P646Effects of personalized therapy-effect predictions on statin treatment decisions by patients and physicians: a three-armed, blinded, randomized controlled trial
Authors: Jaspers N E M , Visseren F L J , Van Der Graaf Y , Damman O C , Smulders Y M , Dorresteijn J A N 
Published: October 2019

Background

Several online tools express an individual's therapy-benefit for various cardiovascular disease (CVD) prevention strategies. The benefit can be expressed in multiple formats, such as absolute 10-year CVD risk reduction or gain in CVD-free life-years. It is increasingly suggested that these estimates can be used in doctor-patient communication to support shared decision-making. However, the actual therapy-benefit to be expected from preventive therapy might be small from the perspective of patients, and it remains unclear how the estimates affect patient and physician decision-making.

Purpose

The primary objective was to determine whether communicating personalized predictions of prognosis and treatment-effects (compared to non-personalized standard practice) leads to lower decisional conflict among patients with stable CVD and prescribed statin medication.

Methods

A hypothesis-blinded, three-armed randomized controlled trial was performed in which 303 patients were randomized in a 1:1:1 ratio to either standard practice (control-group) or to one of two intervention arms. Intervention arms received personalized estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (atorvastatin 80 mg). Intervention arms differed only in the format of the treatment effect estimates: change in personal 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group). Primary outcome was patient decisional conflict score (DCS) after one-month, which varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at one or six months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomization low-density lipoprotein cholesterol levels, and physician opinion of statin therapy decisions and the intervention. Outcomes are reported as median (25th–75th percentile).

Results

In the iAR group, the change in 10-year absolute CVD-risk was −2.4 (−1.2 to −3.9%) from intensification and +10.2% (+7.7 to +13.5) from discontinuation. In the iLE group, the change in CVD-free life-expectancy was +0.5 years (+0.3 to +0.8) from intensification and −2.0 years (−1.3 to −2.8) from discontinuation. Decisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value versus control 0.002), and iLE-group 25 (10–31; p-value versus control 0.02). No differences in secondary outcomes were observed.

Figure 1. Part of the personalized information received by iAR-group (left) and iLE-group (right).

Conclusion

In patients with clinically manifest CVD, providing personalized estimations of treatment-effects lowers decisional conflict associated with statin use. The results support the use of personalized predictions for patient decision making.

Acknowledgement/Funding

Partially funded by a Netherlands Heart Foundation grant (2016T026)