'Smartscopy' as an alternative device for cervical cancer screening: a pilot study.
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ABSTRACT:
SUBMITTER: Tanaka Y
PROVIDER: S-EPMC5543027 | biostudies-other | 2017 Apr
REPOSITORIES: biostudies-other
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Project description:Background: Cervical screening programs target entire populations, although it is well established that cervical cancer risks can vary >100-fold based, in particular, on the woman's screening history. Since cervical screening switched to Human Papillomavirus (HPV) testing as the primary screening method, the risk differences are even larger as different HPV types may vary in associated cancer risk by 100 times. Furthermore, HPV infections with the most oncogenic types are declining dramatically because of HPV vaccination programs. Tailoring screening intensity based on the known cancer risk of the individual (risk-stratified screening) therefore has great potential to increase both the sensitivity and specificity. Within Horizon 2020 a major project for Risk-stratified Screening for Cervical Cancer (RISCC) has therefore been launched. We performed a pilot study of risk-stratified screening to evaluate feasibility and acceptability of offering vaginal HPV self-sampling tests to women with a higher risk of cervical cancer. Methods: We identified resident women who had had either i) atypical glandular cells in screening tests during the past six years (risk >150/100,000 woman-years) or ii) abnormal screening findings above the age of 50, but without sufficient follow-up (risk >65/100,000). The women were invited, either by short message service (SMS) or physical letters, to order an HPV self-sampling kit via the study web-platform. The returned self-collected samples were tested for HPV. If positive, women were invited for clinical follow-up. Results: Among 920 targeted women, 191 (21%) placed an order and 163 (18%) returned a self-collected sample. Among all tested samples, 19 (12%) were positive for hrHPV and 18 of these women attended clinical follow-up. Conclusions: SMS invitations to high-risk women complemented with physical letters are feasible and result in substantial requests for kits and submission of samples. Future work will focus on improving the efficiency of the procedure and further increasing attendance.
| S-EPMC10445943 | biostudies-literature
Project description:UnlabelledSelf-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008-2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1-3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV or for HPV testing with cytology triage is warranted.Trial registrationClinicalTrials.gov NCT00702208.
| S-EPMC3869665 | biostudies-literature
Project description:Visual inspection of the cervix after application of 5% acetic acid (VIA) is a screening technique for cervical cancer used widely in low and middle-income countries (LMIC). To improve VIA screening performance, digital images after acid acetic application (D-VIA) are taken. The aim of this study was to evaluate the use of a smartphone for on- and off-site D-VIA diagnosis.Women aged 30-65 years, living in the city of Ambanja, Madagascar, were recruited through a cervical cancer screening campaign. Each performed a human papillomavirus (HPV) self-sample as a primary screen. Women testing positive for HPV were referred for VIA followed by D-VIA, cervical biopsy and endocervical curettage according to routine protocol. In addition, the same day, the D-VIA was emailed to a tertiary care center for immediate assessment. Results were scored as either D-VIA normal or D-VIA abnormal, requiring immediate therapy or referral to a tertiary center. Each of the three off-site physicians were blinded to the result reported by the one on-site physician and each gave their individual assessment followed by a consensus diagnosis. Statistical analyses were conducted using STATA software.Of the 332 women recruited, 137 (41.2%) were HPV-positive and recalled for VIA triage; compliance with this invitation was 69.3% (n = 95). Cervical intraepithelial neoplasia was detected in 17.7% and 21.7% of digital images by on-site and off-site physicians, respectively. The on-site physician had a sensitivity of 66.7% (95%CI: 30.0-90.3) and a specificity of 85.7% (95%CI: 76.7-91.6); the off-site physician consensus sensitivity was 66.7% (95%CI: 30.0-90.3) with a specificity of 82.3% (95%CI: 72.4-89.1).This pilot study supports the use of telemedicine for off-site diagnosis of cervical intraepithelial neoplasia, with diagnostic performance similar to those achieved on-site. Further studies need to determine if smartphones can improve cervical cancer screening efficiency in LMIC.
| S-EPMC4519052 | biostudies-other
Project description:Among providers who serve low-income and uninsured women, resistance to extending the cervical cancer screening interval following normal Pap and co-test results has been documented. Our objective was to examine provider characteristics and beliefs associated with guideline-consistent screening interval recommendations.We collected cross-sectional survey data between 2009 and 2010 from 82 primary care providers in six Federally Qualified Health Centers in Illinois, USA. The relationships between characteristics, beliefs, and screening interval recommendations (1 year vs. 3 years) were tested with Pearson chi-square, negative binomial and ordered logistic regression.Compared to providers who recommended annual intervals after a normal co-test, providers who recommended a guideline-consistent (i.e., 3 years) screening interval were significantly more likely to report the goodness, ease, and benefit of their recommendation and perceived encouragement for a 3-year interval from professional organizations and journals (p < .05). Providers who recommended a 3-year interval were also less likely to report that longer intervals increase patient risk for cervical cancer (p < .05). Interval recommendations were not associated with provider specialty, gender, or years in practice.Messages that promote the benefits of longer screening intervals after a normal co-test, the natural history of human papillomavirus and cervical cancer, and low risk of developing cancer with a longer interval may be useful to promote evidence-based screening in this population of Federally Qualified Health Center providers. Dissemination of targeted messages through professional journals and specialty organizations should be considered.
| S-EPMC4508246 | biostudies-other
Project description:Introduction: Alignment of the uterine cervix with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently available instruments are traumatic tenacula, which can cause pain and bleeding and represent an obstacle for certain patients to pursue their medical follow-up. A novel investigational cervical vacuum tenaculum, enables atraumatic traction of the cervix using a semi-circular suction pad, designed to conform to the anatomical shape of the external cervical os. Suction is generated by manually pulling out a sliding tube in a vacuum chamber. Methods: We performed a single arm non-comparative pilot study to assess the safety and efficacy of the cervical vacuum tenaculum in 13 women receiving an IUD. Data on procedural efficacy, safety, patient-reported pain scores at specific time points during IUD insertion procedure and patient satisfaction were collected prospectively. Results: Insertion of IUD was successful with use of the study device in 7 of the 13 enrolled patients (54%). No bleeding or only limited ecchymosis were caused by the device. No adverse events were reported. Participants reported very little pain (mean Visual Analog Scale <10) when applying the device. Participants who achieved IUD insertion with the device reported strong overall satisfaction with the procedure. Conclusions: The suction-based atraumatic tenaculum can be used to manipulate the cervix during IUD insertion with satisfactory efficacy and safety. The results of this pilot study support further studies of this device in larger populations comparing with standard single-tooth tenaculum. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04441333.
| S-EPMC8732360 | biostudies-literature
Project description:This study aims to determine whether a novel cervical cancer screening toolkit will increase rates of pap test completion and HPV vaccination among Somali women living in the United States. We conducted a randomized controlled, pilot trial from June 2021 to February 2022. Somali women aged 21 to 70 were randomized to either receive a toolkit (infographic, video and an in-person health seminar) or not. Health passports confirming a completed pap test and/or HPV vaccination by clinician signature were used to measure outcomes. The primary outcome was pap test completion and the secondary outcome was HPV vaccination. We enrolled 57 participants. Patients randomized to the treatment arm were significantly more likely to have had a pap test (53.7% vs. 3.7%, p < 0.0001) and were also more likely to have received the HPV vaccine (10.7% vs. 3.7%, p = 0.6110). This toolkit increased rates of pap test completion and more participants in the intervention arm received HPV vaccination, though numbers were low. The study design may serve as a reproducible model to determine the effectiveness of patient education materials.
| S-EPMC10111298 | biostudies-literature
Project description:ObjectivesTo provide updated evidence about the risk of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) and cervical cancer after a negative human papillomavirus (HPV) test in primary cervical screening, by age group and test assay.DesignObservational study.SettingReal world data from the English HPV screening pilot's first and second rounds (2013-16, follow-up to end of 2019).Participants1 341 584 women.InterventionsCervical screening with HPV testing or liquid based cytological testing (cytology or smear tests). Women screened with cytology were referred to colposcopy after high grade cytological abnormalities or after borderline or low grade abnormalities combined with a positive HPV triage test. Women screened with HPV testing who were positive were referred at baseline if their cytology triage test showed at least borderline abnormalities or after a retest (early recall) at 12 and 24 months if they had persistent abnormalities.Main outcome measuresDetection of CIN3+ and cervical cancer after a negative HPV test.ResultsFor women younger than 50 years, second round detection of CIN3+ in this study was significantly lower after a negative HPV screen in the first round than after cytology testing (1.21/1000 v 4.52/1000 women screened, adjusted odds ratio 0.26, 95% confidence interval 0.23 to 0.30), as was the risk of interval cervical cancer (1.31/100 000 v 2.90/100 000 woman years, adjusted hazard ratio 0.44, 0.23 to 0.84). Risk of an incident CIN3+ detected at the second screening round in the pilot five years after a negative HPV test was even lower in women older than 50 years, than in three years in women younger than 50 years (0.57/1000 v 1.21/1000 women screened, adjusted odds ratio 0.46, 0.27 to 0.79). Women with negative HPV tests at early recall after a positive HPV screening test without cytological abnormalities had a higher detection rate of CIN3+ at the second routine recall than women who initially tested HPV negative (5.39/1000 v 1.21/1000 women screened, adjusted odds ratio 3.27, 95% confidence interval 2.21 to 4.84). Detection after a negative result on a clinically validated APTIMA mRNA HPV test was similar to that after clinically validated cobas and RealTime DNA tests (for CIN3+ at the second round 1.32/1000 v 1.14/1000 women screened, adjusted odds ratio 1.05, 0.73 to 1.50).ConclusionsThese data support an extension of the screening intervals, regardless of the test assay used: to five years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older. The screening interval for HPV positive women who have negative HPV tests at early recall should be kept at three years.
| S-EPMC9153243 | biostudies-literature
Project description:To evaluate alternative cervical cancer screening methods, digital colposcopy and collection of cervical exfoliated cells for liquid-based cytology (LBC) and hybrid capture 2 (HC2) testing were performed among 2562 women aged 15-59 years in three study sites in the People's Republic of China (rural Shanxi province, Shenyang city in Liaoning province and Shenzhen city in Guangdong province). Visual inspection with acetic acid (VIA) was also evaluated independently from colposcopy. A total of 74 cases of histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) were identified, and 16 CIN2+ cases were imputed among unbiopsied women to correct for verification bias. Corrected sensitivity for CIN2+ was 37% for VIA, 54% for colposcopy, 87% for LBC with a threshold of atypical cells of undetermined significance (LBC>or=ASCUS), 90% for HC2, 84% for LBC using HC2 to triage ASCUS and 96% for positivity to LBC>or=ASCUS or HC2. For VIA, sensitivity was much lower among women >or=40 years (12%) than those aged <or=39 years (50%). Specificity varied from 77% for positivity to LBC>or=ASCUS or HC2, up to 94% for LBC using HC2 to triage ASCUS. In conclusion, LBC, HC2 and their combinations performed well, whereas VIA missed a majority of CIN2+, particularly in older women. Digital colposcopy performed better than VIA, but still missed nearly half of CIN2+ in this study.
| S-EPMC2658545 | biostudies-other
Project description:BACKGROUND:Emergency departments (EDs) have the potential to promote critical public and preventive health interventions. Cervical cancer (CC) screening has been a cornerstone of preventive health efforts for decades. Approximately 20% of U.S. women are not adherent with CC screening guidelines-considerably below the U.S. Federal Government's target. ED patients are disproportionately nonadherent with CC screening guidelines. The ED, therefore, is an optimal setting to target women with an intervention that promotes CC screening. OBJECTIVES:To assess the feasibility and potential efficacy of an intervention, grounded in behavioral change theory, to promote uptake of CC screening among ED patients. METHODS:Design: Randomized clinical trial pilot study; Patients: Women aged 21-65 years that were identified in the ED to be nonadherent with CC screening recommendations; Setting: Single center urban academic ED. RESULTS:Among enrolled participants, 355 (79%) were determined to be adherent with screening recommendations and 95 (21%) were determined to be either nonadherent or have uncertain adherence. Among the nonadherent/uncertain group, 47 were randomized to the control condition (referral only) and 48 were randomized to the intervention condition. Thirty-six percent of participants in the control condition received or scheduled screening during the follow-up period. In the intervention condition, 43% received or scheduled screening during the follow-up period-a 19% relative improvement over the control condition. CONCLUSION:This pilot study demonstrates feasibility and preliminary efficacy of a behavioral intervention to increase uptake of CC screening among ED patients.
| S-EPMC6904518 | biostudies-literature
Project description:BackgroundWomen in rural and remote northern Alberta access breast cancer screening through a mobile mammogram program (Screen Test). The Enhanced Access to Cervical and Colorectal Cancer Screening (EACS) project was a 2-year pilot that aimed to integrate cervical and colorectal cancer screening with the Screen Test program. This study compares cervical and colorectal cancer screening uptake among women screened through the pilot (Screen Test-EACS) versus Screen Test.MethodsScreen Test-EACS was offered between 2013 and 2015 in selected rural and remote sites, with a focus on hard-to-reach women living in First Nations, Métis and Hutterite communities. Participation in cervical and colorectal cancer screening was analyzed for Screen Test and Screen Test-EACS participants 6 weeks before clients received their mammogram and then again 3 months after.ResultsA total of 8390 and 1312 women participated in Screen Test and Screen Test-EACS, respectively. Screen Test-EACS significantly increased uptake of cervical (10.1% v. 27.5%) and colorectal (10.9% v. 22.5%) cancer screening, increasing the prevalence of women up to date with screening from 52.5% to 62.9% for cervical cancer screening and from 37.3% to 48.7% for colorectal cancer screening.InterpretationScreen Test-EACS increased participation in and the overall prevalence of cervical and colorectal cancer screening among hard-to-reach clients in northern Alberta, probably through removal of barriers to access and increased awareness. Further research should focus on balancing the benefits of increased participation with the costs and potential risks of over-screening.
| S-EPMC5741430 | biostudies-literature