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

Assistance Publique - Hôpitaux de Paris

Status: Withdrawn

Conditions: The Study Focus on no Specific Condition

Treatments: Other: News items without spin; Other: News items with spin

Study type: Interventional

Funder types: Other

Identifiers

NCT03094130

ISB-008

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Native French speakers

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

News with Spin

Active Comparator group

Description:

News items reporting results of phase I/II (non-randomized) trials with spin

Treatment:

Other: News items with spin

News without spin

Experimental group

Description:

News items reporting results of phase I/II (non-randomized) trials without spin

Treatment:

Other: News items without spin