Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by French-speaking Patients
NCT ID: NCT03094117
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WITHDRAWN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: "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
1. 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.
2. Participants: The participants will include French-speaking patients from an e-cohort COMPARE.
3. Sample size: For this RCT, the sample size will be 300 participants.
4. 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.
5. 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.
6. 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 phase I/II (non-randomized) trials with spin
News items with spin
Interpretation of news items with spin
News without spin
News items reporting results of phase I/II (non-randomized) trials 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Isabelle BOUTRON
Professor
Principal Investigators
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Isabelle BOUTRON, Prof.
Role: PRINCIPAL_INVESTIGATOR
INSERM U1153, University of Paris-Descartes
Romana HANEEF, PhD researcher
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
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-007
Identifier Type: -
Identifier Source: org_study_id
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