UWL: Food, Appetite and Environment (2009)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To review the effectiveness, safety and acceptability of nutritional interventions in the care of older people recovering from hip fracture.

Inclusion Criteria:
  • Randomized and quasi-randomized controlled trials of nutritional interventions for people age older than 65 years with hip fracture
  • Older people recovering from any type of hip fracture
  • Trials that could not be analyzed on an intention-to-treat basis were included
  • Trials were included despite lack of blinding or placebo treatment
  • Studies reporting results on mixed populations of orthopedic or other geriatric patients were included only if either separate data were available from the patients with fracture of the hip or when contact with the authors resulted in the provision of such data
  • Participants studied may have resided in a hospital or in a rehabilitation unit, or any location after discharge from either of these facilities.
Exclusion Criteria:
  • Studies of nutrition interventions that examined the secondary prevention of osteoporotic fractures after hip fracture
  • Trials that focused specifically or mainly on younger participants, multiple trauma patients or participants with pathological fractures (e.g., cancer-related fractures)
  • Trials published before 1980 with undefined geriatric populations or with mixed populations with fewer than five hip fracture patients in each intervention group
  • Trials evaluating intravenous fluid administration in the immediate post-operative period for hydration purposes.
Description of Study Protocol:

Recruitment

The following databases were searched: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register through December 2005; the Cochrane Central Register of Controlled Trials (through 2006, Issue 1); MEDLINE (1966 to January 2006); Nutrition Abstracts and Reviews (1984 to December 2005); the National Research Register (through Issue 1, 2006); EMBASE (1980 to week four, 2006); BIOSIS (1985 to January 2006); CINAHL (1982 to December 2005); HEALTHSTAR (1975 to March 2002) and reference lists of articles. Investigators were also contacted. Journals were hand-searched. Several search strategies were used.

Design

Systematic review.

Blinding used

Trials were included despite lack of blinding or placebo treatment.

Intervention

Both authors independently selected trials, extracted data and assessed trial quality. Methodological quality was assessed using a subject-specific modification of the generic evaluation tool developed by the Cochrane Bone, Muscle and Joint Trauma Group.

Statistical Analysis

Data were pooled for primary outcomes. For each study, relative risks and 99% confidence intervals were calculated for dichotomous outcomes and mean differences and 99% confidence intervals for continuous outcomes. Where appropriate, results of comparable effects of trials were combined using both fixed-effect and random-effects models, and results presented with 95% confidence intervals. Heterogeneity between comparable trials was tested using chi-squared and I-squared tests. Sensitivity analyses were done when appropriate.

Data Collection Summary:

Timing of Measurements

Nutrition interventions after hip fracture, started within the first month after hip fracture and given for up to one year.

Dependent Variables

  • All-cause mortality
  • Morbidity and postoperative complications
  • Length of hospital and rehabilitation unit stay
  • Postoperative functional status
  • Level of care and extent of support required after discharge
  • Patients' perceived quality of life after discharge
  • Fracture healing
  • Putative side effects of treatment
  • Patient tolerance of and compliance with nutrition intervention
  • Carer burden and stress
  • Economic outcomes
  • Changes in anthropometric indices
  • New fractures
  • Changes in bone mineral density
  • Changes in nutritional indicators measured in blood
  • Changes in functional markers of nutritional status.

Independent Variables

  • Nutrition interventions including supplements, aimed to improve the intake of energy, protein, vitamins and minerals, alone or in combination
  • Provided by oral, enteral or parenteral routes
  • Evaluating the administration of nutrition, such as use of dietetic assistants 
  • Pre-existing nutritional status: malnourished or not malnourished.

 

Description of Actual Data Sample:

Initial N: 56 studies identified with search strategy

Attrition (final N): 21 randomized trials were included, representing 1,727 participants. Results from 19 trials are presented.

Age: Not mentioned

Ethnicity: Not mentioned

Location: Worldwide studies.

Summary of Results:

Other Findings

Overall trial quality was poor, specifically regarding allocation concealment, assessor blinding, and intention-to-treat analysis and limited availability of outcome data.

Eight trials evaluated oral multi-nutrient feeds providing non-protein energy, protein and some vitamins and minerals.

Oral feeds had no statistically significant effect on mortality [15/161 vs. 17/176, relative risk 0.89, 95% confidence interval (CI) 0.47 to 1.68], but may reduce unfavorable outcomes (combined outcome of mortality and survivors with medical complications, 14/66 vs. 26/73, relative risk 0.52, 95% CI 0.32 to 0.84).

The effect of the oral supplement on length of stay in hospital (acute and rehabilitation) is inconclusive.

Four trials examining nasogastric multi-nutrient feeding showed no evidence of an effect on mortality (relative risk 0.99, 95% CI 0.50 to 1.97), but the studies were heterogeneous regarding case mix. Nasogastric feeding was poorly tolerated.  There was insufficient information for other outcomes.

Increasing protein intake in an oral feed was tested in four trials. There was no evidence for an effect on mortality (relative risk 1.42, 95% CI 0.85 to 2.37). Protein supplementation may have reduced the number of long-term medical complications.

Two trials testing intravenous vitamin B1 and other water-soluble vitamins, or 1-alpha-hydroxycholecalciferol (an active form of vitamin D), respectively, produced no evidence of effect for either supplement.

One trial, evaluating dietetic assistants to help with feeding, showed a trend for reduction in mortality (relative risk 0.57, 99% CI 0.29 to 1.11).

The use of dietetic assistants increased the intake of supplements and patient satisfaction.

Author Conclusion:

Some evidence exists for the effectiveness of oral protein and energy feedings, but overall the evidence for the effectiveness of nutritional supplementation remains weak. Adequately sized trials are required to overcome the methodological defects of the reviewed studies. In particular, the role of dietetic assistants requires further evaluation.

Funding Source:
Government: Chief Scientist Office of the Scottish Executive Health Department
University/Hospital: University of Teesside, Middlesbrough UK and University of Aberdeen UK
Reviewer Comments:

Authors note the following limitations:

  • Only very limited evidence for the benefit of nutritional supplementation after hip fracture
  • Variety of interventions and outcomes made data synthesis difficult
  • Failure to confirm an effect may reflect poor study design and inadequate size
  • Studies are limited by inadequate sample size, failure to undertake intention-to-treat analysis, failure to blind outcome assessors and inadequate period of follow-up with insufficient ascertainment of important outcomes
  • Incomplete compliance with nutritional supplements was a major problem in these studies.
Quality Criteria Checklist: Review Articles
Relevance Questions
  1. Will the answer if true, have a direct bearing on the health of patients? Yes
  2. Is the outcome or topic something that patients/clients/population groups would care about? Yes
  3. Is the problem addressed in the review one that is relevant to dietetics practice? Yes
  4. Will the information, if true, require a change in practice? Yes
 
Validity Questions
  1. Was the question for the review clearly focused and appropriate? Yes
  2. Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described? Yes
  3. Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased? Yes
  4. Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible? Yes
  5. Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined? Yes
  6. Was the outcome of interest clearly indicated? Were other potential harms and benefits considered? Yes
  7. Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described? Yes
  8. Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included? Yes
  9. Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed? Yes
  10. Was bias due to the review's funding or sponsorship unlikely? Yes