Reliability and Validity of a Histologic Score as a Marker for Skin Cancer Chemoprevention Studies

Paul Bozzo, Kathylynn Saboda, Janine G. Einspahr, James Ranger-Moore, Evan R. Farmer, Clay J. Cockerell, David E. Elder, Jerry L. Bangert, Nancy Hart, Cheryl B. Kramer, David S. Alberts

Research output: Contribution to journalArticlepeer-review

8 Scopus citations


OBJECTIVE: To develop a reliable and valid scoring system for grading skin biopsies from actinic keratosis (AK) and sun-damaged skin for use in evaluating the efficacy of skin cancer chemopreventive agents. STUDY DESIGN: A panel of dermatopathologists developed histologic criteria and diagnostic definitions for the progression of lesions from early AK to AK. The criteria were then applied to a sample of 335 histologic slides from an ongoing chemoprevention study. A 10% sample of 35 slides was reread in order to assess intrarater reliability. RESULTS: Six of the 7 criteria demonstrated high reliability (>85%). The total histologic score, calculated using the 6 criteria, was found to significantly differentiate between (blinded) biopsy location (normal, pre-AK, AK and adjacent to squamous cell carcinoma) and histologic diagnosis (normal, pre- or early AK, AK and squamous cell carcinoma). CONCLUSION: The total histologic score, having demonstrated reliability on repeated readings and validity in its association with biopsy location and histologic score, is a reliable and valid end point for judging the efficacy of agents in skin cancer chemoprevention studies. Additional interrater reliability tests utilizing larger test sets and a rigorous statistical design should be undertaken to establish its portability.

Original languageEnglish (US)
Pages (from-to)285-292
Number of pages8
JournalAnalytical and Quantitative Cytology and Histology
Issue number5
StatePublished - Oct 2003


  • Actinic keratosis
  • Chemoprevention
  • Histology
  • Keratosis
  • Skin cancer

ASJC Scopus subject areas

  • Anatomy
  • Histology


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