- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03359122
Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients (MARU)
Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients-Retrospective Observational Cohort Study
연구 개요
상태
상세 설명
Objectives: The primary objective of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.
Study design: This study is a retrospective database analysis using 2014-2016 Guangzhou City health insurance database.
Data Source(s): Guangzhou city health insurance database will be used for this study. All outpatient and inpatient visits for one patient during 2014-2016 were available.
Study Population: This study will include patients with a physician COPD diagnosis in Guangzhou city health insurance database during 2015 and with complete treatment data during 1 year before and 1 year after the index date. The rough sample size of the study population was 49,000.
Outcome(s):
- Indicators of COPD control: exacerbations;
- Health resource utilization: annual number of inpatient days, inpatient visit number, emergency department (ED) visit number;
- Costs: COPD exacerbation hospitalization expenditures, all-cause hospitalization expenditure.
Statistical Analysis:
Descriptive statistics will be used for all variables, as appropriate. Continuous variables will be summarized by the number of observations, mean, standard deviation, median, minimum, maximum, first quartile and third quartile. Categorical variables will be summarized by frequency counts and percentages at each category. Number of patients and number of missing for each variable will be summarized.
Logistic regression will be used to estimate the risk of any hospitalization. Generalized Linear Models (GLMs) with a gamma distribution and log link will be used to approximate the highly right-skewed distribution of medical expenditure.
For exploratory objectives, Propensity Score Matching (PSM) will be used to explore the association of medication class and health resource utilization if applicable. The interaction of medication class * adherence or subgroup analysis (by medication class) will be considered when conducting the regression model.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Beijing, 중국, 100000
- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients diagnosed with COPD in 2015;
- Patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up;
- Patients had at least one COPD exacerbation during 1 year prior to the index date;
- Patients had at least 2 COPD maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence.
Exclusion Criteria:
- Inability to determine diagnoses from claims;
- Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Indicators of COPD control
기간: 2015.01-2016.12
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Number of exacerbations
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2015.01-2016.12
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Health resource utilization
기간: 2015.01-2016.12
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Annual number of inpatient days
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2015.01-2016.12
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Costs of inpatient treatment
기간: 2015.01-2016.12
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Cost of COPD exacerbation inpatient treatment
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2015.01-2016.12
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Health resource utilization
기간: 2015.01-2016.12
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Inpatient visit number
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2015.01-2016.12
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Health resource utilization
기간: 2015.01-2016.12
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Emergency department (ED) visit number
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2015.01-2016.12
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Costs of inpatient treatment
기간: 2015.01-2016.12
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Cost of all-cause inpatient treatment
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2015.01-2016.12
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- D2287R00123
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
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