METHODS: The questionnaire was translated into Mandarin. Upon enrollment, caregivers completed the Mandarin PEDS and answered four questions about its acceptability and usefulness, and its ease of understanding and completion. The Mandarin PEDS was independently evaluated by a pediatrician and a community nurse, and classified as high risk (≥two predictive concerns), medium risk (one predictive concern), low risk (any non-predictive concerns) or no risk (if no concern) for developmental delays. The caregivers repeated Mandarin PEDS at a 2 week interval for test-retest reliability, while the children underwent testing for accuracy using a developmental assessment test.
RESULTS: The majority (≥85%) of the 73 caregivers perceived the Mandarin PEDS as acceptable and useful, as well as easy to understand and complete. Fifteen (20.5%) and 24 responses (33.9%) were classified as high and moderate risk, respectively. The test-retest and inter-rater reliabilities were excellent, with an intra-class correlation coefficient of 0.812 (95% CI: 0.701-0.881, P
MATERIALS AND METHOD: This cross-sectional study was conducted at Klinik Rawatan Keluarga (KRK), Orthopedic clinic and wards in Hospital Universiti Sains Malaysia (USM) from May 2020 to December 2020. A total of 264 participants were recruited and divided into three groups: 50 diabetic patients with no ulcers (control), 107 patients with non-infected diabetic foot ulcers (NIDFU), and 107 patients with infected diabetic foot ulcers (IDFU). The level of PCT was taken for all patients. Total white count (TWC) and C-reactive protein (CRP) were taken only for IDFU patients. Diagnosis of infection was based on the Infectious Disease Society of America-International Working Group of Diabetic Foot (IDSA-IMWGDF), and the severity of infection was graded according to the Wagner Classification.
RESULTS: The level of PCT was higher in IDFU than in NIDFU and diabetic patient, with a median (IQR) of 0.355 (0.63) ng/mL, 0.077 (0.15) ng/mL and 0.028 (0.02) ng/mL, respectively. PCT and CRP showed moderate positive correlations in IDFU patients (p<0.001). The sensitivity and specificity were 63.6% and 83.2%, respectively, at the best cut-off at 0.25 ng/mL.
CONCLUSION: PCT is a valuable biomarker for the diagnosis of infection; however, it adds little value in the early diagnosis of IDFU in view of its low sensitivity.