Smith 2010.
Methods | Randomized to detailed vs simple decision aid vs usual care | |
Participants | 196 + 188 + 188 socioeconomically disadvantaged participants diagnosed with average or slightly above average risk of bowel cancer considering bowel cancer screening in Australia | |
Interventions | DA: booklet + DVD + worksheet + question prompt list on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, guidance (step‐by‐step process for making the decision; worksheet; encourages patients to communicate with practitioners by asking questions; summary) Comparator: booklet + DVD + worksheet on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, guidance (step‐by‐step process for making the decision; worksheet; encourages patients to communicate with practitioners by asking questions; summary) Comparator: usual care using standard information booklet |
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Outcomes | Primary outcomes: values congruent with chosen option (post‐DA), participation in decision making (pre, post‐DA) Secondary outcomes: knowledge (pre, post‐DA), attitude, actual choice (post‐DA), decisional conflict (post‐DA), decision satisfaction (post‐DA), confidence in decision making (post‐DA), general anxiety (post‐DA), worry about developing bowel cancer (pre, post‐DA), risk perception Other outcomes (Smith 2014): screening participation (357 + 173 participants) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants who verbally consented to take part were then randomised to one of the three groups using random permutated blocks of size 6 and 9 for each sex stratum" (p 3, Participants and recruitment section) |
Allocation concealment (selection bias) | Low risk | Central allocation; "interviewers responsible for recruiting participants were not aware of the randomization sequence or allocation and therefore did not know which intervention respondents would receive" (p 3, Participants and recruitment section) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "It was not possible for the reviewers to be blinded to the group allocation. However, all questions used standardised wording with pre‐coded responses and were asked within a supervised environment, where interviewer performances were regularly monitored to ensure scripts were read as written" (p 3, Outcome measures section) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "[A]nalyses were by intention to treat and carried out blinded to intervention" (p 5, Statistical analysis section); outcomes measured were not subject to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Explanation for the missing data reported at base of tables |
Selective reporting (reporting bias) | Low risk | Study protocol available (ClinicalTrials.gov NCT00765869 and Australian New Zealand Clinical Trials Registry 12608000011381) |
Other bias | Low risk | Appears to be free of other potential sources of bias |