A two-stage validation study for determining sensitivity and specificity

Environ Health Perspect. 1994 Nov;102 Suppl 8(Suppl 8):11-4. doi: 10.1289/ehp.94102s811.

Abstract

A two-stage procedure for estimating sensitivity and specificity is described. The procedure is developed in the context of a validation study for self-reported atypical nevi, a potentially useful measure in the study of risk factors for malignant melanoma. The first stage consists of a sample of N individuals classified only by the test measure. The second stage is a subsample of size m, stratified according the information collected in the first stage, in which the presence of atypical nevi is determined by clinical examination. Using missing data methods for contingency tables, maximum likelihood estimators for the joint distribution of the test measure and the "gold standard" clinical evaluation are presented, along with efficient estimators for the sensitivity and specificity. Asymptotic coefficients of variation are computed to compare alternative sampling strategies for the second stage.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Cohort Studies
  • Female
  • Humans
  • Likelihood Functions
  • Mass Screening / methods
  • Mass Screening / statistics & numerical data
  • Melanoma / diagnosis*
  • Melanoma / epidemiology*
  • Melanoma / prevention & control
  • Middle Aged
  • Nevus / diagnosis*
  • Nevus / epidemiology*
  • Nevus / prevention & control
  • Prevalence
  • Reproducibility of Results
  • Risk Factors
  • Sample Size
  • Self-Examination / statistics & numerical data
  • Sensitivity and Specificity
  • Skin Neoplasms / diagnosis*
  • Skin Neoplasms / epidemiology*
  • Skin Neoplasms / prevention & control