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Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population

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ClinicalTrials.gov Identifier: NCT03094104
Recruitment Status : Not yet recruiting
First Posted : March 29, 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 phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect, having highest 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 phase I/II (non-randomized) trials with and without spin will be interpreted by English-speaking population.

Condition or disease Intervention/treatment Phase
The Study Focus on no Specific Condition Other: News items with spin Other: News 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: "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 English-speaking population from FindParticipants (https://www.findparticipants.com/).
  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) trials by English-speaking population.

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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 Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-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 phase I/II (non-randomized) trials with spin
Other: News items 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
Other: News items without spin
Interpretation of news items without spin




Primary Outcome Measures :
  1. 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])


Secondary Outcome Measures :
  1. 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])

  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 point 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 point 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 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])



Information from the National Library of Medicine

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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 English speakers or have a very good level in reading and understanding of English language

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): NCT03094104


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

Locations
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France
Assistance Publique - Hôpitaux de Paris Not yet recruiting
Paris, Ile-de-france, France, 75004
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   
Principal Investigator: Isabelle BOUTRON, Prof.         
Principal Investigator: Romana HANEEF, PhD candidate         
Sub-Investigator: Amelie YAVCHITZ, Dr.         
Sub-Investigator: Philippe RAVAUD, Prof.         
Sub-Investigator: Ivan ORANSKY, Prof.         
Sub-Investigator: Gary SCHWITZER, Prof.         
Sub-Investigator: Gabriel BARON, Mr.         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Isabelle BOUTRON, Prof. INSERM U1153, University of Paris-Descartes
Principal Investigator: Romana HANEEF, PhD researcher INSERM U1153

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03094104     History of Changes
Other Study ID Numbers: ISB-006
First Posted: March 29, 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
phase I/II trials
non-randomized trials
Patients