Recent evidence suggests that screening for high-risk human papillomavirus (HPV) is more sensitive than using the standard Papanicolaou (Pap) test for identifying women with high grade cervical lesions, as precursors to cervical cancer.1 Furthermore, studies have shown that specimens collected by women themselves are equivalent to clinician-collected specimens for the detection of high-risk HPV using nucleic acid amplification tests.2–4 The use of self-collected specimens enables cervical cancer screening to occur in home and community settings, which could expand program coverage, facilitate outreach, streamline clinic processes, and remove barriers to care. Low uptake of cervical cancer screening in some groups of women suggests imperfect acceptability of the standard Pap.5 We need to expand ways for women to be screened for cervical cancer, including using validated self-sampling techniques.
In the Netherlands, a national governmental program for cervical cancer screening has been implemented since 1988. The program currently invites all women from a centralized registry between the ages of 30 and 60 by mail to appointments with a general practitioner for a Pap smear. Women with normal cytology are followed every 5 years. Despite organized outreach, over 30% of women do not respond to screening invitations, with fear of the Pap smear and shame commonly cited as reasons for nonattendance.6 Furthermore, approximately 50% of cervical cancers is identified in women who did not respond to screening invitations.7 Use of validated self-sampling techniques combined with HPV testing could improve program coverage for these women, at a cost comparable to that of a Pap smear.
We therefore investigated the acceptability of using a self-lavaging device (Pantarhei Devices, Zeist, The Netherlands) compared with the standard pelvic exam among 91 women in the Netherlands. The validity of the specimens in combination with the GP 5+/6+ polymerase chain reaction test for detection of high-risk HPV has been previously described.8 In this paper, we describe women’s responses to using the device.
From February to October 2004, 106 women were invited from 3 obstetric and gynecology hospital departments in Veldhoven, Arnhem, and Tilburg, in the Netherlands, of which 104 agreed to participate. Seventy women scheduled for colposcopy due to a recent abnormal Pap smear were recruited by phone and/or mail before their colposcopy appointment; 34 women attending the outpatient clinic for reasons not related to cervical abnormalities and who were due for a Pap smear were recruited in person at the clinic. To be eligible women had to be proficient in Dutch, not pregnant or currently lactating, and without a mental or physical handicap that would prevent self-collection of specimens.
Participating women were mailed an informed consent form, the self-sampling device for collection of specimens, instructions on how to use the device with diagrams, and a short self-administered acceptability questionnaire with open-ended questions. They were asked to collect a specimen at home using the Pantarhei Screener 1 week before their scheduled pelvic exam. Women brought the informed consent, specimen and questionnaire to their clinic appointment, and completed a second acceptability questionnaire after the pelvic exam at the clinic. The study was approved by the Medical Ethical Board at the Máxima Medical Center in Veldhoven.
The Pantarhei Screener is a sterile, plastic, syringe-like device containing 5 mL buffered saline.8 The woman inserts the device until she feels resistance, plunges, counts to five, and releases. The plunger then retracts automatically collecting the saline and cervicovaginal cells. She removes the device and transfers the fluid into a separate container by plunging into the container and releasing.
Of the 104 women who were sent the device, 101 (97%) used the device at home and brought it to the clinic, and 99 (95%) also had a Pap smear done during the clinic visit. Of the 99 women who used both collection methods, 91 (92%) completed the first acceptability questionnaire, while 30 (30%) of these women completed the second acceptability questionnaire at the end of the clinic visit. Results are presented for the 91 women with acceptability data.
The women with acceptability data were between 18 and 59 years old, with a median age of 35. Ninety out of 91 (99%) women reported that the device was easy to use when asked whether it was easy or difficult; 1 woman reported it was both easy and difficult. Asked for an explanation, 25 (28%) remarked that the user instructions were very clear, 19 (21%) that it was quick and/or did not require an appointment with the doctor, and 11 (12%) that they liked being able to do it at home. Seventeen women (19%) had some questions about whether they had collected the specimen correctly, especially in terms of the amount of fluid aspirated in the plunger. One woman thought the device was “scary.” When asked if they would prefer to self-sample or to have a pelvic for their next screening, after having used the device at home, 68 (75%) reported preferring to self-sample, with 3 on the condition that test accuracy was equivalent, 18 (20%) prefer cervical smear by the doctor, and 5 (5%) had no preference, with no differences by age. The main reason women reported preferring self-sampling was that they could use the device at home which saved time (37 women, 54%), with some adding they no longer would need to take time off from work and others that they liked to be able to choose when they took the specimen. For example, one woman reported, “It can be done whenever you want, at ease and in a familiar environment.” Other reasons for preferring to self-sample included convenience (n = 15), avoiding embarrassment at the doctors,(12) feeling relaxed at home,(11) less pain or discomfort than using the speculum,(10) privacy,(6) and less expensive.(3) Women reported for example, “… for me a cervical smear by the doctor is still embarrassing”; “the duck’s bill [speculum] and the scraping are not nice and a little painful”; and “the location [home] is less emotionally charged.” For the 18 women who reported preferring a cervical smear by the doctor, all reported having greater confidence in the results. For example, one woman stated, “Then I know 100% for sure that it was done well.”
Among the 30 women who answered the second acceptability questions during their clinic visit, 26 (87%) reported they would prefer to self-sample in the future, 3 (10%) would prefer cervical smear by the doctor, and 1 (3%) had no preference. Four women changed their preferences: 2 from no preference to self-sampling, 1 from no preference to cervical smear by doctor, and 1 from self-sampling to no preference.
In this study, women generally found the Pantarhei Screener easy to use for the collection of cervico-vaginal cells to be tested for high-risk HPV. However, some further refinements to the user instructions, most notably in terms of how the fluid is extracted and how much fluid women should anticipate, may further improve acceptability. Additionally, as lack of confidence in the self-sampling results was the most common reason women preferred clinician-sampling, information on the validity of results from self-sampled specimens should be included. Further, these women were recruited from obstetric and gynecology clinics; acceptability of use among nonclinic attendees may be different. The majority of women in this study reported preferring being able to use the device at home rather than coming to a clinician for a Pap smear. Given the high acceptability of the device overall and high agreement between the device and clinician-obtained specimens for the detection of high-risk HPV (κ = 0.71),8 researchers at the Vrije Universiteit Medical Center in Amsterdam are currently using the device to evaluate uptake among approximately 30,000 women who did not respond to 2 invitations from the National Screening Program for a Pap smear in the Netherlands.9 Self-sampling techniques, such as the use of this device, may provide a needed alternative for women seeking cervical cancer screening, and may help to increase coverage of existing screening programs.
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8. Brink AATP, Meijer CJLM, Wiegerinck MAHM, et al. High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. J Clin Microbiol 2006; 44:2518–2523.
9. Gök M, Heideman DA, van Kemenade FJ, et al. Offering hrHPV testing on self-sampled specimens to non-responders in a screening program: interim findings. Paper presented at the 24th International Papillomavirus Conference; November 3–9, 2007; Beijing, China.