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. 2022 Sep 7;2022(9):CD001704. doi: 10.1002/14651858.CD001704.pub5

Williams 2016.

Study characteristics
Methods Randomised controlled trial. Stratified by hospital and gender
Participants 3 main acute hospitals of Betsi Cadwaladr University Health Board (BCUHB) in North Wales (Wrexham Maelor, Ysbyty Glan Clwyd and Ysbyty Gwynedd)
Period of study: June 2014 to June 2016
61 participants randomised (62 recruited)
Inclusion: age 65 years or older; recent proximal hip fracture; surgical repair by replacement arthroplasty or internal fixation; living in their own home prior to hip fracture; capacity to give informed consent, as assessed by the clinical team in the acute hospital; people with postoperative delirium were approached if this was resolved prior to discharge from the acute hospital; living and receiving rehabilitation from the National Health Service in the area covered by BCUHB
Exclusion: living in residential or nursing homes prior to hip fracture; not able to understand Welsh or English
Age: mean (SD) 79.4 (7.6); range 66 to 99
% male: 25
Number lost to follow‐up: 13/62
Interventions 1. Intervention: usual care plus enhanced rehabilitation package, including 6 additional home‐based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal‐setting diary
2. Control: usual care
Outcomes 3 months:
Walking speed
Barthel Activities of Daily Living
Nottingham Extended Activities of Daily Living scale
Eight‐foot Get Up and Go test
Sit to Stand
Pain
EuroQol‐5D
Mortality
Notes Measured adherence
‐ "Stratification by hospital was necessary as each hospital has differing usual care pathways and, due to the geography of the area, different therapy teams delivered the intervention in different areas".
‐ Timed Up and Go test and gait speed were only measured in people with unaided gait. Therefore they had very poor follow‐up (n = 24 of the 60 randomised, compared with n = 59 for primary outcome, the Barthel Index).
‐ The 3‐month follow‐up of TUG and gait speed were performed on average 3 weeks later in the control group than in the intervention group.
Funding: National Institute for Health Research’s Health Technology Assessment Programme
Conflict of interest: CS reports being a member of the NIHR HSDR board.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The randomisation was performed by dynamic allocation to ensure that good balance in the allocation ratio of 1: 1 was maintained, both within each stratification variable and across the trial. Participants were stratified by (1) hospital and (2) gender".
Allocation concealment (selection bias) Low risk "Randomisation was achieved by secure web access to the remote randomisation centre at the North Wales Organisation for Randomised Trials in Health (NWORTH) at Bangor University. This system was set up, maintained and monitored independently of the trial statistician and other trial staff".
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and intervention staff not blind to group allocation. Effect of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement Low risk Blinded assessors
Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement Unclear risk Adverse events were reported to researchers; however, blinding is not clear. Method of detecting death is unclear.
Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement High risk More than 20% did not complete 3‐month follow‐up for physical function tests.
Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home Unclear risk 20% withdrawals or loss to follow‐up; proportion followed up for death unclear
Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes High risk More than 20% did not complete 3‐month follow‐up for pain outcome.
Selective reporting (reporting bias) Low risk All outcomes in trial registration are reported in results section
Free from baseline imbalance bias? Unclear risk "The proportions in the two groups were similar according to gender, living status, type of property, type of fracture, type of surgery and admitting hospital. The mean age of the intervention group was 2.9 years older than the control group. After the hospital admission, there was a small discrepancy between those discharged directly to their place of usual residence (34% in the intervention group; 53% in the control group), and those sent to a community hospital for rehabilitation (52% in the intervention group; 22% in the control group). The baseline scores of the outcome measures and physical function tests were similar between the 2 groups (table 3). However, the Nottingham Extended Activities of Daily Living score was 2.4 points higher in the control group".
Free from performance bias due to non‐trial interventions? Unclear risk Pragmatic, usual care varied as per protocol

ADL: activities of daily living; AGT: antigravity treadmill; CBT: cognitive behavioural therapy; EQ‐5D(‐3L): EuroQol Quality of Life Questionnaire Five‐Dimensional Classification (3 levels); ES: electrical stimulation; HRQoL: health‐related quality of life; ITT: intention to treat; IU: international units; MMSE: Mini Mental State Examination; N·m/kg: newton‐metre/kilogram; PAM: physical activity monitor; RM: repetition maximum; ROM: range of motion; SD: standard deviation; SF‐12/SF‐36: 12‐Item/36‐Item Short Form Health Survey; TENS: transcutaneous electrical nerve stimulation; TUG: Timed Up and Go test; VAS: visual analogue scale; WHOQOL‐BREF: World Health Organization abbreviated Quality of Life scale