Extension Reports in Clinical Trials: A Systematic Review and Consequent Guidance.

Investigators often have sequel publications based on extended follow-up; yet, no guidelines exist for such extension reports.

研究人员经常基于延长随访时间发布后续出版物；然而，目前还没有针对此类扩展报告的指南。

The purpose of this analysis was to assess the characteristics of extension reports of cardiovascular trials published in 7 high-impact medical journals.

本次分析旨在评估在7种高影响力医学期刊上发表的心血管试验扩展报告的特点。

Methods

We searched MEDLINE to identify cardiovascular trial extension papers published between January 2019 and October 2023 in 7 high-impact medical journals.

我们在MEDLINE上进行了搜索，以确定2019年1月至2023年10月期间在7种高影响力医学期刊上发表的心血管试验扩展论文。

Extension reports were defined as those presenting additional follow-up data after publication of the primary results.

扩展报告被定义为那些在主要结果发表后提供额外随访数据的报告。

Papers were screened by 2 reviewers before extracting data using a standard proforma.

在提取数据之前，由2名评审员对论文进行筛选，并使用标准表格进行数据提取。

Results

After screening 1,388 papers, 69 extension reports across 64 trials were identified.

在筛选了1,388篇论文后，确定了64项试验的69份扩展报告。

A variety of cardiovascular topics were covered, coronary heart disease (n = 20) being the most common.

涵盖了多种心血管主题，其中冠心病（n = 20）是最常见的。

Interventions were medical devices, drugs, surgery, or treatment strategies.

干预措施包括医疗器械、药物、手术或治疗策略。

Duration of follow-up varied considerably, most common being an original 1-year report (n = 20) with extension at 2, 3, 5, or 10 years.

随访时间差异很大，最常见的是一开始为期1年的报告（n = 20），随后延长至2年、3年、5年或10年。

Nearly all extension reports had a superiority hypothesis (n = 68).

几乎所有扩展报告都有一个优势假设（n = 68）

Most extensions (n = 53) examined the same primary outcome as the original publication.

大多数扩展报告（n = 53）检查了与原始出版物相同的首要结果

There were also 7 nonrandomized open-label extensions, which suffered from the lack of a concurrent control arm.

此外，还有7项非随机开放标签扩展研究，这些研究缺乏同时期的对照组。

In 18 reports, treatment crossovers were permitted during the extension, and in 16 cases, alternatives to analysis by intention to treat were utilized.

在18份报告中，允许在扩展研究期间进行治疗交叉，并且在16个案例中，使用了意向治疗分析以外的其他分析方法。

One-half of the extension studies were prespecified (n = 38), and only 10 had dedicated protocols or statistical analysis plans.

一半的扩展研究是预先设定的（n = 38），仅有10个研究拥有专门的研究方案或统计分析计划。

No study used multiplicity corrections to control type I error across the totality of evidence.

没有任何研究使用多重性校正来控制整体证据中的第一类错误。

Landmark analyses were common (n = 39) which, while descriptively useful, were not based on the original randomized groups.

地标分析很常见（n = 39），虽然在描述上有用，但并非基于原始的随机分组。

Considerable loss to follow-up (>10%) occurred in 10 of 50 extension reports with clear reporting of this issue.

在50个扩展报告中有10个报告了随访丢失率超过10%，并且这个问题的报告是清晰的。

For some trials, the conclusions regarding treatment effects were altered by the extended follow-up.

对于一些试验，延长随访后，关于治疗效果的结论发生了改变。

In a previous survey of cardiovascular trials published in the New England Journal of Medicine, Lancet, and Journal of the American Medical Association in 2019, we identified a total of 23 of 84 trials involving extensions in some form.

在2019年发表于《新英格兰医学杂志》、《柳叶刀》和《美国医学会杂志》上的一项关于心血管试验的先前调查中，我们共识别出84项试验中有23项涉及某种形式的延长随访。

Conclusions

This first systematic investigation into the reporting of extension studies found a great diversity in practice, noting several issues that need more adequate consideration.

这项首次对扩展研究报告进行的系统调查发现实践中的巨大多样性，指出了几个需要更充分考虑的问题。

Considerations are provided on what trialists should consider when planning, conducting, and reporting extension studies.

提供了关于临床试验者在规划、进行和报告扩展研究时应考虑的因素。