Hanson 2011

Methods	Cluster randomised controlled trial, in 24 nursing homes in the US, randomisation at the nursing home level, with enrolment over a 2‐year period.
Participants	In total, 256 dyads of a resident with advanced dementia and feeding problems and their surrogate were enrolled in the study, 127 in intervention group, 129 in control group. Of these, 90 dyads included a resident with advanced dementia staged as GDS 7 and their surrogate, 46 in intervention group, 44 in control group.
Interventions	Intervention: surrogates received a structured decision aid (printed or audio version) providing information about dementia and feeding options, including feeding for comfort near the end of life, and the outcomes, advantages and disadvantages of feeding tubes or assisted oral feeding. The decision aid also discussed the surrogate's role in decision making. Surrogates reviewed the decision aid during their enrolment interview and received the printed decision aid to take home. Research assistants prompted the surrogates to discuss the decision aid with healthcare providers. Control: surrogates received usual care, including any information typically provided by healthcare providers.
Outcomes	For all study participants: Primary outcome: decisional conflict at 3 months, measured by the Decisional Conflict Scale (O'Connor 1995) Secondary outcomes (at 3 months): surrogate knowledge about dementia and feeding options, surrogate‐reported frequency of feeding discussions between surrogate and care provider, and feeding treatment use Secondary outcomes (at 9 months): use of new feeding tubes, number of 'do not tube feed' orders, weight loss and mortality Outcomes included in re‐analysis of subset of participants meeting the inclusion criteria of this review (as requested by review team): Primary outcome: decisional conflict at 3 months, measured by the Decisional Conflict Scale (O'Connor 1995) Secondary outcomes: frequency of feeding discussions between surrogate and care providers and the use of assisted feeding treatments
Notes	90/256 (35%) participants had advanced dementia as defined for this systematic review (staged at GDS 7). The study team reran the analysis to produce data for this subset of the study population for this review. Funding source: NIH‐National Institute for Nursing Research RO1 NR009826
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Nursing homes were randomized in pairs matched on variable associated with tube feeding rates… Paired nursing homes were assigned to intervention or control conditions by computerized random number generation conducted by a single investigator (JG)."
Allocation concealment (selection bias)	Low risk	"Randomization was completed and allocation concealed prior to enrolment."
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Information shared with physicians and other health care providers was specific to intervention or control assignment, and direct health care providers were told the general purpose of the study but did not know specifically what the outcome measures were." It was not possible to blind surrogates to the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	"Due to cluster randomization, data collectors were not blinded to group assignment." We judged this lack of blinding to be a high risk of bias for all outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Numbers lost to 3‐month follow‐up in both groups was low (5% and 13%).
Selective reporting (reporting bias)	Low risk	All outcomes listed in the Methods section were reported and there was no evidence of selective outcome reporting.
Recruitment bias (cluster trials only)	High risk	Because of the nature of the intervention, nursing homes were randomised before recruitment of all participants and surrogate dyads.
Other bias	Low risk	Baseline imbalance between clusters and cluster effects both accounted for in analysis.

FAST: Functional Assessment Staging Test; GDS: Global Deterioration Scale.