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

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
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
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