TY - JOUR
T1 - Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy
T2 - Does it improve decisional conflict? Three-armed, blinded, randomised controlled trial
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.
N1 - Funding Information: Contributors NEMJ, FLJV, YvdG, OD, CB and JAND contributed to the conception, design of the work and interpretation of the data; YMS and GR contributed to the interpretation. NEMJ drafted the work and performed the analyses; FLJV, YvdG, OD, CB, JAND, YMS and GR critically revised the work. All authors gave final approval and agreed to be accountable for the work. Funding Partially funded by a Netherlands Heart Foundation grant (2016T026). Funder was not involved in the design or assessment of the study. Competing interests None declared. Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/7/16
Y1 - 2021/7/16
N2 - 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 trial Setting and participants 303 statin users with stable CVD enrolled in a cohort Intervention 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.
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 trial Setting and participants 303 statin users with stable CVD enrolled in a cohort Intervention 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.
KW - cardiology
KW - lipid disorders
KW - preventive medicine
KW - public health
KW - vascular medicine
UR - http://www.scopus.com/inward/record.url?scp=85110599488&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2020-041673
DO - https://doi.org/10.1136/bmjopen-2020-041673
M3 - Article
C2 - 34272216
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e041673
ER -