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A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries.
Okonkwo, Henry; Bryant, Ruth; Milne, Jeanette; Molyneaux, Donna; Sanders, Julie; Cunningham, Glen; Brangman, Sharon; Eardley, William; Chan, Garrett K; Mayer, Barbara; Waldo, Mary; Ju, Barbara.
Afiliação
  • Okonkwo H; Seacliff Healthcare Center, Los Angeles, California.
  • Bryant R; Grand Park Convalescent Hospital, Los Angeles, California.
  • Milne J; Vermont Convalescent Care Center, Los Angeles, California.
  • Molyneaux D; Providence Health Care, Spokane, Washington.
  • Sanders J; Tissue Viability & Community Research Service, Nursery Park Health Centre, Northumbria NHS Trust, Northumberland, UK.
  • Cunningham G; Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
  • Brangman S; Gwynedd Mercy University, Gwynedd Valley, Pennsylvania.
  • Eardley W; St Bartholomew's Hospital, Barts Health NHS Trust, London, UK.
  • Chan GK; Good Samaritan Regional Medical Center, Corvallis, Oregon.
  • Mayer B; SUNY Upstate Medical University and Loretto Health and Rehabilitation, Syracuse, New York.
  • Waldo M; Department of Trauma and Orthopaedics Middlesbrough, James Cook University Hospital, Middlesbrough, UK.
  • Ju B; Stanford Health Care, Stanford, California.
Wound Repair Regen ; 28(3): 364-374, 2020 05.
Article em En | MEDLINE | ID: mdl-31965682
ABSTRACT
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 < .001). SEM changes were observed 4.7 (± 2.4 days) earlier than diagnosis of a PI via STA alone. Latency between the SEM biomarker and later onset of a PI, in combination with standard of care interventions administered to at-risk patients, may have confounded specificity. Aggregate SEM sensitivity and specificity and 67.13% AUC exceeded that of clinical judgment alone. While acknowledging specificity limitations, these data suggest that SEM biocapacitance measures can complement STAs, facilitate earlier identification of the risk of specific anatomies developing PIs, and inform earlier anatomy-specific intervention decisions than STAs alone. Future work should include cost-consequence analyses of SEM informed interventions.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Capacitância Elétrica / Úlcera por Pressão / Epiderme Tipo de estudo: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Capacitância Elétrica / Úlcera por Pressão / Epiderme Tipo de estudo: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2020 Tipo de documento: Article