Observational and interventional study design types; an overview

Abstract

The appropriate choice in study design is essential for the successful execution of biomedical and public health research.There are many study designs to choose from within two broad categories of observational and interventional studies.Each design has its own strengths and weaknesses, and the need to understand these limitations is necessary to arrive at correct study conclusions.Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.Observational study designs include ecological designs, cross sectional, case-control, case-crossover, retrospective and prospective cohorts.An important subset of observational studies is diagnostic study designs, which evaluate the accuracy of diagnostic procedures and tests as compared to other diagnostic measures.These include diagnostic accuracy designs, diagnostic cohort designs, and diagnostic randomized controlled trials.Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.Each study design has specific outcome measures that rely on the type and quality of data utilized.Additionally, each study design has potential limitations that are more severe and need to be addressed in the design phase of the study.This manuscript is meant to provide an overview of study design types, strengths and weaknesses of common observational and interventional study designs.Key words: study design; epidemiology; observational study; randomized trials; study strengths and weaknesses statistical comparison made between groups to assess potential relationships between the exposure and outcome, all of which are defined by the researcher (1-4,8,13).The measure of exposure in epidemiologic studies may be tobacco use ("Yes" vs. "No") to define the two groups and may be the treatment (Active drug vs. placebo) in interventional studies.Health outcome(s) can be the development of a disease or symptom (e.g.lung cancer) or curing a disease or symptom (e.g.reduction of pain).Descriptive studies, which are not epidemio-