PT - JOURNAL ARTICLE AU - Jaspers, Nicole E M AU - Visseren, Frank L J AU - van der Graaf, Yolanda AU - Smulders, Yvo M AU - Damman, Olga C AU - Brouwers, Corline AU - Rutten, Guy E H M AU - Dorresteijn, Jannick A N TI - Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial AID - 10.1136/bmjopen-2020-041673 DP - 2021 Jul 01 TA - BMJ Open PG - e041673 VI - 11 IP - 7 4099 - http://bmjopen.bmj.com/content/11/7/e041673.short 4100 - http://bmjopen.bmj.com/content/11/7/e041673.full SO - BMJ Open2021 Jul 01; 11 AB - Objective To determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.Design Hypothesis-blinded, three-armed randomised controlled trialSetting and participants 303 statin users with stable CVD enrolled in a cohortIntervention Participants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).Outcome Primary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 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-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).Results Decisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.Conclusion In patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registration NTR6227/NL6080.Some individual deidentified participant data (including data dictionaries) may be shared upon reasonable request pending approval by the department and institution on a case-by-case basis. Approval will be based the scientific question to be answered with the data, ability of the authors of this manuscript to co-operate on the project and compliance with contracts acquired for the questionnaires in this study and hospital and SMART-cohort policy.