Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06097494
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2023-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigating Healthcare Disparities in Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ranjit.nagra@pfizer.com', 'phone': '01304 616161', 'title': 'Ranjit Nagra', 'organization': 'Pfizer Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Deaths, serious adverse events, and nonserious adverse events were not assessed for study participants.', 'eventGroups': [{'id': 'EG000', 'title': 'People With Vitiligo', 'description': 'Children and adults with new onset Vitiligo registered with OPCRD during the study period.\n\nNo intervention: Observational analysis of usual care only.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'People Without Vitiligo', 'description': 'Children and adults without Vitiligo registered with OPCRD during the study period\n\nNo intervention: Observational analysis of usual care only.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Risk of Depression Within Patients With Vitiligo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}, {'value': '31484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '1412', 'groupId': 'OG000'}, {'value': '5395', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.15', 'estimateComment': 'Calculated as the odds of a person diagnosed with vitiligo having with depression versus people not diagnosed with vitiligo', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Adjusted odds ratio calculated using logistic regression.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Risk of Anxiety Within Patients With Vitiligo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}, {'value': '31484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '708', 'groupId': 'OG000'}, {'value': '2430', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.09', 'ciUpperLimit': '1.30', 'estimateComment': 'Calculated as the odds of people diagnosed with vitiligo having anxiety compared to people not diagnosed with vitilligo.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Adjusted odds ratio calculated using logistic regression.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Risk of Depression or Anxiety Within Patients With Vitiligo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}, {'value': '31484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '1614', 'groupId': 'OG000'}, {'value': '6064', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.17', 'estimateComment': 'Calculated as the odds of people diagnosed with vitiligo having anxiety or depression compared to people not diagnosed with vitilligo.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Adjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression .', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care Encounters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}, {'value': '31484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '134207', 'groupId': 'OG000'}, {'value': '439633', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.32', 'estimateComment': 'Adjusted incident rate ratio for increased primary care use was calculated by comparing patients with vitiligo versus matched controls not having vitiligo,using negative binomial regression.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dermatology Referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method.', 'unitOfMeasure': 'percentage of participants analyzed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Dermatology referrals were assessed only in patients with vitiligo'}, {'type': 'SECONDARY', 'title': 'Mental Health Referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}, {'value': '31484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}, {'value': '1191', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.20', 'estimateComment': 'Hazard ratios for mental health referrals was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unemployment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6241', 'groupId': 'OG000'}, {'value': '23187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Adults aged 18-65 years with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Adults aged 18-65 years without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.15', 'estimateComment': 'Hazard ratios for unemployment was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of participants of working age'}, {'type': 'SECONDARY', 'title': 'Time Off Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6241', 'groupId': 'OG000'}, {'value': '23187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Adults aged 18-65 years with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Adults aged 18-65 years without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '746', 'groupId': 'OG000'}, {'value': '2472', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.24', 'estimateComment': 'Hazard ratios for time off work was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of participants of working age'}, {'type': 'SECONDARY', 'title': 'Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'OG000'}, {'value': '31484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo (reference group)\n\nNo intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '1102', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.31', 'estimateComment': 'Hazard ratios for sleep disturbance was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Describe any disparities in sleep disturbance reported as adjusted hazard ratios.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'People With Vitiligo', 'description': 'Children and adults with new onset Vitiligo registered with OPCRD during the study period.\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'FG001', 'title': 'People Without Vitiligo (Reference Group)', 'description': 'Children and adults without Vitiligo registered with OPCRD during the study period\n\nNo intervention: Observational analysis of usual care only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7890'}, {'groupId': 'FG001', 'numSubjects': '31484'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7890'}, {'groupId': 'FG001', 'numSubjects': '31484'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All adults and children (aged ≥ 13 years) contributing to the Optimum Patient Care Research Database (OPCRD) between 1 January 2004 and 31 December 2020, without a diagnosis of vitiligo prior to1 January 2004 were eligible for inclusion.', 'preAssignmentDetails': 'Participants with a diagnosis for an alternative depigmenting disorder or were diagnosed with vitiligo within 6 months of registering with their general practice (GP) were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7890', 'groupId': 'BG000'}, {'value': '31484', 'groupId': 'BG001'}, {'value': '39374', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'People With Vitiligo', 'description': 'Children (≥ 13 years) and adults with new onset Vitiligo registered with Optimum Patient Care Research Database during the study period.\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'BG001', 'title': 'People Without Vitiligo', 'description': 'Children (≥ 13 years) and adults without Vitiligo registered with Optimum Patient Care Research Database during the study period\n\nNo intervention: Observational analysis of usual care only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '57'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '59'}, {'value': '42.5', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '13-17 years', 'measurements': [{'value': '487', 'groupId': 'BG000'}, {'value': '1915', 'groupId': 'BG001'}, {'value': '2402', 'groupId': 'BG002'}]}, {'title': '18-29 years', 'measurements': [{'value': '1370', 'groupId': 'BG000'}, {'value': '5471', 'groupId': 'BG001'}, {'value': '6841', 'groupId': 'BG002'}]}, {'title': '30-49 years', 'measurements': [{'value': '3063', 'groupId': 'BG000'}, {'value': '12242', 'groupId': 'BG001'}, {'value': '15305', 'groupId': 'BG002'}]}, {'title': '50+ years', 'measurements': [{'value': '2970', 'groupId': 'BG000'}, {'value': '11856', 'groupId': 'BG001'}, {'value': '14826', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4131', 'groupId': 'BG000'}, {'value': '16492', 'groupId': 'BG001'}, {'value': '20623', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3759', 'groupId': 'BG000'}, {'value': '14992', 'groupId': 'BG001'}, {'value': '18751', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '3726', 'groupId': 'BG000'}, {'value': '14894', 'groupId': 'BG001'}, {'value': '18620', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '708', 'groupId': 'BG001'}, {'value': '904', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1197', 'groupId': 'BG000'}, {'value': '4775', 'groupId': 'BG001'}, {'value': '5972', 'groupId': 'BG002'}]}, {'title': 'Mixed', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '1220', 'groupId': 'BG001'}, {'value': '1519', 'groupId': 'BG002'}]}, {'title': 'Not recorded', 'measurements': [{'value': '2392', 'groupId': 'BG000'}, {'value': '9555', 'groupId': 'BG001'}, {'value': '11947', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Ethnicity categorized according to the UK's Office for National Statistics definitions of major UK ethnic groups", 'unitOfMeasure': 'Participants'}, {'title': 'Index of Multiple Deprivation', 'classes': [{'categories': [{'title': '1 (most deprived)', 'measurements': [{'value': '1525', 'groupId': 'BG000'}, {'value': '6094', 'groupId': 'BG001'}, {'value': '7619', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '1392', 'groupId': 'BG000'}, {'value': '5545', 'groupId': 'BG001'}, {'value': '6937', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '1355', 'groupId': 'BG000'}, {'value': '5418', 'groupId': 'BG001'}, {'value': '6773', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '1527', 'groupId': 'BG000'}, {'value': '6084', 'groupId': 'BG001'}, {'value': '7611', 'groupId': 'BG002'}]}, {'title': '5 (least deprived)', 'measurements': [{'value': '1484', 'groupId': 'BG000'}, {'value': '5928', 'groupId': 'BG001'}, {'value': '7412', 'groupId': 'BG002'}]}, {'title': 'Not recorded', 'measurements': [{'value': '607', 'groupId': 'BG000'}, {'value': '2415', 'groupId': 'BG001'}, {'value': '3022', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Index of Multiple Deprivation (IMD) is a UK national deprivation measure of deprivation which is based on the patient postcode. IMD has been stratified into quintiles with IMD 1 representing most deprived and IMD 5 being the least deprived.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index, Categorical', 'classes': [{'categories': [{'title': '< 18.5 (underweight)', 'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '1323', 'groupId': 'BG002'}]}, {'title': '18.5-25 (normal weight)', 'measurements': [{'value': '2324', 'groupId': 'BG000'}, {'value': '8504', 'groupId': 'BG001'}, {'value': '10828', 'groupId': 'BG002'}]}, {'title': '25-30 (overweight)', 'measurements': [{'value': '2386', 'groupId': 'BG000'}, {'value': '8938', 'groupId': 'BG001'}, {'value': '11324', 'groupId': 'BG002'}]}, {'title': '30-35 (class I obesity)', 'measurements': [{'value': '1137', 'groupId': 'BG000'}, {'value': '4410', 'groupId': 'BG001'}, {'value': '5547', 'groupId': 'BG002'}]}, {'title': '35-40 (class II obesity)', 'measurements': [{'value': '372', 'groupId': 'BG000'}, {'value': '1654', 'groupId': 'BG001'}, {'value': '2026', 'groupId': 'BG002'}]}, {'title': '> 40 (class III obesity)', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '940', 'groupId': 'BG001'}, {'value': '1154', 'groupId': 'BG002'}]}, {'title': 'Not recorded', 'measurements': [{'value': '1188', 'groupId': 'BG000'}, {'value': '5984', 'groupId': 'BG001'}, {'value': '7172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Body Mass Index (BMI) is a based on a participants height and weight.', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status, Categorical', 'classes': [{'categories': [{'title': 'Never smoked', 'measurements': [{'value': '2709', 'groupId': 'BG000'}, {'value': '10000', 'groupId': 'BG001'}, {'value': '12709', 'groupId': 'BG002'}]}, {'title': 'Current smoker', 'measurements': [{'value': '1229', 'groupId': 'BG000'}, {'value': '6114', 'groupId': 'BG001'}, {'value': '7343', 'groupId': 'BG002'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '3642', 'groupId': 'BG000'}, {'value': '13435', 'groupId': 'BG001'}, {'value': '17077', 'groupId': 'BG002'}]}, {'title': 'Not recorded', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '1935', 'groupId': 'BG001'}, {'value': '2245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol consumption, Categorical', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '2605', 'groupId': 'BG000'}, {'value': '10014', 'groupId': 'BG001'}, {'value': '12619', 'groupId': 'BG002'}]}, {'title': 'Within limits', 'measurements': [{'value': '2913', 'groupId': 'BG000'}, {'value': '11376', 'groupId': 'BG001'}, {'value': '14289', 'groupId': 'BG002'}]}, {'title': 'In excess of limits', 'measurements': [{'value': '1005', 'groupId': 'BG000'}, {'value': '3685', 'groupId': 'BG001'}, {'value': '4690', 'groupId': 'BG002'}]}, {'title': 'Harmful', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '584', 'groupId': 'BG002'}]}, {'title': 'Not recorded', 'measurements': [{'value': '1246', 'groupId': 'BG000'}, {'value': '5946', 'groupId': 'BG001'}, {'value': '7192', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-25', 'size': 459331, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-13T11:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39374}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2023-10-09', 'resultsFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-25', 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of Depression Within Patients With Vitiligo', 'timeFrame': '2 years', 'description': 'Adjusted odds ratio calculated using logistic regression.'}, {'measure': 'Risk of Anxiety Within Patients With Vitiligo', 'timeFrame': '2 years', 'description': 'Adjusted odds ratio calculated using logistic regression.'}, {'measure': 'Risk of Depression or Anxiety Within Patients With Vitiligo', 'timeFrame': '2 years', 'description': 'Adjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression .'}], 'secondaryOutcomes': [{'measure': 'Primary Care Encounters', 'timeFrame': '2 years', 'description': 'Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios'}, {'measure': 'Dermatology Referrals', 'timeFrame': '2 years', 'description': 'Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method.'}, {'measure': 'Mental Health Referrals', 'timeFrame': '2 years', 'description': 'Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios'}, {'measure': 'Unemployment', 'timeFrame': '2 years', 'description': 'Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios.'}, {'measure': 'Time Off Work', 'timeFrame': '2 years', 'description': 'Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios.'}, {'measure': 'Sleep Disturbance', 'timeFrame': '2 years', 'description': 'Describe any disparities in sleep disturbance reported as adjusted hazard ratios.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitiligo']}, 'referencesModule': {'references': [{'pmid': '39018020', 'type': 'DERIVED', 'citation': 'Eleftheriadou V, Ahmed A, Nesnas J, Nagra R. The lifetime risk and impact of vitiligo across sociodemographic groups: a UK population-based cohort study. Br J Dermatol. 2024 Dec 23;192(1):63-71. doi: 10.1093/bjd/ljae282.'}]}, 'descriptionModule': {'briefSummary': 'Vitiligo is an acquired, non contagious skin disorder characterised by depigmented patches of skin that may appear in a localised or very generalised distribution, and affecting 0.5-2.0% of the global population.There are however, limited population-based studies on the burden of vitiligo and disparities across people of different ethnicities and deprivation.\n\nThe overall purpose of this study is to provide an estimate of the lifetime risk of vitiligo in the population overall and by sociodemographic subgroups. Moreover, to do a subgroup analysis in the vitiligo population to identify health-related disparities across people in different sex, age, deprivation and ethnicity. A detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.', 'detailedDescription': 'This study will provide estimate of the cumulative lifetime risk of vitiligo in the population overall, and by important sociodemographic groups, including age, sex, ethnicity and deprivation, which will prevalent key data to show the relative burden of vitiligo across the aforementioned groups. These approaches allow creation of cumulative lifetime risk plots which provide an excellent and accessible way to display the relative disease burden across groups.\n\nThe cumulative lifetime risk of vitiligo will be estimated at age 80 years (approximate lifetime expectancy in the UK) using survival models, with age as the timescale and accounting for competing risk of death.\n\nThis study will also perform a subgroup analysis in the vitiligo population to identify health-related disparities across people in different deprivation, sex and ethnic groups. The disparities that will be considered are: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment),\n\nThe assessment of any associations with baseline characteristics and the outcome of interest will be used using Cox proportional hazards models (time to event outcomes) and generalised linear models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Incident cases will be defined as people with a first ever diagnosis code of vitiligo during the study period. People with a diagnosis of vitiligo prior to the study period will be excluded. Each case will be assigned an index date at the time of their vitiligo diagnosis. Controls will be matched to people without Vitiligo matched on age, sex, ethnicity and deprivation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The cohort for the endpoint analysis will consist of all adults and adolescents (aged 13+) contributing to OPCRD during the study period (2004-2020).\n* The cohort for the lifetime risk analysis will consist of all people contributing to OPCRD during the study period.\n* The vitiligo cohort consists of people newly diagnosed with vitiligo at any point during the study period.\n\nExclusion Criteria:\n\n* People with the alternative non-vitiligo diagnoses (other hypopigmenting conditions).\n* People with vitiligo diagnosis within 6 months of practice registration.\n* People without vitiligo with less than 1 year of follow up within the dataset.\n* People over the age of 95 (for those reaching age 95 during the follow up period follow up was censored at age 95).\n* People who have opted out of record sharing.'}, 'identificationModule': {'nctId': 'NCT06097494', 'briefTitle': 'Investigating Healthcare Disparities in Vitiligo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Momentum Data'}, 'officialTitle': 'Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK', 'orgStudyIdInfo': {'id': 'P084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'People with Vitiligo', 'description': 'Children and adults with new onset Vitiligo registered with OPCRD during the study period.', 'interventionNames': ['Other: No intervention']}, {'label': 'People without Vitiligo', 'description': 'Children and adults without Vitiligo registered with OPCRD during the study period', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational analysis of usual care only.', 'armGroupLabels': ['People with Vitiligo', 'People without Vitiligo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Momentum Data Limited', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Andrew McGovern, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Momentum Data'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.', 'ipdSharing': 'YES', 'description': 'Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.', 'accessCriteria': 'As above.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Momentum Data', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}