ABSTRACT
The overall goal of healthcare information technology evaluations is to provide feedback information to decision-makers, clinicians, administrators, patients, and other relevant people and groups. Experimental study designs such as RCT are powerful tools and can be used in areas of health IT to obtain evidence on systems impacts. The protocol and final report should describe the study design for goals to be evaluated by the readership and provide the ability to reproduce the study. As, currently, there is no requirement for FDA approval of EMR or a majority of software health IT products, this study design is not popular within the industry. However, because an RCT is considered the strongest study design in the evidence pyramid, researchers should consider such a design for use in field setting evaluations. Good evaluation questions for clinically relevant problems should always be designed around the PICO concept.
