title: 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.
abstract: The 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.
  
  
  
  Thirty-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.
  
  
  
  Regarding 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).
  
  
  
  The 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.
  
  
  
  The 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).
authors.affiliation: Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany. adarkwah@uni-marburg.de.|CAPHRI School for Public Health and Primary Care, Department of Health Services Research, Maastricht University, Maastricht, The Netherlands. adarkwah@uni-marburg.de.
authors.forename: Charles Christian
authors.identifier: 0000-0002-1073-5866
authors.initials: CC
authors.lastname: Adarkwah
authors.affiliation: Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany.
authors.forename: Nikita
authors.initials: N
authors.lastname: Jegan
authors.affiliation: Department of Child and Adolescent Psychiatry, Philipps-University, Marburg, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Heinzel-Gutenbrunner
authors.affiliation: 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.
authors.forename: Felicitas
authors.initials: F
authors.lastname: Kühne
authors.affiliation: 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.
authors.forename: Uwe
authors.initials: U
authors.lastname: Siebert
authors.affiliation: Department of General Practice, Georg-August-University, Göttingen, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Popert
authors.affiliation: Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Donner-Banzhoff
authors.affiliation: Department of General Practice and Family Medicine, Philipps-University, Marburg, Germany.|Department of Public Health, University of Bielefeld, Bielefeld, Germany.
authors.forename: Sarah
authors.initials: S
authors.lastname: Kürwitz
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment / Q000706:statistics & numerical data*
keywords: Accessibility; ArribaTM; Cardiovascular disease; Decision-aid; Decisional conflict; Lifetime risk; Randomized-controlled trial; Risk-assessment; Shared decision-making; Ten-year-prognosis; Time-to-event