title: Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993).
abstract: BACKGROUND
  Historically, skin toxicity has been assessed in prospective clinical trials using the clinician-reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The patient-reported Skindex-16 measures symptoms and perceptions of toxicity. This study was designed to compare information provided by these two measures.
  
  
  METHODS
  Data were compiled from three placebo-controlled North Central Cancer Treatment Group studies (N06C4, N03CB, N05C4) having rash prevention as the primary objective. All used the Skindex-16 and CTCAE at baseline, weekly during treatment and during a minimum 2-week follow-up period. Statistical procedures, including Pearson correlations, were utilized to determine relationships between adverse event (AE) grades and Skindex-16 scores.
  
  
  RESULTS
  Four hundred and twelve individual patients provided data (median age, 61; 134 male). Patients' Skindex-16 score results show a 0.9 overall mean (range 0-6 with 6 being worse symptoms), a 0.4 baseline mean (range, 0-4.3) and a 1.3 end-of-treatment mean (range, 0-5.9). Ninety-three, 142 and 177 patients experienced a grade 0, 1 and 2+ CTCAE skin toxicity, respectively. Baseline Skindex-16 scores had relatively low correlation with CTCAE grades. The correlation of rash grade with Skindex-16 scores ranged from r = 0.49 with the function subscale to r = 0.62 with the symptom subscale. The highest correlations of the maximum grade of any dermatological AE with the Skindex-16 were r = 0.48 for the total score and r = 0.55 for the symptom subscale.
  
  
  CONCLUSIONS
  The data reported support the decision to include both measures in a clinical trial to assess the patient experience, as each measure may specifically target varying symptoms and intensities.
authors.affiliation: Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905, USA. atherton@mayo.edu
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton
authors.forename: Kelli N
authors.initials: KN
authors.lastname: Burger
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Neben Wittich
authors.forename: Robert C
authors.initials: RC
authors.lastname: Miller
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
mesh_terms: D000465:Algorithms; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000532:radiotherapy; D000068818:Cetuximab; D000069347:Erlotinib Hydrochloride; D005076:Exanthema / Q000139:chemically induced* / Q000145:classification*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009369:Neoplasms / Q000150:complications* / Q000628:therapy*; D011244:Pregnadienediols / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000009:adverse effects; D011500:Protein Synthesis Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000009:adverse effects; D011855:Radiodermatitis / Q000145:classification* / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013473:Sunscreening Agents / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D009626:Terminology as Topic; D013752:Tetracycline / Q000627:therapeutic use
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D011244:Pregnadienediols; D047428:Protein Kinase Inhibitors; D011500:Protein Synthesis Inhibitors; D011799:Quinazolines; D013473:Sunscreening Agents; D000068656:Mometasone Furoate; D000069347:Erlotinib Hydrochloride; D013752:Tetracycline; D000068818:Cetuximab; D000077156:Gefitinib