Biophysical Measure To Predict Pressure Ulcers In Nursing Home Residents

描述（由申请人提供）：本研究将使用多中心纵向队列设计，在浅肤色或深肤色的疗养院（NH）居民中测试I期压疮（PU）非视觉评估策略的有效性。PU是常见的，通常是可以预防的，并且成本高昂;早期PU的检测很重要，因为干预可以防止下降到更严重的PU。标准的检测方法，视觉皮肤评估非漂白性红斑，是有点可靠的个人与浅肤色，但检测变化后，皮肤损伤已经发生。此外，视觉皮肤评估无法检测深色皮肤的人的肤色变化。记录的健康差异之间的非洲裔美国人和高加索人的发病率I期PU和预防干预可能与缺陷的检测。在我们之前的研究中，我们表明，一种评估表皮下水分（SEM）的手持设备，这是一种衡量组织中炎症变化引起的水肿的指标，可识别I期PU。此外，SEM更高（例如，水肿和炎症增加），当时没有可见的皮肤损伤，但一周后在皮肤上可见I期PU; SEM值预测26%的后续I期PU。在一小群肤色较深的NH居民中，结果相似。我们建议测试这种创新方法检测PU的有效性，特别是关注深色肤色的居民;测试用于检测I期PU和检测I期PU向II+期PU进展的阈值SEM值。我们将招募389名NH居民，其中62人将具有深色肤色，根据24个NH的最小数据集评估，他们有PU的风险。对于知情同意的住院医生，研究人员将至少每周完成一次皮肤目视评估和设盲SEM测量，持续4个月。NH居民的肤色将使用颜色瓷砖进行评估，而不是像以前的研究那样通过种族的替代措施进行评估。此外，将通过病历审查获得受试者人口统计学、功能水平的MDS评估数据和合并症。将在基线时收集使用Braden压疮预测量表进行的风险评估。将使用广义有序逻辑模型（对重复观察和时间依赖性指标进行适当建模）评价SEM指标识别未来皮肤损伤的有效性。SEM的测量是一个潜在的重要工具，用于减少不同肤色的人之间的预防干预措施的差异。公共卫生相关性：对公众健康的声明该项目是对褥疮新评估技术进行评估的下一步，褥疮是养老院居民的常见问题。如果这种测量可以在早期阶段识别皮肤损伤，以便及时干预，那么通过临床试验评估其使用的证据将是有力的。此外，取代依赖于肤色变化的皮肤损伤评估方法，有可能降低深色皮肤者皮肤损伤的严重程度，从而减少观察到的健康差异，并在预防措施最有效的时候均衡检测损伤的机会。

DESCRIPTION (provided by applicant): This study will test the validity of a non-visual assessment strategy for stage I pressure ulcers (PUs) among nursing home (NH) residents with light or dark skin tones using a multi-site, longitudinal cohort design. PUs are common, often preventable, and costly; detection of early-stage PUs is important because intervention may prevent decline to more severe PUs. The standard method of detection, visual skin assessment for non- blanchable erythema, is somewhat reliable for individuals with light skin tones but detects changes after skin damage has already occurred. In addition, visual skin assessment fails to detect skin color changes in persons with darkly pigmented skin. Documented health disparities between African Americans and Caucasians for incidence of stage I PUs and prevention intervention may be related to deficiencies in detection. In our prior studies, we showed that a hand-held device that assesses sub-epidermal moisture (SEM), a measure of edema from inflammatory changes in the tissues, identified stage I PUs. Further, SEM was higher (e.g., increased edema and inflammation) when there was no visible skin damage at the time but a stage I PU was visible on the skin one week later; SEM values predicted 26 percent of the subsequent stage I PUs. Findings were similar in a small sub-sample of NH residents with dark skin tones. We propose to test the validity of this innovative approach to detecting PUs, particularly focusing on residents with dark skin tones; to test threshold SEM values for detecting stage I PUs and detecting progression of stage I PUs to stage II+ PUs. We will recruit 389 NH residents, 62 of whom will have dark skin tones, who are at risk for PU based on the Minimum Data Set Assessment from 24 NHs. Visual skin assessments and blinded SEM measures will be completed by research staff at least weekly for consented residents for 4 months. Skin tone of NH residents will be assessed using color tiles rather than by proxy measures of ethnicity as in previous research. In addition, participant demographics, MDS assessment data on functional level, and comorbid medical conditions will be obtained from medical record review. Risk assessments using the Braden Scale for Predicting Pressure Sores will be collected at baseline. Generalized ordered logistic modeling, appropriately modeling the repeated observations and time-dependent measures, will be used to evaluate the effectiveness of SEM measures to identify future skin damage. Measurement of SEM represents a potentially important tool for decreasing the disparity of prevention interventions between persons with different skin tones. PUBLIC HEALTH RELEVANCE: Statement to Public Health This project is the next step in the evaluation of a new assessment technique for bedsores, a common problem for nursing home residents. If this measurement can identify skin damage at an earlier stage to allow prompt intervention, evidence will be powerful for evaluating its use through a clinical trial. In addition, replacing methods of assessing skin damage that rely on skin color changes has the potential of reducing the severity of skin damage in persons with darkly pigmented skin, leading to reduction in observed health disparities and equalizing the chance of detecting damage at a point when prevention practices can be most effective.