Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Patients
NCT ID: NCT03094065
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-06-30
2019-12-31
Brief Summary
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Detailed Description
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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
1. 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.
2. Participants: The participants will include French-speaking patients from COMPARE: French patient community.
3. Sample size: For this RCT, the sample size will be 300 participants.
4. 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.
5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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News with Spin
News items reporting results of pre-clinical studies with spin.
News items with spin
Interpretation of news items with spin
News without spin
News items reporting results of pre-clinical studies without spin.
News items without spin
Interpretation of news items without spin
Interventions
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News items with spin
Interpretation of news items with spin
News items without spin
Interpretation of news items without spin
Eligibility Criteria
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Inclusion Criteria
* Have at least one chronic disease
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Isabelle BOUTRON
Professor
Locations
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Assistance Publique - Hôpitaux de Paris
Paris, Île-de-France Region, France
Countries
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Related Links
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Related Info
Other Identifiers
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ISB-001
Identifier Type: -
Identifier Source: org_study_id
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