Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-04 @ 12:11 PM
Study NCT ID:
NCT03094104
Status:
UNKNOWN
Last Update Posted:
2018-09-11
First Post:
2017-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-12', 'releaseDate': '2023-10-24'}], 'estimatedResultsFirstSubmitDate': '2023-10-24'}}, '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': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', '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\\])'}, {'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', 'phase I/II trials', 'non-randomized trials', 'Patients'], 'conditions': ['The Study Focus on no Specific Condition']}, 'referencesModule': {'references': [{'pmid': '31159786', 'type': 'DERIVED', 'citation': 'Boutron I, Haneef R, Yavchitz A, Baron G, Novack J, Oransky I, Schwitzer G, Ravaud P. Three randomized controlled trials evaluating the impact of "spin" in health news stories reporting studies of pharmacologic treatments on patients\'/caregivers\' interpretation of treatment benefit. BMC Med. 2019 Jun 4;17(1):105. doi: 10.1186/s12916-019-1330-9.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). The news items which reported 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 phase I/II (non-randomized) trials with and without spin will be interpreted by English-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 phase I/II (non-randomized) trials 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 phase I/II (non-randomized) trials.\n\nDesign: A randomized controlled trial\n\n1. Interventions: Health news items reporting results of phase I/II (non-randomized) studies with and without spin will be compared. A sample of health news items reporting the results of phase I/II (non-randomized) 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.\n2. Participants: The participants will include English-speaking population from FindParticipants (https://www.findparticipants.com/).\n3. Sample size: For this RCT, the sample size will be 300 participants.\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. Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of phase I/II (non-randomized) trials by English-speaking population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Native English speakers or have a very good level in reading and understanding of English language\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03094104', 'briefTitle': 'Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-speaking Population', 'orgStudyIdInfo': {'id': 'ISB-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'News with Spin', 'description': 'News items reporting results of phase I/II (non-randomized) trials with spin', 'interventionNames': ['Other: News items with spin']}, {'type': 'EXPERIMENTAL', 'label': 'News without spin', 'description': 'News items reporting results of phase I/II (non-randomized) trials 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', 'contacts': [{'name': 'Isabelle BOUTRON, Prof.', 'role': 'CONTACT', 'email': 'isabelle.boutron@aphp.fr', 'phone': '+33 (0)1.42.34.78.33'}, {'name': 'Audrey Conjaud', 'role': 'CONTACT', 'email': 'secretariat.epidemiologie.htd@aphp.fr', 'phone': '+33 (0)1.42.34.89.87'}, {'name': 'Isabelle BOUTRON, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Romana HANEEF, PhD candidate', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amelie YAVCHITZ, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe RAVAUD, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ivan ORANSKY, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gary SCHWITZER, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gabriel BARON, Mr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle BOUTRON, Prof.', 'role': 'CONTACT', 'email': 'isabelle.boutron@aphp.fr', 'phone': '+33 (0)1.42.34.78.33'}, {'name': 'Audrey Conjaud, PhD candidate', 'role': 'CONTACT', 'email': 'secretariat.epidemiologie.htd@aphp.fr', 'phone': '+33 (0)1.42.34.89.87'}], 'overallOfficials': [{'name': 'Isabelle BOUTRON, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM U1153, University of Paris-Descartes'}, {'name': 'Romana HANEEF, PhD researcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, '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'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-24', 'type': 'RELEASE'}, {'date': '2024-04-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris'}}}}