Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT04850612
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural Haematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSDH Core Outcome Set (COS)', 'timeFrame': '3 months', 'description': 'Definition of a Core Outcome Set (COS) for reporting in all future CSDH studies through a Delphi survey process including all relevant stakeholders.'}], 'secondaryOutcomes': [{'measure': 'CSDH Definition and Data Elements', 'timeFrame': '3 months', 'description': 'Identify a unified CSDH definition and data elements (DE) for reporting in future CSDH studies, through a Delphi survey process including healthcare profession and research (HCPR) stakeholders.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head injury', 'core outcome set', 'elderly'], 'conditions': ['Chronic Subdural Hematoma']}, 'descriptionModule': {'briefSummary': 'This study is aimed at improving reporting in Chronic Subdural Haematoma (CSDH) research studies, through development of a standardised Core Outcome Set (COS), a unified CSDH Definition and set of Data Elements (DE) for reporting.\n\nThe study design includes a Delphi survey process from two main stakeholder groups: Health-Care Professionals or Researchers (HCPR) and Patients or carers. HCPR, patients and carers will all be invited to complete the survey on the COS, only the HCPR survey will include questions on definition and DE. Results of the Delphi Survey will be discussed at a final consensus meeting before results are confirmed and published.', 'detailedDescription': 'Chronic subdural haematoma (CSDH) is a collection of blood and fluid surrounded by membranes that accumulates on the brain surface over weeks to months. It predominately affects older people and often has a delayed association with a preceding head trauma.\n\nThere has been significant growth in the number of CSDH publications in recent years mirroring progress in potential management options but there is wide variation in how and when patient outcome is measured amongst studies. Much could be gained by agreeing a minimum set of standardized outcomes that should be measured and reported in all CSDH studies, known as a Core Outcome Set (COS).\n\nThe overall study design includes a Delphi survey process.This is a process whereby all outcomes and data elements from the CSDH literature and expert opinion are presented to a large group of patients, carers and HCPR via a survey. Each survey participant has the opportunity to rank the elements and outcomes in levels of importance to them, and the survey is then repeated including presentation of the results from the first round, in order to attempt to gain agreement between participants on what is important. All elements are then reviewed at a final "consensus" meeting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthcare Professionals, Researchers, patients and carers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll invited participants who provide consent to take part in 2 rounds of survey'}, 'identificationModule': {'nctId': 'NCT04850612', 'acronym': 'CODE-CSDH', 'briefTitle': 'Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural Haematoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural', 'orgStudyIdInfo': {'id': 'CA_2020-21-303'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthcare professionals and researchers (HCPR)', 'description': 'All researchers and healthcare professionals involved in the management of patients with CSDH', 'interventionNames': ['Other: Survey']}, {'label': 'Patients and carers', 'description': 'Patients who have previously had a diagnosis of CSDH, and their carers', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Delphi Survey on core outcomes, CSDH definition and data elements', 'armGroupLabels': ['Healthcare professionals and researchers (HCPR)', 'Patients and carers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'University Hospitals Plymouth NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Protocol submitted for open publication prior to commencing study. Final study report will be published at end of study including full anonymised survey responses.', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer in Neurosurgery', 'investigatorFullName': 'Ellie Edlmann', 'investigatorAffiliation': 'University Hospital Plymouth NHS Trust'}}}}