title: Development and validation of a self-report lower-extremity lymphedema screening questionnaire in women.
abstract: BACKGROUND
  Patient-reported signs and symptoms are often the first indication of clinically relevant lymphedema.
  
  
  OBJECTIVE
  The purpose of this study was to develop and assess the diagnostic accuracy of a screening questionnaire to detect lower-extremity lymphedema (LEL) among normal-weight women and women with obesity.
  
  
  METHODS
  This was a cross-sectional survey study.
  
  
  METHODS
  The authors reviewed existing questionnaires assessing upper-extremity lymphedema (UEL) for potential questions and worked with content experts to generate new items. A draft questionnaire with 59 items was reviewed by 5 physicians and 5 physical therapists who specialized in lymphedema management and 5 female patients with clinically confirmed secondary LEL. A revised questionnaire with 45 items was administered by mail to 186 women with clinically confirmed LEL (n=116) or UEL (n=70). A total of 99 women (53.2% of 186) completed the mailed survey, and 28 women with lymphedema who were recruited directly in a lymphedema clinic waiting area also completed the survey. A parsimonious subset of items that best discriminated patients with and without LEL was identified using chi-square tests and logistic regression. Sensitivity and specificity for detecting LEL and positive and negative likelihood ratios (LR+, LR-) were estimated for the entire sample and for subsamples defined by obesity (body mass index ≥30 versus <30 kg/m(2)), which may confound the accurate diagnosis of LEL.
  
  
  RESULTS
  Questionnaires were completed by 127 women (LEL group, n=88; UEL group, n=39). A sum of 13 items (score range=0-52) was the most discriminating. Using a cutoff score of ≥5 points, the sensitivity and specificity for detecting LEL among all participants were 95.5% and 86.5%, respectively (LR+=7.1, LR-=0.05), and 94.8% and 76.5%, respectively (LR+=4.0, LR-=0.07), for participants who were obese.
  
  
  CONCLUSIONS
  By enumerating a sample with a high prevalence of LEL, a spectrum bias may have been introduced, which may have affected the accuracy of the screening questionnaire.
  
  
  CONCLUSIONS
  The brief, 13-item self-report questionnaire is a sensitive and specific tool for detecting clinically relevant LEL among women, including those with a body mass index of ≥30 kg/m(2).
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, 200 First St W, Rochester, MN 55905, USA. yost.kathleen@mayo.edu
authors.forename: Kathleen J
authors.initials: KJ
authors.lastname: Yost
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Cheville
authors.forename: Amy L
authors.initials: AL
authors.lastname: Weaver
authors.forename: Mariam
authors.initials: M
authors.lastname: Al Hilli
authors.forename: Sean C
authors.initials: SC
authors.lastname: Dowdy
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D035002:Lower Extremity; D008197:Lymph Node Excision / Q000009:adverse effects; D008209:Lymphedema / Q000175:diagnosis* / Q000453:epidemiology* / Q000209:etiology; D008403:Mass Screening / Q000379:methods; D009765:Obesity / Q000453:epidemiology*; D057566:Self Report; D011795:Surveys and Questionnaires