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Development and psychometric validation of a barrier assessment tool for adherence to prescribed medication regimens
Anit Kumar Sinha1, Pandey Pratima1, Pooja Arora1
1Department of Pharmacy Practice and Clinical Research, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali), India.
Background:
Coronary artery disease (CAD) is a leading cause of morbidity and mortality worldwide, affecting approximately 197 million people and causing over 9 million deaths annually. Although percutaneous coronary intervention (PCI) improves survival, medication non-adherence affects more than one-quarter of patients after myocardial infarction. Validated instruments assessing multidimensional adherence barriers in post-PCI patients remain limited. This study developed and validated the Post-PCI Barrier Scale for Adherence to Prescribed Medication Regimens (PCI-BSAR).
Methods:
A methodological cross-sectional study was conducted in a tertiary care cardiology outpatient department. Questionnaire items were generated through literature review, patient interviews, and the WHO multidimensional adherence framework. Content validity, pilot testing (n = 50), exploratory factor analysis, reliability testing, and measurement model assessment were performed in 253 post-PCI patients.
Results:
The final 23-item PCI-BSAR demonstrated excellent content validity (S-CVI/Ave = 0.92). Exploratory factor analysis identified four domains: patient- and clinical-related, treatment and healthcare interaction-related, socioeconomic, and healthcare access and system-related barriers, explaining 69.6% of the variance. The questionnaire showed high internal consistency (Cronbach's α = 0.909), composite reliability (0.848-0.938), AVE >0.50, and HTMT <0.85.
Conclusion:
PCI-BSAR is a reliable and valid instrument for identifying multidimensional medication adherence barriers in post-PCI patients and may support individualized adherence assessment during routine outpatient follow-up.