SCI: Pressure Ulcers (2003)

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

To evaluate the metabolic demands of pressure ulcers in subjects with quadriplegia who were hospitalized for pressure ulcer treatment using indirect calorimetry.

Inclusion Criteria:
  • SCI with quadriplegia more than a year post-injury
  • Males
Exclusion Criteria:
  • Dialysis or ventilator patients.
Description of Study Protocol:

Recruitment:  Methods not specified.

Design:  Case-Control Study.

Blinding Used (if applicable):  not applicable

Intervention (if applicable):  Indirect calorimetry, food records

Statistical Analysis:

One-way ANOVA used to compare groups.  Unpaired t tests and paired t tests also used.  Simple linear regression used to determine the relationship between pressure ulcer surface area and REE.  Chi-square test with continuity correction used to determine significant differences in ASIA scores between 2 groups with quadriplegia.  Two-factor ANOVA was used to determine effects of completeness of lesion and group on REE percent predicted.

Data Collection Summary:

Timing of measurements

Weights obtained 1 month before and again after the indirect calorimetry measurements.

Dependent Variables

  • Pressure ulcer measurements:  surface area and PU stage by nurses
  • Indirect calorimetry using metabolic cart--REE
  • Predicted BEE using the Harris Benedict equation

Dependent Variables

  • 3-day caloric intakes using food records for 8 quad outpatients, and tray observation for 16 inpatients, thyroid function tests for the 32 quad patients.

Control Variables

Description of Actual Data Sample:

Initial N:  16 PU-QUAD, 16 NPU-QUAD, 16 control.

Attrition (final N):  as above 

Age: 21-68

Ethnicity: Similar

Other relevant demographics: Male veterans, Similar except: BMI lower in PU-Quad and in NPU quad groups vs. controls

Anthropometrics: 

16 inpatients with quadriplegia and pressure ulcers (PU-quad) were matched (by age within 10 years and height within 20cm) with 16 healthy outpatients with quadriplegia and no pressure ulcers (NPU-quad), and 16 controls with neither.

Location: Conducted at Veterans Affairs Medical Center, Bronx, NY.

Summary of Results:

Other Findings

  • Predicted basal energy expenditure—BEE (using the Harris Benedict equation) was not significantly different between groups.
  • Measured REE and % Predicted REE were significantly higher in the PU-quad group compared to the NPU quad group, and were not different from the control group.
  • A direct linear association was found between PU surface area and % predicted energy expenditure.
  • On average, PU-quad patients were normometabolic (between 90% to 110% of predicted energy expenditure) while NPU-quad patients were hypometabolic.
  • PU-quad required 24.3 kcal/kg/day while NPU-quad required 20.9 kcal/kg/day.
  • PU-quad were consuming less than their measured REE and the NPU-quad group were eating slightly more than their measured REE.
Author Conclusion:
  • Patients with quadriplegia and pressure ulcers have a significant increase in resting energy expenditure compared to patients with quadriplegia but no pressure ulcer.
  • To ensure optimal care of patients with quadriplegia and pressure ulcers, quantification of energy expenditure with provision of adequate caloric intake is recommended. Measuring energy expenditure to determine caloric requirements of spinal cord inured patients with pressure ulcers is strongly recommended.
Funding Source:
University/Hospital: Veterans Affairs Medical Center, Mount Sinai Medical Center
Reviewer Comments:
  • Method of recruiting/selecting subjects was not reported.
  • Two patients in PU-quad had tracheostomies and exhaled air was collected with canopy rather than facemask.
  • Different methods of food intake measurement could explain differences in caloric intake.
  • Sample size/power not addressed.
  • Statistics were appropriate for study design.
  • Results generalizable to adult males with quadriplegia.
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) 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
 
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? ???
  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? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
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? ???
  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.) 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? 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? ???
  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? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? ???
  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? 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? ???
  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? 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)? Yes
  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? Yes
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