Adarkwah 2016.
Methods |
Study design: randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: unclear |
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Participants |
Care setting: primary care, Germany Health professionals: 32; general practitioners; fully trained Patients: 304; cardiovascular risk prevention; male and female |
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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 |
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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. |