Marcantonio 2011.
| Methods | Design: Pilot randomised controlled trial of donepezil for delirium after hip fracture Date of study: January 2007 ‐ August 2008 Power calculation: No Frequency of outcomes assessment: Daily during hospital stay and at weeks 2, 4 and 6 Inclusion criteria: Admitted to the orthopaedic service for surgical repair of hip fracture and: age 70 and older, English speaking, residence within 40 mile radius of medical centre, life expectancy 6 months or greater, not currently taking cholinesterase inhibitor therapy Exclusion criteria: Pathological fracture due to metastatic cancer, advanced dementia, little potential for functional recovery |
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| Participants | Number in study: 16 Country: USA Setting: Orthopaedic hip fracture patients Age: Mean age 88.0 years (SD 5.2) in intervention group; 87.0 (3.7) in control group Sex: 71% female in intervention group; 44% female in control group Co‐morbidity: Not reported Dementia: 43 % in intervention group, 44% in control group |
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| Interventions | Intervention: 5 mg dose of donepezil initiated on the day before or within 24 hours of surgery and continued for a total of 30 days. Control: Matching placebo. All participants received perioperative co‐management from a geriatric team on orthogeriatric ward |
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| Outcomes | 1. Incident delirium, measured using CAM but not included in meta‐analysis as reported as cumulative measures within individuals 2. Delirium severity, measured using MDAS 3. Withdrawal from trial 4. Adverse events |
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| Notes | Funding Source: National Institute of Aging Declarations of interest: "The authors have no financial or any other kind of personal conflicts with this paper" Delirium not excluded at enrolment Only 16 participants in pilot trial |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Adequate allocation concealment likely: on‐site pharmacy prepared and dispensed active medication and placebo; study team masked to treatment assignment. |
| Random sequence generation (selection bias) | Unclear risk | Permuted block randomisation used but method of sequence generation not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and personnel blinded to allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Delirium assessment conducted by trained research interviewer blinded to allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis performed, all randomised participants included in the analysis |
| Selective reporting (reporting bias) | Low risk | Protocol for Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (SHARP) NCT00586196; reporting in accordance with protocol |
| Other bias | Low risk | No evidence of other bias |