Designing, Conducting, and Reporting Clinical Decision Support Studies: Recommendations and Call to Action

Abstract

By enabling more efficient and effective medical decision making, computer-based clinical decision support (CDS) could unlock widespread benefits from the significant investment in electronic health record (EHR) systems in the United States. Evidence from high-quality CDS studies is needed to enable and support this vision of CDS-facilitated care optimization, but limited guidance is available in the literature for designing and reporting CDS studies. To address this research gap, this article provides recommendations for designing, conducting, and reporting CDS studies to: 1) ensure that EHR data to inform the CDS are available; 2) choose decision rules that are consistent with local care processes; 3) target the right users and workflows; 4) make the CDS easy to access and use; 5) minimize the burden placed on users; 6) incorporate CDS success factors identified in the literature, in particular the automatic provision of CDS as a part of clinician workflow; 7) ensure that the CDS rules are adequately tested; 8) select meaningful evaluation measures; 9) use as rigorous a study design as is feasible; 10) think about how to deploy the CDS beyond the original host organization; 11) report the study in context; 12) help the audience understand why the intervention succeeded or failed; and 13) consider the financial implications. If adopted, these recommendations should help advance the vision of more efficient, effective care facilitated by useful and widely available CDS.