title: Validation of Photograph-Based Toxicity Score for Topical 5-Fluorouracil Cream Application.
abstract: BACKGROUND
  An objective tool quantifying the toxicity of 5-fluorouracil (5-FU) from photographs was recently reported, and its reliability was confirmed.
  
  
  OBJECTIVE
  The aim of this study was to validate the photograph-based toxicity score.
  
  
  METHODS
  Photograph-based toxicity scores of participants assigned to the 5-FU arm of a randomized placebo-controlled trial were tested for correlations with their patient-reported symptom scores and baseline characteristics.
  
  
  RESULTS
  Each pair of individual and overall scores of patient-reported symptoms and photograph-based toxicity was correlated at 2 and 4 weeks (correlation coefficient range, 0.34-0.95; P < .001 for all). Older age, more actinic keratoses, previous topical 5-FU use, and more keratinocyte carcinomas on the face and ears in the previous 5 years were correlated with increased 5-FU toxicity at 2 weeks (P < .05). An increase in the total number of 5-FU applications during the trial was correlated with less severe toxicity at 2 weeks (P < .001), but with increased toxicity at 4 weeks (P < .001).
  
  
  CONCLUSIONS
  This study provides evidence for construct validity of the photograph-based 5-FU toxicity score. The tool can be used to objectively measure 5-FU toxicity in clinical or research setting, and it can be a prototype for toxicity measurements of other topical medications.
authors.affiliation: Center for Dermatoepidemiology, VA Medical Center, Providence, RI, USA Department of Dermatology, Brown University, Providence, RI, USA hyemin.pomerantz@gmail.com.
authors.forename: Hyemin
authors.initials: H
authors.lastname: Pomerantz
authors.affiliation: Center for Dermatoepidemiology, VA Medical Center, Providence, RI, USA Department of Dermatology, Brown University, Providence, RI, USA.
authors.forename: Kaveri
authors.initials: K
authors.lastname: Korgavkar
authors.affiliation: Center for Dermatoepidemiology, VA Medical Center, Providence, RI, USA Department of Dermatology, Brown University, Providence, RI, USA.
authors.forename: Kachiu C
authors.initials: KC
authors.lastname: Lee
authors.affiliation: The Massachusetts Veterans Epidemiology Research and Information Center, Boston, MA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Lew
authors.affiliation: Center for Dermatoepidemiology, VA Medical Center, Providence, RI, USA The Massachusetts Veterans Epidemiology Research and Information Center, Boston, MA, USA Department of Epidemiology, Brown University, Providence, RI, USA.
authors.forename: Martin A
authors.initials: MA
authors.lastname: Weinstock
mesh_terms: D000279:Administration, Cutaneous; D000367:Age Factors; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis*; D003875:Drug Eruptions / Q000209:etiology*; D004428:Ear Neoplasms / Q000175:diagnosis*; D005153:Facial Neoplasms / Q000175:diagnosis*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy; D008297:Male; D010781:Photography; D019233:Retreatment; D012307:Risk Factors; D012720:Severity of Illness Index; D063465:Skin Cream / Q000009:adverse effects
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil
keywords: 5-fluorouracil; skin cancer; topical medication; validity study