Volk 1999.
Methods | Randomized to decision aid vs usual care | |
Participants | 80 + 80 men considering PSA testing in the USA | |
Interventions | DA: Health Dialog videotape and brochure on options' outcomes, clinical problem, outcome probability, others' opinion Comparator: usual care | |
Outcomes | Primary outcomes: knowledge, preferred/uptake of option | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Volk 1999 (primary study), p 3: "[r]andomization by permuted blocks" "Each block included the numbers 1 through 4"; Volk 2003, p 2, Methods: Randomization by permuted blocks was used to balance the number of subjects in each arm of the study. |
Allocation concealment (selection bias) | Unclear risk | Volk 1999 (primary study): no information provided Volk 2003, p 2: "[d]etails of the study procedures, subjects, and 2‐week follow‐up results can be found elsewhere" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were not blinded to the treatment assignment, but the physicians were; therefore outcomes were unlikely to be biased. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Interviewers were not blinded but outcomes were objectively measured and not subjective to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Volk 1999 (primary study), p 2, Procedures: baseline values included. Volk 2003, p 4 Fig 1 ‐ flow diagram; baseline data not included |
Selective reporting (reporting bias) | Unclear risk | No information provided |
Other bias | Low risk | Volk 1999 (primary study): appears to be free of other potential biases Volk 2003: appears to be free of other sources of bias |