Hanson 2011.
Methods | Randomized to decision aid vs usual care | |
Participants | 127 + 129 patients diagnosed with advanced dementia and eating problems considering long‐term feeding tube placement in the USA | |
Interventions | DA: booklet or audio recording on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, others' opinion, guidance (steps in decision making, worksheet, summary) Comparator: usual care |
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Outcomes | Primary outcomes: decisional conflict (3 months post‐DA) Secondary outcomes: surrogate knowledge, risk perceptions, frequency of communication with providers (3 months post‐DA), feeding treatment use (3, 6 and 9 months post‐DA), participation in decision making, satisfaction with the decision, decisional regret |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerized random number generation (p 2010, Randomization) |
Allocation concealment (selection bias) | Unclear risk | No description of method used to conceal allocation (p 2010, Randomization) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Cluster randomization prevented double blinding and may have introduced bias due to site effects" (p 2014, Discussion); study authors unsure of effect on study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "[B]ecause of cluster randomization, data collectors were not blinded to group assignment" (p 2010, Randomization); authors believe has little impact on study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Intervention group missing data for 1 participant, reason for omission not reported (table 1) No explanation for number of participants in each group (n = 127) given numbers vary from those in 'recruitment and retention' figure (table 4) |
Selective reporting (reporting bias) | Low risk | Registered with clinicaltrials.gov, protocol on website |
Other bias | Low risk | Appears to be free of other potential biases |