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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100000
- Research Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Indicators of COPD control
Délai: 2015.01-2016.12
|
Number of exacerbations
|
2015.01-2016.12
|
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Health resource utilization
Délai: 2015.01-2016.12
|
Annual number of inpatient days
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2015.01-2016.12
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Costs of inpatient treatment
Délai: 2015.01-2016.12
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Cost of COPD exacerbation inpatient treatment
|
2015.01-2016.12
|
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Health resource utilization
Délai: 2015.01-2016.12
|
Inpatient visit number
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2015.01-2016.12
|
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Health resource utilization
Délai: 2015.01-2016.12
|
Emergency department (ED) visit number
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2015.01-2016.12
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Costs of inpatient treatment
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D2287R00123
Informations sur les médicaments et les dispositifs, documents d'étude
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