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

NCT ID: NCT03095586

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2017-11-16

Brief Summary

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 English-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 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 English-speaking patients from an online patient community.

3. Sample size: The 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. Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of RCTs by English-speaking patients.

6. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Conditions

The Study Focus on no Specific Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

News with Spin

News items reporting results of RCTs with spin

Group Type: ACTIVE_COMPARATOR

News items with spin

Intervention Type: OTHER

Interpretation of news items with spin

News without spin

News items reporting results of RCTs without spin

Group Type: EXPERIMENTAL

News items without spin

Intervention Type: OTHER

Interpretation of news items without spin

Interventions

News items with spin

Interpretation of news items with spin

Intervention Type: OTHER

News items without spin

Interpretation of news items without spin

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Native English speakers or have a very good level in reading and understanding of English language
• Have at least one chronic disease

Exclusion Criteria

-

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Isabelle BOUTRON

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabelle BOUTRON, Prof.

Role: PRINCIPAL_INVESTIGATOR

INSERM U1153, University of Paris-Descartes

Romana HANEEF, PhD researcher

Role: PRINCIPAL_INVESTIGATOR

INSERM U1153, University of Paris-Descartes

Locations

Assistance Publique - Hôpitaux de Paris

Paris, Île-de-France Region, France

Countries

France

References

Boutron I, Haneef R, Yavchitz A, Baron G, Novack J, Oransky I, Schwitzer G, Ravaud P. Three randomized controlled trials evaluating the impact of "spin" in health news stories reporting studies of pharmacologic treatments on patients'/caregivers' interpretation of treatment benefit. BMC Med. 2019 Jun 4;17(1):105. doi: 10.1186/s12916-019-1330-9.

Reference Type: DERIVED

PMID: 31159786 (View on PubMed)

Other Identifiers

ISB-009

Identifier Type: -

Identifier Source: org_study_id