Hempenius 2013.
| Methods | Design: multi‐centre, randomised controlled trial Date of study: June 2007‐June 2010 Power calculation: Yes but study underpowered Frequency of outcomes assessment: days 1‐10 postoperatively, 3 times per day 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 |
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| Participants | Number in study: 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 vs. 26.33 in usual care group (P = 0.49) |
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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 Usual care: only had access to geriatric care if treating physician requested referral |
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| Outcomes | 1. Incident delirium, using DOSS ‐ if > 3 then had specialist assessment using DSM‐IV. Assessments performed up to 10 days postoperatively 2. Delirium severity, using DRS‐R‐98 3. Length of admission 4. Mortality 5. Return to independent living 6. Postoperative complications 7. Quality of life using Short‐Form‐36 8. Falls |
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| Notes | Funding source: Netherlands Organisation for Health Research and Development Declarations of interest: "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 |
| Allocation concealment (selection bias) | Low risk | Central allocation system |
| Random sequence generation (selection bias) | Low risk | Interactive voice response telephone system for randomisation provided by university |
| 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 |