Replication of the POET-COPD Trial in Healthcare Claims Data

NCT ID: NCT05083429

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8716 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2021-08-09

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Salmeterol inhaler

Reference group

Salmeterol

Intervention Type: DRUG

Salmeterol inhaler dispensing claim is used as the reference

Tiotropium

Exposure group

Tiotropium

Intervention Type: DRUG

Tiotropium dispensing claim is used as the reference

Interventions

Salmeterol

Salmeterol inhaler dispensing claim is used as the reference

Intervention Type: DRUG

Tiotropium

Tiotropium dispensing claim is used as the reference

Intervention Type: DRUG

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]

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shirley Vichy Wang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Wang, PhD, ScM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018P002966-DUP-POET-COPD

Identifier Type: -

Identifier Source: org_study_id