A CROSS-SECTIONAL, HYBRID, PATIENT SURVEY AND CHART REVIEW STUDY DESIGN TO ASSESS PATTERNS OF CARE, PATIENT REPORTED OUTCOMES, AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Author(s)
Desrosiers MP*1;Payne KA1;Boulanger L2;Lordan N2;Alas V2;Zhang J3, Massaro SM3 1United BioSource Corporation, Dorval, QC, Canada, 2United BioSource Corporation, Lexington, MA, USA, 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
OBJECTIVES: To describe the design and execution of a hybrid, cross-sectional study of COPD patients, highlighting important strengths, weaknesses, and general considerations for use in burden of illness and health economic analyses.
METHODS: A cross-sectional, observational study of 407 COPD patients was conducted in 3 centers in the southeastern region of the U.S. This hybrid study combined a cross-sectional patient survey and retrospective chart review. All patients diagnosed with COPD managed by a primary care physician (PCP) or pulmonologist who had their most recent visit within the eligibility period were invited to complete a baseline survey; chart data was abstracted by site medical staff for all patients who consented and completed the survey. Each clinic enrolled patients in 2 cohorts: COPD patients managed primarily by a PCP (N=152; male: 49.3 %; mean age: 70.9 ± 9.5 years) veersus pulmonologist (N=255; male: 50.6%; mean age: 71.2 ± 8.9 years). Anonymized patient data was recorded in a secure web-based database: demographics, clinical characteristics, COPD exacerbations and severity, resource utilization, treatment, symptoms, daily functioning, and quality of life. Key design challenges related primarily to patient recruitment: identifying a PCP versus pulmonologist for patient subgroup assignment; identification of COPD patients through comprehensive medical chart review; mitigation of selection bias for severe COPD cases that are more likely to visit an HCP for COPD-related reasons only; missing medical chart data; and temporality and causality associated with study outcomes. RESULTS: The key operational challenges were maximizing survey response rates and completeness of chart review with limited possibility of follow-up. CONCLUSIONS: Cross-sectional design is an efficient method of collecting data in COPD patients that could be used for health services research. However, it is associated with design and operational challenges that can be anticipated and mitigated early in study planning and conceptualization.
Conference/Value in Health Info
2013-05, ISPOR 2013, New Orleans, LA, USA
Value in Health, Vol. 16, No. 3 (May 2013)
Code
PRS46
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Respiratory-Related Disorders