Botella‐Carretero 2010.
Methods | Method of randomisation: randomised, open two‐arm trial, using sealed opaque envelopes Intention‐to‐treat analysis: in acute hospital; complications, length of stay, mobilisation not collected after moved to another centre for rehabilitation Lost to follow‐up: 53% lost to complete follow‐up (moved to another centre for rehabilitation) |
|
Participants | Location: Hospital Universitario Ramon y Cajal, Madrid, Spain Period of study: recruitment May 2007–September 2008 60 participants Inclusion criteria: age > 65 years, hip fracture where orthopaedic surgery considered treatment of choice Exclusion criteria: moderate–severe malnutrition (weight loss of > 5% in the previous month or > 10% in the previous 6 months, and/or serum albumin concentrations < 2.7 g/dL), acute and/or chronic renal failure, hepatic insufficiency or cirrhosis (Child B or C), severe heart failure with class III or IV of the New York Heart Association, respiratory failure, gastrointestinal condition precluding adequate oral nutritional intake. Sex: 44 female, 16 male Age: mean 84 years Fracture type: fracture type not given |
|
Interventions | Timing of intervention: from admission (including pre‐operative) until discharge (a) Energy and protein supplements by means of commercial enteral nutrition for oral intake (Fortimel, 200 mL bricks, each provides 20 g protein and 200 kcal, Nutricia Advanced Medical Nutrition – Danone Group) to aim at 40 g of protein and 400 kcal per day (2 bricks a day) and every participant was prescribed a standard or texture‐adapted diet to meet their calculated metabolic rate. The Harris–Benedict equation was employed to calculate the basal metabolic rate and a coefficient of 1.3 was employed to estimate the total metabolic rate. In‐hospital diets provided a mean of 100 g of protein per day (range 80–120 g). (b) Every participant was prescribed a standard or texture‐adapted diet to meet their calculated metabolic rate. The Harris–Benedict equation was employed to calculate the basal metabolic rate and a coefficient of 1.3 was employed to estimate the total metabolic rate. In‐hospital diets provide a mean of 100 g of protein per day (range 80–120 g). Allocated: 30/30 Assessed: 18/14 |
|
Outcomes | Length of follow‐up: until discharge from hospital Main outcomes: Mortality Postoperative hospital stay, Postoperative hospital complications Requiring rehabilitation Other outcomes: Compliance |
|
Notes | Emailed jbotella.hrc@salud.madrid.org 25 November 2014 to enquire about numbers in intervention and control groups going to rehabilitation hospital (text differs from flow chart) and whether data were collected in rehabilitation hospital for complications, mobilisation and length of stay. Replied with further information 26 November 2014 for all these queries | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "patients were randomized using sealed opaque envelopes to yield two groups with 30 patients each." |
Allocation concealment (selection bias) | Low risk | States "patients were randomized using sealed opaque envelopes to yield two groups with 30 patients each... The investigators who designed the study prepared the envelopes and assigned participants to their groups, but had no contact with the patients throughout the study. The investigator recruiting the patients, administering the interventions and evaluating the outcomes had no role on the randomization process." |
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 also "The investigator recruiting the patients, administering the interventions and evaluating the outcomes had no role on the randomization process." 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 "The investigator recruiting the patients, administering the interventions and evaluating the outcomes had no role on the randomization process." Comment: may have been influenced by lack of blinding |
Incomplete outcome data (attrition bias) Primary outcomes | High risk | Missing outcome data balanced in numbers across intervention (18) and control groups (14), but proportion high enough to likely induce a clinically relevant bias in observed effect size |
Incomplete outcome data (attrition bias) Secondary and other outcomes | High risk | Missing outcome data balanced in numbers across intervention (18) and control groups (14), but proportion high enough to likely induce a clinically relevant bias in observed effect size |
Selective reporting (reporting bias) | Unclear risk | Insufficient details provided to judge |
Other bias | Low risk | States "The funding source, Fundacion para la Investigacion Biomedica, Hospital Ramon y Cajal (FIBio‐RyC), Madrid, Spain, had no role in the study design, the collection, analysis, and interpretation of data, the writing of the report, or the decision to submit the paper for publication. The ONS employed in this study were provided by the Hospital Ramo´n y Cajal, Madrid, Spain." |