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.

Autor:	Jaspers NEM; University Medical Center Utrecht, Department of Vascular Medicine, Utrecht University, Utrecht, Utrecht, The Netherlands., Visseren FLJ; University Medical Center Utrecht, Department of Vascular Medicine, Utrecht University, Utrecht, Utrecht, The Netherlands., van der Graaf Y; Julius Center for Health Sciences and Primary Care, Utrecht University, Utrecht, Utrecht, The Netherlands., Smulders YM; University Medical Centre, Department of Internal Medicine, Vrije Universiteit Amsterdam, Amsterdam, Noord-Holland, The Netherlands., Damman OC; Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Amsterdam, North-Holland, The Netherlands., Brouwers C; Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Amsterdam, North-Holland, The Netherlands., Rutten GEHM; Julius Center for Health Sciences and Primary Care, Utrecht University, Utrecht, Utrecht, The Netherlands., Dorresteijn JAN; University Medical Center Utrecht, Department of Vascular Medicine, Utrecht University, Utrecht, Utrecht, The Netherlands j.a.n.dorresteijn-2@umcutrecht.nl.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Jul 16; Vol. 11 (7), pp. e041673. Date of Electronic Publication: 2021 Jul 16.
DOI:	10.1136/bmjopen-2020-041673
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© 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.)
Databáze:	MEDLINE
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