Haneef Romana, Yavchitz Amélie, Ravaud Philippe, Baron Gabriel, Oransky Ivan, Schwitzer Gary, Boutron Isabelle
METHODS team, Epidemiology and Biostatistics Sorbonne Paris Cité Center (CRESS), UMR 1153, INSERM, Paris, France.
Faculté de Médecine, Sorbonne Paris Cité, Paris Descartes University, Paris, France.
BMJ Open. 2017 Nov 17;7(11):e017425. doi: 10.1136/bmjopen-2017-017425.
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.
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.
This study has obtained ethics approval from the Institutional Review Board of the Institut national de la santé et de la recherche médicale (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.
CRD42017058941.
我们旨在比较对带有或不带有倾向性报道的健康新闻的解读。“倾向性报道”被定义为对研究结果的歪曲,无论其动机(有意或无意)如何,这种歪曲会过度强调干预措施的有益效果,并与研究结果所示相比夸大安全性。
我们计划进行一系列16项随机对照试验(RCT)以开展一项前瞻性荟萃分析。我们将选取一组报道四种研究设计结果的健康新闻样本,评估药物治疗效果且在标题和正文里带有最多倾向性报道。将纳入报道四种研究类型的新闻:(1)临床前研究;(2)I/II期(非随机)试验;(3)随机对照试验;(4)观察性研究。我们将重写所选新闻并去除倾向性报道。原始新闻和重写后的新闻将由四类人群进行评估:(1)说法语的患者;(2)说法语的普通公众;(3)说英语的患者;(4)说英语的普通公众。每项随机对照试验将探究每类人群对报道四种研究设计之一的新闻的解读,且每项试验将纳入300名参与者。主要结局将是参与者在阅读新闻后对治疗益处的解读:(您认为治疗X对患者有益的可能性有多大?(量表,0(极不可能)至10(极有可能))。本研究将评估倾向性报道对患者和普通公众解读研究健康新闻报道结果的影响。
本研究已获得法国国家健康与医学研究院(INSERM)机构审查委员会的伦理批准(注册号:IRB00003888)。这项前瞻性荟萃分析的所有步骤及结果描述将在网上公布,并将作为已发表文章进行传播。本研究完成后,结果将发送给所有参与者。
PROSPERO注册号:CRD42017058941。