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PURPOSE: Health Economic Evaluations (HEEs) calculate a cost-benefit ratio using utility and effectiveness instruments. It is unknown whether existing instruments measure the items of the Prosthetic Interventions Core Outcome Set (PI-COS) that represent the benefits most important to lower-limb prosthesis users and funders. Comparing the content of existing instruments against the PI-COS will support instrument selection for future prosthetic HEEs. MATERIALS AND METHODS: Utility and effectiveness instruments used to evaluate prosthetic interventions were identified and their International Classification of Functioning, Disability and Health framework (ICF) linking results were extracted. Content of each instrument was compared to the PI-COS through three metrics: content density, content diversity and bandwidth. RESULTS: Of the 130 utility and effectiveness instruments, 24 had previously been linked to the ICF. The instrument with the greatest bandwidth (i.e., broadest content coverage of the PI-COS) was the SF-36 given it linked to 6 of the 14 items of the PI-COS. Combining PROMIS subscales and short-forms allow measurement of a greater range of the PI-COS items. CONCLUSIONS: There is no perfect fit instrument providing coverage of the PI-COS using the metrics of content density, content diversity and bandwidth. The PROMIS instrument may provide increase coverage of the PI-COS in future HEEs.
Existing utility and effectiveness instruments provide varying levels of coverage of the Prosthetic Interventions Core Outcome Set (PI-COS), which describes the outcomes most important to prosthetic users and funders.Rehabilitation professionals can use the content mapping in this study to guide the selection of an instrument that best measures the benefits of a lower-limb prosthetic intervention given the purpose of study.Future health economic evaluations of lower-limb prosthetic interventions should use utility and effectiveness instruments that provide the greatest coverage of the PI-COS and as such, we recommend the 42 questions of the combined PROMIS-29 + 2 and the PROMIS Physical Function with Mobility Aid short-form.
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BACKGROUND: To help improve outcomes for children with cerebral palsy (CP), ankle-foot orthoses (AFOs) and supramalleolar orthoses (SMOs) are prescribed. However, it is not clear why one intervention is prescribed over the other. OBJECTIVES: To explore the rationale for prescribing AFOs and SMOs in children with CP and its link to the choice of outcome measure used. STUDY DESIGN: Narrative review. METHODS: Six databases were searched (eg, Medline) and data extracted from articles that met the inclusion criteria. Data describing the participant demographics, type of orthosis, and outcome measures used were summarized to provide context for the different rationale for orthotic prescription that were thematically analyzed. DISCUSSION: Forty-seven articles were included. Participants were aged 9 ± 2 years, 59% were male, 79% had diplegia, and 38% were classified as Gross Motor Function Classification System level I. All studies included a rationale for prescribing AFOs that, in most cases, reflected the outcome measures used. These rationale statements were synthesized into 5 specific themes (e.g., reduced energy expenditure and metabolic costs). By comparison, 5 of these studies described the rationale for providing SMOs, and of those that did, most of the rationale statements were nonspecific. CONCLUSIONS: A large and contemporary body of literature describes the rationale for prescribing AFOs for children with CP. There are opportunities for future research that clearly articulates the rationale for prescribing SMOs for children living with CP and to focus the rational for orthotic intervention on the real-world challenges that are most important to children living with CP, such as the ability to participate among peers.
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Paralisia Cerebral , Órtoses do Pé , Humanos , Paralisia Cerebral/reabilitação , Paralisia Cerebral/terapia , Criança , Masculino , Prescrições , Feminino , Desenho de Equipamento , Articulação do Tornozelo , Resultado do TratamentoRESUMO
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.
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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.
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Membros Artificiais , Telemedicina , Adulto , Criança , Feminino , Humanos , Pessoa de Meia-Idade , Aparelhos Ortopédicos , Satisfação do Paciente , Reprodutibilidade dos Testes , MasculinoRESUMO
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.
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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.
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Pessoas com Deficiência , Classificação Internacional de Funcionalidade, Incapacidade e Saúde , Humanos , Reprodutibilidade dos Testes , Projetos PilotoRESUMO
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.
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Amputados , Pessoas com Deficiência , Humanos , Análise Custo-Benefício , Extremidade Inferior , Avaliação de Resultados em Cuidados de Saúde , Avaliação da Deficiência , Classificação Internacional de Funcionalidade, Incapacidade e Saúde , Atividades CotidianasRESUMO
BACKGROUND: Amputation has significant negative impacts on physical, psychological, social and economic wellbeing of individuals and families. This is potentially compounded by significant delays to rehabilitation in Bangladesh. OBJECTIVE: To quantify disability, occupation and socioeconomic status of people with unilateral lower-limb amputation (LLA) and their families in Bangladesh, post-amputation and pre-rehabilitation. METHODS: Between November 2017 and February 2018, people with unilateral LLA attending two locations of Center for the Rehabilitation of the Paralyzed, Bangladesh, for prosthetic rehabilitation were surveyed pre-rehabilitation, using the World Health Organization Disability Assessment Schedule (WHODAS-2.0) with additional socio-economic questions. Data were analysed descriptively, using cross-tabulation with Chi-square and Fisher's exact tests. RESULTS: Seventy-six individuals participated. The majority had traumatic (64.5%), transtibial amputation (61.8%), were young adults (37.92±12.35 years), in paid work prior to LLA (80%), married (63.2%), male (81.6%), from rural areas (78.9%), with primary/no education (72.4%). After LLA mobility (WHODAS score 74.61±13.19) was their most negatively affected domain. Most (60.5%) did not return to any occupation. Acute healthcare costs negatively impacted most families (89.5%), over 80% becoming impoverished. Nearly 70% of previous income-earners became economically dependent changing traditional family roles. CONCLUSIONS: Following LLA, most participants experienced significant mobility impairment and became economically dependent. The impact of LLA extends beyond the individual, to families who often face challenges to traditional primary earner gendered roles. Improved access to timely and affordable rehabilitation is required to reduce the significant personal and societal costs of disability after LLA.
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Pessoas com Deficiência , Extremidade Inferior , Adulto Jovem , Masculino , Humanos , Estudos Transversais , Bangladesh , Amputação CirúrgicaRESUMO
Polycomb Repressive Complex 2 (PRC2) plays an important role in transcriptional regulation during animal development and in cell differentiation, and alteration of PRC2 activity has been associated with cancer. On a molecular level, PRC2 catalyzes methylation of histone H3 lysine 27 (H3K27), resulting in mono-, di-, or trimethylated forms of H3K27, of which the trimethylated form H3K27me3 leads to transcriptional repression of polycomb target genes. Previously, we have shown that binding of the low-molecular-weight compound EED226 to the H3K27me3 binding pocket of the regulatory subunit EED can effectively inhibit PRC2 activity in cells and reduce tumor growth in mouse xenograft models. Here, we report the stepwise optimization of the tool compound EED226 toward the potent and selective EED inhibitor MAK683 (compound 22) and its subsequent preclinical characterization. Based on a balanced PK/PD profile, efficacy, and mitigated risk of forming reactive metabolites, MAK683 has been selected for clinical development.
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Histonas , Neoplasias , Animais , Inibidores Enzimáticos , Histonas/metabolismo , Humanos , Metilação , Camundongos , Neoplasias/tratamento farmacológico , Complexo Repressor Polycomb 2RESUMO
PURPOSE: To explore factors impacting access to and participation in rehabilitation for people with lower limb amputation (LLA) in East, South, and Southeast Asian developing countries. MATERIALS AND METHODS: A scoping review was undertaken following the PRISMA-ScR guidelines. Five electronic databases (PsycINFO (Ovid), Medline (Ovid), CINAHL (EBSCO), AMED, and Proquest Social Sciences) were searched for articles from January 1980 till March 2020. Two authors independently assessed articles for inclusion. Included articles were classified according to the Health Care Delivery System Approach (HCDSA) framework levels. RESULTS: Twenty-four studies from 14 countries were identified. At patient level, age, gender, limited rehabilitation awareness, and economic status; at the rehabilitation level, gaps in referrals, family support, and professional skills; at the environmental level, services availability, and location; and, at government level, service costs, income loss, and lack of supporting policies were identified as important influencing factors. CONCLUSIONS: Rehabilitation access and participation factors were identified at multiple levels of the HCDSA. Contextually appropriate and accessible services considering individual characteristics and socio-economic status of individuals with LLA are needed, with timely referral to rehabilitation by trained professionals. Improving rehabilitation services for people with LLA in Asian developing countries requires supportive environments, accessible transport, social and financial security, and increased awareness, underpinned by appropriate policy.Implications for rehabilitationProvision of timely referral to rehabilitation by primary/acute health care settings with involvement of family/peer supports.Improved government support systems to facilitate individual access to and participation in rehabilitation with consideration of contextual socio-demographic and economic factors.Prioritisation of adequately resourced and well-designed rehabilitation centres by health care organisations in accessible locations.Implementation by local government of strategies to support development and implementation of well resourced, accessible, equitable, and contextually responsive rehabilitation services.
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Países em Desenvolvimento , População do Sudeste Asiático , Humanos , Amputação Cirúrgica , Atenção à Saúde , Extremidade Inferior/cirurgiaRESUMO
Gefapixant is the approved generic name for a compound also known as MK-7264, and prior to that AF-219 and RO-4926219. It is the first-in-class clinically developed antagonist for the P2X3 subtype of trimeric ionotropic purinergic receptors, a family of ATP-gated excitatory ion channels, showing nanomolar potency for the human P2X3 homotrimeric channel and essentially no activity at related channels devoid of P2X3 subunits. As the first P2X3 antagonist to have progressed into clinical studies it has now progressed to the point of successful completion of Phase 3 investigations for the treatment of cough, and the NDA application is under review with US FDA for treatment of refractory chronic cough or unexplained chronic cough. The molecule was discovered in the laboratories of Roche Pharmaceuticals in Palo Alto, California, but clinical development then continued with the formation of Afferent Pharmaceuticals for the purpose of identifying the optimal therapeutic indication for this novel mechanism and establishing a clinical plan for development in the optimal patient populations selected. Geoff Burnstock was a close collaborator and advisor to the P2X3 program for close to two decades of discovery and development. Progression of gefapixant through later stage clinical studies has been conducted by the research laboratories of Merck & Co., Inc., Kenilworth, NJ, USA (MRL; following acquisition of Afferent in 2016), who may commercialize the product once authorization has been granted by regulatory authorities.
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Antagonistas do Receptor Purinérgico P2X , Pirimidinas , Trifosfato de Adenosina , Tosse , Humanos , Receptores Purinérgicos P2X3 , SulfonamidasRESUMO
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.
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Acreditação , Pessoal Técnico de Saúde , Ocupações em Saúde , Humanos , Recursos HumanosRESUMO
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.
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Competência Clínica , Ortodontia , Austrália , Documentação/normas , Avaliação Educacional , Humanos , Ortodontia/normasRESUMO
BACKGROUND: The extent to which current prosthetic health economic evaluations inform healthcare policy and investment decisions is unclear. To further the knowledge in this area, existing evidence gaps and method design issues must be identified, thereby informing the design of future research. OBJECTIVES: The aim of this systematic review was to identify evidence gaps, critical method design and reporting issues and determine the extent to which the literature informs a wide range of policy and investment decisions. STUDY DESIGN: Systematic review. METHODS: A range of databases were searched using intervention- and health economic evaluation-related terms. Issues with methodological design and reporting were evaluated using the Consolidated Health Economic Checklist - Extended and the Checklist for Health Economic Evaluation Reporting Standards. RESULTS: The existing health economic evaluation literature was narrowly focused on informing within-participant component decisions. There were common method design (e.g. time horizon too short) and reporting issues (e.g. competing intervention descriptions) that limit the extent to which this literature can inform policy and investment decisions. CONCLUSION: There are opportunities to conduct a wider variety of health economic evaluations to support within- and across-sector policy and investment decisions. Changes to aspects of the method design and reporting are encouraged for future research in order to improve the rigour of the health economic evaluation evidence. CLINICAL RELEVANCE: This systematic review will inform the clinical focus and method design of future prosthetic health economic evaluations. It will also guide readers and policy-makers in their interpretation of the current literature and their understanding of the extent to which the current literature can be used to inform policy and investment decisions.
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Membros Artificiais , Lista de Checagem , Análise Custo-Benefício , Humanos , Aparelhos Ortopédicos , Implantação de PróteseRESUMO
BACKGROUND: Health economic evaluations (HEEs) in orthotics are in their infancy. Identification of evidence gaps and method design issues will inform the design of future HEEs that advance knowledge and contributes to policy and investment decisions. OBJECTIVES: The aim of this systematic review was to critically appraise the existing orthotic/prosthetic health economic evaluation literature and therefore determine evidence gaps, critical method design issues, and the extent to which the literature informs orthotic policy and investment decisions. STUDY DESIGN: Systematic review. METHODS: A range of databases were searched using intervention- and HEE-related terms. The Consolidated Health Economic Checklist-Extended and the Checklist for Health Economic Evaluation Reporting Standards were used to identify issues with method design and reporting. RESULTS: Nine orthotic HEEs were narrowly focused on the cost-effectiveness of low-cost orthotic devices (eg, ankle orthoses for ankle sprains). Method design (eg, cost identification and valuation) and reporting issues (eg, lack of detail about the study population) limited the extent to which this literature can inform policy and investment decisions. CONCLUSIONS: HEEs comparing a wider variety of interventions are required, particularly for commonly used orthoses (eg, ankle-foot orthoses) and clinical presentations (eg, post-stroke). There are opportunities to strengthen future orthotic HEEs by adopting method design features (eg, microcosting and sensitivity analyses) as recommended by HEE appraisal and reporting tools.
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Membros Artificiais , Aparelhos Ortopédicos , Análise Custo-Benefício , Humanos , Implantação de PróteseRESUMO
AIMS: To describe how patients respond to early signs of foot problems and the factors that result in delays in care. METHODS: Semi-structured interviews were conducted with a large sample of Veterans from across the United States with diabetes mellitus who had undergone a toe amputation. Data were analyzed using inductive content analysis. RESULTS: We interviewed 61 male patients. Mean age was 66 years, 41% were married, and 37% had a high school education or less. The patient-level factors related to delayed care included: 1) not knowing something was wrong, 2) misinterpreting symptoms, 3) "sudden" and "unexpected" illness progression, and 4) competing priorities getting in the way of care-seeking. The system-level factors included: 5) asking patients to watch it, 6) difficulty getting the right type of care when needed, and 7) distance to care and other transportation barriers. CONCLUSION: A confluence of patient factors (e.g., not examining their feet regularly or thoroughly and/or not acting quickly when they noticed something was wrong) and system factors (e.g., absence of a mechanism to support patient's appraisal of symptoms, lack of access to timely and convenient-located appointments) delayed care. Identifying patient- and system-level interventions that can shorten or eliminate care delays could help reduce rates of limb loss.