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: | Frank L.J. Visseren, N E M Jaspers, Jannick A N Dorresteijn, G.E.H.M. Rutten, Yolanda van der Graaf, Olga C. Damman, Corline Brouwers, Yvo M. Smulders |
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| Přispěvatelé: | Internal medicine, ACS - Atherosclerosis & ischemic syndromes, ACS - Diabetes & metabolism, Public and occupational health, APH - Methodology, APH - Quality of Care |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Statin medicine.drug_class Decisional conflict 030204 cardiovascular system & hematology Cardiovascular Medicine preventive medicine law.invention 03 medical and health sciences 0302 clinical medicine Quality of life Randomized controlled trial law Intervention (counseling) medicine lipid disorders Humans 030212 general & internal medicine Referral and Consultation Preventive healthcare business.industry public health General Medicine vascular medicine Discontinuation Telephone Cardiovascular Diseases cardiology Cohort Physical therapy Quality of Life Medicine Hydroxymethylglutaryl-CoA Reductase Inhibitors business |
| Zdroj: | BMJ Open BMJ Open, Vol 11, Iss 7 (2021) BMJ Open, 11(7):e041673. BMJ Publishing Group Jaspers, N E M, Visseren, F L J, Van Der Graaf, Y, Smulders, Y M, Damman, O C, Brouwers, C, Rutten, G E H M & Dorresteijn, J A N 2021, ' 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 ', BMJ Open, vol. 11, no. 7, e041673 . https://doi.org/10.1136/bmjopen-2020-041673 |
| ISSN: | 2044-6055 |
| Popis: | ObjectiveTo 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.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants 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).OutcomePrimary 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).ResultsDecisional 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.ConclusionIn 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 registrationNTR6227/NL6080. |
| Databáze: | OpenAIRE |
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