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 |
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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 |
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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 |
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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 |