A goal of Twenty-First Century Healthcare is to establish and enhance the Learning Healthcare System (LHS). As discussed in numerous forums, journals, and social media, the LHS is viewed as critical to improving healthcare. Fundamentally, the LHS converts data about care and operations into knowledge that it translates into evidence-based clinical practice and health system change. In so doing, the LHS utilizes as vehicles health information technology, databases, the electronic healthcare record (EHR) and, importantly, a research infrastructure. The continuing narrow evidence base for clinical care combined with the need for substantial amounts of data to fill large evidentiary gaps, among other factors, have fostered the LHS concept.
To assure the utility and validity of data converted and then translated into improvements by the LHS, we need rigorous research approaches that are also efficient. Research is defined as “a systematic investigation…designed to develop or contribute to generalizable knowledge.” At present, evidentiary inputs to the LHS range from activities not generally considered research (e.g., programmatic and quality improvement evaluations) to various forms of research that are sufficiently rigorous, but for various reasons, can be difficult to employ and translate into the routine workings of the LHS.
For example, the randomized clinical trial (RCT) — considered the cornerstone, or “gold standard” methodology — provides the best data, but by its very nature, is separate from the workings of clinical care in a given healthcare system (HCS). Instead, the RCT functions in an alternate environment precisely controlled for the approach’s particulars. Further, the RCT is costly and time-consuming, and its rather narrow entry criteria may diminish its ability to be generalized to routine patients (e.g., those with comorbidities, or those outside of the entry criteria of age and severity).
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