Methods |
Randomized to decision aid vs usual care |
Participants |
126 + 122 men considering PSA testing in Australia |
Interventions |
DA: pamphlet on options' outcomes, clinical problem, outcome probability, explicit values clarification
Comparator: usual care using brief information on screening test and chances of false‐positive results |
Outcomes |
Preferred option, knowledge, decisional conflict, accurate risk perceptions, perceived ability to make an informed choice |
Notes |
Primary outcome was not specified |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Pre‐randomized code ‐ no further information (p 1) |
Allocation concealment (selection bias) |
Low risk |
Pre‐randomized code unobtrusively marked on envelopes (p 1) |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Consenting men were blinded to allocation, but unclear if personnel were blinded |
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 |
Pre‐test characteristics included. Flow chart not included and reasons for attrition not mentioned; some attrition but balanced between groups |
Selective reporting (reporting bias) |
Unclear risk |
No information provided |
Other bias |
Low risk |
Appears to be free of other potential biases |