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. 2017 Apr 12;2017(4):CD001431. doi: 10.1002/14651858.CD001431.pub5

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)
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
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