SCI: Preventing Overweight (2007)
- To document the nutritional status of patients with paraplegic and quadriplegic injuries.
- Patients with either paraplegic or quadriplegic injures who were injured more than three months.
- On a regular selective diet
- Patients who were injured less than three months were excluded, to prevent the possibility of inaccurate lab data gathered during the acute stages of SCI shock.
Recruitment: Not provided
Design : Comparison by level of injury (para, quad) of anthropometric and biochemical data with established standards at the medical center and of dietary data with 1980 RDAs.
Blinding used (if applicable): not applicable
Intervention (if applicable): subjects received nutritional assessment
Statistical Analysis: None except for mean and standard deviation calculations
Timing of Measurements: Once
- Anthropometric: Height, weight, ideal body weight, weight prior to injury
- A 24-hour diet record: Kcal, protein, vitamin A, thiamin, riboflavin, niacin, ascorbic acid, calcium, and iron
- Biochemical data: Hemoglobin, hematocrit, and serum albumin, 24-h urine creatinine.
Independent Variables: Type of chronic SCI (quadraplegia, paraplegia)
Control Variables: None
- 9 paraplegic patients (8 males, 1 female)
- 9 quadraplegic patients (all males)
Attrition (final N): 18
Age: Ranged from 18-80 years; 61% were over the age of 50
Ethnicity: not reported
Other relevant demographics: Length of time since injury for paraplegics, 5.2±6.7 yrs; for quadriplegics, 5.4±3.8
Anthropometrics: Body weight for paraplegics, 64.2±12.7kg; for quadriplegics, 62.3±11.7
Location: East Orange Veteran's Administration Medical Center, East Orange, NJ
- 44% of both groups of patients were 10% below ideal body weight.
- Intake of thiamin, riboflavin, vitamin A, calcium, and iron were below the recommended allowances.
- 44% of those with paraplegic injuries and 55% of those with quadriplegic injuries had deficient hematocrit values.
- 55% of both groups were below the 60% creatinine-height index standard, signifying severe depletion.
Other Findings: The following guidelines were established as positive indicators of nutritional risk:
- Body weight: More than 10% below the recommended ideal body weight.
- Serum albumin: Less than 3.0g/dl
- Caloric intake: Less than calculated maintenance or anabolic requirements
- Protein intake: Less than calculated maintenance or anabolic requirement
- Hemoglobin: Less than 12 g/dl
- Hematocrit: Less than 37%
- Creatinine-height index: Less than 60% of standard.
Patients with two or three abnormal parameters were considered to be mildly at risk. Patients with four to five were considered moderately at risk, while those with more than six were severely at risk.
- Weight recommendations (from East Orange Veterans Administration Medical Center)
Paraplegia: 10-15# below NY Metropolitan Life Insurance tables for height and frame size
Quadriplegia: 15-20# below.
|Government:||Veterans Association Medical Center-East Orange NJ|
- The study protocol did not address the duration of the study.
- Nutritional status may change after a certain period of time or by the level of recovery.
- Study population was small.
- Limitations of the study were not discussed.
- The guidelines should be tested.
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)||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|
|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?||???|
|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?||???|
|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?||???|
|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?||N/A|
|4.1.||Were follow-up methods described and the same for all groups?||N/A|
|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%.)||N/A|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||N/A|
|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?||N/A|
|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?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||N/A|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||N/A|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||N/A|
|6.6.||Were extra or unplanned treatments described?||N/A|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||N/A|
|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?||???|
|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?||N/A|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||N/A|
|7.5.||Was the measurement of effect at an appropriate level of precision?||???|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||???|
|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?||N/A|
|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?||No|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||No|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||N/A|
|10.2.||Was the study free from apparent conflict of interest?||Yes|