Allen 2010.
Methods | Cluster‐randomized to decision aid vs usual care | |
Participants | 398 + 414 men considering prostate cancer screening in the USA | |
Interventions | DA: computer tailored programme on clinical problem, outcome probabilities, explicit values clarification, others' opinion and guidance (step‐by‐step process for making the decision; interactive computer programme: inherently guided the patient through the decision aid and decision making process), tailored printout given to patients to promote discussion with others (practitioner, significant others) Comparator: no intervention |
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Outcomes | Primary outcomes: decisional status, knowledge, decision self‐efficacy, decisional consistency Secondary outcomes: desire for involvement in decision making, decisional conflict, preferred options Outcomes assessed pre‐ and postintervention |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Sites were blocked on size and percent of male employees and randomly assigned by computer‐generated random numbers to condition within blocks" (p 2173, Setting) |
Allocation concealment (selection bias) | Unclear risk | The study does not address this criterion. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study does not address this criterion. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes measured were not subjective to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data and low rate of attrition that was consistent between groups |
Selective reporting (reporting bias) | Unclear risk | No mention of protocol |
Other bias | Low risk | Intervention delivery: mention of money incentive to complete paperwork, but was judged to have no effect on outcomes measured (p 2175) |