Brodovicz Kimberly G, McNaughton Kristin, Uemura Naoto, Meininger Gary, Girman Cynthia J, Yale Steven H
Department of Epidemiology, Merck Research Laboratories, North Wales, Pennsylvania 19454, USA.
Clin Med Res. 2009 Jun;7(1-2):21-31. doi: 10.3121/cmr.2009.819. Epub 2009 Feb 26.
To evaluate methods to assess peripheral edema for reliability, feasibility and correlation with the classic clinical assessment of pitting edema.
Cross-sectional observational study.
Large primary care clinic in Marshfield, Wisconsin, USA.
Convenience sample of 20 patients with type 2 diabetes and a range of edema severity, including patients without edema.
Eight methods of edema assessment were evaluated: (1) clinical assessment of pit depth and recovery at three locations, (2) patient questionnaire, (3) ankle circumference, (4) figure-of-eight (ankle circumference using eight ankle/foot landmarks), (5) edema tester (plastic card with holes of varying size pressed to the ankle with a blood pressure cuff), (6) modified edema tester (edema tester with bumps), (7) indirect leg volume (by series of ankle/leg circumferences), and (8) foot/ankle volumetry by water displacement. Patients were evaluated independently by three nurse examiners.
Water displacement and ankle circumference had high inter-examiner agreement (intraclass correlation coefficient 0.93, 0.96 right; 0.97, 0.97 left). Agreement was inconsistent for figure-of-eight (0.64, 0.86), moderate for indirect leg volume (0.53, 0.66), and low for clinical assessments at all locations. Agreement was low for the edema testers but varied by the pressure administered. Correlation with the classic, subjective clinical assessment was good for the nurse-performed assessments and patient questionnaire. Ankle circumference and patient questionnaires each took 1 minute to complete. Other tools took >5 minutes to complete.
Water displacement and ankle circumference showed excellent reliability; however, water displacement is a time-consuming measure and may pose implementation challenges in the clinical and clinical trial environments. Patient-reported level and frequency of edema, based on an unvalidated questionnaire, was generally well correlated with the physician assessment of edema severity and may prove to be another reliable and accurate method of assessing edema. Additional study is needed to evaluate the validity and responsiveness of these methods.
评估评估外周水肿的方法在可靠性、可行性以及与凹陷性水肿经典临床评估的相关性方面的表现。
横断面观察性研究。
美国威斯康星州马什菲尔德的大型初级保健诊所。
20名2型糖尿病患者的便利样本，水肿严重程度各异，包括无水肿患者。
评估了八种水肿评估方法：（1）在三个部位对凹陷深度和恢复情况进行临床评估；（2）患者问卷；（3）踝围；（4）“8”字形测量法（使用八个踝/足标志点测量踝围）；（5）水肿测试仪（带有不同尺寸孔的塑料卡，用血压袖带压在脚踝上）；（6）改良水肿测试仪（带凸起的水肿测试仪）；（7）间接腿部容积法（通过一系列踝/腿周长测量）；（8）通过排水法测量足/踝容积。由三名护士检查人员对患者进行独立评估。
排水法和踝围测量法在检查人员间的一致性较高（组内相关系数分别为右侧0.93、0.96；左侧0.97、0.97）。“8”字形测量法的一致性不一致（0.64、0.86），间接腿部容积法的一致性为中等（0.53、0.66），所有部位的临床评估一致性较低。水肿测试仪的一致性较低，但因施加的压力而异。护士进行的评估和患者问卷与经典的主观临床评估相关性良好。踝围测量和患者问卷每项均需1分钟完成。其他工具完成时间超过5分钟。
排水法和踝围测量法显示出极佳的可靠性；然而，排水法耗时较长，可能在临床和临床试验环境中带来实施挑战。基于一份未经验证的问卷，患者报告的水肿程度和频率通常与医生对水肿严重程度的评估密切相关，可能成为另一种可靠且准确的水肿评估方法。需要进一步研究来评估这些方法的有效性和反应性。
