Sensitivity and laboratory performances of a second‐generation sub‐epidermal moisture measurement device

Peko, Lea; Gefen, Amit

doi:10.1111/iwj.13339

Cited by 10 publications

(22 citation statements)

References 6 publications

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“…Several studies have demonstrated the effectiveness of the SEM test as an objective biomarker in predicting or detecting deep and early stage PI/PUs. 15,17,18,[26][27][28][29][30][31] The role of localised inflammatory oedema/SEM was recognised as 'one of the earliest signs of cell death in pressure injuries' in the 2019 Clinical Practice Guidelines 24 emphasising the importance of SEM as an aetiological biomarker in predicting impending skin damage. 32 Results from this study add to the body of evidence that spatial SEM tests have clinical utility in aiding HCP determination of healthy versus damaged tissue.…”

Section: Discussionmentioning

confidence: 99%

“…The SEM-delta measure (rather than the individual SEM values) provides a clinically useful statistic distinguishing the presence or absence of localised inflammation associated with healthy or pressure damaged tissue. 14,17 The two SEM delta algorithms (A and B) reported here provide a single reported SEM delta value, albeit computed using different methods. For both algorithms, ROC curves were derived and AUCs (degree of separability between healthy and damaged skin) were computed.…”

Section: Discussionmentioning

confidence: 99%

“…The difference between the highest and lowest readings, the delta (Δ), is used to assess tissue health; a delta <0.6 indicates low SEM variance (healthy tissue), whereas delta ≥0.6 is a high variance and indicates developing pressure damage. 14,17,18 This study describes the derivation of the SEM delta calculation in detail.…”

Section: Sem Scannermentioning

confidence: 99%

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Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Gershon¹,

Okonkwo²

2021

J Wound Care

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Background: Sub-epidermal moisture (SEM) is a measurable biomarker detecting early pressure damage in order to objectively support current ‘gold standard’ skin tissue assessments (STA) for the detection of deep and early-stage pressure-induced injuries or ulcers (PI/PUs). Objective: A multi-site, dual arm, cross sectional, retrospective study was conducted to evaluate the sensitivity, specificity and clinical utility of spatial variation in SEM readings between healthy and damaged skin tissue. Method: The study enrolled 175 subjects: 125 with confirmed PI/PUs or suspected deep tissue injury (sDTI), and 50 confirmed healthy subjects. Expert principal investigators and PI/PU healthcare practitioners (HCPs) evaluating all subjects were trained in SEM measurements but blinded to clinical interpretation of SEM readings. Sequential and spatial SEM readings of the sacrum and heels, subjects' demographic data, STAs, risk assessment tool scores (RATS), pain assessment and potential confounders were recorded. Independent statistical analyses were performed. Results: Mean spatial SEM measures within subjects with healthy tissue and within subjects with damaged tissue were statistically similar. Mean spatial SEM measures within anatomies of subjects with damaged tissue were significantly different (p<0.05). There was no significant difference between spatial readings in healthy subjects. Algorithms computing a range of SEM delta thresholds indicated a sensitivity of 82–87% and a specificity of 51–88% at an SEM delta ≥0.6. Receiver operating characteristic (ROC) curves computed areas under the curve (AUC) of 0.7809–0.9181 (95% CI: 0.7221–0.8817, 0.8397–0.9545, p<0.0001) exceeding clinical judgement. Conclusion: These SEM data augment clinical decision-making for developing intact skin PI/PUs including sDTIs and Stage I PI/PUs. Informing HCPs of this subclinical, non-visible skin and tissue damage and providing opportunities for alternative PI/PU care pathways is an exciting prospect.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Gershon¹,

Okonkwo²

2021

J Wound Care

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“…The Provizio ® SEM Scanner and the SEM Scanner 200 are identical in their technology, intended use, and clinical interpretation [48]. Hereafter, in this review, the use of 'SEM Scanner' will define the SEM Scanner series (Provizio ® SEM Scanner and the SEM Scanner 200).…”

Section: How the Device Workmentioning

confidence: 99%

Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning

Bryant

Moore

Iyer

2021

Expert Review of Medical Devices

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Introduction: Pressure injuries (PIs) are a global health concern. Current PI care standards, including skin tissue assessments (STA) and health care professional (HCP) clinical judgment, diagnose visibly manifested PIs on the skin's surface, i.e. after the damage has already occurred. However, objective assessment of early-stage, non-visible, pressure-induced tissue damage is clinically impossible within the current standard of care. The SEM Scanner is the first device authorized by the Food and Drug Administration (FDA) that addresses this unmet clinical need. Areas covered: This review describes the novel sub-epidermal moisture (SEM) scanning technology of the device and summarizes the clinical safety and efficacy data that support the use of the scanner in routine PI care practice. Expert opinion: The clinical strategy for developing the SEM Scanner is noteworthy. SEM technology using anatomy-specific data enables HCPs to provide early PI prevention interventions before visible signs of tissue damage develop while the damage is still reversible. When adopted into routine practice, the device identifies an increased risk of developing PIs 5 days (median) earlier than STA. FDA clearance was based on bench studies and data from three foundational trials that demonstrate the diagnostic accuracy of the device algorithm significantly exceeding clinical judgment (p < 0.001).

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“…This temporal gap results in current skin tissue Standard of Cares (SoC) to be ineffective in achieving timely detection of PI/PUs. There is no evidence‐based tool for a nurse practitioner relying on current risk assessment tools (RATs) and STAs to detect the developing injury in a timely way (Peko & Gefen, 2020; Ross & Gefen, 2019). This evident diagnostic latency in anatomically targeted detection of early non‐visible tissue damage is the true barrier to effective and objective PI/PU prevention.…”

Section: Aetiological Contextmentioning

confidence: 99%

Evaluating the impact on hospital acquired pressure injury/ulcer incidence in a United Kingdom NHS Acute Trust from use of sub‐epidermal scanning technology

Nightingale

Musa

2021

Journal of Clinical Nursing

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Background The incidence of pressure injury/ulcers is persistent despite multiple prevention strategies in hospitals across the globe. Current standard of pressure injury/ulcer care supported by subjective skin tissue assessments, risk assessment tools and clinical judgement is ineffective in consistent pressure injury/ulcer prevention. Aim A pragmatic study, aligning with SQUIRE guidelines, was conducted at Chelsea and Westminster hospitals to measure the impact of adding scanning technology to the prevailing standard of care pathway on the incidence of category 2–4 hospital‐acquired pressure injury/ulcers. Methods Six hundred and ninety‐seven mixed‐population patients at risk for pressure injuries/ulcers with a Waterlow score of ≥10 and a mean age ≥65 years were enrolled across four wards over a 6‐month period. Scanning technology was added to the prevailing standard of care as a device adjunctive to clinical judgement for the detection of deep and early‐stage pressure‐induced tissue damage. Ward staff completed comprehensive device training by the device manufacturer. Clinical interventions were initiated by clinical judgement informed by injury/ulcer risk assessments, skin and tissue assessments and scanner readings. Incidence of reportable category 2–4 pressure injuries/ulcers from the prior 12‐month period from the same wards were used as a control comparator population. All diagnosed category 2–4 pressure injuries/ulcers, unstageable and deep‐tissue injuries were recorded. Results Prior study 12‐month pressure injury/ulcer incidence was 0.6% (5/892 patients) in ward A, 4.4% (9/206 patients) in Ward B, 1.1% (12/1,123 patients) in Ward C and 2.6% (16/625 patients) in Ward D. Two pressure injury/ulcers in Ward B were recorded during the study. Zero pressure injuries/ulcers were recorded in the remaining three wards resulting in an 81% incidence reduction across all four wards. Improved clinical decisions from clinical judgement based on Sub‐Epidermal Moisture (SEM) Scanner data were reported in 83% patients (n=578/697). Conclusion Implementing scanning technology into routine clinical practice achieves consistent reductions in pressure injury/ulcer incidence.

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Sensitivity and laboratory performances of a second‐generation sub‐epidermal moisture measurement device

Cited by 10 publications

References 6 publications

Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning

Evaluating the impact on hospital acquired pressure injury/ulcer incidence in a United Kingdom NHS Acute Trust from use of sub‐epidermal scanning technology

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