Visual Inspection with Acetic Acid Positivity in Screening and Early Detection of Cervical Dysplasia in Africa, 2023: A Meta-Analysis.

Background: Visual Inspection with Acetic acid (VIA) is the best feasible method of screening and early detecting for cervical dysplasia for resource limited settings like Africa. There is no study that can represent Africa on VIA positivity. Therefore, this metaanalysis was planned to verify the best available articles to pool the visual inspection with acetic acid positivity in screening and early detection of cervical dysplasia in Africa. Methods: The Cochrane Library, Web of Science, PubMed, Scopus, free Google database search engines, Google Scholar, and Science Direct databases were used to conduct a true search of this research article. STATA version 14.0 was used to do the metaanalysis. This meta-analysis was registered in PROSPERO database under the identity pf CRD42023392197. Result: This meta-analysis analyzed data from 21,066 women who had VIA examination to estimate the pooled VIA positivity in Africa. The overall pooled effect estimate of VIA positivity in Africa was 11.93 (95%CI: 11.48-12.37). Age <16 year during first intercourse 2.58(95%CI: 1.53-3.62), lifetime sexual partner ≥2 3.92(95%CI: 2.05-5.78) and HIV positivity 2.92(95%CI: 1.72-4.12) were the significant variables which influence VIA positivity. Conclusion: Overall pooled effect estimate of VIA positivity in Africa was high compared to other continents. The main factors that affect VIA positivity are age at first sexual contact being under 16 years old, the number of lifetime sexual partners being at least two, and HIV positivity. Therefore, the WHO's goal of creating Africa free of cervical cancer is still one that requires significant effort.

Utilizing Deep Learning for Defect Inspection in Hand Tool Assembly.

The integrity of product assembly in the precision assembly industry significantly influences the quality of the final products. During the assembly process, products may acquire assembly defects due to personnel oversight. A severe assembly defect could impair the product's normal function and potentially cause loss of life or property for the user. For workpiece defect inspection, there is limited discussion on the simultaneous detection of the primary kinds of assembly anomaly (missing parts, misplaced parts, foreign objects, and extra parts). However, these assembly anomalies account for most customer complaints in the traditional hand tool industry. This is because no equipment can comprehensively inspect major assembly defects, and inspections rely solely on professionals using simple tools and their own experience. Thus, this study proposes an automated visual inspection system to achieve defect inspection in hand tool assembly. This study samples the work-in-process from three assembly stations in the ratchet wrench assembly process; an investigation of 28 common assembly defect types is presented, covering the 4 kinds of assembly anomaly in the assembly operation; also, this study captures sample images of various assembly defects for the experiments. First, the captured images are filtered to eliminate surface reflection noise from the workpiece; then, a circular mask is given at the assembly position to extract the ROI area; next, the filtered ROI images are used to create a defect-type label set using manual annotation; after this, the R-CNN series network models are applied to object feature extraction and classification; finally, they are compared with other object detection models to identify which inspection model has the better performance. The experimental results show that, if each station uses the best model for defect inspection, it can effectively detect and classify defects. The average defect detection rate (1-ß) of each station is 92.64%, the average misjudgment rate (α) is 6.68%, and the average correct classification rate (CR) is 88.03%.

Comparison of Knowledge, Attitude, and Practices of Nursing Staff Regarding Cervical Cancer Screening at Various Levels of Health Care Facilities in Western India.

Background: Cervical cancer is a public health problem, and nursing personnel are crucial for successful implementation of low-cost cervical cancer screening approaches in low-resource settings. The following study assessed and compared the knowledge, attitude, and practices regarding cervical cancer and its screening among female nursing staff at different levels of health care facilities in western Rajasthan, India. Methodology: An anonymous pre-validated, structured questionnaire was used as the study tool among 233 female nursing personnel of primary, secondary, and tertiary care health facilities. Multiple logistic regression was performed to determine the association between level of knowledge with level of health care and other demographic variables. Results: The nursing staff of the tertiary care health facility demonstrated significantly higher knowledge compared to those working at primary and secondary levels [adjusted odds ratio (95% confidence interval) 11.01 (3.80-32.40)]. At tertiary care, the practices of the nursing professionals were not found significantly associated with any socio-demographic variable including age, marital status, or level of health care facility. Conclusion: The overall knowledge of cervical cancer was poor, especially among staff nurses at primary and secondary levels of health care. In order to implement a successful population-based screening program in India, it is important to update the nursing curriculum and start in-service trainings at primary and secondary levels of health care facilities.

Cost-effectiveness analysis of alternative screening strategies for the detection of cervical cancer among women in rural areas of Western Kenya.

While the incidence of cervical cancer has dropped in high-income countries due to organized cytology-based screening programs, it remains the leading cause of cancer death among women in Eastern Africa. Therefore, the World Health Organization (WHO) now urges providers to transition from widely prevalent but low-performance visual inspection with acetic acid (VIA) screening to primary human papillomavirus (HPV) DNA testing. Due to high HPV prevalence, effective triage tests are needed to identify those lesions likely to progress and so avoid over-treatment. To identify the optimal cost-effective strategy, we compared the VIA screen-and-treat approach to primary HPV DNA testing with p16/Ki67 dual-stain cytology or VIA as triage. We used a Markov model to calculate the budget impact of each strategy with incremental quality-adjusted life years and incremental cost-effectiveness ratios (ICER) as the main outcome. Deterministic cost-effectiveness analyses show that the screen-and-treat approach is highly cost-effective (ICER 2469 Int$), while screen, triage, and treat with dual staining is the most effective with favorable ICER than triage with VIA (ICER 9943 Int$ compared with 13,177 Int$). One-way sensitivity analyses show that the results are most sensitive to discounting, VIA performance, and test prices. In the probabilistic sensitivity analyses, the triage option using dual stain is the optimal choice above a willingness to pay threshold of 7115 Int$ being cost-effective as per WHO standards. The result of our analysis favors the use of dual staining over VIA as triage in HPV-positive women and portends future opportunities and necessary research to improve the coverage and acceptability of cervical cancer screening programs.

Comparison of Visual Inspection Methods with Pap Smear as Screening Test for Premalignant Lesions of the Cervix.

Aim and Objectives: The present study was done to compare the visual inspection methods with Pap smear as a screening test for premalignant lesions of the cervix. Materials and Methods: The present observational prospective study was done at the Department of Obstetrics and Gynecology at Teerthanker Mahaveer Medical College and Research Center for 18 months. All study subjects were subjected to Papanicolaou smear, VIA, and VILI examination. If any of these tests were found positive, then a colposcopy and cervical biopsy were done. Results: The sensitivity of Pap, VIA, VILI, and colposcopy was 52.63%, 84.21%, 73.68%, and 84.21%, respectively. The specificity of Pap, VIA, VILI, and colposcopy was 60.0%, 80.0%, 60.0%, and 80.0%, respectively. The accuracy of Pap, VIA, VILI, and colposcopy was 54.17%, 83.33%, 70.83%, and 83.33%, respectively. Conclusion: It is well known that VIA and VILI are very easy to carry out and apply. Even technically they do not cost much, consume less tax and can be applied to all the patients. Even the results are calculated in a faster manner which helps in chalking out the plan in an easy way.

Visual Field Restriction in the Recognition of Basic Facial Expressions: A Combined Eye Tracking and Gaze Contingency Study.

Uncertainties and discrepant results in identifying crucial areas for emotional facial expression recognition may stem from the eye tracking data analysis methods used. Many studies employ parameters of analysis that predominantly prioritize the examination of the foveal vision angle, ignoring the potential influences of simultaneous parafoveal and peripheral information. To explore the possible underlying causes of these discrepancies, we investigated the role of the visual field aperture in emotional facial expression recognition with 163 volunteers randomly assigned to three groups: no visual restriction (NVR), parafoveal and foveal vision (PFFV), and foveal vision (FV). Employing eye tracking and gaze contingency, we collected visual inspection and judgment data over 30 frontal face images, equally distributed among five emotions. Raw eye tracking data underwent Eye Movements Metrics and Visualizations (EyeMMV) processing. Accordingly, the visual inspection time, number of fixations, and fixation duration increased with the visual field restriction. Nevertheless, the accuracy showed significant differences among the NVR/FV and PFFV/FV groups, despite there being no difference in NVR/PFFV. The findings underscore the impact of specific visual field areas on facial expression recognition, highlighting the importance of parafoveal vision. The results suggest that eye tracking data analysis methods should incorporate projection angles extending to at least the parafoveal level.

Evaluation of Usage of Different Diagnostic Aids for Oral Cancer by Oral and Maxillofacial Surgeons: An Original Research.

Objective: The purpose of this study was to assess how oral and maxillofacial surgeons used various diagnostic tools for oral cancer. Materials and Methods: A cross-sectional methodology was used, and a standardized questionnaire was given to oral and maxillofacial surgeons randomly chosen sample. The questionnaire gathered information on demographics and the use of diagnostic tools. Data analysis methods included Chi-square testing and descriptive statistics. Results: The study included 200 oral and maxillofacial surgeons in total. The most often used diagnostic tool (95%) was visual inspection, followed by toluidine blue staining (48%) and brush biopsy (32%). Less frequently used were newer methods like optical coherence tomography (12.5%) and autofluorescence imaging (15%). No significant correlations between demographic factors and patterns of use of diagnostic tools were found by Chi-square tests. Conclusion: The results show that oral and maxillofacial surgeons frequently use brush biopsy, toluidine blue staining, and ocular evaluation. However, there is a need for more widespread adoption of cutting-edge technologies. By removing obstacles and offering training opportunities, one can increase the use of diagnostic tools, improving patient outcomes and the diagnosis of oral cancer.

Prevalence of high-risk human papillomavirus infection among women with diabetes mellitus in Accra, Ghana.

BACKGROUND: There is increasing evidence of a higher risk and poorer prognosis of cervical cancer among women with diabetes mellitus (DM) compared to the general population. These are mediated by higher susceptibility to persistent high-risk human papillomavirus (hr-HPV) infection due to dysfunctional clearance in an immunocompromised state. We aimed to determine the prevalence of hr-HPV infection and cervical lesions in a cohort of women with DM in Ghana. We further disaggregated the prevalence according to DM type and explored factors associated with hr-HPV infection. METHODS: This retrospective descriptive cross-sectional study assessed 198 women with DM who underwent cervical screening via concurrent hr-HPV DNA testing and visual inspection with acetic acid in an outpatient department of the National Diabetes Management and Research Centre in Korle-Bu Teaching Hospital, Accra from March to May 2022. Univariate and multivariable binary logistic regression were used to explore factors associated with hr-HPV positivity. RESULTS: Among 198 women with DM (mean age, 60.2 ± 12.1 years), the overall hr-HPV prevalence rate was 21.7% (95% CI, 16.1-28.1), disaggregated as 1.5% (95% CI, 0.3-4.4) each for HPV16 and HPV18 and 20.7% (95% CI, 15.3-27.0) for other HPV genotype(s). Respective hr-HPV prevalence rates were 37.5% (95% CI, 15.2-64.6) for type 1 DM, 19.8% (95% CI, 13.9-26.7) for type 2 DM, and 25.0% (95% CI, 8.7-49.1) for unspecified/other DM types. Past use of the combined contraceptive pill independently increased the risk of hr-HPV infection by approximately three times (adjusted odds ratio [aOR] = 2.98; 95% CI, 1.03 - 8.64; p-value = 0.045), whereas each unit increase in FBG level increased the odds of hr-HPV infection by about 15% (aOR = 1.15; 95% CI, 1.02 - 1.30; p-value = 0.021). CONCLUSION: Our study points to a high prevalence of hr-HPV among women with DM and highlights a need for glycemic control among them as this could contribute to lowering their odds of hr-HPV infection. The low overall rates of HPV vaccination and prior screening also indicate a need to build capacity and expand the scope of education and services offered to women with DM as regards cervical precancer screening.

Prevalence of precancerous lesions and other cervical abnormalities among internally displaced women in Benue State Nigeria.

Introduction: visual inspection is a low-cost screening strategy that can be used to prevent cervical cancer in women. These techniques can improve screening health outcomes for internally displaced women (IDW) who have poor sexual and reproductive health and rights' behaviors and outcomes. This study aimed to determine the prevalence of precancerous lesions and other clinical features using a visual inspection with acetic acid (VIA) technique during a cervical cancer screening campaign in two internally displaced people (IDP) camps in Benue State, Nigeria. Methods: this was a cross-sectional study of 166 IDW who voluntarily participated in the study during a VIA cervical cancer screening campaign in two IDP camps in Benue State, Nigeria the screening was done by a group of qualified and trained healthcare workers and data was collected using a structured, pretested questionnaire. Results: a total of 99(60%) of the women had a first sexual experience at 16 years, while 78(47%) had more than 5 full-term pregnancies. Although only 72(43.4%) of the women acknowledged having more than one sexual partner, over 70% of the women stated that their sexual partner had another sexual partner. The prevalence of precancerous lesions among women was 10.8%. Smoking(p=0.003), age at menarche (p≤ 0.001) and sexual behaviors (p=0.009, p=0.004) were factors that had a statistically significant relationship with the presence of a precancerous lesion among the IDW. The study also highlights the high rate (95%) of cervicitis among the women and the relatively high rate (5.4%) of leukoplakia. Conclusion: the majority of IDW had sociodemographic and lifestyle characteristics that predisposed them to developing cervical cancer More targeted interventions aimed at improving the sociodemographic and lifestyle characteristics of IDW are recommended. In addition, there is a need to create awareness about cervical cancer among IDW and make screening available in camp facilities for early detection and management.

Visual inspection problem-solving strategies at different experience levels.

Airport security screening is a visual inspection task comprising search and decision. Problem solving is used to support decision making. However, it is not well understood. This study investigated how airport security screeners employ problem solving during x-ray screening, and how strategies change with experience. Thirty-nine professional security screeners were observed performing x-ray screening in the field at an Australian International Airport. Video and eye-tracking data were collected and analysed to explore activity phases and problem-solving strategies. Less-experienced screeners performed more problem solving and preferred problem-solving strategies that rely on visual examination without decision support or that defer decision making, compared to more-experienced screeners, who performed efficient and independent strategies. Findings also show that screeners need more time to develop problem-solving skills than visual scanning skills. Screeners would benefit from problem-solving support tools and intensified training and mentorship within the first six months of experience to advance problem-solving competencies.

Correlation between variant call accuracy and quality parameters in comprehensive cancer genomic profiling tests.

Background: Comprehensive genomic profiling (CGP) tests have been widely utilized in clinical practice. In this test, the variant list automatically output from the data analysis pipeline often contains false-positive variants, although the correlation between the quality parameters and prevalence of false-positive variants remains unclear. Methods: We analyzed 125 CGP tests performed in our laboratory. False-positive variants were manually detected via visual inspection. The quality parameters of both wet and dry processes were also analyzed. Results: Among the 125 tests, 52 (41.6%) required more than one correction of the called variants, and 21 (16.8%) required multiple corrections. A significant correlation was detected between somatic false-positive variants and quality parameters in the wet (ΔΔCq, pre-capture library peak size, pre-capture library DNA amount, capture library peak size, and capture library concentration) and dry processes (total reads, mapping rates, duplication rates, mean depth, and depth coverage). Capture library concentration and mean depth were strong independent predictors of somatic false-positive variants. Conclusions: We demonstrated a correlation between somatic false-positive variants and quality parameters in the CGP test. This study facilitates gaining a better understanding of CGP test quality management.

A Cross-Sectional Study on Knowledge, Attitude, and Practices Related to Cervical Cancer Screening Among the Nursing Staff in a Tertiary Care Hospital in the Western Region of India.

Background Cervical cancer is the fourth most common cancer in women globally. It is one of the leading causes of cancer deaths in females in India. Cervical cancer has a long latent precancerous period from index human papillomavirus (HPV) infection to potential cancer development, making screening one of the most effective methods of cancer prevention. Despite the national cancer prevention programme for cancer cervix, with defined guidelines for cervical cancer screening by the auxiliary nurse midwives (ANM) and nurses, cervical cancer screening is very limited in India. In this study, we aim to assess the knowledge, attitude, and practices related to cervical cancer and screening methods among the nursing staff in a tertiary care hospital attached to a medical teaching institute. Methodology A cross-sectional study was conducted by a semi-structured questionnaire in a tertiary care hospital in Morbi, situated in the western region of India, between November and December 2023. Female nursing staff of the hospital in the age of 20 to 60 years were included as study participants. The study was approved by the Institutional Ethical Committee. Results In the study, 64.9% of participants were in the age group of 20-29 years, and 52.6% were unmarried, forming a major portion of the study group being of young age. Of the participants, 70.1% identified cancer of the cervix as a major public health problem. Only 28.8% of the participants had adequate and comprehensive knowledge of cervical cancer screening. Though 92.8% of the participants knew of Pap smear as a cervical cancer screening method, only 12.4% of participants were aware of the visual inspection with acetic acid (VIA) and 2% were aware of HPV testing as a tool for cervical cancer screening. Only 5.2% of the study participants had themselves been screened for cervical cancer. Of the participants, 87.6% had never taken a Pap smear, and 95.8% of participants had never taken VIA of any woman. A total of 32.3% of participants gave the reason of not having adequate skills to perform VIA as the reason for not ever having screened the patient with VIA. A total of 6.2% of participants had been trained in cervical screening methods formally. Conclusion The limited knowledge of the nursing staff of cervical cancer and its screening and low self-screening prevalence among healthcare professionals highlight the need to increase awareness of cervical cancer and screening to bring the impetus to training and result-driven implementation of screening programmes for cervical cancer in India.

An Integrated Framework for Image Acquisition, Processing, and Analysis Procedures for Automated Damage Evaluation of Concrete Surfaces.

Concrete surface cracks serve as early indicators of potential structural threats. Visual inspection, a commonly used and versatile concrete condition assessment technique, is employed to assess concrete degradation by observing signs of damage on the surface level. However, the method tends to be qualitative and needs to be more comprehensive in providing accurate information regarding the extent of damage and its evolution, notwithstanding its time-consuming and environment-sensitive nature. As such, the integration of image analysis techniques with artificial intelligence (AI) has been increasingly proven efficient as a tool to capture damage signs on concrete surfaces. However, to improve the performance of automated crack detection, it is imperative to intensively train a machine learning model, and questions remain regarding the required image quality and image collection methodology needed to ensure the model's accuracy and reliability in damage quantitative analysis. This study aims to establish a procedure for image acquisition and processing through the application of an image-based measurement approach to explore the capabilities of concrete surface damage diagnosis. Digitizing crack intensity measurements were found to be feasible; however, larger datasets are required. Due to the anisotropic behavior of the damage, the model's ability to capture crack directionality was developed, presenting no statistically significant differences between the observed and predicted values used in this study with correlation coefficients of 0.79 and 0.82.

From Anomaly Detection to Defect Classification.

This paper proposes a new approach to defect detection system design focused on exact damaged areas demonstrated through visual data containing gear wheel images. The main advantage of the system is the capability to detect a wide range of patterns of defects occurring in datasets. The methodology is built on three processes that combine different approaches from unsupervised and supervised methods. The first step is a search for anomalies, which is performed by defining the correct areas on the controlled object by using the autoencoder approach. As a result, the differences between the original and autoencoder-generated images are obtained. These are divided into clusters using the clustering method (DBSCAN). Based on the clusters, the regions of interest are subsequently defined and classified using the pre-trained Xception network classifier. The main result is a system capable of focusing on exact defect areas using the sequence of unsupervised learning (autoencoder)-unsupervised learning (clustering)-supervised learning (classification) methods (U2S-CNN). The outcome with tested samples was 177 detected regions and 205 occurring damaged areas. There were 108 regions detected correctly, and 69 regions were labeled incorrectly. This paper describes a proof of concept for defect detection by highlighting exact defect areas. It can be thus an alternative to using detectors such as YOLO methods, reconstructors, autoencoders, transformers, etc.

Consistent Visual Analysis of Multielement Data: A Preliminary Evaluation.

Experimenters provided 33 graphical displays of hypothetical data depicted in a multielement experimental design to editorial board members of prominent, applied, behavior-analytic journals via an online survey. For each display, participants indicated (a) the presence or absence of experimental control and (b) the degree of experimental control (rated on a 1-100 scale). Each depiction varied systematically in (a) the number of data paths, (b) the number of data paths elevated above the control, (c) the mean difference between affected data paths and control conditions, and (d) the degree of variability within conditions. Correspondence among experts' ratings of experimental control was high across all presented graphical displays, supporting the reliability of visual analysis as an evaluative tool for these designs.

Development of a one-pot and sequence-specific LAMP assay based on the self-quenching probe integrated by the complementary oligonucleotide for an enhanced fluorescence quenching.

Single-modified fluorogenic primer (Sfp) enables accurate identification of LAMP amplicons without being affected by non-specific products. However, the fluorescence self-quenching by nucleobases for Sfp is generally of low efficiency, and the high background signal makes it a great challenge to achieve visual inspection with naked eyes. In the present study, the oligonucleotide (Ao) complementary to Sfp was designed, which would hybridize to Sfp and dramatically heighten the quenching effect, leading to a low background signal in negative reaction. Instead, for positive reaction, Sfp is incorporated into the double-stranded amplicons, resulting in dequenching and consequently, enhanced fluorescence. The detection scheme can be further improved by a dual-color fluorescence strategy, allowing visual detection of 1 pg rainbow trout DNA in a closed-tube format within 30 min. Therefore, our LAMP-Ao-Sfp assay represents a useful tool for rapid and sensitive detection, and can serve as a reliable method for on-site detection in low-resource settings.

Effectiveness of a culturally tailored text messaging program for promoting cervical cancer screening in accra, Ghana: a quasi-experimental trial.

INTRODUCTION: Despite breakthroughs in cervical cancer detection, resource-constrained countries continue to have a disproportionately high incidence and death rate. Mhealth has been identified as an important tool for increasing cervical cancer screening rates in Sub-Saharan Africa. We determined whether sending Ghanaian women culturally tailored one-way mobile phone SMS text messages about cervical cancer would encourage the uptake of the human papillomavirus (HPV) test. METHODS: From August to November 2016, 88 women aged 18 to 39 living or working in an urban community (Accra, Ghana) participated in a quasi-experimental study. For 8 weeks, 32 SMS messages regarding cervical cancer were developed and sent to the personal phones of intervention arm participants (n = 42). Women in the control group (n = 46) received SMS texts with general health and lifestyle advice. Fischer's exact tests were performed to assess cervical cancer screening uptake and associated reasons for non-uptake between the intervention and control groups (p < 0.05). RESULTS: At the baseline, women differed in terms of ethnicity and wealth. After the intervention, participants' self-reported risk factors for cervical cancer, such as early menarche, usual source of medical treatment, family history of cancer, smoking, and alcohol history, changed. None of the women in the intervention group sought cervical cancer screening after the intervention, but only one (2.2%) of the control arm participants did. Almost all the women (> 95%) agreed that an HPV test was essential and that regular healthcare check-ups could help prevent cervical cancer. Some women believed that avoiding particular foods could help prevent cervical cancer (23.8% intervention vs. 58.7% control, p < 0.001). Time constraints and out-of-pocket expenses were significant barriers to cervical cancer screening. CONCLUSION: A one-way SMS delivered to urban women did not increase cervical cancer screening attendance. The time spent in screening facilities and the lack of coverage by the National Health Insurance Scheme limited screening uptake. We urge for the establishment of screening centers in all healthcare facilities, as well as the inclusion of cervical cancer screening in healthcare programs through cost-sharing.

Triage of HPV positivity in a high HIV prevalence setting: A prospective cohort study comparing visual triage methods and HPV genotype restriction in Botswana.

OBJECTIVE: Guidelines for effective triage following positive primary high-risk human papillomavirus (HPV) screening in low- and middle-income countries with high human immunodeficiency virus (HIV)-prevalence have not previously been established. In the present study, we evaluated the performance of three triage methods for positive HPV results in women living with HIV (WLHIV) and without HIV in Botswana. METHODS: We conducted baseline enrollment of a prospective cohort study from February 2021 to August 2022 in South-East District, Botswana. Non-pregnant women aged 25 or older with an intact cervix and no prior diagnosis of cervical cancer were systematically consented for enrollment, with enrichment of the cohort for WLHIV. Those who consented completed a questionnaire and then collected vaginal self-samples for HPV testing. Primary HPV testing for 15 individual genotypes was conducted using Atila AmpFire® HPV assay. Those with positive HPV results returned for a triage visit where all underwent visual inspection with acetic acid (VIA), colposcopy, and biopsy. Triage strategies with VIA, colposcopy and 8-type HPV genotype restriction (16/18/31/33/35/45/52/58), separately and in combination, were compared using histopathology as the gold standard in diagnosing cervical intraepithelial neoplasia (CIN) 2 or worse (CIN2+). RESULTS: Among 2969 women enrolled, 1480 (50%) tested HPV positive. The cohort included 1478 (50%) WLHIV; 99% were virologically suppressed after a mean of 8 years on antiretroviral therapy. In total, 1269 (86%) women had histopathology data for analysis. Among WLHIV who tested positive for HPV, 131 (19%) of 688 had CIN2+ compared with 71 (12%) of 581 in women without HIV. Screening by 8-type HPV genotype restriction was more sensitive as triage to detect CIN2+ in WLHIV 87.79% (95% CI: 80.92-92.85) and women without HIV 85.92% (95% CI: 75.62-93.03) when compared with VIA (WLHIV 62.31% [95% CI: 53.39-70.65], women without HIV 44.29% [95% CI: 32.41-56.66]) and colposcopy (WLHIV 70.77% [95% CI: 62.15-78.41], women without HIV 45.71% [95% CI: 33.74-58.06]). However, 8-type HPV genotype restriction had low specificity in WLHIV of 30.88% (95% CI: 27.06-34.90) and women without HIV 37.06% (95% CI: 32.85-41.41). These results were similar when CIN3+ was used as the outcome. When combining 8-type HPV genotype restriction with VIA as the triage strategy, there was improved specificity to detect CIN2+ in WLHIV of 81.65% (95% CI: 78.18-84.79) but dramatically reduced sensitivity of 56.15% (95% CI: 47.18-64.84). CONCLUSIONS: Eight-type HPV genotype restriction is a promising component of effective triage for HPV positivity. However, novel triage strategies in LMICs with high HIV prevalence may be needed to avoid the trade-off between sensitivity and specificity with currently available options. CLINICAL TRIALS REGISTRATION: This study is registered on Clinicaltrials.gov no. NCT04242823, https://clinicaltrials.gov/ct2/show/NCT04242823.

Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility.

Visible particles are a critical quality attribute for parenteral products and must be monitored. A carefully designed, executed, and controlled drug product manufacturing process including a final 100 % visual inspection and appropriate end-product controls ensures that visible particles are consistently minimized and demonstrates that the injectable DP is practically free from visible particles. Visual inspection, albeit appearing as a simple analytical procedure, requires several technical and operational controls to ensure adequate performance. To gather new data on particle visibility and shed light on this decade-old challenge, a multi-company blinded visual inspection threshold study was conducted. A major goal of the study was visual assessment of several particle types of different sizes in small volume vials, as a challenging configuration for visual inspection, across 9 biopharmaceutical companies in order to determine the visibility limit. The study results provide key insights into limitations and challenges of visual inspection, namely, no universal visibility limit can be applied to all particle types as the detectability varies with particle type, number, and size. The study findings underscore the necessity of setting realistic expectations on size-based visibility limits in visual inspection, robust procedures for analyst training and qualification, and harmonization of guidelines globally.

Further Progress Toward Automating Functional Analysis Interpretation.

It is considered best practice to conduct a functional analysis and visually inspect data collected to determine the function of problem behavior, which then informs the intervention approaches applied. Visual inspection has been described as a "subjective" process that may be affected by factors unrelated to the data. Structured decision-making guidelines have been established to address some of these shortcomings. The current paper is a follow-up to earlier work describing positive outcomes related to the viability of a decision support system based on structured criteria from Roane et al. Here, we demonstrate important improvements in a computer script's interpretation of functional analysis data, including improvement in agreement between the updated computer script version and experienced human raters (89%) compared to our original agreement outcomes (81%). This paper further supports the use of decision support systems for functional analysis interpretation.