- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095950
Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by French-speaking Population
Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 RCTs 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 RCTs.
Design: A randomized controlled trial
- Interventions: Health news items reporting results of RCTs with and without spin will be compared. A sample of health news items reporting the results of RCTs evaluating the effect of pharmacologic treatment and containing highest number of spin in the headline and text will be selected. Spin will be deleted in the selected news items and will be rewritten the news items without spin.
- Participants: The participants will include French-speaking population from an e-cohort Nutrinet santé.
- Sample size will be 300 patients.
- 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.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ile-de-france
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Paris, Ile-de-france, France, 75004
- Assistance Publique - Hôpitaux de Paris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Native French speakers
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: News with Spin
News items reporting results of RCTs with spin
|
Interpretation of news items with spin
|
Experimental: News without spin
News items reporting results of RCTs without spin
|
Interpretation of news items without spin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of beneficial effect of the treatment X
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
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
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
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?
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
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?
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
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?
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Isabelle BOUTRON, Prof., INSERM U1153, University of Paris-Descartes
- Principal Investigator: Romana HANEEF, PhD researcher, INSERM U1153, University of Paris-Descartes
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ISB-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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