Tidermark 2004.
| Methods | Randomised controlled trial | |
| Participants | 60 women (mean age 82.9 years) aged over 70 years treated surgically (internal fixation) for an acute femoral neck fracture Inclusion criteria: aged over 70 years, body mass index (BMI) less than or equal to 24 kg/m², without severe cognitive dysfunction, independent living status and independent walking capability with or without walking aids Exclusion criteria: fracture not suitable for internal fixation, i.e. pathological fractures or were displaced fractures older than 24 hours at the time of arrival at the emergency room; rheumatoid arthritis; or radiographic osteoarthritis |
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| Interventions | Steroid group: nandrolone decanoate (Deca‐Durabol 25 mg every 3 weeks) + protein‐rich formula (Fortimel 200ml/day, 20 g protein/day) + daily calcium (1g) and vitamin D (CalchichewD3 800 IE), N = 20 Protein supplementation group: protein‐rich formula (Fortimel) + daily calcium + vitamin D, N = 20 Control group: daily calcium and vitamin D, N = 20 Intervention period: 6 months Analysis: 17 versus 18 versus 17 at 12 months |
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| Outcomes | Follow‐up: assessments at 6 and 12 months 1. Katz index (activities of daily living) 2. EQ‐5D 3. Mobility (data not shown in trial report) 4. Mortality 5. Fracture healing complications 6. Urinary tract infections 7. Nutritional indices 8. Body composition 9. Length of hospital stay |
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| Setting | Soder Hospital then in the community, Stockholm, Sweden | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random sequence generation not described |
| Allocation concealment (selection bias) | Low risk | "The patients were randomised, using opaque, sealed envelopes, to open treatment during 6 months" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The study was an open label study with no blinding of participants. Of note, however, is that the research nurse visited all patients "in order to minimise differences between treatments" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "A research nurse not involved in the surgery or clinical decisions assessed all clinical variables." No mention of blinding, however |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Patient flowchart provided: "One patient in the PR/N group withdrew her consent after inclusion and was accordingly excluded from the follow‐up. Two patients (3%) died and 5 (8%) were lost to follow‐up, giving a total of 52 out of 59 patients (88%) available at the final follow‐up (Fig. 1)." Intention‐to‐treat analysis not mentioned |
| Selective reporting (reporting bias) | Unclear risk | No description of protocol provided in the text of the review but the outcomes mentioned in the methods section were all reported in the results. Actual figures of the Katz Index were not provided. Instead the results were dichotomised into functionally independent and functionally dependent groups and the results were presented as a graph, which makes it impossible to pool results in meta‐analysis. EQ‐5D scores were also presented as graph only using linear regression. No mean scores or mean change scores were provided. Posthoc analysis was performed but was not intended and it was published separately |
| Other bias | Low risk | No signs of baseline differences among the groups and no signs of early termination of the trial |