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Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071627
Recruitment Status : Unknown
Verified September 2018 by Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date September 11, 2018
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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 ]
With the choices of answers on a 10 points Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • 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, (scale, [none, small, moderate or large]) -- analysis none, small vs moderate, large
  • 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 points Likert scale, (scale, 0 [very unsafe] to 10 [very safe])
  • 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 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
  • 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 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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, (scale, [none, small, moderate or large])
  • 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 points Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
  • 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 points Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
  • 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 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population
Official Title  ICMJE Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
Brief Summary The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of pre-clinical studies with and without spin will be interpreted by French-speaking population.
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

  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 healthy population from Nutrinet santé.
  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]).
  5. Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of pre-clinical studies by French-speaking population.
  6. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two arms, parallel group, randomized controlled trial
Masking: Single (Participant)
Masking Description:
Participants will be blinded to the study hypothesis.
Primary Purpose: Other
Condition  ICMJE The Study Focus on no Specific Condition
Intervention  ICMJE
  • Other: New items with spin
    Interpretation of news items with spin
  • Other: New items without spin
    Interpretation of news items without spin
Study Arms  ICMJE
  • Active Comparator: News with Spin
    News items reporting results of animal studies with spin.
    Intervention: Other: New items with spin
  • Experimental: News without spin
    News items reporting results of animal studies without spin.
    Intervention: Other: New items without spin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Native French speakers who can read the news

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071627
Other Study ID Numbers  ICMJE ISB-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP