Montori 2011.
Methods | Randomized to decision aid vs usual care + booklet | |
Participants | 52 + 48 women with low bone mass or osteoporosis considering taking bisphosphonates in the USA | |
Interventions | DA (in consultation): worksheet on options' outcomes, clinical problem, outcome probabilities, guidance (administered by physician) Comparator: usual care + general information booklet on osteoporosis |
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Outcomes | Patient knowledge (post‐DA), satisfaction with knowledge transfer (post‐DA), decisional conflict (post‐DA), patient‐clinician communication (OPTION), trust with physician (during intervention), clinician's perception of decision quality (post‐DA), clinician's satisfaction with knowledge transfer (post‐DA), uptake (post‐DA), adherence (post‐DA), fidelity (post‐DA), contamination (post‐DA), risk perception | |
Notes | Primary outcome was not specified | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer generated allocation" (p 551, Randomization) |
Allocation concealment (selection bias) | Low risk | Patients randomized "in a concealed fashion (using a secure study website)" (p 551, Randomization) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of participants being blinded to their allocation; only mention of data collectors and analysts blinding (p 551, Randomization) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "After randomization, data collectors and data analysts were blind to allocation" (p 551, Randomization); Outcomes were not subject to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | "The protocol for this trial has been reported in full" (p 550, Design) |
Other bias | Unclear risk | Appears to be free of other potential biases |