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*
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Perception of beneficial effect of the treatment X
Study Overview
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
- 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.
- Participants: The participants will include English-speaking population from FindParticipants (https://www.findparticipants.com/).
- Sample size: For this RCT, the sample size will be 300 participants.
- 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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants will be blinded to the study hypothesis.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Native English speakers or have a very good level in reading and understanding of English language
Exclusion Criteria
- Not provided
Arms & Interventions
News without spin
News items reporting results of phase I/II (non-randomized) trials without spin
Intervention: News items without spin (Other)
News with Spin
News items reporting results of phase I/II (non-randomized) trials with spin
Intervention: News items with spin (Other)
Outcomes
Primary Outcomes
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 Outcomes
- How safe do you think that treatment X would be for patients?(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(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?(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?(As the intervention is assigned (reading the news item) i.e., 1-2 hours)
Investigators
Isabelle BOUTRON
Professor
Assistance Publique - Hôpitaux de Paris