The Inter-rater Reliability of the Clinical Signs and Symptoms Checklist in Diabetic Foot Ulcers

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Sue E. Gardner, PhD, RN; Rita A. Frantz, PhD, RN; Heeok Park, MSN, RN; and Melody Scherubel, BSN

Index: Ostomy Wound Manage. 2007;53(1):46-51.


  The Clinical Signs and Symptoms Checklist (CSSC)1 is a tool designed to objectively measure 12 clinical signs and symptoms of localized chronic wound infection. Five of these signs and symptoms are commonly known as the classic signs of infection (pain, erythema, heat, edema, and purulent exudate); the other seven are signs specific to wounds healing by secondary intention (serous exudate, sanguineous drainage, delayed healing, discoloration of granulation tissue, friable granulation tissue, wound base pocketing, foul odor, wound breakdown).2 Each sign and symptom is represented with a specific descriptor; the conceptual definitions and the development of their descriptors have been reported elsewhere.1 During first testing, the reliabilities of the items on the tool were found to range between 0.53 and 1.00.

  Since its initial development, the CSSC has been revised to include sanguineous drainage as a sign or symptom because wound drainage with a bloody composition did not fit the descriptors for serous exudate or purulent exudate (see Figure 1). Adding sanguineous drainage enhanced discrimination regarding wound drainage. The reliability of the revised CSSC has not been examined. Furthermore, the reliability of the CSSC has not been examined in a homogenous sample of chronic wounds. The purpose of this study was to examine the reliability of the revised CSSC in a sample of diabetic foot ulcers. The findings reported here were obtained in conjunction with a larger study designed to examine the validity of each sign and symptom for identifying infection in diabetic foot ulcers.

Methods and Procedures

  Participants. In this observational, cross-sectional design, two members of the research team independently assessed patients with diabetic foot ulcers for the presence of signs and symptoms of infection using the CSSC. In addition to the principal investigator (PI) – a Registered Nurse, three other Registered Nurses were trained in CSSC use in order to examine its reliability. All participating nurses had training and experience in chronic wound management – two of the nurses were certified wound care nurses and the other two had more than 3 years of wound care experience. Each nurse reviewed the items on the CSSC and practiced using this tool to assess wounds in conjunction with the PI.
Competency was typically achieved with fewer than five practice wounds.
  Study subjects included patients with diabetic foot ulcers. Subjects were screened and enrolled based on the following criteria: 1) 18 years of age or older, 2) presence of a full-thickness diabetic foot ulcer, 3) white blood count >1,500 cells/mm3, 4) platelet count >125,000/mm, and 5) no coagulapethies. If a subject had more than one diabetic foot ulcer, one was randomly selected for inclusion in the study. Human subject approval was obtained from the Institutional Review Board at each site before data collection commenced. Informed consent was obtained from all patient participants. Subjects were enrolled in the study from August 2001 through August 2004.

  Setting. A Department of Veteran’s Affairs Medical Center and a university-associated tertiary hospital served as settings for the study.

  Wound assessment. The CSSC was used to assess the presence of the clinical signs and symptoms of infection.

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