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Completed

NCT Number: NCT03095586

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

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.

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Key information

Conditions

the Study Focus on no Specific Condition

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Paris

Paris, Île-de-France Region, 75004, France

About this study

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

  • 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.
  • Participants: The participants will include English-speaking patients from an online patient community.
  • Sample size: The sample size will be 300 patients.
  • 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.
  • Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of RCTs by English-speaking patients.
  • This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

News items with spin

Other

Interpretation of news items with spin

News items without spin

Other

Interpretation of news items without spin

Primary outcomes

  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 outcomes

  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])

  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]) analysis: none, small vs moderate or large

  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 [absolutely no] to 10 [absolutely yes])

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin: A Randomized Controlled Trial Among English-speaking Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2017
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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