Rationale and development of an on-line quality assurance programme for colposcopy in a population-based cervical screening setting in Italy.
ABSTRACT: BACKGROUND: Colposcopy, the key step in the management of women with abnormal Pap smear results, is a visual technique prone to observer variation, which implies the need for prolonged apprenticeship, continuous training, and quality assurance (QA) measures. Colposcopy QA programmes vary in level of responsibility of organizing subjects, geographic coverage, scope, model, and type of actions. The programmes addressing the clinical standards of colposcopy (quality of examination and appropriateness of clinical decisions) are more limited in space and less sustainable over time than those focused on the provision of the service (resources, accessibility, etc.). This article reports on the protocol of a QA programme targeting the clinical quality of colposcopy in a population-based cervical screening service in an administrative region of northern Italy. METHODS/DESIGN: After a situation analysis of local colposcopy audit practices and previous QA initiatives, a permanent web-based QA programme was developed. The design places more emphasis on providing education and feedback to participants than on testing them. The technical core is a log-in web application accessible on the website of the regional Administration. The primary objectives are to provide (1) a practical opportunity for retraining of screening colposcopists, and (2) a platform for them to interact with colposcopists from other settings and regions through exchange and discussion of digital colposcopic images. The retraining function is based on repeated QA sessions in which the registered colposcopists log-in, classify a posted set of colpophotographs, and receive on line a set of personal feedback data. Each session ends with a plenary seminar featuring the presentation of overall results and an interactive review of the test set of colpophotographs. This is meant to be a forum for an open exchange of views that may lead to more knowledge and more diagnostic homogeneity. The protocol includes the criteria for selection of colpophotographs and the rationale for colposcopic gold standards. DISCUSSION: This programme is an ongoing initiative open to further developments, in particular in the area of basic training. It uses the infrastructure of the internet to give a novel solution to technical problems affecting colposcopy QA in population-based screening services.
Project description:BACKGROUND:The World Health Organization (WHO) called for global action towards the elimination of cervical cancer. One of the main strategies is to screen 70% of women at the age between 35 and 45?years and 90% of women managed appropriately by 2030. So far, approximately 85% of cervical cancers occur in low- and middle-income countries (LMICs). The colposcopy-guided biopsy is crucial for detecting cervical intraepithelial neoplasia (CIN) and becomes the main bottleneck limiting screening performance. Unprecedented advances in artificial intelligence (AI) enable the synergy of deep learning and digital colposcopy, which offers opportunities for automatic image-based diagnosis. To this end, we discuss the main challenges of traditional colposcopy and the solutions applying AI-guided digital colposcopy as an auxiliary diagnostic tool in low- and middle- income countries (LMICs). MAIN BODY:Existing challenges for the application of colposcopy in LMICs include strong dependence on the subjective experience of operators, substantial inter- and intra-operator variabilities, shortage of experienced colposcopists, consummate colposcopy training courses, and uniform diagnostic standard and strict quality control that are hard to be followed by colposcopists with limited diagnostic ability, resulting in discrepant reporting and documentation of colposcopy impressions. Organized colposcopy training courses should be viewed as an effective way to enhance the diagnostic ability of colposcopists, but implementing these courses in practice may not always be feasible to improve the overall diagnostic performance in a short period of time. Fortunately, AI has the potential to address colposcopic bottleneck, which could assist colposcopists in colposcopy imaging judgment, detection of underlying CINs, and guidance of biopsy sites. The automated workflow of colposcopy examination could create a novel cervical cancer screening model, reduce potentially false negatives and false positives, and improve the accuracy of colposcopy diagnosis and cervical biopsy. CONCLUSION:We believe that a practical and accurate AI-guided digital colposcopy has the potential to strengthen the diagnostic ability in guiding cervical biopsy, thereby improves cervical cancer screening performance in LMICs and accelerates the process of global cervical cancer elimination eventually.
Project description:The aim of this study is to compare colposcopic findings and the accuracy of colposcopic impression in HIV seropositive and seronegative women with abnormal Pap tests.HIV seropositive and seronegative women in a national cohort study had Pap tests collected every six months, with colposcopy for any abnormal result. Prospectively collected colposcopy and histology findings were analyzed retrospectively using Pearson Chi-square, t-test and Wilcoxon two-sample tests, logistic regression models, and Kappa coefficients.After adjusting for age and Pap result, 1618 eligible HIV seropositive women were more likely than 406 seronegative women to have inadequate colposcopic examinations, abnormal colposcopic findings, and large cervical lesions. However, among those with abnormal colposcopy, colposcopic characteristics and lesion size and number did not differ by HIV serostatus. Agreement between colposcopists' impressions and highest grade biopsy diagnoses was fair (kappa coefficient 0.35, 95% C.I. 0.31, 0.38). Agreement did not differ by HIV serostatus and did not improve with multiple biopsies (weighted kappa coefficient 0.35, 95% C.I. 0.32, 0.39) or after including all histology results over two years following colposcopy.Although HIV seropositive women with abnormal cytology are more likely to have colposcopic abnormality, the performance of colposcopy appears to be similar to that in HIV seronegative women. Biopsy is required to confirm colposcopic impression.
Project description:OBJECTIVE:Colposcopic biopsy is a discomfortable procedure. Additionally, it creates negative influence on sexuality. This study aimed to investigate the relationships among tenaculum, pain perception, and biopsy size during colposcopy. METHODS:In total, 228 patients who underwent colposcopy-directed biopsy were included, and randomized into 4 groups based on whether analgesic and tenaculum were used and replaced (tenaculum with n=58/without analgesic n=56, no tenaculum replacement with n=57/without analgesic n=57). Lidocaine hydrochloride (40 mg) plus adrenaline (0.025 mg) was administered in the analgesic groups. The pain was assessed using a linear visual analog scale. The biopsy specimen size was measured in millimeters. RESULTS:The mean age of the patients was 42.85±8.88 years. The most frequent colposcopy indications were atypical squamous cells of undetermined significance and human papilloma virus-positive results on cervical cytology (30.2%; n=69). Low- and high-grade intraepithelial lesions were noted in 14.91% (n=34) and 10.96% (n=25) women through colposcopy-directed biopsy results, respectively. Tenaculum replacement increased pain perception in the without analgesic group; however, no statistically significant differences were noted between of the groups with and without tenaculum replacement with analgesic. The size and number of biopsy specimens were not associated with tenaculum replacement and analgesic use. CONCLUSION:Administration of analgesics decreased discomfort and pain in patients. Tenaculum replacement aided colposcopists in manipulating the cervix. Additionally, administration of analgesics relieved pain in the tenaculum replacement group. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03279666.
Project description:This retrospective cohort study focused on colposcopic accuracy for the diagnosis of cervical premalignant lesions using cytology and histology, as well as HPV data not included in current cervical screening practices in Kazakhstan. Colposcopy performance was assessed using the modified Reid index in women aged 18-63 years. In total, 1,129 colposcopic-HPV-cytology triple samples and 94 histology findings were collected. The sensitivity of colposcopy was 81.6% with specificity 72.6% for LSIL but fell to 56.6% with specificity 88.3% for CIN2+ vs. 89.6% and 74.5% for cytology at CIN2+, respectively. The ORs for high-grade lesion occurrence within each colposcopy group at viral load rising vs. ORs for HPV-negative women were 3.4; 5.3; and 39.7, respectively (p < 0.0001). Total attributive agreement between the colposcopy and histology findings reached 55.3%, ? 0.47 ± 0.06 vs. 0.62 ± 0.08 for cytology, and 0.34 ± 0.13 and 0.58 ± 0.1, for specialists, respectively. Outcomes obtained for colposcopy alone failed to show satisfactory reliability. Globally adopted primary HPV screening would be the best option despite the related costs.
Project description:Introduction In connection with the reorganisation of cervical carcinoma screening, the importance of colposcopy as an integral part of the planned series of clarification testing will greatly increase. Quality standards for performing the colposcopic examination should therefore be defined in detail. A precondition for this is surveying the current standard in clinical practice. The objective of this study was to evaluate the current practice of colposcopy and conisation in Germany by means of a questionnaire aimed at gynaecologists who perform colposcopies in order to document the actual therapeutic standard of treatment of cervical dysplasia. Materials and Methods Gynaecologists were invited via e-mail or during events to participate in a web-based survey. The questionnaire contained 38 questions on management before, during and after the examination as well as questions on the technical implementation of colposcopy and conisation. Results From February 2018 to April 2018, 961 e-mails were sent. A response was received in 197 cases (response rate 20.5%). Responses were received for another 40 questionnaires during events (response rate approx. 80%). After taking the inclusion criteria into account, 160 questionnaires were evaluated. The majority of those surveyed take an average of 2 cervical biopsies (67.3%) and nearly all of those surveyed (94.5%) do not use any local anaesthetic. As a standard method for removing cervical precancerous cells, most of the physicians surveyed perform a loop excision with the electrosurgical loop (91.2%) under colposcopic visualisation (61.2%) under general anaesthesia (92.5%). Postoperative bleeding prophylaxis by means of tamponade is performed only in 27.6% of all cases. Conclusion A differential colposcopy with two colposcopically targeted biopsies and treatment with the electrosurgical loop are the methods most frequently used by clinicians who perform colposcopy in Germany. A uniform procedure should be defined in detail within the scope of directives or guidelines.
Project description:Background:Colposcopy is a key part of cervical cancer control. As cervical cancer screening and prevention strategies evolve, monitoring colposcopy performance will become even more critical. In the present paper, we describe population-based colposcopy quality indicators that are recommended for ongoing measurement by cervical cancer screening programs in Canada. Methods:The Pan-Canadian Cervical Cancer Screening Network established a multidisciplinary expert working group to identify population-based colposcopy quality indicators. A systematic literature review was conducted to ascertain existing population and program-level colposcopy quality indicators. A systems-level cervical cancer screening pathway describing each step from an abnormal screening test, to colposcopy, and back to screening was developed. Indicators from the literature were assigned a place on the pathway to ensure that all steps were measured. A prioritization matrix scoring system was used to score each indicator based on predetermined criteria. Proposed colposcopy quality indicators were shared with provincial and territorial screening programs and subsequently revised. Results:The 10 population-based colposcopy quality indicators identified as priorities were colposcopy uptake, histologic investigation (biopsy) rate, colposcopy referral rate, failure to attend colposcopy, treatment frequency in women 18-24 years of age, re-treatment proportion, colposcopy exit-test proportion, histologic investigation (biopsy) frequency after low-grade Pap test results, length of colposcopy episode of care, and operating room treatment rate. Two descriptive indicators were also identified: colposcopist volume and number of colposcopists per capita. Summary:High-quality colposcopy services are an essential component of provincial cervical cancer screening programs. The proposed quality and descriptive indicators will permit colposcopy outcomes to be compared between provinces and across Canada so as to identify opportunities for improving colposcopy services.
Project description:The performance of endocervical curettage (ECC) is a dispute in population screening programs. Data of 3,460 women referred to colposcopy examination and had completed pathological results in the Shanxi Province Cervical Cancer Screening Study I and II were reviewed. Among them, 0.6% and 2.7% women were identified as the histopathological confirmed high-grade squamous intraepithelial lesion or worse (HSIL+) by ECC alone or both ECC and quadrants biopsy respectively. Age, cytology, and colposcopy impression are the impact factors for the HSIL+ yield of ECC (P<0.05). The age-adjusted odds ratio for cytology and colposcopic impression were 5.283 (95%CI: 3.989-6.997) and 3.609 (95%CI: 2.910-4.476) respectively. In low-grade squamous intraepithelial lesion cytology and abnormal colposcopy, no additional HSIL+ was found by ECC. In low-grade squamous intraepithelial lesion cytology but normal colposcopy, the additional yield was 0.6%, 0.8% and 1.1% for the three age groups respectively. In high-grade squamous intraepithelial lesion or worse cytology, the additional HSIL+ yield by ECC ranged between 1.4% and 6.6%. We conclude that the performance of ECC increases with age, the severity of cytology, and colposcopic impression. For women 35 years and older, ECC should be performed if the cytological finding is high-grade or worse in cervical cancer screening program.
Project description:OBJECTIVE:To calculate pooled risk estimates for combinations of cytology result, human papillomavirus (HPV) 16/18 genotype and colposcopy impression to provide a basis for risk-stratified colposcopy and biopsy practice. DATA SOURCE:A PubMed search was conducted on June 1, 2016, and a ClinicalTrials.gov search was conducted on June 9, 2018, using key words such as "uterine cervical neoplasms," "cervical cancer," "mass screening," "early detection of cancer," and "colposcopy." METHODS OF STUDY SELECTION:Eligible studies must have included colposcopic impression and either cytology results or HPV 16/18 partial genotype results as well as a histologic biopsy diagnosis from adult women. Manuscripts were reviewed for the following: cytology, HPV status, and colposcopy impression as well as age, number of women, and number of cervical intraepithelial neoplasia (CIN) 2, CIN 3, and cancer cases. Strata were defined by the various combinations of cytology, genotype, and colposcopic impression. TABULATION, INTEGRATION, AND RESULTS:Of 340 abstracts identified, nine were eligible for inclusion. Data were also obtained from three unpublished studies, two of which have since been published. We calculated the risk of CIN 2 or worse and CIN 3 or worse based on cytology, colposcopy, and HPV 16/18 test results. We found similar risk patterns across studies in the lowest risk groups such that risk estimates were similar despite different referral populations and study designs. Women with a normal colposcopy impression (no acetowhitening), less than high-grade squamous intraepithelial lesion cytology, and HPV 16/18-negative were at low risk of prevalent precancer. Women with at least two of the following: high-grade squamous intraepithelial lesion cytology, HPV16- or HPV18-positive, and high-grade colposcopic impression were at highest risk of prevalent precancer. CONCLUSION:Our results support a risk-based approach to colposcopy and biopsy with modifications of practice at the lowest and highest risk levels.
Project description:We evaluated a 'see and treat' procedure involving screening, colposcopy, biopsy and cryotherapy by trained nurses in one-visit in field clinics in a cervical screening study in South India for its acceptability, safety and effectiveness in curing cervical intraepithelial neoplasia (CIN). Women positive on visual inspection with acetic acid (VIA) were advised colposcopy, directed biopsies and cryotherapy if they had colposcopic impression of CIN in one visit by nurses in field clinics supervised by a doctor. Side effects and complications were assessed and cure rates were evaluated with VIA, colposcopy and biopsy if colposcopic abnormalities were suspected. Cure was defined as no clinical or histological evidence of CIN at > or =6 months from treatment. Of the 2513 women offered 'see and treat' procedure, 1879 (74.8%) accepted. Of the 1397 women with histologically proved CIN treated with cryotherapy, 1026 reported for follow-up evaluation. Cure rates were 81.4% (752 out of 924) for women with CIN 1; 71.4% (55 out of 77) for CIN 2 and 68.0% (17 out of 25) for CIN 3. Minor side effects and complications were documented in less than 3% of women. 'See and treat' with cryotherapy by nurses under medical supervision is acceptable, safe and effective for cervical cancer prevention in low-resource settings.
Project description:Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination.Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (? 8) and significant anxiety (? 11; "30-month percentages"). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (? 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance.There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21) or anxiety (OR = 0.97, 95% CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points.There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost.Controlled-Trials.com ISRCTN 34841617.