- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03071627
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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: 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. "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.
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
- 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.
- Participants: The participants will include French-speaking healthy population from Nutrinet santé.
- Sample size: For this RCT, the sample size will be 300 participants.
- Main outcome measures: The primary outcome will be participants' interpretation of the benefit of treatment after reading the news (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]).
- Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of pre-clinical studies by French-speaking population.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ile-de-france
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Paris, Ile-de-france, Frankrig, 75004
- Assistance Publique - Hôpitaux de Paris
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Native French speakers who can read the news
Exclusion Criteria:
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Nyheder med Spin
Nyheder, der rapporterer resultater af dyreforsøg med spin.
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Interpretation of news items with spin
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Eksperimentel: Nyheder uden spin
Nyheder, der rapporterer resultater af dyreforsøg uden spin.
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Interpretation of news items without spin
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Perception of beneficial effect of the treatment X. We ask participants, What do you think is the probability that treatment X would be beneficial to patients?
Tidsramme: As the intervention is assigned (reading the news item) i.e., 1-2 hours
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With the choices of answers on a 10 points Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
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As the intervention is assigned (reading the news item) i.e., 1-2 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Perception of efficacy, safety, availability and clinical utility in existing clinical practice for the treatment X. We will ask the participants: What do you think is the size of the potential benefit for patients?
Tidsramme: As the intervention is assigned (reading the news item) i.e., 1-2 hours
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With the choice of answers on a 5 points scale, (scale, [none, small, moderate or large]) -- analysis none, small vs moderate, large
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As the intervention is assigned (reading the news item) i.e., 1-2 hours
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How safe do you think that treatment X would be for patients?
Tidsramme: As the intervention is assigned (reading the news item) i.e., 1-2 hours
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With the choices of answers on a 10 points Likert scale, (scale, 0 [very unsafe] to 10 [very safe])
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As the intervention is assigned (reading the news item) i.e., 1-2 hours
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Do you think this treatment should be offered to patients in the short term?
Tidsramme: As the intervention is assigned (reading the news item) i.e., 1-2 hours
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With the choices of answers on a 10 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
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As the intervention is assigned (reading the news item) i.e., 1-2 hours
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Do you think this treatment will make a difference in the existing clinical practice?
Tidsramme: As the intervention is assigned (reading the news item) i.e., 1-2 hours
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With the choices of answers on a 10 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
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As the intervention is assigned (reading the news item) i.e., 1-2 hours
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ISB-002
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med New items with spin
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The University of Texas Health Science Center,...Eunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereRekrutteringMultipel scleroseForenede Stater