EAL

SCI: Pressure Ulcers (2003)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To develop a pressure ulcer risk assessment scale, specifically for persons with SCI.

Inclusion Criteria:

SCI with a neurologic deficit due to SC but not brain
Treatment or evaluation between 8/4/1987 to 12/14/1993
Mobility limitations, attributable to a neurologic deficit
Traumatic or neoplastic etiology with a sudden onset of SCI

Exclusion Criteria:

Excluded if not included above. Degenerative causes were excluded.

Description of Study Protocol:

Recruitment

A retrospective study with treatment or evaluation between 8/4/1987 to 12/14/1993. The setting was a SCI Unit in a 240-bed, long-term care Dept of Veterans Affairs Medical Center.

Design: Retrospective cohort study

Blinding Used (if applicable): not applicable

Intervention (if applicable)

Criteria for risk factors:

For a factor to be included it had to meet all four of the following:

Statistical association that this factor was significantly associated with PU development or severity
Biologically plausible mechanism for PU development
Co-evidence in the literature that this factor was associated with development of PU
An improvement in the total score caused by the addition of each factor

Statistical Analysis

A large variety of analysis was used. Categoric variables were assessed with Pearson's chi-square and ordinal variables with Mantel-Haenszel test. Continuous variables were analyzed with the unpaired Student's t test. Potential risk factors that were biologically plausible and had P values of less than 0.2 in the univariate analysis were used in multivariate analysis.

Data Collection Summary:

Timing of Measurements

The analysis included information on SCI individuals (with and without pressure ulcer), who were treated or evaluated at annual examination during a 6-yr period.

Dependent Variables

Pressure ulcer development

Independent Variables

Spinal cord injury

Control Variables

Description of Actual Data Sample:

Initial N: 219 SCI patients, 2 females, 217 males

Attrition (final N): 219 patients

Age: range 18 - 88 years

Ethnicity: Not mentioned

Other relevant demographics:

Anthropometrics:

Location: New York

Summary of Results:

Other Findings:

80.4% had a history of 1 or more pressure ulcer development.

15 risk factors met the four criteria for inclusion in the risk assessment scale:

the level of activity, statistically the most significant risk factor for PU development,
mobility level, independent of level of activity,
complete SCI,
urinary incontinence,
autonomic dysreflexia,
advanced age,
the comoribidities of cardiac,
pulmonary,
and renal disease,
impaired cognitive function,
diabetes,
cigarette smoking,
residence in a nursing home or hospital,
hypoalbuminemia, and
anemia.
Six of these factors significantly different for the Stages 3 and 4 ulcer patients compared to Stage 1 and 2 were severe ulcers associated with cigarette smoking, pulmonary disease, diabetes, low hematocrit, cardiac, and renal disease

Author Conclusion:

Compared with the more general scales available, for quantifying the risk of pressure ulcer development, preliminary results suggest that this new scale is a significant improvement for the spinal cord-disabled. A major strength of this study was the length of time patients had been at risk for pressure ulcers. This long follow-up period proved essential for developing an accurate and stable scale. Prevention of Pressure ulcers, before extensive injury has occurred, is of primary importance for SCI individuals. We believe that this tool is easy to use and should prove cost-effective. Further research must test the validity, reliability, and appropriate time to use new scoring systems.

Funding Source:

Government:	New York State Department of Health, Centers for Disease Control and Prevention
University/Hospital:	New York Medical College, Westchester County Medical Center, Our Lady of Mercy Hospital, Castle Point Veterans Affairs Medical Center

Reviewer Comments:

The long follow-up period proved essential for developing an assessment scale specifically with SCI individuals.

Some "critical interactions" were briefly discussed with nutritional implications are diabetes and smoking, pulmonary disease and malnutrition, and abnormal electrocardiograms and malnutrition and need further research.

Authors note that further research must test the validity and reliability of the scoring system.

Cohort was primarily male - may not be generalizable to females.

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?	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?		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%.)	N/A
	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?		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?	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?	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?		???
	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?	???
	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?		???
	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?	???
	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)?	???
	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?	No
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes