Specialised driving lessons

DOCUMENT 1 FOI 24/25-1212

Specialised driving lessons

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: 1. How many hours of specialised driving lessons is generally required for an individual with a disability to learn how to drive and attain their driver’s license? How does this vary between disability populations (e.g. ABI, Stroke, ID, ASD)? 2. What is the best practice approach for a driver rehabilitation program, are there any guidelines regarding the frequency of driving lessons and frequency of Driver Trained Occupational Therapist review/re-assessment? 3. What are the factors which determine successful attainment of licensing, especially for individuals with cognitive impairments? Date: 01/12/2022 Requestor: Melody [s47F- personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) Endorsed by: Katrin s47F- personal priva Researcher: Aaron [s47F- personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) Cleared by: Stephanie s47F- personal privacy Review date:

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1. Contents Specialised driving lessons ………………………………………………………………………………………….. 1

2. Contents ……………………………………………………………………………………………………….. 2

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

4. Guidelines ……………………………………………………………………………………………………… 3

5. Evidence for on-road driving lessons …………………………………………………………………. 4 4.1 General ………………………………………………………………………………………………………. 4 4.2 Autism Spectrum Disorder …………………………………………………………………………….. 5 4.3 Traumatic brain injury …………………………………………………………………………………… 6

6. References ……………………………………………………………………………………………………. 6

7. Summary This paper focussed on on-road driver training interventions for people with cognitive or emotional concerns which impact their driving. There is very little evidence evaluating on-road driving lessons despite this being one of the most widespread interventions used for driver training and rehabilitation. Lack of evidence for on-road driving lessons is a known issue for researchers and driver trained occupational therapists (DTOTs) and is frequently remarked on in the research literature. Relevant studies have been conducted for drivers with Autism Spectrum Disorder (ASD) and traumatic brain injury (TBI). Surveys of driving instructors suggest learners with ASD may require 20-40 formal driving lessons. Evidence shows that while most people with TBI can return to driving, those who require additional training need on average seven 2hr formal driving lessons. Researchers have explored for other cohorts (stroke, mild cognitive impairment, psychosocial disability) but available studies were either exploratory (e.g., describing driver profiles) or examined other interventions (e.g., simulator training, driver education, physical rehabilitation etc.). While there is consistent evidence that suggests people with disability take longer to get their license, any quantified results are based on very few studies and should be treated with caution. No guidelines were found which offered recommendations for duration, frequency or number of driving lessons for people with cognitive or emotional concerns that might impact their driving. In response to lack of evidence, guidelines stress the need for individualised interventions which account for the learners’ specific needs.

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3. Guidelines Database searches uncovered no published guidelines recommending an overall approach to frequency or duration of specialised driving lessons, reviews or reassessments for people with cognitive or emotional concerns that might impact their driving. Assessing fitness to drive is a collaboration of AustRoads and the National Transport Commission and provides guidelines for determining when a driver with some medically relevant impairment meets licensing requirements (AustRoads & National Transport Commission, 2022). This includes required frequency of reassessment after a person has obtained their license. For example, reassessment may be more frequent if a driver has a progressive condition. However, Assessing fitness to drive does not provide recommendations around frequency of reassessment for drivers prior to obtaining their license. Nor does it provide guidelines around frequency or duration of lessons or rehabilitation strategy for drivers wanting to gain or regain their license. In fact, the guidelines state explicitly, “there is currently limited evidence to support the use of particular rehabilitation or retraining strategies” (AustRoads & National Transport Commission, 2022, p.23). VicRoad’s Guidelines for Occupational Therapy Driver Assessors (VicRoads) does include some recommendations around driving lessons. VicRoads says, for instance, that driving instructors need to “use appropriate training methods to accommodate the driver’s past experience, current skill level and communication/impairment needs” (p.33). This might involve specifying number of lessons or recommending a duration of lessons. However, the guidelines do not specify how the DTOT’s should recommend frequency or duration of lessons. Queensland’s Controlled Environment Driver Training Guidelines (Department of Transport and Main Roads, 2021) emphasises responding to individual learner circumstances and does not make recommendations around frequency or duration of lessons: … consideration should be given to offering flexibility of approach and adapting learning principles to the needs of individuals, including those students with physical or mental health challenges. Driver trainers are not expected to conduct clinical assessments of special needs or challenges, but as educators there is a responsibility to be sensitive to these issues and to try to respond to them. Unfortunately, there is little research and evidence to prescribe specific driver training techniques for students with special needs; however, the key principle is to try to understand their circumstances and be as flexible in the conduct of training and communication methods as is reasonably practicable (2021, p.11). The UK’s National standard for driver and rider training (National standard, 2020) outlines what a driver instructor should know when training learner drivers. It describes a client-centred approach which responds to individual needs and takes into account to prior knowledge and experience of the learner. It does not provide guidance on frequency or duration of lessons.

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4. Evidence for on-road driving lessons There is a notable lack of evidence regarding the efficacy of on-road driving lessons for people with disabilities. A 2014 systematic review of occupational therapy assisted driver rehabilitation notes: while it is our experience that the most common intervention approach used in clinical practice is a series of lessons with a driving instructor, we were unable to identify any studies that evaluated this intervention approach. This kind of intervention has received very limited description in the literature which may be due to the heterogeneous nature of the training provided. (Unsworth & Baker, 2014, p.112) While there is some efficacy data published since 2014, the lack of evidence of on-road driving lessons for people with disabilities is noted in almost all studies referenced in this paper (AustRoads & National Transport Commission, 2022; Berndt et al, 2022; Vindin et al, 2021; Department of Transport and Main Roads, 2021; Dun et al, 2020; Sangrar et al, 2019; Wilson et al, 2018; Lindsay & Stoica, 2018; Unsworth et al, 2015; George et al, 2014). For example, as recently as 2021, Australian researchers in Perth and Sydney could claim to have completed the first experimental on-road driving training intervention study for people with ASD (Vindin et al, 2021, p.3708).

4.1 General In a recent interview-based study of Australian DTOTs looking at self-reported clinical reasoning regarding recommendations for interventions, Berndt et al note that: Participants asserted that peer-reviewed scientific research evidence for particular driver rehabilitation interventions was sparse, so they often deferred to clinical judgment and experience to guide practice. In the absence of specific driver rehabilitation intervention research evidence, general evidence was transferred across to a driver rehabilitation context, applied and then evaluated (Berndt et al, 2022, p.442). Unfortunately, the authors do not elaborate on what this general evidence consists of. Participants reported factors related to on-road driving lessons as crucial to their decision making. For example, participants noted that in order to determine whether a skill was acquired, they needed to observe the skill being implemented across multiple lessons, rather than just once during an assessment. Responses also imply that a DTOT will create a hypothesis about the learner’s driving ability and then test the hypothesis over multiple lessons. Breault et al (2019) found young learners with disabilities took longer on average to learn to drive compared to young people without disabilities but did not provide details about average duration or frequency of lessons. In their review, Sangrar et al (2019) found interventions including in-vehicle training could reduce driver errors and improve control of vehicle for older drivers. However, as the

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interventions generally included multiple components (e.g., simulator training and group education) it is unclear how much of the effect could be attributed to on-road lessons. Also, the on-road component of training in these studies was generally limited to one or 2 sessions. Similar findings for older drivers were reported by Castalucci et al (2020). Beanland and Huemer (2021) raise the same concern regarding one- or 2-day driver training programs for all post-license drivers.

4.2 Autism Spectrum Disorder A 2019 systematic review reported on 3 papers recommending strategies to assist people with ASD to drive. Strategies included shorter lessons, repetitions of lessons and regular, frequent and consistent lessons (Lindsay, 2019). The necessity for repeating lessons could be a reason people with ASD often take longer to learn to drive (Tyler, 2013). The use of frequent repetition of lessons was supported in two publications reporting on an interview-based study of driving instructors (Myers et al, 2019; Myers et al, 2021). These studies always noted other specific strategies around duration and frequency of on-road driving lessons. One driving instructor suggested a typical pattern was 24hrs formal instruction from a driving instructor/OT plus another 200 hours of driving practice with parents/carers. Others described requiring 3 to 4 times more hours of on-road practice for people with ASD compared to those without. The authors suggested lessons can continue for 2-3 years. Instructors often recommended a course of driving lessons, followed by months or years of on- road practice with informal supports. During this time students were instructed to work on foundational pre-driving skills (e.g., learning to ride a bike or catch public transport independently) after which they may return for another course of driving lessons. Participants in the Myers et al study predicted that around 30% of their students eventually got their license (Myers et al, 2019; Myers et al, 2021). This is consistent with evidence that 1 in 3 young people with ASD acquire their driver’s license (Curry et al, 2018). In 2018-2019, an Australian team of researchers completed a scoping review and RCT to examine interventions for young learner drivers with autism (Wilson et al, 2018; Vindin et al, 2021). The scoping review supports the suggestion raised in other studies (Myers et al, 2021; Myers et al, 2019; Lindsay, 2019; Tyler, 2013) that young drivers with ASD may require more lessons of shorter duration compared to those without ASD. In a survey of 388 respondents, Shepard et al (2022) found drivers with ASD typically required 20-40 professional driving lessons compared to people without who required on average 0-20 lessons, and driver with ASD typically got their license later. This is consistent with the only other quantified recommendation of an average of 24 lessons (Myers et al, 2019). Wilson et al’s (2018) scoping review found interventions reporting simulator or computer-based training but found no studies examining on-road driving lesson interventions. To address this gap, the research team designed an RCT to assess the efficacy of an on-road driving program for 72 young people with ASD (Vindin et al, 2021). In this study, both the intervention and control group were given 10 driving lessons with driving instructors who were not DTOTs. The

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intervention group lessons were delivered by instructors trained in an ASD specific driving program. The control group lessons were delivered by instructors with no additional training. The researchers found large effect sizes for both groups but found no statistically significant difference between groups. It is noteworthy that both groups showed significant benefit after a course of on-road driving lessons with mainstream professional driving instructors. However, the authors note there is a possibility of self-selection bias resulting in a group of driving instructors with interest or experience in training young people with ASD.

4.3 Traumatic brain injury Duration of driver training after traumatic brain injury depends on the severity of the injury (Schultheis & Whipple, 2014). Estimates for return to driving after TBI range from 42% to 98%. In their sample of 48 people with traumatic brain injury, Stolwyck et al (2019) found 31 were fit to drive following an assessment from an occupational therapist, while 9 of the 17 who failed the assessment were recommended take one or more driving lessons before being reassessed. All those who underwent driving lessons were re-assessed and cleared to return to driving. However, the report does not make clear how many lessons were required for the cohort of participants who failed the initial test. Ross et al (2018) found in an Australian sample of 340 people with traumatic brain injury, 72% passed the initial post-injury driver assessment and of the 28% who failed the initial assessment, 98% passed after an average of 7 driving lessons (14 specialist driving instructor hours) and 2.5 on-road assessments (9.8 OT hours and 3.8 specialist driving instructor hours). Only 7 out of the 340 were not able to return to driving. 5. References AustRoads & National Transport Commission. (2022). Assessing fitness to drive for commercial and private vehicle drivers. Australian Government. https://austroads.com.au/publications/assessing-fitness-to-drive/ap-g56 Beanland, V and Huemmer, I. (2021) The effectiveness of advanced driver training. Waka Kotahi NZ Transport Agency research report 677. https://nzta.govt.nz/assets/resources/research/reports/677/677-the-effectiveness-of- advanced-driver-training.pdf Berndt, A., Hutchinson, C., Tepper, D., & George, S. (2022). Professional reasoning of occupational therapy driver rehabilitation interventions. Australian Occupational Therapy Journal, 69(4), 436–446. https://doi.org/10.1111/1440-1630.12804 Breault, C., Giroux, L., Gauvreau, A., Belanger, S., Lamontagne, M.-E., & Morales, E. (2019). Acceptability of the process of obtaining a driver’s license by young people with and without disabilities. Journal of Accessibility and Design for All, 9(1), 90–117. https://doi.org/10.17411/jacces.v9i1.198

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Castellucci, H. I., Bravo, G., Arezes, P. M., & Lavallière, M. (2020). Are interventions effective at improving driving in older drivers?: A systematic review. BMC Geriatrics, 20(1), 125. https://doi.org/10.1186/s12877-020-01512-z Curry, A. E., Yerys, B. E., Huang, P., & Metzger, K. B. (2018). Longitudinal study of driver licensing rates among adolescents and young adults with autism spectrum disorder. Autism: The International Journal of Research and Practice, 22(4), 479–488. https://doi.org/10.1177/1362361317699586 Department of Transport and Main Roads. (2021). Controlled environment driver training guidelines. Queensland Government. https://www.tmr.qld.gov.au/- /media/busind/accreditations/driverandridertrainers/Controlled-Environment-Driver- Training-Guidelines.pdf?la=en Di Stefano, M & Ross, P. (2018). VicRoads Guidelines for Occupational Therapy Driver Assessors (3rd edition). Roads Corporation Victoria, Melbourne. George, S., Crotty, M., Gelinas, I., & Devos, H. (2014). Rehabilitation for improving automobile driving after stroke. Cochrane Database of Systematic Reviews, 2, CD008357. https://doi.org/10.1002/14651858.CD008357.pub2 Myers, R. K., Bonsu, J. M., Carey, M. E., Yerys, B. E., Mollen, C. J., & Curry, A. E. (2019). Teaching autistic adolescents and young adults to drive: Perspectives of specialized driving instructors. Autism in Adulthood Knowledge Practice and Policy, 1(3), 202–209. https://doi.org/10.1089/aut.2018.0054 Myers, R. K., Carey, M. E., Bonsu, J. M., Yerys, B. E., Mollen, C. J., & Curry, A. E. (2021). Behind the wheel: Specialized driving instructors’ experiences and strategies for teaching autistic adolescents to drive. The American Journal of Occupational Therapy: Official Publication of the American Occupational Therapy Association, 75(3), 7503180110p1. https://doi.org/10.5014/ajot.2021.043406 National standard for driver and rider training. (2020). Driver and Vehicle Standards Agency. https://www.gov.uk/government/publications/national-standard-for-driver-and-rider- training/national-standard-for-driver-and-rider-training#unit-2—design-learning- programmes Lindsay, S. (2017). Systematic review of factors affecting driving and motor vehicle transportation among people with autism spectrum disorder. Disability and Rehabilitation, 39(9), 837–846. https://doi.org/10.3109/09638288.2016.1161849 Lindsay, S., & Stoica, A. (2017). A systematic review of factors affecting driving and public transportation among youth and young adults with acquired brain injury. Brain Injury, 31(10), 1257–1269. https://doi.org/10.1080/02699052.2017.1321140 Ross, P. E., Di Stefano, M., Charlton, J., Spitz, G., & Ponsford, J. L. (2018). Interventions for resuming driving after traumatic brain injury. Disability and Rehabilitation, 40(7), 757– 764. https://doi.org/10.1080/09638288.2016.1274341

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Sangrar, R., Mun, J., Cammarata, M., Griffith, L. E., Letts, L., & Vrkljan, B. (2019). Older driver training programs: A systematic review of evidence aimed at improving behind-the- wheel performance. Journal of Safety Research, 71, 295–313. https://doi.org/10.1016/j.jsr.2019.09.022 Sheppard, E., van Loon, E. & Ropar, D. (2022). Dimensions of Self-Reported Driving Difficulty in Autistic and Non-Autistic Adults and their Relationship with Autistic Traits. Journal of Autism and Developmental Disorders. https://doi.org/10.1007/s10803-021-05420-y Schultheis, M. T., & Whipple, E. (2014). Driving after traumatic brain injury: evaluation and rehabilitation interventions. Current Physical Medicine and Rehabilitation Reports, 2(3), 176–183. https://doi.org/10.1007/s40141-014-0055-0 Stolwyk, R. J., Charlton, J. L., Ross, P. E., Bédard, M., Marshall, S., Gagnon, S., Gooden, J. R., & Ponsford, J. L. (2019). Characterizing on-road driving performance in individuals with traumatic brain injury who pass or fail an on-road driving assessment. Disability and Rehabilitation, 41(11), 1313–1320. https://doi.org/10.1080/09638288.2018.1424955 Tyler S. (2013). Asperger’s syndrome: the implications for driver training methods and road safety. Journal of the Australasian College of Road Safety, 24, 55–62. Unsworth, C. A., & Baker, A. (2014). Driver rehabilitation: a systematic review of the types and effectiveness of interventions used by occupational therapists to improve on-road fitness-to-drive. Accident; Analysis and Prevention, 71, 106–114. https://doi.org/10.1016/j.aap.2014.04.017 Unsworth, C., Harries, P., & Davies, M. (2015). Using Social Judgment Theory method to examine how experienced occupational therapy driver assessors use information to make fitness-to-drive recommendations. The British Journal of Occupational Therapy, 78(2), 109–120. https://doi.org/10.1177/0308022614562396 Vindin, P., Cordier, R., Wilson, N. J., & Lee, H. (2021). A driver training program intervention for student drivers with autism spectrum disorder: A multi-site randomised controlled trial. Journal of Autism and Developmental Disorders, 51(10), 3707–3721. https://doi.org/10.1007/s10803-020-04825-5 Wilson, N. J., Lee, H. C., Vaz, S., Vindin, P., & Cordier, R. (2018). Scoping review of the driving behaviour of and driver training programs for people on the autism spectrum. Behavioural Neurology, 2018, 6842306. https://doi.org/10.1155/2018/6842306

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DOCUMENT [ResearchFOI 24/25-1212type] 2

OFFICIAL For Internal Use Only

Outcome comparison of catheter model and technique

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:

Date: 02/03/2022 Requestor: Nicola s47F- personal priva

[[s47F- personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/)](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) Endorsed by: Charika Researcher: Aaron s47F- personal privacy Cleared by: Aaron s47F- personal privacy

1. Contents

Outcome comparison of catheter model and technique ……………………………………………………. 1

1. Contents ……………………………………………………………………………………………………….. 1

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

3. Catheter types and methods …………………………………………………………………………….. 2

4. Outcomes ……………………………………………………………………………………………………… 3

4.1 Risk of urinary tract infections ………………………………………………………………………… 4

4.2 Other adverse events …………………………………………………………………………………… 5

4.3 User preference …………………………………………………………………………………………… 5

5. Cost-effectiveness ………………………………………………………………………………………….. 5

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6. References ……………………………………………………………………………………………………. 7

7. Summary

Different catheter types and different methods of use, cleaning and management may affect the comfort, usability and potential risks of catheter use. Due to inconsistency in the literature, firm conclusions are not possible regarding the effect of different catheter types or methods on risk of UTI and other health complications. No conclusions can be drawn to suggest hydrophilic catheters, closed system catheter sets, or ‘no touch’ catheters lower risk of health complications.

Catheter types and management strategies can vary widely in cost. Reusable non-coated catheters are the least expensive catheter type by unit cost. The most expensive is likely single-use, closed-system, hydrophilic catheters. However, when associated costs such as health-care and employment are included, the overall costs may be different.

Most cost-effectiveness studies from the last 7 years find that hydrophilic catheters are more cost-effective over a lifetime compared to single-use uncoated catheters. An Australian study calculates a lifetime saving of $298,450 in favour of hydrophilic catheters. All cost- effectiveness analyses reviewed are limited by assumptions and inferences that may not be supported by current evidence. Therefore, it is not possible to say with confidence that the hydrophilic catheter is more cost-effective than lower cost options.

Risk of urinary tract infection (UTI) and associated health-care costs are a key feature of cost- effectiveness analyses. Most cost-effectiveness studies fix an incidence rate for UTI for different types of catheter. The studies finding that hydrophilic catheters are more cost- effective generally infer a reduced risk of UTI for hydrophilic compared to other types of catheter. However, this conclusion may not be supported by current evidence.

While there are a number of reviews and meta-analyses which favour hydrophilic catheters for reducing risk of UTI and other health complications, the evidence is not firm. Several studies find no difference between catheter types. There is moderate level evidence that hydrophilic catheters may even increase the risk of urethral trauma.

There are also some notable limitations in the literature. There is significant heterogeneity especially around the definition of UTI. Studies are often not generalisable due to non- representative samples and attrition bias.

3. Catheter types and methods

In-dwelling catheterisation involves leaving the catheter in place for a period of time. This is not the preferred option for most people requiring catheterisation but is still used by around one third of people with a spinal cord injury (Wu et al, 2022). Intermittent catheterisation involves

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inserting and removing a catheter multiple times a day. Catheters used in intermittent catheterisation may be used once and discarded (single-use) or used multiple times (reusable). Reusable catheters may be used for one day or for longer periods. They usually require washing between uses (Wu et al, 2022; Ye et al, 2021; Health Quality Ontario, 2019).

Single-use catheters can be used with either a sterile technique (sterile catheter, gloves, in a sterile environment as far as possible) or a clean technique (clean hands or gloves). Reusable catheters can only be used with a clean technique (Prieto et al, 2021; Ye et al, 2021; Health Quality Ontario, 2019).

Some catheters require the user or carer to add lubricant before insertion. They are referred to as non-coated catheters to distinguish them from hydrophilic-coated catheters which have a polymer coating that acts as a lubricant when it interacts with water. Hydrophilic catheters may also come in sterile packaging with saline solution, which means the user does not need to add water before insertion. These are called pre-activated hydrophilic catheters. Non-coated catheters may also come in a sterile package pre-lubricated. Catheters may be purchased by themselves or with a urine collection bag already attached (Ye et al, 2021; Health Quality Ontario, 2019).

4. Outcomes

Research on outcomes associated with catheter use focusses on:

 incidence of UTIs  other adverse events (like haematuria, urethral trauma, bladder stones etc.)  preference or satisfaction with different types or methods.

Most contemporary research focusses on comparisons of different intermittent catheterisation techniques using hydrophilic or non-coated catheters. Despite this being a well-researched area, few firm conclusions are possible. Many systematic reviews and meta-analyses show inconsistent results.

Due to the quantity of research material available, we have prioritised:

 evidence published in the last 7 years (2017-2023)  review articles and cost-effectiveness studies  evidence related to an Australian context where possible.

The following discussion of catheter type and method outcomes is based on 17 systematic reviews conducted between 2017 and 2023.

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4.1 Risk of urinary tract infections

Low level evidence suggests that intermittent catheterisation is associated with fewer UTIs than in-dwelling catheterisation (Wu et al, 2022; Kinnear et al, 2020).

There is significant disagreement in the literature as to whether hydrophilic catheters are associated with lower risk of developing a UTI. Some meta-analyses have found a significantly reduced risk of UTI for people using hydrophilic catheters (Plata et al, 2023; Gauhur et al 2022; Ye et al, 2021; Feng et al, 2020; Rognoni & Taraconi, 2017). However, the results are not straight-forward. Feng et al (2020) found a 54% reduction in frequency of UTI associated with use of hydrophilic catheters. Rognoni & Taraconi (2017) found a lower risk of UTI associated with hydrophilic catheter compared to single-use non-coated catheter. This contrasts with Plata et al (2023), who found a reduction in frequency of UTIs overall, but not if the comparison is limited to single-use hydrophilic versus single-use non-coated. They found a significantly lower risk in adult hydrophilic catheter users but not the paediatric group. Gauhur et al (2022) found hydrophilic catheters are associated with a statistically significant reduction in UTIs only if the sub-group is limited to long term catheter users. When comparing all subjects, there was no significant difference in UTI frequency. Ye et al (2021) found a significant reduction in UTIs for both hydrophilic and gel-lubricated catheters when compared to non-coated catheters, but no significant difference between hydrophilic and pre-lubricated models. There is some low-very low certainty evidence favouring pre-lubricated catheters presented in other reviews (Health Quality Ontario, 2019; Shamout et al, 2017). A report from Health Quality Ontario (2019) did not find significantly different levels of risk in the development of UTI for any catheter type. Prieto et al (2021) note that both higher risk of UTI and lower risk of UTI are possible considering the margin of error.

This inconsistency is reflected in reviews that did not complete a meta-analysis. Shamout et al (2017) found only one out of 6 papers reviewed found a significant reduction in risk of UTI associated with use of hydrophilic catheter. Barken & Vaabengaard (2022) in contrast, found 8 out of 10 studies supported the use of hydrophilic catheters to reduce UTI frequency.

Prieto et al (2021) suggest that the most impactful question regarding risk of UTI is whether risk is affected by single-use or multiple-use catheter practice. The authors found no compelling evidence that single- or multiple-use was associated with different rates of UTI. This is echoed in the Health Quality Ontario report (2019).

Furthermore, there is some emerging evidence that other strategies such as catheter cleaning techniques or education programs for nurses or carers can decrease risk of UTI for long term catheter users (Alex et al, 2022; Mitchell et al, 2021; Shamout et al, 2017). However, evidence is not sufficient to draw a conclusion regarding these interventions (Prieto et al, 2021; Mangal et al, 2021; Sheperd et al, 2017).

Due to inconsistency of results, firm conclusions are not possible regarding the effect of different catheter types or methods on risk of UTI. Some limitations are pervasive in the literature. Reviewers often refer to differences in the definition of UTI to explain the

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inconsistency of results (Plata et al, 2023; Barken & Vaabengaard, 2022; Prieto et al, 2021; Rognoni & Taraconi, 2017). Many studies included in systematic reviews and meta-analyses have disproportionate levels of male participants and high drop-out rates, especially for hydrophilic treatment groups (Plata et al, 2023; Ye et al, 2021; Rognoni & Taraconi, 2017).

4.2 Other adverse events

Prieto et al (2021) found moderate certainty evidence that non-coated catheters slightly reduce the risk of urethral trauma and bleeding compared with hydrophilic catheters. Whereas Feng et al (2020) found a 55% reduction in risk of urethral trauma associated with hydrophilic catheters. Liao et al (2022) found a significant reduction in microscopic haematuria with hydrophilic catheters compared to non-coated catheters, but no statistically significant difference for gross haematuria. Health Quality Ontario (2019) and Plata et al (2023) found a similar result. Rognoni & Taraconi (2017) found a higher, but non-significant risk of haematuria for hydrophilic catheters.

4.3 User preference

Most studies that track user preference favour hydrophilic catheters (Barken & Vaabengaard 2022; Feng et al, 2020; Shamout et al, 2017). Ye et al (2021) found a stronger preference for pre-activated hydrophilic catheters followed by reusable non-coated, non-preactivated hydrophilic, pre-lubricated and single-use non-coated. However the differences between these groups were not significant. Health Quality Ontario (2019) found a stronger preference for pre- lubricated single use catheters. Prieto et al (2021) found no reliable evidence of difference in preference between catheter models.

5. Cost-effectiveness

Cost-effectiveness studies have been completed for Australia (Couchman et al, 2022), Japan (Watanabe et al, 2017), Italy (Rognoni & Tarricone, 2017), United Kingdom (Baker et al, 2023), Brazil (Truzzi et al, 2018), Canada (Health Quality Ontario, 2019; Welk et al, 2018) and United States (Hutton et al, 2018). Multiple systematic reviews consider cost-effectiveness of different catheter models or techniques (Barken & Vaabengaard 2022; Prieto et al 2021; Feng et al 2020; Shamout et al, 2017) but only one was found for which cost-effectiveness was the main focus (Xi et al, 2021).

Most cost-effectiveness analyses have focussed on costs and outcomes for people with spinal cord injury (Couchman et al, 2022; Xi et al, 2021; Truzzi et al, 2018; Welk et al, 2018; Watanabe et al, 2017; Rognoni & Tarricone, 2017). Baker et al (2023) included patients with either spinal cord injury or multiple sclerosis. Hutton et al (2018) included patients with indwelling catheters residing in nursing homes. The study from Health Quality Ontario (2019) focussed on participants with chronic urinary retention.

The international studies from Japan, Canada, UK, USA, Brazil and Italy all suggest that the single use hydrophilic catheter is a cost-effective option in their respective contexts. This is

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primarily due to costs of treatment of UTIs and other complications of UTIs. The exception is one study from Ontario, Canada, which found multiple-use non-coated catheters were the most cost-effective option:

Given the marginal differences in total QALYs across catheter types, the lowest-cost intervention—multiple-use noncoated catheters (one per week)—had the highest probability of being cost-effective when compared with multiple-use noncoated (one per day), single-use noncoated, and single-use hydrophilic catheters. Where it may not be feasible for some patients to clean and reuse catheters, single-use noncoated catheters have the highest probability of being cost-effective (Health Quality Ontario, 2019, pp.79- 80).

This conclusion likely differs from most other cost-effectiveness analyses due to:

 limited horizon of 5 years compared with lifetime horizon of other studies  a very high estimate of the difference in cost between hydrophilic and non-coated

catheters relative to other studies  the authors’ assessment that there is a low level of evidence for significantly

different outcomes for hydrophilic, non-coated catheters and for single or multiple-

use catheters.

Regarding the 5 year horizon, the authors justify this based on limited evidence for the long term incidence of complications for different catheter types and lack of data on the associated costs of complications. Other studies either: i) make cost and incidence predictions based on inferences from related data, or ii) assume costs and risk are constant over a lifetime.

Regarding the high cost estimate, the authors based monthly and unit costs on information providers made available online. They calculated a minimum of $800 per month for single use hydrophilic catheters based on a unit cost of $7.02 and a minimum of $135 per month for single use non-coated catheters based on a unit cost of $1.09 (all prices in Canadian dollars). In contrast, the other Canadian based cost-effectiveness analysis set prices at $3.77 hydrophilic catheters and $1.07 for non-coated catheters (Welk et al, 2018). The hydrophilic catheter unit cost is almost double from one study to the next, which is bound to make a significant difference to the final analysis.

It is important to note that all of these international studies are limited in terms of generalisability. Conclusions may not transfer to other contexts or service systems. As with the two Canadian studies, Xi et al (2021) note that the stated difference in costs between hydrophilic and non-hydrophilic catheters varied considerably between the studies they reviewed (from $2.49 USD to $24.24 USD per day). Few of the cost-effectiveness studies reviewed considered other types of catheters, for example, gel-lubricated non-hydrophilic catheters. All these studies also make assumptions inferences or about the benefits of hydrophilic catheters which may not be supported by the current evidence. And most recognise that either important data points are missing or the quality of the included clinical

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evidence is low. As such, its not clear if long term costs of either product are under- or over- estimated.

One study looked at the cost-effectiveness of hydrophilic catheters for people with spinal cord injury in an Australian context. Couchman et al (2022) found hydrophilic catheters have higher unit cost, but ultimately provide a more cost-effective option due to reduction in UTIs, quality of life, life years gained and productivity. Including unit cost and societal costs such as productivity loss, hospital admissions and treatment for UTIs and other complications, the authors calculate a lifetime saving of $298,450 in favour of hydrophilic catheters.

This study has some limitations. The authors were not able to source Australian data on UTI frequency for people with spinal cord injury living in the community or for costs associated with some UTI complications. They inferred a UTI frequency based on in-hospital incidence and clinical judgement. Outcomes for hydrophilic catheters (e.g reduction in UTIs) were based on only meta-analyses which showed a positive effect on UTI frequency in favour of hydrophilic catheters. A few of those meta-analyses were published over 25 years ago. Furthermore, the authors note that a longitudinal cost-effective analysis based on real-world cost and health outcome information would be more reliable.

6. References

Alex, J., Maneze, D., Ramjan, L. M., Ferguson, C., Montayre, J., & Salamonson, Y. (2022). Effectiveness of nurse-targeted education interventions on clinical outcomes for patients with indwelling urinary catheters: A systematic review. Nurse education today, 112, 105319. https://doi.org/10.1016/j.nedt.2022.105319

Baker, H., Avey, B., Overbeck Rethmeier, L., Mealing, S., Lynge Buchter, M., Averbeck, M. A., & Thiruchelvam, N. (2023). Cost-effectiveness analysis of hydrophilic-coated catheters in long-term intermittent catheter users in the UK. Current medical research and opinion, 39(2), 319–328. https://doi.org/10.1080/03007995.2022.2151734

Barken, K. B., & Vaabengaard, R. (2022). A scoping review on the impact of hydrophilic versus non-hydrophilic intermittent catheters on UTI, QoL, satisfaction, preference, and other outcomes in neurogenic and non-neurogenic patients suffering from urinary retention. BMC urology, 22(1), 153. https://doi.org/10.1186/s12894-022-01102-8

Feng, D., Cheng, L., Bai, Y., Yang, Y., & Han, P. (2020). Outcomes comparison of hydrophilic and non-hydrophilic catheters for patients with intermittent catheterization: An updated meta-analysis. Asian journal of surgery, 43(5), 633–635. https://doi.org/10.1016/j.asjsur.2019.12.009

Gauhar, V., Castellani, D., Teoh, J. Y., Nedbal, C., Chiacchio, G., Gabrielson, A. T., Heldwein, F. L., Wroclawski, M. L., de la Rosette, J., Donalisio da Silva, R., Galosi, A. B., & Somani, B. K. (2022). Catheter-Associated Urinary Infections and Consequences of Using Coated versus Non-Coated Urethral Catheters-Outcomes of a Systematic

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Review and Meta-Analysis of Randomized Trials. Journal of clinical medicine, 11(15), 4463. https://doi.org/10.3390/jcm11154463

Health Quality Ontario (2019). Intermittent Catheters for Chronic Urinary Retention: A Health Technology Assessment. Ontario health technology assessment series, 19(1), 1–153.

Hutton, D. W., Krein, S. L., Saint, S., Graves, N., Kolli, A., Lynem, R., & Mody, L. (2018). Economic Evaluation of a Catheter-Associated Urinary Tract Infection Prevention Program in Nursing Homes. Journal of the American Geriatrics Society, 66(4), 742–747. https://doi.org/10.1111/jgs.15316

Kinnear, N., Barnett, D., O’Callaghan, M., Horsell, K., Gani, J., & Hennessey, D. (2020). The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Neurourology and urodynamics, 39(2), 854–862. https://doi.org/10.1002/nau.24253 Liao, X., Liu, Y., Liang, S., & Li, K. (2022). Effects of hydrophilic coated catheters on urethral trauma, microtrauma and adverse events with intermittent catheterization in patients with bladder dysfunction: a systematic review and meta-analysis. International urology and nephrology, 54(7), 1461–1470. https://doi.org/10.1007/s11255-022-03172-x

Mangal, S., Pho, A., Arcia, A., & Carter, E. (2021). Patient and Family Engagement in Catheter-Associated Urinary Tract Infection (CAUTI) Prevention: A Systematic Review. Joint Commission journal on quality and patient safety, 47(9), 591–603. https://doi.org/10.1016/j.jcjq.2021.05.009

Mitchell, B., Curryer, C., Holliday, E., Rickard, C. M., & Fasugba, O. (2021). Effectiveness of meatal cleaning in the prevention of catheter-associated urinary tract infections and bacteriuria: an updated systematic review and meta-analysis. BMJ open, 11(6), e046817. https://doi.org/10.1136/bmjopen-2020-046817

Plata, M., Santander, J., Zuluaga, L., Torres-Sandoval, C., Valencia, S., Azuero, J., & Trujillo, C. G. (2023). Hydrophilic versus non-hydrophilic catheters for clean intermittent catheterization: a meta-analysis to determine their capacity in reducing urinary tract infections. World journal of urology, 41(2), 491–499. https://doi.org/10.1007/s00345-022- 04235-5

Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database of Systematic Reviews 2021, Issue 10. Art. No.: CD006008. DOI: 10.1002/14651858.CD006008.pub5. Accessed 27 February 2023

Rognoni, C., & Tarricone, R. (2017a). Intermittent catheterisation with hydrophilic and non- hydrophilic urinary catheters: systematic literature review and meta-analyses. BMC urology, 17(1), 4. https://doi.org/10.1186/s12894-016-0191-1

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Rognoni, C., & Tarricone, R. (2017b). Healthcare resource consumption for intermittent urinary catheterisation: cost-effectiveness of hydrophilic catheters and budget impact analyses. BMJ open, 7(1), e012360. https://doi.org/10.1136/bmjopen-2016-012360

Shamout, S., Biardeau, X., Corcos, J., & Campeau, L. (2017). Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review. Spinal cord, 55(7), 629–643. https://doi.org/10.1038/sc.2016.192

Shepherd AJ, Mackay WG, Hagen S. Washout policies in long-term indwelling urinary catheterisation in adults. Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD004012. DOI: 10.1002/14651858.CD004012.pub5. Accessed 28 February 2023

Truzzi, J. C., Teich, V., & Pepe, C. (2018). Can hydrophilic coated catheters be beneficial for the public healthcare system in Brazil? - A cost-effectiveness analysis in patients with spinal cord injuries. International braz j urol : official journal of the Brazilian Society of Urology, 44(1), 121–131. https://doi.org/10.1590/S1677-5538.IBJU.2017.0221

Xi, M., Elterman, D. S., Welk, B., Pakosh, M., & Chan, B. C. F. (2020). Cost-effectiveness of hydrophilic-coated urinary catheters for individuals with spinal cord injury: A systematic review. BJUI compass, 2(2), 71–81. https://doi.org/10.1002/bco2.63

Watanabe, T., Yamamoto, S., Gotoh, M., Saitoh, T., Yokoyama, O., Murata, T., & Takeda, M. (2017). Cost-Effectiveness Analysis of Long-Term Intermittent Self-Catheterization with Hydrophilic-Coated and Uncoated Catheters in Patients with Spinal Cord Injury in Japan. Lower urinary tract symptoms, 9(3), 142–150. https://doi.org/10.1111/luts.12122

Welk, B., Isaranuwatchai, W., Krassioukov, A., Husted Torp, L., & Elterman, D. (2018). Cost- effectiveness of hydrophilic-coated intermittent catheters compared with uncoated catheters in Canada: a public payer perspective. Journal of medical economics, 21(7), 639–648. https://doi.org/10.1080/13696998.2018.1443112

Wu, S. Y., Jhang, J. F., Liu, H. H., Chen, J. T., Li, J. R., Chiu, B., Chen, S. L., & Kuo, H. C. (2022). Long-Term Surveillance and Management of Urological Complications in Chronic Spinal Cord-Injured Patients. Journal of clinical medicine, 11(24), 7307. https://doi.org/10.3390/jcm11247307

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