title: Development and preliminary testing of head and neck cancer related external lymphedema and fibrosis assessment criteria.
abstract: OBJECTIVE
  To develop assessment criteria for evaluating and documenting status of external lymphedema and fibrosis in patients with head and neck cancer (HNC).
  
  
  METHODS
  This 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.
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  Validation of the modified HN-ELAF Assessment Criteria in larger sample sizes is ongoing.
authors.affiliation: 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.
authors.forename: Jie
authors.initials: J
authors.lastname: Deng
authors.affiliation: School of Nursing, Vanderbilt-Ingram Cancer Center, and Department of Biostatistics, School of Medicine, Vanderbilt University, Nashville TN, USA.
authors.forename: Sheila H
authors.initials: SH
authors.lastname: Ridner
authors.affiliation: School of Nursing, Vanderbilt-Ingram Cancer Center, and Department of Biostatistics, School of Medicine, Vanderbilt University, Nashville TN, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Wells
authors.affiliation: School of Nursing, Vanderbilt-Ingram Cancer Center, and Department of Biostatistics, School of Medicine, Vanderbilt University, Nashville TN, USA.
authors.forename: Mary S
authors.initials: MS
authors.lastname: Dietrich
authors.affiliation: School of Nursing, Vanderbilt-Ingram Cancer Center, and Department of Biostatistics, School of Medicine, Vanderbilt University, Nashville TN, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Murphy
mesh_terms: D000368:Aged; D005260:Female; D005355:Fibrosis / Q000175:diagnosis / Q000209:etiology; D006258:Head and Neck Neoplasms / Q000150:complications* / Q000473:pathology*; D006801:Humans; D008209:Lymphedema / Q000175:diagnosis* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D063189:Symptom Assessment
keywords: Assessment criteria; Fibrosis; Head and neck cancer; Instrument development; Lymphedema