Kimmel 2016.
Study characteristics | ||
Methods | Randomised controlled trial. Randomly assigned by computer program | |
Participants | The Alfred Hospital, a level 1 trauma centre, Melbourne, Australia Period of study: March 2014 to January 2015 92 participants Inclusion: at least 65 years old, admitted with an isolated subcapital or intertrochanteric hip fracture, treated by internal fixation or hemiarthroplasty Exclusion: subtrochanteric or pathological fracture; postoperative orders for non‐weight bearing on the operated hip; unable to move independently or needed a gait aid prior to admission; admitted from nursing home Age: mean (SD) = 81.3 (8.2) % male: 36 Number lost to follow‐up: 13 (died = 1, unable to contact via telephone at 6 months = 12) | |
Interventions | 1. Intervention group: usual care* in the morning plus 2 additional daily sessions, 7 days per week. One session (delivered by allied health assistant) practised the achievements of the morning session. One session (delivered by physiotherapist) aimed to improve the functional advances achieved during the earlier physiotherapy session; e.g. increased independence, progression of gait aid (e.g. from frame to crutches) and increasing the distance walked. 2. Control: usual care* in the morning *Usual care: participants in both groups received daily physiotherapy according to usual practice in the trauma centre, 7 days per week. Treatment was individualised and involved bed‐based limb exercises (e.g. strength exercises, such as knee extension, and active hip exercises) and gait re‐training. The goal was early, independent transfer and mobility, with the objective of discharge directly home or to fast stream rehabilitation. |
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Outcomes | Length of follow‐up: Mobility and Modified Iowa Level of Assistance outcomes = Day 5 postop (or discharge, if discharged before Day 5); QOL 6 months. Modified Iowa Level of Assistance score (hip‐fracture‐specific outcome, with 6 domains, including bed and chair transfer, ambulation, ascending/descending 1 step, and gait aid used, 0 (independent in all activities without a gait aid) to 36 (unable to attempt any of the activities). Day 5 or day of discharge (if earlier) Timed Up and Go test Day 5 or day of discharge (if earlier) Length of stay (acute, inpatient rehabilitation, combined) Inpatient complication Re‐admission SF‐12, EQ‐5D (6 months) Discharge destination Death |
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Notes | Resource use collected: physiotherapy hours of service, acute / rehab / combined hospital length of stay Funding: Victorian Department of Health (Workforce Innovation and Allied Health) Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned by computer program" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not specified. Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear. The usual care physiotherapist was blinded to allocated group. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | Blinding specified for Modified Iowa Level of Assistance, Timed Up and Go test. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Blinding not specified, but likely as data were collected from Victorian Orthopaedic Trauma Outcomes Registry, for SF‐12, EQ‐5D and Glasgow Outcome Scale. Blinding not specified for length of stay, inpatient complications, re‐admissions. Outcome measurement is unlikely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Health‐related quality of life data derived from data in the Victorian Orthopaedic Trauma Outcomes Registry. Can assume this was collected by personnel blinded to the study. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | Timed Up and Go test performed only for people who could walk, so only 40/92 (42%) of participants contributed to this measure. All participants contributed to other measures at 5 days postop. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | 13/92 (14%) lost to follow‐up at 6 months |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Low risk | 15% lost to follow‐up at 6 months for health‐related quality of life |
Selective reporting (reporting bias) | Low risk | All outcomes specified in trial registry and methods section were reported in the results |
Free from baseline imbalance bias? | High risk | There were statistically significant between‐group differences in anaesthetic type (general versus spinal), proportion of men, and having a carer at home. |
Free from performance bias due to non‐trial interventions? | Low risk | Care and experience of care providers was consistent across groups |