EAL

SCI: Caloric and Protein Needs in Acute and Rehabilitation Phases (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To define the changes in dietary intake, anthropometric measurements, and serum nutrient levels during the early weeks after SCI.
To examine association between nutritional status and the occurrence of secondary medical complications.

Inclusion Criteria:

SCI patients who were admitted within 28 days of injury, between 18 and 60 years of age, and had neurologically complete, sensory sparing, or motor nonfunctional lesions.

Exclusion Criteria:

Patients with severe brain injury, Brown-Sequard Syndrome, motor functional lesions, or injury to the cauda equine were excluded.

Description of Study Protocol:

Recruitment: Patients hospitalized between 1983 and 1986.

Design: Case Series.

Blinding used (if applicable): not applicable

Intervention (if applicable)

Subjects were admitted 5.7±8.0 days after injury, remained in hospital 71±29 days and were nutritionally assessed at 2, 4 and 8 weeks after injury.

Statistical Analysis

Descriptive statistics (frequencies and percentages, means and standard deviations), chi-square and Student t statistics, correlation coefficients, and stepwise multiple linear regression coefficients were calculated as appropriate.

Data Collection Summary:

Timing of Measurements

Height was measured at admission. Weight was measured weekly for eight weeks. Nutritional status of SCI patients were assessed by biochemical assays at two, four, and eight weeks after injury.
Muscle strength and occurrence of secondary medical complications were also assessed at two, four, eight weeks.

Dependent Variables

Anthropometric parameters
Nutrition biochemistry and clinical lab values
Muscle strength
Medical compliance

Independent Variables

Protein and energy intake estimated by daily observation of the meal tray.

Control Variables

Description of Actual Data Sample:

Initial N: 51 patients were included, 46 were men (90%) and five were women (10%).

Attrition (final N): 51

Age: Mean age 29.5 +/- 10.1 years

Ethnicity: Not mentioned

Other relevant demographics: Had neurologically complete, sensory sparing, or motor nonfunctional lesions.

Anthropometrics:

Location: Alabama

Summary of Results:

Variables	2 weeks	4 weeks	8 weeks
Average number of nutrient abnormalities post injury	2.1	1.6	1.2
Mean body weight	Declined 1.3 +/- 3.9 kg	Declined 2.0 +/- 4.4 kg	Declined 0.4 +/- 2.0 kg

Other Findings

Nutrient deficiencies such as albumin, carotene, transferring, ascorbate, thiamine, folate, and copper were documented most frequently at two weeks postinjury.
Most depressed nutrient parameters improved with time; however, diet-dependent plasma protein remained low during the entire eight-week period.
Although nutrient status improved with time, the association between nutrition and the risk of secondary medial complications was not found.

Author Conclusion:

Nutrition status is often adversely affected by SCI, particularly during the first two weeks after injury. A routine vitamin screen and plasma albumin and transferrin levels should probably be obtained during first two weeks after SCI.
Average intakes of the patients were not sufficient to meet published estimates of basal energy expenditures. However, patients did not appear malnourished, and the incidence of secondary complications was no greater than expected, suggesting that the basal energy requirements are lower. Intake of 1500kcal/day may be sufficient to prevent most untoward nutrition-related secondary complication.

Funding Source:

Government:

US Dept. of Education

Reviewer Comments:

Descriptive statistics, chi-square, t-test, correlation coefficient were used as appropriate.
Well-defined criteria to define nutrient deficiencies.
Study population was sufficient for SCI cases. Results can be generalized to other SCI population.

Quality Criteria Checklist: Primary Research
Relevance Questions
	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)	N/A
	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)	N/A

Validity Questions
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?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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.)	N/A
	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?		N/A
	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.)	N/A
	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?	N/A
	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?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	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?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	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)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	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