Lundstrom 2007.
Study characteristics | ||
Methods | Design: RCT of multi‐component delirium prevention intervention for older hip fracture patients Date of study: May 2000 to December 2002 Power calculation: yes Inclusion criteria: patients aged 70 years and older consecutively admitted to the orthopaedic department in Umea hospital, Sweden. Exclusion criteria: age under 70, severe rheumatoid arthritis, severe hip osteoarthritis, severe renal failure, pathological fracture and patients who were bedridden before the fracture | |
Participants | Sample size: 199
Country: Sweden
Setting: orthopaedic hip fracture patients
Age: Mean age 82 years
Sex: 74% female
Co‐morbidity: no baseline between group differences in cardiovascular disease, respiratory disease, hypertension or diabetes. More patients in control group with depression (46% versus 32%, P = 0.03)
Dementia: 27.5 % in intervention group, 37.1% in control group Frailty: not reported |
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Interventions | Intervention: multi‐disciplinary team providing comprehensive geriatric assessment, management and rehabilitation on a geriatric ward. Intervention comprising: staff education; teamwork; individual care planning; delirium prevention detection and treatment; prevention and treatment of complications; bowel/bladder function; sleep; decubitus ulcer prevention/treatment; pain management; oxygenation; body temperature measurement; nutrition; rehabilitation; secondary prevention of falls/fractures and osteoporosis prophylaxis Control: usual care on orthopaedic ward. |
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Outcomes | Outcomes reported: ‐ Incident delirium, diagnosed retrospectively using DSM‐IV based on nursing notes (for the duration of the inpatient stay) and organic brain scale (measured once between the 3rd and 5th postoperative day) ‐ Duration of delirium, diagnosed retrospectively using DSM‐IV based on nursing notes and OBS ‐ Length of admission ‐ Cognitive status, measured using MMSE ‐ Falls ‐ New pressure ulcers ‐ Psychological morbidity (Depression) ‐ Mortality ‐ inpatient and at 12 months Outcomes not reported: None Frequency of outcomes assessment: all patients tested once between day 3 and day 5 postoperatively using organic brain scale, MMSE and geriatric depression scale. Delirium diagnosed retrospectively after the study had finished by specialist in geriatric medicine blind to allocation group on the basis of the nursing assessments by applying the DSM IV criteria |
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Notes | Funding source: Swedish Research Council & Vardal Foundation Declarations of interest: not reported Prevalent delirium not excluded at enrolment (21.8% intervention group, 30.9% control group) but, patients with prevalent delirium appear to have been included in outcome data | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information given on how randomisation sequence generated |
Allocation concealment (selection bias) | Low risk | Sealed‐opaque envelopes to conceal allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | All staff aware of allocation group, patients potentially aware due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Staff recording outcome measurements not blind to study arm. Blinded specialist made diagnosis of delirium retrospectively based on staff measurements and medical/ nursing records |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised patients included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to assess |
Other bias | Low risk | No evidence of other bias |