Whelan 2003.
Methods | Randomized to decision aid vs usual care | |
Participants | 82 + 93 women with node negative breast cancer considering adjuvant chemotherapy in Canada | |
Interventions | DA: decision board and booklet on options' outcomes, clinical problem, outcome probability, guidance/coaching Comparator: booklet on clinical problem | |
Outcomes | Primary outcomes: knowledge, satisfaction of participant Secondary outcomes: preferred option, anxiety, accurate risk perceptions, 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 | No information provided |
Allocation concealment (selection bias) | Low risk | Randomization, which was performed at a central location (p 3) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unable to blind participants in our trial for practical reasons, measures were taken to minimize bias in the design of the study and the assessment of outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes were objectively measured and not subjective to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Flow diagram not included. "[O]ne patient excluded from analysis, determined by physician not to be candidate for chemotherapy" (p 4). Baseline data/characteristics included. |
Selective reporting (reporting bias) | Unclear risk | Unclear if lack of blinding contributed to potential risk of bias |
Other bias | Low risk | Appears to be free of other potential biases |