| Methods |
Method of randomisation: numbered opaque sealed envelopes, unclear if randomisation fully concealed since the envelopes prepared and opened by the same research nurse
Assessor blinding: not reported
Intention‐to‐treat analysis: appears so
Lost to follow‐up: details given |
| Participants |
Location: hospital(s) in Stockholm, Sweden
Period of study: before October 2002
40 participants
Inclusion criteria: age at least 70 years, BMI 24 kg/m2 or less, not institutionalised, absence of severe cognitive dysfunction, independent walking with or without walking aids
Exclusion criteria: fracture not suitable for internal fixation, displaced fracture older than 24 h at time of arrival in emergency room, rheumatoid arthritis, radiographic osteoarthritis
Sex: all female
Age: mean age 84 years
Fracture type: 40 femoral neck (24 displaced) |
| Interventions |
Timing of intervention: 6 months, unclear when started
(a) Fortimel protein‐rich liquid oral supplement, 20 g protein/200 ml, unclear if 200 or up to 400 ml/day
(b) Standard treatment
(c) Nandrolone decanoate (anabolic steroid) 25 mg intramuscular injection/3 weeks and Fortimel as in (a): group not included in review
Allocated: 20/20
Assessed: 20/20 for mortality |
| Outcomes |
Length of follow‐up: 12 months
Main outcomes:
Mortality
Morbidity and complications: deep infection, urinary tract infection, fracture healing complication
Length of hospital stay
Activities of daily living: Katz score, mobility
Quality of life: EuroQol
Fracture healing
Adverse events
Other outcomes:
Patient compliance |
| Notes |
Request for further details (complications) sent. Reply from trialists (14 October 2004) gave further details of infections. Request for further details (randomisation) sent. Reply from trialists (10 November 2004) gave full details of randomisation process |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States randomised, but no further details on sequence generation |
| Allocation concealment (selection bias) |
Unclear risk |
"Patients were randomised, using opaque sealed envelopes". (Also numbered.) However, the envelopes were prepared and opened by the same research nurse, involved in the trial |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No placebo group. Comment: likely to have been influenced by lack of blinding |
| Blinding of outcome assessment (detection bias)
Primary outcomes |
Low risk |
No placebo group. States that " A research nurse not involved in the surgery or clinical decisions assessed all clinical variables." Comment: unlikely to have been influenced by lack of blinding |
| Blinding of outcome assessment (detection bias)
Secondary and other outcomes |
Unclear risk |
No placebo group. States that " A research nurse not involved in the surgery or clinical decisions assessed all clinical variables." Comment: may have been influenced by lack of blinding |
| Incomplete outcome data (attrition bias)
Primary outcomes |
Unclear risk |
Two in control group and one in supplement group lost to follow‐up, unlikely to have an impact on outcome assessment |
| Incomplete outcome data (attrition bias)
Secondary and other outcomes |
Unclear risk |
Two in control group and one in supplement group lost to follow‐up, unlikely to have an impact on outcome assessment |
| Selective reporting (reporting bias) |
Low risk |
Protocol not available, but expected outcomes provided |
| Other bias |
High risk |
Displaced fractures in 75% of controls and 45% of supplement group. Funded by Trygg‐Hansa Insurance Company, the Swedish Orthopaedic Association, the Swedish Research Council, Novo Nordic Fund, Nutricia Nordic AB and Nycomed AB |
