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

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).Electronic supplementary materialThe online version of this article (doi:10.1186/s12911-016-0393-1) contains supplementary material, which is available to authorized users.

Sex and gender considerations in implementation interventions to promote shared decision making: A secondary analysis of a Cochrane systematic review

“…Out of 87 included studies, all published between 1995 and 2017, almost a quarter (23.4%) were published in 2016 or 2017 [ 51 – 70 ]. The studies were mainly (54%) conducted in North America [ 52 , 54 – 58 , 61 , 66 – 68 , 71 – 105 ].…”

“…The studies were mainly (54%) conducted in North America [ 52 , 54 – 58 , 61 , 66 – 68 , 71 – 105 ]. Forty-four (50.6%) studies evaluated interventions targeting patients [ 32 , 51 , 52 , 54 , 57 , 59 – 64 , 66 , 67 , 69 , 72 , 75 – 79 , 84 – 86 , 88 , 90 – 92 , 96 , 98 , 99 , 102 , 103 , 106 – 116 ]. Fifteen (17.2%) studies evaluated interventions targeting health professionals [ 53 , 55 , 65 , 94 , 101 , 109 , 117 – 125 ].…”

“…Out of 87 included studies, the term, sex was mentioned in 37 (42.5%) studies [ 54 – 58 , 60 – 64 , 66 , 68 , 70 , 71 , 79 , 83 , 85 , 87 , 89 , 95 , 96 , 98 , 103 , 105 , 107 , 110 , 112 , 114 , 119 – 122 , 126 , 128 , 130 – 132 ]. Gender was mentioned in 36 (41.4%) studies [ 51 , 52 , 58 , 60 , 61 , 63 , 65 , 70 , 71 , 77 , 82 , 87 , 89 , 91 , 96 – 99 , 101 , 104 , 106 , 112 , 114 , 117 – 119 , 121 , 124 , 125 , ...…”

“…Gender was mentioned in 36 (41.4%) studies [ 51 , 52 , 58 , 60 , 61 , 63 , 65 , 70 , 71 , 77 , 82 , 87 , 89 , 91 , 96 – 99 , 101 , 104 , 106 , 112 , 114 , 117 – 119 , 121 , 124 , 125 , 131 , 133 – 135 , 137 ]. The terms sex and/or gender were mentioned in 58 (66.7%) studies [ 51 , 53 – 66 , 68 , 70 , 71 , 77 , 79 , 82 , 83 , 85 , 87 – 89 , 91 , 95 – 98 , 101 , 103 – 107 , 110 , 112 , 114 , 117 – 120 , 122 ...…”

Pregnant women’s views on how to promote the use of a decision aid for Down syndrome prenatal screening: a theory-informed qualitative study

“…The BCTs identified covered a range of intervention functions, ultimately illustrating the possible need for a multi-component intervention that targets several determinants of behaviour change. This would create a more convincing intervention than is typically observed in other SDM interventions in which a PtDA is used, which focus mostly on the functions of education and training [ 55 – 58 ]. This was the case, for example, in a study aiming to improve SDM for women deciding about prenatal testing for foetal abnormalities [ 59 ], in which a health professional gave women the PtDA but no additional decision support and no follow up [ 59 ].…”