric Quality of Life Inventory 4.0 Generic Core Scales among paediatric patients with retinoblastoma have been found to be statistically significantly lower than those of healthy children [5].

The lived experience of parents of children with retinoblastoma has also shown that the fitting and management of eye prostheses resulted in challenges that tested parents coping strategies and raised concerns for their child’s future, their acceptance by others and their ability to lead a normal life [6].

Role of prosthetic eyes in ocular function

Every part of the human body holds significance and function; however, the face is particularly unique. It is principally how individuals are recognized and what is recalled when the person is absent. The face communicates perceptions, intensity of emotion, awareness, and ideas. Eyes in particular convey understanding and insight, and have an important role in non-verbal communication and self-expression.

The loss or absence of an eye may be caused due to congenital defect, irreparable trauma, tumour, painful blind eye, sympathetic ophthalmia or the need for histological confirmation of a suspected diagnosis [7]. Surgical procedures in the removal of an eye can be broadly classified as [7, 8]:

• Evisceration - where the contents of the globe are removed leaving the sclera intact

• Enucleation - most common, where the entire eyeball is removed after severing the muscles and the optic nerve

• Exenteration - where the entire contents of the orbit including the eyelids and the surrounding tissues are removed

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An implant is usually placed in the orbit to replace the lost tissues and provide some support for the accessory organs (Figure 1). If the ocular muscles can be attached to the implant, their normal innervation will cause it to move in coordination with the natural eye [8]. If an intra-ocular implant isn’t used post-enucleation socket syndrome can occur. The symptoms of this include:

• Enophthalmos (posterior displacement of orbital contents)
• Deep upper eyelid sulcus
• Ptosis (droopy upper lid)
• Laxity of the lower lid Figure 1. Schematic illustration showing a spherical orbital implant placed in the anophthalmic cavity after enucleation. The orbital implant can be (A) “buried” under the patient’s conjunctiva (“nonintegrated” implant) without any mechanical connection to the ocular prosthesis or (B) connected to the ocular prosthesis by a peg (“integrated” implant). Pegged implants, although allowing a wider range of movements to the ocular prosthesis, are seldom adopted nowadays due to the need for a second surgery for peg placement [9].

Prosthetic Eye

A prosthetic eye is in addition to the orbital implant and fits over the top (Figure 1). A custom prosthetic eye is made with an impression-fitting technique and should move nearly as well as the tissue in the socket, depending on the shape and edges of the prosthesis.

After the loss of an eye, if a prosthetic eye is not soon fitted then the eye socket will begin to close in on itself and the eyelid will droop and not function properly [8]. Ocular prostheses meet an aesthetic or cosmetic need but are also functional in that their presence prevents possible complications like ulcers, infections, tissue retraction, severe orbital defects, and also the fallen eyebrows, eyelids and forehead that can occur in cavities without eyeballs [10-12]. They also restore lacrimal dynamics and help the tear-glands

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partially recover their natural position [11, 13, 14]. A study investigating the electrical activity of muscles following prosthetic rehabilitation has shown that the orbicularis oculi muscles re-establish muscle tone and function after only one week of ocular prosthesis wear [15].

Custom prosthetic eyes have several advantages including better mobility, even distribution of pressure due to equal movement thereby reducing the incidence of ulceration, improved fit, comfort, improved facial contours, and enhanced aesthetics gained from the control over the size of the iris, pupil, and colour of the iris and sclera [16]. These benefits are not gained from wearing an eye patch [12]. Complications can occur from using a ‘stock’ prosthesis [12]. Poor fitting ocular prosthetics can cause socket and lid contraction, ptosis, forniceal shortening, implant migration, and conjunctival/tenons tissue thinning leading to exposure/extrusion [12, 17].

Scleral Shell/Cosmetic Shell

A scleral shell (sometimes called cosmetic shell) (Figure 2) is similar to a prosthetic eye, but is shaped more like a thin contact lens and covers the existing eye [18]. In cases of a non painful blind eye due to phthisis bulbi or microphthalmia with no useful vision; a scleral shell is a good alternative as it can spare the patient from the surgical and psychological trauma associated with removal of the eye [18]. The scleral shell is custom made and covers the entire surface of the eyeball allowing for movements to mirror the sighted eye.

Similarly to a prosthetic eye, a scleral shell medically aids the eye’s function by protecting it against corneal abrasion and assists the effective working of the eyelids.

Conformer

Conformers (Figure 2) help to form the fornices (cul-de-sac) of the anopthalmic or microphthalmic socket. For enucleation or evisceration surgery, conformers are fit approximately 2 weeks post-op to aid in the shaping of the socket for a prosthetic eye or scleral shell [19, 20]. Conformers can help reduce surgical swelling and provide comfort and support for eyelid function. Another purpose of conformers is as a therapeutic prosthesis to expand tissue in cases of microphthalmia, anophtalmia or contracted tissue [19, 20]. Sequential sized conformers can be used to grow the soft tissue and promote bony tissue growth in the orbit. Eye lid function and lengthening of the horizontal fissure opening are major considerations for the use of this type of prosthesis [19, 20].

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Figure 2. Ocular prosthetic types

Prevalence

Indications for enucleation vary between countries and across age brackets. In a study by Kord Valeshabad, Naseripour [21], the most common indication for enucleation in young patients (≤20 years) was retinoblastoma (82%; p < 0.001). Atrophic bulbi or phthisis bulbi (39%; p < 0.001) in middle-age adults, and uveal melanoma (42%; p < 0.001) in older adults.

Over the years, there was a decreasing trend of enucleations for atrophic bulbi/phthisis bulbi/painful blind eye (33% from the years 1996 through 2000 to 7% from 2010 to 2018; p < 0.001) and acute trauma (3% from the years 1996 through 2000 to < 1% from 2010 to 2018; p < 0.001). However, there was an increasing trend for intraocular tumours including retinoblastoma (56% from the years 1996 through 2000 to 73% from 2010 to 2018; p = 0.01) and uveal melanoma (3% from the years 1996 through 2000 to 11% from 2010 to 2018; p < 0.006).

According to the most recent Australian National Eye Health Survey (2015/2016) 2.4% (95% CI, 1.7%-3.3%) of Indigenous and 1.4% (95% CI, 1.0%-1.8%) of Non-Indigenous Australians are unilaterally blind [22]. Enucleation accounts for 8.3% (95% CI 2.6-23.9) of unilateral blindness in Indigenous Australians and 14.6% (95% CI 6.9-28.2) of Non-Indigenous Australians [22]. The accuracy of these estimates need to be evaluated with caution as the confidence intervals are wide and only 10 participants screened had undergone an enucleation. Previous large scale Australian studies have not reported on enucleation, rather including it as a sub-set labelled ‘other’. An Australian Institute of Health and Wellbeing report showed that traumatic enucleation accounted for 0.1% of the 106,306 eye injury hospitalisations between 1999 and 2006 [23].

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The social, emotional and physical impact of living with a prosthetic eye

The impact of living with a prosthetic eye has been extensively researched in the literature. All studies located were observational, cross sectional surveys of low to moderate quality. Those studies rated as low were due to small samples sizes or delivery of surveys that were developed by the authors and not externally validated. Table 1 at the end of the document provides a more in-depth assessment of each included study.

Depression, anxiety and health related quality of life Clinical depression, clinical and social anxiety, and health related outcomes in the ocular prosthesis population has been shown to be highly prevalent [24-27].

McBain, Ezra [26] reported that:

• 18% of the patients were experiencing clinical depression
• 18% of the patients were experiencing clinical anxiety
• 21% of patients reported considerable levels of social anxiety and avoidance in relation to their appearance

Furthermore, a study by Clarke, Rumsey [28] recruited patients across three clinics and found even higher rates:

• 10-45% ‘case’ levels of anxiety

• 3-18% exhibited ‘case’ levels of depression

• 16-45% experienced considerable levels of appearance-related distress and social avoidance

• 21–72% of participants scored below normative levels for quality of life (QoL) It is concerning to note that there seems to be a significant underdiagnosing for both depression and anxiety disorders (p < 0.001, respectively) within this population [29]. Unsurprisingly, depression (p =.012), anxiety (p = 0.001) and stress (p= 0.006) have been found to be significantly positively correlated with appearance anxiety [25].

In the study by James, Jenkinson [24] Anophthalmic patients scored lower in all categories (body pain, general health perception, mental health, physical functioning, role function emotional, function physical, vitality, social functioning) of SF-36 compared with controls.

What effect does receiving a prosthesis have on the patient? Scores for anxiety and depression have been shown to be significantly lower (p <0.05) following prosthesis rehabilitation in various studies [30, 31]. This indicates that the

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negative emotions (anxiety and depression) due to anophthalmia improve significantly after orbital implant insertion and prosthesis wearing [31]. In addition, QoL domains have been shown to improve following rehabilitation with a prosthetic eye [31].

Overall rates of patient satisfaction with ocular prosthesis have been shown to be high [32, 33]. Furthermore, improvements in psychosocial awareness following rehabilitation significantly improve feelings of shame, shyness, personal relationships, preoccupation with hiding it, sadness, insecurity and fear [30].

A thesis by Knowles [34] explored the psychosocial and social impact of eye loss at the time of eye removal and following the delivery of prosthesis delivery. At the time of eye loss, 50.7% experienced extreme feelings of anger, 54.9% experienced extreme sorrow and 44.3% reported feeling extreme frustration.

Upon receiving their first prosthesis participants reported:

• Extreme happiness – 52.1%

• Extreme emotions of relief – 52.1%

• Felt healed – 42.3% Feelings with current prosthesis:

• 40.8% felt they look extremely attractive with their prosthesis

• 38% felt an improvement in their appearance whilst wearing their prosthesis

• 80.3% stated that they did not believe their prosthesis was purely of cosmetic or aesthetic value to them.

• 76.1% of respondents stated that their prostheses contributed greatly to their self- esteem

• 67.6% responded that their prosthesis contributed to their psychological health in a major way

• 60.6% stated that their prosthesis made them feel much better about social acceptance

Feelings when not wearing their prosthesis

• 77.5% reported feeling extremely unattractive without their prosthesis in.

• 71.8% reported feeling extremely uncomfortable without their prosthesis in.

• 57.7% of participants reported feeling extremely insecure whilst not wearing their prosthesis

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Gender differences Various studies have found differences between genders when it comes to coping with the loss of an eye and appearance related concerns.

• Females who were married or those with children had lower QoL [27]

• Female experience greater levels of general anxiety [24, 29]

• Reported higher levels of [24, 29, 35]: o Distress and dysfunction in relation to their appearance o Placed more value on their appearance o Compared their appearance more often with others o Evaluated their appearance more negatively

• Females develop greater psychosocial awareness after rehabilitation with a prosthetic eye (P = 0.01) [30]

Age and time since injury There are differences in terms of age at time of eye loss and the emotional response over time.

Younger patients experience significantly more negative feelings compared to older individuals.

Pine, de Terte [36] found that:

• Participants who lost their eye due to an accident, as opposed to a medical condition, were younger and initially had stronger negative feelings.

• Younger participants (especially adolescents) initially had stronger negative feelings, but at least two years later, eye loss at any age produced similar (much reduced) negative feelings.

In addition, Pine and Pine [25] found that socially isolated younger prosthetic eye wearers who have recently lost their eye and who worry about their appearance are more likely to be depressed.

In contrast, the older participants were when they lost their eye, the lower was their current concern about appearance (p = 0.007), and the greater was their initial concern about visual perception (p = 0.003) [35]. A significant negative correlation was also found between age and measures of appearance (P<0.01) and salience (p 0.03), with older participants experiencing less distress and dysfunction, as a result of their appearance and considered appearance to be less important [24].

Concerns of patients At the time of eye loss, the five main concerns of participants were [37]:

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• Health of the remaining eye
• Change in appearance
• Comfort
• Colour of the prosthesis
• Movement of the prosthesis However, after at least two years these concerns reduce significantly (p < 0.05).

The main present-day concerns have been shown to be [37]:

• Watering

• Crusting

• Discharge - which was experienced by 81.1% of the participants, 55.5% of them on a daily basis

• Appearance (79% [24] and 95% [26] – leading to social anxiety and avoidance of social siutations. o There is a small cohort who feel their appearance is improved as the prosthesis “is a great change from my previously damaged eye”[35]

Prosthesis type Comparison of experiences and satisfaction between prosthetic eye and cosmetic shell wearers has been compared in two studies [18, 32]. In the study by Shapira, Worrell [18], comfort and adjustment to prosthesis wear were similar between groups, however, appearance (p=0.032) and motility (p<0.0001) were found to be significantly superior for those wearing a cosmetic shell. In comparison, Hatamleh, Alnazzawi [32] found that artificial eye wearers were significantly (p <0.05) likely to agree with statements regarding the comfort, appearance; patient’s expectations, self-esteem and perception; and cooperation with their ocularist. These dissimilarities are likely due to sample size differences between studies (1198 Vs 126). However, overall patients had a very high satisfaction rate no matter what the prosthesis type.

A comparison of immediate post-operative clear conformers compared to temporary, cosmetic, painted prostheses was conducted by Avisar, Norris [38]. The most commonly used conformers are transparent, the advantage being that the wound can be seen easily by the clinician with minimal manipulation. This transparency, however, can cause embarrassment. Some patients consider visualisation of the underlying socket unsightly and the conformer does not resemble the contralateral eye. Results showed that 68.7% of adults and all children (100%) did not wear any patch/dark glasses after surgery due to improved appearance of the temporary painted prosthesis. Overall, 90% of respondents expressed a definite preference towards the painted shell over a clear shell.

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Recreation, occupational and social areas of functioning Pine, De Terte [39] explored the impact of eye loss on recreational, occupational and social

areas of functioning. Participants with recreational difficulties reported significantly stronger negative feelings than those without difficulties (p< 0.001). Those with recreational problems were also significantly more concerned about their appearance and visual perception.

Prosthetic eye wearers who reported experiencing social problems had significantly stronger negative feelings than those without (p< 0.001). Those with social difficulties also had significantly higher discharge, appearance and visual perception concerns than those without

Prosthetic eye wearers who have experienced employment problems reported having significantly stronger negative emotions than those with no employment problems (p< 0.001). They were also significantly more concerned about appearance and visual perception than those without employment problems.

Costing

Three quotes were obtained from three different states e All quotes cover consultation, manufacture, fitting and adjustment e All businesses contacted were members of the Ocularists Association of Australia

e  |t was clearly advised that there is a flat cost and that the prosthesis is tailor made to

the clients’ requirements regardless of any other conditions or complications.

Business Details Quote & Other Details

NSW $2150.00

James Morphett

Artificial Eyes

20 Macquarie Street

Parramatta NSW 2150

(02) 9633 9481

Email morphett-eyes@bigpond.com Telephone: Sydney 02 9223 8899 www.artificialeyes.net

Person Contacted: James Morphett

Research - Prosthetic Eyes Update Page | 13

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QLD $1998.00

Artificial Eyes Also advised prosthesis would Level 11 normally require clean and Watkins Medical Centre polish every 6 to 12 months of 225 Wickham Terrace which there is a charge of Brisbane QLD 4000 $65.00 Phone: +617 3832 1171 Email: admin@artificialeyes.com.au www.artificialeyes.com.au

Person Contacted: Annette Watts

WA $1900.00

Artificial Eye Services

Suite 12, 1329 Hay Street

West Perth WA 6005

Phone: +618 9322 5576 Email: paul@geelen.com www.geelen.com.au

Person Contacted: Emily Geelen

Longevity of the ocular prosthesis Over the years, the cavity and surrounding tissues may change so that the ocular prosthesis no longer fits well; this can induce tissue hyperplasia [11]. Furthermore, the material of the prosthesis becomes more porous, encouraging bacterial growth, increased secretion, a ‘foreign-body’ sensation and discomfort [11]. Ultimately, these factors favour the onset of chronic conjunctivitis [40, 41] and so it is clear that an ocular prosthesis does not have an endless useful life. Although there are no specific articles addressing this issue in the scientific literature, there seems to be general agreement that the life-time of a prosthetic eye is between 2 and 6 years in an adult, depending on the patient’s age, occupation, care of the prosthesis and its constituent materials [11, 40, 41]. Due to the fact that all patients are different, regular yearly check-ups are very important to review the fit and condition of the prosthesis.

Difference between unilateral and bilateral eye loss

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Literature investigating differences between unilateral and bilateral enucleation is scant. A study by Friedman, Chou [42] found that a history of bilateral retinoblastoma (including a cohort of bilateral enucleation) was associated with inferior overall vision-targeted health related QoL. In contrast, Ford, Chou [43] reported that bilateral retinoblastoma survivors were no more likely to have depression, anxiety, or somatic complaints than unilateral survivors. These too papers are limited by the fact that they don’t separate bilateral disease from bilateral enucleation. Therefore, we cannot generalise these results to the cohort that have both eyes removed.

In the thesis by Knowles [34], only 3% of participants had bilateral prosthesis. Performing a sub-analysis based on this characteristic would lead to unreliable results/comparisons due to the potentially small sample size.

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Table 1. Literature Review

James,

Jenkinson

[24]

To determine the

psychosocial and

appearance-related concerns of a sample of

ophthalmic patients by measuring a range of psychological, social, and demographic factors.

Observational - Cross sectional survey

98 participants attending ophthalmic outpatient clinics in

either London, Bristol, Sheffield

or Bradford.

Outcome measure

e Hospital Anxiety and

Depression Scale

(HADS)

e Appearance-related social anxiety and social avoidance, as measured by the Derriford

Appearance Scale

(DAS24)

e Physical Appearance

Discrepancy

Questionnaire (PADQ)

e Valence of Appearance scale (CARVAL)

e = Salience of Appearance scale (CARSAL)

e lowa-Netherlands

Comparison Orientation

measures (INCOM)

62% were female and 81% were white

For 79% of participants, the eyes were their main area of concern in regards to their appearance.

The DAS24, anxiety, and depression mean scores were within the normal range. However, standard deviations and ranges indicate that the variation in scores between participants was considerable with some patients experiencing considerable levels of generalized anxiety.

Significant negative correlation was found between age and the DAS24 (P<0.01) and salience (p 0.03), with older participants experiencing less distress and dysfunction, as a result of their appearance and considered appearance to be less important.

Female participants were found to experience greater levels of general anxiety, reported higher levels of distress and dysfunction in relation to their appearance, placed more value on their appearance, compared their appearance more often with others and evaluated their appearance more negatively.

Low/Moderate

Exploratory, cross sectional, and with a modest sample size.

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of

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Anxiety  discharge OFFICIALFOI                                                                                                                                           Page

and                                                                                      and                                  21) and                                                                                  21) and                                                                                                                 study                        ocular                                                                                                                                               years                                                            or   29                                                                                   (SAAS)       (SSQ)                                                                                                                                                                                                                                                                    (SAAS)       (SSQ)                                     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Pine Prosthetic

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Pine [25] Research

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on         social                                                  of                                                                                                                                  (a)                                                                                   impact      wear                                                        and                                                                       to:                                                                                                                                                                                                                                                                                                                                                                                                                                                                          prosthetic in                                                                                                                                                                                                                                                                                                                                                                     concerns                                         the and eye                                                                                                                                  are                                                                                                                                                                                                                           functioning                                                                       the                                                            loss                                        of                                                                                                                                                                             aims                   wearers                    Update                                                                                                 explore eye                            To of  prosthetic   recreational,   occupational areas                                                                   The  identify  experienced eye             Eyes

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FOI                                                                        of                                            Page

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Norris Prosthetic

Avisar, [38]           -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Research

size. recall

less                                                                                                                              tools.                                                                                                                                                            sample          to                                                                                                                                                                                                                                                                                      cross-sectional

big

lead          to                                                                               with  validated                               likely bias.                                                                                                                                 Moderate   Exploratory, study Used

a

any used            had                                                                                     had      both                                                       felt                                                                           (8.8%)                                      until                                                                                                       with                              non-                                                                                                   shell                                                                                                                                                                                                                              health                     wear                                                             present was                                                                                             for                                                                                                                                                                                                                                                           mental                                      the                                                                               years).  patients                                                                                                                                 and                not  (12.5%) patch of               was                   clear          31          (13.6%)                                     respectively).                                                                                                                                                                                                                          patients                                                                                                              patients   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definite                                                                                                                            18–95                                                      26                                                                                                                                                                                                                                                                                                                                                         associated                   a                                                                                                                                                                                                                                                                                                             degree,                                                                                                                             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of                                                                                                                            62.54                       and                                                                                                                                                                                                                                                                   related and                           associated                                                                                       their                                             glasses                                                                                                                                           towards                                                              to and                                                                                         prosthesis       (50%)       stock degree                                                  of  (67.1%)                                                                                                                                     eye                119                                    (68.7%)                                                                                                             only  anxiety                                                        90%                                                                                  had                                                                                                                                                                                  prostheses.                                                                                                                                                                                                                                                  anxiety  patient                           patient                 functioning,             of                                                                                                    movement                                                                      with                                                                          age 295                                                                                                                                                          seems                                                      glasses                         same                                                                                           participants   of      only  depression                               adults                                         patients               both                                                                         11125/26-0594          11  patch/dark dark  permanent   unsatisfactory 26 better  temporary that in better  Overall,  preference        295 Mean 198  (10.5%) had both There  depression         Higher higher  appearance   functioning,         Higher   significantly health  traumatic        OFFICIAL                                                                                                                                                                                                                                                                                 OFFICIAL

FOI               a                     a                                                                                    Page

of of

for                                                                 from of                                                                                                        over                                            asked               and                                                                                                         using                                                                      cost (iii)                                                                              age                                                                                                                                                                                                                                                                                                                           anxiety-                                            vision-                                    orbital  implant             addition,                              (ii)                                              sectional                                                                                                                                                                                                                                         general                                   diagnosed                                                                                                                                                                                                                                                                                                                              health-

in                                                                                                                                        glass                              were and                                              socket                                                                                                                                                                                                                                                                                                                                                                                                                                                          evaluation       life,                                                                                 painted,                                         reported          finally  acceptance

a                                                                                                                      Cross      were                                     and                           and                                                                                             of                                             orbital                        -                                as                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      standardized                                                                                                                                          data                                                                                                                                                                                                                                                                                                                                                                                                                 three-section                                                                                                                          review,                                                                                                         related                                                                                                                                                                                                                                                                           already                                                                                                                                                                                                                   prostheses                                      (iii)                                                                                                                                                                                                                          cryolite             an                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          questionnaires            anxiety,                                                                                                                                                                                                                                                                   history                                                                                                                 prosthesis                                               secondary                                                                                                                                                                                                                                                                                              patients                                                                                                                             six                                                                                                                                                                                                                                                                                                            requested                                                             stock,                                                                            of                                                                                                                  eyes               or                                                                                                              measures                                    - 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Observational survey  Inclusion 18,  prosthetic                 Standardized   questionnaire  Section  demographic  Section about  treatment active  related  Section  established the  depression,  related

in with identify

or in                                                                                                                                                                     anxiety levels                               define                                                                     to                                                              to                                                      adults.                eye                                                                                                                                                                                                                         eye–wearing                                                                                        healthcare                                                                                                       and          of  surgery and                                                                                             using                                       associated                                                                                                                                                                                                                                                                                                                                                                                                                                                 psychological                                                                                                                                                                                                                                                        depression                                                                                                                                                                                                                                                                   investigate                                                                                                                                                                                                     Update                                                                                                                                                                                                                                                                                                                                 potential                                    removal socket  children                              To and  prosthetic  patients   standardized   psychometric   instruments,  factors these  diseases, a gap.                                                                Eyes

[29] Prosthetic

Heindl,  Trester                               -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Research

size. statistics

reviewed. sample                                                                                                                                                                     descriptive                                  Low  Non-peer  Reasonable Only used.

the

18.3% the                                                                  but the                                                                                                        only                                      52.1%                                at                                                                                                                                                                                                                                                                           feeling                                                                                                                                                                                   reported                                                                                                                                                          21.1%                                                                                          whilst age                                                                                                                                                                    towards             their  appearance                                                                                                                                                            whilst                                             whilst                                                   emotion.                                                                                                                                                                                                                                                                                                                                                                  ‘healed’,                                                                                                                40.8%                                                              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                                                                                                                   feelings                                                                                                                       sorrow                                                                       of                                                                                                                                                                                                                                             received extreme                                                 due                                                                                                                                                                                                                                           acceptance             level                                                                                                                                                                                                                                                                                                                                              analogue                                                                                                                                                            extreme                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                dysfunctional                                                              of                   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|                                                                                                                       when          extreme                                                                                                             high                                                                                                                                                                                                                                                                                                                                                                                                              extremely an  prosthesis.                                                                                                                                                                                                                                                           visual                           a                                                                                                         extreme                                                                of                                                                                                                                           extreme             level                                                                                                                                                                                                                                                                                              emotions                                                                                                                                  possibly                                                                                                                                                                                                                                                              Page        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                                                                                              Page

18 give

of   to the                   and                                                                                                                           0-10                                        in                       socket                        suffering                                                              of                       and                                   sectional        age                                                     social                                                                                                                                                                    methods                          life,                                            were: the                                                               Cross                                         declined                                    serious                         scale  structured

of                                                                                                                                                                                                                                                  varying                                                                     distress,             -                       study.            involved              Australian                                   developed  patients                                                                                                                                                                                                                                                                                                            different on                                                                                                                        criteria under                                   of who be                with                                short

to                                    quality                                                                                                               using     on                                                                      time                                                                                                   analogue                                                                                                                                                                             based                                                                                                                       loss                                                                                                                                  Patients the  Patients                           Indigenous            Patients                                    related    appearance-related   psychological    appearance-related   interactions.  Thesis   Observational survey  Exclusions 1) at 2)  consent study. 3)  patients. 4)   complications.   Questionnaire  trialled eye Visual and/or  interviews, used   circumstances.

the social on and loss data eye

collect   of                                                                                                                                                                                                                                                                              Update                       To   psychological impact                                                                                                                                                                                    Eyes

[34] Prosthetic

Knowles Research

examination objective cross-sectional

of verify Lack

to                                                                                                                                                                                                                                                                                                                                     Moderate   Exploratory, study. data  measures.

was                                                                                                                                  their                                      their                   238

to                                                                                                         without                     insecure                              madeit             to           much             while                                                                               without                                                                                                       feel                                             looking  looking                                                                                                                                        prosthesis                                                                                             eye’,

as as                                                                                                                                                                        extremely             their                               believed                                        them                                                                                                                     them.                contributed                                       prostheses                             contributed                          them them                                               to           they                                                                                                                                        unattractive                                   uncomfortable                                                                                                                                                          their                         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                                           described                                                                                                                                                                       wore  shell’.                                                                                                                                                                                                      prosthesis                                                                          major                                                                                                      extremely                        extremely                                                                                                                                                                                                                                                                                                                                                  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       Page                                                                                                                                                                                                       better.                       say                   feeling in.          feeling in.                                                                                                                                                                                                                                                                                                                                                                                                   ‘cosmetic

a                                                                                                                                                                                                                      health      that social                                                                                                                                                                                                                                                                                                                                                                                                                                                                            respondents                          that                                                           that                   whether 77.5%                           greatly                                                                                                                                           wearing                              much                                                119                                      42.6%                                                                                                                        participants                                                                      cosmetic/aesthetic                                                                     respondents                                                                                                                                                                            wore             of                                     of not         stated of       asked      look                                                              of                        responded                stated about   respondents                                             feeling                               reported  prosthesis            reported  prosthesis                                                                                                                                                                                                                                                                                                     (79.4%)                                                                                                           11325/26-0594                                36.8%  ‘normal’.  excellent.       77.5% their       71.8% their       57.7% whilst       80.3% purely      When  appearance, them       76.1%  contributed       67.6%   psychological       60.6% better 1198 951  (19.9%)          Comfort        OFFICIAL                                                                                                                                                                                                                                                                                 OFFICIALFOI                                                                                                                                           Page

across sectional Cross delivered

• survey sites. Observational survey National 40

to

unique         versus                                                                                                                                                                                 (CS)                                                                                                                          the  related (AE)

shell

compare    eye                                                  Update                                                                                 To  experiences  artificial  cosmetic wear.                     Eyes

[18] Prosthetic

Shapira,  Worrell                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Research

was

No   it                                                                                                                                                                                                                                                                                              internal                                                                                                                                                                                                        survey                                               developed                                                                       an                                                                                                                                                                                                                                                  whether                                                                                                                                                                                                                                                                                                                                                                                                                                                                               cross-sectional  sample.                                                   experts.                                                                              how or            process.

of                                                    of                                                                                                                                                                small                                                                                                                                                                                                                                                          through                                panel                                                                    Questionnaire by                                                                   Low   Exploratory, study,  mention  developed went  validation

into                when                                     CS          to          an                           be        in 64.7%          AE                              is

to          by                                                                                                                                                                their                     with                                                                                                               adjust                   statistically                       CS  (p=0.032),                                                                                                                                                                                                                                                                                                                                                   prosthetics all                                                                                                                                                                                                                                                                 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                                          higher                                                                                                                                                                                                               them).                                                           was  respondents                                                               respondents,                                                                                                                                                                                                                       among                                                                            in                                                                                                                                          respondents                                                                          has                          their                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                statistically                                                                                                                                                                                 type                                          CS                                                                                                                                                                                                                                                                                    wearers         covers          CS  81.41±1.45                                                                                                                                                                                                                                                  significantly                                                                                                                                                                                                                                                                                                                                                                                                                self-esteem,                         AE         (44.5%                                                                                                                                                                       that                                          of           that  slightly  difference                                       realistic;             vs                       ranked                                                                                                                           with                and                                                                    reporting                                         motility                                                                                                                                                                                                                                                                                    perceive                   shell                                                                                                                                                                      their                                                  with                         rated                                                                                                       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                                                                                                                     with    eye                                                                                                                                                                                                                                                               (p=0.17).                  satisfaction                              by                                               to    the                                                                                                        and    eye                                                                       of                                                                                    an                                                                                                                                                                                                                          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Appearance  Appearance  respondents with  excellent              Prosthesis  Prosthesis  (p<0.0001). of             Adjusting   Self-reported  wearing   respondents;  significant 126 Very   (comfortable   expectations,  society,              Artificial higher  compared         Having  associated  regardless        OFFICIAL                                                                                                                                                                                                                                                                                 OFFICIALFOI                                                                                                                                           Page

of

on        and                                      and                           was                                                                                                                                                                                  assessed                          years                                                                                                                                                                                                                   sectional                                                                                                                                                                                         views          18                                                                              was                                                  panel                                                                                 and                                                                                                                                                    Cross                                       statements                                                                     cooperation          a                   -                                    aspects                                                                                                                                                                                                                                                                                                                                                                                                                                                               self-esteem                     were                                                                                                                                                                                                                                                                                                                                                                  patient’s                    by  experienced   prosthetists  specialists                                                           The                                                                                                                             and                                                                                                                                                                                                                                                                                                        patients                       of                                                                                                                                                                                                                  closed-end                           comfort                who                                   questionnaire                       8                                                                                                                                                                                                                                                                                                                                                                                                 satisfaction                   various                                       older.                                                                                                                                                                                                                                                                                                                                                                                                                                              ocularist.             or                                          Patients age       items37  constructed  consisting   maxillofacial   oculoplastic                                                                                                                                                                                                  Observational survey  Patient  through  statements.  reflect  concerning  prosthesis  appearance;   expectations,  perception; with

ocular                                                                                                                                                                      cross        of                                                                                                                                                                                                                                                                                                                           patients of  managing  prosthesis                                                                                                                                                                                                                                                 various  variables                                                                                                                                                                                                               patient with and and                                                                     of                   satisfaction.                                                               evaluated.                                                                                                                                                                  ways and                                                                                                                                                                                         their  complaints    the                                                                                                                                                                                                                                             evaluate                                                                          ocular also                                         Update                                                           To   satisfaction  prosthetics  association  tabulation   aetiological with The   anophthalmic and  wearing their were                           Eyes

Prosthetic

Hatamleh,  Alnazzawi [32]                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Research

status work or age retired) gender, or 28

|

Page                                    between                                                                unemployed                                                                                            119

of                                                         differences                                                                                                           11525/26-0594          No  (working,        OFFICIAL                                                                                                                                                                                                                                                                                 OFFICIAL

FOI          of                                                                                                                              Page

as                                    options and                     services

3                                                         rated  ‘‘good,’’                                       agree,                                                                                                                                                                                                ‘‘excellent.’’                had                                             also                                         and                                                                                                     prosthetic                                             were                                                                                                                                                      ‘‘average,’’                                                                moderately                                            good,’’                                               statement                                                             ocular                     Each agree,  disagree.    The  provided  ‘‘poor,’’ ‘‘very

Update

Eyes

Prosthetic

Research

Revision History

Revised Research

Revision = Register No. Summary of Revision

1 16/07/2021 2020/0146 NED20/466244 New request for literature on paediatric population, Medicare item number for prosthetics eyes and information on mainstream services.

References

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7. Pavaiya A, Saumyendra Singh V, Chand P, Raghuvar Singh D. Fabrication of an Ocular

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9. Baino F, Verne E, Fiume E, Peitl O, Zanotto ED, Brand&o SM, et al. Bioactive glass and glass- ceramic orbital implants. International Journal of Applied Ceramic Technology [Internet]. 2019 2019/09/01; 16(5):[1850-63 pp.]. Available from: https://doi.org/10.1111/ijac.13236.

10. Clauser L, Sarti E, Dallera V, Galié M. Integrated reconstructive strategies for treating the anophthalmic orbit. Journal of Cranio-Maxillofacial Surgery [Internet]. 2004 2004/10/01/;

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11. Bonaque-González S, Amigó A, Rodríguez-Luna C. Recommendations for post-adaption care of an ocular prosthesis: A review. Contact Lens and Anterior Eye [Internet]. 2015 2015/12/01/; 38(6):[397-401 pp.]. Available from: http://www.sciencedirect.com/science/article/pii/S1367048415300059.

12. Cevik P, Dilber E, Eraslan O. Different Techniques in Fabrication of Ocular Prosthesis. Journal
    

of Craniofacial Surgery [Internet]. 2012; 23(6). Available from: https://journals.lww.com/jcraniofacialsurgery/Fulltext/2012/11000/DifferentTechniquesinFabricationofOcular.48.aspx.

13. Goiato MC, de Caxias FP, dos Santos DM. Quality of life living with ocular prosthesis. Expert Review of Ophthalmology [Internet]. 2018 2018/07/04; 13(4):[187-9 pp.]. Available from: https://doi.org/10.1080/17469899.2018.1503534.

14. Goiato MC, Mancuso DN, Sundefeld MLMM, Da Motta Gabriel MB, Murakawa AC, Guiotti AM. Aesthetic and functional ocular rehabilitation. Oral Oncology Extra [Internet]. 2005 2005/09/01/; 41(8):[162-4 pp.]. Available from: http://www.sciencedirect.com/science/article/pii/S1741940905000294.

15. Goiato MC, Santos MR, Monteiro BCZ, Moreno A, Bannwart LC, Filho AJV, et al. Electrical activity of the orbicularis muscles before and after installation of ocular prostheses. International Journal of Oral and Maxillofacial Surgery [Internet]. 2015 2015/01/01/; 44(1):[127-31 pp.]. Available from: http://www.sciencedirect.com/science/article/pii/S0901502714003804.

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