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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

Tracking Information
First Submitted Date  ICMJE March 22, 2017
First Posted Date  ICMJE March 29, 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 22, 2017)
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])
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03094104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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])
  • 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])
  • 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])
  • 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])
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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])
  • 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 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 point 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 point 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 Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population
Official Title  ICMJE 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
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.
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.
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: News items with spin
    Interpretation of news items with spin
  • Other: News items without spin
    Interpretation of news items without spin
Study Arms  ICMJE
  • Active Comparator: News with Spin
    News items reporting results of phase I/II (non-randomized) trials with spin
    Intervention: Other: News items with spin
  • Experimental: News without spin
    News items reporting results of phase I/II (non-randomized) trials without spin
    Intervention: Other: News items without spin
Publications * Boutron I, Haneef R, Yavchitz A, Baron G, Novack J, Oransky I, Schwitzer G, Ravaud P. Three randomized controlled trials evaluating the impact of "spin" in health news stories reporting studies of pharmacologic treatments on patients'/caregivers' interpretation of treatment benefit. BMC Med. 2019 Jun 4;17(1):105. doi: 10.1186/s12916-019-1330-9. Erratum in: BMC Med. 2019 Jul 27;17(1):147.

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 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 English speakers or have a very good level in reading and understanding of English language

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: 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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03094104
Other Study ID Numbers  ICMJE ISB-006
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
Principal Investigator: Isabelle BOUTRON, Prof. INSERM U1153, University of Paris-Descartes
Principal Investigator: Romana HANEEF, PhD researcher INSERM U1153
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