- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094104
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-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 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 English-speaking population from FindParticipants (https://www.findparticipants.com/).
- 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) trials by English-speaking population.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Isabelle BOUTRON, Prof.
- Phone Number: +33 (0)1.42.34.78.33
- Email: isabelle.boutron@aphp.fr
Study Contact Backup
- Name: Audrey Conjaud, PhD candidate
- Phone Number: +33 (0)1.42.34.89.87
- Email: secretariat.epidemiologie.htd@aphp.fr
Study Locations
-
-
Ile-de-france
-
Paris, Ile-de-france, France, 75004
- Assistance Publique - Hôpitaux de Paris
-
Contact:
- Isabelle BOUTRON, Prof.
- Phone Number: +33 (0)1.42.34.78.33
- Email: isabelle.boutron@aphp.fr
-
Contact:
- Audrey Conjaud
- Phone Number: +33 (0)1.42.34.89.87
- Email: secretariat.epidemiologie.htd@aphp.fr
-
Principal Investigator:
- Isabelle BOUTRON, Prof.
-
Principal Investigator:
- Romana HANEEF, PhD candidate
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Sub-Investigator:
- Amelie YAVCHITZ, Dr.
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Sub-Investigator:
- Philippe RAVAUD, Prof.
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Sub-Investigator:
- Ivan ORANSKY, Prof.
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Sub-Investigator:
- Gary SCHWITZER, Prof.
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Sub-Investigator:
- Gabriel BARON, Mr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Native English speakers or have a very good level in reading and understanding of English language
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 phase I/II (non-randomized) trials with spin
|
Interpretation of news items with spin
|
Experimental: News without spin
News items reporting results of phase I/II (non-randomized) trials 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 |
---|---|---|
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
|
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])
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Romana HANEEF, PhD researcher, INSERM U1153
- Principal Investigator: Isabelle BOUTRON, Prof., INSERM U1153, University of Paris-Descartes
Publications and 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-006
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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