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The CONRAD/WHO Update 2000 Colposcopy Manual: how well is it working?

Njoroge, Betty*; Chirenje, Zvavahera Mike MD; Pandey, Bina MBBS, MD; Mirembe, Florence MD§; Joshi, Smita MBBS§; Low-Beer, Naomi MBBS, MD#; Maslankowski, Lisa A. MD

JAIDS Journal of Acquired Immune Deficiency Syndromes: October 2004 - Volume 37 - Issue - p S150–S151
SUPPLEMENT ARTICLE
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*Department of OBGY, University of Nairobi, P.O. Box 19676, KNH Post code 00202, Nairobi, Kenya

UZ-UCSF, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe

Makerere University Medical School, Department of Obstetrics and Gynaecology, P.O. Box 7072, Kampala, Uganda

§National AIDS Research Institute, G-73, MIDC, Post Box 1895, Bhosari, Pune 411 026, India

#Imperial College, St Mary's Campus, Clinical Trials Centre, Praed Street, London W2 1PY, UK

University of Pennsylvania, 3535 Market Street, 4th Floor, Office # 4051, Philadelphia, PA 19104, USA

Correspondence to Christine Mauck, MD, MPH, CONRAD, Eastern Virginia Medical School, 1611 N. Kent Street, Suite 806, Arlington, VA 22209, USA. Tel: +1 703 276 3912; fax: +1 703 524 4770; e-mail: cmauck@conrad.org

Seven panelists were asked to describe their experience with the Update 2000 manual. Their responses had many commonalities and have been combined into this single manuscript. The panelists' experience came from clinical trials of Pro2000, BufferGel, cellulose sulfate, dextrin sulfate, nonoxynol-9, K-Y Jelly, tenofovir, Praneem, and vaginal diaphragms.

In general, it was felt that the Update 2000 manual was clear, concise, and easy to follow. The procedure is short (5–7 min) and simple once the colposcopist has been properly trained. The use of digital imaging was endorsed as a way to reduce both inter and intra-observer variability, and to ensure good image quality when the examination was still in progress. The need for equipment, reliable electricity, and training were limitations of the procedure.

The most common recommendation was the reintroduction of ‘terms’, namely clinical labels for changes seen, such as erythema, edema, abrasion, ulcer, etc. These had been removed from the Update 2000 manual in favor of simply recording the status of the epithelium and blood vessels as either intact or not intact. The latter was felt to be more meaningful in terms of HIV/sexually transmitted infection risk, and the previously used terms had for some time been analysed only with respect to the intactness they represented.

However, the panelists pointed out that the terms were still being used during discussions among clinicians and study staff, as they were more easily visualized than descriptions of intactness. CONRAD has found that in studies in which both the intactness and terms were recorded and there were discrepancies, it was usually the term that was correct. As a result of this feedback, the new Update 2004 includes places for recording both terms and intactness.

Several aspects of the lavage step were discussed. Different types of syringes for lavaging were described, with each having different merits that are somewhat dependent on the type of study being carried out. As a result, the type of syringe is no longer specified in the Update 2004 manual, but can be protocol-specific. Several panelists reported that lavage was often inadequate for the removal of product, and that saline-moistened swabs had to be used. This was added to the Update 2004 manual. Also, when microbiology specimens from the endocervix were taken before lavage, the lavage samples were frequently contaminated with blood, which confounded the results of viral load and cytokine analyses when the lavage was used for this purpose. The Update 2004 manual states that if the collection of lavage fluid for the measurement of inflammatory markers is felt to be of higher priority than the collection of cervical or vaginal specimens, it may be collected first.

It was suggested that the degree of cervical ectopy be recorded, and the recording of findings such as cervical polyps be addressed; both were added to in Update 2004. The recording of blood observed on the examination was also added. Possible changes in colposcopically observed vascular patterns because of the day of the menstrual cycle or other hormonal influences were brought up as an area deserving investigation.

Several panelists brought up the cumbersome nature of the reporting forms, which required many pages for each finding. One speaker had redesigned the form so that up to 10 findings could be recorded on one form. This change was incorporated into the Update 2004 manual. In addition, the numbering of the anatomical sites was changed so that a single numbering sequence incorporated both the vagina and cervix, rather than having separate sequences for each. The date of first observation and the date when findings were noticed to have resolved was added.

Other suggestions included examining the anterolateral and posterolateral fornices rather than the anterior, posterior, and lateral fornices, and always starting with the same fornix. It was also reported that rotating the speculum 90° was well tolerated by some women and allowed the examination of the anterior and posterior vaginal walls after the lateral walls had been examined.

The uncertainty about the relevance of colposcopic findings to the risk of HIV/sexually transmitted infections was brought up as the most critical issue surrounding colposcopy, but this is a limitation of colposcopy, not specifically of the Update 2000 procedure. The consensus of opinion is that genital epithelial disruption is of certain relevance, and the relevance of other findings is uncertain. The number of variables collected (number of findings, type, size, location, etc.) was felt to make analysis difficult by splitting the data too many ways, but is necessary until the relevance of individual variables is better understood.

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CONTRIBUTORS

Elizabeth Bukusi, Deputy Director, P.I.D Project, Senior Research Officer, Kenya Medical Research Institute, P.O. Box 19464, KNH Post code 00202, Nairobi, Kenya; Susan Ballagh, CONRAD/EVMS, 69/01 Colley Avenue, Norfolk, VA 23507, USA; Nelly Mugo, Department of Obstetrics and Gynecology, University of Nairobi, P.O. Box 19676, KNH Post code 00202, Nairobi, Kenya; Craig R. Cohen, Director, P.I.D. Project, Associate Professor, University of California at San Francisco, 74 New Montgomery Street, Suite 600, San Francisco, CA 94105, USA.

© 2004 Lippincott Williams & Wilkins, Inc.