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.
Highlights
Study design plays an important role in the quality, execution, and interpretation of biomedical and public health research [1,2,3,4,5,6,7,8,9,10,11,12]
Each study design has their own inherent strengths and weaknesses, and there can be a general hierarchy in study designs, any hierarchy cannot be applied uniformly across study design types [3,5,6,9]
The measures of risk for the exposure-outcome relationship that can be calculated in cross-sectional study design of odds ratio, prevalence odds ratio, prevalence ratio, and prevalence difference can be calculated in cohort studies as well
Summary
Study design plays an important role in the quality, execution, and interpretation of biomedical and public health research [1,2,3,4,5,6,7,8,9,10,11,12]. Epidemiological and interventional research studies include three elements; 1) definition and measure of exposure in two or more groups, 2) measure of health outcome(s) in these same groups, and 3). Common categorization schema include temporal nature of the study design (retrospective or prospective), usability of the study results (basic or applied), investigative purpose (descriptive or analytical), purpose (prevention, diagnosis or treatment), or role of the investigator (observational or interventional). This manuscript categorizes study designs by observational and interventional criteria, other categorization methods are described as well.
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