Mathieu 2007.
Methods | Randomized to decision aid versus usual care | |
Participants | 367 + 367 women aged 70 to 71 years and considering a subsequent screening mammography in Australia | |
Interventions | DA: booklet on options' outcomes, clinical problem, outcome probability, explicit values clarification, others' opinions, guidance with worksheet (Ottawa Decision Support Framework) Comparator: BreastScreen NSW brochure ‐ includes information for women 70 + but no numeric information about the outcomes of screening |
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Outcomes | Primary outcomes: actual decision, informed choice Secondary outcomes: knowledge (includes 5 questions about risk perceptions), anxiety, decisional conflict, breast cancer worry, preference/intension, attitudes about screening, relationship between objective and perceived risk of breast cancer |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer programme, which assigned allocations in accordance with a simple randomization schedule (p 2, Methods) |
Allocation concealment (selection bias) | Low risk | Randomized by interview staff who accessed a previously concealed computer programme (p 2, Methods) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Interviewers [at follow‐up] were blinded, outcomes were objectively measured and not subjective to to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Fig 1 flow diagram (p 2) |
Selective reporting (reporting bias) | Low risk | "The trial was registered with the Australian Clinical Trials Registry and the Clinical Trials Registration System" (p 5) |
Other bias | Low risk | Appears to be free of other potential biases |