Time-to-event versus ten-year-absolute-risk in cardiovascular risk prevention – does it make a difference? Results from the Optimizing-Risk-Communication (OptRisk) randomized-controlled trial

BMC Medical Informatics and Decision Making

Research Article

Monika Heinzel-Gutenbrunner¹  Norbert Donner-Banzhoff²  Nikita Jegan²  Charles Christian Adarkwah³  Sarah Kürwitz⁴  Uwe Popert⁵  Felicitas Kühne⁶  Uwe Siebert⁷ 

[1] Department of Child and Adolescent Psychiatry, Philipps-University, Marburg, Germany;Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany;Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany;CAPHRI School for Public Health and Primary Care, Department of Health Services Research, Maastricht University, Maastricht, The Netherlands;Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany;Department of Public Health, University of Bielefeld, Bielefeld, Germany;Department of General Practice, Georg-August-University, Göttingen, Germany;Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria;Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria;Division of Public Health Decision Modelling, Health Technology Assessment and Health Economics, ONCOTYROL - Center for Personalized Cancer Medicine, Innsbruck, Austria;Center for Health Decision Science, Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA;

关键词: Randomized-controlled trial;    Arriba;    Decision-aid;    Shared decision-making;    Ten-year-prognosis;    Risk-assessment;    Lifetime risk;    Time-to-event;    Cardiovascular disease;    Decisional conflict;    Accessibility;   

DOI  :  10.1186/s12911-016-0393-1

 received in 2016-08-01, accepted in 2016-11-22,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe concept of shared-decision-making is a well-established approach to increase the participation of patients in medical decisions. Using lifetime risk or time-to-event (TTE) formats has been increasingly suggested as they might have advantages, e.g. in younger patients, to better show consequences of unhealthy behaviour. In this study, the most-popular ten-year risk illustration in the decision-aid-software arribaTM (emoticons), is compared within a randomised trial to a new-developed TTE illustration, which is based on a Markov model.MethodsThirty-two General Practitioners (GPs) took part in the study. A total of 304 patients were recruited and counseled by their GPs with arribaTM, and randomized to either the emoticons or the TTE illustration, followed by a patient questionnaire to figure out the degree of shared-decision-making (PEF-FB9, German questionnaire to measure the participation in the shared decision-making process, primary outcome), as well as the decisional conflict, perceived risk, accessibility and the degree of information, which are all secondary outcomes.ResultsRegarding our primary outcome PEF-FB9 the new TTE illustration is not inferior compared to the well-established emoticons taking the whole study population into account. Furthermore, the non-inferiority of the innovative TTE could be confirmed for all secondary outcome variables. The explorative analysis indicates even advantages in younger patients (below 46 years of age).ConclusionThe TTE format seems to be as useful as the well-established emoticons. For certain patient populations, especially younger patients, the TTE may be even superior to demonstrate a cardiovascular risk at early stages. Our results suggest that time-to-event illustrations should be considered for current decision support tools covering cardiovascular prevention.Trial registrationThe study was registered at the German Clinical Trials Register and at the WHO International Clinical Trials Register Platform (ICTRP, ID DRKS00004933); registered 2 February 2016 (retrospectively registered).

【 授权许可】

CC BY   
© The Author(s). 2016