RESUMO
BACKGROUND: People living with human immunodeficiency virus (HIV) are living longer with health-related disability associated with ageing, including complex conditions. However, health systems in Canada have not adapted to meet these comprehensive care needs. METHODS: We convened three citizen panels and a national stakeholder dialogue. The panels were informed by a plain-language citizen brief that outlined data and evidence about the challenge/problem, elements of an approach for addressing it and implementation considerations. The national dialogue was informed by a more detailed version of the same brief that included a thematic analysis of the findings from the panels. RESULTS: The 31 citizen panel participants emphasized the need for more prevention, testing and social supports, increased public education to address stigma and access to more timely data to inform system changes. The 21 system leaders emphasized the need to enhance person-centred care and for implementing learning and improvement across provinces, territories and Indigenous communities. Citizens and system leaders highlighted that policy actions need to acknowledge that HIV remains unique among conditions faced by Canadians. CONCLUSIONS: Action will require a national learning collaborative to support spread and scale of successful prevention, care and support initiatives. Such a collaborative should be grounded in a rapid-learning and improvement approach that is anchored on the needs, perspectives and aspirations of people living with HIV; driven by timely data and evidence; supported by appropriate decision supports and aligned governance, financial and delivery arrangements; and enabled with a culture of and competencies for rapid learning and improvement.
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Assistência Integral à Saúde , Infecções por HIV , Estigma Social , Participação dos Interessados , Humanos , Infecções por HIV/terapia , Canadá , Assistência Integral à Saúde/organização & administração , Atenção à Saúde , Apoio Social , Política de Saúde , Necessidades e Demandas de Serviços de Saúde , Feminino , Assistência Centrada no Paciente , Masculino , Participação da Comunidade , Acessibilidade aos Serviços de SaúdeRESUMO
Research indicates a positive relationship between physical literacy and healthy aging; however, there is no consensus on the components required to become a physically literate adult. The objective of this study was to understand how physical literacy for adults with chronic conditions is characterized from the perspective of healthcare professionals. Physiotherapy leaders and physical literacy researchers within North America were invited to an online consensus panel and presented with questions related to physical literacy and rehabilitation. A nominal group technique was used for idea generation, clarification, and ranking. Confidence and safety with movements, motivation and commitment to physical activity, the ability to self-monitor changes in function, and understanding the benefits of physical activity were key components when defining physical literacy. There is a need to reconceptualize physical literacy to include the rehabilitation needs of adults living with chronic conditions, and to design programs that promote physical literacy to enhance function and mobility.
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Consenso , Letramento em Saúde , Humanos , Doença Crônica , Adulto , Feminino , Masculino , Motivação , Exercício Físico/fisiologiaRESUMO
INTRODUCTION: The unique evidentiary, economic and ethical challenges associated with health technology assessment (HTA) of precision therapies limit access to novel drugs and therapeutics for children and youth, for whom such challenges are amplified. We elicited citizens' perspectives about values-based criteria relevant to the assessment of paediatric precision therapies to inform the development of a child-tailored HTA framework. METHODS: We held four citizen panels virtually in May-June 2021, informed by a plain-language citizen brief summarizing global and local evidence about the challenges, policy and programmatic options and implementation strategies related to enhancing access to precision therapies for Canadian children and youth. Panellists were recruited through a nationally representative database, medical/patient networks and social media. We inductively coded and thematically analysed panel transcripts to generate themes and identify priority values. RESULTS: The perspectives of panellists (n = 45) coalesced into four overlapping themes, with attendant subthemes, relevant to a child-tailored HTA framework: (1) Childhood Distinctions: vulnerability, 'fair innings', future potential, family impacts; (2) Voice: agency of children and youth; lived versus no lived experience; (3) One versus Many: disease severity, rarity, equity, unmet need and (4) Health System Governance: funding, implementation inequities, effectiveness and safety. Participants broadly agreed that childhood distinctions, particularly family impacts, justify child-tailored HTA. Dissent arose over whose voice should inform HTA and how such perspectives are best incorporated. CONCLUSIONS: Citizens can offer unique insights into criteria relevant to the development or revision of HTA frameworks to capture holistic, societally responsive dimensions of value attached to unique contexts or populations, including children. Balancing the hopes and expectations of patients and caregivers for access to expensive but potential life-altering therapies against the opportunity costs borne by encompassing health systems is a fundamental challenge that will require rigorous methods to elicit, weigh and reconcile varied views. PATIENT OR PUBLIC CONTRIBUTION: A patient advocate served on the steering committee of this study and co-authored this article. Key informants for the Citizen Brief included patient advocates and caregivers; a separate patient advocate reviewed the Brief before dissemination. Qualitative and quantitative data were collected from the general public and caregivers of children, with written consent.
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Políticas , Avaliação da Tecnologia Biomédica , Humanos , Adolescente , Criança , Canadá , Custos e Análise de CustoRESUMO
BACKGROUND: The perspectives of citizens are an important and often overlooked source of evidence for informing health policy. Despite growing encouragement for its adoption, little is known regarding how citizen engagement may be integrated into evidence-informed health policy-making in low- and middle-income counties (LMICs) and newly democratic states (NDSs). We aimed to identify the factors and variables affecting the potential integration of citizen engagement into evidence-informed health policy-making in LMICs and NDSs and understand whether its implementation may require a different approach outside of high-income western democracies. Further, we assessed the context-specific considerations for the practical implementation of citizen engagement in one focus region-eastern Europe and central Asia. METHODS: First, adopting a scoping review methodology, we conducted and updated searches of six electronic databases, as well as a comprehensive grey literature search, on citizen engagement in LMICs and NDSs, published before December 2019. We extracted insights about the approaches to citizen engagement, as well as implementation considerations (facilitators and barriers) and additional political factors, in developing an analysis framework. Second, we undertook exploratory methods to identify relevant literature on the socio-political environment of the focus region, before subjecting these sources to the same analysis framework. RESULTS: Our searches identified 479 unique sources, of which 28 were adjudged to be relevant. The effective integration of citizen engagement within policy-making processes in LMICs and NDSs was found to be predominantly dependent upon the willingness and capacity of citizens and policy-makers. In the focus region, the implementation of citizen engagement within evidence-informed health policy-making is constrained by a lack of mutual trust between citizens and policy-makers. This is exacerbated by inadequate incentives and capacity for either side to engage. CONCLUSIONS: This research found no reason why citizen engagement could not adopt the same form in LMICs and NDSs as it does in high-income western democracies. However, it is recognized that certain political contexts may require additional support in developing and implementing citizen engagement, such as through trialling mechanisms at subnational scales. While specifically outlining the potential for citizen engagement, this study highlights the need for further research on its practical implementation.
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Política de Saúde , Formulação de Políticas , Pessoal Administrativo , Ásia , Humanos , Relatório de PesquisaRESUMO
BACKGROUND: As systematically developed statements regarding possible courses of action, health system guidance (HSG) can assist with making decisions about addressing problems or achieving goals in health systems. However, there are conceptual and methodological challenges in HSG implementation due to the complexity of health-system policy-making, the diversity of available evidence and vast differences in contexts. To address these gaps, we aim to develop a theoretical framework for supporting HSG implementation as part of a broader effort to promote evidence-informed policy-making in health systems. METHODS: To develop a theoretical framework about facilitators, barriers and strategies for HSG implementation, we will apply a critical interpretive synthesis (CIS) approach to synthesize the findings from a range of relevant literature. We will search 11 electronic databases and seven organizational websites to identify relevant published and grey literature. We will check the references of included studies and contact experts to identify additional eligible papers. Finally, we will conduct purposively sampling of the literature to fill any identified conceptual gaps. We will use relevance and five quality criteria to assess included papers. A standardized form will be developed for extracting information. We will use an interpretive analytic approach to synthesize the findings, including a constant comparative method throughout the analysis. Two independent reviewers will conduct the literature screening and relevance assessment, and disagreements will be resolved through discussion. The principal investigator will conduct data extraction and synthesis, and a second reviewer will check the sample of extracted data for consistency and accuracy. DISCUSSION: A new theoretical framework about facilitators, barriers and strategies for HSG implementation will be developed using a CIS approach. The HSG implementation framework could be widely used for supporting the implementation of HSG covering varied topics and in different contexts (including low-, middle- and high-income countries). In later work, we will develop a tool for supporting HSG implementation based on the theoretical framework. Registration PROSPERO CRD42020214072. Date of Registration: 14 December 2020.
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Tomada de Decisões , Promoção da Saúde , Humanos , Projetos de PesquisaRESUMO
The time has come to develop and implement a Canadian strategy on equitable access to Assistive Technology (AT). AT use has significant health, social, and economic benefits for people with disabilities and older people, and benefits society by assisting to mitigate the most prominent health and social challenges of our time. Our research with citizens (with/without experiences of disabilities or AT use) and system leaders across Canada determined that access is variable and inequitable, with unmet needs, restricted funding, and inefficiencies. Collaboratively, we devised a blueprint, comprising a policy vision, three priority issues to address, principles to underpin policy actions, and short- and long-term priorities, from which to build a strategy. We hope the blueprint sparks action among citizens and health leaders, especially those working across governments, sectors, and communities to promote leadership and create a cross-jurisdictional coalition to elaborate on a national strategy and action plans for moving forward.
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Pessoas com Deficiência , Tecnologia Assistiva , Humanos , Idoso , CanadáRESUMO
Enhancing the use of technology in long-term care has been identified as a key part of broader efforts to strengthen the sector in the wake of the COVID-19 pandemic. To inform such efforts, we convened a series of citizen panels, followed by a national stakeholder dialogue with system leaders focused on reimagining the long-term care sector using technology. Key actions prioritized through the deliberations convened included: developing an innovation roadmap/agenda (including national standards and guidelines); using co-design approaches for the strengthening the long-term care sector and for technological innovation; identifying and coordinating existing innovation projects to support scale and spread; enabling rapid-learning and improvement cycles to support the development, evaluation, and implementation of new technologies; and using funding models that enable the flexibility needed for such rapid-learning cycles.
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COVID-19 , Assistência de Longa Duração/métodos , Participação dos Interessados , Tecnologia/métodos , Canadá , Humanos , Assistência de Longa Duração/tendências , Pandemias , Tecnologia/tendênciasRESUMO
BACKGROUND: Despite the significant variability in the role and integration of midwifery across provincial and territorial health systems, there has been limited scholarly inquiry into whether, how and under what conditions midwifery has been assigned roles and integrated into Canada's health systems. METHODS: We use Yin's (2014) embedded single-case study design, which allows for an in-depth exploration to qualitatively assess how, since the regulation of midwives in 1994, the Ontario health system has assigned roles to and integrated midwives as a service delivery option. Kingdon's agenda setting and 3i + E theoretical frameworks are used to analyze two recent key policy directions (decision to fund freestanding midwifery-led birth centres and the Patients First primary care reform) that presented opportunities for the integration of midwives into the health system. Data were collected from key informant interviews and documents. RESULTS: Nineteen key informant interviews were conducted, and 50 documents were reviewed in addition to field notes taken during the interviews. Our findings suggest that while midwifery was created as a self-regulated profession in 1994, health-system transformation initiatives have restricted the profession's integration into Ontario's health system. The policy legacies of how past decisions influence the decisions possible today have the most explanatory power to understand why midwives have had limited integration into interprofessional maternity care. The most important policy legacies to emerge from the analyses were related to payment mechanisms. In the medical model, payment mechanisms privilege physician-provided and hospital-based services, while payment mechanisms in the midwifery model have imposed unintended restrictions on the profession's ability to practice in interprofessional environments. CONCLUSIONS: This is the first study to explain why midwives have not been fully integrated into the Ontario health system, as well as the limitations placed on their roles and scope of practice. The study also builds a theoretical understanding of the integration process of healthcare professions within health systems and how policy legacies shape service delivery options.
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Atenção à Saúde/organização & administração , Tocologia , Papel Profissional , Feminino , Humanos , Ontário , GravidezRESUMO
BACKGROUND: Midwives' roles in sexual and reproductive health and rights continues to evolve. Understanding the profession's role and how midwives can be integrated into health systems is essential in creating evidence-informed policies. Our objective was to develop a theoretical framework of how political system factors and health systems arrangements influence the roles of midwives within the health system. METHODS: A critical interpretive synthesis was used to develop the theoretical framework. A range of electronic bibliographic databases (CINAHL, EMBASE, Global Health database, HealthSTAR, Health Systems Evidence, MEDLINE and Web of Science) was searched through to 14 May 2020 as were policy and health systems-related and midwifery organisation websites. A coding structure was created to guide the data extraction. RESULTS: A total of 4533 unique documents were retrieved through electronic searches, of which 4132 were excluded using explicit criteria, leaving 401 potentially relevant records, in addition to the 29 records that were purposively sampled through grey literature. A total of 100 documents were included in the critical interpretive synthesis. The resulting theoretical framework identified the range of political and health system components that can work together to facilitate the integration of midwifery into health systems or act as barriers that restrict the roles of the profession. CONCLUSIONS: Any changes to the roles of midwives in health systems need to take into account the political system where decisions about their integration will be made as well as the nature of the health system in which they are being integrated. The theoretical framework, which can be thought of as a heuristic, identifies the core contextual factors that governments can use to best leverage their position when working to improve sexual and reproductive health and rights.
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Tocologia , Saúde Sexual , Feminino , Governo , Programas Governamentais , Humanos , Política , GravidezRESUMO
BACKGROUND: Although values underpin the goals pursued in health systems, including how health systems benefit the population, it is often not clear how values are incorporated into policy decision-making about health systems. The challenge is to encompass social/citizen values, health system goals, and financial realities and to incorporate them into the policy-making process. This is a challenge for all health systems and of particular importance for Latin American (LA) countries. Our objective was to understand how and under what conditions societal values inform decisions about health system financing in LA countries. METHODS: A critical interpretive synthesis approach was utilised for this work. We searched 17 databases in December 2016 to identify articles written in English, Spanish or Portuguese that focus on values that inform the policy process for health system financing in LA countries at the macro and meso levels. Two reviewers independently screened records and assessed them for inclusion. One researcher conceptually mapped the included articles, created structured summaries of key findings from each, and selected a purposive sample of articles to thematically synthesise the results across the domains of agenda-setting/prioritisation, policy development and implementation. RESULTS: We identified 5925 references, included 199 papers, and synthesised 68 papers. We identified 116 values and developed a framework to explain how values have been used to inform policy decisions about financing in LA countries. This framework has four categories - (1) goal-related values (i.e. guiding principles of the health system); (2) technical values (those incorporated into the instruments adopted by policy-makers to ensure a sustainable and efficient health system); (3) governance values (those applied in the policy process to ensure a transparent and accountable process of decision-making); and (4) situational values (a broad category of values that represent competing strategies to make decisions in the health systems, their influence varying according to the four factors). CONCLUSIONS: It is an effort to consolidate and explain how different social values are considered and how they support policy decision-making about health system financing. This can help policy-makers to explicitly incorporate values into the policy process and understand how values are supporting the achievement of policy goals in health system financing. TRIAL REGISTRATION: The protocol was registered with PROSPERO, ID=CRD42017057049 .
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Política de Saúde , Formulação de Políticas , Atenção à Saúde , Programas Governamentais , Humanos , América LatinaRESUMO
Scoping reviews, a type of knowledge synthesis, follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps. Although more scoping reviews are being done, their methodological and reporting quality need improvement. This document presents the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist and explanation. The checklist was developed by a 24-member expert panel and 2 research leads following published guidance from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. The final checklist contains 20 essential reporting items and 2 optional items. The authors provide a rationale and an example of good reporting for each item. The intent of the PRISMA-ScR is to help readers (including researchers, publishers, commissioners, policymakers, health care providers, guideline developers, and patients or consumers) develop a greater understanding of relevant terminology, core concepts, and key items to report for scoping reviews.
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Literatura de Revisão como Assunto , Lista de Checagem , Técnica Delphi , Humanos , Metanálise como Assunto , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Health system expenditure on cancer drugs is rising rapidly in many OECD countries given the costly new treatments and increased rates of use due to a growing and ageing population. These factors put considerable strain on the sustainability of health systems worldwide, sparking public debate among clinicians, pharmaceutical companies, policy-makers and citizens on issues of affordability and equity. We engaged Canadians through a series of deliberative public engagement events to determine their priorities for making cancer drug funding decisions fair and sustainable in Canada's publicly financed health system. METHODS: An approach to deliberation was developed based on the McMaster Health Forum's citizen panels and the established Burgess and O'Doherty model of deliberative public engagement. Six deliberations were held across Canada in 2016. Transcripts were coded in NVivo and analysed to determine where participants' views converged and diverged. Recommendations were grouped thematically. RESULTS: A total of 115 Canadians participated in the deliberative events and developed 86 recommendations. Recommendations included the review and regular re-review of approved drugs using 'real-world' evidence on effectiveness and cost-effectiveness; prioritisation of treatments that restore patients' independence, mental health and general well-being; ensuring that decision processes, results and their rationales are transparent; and commitment to people with similar needs receiving the same care regardless of where in Canada they live. CONCLUSIONS: The next steps for policy-makers should be to develop mechanisms for (1) re-reviewing effectiveness and cost-effectiveness data for all cancer drugs; (2) making disinvestments in cancer drugs that satisfy requirements relating to grandfathering and compassionate access; (3) ensuring fair and equitable access to cancer drugs for all Canadians; and (4) fostering a pan-Canadian approach to cancer drug funding decisions.
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Antineoplásicos/economia , Atitude , Participação da Comunidade , Gastos em Saúde , Política de Saúde , Acessibilidade aos Serviços de Saúde/economia , Opinião Pública , Canadá , Análise Custo-Benefício , Tomada de Decisões , Financiamento Governamental , Prioridades em Saúde , Humanos , Formulação de Políticas , Justiça SocialRESUMO
OBJECTIVE: Ethnic minorities (nonwhites) with critical limb ischemia (CLI) have historically performed worse compared with whites with regard to major amputation risk reduction and amputation-free survival (AFS) after peripheral vascular intervention. This post hoc analysis was completed to determine whether this precedent also extended to treatment of CLI without a suitable revascularization option with intramuscular injections of concentrated bone marrow aspirate (cBMA). METHODS: The treatment arm of the randomized, double-blind, multicenter MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial was stratified by ethnicity and evaluated for demographics, comorbidities, and outcomes. The primary and therapeutic end point was 1-year AFS and major amputation, respectively. Noninferiority analysis was performed with the margin set at historically reported hazard ratios. RESULTS: Thirty-seven minority (African American, Hispanic, other) CLI patients (9 placebo, 28 cBMA) with no suitable revascularization option were randomized to cBMA or placebo at a 3:1 ratio during the MOBILE trial. At 1-year follow-up for the treatment group, overall AFS was 80%. Of the 28 minority patients randomized to cBMA intervention, an 89% AFS rate was observed compared with 77% in whites. Specifically, 22 of 24 (92%) African Americans survived amputation free at 1-year follow-up. Noninferiority testing confirmed no difference between whites and the ethnic minority treated with cBMA with respect to major amputation reduction; however, noninferiority could not be confirmed with regard to AFS. No significant differences favoring whites treated with cBMA were noted in the secondary end points of vascular quality of life, limb pain, ankle-brachial index, toe-brachial index, transcutaneous oximetry, and 6-minute walk testing. CONCLUSIONS: This post hoc analysis of the MOBILE trial demonstrates noninferiority of cBMA intervention in minorities with no-option CLI for the therapeutic end point of major amputation prevention. cBMA represents a novel treatment paradigm and should be explored for minorities with poor revascularization options who face impending amputation secondary to progressive CLI.
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Amputação Cirúrgica , Transplante de Medula Óssea/efeitos adversos , Etnicidade , Isquemia/cirurgia , Grupos Minoritários , Doença Arterial Periférica/cirurgia , População Branca , Idoso , Estado Terminal , Intervalo Livre de Doença , Método Duplo-Cego , Feminino , Disparidades nos Níveis de Saúde , Humanos , Isquemia/diagnóstico , Isquemia/etnologia , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/etnologia , Fatores de Risco , Fatores de Tempo , Transplante Autólogo , Resultado do TratamentoRESUMO
BACKGROUND: Satisfaction is a key component of the care experience and part of the health system "triple aim," along with improving population health and reducing per capita health care costs, the other two parts of the "triple aim." The objectives of the study were to examine birth-experience satisfaction among women in Ontario, Canada, who received care from midwives, family physicians, and obstetricians. METHODS: We used Statistics Canada's 2006 national Maternity Experiences Survey. The sample includes 1900 Ontario women and is, with appropriate weighting, representative of an estimated population of 29 700 women who gave birth in Ontario to a singleton baby during the study period. Information was collected on respondents' satisfaction with their health care providers, demographic characteristics, and a range of pregnancy, labor, birth, and postpartum experiences. We used logistic regression analysis to assess differences in patient/client satisfaction by type of health care provider. RESULTS: Women cared for by midwives were three times more likely to be satisfied with their care (OR 3.32 [95% CI 2.26-4.86]) when compared with obstetrician-led care. Depression symptoms, having to travel outside the respondents' community to give birth, and being born in an East Asian country were associated with lower levels of satisfaction. CONCLUSION: Given recent health system reforms emphasizing the importance of shifting from expensive acute hospital-based care to community-based care, our findings support empirically the importance of supporting women's access to midwifery services within their communities. Findings of ethnocultural differences in satisfaction with care can inform policy makers as health systems move to provide culturally appropriate care to increasingly diverse populations.
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Depressão Pós-Parto/epidemiologia , Pessoal de Saúde/estatística & dados numéricos , Trabalho de Parto/psicologia , Mães/psicologia , Satisfação do Paciente/estatística & dados numéricos , Adolescente , Adulto , Feminino , Humanos , Renda/estatística & dados numéricos , Modelos Logísticos , Serviços de Saúde Materna/organização & administração , Ontário , Gravidez , Qualidade da Assistência à Saúde/organização & administração , Adulto JovemRESUMO
BACKGROUND: Health systems are increasingly focusing on the issue of 'overuse' of health services and how to address it. We developed a framework focused on (1) the rationale and context for health systems prioritising addressing overuse, (2) elements of a comprehensive process and approach to reduce overuse and (3) implementation considerations for addressing overuse. METHODS: We conducted a critical interpretive synthesis informed by a stakeholder-engagement process. The synthesis identified relevant empirical and non-empirical articles about system-level overuse. Two reviewers independently screened records, assessed for inclusion and conceptually mapped included articles. From these, we selected a purposive sample, created structured summaries of key findings and thematically synthesised the results. RESULTS: Our search identified 3545 references, from which we included 251. Most articles (76%; n = 192) were published within 5 years of conducting the review and addressed processes for addressing overuse (63%; n = 158) or political and health system context (60%; n = 151). Besides negative outcomes at the patient, system and global level, there were various contextual factors to addressing service overuse that seem to be key issue drivers. Processes for addressing overuse can be grouped into three elements comprising a comprehensive approach, including (1) approaches to identify overused health services, (2) stakeholder- or patient-led approaches and (3) government-led initiatives. Key implementation considerations include the need to develop 'buy in' from stakeholders and citizens. CONCLUSIONS: Health systems want to ensure the use of high-value services to keep citizens healthy and avoid harm. Our synthesis can be used by policy-makers, stakeholders and researchers to understand how the issue has been prioritised, what approaches have been used to address it and implementation considerations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014013204 .
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Serviços de Saúde/estatística & dados numéricos , Uso Excessivo dos Serviços de Saúde/prevenção & controle , Aceitação pelo Paciente de Cuidados de Saúde , Participação da Comunidade , Programas Governamentais , Humanos , Participação dos InteressadosRESUMO
OBJECTIVE: Critical limb ischemia (CLI) continues to place a significant encumbrance on patients and the health care system as it progresses to limb loss and long-term disability. Traditional methods of revascularization offer a significant benefit; however, for one-third of CLI patients, these surgical options are not technically possible or patency is severely limited by disease burden (deemed "poor-option" for revascularization). In a previous phase I trial, we demonstrated intramuscular injection of concentrated bone marrow aspirate (cBMA) via MarrowStim (Zimmer Biomet, Warsaw, Ind) harvest is safe and may decrease major amputation in patients with CLI unfit for surgical revascularization. Therefore, we describe and rationalize the MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial, a study geared to provide the pivotal proof of efficacy of cBMA in CLI. METHODS: MOBILE is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy of intramuscular injections of cBMA in promoting amputation-free survival in patients with poor-option CLI. Patients (aged >21 years) with rest pain or tissue loss resulting from advanced peripheral arterial disease, as characterized by ankle-brachial index (<0.6), toe-brachial index (<0.4), or transcutaneous pressure of oxygen (<50 mm Hg), were eligible for inclusion if surgical revascularization was not possible secondary to advanced disease. RESULTS: Treatment and 1-year follow-up of 152 patients enrolled in MOBILE are completed. Long-term follow-up is ongoing. Currently, we are in the process of unblinding the initial results for preliminary data analysis. CONCLUSIONS: If successful, MOBILE could add definitive, high-quality evidence in support of cBMA for the treatment of poor-option CLI patients and provide an additional modality for patients who face amputation secondary to advanced limb ischemia.
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Transplante de Medula Óssea/métodos , Separação Celular/instrumentação , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Índice Tornozelo-Braço , Monitorização Transcutânea dos Gases Sanguíneos , Transplante de Medula Óssea/efeitos adversos , Protocolos Clínicos , Estado Terminal , Método Duplo-Cego , Desenho de Equipamento , Humanos , Injeções Intramusculares , Isquemia/diagnóstico , Isquemia/fisiopatologia , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Projetos de Pesquisa , Índice de Gravidade de Doença , Fatores de Tempo , Transplante Autólogo , Resultado do TratamentoRESUMO
PURPOSE: This patient study was designed to measure the validity of both the horizontal and Camper's planes, which are used as benchmarks to reestablish the sagittal orientation of the occlusal plane angles in dental rehabilitation. MATERIALS AND METHODS: Profile digital photographs were made of the first 100 consenting dentate patients as they closed on an occlusal plane analyzer while maintaining natural head posture. Using a digital screen protractor, three angles were measured: the occlusal plane angle relative to the horizontal plane, and the angle between the occlusal plane and Camper's plane from both the superior and inferior borders of the tragus of the ear. RESULTS: The angle between the occlusal plane and the horizontal reference plane for the 100 patients ranged from -8.72° to +18.08° (mean +3.25°); the angle between the occlusal plane and Camper's plane, from the superior border of the tragus to the ala of the nose demonstrated a range from -8.49° to +15.16° (mean +3.03°); and the angle between Camper's plane, from the inferior border of the tragus to the ala of the nose and the occlusal plane demonstrated a range from -15.57° to +9.15° (mean -4.09°). CONCLUSIONS: Occlusal plane angles measured in this patient population with natural dentitions demonstrated a relatively small mean deviation from both the horizontal plane and Camper's plane when using the superior border of the tragus as the distal reference point, but the range was quite broad and could result in unacceptable occlusal plane angles in many patients undergoing dental rehabilitation. CLINICAL IMPLICATIONS: Both Camper's plane and the horizontal reference plane may be acceptable initial reference planes for oral rehabilitation, but additional anatomic and esthetic parameters are required for verification of an esthetically pleasing occlusal plane angle.
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Benchmarking , Oclusão Dentária , Estética Dentária , Reabilitação Bucal , Adulto , Idoso , Pontos de Referência Anatômicos , Pavilhão Auricular/anatomia & histologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nariz/anatomia & histologia , Planejamento de Assistência ao Paciente , Fotografação , PosturaRESUMO
OBJECTIVE: We have previously shown that autologous bone marrow mononuclear cell (ABMNC) therapy improves measures of limb perfusion, rest pain, wound healing, and amputation-free survival (AFS) at 1 year in patients with critical limb ischemia (CLI). Long-term durability of ABMNC therapy for CLI remains unknown. The objective of the current study was to evaluate long-term clinical outcomes 5 years after treatment. METHODS: Data were retrospectively gathered from a database and via a patient survey and review of medical records of patients previously enrolled in this phase I/II trial. AFS, freedom from major amputation, and freedom from major adverse limb events (MALE) were calculated using the product-limit estimate. The incidence of cardiac, malignant, and other medical events relevant to the safety of cell therapy were tabulated during the time from treatment to follow-up. RESULTS: Twenty-one of the 24 patients (88%) who completed the initial 1-year phase I/II trial were available for the 5-year analysis; AFS was 74% (95% confidence interval [CI], 0.53-0.87), freedom from major amputation was 78% (95% CI, 0.58-0.90), and freedom from MALE was 65% (95% CI, 0.45-0.80). Three patients (14%) had major cardiac events. There were no incidences of malignancies or diagnoses of clinically significant proliferative retinopathy. Fifteen patients (71%) report continued improvement in pain-free walking. Nineteen (90%) patients believed that the study was of significant medical value and would participate again. CONCLUSIONS: ABMNC therapy provides long-term freedom from AFS, major amputation, and MALE that are comparable with other reports of patients who underwent surgical and endovascular interventions for CLI. Furthermore, no patients developed tumorigenesis or clinically significant retinopathy. Because of the limited number of patients studied, our findings will need to be followed up in a larger phase III trial.
Assuntos
Transplante de Medula Óssea/métodos , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Transplante de Medula Óssea/efeitos adversos , Ensaios Clínicos Fase I como Assunto , Ensaios Clínicos Fase II como Assunto , Estado Terminal , Bases de Dados Factuais , Intervalo Livre de Doença , Tolerância ao Exercício , Feminino , Humanos , Isquemia/diagnóstico , Isquemia/fisiopatologia , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Satisfação do Paciente , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Transplante Autólogo , Resultado do Tratamento , Caminhada , Adulto JovemRESUMO
BACKGROUND: Accumulating evidence suggests responses to HIV that combine individual-level interventions with those that address structural or contextual factors that influence risks and health outcomes of infection. Housing is such a factor. Housing occupies a strategic position as an intermediate structural factor, linking "upstream" economic, social, and cultural determinants to the more immediate physical and social environments in which everyday life is lived. The importance of housing status for HIV prevention and care has been recognized, but much of this attention has focused on homeless individuals as a special risk group. Analyses have less often addressed community housing availability and conditions as factors influencing population health or unstable, inadequate, or unaffordable housing as a situation or temporary state. A focus on individual-level characteristics associated with literal homelessness glosses over social, economic, and policy drivers operating largely outside any specific individual's control that affect housing and residential environments and the health resources or risk exposures such contexts provide. OBJECTIVES: We examined the available empirical evidence on the association between housing status (broadly defined), medical care, and health outcomes among people with HIV and analyzed results to inform future research, program development, and policy implementation. SEARCH METHODS: We searched 8 electronic health and social science databases from January 1, 1996, through March 31, 2014, using search terms related to housing, dwelling, and living arrangements and HIV and AIDS. We contacted experts for additional literature. SELECTION CRITERIA: We selected articles if they were quantitative analyses published in English, French, or Spanish that included at least 1 measure of housing status as an independent variable and at least 1 health status, health care, treatment adherence, or risk behavior outcome among people with HIV in high-income countries. We defined housing status to include consideration of material or social dimensions of housing adequacy, stability, and security of tenure. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed data extraction and quality appraisal. We used the Cochrane Risk of Bias Tool for randomized controlled trials and a modified version of the Newcastle Ottawa Quality Appraisal Tool for nonintervention studies. In our quality appraisal, we focused on issues of quality for observational studies: appropriate methods for determining exposure and measuring outcomes and methods to control confounding. RESULTS: Searches yielded 5528 references from which we included 152 studies, representing 139,757 HIV-positive participants. Most studies were conducted in the United States and Canada. Studies examined access and utilization of HIV medical care, adherence to antiretroviral medications, HIV clinical outcomes, other health outcomes, emergency department and inpatient utilization, and sex and drug risk behaviors. With rare exceptions, across studies in all domains, worse housing status was independently associated with worse outcomes, controlling for a range of individual patient and care system characteristics. CONCLUSIONS: Lack of stable, secure, adequate housing is a significant barrier to consistent and appropriate HIV medical care, access and adherence to antiretroviral medications, sustained viral suppression, and risk of forward transmission. Studies that examined the history of homelessness or problematic housing years before outcome assessment were least likely to find negative outcomes, homelessness being a potentially modifiable contextual factor. Randomized controlled trials and observational studies indicate an independent effect of housing assistance on improved outcomes for formerly homeless or inadequately housed people with HIV. Housing challenges result from complex interactions between individual vulnerabilities and broader economic, political, and legal structural determinants of health. The broad structural processes sustaining social exclusion and inequality seem beyond the immediate reach of HIV interventions, but changing housing and residential environments is both possible and promising.
Assuntos
Infecções por HIV , Acessibilidade aos Serviços de Saúde , Habitação/classificação , Adesão à Medicação , Determinantes Sociais da Saúde , Bases de Dados Bibliográficas , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , Pessoas Mal Alojadas , Humanos , Avaliação de Resultados em Cuidados de SaúdeRESUMO
BACKGROUND: HIV-related stigma continues to negatively impact the health and well-being of people living with HIV, with deleterious effects on their care, treatment and quality of life. A growing body of qualitative research has documented the relationship between HIV-related stigma and health. This review aims to synthesize qualitative evidence that explored the intersections of stigma and health for people with HIV. METHODS: A thematic summary was conducted that was guided by the qualitative metasummary technique developed by Sandelowski and Barraso. Literature searches yielded 8,622 references of which 55 qualitative studies were identified that illustrated HIV-related stigma in the context of health. RESULTS: The metasummary classified qualitative findings into three overarching categories: conceptualizing stigma which identified key dimensions of HIV-related stigma; experiencing stigma which highlighted experiences of stigma in the health context, and managing stigma which described ways in which stigma is avoided or addressed. To better illustrate these connections, the qualitative literature was summarized into the following themes: stigma within health care settings, the role of stigma in caring for one's health, and strategies to address HIV-related stigma in the health context. A number of health care practices were identified--some rooted in institutional practices, others shaped by personal perceptions held by practitioners--that could be stigmatizing or discriminatory towards people with HIV. There existed interconnections between enacted stigma and felt stigma that influenced health care utilization, treatment adherence, and overall health and well-being of people with HIV. Intersectional stigma also emerged as instrumental in the stigma experiences of people living with HIV. A number of strategies to address stigma were identified including social support, education, self-efficacy, resilience activities, and advocacy. CONCLUSION: This review of the qualitative evidence indicates that HIV-related stigma within health contexts is a broad social phenomenon that manifests within multiple social spheres, including health care environments. Findings from this review indicate that future stigma research should consider the social structures and societal practices--within and outside of health care environments--that perpetuate and reinforce stigma and discrimination towards people with HIV.