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. 2017 Apr 12;2017(4):CD001431. doi: 10.1002/14651858.CD001431.pub5

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
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)
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