How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis.
How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis.
复制标题
DOI：
10.1186/s13063-022-06063-9
复制
发表时间：
2022-02-10
期刊：
影响因子：
2.5
通讯作者：
Albury C
中科院分区：
文献类型：
--
作者：
Mellor K;Dutton SJ;Hopewell S;Albury C
外部随机试验帮助研究人员决定是否以及如何进行未来的确定性随机试验。进展标准通常是预先规定的，以告知初步试验结果的解释和随后的进展决策。我们旨在探索和了解关键利益相关者在外部试点试验后做出进展决定时的观点和经验。与外部随机化试点试验团队成员（包括首席研究者、试验经理、统计学家以及患者和公众参与（PPI）代表）进行的35次远程半结构化访谈。问题集中在试点试验进展决定的经验和看法，以及进展标准是否以及如何告知这一决定。采用专题分析的框架方法对数据进行了分析。采用了确保可信度和严格性的策略。访谈于二零二零年十二月至二零二一年七月期间进行。制定了六个描述性主题，以反映参与者的经验和观点。这些是（1）对进展标准的价值和发展的不同意见，（2）（避免）个人利益影响进展标准和进展决策的可能性，（3）利益相关者参与制定进展标准和做出进展决策，（4）从试点试验中吸取的教训及其对进展标准适用性的影响，（5）告知进展决定的其他因素和（6）外部随机化试点试验的进展-资金考虑和限制。这些主题由一个总体解释性主题“单一的进展方法并不适合所有人”支撑，以描述外部随机化试点试验后发生的高度细微差别和复杂的决策过程。进展标准很少是决定进行未来研究的唯一考虑因素;非预期事件，疗效信号和研究团队的连续性是研究人员考虑的其他因素。当涉及到进展标准和试点试验进展时，一种尺寸并不适合所有人。进展标准只是研究人员在决定试点试验是否可行时的众多考虑因素之一。即使初步试验被认为是可行的（基于进展标准和/或其他考虑因素），外部初步试验的进展也得不到保证，这表明效率低下和潜在的研究浪费。开放科学框架osf.io/5N2KZ在线版本包含补充材料，可在10.1186/s13063-022-06063-9获得。
External randomised pilot trials help researchers decide whether, and how, to do a future definitive randomised trial. The progression criteria are often prespecified to inform the interpretation of pilot trial findings and subsequent progression decision-making. We aimed to explore and understand the perspectives and experiences of key stakeholders when making progression decisions following external pilot trials. Thirty-five remote semi-structured interviews with external randomised pilot trial team members including chief investigators, trial managers, statisticians and patient and public involvement (PPI) representatives. Questions focussed on experiences and perceptions of pilot trial progression decisions and whether and how progression criteria informed this decision. Data were analysed using the framework method approach to thematic analysis. Strategies to ensure trustworthiness and rigour were used. Interviews were conducted between December 2020 and July 2021. Six descriptive themes were developed to capture the experiences and perspectives of participants. These were (1) divided opinions on the value and development of progression criteria, (2) (avoiding) the potential for personal interest to influence progression criteria and progression decision-making, (3) stakeholder engagement in setting progression criteria and making progression decisions, (4) lessons learned from doing the pilot trial and their impact on progression criteria applicability, (5) other factors that inform the progression decision and (6) progression of external randomised pilot trials—funding considerations and constraints. These themes were underpinned by an overarching interpretative theme ‘a one-size approach to progression does not fit all’ to describe the highly nuanced and complex decision-making process that occurs following external randomised pilot trials. The progression criteria are rarely the only consideration informing the decision to progress to future research; unanticipated events, signals of efficacy and continuity of the research team are other factors that researchers consider. One size does not fit all when it comes to the progression criteria and pilot trial progression. The progression criteria are only one of many considerations researchers have when deciding whether a pilot trial is feasible. External pilot trial progression is not guaranteed even when a pilot trial is considered feasible (based on the progression criteria and/or other considerations), indicating inefficiency and potential research waste. Open Science Framework osf.io/5N2KZ The online version contains supplementary material available at 10.1186/s13063-022-06063-9.
登录
查看更多内容
影响因子：
2.9
作者：
Avery KN;Williamson PR;Gamble C;O'Connell Francischetto E;Metcalfe C;Davidson P;Williams H;Blazeby JM;members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research
通讯作者：
members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research
影响因子：
1.7
作者：
Baldeh T;MacDonald T;Kosa SD;Lawson DO;Stalteri R;Olaiya OR;Alotaibi A;Thabane L;Mbuagbaw L
通讯作者：
Mbuagbaw L
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
影响因子：
2.5
作者：
Bugge, Carol;Williams, Brian;Sinclair, Lesley
通讯作者：
Sinclair, Lesley
影响因子：
4
作者：
Gale NK;Heath G;Cameron E;Rashid S;Redwood S
通讯作者：
Redwood S