Pilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial. Clear progression criteria are required to determine if a definitive or main trial is feasible and how it should be designed. We sought to determine how often progression criteria are reported and the associated factors. We conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols (BMJ Open, Trials, Pilot and Feasibility Studies), using a PubMed search (2013–2017). We extracted bibliometric information including the country in which the study was conducted, source of funding, type of intervention, use of a primary feasibility outcome, sample size reporting, and justification. We used generalised linear models to determine the factors associated with reporting progression criteria. Our search retrieved 276 articles, of which 49 were not eligible. We included 227 articles. Overall, 45/227 (19.8%; 95% confidence interval [CI] 14.8–25.6) reported progression criteria. Protocols published in more recent years were significantly associated with higher odds of reporting progression criteria (adjusted odds ratio [aOR] 1.40; 95% CI 1.03–1.92; p = 0.034). Pilot trials from Europe (aOR 0.19; 95% CI 0.08–0.48; p < 0.001) and the rest of the world (aOR 0.05; 95% CI 0.01–0.18; p < 0.003) compared to North America were significantly associated with lower odds of reporting progression criteria. Journal, source of funding, sample size, intervention type, and having a primary outcome related to feasibility were not significantly associated with reporting progression criteria. Progression criteria are not often explicitly stated in protocols of pilot trials leaving room for varied interpretation of findings. The development of formal guidance for progression criteria in protocols of pilot trials is warranted.

中文翻译：

---

旨在评估主要试验可行性的试点试验方案中的进展标准报告不足：一项元流行病学研究

进行试点和可行性试验以确定可行性或收集信息，为更大的确定性试验的设计提供信息。需要明确的进展标准来确定最终试验或主要试验是否可行以及应如何设计。我们试图确定报告进展标准的频率以及相关因素。我们使用 PubMed 搜索 (2013-2017) 对发表在三个发表研究方案的期刊（BMJ Open、Trials、Pilot 和 Feasibility Studies）上的试验性随机试验方案进行了方法学审查。我们提取了文献计量信息，包括进行研究的国家、资金来源、干预类型、主要可行性结果的使用、样本量报告和理由。我们使用广义线性模型来确定与报告进展标准相关的因素。我们的搜索检索到 276 篇文章，其中 49 篇不符合条件。我们收录了 227 篇文章。总体而言，45/227（19.8%；95% 置信区间 [CI] 14.8–25.6）报告了进展标准。近年来公布的方案与报告进展标准的更高几率显着相关（调整优势比 [aOR] 1.40；95% CI 1.03–1.92；p = 0.034）。与北美相比，来自欧洲（aOR 0.19；95% CI 0.08–0.48；p < 0.001）和世界其他地区（aOR 0.05；95% CI 0.01–0.18；p < 0.003）的试点试验与较低的几率显着相关报告进展标准。期刊、资金来源、样本量、干预类型、并且具有与可行性相关的主要结果与报告进展标准没有显着相关性。在试点试验方案中通常没有明确说明进展标准，从而为结果的不同解释留下了空间。有必要为试点试验方案中的进展标准制定正式指南。