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

Montgomery 2007.

Methods Randomized to decision aid with values clarification vs decision aid without values clarification vs usual care
Participants 245 + 250 + 247 women with previous caesarean section in the UK
Interventions DA: options' outcomes, clinical problem, outcome probability, explicit values clarification
Comparator: options' outcomes, clinical problem, outcome probability
Comparator: usual care
Outcomes Primary outcomes: decisional conflict
Secondary outcomes: choice, anxiety, knowledge, satisfaction with decision
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Blocked by using randomly permuted and selected blocks of sizes 6, 9, 12, and 15 generated by computer (p 2 Methods, Randomization)
Allocation concealment (selection bias) Low risk 1 member of the study team generated the randomization sequence by computer, and another member of staff with no other involvement in the trial performed the allocation (p 2 Methods, Randomization)
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unclear blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Unclear blinding but outcomes were objectively measured and not subjective to to interpretation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk See flow of women through the study
Selective reporting (reporting bias) Low risk Trials registry ISRCTN84367722
Other bias Low risk Recruited more than planned to account for lost data (p 4, Sample size); baseline characteristics were balanced