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

The Study Focus on no Specific Condition Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03094117
• Other study ID #: ISB-007
• Status: Withdrawn
• Phase: N/A
• Start date: June 2019
• Est. completion date: December 2019

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Native French speakers
• Have at least one chronic disease Exclusion Criteria: -

Related Conditions & MeSH terms

• The Study Focus on no Specific Condition

Intervention

Other:
• News items with spin
Interpretation of news items with spin
• News items without spin
Interpretation of news items without spin

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris	Ile-de-france

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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? With the choices of answers on a 10 point Likert scale, (scale, 0 [very unlikely] to 10 [very likely])	As the intervention is assigned (reading the news item) i.e., 1-2 hours
Secondary	Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice	We will ask participants, what do you think is the size of the potential benefit for patients? With the choices of answers on a 5 point scale (scale, [none, small, moderate or large]); analysis none, small vs moderate or large	As the intervention is assigned (reading the news item) i.e., 1-2 hours
Secondary	How safe do you think that treatment X would be for patients?	With the choices of answers on a 10 point Likert scale, (scale, 0 [very unsafe] to 10 [very safe])	As the intervention is assigned (reading the news item) i.e., 1-2 hours
Secondary	Do you think this treatment should be offered to patients in the short term?	With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])	As the intervention is assigned (reading the news item) i.e., 1-2 hours
Secondary	Do you think this treatment will make a difference in the existing clinical practice?	With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])	As the intervention is assigned (reading the news item) i.e., 1-2 hours

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