Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by French-speaking Patients

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Status: Withdrawn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

NCT03095924

ISB-011

Details and patient eligibility

About

The main objective of this study is to compare the interpretation of health news items reporting results of randomized controlled trials (RCTs) with or without spin (i.e., distortion of research results). The news items which reported those 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 RCTs with and without spin will be interpreted by French-speaking patients.

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 RCTs 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 RCTs.

Design: A randomized controlled trial

1. Interventions: Health news items reporting results of RCTs with and without spin will be compared. A sample of health news items reporting the results of RCTs 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 items without spin.
2. Participants: The participants will include French-speaking patients from an e-cohort COMPARE.
3. Sample size will be 300 patients.
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. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Native French speakers
• Have at least one chronic disease

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 RCTs with spin

Treatment:

Other: News items with spin

News without spin

Experimental group

Description:

News items reporting results of RCTs without spin

Treatment:

Other: News items without spin