Submission Type

Original Article


The increasing availability of electronic clinical data (ECD) may present opportunities to answer research questions that can drive improvement in patient outcomes. This brief outlines important research design considerations when using ECD for comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). A practical orientation to study designs is provided to encourage consideration of which methods are best suited to answer particular research and quality improvement (QI) questions using ECD, and ways of making information obtained from ECD more useful in the clinical setting are suggested. Differences between observational studies and randomized controlled trials (RCTs) are outlined, and specific challenges of each are discussed. Promising study design and analytic approaches that can be used with observational ECD for CER - and considerations for each - are addressed.