NURS 362 Research Critique Form

In evidence based practice the literature is not only critiqued, it is graded.

Author: Kazuki Ikura, Ko Hanai, Takamichi Shinjyo, Yasuko Uchigata

Title: HDL cholesterol as a predictor for the incidence of lower extremity amputation and wound-related death in

patients with diabetic foot ulcers

Citation: (journal, year, month published: volume (issue): pgs): Elsevier, Atherosclerosis 239, February 2015, pgs

465-469

Study Question: (What is being studied?) To examine whether HDL cholesterol levels are a predictor for an

incidence of lower-extremity amputation (LEA) and wound-related death in patients with diabetic foot ulcers

(DFUs). The primary composite endpoint was defined as the worst of the following outcomes for each individual:

(1) minor amputation, defined as amputation below the ankle, (2) major amputation, defined as amputation above

the ankle, and (3) wound-related death defined as death with unhealed ulcers with or without any amputation.

Study Design: (See glossary and other resources for types) Single-center, observational, longitudinal historic cohort

study of adult Japanese ambulatory patients with diabetic foot ulcers.

Sampling: (What was the sample size and how were participants selected?) They recruited 177 consecutive patients

with the chief complaint of diabetic foot ulcer at the foot care unit in the Diabetes Center of Tokyos Womens

Medical University Hospital in Tokyo Japan between January 2008 and September 2012. All of the participants were

treated at the foot care unit during the study period. Patients with missing values for baseline profiles (n=14) were

excluded. Overall, a total of 163 patients were enrolled. They were 45 woman and 118 men with a mean age of 62

(14) years)

Data Collection: (What were the data collection strategies-i.e. interview, observation, field note, etc?) Observation

and laboratory values (serum lipids, creatinine, and plasma hemoglobin A1C (HbA1c).

Findings: (What were the results of the study?) They found that patients with diabetic foot ulcers, lower HDL

cholesterol levels were significantly association with the incidence of primary composite endport of minor extremity

amputation, major extremity amputation, or wound-related death. The association was independent of other risk

factors and was confirmed by treating HDL cholesterol levels as both a continuous and categorical variable.
Limitations: What does the author state as limitations? What other limitations do you see? First, the present

findings were based on analyses using a historical cohort; however, the patients were consecutively added to the

cohort. Second, this study was performed using a small cohort. Third, we did not evaluate time-dependent changes

in serum lipid profiles during the followup period. Interestingly, an earlier study has shown that in human sepsis,

HDL cholesterol levels increased only in survivors during intensive care units stay [31]. In contrast, total cholesterol

and LDL cholesterol levels increased in both survivors and non-survivors [31]. Fourth, we did not evaluate

apolipoproteins and proinflammatory cytokines such as interleukin-6 and tumor necrosis factor (TNF) -a. Finally,

this study was carried out in a single urban university hospital, which may not be representative of the entire

Japanese population with diabetes.

- I agree with the authors limitations. This study was conducted in a small region of Japan with a small number of

participants.

Mosby Research Tool and Synthesized Articles

Level of Evidence Description Articles

Reviewed
I Meta-analysis
II Experimental design/Randomized Control Trial
III Quasi-experimental design
IV Case controlled, cohort studies, longitudinal studies
V Correlation studies
VI Descriptive studies including surveys, cross sectional design,
developmental design, and qualitative studies
VII Authority opinion or expert committee reports
Other Performance improvement, review of literature

Internal Validity: Indicate which category of internal validity applies to the study____

Good (meets all the criteria for the study design)

Fair (does not meet all criteria but is judged to have no fatal flaw that invalidates the results)
Poor (contains fatal flaw)

General Comments: Although this study was conducted with a small cohort in one region of Japan, I found it to be
interesting and helpful especially working on the orthopedic floor in clinical. It would be good to see this study
carried out even further with a larger cohort and a variety of ethnic backgrounds.

Applicability to Practice: I will definitely use this information while working with patients with diabetes. Ive had
many diabetic patients on the orthopedic floor at Queens hospital. In my teachings, I always include proper foot
care but now I feel like I should place an emphasis on maintaining a well-balanced diet on top of adequately
controlling their glucose levels.

Three Key Points:

 Patients with diabetic foot ulcers and lower HDL cholesterol levels were significantly associated with the
incidence of a primary composite endpoint of minor extremity amputation, major extremity amputation, or
wound-related death.
The association was independent of other risk factors and was confirmed by treating HDL cholesterol
levels as both a continuous and a categorical variable.
Despite current research; many cases of diabetic foot ulcers are intractable to treatment and rapidly worsen,
therefore treatment is urgently needed.

Updated Spring 2017 DH