Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population
9 de febrero de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Retirado
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ile-de-france
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Paris, Ile-de-france, Francia, 75004
- Assistance Publique - Hôpitaux de Paris
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Native French speakers who can read the news
Exclusion Criteria:
-
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Noticias con Spin
Noticias que informan sobre los resultados de estudios en animales con spin.
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Interpretation of news items with spin
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Experimental: Noticias sin giro
Artículos de noticias que informan los resultados de estudios en animales sin giro.
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Interpretation of news items without spin
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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?
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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?
Periodo de tiempo: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
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?
Periodo de tiempo: 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?
Periodo de tiempo: 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?
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de junio de 2019
Finalización primaria (Anticipado)
1 de diciembre de 2019
Finalización del estudio (Anticipado)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
13 de febrero de 2017
Primero enviado que cumplió con los criterios de control de calidad
1 de marzo de 2017
Publicado por primera vez (Actual)
7 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de febrero de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ISB-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .