Bischoff‐Ferrari 2010.
Study characteristics | ||
Methods | Randomised trial: 2x2 factorial design | |
Participants | Triemli City Hospital, Switzerland
Period of study: January 2005 to December 2007
173 participants
Inclusion: aged 65 years or over with a surgically‐repaired hip fracture, MMSE ≥ 15, able to walk 3 m, German speaking, creatinine clearance of more than 15 mL/min (to convert to millilitres per second, multiply by 0.0167)
Exclusion: prior fracture of same hip, metastatic cancer or chemotherapy in the last year, severe visual or hearing impairment, kidney stone in the past 5 years, hypercalcaemia, primary hyperparathyroidism or sarcoidosis Age: mean 84 years (range 65 to 99) % male: 21 Number lost to follow‐up: 22. Analysed as ITT |
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Interventions | Extended physiotherapy plus high/low dose cholecalciferol 1. Extended physiotherapy plus 800 IU/d cholecalciferol. Supervised 60 min during acute care (additional 30 min home programme instruction each day during acute care) plus unsupervised home programme over 12 months. Advised to maintain usual diet and avoid additional calcium and cholecalciferol supplements. 2. Standard physiotherapy (supervised 30 min/day during acute care plus no home programme) plus 2000 IU/d cholecalciferol 3. Extended physiotherapy plus 2000 IU/d cholecalciferol. 4. Control. Standard physiotherapy (supervised 30 min/day during acute care plus no home program) plus 800 IU/d cholecalciferol. Advised to maintain usual diet and avoid additional calcium and cholecalciferol supplements. Only the comparison of standard versus extended physiotherapy eligible for inclusion in this review. |
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Outcomes | Length of follow‐up: 24 weeks Mortality Knee extensor Timed Up & Go EQ‐5D‐3L Adverse effects: re‐fracture rate, re‐admission, admission to institution, falls, mild hypercalcaemia, nephrolithiasis Adherence (total days and minutes of physiotherapy) |
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Notes | Measured adherence Funding: this study was supported by Swiss National Foundations (NFP‐53), Vontobel Foundation, Baugarten Foundation and Swiss National Foundations professorship grant PP00B‐ 114864. Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based randomisation |
Allocation concealment (selection bias) | Unclear risk | Not clearly reported |
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 |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | Outcome assessors blinded |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Outcome assessors blinded. All admission records were reviewed by 3 blinded co‐investigators to determine the main cause of re‐admission. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Outcome assessors blinded for health‐related quality of life. Blinding of personnel collecting fall data and answering hotline telephones was not specified. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | High risk | Large degree of loss to follow‐up. Although analysed as ITT, the high degree of attrition incurs a high risk of bias. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | High risk | Large loss to follow‐up |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | High risk | Large loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Mobility outcomes not clearly stated in study registration |
Free from baseline imbalance bias? | Low risk | Groups balanced at baseline |
Free from performance bias due to non‐trial interventions? | High risk | Extended physiotherapy had home visits which may have a confounding effect due to the social interaction |
Method of ascertaining falls | Low risk | Falls recorded via monthly telephone calls and a patient diary. Also, a telephone hotline to report falls at any time |