Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Perception of beneficial effect of the treatment X. We ask participants, What do you think is the probability that treatment X would be beneficial to patients?
研究概览
简要总结
The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of pre-clinical studies with and without spin will be interpreted by French-speaking population.
详细描述
Health news is an important way to communicate updated medical research to the public. News items reporting the results of medical research attract a large audience. However, the quality of reporting in health news is questionable. The merits of a wide range of treatments and tests are overplayed and harms are underplayed. Several studies have shown the presence of spin (i.e., distorted presentation of study results) in health news. Distorted facts can be misleading and can affect the behaviour of physicians, healthcare providers and patients. However, little research has assessed whether spin can affect readers' interpretation of health news items.
Objective
To compare the interpretation of health news items reported with or without spin. News items reporting pre-clinical studies evaluating the effect of a pharmacological treatment that received high online public attention will be focused. "Spin" is defined as a misrepresentation of study results whatever the motive (intentionally or unintentionally) to highlight that the beneficial effect of the intervention in terms of efficacy and safety is greater than that shown by the results.
Hypothesis
The hypothesis of this study is that the spin can influence the reader's interpretation of health news items reporting results of pre-clinical studies.
Design: A randomized controlled trial
- Interventions: Health news items reporting results of pre-clinical studies with and without spin will be compared. A sample of health news items reporting the results of pre-clinical studies evaluating the effect of pharmacologic treatment and containing spin in the headline and text will be selected. Spin will be deleted in the selected news items and will be rewritten the news without spin.
- Participants: The participants will include French-speaking healthy population from Nutrinet santé.
- Sample size: For this RCT, the sample size will be 300 participants.
- Main outcome measures: The primary outcome will be participants' interpretation of the benefit of treatment after reading the news (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]).
- Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of pre-clinical studies by French-speaking population.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the study hypothesis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native French speakers who can read the news
排除标准
- 未提供
研究组 & 干预措施
News without spin
News items reporting results of animal studies without spin.
干预措施: New items without spin (Other)
News with Spin
News items reporting results of animal studies with spin.
干预措施: New items with spin (Other)
结局指标
主要结局
Perception of beneficial effect of the treatment X. We ask participants, What do you think is the probability that treatment X would be beneficial to patients?
时间窗: As the intervention is assigned (reading the news item) i.e., 1-2 hours
With the choices of answers on a 10 points Likert scale, (scale, 0 \[very unlikely\] to 10 \[very likely\])
次要结局
- Perception of efficacy, safety, availability and clinical utility in existing clinical practice for the treatment X. We will ask the participants: What do you think is the size of the potential benefit for patients?(As the intervention is assigned (reading the news item) i.e., 1-2 hours)
- How safe do you think that treatment X would be for patients?(As the intervention is assigned (reading the news item) i.e., 1-2 hours)
- Do you think this treatment should be offered to patients in the short term?(As the intervention is assigned (reading the news item) i.e., 1-2 hours)
- Do you think this treatment will make a difference in the existing clinical practice?(As the intervention is assigned (reading the news item) i.e., 1-2 hours)
研究者
Isabelle BOUTRON
Professor
Assistance Publique - Hôpitaux de Paris