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

Background: 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 arriba^TM (emoticons), is compared within a randomised trial to a new-developed TTE illustration, which is based on a Markov model.

Methods: Thirty-two General Practitioners (GPs) took part in the study. A total of 304 patients were recruited and counseled by their GPs with arriba^TM, 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.

Results: 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).

Conclusion: 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.

Trial registration: 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).

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.

Fig. 1

Flowchart of participation

Fig. 2

Emoticon-interface of the arriba^TM decision-aid (a Medical history taking¹, b visualization of treatment options²) Footnote: ¹On the left, information regarding the medical history must be filled in, which is (from top to bottom): gender, age, smoking-status, presence of manifest arteriosclerosis, positive family history, taking of antihypertensive medications, systolic blood pressure, total cholesterol level, high density lipoproteins (HDL) level, presence of diabetes, HbA1c level. On the right, the emoticons are displayed, accompanied by the following headline: “Out of 100 men with the same risk profile, 25 will suffer a myocardial infarction or stroke within the next 10 years.” ²On the left, the treatment options are shown, which are (from top to bottom): behavioral changes, like smoking cessation, nutrition, sports and on the other hand drug treatment, i.e. statins, antihypertensive drugs, aspirin, metformin. On the right, the emoticons are displayed, accompanied by the following headline: “Out of 100 treated men with the same risk profile, 14 will suffer a myocardial infarction or stroke within the next 10 years.” The risk reduction (here due to nutrition modification and sports) is indicated with orange-colored emoticons

Fig. 3

TTE-interface of the arriba^TM decision-aid (a Medical history taking³, b visualization of treatment options⁴) Footnote: ³On the left, the information regarding the medical history must be filled in, which is (from top to bottom): gender, age, smoking-status, presence of manifest arteriosclerosis, positive family history, taking of antihypertensive medications, systolic blood pressure, total cholesterol level, high density lipoproteins (HDL) level, presence of diabetes. On the right, the TTE graph is displayed, accompanied by the following headline: “A 62y old man with the same risk profile could suffer a myocardial infarction or stroke in in average time of 8 years form now (at 70y of age). ⁴On the left, the treatment options are shown, which are (from top to bottom): behavioral changes, like smoking cessation, nutrition, sports and on the other hand drug treatment, i.e. statins, antihypertensive drugs, aspirin. On the right, TTE graphs are displayed, accompanied by the following headline: “A 62y old treated man with the same risk profile could suffer a myocardial infarction or stroke in in average time of 9 years form now (at 71y of age). The risk reduction (here due to sports) is indicated with the orange-colored timeline. The following statistical information is added: “35,8% of this group suffer a myocardial infarction or stroke at all”

Fig. 4

Risk perception as a function of age-group and illustration

Fig. 5

Accessibility as a function of age-group and illustration

Fig. 6

DCS (total score) as a function of age-group and illustration

Fig. 7

DCS (effective decision subscore) as a function of age-group and illustration

Fig. 8

PDMS-D (subscore patients’s preparation for the GP consultation) as a function of age-group and illustration