PURPOSE To assess whether, in the retrospective assessment of the pragmatic/explanatory features of pragmatic randomized controlled trials (pRCTs), the nine PRECIS-2 domain scores using the information provided in articles were modified after using the information reported in other publicly available sources. METHODS This is a cross-sectional study of participant-level pRCTs published in July 2018 to December 2019 in the four highest-impact general medicine journals. The articles described the main results of pRCTs assessing medicines in one or more arms that were not in the pre-licensing phases. The information reported in trial full protocols, published protocols, and other publications, registries, and trial websites were assessed and scored, and compared with that previously obtained after reviewing the information reported in the articles. RESULTS Out of 76 articles on pRCTs, 13 (17%) were included in the analysis. All were two-arm trials, assessing medicines only (n = 7), medicine vs device (n = 2), medicine vs surgery (n = 1), or medicine vs placebo (n = 3). Seven were open-label trials, and six had any type of masking. All except one had the full protocol available and/or published protocol; seven had other types of publication available. The assessment of the nine PRECIS-2 domains with the information reported in the 13 articles was changed in all trials after using the information included in other additional available sources. Between one (n = 1 article) and six (n = 2) domains were modified in each pRCT. The domains that most commonly changed were "organization" (n = 12), "recruitment" (n = 11), and "follow-up" (n = 8). "Primary outcome" and "primary analysis" were not modified in any trial. Eight percent of all domains could not be assessed due to inadequate or lack of information in seven articles; those were "recruitment" (n = 3), "organization" (n = 3), "setting" (n = 2), and "flexibility:adherence" (n = 1). CONCLUSION Articles describing the trial main results are usually insufficient for the appropriate retrospective assessment of the pragmatic/explanatory features of a pRCT by authors not involved in the conduct of the trial. To address this issue, editors should require the submission of the original full protocol and final full protocol with the history of amendments to be published as supplementary material to the article.

中文翻译：

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文章提供的信息不足，无法使用PRECIS-2工具对医学试验的实用/解释性特征进行适当的回顾性评估。

目的评估在回顾性评估实用随机对照试验（pRCTs）的实用/解释特征时，使用其他公开信息中报告的信息后，使用文章中提供的信息对9个PRECIS-2域评分进行了修改。方法这是一项在2018年7月至2019年12月在影响最大的四种普通医学期刊上发表的参与者水平pRCT的横断面研究。文章描述了pRCT在一个或多个非许可前阶段评估药物的主要结果。评估并评分了在试验完整方案，已发布方案以及其他出版物，注册管理机构和试验网站中报告的信息，并将其与先前在查看文章中报告的信息后获得的信息进行比较。结果在关于pRCT的76篇文章中，有13篇（17％）被纳入分析。所有试验均为两臂试验，仅评估药物（n = 7），药物与器械（n = 2），药物与手术（n = 1）或药物与安慰剂（n = 3）。有7项是开放标签试验，有6项具有任何类型的掩蔽。除一个以外，所有协议均具有完整的可用协议和/或已发布的协议；七家有其他类型的出版物。在使用所有其他可用资源中包含的信息后，在所有试验中均更改了使用13条文章中所报告信息对9个PRECIS-2域的评估。每个pRCT中修改了一个（n = 1文章）和六个（n = 2）域。最常更改的领域是“组织”（n = 12），“招聘”（n = 11）和“跟进”（n = 8）。” 由于七篇文章中的信息不足或缺乏，无法评估所有领域的百分之八；这些是“招聘”（n = 3），“组织”（n = 3），“设置”（n = 2）和“灵活性：坚持”（n = 1）。结论描述试验主要结果的文章通常不足以由不参与试验的作者对pRCT的语用/解释特征进行适当的回顾性评估。为了解决此问题，编辑人员应要求提交原始完整协议和最终完整协议，并附有修订历史，以作为本文的补充材料进行发布。由于七篇文章中的信息不足或缺乏，无法评估所有领域的百分之八；这些是“招聘”（n = 3），“组织”（n = 3），“设置”（n = 2）和“灵活性：坚持”（n = 1）。结论描述试验主要结果的文章通常不足以由不参与试验的作者对pRCT的语用/解释特征进行适当的回顾性评估。为了解决此问题，编辑人员应要求提交原始完整协议和最终完整协议，并附有修订历史，以作为本文的补充材料进行发布。