Department of Obstetrics & Gynaecology, Monash University, Clayton, Australia; the Centre for Reproductive Medicine, Amsterdam UMC, Amsterdam, the Netherlands; and the Aberdeen Centre for Women's Health Research, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.
Obstet Gynecol. 2021 Sep 1;138(3):338-347. doi: 10.1097/AOG.0000000000004513.
Randomized controlled trials (RCTs) serve as the pillar of evidence-based medicine and guide medical practice. Compromised data integrity in RCTs undermines the authority of this valuable tool for science and puts patients at risk. Although a large number of retractions due to data issues in obstetrics and gynecology have occurred in the past few years, many problematic RCTs could still go uncovered because in general there is insufficient willingness to envisage and confront research misconduct. In this article, we discuss the necessity of assessing research misconduct, summarize methods that have been applied in detecting previous cases of misconduct, and propose potential solutions. There is no established mechanism to monitor feedback on published articles and the current system that handles potential research misconduct is unsatisfactory. Fortunately, there are methods to assess data integrity in RCTs both with and without individual participant data. Investigations into research misconduct can be facilitated by assessing all publications from a leading author or author group to identify duplication and patterns of ongoing misconduct. There is a pressing need to improve the mechanism that investigates data manipulation. The mechanism that handles misconduct should prioritize the interests of patients and readers rather than trial authors and their institutions. An equally urgent issue is to establish mechanisms that prevent compromised trials from polluting evidence synthesis or misguiding practice.
随机对照试验（RCTs）是循证医学的基石，指导着医学实践。RCT 中数据完整性受损会破坏这一宝贵科学工具的权威性，并使患者面临风险。尽管过去几年妇产科领域因数据问题导致了大量的撤稿，但仍有许多有问题的 RCT 可能未被发现，因为总体来说，人们对研究不端行为缺乏足够的预见和应对意愿。本文讨论了评估研究不端行为的必要性，总结了已应用于检测先前不端行为案例的方法，并提出了潜在的解决方案。目前没有用于监测已发表文章反馈的既定机制，而现行处理潜在研究不端行为的系统也不尽如人意。幸运的是，有一些方法可以评估有无个体参与者数据的 RCT 中的数据完整性。通过评估主要作者或作者群体的所有出版物，可以识别重复和持续不端行为模式，从而促进对研究不端行为的调查。迫切需要改进数据操纵的调查机制。处理不当行为的机制应优先考虑患者和读者的利益，而不是试验作者及其机构的利益。同样紧迫的问题是建立机制，防止有问题的试验污染证据综合或误导实践。
