Usability of a smartphone-compatible, confocal micro-endoscope for cervical cancer screening in resource-limited settings.

BACKGROUND: More efficient methods to detect and treat precancerous lesions of the cervix at a single visit, such as low-cost confocal microscopy, could improve early diagnosis and hence outcomes. We piloted a prototype smartphone-compatible confocal micro-endoscope (SCME) among women presenting to a public cervical cancer screening clinic in Kampala, Uganda. We describe the piloting of the SCME device at an urban clinic used by lower cadre staff. METHODS: We screened women aged 18 and 60 years, who presented for cervical cancer screening at the Kawempe National Referral Hospital Kampala, and evaluated the experience of their providers (nurses). Nurses received a 2-day training by the study doctors on how to use the SCME, which was added to the standard Visual Inspection with Acetic acid (VIA)-based cervical cancer screening. The SCME was used to take colposcopy images before and after VIA at positions 12 and 6 O'clock if VIA negative, and on precancer-suspicious lesions if VIA positive. We used questionnaires to assess the women's experiences after screening, and the experience of the nurses who operated the SCME. RESULTS: Between November 2021 and July 2022, we screened 291 women with a median age of 36 years and 65.7% were HIV positive. Of the women screened, 146 were eligible for VIA, 123 were screened with the SCME, and we obtained confocal images from 103 women. Of those screened with the SCME, 60% found it comfortable and 81% were willing to screen again with it. Confocal images from 79% of the women showed distinguishable cellular features, while images from the remaining 21% were challenging to analyze. Nurses reported a mean score of 85% regarding the SCME's usefulness to their work, 71% regarding their satisfaction and willingness to use it again, 63% in terms of ease of use, and 57% concerning the ease of learning how to operate the SCME. CONCLUSION: Our findings demonstrate the feasibility of using the SCME by lower cadre staff in low-resource settings to aid diagnosis of precancerous lesions. However, more work is needed to make it easier for providers to learn how to operate the SCME and capture high-quality confocal images.

The role of endocervical curettage in the diagnosis of cervical intraepithelial neoplasia in human papillomavirus positive patients.

BACKGROUND: The role of endocervical curettage (ECC) in the diagnosis of cervical intraepithelial neoplasia (CIN) is a controversial topic. OBJECTIVES: Investigate the role of ECC in the diagnosis of CIN in human papillomavirus (HPV) positive patients. DESIGN: Retrospective. SETTING: A tertiary training and research hospital. PATIENTS AND METHODS: This study included patients who were referred for colposcopy between 2018-2022 because of abnormal screening results. ECC results, age, cytology, HPV status, and colposcopic impression of the patients were extracted from the medical records. Multinomial logistic regression analyses were performed to identify factors that could predict CIN on ECC. MAIN OUTCOME AND MEASURES: The likelihood of high-grade squamous intraepithelial lesions (HSIL) in ECC in patients with cervical biopsy results of normal and low-grade squamous intraepithelial lesion (LSIL). SAMPLE SIZE: 2895 women. RESULTS: In patients with normal and LSIL cervical biopsy results, HSILs were detected in 6.7% of ECC results. There was no difference in the detection rates of CIN in ECC among groups with smear results negative for intraepithelial lesions or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), and LSIL. The likelihood of HSIL being observed in ECC was 2.2 times higher in patients with HPV16. The probability of LSIL disanois was 2.3 times higher in women aged 50-59 years and 2.8 times higher in women ≥ 60 years compared to the reference group of <30 years. The probability of LSIL was 2.3 and HSIL by ECC was 2.2 times higher in both age categories (P<.012 and P=.032, respectively) than the reference group of <30 years. CONCLUSION: Regardless of colposcopic findings, ECC should be performed in patients with smear results of NILM who are positive for HPV16, in patients with smear results of ASC-US and LSIL who are positive for any oncogenic type of HPV and in patients 50 and above with any result of smear or any oncogenic HPV type. LIMITATIONS: We did not have the components of the HPV types in mixed groups.

Is the colposcopic lesion size a predictor of high-grade lesions in young patients?

OBJECTIVE: This study aimed to evaluate whether severity changes with colposcopic lesion size, regardless of age. METHODS: This retrospective comparative study reviewed the records of 428 women with altered cytopathology reports who were directed by primary health care. Only those women with colposcopic alterations were evaluated (n=411). Histopathological analyses were restricted to patients who underwent excisional treatment (n=345). According to their age, they were grouped into the following: <21, 21-24, 25-35, and >35 years, and also, ≤24 and ≥25 years. The cytopathological, colposcopic, and histopathological findings were grouped according to severity. Lesion size was subjectively assessed from the colposcopic drawing recorded in the chart and according to the number of quadrants of the total cervical surface affected by colposcopic alterations in the transformation zone. Statistical significance was set at p<0.05. RESULTS: The evaluations suggested that the lesion size was directly related to the severity of the cytopathology, colposcopy, and histopathology reports for the age groups ≤24 or ≥25 years. We observed associations between lesion size and severity of the cytopathology (≤24 years, p=0.037) and histopathology (≥25 years, p=0.003) findings. CONCLUSION: The size of the lesion was directly related to the severity of the histopathological lesion in patients aged ≥25 years and cytopathological in patients aged ≤24 years.

Diagnostic cervical excision in patients with HPV positivity, cytological abnormalities- and preoperative cervical stenosis.

AIM: There is currently no protocol for classifying patients with HPV persistence and preoperative stenosis of the cervical canal. This has a significant impact on cytology results, colposcopy results and the possibility of obtaining reliable cervical histology outcomes. Our analysis clearly shows that colposcopy and cytology underestimate the histological results in patients with limited visibility due to the presence of a type 3 transformation zone (TZ). Our analysis revealed a significant discrepancy between the colposcopy and cytology results and the histological outcomes. Insufficient colposcopy led to the underdiagnosis of dysplastic lesions in patients with a type 3 TZ and cervical stenosis. In the case of repeated cytological abnormalities and inadequate colposcopy examination, it is crucial to perform a diagnostic conization to exclude high-grade dysplastic changes and cervical carcinoma. METHODS: We conducted a retrospective analysis of 1,021 conizations performed in tertiary care hospital in Wolfsburg, Germany between 2014 and 2020. Of these surgical procedures, 89 were diagnostic conizations. In our analysis, we defined diagnostic conization as a procedure performed when there is HPV persistence and repeated cytologic abnormalities in combination with a type 3 TZ, and when it is not possible to retrieve a relevant cervical histology sample. RESULTS: In this period, 8.7% of all conizations were diagnostic excisions. We found histological abnormalities in 48 of 89 patients (53.9%). The histological examination of the excised cone revealed high-grade cervical intraepithelial neoplasia (CIN/HSIL) in 9 patients (10.1%) and CIN 2+ (HSIL) in 23 out of the 89 patients (25.8%). Two cases of early-stage cervical carcinoma (FIGO IA1 and FIGO IA2) were confirmed (2.3%). CONCLUSION: Patients with cervical stenosis, high-risk HPV persistence and repeated cytological abnormalities are at high risk of undetected high-grade cervical dysplasia. Histologic confirmation must be ensured in this patient consultation and this can be achieved by performing diagnostic excisions.

Expanding management strategies for cervical precancerous lesions in resource-limited settings: insights from a training center in a district hospital in Ghana.

BACKGROUND: Cervical cancer continues to disproportionately burden women in low/middle-income countries like Ghana. We examined treatment patterns and histopathological outcomes among women screened using visual inspection with acetic acid (VIA) and/or mobile colposcopy who subsequently underwent thermal ablation, large loop excision of the transformation zone (LLETZ), or cold knife conization at the Cervical Cancer Prevention and Training Centre, Battor. We also assessed the prevalence of cervical intraepithelial neoplasia 2+ (CIN2+) or micro-invasive disease and their associated factors for women who underwent excisional treatments. The treatment choices for cervical precancerous lesions suitable for resource-limited settings have also been described from the perspective of a center that manages a heterogenous population. METHODS: We conducted an analysis of secondary data collected between June 2016 and June 2023 among women with positive findings on VIA or mobile colposcopy who subsequently underwent thermal ablation or large loop excision of the transformation zone (LLETZ). The prevalence of histopathology outcomes, including no dysplasia, CIN1 - 3, and micro-invasive disease, were estimated with 95% confidence intervals (CIs). Factors associated with histopathological findings were modeled using multinomial logistic regression. RESULTS: For the study period, 14 (10.6%) of the total 132 participants underwent cervical lesion treatment at outreach locations, all via thermal ablation. The remaining 118 (89.4%) were treated at the Catholic Hospital, Battor using LLETZ (n = 66, 55.9%), thermal ablation (n = 51, 43.2%), and cold knife conization (n = 1, 0.9%). Among 65 women with histopathology reports, the most frequent histopathological finding was no dysplasia (47.7%; 95% CI, 35.1 - 60.5), followed by CIN2 and CIN3 (20.0%; 95% CI, 11.1 - 31.8 each), CIN1 (7.7%; 95% CI, 2.5 - 17.0) and micro-invasion (4.6%; 95% CI, 1.0 - 12.9). Those with micro-invasive disease were significantly older than those with CIN1, CIN2, and CIN3 (p = 0.036, 0.022, 0.009, respectively), but not significantly older than those who showed no dysplasia (p = 0.088). For each unit increase in age, the likelihood of CIN3 was relatively significantly reduced compared to no dysplasia (crude relative risk ratio [RRR] = 0.93; 95% CI, 0.86 - 0.99). This association was neither observed with the remaining histopathological groups nor for parity and persisted after controlling for parity (adjusted RRR = 0.92; 95% CI, 0.85 - 0.99; p = 0.025). CONCLUSION: This paper largely demonstrates treatment options available to women and practitioners in LMICs. The high combined prevalence of high-grade precancerous lesions and micro-invasive disease underscores the need to increase cervical cancer awareness that would enhance screening attendance and hasten efforts at moving from opportunistic to organized screening in Ghana. This will enhance early cervical lesion detection and treatment, while simultaneously re-evaluating and cutting down on unnecessary treatment.

Modified swede colposcopic index versus modified reid index in colposcopic screening for premalignant & malignant lesions of the cervix: a cross-sectional analysis.

BACKGROUND: Cervical cancer cases in India account for one-fourth of the worldwide burden. Colposcopy is used to evaluate the cervix of women with abnormal screening test results. For standardized reporting, various scores were introduced of those, Reid Colposcopic Index (RCI) and Swede score are the most commonly used. AIMS AND OBJECTIVES: This study is undertaken to determine the diagnostic efficacy and clinical relevance of the newly introduced MSCI and compare MSCI and Modified Reid Index. RESULTS: 225 women out of 237 were analyzed. MSCI score 9 perform best for colposcopic diagnosis of CIN 2 or higher lesions. The sensitivity, specificity, PPV, and NPV for threshold score 9 for CIN 2 or higher lesions were 94.92 %, 67.88 %, 51.38 %, and 97.39 % respectively. Modified Reid Index threshold 3 performed best for the detection of CIN 2 or higher lesions with a sensitivity, specificity, PPV, and NPV of 84.75 %, 44.85 %, 35.46 %, and 89.16 % respectively. On comparing the area under the curve (AUC) for MSCI and MRI, we found that the difference between the AUC of MSCI (0.854) and Modified Reid Index (0.657) was significant (P < 0.05). CONCLUSION: MSCI performs better than the modified reid index for the diagnosis of both HGL and LGL or higher. Also, the omission of impractical measurements and inclusion of easier and more practical parameters than the Swede score or Modified Reid Index makes MSCI a simple and effective screening tool.

Analysis of the clinical characteristics and surgical methods of high-grade squamous intraepithelial lesions of the cervix in postmenopausal women: A retrospective case study.

The purpose of this study was to thoroughly evaluate the clinical features and surgical options for high-grade squamous intraepithelial lesions (HSIL) in postmenopausal women. A total of 308 patients diagnosed with HSIL through colposcopic cervical biopsy and endocervical curettage were included. Their clinical characteristics, surgical treatments, and postoperative pathology were analyzed. Key findings include: 1. Patients with positive preoperative thinprep cytologic test (TCT) results and postoperative pathology indicating HSIL or squamous cell carcinoma (≥HSIL) were significantly more frequent than those with negative preoperative TCT results (P < .05). 2. Univariate analysis indicated significant impacts of TCT, human papillomavirus (HPV) type, transformation zone (TZ) location, and surgical technique on postoperative pathology (P < .05). 3. Logistic regression analysis confirmed significant influences of TCT, HPV type, TZ location, and surgical method on postoperative pathology outcomes (P < .05), showing that each unit increase in TZ raised the probability of ≥HSIL in postoperative pathology by 49.7%. In surgical comparisons, cold knife conization (CKC) and extrafascial hysterectomy resulted in 8.379 and 4.427 times higher probabilities of ≥HSIL in postoperative pathology, respectively, compared to loop electrosurgical excision procedure (LEEP). 4. Surgical methods significantly influenced margin results (P < .05). After LEEP, 17.5% of cases had positive margins, compared to 9.4% after CKC, and 3.7% after extrafascial hysterectomy, indicating the highest rate of positive surgical margins occurred with LEEP. 1. Combined TCT and HPV screening is crucial for cervical cancer prevention, early detection, and management in postmenopausal women. Women with positive results for both TCT and HPV should undergo colposcopic cervical biopsy and endocervical curettage. 2. For patients with TZ3, CKC is the recommended surgical option. 3. CKC is the preferred treatment for postmenopausal women with HSIL, as it effectively diagnoses and treats the lesion, showing superior outcomes in managing postmenopausal HSIL.

[Artificial Intelligence: accuracy for the diagnosis of precancerous lesions of the cervix]. / Inteligencia Artificial: precisión diagnóstica de lesiones preneoplásicas de cérvix uterino.

INTRODUCTION: To compare the diagnostic sensitivity of artificial intelligence (AI) assisted videocolposcopy with standard videocolposcopy performed by specialist colposcopists. METHODS: A descriptive retrospective cross-sectional study, 782 anonymized medical records from the Computerized System for Screening (SITAM) of women who underwent videocolposcopy with AI and colposcopy with common videocolposcopy performed by specialists, with their corresponding biopsies (gold standard) were analyzed. The relationship between the results of IA videocolposcopy and regular videocolposcopy and the results of biopsies was evaluated. The overall accuracy of each diagnostic procedure was calculated. The sensitivity and concordance of the results of AI videocolposcopy with the gold standard (biopsy) were determined. RESULTS: A total of 395 patient records of patients with IA videocolposcopy and 387 with regular videocolposcopy were analyzed. The accuracy of results was 80% (IC 95%: 75-83%) in IA videocolposcopy and 65% (IC 95%: 60-69%) in regular videocolposcopy (p<0.001). Videocolposcopy results with IA and common colposcopy were significantly correlated with biopsy results, rs=0.75 vs. rs=0.57 respectively (p<0.001). The sensitivity of videocolposcopy with AI was 96% (95% CI: 94-98%), and 93% (95% CI: 89-95%) for regular colposcopy. The overall agreement of colposcopic impressions classified by videocolposcopy with AI and disease was higher than that of colposcopic interpretation by colposcopists (90% vs. 83%, Kappa 0.59 vs. 0.47, p<0.001). CONCLUSION: The high diagnostic accuracy of AI videocolposcopy allows obtaining highly sensitive studies that help in the early detection of precursor lesions of cervical neoplasia.

Introducción: Objetivo: comparar sensibilidad diagnóstica de videocolposcopia con inteligencia artificial (IA) auxiliar, con la videocolposcopia común realizada por colposcopistas. Métodos: Estudio descriptivo de corte transversal retrospectivo, en 782 historias clínicas anonimizadas del Sistema Informático para el Tamizaje (SITAM), de mujeres a las cuales se les efectuaron videocolposcopia con IA y colposcopías con videocolposcopio común realizadas por especialistas, con sus biopsias (gold standard). Se evaluó la relación entre los resultados de videocolposcopia con IA y videocolposcopia común con resultados de las biopsias. Se calculó precisión global de cada procedimiento diagnóstico. Se determinó sensibilidad y concordancia de los resultados de la videocolposcopia con IA, con el gold standard. Resultados: Se analizaron 395 historias clínicas de pacientes con videocolposcopia con IA y 387 con videocolposcopia común. La precisión diagnóstica de resultados fue 80% (IC 95%: 75-83%) en videocolposcopias con IA y 65% (IC 95%: 60-69%) en videocolposcopia común (p<0.001). Los resultados de videocolposcopia con IA y colposcopia común se correlacionaron significativamente con los resultados de las biopsias, rs=0.75 vs. r s=0.57 respectivamente (p<0.001). La sensibilidad de videocolposcopia con IA fue 96% (IC 95%: 94-98%), y 93% (IC 95%: 89-95%) en colposcopías comunes. La concordancia general de las impresiones colposcópicas clasificadas por videocolposcopia con IA y enfermedad fue mayor que la de la interpretación colposcópica de los colposcopistas (90% frente a 83%, Kappa 0.59 frente a 0.47, p<0.001). Conclusión: La alta precisión diagnóstica de videocolposcopia con IA permite aumentar la sensibilidad del estudio y mejorar la detección precoz de lesiones precursoras de neoplasias cervicouterinas.

Improving diagnostic of cervical dysplasia among postmenopausal women aged ≥50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study).

INTRODUCTION: Colposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal women, as the majority will have a non-visible transformation zone, resulting in increased risk of missing disease, a diagnostic cone biopsy and prolonged follow-up with repeated colposcopies. This study will be among the first to investigate, if treatment with vaginal oestrogen prior to colposcopy will improve the colposcopy performance, to ensure accurate and timely diagnosis of precancerous cervical lesions among postmenopausal women. METHODS AND ANALYSIS: A randomised blinded controlled multicentre study. Enrolment will be performed at gynaecology departments in Central Denmark Region and Region of Southern Denmark. A total of 150 postmenopausal women aged ≥50 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 µg or placebo once a day for 14 days prior to colposcopy. The primary outcome will be to compare the percentage of women in the two groups with a visible transformation zone at colposcopy, and biopsies representative of the transformation zone. Secondary outcomes will be the proportion of detected cervical intraepithelial neoplasia grade 2 or higher in the cervical biopsies; the proportion of diagnostics cone biopsies; the patients' report on possible side effects and compliance to the pretreatment. ETHICS AND DISSEMINATION: The study has been approved by the Central Denmark Region Committee on Biomedical Research Ethics (1-10-72-34-22), the Central Denmark Regions' Research Unit (1-16-02-72-22) and The Danish Health Authority (Danish Medicine Agency; 2022015030). The study's EudraCT number is (1-23-456; 2022-000269-42) and it is registered on www. CLINICALTRIALS: gov. The local Good Clinical Practice (GCP) unit will supervise and monitor the study closely before, during and after the study period. Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences. TRIAL REGISTRATION NUMBER: NCT05283421.

Deep Learning Diagnostic Classification of Cervical Images to Augment Colposcopic Impression.

OBJECTIVE: A deep learning classifier that improves the accuracy of colposcopic impression. METHODS: Colposcopy images taken 56 seconds after acetic acid application were processed by a cervix detection algorithm to identify the cervical region. We optimized models based on the SegFormer architecture to classify each cervix as high-grade or negative/low-grade. The data were split into histologically stratified, random training, validation, and test subsets (80%-10%-10%). We replicated a 10-fold experiment to align with a prior study utilizing expert reviewer analysis of the same images. To evaluate the model's robustness across different cameras, we retrained it after dividing the dataset by camera type. Subsequently, we retrained the model on a new, histologically stratified random data split and integrated the results with patients' age and referral data to train a Gradient Boosted Tree model for final classification. Model accuracy was assessed by the receiver operating characteristic area under the curve (AUC), Youden's index (YI), sensitivity, and specificity compared to the histology. RESULTS: Out of 5,485 colposcopy images, 4,946 with histology and a visible cervix were used. The model's average performance in the 10-fold experiment was AUC = 0.75, YI = 0.37 (sensitivity = 63%, specificity = 74%), outperforming the experts' average YI of 0.16. Transferability across camera types was effective, with AUC = 0.70, YI = 0.33. Integrating image-based predictions with referral data improved outcomes to AUC = 0.81 and YI = 0.46. The use of model predictions alongside the original colposcopic impression boosted overall performance. CONCLUSIONS: Deep learning cervical image classification demonstrated robustness and outperformed experts. Further improved by including additional patient information, it shows potential for clinical utility complementing colposcopy.

Enhancing cervical cancer detection and robust classification through a fusion of deep learning models.

Cervical cancer, the second most prevalent cancer affecting women, arises from abnormal cell growth in the cervix, a crucial anatomical structure within the uterus. The significance of early detection cannot be overstated, prompting the use of various screening methods such as Pap smears, colposcopy, and Human Papillomavirus (HPV) testing to identify potential risks and initiate timely intervention. These screening procedures encompass visual inspections, Pap smears, colposcopies, biopsies, and HPV-DNA testing, each demanding the specialized knowledge and skills of experienced physicians and pathologists due to the inherently subjective nature of cancer diagnosis. In response to the imperative for efficient and intelligent screening, this article introduces a groundbreaking methodology that leverages pre-trained deep neural network models, including Alexnet, Resnet-101, Resnet-152, and InceptionV3, for feature extraction. The fine-tuning of these models is accompanied by the integration of diverse machine learning algorithms, with ResNet152 showcasing exceptional performance, achieving an impressive accuracy rate of 98.08%. It is noteworthy that the SIPaKMeD dataset, publicly accessible and utilized in this study, contributes to the transparency and reproducibility of our findings. The proposed hybrid methodology combines aspects of DL and ML for cervical cancer classification. Most intricate and complicated features from images can be extracted through DL. Further various ML algorithms can be implemented on extracted features. This innovative approach not only holds promise for significantly improving cervical cancer detection but also underscores the transformative potential of intelligent automation within the realm of medical diagnostics, paving the way for more accurate and timely interventions.

Classification of cervical lesions based on multimodal features fusion.

Cervical cancer is a severe threat to women's health worldwide with a long cancerous cycle and a clear etiology, making early screening vital for the prevention and treatment. Based on the dataset provided by the Obstetrics and Gynecology Hospital of Fudan University, a four-category classification model for cervical lesions including Normal, low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) and cancer (Ca) is developed. Considering the dataset characteristics, to fully utilize the research data and ensure the dataset size, the model inputs include original and acetic colposcopy images, lesion segmentation masks, human papillomavirus (HPV), thinprep cytologic test (TCT) and age, but exclude iodine images that have a significant overlap with lesions under acetic images. Firstly, the change information between original and acetic images is introduced by calculating the acetowhite opacity to mine the correlation between the acetowhite thickness and lesion grades. Secondly, the lesion segmentation masks are utilized to introduce prior knowledge of lesion location and shape into the classification model. Lastly, a cross-modal feature fusion module based on the self-attention mechanism is utilized to fuse image information with clinical text information, revealing the features correlation. Based on the dataset used in this study, the proposed model is comprehensively compared with five excellent models over the past three years, demonstrating that the proposed model has superior classification performance and a better balance between performance and complexity. The modules ablation experiments further prove that each proposed improved module can independently improve the model performance.

Efficacy of Lidocaine Spray for Pain Reduction during Colposcopy-Directed Cervical Biopsies: A Randomized Controlled Trial.

Objectives: The objective of this study was to evaluate the efficacy of lidocaine spray in reducing the pain during colposcopy-directed cervical biopsy (CDB). Methods: From December 2017 to February 2019, 312 women undergoing CDBs were enrolled. The participants were randomized to three groups: group 1 (lidocaine spray), in which lidocaine spray was applied thoroughly to the cervix; group 2 (placebo), in which normal saline was applied thoroughly to the cervix; and group 3 (control), in which no anesthetic agent was applied to the cervix. Each woman completed a 10 cm visual analog scale to classify the subjective pain experience at three time points: baseline, immediately after biopsy, and 10 min after the procedure. The primary outcome of this study was the biopsy pain score. Results: The 312 enrolled women were randomly assigned to the three groups, amounting to 104 women per group. The clinical and pathological characteristics of the participants in all groups were comparable. The baseline, the biopsy, and the post-procedure pain scores were comparable among the three groups. There was a significant increase in the pain score from baseline to biopsy and from baseline to post-procedure in each group. The pain-score changes from baseline to biopsy in the lidocaine spray group significantly decreased when compared with the normal saline group (<0.001), and tended to decrease, though not significantly (p = 0.06), when compared with the control group. No complication with the intervention was observed. Conclusions: The application of lidocaine spray to the cervix has the benefit of reducing the pain associated with CDBs by a small amount. However, the intervention is safe and may be considered in nulliparous and/or overly anxious women undergoing the procedure.

Assessing colposcopy competencies in medically underserved communities: a multi-center study in China.

BACKGROUND: Colposcopy plays an essential role in diagnosing cervical lesions and directing biopsy; however, there are few studies of the capabilities of colposcopists in medically underserved communities in China. This study aims to fill this gap by assessing colposcopists' competencies in medically underserved communities of China. METHODS: Colposcopists in medically underserved communities across China were considered eligible to participate. Assessments involved presenting participants with 20 cases, each consisting of several images and various indications. Participants were asked to determine transformation zone (TZ) type, colposcopic diagnoses and to decide whether biopsy was necessary. Participants are categorized according to the number of colposcopic examinations, i.e., above or below 50 per annum. RESULTS: There were 214 participants in this study. TZ determination accuracy was 0.47 (95% CI 0.45,0.49). Accuracy for colposcopic diagnosis was 0.53 (95% CI 0.51,0.55). Decision to perform biopsies was 0.73 accurate (95% CI 0.71,0.74). Participants had 0.61 (95% CI 0.59,0.64) sensitivity and a 0.80 (95% CI 0.79,0.82) specificity for detecting high-grade lesions. Colposcopists who performed more than 50 cases were more accurate than those performed fewer across all indicators, with a higher sensitivity (0.66 vs. 0.57, p = 0.001) for detecting high-grade lesions. CONCLUSIONS: In medically underserved communities of China, colposcopists appear to perform poorly at TZ identification, colposcopic diagnosis, and when deciding to biopsy. Colposcopists who undertake more than 50 colposcopies each year performed better than those who perform fewer. Therefore, colposcopic practice does improve through case exposure although there is an urgent need for further pre-professional and clinical training.

Knowledge of cytology results affects the performance of colposcopy: a crossover study.

OBJECTIVE: To determine whether knowledge of cytology affects the colposcopist's diagnostic accuracy in the identification of cervical intraepithelial neoplasia grade 2 and worse (≥ CIN2). METHOD: In this cross-over study, healthcare professionals interpreted colposcopy images from 80 patient cases with known histological diagnoses. For each case, 2 images taken with a colposcope were provided (native and after acetic acid application). Inclusion criteria consisted of women with a transformation zone type 1 or 2, who had both a cytological and histological diagnosis. Cases were distributed across two online surveys, one including and one omitting the cytology. A wash-out period of six weeks between surveys was implemented. Colposcopists were asked to give their diagnosis for each case as < CIN2 or ≥ CIN2 on both assessments. Statistical analysis was conducted to compare the two interpretations. RESULTS: Knowledge of cytology significantly improved the sensitivity when interpreting colposcopic images, from 51.1% [95%CI: 39.3 to 62.8] to 63.7% [95%CI: 52.1 to 73.9] and improved the specificity from 63.5% [95%CI: 52.3 to 73.5] to 76.6% [95%CI: 67.2 to 84.0]. Sensitivity was higher by 38.6% when a high-grade cytology (ASC-H, HSIL, AGC) was communicated compared to a low-grade cytology (inflammation, ASC-US, LSIL). Specificity was higher by 31% when a low-grade cytology was communicated compared to a high-grade. CONCLUSIONS: Our data suggests that knowledge of cytology increases sensitivity and specificity for diagnosis of ≥ CIN2 lesions at colposcopy. Association between cytology and histology may have contributed to the findings.

Multiscale Optical Imaging Fusion for Cervical Precancer Diagnosis: Integrating Widefield Colposcopy and High-Resolution Endomicroscopy.

OBJECTIVE: Early detection and treatment of cervical precancers can prevent disease progression. However, in low-resource communities with a high incidence of cervical cancer, high equipment costs and a shortage of specialists hinder preventative strategies. This manuscript presents a low-cost multiscale in vivo optical imaging system coupled with a computer-aided diagnostic system that could enable accurate, real-time diagnosis of high-grade cervical precancers. METHODS: The system combines portable colposcopy and high-resolution endomicroscopy (HRME) to acquire spatially registered widefield and microscopy videos. A multiscale imaging fusion network (MSFN) was developed to identify cervical intraepithelial neoplasia grade 2 or more severe (CIN 2+). The MSFN automatically identifies and segments the ectocervix and lesions from colposcopy images, extracts nuclear morphology features from HRME videos, and integrates the colposcopy and HRME information. RESULTS: With a threshold value set to achieve sensitivity equal to clinical impression (0.98 [p = 1.0]), the MSFN achieved a significantly higher specificity than clinical impression (0.75 vs. 0.43, p = 0.000006). CONCLUSION: Our findings show that multiscale optical imaging of the cervix allows the highly sensitive and specific detection of high-grade precancers. SIGNIFICANCE: The multiscale imaging system and MSFN could facilitate the accurate, real-time diagnosis of cervical precancers in low-resource settings.

Chromocolposcopy with fluorescein sodium for detection of premalignant and malignant lesions of the cervix: A cross-sectional study.

OBJECTIVE: The aim of the study was to explore the utility of fluorescein sodium (FNa) as a contrast agent for colposcopy to detect premalignant and malignant lesions of cervix. The primary objective was to determine and compare the percentage detection of premalignant and malignant lesions of FNa and acetic acid (AA) positive areas. METHODS: This study included 120 screen positive women who underwent colposcopy using both 3% AA and FNa (0.06%). Observations for FNa staining were made under blue filter and directed biopsies were taken from acetowhite and fluorescent green areas. Benign lesions were considered as disease-negative and low grade squamous intraepithelial lesions (LSIL), high grade SIL (HSIL), and invasive cancer were considered as disease-positive. Correlation between histopathology and FNa and AA was determined by Kappa statistics. RESULTS: The mean age was 39.59 ± 10.73 years and median parity was 2. Out of 120 patients, 57 had benign lesions, 18 had LSIL, 33 had HSIL and 12 had invasive carcinomas. Sensitivity was 98.41% versus 64.91% respectively and specificity was 85.71% versus 35.09% respectively with FNa and AA. Diagnostic accuracy of FNa and AA was 82.50% versus 61.60%. There was good agreement between FNa staining and final histopathology and fair agreement between AA application and HPE (κ = 0.643 vs 0.213, P < 0.001). CONCLUSION: Using FNa as a contrast agent during colposcopy results in greater accuracy for detection of premalignant and malignant lesions of the cervix as compared to AA.

Presence of 10 transformation zone cells in endocervical curettage should not be required for adequacy.

OBJECTIVES: In another publication, we concluded endocervical curettage (ECC) should have a minimum number of squamous cells for adequacy, similar to the requirements for adequate cervical Papanicolaou smears. Here, we investigate if also, similar to cervical Papanicolaou smears, the presence of at least 10 cells from the endocervical/transformation zone (EC/TZ) in ECCs should be used as a quality assurance measure or if, instead, at least 10 EC/TZ cells should be part of the adequacy criteria for ECC, with an emphasis on diagnosis of at least high-grade squamous dysplasia (HGD). METHODS: All patients with at least HGD diagnosed on an excisional biopsy specimen (loop electrosurgical excision procedure [LEEP]) from May 1, 2018, to December 31, 2019, and an ECC in the preceding 6 months at our institution were included. Number of EC/TZ cells present in ECCs was counted visually and categorized as less than or greater than 10 TZ cells. A χ2 test was used to evaluate the proportion of ECCs with and without HGD and the presence or absence of at least 10 EC/TZ cells. Given our recent work encouraging at least 1000 squamous cells in an ECC to be considered adequate, we also evaluated only ECCs with greater than 1000 squamous cells with and without HGD and the presence or absence of at least 10 EC/TZ cells. P value was <.05. RESULTS: Fifty-one LEEPs with HGD and a preceding ECC in the previous 6 months were identified. Of the 51 ECCs, 6 had fewer than 10 EC/TZ cells and 45 had at least 10 EC/TZ cells. A similar proportion of the ECCs with HGD had at least 10 EC/TZ cells as those without HGD (93% vs 86%, P = .53). Using only ECCs with greater than 1000 squamous cells, we still found no statistical difference in the proportion of ECCs with HGD having greater than 10 EC/TZ cells compared to those without HGD (91% vs 100%, P = .49). CONCLUSIONS: We found that the presence of at least 10 EC/TZ cells does not increase the likelihood of finding HGD in an ECC performed in the 6 months prior to a LEEP with HGD. Similar to the use of the TZ component in cervical Papanicolaou smears, the presence or absence of at least 10 TZ cells in an ECC should only be considered a quality assurance measure and not be used as a criterion for adequacy of the specimen.

Agreement on Lesion Presence and Location at Colposcopy.

OBJECTIVES/PURPOSE: The reproducibility and sensitivity of image-based colposcopy is low, but agreement on lesion presence and location remains to be explored. Here, we investigate the interobserver agreement on lesions on colposcopic images by evaluating and comparing marked lesions on digitized colposcopic images between colposcopists. METHODS: Five colposcopists reviewed images from 268 colposcopic examinations. Cases were selected based on histologic diagnosis, i.e., normal/cervical intraepithelial neoplasia (CIN)1 ( n = 50), CIN2 ( n = 50), CIN3 ( n = 100), adenocarcinoma in situ ( n = 53), and cancer ( n = 15). We obtained digitized time-series images every 7-10 seconds from before acetic acid application to 2 minutes after application. Colposcopists were instructed to digitally annotate all areas with acetowhitening or suspect of lesions. To estimate the agreement on lesion presence and location, we assessed the proportion of images with annotations and the proportion of images with overlapping annotated area by at least 4 (4+) colposcopists, respectively. RESULTS: We included images from 241 examinations (1 image from each) with adequate annotations. The proportion with a least 1 lesion annotated by 4+ colposcopists increased by severity of histologic diagnosis. Among the CIN3 cases, 84% had at least 1 lesion annotated by 4+ colposcopists, whereas 54% of normal/CIN1 cases had a lesion annotated. Notably, the proportion was 70% for adenocarcinoma in situ and 71% for cancer. Regarding lesion location, there was no linear association with severity of histologic diagnosis. CONCLUSION: Despite that 80% of the CIN2 and CIN3 cases were annotated by 4+ colposcopists, we did not find increasing agreement on lesion location with histology severity. This underlines the subjective nature of colposcopy.

Colposcopy-A Valuable Diagnostic Tool for Pregnant Women With Unexplained Vaginal Bleeding.

OBJECTIVES: We aimed to examine the diagnostic value of colposcopy in a large cohort of pregnant women with unexplained vaginal bleeding during the second or third trimester. MATERIALS AND METHODS: This retrospective study included women who underwent colposcopy due to vaginal bleeding in the second and third trimesters during 2012-2022 at a tertiary care hospital. Demographics, obstetric data, bleeding characteristics, colposcopy results, cervical cytology testing, a sonogram directed at the placenta, and birth details were collected. RESULTS: In total, 364 women were included. The mean maternal age was 29.7 years and the mean gestational age at examination was 30.7 weeks. Vaginal bleeding was mild in 80.8%, moderate in 14.6%, and severe in 4.7%. Only 3.3% had been vaccinated against human papilloma virus and 25.5% underwent a Pap smear study before pregnancy. Colposcopy diagnosed the bleeding source in 83 women (22.8%). The colposcopic examination revealed vaginal bleeding due to contact bleeding from ectropion in 46 (12.6%), a decidual/cervical polyp in 37 (10.2%), acetowhite epithelium in 12 (3.3%), herpes genetalis in 2 (0.5%), and bleeding from vaginal varices in 2 (0.5%). Of those who were recommended a follow-up examination after the postpartum period, only 49.1% completed such.Among women with compared to without postcoital bleeding ( N = 72), the risk of abnormal colposcopic findings was higher (24 [33.3%] vs 54 [19.7%], p = .017) and the rate of abnormal Pap smear was higher (7 [13.2%] vs 7 [3.2%], p = .008). CONCLUSIONS: Colposcopy can be a valuable diagnostic tool for women with unexplained vaginal bleeding in the second or third trimester.