Watne 2014.
Study characteristics | ||
Methods | Randomised trial: sealed, opaque, numbered envelopes; stratified by whether or not the patients were admitted from nursing homes Assessor blinding: yes, for study nurses assessing participants at follow‐up visits and two specialists assessing dementia Length of follow‐up: 12 months | |
Participants | University hospital in Oslo, Norway.
Conducted: September 2009 to January 2012 (recruitment).
332 people with hip fracture. 25.1% male. Median age 85 years, range 46 to 101. Cognitive status: of 329, 49.2% had dementia.
Inclusion criteria: acute admission for hip fracture (femoral neck fracture, a trochanteric or a sub‐trochanteric fracture). Informed consent by patient or relative.
Exclusion criteria: hip fracture was a part of a high‐energy trauma (defined as a fall from higher than one metre), terminal illness on admission. Not resident in catchment area of hospital. Assigned (3 'moribund patients' excluded): 163/166 [Geriatric ward / Orthopaedic ward] Assessed (mortality): 163/166 Loss to follow‐up (at 12 months): 65 versus 71 (deceased, withdrew, hospitalised, unreachable). |
|
Interventions | Randomisation took place in the emergency department, overseen by the duty orthopaedic surgeon (thus before surgery). Transfer to the allocated wards was as soon as possible, with return to the same ward after surgery and a few hours in the postoperative care unit.
(1) Acute geriatric ward: Preoperative and postoperative orthogeriatric care integrated in an acute geriatric ward. Comprehensive Geriatric Assessment (CGA) was used as a basis for treatment planning. All team members (geriatrician, nurse, physiotherapist and occupational therapist) were expected to assess patients during their first day on the ward. The team had daily meetings to co‐ordinate treatment and to plan discharge. Piloted clinical routines, with checklists, included medication reviews, early and intensive mobilisation, optimising pre‐ and postoperative nutrition (including supplementation) and early discharge planning.
(2) Orthopaedic ward. There were no multidisciplinary meetings and no geriatric assessments. Early mobilisation was emphasised, and hip fracture patients were seen by a physiotherapist soon after surgery. Relevant specialists were seen on request. The postoperative care unit was within the orthopaedic ward, where all trial participants were observed after surgery. All participants were offered a follow‐up appointment in the orthopaedic outpatient clinic four months after surgery. There was no additional intervention after discharge from hospital. |
|
Outcomes | 'Poor outcome': mortality at 12 months + new nursing home admissions + lost‐to‐follow‐up because of being hospitalised or too ill to approach (also available at 4 months) Other outcomes: mortality (in hospital, 4 and 12 months); patient function (mobility; ADL at 4 and 12 months); length of stay; discharge to rehabilitation facility; new nursing home admissions (4 and 12 months); readmissions (at 4 and 12 months); morbidity, medical and surgical complications; delirium and dementia | |
Funding and conflict of interest statements | Funding was mainly by the Research Council of Norway (grant 187980/H10). Also Oslo University Hospital, the Sophies Minde Foundation, the Norwegian Association for Public Health and Civitan's Research Foundation. The sponsors had no role in the design, conduct and reporting of the trial. The authors declared they had no competing interests. | |
Notes | The acute geriatric ward (20 beds) mainly admitted older patients suffering from acute medical disorders; the only surgical patients treated in the ward were the hip fracture patients included in the trial. Since the acute geriatric ward was regularly full, the ward was instructed to admit included hip fracture patients even if these had to be treated in the corridor until a room was available, usually within the first 24 hours. The orthopaedic ward (52 beds) admitted a range of elective and non‐elective orthopedic patients. The staff‐patient ratio was similar to that of the acute geriatric ward. Subgroup data available for participants with dementia and those from nursing homes. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was based on computer‐generated random numbers (blocks of variable and unknown size) and was carried out by a statistician (ES) not involved in the clinical service. Randomization was stratified according to whether or not the patients were admitted from nursing homes." |
Allocation concealment (selection bias) | Low risk | "Allocation was by sealed, opaque, numbered envelopes." |
Blinding (performance bias and detection bias) Death, residence, readmission | Unclear risk | Participants and care personnel were not blinded. However, these outcomes less susceptible to detection bias. |
Blinding (performance bias and detection bias) Function, QOL | High risk | Participants and care personnel were not blinded. Data collected at the 4 and 12 months' follow‐up were collected by study nurses blind to allocation. However, as reported in the protocol, in "5‐10% of the cases" the research nurses were unblinded because of information from the trial participants or their relatives. |
Incomplete outcome data (attrition bias) Death, residence, readmission | Low risk | This assessment after consideration of two minor intention‐to‐treat deviations: the post‐randomisation exclusion of 3 moribund patients (incorrectly included) and the analysis of the results of two patients according to the ward they received treatment (one in each group) instead of their allocated ward. |
Incomplete outcome data (attrition bias) Function, QOL | High risk | In part reflecting that 27% had died by 12 months, but data for function were only available for 59% of the population at that time. |
Selective reporting (reporting bias) | Low risk | Although trial was registered after recruitment had started, and the protocol reported on the numbers randomised, there did not appear to be problems with selective outcome reporting. All recorded outcomes were reported. |
Free of bias resulting major imbalances at baseline | Low risk | Participants in the two groups were "well matched" with no major differences in baseline characteristics. |
Free of performance bias (from non‐trial differences in care provision)? | Low risk | This was equivalent as evidenced: "The staff‐patient ratio was similar [in the orthopaedic ward] to that of the acute geriatric ward." "All patients included in the trial were offered a control in the orthopedic outpatient clinic four months after surgery. There was no additional intervention after discharge from hospital." |
Free of detection bias (from e.g. differences in follow‐up procedures)? | Low risk | Identical follow‐up procedures. |