队列研究中治疗效果异质性的报告：文献综述。

Reporting of heterogeneity of treatment effect in cohort studies: a review of the literature.

机构信息

INSERM U1153, ECAMO, METHODS, 27 rue du faubourg Saint-Jacques, Université Paris-Descartes, 75014, Paris 5, France.

出版信息

BMC Med Res Methodol. 2018 Jan 12;18(1):10. doi: 10.1186/s12874-017-0466-6.

DOI:10.1186/s12874-017-0466-6

PMID:29329525

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5767059/

Abstract

BACKGROUND

This article corresponds to a literature review and analyze how heterogeneity of treatment (HTE) is reported and addressed in cohort studies and to evaluate the use of the different measures to HTE analysis.

METHODS

prospective cohort studies, in English language, measuring the effect of a treatment (pharmacological, interventional, or other) published among 119 core clinical journals (defined by the National Library of Medicine) in the last 16 years were selected in the following data source: Medline. One reviewer randomly sampled journal articles with 1: 1 stratification by journal type: high impact journals (the New England Journal of Medicine, JAMA, LANCET, Annals of Internal Medicine, BMJ and Plos Medicine) and low impact journal (the remaining journals) to identify 150 eligible studies. Two reviewers independently and in duplicate used standardized piloted forms to screen study reports for eligibility and to extract data. They also used explicit criteria to determine whether a cohort study reported HTE analysis. Logistic regression was used to examine the association of prespecified study characteristics with reporting versus not reporting of heterogeneity of treatment effect.

RESULTS

One hundred fifty cohort studies were included of which 88 (58%) reported HTE analysis. High impact journals (Odds Ratio: 3.5, 95% CI: 1.78-7.5; P < 0.001), pharmacological studies (Odds Ratio: 0.26, 95% CI: 0.13-0.51; P < 0.001) and studies published after 2014 (Odds Ratio: 0.5, 95% CI: 0.25-0.97; P = 0.004) were associated with more frequent reporting of HTE. 27 (31%) studies which reported HTE used an interaction test.

CONCLUSION

More than half cohort studies report some measure of heterogeneity of treatment effect. Prospective cohort studies published in high impact journals, with large sample size, or studying a pharmacological treatment are associated with more frequent HTE reporting. The source of funding was not associated with HTE reporting. There is a need for guidelines on how to perform HTE analyses in cohort studies.

摘要

背景

本文对应文献综述，分析了在队列研究中如何报告和处理治疗异质性（HTE），并评估了不同的 HTE 分析方法的使用情况。

方法

选择了过去 16 年中在 119 种核心临床期刊（由美国国立医学图书馆定义）中发表的以英语撰写的、测量治疗效果（药物治疗、介入治疗或其他治疗）的前瞻性队列研究，这些研究来源于 Medline 数据资源。一位评审员按照期刊类型进行 1:1 分层，随机抽取了《新英格兰医学杂志》、《美国医学会杂志》、《柳叶刀》、《内科学年鉴》、《英国医学杂志》和《公共科学图书馆医学》（高影响力期刊）和其余期刊（低影响力期刊）的杂志文章，以识别 150 项符合条件的研究。两位评审员独立且重复使用标准化预试表格筛选研究报告的合格性并提取数据。他们还使用明确的标准来确定队列研究是否报告了治疗效果的异质性分析。使用逻辑回归来检查预先指定的研究特征与报告和未报告治疗效果异质性之间的关联。

结果

共纳入 150 项队列研究，其中 88 项（58%）报告了 HTE 分析。高影响力期刊（比值比：3.5，95%置信区间：1.78-7.5；P<0.001）、药物研究（比值比：0.26，95%置信区间：0.13-0.51；P<0.001）和 2014 年后发表的研究（比值比：0.5，95%置信区间：0.25-0.97；P=0.004）与更频繁地报告 HTE 相关。27 项（31%）报告 HTE 的研究使用了交互检验。