Improving the design, conduct, analysis and reporting of external pilot and feasibility studies

改进外部试点和可行性研究的设计、实施、分析和报告

• 批准号: 2292601
• 金额: --
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-2292601
• 关键词: Improving; design; conduct; analysis; reporting

This research project fall's within the MRC research priorities aim 1 "Setting research priorities which are most likely to deliver improved health outcomes". The research project aims to improve the design, conduct and reporting of external pilot and feasibility studies. Randomised controlled trials provide the best evidence about the effectiveness (and harms) of health care interventions and are a crucially important part of the practice of evidence-based medicine and delivering improved health outcomes for patients. However, randomised trials are often expensive and complicated to run. Because of this, researchers frequently conduct pilot and feasibility studies in advance of randomised trials assessing effectiveness. These pilot and feasibility studies help them to understand whether the future randomised trial can be successfully carried out, whether they should proceed with it, and if so how. There is still a great deal of variability in the way pilot and feasibility studies are designed, conducted, and analysed, and quite a lot of uncertainty amongst the research community about how best to do this. The aims of this project are to address important uncertainties in design, conduct, analysis and reporting of external pilot and feasibility studies.

该研究项目属于MRC研究优先事项目标1“确定最有可能改善健康结果的研究优先事项”。该研究项目旨在改进外部试点和可行性研究的设计、开展和报告。随机对照试验提供了有关医疗保健干预措施有效性（和危害）的最佳证据，是循证医学实践的重要组成部分，为患者提供更好的健康结果。然而，随机试验往往是昂贵和复杂的运行。正因为如此，研究人员经常在随机试验评估有效性之前进行试点和可行性研究。这些试点和可行性研究有助于他们了解未来的随机试验是否可以成功进行，他们是否应该继续下去，如果是的话，如何进行。试点和可行性研究的设计、实施和分析方式仍然存在很大的差异，研究界对如何最好地做到这一点也存在很大的不确定性。该项目的目的是解决外部试点和可行性研究的设计、实施、分析和报告方面的重要不确定性。

项目成果

Inclusion of progression criteria in external randomised pilot trials: a cross-sectional study of funding applications submitted to the NIHR Research for Patient Benefit Programme.

• DOI: 10.1186/s13063-022-06868-8
• 发表时间: 2022-11-08
• 期刊: Trials
• 影响因子: 2.5

How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis.

• DOI: 10.1186/s13063-022-06063-9
• 发表时间: 2022-02-10
• 期刊: Trials
• 影响因子: 2.5
• 作者: Mellor K;Dutton SJ;Hopewell S;Albury C
• 通讯作者: Albury C

Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.

• DOI: 10.1136/bmjopen-2020-048178
• 发表时间: 2021-06-28
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Mellor K;Eddy S;Peckham N;Bond CM;Campbell MJ;Lancaster GA;Thabane L;Eldridge SM;Dutton SJ;Hopewell S
• 通讯作者: Hopewell S