Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
Study NCT ID:
NCT03095950
Status:
WITHDRAWN
Last Update Posted:
2021-02-12
First Post:
2017-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by French-speaking Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C104434', 'term': 'spindlin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be blinded to the study hypothesis.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms, parallel group, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception of beneficial effect of the treatment X', 'timeFrame': 'As the intervention is assigned (reading the news item) i.e., 1-2 hours', 'description': '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\\])'}], 'secondaryOutcomes': [{'measure': 'Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice', 'timeFrame': 'As the intervention is assigned (reading the news item) i.e., 1-2 hours', 'description': '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'}, {'measure': 'How safe do you think that treatment X would be for patients?', 'timeFrame': 'As the intervention is assigned (reading the news item) i.e., 1-2 hours', 'description': 'With the choices of answers on a 10 point Likert scale, (scale, 0 \\[very unsafe\\] to 10 \\[very safe\\])'}, {'measure': 'Do you think this treatment should be offered to patients in the short term?', 'timeFrame': 'As the intervention is assigned (reading the news item) i.e., 1-2 hours', 'description': 'With the choices of answers on a 10 point Likert scale, (scale, 0 \\[absolutely no\\] to 10 \\[absolutely yes\\])'}, {'measure': 'Do you think this treatment will make a difference in the existing clinical practice?', 'timeFrame': 'As the intervention is assigned (reading the news item) i.e., 1-2 hours', 'description': 'With the choices of answers on a 10 point Likert scale, (scale, 0 \\[absolutely no\\] to 10 \\[absolutely yes\\])'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spin', 'Misleading reporting', 'Misleading interpretation', 'Misleading extrapolation', 'Randomized controlled trials', 'Patients'], 'conditions': ['The Study Focus on no Specific Condition']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.etude-nutrinet-sante.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the interpretation of health news items reporting results of randomized controlled trials (RCTs) with or without spin (i.e., distortion of research results). The news items which reported those 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 RCTs with and without spin will be interpreted by French-speaking population.', 'detailedDescription': '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.\n\nObjective: "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 RCTs with or without spin. News items evaluating the effect of a pharmacological treatment that received high online public attention will be focused.\n\nHypothesis: The hypothesis of this study is that the spin can influence the reader\'s interpretation of health news items reporting results of RCTs.\n\nDesign: A randomized controlled trial\n\n1. Interventions: Health news items reporting results of RCTs with and without spin will be compared. A sample of health news items reporting the results of RCTs evaluating the effect of pharmacologic treatment and containing highest number of spin in the headline and text will be selected. Spin will be deleted in the selected news items and will be rewritten the news items without spin.\n2. Participants: The participants will include French-speaking population from an e-cohort Nutrinet santé.\n3. Sample size will be 300 patients.\n4. The primary outcome will be 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? (scale, 0 \\[very unlikely\\] to 10 \\[very likely\\]). Perception of safety and beneficial effects of treatment in clinical studies is considered as a surrogate marker of health outcome as it may have an impact on the future development of the drug, and then the potential use of the drug for patients.\n5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Native French speakers\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03095950', 'briefTitle': 'Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by French-speaking Population', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Population', 'orgStudyIdInfo': {'id': 'ISB-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'News with Spin', 'description': 'News items reporting results of RCTs with spin', 'interventionNames': ['Other: News items with spin']}, {'type': 'EXPERIMENTAL', 'label': 'News without spin', 'description': 'News items reporting results of RCTs without spin', 'interventionNames': ['Other: News items without spin']}], 'interventions': [{'name': 'News items with spin', 'type': 'OTHER', 'description': 'Interpretation of news items with spin', 'armGroupLabels': ['News with Spin']}, {'name': 'News items without spin', 'type': 'OTHER', 'description': 'Interpretation of news items without spin', 'armGroupLabels': ['News without spin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Isabelle BOUTRON, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM U1153, University of Paris-Descartes'}, {'name': 'Romana HANEEF, PhD researcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM U1153, University of Paris-Descartes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Isabelle BOUTRON', 'investigatorAffiliation': 'Assistance Publique - Hôpitaux de Paris'}}}}