- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094065
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Patients
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Patients
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: 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 patients from COMPARE: French patient community.
- 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]).
The primary outcome of our study is the perception of the benficial effect of treatment and involve human particpants who are patients.
Previous studies have demonstrated that the perception of safety and beneficial effects of treatment in preclinical studies will have an impact on the future development of the drug, and then the possible use of the drug for patients. Therefore our primary outcome could be considered as a surrogate marker of health outcome.
- 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
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Native French speakers
- Have at least one chronic disease
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 pre-clinical studies with spin.
|
Interpretation of news items with spin
|
Experimental: News without spin
News items reporting results of pre-clinical studies 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. We ask participants, What do you think is the probability that treatment X would be beneficial to patients?
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
The primary outcome of our study is the perception of the benficial effect of treatment and involve human particpants who are patients. Previous studies have demonstrated that the perception of safety and beneficial effects of treatment in preclinical studies will have an impact on the future development of the drug, and then the possible use of the drug for patients. Therefore our primary outcome could be considered as a surrogate marker of health outcome. Moreover, this study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888 With the choice of answers on a 10 points 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 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?
Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
With the choice of answers on a 5 points scale (none, small, moderate, 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 choice of answers on a 10 points 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 choice of answers on a 10 points 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 choice of answers on a 10 points 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
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-001
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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