Impact of selective reporting bias on stroke trials: potential compromise in evidence synthesis - A cross-sectional study.

IF 3.9 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES

BMC Medical Research Methodology Pub Date : 2024-10-28 DOI:10.1186/s12874-024-02381-5

Xinyao Wang, Youlin Long, Na Zhang, Xinyi Wang, Qiong Guo, Ya Deng, Jin Huang, Liang Du

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引用次数: 0

Abstract

Background: Accurate reporting of outcomes is crucial for interpreting the results of randomized controlled trials (RCTs). However, selectively reporting outcomes in publications to achieve researchers' anticipated results still occurs frequently. This study aims to investigate the prevalence of selective reporting of outcomes in RCTs on treating acute ischemic stroke (AIS), identify factors contributing to this issue, and assess its potential impact on the degree and direction of intervention effect.

Methods: A search was conducted in MEDLINE, Embase, and the Cochrane Library to collect interventional RCTs on AIS published from 2020 to 2022. Full texts of RCTs were reviewed, and only those reporting International Clinical Trials Registry Platform primary registry numbers were included. Registration information of the RCTs was extracted from the registry platforms and compared with the publications' details to assess the selective reporting of outcomes. Bayesian multilevel logistic regression was used to analyze the reasons behind selective reporting.

Results: Among the total of 159 AIS RCTs identified, 82 (51.6%) were ultimately included, as they reported registration numbers, which encompassed 819 outcomes. Among them, 72 RCTs (87.8%) and 497 outcomes (60.7%) exhibited selective reporting. Omission-type selective reporting (downgrading, omitting, or ambiguously reporting) accounted for 36.4%, while addition-type selective reporting (upgrading, adding, or altering the measurement scope of outcomes) comprised 63.6%. Omission-type selective reporting correlated with negative results (OR: 7.39; 95% CI: 4.08-13.44), whereas addition-type selective reporting correlated with positive results (OR: 2.07; 95% CI: 1.34-3.26) and publication in journals that are not in the top quartile of the Journal Citation Reports (OR: 2.48; 95% CI: 1.15-5.38).

Conclusions: Registered interventional AIS RCTs still face significant issues regarding selective reporting of outcomes. Therefore, it is necessary to further evaluate the influence of selective reporting bias on the positive results obtained from individual AIS RCTs and the systematic reviews based on these RCTs.

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选择性报告偏差对脑卒中试验的影响：证据综合中可能出现的问题 - 一项横断面研究。

背景：准确报告结果对于解释随机对照试验（RCT）的结果至关重要。然而，为了达到研究人员预期的结果而在出版物中选择性地报告结果的现象仍时有发生。本研究旨在调查治疗急性缺血性卒中（AIS）的随机对照试验中选择性报告结果的普遍程度，确定导致这一问题的因素，并评估其对干预效果的程度和方向的潜在影响：方法：在 MEDLINE、Embase 和 Cochrane 图书馆中进行检索，收集 2020 年至 2022 年间发表的有关 AIS 的干预性 RCT。对 RCT 全文进行了审查，仅纳入了报告国际临床试验注册平台主要注册号的 RCT。我们从注册平台中提取了RCT的注册信息，并将其与出版物的详细信息进行比较，以评估结果的选择性报告。贝叶斯多层次逻辑回归用于分析选择性报告背后的原因：在已确定的总共 159 项 AIS RCT 中，有 82 项（51.6%）最终被纳入，因为它们报告了注册号，其中包括 819 项结果。其中，72 项 RCT（87.8%）和 497 项结果（60.7%）存在选择性报告。遗漏型选择性报告（降级、遗漏或模棱两可的报告）占 36.4%，而添加型选择性报告（升级、添加或改变结果的测量范围）占 63.6%。遗漏型选择性报告与阴性结果相关（OR：7.39；95% CI：4.08-13.44），而添加型选择性报告与阳性结果相关（OR：2.07；95% CI：1.34-3.26），且发表在期刊引文报告排名前四分之一以外的期刊上（OR：2.48；95% CI：1.15-5.38）：已登记的介入性 AIS RCT 在选择性报告结果方面仍面临重大问题。因此，有必要进一步评估选择性报告偏差对个别 AIS RCT 和基于这些 RCT 的系统综述所获得的积极结果的影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMC Medical Research Methodology 医学-卫生保健

CiteScore

6.50

自引率

2.50%

发文量

298

审稿时长

3-8 weeks

期刊介绍： BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.