Bernstein 1998.
Methods | Randomized to decision aid vs usual care | |
Participants | 65 + 53 patients with coronary artery disease considering revascularization surgery in the USA | |
Interventions | DA: Health Dialog video on options' outcomes, clinical problem, outcome probability, others' opinion Comparator: usual care (no information provided) | |
Outcomes | Primary outcome: satisfaction with decision and decision making process Secondary outcomes: uptake of option, knowledge, satisfaction with care, general health outcomes, condition specific health outcomes |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was stratified by study site in blocks of 10" (p 3) |
Allocation concealment (selection bias) | Low risk | "[R]andomization performed by a study coordinator opening opaque, sealed envelopes at study headquarters" (p 3) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Neither subjects nor study staff were blinded to treatment assignment ‐ could lead to different satisfaction ratings based on knowing the treatment received |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes were objectively measured |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow diagram (p 3); low attrition of eligible participants randomized and consistent between group |
Selective reporting (reporting bias) | Unclear risk | No information provided indicating trial was included in central trials registry |
Other bias | Low risk | Appears to be free of other potential biases |