Davison 1997.
Methods | Randomized to decision aid + audio‐taped consultation vs usual care | |
Participants | 30 + 30 men with prostate cancer considering treatment in Canada | |
Interventions | DA: written + audiotape consultation of options' outcomes, clinical problem, outcome probability, others' opinion Comparator: usual care (general information pamphlets on clinical problem) | |
Outcomes | Primary outcomes: role in decision making Secondary outcomes: anxiety, depression |
|
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The group to which subjects were assigned was predetermined by a block randomization procedure. This ensured there were an equal number of subjects in both groups for each physician." (p 5, Data collection) |
Allocation concealment (selection bias) | Unclear risk | Not mentioned; group assignment predetermined by block randomization procedure (p 5) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No blinding; study does not report on how the results could be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear blinding and whether outcomes could be affected by unblinded assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No flow diagram; p 12 explains why certain men did not listen to audiotape. All men approached by study investigator agreed to participate; only 1 man refused to complete the second set of questionnaires. |
Selective reporting (reporting bias) | Unclear risk | Protocol not mentioned |
Other bias | Low risk | Appears to be free of other sources of bias; similar baseline characteristics |