Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by English-speaking Patients
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| ClinicalTrials.gov Identifier: NCT03095586 |
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Recruitment Status :
Completed
First Posted : March 29, 2017
Last Update Posted : September 12, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| The Study Focus on no Specific Condition | Other: News items with spin Other: News items without spin | Not Applicable |
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
| 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 Randomized Controlled Trials 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: News with Spin
News items reporting results of RCTs with spin
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Other: News items with spin
Interpretation of news items with spin |
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Experimental: News without spin
News items reporting results of RCTs without spin
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Other: News items without spin
Interpretation of news items without spin |
- 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])
- 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])
- 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
- 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])
- 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])
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
-
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095586
| France | |
| Assistance Publique - Hôpitaux de Paris | |
| Paris, Ile-de-france, France, 75004 | |
| Principal Investigator: | Isabelle BOUTRON, Prof. | INSERM U1153, University of Paris-Descartes | |
| Principal Investigator: | Romana HANEEF, PhD researcher | INSERM U1153, University of Paris-Descartes |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT03095586 History of Changes |
| Other Study ID Numbers: |
ISB-009 |
| First Posted: | March 29, 2017 Key Record Dates |
| Last Update Posted: | September 12, 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:
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Spin Misleading reporting Misleading interpretation |
Misleading extrapolation Randomized controlled trials Patients |