Biophysical Measure To Predict Pressure Ulcers In Nursing Home Residents

描述（由申请人提供）：本研究将采用多站点、纵向队列设计，对浅色或深色皮肤的养老院（NH）居民进行I期压疮（PUs）的非视觉评估策略的有效性进行测试。脓液很常见，通常可以预防，而且费用昂贵；早期脓毒症的检测很重要，因为干预可以防止脓毒症恶化到更严重的程度。标准的检测方法，视觉皮肤评估非漂白性红斑，在一定程度上是可靠的个人浅色肤色，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。非裔美国人和白种人在I期脓肿发病率和预防干预方面的健康差异可能与检测缺陷有关。在我们之前的研究中，我们展示了一种手持式设备，用于评估表皮下水分（SEM），这是一种测量组织炎症变化引起的水肿的方法，可识别I期脓液。此外，当当时没有明显的皮肤损伤，但一周后皮肤上可见I期PU时，SEM更高（例如，水肿和炎症增加）；SEM值预测了26%的后续I期pu。在一小部分深色肤色的新罕布什尔州居民中，研究结果也类似。我们建议测试这种检测脓液的创新方法的有效性，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到II+ pu的进程的阈值SEM值。我们将招募389名NH居民，其中62人肤色较深，根据24个NHs的最小数据集评估，他们有PU风险。研究人员将在4个月内至少每周为同意的受试者完成一次视觉皮肤评估和盲法扫描电镜测量。NH居民的肤色将使用彩色瓷砖进行评估，而不是像以前的研究那样通过代理度量种族。此外，参与者的人口统计数据、MDS在功能水平上的评估数据和合并症的医疗条件将从医疗记录审查中获得。使用布雷登压疮预测量表的风险评估将在基线收集。广义有序逻辑模型，适当地模拟重复观察和时间相关的措施，将用于评估扫描电镜措施识别未来皮肤损伤的有效性。扫描电镜的测量代表了一个潜在的重要工具，以减少不同肤色的人之间的预防干预的差异。与公共卫生的相关性：对公共卫生的声明这个项目是评估褥疮新评估技术的下一步，褥疮是养老院居民的一个常见问题。如果这种测量能够在早期阶段识别出皮肤损伤，从而允许及时干预，那么通过临床试验评估其使用的证据将是强有力的。此外，替代依赖肤色变化评估皮肤损伤的方法有可能减轻深色皮肤患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平衡发现损伤的机会。

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.