SCI: Pressure Ulcers (2003)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  • To evaluate the nutritional status at the time of development of a pressure ulcer for Stages II, III, and IV.
  • To identify and implement dietary interventions as appropriate.
  • To monitor the residents’ responses to all interventions.
  • To collect economic data associated with the outcomes as well as the cost of the dietary interventions.
Inclusion Criteria:
  • Residents who were 60 years and older and who had Stage II or Stage III pressure ulcers.
Exclusion Criteria:
  • Hospice patients were excluded.
Description of Study Protocol:

Recruitment:  Methods not mentioned. 

Design:  Prospective cohort study.

Blinding Used (if applicable):  not applicable.

Intervention (if applicable)

  • The nutrition interventions followed a standard protocol for the assessed nutrients.
  • The residents’ physical condition and diagnoses were noted along with weight, lab data, and the time in healing.
  • Data on the time and cost of interventions were combined to get the cost of medical nutrition therapy.

Statistical Analysis

Statistical analysis not completed or described.

Data Collection Summary:

Timing of Measurements

Not described.

Dependent Variables

  • Clinical outcome: Healing of pressure ulcers.
  • Economic outcome: Cost of treatment with or without hospitalization.

Independent Variables

  • Spinal cord injury

Control Variables

Description of Actual Data Sample:

Initial N:  13 residents: Nine women, four men.

Attrition (final N):  13 residents

Age:  mean age women:  83.5 years, mean age men:  79.5 years

Ethnicity:  not mentioned

Other relevant demographics:

Anthropometrics:

Location:  Ohio

Summary of Results:

Other Findings

  1. The Stage II pressure ulcers took 10 to 45 days to heal, with the cost of medical nutrition therapy evaluated at an average of $58.55 per ulcer.
  2. The Stage III pressure ulcers took 49 to 138 days to heal, with the cost of medical nutrition therapy evaluated at an average of $179.02 per ulcer.

These costs reflect the dietitian’s time and the cost of the extra interventions.

Includes table of Nutrition Protocol for Pressure Ulcer Healing at Each Stage listing calorie, protein, fluid and vitamin/mineral supplementation recommendations.

Author Conclusion:
  • The information of the cost of medical nutrition therapy can be used to implement an interdisciplinary protocol for the treatment of pressure ulcer.
Funding Source:
Industry:
Salubrity
Other:
Reviewer Comments:
  • Sample unclear—30 for cost of other treatment and 13 for cost of MNT. Potential exists for investigator bias.
  • Did not show the actual calculations of the economic outcome.
  • Results only reflected one purpose—economic outcome.
  • Responses for nutrition intervention and nutritional evaluation for pressure ulcer residents were not discussed, nor were limitations of the study discussed.
  • Statistical analysis not described.
  • Small sample size and recruitment methods not described.
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? 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? 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? Yes
  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? ???
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? ???
  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? ???
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? ???
  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? ???
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  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? N/A
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  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? ???
  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)? ???
  8.6. Was clinical significance as well as statistical significance reported? ???
  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? ???
  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? ???
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? ???