title: Preliminary evaluation of reliability and validity of head and neck external lymphedema and fibrosis assessment criteria.
abstract: OBJECTIVE
  Measurement of head and neck external lymphedema and fibrosis (LEF) is challenging. To address this gap, we developed the Head and Neck External Lymphedema and Fibrosis (HN-LEF) Assessment Criteria. This article aimed to report preliminary data on reliability and validity of the HN-LEF Assessment Criteria.
  
  
  METHODS
  Sixty head and neck cancer (HNC) patients who were ≥3-month post cancer therapy were recruited. Study measures included 1) demographic/medical data; 2) LEF physical examination completed independently by two staff members for interrater reliability (intrarater reliability completed by one of them); and 3) grayscale ultrasound examination of the head and neck skin. Reliability estimates used percent agreement and Kappa statistic. Validity was assessed via Spearman correlations of physical examination findings with ultrasound measurements.
  
  
  RESULTS
  Fifty-one out of 60 HNC patients completed both physical examination and ultrasound assessments. Interrater reliability: 91.0% agreement (Kappa = 0.81, p < 0.001) on the presence of types of LEF; 84.9% agreement regarding the grade of LEF (Kappa = 0.70, p < 0.001) across all anatomic sites. Intrarater reliability: 96.1% agreement for type of LEF; and 91.4% agreement for grade across all sites. Ultrasound examination demonstrates characteristics and patterns for different types of LEF (particularly in the cheek, submental, and neck regions).
  
  
  CONCLUSIONS
  The study provided initial reliability and validity data for a clinician-reported tool evaluating external LEF in the HNC population. These preliminary findings demonstrate that the tool had good reliability. Associations with the ultrasound examination results demonstrate that the tool validly captures soft tissue changes at select sites. Further validation of the tool is warranted.
authors.affiliation: School of Nursing, 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 University, Nashville, TN, USA.
authors.forename: Mary S
authors.initials: MS
authors.lastname: Dietrich
authors.affiliation: School of Nursing, Vanderbilt University, Nashville, TN, USA.
authors.forename: Sheila H
authors.initials: SH
authors.lastname: Ridner
authors.affiliation: Radiology and Radiological Sciences, Vanderbilt University, Nashville, TN, USA.
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Fleischer
authors.affiliation: School of Nursing, Vanderbilt University, Nashville, TN, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Wells
authors.affiliation: Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Murphy
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005355:Fibrosis; D006258:Head and Neck Neoplasms / Q000150:complications* / Q000000981:diagnostic imaging / Q000473:pathology*; D006801:Humans; D008209:Lymphedema / Q000175:diagnosis* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D015203:Reproducibility of Results
keywords: Assessment criteria; Clinician-reported outcome measure; Fibrosis; Head and neck cancer; Lymphedema; Measurement; Radiation; Reliability; Ultrasonography; Validation