Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population
9. februar 2021 oppdatert av: Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
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 French-speaking population.
Studieoversikt
Status
Tilbaketrukket
Intervensjon / Behandling
Detaljert 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
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ile-de-france
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Paris, Ile-de-france, Frankrike, 75004
- Assistance Publique - Hôpitaux de Paris
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Native French speakers who can read the news
Exclusion Criteria:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Nyheter med Spin
Nyheter som rapporterer resultater fra dyrestudier med spinn.
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Interpretation of news items with spin
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Eksperimentell: Nyheter uten spinn
Nyheter som rapporterer resultater fra dyrestudier uten spinn.
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Interpretation of news items without spin
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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])
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. juni 2019
Primær fullføring (Forventet)
1. desember 2019
Studiet fullført (Forventet)
1. desember 2019
Datoer for studieregistrering
Først innsendt
13. februar 2017
Først innsendt som oppfylte QC-kriteriene
1. mars 2017
Først lagt ut (Faktiske)
7. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ISB-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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