SCI: Caloric and Protein Needs in Acute and Rehabilitation Phases (2007)
- To test the hypothesis that negative nitrogen balance (NB) is obligatory in SCI patients.
- To determine the profile of the metabolic response to SCI.
- Acute SCI, fewer than seven weeks postinjury
- Controls with multi-system trauma but no spinal cord injury
- Not specified.
Recruitment: Patients admitted to Level I trauma center
Design: Case-control study.
Blinding Used (if applicable): not applicable
Intervention (if applicable)
- Total nutrition support within 72 hours of admission (based on predicted energy expenditure = Harris Benedict equation x 1.2 x 1.6) and 2g of protein per kg of ideal body weight.
- Subsequent changes in nutrient delivery were based on nitrogen balance.
- Indirect calorimetry was performed.
Statistical analysis methods not described - descriptive statistics used.
Timing of Measurements
Changes in nutrient delivery were based on nitrogen balance.
- Nitrogen balance determined through 24-hour urinary urea nitrogen collections
- Presence of SCI
- Nutritional support: calorie and protein intakes, types of formulas, and formula tolerances were recorded on a daily basis.
- Multi-system trauma but no SCI.
Initial N: 10 SCI patient cases (8 men, 2 women), 20 control subjects (16 men, 4 women) with multi-system trauma but no SCI
Attrition (final N): as above
Age: Mean age of patients = 48 years (range 25 - 83 years), controls = 45 years (range 16 - 80)
Ethnicity: Not mentioned
Other relevant demographics:
Anthropometrics: Cases and controls matched for time, sex, age, and injury severity score.
Location: New Mexico
- No SCI patients established positive NB during the seven-week period following injury, despite an average delivery of 2.4 g of protein/kg IBW and 120% of the PEE at the time of peak negative NB (-10.5).
- In six SCI patients, an average increase of 25% in delivered protein, and 12% in delivered calories over a one-week period, affected no change in average NB.
- Indirect calorimetry in five SCI patients showed that calorie intakes were 110% more than average measured energy expenditure.
- 17 of 20 control patients achieve positive NB within three weeks of admission. They required an average delivery of 2.3g of protein per kg IBW and 110% of PEE to reach positive NB.
- The data demonstrates the phenomenon of obligatory negative NB acutely following SCI. Aggressive attempts to achieve positive NB in these patients fail and result in overfeeding.
|University/Hospital:||University of New Mexico|
- Well designed case-control study. Study period was long enough to assess the effects of nutrition support in nitrogen balance.
- Great selection of the control group, the data is comparable.
- Results have significant clinical and nutritional implications on SCI care.
- Statistical analysis not described - descriptive statistics used
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||Yes|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||N/A|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||Yes|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||N/A|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||Yes|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||N/A|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||N/A|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||Yes|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||Yes|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||No|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||No|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||No|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||No|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||N/A|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||No|
|8.6.||Was clinical significance as well as statistical significance reported?||No|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||???|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|