Interpretation of health news items reported with or without spin: protocol for a prospective meta-analysis of 16 randomised controlled trials
Interpretation of health news items reported with or without spin: protocol for a prospective meta-analysis of 16 randomised controlled trials
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DOI：
10.1136/bmjopen-2017-017425
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发表时间：
2017-11-01
期刊：
影响因子：
2.9
通讯作者：
Boutron, Isabelle
中科院分区：
文献类型：
--
作者：
Haneef, Romana;Yavchitz, Amelie;Boutron, Isabelle
引言我们的目的是比较健康的新闻报道或不旋转的解释。“自旋”被定义为一个歪曲的研究结果，无论动机（有意或无意），过分强调的干预措施的有益效果和夸大的安全性相比，所示的results.Methods和分析我们已经计划了一系列的16个随机对照试验（RCT）进行前瞻性荟萃分析。我们将选择一个健康新闻项目的样本，报告四种类型的研究设计的结果，评估药物治疗的效果，并在标题和文本中包含最高的旋转量。报告四类研究的新闻项目将包括：（1）临床前研究;（2）I/II期（非随机）试验;（3）RCT和（4）观察性研究。我们将重写选定的新闻项目，并删除旋转。原始新闻和改写新闻将由四类人群进行评价：（1）讲法语的病人;（2）讲法语的一般公众;（3）讲英语的病人;（4）讲英语的一般公众。每个随机对照试验将探索每种人群对报道四种研究设计之一的新闻项目的解释，并将包括300名参与者的样本量。主要结果将是参与者在阅读新闻后对治疗益处的解释：（您认为治疗X对患者有益的概率是多少？（量表，0（非常不可能）至10（非常可能））。本研究将评估患者和公众对健康新闻报道结果的解释的影响。伦理学和传播本研究已获得国家卫生和医学研究所（Institut national de la sante et de la recherche medicale，简称CNOM）机构审查委员会的伦理学批准（注册号：IRB 00003888）。所有步骤的描述和这项前瞻性荟萃分析的结果将在网上提供，并将作为发表的文章传播。研究完成后，将结果发送给所有参与者。
Introduction We aim to compare the interpretation of health news items reported with or without spin. 'Spin' is defined as a misrepresentation of study results, regardless of motive (intentionally or unintentionally) that overemphasises the beneficial effects of the intervention and overstates safety compared with that shown by the results.Methods and analysis We have planned a series of 16 randomised controlled trials (RCTs) to perform a prospective meta-analysis. We will select a sample of health news items reporting the results of four types of study designs, evaluating the effect of pharmacological treatment and containing the highest amount of spin in the headline and text. News items reporting four types of studies will be included: (1) preclinical studies; (2) phase I/II (non-randomised) trials; (3) RCTs and (4) observational studies. We will rewrite the selected news items and remove the spin. The original news and rewritten news will be appraised by four types of populations: (1) French-speaking patients; (2) French-speaking general public; (3) English-speaking patients and (4) English-speaking general public. Each RCT will explore the interpretation of news items reporting one of the four study designs by each type of population and will include a sample size of 300 participants. The primary outcome will be participants' interpretation of the benefit of treatment after reading the news items: (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 (very unlikely) to 10 (very likely)). This study will evaluate the impact of spin on the interpretation of health news reporting results of studies by patients and the general public.Ethics and dissemination This study has obtained ethics approval from the Institutional Review Board of the Institut national de la sante et de la recherche medicale (INSERM) (registration no: IRB00003888). The description of all the steps and the results of this prospective meta-analysis will be available online and will be disseminated as a published article. On the completion of this study, the results will be sent to all participants.