Offering self-sampling for human papillomavirus testing to non-attendees of the cervical screening programme: Characteristics of the responders.
TL;DR: Offering hrHPV self-sampling increases the efficacy of the screening programme by targeting a substantial portion of non-attendees of all ethnic groups who have not regularly been screened and are at highest risk of ≥ CIN2.
About: This article is published in European Journal of Cancer.The article was published on 2012-08-01 and is currently open access. It has received 81 citations till now. The article focuses on the topics: Cervical screening & Cervical intraepithelial neoplasia.
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TL;DR: An updated review of the literature suggests that HPV self‐sampling could be an additional strategy that can improve screening performance compared to current cytology‐based call‐recall programs.
Abstract: This review elaborates on the accuracy and feasibility of human papillomavirus (HPV) self-sampling, i.e., offering self-sampling of (cervico-)vaginal cell material by women themselves in nonclinical settings for high-risk HPV (hrHPV) detection in the laboratory, for cervical screening. To that end a bibliographic database search (PubMed) was performed to identify studies (published between January 1992 and January 2012) that compared clinical accuracy of HPV testing on self-sampled material with that of cytology or HPV testing on clinician-taken samples, and studies comparing response to offering HPV self-sampling with a recall invitation. Overall, hrHPV testing on self-samples appeared to be at least as, if not more, sensitive for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) as cytology on clinician-obtained cervical samples, though often less specific. In most studies, hrHPV testing on self- and clinician-sampled specimens is similarly accurate with respect to CIN2+ detection. Variations in clinical performance likely reflect the use of different combinations of collection devices and HPV tests. Because it is known that underscreened women are at increased risk of cervical cancer, targeting non-attendees of the screening program could improve the effectiveness of cervical screening. In developed countries offering self-sampling has shown to be superior to a recall invitation for cytology in re-attracting original non-attendees into the screening program. Additionally, self-testing has shown to facilitate access to cervical screening for women in low resource areas. This updated review of the literature suggests that HPV self-sampling could be an additional strategy that can improve screening performance compared to current cytology-based call-recall programs.
224 citations
Cites background from "Offering self-sampling for human pa..."
...Indeed, a pooled analysis of two large studies on Dutch non-responders has revealed that the response rate was related to ethnicity.(53) Native Dutch women showed the highest response (32....
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TL;DR: FAM19A4 is an attractive triage marker for hrHPV-positive women, with a high reassurance for the detection of cervical carcinoma and advanced CIN2/3 lesions.
Abstract: Primary testing for human papillomavirus (HPV) in cervical screening requires triage to differentiate women with transient infection from those with persistent infection who require more intensive management given their risk for cervical (pre)cancer. In this study, the clinical performance of a novel methylation marker FAM19A4 for the triage of high-risk (hr)HPV-positive women was evaluated. Using a training-validation set approach, we analyzed a FAM19A4 quantitative methylation-specific PCR (qMSP). The training set comprised hrHPV-positive cervical scrapes of 43 women with cervical intraepithelial neoplasia grade 3 or worse (CIN3+) and 135 women with ≤CIN1. The validation set comprised hrHPV-positive cervical scrapes of 52 women with CIN2+, including 33 CIN3+, 19 CIN2, and 166 women with ≤CIN1. The methylation threshold of FAM19A4 qMSP that gave rise to CIN3+ specificity of 70% in the training set was applied in the validation set. This resulted in CIN3+ sensitivity of 75.8% [95% confidence interval (CI), 61.1–90.4] at 67.0% (95% CI, 60.3–73.8) specificity. Next, the validated qMSP was applied to an independent series of hrHPV-positive cervical scrapes of 22 women with cervical cancer, 29 with advanced CIN2/3 [i.e., women with a known preceding hrHPV infection (PHI) lasting ≥5 years as proxy of longer duration of lesion existence], and 19 with early CIN2/3 (i.e., PHI <5 years). All carcinomas (22/22) and advanced CIN2/3 lesions (29/29) were FAM19A4 methylation–positive, compared with 42.1% (8/19; 95% CI, 19.9–64.3) of early CIN2/3 lesions. In conclusion, FAM19A4 is an attractive triage marker for hrHPV-positive women, with a high reassurance for the detection of cervical carcinoma and advanced CIN2/3 lesions. Cancer Prev Res; 7(12); 1251–7. ©2014 AACR .
99 citations
TL;DR: FAM19A4/mir124-2 methylation analysis performs equally well in HPV-positive lavage- and brush self-samples to identify women with CIN3+.
82 citations
Cites methods from "Offering self-sampling for human pa..."
...Here, we conducted a post-hoc analysis on 1049 HPV-positive selfsamples from previous PROHTECT studies that had been collected by either lavage- and or brush-based self-collection devices [5,22,42]....
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TL;DR: The arguments in favor of, and concerns on aspects of implementation of hrHPV testing in primary cervical cancer screening, such as the age to start HRHPV-based screening, ways to increase screening attendance, requirements for candidateHRHPV tests to be used, and triage algorithms for screen-positive women are discussed.
80 citations
TL;DR: HPV self‐sampling improves participation in cervical screening for never‐ and under‐screened women and most women with HPV detected have appropriate clinical investigation.
Abstract: We conducted a randomized controlled trial to determine whether HPV self-sampling increases participation in cervical screening by never- and under-screened (not screened in past 5 years) women when compared with a reminder letter for a Pap test. Never- or under-screened Victorian women aged 30-69 years, not pregnant and with no prior hysterectomy were eligible. Within each stratum (never-screened and under-screened), we randomly allocated 7,140 women to self-sampling and 1,020 to Pap test reminders. The self-sampling kit comprised a nylon tipped flocked swab enclosed in a dry plastic tube. The primary outcome was participation, as indicated by returning a swab or undergoing a Pap test; the secondary outcome, for women in the self-sampling arm with a positive HPV test, was undergoing appropriate clinical investigation. The Roche Cobas® 4800 test was used to measure presence of HPV DNA. Participation was higher for the self-sampling arm: 20.3 versus 6.0% for never-screened women (absolute difference 14.4%, 95% CI: 12.6-16.1%, p < 0.001) and 11.5 versus 6.4% for under-screened women (difference 5.1%, 95% CI: 3.4-6.8%, p < 0.001). Of the 1,649 women who returned a swab, 45 (2.7%) were positive for HPV16/18 and 95 (5.8%) were positive for other high-risk HPV types. Within 6 months, 28 (62.2%) women positive for HPV16/18 had colposcopy as recommended and nine (20%) had cytology only. Of women positive for other high-risk HPV types, 78 (82.1%) had a Pap test as recommended. HPV self-sampling improves participation in cervical screening for never- and under-screened women and most women with HPV detected have appropriate clinical investigation.
75 citations
Cites background from "Offering self-sampling for human pa..."
...8%).(16,32,33) In both Sweden and The Netherlands, researchers had more up-to-date information on women (e....
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References
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TL;DR: C cervical screening has prevented an epidemic that would have killed about one in 65 of all British women born since 1950 and culminated in about 6000 deaths per year in this country, at a cost per life saved of about pound 36000.
764 citations
"Offering self-sampling for human pa..." refers background in this paper
...09%) had cervical carcinoma.(1) The overall PCIN2 and PCIN3 yields were 1....
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TL;DR: The PALGA system is a unique system that requires a minimal effort on the part of the participating laboratories, while providing them a powerful tool in their daily practices, while contributing to the quality of daily patient care.
Abstract: Since 1991, a nationwide histopathology and cytopathology network and archive is in operation in The Netherlands under the name PALGA, encompassing all sixty-four pathology laboratories in The Netherlands. The overall system comprises decentralized systems at the participating laboratories, a central databank, and a dedicated communication and information exchange tool. Excerpts of all histopathology and cytopathology reports are generated automatically at the participating laboratories and transferred to the central databank. Both the decentralized systems and the central system perform checks on the quality and completeness of excerpts. Currently, about 42 million records on almost 10 million patients are stored in the central databank. Each excerpt contains patient identifiers, including demographic data and the so-called PALGA diagnosis. The latter is structured along five classification axes: topography, morphology, function, procedure, and diseases. All data transfer and communication occurs electronically with encryption of patient and laboratory identifiers. All excerpts are continuously available to all participating pathology laboratories, thus contributing to the quality of daily patient care. In addition, external parties may obtain permission to use data from the PALGA system, either on an ongoing basis or on the basis of a specific permission. Annually, 40 to 60 applications for permission to use PALGA data are submitted. Among external users are the Dutch cancer registry, population-based screening programs for cancer of the uterine cervix and breast cancer in The Netherlands, and individual investigators addressing a range of research questions. Many scientific papers and theses incorporating PALGA data have been published already. In conclusion, the PALGA system is a unique system that requires a minimal effort on the part of the participating laboratories, while providing them a powerful tool in their daily practices.
708 citations
TL;DR: Results indicate that HPV testing of self-collected vaginal swabs is less specific than but as sensitive as Papanicolaou smears for detecting high-grade cervical disease in women aged 35 years and older, and HPV testing offers an important new way to increase screening in settings where cytology is not readily performed.
Abstract: ContextMore than half of the women diagnosed as having cervical cancer in the
United States have not been screened within the last 3 years, despite many
having had contact with the health care system. In many other regions of the
world, there is only limited access to cervical cancer screening.ObjectiveTo determine whether testing of self-collected vaginal swabs for human
papillomavirus (HPV) DNA can be used to screen for cervical disease in women
aged 35 years and older.DesignCross-sectional observational study comparing Papanicolaou smears with
HPV DNA testing of self-collected vaginal swabs.SettingOutpatient clinics in a periurban settlement outside of Cape Town, South
Africa, between January 1998 and April 1999.ParticipantsScreening was performed on 1415 previously unscreened black South African
women aged 35 to 65 years.InterventionWomen self-collected a vaginal swab for HPV testing in the clinic and
were then screened using 4 different tests: Papanicolaou smear, direct visual
inspection of the cervix after the application of 5% acetic acid, cervicography,
and HPV DNA testing of a clinician-obtained cervical sample. Women with abnormal
results on any of the screening tests were referred for colposcopy.Main Outcome MeasureBiopsy-confirmed high-grade cervical squamous intraepithelial lesions
or invasive cancer.ResultsHigh-grade squamous intraepithelial lesions were identified in 47 (3.4%)
of 1365 women adequately assessed, and there were 9 cases of invasive cancer.
Of women with high-grade disease, 66.1% (95% confidence interval
[CI], 52.1%-77.8%) had high-risk HPV detected in self-collected vaginal samples, and 67.9%
(95% CI, 53.9%-79.4%) had an abnormal Papanicolaou smear (P = .78). The false-positive rates for HPV DNA testing of self-collected
vaginal samples and Papanicolaou smears were 17.1% (95% CI, 15.1%-19.3%) and
12.3% (95% CI, 10.5%-14.2%), respectively (P<.001).
A high-risk type of HPV DNA was detected in 83.9% (95% CI, 71.2%-91.9%) of
women with high-grade disease and 15.5% (95% CI, 13.6%-17.7%) of women with
no evidence of cervical disease using a clinician-obtained cervical sample.ConclusionsThese results indicate that HPV testing of self-collected vaginal swabs
is less specific than but as sensitive as Papanicolaou smears for detecting
high-grade cervical disease in women aged 35 years and older, and HPV testing
offers an important new way to increase screening in settings where cytology
is not readily performed.
447 citations
"Offering self-sampling for human pa..." refers methods in this paper
...Further study details have been described before.(6,13,14) Apart from the self-sampling method, both PROHTECT studies were essentially the same in design....
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TL;DR: The response rate and the yield of high grade lesions support implementation of this method for women who do not attend regular cervical screening programmes, and offering self sampling by sending a device for collecting cervicovaginal specimens for high risk HPV testing is a feasible and effective method of increasing coverage in a screening programme.
Abstract: Objective To determine whether offering self sampling of cervicovaginal material for high risk human papillomavirus (HPV) testing is an effective screening method for women who do not attend regular cervical screening programmes. Design Cohort study (the PROHTECT trial). Settings Noord-Holland and Flevoland regions of the Netherlands, December 2006 to December 2007, including 13 laboratories, gynaecologists, and more than 800 general practitioners. Participants 28 073 women who had not responded to two invitations to the regular cervical screening programme: 27 792 women were assigned to the self sampling group and invited to submit a self collected cervicovaginal sample for HPV testing; 281 were assigned to the recall control group and received a second re-invitation for conventional cytology. Intervention Women with a positive result on the high risk HPV test on their self sample material were referred to their general practitioner. Women with abnormal results on cytology were referred for colposcopy. Women with normal results on cytology were re-evaluated after one year by cytology and high risk HPV testing and referred for colposcopy if either result was positive. Main outcome measures Attendance rate in both groups and yield of cervical intraepithelial neoplasia grade II/III or worse (≥CIN II/≥CIN III) in self sampling responders. Results The compliance rate in the self sampling group was significantly higher than in the control group (crude 26.6% v 16.4%, P Conclusions Offering self sampling by sending a device for collecting cervicovaginal specimens for high risk HPV testing to women who did not attend regular screening is a feasible and effective method of increasing coverage in a screening programme. The response rate and the yield of high grade lesions support implementation of this method for such women. Trial registrationISRCTN45527158.
273 citations
"Offering self-sampling for human pa..." refers background or methods or result in this paper
...Response rate in PROHTECT was operationally defined as the proportion of eligible women of both arms who sent in an informed consent form, combined with submission of a selfsampled specimen for women assigned to the self-sampling group.(6,7) hrHPV prevalence was defined as percentage of women with HC2 hrHPV-positive self-sampled specimens....
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...We showed earlier that compliance to direct cytology triage is high (P90%) but that there is poor adherence to follow-up testing after 1 year ( 60%), which needs careful attention.(6,7) Still, these results strongly argue to implement hrHPV testing on self-sampled material as an alternative for hrHPV testing on a physician taken scrape....
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...In addition, are targeted by HPV self-sampling, and how these characteristics relate to hrHPV prevalence and yield of PCIN2 and PCIN3.(6,7)...
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...In addition, are targeted by HPV self-sampling, and how these characteristics relate to hrHPV prevalence and yield of PCIN2 and PCIN3....
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...Non-attendees of the regular screening programme All 54,482 women out of 230,509 invitees (aged 30–60 years) in the counties Noord-Holland and Flevoland who did not attend the cervical screening programme after two invitations in 2005 and 2006 were registered as screening non-attendees and were recruited to participate in the PROHTECT studies from December 2006 to March 2008.(6,7) In these studies, the effect of offering self-sampling for hrHPV DNA testing by Hybrid Cap-...
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TL;DR: Assessment of the effect of combined failures in the process of care must be done in comprehensive audit studies to avoid missed opportunities to prevent invasive cervical cancer.
240 citations