Arterburn 2011.
Methods | Randomized to decision aid vs usual care | |
Participants | 75 + 77 participants considering bariatric surgery in the USA | |
Interventions | DA: booklet + video on options' outcomes, clinical problem, outcome probabilities, others' opinion, guidance (list of questions to discuss with clinician) Comparator: usual care (general information pamphlets on clinical problem) |
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Outcomes | Primary outcomes: knowledge, values, values concordance Secondary outcomes: treatment preference, decisional conflict, decisional self‐efficacy, proportion undecided Primary outcomes assessed at baseline, postintervention and 3 months follow‐up; secondary outcomes assessed at baseline and postintervention |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[U]sed computer‐assisted, block randomisation process to ensure balanced allocation of participants" (p 1670, Participants and randomization) |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment and no mention of impact on study |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "[S]tudy was not blinded" (p 1670, Participants and randomization); no mention of impact on study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes were objectively measured and not subject to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Measures: mentioned 4 choices for treatment preference (surgery, drug therapy, diet and/or exercise programme and unsure) but only reported on surgery and unsure options (p 1671); minimal attrition that was consistent between groups |
Selective reporting (reporting bias) | Unclear risk | No mention of study protocol or trial registration; all pre‐specified outcomes included |
Other bias | Low risk | The study appears to be free of other sources of bias |