Proportionate mortality following dysvascular partial foot amputation and how this compares to transtibial amputation: a systematic review.

PURPOSE: A large proportion of people die in the years following dysvascular partial foot amputation (PFA) or transtibial amputation (TTA) given the long-term consequences of peripheral vascular disease and/or diabetes. A critical appraisal of recent research is needed to understand the underlying cause of variation and synthesise data for use in consultations about amputation surgery and patient-facing resources. This systematic review aimed to describe proportionate mortality following dysvascular PFA and to compare this between PFA and TTA. MATERIALS AND METHODS: The review protocol was registered in PROSPERO (CRD42023399161). Peer-reviewed studies of original research were included if they: were published in English between 1 January 2016, and 12 April 2024, included discrete cohorts with PFA, or PFA and TTA, and measured proportionate mortality following dysvascular amputation. RESULTS: Seventeen studies were included in the review. Following dysvascular PFA, proportionate mortality increased from 30 days (2.1%) to 1-year (13.9%), 3-years (30.1%), and 5-years (42.2%). One study compared proportionate mortality 1-year after dysvascular PFA and TTA, showing a higher relative risk of dying after TTA (RR 1.51). CONCLUSIONS: Proportionate mortality has not changed in recent years. These results are comparable to a previous systematic review that included studies published before 31 December 2015.Implications for rehabilitationIt is important to ensure data describing mortality in the years following dysvascular partial foot or transtibial amputation is up to date and accurate.Evidence about proportionate mortality has not changed in recent years and the results are comparable to previous systematic reviews.Data describing mortality outcomes can be used in decision aids that support conversations about the choice of amputation level.

Describe the population receiving orthotic/prosthetic services using telehealth in Australia, and their experience and satisfaction: a quantitative and qualitative investigation.

PURPOSE: Telehealth may help meet the growing demand for orthotic/prosthetic services. Despite the resurgence of telehealth due to COVID-19, there is limited evidence to inform policy and funding decisions, nor guide practitioners. METHODS: Participants were adult orthosis/prosthesis users or parents/guardians of child orthosis/prosthesis users. Participants were convenience sampled following an orthotic/prosthetic telehealth service. An online survey included: demographics, Telehealth Usability Questionnaire, and the Orthotic Prosthetic Users Survey - Client Satisfaction with Services. A subsample of participants took part in a semi-structured interview. RESULTS: Most participants were tertiary educated, middle-aged, female, and lived in metropolitan or regional centres. Most telehealth services were for routine reviews. Most participants chose to use telehealth given the distance to the orthotic/prosthetic service, irrespective of whether they lived in metropolitan cities or regional areas. Participants were highly satisfied with the telehealth mode and the clinical service they received via telehealth.While orthosis/prosthesis users were highly satisfied with the clinical service received, and the telehealth mode, technical issues affected reliability and detracted from the user experience. Interviews highlighted the importance of high-quality interpersonal communication, agency and control over the decision to use telehealth, and a degree of health literacy from a lived experience of using an orthosis/prosthesis.

Orthotic/prosthetic users were highly satisfied with the clinical services they received via telehealth.Satisfaction was linked to having agency and control over the decision to use telehealth, a clear understanding of the purpose of the appointment and any requirements, and a degree of health literacy that facilitated communication.Orthosis/prosthesis users and practitioners can make informed choices about using telehealth which suggests that many telehealth guidelines maybe unnecessarily risk averse.Telehealth is a useful tool to overcome barriers to accessing orthotic/prosthetic care for people in both metropolitan and regional areas.There are opportunities to support clinicians with targeted telehealth education to improve practice and reduce barriers to high-quality telehealth services.

Development of a Core Outcome Set for users and funders of lower-limb prosthetic interventions (PI-COS): a step to inform the benefits measured in prosthetic health economic evaluations.

PURPOSE: Little is known about the outcomes that are most important to prosthesis users and funders. A Prosthetic Interventions Core Outcome Set (PI-COS) will help researchers and practitioners measure outcomes that are the most important to prosthesis users and funders. MATERIALS AND METHODS: Prosthesis users and funders rated the importance of 121 International Classification of Functioning, Disability, and Health (ICF) second-level categories using a two-round Delphi survey. A Consensus Meeting using the nominal group technique resolved rating differences between groups. The ICF second-level categories were ranked according to importance and a K-Means Cluster Analysis helped establish the PI-COS. RESULTS: 65 users and 8 funders completed the Delphi surveys, followed by a Consensus Meeting. 26 ICF second-level categories were considered important to prosthesis users and funders and a PI-COS of 14 ICF second-level categories drawn predominantly from five ICF chapters was established: Sensory Functions and Pain (b2), Neuromusculoskeletal and Movement-related Functions (b7), General Tasks and Demands (d2), Mobility (d4), and Products and Technology (e1). CONCLUSIONS: The PI-COS describes the outcomes that are most important to prosthesis users and funders. The PI-COS can help focus on the most important outcome measures in clinical practice and research, including future prosthetic health economic evaluations.

Inter-Rater Reliability of Novice Linkers Using an Innovative Sequential Iterative Linking Method to Link Prosthetic Outcomes to The International Classification of Functioning, Disability and Health.

OBJECTIVE: When linking outcomes to the International Classification of Functioning, Disability and Health (ICF), inter-rater reliability is typically assessed at the conclusion of the linking process. This method does not allow for iterative evaluation and adaptations that would improve inter-rater reliability as novices gain experience. This pilot study aims to quantify the inter-rater reliability of novice linkers when using an innovative, sequential, iterative linking method to link prosthetic outcomes to the ICF. METHODS: Across 5 sequential rounds, 2 novices independently linked outcomes to the ICF. A consensus discussion followed each round that informed refinement of the customized ICF linking rules. The inter-rater reliability was calculated for each round using Gwet's agreement coefficient (AC1). RESULTS: A total of 1,297 outcomes were linked across 5 rounds. At the end of round 1 inter-rater reliability was high (AC1 = 0.74, 95% confidence interval (95% CI) 0.68-0.80). At the end of round 3, interrater reliability (AC1 = 0.84, 95% CI 0.80-0.88) was significantly improved and marked the point of consistency where further improvements in inter-rater reliability were not statistically significant. CONCLUSION: A sequential iterative linking method provides a learning curve that allows novices to achieve high-levels of agreement through consensus discussion and iterative refinement of the customized ICF linking rules.

Identifying and linking prosthetic outcomes to the ICF framework: a step to inform the benefits measured in prosthetic health economic evaluations.

PURPOSE: Prosthetic research seems focused on measuring gait-related outcomes that may not adequately measure real-world benefits of prosthetic interventions. Systematically cataloguing a comprehensive range of outcomes is an important steppingstone towards developing a holistic way to measure the benefits of prosthetic interventions for future health economic evaluations. The purpose of this research was to identify and catalogue the outcomes measured in lower-limb prosthetic research using the International Classification of Functioning, Disability, and Health (ICF) framework and a custom clinical framework, and thereby describe the existing research focus and identify evidence gaps. MATERIALS AND METHODS: A structured literature search identified systematic reviews of lower-limb prosthetic interventions. Reported outcomes were extracted from included studies and linked to the ICF- and clinical-frameworks. RESULTS: Of the 1297 extracted outcomes, 1060 were linked to the ICF framework. Most outcomes linked to second- (63.8%) or third-level categories (33.4%), such as Gait Pattern Functions (b770, 49.8%). Most of these outcomes (31.2%) describe temporospatial, kinematic or kinetic gait measures as categorised by the clinical framework. CONCLUSIONS: Lower-limb prosthetic research is focused on laboratory-based measures of gait. There are evidence gaps describing participation in real-world activities - important outcomes to inform policy and investment decisions that determine the prosthetic interventions available for people with limb-loss.Implications for rehabilitationCataloguing the outcomes used in prosthetic research to the International Classification of Functioning, Disability, and Health (ICF) allows important evidence gaps to be illuminated given the holistic description of function and disability.Establishing a comprehensive list of prosthetic outcomes, described using an internationally recognised framework with unified and consistent language, is an important steppingstone towards developing a core outcome set (COS) for prosthetic interventions and informing the benefits measured in future prosthetic health economic evaluations (HEEs).Being able to measure the benefits of a prosthesis that are most important to prosthesis users and funders has potential to fundamentally change future HEEs that influence funding policies, and ultimately the prostheses made available to people living with limb-loss.

Regulation of the global orthotist/prosthetist workforce, and what we might learn from allied health professions with international-level regulatory support: a narrative review.

BACKGROUND: By 2050, the global demand for orthotic and prosthetic services is expected to double. Unfortunately, the orthotic/prosthetic workforce is not well placed to meet this growing demand. Strengthening the regulation of orthotist/prosthetists will be key to meeting future workforce demands, however little is known about the extent of orthotist/prosthetist regulation nor the mechanisms through which regulation could best be strengthened. Fortunately, a number of allied health professions have international-level regulatory support that may serve as a model to strengthen regulation of the orthotic/prosthetic profession. The aims of this study were to describe the national-level regulation of orthotist/prosthetists globally, and the international-level regulatory support provided to allied health professions. METHOD: Two environmental scans benchmarked the national-level regulation of the orthotist/prosthetist workforce, and the regulatory support provided by international allied health professional bodies using a set of nine core practitioner standards (core standards) including: Minimum Training/Education, Entry-level Competency Standards, Scope of Practice, Code of Conduct and/or Ethics, Course Accreditation, Continuing Professional Development, Language Standard, Recency of Practice, and Return-to-Practice. Each identified country was categorised by income status (i.e. High-, Upper-Middle-, Lower-Middle-, and Low-Income countries). RESULTS: Some degree of regulation of the orthotist/prosthetist workforce was identified in 30 (15%) of the world's 197 countries. All core standards were present in 6 of these countries. Countries of higher economic status had more core standards in place than countries of lower economic status. International-level professional bodies were identified for 14 of 20 allied health professions. International bodies for the physical therapy (8 core standards) and occupational therapy (5 core standards) professions provided regulatory support to help national associations meet most of the core standards. CONCLUSION: Given the small proportion of countries that have national practitioner regulatory standards in place, most orthotist/prosthetists are working under little-to-no regulation. This presents an opportunity to develop rigorous national-level regulation that can support workforce growth to meet future workforce demands. Given the financial and expertise barriers that hinder the development of a more regulated orthotist/prosthetist workforce, particularly for Low- and Lower-Middle-Income countries, we recommend the establishment of an international professional body with the express purpose to support national-level regulation of orthotist/prosthetists, and thereby build the regulatory capacity of national orthotic/prosthetic associations.

Interassessor agreement of portfolio-based competency assessment for orthotists/prosthetists in Australia: a mixed method study.

BACKGROUND: Internationally qualified orthotists/prosthetists who want to practice in Australia must pass a portfolio-based competency assessment. Testing the agreement between independent assessors is important to engender confidence in the assessment, and continually improve the processes. OBJECTIVES: To quantify interassessor agreement for all 68 performance indicators in the Australian Orthotic Prosthetic Association's Entry Level Competency Standards and where there was significant disagreement between assessors, to explore the reasons why. STUDY DESIGN: Mixed methods: explanatory sequential. METHOD: Fifteen portfolios were assigned to independent assessors. Assessors determined whether the evidence presented met the requirements of each performance indicator. Interassessor agreement was calculated using Gwet's Agreement Coefficient 1 (AC1), and these data informed semistructured interviews to explore the reasons for disagreement. RESULTS: Most performance indicators (87%) had moderate to substantial agreement (AC1 > 0.71), which could be attributed to a variety of factors including the use of a simple assessment rubric with supporting guidelines and assessor training to establish shared expectations. The remaining performance indicators (13%) had fair to slight agreement (AC1 ≤ 0.7). Interviews with assessors suggested that disagreement could be attributed to the complexity of some performance indicators, unconscious bias, and the appropriateness of the evidence presented. CONCLUSIONS: Although most performance indicators in Australian Orthotic Prosthetic Association's Entry Level Competency Standard were associated with moderate to substantial interassessor agreement, there are opportunities to improve agreement by simplifying the wording of some performance indicators and revising guidelines to help applicants curate the most appropriate evidence for each performance indicator.

The changing demographics of the orthotist/prosthetist workforce in Australia: 2007, 2012 and 2019.

BACKGROUND: Previous Australian workforce analyses revealed a small orthotist/prosthetist workforce with a low number of practitioners per 100,000 Australians. In recent years, initiatives were implemented to increase relative workforce size, including a government-led change in immigration policy to facilitate entry of experienced internationally trained orthotist/prosthetists into the Australian workforce. Given these changes, this project aimed to compare demographics of the orthotist/prosthetist workforce in Australia and each state/territory between 2007, 2012 and 2019. METHODS: This quasi-experiment analysed data from the Australian Orthotic Prosthetic Association (AOPA) database of certified orthotist/prosthetists, to compare changes in the absolute number of practitioners and the number of practitioners per 100,000 population, as well as practitioner age, gender and service location (i.e., metropolitan, regional/remote) across three time points, with a breakdown by each Australian state and territory. RESULTS: Between 2007 and 2019, the number of orthotist/prosthetists per 100,000 population increased 90%. Average age reduced significantly between 2007 (41.5 years) and 2019 (35 years) (p = 0.001). While the proportion of female practitioners increased significantly between 2007 (30%) and 2019 (49%), and between 2012 (38%) and 2019 (49%) (p < 0.05); only 22% of the female workforce is over 40 years of age. The proportion of practitioners servicing a regional/remote location did not change over time (range 13-14%). CONCLUSIONS: Between 2007 and 2019, the national orthotist/prosthetist workforce increased at a rate that exceeded Australia's population growth, became younger, and more female. However, the number of practitioners per 100,000 population remains below international recommendations; particularly in states outside of Victoria and Tasmania, and in regional/remote areas. In addition, low numbers of mid-late career female practitioners suggest challenges to retention of this particular cohort. These data can help inform workforce initiatives to retain a younger and more female workforce, and improve access to orthotic/prosthetic services.

The effect of participation in a mobility clinic on self-reported mobility and quality of life in people with lower limb amputation: A pilot study.

BACKGROUND: Many people with lower limb amputation experience mobility impairment and reduced quality of life. Mobility clinics are designed to improve mobility and quality of life for people with lower limb amputation, but their effectiveness is unknown. OBJECTIVES: To compare changes in mobility prior to, and 12 weeks following participation in mobility clinic for people with lower limb amputation, and to explain whether changes in mobility explained changes in quality of life. To determine whether the PLUS-M™ was sensitive to the effects of participation in the mobility clinic, and to estimate the sample size required for a definitive study. STUDY DESIGN: Longitudinal observational. METHODS: Electronic versions of the PLUS-M and SF-36v2® were completed by people living in the community with lower limb amputation prior to, and 12 weeks following participation in a mobility clinic. RESULTS: There was a significant increase in mobility from baseline to 12 weeks post participation in the clinic (p = 0.012). Changes in mobility explained a significant proportion of variance in the SF-36v2 mental component summary (p = 0.024) but not the physical component summary (p = 0.804). CONCLUSION: For people with lower limb amputation, mobility increased after participation in the clinic and this explained improvements in SF-36v2 mental component summary. The PLUS-M was sensitive enough to detect a change in mobility over time. CLINICAL RELEVANCE: This preliminary data indicated that participation in a mobility clinic improved mobility and the mental components of quality of life for people living with lower limb amputation. The PLUS-M™ seems sensitive to changes in mobility as a result of participation in a mobility clinic.

Demographics of the Australian orthotic and prosthetic workforce 2007-12.

Objective Health workforce data are vital to inform initiatives to meet the future healthcare needs of our society, but there are currently no data describing the Australian orthotic and prosthetic workforce. The aim of the present study was to describe demographic changes in the Australian orthotic and prosthetic workforce from 2007 to 2012. Methods In the present retrospective time series study, data from the Australian Orthotic Prosthetic Association member database were analysed for trends from 2007 to 2012. Data describing the absolute number of practitioners, the number of practitioners per 100000 population, age, gender, state or territory of residence and service location (i.e. metropolitan, regional and remote) were analysed for significant changes over time using linear regression models. Results Although the number of orthotist/prosthetists in Australia increased (P=0.013), the number of orthotist/prosthetists per 100000 population remained unchanged (P=0.054). The workforce became younger (P=0.004) and more female (P=0.005). Only Victoria saw an increase in the proportion of orthotist/prosthetists in regional and remote areas. There was considerable state-to-state variation. Only Victoria (P=0.01) and Tasmania (P=0.003) saw an increase in the number of orthotist/prosthetists per 100000 population. Conclusions The orthotic and prosthetic workforce has increased proportionately to Australia's population growth, become younger and more female. The proportion of practitioners in regional and remote areas has remained unchanged. These data can help inform workforce initiatives to increase the number of orthotist/prosthetists relative to the Australian population and make the services of orthotist/prosthetists more accessible to Australians in regional and remote areas. What is known about the topic? Currently, there are no demographic data describing changes in the Australian orthotic and prosthetic workforce over time. These data are vital to inform initiatives to increase the size of the workforce, locate practitioners where health services are most needed and thereby plan to meet the future health care needs of our society. What does this paper add? This paper describes changes in the Australian orthotic and prosthetic workforce, where previously these data have not been available as part of federal initiatives to plan for future workforce needs. What are the implications for practitioners? Demographic data describing changes in the orthotic and prosthetic workforce are needed to inform workforce initiatives that improve access in regional and remote Australia, and retain a younger and more female workforce.

A mixed-methods research approach to the review of competency standards for orthotist/prosthetists in Australia.

AIM: The requirement for an allied health workforce is expanding as the global burden of disease increases internationally. To safely meet the demand for an expanded workforce of orthotist/prosthetists in Australia, competency based standards, which are up-to-date and evidence-based, are required. The aims of this study were to determine the minimum level for entry into the orthotic/prosthetic profession; to develop entry level competency standards for the profession; and to validate the developed entry-level competency standards within the profession nationally, using an evidence-based approach. METHODS: A mixed-methods research design was applied, using a three-step sequential exploratory design, where step 1 involved collecting and analyzing qualitative data from two focus groups; step 2 involved exploratory instrument development and testing, developing the draft competency standards; and step 3 involved quantitative data collection and analysis - a Delphi survey. In stage 1 (steps 1 and 2), the two focus groups - an expert and a recent graduate group of Australian orthotist/prosthetists - were led by an experienced facilitator, to identify gaps in the current competency standards and then to outline a key purpose, and work roles and tasks for the profession. The resulting domains and activities of the first draft of the competency standards were synthesized using thematic analysis. In stage 2 (step 3), the draft-competency standards were circulated to a purposive sample of the membership of the Australian Orthotic Prosthetic Association, using three rounds of Delphi survey. A project reference group of orthotist/prosthetists reviewed the results of both stages. RESULTS: In stage 1, the expert (n = 10) and the new graduate (n = 8) groups separately identified work roles and tasks, which formed the initial draft of the competency standards. Further drafts were refined and performance criteria added by the project reference group, resulting in the final draft-competency standards. In stage 2, the final draft-competency standards were circulated to 56 members (n = 44 final round) of the Association, who agreed on the key purpose, 6 domains, 18 activities, and 68 performance criteria of the final competency standards. CONCLUSION: This study outlines a rigorous and evidence-based mixed-methods approach for developing and endorsing professional competency standards, which is representative of the views of the profession of orthotist/prosthetists.

A new method for measuring AFO deformation, tibial and footwear movement in three dimensional gait analysis.

Solid ankle-foot orthoses (AFOs) are designed to immobilise the ankle but numerous studies have measured a considerable ankle range of motion (ROM) in AFO users. Measurement of ankle kinematics may be affected by soft-tissue artefact (STA) of the knee marker, deformation of the AFO or tibial movement within the AFO. A new model based on the Conventional Gait Model (CGM) was developed to calculate these effects. Although movement of the AFO within the shoe should not affect the measured ankle joint angle the model also allows an estimation of this movement. Seven children (13 limbs) with spastic diplegic cerebral palsy were assessed to present the benefits of the new model compared to the CGM. STA of the knee marker was estimated to result in a 1.5° overestimation of total ankle ROM (from 8.2° to 9.7°). STA error was strongly related to angle of knee flexion (r=0.82) with an average maximum error of 3.8°. AFO deformation contributed approximately two thirds of the ankle ROM (6.0±4.3°) with the remaining third from tibial movement relative to the AFO (2.8±0.9°). Movement of the AFO within the footwear was very small (1.8±0.8°). A strong positive relationship (r=0.9) was found between body mass (kg) and AFO deformation which was statistically significant (p<0.001). This is the first model to attempt to quantify different contributions to ankle dorsiflexion measured during gait analysis of people wearing AFOs.

A systematic review to determine best practice reporting guidelines for AFO interventions in studies involving children with cerebral palsy.

Studies which have examined the effects of ankle-foot orthoses (AFOs) on children with cerebral palsy (CP) often report insufficient detail about the participants, devices and testing protocols. The aim of this systematic review was to evaluate the level and quality of detail reported about these factors in order to generate best practice guidelines for reporting of future studies. A systematic search of the literature was conducted to identify studies which examined any outcome measure relating to AFO use in children with CP. A customized checklist was developed for data extraction and quality assessment. There was substantial variability in the level and quality of detail reported across the 41-paper yield. Many papers reported insufficient detail to allow synthesis of outcomes across studies. The findings of this review have been used to generate guidelines for best practice of reporting for AFO intervention studies. It is important to ensure homogeneity of gait pattern in a subject sample or to subdivide a sample to investigate the possibility that heterogeneity affected results. It is also important to describe the orthosis in sufficient detail that the device can be accurately replicated because differences in designs have been shown to affect outcomes. These guidelines will help researchers provide more systematic and detailed reports and thereby permit future reviewers to more accurately assess both the reporting and quality of orthotic interventions, and will facilitate synthesis of literature to enhance the evidence base.