Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.
Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.
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DOI：
10.1136/bmjopen-2020-048178
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发表时间：
2021-06-28
期刊：
影响因子：
2.9
通讯作者：
Hopewell S
中科院分区：
文献类型：
--
作者：
Mellor K;Eddy S;Peckham N;Bond CM;Campbell MJ;Lancaster GA;Thabane L;Eldridge SM;Dutton SJ;Hopewell S
预先规定的进展标准可以为从外部随机化初步试验进展到确定性随机对照试验的决定提供信息。我们评估了外部随机化先导试验方案和结果出版物中报告的进展标准的特征，包括进展标准是否事先规定并在出版前同行评审报告中提及。方法审查。我们通过PubMed检索了四种期刊：英国医学期刊开放，试点和可行性研究，试验和公共科学图书馆。报告了外部随机化初步试验方案或结果的合格出版物，发表于2018年1月至2019年12月之间，并报告了进展标准。我们提取了25%的纳入出版物的双倍数据。在这里，我们报告的进展标准的特点。我们纳入了160篇出版物（123项方案和37项已完成的试验）。招聘和保留是最常见的指标，有助于进展标准。进展标准大多报告为不同的阈值（例如，达到特定目标; 133/160，83%）。在计划和完成的包括定性研究的试点试验中，不到三分之一的试验报告了这些研究结果如何有助于达到进展标准（34/108，31%）。出版物很少说明谁制定了进展标准（12/160，7.5%）或提供了进展标准的依据或理由（44/160，28%）。大多数已完成的初步试验报告了进行最终试验的意图（30/37，81%），但不到一半严格符合所有进展标准（17/37，46%）。153/160篇出版物（96%）的出版前同行评审员报告可用。86/153篇（56%）出版物的同行评审员报告提到了进展标准，35篇出版物的同行评审员评论说进展标准似乎未指定。许多外部随机化初步试验出版物没有充分报告或提出预先规定的进展标准，以告知是否继续进行未来的确定性随机对照试验。
Prespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports. Methodological review. We searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics. We included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified. Many external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.
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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
DOI：
10.1136/bmj.b2535
发表时间：
2009-07-21
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moher D;Liberati A;Tetzlaff J;Altman DG;PRISMA Group
通讯作者：
PRISMA Group
DOI：
10.1186/1478-7547-4-14
发表时间：
2006-08-21
期刊：
Cost effectiveness and resource allocation : C/E
影响因子：
--
作者：
Baltussen R;Niessen L
通讯作者：
Niessen L
影响因子：
2.5
作者：
Herbert, Esther;Julious, Steven A.;Goodacre, Steve
通讯作者：
Goodacre, Steve
影响因子：
2.3
作者：
Eldridge, Sandra M.;Costelloe, Ceire E.;Kerry, Sally M.
通讯作者：
Kerry, Sally M.