EAL

SCI: Pressure Ulcers (2003)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the pathogenesis of the anemia and the serum protein alteration in patients with sacral pressure ulcers.

Inclusion Criteria:

Patients with pressure ulcers >30 days.

Exclusion Criteria:

Patients with neoplastic pathologies, chronic inflammatory and infectious diseases, collagenopathies, and pre-existing anemias (treated with iron therapy or blood transfusion).

Description of Study Protocol:

Recruitment: Recruitment methods not described.

Design: Cohort Study

Blinding Used (if applicable): not applicable

Intervention (if applicable)

All patients underwent lab examinations.

Statistical Analysis

Wilcoxon Score Test for non-parametric data. Decubitus ulcer area was correlated with degree of anaemia and serum protein alteration by means of Spearman's rank correlation coefficient.

Data Collection Summary:

Timing of Measurements

Baseline and then the findings were compared with those obtained from the same patient 30-60 days after sore healing.

Dependent Variables

Lab examinations: Electroproteinogram, Erythrocyte Sedimentatino rate, C-Reactive Protein, blood cell count, serum iron, transferrinemia with percent saturation, and ferritinema.

Independent Variables

Presence of sacral pressure ulcers

Control Variables

Description of Actual Data Sample:

Initial N: 40 patients, 17 males, 23 females

Attrition (final N): 40 patients

Age: mean age 53.5 years

Ethnicity: not mentioned

Other relevant demographics: 29 with SPI, 7 with hemiparesis and 4 with a broken femur.

Anthropometrics:

Location: Italy

Summary of Results:

Other Findings

The patients afflicted with pressure ulcers show mild anemia in 70% of cases, and moderate anemia in the remaining 30% cases.
The coexistence of anemia and inflammatory status demonstrate that patients' anemia fall in to the “anemias of chronic disorder," which is characterized by normal iron stores in reticuloendothelial system (RES), and is probably due to the inability to use the iron stored in the RES.
The result suggested is that both aneaemia and serum protein alteration depend on the chronic inflammatory state due to the presence of pressure ulcers.
Both anemia and hypoproteinemia disappeared after pressure ulcer healing.

Author Conclusion:

A correct diagnosis is important for treatment.
Iron therapy is useless and potentially dangerous, since anemia is the result of the inability to use iron stores, and not iron deficiency.
The main cause of hypoalbuminemia is not protein loss from the ulcer, but reduced hepatic synthesis secondary to the chronic inflammatory state.
The treatment of serum protein alterations should be based on a dietary therapy rich in protein and calories; the administration of albumin should be reduced, since albumin is low in essential amino-acids and too expensive; Albumin administration should be limited to cases with server hypoproteinemia.

Funding Source:

University/Hospital:

IRCCS Ospedale di Riabilitazione

Reviewer Comments:

Generate hypothesis of the occurrence of hypoalbuminemia and anemia, based on the observational data. Further investigation should be conducted to support the hypotheses.
Treatments of anemia and hypoalbuminemia were very well justified by the observational data, however the outcome should be evaluated in a control trial.

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?		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?	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?	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?	N/A
	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?	N/A
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