Critical Appraisal of a Research Article: Diabetic Foot Ulcers

This report presents a critical appraisal of a research article focusing on the efficacy of dehydrated human amnion/chorion membrane allograft (dHACM) in the treatment of chronic lower extremity ulcers, particularly in patients with diabetes. The appraisal includes a detailed examination of the rationale, research question (PICO(T) framework), internal and external validity, and overall impression of the paper. The internal validity assessment utilizes the Cochrane Risk of Bias Tool, evaluating study design, interventions, and outcomes. Precision of the estimate is considered, including sample size, missing data, and confidence intervals. External validity is analyzed using the PRECIS tool. The report concludes with an overall assessment, noting the paper's strengths and potential for adoption into clinical practice. The study's findings suggest that dHACM is effective in treating diabetic foot ulcers, and the appraisal provides a comprehensive overview of the study's methodology and conclusions. The report also includes references to supporting literature.

Critical Appraisal

Table of Contents
Rationale.....................................................................................................................................................3
Research Question.......................................................................................................................................3
Internal validity...........................................................................................................................................3
Precision of the estimate..............................................................................................................................3
External validity..........................................................................................................................................4
Summary.....................................................................................................................................................4
Overall impression of the paper...................................................................................................................4
References...................................................................................................................................................5

Rationale
The rationale of the chosen article is to identify the efficacy of the dehydrated human amnion or
chorion membrane allograft (dHACM) for the purpose of treating chronic lower extremity ulcers
(1).
Research Question
The research question present in the chosen article using PICO (T) is provided in the following
point:-
 In what way the efficacy of the dehydrated human amnion or chorion membrane allograft
(dHACM) for the purpose of treating chronic lower extremity ulcers can be carried out?
Internal validity
The internal validity of the article is carried out by the help of Cochrane Risk bias Tool. The tool
is helping in gathering information related to study design, interventions, specific outcomes, and
specific numerical results, reviewing of aim with the result and assessing the effect of adhering
to intervention. The study design is showing the random selection of the patients. The inventions
designs are the offloading or standard of care with alginating wound dressing process for 12
weeks. The specific outcomes gained are measured by the dHACM application. The specific
numerical results are reflecting the (ITT—70% versus 50%, P = 0.0338, per-protocol—81%
versus 55%, P = 0.0093). The aim of the study is completely achieved by reflecting the
implementation of dHACM.
Precision of the estimate
The sample size chosen is 100 patients. The number of events conducted is found to be carried
out for 4 weeks. The proportion of missing or excluded data is 80%. The interpretation of the
confidence interval around the difference between the treatment groups for identifying the
outcomes is 95% (3).

External validity
The PRECIS tool is helping in focusing on the trial design process. It will be helping the
researcher in decreasing the proportion of excluded data. The trial results will be included in this
process for maximizing the applicability. The different trial- design will be included which will
be helping in setting the specialized care for the patients (2).
Summary
Internal Validity
The overall ration provided to the internal validity is reflecting the moderate rating process. As in
the internal validity, the proportion of data excluded is identified to be 80%. These are creating
an impact on the execution of activities.
Precision Scale
The proportion of missing or excluded data is 80%. The interpretation of the confidence interval
around the difference between the treatment groups for identifying the outcomes is 95%.
External Validity
The PRECIS tool is helping in focusing on the trial design process. The different trial- design
will be included which will be helping in setting the specialized care for the patients.
Overall impression of the paper
The overall impression of the paper is reflecting the strong impression as the low to moderate
risk bias with the moderate to high precision is seen. These practices are ready to be adopted into
practice which will be helping in determining the accuracy of the gathered data. Thus, it is
identified to be beneficial for carrying out the activities in an appropriate way (3).

References
1. Tettelbach W, Cazzell S, Reyzelman A, Sigal F, Caporusso J, Agnew P. A confirmatory study
on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the
management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled
study of 110 patients from 14 wound clinics. International Wound Journal. 2018;16(1):19-
29.
2. Zelen C, Serena T, Snyder R. A prospective, randomised comparative study of weekly versus
biweekly application of dehydrated human amnion/chorion membrane allograft in the
management of diabetic foot ulcers. International Wound Journal. 2014;11(2):122-128.
3. Zelen C, Serena T, Fetterolf D. Dehydrated human amnion/chorion membrane allografts in
patients with chronic diabetic foot ulcers: A long-term follow-up study. Wound Medicine.
2014;4:1-4.