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The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) 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 English-speaking population.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| News with Spin | Active Comparator | News items reporting results of phase I/II (non-randomized) trials with spin |
|
| News without spin | Experimental | News items reporting results of phase I/II (non-randomized) trials without spin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| News items with spin | Other | Interpretation of news items with spin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Romana HANEEF, PhD researcher | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Isabelle BOUTRON, Prof. | INSERM U1153, University of Paris-Descartes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris | Paris | Île-de-France Region | 75004 | France |
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Two arms, parallel group, randomized controlled trial
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Participants will be blinded to the study hypothesis.
| News items without spin |
| Other |
Interpretation of news items without spin |
|
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| C104434 | spindlin |
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