Weymiller 2007.
| Methods | Cluster‐randomized to decision aid vs usual care | |
| Participants | 51 + 46 patients with type 2 diabetes in the USA | |
| Interventions | DA (in consultation): 1‐page decision aid options' outcomes, clinical problem, tailored outcome probability, guidance/coaching Comparator: booklet on cholesterol management | |
| Outcomes | Primary outcomes: knowledge, decisional conflict Secondary outcomes: consultation length, acceptability of the intervention, adherence, estimated personal risk, trust, patient participation (OPTION), choice |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated allocation sequence (p 2) Nannenga 2009: no information provided |
| Allocation concealment (selection bias) | Low risk | Computer‐generated allocation sequence, unavailable to personnel enrolling patients. "[W]ith concealed allocation" (Abstract); "maintained allocation concealment" (p 5); randomized by concealed central allocation (Nannenga 2009, p 2) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and clinicians blinded to the study objectives, providers and patients were naive to this study objective |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data analysts and statisticians blinded to allocation; intervention and outcomes; adequate blinding wherever possible |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow diagram (p 3); reasons for attrition mentioned (p 4); baseline characteristics included; flow diagram Nannenga 2009, p 3: reasons for attrition mentioned and study groups balanced; baseline characteristics included |
| Selective reporting (reporting bias) | Low risk | ClinicalTrials.gov identifier: NCT00217061 |
| Other bias | Low risk | Enrollment of patients already receiving statin therapy and limited statin uptake decreased the precision of our results; results should best be interpreted as preliminary and requiring verification Nannenga 2009: appears to be free of other potential biases |