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本文引用的文献

1
Revisiting the commercial-academic interface in medical journals.重新审视医学期刊中的商业-学术界面。
BMJ. 2015 Jun 2;350:h2957. doi: 10.1136/bmj.h2957.
2
Beyond moral outrage--weighing the trade-offs of COI regulation.超越道德义愤——权衡利益冲突监管的利弊
N Engl J Med. 2015 May 21;372(21):2064-8. doi: 10.1056/NEJMms1502498.
3
Understanding bias--the case for careful study.理解偏差——认真研究的必要性
N Engl J Med. 2015 May 14;372(20):1959-63. doi: 10.1056/NEJMms1502497.
4
Conflicts of interest: part 1: Reconnecting the dots--reinterpreting industry-physician relations.利益冲突:第1部分:梳理脉络——重新解读制药企业与医生的关系
N Engl J Med. 2015 May 7;372(19):1860-4. doi: 10.1056/NEJMms1502493.
5
Revisiting the commercial-academic interface.重新审视商业与学术的界面。
N Engl J Med. 2015 May 7;372(19):1853-4. doi: 10.1056/NEJMe1503623.
6
Sharing individual patient data from clinical trials.分享来自临床试验的个体患者数据。
N Engl J Med. 2015 Jan 15;372(3):201-2. doi: 10.1056/NEJMp1415160.
7
Differences between information in registries and articles did not influence publication acceptance.注册处和文章中的信息差异不影响出版接受。
J Clin Epidemiol. 2015 Sep;68(9):1059-67. doi: 10.1016/j.jclinepi.2014.11.019. Epub 2014 Nov 29.
8
Under-reporting of conflicts of interest among trialists: a cross-sectional study.试验者利益冲突报告不足:一项横断面研究。
J R Soc Med. 2015 Mar;108(3):101-7. doi: 10.1177/0141076814557878. Epub 2014 Nov 11.
9
Act II of the Sunshine Act.《阳光法案》第二部
PLoS Med. 2014 Nov 4;11(11):e1001754. doi: 10.1371/journal.pmed.1001754. eCollection 2014 Nov.
10
Financial conflicts of interest and conclusions about neuraminidase inhibitors for influenza: an analysis of systematic reviews.抗流感神经氨酸酶抑制剂的财务利益冲突与结论:系统评价分析。
Ann Intern Med. 2014 Oct 7;161(7):513-8. doi: 10.7326/M14-0933.

生物医学研究中的利益冲突披露:当前实践、偏见以及公共注册机构在提高透明度方面的作用综述

Conflict of interest disclosure in biomedical research: A review of current practices, biases, and the role of public registries in improving transparency.

作者信息

Dunn Adam G, Coiera Enrico, Mandl Kenneth D, Bourgeois Florence T

机构信息

Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University; Sydney NSW 2109 Australia.

Department of Pediatrics, Harvard Medical School; Boston MA 02115; Computational Health Informatics Program, Boston Children's Hospital; Boston MA 02115; Department of Biomedical Informatics, Harvard Medical School, Boston MA 02115.

出版信息

Res Integr Peer Rev. 2016;1. doi: 10.1186/s41073-016-0006-7. Epub 2016 May 3.

DOI:10.1186/s41073-016-0006-7
PMID:27158530
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4854425/
Abstract

Conflicts of interest held by researchers remain a focus of attention in clinical research. Biases related to these relationships have the potential to directly impact the quality of healthcare by influencing decision-making, yet conflicts of interest remain under-reported, inconsistently described, and difficult to access. Initiatives aimed at improving the disclosure of researcher conflicts of interest are still in their infancy but represent a vital reform that must be addressed before potential biases associated with conflicts of interest can be mitigated, and trust in the impartiality of clinical evidence restored. In this review, we examine the prevalence of conflicts of interest, evidence of the effects that disclosed and undisclosed conflicts of interest have had on the reporting of clinical evidence, and the emerging approaches for improving the completeness and consistency of disclosures. Through this review of emerging technologies, we recognize a growing interest in publicly-accessible registries for researcher conflicts of interest, and propose five desiderata aimed at maximizing the value of such registries: mandates for ensuring that researchers keep their records up to date; transparent records that are made available to the public; interoperability to allow researchers, bibliographic databases, and institutions to interact with the registry; a consistent taxonomy for describing different classes of conflicts of interest, and the ability to automatically generate conflicts of interest statements for use in published articles.

摘要

研究人员的利益冲突仍是临床研究关注的焦点。与这些关系相关的偏差有可能通过影响决策直接影响医疗质量,但利益冲突仍未得到充分报告,描述不一致,且难以获取。旨在改善研究人员利益冲突披露情况的举措仍处于起步阶段,但却是一项至关重要的改革,在与利益冲突相关的潜在偏差得以缓解、对临床证据公正性的信任得以恢复之前,必须加以解决。在本综述中,我们研究了利益冲突的普遍性、已披露和未披露的利益冲突对临床证据报告产生影响的证据,以及提高披露完整性和一致性的新方法。通过对新兴技术的综述,我们认识到人们对研究人员利益冲突的公开登记册兴趣日增,并提出了五项要求,旨在最大限度地提高此类登记册的价值:强制要求研究人员及时更新记录;向公众提供透明的记录;具备互操作性,以便研究人员、书目数据库和机构与登记册进行交互;采用一致的分类法来描述不同类型的利益冲突,以及能够自动生成用于已发表文章的利益冲突声明。