The utility of observational studies in clinical decision making: Lessons learned from statin trials

An article published in the May 2010 issue of Postgraduate Medicine explains the benefits observational studies have in assessing clinical practice and thereby aid in improved processes of clinical care.

The authors report that the most widely used and acceptable means in developing guidelines for clinical practice are randomized controlled trials (RCTs). Although very beneficial, RCTs cannot be designed to answer all clinical questions because some may be unethical or impractical to perform. With the value of observational research improving since the development of standards for the publication of cohort, case-control, and cross-sectional studies in the form of the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, observational studies’ results should not be overlooked.

To exemplify the viability of observational studies, the authors site the statin trials. Randomized controlled trials were successful in establishing the safety and efficacy of each statin in a specific population, but they did not answer questions about statin’s effectiveness in a wide range of patient populations with varying levels of cardiovascular risk, age, and concomitant disease. The authors site various observational studies that help solve the unanswered questions left by the RCTs.

The authors suggest that physicians should carefully consider the potential impact of switching statins and the relative effectiveness of different statins when treating individual patients. Observational studies are able to take the success of RTCs in enhancing the understanding of newly identified treatment approaches to the next level by enhancing the appreciation of clinical effectiveness, quality assessment, and clinical utility.

Full text available at www.postgradmed.com