Reliability and validity of a histologic score as a marker for skin cancer chemoprevention studies.

Abstract

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.

• Authors: 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
• Journal: Analytical and quantitative cytology and histology (Anal Quant Cytol Histol) Vol. 25 Issue 5 Pg. 285-92 (Oct 2003) United States
• PMID: 14603727 (Publication Type: Journal Article, Research Support, U.S. Gov't, P.H.S., Validation Study)

Chemical References

• Collagen

Topics

• Biopsy
• Chemoprevention
• Collagen (radiation effects)
• Histological Techniques
• Humans
• Keratinocytes (pathology, radiation effects)
• Keratosis (etiology, pathology)
• Predictive Value of Tests
• Radiation Injuries (pathology)
• Reproducibility of Results
• Severity of Illness Index
• Skin Neoplasms (pathology, prevention & control)
• Ultraviolet Rays (adverse effects)