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

February 9, 2021 updated by: Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris

Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Population

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 on human health, 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 phase I/II (non-randomized) trials with and without spin will be interpreted by French-speaking population.

Study Overview

Status

Withdrawn

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

  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 highest number of 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 population from an e-cohort Nutrinet santé.
  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 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) studies by French-speaking population.
  6. This study is approved by ethics review regulations by INSERM (CEEI-IRB):IRB00003888

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-france
      • Paris, Ile-de-france, France, 75004
        • Assistance Publique - Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Native French speakers

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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]); analysis: none, small vs moderate or large
As the intervention is assigned (reading the news item) i.e., 1-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Romana HANEEF, PhD researcher, INSERM U1153
  • Principal Investigator: Isabelle BOUTRON, Prof., INSERM U1153, University of Paris-Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISB-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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