Lam 2013.
| Methods | Randomized to decision aid or standard information booklet after initial consultation | |
| Participants | 138 + 138 women considering breast cancer surgery for early‐stage breast cancer | |
| Interventions | DA: take‐home booklet on clinical problem, options' outcomes, outcome probabilities, guidance, explicit values clarification Comparator: standard information booklet |
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| Outcomes | Primary outcomes: treatment decision making difficulties and decisional conflict scale at 1 week post consultation, knowledge at 1‐week postconsultation, decision regret at 1 month after surgery Secondary outcomes: postoperative psychological distress (anxiety and depression) at 1, 4, and 10 months after surgery, decision regret at 4 and 10 months after surgery, treatment decision |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patient assignment to treatment and control arms was performed using a prior computer‐generated random‐number sequence" (p 2880) |
| Allocation concealment (selection bias) | Low risk | "A serially labeled, opaque, sealed‐envelope method was used for block randomization" (p 2880) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Two research staff members ‐ one responsible for preintervention assessment and block allocation and the other for postintervention assessments ‐ ensured that the researcher performing follow‐up assessments was blinded regarding women's allocation status." "Blinding surgeons to allocation status proved impractical." (p 2880) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | 1 research staff member was responsible for postintervention assessments to ensure that the researcher performing follow‐up assessments was blinded regarding women's allocation status (p 2880). |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Does not appear to be missing any outcome data; similar attrition in both groups |
| Selective reporting (reporting bias) | Low risk | Study protocol available online with published study |
| Other bias | Low risk | Does not appear to be subject to other sources of bias |