Clinical trial NCT05083429: Replication of the POET-COPD Trial in Healthcare Claims Data
Official title: Replication of the POET-COPD Trial in Healthcare Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 8716
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive pulmonary disease (COPD)

Brief summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Detailed description: This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility criteria: Inclusion Criteria:

* Age greater or equal than 40: days \[0,0\]
* Diagnosis of COPD: days \[-All Data, 0\]
* History of at least 1 COPD exacerbation within the past year requiring treatment with antibiotics and/or systemic steroids and/or requiring hospitalization: days \[-365, -28\]

Exclusion Criteria:

* Patients with 3 diagnosis of asthma: days \[-180, 0\]
* Patients with current severe cardiovascular disorders (Heart Transplantation, LVAD/Implantable heart, Pulmonary hypertension/other pulmonary disease) and use of systemic corticosteroid medication at unstable doses: days \[-365, 0\]
* Patients with any respiratory infection (Acute respiratory infections, pneumonia and influenza) or COPD exacerbation: days \[-28, 0\]
* Exclude use of salmeterol or tiotropium containing inhaler use \[-180, 0\]

Primary outcomes:
measure: Time to first COPD exacerbation
timeFrame: [Time Frame: To censoring or study completion, up to 365 days]
Secondary outcomes:
measure: All-cause death
timeFrame: [Time Frame: To censoring or study completion, up to 365 days]
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shirley Wang, PhD, ScM
role: PRINCIPAL_INVESTIGATOR
References: