Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-speaking Population
研究概览
详细说明
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: "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. To compare the interpretation of health news items reporting phase I/II (non-randomized) trials with or without spin. News items evaluating the effect of a pharmacological treatment that received high online public attention will be focused.
Hypothesis: The hypothesis of this study is that the spin can influence the reader's interpretation of health news items reporting results of phase I/II (non-randomized) trials.
Design: A randomized controlled trial
- Interventions: Health news items reporting results of phase I/II (non-randomized) studies with and without spin will be compared. A sample of health news items reporting the results of phase I/II (non-randomized) 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 English-speaking population from FindParticipants (https://www.findparticipants.com/).
- Sample size: For this RCT, the sample size will be 300 participants.
- The primary outcome will be perception of beneficial effect of the treatment X. We will ask participants, what do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]). Perception of safety and beneficial effects of treatment in clinical studies is considered as a surrogate marker of health outcome as it may have an impact on the future development of the drug, and then the potential use of the drug for patients.
- Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of phase I/II (non-randomized) trials by English-speaking population.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ile-de-france
-
Paris、Ile-de-france、法国、75004
- Assistance Publique - Hôpitaux de Paris
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Native English speakers or have a very good level in reading and understanding of English language
Exclusion Criteria:
-
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：自旋新闻
报道 I/II 期（非随机）自旋试验结果的新闻项目
|
用 spin 解读新闻
|
|
实验性的：没有旋转的新闻
新闻项目报告 I/II 期（非随机）试验的结果，没有旋转
|
没有旋转的新闻条目的解释
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
对治疗有益效果的认识 X
大体时间：分配干预（阅读新闻）即 1-2 小时
|
我们将询问参与者，您认为治疗 X 对患者有益的概率是多少？
在 10 点李克特量表上选择答案，（量表，0 [非常不可能] 到 10 [非常可能]）
|
分配干预（阅读新闻）即 1-2 小时
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
您认为治疗 X 对患者的安全性如何？
大体时间：分配干预（阅读新闻）即 1-2 小时
|
在 10 点李克特量表上选择答案，（量表，0 [非常不安全] 到 10 [非常安全]）
|
分配干预（阅读新闻）即 1-2 小时
|
|
您认为这种治疗应该在短期内提供给患者吗？
大体时间：分配干预（阅读新闻）即 1-2 小时
|
在 10 点李克特量表上选择答案，（量表，0 [绝对否] 到 10 [绝对是]）
|
分配干预（阅读新闻）即 1-2 小时
|
|
您认为这种治疗会对现有的临床实践产生影响吗？
大体时间：分配干预（阅读新闻）即 1-2 小时
|
在 10 点李克特量表上选择答案，（量表，0 [绝对否] 到 10 [绝对是]）
|
分配干预（阅读新闻）即 1-2 小时
|
|
在现有临床实践中对治疗 X 的有效性、安全性、可用性和临床实用性的认识
大体时间：分配干预（阅读新闻）即 1-2 小时
|
我们将询问参与者，您认为对患者的潜在益处有多大？
在 5 点量表上选择答案（量表，[无，小，中等或大]）
|
分配干预（阅读新闻）即 1-2 小时
|
合作者和调查者
调查人员
- 首席研究员：Romana HANEEF, PhD researcher、INSERM U1153
- 首席研究员：Isabelle BOUTRON, Prof.、INSERM U1153, University of Paris-Descartes
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.