Vodermaier 2009.
Methods | Randomized to decision aid vs usual care | |
Participants | 74 + 78 women with breast cancer considering treatment options in Germany | |
Interventions | DA: Decision board administered by research psychologists and booklet on options' outcomes, clinical problem, outcome probability Comparator: booklet on clinical problem | |
Outcomes | Primary outcome: decisional conflict Secondary outcomes: choice, length of consultation, satisfaction with decision making, participation in decision making |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomisation after the patient gave written informed consent" "Random assignment was performed by means of numbered cards in envelopes" "stratified by age group" (p 2) |
Allocation concealment (selection bias) | Low risk | "[N]umbered cards in envelopes" (p 2) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not blinded ‐ unclear if this would introduce bias to outcome assessed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not blinded but outcomes were objectively measured and not subjective to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Flow diagram, p 5; baseline characteristics not included |
Selective reporting (reporting bias) | Unclear risk | No information provided |
Other bias | Low risk | Appears to be free of other potential biases |