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. 2021 Nov 26;2021(11):CD013307. doi: 10.1002/14651858.CD013307.pub3

Hempenius 2013.

Study characteristics
Methods Design: multi‐centre, RCT
Date of study: June 2007‐June 2010
Power calculation: yes but study underpowered
Inclusion criteria: over 65 yrs; due to undergo elective surgery for a solid tumour, deemed to be frail (using Groningen Frailty Indicator >3)
Exclusion criteria: unable to complete protocol; unable to complete follow‐up; unable to complete questionnaire
Participants Sample size: 297
Country: the Netherlands
Setting: 3 hospitals (1 university medical centre, 1 teaching hospital and 1 community hospital)
Age: Mean age 77.45 (SD 6.72) in intervention group; 77.63 (SD 7.69) in usual care group
Sex: 62.2% of intervention group were female compared with 65.8%of usual care group
Co‐morbidity: stratified into < or equal to 2 co‐morbidities (39.6% of intervention group 40.4% of usual care group) or >2 co‐morbidities (60.4% in intervention group 59.6% of usual care group)
Dementia: MMSE performed at baseline; mean score 26.6 in intervention group versus 26. 33 in usual care group (P = 0.49)
Frailty: not reported
Interventions Intervention: multi‐component intervention focused on best supportive care and the prevention of delirium. Preoperative geriatric team assessment with daily monitoring during hospital stay, supported by the use of standardised checklists
Control: only had access to geriatric care if treating physician requested referral
Outcomes Outcomes reported:
‐ Incident delirium, using DOSS ‐ if > 3 then had specialist assessment using DSM‐IV.
‐ Delirium severity, using DRS‐R‐98
‐ Length of admission
‐ Mortality
‐ Return to independent living
‐ Postoperative complications
‐ Quality of life using Short‐Form‐36
‐ Falls
‐ ADL using validated instrument using the Care Dependency
Scale (CDS)
‐ Withdrawals
Outcomes not reported: none
Frequency of outcomes assessment: days 1‐10 postoperatively, 3 times per day
Notes Funding source: Netherlands Organisation for Health Research and Development
Declarations of interest: quote: “The authors declared that no competing interests exist”
Delirium not excluded at enrolment
No record of how many in usual care group received geriatrician input
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Interactive voice response telephone system for randomisation provided by university
Allocation concealment (selection bias) Low risk Central allocation system
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and research nurses unblinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Delirium assessment blinded to allocation
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 297 participants randomised, outcome assessments available for 260 (n = 127 in intervention group and n = 133 in control
group) ‐ no information provided, described as ’lost to follow‐up’
Selective reporting (reporting bias) Low risk Outcomes reported as per original protocol
Other bias Low risk No evidence of other bias