Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin by English-speaking Patients

• ClinicalTrials.gov Identifier: NCT03094078
• Recruitment Status: Completed
• First Posted: March 29, 2017
• Last Update Posted: September 11, 2018
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, 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 pre-clinical studies with and without spin will be interpreted by English-speaking patients.

Condition or disease	Intervention/treatment	Phase
The Study Focus on no Specific Condition	Other: News item with spin; Other: News item without spin	Not Applicable

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 reported with or without spin. News items reporting pre-clinical studies 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 pre-clinical studies.

Design: A randomized controlled trial

1. Interventions: Health news items reporting results of pre-clinical studies with and without spin will be compared. A sample of health news items reporting the results of pre-clinical 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 English-speaking patients from an online patient community.
3. Sample size: For this RCT, 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]).
5. Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of pre-clinical studies by English-speaking patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two arms, parallel group, randomized controlled trial
• Masking: Single (Participant)
• Masking Description: Participants will be blinded to the study hypothesis.
• Primary Purpose: Other
• Official Title: Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among English-speaking Patients
• Actual Study Start Date: October 16, 2017
• Actual Primary Completion Date: November 16, 2017
• Actual Study Completion Date: November 16, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: News with Spin; News items reporting results of pre-clinical studies with spin	Other: News item with spin; Interpretation of news item with spin
Experimental: News without spin; News items reporting results of pre-clinical studies without spin	Other: News item without spin; Interpretation of news item without spin

Outcome Measures

Primary Outcome Measures :

1. Perception of beneficial effect of the treatment X [ Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours ]
   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])

Secondary Outcome Measures :

1. Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice [ Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours ]
   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
2. How safe do you think that treatment X would be for patients? [ Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours ]
   With the choices of answers on a 10 point Likert scale, (scale, 0 [very unsafe] to 10 [very safe])
3. Do you think this treatment should be offered to patients in the short term? [ Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours ]
   With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
4. Do you think this treatment will make a difference in the existing clinical practice? [ Time Frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours ]
   With the choices of answers on a 10 point Likert scale, (scale, 0 [very unlikely] to 10 [very likely])

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Locations

France

Assistance Publique - Hôpitaux de Paris

Paris, Ile-de-france, France, 75004

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: BMC Med. 2019 Jul 27;17(1):147.

• Responsible Party: Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03094078
• Other Study ID Numbers: ISB-004
• First Posted: March 29, 2017
• Last Update Posted: September 11, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris:

Spin; Misleading reporting; Misleading interpretation; Misleading extrapolation; Animal studies; Cell culture studies; Pre-clinical studies