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 |
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Outcomes | Primary outcomes: decisional conflict Secondary outcomes: choice, anxiety, knowledge, satisfaction with decision |
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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 |