McCaffery 2010.
Methods | Randomized to decision aid + informed choice vs HPV testing vs repeat smear | |
Participants | 104 + 104 + 106 women screened as HPV indeterminate considering HPV testing in Australia | |
Interventions | DA: pamphlet on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, others' opinion and guidance (worksheet) Comparator 1: no decision support, received immediate HPV testing Comparator 2: no decision support, received a repeat cervical smear at 6 months |
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Outcomes | Primary outcomes: quality of life (post‐DA) Secondary outcomes: waiting time anxiety (post‐DA), , perceived risk (post‐DA), perceived seriousness of cancer (post‐DA), worriedness (post‐DA), intrusive thoughts (post‐DA), satisfaction with care (post‐DA), anxiety (post‐DA), distress and concerns (post‐DA), self‐esteem (post‐DA), effect on sexual behaviour (post‐DA), help seeking behaviour (post‐DA), knowledge (post‐DA) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomised centrally by the research team within each clinic in blocks of three" (p 2, Design) |
Allocation concealment (selection bias) | Low risk | "Participants were randomised centrally by the research team within each clinic in blocks of three" (p 2, Design) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Patients and staff were unblinded, but objective outcomes were used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcomes are on questionnaires; not subject to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Figure 3: sensitivity analysis was done to include most of the patients |
Selective reporting (reporting bias) | Low risk | Protocol available |
Other bias | Low risk | Appears to be free of other sources of bias |