Whether disclosure of genetic risk for coronary heart disease (CHD) influences shared decision-making (SDM) regarding use of statins to reduce CHD risk is unknown. We randomized 207 patients, age 45–65 years, at intermediate CHD risk, and not on statins, to receive the 10-year risk of CHD based on conventional risk factors alone (n=103) or in combination with a genetic risk score (n=104). A genetic counselor disclosed this information followed by a physician visit for SDM regarding statin therapy. A novel decision aid was used in both encounters to disclose the CHD risk estimates and facilitate SDM regarding statin use. Patients reported their decision quality and physician visit satisfaction using validated surveys. There were no statistically significant differences between the two groups in the SDM score, satisfaction with the clinical encounter, perception of the quality of the discussion or of participation in decision-making and physician visit satisfaction scores. Quantitative analyses of a random subset of 80 video-recorded encounters using the OPTION5 scale also showed no significant difference in SDM between the two groups. Disclosure of CHD genetic risk using an electronic health record-linked decision aid did not adversely affect SDM or patients’ satisfaction with the clinical encounter.
Trial registration number NCT01936675; Results.
Contributors IJK and VMM contributed to study concept and design. HJ, RAH, TSM, S-AB, TMK, EEA, KS and EMB were involved in acquisition, analysis, and interpretation of data. EEA was involved in statistical analysis. HJ, RAH, TSM, S-AB, EEA, RC, VMM and IJK contributed to drafting of the manuscript. All authors were involved in critical revision of the manuscript for important intellectual content.
Funding This study was funded as part of the National Human Genome Research Institute-supported eMERGE (Electronic Records and Genomics) Network (U01HG04599 and U01HG006379) and the Mayo Clinic Center for Individualized Medicine. Data management was performed with the use of REDCap, which is funded by the Center for Clinical and Translational Science (UL1TR000135).
Competing interests None declared.
Ethics approval This study was approved by the Mayo Clinic institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.