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Portable colposcopy in low-resource settings

Walmer, David K. MD, PhD*; Merisier, Delson MD; Littman, Eva MD; Rodriguez, Gustavo MD§; Venero, Nick BS, ME#; Henderson, Marcus PhD#; Katz, David PhD#; Edwards, Rosemary MD

JAIDS Journal of Acquired Immune Deficiency Syndromes: October 2004 - Volume 37 - Issue - p S167–S170
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Screening for cervical dysplasia is an important public health effort worldwide. In unscreened populations, the incidence of cervical cancer ranges between 2 and 4% of the adult female population, whereas less than 0.1% of the screened population of Caucasian women has cervical cancer in the United States. In developing countries, cervical cytology is difficult to implement successfully because of the cost, cultural constraints, limited access to pathology services, etc. Bypassing cytology and going directly to colposcopy has been successfully implemented as a screening strategy for dysplasia in low resource settings. In this article we describe the development and utilization of a portable binocular colposcope that does not require electricity.

*Division of Reproductive Endocrinology and Fertility, Duke University Medical Center, Durham, NC, USA

Hopital Sainte Croix, Leogane, Haiti

Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA

§Department of Obstetrics and Gynecology, Northwestern University, Durham, NC, USA

#Department of Medical Engineering, Duke University Medical Center, Durham, NC, USA

Department of Pathology, Mercy Hospital Pittsburgh, PA, USA

Correspondence to David K. Walmer, MD, PhD, Division of Reproductive Endocrinology and Fertility, Duke University Medical Center, Box 3143, Durham, NC 27710, USA. Tel: +1 919 684 5327; fax: +1 919 681 7904; e-mail: walme001@mc.duke.edu

The colposcope is a binocular instrument used by gynecologists to examine the vaginal epithelium with white or green light under magnification. Since its invention in Germany in 1925,1 the colposcope has become an important screening tool worldwide for identifying premalignant lesions of the cervix. Most commercial colposcopes are stand-alone instruments that offer a wide range of magnifications up to 30×. However, because commercial colposcopes are fairly expensive, rely on electricity and are not very portable, their utility is often limited in remote communities with few financial resources. Therefore, colposcopes are being modified by healthcare providers to provide an acceptable compromise between performance and practicality in the developing world. These strategies include visual inspection with acetic acid (VIA) without magnification2–4 and VIA with low magnification of less than 10×.5

The motivation for developing the Family Health Ministries, Inc. (FHM)-Duke portable colposcope, a VIA device with low magnification of less than 10×, arose from a series of experiences at Hopital Sainte Croix (HSC) in Leogane, Haiti, during the first four years after initiating a cervical cancer prevention program in 1993. This program serves an area of 225 square miles of alluvial plains and remote mountainous communities, and many patients travel 22 km from Port-au-Prince for care. In setting up the cervical cancer prevention program at HSC, we discovered that the communities around HSC had limited access to electricity, roads and pathology services. Although electricity was usually available at the hospital, we soon discovered the merits of purchasing a voltage regulator when relying on Haitian-generated power. Two donated colposcopes had their lives significantly shortened from wide voltage fluctuations. We also found it difficult to transport the colposcopes to remote generator-powered health clinics that were accessible only by mountain trails.

In 1998, we were inspired to construct and test our first hands-free, battery-powered, portable colposcope. This instrument included Keeler XL Advantage surgical loupes (3.5×; Broomall, PA, USA), a bicycle halogen headlight (VL511 Draco; Rantoul, IL, USA), and a green camera filter (Tiffen 52 mm, 11 Green 1; Hauppauge, NY, USA; Figure 1). It can be carried in a 4 × 7 × 10-inch fanny pack. The optical resolution is between the 6x magnification of a Leisegang colposcope and the naked eye (see Figure 2). We initially tested the portable colposcope in a randomized, prospective clinical trial in the Duke cervix clinic and then in the field in Haiti.

FIGURE 1

FIGURE 1

FIGURE 2

FIGURE 2

After obtaining Institutional Review Board (IRB) approval, we recruited 47 female patients, aged 25–55 years, who were referred to the Duke cervix clinic for cytological evidence of dysplasia. The study population included 25 African American, 17 Caucasian, four Hispanic and one Asian woman. Referring cytology reports ranged from atypical glandular cells of undetermined significance (AGUS; 2%), atypical squamous cells of undetermined significance (ASCUS; 19%), low grade squamous intraepithelial lesion (LGSIL; 54%), high grade squamous intraepithelial lesion (HGSIL; 23%) and carcinoma in-situ (2%). All examinations were performed after applying 4% acetic acid solution to the cervix. The first examination was performed by a gynecologist (Littman) using the portable colposcope. The second examination was performed by Dr Littman using the standard colposcope, and the third examination was performed by board-certified gynecological oncologist (Rodriguez) using the standard colposcope. Drs Littman and Rodriguez were blinded to each other's observations. After each examination, they recorded the number, location, and characteristics (white, mosaic, punctuation) of all lesions on a diagram of an exocervix. Pap smear and biopsy results were also obtained and recorded for correlation with the colposcopic findings. A third gynecologist who was not present at the colposcopic examinations independently reviewed the diagram, and determined whether each lesion was seen by both observers or not. The outcome variables included a correlation between lesions seen by one observer using both the portable and standard colposcope (Table 1), two observers using the portable and standard colposcope (Table 2) and two observers using the standard colposcope (Table 3).

TABLE 1

TABLE 1

TABLE 2

TABLE 2

TABLE 3

TABLE 3

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RESULTS

In this trial, the variation seen between the portable and standard colposcope was no greater than that caused by interobserver variability, suggesting that the portable colposcope was sensitive enough to visualize the cervical lesions despite the limitation in magnification.

In phase II of the experiment, 125 Haitian women living in an urban slum called Cite Soleil (aged 20–86 years), with unknown cervical pathology, were screened with the portable colposcope and Thin Prep Pap test. The IRB at Duke waived the need for informed consent in this phase of the trial. The types of abnormalities visualized were recorded as well as the adequacy of visualization of the transformation zone. The Haitian gynecologist, Dr Delson Merisier, found the portable colposcope easy to transport to the outlying clinic, and on several occasions there was no electricity as a result of generator problems and he was able to continue screening. Dr Merisier estimated that 64% of the women had a normal appearing cervix, 30% had what appeared to be LGSIL, 4% had what appeared to be HGSIL and 2% had grossly apparent cancers.

From the above two trials, we concluded that the FHM-Duke portable colposcope is a sensitive, hands-free instrument for detecting cervical dysplasia that is easy to use in a low-resource setting such as a Haitian urban slum. Therefore, the FHM-Duke portable colposcope may provide a promising strategy to screen and treat cervical dysplasia in developing countries.

Since our initial trial, Dr Merisier has screened 805 women in Leogane, Haiti, and found that approximately 3.62% had advanced untreatable cervical cancers. Based on a normal distribution of dysplasia/cancer, we estimate that approximately 30% of the women seen in our clinic have low-grade lesions and another 4% have high-grade dysplasia. Routine cytological screening has not been helpful as many of the smears are unreadable as a result of obscuring inflammation. Cytopathology screening at HSC has only identified 28 dysplasias, which suggests that Pap smears alone are missing many premalignant lesions. Colposcopic examination appears to be more accurate in this population based on the finding of a much more normal distribution of premalignant lesions. Dr Rosemary Edwards has reviewed a sampling of the cervical cytopathology slides from HSC and confirmed a high incidence of obscuring inflammation (Figure 3). These observations indicate that the colposcope is even more important until other screening strategies such as Thin Prep methodology or human papillomavirus serotyping can be implemented.

FIGURE 3

FIGURE 3

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Modifications of the FHM-Duke portable colposcope

Since the initial trial was performed, medical engineers at Duke have volunteered their time and efforts to modify the FHM-Duke portable colposcope several times. These modifications include moving the green lights into direct alignment with the field of vision and the substitution of light-emitting diode (LED) bulbs for incandescent bulbs (Figure 4). The light source consists of 13 green LEDs (Hosfelt Electronics Inc., Steubenville, OH, USA, 25–377, 10 000 μd luminosity 525 nm wavelength. Total luminosity 130 000 μd) and 20 white LEDs (Hosfelt Electronics PN: 25-363, 7000 μd luminosity. Total luminosity 140 000 μd). The energy source is four AA alkaline batteries in series to give 6 VDC, 12 A hours of power (anticipated battery life 12–15 h).

FIGURE 4

FIGURE 4

A prospective trial of the latest modification is being reviewed by the Duke IRB. These modifications will be demonstrated at the conference.

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DISCUSSION

Visual inspection of the cervix appears to be more important for the detection of premalignant lesions of the cervix in Haiti than conventional Pap smears because of the high incidence of inflammation. Modifications of commercial colposcopes are being manufactured and tested in the developing world. The variables being evaluated include binocular vision, hands-free operation, green light, and the degree of magnification that is needed to achieve acceptable results.

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REFERENCES

1. Torres JE, Riopelle MA. History of colposcopy in the United States. Chronology of colposcopy development worldwide. Obstet Gynecol Clin North Am, 1993;20:1–12.
2. Sankaranarayanan R, Wesley R, Thara S, et al. Test characteristics of visual inspection with 4% acetic acid (VIA) and Lugol's iodine (VILI) in cervical cancer screening in Kerala, India. Int J Cancer, 2003; 106: 404–408.
3. Visual inspection with acetic acid for cervical-cancer screening: test qualities in a primary-care setting. University of Zimbabwe/JHPIEGO Cervical Cancer Project [Comment]. Lancet, 1999;353:869–873.
4. Megevand E, Denny L, Dehaeck K, et al. Acetic acid visualization of the cervix: an alternative to cytologic screening. Obstet Gynecol, 1996;88: 383–386.
5. Winkler JL, Tsu VD, Bishop A, et al. Confirmation of cervical neoplasia using a hand-held, lighted magnification device. Int J Gynaecol Obstet, 2003;81:35–40.
Keywords:

Cervical cancer; cervical dysplasia; colposcopy; developing countries

© 2004 Lippincott Williams & Wilkins, Inc.