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1.
Sci Eng Ethics ; 30(3): 17, 2024 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-38720094

RESUMO

Wandering is a symptom of dementia that can have devastating consequences on the lives of persons living with dementia and their families and caregivers. Increasingly, caregivers are turning towards electronic tracking devices to help manage wandering. Ethical questions have been raised regarding these location-based technologies and although qualitative research has been conducted to gain better insight into various stakeholders' views on the topic, developers of these technologies have been largely excluded. No qualitative research has focused on developers' perceptions of ethics related to electronic tracking devices. To address this, we performed a qualitative semi-structured interview study based on grounded theory. We interviewed 15 developers of electronic tracking devices to better understand how they perceive ethical issues surrounding the design, development, and use of these devices within dementia care. Our results reveal that developers are strongly motivated by moral considerations and believe that including stakeholders throughout the development process is critical for success. Developers felt a strong sense of moral obligation towards topics within their control and a weaker sense of moral obligation towards topics outside their control. This leads to a perceived moral boundary between development and use, where some moral responsibility is shifted to end-users.


Assuntos
Cuidadores , Demência , Entrevistas como Assunto , Obrigações Morais , Pesquisa Qualitativa , Humanos , Demência/terapia , Cuidadores/ética , Comportamento Errante/ética , Teoria Fundamentada , Participação dos Interessados , Eletrônica/ética , Feminino , Motivação/ética
2.
J Glob Health ; 14: 04098, 2024 May 10.
Artigo em Inglês | MEDLINE | ID: mdl-38721686

RESUMO

Background: Emergency obstetric and newborn care (EmONC) in Bangladesh focusses on maternal health, whereby it addresses childbirth and postpartum complications to ensure women's health and well-being. It was transitioned to a digital platform to overcome challenges with the paper-based EmONC register and we conducted implementation research to assess the outcome. Here we outline the stakeholder engagement process integral to the implementation research process. Methods: We adopted a four-step stakeholder engagement model based on the identification, sensitisation, involvement, and engagement of stakeholders. The approach was informed by previous experience, desk reviews, and expert consultations to ensure comprehensive engagement with stakeholders at multiple levels. Led by the Maternal Health Programme of the Government of Bangladesh, we involved high-power and high-interest stakeholders in developing a joint action plan for digitisation of the paper-based EmONC register. Finally, we demonstrated this digital EmONC register in real-life settings to stakeholders at different levels. Results: The successful demonstration process fostered government ownership and collaboration with multiple stakeholders, while laying the foundation for scalability and sustainability. Nevertheless, our experience highlighted that the stakeholder engagement process is context-driven, time-consuming, resource-intensive, iterative, and dynamic, and it requires involving stakeholders with varied expertise. Effective strategic planning, facilitation, and the allocation of sufficient time and resources are essential components for successful stakeholder engagement. Conclusions: Our experience demonstrates the potential of adopting the 'identification, sensitisation, involvement, and engagement' stakeholder engagement model. Success in implementing this model in diverse settings depends on leveraging knowledge gained during implementation, maintaining robust communication with stakeholders, and harnessing the patience and determination of the facilitating organisation.


Assuntos
Participação dos Interessados , Humanos , Bangladesh , Feminino , Gravidez , Recém-Nascido , Serviços de Saúde Materna/organização & administração , Sistema de Registros , Serviços Médicos de Emergência/organização & administração
3.
BMJ Open ; 14(5): e082598, 2024 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-38697756

RESUMO

OBJECTIVES: The burden of malaria has persistently been high in Ebonyi state and Nigeria despite long-standing collaborations with international partners with huge and increased amounts of financial investments. We explored the system-wide governance challenges of the Ebonyi State Malaria Elimination Programme (SMEP) and the factors responsible in order to make recommendations for malaria health system strengthening. DESIGN: We did a qualitative study informed by the health system governance framework by Mikkelsen-Lopez et al and Savedoff's concept of governance. SETTING AND PARTICIPANTS: Between 18 October 2022 and 8 November 2022, 25 semistructured face-to-face in-depth interviews were conducted in English with purposively selected key stakeholders in the Ebonyi SMEP aged 18 years or older with at least 2 years of involvement in the SMEP and who gave consent. ANALYSIS: Data were analysed deductively and the analytical strategy was informed by the framework method for the analysis of qualitative data by Gale et al. RESULTS: Many system-wide governance challenges of the SMEP were identified including the absence of state's strategic vision and plans for malaria elimination; very weak primary and secondary healthcare systems; inadequate financial allocation and untimely release of budgeted funds by the state government; lack of human resources for health and very poor mosquito net distribution system. Other challenges were inadequate stakeholders' participation; poor accountability culture; impaired transparency and corruption and impaired ability to address corruption. The fundamental responsible factors were the lack of state government's concern for people's welfare and lack of interest and commitment to the malaria elimination effort, chronic non-employment of staff and lack of human resources in the entire health sector including SMEP, and nepotism and godfatherism. CONCLUSIONS: The system-wide governance challenges and the responsible factors call for changing the 'business as usual' and refocusing on strengthening malaria health system governance in addressing the persisting malaria health problems in Ebonyi state (and Nigeria).


Assuntos
Malária , Pesquisa Qualitativa , Humanos , Nigéria , Malária/prevenção & controle , Erradicação de Doenças/organização & administração , Erradicação de Doenças/métodos , Participação dos Interessados , Atenção à Saúde/organização & administração , Entrevistas como Assunto , Feminino , Masculino
4.
BMC Med Ethics ; 25(1): 54, 2024 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-38745276

RESUMO

BACKGROUND: A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. METHODS: The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. RESULTS: The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. CONCLUSION: In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.


Assuntos
Vacinas contra a AIDS , Pesquisa Participativa Baseada na Comunidade , Infecções por HIV , Negociação , Pesquisa Qualitativa , Humanos , Vacinas contra a AIDS/administração & dosagem , Infecções por HIV/prevenção & controle , Tanzânia , Ensaios Clínicos como Assunto , Grupos Focais , Masculino , Feminino , Tomada de Decisões , Pesquisadores , Participação dos Interessados , Países em Desenvolvimento , Adulto
5.
PLoS One ; 19(5): e0297489, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38722852

RESUMO

BACKGROUND: There are few data reporting the needs and priorities of older adults in Brazil. This hampers the development and/or implementation of policies aimed at older adults to help them age well. The aim of this study was to understand areas of importance, priorities, enablers and obstacles to healthy ageing as identified by older adults and key stakeholders in both urban and rural environments. METHODS: Two locations were selected, one urban and one rural in the municipality of Santo André, in the metropolitan region of São Paulo (SP). Workshops for older adults (>60 y) and stakeholders were conducted separately in each location. The workshops incorporated an iterative process of discussion, prioritisation and ranking of responses, in roundtable groups and in plenary. Areas of commonality and differences between older adult and stakeholder responses were identified by comparing responses between groups as well as mapping obstacles and enablers to healthy ageing identified by older adults, to the priorities identified by stakeholder groups. The socio-ecologic model was used to categorise responses. RESULTS: There were few shared responses between stakeholders and older adults and little overlap between the top ranked responses of urban and rural groups. With respect to areas of importance, both stakeholder groups ranked policies for older people within their top five reponses. Both older adult groups ranked keeping physically and mentally active, and nurturing spirituality. There was a marked lack of congruence between older adults' obstacles and enablers to healthy ageing and stakeholder priorities, in both urban and rural settings. Most responses were located within the Society domain of the socio-ecologic model, although older adults also responded within the Individual/ Relationships domains, particularly in ranking areas of most importance for healthy ageing. CONCLUSIONS: Our results highlight substantial differences between older adults and stakeholders with respect to areas of importance, priorities, enablers and obstacles to healthy ageing, and point to the need for more engagement between those in advocacy and policymaking roles and the older people whose needs they serve.


Assuntos
População Rural , População Urbana , Humanos , Brasil , Idoso , Masculino , Feminino , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Participação dos Interessados , Prioridades em Saúde , Envelhecimento Saudável , Necessidades e Demandas de Serviços de Saúde
6.
BMC Public Health ; 24(1): 1299, 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38741039

RESUMO

AIM: To investigate the potential of embedded research in bridging the gap between research evidence and its implementation in public health practice. METHODS: Using a case study methodology, semi-structured interviews were conducted with 4 embedded researchers, 9 public health practitioners, and 4 other stakeholders (2 teachers and 2 students) across four case study sites. Sites and individuals were purposively selected. Sites included two local authorities, one secondary school, and one sports organisation. Thematic data analysis was adopted to analyse the qualitative data. RESULTS: Four themes were identified: (1) building and maintaining relationships, (2) working with stakeholders, (3) informing practice, and (4) critical reflection. CONCLUSIONS: Embedded researchers build and maintain relationships with practitioners and other stakeholders to produce research. Evidence from the co-produced research informs future practice and research to improve service and delivery rendered to the public. Thus, embedded researchers use their role to bridge the research evidence - implementation gap in public health practice.


Assuntos
Prática de Saúde Pública , Pesquisa Qualitativa , Humanos , Entrevistas como Assunto , Estudos de Casos Organizacionais , Prática Clínica Baseada em Evidências , Participação dos Interessados , Pesquisa sobre Serviços de Saúde
7.
Health Expect ; 27(3): e14063, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38711219

RESUMO

INTRODUCTION: Advanced therapies offer unprecedented opportunities for treating rare neurological disorders (RNDs) in children. However, health literacy, perceptions and understanding of novel therapies need elucidation across the RND community. This study explored healthcare professionals' and carers' perspectives of advanced therapies in childhood-onset RNDs. METHODS: In this mixed-methodology cross-sectional study, 20 healthcare professionals (clinicians, genetic counsellors and scientists) and 20 carers completed qualitative semistructured interviews and custom-designed surveys. Carers undertook validated psychosocial questionnaires. Thematic and quantitative data analysis followed. RESULTS: Participants described high positive interest in advanced therapies, but low knowledge of, and access to, reliable information. The substantial 'therapeutic gap' and 'therapeutic odyssey' common to RNDs were recognised in five key themes: (i) unmet need and urgency for access; (ii) seeking information; (iii) access, equity and sustainability; (iv) a multidisciplinary and integrated approach to care and support and (v) difficult decision-making. Participants were motivated to intensify RND clinical trial activity and access to advanced therapies; however, concerns around informed consent, first-in-human trials and clinical trial procedures were evident. There was high-risk tolerance despite substantial uncertainties and knowledge gaps. RNDs with high mortality, increased functional burdens and no alternative therapies were consistently prioritised for the development of advanced therapies. However, little consensus existed on prioritisation to treatment access. CONCLUSIONS: This study highlights the need to increase clinician and health system readiness for the clinical translation of advanced therapeutics for RNDs. Co-development and use of educational and psychosocial resources to support clinical decision-making, set therapeutic expectations and promotion of equitable, effective and safe delivery of advanced therapies are essential. PATIENT OR PUBLIC CONTRIBUTION: Participant insights into the psychosocial burden and information need to enhance the delivery of care in this formative study are informing ongoing partnerships with families, including co-production and dissemination of psychoeducational resources featuring their voices hosted on the Sydney Children's Hospitals Network website SCHN Brain-Aid Resources.


Assuntos
Doenças do Sistema Nervoso , Doenças Raras , Humanos , Doenças Raras/terapia , Estudos Transversais , Doenças do Sistema Nervoso/terapia , Feminino , Masculino , Austrália , Adulto , Cuidadores/psicologia , Inquéritos e Questionários , Entrevistas como Assunto , Participação dos Interessados , Pessoa de Meia-Idade , Pessoal de Saúde/psicologia , Pesquisa Translacional Biomédica , Pesquisa Qualitativa
8.
Br J Nurs ; 33(9): 435-436, 2024 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-38722009

RESUMO

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discuses some key NHS stakeholder perspectives on NHS patient safety.


Assuntos
Segurança do Paciente , Medicina Estatal , Medicina Estatal/organização & administração , Segurança do Paciente/normas , Humanos , Reino Unido , Participação dos Interessados
9.
PLoS One ; 19(5): e0301370, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38709752

RESUMO

Occupational injuries in the construction industry have plagued many countries, and many cases have shown that accidents often occur because of a combination of project participants. Assembled construction (AC) projects have received extensive attention from Chinese scholars as a future trend, but few studies have explored the interrelationships and potential risks of various stakeholders in depth. This study fills this research gap by proposing a multi-stakeholder AC risk framework. The study surveyed 396 stakeholders, then analyzed the collected data and created a risk framework based on Structural Equation Modelling (SEM) and the CRITIC weighting method. The results revealed that factors like "regular supervision is a formality," "blindly approving the wrong safety measures," and "failure to organize effective safety education and training." are vital risks in AC of China. Finally, the study validates the risk factors and the framework with 180 real-life cases, which shows that the proposed framework is theoretically grounded and realistic. The study also suggests multi-level strategies such as introducing AI-based automated risk monitoring, improving the adaptability of normative provisions to technological advances, and advancing the culture of project communities of interest to ensure AC's safe practices.


Assuntos
Indústria da Construção , Humanos , China , Acidentes de Trabalho/prevenção & controle , Participação dos Interessados , Fatores de Risco , Análise de Classes Latentes , Traumatismos Ocupacionais/prevenção & controle , Traumatismos Ocupacionais/epidemiologia , Medição de Risco/métodos , Inquéritos e Questionários
10.
BMC Prim Care ; 25(1): 152, 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38711025

RESUMO

BACKGROUND: Action on the social determinants of health is important to strengthen primary health care and promote access among underserved populations. We report on findings from stakeholder consultations undertaken at one of the Canadian sites of the Innovative Models Promoting Access-to-Care Transformation (IMPACT) program, as part of the development of a best practice intervention to improve access to primary health care. The overarching objective of this qualitative study was to understand the processes, barriers, and facilitators to connect patients to health enabling community resources (HERs) to inform a patient navigation model situated in primary care. METHODS: Focus groups and interviews were conducted with primary care physicians, and community health and social service providers to understand their experiences in supporting patients in reaching HERs. Current gaps in access to primary health care and the potential of patient navigation were also explored. We applied Levesque et al., (2013) access framework to code the data and four themes emerged: (1) Approachability and Ability to Perceive, (2) Acceptability and Ability to Seek, (3) Availability and Accommodation, and Ability to Reach, and (4) Appropriateness. RESULTS: Determinants of access included patient and provider awareness of HERs, the nature of the patient-provider relationship, funding of HERs, integration of primary and community care services, and continuity of information. Participants' perspectives about the potential scope and role of a patient navigator provided valuable insight for the development of the Access to Resources in the Community (ARC) navigation model and how it could be embedded in a primary care setting. CONCLUSION: Additional consultation with key stakeholders in the health region is needed to gain a broader understanding of the challenges in caring for primary care patients with social barriers and how to support them in accessing community-based primary health care to inform the design of the ARC intervention.


Assuntos
Grupos Focais , Acessibilidade aos Serviços de Saúde , Médicos de Atenção Primária , Atenção Primária à Saúde , Pesquisa Qualitativa , Humanos , Acessibilidade aos Serviços de Saúde/organização & administração , Atenção Primária à Saúde/organização & administração , Médicos de Atenção Primária/psicologia , Canadá , Masculino , Feminino , Participação dos Interessados , Navegação de Pacientes/organização & administração , Serviços de Saúde Comunitária/organização & administração , Atitude do Pessoal de Saúde
11.
BMC Health Serv Res ; 24(1): 569, 2024 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-38698386

RESUMO

BACKGROUND: The national breast screening programme in the United Kingdom is under pressure due to workforce shortages and having been paused during the COVID-19 pandemic. Artificial intelligence has the potential to transform how healthcare is delivered by improving care processes and patient outcomes. Research on the clinical and organisational benefits of artificial intelligence is still at an early stage, and numerous concerns have been raised around its implications, including patient safety, acceptance, and accountability for decisions. Reforming the breast screening programme to include artificial intelligence is a complex endeavour because numerous stakeholders influence it. Therefore, a stakeholder analysis was conducted to identify relevant stakeholders, explore their views on the proposed reform (i.e., integrating artificial intelligence algorithms into the Scottish National Breast Screening Service for breast cancer detection) and develop strategies for managing 'important' stakeholders. METHODS: A qualitative study (i.e., focus groups and interviews, March-November 2021) was conducted using the stakeholder analysis guide provided by the World Health Organisation and involving three Scottish health boards: NHS Greater Glasgow & Clyde, NHS Grampian and NHS Lothian. The objectives included: (A) Identify possible stakeholders (B) Explore stakeholders' perspectives and describe their characteristics (C) Prioritise stakeholders in terms of importance and (D) Develop strategies to manage 'important' stakeholders. Seven stakeholder characteristics were assessed: their knowledge of the targeted reform, position, interest, alliances, resources, power and leadership. RESULTS: Thirty-two participants took part from 14 (out of 17 identified) sub-groups of stakeholders. While they were generally supportive of using artificial intelligence in breast screening programmes, some concerns were raised. Stakeholder knowledge, influence and interests in the reform varied. Key advantages mentioned include service efficiency, quicker results and reduced work pressure. Disadvantages included overdiagnosis or misdiagnosis of cancer, inequalities in detection and the self-learning capacity of the algorithms. Five strategies (with considerations suggested by stakeholders) were developed to maintain and improve the support of 'important' stakeholders. CONCLUSIONS: Health services worldwide face similar challenges of workforce issues to provide patient care. The findings of this study will help others to learn from Scottish experiences and provide guidance to conduct similar studies targeting healthcare reform. STUDY REGISTRATION: researchregistry6579, date of registration: 16/02/2021.


Assuntos
Algoritmos , Inteligência Artificial , Neoplasias da Mama , COVID-19 , Pesquisa Qualitativa , Participação dos Interessados , Humanos , Neoplasias da Mama/diagnóstico , Feminino , COVID-19/diagnóstico , COVID-19/epidemiologia , Detecção Precoce de Câncer/métodos , Reino Unido , SARS-CoV-2 , Escócia , Grupos Focais
12.
Mar Pollut Bull ; 202: 116341, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38608427

RESUMO

The paper explores maritime environmental regulations, analyzing industry perspectives and their operational execution. It critically assesses the International Maritime Organization (IMO) regulations' effectiveness in mitigating climate challenges within the shipping domain. The central argument is that the evolving and intricate nature of maritime regulations often impedes policy goal realization, enforcement, impact evaluation, and equity perception. Utilizing both quantitative and qualitative methodologies, this research gathers, analyses, and interprets data via surveys and interviews. This exploration seeks to evaluate the regulations' impact on reducing shipping's negative impact, especially concerning emissions, waste management, and noise pollution, under the umbrella of smart regulations. The results indicate that the current regulatory approach is neither comprehensive nor immediate, necessitating a more agile, digitally enabled framework to adapt to fast-changing industry conditions.


Assuntos
Navios , Navios/legislação & jurisprudência , Gerenciamento de Resíduos/legislação & jurisprudência , Gerenciamento de Resíduos/métodos , Política Ambiental , Participação dos Interessados
13.
PLoS One ; 19(4): e0300521, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38558082

RESUMO

Calls to leverage routinely collected data to inform health system improvements have been made. Misalignment between home care services and client needs can result in poor client, caregiver, and system outcomes. To inform development of an integrated model of community-based home care, grounded in a holistic definition of health, comprehensive clinical profiles were created using Ontario, Canada home care assessment data. Retrospective, cross-sectional analyses of 2017-2018 Resident Assessment Instrument Home Care (RAI-HC) assessments (n = 162,523) were completed to group home care clients by service needs and generate comprehensive profiles of each group's dominant medical, functional, cognitive, and psychosocial care needs. Six unique groups were identified, with care profiles representing home care clients living with Geriatric Syndromes, Medical Complexity, Cognitive Impairment and Behaviours, Caregiver Distress and Social Frailty. Depending on group membership, between 51% and 81% of clients had identified care needs spanning four or more Positive Health dimensions, demonstrating both the heterogeneity and complexity of clients served by home care. Comprehensive clinical profiles, developed from routinely collected assessment data, support a future-focused, evidence-informed, and community-engaged approach to research and practice in integrated home-based health and social care.


Assuntos
Serviços de Assistência Domiciliar , Reabilitação Psiquiátrica , Adulto , Humanos , Idoso , Ontário , Estudos Retrospectivos , Estudos Transversais , Participação da Comunidade , Participação dos Interessados , Cognição
14.
BMJ Glob Health ; 9(4)2024 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-38649181

RESUMO

BACKGROUND: Research and development (R&D) of new drugs and regimens against tuberculosis (TB) is evolving to meet new challenges and face limited investments in the sector. To effectively improve and fill existing gaps, researchers and trialists should engage a broad spectrum of stakeholders. With this study, we aim to map the interests in TB R&D raised by the main stakeholders in the TB field. METHODS: We conducted semistructured, short interviews to gather insight and viewpoints on innovation on TB drugs and regimens R&D of policy-makers, national TB programme officers, donors, funders, non-governmental organisations and research institutions.A composite measure of the relevance of topics that emerged was computed by implementing different models considering the importance for researchers and the urgency to implement those changes during the trial, the number of citations each topic received, and the maximum value of the influence of stakeholders who had raised the topic. RESULTS: 50 stakeholders, out of 56 identified, were interviewed and almost half were policy-makers and governmental institutions. Several stakeholders highlighted the importance of disseminating information about clinical trials' methodology and emerging preliminary results, followed by the need to pursue early discussion around access and pricing of safe and effective TB innovations, although different categories of stakeholders prioritised different topics. Using different methods for ranking topics, the results remained almost unchanged. Notably, post-trial operational research ranked higher in models with higher weight for the parameter considering the number of citations. CONCLUSION: Researchers and research consortia embarking on phase 2 and 3 clinical trials should consider a broad set of elements when planning and designing trials' protocols, all aiming at lowering the price and improving access to emerging TB innovations, besides meeting regulatory criteria. This can only be achieved by consulting and engaging relevant stakeholders in the discussion.


Assuntos
Antituberculosos , Ensaios Clínicos como Assunto , Participação dos Interessados , Tuberculose , Humanos , Tuberculose/tratamento farmacológico , Antituberculosos/uso terapêutico , Antituberculosos/economia , Política de Saúde
15.
Trials ; 25(1): 278, 2024 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-38659031

RESUMO

To ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investigators and relevant public health stakeholders and the Joint Access Advisory Mechanism (JAAM) to streamline access of new intervention arms to the platform trials. Both the TCB and the JAAM emerged as efficient instruments to promote cooperation and optimise the use of resources within EU-funded adaptive platform trials. In addition, an adaptive platform trial toolbox was developed to collect information and literature on challenges and solutions identified to date. The recently funded 'Coordination MEchanism for Cohorts and Trials' (CoMeCT) project will endeavour to make this model sustainable, with a further expansion to other emerging infectious diseases, as part of the governance of the current and future platform trials for pandemic preparedness. This example could serve as a model for platform trial coordination in other disease areas.


Assuntos
COVID-19 , Humanos , COVID-19/epidemiologia , Europa (Continente) , Ensaios Clínicos como Assunto/métodos , SARS-CoV-2 , Participação dos Interessados , União Europeia
17.
PLoS One ; 19(4): e0302755, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38687699

RESUMO

BACKGROUND: Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting. METHODS: We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response strategies was reached. RESULTS: We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes. DISCUSSION: Potential response strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core response strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.


Assuntos
COVID-19 , Ensaios Clínicos como Assunto , Consentimento Livre e Esclarecido , Pandemias , Humanos , COVID-19/epidemiologia , COVID-19/psicologia , Consentimento Livre e Esclarecido/ética , Ensaios Clínicos como Assunto/ética , SARS-CoV-2 , Participação dos Interessados , Alemanha , Entrevistas como Assunto
18.
Int J Technol Assess Health Care ; 40(1): e22, 2024 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-38629196

RESUMO

OBJECTIVES: The rising costs of drugs have necessitated the exploration of innovative payment methods in healthcare systems. Risk-sharing agreements (RSAs) have been implemented in many countries as a value-based payment mechanism to manage the uncertainty associated with expensive technologies. This study aimed to investigate stakeholder perspectives on value-based payment in the Singaporean context, providing insights for future directions in health technology assessment and financing. METHODS: This descriptive qualitative inquiry involved participant interviews conducted between October 2021 and April 2022. Thematic analysis was conducted in two phases to analyze the interview transcripts. RESULTS: Seventeen respondents participated in the study, and five key themes emerged from the analysis. Stakeholders viewed RSAs as moderately positive, despite limited experience with them. They emphasized the importance of clearly defining objectives and establishing transparent criteria for implementing these schemes. The current data infrastructure was identified as both a barrier and facilitator, as RSAs impose administrative burdens. To successfully implement these payment mechanisms, capacity building, and effective stakeholder engagement that fosters mutual trust and cocreation are crucial. CONCLUSION: This study confirms previously identified barriers and facilitators to successful RSA implementation while contextualizing them within the Singaporean setting. The findings suggest that value-based payment has the potential to address uncertainty and improve access to healthcare technologies, but these barriers must be addressed for the schemes to be effective.


Assuntos
Pesquisa Qualitativa , Participação dos Interessados , Avaliação da Tecnologia Biomédica , Singapura , Humanos , Avaliação da Tecnologia Biomédica/organização & administração , Participação no Risco Financeiro/organização & administração , Entrevistas como Assunto
19.
Diabet Med ; 41(6): e15318, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38551208

RESUMO

BACKGROUND: Shift workers, compared to day workers, are more likely to be diagnosed with type 2 diabetes (T2D). Currently, there is no tailored programme of dietary support available to either shift workers living with T2D or employers. METHODS: An intervention development consultation workshop was convened in June 2023 with the aim of evaluating potential interventions to identify those with a potential to take forward for further development. Findings from prior formative research into factors influencing dietary behaviour in shift workers with T2D were mapped to potential interventions addressing the barriers and enablers to healthy eating reported by shift workers with T2D. The findings of the Shift-Diabetes Study were presented in the context of the COM-B (Capability, Opportunity, Motivation, Behaviour) theoretical framework of behaviour change. Three interventions in turn were presented to attendees: (1) Educational resources and structured education, (2) Increasing availability and accessibility of food on a night shift and (3) Biofeedback and tailored advice. Seven workshop attendees were invited to express their thoughts, using the APEASE criteria (Affordability, Practicability, Effectiveness, Acceptability, Side-effects/Safety, Equity) to guide the discussion. The workshop was conducted online and recorded, and transcripts were thematically coded to the APEASE framework. RESULTS/CONCLUSIONS: The workshop highlighted the importance of multilevel interventions to support dietary behaviour change in this occupational group. Priority actions identified include (i) understanding barriers to 24/7 food availability, (ii) including shift workers in clinical diabetes studies and (iii) research to understand the effectiveness of continuous glucose monitoring in shift workers with T2D.


Assuntos
Diabetes Mellitus Tipo 2 , Jornada de Trabalho em Turnos , Humanos , Diabetes Mellitus Tipo 2/dietoterapia , Participação dos Interessados , Feminino , Masculino , Dieta Saudável , Pessoa de Meia-Idade , Comportamento Alimentar , Educação de Pacientes como Assunto
20.
Qual Life Res ; 33(5): 1415-1422, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38438665

RESUMO

OBJECTIVE: Valuing child health is critical to assessing the value of healthcare interventions for children. However, there remain important methodological and normative issues. This qualitative study aimed to understand the views of Canadian stakeholders on these issues. METHODS: Stakeholders from health technology assessment (HTA) agencies, pharmaceutical industry representatives, healthcare providers, and academic researchers/scholars were invited to attend an online interview. Semi-structured interviews were designed to focus on: (1) comparing the 3-level and 5-level versions of the EQ-5D-Y; (2) source of preferences for valuation (adults vs. children); (3) perspective of valuation tasks; and (4) methods for valuation (discrete choice experiment [DCE] and its variants versus time trade-off [TTO]). Participants were probed to consider HTA guidelines, cognitive capacity, and potential ethical concerns. All interviews were recorded and transcribed verbatim. Framework analysis with the incidence density method was used to analyze the data. RESULTS: Fifteen interviews were conducted between May and September 2022. 66.7% (N = 10) of participants had experience with economic evaluations, and 86.7% (N = 13) were parents. Eleven participants preferred the EQ-5D-Y-5L. 12 participants suggested that adolescents should be directly involved in child health valuation from their own perspective. The participants were split on the ethical concerns. Eight participants did not think that there was ethical concern. 11 participants preferred DCE to TTO. Among the DCE variants, 6 participants preferred the DCE with duration to the DCE with death. CONCLUSIONS: Most Canadian stakeholders supported eliciting the preferences of adolescents directly from their own perspective for child health valuation. DCE was preferred if adolescents are directly involved.


Assuntos
Pesquisa Qualitativa , Participação dos Interessados , Humanos , Canadá , Criança , Adolescente , Masculino , Feminino , Participação dos Interessados/psicologia , Qualidade de Vida , Entrevistas como Assunto , Saúde da Criança , Avaliação da Tecnologia Biomédica , Adulto , Pessoal de Saúde/psicologia , Inquéritos e Questionários
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