Approaches to Optimize Medication Data Analysis in Clinical Cohort Studies.

Abstract

Methods for pharmacoepidemiologic studies of large-scale data repositories are established. Although clinical cohorts of older adults often contain critical information to advance our understanding of medication risk and benefit, the methods best suited to manage medication data in these samples are sometimes unclear and their degree of validation unknown. We sought to provide researchers, in the context of a clinical cohort study of delirium in older adults, with guidance on the methodological tools to use data from clinical cohorts to better understand medication risk factors and outcomes. Prospective cohort study. The Successful Aging After Elective Surgery (SAGES) prospective cohort. A total of 560 older adults (aged ≥70 years) without dementia undergoing elective major surgery. Using the SAGES clinical cohort, methods used to characterize medications were identified, reviewed, analyzed, and distinguished by appropriateness and degree of validation for characterizing pharmacoepidemiologic data in smaller clinical data sets. Medication coding is essential; the American Hospital Formulary System, most often used in the United States, is not preferred over others. Use of equivalent dosing scales (e.g., morphine equivalents) for a single medication class (e.g., opioids) is preferred over multiclass analgesic equivalency scales. Medication aggregation from the same class (e.g., benzodiazepines) is well established; the optimal prevalence breakout for aggregation remains unclear. Validated scale(s) to combine structurally dissimilar medications (e.g., anticholinergics) should be used with caution; a lack of consensus exists regarding the optimal scale. Directed acyclic graph(s) are an accepted method to conceptualize causative frameworks when identifying potential confounders. Modeling-based strategies should be used with evidence-based, a priori variable-selection strategies. As highlighted in the SAGES cohort, the methods used to classify and analyze medication data in clinically rich cohort studies vary in the rigor by which they have been developed and validated.