A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries
| Autor: | Donna Molyneaux, Henry Okonkwo, Barbara Ju, Glen Cunningham, Garrett K. Chan, Julie Sanders, Jeanette Milne, Ruth Bryant, Barbara Mayer, Sharon A. Brangman, Mary Waldo, William Eardley |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Population Early detection Dermatology Electric Capacitance Sensitivity and Specificity Clinical study 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Measurement device Internal medicine Medicine Humans Single-Blind Method Longitudinal Studies Prospective Studies Stage (cooking) education Aged Aged 80 and over Pressure Ulcer education.field_of_study Receiver operating characteristic business.industry Gold standard (test) Middle Aged Early Diagnosis Biomarker (medicine) Surgery Female Epidermis business Original Research‐clinical Science |
| Zdroj: | Wound Repair and Regeneration |
| ISSN: | 1524-475X |
| Popis: | This study aimed to evaluate the sensitivity and specificity of subepidermal moisture (SEM), a biomarker employed for early detection of pressure injuries (PI), compared to the “Gold Standard” of clinical skin and tissue assessment (STA), and to characterize the timing of SEM changes relative to the diagnosis of a PI. This blinded, longitudinal, prospective clinical study enrolled 189 patients (n = 182 in intent‐to‐treat [ITT]) at acute and post‐acute sites (9 USA, 3 UK). Data were collected from patients' heels and sacrums using a biocapacitance measurement device beginning at admission and continuing for a minimum of 6 days to: (a) the patient developing a PI, (b) discharge from care, or (c) a maximum of 21 days. Standard of care clinical interventions prevailed, uninterrupted. Principal investigators oversaw the study at each site. Blinded Generalists gathered SEM data, and blinded Specialists diagnosed the presence or absence of PIs. Of the ITT population, 26.4% developed a PI during the study; 66.7% classified as Stage 1 injuries, 23% deep tissue injuries, the remaining being Stage 2 or Unstageable. Sensitivity was 87.5% (95% CI: 74.8%‐95.3%) and specificity was 32.9% (95% CI: 28.3%‐37.8%). Area under the receiver operating characteristic curve (AUC) was 0.6713 (95% CI 0.5969‐0.7457, P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text