Early Detection and Diagnosis

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Inappropriate gold standard bias in cervical cancer screening studies†

  1. Robert G. Pretorius1,‡,§,*,
  2. Yan-Ping Bao2,‡,
  3. Jerome L. Belinson3,
  4. Raoul J. Burchette4,
  5. Jennifer S. Smith5,
  6. You-Lin Qiao2,¶,*

Article first published online: 26 JUL 2007

DOI: 10.1002/ijc.22991

Issue

International Journal of Cancer

International Journal of Cancer

Volume 121, Issue 10, pages 2218–2224, 15 November 2007

Additional Information

How to Cite

Pretorius, R. G., Bao, Y.-P., Belinson, J. L., Burchette, R. J., Smith, J. S. and Qiao, Y.-L. (2007), Inappropriate gold standard bias in cervical cancer screening studies. Int. J. Cancer, 121: 2218–2224. doi: 10.1002/ijc.22991

Author Information

  1. 1

    Department of Obstetrics and Gynecology, S.C.P.M.G.-Fontana, Fontana, CA

  2. 2

    Cancer Institute/Hospital, Chinese Academy Medical Sciences, Beijing, China

  3. 3

    Department of Gynecology, The Cleveland Clinic Foundation, Cleveland, OH

  4. 4

    Department of Research and Evaluation, S.C.P.M.G., Los Robles, CA

  5. 5

    Department of Epidemiology, University of North Carolina, Chapel Hill, NC

  1. ‡

    The first two authors contributed equally to this author.

  2. §

    Fax: +909-427-4536.

  3. Fax: +86-10-6771-3648.

*Department of Obstetrics and Gynecology, S.C.P.M.G.-Fontana, 9961 Sierra Ave., Fontana, CA 92335, USA

  1. †

    Participants are from the Shanxi Province Cervical Cancer Screening Study II conducted in Xiangyuan and Yangcheng Counties, Shanxi Province, China.

Publication History

  1. Issue published online: 25 SEP 2007
  2. Article first published online: 26 JUL 2007
  3. Manuscript Accepted: 21 MAY 2007
  4. Manuscript Received: 11 SEP 2006

Funded by

  • Preventive Oncology International™
  • The Cancer Institute/Hospital, Chinese Academy of Medical Sciences, Beijing, China
  • Taussig Cancer Center of The Cleveland Clinic Foundation
  • Goldway Industrial INC, Shenzhen, China

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Keywords:

  • gold standard;
  • acetic acid-aided visual inspection;
  • colposcopy;
  • cervical neoplasia

Abstract

As acetic acid-aided visual inspection (VIA) and colposcopic-directed biopsy miss small ≥cervical intraepithelial neoplasia (CIN) 2, inflation of sensitivity of VIA may occur when colposcopic-directed biopsy is the gold standard for ≥CIN 2. To determine whether such inflation occurs, we reviewed 375 women with ≥CIN 2 from the Shanxi Province Cervical Cancer Screening Study II. These women had positive self or physician-collected tests for high-risk human papillomavirus or abnormal cervical cytology and had VIA followed by colposcopy with directed biopsy and endocervical curettage (ECC). If a cervical quadrant had no lesion, a random biopsy at the squamocolumnar junction within that quadrant was obtained. Sensitivity of colposcopic-directed biopsy was higher for ≥CIN 2 involving 3–4 cervical quadrants (81.3%) than for ≥CIN 2 involving 0–2 quadrants (49.0%, p < 0.001). Sensitivities of VIA, cytology of ≥ASC-US, ≥LSIL, and ≥HSIL were higher for ≥CIN 2 involving 3–4 quadrants than for ≥CIN 2 involving 0–2 quadrants. When a colposcopic-directed biopsy gold standard was compared with that of a 5-biopsy standard (which included ≥CIN 2 from colposcopic-directed biopsy, random biopsy, or ECC), the sensitivity for ≥CIN 2 of VIA was inflated by 20.0% (65.9% vs. 45.9%, p < 0.001). Sensitivities of other screening tests were not affected. Similar inflation of sensitivity of VIA was found with an endpoint of ≥CIN 3 (70.4% vs. 52.0%, p = 0.0013). Inflation of sensitivity of VIA depended upon agreement between colposcopic-directed biopsy and the screening tests as measured by kappa. Studies of VIA that used colposcopic-directed biopsy as the gold standard require reevaluation. © 2007 Wiley-Liss, Inc.

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