Impact of Reporting Funding Sources and Conflicts of Interest in RCTs' Abstracts on General Practitioners' Confidence: a 3-arms Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- GPS' confidence on the conclusion of the abstract
研究概览
简要总结
Objective: The aim of this study is to assess the impact of reporting, in abstracts of randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs) of the authors on General Practitioners' confidence in the abstracts' conclusions.
Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They will be recruited among residents from the Primary Care department of the Paris Descartes University and among a GP network who agreed to participate to research studies.
The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants will be blind of the hypothesis and of the randomization. Allocation concealment will be provided because only the statistician will have access to the randomization list.
Methods: Three interventions will be assessed corresponding to three different types of abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2) abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of authors.
A sample of abstracts will be selected from published randomized trials, testing superiority, assessing pharmacological treatment, in the field of Primary Care and General Practice and having a conclusion in favor of the beneficial effect of experimental treatment in terms of tolerance and / or efficacy. They will then be standardized and modified to obtain three types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without either source of funding or COIs.
Participants will be asked to assess one abstract of their randomization arm. Outcome: The primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be the quality perception of the study and the interpretation of the benefit of experimental treatment. Responses will be ranged by a 10-point numeric scale.
Potential interests: This study takes place in the field of Primary Care. We believe that better understandings of impact of funding sources and conflicts of interests are necessary to allow more transparency in medical research and in his translation into medical practice.
Sample size expected: 354 participants.
详细描述
Dissemination of knowledge and research results is an essential step in the practice of Evidence-Based Medicine (EBM) (1).With the growing number of publications, a lack of accessibility, and the need for timely messages among information resources larger and larger, the General Practitioners (GP) often rely on abstracts of published trials (2).
Several methodological studies have shown an association between mode of financing, including industry funding, and how the results and conclusions of published trials are reported (3-14).
To improve transparency, the CONSORT recommends to report funding sources (15) in abstracts of randomized trials, which is not always followed. Efforts are also made to report conflicts of interest of authors (COIs). In its version in July 2010, the International Committee of Medical Journal Editors Uniform Disclosure Form for Potential Conflicts of Interest (ICMJE) recommends that editors ask to all authors who submit a manuscript, to complete the ICMJE statement (16,17). Despite this, understanding the complexity and severity of conflicts of interest is not yet fully taken into account by all the guidelines (18).
It was further demonstrated that the interpretation of results by physicians varies with their mode of presentation (19-22).
The investigators do not know to what extent the knowledge of funding sources and COIs may influence the interpretation of findings by the reader. The investigators are therefore interested in the impact of the presence of these elements in abstracts of published trials on GPs' confidence in the conclusions presented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General practitioners
排除标准
- 未提供
结局指标
主要结局
GPS' confidence on the conclusion of the abstract
时间窗: 30 days
measure on a numeric scale frome 0 to 10 where 0 is "no confidence" and 10 is "full confidence"
次要结局
- GPs' quality perception of the study(30 days)
- GPs' interpretation of the benefit of experimental treatment(30 days)
研究者
Celine Buffel du Vaure
Resident
Hotel Dieu Hospital