Questions asked and answered in pilot and feasibility randomized controlled trials
Questions asked and answered in pilot and feasibility randomized controlled trials
复制标题
DOI：
10.1186/1471-2288-11-117
复制
发表时间：
2011-08-16
影响因子：
4
通讯作者：
Weatherall, Mark
中科院分区：
文献类型：
--
作者：
Shanyinde, Milensu;Pickering, Ruth M.;Weatherall, Mark
背景：在过去十年中，几位作者回顾了试点研究和可行性研究的特点，并就其中应解决的问题提出了建议。我们通过检查已发表的纳入随机分配的试点/可行性试验来扩展这一文献，检查它们陈述的目标、结果和得出的结论，并比较药物试验和非药物试验。方法：搜索2000年至2009年的EMBASE和MEDLINE数据库，发现符合我们搜索标准的3652篇文章。随机抽取50个样本进行详细的综述。结果：大多数文献都集中在疗效上：那些报道药物试验的文献额外讨论了安全性/毒性；而那些报道非药物试验的文献额外地讨论了方法学问题。只有56%(95%可信区间41%至70%)对方法学问题进行了相当深入的讨论，18%(95%可信区间9%至30%)讨论了未来的试验，只有12%(95%可信区间5%至24%)的作者实际正在进行试验。结论：尽管最近就可以恰当地描述为试验或可行性研究的主题提出了建议，但大多数最近发表的论文作者将他们的试验描述为试验或解决可行性问题，并没有主要解决为计划后续研究做准备的方法学问题，尤其是报告药物试验的论文。许多期刊仍然愿意接受试验的试点/可行性指定，这可能表明结果不确定或缺乏足够的样本量。
Background: In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials.Methods: A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review.Results: Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one.Conclusions: Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.