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Factors influencing use and choice of Core Outcome Sets and outcome measurement instruments in trials of interventions to prevent childhood obesity: A survey protocol 影响预防儿童肥胖干预试验中使用和选择核心结果集和结果测量工具的因素:调查方案
Pub Date : 2024-05-01 DOI: 10.12688/hrbopenres.13884.1
K. Matvienko-Sikar, Reindolf Anokye, Dimity Dutch, Moira Duffy, Eibhlin Looney, Vicki Brown, John Browne, Darren Dahly, Declane Devane, Janas Harrington, Catherine Hayes, Brittany Johnson, Patricia M Kearney, Jamie J Kirkham, Patricia Leahy-Warren, Andrew W Murphy, Sarah Redsell, A. Seidler, Helen Skouteris
Background Two core outcome sets for childhood obesity prevention have been developed; standardised sets of outcome measurement instruments for these core outcome sets are currently being developed. Core outcome sets and standardised measurement sets can reduce heterogeneity and improve evidence syntheses for trials of interventions to prevent childhood obesity and/or interventions to improve child health behaviours related to childhood obesity. Such benefits are only realised if core outcome sets and standardised measurement sets are used in trials. The aims of this study are 1) to examine trialists’ awareness and attitudes towards the two existing core outcome sets and factors influencing their use; 2) to explore the characteristics of outcome measurement instruments that trialists currently use; and 3) to better understand how trialists choose outcome measurement instruments and the factors that influence those choices. Methods A cross-sectional online survey will be conducted with researchers involved in the design and/or conduct of trials of interventions to prevent childhood obesity and/or to improve child health behaviours related to childhood obesity, in children aged 0 to 5 years (trialists). Trialists will be recruited using purposive sampling, and will complete a 22-item survey examining trialist characteristics, awareness of the existing core outcome sets, factors influencing use of the existing core outcome sets, characteristics of measurement instruments, how trialists choose measurement instruments, and factors influencing choice of measurement instrument. Quantitative data will be analysed descriptively; responses to open-ended questions will be analysed using qualitative content analysis. Conclusions Findings from this study will inform approaches to maximising use of core outcome sets and standardised measurement sets for childhood obesity prevention. Use of standardised approaches to what and how outcomes are measured in this area will reduce heterogeneity and research waste and enhance evidence syntheses to better determine intervention effects.
背景 已开发出两套预防儿童肥胖症的核心结果集;目前正在开发针对这些核心结果集的标准化结果测量工具集。核心结果集和标准化测量工具集可以减少异质性,并改进预防儿童肥胖和/或改善与儿童肥胖有关的儿童健康行为干预试验的证据综合。只有在试验中使用核心结果集和标准化测量集,才能实现这些益处。本研究的目的是:1)考察试验人员对现有两套核心结果集的认识和态度以及影响其使用的因素;2)探讨试验人员目前使用的结果测量工具的特点;3)更好地了解试验人员如何选择结果测量工具以及影响这些选择的因素。方法 将对参与设计和/或开展干预试验的研究人员(试验人员)进行横断面在线调查,这些试验旨在预防儿童肥胖和/或改善与儿童肥胖相关的儿童健康行为,对象为 0 至 5 岁儿童。将采用有目的的抽样方式招募试验者,试验者将完成一项包含 22 个项目的调查,调查内容包括试验者的特征、对现有核心结果集的认识、影响现有核心结果集使用的因素、测量工具的特征、试验者如何选择测量工具以及影响测量工具选择的因素。将对定量数据进行描述性分析;对开放式问题的回答将采用定性内容分析法进行分析。结论 本研究的结果将为最大限度地利用核心结果集和标准化测量集预防儿童肥胖提供参考。在这一领域使用标准化方法来衡量结果的内容和方式将减少异质性和研究浪费,并加强证据综合,从而更好地确定干预效果。
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引用次数: 0
Factors influencing mental health service delivery during public health emergencies: a scoping review protocol 影响公共卫生突发事件期间提供心理健康服务的因素:范围界定审查协议
Pub Date : 2024-02-16 DOI: 10.12688/hrbopenres.13850.1
Pawel Hursztyn, Almas Khan, K. Matvienko-Sikar, K. Kõlves, Marguerite M. Nyhan, John Browne
Background Unforeseeable public health emergencies (PHEs) profoundly impact psychological well-being and disrupt mental health care provision in affected regions. To enhance preparedness for future emergencies, it is crucial to understand the effectiveness of mental health services, their underlying mechanisms, the populations they are tailored to, and their appropriateness across distinct emergencies. The aim of this scoping review will be to explore how mental health services have responded to PHEs, focusing on their effectiveness as well as barriers and facilitators to implementation. Methods Following the five-stage Arksey-O'Malley guidance, as updated further by Westphaln and colleagues, this mixed-methods scoping review will search academic and grey literature. Publications related to mental health interventions and supports delivered during PHEs will be considered for inclusion. The interventions and supports are operationally defined as any adaptations to mental health service provision at the international, national, regional or community level as a consequence of PHEs. The “Four Ss” framework will be utilised to provide structure for the evidence synthesis and inform categorisation of interventions and supports delivered during PHEs. Any research methodology will be considered for inclusion. Two reviewers will independently screen titles, abstracts, and full texts of publications against eligibility criteria. The gathered data will be depicted in accordance with the Four Ss” framework through the utilisation of descriptive/analytical statistics and supplemented by narrative exploration of findings. Conclusions Considering the diverse research methodologies and the varied applicability of services in different contexts of PHEs, this review will offer insights into the type, effectiveness, and implementation barriers and facilitators of mental health interventions and supports delivered during PHEs. By employing the “Four Ss” framework, the review will guide decision-making bodies in identifying effective and practical aspects of mental health system operations during emergencies.
背景不可预见的公共卫生突发事件(PHEs)对受影响地区的心理健康造成了深远的影响,并扰乱了心理保健服务的提供。为了加强对未来突发事件的准备,了解心理健康服务的有效性、其基本机制、服务对象以及在不同突发事件中的适宜性至关重要。本次范围界定审查的目的是探讨心理健康服务如何应对紧急状况,重点关注其有效性以及实施过程中的障碍和促进因素。方法 按照由 Westphaln 及其同事进一步更新的 Arksey-O'Malley 五阶段指南,本范围界定综述将采用混合方法搜索学术文献和灰色文献。与公共健康教育期间提供的心理健康干预和支持相关的出版物将被考虑纳入其中。干预和支持在操作上被定义为因公共健康教育而在国际、国家、地区或社区层面对心理健康服务提供的任何调整。将利用 "四个S "框架为证据综述提供结构,并为在公共健康教育期间提供的干预和支持的分类提供信息。任何研究方法都将被考虑纳入。两名审稿人将根据资格标准独立筛选出版物的标题、摘要和全文。收集到的数据将按照 "四个 S "框架进行描述,即利用描述性/分析性统计,并辅以对研究结果的叙述性探讨。结论 考虑到研究方法的多样性以及公共卫生教育服务在不同情况下的不同适用性,本综述将对公共卫生教育期间所提供的心理健康干预和支持的类型、有效性、实施障碍和促进因素进行深入分析。通过采用 "四个 S "框架,本综述将指导决策机构确定紧急情况下心理健康系统运作的有效和实用方面。
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引用次数: 0
Strategies for recruitment of adolescent girls into physical activity programmes: a systematic review protocol 招募少女参加体育活动计划的策略:系统性审查协议
Pub Date : 2024-02-16 DOI: 10.12688/hrbopenres.13834.1
Tanya O'Brien, Catherine D Darker, D. Mockler, E. Barrett
Background Physical activity is essential for youth physical and mental health, yet just 15% of adolescent girls versus 22% of adolescent boys worldwide meet the World Health Organization guideline of 60 minutes of moderate-to-vigorous physical activity per day. As activity patterns established in adolescence often persist into adulthood, there is a looming risk of adverse health outcomes due to insufficient physical activity. A persistent challenge faced by physical activity providers, however, is recruiting adolescent girls into their programmes. This systematic review will quantitatively synthesise existing knowledge surrounding the recruitment of adolescent girls into physical activity interventions and aims to provide evidence-based recommendations for optimal recruitment practices. Methods Five electronic databases will be searched to identify randomised controlled trials of physical activity interventions for adolescent girls worldwide. Hand-searches of reference lists of included randomised controlled trials, relevant systematic reviews, and author publications will also be conducted. Data will be extracted regarding study, participant, and intervention characteristics, pre-determined recruitment goals, recruitment strategies employed, and the number of participants screened, eligible, approached, randomised, and retained. Outcomes will include whether pre-determined recruitment goals were met, recruitment rate, and any adapted or extended recruitment measures required mid-study. Descriptive statistics, including the median recruitment rate for all included studies, will be calculated and stratified by subgroups such as the type or setting of physical activity. Recruitment strategies will be categorised, and the percentage of studies using each category, along with their associated recruitment rates, will be documented. If sufficient studies are found, multi-variable regression will be employed to determine if the use of a specific recruitment strategy increases enrolment. Discussion Application of the findings of this review by physical activity programme providers may enhance their recruitment processes, potentially increasing teenage girls’ physical activity enrolment worldwide. Systematic review registration PROSPERO CRD#42023475858
背景 体育锻炼对青少年的身心健康至关重要,然而,全世界仅有 15%的少女和 22%的少男达到了世界卫生组织规定的每天 60 分钟中等强度到高强度体育锻炼的标准。青少年时期形成的活动模式往往会持续到成年,因此,由于体育锻炼不足而导致不良健康后果的风险迫在眉睫。然而,体育锻炼提供者一直面临的一个挑战就是如何招募少女参加体育锻炼项目。本系统性综述将对有关招募少女参加体育锻炼干预活动的现有知识进行定量综合,旨在为最佳招募实践提供循证建议。方法 将检索五个电子数据库,以确定全球范围内针对少女的体育活动干预随机对照试验。此外,还将对所纳入随机对照试验的参考文献列表、相关系统综述和作者出版物进行手工检索。我们将提取有关研究、参与者和干预措施特征、预先确定的招募目标、所采用的招募策略以及经筛选、符合条件、接触、随机化和保留的参与者人数的数据。结果将包括是否达到了预先确定的招募目标、招募率以及研究中期所需的任何调整或扩展招募措施。将计算描述性统计数据,包括所有纳入研究的招募率中位数,并按体育活动的类型或环境等亚组进行分层。将对招募策略进行分类,并记录采用各类策略的研究的百分比及其相关招募率。如果发现足够多的研究,将采用多变量回归法来确定使用特定招募策略是否会提高注册率。讨论 体育活动项目提供者应用本综述的研究结果可能会改善其招募过程,从而有可能提高全球少女的体育活动注册率。系统综述注册 PROSPERO CRD#42023475858
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引用次数: 0
Behavioural change for Parkinson’s Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s: study protocol 帕金森病的行为改变:一项随机对照可行性研究,旨在促进帕金森病患者的体育锻炼和坚持锻炼:研究方案
Pub Date : 2024-02-16 DOI: 10.12688/hrbopenres.13843.1
L. Ahern, Suzanne Timmons, Sarah E. Lamb, R. McCullagh
Background Parkinson’s is a common progressive neurological condition characterized by motor and non-motor deficits. Physical activity and exercise can improve health, but many people with Parkinson’s (PwP) have trouble reaching the recommended dosage. Our recent literature review found improvements in exercise adherence with behavioural change interventions, but it remains unclear which are most effective. Further qualitative research and patient and public involvement has informed a novel behavioural change intervention to be tested alongside an existing exercise program. Objective To examine the feasibility of behavioural change techniques delivered alongside an exercise programme to improve physical activity, function, and self-efficacy in PwP (and study procedures) to inform a future pilot RCT trial. Methods A parallel-arm single blinded randomised feasibility study. Twenty participants with Parkinson’s (Hoehn and Yahr stage 1-3) will be recruited from a physiotherapy primary-care waiting list. Following written consent, and baseline assessment, the participants will be randomly allocated to the intervention (n=10) or the control group (n=10). Both groups will receive usual care, which includes a weekly program of a multidisciplinary education, a supervised exercise class and a prescribed home exercise program. The intervention group will receive additional behavioural change techniques, targeting behaviour regulation, belief about capabilities and social influences. Class and home exercise adherence, behavioural component uptake and adherence, and negative events will be recorded. Outcomes will include enrolment and maintenance rates, physical function, falls, physical activity, and exercise self-efficacy measured pre- and post- the 12-week program (in-person). Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques. Discussion The results will help inform a future pilot RCT, based on the intervention acceptability, consent rate, maintenance, and protocol integrity. Trial Registration ClincialTrials.gov NCT06192628
背景 帕金森病是一种常见的进行性神经系统疾病,以运动和非运动障碍为特征。体育活动和锻炼可以改善健康状况,但许多帕金森病患者(PwP)难以达到建议的运动量。我们最近的文献综述发现,通过改变行为的干预措施,患者坚持锻炼的情况有所改善,但目前仍不清楚哪些干预措施最为有效。通过进一步的定性研究以及患者和公众的参与,我们提出了一种新的行为改变干预方法,该方法将与现有的锻炼计划一起进行测试。目的 研究行为改变技术与运动计划一起实施的可行性,以改善残疾人的体育锻炼、功能和自我效能(以及研究程序),为未来的 RCT 试验提供参考。方法 平行臂单盲随机可行性研究。将从物理治疗初级保健候诊名单中招募 20 名帕金森病患者(Hoehn 和 Yahr 1-3 期)。在获得书面同意和基线评估后,参与者将被随机分配到干预组(10 人)或对照组(10 人)。两组都将接受常规护理,包括每周一次的多学科教育、有指导的锻炼课程和规定的家庭锻炼计划。干预组将接受额外的行为改变技术,主要针对行为调节、能力信念和社会影响。将记录课堂和家庭锻炼的坚持情况、行为成分的吸收和坚持情况以及负面事件。结果将包括入学率和保持率、身体功能、跌倒、体育锻炼和运动自我效能,在为期 12 周的计划前后进行测量(面对面)。调查将用于比较各组之间的体验和满意度。仅对干预组进行退出访谈,了解他们对行为改变技术的体验。讨论 根据干预的可接受性、同意率、维持率和方案的完整性,研究结果将有助于为未来的试验性 RCT 提供信息。试验注册 ClincialTrials.gov NCT06192628
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引用次数: 0
Examining universal access to acute hospital care in Ireland during the first three months of COVID-19: Lessons from the policy process 在 COVID-19 的前三个月中,对爱尔兰普及急症医院护理的研究:从政策制定过程中汲取的经验教训
Pub Date : 2024-02-15 DOI: 10.12688/hrbopenres.13848.1
Luisne Mac Conghail, Sarah Parker, S. Burke
Background The onset of the COVID-19 pandemic prompted the Irish state to address unprecedented challenges by prioritising public health and equitable access to care. Confronted with the threat of overwhelmed capacity in acute public hospitals, Ireland, initiated a historic Safety Net Agreement (SNA) with 19 private hospitals in March 2020, marking the inaugural establishment of universal single-tier access to hospital care in Ireland. This research aimed to comprehensively examine the policy process underlying the agreement, deriving insights for the implementation of Universal Healthcare. Methods Employing a retrospective qualitative case study approach, the research examined the policy process, including the content, context, actors, and mechanisms involved in the SNA’s implementation. The study used a dataset of 68 policy documents and conducted seven key informant interviews. Results Responding to the pandemic, Ireland classified COVID-19 as a notifiable infectious disease under the 1947 Health Act, exempting affected patients from public hospital charges. The government swiftly implemented health policy measures for universal access through the SNA, recognising challenges in public healthcare capacity and ethical dilemmas within the two-tier hospital system. The agreement's discontinuation was heavily influenced by private hospital consultants, revealing strained relationships and misunderstandings of the private sector. The ongoing policy drift since the pandemic highlights the need for a reassessment of private-sector strategies to alleviate capacity pressures in Ireland's public health system. The SNA also sparked the consideration of a Universal Health Insurance model for Ireland's hospital care. Conclusions Exploring the policy dynamics at the intersection of public and private healthcare, the study imparts lessons for health system reform. The insights have the potential to contribute to long-term goal alignment, robust governance practices, and trust-building mechanisms for effective public-private collaborations in a two-tier health system, offering valuable guidance for future healthcare policy and implementation.
背景 COVID-19 大流行的爆发促使爱尔兰政府优先考虑公共卫生和公平获得医疗服务,以应对前所未有的挑战。面对公立急症医院不堪重负的威胁,爱尔兰于 2020 年 3 月与 19 家私立医院签订了历史性的《安全网协议》(SNA),标志着爱尔兰首次建立了普遍的单级医院医疗服务。本研究旨在全面考察该协议背后的政策过程,为全民医疗的实施提供启示。研究方法 本研究采用回顾性定性案例研究方法,对政策过程进行了考察,包括 SNA 实施过程中涉及的内容、背景、参与者和机制。研究使用了 68 份政策文件的数据集,并进行了 7 次关键信息提供者访谈。结果 爱尔兰在应对大流行病时,根据 1947 年《卫生法》将 COVID-19 列为应呈报的传染病,免除了受影响病人的公立医院费用。政府认识到公共医疗能力面临的挑战和两级医院系统内的道德困境,迅速通过 SNA 实施了普及医疗服务的卫生政策措施。该协议的终止在很大程度上受到了私立医院顾问的影响,暴露出与私营部门的紧张关系和误解。自大流行病以来,政策的不断偏移凸显了重新评估私营部门战略的必要性,以缓解爱尔兰公共医疗系统的能力压力。国民账户体系还引发了对爱尔兰医院医疗的全民医疗保险模式的考虑。结论 本研究探讨了公共和私营医疗保健交汇处的政策动态,为医疗系统改革提供了借鉴。这些见解有可能有助于在两级医疗体系中实现长期目标一致、稳健的治理实践以及建立有效的公私合作信任机制,为未来的医疗政策和实施提供宝贵的指导。
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引用次数: 0
Examining universal access to acute hospital care in Ireland during the first three months of COVID-19: Lessons from the policy process 在 COVID-19 的前三个月中,对爱尔兰普及急症医院护理的研究:从政策制定过程中汲取的经验教训
Pub Date : 2024-02-15 DOI: 10.12688/hrbopenres.13848.1
Luisne Mac Conghail, Sarah Parker, S. Burke
Background The onset of the COVID-19 pandemic prompted the Irish state to address unprecedented challenges by prioritising public health and equitable access to care. Confronted with the threat of overwhelmed capacity in acute public hospitals, Ireland, initiated a historic Safety Net Agreement (SNA) with 19 private hospitals in March 2020, marking the inaugural establishment of universal single-tier access to hospital care in Ireland. This research aimed to comprehensively examine the policy process underlying the agreement, deriving insights for the implementation of Universal Healthcare. Methods Employing a retrospective qualitative case study approach, the research examined the policy process, including the content, context, actors, and mechanisms involved in the SNA’s implementation. The study used a dataset of 68 policy documents and conducted seven key informant interviews. Results Responding to the pandemic, Ireland classified COVID-19 as a notifiable infectious disease under the 1947 Health Act, exempting affected patients from public hospital charges. The government swiftly implemented health policy measures for universal access through the SNA, recognising challenges in public healthcare capacity and ethical dilemmas within the two-tier hospital system. The agreement's discontinuation was heavily influenced by private hospital consultants, revealing strained relationships and misunderstandings of the private sector. The ongoing policy drift since the pandemic highlights the need for a reassessment of private-sector strategies to alleviate capacity pressures in Ireland's public health system. The SNA also sparked the consideration of a Universal Health Insurance model for Ireland's hospital care. Conclusions Exploring the policy dynamics at the intersection of public and private healthcare, the study imparts lessons for health system reform. The insights have the potential to contribute to long-term goal alignment, robust governance practices, and trust-building mechanisms for effective public-private collaborations in a two-tier health system, offering valuable guidance for future healthcare policy and implementation.
背景 COVID-19 大流行的爆发促使爱尔兰政府优先考虑公共卫生和公平获得医疗服务,以应对前所未有的挑战。面对公立急症医院不堪重负的威胁,爱尔兰于 2020 年 3 月与 19 家私立医院签订了历史性的《安全网协议》(SNA),标志着爱尔兰首次建立了普遍的单级医院医疗服务。本研究旨在全面考察该协议背后的政策过程,为全民医疗的实施提供启示。研究方法 本研究采用回顾性定性案例研究方法,对政策过程进行了考察,包括 SNA 实施过程中涉及的内容、背景、参与者和机制。研究使用了 68 份政策文件的数据集,并进行了 7 次关键信息提供者访谈。结果 爱尔兰在应对大流行病时,根据 1947 年《卫生法》将 COVID-19 列为应呈报的传染病,免除了受影响病人的公立医院费用。政府认识到公共医疗能力面临的挑战和两级医院系统内的道德困境,迅速通过 SNA 实施了普及医疗服务的卫生政策措施。该协议的终止在很大程度上受到了私立医院顾问的影响,暴露出与私营部门的紧张关系和误解。自大流行病以来,政策的不断偏移凸显了重新评估私营部门战略的必要性,以缓解爱尔兰公共医疗系统的能力压力。国民账户体系还引发了对爱尔兰医院医疗的全民医疗保险模式的考虑。结论 本研究探讨了公共和私营医疗保健交汇处的政策动态,为医疗系统改革提供了借鉴。这些见解有可能有助于在两级医疗体系中实现长期目标一致、稳健的治理实践以及建立有效的公私合作信任机制,为未来的医疗政策和实施提供宝贵的指导。
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引用次数: 0
IRB challenges in multisite studies: A case report and commentary from the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA) 多站点研究中的 IRB 挑战:爱尔兰老龄化纵向研究(IDS-TILDA)智障补充案例报告与评论
Pub Date : 2024-02-12 DOI: 10.12688/hrbopenres.13854.1
D. McCausland, Margaret Haigh, P. McCallion, M. McCarron
A shift from single to multi-site health studies enabled a range of research benefits including faster recruitment of larger and more diverse samples; increased statistical power, greater rigour, generalisability, and external reliability; and increased likelihood of impacting policy and clinical practice. However, ethical review of multi-site studies by Institutional Review Boards (IRBs) raises specific challenges compared with single site studies, with requirements to apply to multiple local IRBs increasing the burden on research, possibly endangering the integrity of the research process or inhibiting development of multi-site studies. The option of a single centralised IRB may offer a clearer, more consistent and efficient review process. This study presents a case report and commentary from 15 years engaging with IRBs in multiple sites in Ireland by the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). It examines the ethics review process for IDS-TILDA through its first four waves. While the majority of 48 IRBs granted ethical approval within 13 weeks, six IRBs took 21–47 weeks to approve, leading to delays in data collection of up to 11 months. Despite additional review time, no changes were required to the study protocol. Therefore, a critical impact of the process was the delay in starting data collection within a small number of organisations, and reduced involvement in the study for one organisation. The ethical review process with multiple IRBs increased the degree of complexity of the process, with added bureaucracy and far greater communication required across 48 IRBs, substantially adding to the resource commitment for the review process. The relatively quick approval from the majority of IRBs was partially a result of the longitudinal study building relationships with organisations throughout multiple waves. That other health studies may not accrue this benefit supports calls for a single IRB system for multi-site health studies.
从单一地点健康研究到多地点健康研究的转变带来了一系列研究优势,包括更快地招募到更多和更多样化的样本;提高统计能力、严谨性、普遍性和外部可靠性;以及更有可能对政策和临床实践产生影响。然而,与单点研究相比,机构审查委员会(IRB)对多点研究的伦理审查提出了特殊的挑战,因为需要向多个地方机构审查委员会提出申请,这增加了研究负担,可能会危及研究过程的完整性或阻碍多点研究的发展。选择单一的集中式 IRB 可以提供更清晰、更一致、更高效的审查流程。本研究介绍了爱尔兰老龄化纵向研究(IDS-TILDA)智障补充项目与爱尔兰多个研究机构合作 15 年的案例报告和评论。本研究探讨了 IDS-TILDA 前四期的伦理审查过程。虽然 48 个独立审查委员会中的大多数都在 13 周内通过了伦理审批,但有 6 个独立审查委员会的审批时间长达 21-47 周,导致数据收集延迟长达 11 个月。尽管增加了审查时间,但研究方案无需更改。因此,该过程的一个重要影响就是少数机构推迟了数据收集的开始时间,一个机构减少了对研究的参与。多个 IRB 的伦理审查过程增加了过程的复杂程度,增加了官僚主义,48 个 IRB 之间需要更多的沟通,大大增加了审查过程的资源投入。大多数 IRB 的批准相对较快,部分原因是纵向研究在多个波次中与各组织建立了关系。其他健康研究可能无法获得这种好处,这也支持了为多地点健康研究建立单一 IRB 系统的呼吁。
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引用次数: 0
IRB challenges in multisite studies: A case report and commentary from the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA) 多站点研究中的 IRB 挑战:爱尔兰老龄化纵向研究(IDS-TILDA)智障补充案例报告与评论
Pub Date : 2024-02-12 DOI: 10.12688/hrbopenres.13854.1
D. McCausland, Margaret Haigh, P. McCallion, M. McCarron
A shift from single to multi-site health studies enabled a range of research benefits including faster recruitment of larger and more diverse samples; increased statistical power, greater rigour, generalisability, and external reliability; and increased likelihood of impacting policy and clinical practice. However, ethical review of multi-site studies by Institutional Review Boards (IRBs) raises specific challenges compared with single site studies, with requirements to apply to multiple local IRBs increasing the burden on research, possibly endangering the integrity of the research process or inhibiting development of multi-site studies. The option of a single centralised IRB may offer a clearer, more consistent and efficient review process. This study presents a case report and commentary from 15 years engaging with IRBs in multiple sites in Ireland by the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). It examines the ethics review process for IDS-TILDA through its first four waves. While the majority of 48 IRBs granted ethical approval within 13 weeks, six IRBs took 21–47 weeks to approve, leading to delays in data collection of up to 11 months. Despite additional review time, no changes were required to the study protocol. Therefore, a critical impact of the process was the delay in starting data collection within a small number of organisations, and reduced involvement in the study for one organisation. The ethical review process with multiple IRBs increased the degree of complexity of the process, with added bureaucracy and far greater communication required across 48 IRBs, substantially adding to the resource commitment for the review process. The relatively quick approval from the majority of IRBs was partially a result of the longitudinal study building relationships with organisations throughout multiple waves. That other health studies may not accrue this benefit supports calls for a single IRB system for multi-site health studies.
从单一地点健康研究到多地点健康研究的转变带来了一系列研究优势,包括更快地招募到更多和更多样化的样本;提高统计能力、严谨性、普遍性和外部可靠性;以及更有可能对政策和临床实践产生影响。然而,与单点研究相比,机构审查委员会(IRB)对多点研究的伦理审查提出了特殊的挑战,因为需要向多个地方机构审查委员会提出申请,这增加了研究负担,可能会危及研究过程的完整性或阻碍多点研究的发展。选择单一的集中式 IRB 可以提供更清晰、更一致、更高效的审查流程。本研究介绍了爱尔兰老龄化纵向研究(IDS-TILDA)智障补充项目与爱尔兰多个研究机构合作 15 年的案例报告和评论。本研究探讨了 IDS-TILDA 前四期的伦理审查过程。虽然 48 个独立审查委员会中的大多数都在 13 周内通过了伦理审批,但有 6 个独立审查委员会的审批时间长达 21-47 周,导致数据收集延迟长达 11 个月。尽管增加了审查时间,但研究方案无需更改。因此,该过程的一个重要影响就是少数机构推迟了数据收集的开始时间,一个机构减少了对研究的参与。多个 IRB 的伦理审查过程增加了过程的复杂程度,增加了官僚主义,48 个 IRB 之间需要更多的沟通,大大增加了审查过程的资源投入。大多数 IRB 的批准相对较快,部分原因是纵向研究在多个波次中与各组织建立了关系。其他健康研究可能无法获得这种好处,这也支持了为多地点健康研究建立单一 IRB 系统的呼吁。
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引用次数: 0
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