Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-29 @ 2:34 AM
Study NCT ID:
NCT05127304
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2021-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'C549647', 'term': 'olodaterol'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study.', 'description': 'As this is a non-interventional study with secondary use of data from commercial and Medicare Advantage Part D (MAPD) beneficiaries, safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".', 'eventGroups': [{'id': 'EG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause Health Care Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Ambulatory visits', 'categories': [{'measurements': [{'value': '32.54', 'groupId': 'OG000', 'lowerLimit': '31.44', 'upperLimit': '33.64'}, {'value': '32.91', 'groupId': 'OG001', 'lowerLimit': '31.84', 'upperLimit': '33.97'}]}]}, {'title': 'Office visits', 'categories': [{'measurements': [{'value': '17.80', 'groupId': 'OG000', 'lowerLimit': '17.25', 'upperLimit': '18.35'}, {'value': '17.57', 'groupId': 'OG001', 'lowerLimit': '17.08', 'upperLimit': '18.06'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '14.82', 'groupId': 'OG000', 'lowerLimit': '13.95', 'upperLimit': '15.69'}, {'value': '15.42', 'groupId': 'OG001', 'lowerLimit': '14.55', 'upperLimit': '16.28'}]}]}, {'title': 'Emergency room visits', 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '1.35'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.50'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.48'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.52'}]}]}, {'title': 'Other medical visits', 'categories': [{'measurements': [{'value': '10.09', 'groupId': 'OG000', 'lowerLimit': '9.69', 'upperLimit': '10.49'}, {'value': '10.48', 'groupId': 'OG001', 'lowerLimit': '10.07', 'upperLimit': '10.89'}]}]}], 'analyses': [{'pValue': '0.639', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.535', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.337', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.176', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care resource utilization. Annualized population averages of visits for each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.) Annualized population averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'visits/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'All-cause Health Care Resource Utilization: Inpatient Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.30', 'groupId': 'OG000', 'lowerLimit': '3.80', 'upperLimit': '4.79'}, {'value': '4.68', 'groupId': 'OG001', 'lowerLimit': '4.12', 'upperLimit': '5.24'}]}]}], 'analyses': [{'pValue': '0.313', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care resource utilization: Inpatient days. Annualized population averages of inpatient days is reported.\n\nAnnualized population averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'inpatient days/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'All-cause Health Care Resource Utilization: Pharmacy Fills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.39', 'groupId': 'OG000', 'lowerLimit': '58.05', 'upperLimit': '60.73'}, {'value': '57.13', 'groupId': 'OG001', 'lowerLimit': '55.75', 'upperLimit': '58.52'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care resource utilization: Pharmacy fills. Annualized population averages for pharmacy fills is reported.\n\nAnnualized population averages of pharmacy fills were calculated as:(\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'pharmacy fills/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD-related Health Care Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Ambulatory visits', 'categories': [{'measurements': [{'value': '8.77', 'groupId': 'OG000', 'lowerLimit': '8.30', 'upperLimit': '9.23'}, {'value': '9.56', 'groupId': 'OG001', 'lowerLimit': '9.05', 'upperLimit': '10.08'}]}]}, {'title': 'Office visits', 'categories': [{'measurements': [{'value': '3.92', 'groupId': 'OG000', 'lowerLimit': '3.80', 'upperLimit': '4.05'}, {'value': '4.07', 'groupId': 'OG001', 'lowerLimit': '3.93', 'upperLimit': '4.20'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '4.85', 'groupId': 'OG000', 'lowerLimit': '4.42', 'upperLimit': '5.28'}, {'value': '5.51', 'groupId': 'OG001', 'lowerLimit': '5.03', 'upperLimit': '5.98'}]}]}, {'title': 'Emergency room visits', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '0.71'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '0.71'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.36', 'upperLimit': '0.42'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.48'}]}]}, {'title': 'Other medical visits', 'categories': [{'measurements': [{'value': '4.28', 'groupId': 'OG000', 'lowerLimit': '4.04', 'upperLimit': '4.53'}, {'value': '4.87', 'groupId': 'OG001', 'lowerLimit': '4.61', 'upperLimit': '5.13'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.124', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.990', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages of visits for each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.).\n\nAnnualized population averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'visits/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD-related Health Care Resource Utilization: Inpatient Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000', 'lowerLimit': '3.43', 'upperLimit': '4.38'}, {'value': '4.42', 'groupId': 'OG001', 'lowerLimit': '3.87', 'upperLimit': '4.97'}]}]}], 'analyses': [{'pValue': '0.163', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization: Inpatient days. Population annualized averages of inpatient days is reported.\n\nAnnualized population averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'inpatient days/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD-related Health Care Resource Utilization: Pharmacy Fills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.48', 'groupId': 'OG000', 'lowerLimit': '15.20', 'upperLimit': '15.77'}, {'value': '15.08', 'groupId': 'OG001', 'lowerLimit': '14.82', 'upperLimit': '15.35'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages for pharmacy fills is reported.\n\nAnnualized population averages of pharmacy fills were calculated as: (\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'pharmacy fills/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD and/or Pneumonia-related Health Care Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Ambulatory visits', 'categories': [{'measurements': [{'value': '9.01', 'groupId': 'OG000', 'lowerLimit': '8.54', 'upperLimit': '9.48'}, {'value': '9.85', 'groupId': 'OG001', 'lowerLimit': '9.33', 'upperLimit': '10.37'}]}]}, {'title': 'Office visits', 'categories': [{'measurements': [{'value': '4.04', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '4.16'}, {'value': '4.19', 'groupId': 'OG001', 'lowerLimit': '4.06', 'upperLimit': '4.33'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '4.98', 'groupId': 'OG000', 'lowerLimit': '4.55', 'upperLimit': '5.42'}, {'value': '5.67', 'groupId': 'OG001', 'lowerLimit': '5.19', 'upperLimit': '6.15'}]}]}, {'title': 'Emergency room visits', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.76'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.76'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '0.43'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.49'}]}]}, {'title': 'Other medical visits', 'categories': [{'measurements': [{'value': '4.36', 'groupId': 'OG000', 'lowerLimit': '4.11', 'upperLimit': '4.61'}, {'value': '4.94', 'groupId': 'OG001', 'lowerLimit': '4.68', 'upperLimit': '5.20'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.894', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics).\n\nPopulation annualized averages of visits in each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (independent laboratory, home health, durable medical equipment, etc.)\n\nPopulation annualized averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'visits/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.97', 'groupId': 'OG000', 'lowerLimit': '3.49', 'upperLimit': '4.45'}, {'value': '4.49', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '5.05'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics).\n\nPopulation annualized averages of inpatient days is reported.\n\nPopulation annualized averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'inpatient days/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.48', 'groupId': 'OG000', 'lowerLimit': '15.20', 'upperLimit': '15.77'}, {'value': '15.08', 'groupId': 'OG001', 'lowerLimit': '14.82', 'upperLimit': '15.35'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics).\n\nPopulation annualized averages of pharmacy fills is reported.\n\nPopulation annualized averages of pharmacy fills were calculated as: (\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'pharmacy fills/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'Pneumonia-related Health Care Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Ambulatory visits', 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.59'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '0.81'}]}]}, {'title': 'Office visits', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.18'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.46'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.64'}]}]}, {'title': 'Emergency room visits', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.11'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.13'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.13'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.17'}]}]}, {'title': 'Other medical visits', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.16'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.16'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.102', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.189', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.767', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position.\n\nPopulation annualized averages of visits in each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (independent laboratory, home health, durable medical equipment, etc.)\n\nPopulation annualized averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'visits/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'Pneumonia-related Health Care Resource Utilization: Inpatient Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '2.08'}, {'value': '1.98', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '2.40'}]}]}], 'analyses': [{'pValue': '0.357', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position.\n\nPopulation annualized averages of inpatient days is reported.\n\nPopulation annualized averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'inpatient days/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD or Pneumonia-attributable Health Care Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Ambulatory visits', 'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000', 'lowerLimit': '3.94', 'upperLimit': '4.46'}, {'value': '4.90', 'groupId': 'OG001', 'lowerLimit': '4.55', 'upperLimit': '5.25'}]}]}, {'title': 'Office visits', 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.17'}, {'value': '2.14', 'groupId': 'OG001', 'lowerLimit': '2.05', 'upperLimit': '2.23'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '2.35'}, {'value': '2.77', 'groupId': 'OG001', 'lowerLimit': '2.44', 'upperLimit': '3.10'}]}]}, {'title': 'Emergency room visits', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.32'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.30'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.26'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.28'}]}]}, {'title': 'Other medical visits', 'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '4.05'}, {'value': '4.27', 'groupId': 'OG001', 'lowerLimit': '4.03', 'upperLimit': '4.51'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.420', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.304', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.326', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical visits', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nPopulation annualized averages of visits in each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (independent laboratory, home health, durable medical equipment, etc.)\n\nPopulation annualized averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'visits/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '3.31'}, {'value': '3.08', 'groupId': 'OG001', 'lowerLimit': '2.59', 'upperLimit': '3.58'}]}]}], 'analyses': [{'pValue': '0.520', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nPopulation annualized averages of inpatient days is reported.\n\nPopulation annualized averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'inpatient days/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.48', 'groupId': 'OG000', 'lowerLimit': '15.20', 'upperLimit': '15.77'}, {'value': '15.08', 'groupId': 'OG001', 'lowerLimit': '14.82', 'upperLimit': '15.35'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nAnnualized population averages for pharmacy claims are calculated as the (\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]). Wald 95% confidence limits for this ratio used the Taylor expansion to estimate the standard error.', 'unitOfMeasure': 'pharmacy fills/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'All-cause Health Care Costs (Insurer + Patient Paid Amounts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Medical costs', 'categories': [{'measurements': [{'value': '16911.48', 'groupId': 'OG000', 'lowerLimit': '15847.98', 'upperLimit': '17974.99'}, {'value': '18471.61', 'groupId': 'OG001', 'lowerLimit': '17239.50', 'upperLimit': '19703.71'}]}]}, {'title': 'Ambulatory costs', 'categories': [{'measurements': [{'value': '7321.14', 'groupId': 'OG000', 'lowerLimit': '6778.92', 'upperLimit': '7863.36'}, {'value': '7858.06', 'groupId': 'OG001', 'lowerLimit': '7294.85', 'upperLimit': '8421.27'}]}]}, {'title': 'Office visits costs', 'categories': [{'measurements': [{'value': '2986.46', 'groupId': 'OG000', 'lowerLimit': '2689.18', 'upperLimit': '3283.74'}, {'value': '3030.56', 'groupId': 'OG001', 'lowerLimit': '2747.15', 'upperLimit': '3313.97'}]}]}, {'title': 'Outpatient visits costs', 'categories': [{'measurements': [{'value': '4334.68', 'groupId': 'OG000', 'lowerLimit': '3904.48', 'upperLimit': '4764.88'}, {'value': '4827.50', 'groupId': 'OG001', 'lowerLimit': '4373.94', 'upperLimit': '5281.07'}]}]}, {'title': 'Emergency room visits costs', 'categories': [{'measurements': [{'value': '991.35', 'groupId': 'OG000', 'lowerLimit': '905.13', 'upperLimit': '1077.57'}, {'value': '1086.48', 'groupId': 'OG001', 'lowerLimit': '985.78', 'upperLimit': '1187.18'}]}]}, {'title': 'Inpatient stay costs', 'categories': [{'measurements': [{'value': '7480.17', 'groupId': 'OG000', 'lowerLimit': '6676.49', 'upperLimit': '8283.85'}, {'value': '8139.51', 'groupId': 'OG001', 'lowerLimit': '7219.72', 'upperLimit': '9059.31'}]}]}, {'title': 'Other medical costs', 'categories': [{'measurements': [{'value': '1118.83', 'groupId': 'OG000', 'lowerLimit': '1030.70', 'upperLimit': '1206.95'}, {'value': '1387.55', 'groupId': 'OG001', 'lowerLimit': '1127.10', 'upperLimit': '1648.01'}]}]}, {'title': 'Pharmacy costs', 'categories': [{'measurements': [{'value': '10192.10', 'groupId': 'OG000', 'lowerLimit': '9694.69', 'upperLimit': '10689.50'}, {'value': '11963.02', 'groupId': 'OG001', 'lowerLimit': '11348.38', 'upperLimit': '12577.66'}]}]}, {'title': 'Total (medical + pharmacy) costs', 'categories': [{'measurements': [{'value': '27103.58', 'groupId': 'OG000', 'lowerLimit': '25871.20', 'upperLimit': '28335.96'}, {'value': '30434.63', 'groupId': 'OG001', 'lowerLimit': '29019.36', 'upperLimit': '31849.89'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.834', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.121', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.159', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient stay costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pharmacy costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total (medical + pharmacy) costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care costs were computed from the payer and patient perspective together.\n\nAnnualized population averages of all-cause health care costs in each of the following categories is reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages of costs were calculated as: (\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the date of the claim and 2020.', 'unitOfMeasure': 'dollars/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD-related Health Care Costs (Insurer + Patient Paid Amounts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Medical costs', 'categories': [{'measurements': [{'value': '9635.45', 'groupId': 'OG000', 'lowerLimit': '8796.38', 'upperLimit': '10474.52'}, {'value': '10820.05', 'groupId': 'OG001', 'lowerLimit': '9863.73', 'upperLimit': '11776.36'}]}]}, {'title': 'Ambulatory costs', 'categories': [{'measurements': [{'value': '2088.43', 'groupId': 'OG000', 'lowerLimit': '1865.20', 'upperLimit': '2311.66'}, {'value': '2278.21', 'groupId': 'OG001', 'lowerLimit': '2098.69', 'upperLimit': '2457.72'}]}]}, {'title': 'Office visits costs', 'categories': [{'measurements': [{'value': '468.94', 'groupId': 'OG000', 'lowerLimit': '449.67', 'upperLimit': '488.21'}, {'value': '493.42', 'groupId': 'OG001', 'lowerLimit': '469.73', 'upperLimit': '517.12'}]}]}, {'title': 'Outpatient visits costs', 'categories': [{'measurements': [{'value': '1619.49', 'groupId': 'OG000', 'lowerLimit': '1398.51', 'upperLimit': '1840.48'}, {'value': '1784.78', 'groupId': 'OG001', 'lowerLimit': '1608.97', 'upperLimit': '1960.60'}]}]}, {'title': 'Emergency room visits costs', 'categories': [{'measurements': [{'value': '426.02', 'groupId': 'OG000', 'lowerLimit': '377.61', 'upperLimit': '474.42'}, {'value': '455.87', 'groupId': 'OG001', 'lowerLimit': '398.69', 'upperLimit': '513.05'}]}]}, {'title': 'Inpatient stay costs', 'categories': [{'measurements': [{'value': '6681.35', 'groupId': 'OG000', 'lowerLimit': '5910.54', 'upperLimit': '7452.17'}, {'value': '7596.04', 'groupId': 'OG001', 'lowerLimit': '6700.88', 'upperLimit': '8491.21'}]}]}, {'title': 'Other medical costs', 'categories': [{'measurements': [{'value': '439.65', 'groupId': 'OG000', 'lowerLimit': '400.07', 'upperLimit': '479.23'}, {'value': '489.92', 'groupId': 'OG001', 'lowerLimit': '416.29', 'upperLimit': '563.56'}]}]}, {'title': 'Pharmacy costs', 'categories': [{'measurements': [{'value': '4729.11', 'groupId': 'OG000', 'lowerLimit': '4675.71', 'upperLimit': '4782.50'}, {'value': '6567.16', 'groupId': 'OG001', 'lowerLimit': '6502.52', 'upperLimit': '6631.79'}]}]}, {'title': 'Total (medical + pharmacy) costs', 'categories': [{'measurements': [{'value': '14364.56', 'groupId': 'OG000', 'lowerLimit': '13521.68', 'upperLimit': '15207.44'}, {'value': '17387.20', 'groupId': 'OG001', 'lowerLimit': '16425.26', 'upperLimit': '18349.15'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.250', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.431', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient stay costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.236', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pharmacy costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total (medical + pharmacy) costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD-related health care costs (HCC) cover the costs for medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of COPD-related HCC for the categories below are reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages of costs = (\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts are adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.', 'unitOfMeasure': 'dollars/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Medical costs', 'categories': [{'measurements': [{'value': '9828.60', 'groupId': 'OG000', 'lowerLimit': '8983.51', 'upperLimit': '10673.68'}, {'value': '11065.38', 'groupId': 'OG001', 'lowerLimit': '10099.14', 'upperLimit': '12031.62'}]}]}, {'title': 'Ambulatory costs', 'categories': [{'measurements': [{'value': '2121.76', 'groupId': 'OG000', 'lowerLimit': '1897.95', 'upperLimit': '2345.56'}, {'value': '2316.77', 'groupId': 'OG001', 'lowerLimit': '2136.31', 'upperLimit': '2497.23'}]}]}, {'title': 'Office visits costs', 'categories': [{'measurements': [{'value': '481.16', 'groupId': 'OG000', 'lowerLimit': '461.70', 'upperLimit': '500.62'}, {'value': '508.60', 'groupId': 'OG001', 'lowerLimit': '484.54', 'upperLimit': '532.65'}]}]}, {'title': 'Outpatient visits costs', 'categories': [{'measurements': [{'value': '1640.60', 'groupId': 'OG000', 'lowerLimit': '1419.10', 'upperLimit': '1862.09'}, {'value': '1808.18', 'groupId': 'OG001', 'lowerLimit': '1631.62', 'upperLimit': '1984.73'}]}]}, {'title': 'Emergency room visits costs', 'categories': [{'measurements': [{'value': '448.83', 'groupId': 'OG000', 'lowerLimit': '399.54', 'upperLimit': '498.12'}, {'value': '482.53', 'groupId': 'OG001', 'lowerLimit': '423.81', 'upperLimit': '541.26'}]}]}, {'title': 'Inpatient stay costs', 'categories': [{'measurements': [{'value': '6811.63', 'groupId': 'OG000', 'lowerLimit': '6036.18', 'upperLimit': '7587.08'}, {'value': '7769.37', 'groupId': 'OG001', 'lowerLimit': '6865.53', 'upperLimit': '8673.21'}]}]}, {'title': 'Other medical costs', 'categories': [{'measurements': [{'value': '446.38', 'groupId': 'OG000', 'lowerLimit': '406.50', 'upperLimit': '486.26'}, {'value': '496.70', 'groupId': 'OG001', 'lowerLimit': '422.80', 'upperLimit': '570.60'}]}]}, {'title': 'Pharmacy costs', 'categories': [{'measurements': [{'value': '4729.11', 'groupId': 'OG000', 'lowerLimit': '4675.71', 'upperLimit': '4782.50'}, {'value': '6567.16', 'groupId': 'OG001', 'lowerLimit': '6502.52', 'upperLimit': '6631.79'}]}]}, {'title': 'Total (medical + pharmacy) costs', 'categories': [{'measurements': [{'value': '14557.70', 'groupId': 'OG000', 'lowerLimit': '13708.73', 'upperLimit': '15406.67'}, {'value': '17632.54', 'groupId': 'OG001', 'lowerLimit': '16660.65', 'upperLimit': '18604.43'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.182', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.386', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.115', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient stay costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.237', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pharmacy costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total (medical + pharmacy) costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nAnnualized population averages of costs for categories below is reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages=(\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.', 'unitOfMeasure': 'dollars/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Medical costs', 'categories': [{'measurements': [{'value': '2857.23', 'groupId': 'OG000', 'lowerLimit': '2293.89', 'upperLimit': '3420.58'}, {'value': '3466.72', 'groupId': 'OG001', 'lowerLimit': '2751.82', 'upperLimit': '4181.63'}]}]}, {'title': 'Ambulatory costs', 'categories': [{'measurements': [{'value': '80.62', 'groupId': 'OG000', 'lowerLimit': '55.70', 'upperLimit': '105.55'}, {'value': '98.19', 'groupId': 'OG001', 'lowerLimit': '74.68', 'upperLimit': '121.69'}]}]}, {'title': 'Office visits costs', 'categories': [{'measurements': [{'value': '15.03', 'groupId': 'OG000', 'lowerLimit': '11.95', 'upperLimit': '18.12'}, {'value': '18.03', 'groupId': 'OG001', 'lowerLimit': '14.56', 'upperLimit': '21.50'}]}]}, {'title': 'Outpatient visits costs', 'categories': [{'measurements': [{'value': '65.59', 'groupId': 'OG000', 'lowerLimit': '42.03', 'upperLimit': '89.14'}, {'value': '80.16', 'groupId': 'OG001', 'lowerLimit': '57.88', 'upperLimit': '102.44'}]}]}, {'title': 'Emergency room visits costs', 'categories': [{'measurements': [{'value': '48.91', 'groupId': 'OG000', 'lowerLimit': '34.33', 'upperLimit': '63.50'}, {'value': '51.33', 'groupId': 'OG001', 'lowerLimit': '37.30', 'upperLimit': '65.37'}]}]}, {'title': 'Inpatient stay costs', 'categories': [{'measurements': [{'value': '2714.94', 'groupId': 'OG000', 'lowerLimit': '2156.01', 'upperLimit': '3273.86'}, {'value': '3297.65', 'groupId': 'OG001', 'lowerLimit': '2588.62', 'upperLimit': '4006.67'}]}]}, {'title': 'Other medical costs', 'categories': [{'measurements': [{'value': '12.77', 'groupId': 'OG000', 'lowerLimit': '3.60', 'upperLimit': '21.93'}, {'value': '19.56', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '40.21'}]}]}, {'title': 'Total (medical + pharmacy) costs', 'categories': [{'measurements': [{'value': '2857.23', 'groupId': 'OG000', 'lowerLimit': '2293.89', 'upperLimit': '3420.58'}, {'value': '3466.72', 'groupId': 'OG001', 'lowerLimit': '2751.82', 'upperLimit': '4181.63'}]}]}], 'analyses': [{'pValue': '0.189', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.203', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.379', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.815', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient stay costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.556', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.189', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total (medical + pharmacy) costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'These costs were calculated for medical claims with a diagnosis for pneumonia in any position.\n\nAnnualized population averages of pneumonia-related health care costs for the categories below is reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages=(\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.', 'unitOfMeasure': 'dollars/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Medical costs', 'categories': [{'measurements': [{'value': '5630.81', 'groupId': 'OG000', 'lowerLimit': '4935.27', 'upperLimit': '6326.35'}, {'value': '6006.47', 'groupId': 'OG001', 'lowerLimit': '5207.40', 'upperLimit': '6805.54'}]}]}, {'title': 'Ambulatory costs', 'categories': [{'measurements': [{'value': '517.27', 'groupId': 'OG000', 'lowerLimit': '476.44', 'upperLimit': '558.11'}, {'value': '623.53', 'groupId': 'OG001', 'lowerLimit': '571.43', 'upperLimit': '675.62'}]}]}, {'title': 'Office visits costs', 'categories': [{'measurements': [{'value': '231.09', 'groupId': 'OG000', 'lowerLimit': '220.79', 'upperLimit': '241.39'}, {'value': '242.99', 'groupId': 'OG001', 'lowerLimit': '231.84', 'upperLimit': '254.15'}]}]}, {'title': 'Outpatient visits costs', 'categories': [{'measurements': [{'value': '286.18', 'groupId': 'OG000', 'lowerLimit': '247.81', 'upperLimit': '324.55'}, {'value': '380.53', 'groupId': 'OG001', 'lowerLimit': '330.93', 'upperLimit': '430.14'}]}]}, {'title': 'Emergency room visits costs', 'categories': [{'measurements': [{'value': '153.87', 'groupId': 'OG000', 'lowerLimit': '128.27', 'upperLimit': '179.47'}, {'value': '130.00', 'groupId': 'OG001', 'lowerLimit': '107.47', 'upperLimit': '152.53'}]}]}, {'title': 'Inpatient stay costs', 'categories': [{'measurements': [{'value': '4595.72', 'groupId': 'OG000', 'lowerLimit': '3912.28', 'upperLimit': '5279.16'}, {'value': '4885.72', 'groupId': 'OG001', 'lowerLimit': '4099.84', 'upperLimit': '5671.61'}]}]}, {'title': 'Other medical costs', 'categories': [{'measurements': [{'value': '363.95', 'groupId': 'OG000', 'lowerLimit': '332.48', 'upperLimit': '395.42'}, {'value': '367.22', 'groupId': 'OG001', 'lowerLimit': '333.81', 'upperLimit': '400.62'}]}]}, {'title': 'Pharmacy costs', 'categories': [{'measurements': [{'value': '4729.11', 'groupId': 'OG000', 'lowerLimit': '4675.71', 'upperLimit': '4782.50'}, {'value': '6567.16', 'groupId': 'OG001', 'lowerLimit': '6502.52', 'upperLimit': '6631.79'}]}]}, {'title': 'Total (medical + pharmacy) costs', 'categories': [{'measurements': [{'value': '10359.92', 'groupId': 'OG000', 'lowerLimit': '9659.97', 'upperLimit': '11059.86'}, {'value': '12573.62', 'groupId': 'OG001', 'lowerLimit': '11768.74', 'upperLimit': '13378.51'}]}]}], 'analyses': [{'pValue': '0.483', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ambulatory costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.123', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Office visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.170', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Emergency room visits costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.582', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient stay costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.887', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Other medical costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pharmacy costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total (medical + pharmacy) costs', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position, or pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nAnnualized population averages are reported and were calculated as=(\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.', 'unitOfMeasure': 'dollars/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'PRIMARY', 'title': 'Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'OG000'}, {'value': '5658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'title': 'Any COPD exacerbation', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.08'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.03'}]}]}, {'title': 'Severe COPD exacerbation', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.30'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.29'}]}]}], 'analyses': [{'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Any COPD exacerbation', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.454', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Severe COPD exacerbation', 'statisticalMethod': 'Weighted clustered linear regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Annualized population averages of COPD exacerbations for the categories below are reported:\n\n* Any COPD exacerbation\n* Severe COPD exacerbation (defined as an inpatient admission or an emergency room (ER) visit with a COPD diagnosis code in the primary position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position and a COPD diagnosis code in any position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position + an inpatient admission or an ER visit within ±7 days with a COPD diagnosis code in any position).\n\nAnnualized population averages= (\\[sum of all exacerbations for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).', 'unitOfMeasure': 'exacerbations/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.04', 'groupId': 'OG000'}, {'value': '18.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Rao-Scott test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Percentage of patients with 30-day all-cause readmission after Chronic Obstructive Pulmonary Disease (COPD) hospitalization is reported.\n\nHospitalizations were classified as COPD-related if they met either of the following 2 criteria:\n\n* ≥1 diagnosis of COPD in the primary position any time during the acute inpatient stay; or\n* ≥1 diagnosis of acute respiratory failure in the primary position and a diagnosis of acute exacerbation of COPD in a later position on the same claim during an acute inpatient stay.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Matched Overall Population with a COPD hospitalization during the follow-up period. Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'FG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Overall post matched', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5658'}, {'groupId': 'FG001', 'numSubjects': '5658'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5658'}, {'groupId': 'FG001', 'numSubjects': '5658'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a non-interventional study using existing data from commercial and Medicare Advantage Part D (MAPD) beneficiaries, using administrative claims data for the period of 01 June 2015 through 30 November 2019.', 'preAssignmentDetails': 'Only subjects that met all inclusion and none of the exclusion criteria were included.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5658', 'groupId': 'BG000'}, {'value': '5658', 'groupId': 'BG001'}, {'value': '11316', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tiotropium Bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'BG001', 'title': 'Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.69', 'spread': '8.69', 'groupId': 'BG000'}, {'value': '71.75', 'spread': '8.61', 'groupId': 'BG001'}, {'value': '71.72', 'spread': '8.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2846', 'groupId': 'BG000'}, {'value': '2866', 'groupId': 'BG001'}, {'value': '5712', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2812', 'groupId': 'BG000'}, {'value': '2792', 'groupId': 'BG001'}, {'value': '5604', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic', 'measurements': [{'value': '311', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '592', 'groupId': 'BG002'}]}, {'title': 'Non- Hispanic Black', 'measurements': [{'value': '731', 'groupId': 'BG000'}, {'value': '740', 'groupId': 'BG001'}, {'value': '1471', 'groupId': 'BG002'}]}, {'title': 'Non- Hispanic White', 'measurements': [{'value': '4015', 'groupId': 'BG000'}, {'value': '3815', 'groupId': 'BG001'}, {'value': '7830', 'groupId': 'BG002'}]}, {'title': 'Non- Hispanic Asian', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Other/unknown', 'measurements': [{'value': '523', 'groupId': 'BG000'}, {'value': '760', 'groupId': 'BG001'}, {'value': '1283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-04', 'size': 1130189, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-13T07:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2021-11-12', 'resultsFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-30', 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Health Care Resource Utilization', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care resource utilization. Annualized population averages of visits for each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.) Annualized population averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'All-cause Health Care Resource Utilization: Inpatient Days', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care resource utilization: Inpatient days. Annualized population averages of inpatient days is reported.\n\nAnnualized population averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'All-cause Health Care Resource Utilization: Pharmacy Fills', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care resource utilization: Pharmacy fills. Annualized population averages for pharmacy fills is reported.\n\nAnnualized population averages of pharmacy fills were calculated as:(\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD-related Health Care Resource Utilization', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages of visits for each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.).\n\nAnnualized population averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD-related Health Care Resource Utilization: Inpatient Days', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization: Inpatient days. Population annualized averages of inpatient days is reported.\n\nAnnualized population averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD-related Health Care Resource Utilization: Pharmacy Fills', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages for pharmacy fills is reported.\n\nAnnualized population averages of pharmacy fills were calculated as: (\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD and/or Pneumonia-related Health Care Resource Utilization', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics).\n\nPopulation annualized averages of visits in each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (independent laboratory, home health, durable medical equipment, etc.)\n\nPopulation annualized averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics).\n\nPopulation annualized averages of inpatient days is reported.\n\nPopulation annualized averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics).\n\nPopulation annualized averages of pharmacy fills is reported.\n\nPopulation annualized averages of pharmacy fills were calculated as: (\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'Pneumonia-related Health Care Resource Utilization', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position.\n\nPopulation annualized averages of visits in each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (independent laboratory, home health, durable medical equipment, etc.)\n\nPopulation annualized averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'Pneumonia-related Health Care Resource Utilization: Inpatient Days', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position.\n\nPopulation annualized averages of inpatient days is reported.\n\nPopulation annualized averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD or Pneumonia-attributable Health Care Resource Utilization', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nPopulation annualized averages of visits in each of the following categories is reported:\n\n* Ambulatory visits\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient visits\n* Other medical visits (independent laboratory, home health, durable medical equipment, etc.)\n\nPopulation annualized averages of visits were calculated as: (\\[sum of all visits for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nPopulation annualized averages of inpatient days is reported.\n\nPopulation annualized averages of inpatient days were calculated as: (\\[sum of all inpatient days for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}, {'measure': 'COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nAnnualized population averages for pharmacy claims are calculated as the (\\[sum of all pharmacy fills for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]). Wald 95% confidence limits for this ratio used the Taylor expansion to estimate the standard error.'}, {'measure': 'All-cause Health Care Costs (Insurer + Patient Paid Amounts)', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'All-cause health care costs were computed from the payer and patient perspective together.\n\nAnnualized population averages of all-cause health care costs in each of the following categories is reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages of costs were calculated as: (\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the date of the claim and 2020.'}, {'measure': 'COPD-related Health Care Costs (Insurer + Patient Paid Amounts)', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'COPD-related health care costs (HCC) cover the costs for medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of COPD-related HCC for the categories below are reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages of costs = (\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts are adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.'}, {'measure': 'COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nAnnualized population averages of costs for categories below is reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages=(\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.'}, {'measure': 'Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'These costs were calculated for medical claims with a diagnosis for pneumonia in any position.\n\nAnnualized population averages of pneumonia-related health care costs for the categories below is reported:\n\n* Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs)\n* Ambulatory\n* Office visits\n* Outpatient visits\n* Emergency room visits\n* Inpatient stay\n* Other medical costs\n* Pharmacy costs\n* Total (medical + pharmacy) costs. Annualized population averages=(\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.'}, {'measure': 'COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts)', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position, or pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics.\n\nAnnualized population averages are reported and were calculated as=(\\[sum of all costs for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).\n\nCosts were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.'}, {'measure': 'Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Annualized population averages of COPD exacerbations for the categories below are reported:\n\n* Any COPD exacerbation\n* Severe COPD exacerbation (defined as an inpatient admission or an emergency room (ER) visit with a COPD diagnosis code in the primary position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position and a COPD diagnosis code in any position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position + an inpatient admission or an ER visit within ±7 days with a COPD diagnosis code in any position).\n\nAnnualized population averages= (\\[sum of all exacerbations for all individuals during the follow-up period\\] / \\[sum of follow-up on-treatment time in years (365 days) for all individuals\\]).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization', 'timeFrame': 'Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).', 'description': 'Percentage of patients with 30-day all-cause readmission after Chronic Obstructive Pulmonary Disease (COPD) hospitalization is reported.\n\nHospitalizations were classified as COPD-related if they met either of the following 2 criteria:\n\n* ≥1 diagnosis of COPD in the primary position any time during the acute inpatient stay; or\n* ≥1 diagnosis of acute respiratory failure in the primary position and a diagnosis of acute exacerbation of COPD in a later position on the same claim during an acute inpatient stay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '37133429', 'type': 'DERIVED', 'citation': 'Sethi S, Palli SR, Bengtson LGS, Buysman EK, Clark B, Sargent A, Shaikh A, Ferguson GT. Clinical and economic outcomes in patients with chronic obstructive pulmonary disease initiating maintenance therapy with tiotropium bromide/olodaterol or fluticasone furoate/umeclidinium/vilanterol. J Manag Care Spec Pharm. 2023 Jul;29(7):791-806. doi: 10.18553/jmcp.2023.22373. Epub 2023 May 3.'}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The sample will include commercial and Medicare Advantage Part D (MAPD) health plan members diagnosed with COPD', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥30 consecutive days with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiated during the patient identification period of 01 June 2015 to 30 November 2019. The index date will be the date of the TIO/OLO or FF/UMEC/VI pharmacy claim that starts the ≥30 consecutive days with the medication.\n* \\>1 facility claim with a diagnosis of chronic obstructive lung disease (COPD) in the primary position or ≥2 professional claims with a diagnosis code for COPD in any position on separate dates of service during the study period\n* ≥40 years of age as of the year of the index date\n* Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period)\n* Continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol.\n\nExclusion Criteria:\n\n* ≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period\n* Pharmacy claims for both TIO/OLO and FF/UMEC/VI on the index date\n* A pharmacy claim for any non-index COPD maintenance medication on the index date, defined as: long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; fixed-dose combination (FDC) ICS/LABA, or FDC LAMA/LABA\n* Free or fixed dose LAMA+LABA maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a LAMA and LABA during a 6-month pre-index period, excluding the index date\n\n \\-- Flags will be created to identify patients excluded for baseline LAMA/LABA use overall and specifically for each FDC LAMA/LABA medication\n* Free or fixed dose triple therapy (TT) defined as ≥7 consecutive days of overlapping days' supply with an ICS, LABA, and LAMA during a 6-month pre-index period, excluding the index date\n* ≥1 medical claim with a procedure code for lung volume reduction during the study period\n* Unknown age, gender, or business line, or unknown/other geographic region"}, 'identificationModule': {'nctId': 'NCT05127304', 'briefTitle': 'A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Health Care Resource Utilization, Cost and Other Outcomes of Patients Diagnosed With COPD Initiating Tiotropium Bromide/Olodaterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol', 'orgStudyIdInfo': {'id': '1237-0113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tiotropium bromide/Olodaterol (TIO/OLO)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication.', 'interventionNames': ['Device: Stiolto Respimat', 'Drug: Tiotropium Bromide/Olodaterol']}, {'label': 'Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication.', 'interventionNames': ['Device: Trelegy Ellipta', 'Drug: Furoate/Umeclidinium/Vilanterol']}], 'interventions': [{'name': 'Trelegy Ellipta', 'type': 'DEVICE', 'description': 'Trelegy Ellipta with Furoate/Umeclidinium/Vilanterol', 'armGroupLabels': ['Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)']}, {'name': 'Stiolto Respimat', 'type': 'DEVICE', 'description': 'Stiolto Respimat with Tiotropium Bromide/Olodaterol', 'armGroupLabels': ['Tiotropium bromide/Olodaterol (TIO/OLO)']}, {'name': 'Furoate/Umeclidinium/Vilanterol', 'type': 'DRUG', 'description': 'Furoate/Umeclidinium/Vilanterol', 'armGroupLabels': ['Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)']}, {'name': 'Tiotropium Bromide/Olodaterol', 'type': 'DRUG', 'description': 'Tiotropium Bromide/Olodaterol', 'armGroupLabels': ['Tiotropium bromide/Olodaterol (TIO/OLO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Optum', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}