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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

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.

Condition or disease Intervention/treatment Phase
The Study Focus on no Specific Condition Other: New items with spin Other: New items without spin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Official Title: Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: News with Spin
News items reporting results of animal studies with spin.
Other: New items with spin
Interpretation of news items with spin

Experimental: News without spin
News items reporting results of animal studies without spin.
Other: New items without spin
Interpretation of news items without spin




Primary Outcome Measures :
  1. 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])


Secondary Outcome Measures :
  1. 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

  2. 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])

  3. 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])

  4. 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])



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Native French speakers who can read the news

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071627


Contacts
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Contact: Isabelle BOUTRON, Prof. +33 (0)1.42.34.78.33 isabelle.boutron@aphp.fr
Contact: Audrey Conjaud +33 (0)1.42.34.89.87 secretariat.epidemiologie.htd@aphp.fr

Locations
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France
Assistance Publique - Hôpitaux de Paris
Paris, Ile-de-france, France, 75004
Contact: Isabelle BOUTRON, Prof.    +33 (0)1.42.34.78.33    isabelle.boutron@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Additional Information:
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Responsible Party: Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03071627    
Other Study ID Numbers: ISB-002
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris:
Spin
Misleading reporting
Misleading interpretation
Misleading extrapolation
Animal studies
Cell culture studies
Pre-clinical studies