A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020.
A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020.
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DOI：
10.1186/s40814-023-01416-w
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发表时间：
2023-11-21
影响因子：
1.7
通讯作者：
Brand, Andrew
中科院分区：
文献类型：
--
作者：
Totton, Nikki;Lin, Jinfeng;Julious, Steven;Chowdhury, Mahima;Brand, Andrew
试点和可行性研究提供了在规划全面试验时使用的信息。试点/可行性研究需要有足够的样本量，这样才能以适当的精度提取这些信息。这项工作建立在以前对试点和可行性研究的审查的基础上，以评估目标样本量是否与最近的建议一致，以及这些目标是否正在实现。使用“试点”和“可行性”两个关键词完成了对ISRCTN登记册的审查。纳入标准是始于2013年(上一次综述结束)至2020年之间的英国随机干预试验。提取了目标样本量、实际样本量和关键设计特征。描述性统计被用来显示总体样本量和主要特征。总共有761项研究被纳入审查，其中448项(59%)被标记为可行性研究，244项(32%)初步研究和69项(9%)被描述为试点和可行性研究。总体而言，包括试点和可行性研究(n = 761)，目标样本中位数为30(IQR20-50)。当被贴上试点或可行性研究标签的人分开时，这是一致的。被标记为试点和可行性的样本容量略大(中位数 = 33，IQR20-50)(n = 69)。具有连续结果的研究(n = 592)的中位目标样本量为30(IQR20-43)，而与推荐一致，具有双重结果的研究的目标样本量更大(中位数 = 50，IQR25-81，n = 97)。基于资助者类型的目标样本量没有描述性差异。在已获得样本量的研究中(N IQR301)，173人(57%)没有达到他们的样本量目标；然而，目标样本量和实际样本量之间的中位数差异很小，只有减去4名参与者( = −25-0)。自2013年上次审查以来，试点和可行性研究的目标样本量一直保持不变。审查中的大多数研究符合较早的和较宽松的建议，但不符合最近最大的建议。此外，大多数研究没有达到他们的目标样本量，这意味着收集的信息可能不足以估计未来确定性随机对照试验所需的参数。网上版载有补充材料，可在10.1186/s40814-023-023-w查阅。
Pilot and feasibility studies provide information to be used when planning a full trial. A sufficient sample size within the pilot/feasibility study is required so this information can be extracted with suitable precision. This work builds upon previous reviews of pilot and feasibility studies to evaluate whether the target sample size aligns with recent recommendations and whether these targets are being reached. A review of the ISRCTN registry was completed using the keywords “pilot” and “feasibility”. The inclusion criteria were UK-based randomised interventional trials that started between 2013 (end of the previous review) and 2020. Target sample size, actual sample size and key design characteristics were extracted. Descriptive statistics were used to present sample sizes overall and by key characteristics. In total, 761 studies were included in the review of which 448 (59%) were labelled feasibility studies, 244 (32%) pilot studies and 69 (9%) described as both pilot and feasibility studies. Over all included pilot and feasibility studies (n = 761), the median target sample size was 30 (IQR 20–50). This was consistent when split by those labelled as a pilot or feasibility study. Slightly larger sample sizes (median = 33, IQR 20–50) were shown for those labelled both pilot and feasibility (n = 69). Studies with a continuous outcome (n = 592) had a median target sample size of 30 (IQR 20–43) whereas, in line with recommendations, this was larger for those with binary outcomes (median = 50, IQR 25–81, n = 97). There was no descriptive difference in the target sample size based on funder type. In studies where the achieved sample size was available (n = 301), 173 (57%) did not reach their sample size target; however, the median difference between the target and actual sample sizes was small at just minus four participants (IQR −25–0). Target sample sizes for pilot and feasibility studies have remained constant since the last review in 2013. Most studies in the review satisfy the earlier and more lenient recommendations however do not satisfy the most recent largest recommendation. Additionally, most studies did not reach their target sample size meaning the information collected may not be sufficient to estimate the required parameters for future definitive randomised controlled trials. The online version contains supplementary material available at 10.1186/s40814-023-01416-w.
影响因子：
2.9
作者：
Barnett AG;Glasziou P
通讯作者：
Glasziou P