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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

Adarkwah 2016.

Methods Study design: randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: unclear
Participants Care setting: primary care, Germany
Health professionals: 32; general practitioners; fully trained
Patients: 304; cardiovascular risk prevention; male and female
Interventions Single intervention: patient‐mediated intervention (Computerised decision aid (TTE))
Quote: "Immediately after giving their informed consent, patients were randomized to consultation with the emoticons (Fig. 2) or the TTE illustration (Fig. 3). GPs entered a study ID into the decision support software, which automatically allocated each patient into one of the two conditions according to an a priori randomized sequence. GPs learned about each patient’s allocation by the illustration displayed by the software. They then started a discussion with their patients on the basis of the allocated display, i.e. either emoticons, or TTE, respectively." Page 3, figure 3
Single intervention: patient‐mediated intervention (Computerised decision aid (emoticon)). Figure 2
Outcomes PEF‐FB‐9 (SDM‐Q9) (continuous)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "GPs entered a study ID into the decision support software, which automatically allocated each patient into one of the two conditions according to an a priori randomized sequence." page 3
Allocation concealment (selection bias) Low risk Quote: "GPs entered a study ID into the decision support software, which automatically allocated each patient into one of the two conditions according to an a priori randomized sequence." page 3
Blinding (performance bias and detection bias) 
 Participant‐reported outcome High risk Performance bias. Quote: "GPs recorded the decision made, such as specific medications, dose adjustments, behavioral measures or no change at all." page 3
Quote: "GPs learned about each patient’s allocation by the illustration displayed by the software." page 3
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome Unclear risk Comment: we cannot assume that all patients replied to all questions related to outcomes. Missing outcome data were not specified.
Selective reporting (reporting bias) Low risk Comment: relevant outcomes pre‐specified in the study protocol were reported in the results (Clinical Trials Register Platform (ICTRP, ID DRKS00004933)).
Other bias Low risk Comment: no evidence of other risk of biases.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: no baseline measure of primary outcome.
Protection against contamination? High risk Comment: patients were randomized.
Baseline characteristics patients Low risk Quote: "Both study arms were well‐balanced regarding socio demographic and clinical variables." page 6. See Table 1
Baseline characteristics healthcare professionals Unclear risk Comment: no report of characteristics.