• Jie Deng, Sheila H Ridner, Nancy Wells, Mary S Dietrich, and Barbara A Murphy.
• School of Nursing, Vanderbilt-Ingram Cancer Center, and Department of Biostatistics, School of Medicine, Vanderbilt University, Nashville TN, USA. Electronic address: jie.deng@vanderbilt.edu.
• Eur J Oncol Nurs. 2015 Feb 1; 19 (1): 75-80.

PurposeTo develop assessment criteria for evaluating and documenting status of external lymphedema and fibrosis in patients with head and neck cancer (HNC).MethodsThis was a two-phase instrument development study. In Phase I, initial assessment criteria for head and neck external lymphedema and fibrosis were generated based on a conceptual framework developed to describe the continuum of lymphedema - fibrosis in HNC patients. The initial Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Assessment Criteria with three components were revised based on expert feedback. In Phase II, a pilot study was conducted to evaluate the revised assessment criteria through direct physical examination of 30 HNC patients with facial swelling and/or scar-like tissue >3 months post-treatment. The following statistical methods were used to evaluate interrater reliability in Phase II: simple percent agreement, the Kappa statistic, and the concordance correlation coefficient. Then, a post-test revision was made to further modify the tool based on the results of the pilot test.ResultsIn Phase I, the initial HN-ELAF was revised including deleting Grade 0 (subclinical disease) and two components (i.e., symptoms and functional impairments). The revised HN-ELAF Assessment Criteria demonstrated good content/face validity. In Phase II, the assessment criteria had an acceptable interrater reliability, e.g., 83% exact agreement on grading lymphedema and fibrosis severity; and kappa = 0.75 (p < .001). The assessment criteria were further modified including three dimensions: type, severity, and anatomical sites of lymphedema and fibrosis.ConclusionsValidation of the modified HN-ELAF Assessment Criteria in larger sample sizes is ongoing.Copyright © 2014 Elsevier Ltd. All rights reserved.

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