Green 2001.
Methods | Randomized to decision aid + counselling vs counselling alone vs usual care | |
Participants | 29 + 14 women with a first degree relative with breast cancer interested in learning about genetic testing in the USA | |
Interventions | DA: CD‐ROM plus counselling on options' outcomes, clinical problem, others' opinions, guidance/coaching Comparator: counselling Comparator: usual care |
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Outcomes | Primary outcome: preferred options Secondary outcome: knowledge |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[B]lock randomization schedule to one of three groups in a 2:2:1 ratio" (p 2) |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "[G]enetic counsellor blinded to randomization until just prior to the session" (p 2), unclear if participants were blinded |
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 | Unclear risk | "Values do not always add up to the number of participants due to missing data"; reasons not mentioned (p 4). "Participants' baseline knowledge was reflected in the control group's answers"; participants balanced in study groups |
Selective reporting (reporting bias) | Unclear risk | No information provided |
Other bias | Low risk | Appears to be free of other sources of bias |