Bozic 2013.
Methods | Randomized to decision aid vs usual care | |
Participants | 95 + 103 participants with hip and/or knee osteoarthritis considering hip/knee surgery | |
Interventions | DA: DVD and booklet on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, others' opinions, and guidance/coaching with health coach Comparator: usual care using pamphlet |
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Outcomes | Primary outcomes: informed decision/knowledge (pre, immediately post, and 6 weeks follow‐up) Secondary outcomes: preferred treatment choice (pre and immediately post), patient and provider satisfaction (immediately post), length of consultation time |
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Notes | Trial registration: NCT01492257 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomization was blocked with use of random permuted blocks in groups of four, six, or eight to help ensure that the groups were balanced" (p 1634) |
Allocation concealment (selection bias) | Low risk | "Patients were randomized to either the intervention group or the control group with use of the sealed envelop method" (p 1634) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "[S]urgeons were not blinded to the intervention" (p 1635). Knowing the allocation of participants, surgeons' favourable scoring could be due to greater investment in decision‐making. Insufficient information to make a judgment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes are objectively measured and not subject to interpretation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 62% (123/198) retention rate therefore high attrition rate ‐ however the attrition was balanced between groups |
Selective reporting (reporting bias) | Low risk | Protocol available |
Other bias | Low risk | Appears to be free of other sources of bias |