Clinical question
Should measurements of focal edema (e.g., subepidermal moisture) be used in addition to standard skin and tissue assessment for identifying early non-visible tissue changes consistent with early signs of pressure-induced injury to inform PI prevention and reduce PI occurrence?
Context
Population:
Intervention:
Comparison:
Purpose:
Main Outcomes:
Setting:
Conflicts on Interest:
People at risk of pressure injuries
Measurement of focal edema plus standard clinical assessment informing preventive PI plan
Standard clinical assessment informing preventive PI plan
Identification of focal edema to inform the development of an appropriate PI prevention plan
Any clinical setting
Pressure injury (PI) occurrence
Accurate measurement of focal edema (an intermediate outcome that address the question)
Time between focal edema detection and visually detectable PI (intermediate outcome)
Prof Zena Moore Dr Pinar Avsar declared conflict of interest and refrained from voting.
Evidence to Decision Framework
(Click on the individual judgements for more information)
Summary of Judgements
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13
14.
15.
Yes
Varies
Large
Don’t know
Very low
Very low
Very low
No important uncertainty or variability
Probably favors the intervention
Moderate costs
Low
Probably favors the intervention
Varies
Probably yes
Varies
1. Problem:
Is the problem (pressure injuries) a priority?
JUDGEMENT
No
Probably No
Probably Yes
Yes
Varies
Don’t Know
RESEARCH EVIDENCE
The problem of preventing pressure injuries is a significant priority to healthcare in most clinical settings. In a stakeholder survey conducted by the Guideline Governance Group in 2021, all groups of stakeholders (individuals with or at risk of PIs, their informal carers and health professionals) identified that receiving guidance on accurate and effective methods for skin and tissue assessment was important (median ranking 5/5, where 5 is the highest priority). In an earlier survey conducted by the previous Guideline Governance Group in 2018,(Haesler, Pittman et al. 2022) 72.5% (278/383) of individuals with or at risk of PIs and 67.5% (574/850 of informal carers rated receiving information about skin and tissue assessments as important or very important.
2. Testing properties:
How accurate are devices for identifying/measuring focal edema?
JUDGEMENT
Very inaccurate
Inaccurate
Accurate
Very accurate
Varies
Don’t Know
RESEARCH EVIDENCE
| Visual skin assessment leading to categorization as skin redness, Category/Stage 1 or 2 PI or DTI |
Visual skin assessment leading to categorization as Category/Stage 1 PI |
Visual skin assessment leading to categorization as DTI |
Visual skin assessment leading to categorization as any skin redding |
|
|---|---|---|---|---|
| Delta readings with ≥0.6 as cut-off for abnormal focal edema values | Sensitivity for all anatomical locations:
|
Sensitivity for any anatomical location: 62% to 75% (Ousey, Stephenson et al. 2022)
Specificity for any anatomical location: 45% to 62% (Ousey, Stephenson et al. 2022) |
||
| Delta readings with >0.5 as cut-off for abnormal focal edema values |
Sensitivity for sacrum and heels:
|
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| Tissue dielectric constant (TDC) (27 TDC cut off for DTI, 29 TDC cut off for Category/Stage 1 PI) |
Sensitivity for heels: 58.6% to 60.8% (Bates-Jensen, McCreath et al. 2018) Specificity for heels: 47.5% to 47.2% (Bates-Jensen, McCreath et al. 2018) |
Sensitivity for heels: 48.3% to 49.3%(Bates-Jensen, McCreath et al. 2018) Specificity for heels: 63.4% to 65%(Bates-Jensen, McCreath et al. 2018) |
Reliability and measurement error of a device to identify/measure focal edema
In studies exploring the reliability of devices to measure focal edema with healthy volunteers in controlled environments, intraclass coefficients (ICCs) are reported as exceeding 0.80 (Clendenin, Jaradeh et al. 2015). Comparing readings of three different devices, ICCs ranged from 0.84 to 0.96 indicating high reliability. Limits of agreement ranged from -0.5 to 0.5 indicating that 95 of 100 readings are expected to vary between ±0.5 of individual readings (Clendenin, Jaradeh et al. 2015). In one study a comparison of two different devices was conducted in a group of young healthy volunteers. Three out of seven readings showed statistically significant mean differences between the two devices (Latimer, Bone et al. 2024). Mean differences were minimal and not clinically significant. The risk of bias in these studies is unclear to high.
No studies were identified that reported reliability or measurement error studies in which healthcare professionals used a device at the bedside to measure delta results in patients under real clinical practice conditions for diagnostic purposes. One study (Clendenin, Jaradeh et al. 2015) explored interrater reliability of trained device operators. ICC ranged between 0.848 (95% CI = 0.827 – 0.867) and 0.961 (95% CI 0.955 to 0.967).
Accuracy of a device to identify/measure focal edema reporting delta changes
Diagnostic accuracy studies comparing heel and sacral measurements using a device to measure focal edema (delta ≥ 0.6 as cut-off for abnormal values) with skin redness, Category/Stage I or II PI, or deep tissue pressure injuries (DTI) resulted in sensitivities ranging from 62% to 91% and specificities from 32% to 86% depending on the used measurement algorithm and anatomical location (Gershon, 2021; Ousey, 2022). The risk of bias in these studies is unclear to high.
Prognostic accuracy studies analyzed abnormal measurements of focal edema (any anatomical location) with the subsequent occurrence of Category/Stage I PI. A narrative systematic review reporting four studies (Bates-Jensen, 2018;Moda Vitoriano Budri, 2020 ;O'Brien, 2018;Okonkwo, 2020) reported a mean sensitivity of 72% (SD = 23.05) and mean specificity of 51.96% (SD = 20.2%).(Moore, 2022)
Diagnostic accuracy of using a device to identify/measure focal edema that reports TDC units
Compared to visual skin assessment leading to the diagnosis of Category/Stage 1 PI at heels, a study in individuals in high level aged care settings yielded a sensitivity of 59% and 61%, respectively, and a specificity of 47 % (Bates-Jensen, McCreath et al. 2018). Compared to visual skin assessment leading to the diagnosis of DTI at heels, a sensitivity of <50 % (48% and 49%, respectively), and a specificity of 63% to 65% were estimated (Bates-Jensen, McCreath et al. 2018). The risk of bias in this study was low, unclear and high across the QUADAS-2 domains.
GGG summary
The GGG noted the high sensitivity, which is useful and possibly explains the observed reduction in PI occurrence when devices to assess focal edema are used as an additional strategy to inform preventive care. However, the specificity is low. Confidence intervals for inter-rater reliability are narrow in controlled laboratory settings. However, confidence intervals reported in clinical trials may be too wide to make clinical decisions. Education and training are critical to ensuring reliability of test results. Based on this, the GGG determined that the accuracy of testing properties is varied.
3. Desirable Effects:
How substantial are the desirable anticipated effects when a device is used to identify/measure focal edema and the result is used to inform preventive PI care?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
| Outcome | Ax with device for focal edema to to inform PI care |
Ax without device for focal edema + PI care |
Odds ratio | Difference |
|---|---|---|---|---|
| PI occurrence | 27/2711 (1.0%) | 409/15880 (2.6%) | OR 0.36 (0.245 to 0.52) |
16 fewer per 1000 (from 19 fewer to 12 fewer) |
Outcome 1: Reduction in PI occurrence
The meta-analysis conducted by the GGG included eight studies (one randomized study and six non-randomized comparative studies) (Raizman, MacNeil et al. 2018, Ore and Carver 2020, Musa, Ore et al. 2021, Nightingale and Musa 2021, Raine 2021, Campbell, Chaboyer et al. 2022, Byrne, Patton et al. 2023, Osborne Chambers and Thompson 2024) that compared using a device to identify/measure focal edema** plus adjusting the PI prevention care based on the results to adjusting PI preventive without using a device to identify/measure focal edema. The studies were conducted in adults in hospital, long term care, community and palliative care settings. In all the studies, an abnormal measurement was considered to be a value of delta ≥ 0.6. After receiving the result from the measurement device, clinical staff implemented individualized PI prevention interventions, which varied between the studies in the meta-analysis but included a combination of:
SSKIN (4 of the studies),
escalated support surface, repositioning and heel off-loading (8 of the studies),
barrier cream (4 of the studies),
preventive dressings (7 of the studies),
increased frequency of skin and tissue assessments (1 of the studies),
nutrition care plan (1 of the studies) and
patient education (1 of the studies).
The meta-analysis showed that using a device to identify/measure focal edema to inform PI preventive care was associated with a significantly lower rate of PIs (odds ratio (0.36), 95% CI 0.245 to 0.53, p <0.000001). This translated to a difference of 16 fewer per 1,000 experiencing a PI. However, the evidence was of very low quality. It is uncertain if the result represents a true effect; the true effect lies between 19 fewer people and 12 fewer people experiencing a PI when a device to identify/measure focal edema is used as a part of skin and tissue assessment compared to only a visual/tactile skin and tissue assessment being used. The evidence was downgraded due to risk of bias from high risk of biased results in more than half the studies, and for directness because the PI interventions varied across the studies
Outcome 3: Time between detection of abnormal focal edema and visibly detectable PI
In one review,{Moore, 2022 #2471} an analysis identified the mean difference in time to PI development (SEM measurement versus visual skin assessment, VSA) was 4.61 days (95% CI 3.94 to 5.28; p = 0.0001) in favor of SEM measurements. In another review,{Chaboyer, 2022 #1395} the pooled time between SEM detection of focal edema and visible PI detection was 4.08 days (95% CI 1.09 to 7.08).
In evaluating the factors on the Evidence to Decision framework, the GGG voted desirable effects to be one of the most important considerations.
** Two different devices were used in the studies, as reported in the data extraction tables
4. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Undesirable effects of inaccurate device measurement
There are no studies reporting the consequences of an inaccurate measurement of focal edema being used to inform clinical decision-making.
Undesirable effects of using a device to identify/measure focal edema
One study (Okonkwo, Bryant et al. 2020) reported risk of device-related adverse events associated with the use of a device. In this study, 189 individuals without pre-existing PIs were evaluated using a device to measure focal edema at the heels and sacrum for between 6 days and 21 days (total of 437 scans performed in the study). Five individuals (2.6%) experienced an adverse event while enrolled in the study, of which none of the events were deemed to be related to using the device. One of the events was mortality, and the other four events were not described. Other studies explored adverse events but reported that none occurred (Gefen and Gershon 2018, Musa, Ore et al. 2021, Nightingale and Musa 2021).
5. Certainty of evidence of device accuracy: What is the overall certainty of the evidence test accuracy?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
| Outcome | Relative Importance | Certainty of Evidence |
|---|---|---|
| SEM accuracy | CRITICAL | VERY LOW |
The evidence was downgraded for risk of bias because all studies were at high or unclear risk in at least one domain, leading directly to the overall evidence being at critical risk of bias. The evidence was downgraded inconsistency because the studies reported variable results and used different devices and different cut-off points.
6. Certainty of evidence of using a device plus standard assessment to inform care: What is the certainty of the evidence of effects?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
| Outcome | Relative Importance | Certainty of Evidence |
|---|---|---|
| PI occurrence | CRITICAL | VERY LOW |
Outcome 1: PI occurrence
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical importance (score of 7-9).
The evidence was downgraded three times for risk of bias because the studies were non-randomised and some characteristics of most of the studies, and therefore the result, may lead directly to the result being at critical risk of bias. The evidence was downgraded for indirectness because not all studies applied the same PI interventions or care pathways, reducing reproducibility in clinical practice.
7. Certainty of effects: What is the overall certainty of the evidence of effects?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
| Outcome | Relative Importance | Certainty of Evidence |
|---|---|---|
| Device accuracy | CRITICAL | VERY LOW |
| PI occurrence | CRITICAL | VERY LOW |
The certainty of the evidence related to the accuracy of device measurements was very low, and the certainty of evidence on the clinical application of the measurement of focal edema to PI prevention care pathways was also of very low certainty.
8. Values:
Is there important uncertainty about or variability in how much people value the main outcomes?
JUDGEMENT
Important uncertainty or variability
Possibly important uncertainty or variability
Probably no important uncertainty or variability
No important uncertainty or variability
RESEARCH EVIDENCE
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical important (score of 7-9) by all types of stakeholders (health professionals, people with or at risk of a PI and their informal carers, industry representatives and researchers). Greater than 90% of the 158 participants rated this outcome measure as critically important (Lechner, Coleman et al. 2022).
9. Balance of Effects:
Does the balance between desirable and undesirable effects favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Favors the intervention
Varies
Don’t know
RESEARCH EVIDENCE
With respect to the device accuracy, the sensitivity indicated that most individuals identified as having focal edema by the device were correctly identified. The specificity data indicated that in the lower ranges of specificity a majority of individuals who were not classified as having a PI were incorrectly identified as having focal edema using the device. There is uncertainty about the potential consequences of theses misclassifications.
The clinical evidence indicated that when an individual had device measurement identifying focal edema and the individualized PI preventive care was adjusted with consideration to the result, there was a lower rate of PI occurrence. There is uncertainty about the potential consequences of changing a PI preventive care plan based on a misclassification.
GGG summary
The GGG considered that the desirable effects of identifying an individual with focal edema and using this data to inform the development of an individualized PI prevention plan most likely outweighs the risks associated with an inaccurate measurement.
10. Resources Required:
How large are resource requirements (costs) of the intervention?
JUDGEMENT
Large costs
Moderate costs
Negligible costs and savings
Moderate savings
Large savings
Varies
Don’t know
RESEARCH EVIDENCE
Device sensors are for single-use and need to be changed between patients.
Recently, an expert panel reviewed current technology for devices that measure/identify focal edema readings (Tzen et al. 2025). They provide several clinical implementation factors including financial considerations. Costs associated with using a device include hardware, licenses, disposables and supplies, personnel, education and training, cost of information technology (IT) and integration of the device into the electronic health record (Tzen, Delmore et al. 2025). For this reason the authors suggested that using a device to identify/measure focal edema should be an advanced add-on to clinical assessment rather than a standard component of a skin and tissue assessment (Tzen, Delmore et al. 2025). Additional information from a feasibility RCT showed that the labor time associated with performing one SEM assessment was an average time of 9 minutes (IQR 3.3 to 32.5) (Campbell et al. 2022).
Cost per individual for use of a device to identify/measure focal edema in the UK health system over an average inpatient length of stay was £1.54 in 2020 (Gershon 2020) and was estimated as £5.50 per patient day in 2024 (Posnett, Moss et al. 2023).
In a qualitative study nurses referred to more difficulty including identifying/measuring focal edema in a skin and tissue assessment when there are limited devices available in the health service. They also identified cost as a potential barrier to use. Other resource requirements that the qualitative study reported included the need for training to understand the use of the device and interpretation of results.(Tobiano, Campbell et al. 2023)
11. Certainty of evidence of required resources:
What is the certainty of evidence of resource requirements (costs) of the intervention (sensor monitor)?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
The quality of evidence on the impact of resource use is limited by design of studies. It is uncertain precisely what components of care were considered in resource evaluations.
12. Cost Effectiveness: Does the cost-effectiveness of the intervention favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Varies
No included studies
RESEARCH EVIDENCE
A probabilistic modelling analysis suggested a cost saving of £0.6 million–£3.3 million per annum of introducing a device to identify/measure focal edema to UK health service. The assumptions were based on PI incidence data published in 2012, data on the accuracy of visual skin assessment published in 2012, data on the accuracy of measurements published in 2019 and unclear sources for resource costs. The cost savings identified in the model were achieved through detection focal edema, higher detection rate of Category/Stage 1 HAPIs and therefore potential prevention of more severe PI, and avoidance of unnecessary PI prevention care. (Gefen, Kolsi et al. 2020). This study was at high risk of bias due to funding by the device manufacturer.
Markov cohort modelling suggested cost-savings of US$4,054 and 0.35 quality-adjusted life years (QALYs) gained per acute care admission when a device to identify/measure focal edema was integrated into care. This translated to a facility cost saving of $39,335 over 12 months in an acute care setting and a cost-savings of $11,577.29 per QALY gained (CI: $10,881.29 to $12,273.29 saved per QALY gained) (Padula, Malaviya et al. 2020). This study was at high risk of bias due to funding by the device manufacturer.
A decision tree model was used to evaluate cost-effectiveness. In a typical NHS acute hospital with 480 beds, the addition of SEM assessment as an adjunct to SoC is expected to reduce the incidence of HAPUs by 32.9% and lead to a cost saving of £26.53 per admission. The probability that adjunctive SEM is cost-effective at a threshold of £30,000 per QALY is 69%.{Posnett, 2023 #3803} This study was at high risk of bias due to funding by the device manufacturer.
The GGG noted that the cost effectiveness data is derived from industry sponsor studies. A review of industry sponsored studies in health settings noted that industry sponsored studies reported cost effectiveness ratios 33% lower than non-industry and were more likely to report cost-effectiveness than independent studies.{Xie, 2022 #7329} However, it is well acknowledged that the cost of a PI can significant should it not be identified early.
13. Inequity:
What would be the impact of recommending the intervention on health inequity?
JUDGEMENT
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
RESEARCH EVIDENCE
Access to devices to identify/measure focal edema is likely to be limited in many geographic locations and clinical settings. Recommending the use of such devices as a part of skin and tissue assessment could increase inequity as many individuals will not have access to the technology.
However, using a device to identify/measure focal edema as a part of a skin and tissue assessment could reduce disparities by increasing the early identification of PIs in individuals with dark skin tones (Smith 2019, Francis 2023). Early skin damage (e.g., erythema) is more difficult to identify in dark skin tones (Smith 2019) using a standard visual and tactile assessment, which may contribute to the under-detection of PIs in individuals with dark skin (VanGilder, MacFarlane et al. 2008) and the subsequent higher severity of PIs they are reported to experience (Oozageer Gunowa, Hutchinson et al. 2018, Bates-Jensen, Anber et al. 2021, LaFond, Solmos et al. 2025). Because identifying/measuring focal edema with a device does not rely on a visual assessment of the skin, incorporating the device into the skin and tissue assessment might increase opportunity to prevent PIs.
14. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In a qualitative study, individuals receiving daily assessment with a device to identify/measure focal edema and nurses who were provided with the results reported that the assessment was easy to implement and not burdensome for patients or clinician staff. The clinicians found the device augmented standard PI preventive care by promoting individualized care (Tobiano, Campbell et al. 2023).
Clinicians have reported that the immediate data that is received when using a with a device to identify/measure focal edema is informative to their immediate clinical decision making with respect to whether to implement PI preventive care, and the type of intervention that might be most appropriate (Scafide, Narayan et al. 2020, Raine 2021, Avsar, Patton et al. 2024).
15. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
Access to with devices that identify/measure focal edema is likely to be limited in many geographic locations and clinical settings.
In the literature, devices to identify/measure focal edema have been used daily, weekly or three times a week, usually at the heels and sacrum, as an additional component of a skin and tissue assessment.(McLaren-Kennedy, Chaboyer et al. 2023) A feasibility RCT showed that the labor time associated with performing measurements was an average time of 9 minutes (IQR 3.3 to 32.5) (Campbell et al. 2022), which may reduce the feasibility of using a device on a routine basis.
A qualitative study was conducted involving 50 nursing home staff members from 5 nursing homes who had used a device to measure focal edema over an 8-month period. They identified the following barriers to device use: poor compatibility with existing workflows (35% of instances), implementation complexity extending beyond device operation (31%), mixed observability of benefits (32%), and concerns about relative advantage amid resource constraints (26%). Compliance with testing declined over time. Recommendations are provided to enhance implementation and maintenance of innovations.(Yap, 2026)
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