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Reliability and Feasibility of Methods to Quantitatively Assess Peripheral Edema

Kimberly G. Brodovicz, DrPH, Department of Epidemiology, Merck Research Laboratories, North Wales, Pennsylvania
Kristin McNaughton, MHS, Department of Epidemiology, Merck Research Laboratories, North Wales, Pennsylvania
Naoto Uemura, MD, Department of Clinical Research–Clinical Pharmacology, Merck Research Laboratories, Rahway, New Jersey
Gary Meininger, MD, Department of Clinical Research–Metabolism, Merck Research Laboratories, Rahway, New Jersey
Cynthia J. Girman, DrPH, Department of Epidemiology, Merck Research Laboratories, North Wales, Pennsylvania
Steven H. Yale, MD, Department of Internal Medicine, Marshfield Clinic and Clinical Research Center, Marshfield Clinic Research Foundation, Marshfield, Wisconsin

Reprint Requests: Kimberly G. Brodovicz, DrPH, Department of Epidemiology, Merck Research Laboratories, PO Box 1000, UG1D-60, North Wales, PA 19454, Tel: 267-305-7490, Fax: 215-616-2042, Email: kimberly_brodovicz{at}merck.com

Objective: To evaluate methods to assess peripheral edema for reliability, feasibility and correlation with the classic clinical assessment of pitting edema.

Design: Cross-sectional observational study.

Setting: Large primary care clinic in Marshfield, Wisconsin, USA.

Participants: Convenience sample of 20 patients with type 2 diabetes and a range of edema severity, including patients without edema.

Methods: 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.

Results: 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.

Conclusions: 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.

Key Words: Measurement • Peripheral edema • Reliability

Research Support: Fully supported by Merck & Co., Inc. SH Yale has received grant support from Merck & Co., Inc. and has been a consultant to and a clinical investigator for the company.