The Study Focus on no Specific Condition Clinical Trial
Official title:
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Patients
NCT number | NCT03094065 |
Other study ID # | ISB-001 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2019 |
Est. completion date | December 2019 |
Verified date | February 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Native French speakers - Have at least one chronic disease |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique - Hôpitaux de Paris | Paris | Ile-de-france |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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? | The primary outcome of our study is the perception of the benficial effect of treatment and involve human particpants who are patients. Previous studies have demonstrated that the perception of safety and beneficial effects of treatment in preclinical studies will have an impact on the future development of the drug, and then the possible use of the drug for patients. Therefore our primary outcome could be considered as a surrogate marker of health outcome. Moreover, this study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888 With the choice of answers on a 10 points Likert scale (scale, 0 [very unlikely] to 10[very likely]) |
As the intervention is assigned (reading the news item) i.e., 1-2 hours | |
Secondary | 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? | With the choice of answers on a 5 points scale (none, small, moderate, large); analysis: none, small vs moderate or large | As the intervention is assigned (reading the news item) i.e., 1-2 hours | |
Secondary | How safe do you think that treatment X would be for patients? | With the choice of answers on a 10 points Likert scale (scale, 0 [very unsafe] to 10[very safe]) | As the intervention is assigned (reading the news item) i.e., 1-2 hours | |
Secondary | Do you think this treatment should be offered to patients in the short term? | With the choice 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 | |
Secondary | Do you think this treatment will make a difference in the existing clinical practice? | With the choice 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 |
Status | Clinical Trial | Phase | |
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