Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by French-speaking Patients

Study Overview
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Brief Summary
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The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (nonrandomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect, having highest 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 phase I/II (non-randomized) trials with and without spin will be interpreted by French-speaking patients.

Detailed Description
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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 French-speaking patients from an e-cohort COMPARE. 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) studies by French-speaking patients. This study is approved by ethics review regulations by INSERM (CEEI-IRB):IRB00003888

Official Title
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Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Patients

Conditions
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The Study Focus on no Specific Condition

Intervention / Treatment
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* Other: News items with spin
* Other: News items without spin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Native French speakers Have at least one chronic disease Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms, parallel group, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: News with Spin<br>News items reporting results of phase I/II (non-randomized) trials with spin | Other: News items with spin<br>* Interpretation of news items with spin<br>|
| Experimental: News without spin<br>News items reporting results of phase I/II (non-randomized) trials without spin | Other: News items without spin<br>* Interpretation of news items without spin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? With the choices of answers on a 10 point Likert scale, (scale, 0 [very unlikely] to 10 [very likely]) | As the intervention is assigned (reading the news item) i.e., 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice | We will ask participants, what do you think is the size of the potential benefit for patients? With the choices of answers on a 5 point scale (scale, [none, small, moderate or large]); analysis none, small vs moderate or large | 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? | With the choices of answers on a 10 point Likert scale, (scale, 0 [very unsafe] to 10 [very safe]) | 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? | With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes]) | 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? | With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes]) | As the intervention is assigned (reading the news item) i.e., 1-2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spin, Misleading reporting, Misleading interpretation, Misleading extrapolation, phase I/II trials, non-randomized trials, Patients