Clinical trial NCT03094117: Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by French-speaking Patients
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 French-speaking Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: The Study Focus on no Specific Condition
Keywords: Spin
Misleading reporting
Misleading interpretation
Misleading extrapolation
phase I/II trials
non-randomized trials
Patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms, parallel group, randomized controlled trial
Primary purpose: OTHER

Brief summary: The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (nonrandomized) 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 French-speaking patients.

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 French-speaking patients from an e-cohort COMPARE.
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) studies by French-speaking patients.
6. This study is approved by ethics review regulations by INSERM (CEEI-IRB):IRB00003888

Eligibility criteria: Inclusion Criteria:

* Native French speakers
* Have at least one chronic disease

Exclusion Criteria:

-

Primary outcomes:
measure: Perception of beneficial effect of the treatment X
timeFrame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Secondary outcomes:
measure: Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice
timeFrame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
measure: How safe do you think that treatment X would be for patients?
timeFrame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
measure: Do you think this treatment should be offered to patients in the short term?
timeFrame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
measure: Do you think this treatment will make a difference in the existing clinical practice?
timeFrame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
state: Ile-de-france
Study officials:
affiliation: INSERM U1153, University of Paris-Descartes
name: Isabelle BOUTRON, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Romana HANEEF, PhD researcher
role: PRINCIPAL_INVESTIGATOR
References: