AKROBATS Trial

Preference for genetic testing among patients offered participation in the Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS) trial.

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Background: Utilization of genetic tests has improved personalized healthcare. However, factors that influence a subject’s decision to accept or decline genetic testing are poorly defined. The objective of this study is to characterize the rationale from patients new to statin therapy to either decline or accept KIF6 genetic testing associated with participation in the AKROBATS trial.

Methods: Subjects were contacted via telephone by study nurses. During this call, subjects were provided information on the study and KIF6 variant testing, and were offered enrollment. Based upon response, patients were queried on reasons to accept or decline study participation. Responses were categorized and collapsed for analysis. Categorical and continuous variables were analyzed using chi-squared and t-tests, respectively (significance at p<0.05).

Results: A total of 773 patients declined participation and 682 subjects agreed to enroll in the AKROBATS study. Enrollees were significantly younger (60±12 vs 64±13) and more likely to be prescribed atorvastatin or lovastatin (p<0.05). Reasons for enrollment included: Confident that KIF6 test results would improve my disease outcomes (53.8%), help humanity (17.4%), general interest/knowledge (15%); family history of heart disease (5.9%), confident others were receiving KIF6 test (1.6%), asked to participate (0.9%), and no reason provided (5.4%). Those declining enrollment indicated no reason (43.1%), no perceived benefit of KIF6 testing (19.7%), time constraints (18.4%), not enough knowledge about KIF6 test (8.8%), privacy concerns (6.7%), anxiety associated with results or lifestyle changes (0.9%), and other (2.5%).

Conclusion: Multiple factors, including age, therapy prescribed, logistical considerations, and health beliefs, may influence the decision to decline or accept genetic testing under trial conditions. Lack of interest, lack of perceived or potential benefit, and time concerns were primary reasons for study participation/KIF6 test declination. In contrast, belief in personal value/utility, altruism, and general interest appeared to drive study participation/KIF6 test acceptance. As genetic testing advances, information such as this is key to fully understanding patients’ attitudes towards acceptance and reservations about genetic testing, and may serve as a basis to develop effective patient communication and education strategies to support individualized decision making.

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