Testing Programs Research Articles

Investigating the ability of standard tests to detect improvements in behavior after a 9-week training program in shelter dogs - A pilot study

Annually, millions of dogs enter shelters worldwide. As such, it is vital to develop effective methods for assessing adoptability and promoting successful rehoming that can be easily implemented by organizations with minimal resources. Many shelters use temperament testing and training programs to facilitate these goals, but there is limited research on the effects of training programs on shelter dog behavior, and no standardized tests for assessing the skills imparted by those programs. Therefore, the primary goal of this study was to evaluate the sensitivity of temperament and basic education tests to detect changes in dog behavior after training in a shelter context. As a secondary goal, we aimed to compare video and live scoring of dog behavior in these tests. Twelve shelter dogs were enrolled in a 9-week training program to learn basic education skills (e.g., walking on a leash without pulling, not jumping on people, responding to cues such as ‘sit’ or ‘stay’). Both before and after the program, each dog was tested using a previously evaluated and published temperament test designed for use in shelters and a test of basic education skills developed by the research team to determine the ability of the tests to measure training progress. Results showed no differences between pre- and post-training temperament test scores for the categories Human Sociability and Playfulness nor for the total temperament test score; however, a decrease was observed in the score for Dog Sociability. Regarding the basic education test, results showed improvements in scores for the categories ‘Walking on a loose leash’, ‘Sit, down and staying in place’, ‘Coming when called’ and for the total basic education test score; conversely, no differences were found for the categories ‘Accepting a friendly stranger’, ‘Waiting politely for petting’, ‘Walking through a crowd’ and ‘Supervised Separation’. Moreover, we found an overall high interrater agreement for both tests. The outcomes of the present study suggest that i) the proposed basic education test is a reliable measure for detecting improvements imparted by basic education programs, and that ii) basic education training has minimal effects on behavior assessed in the employed temperament test. We discuss how the utilized behavior tests and training programs may be beneficial in a shelter context.

Experiences across a genetic screening and testing programme pathway: a qualitative study of mammogram patient perspectives

BackgroundPopulation-based genetic screening and testing programmes have substantial potential to improve cancer-related outcomes through early detection and cancer prevention. Yet, genetic testing for cancer risk remains largely underused. This study...

Decreased variability in the site-specific results during participation in the External Quality Assurance Program Oversight Laboratory (EQAPOL) proficiency program for IFN-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay

The NIAID DAIDS-sponsored External Quality Assurance Program Oversight Laboratory (EQAPOL) manages an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) external proficiency program. The ELISpot program evaluates the accuracy and variability of results across laboratories. The variability in the program is quantified via the dispersion, which is the ratio of the variance over the mean of the background-corrected spot-forming cells (SFC) replicates obtained under stimulation with different peptide pools (CMV, CEF). This report includes the longitudinal analysis of the ELISpot program cohort composed of 22 laboratories from 2011 to 2022 to assess whether the within-lab variability has improved over time. Random intercept models of the dispersion over time showed a significant decrease in overall dispersion from an average of approximately 1.8 in 2011 to approximately 1.25 in 2022. Out of the 21 sites, 16 sites (4 being statistically significant) had a negative trend for dispersion over time. Our finding of a reduction of overall within-lab variability demonstrates the need for and benefit of proficiency testing programs.

Impacts of testing and immunity acquired through vaccination and infection on covid-19 cases in Massachusetts elementary and secondary students

BackgroundDuring the 2021–22 academic year, Massachusetts supported several in-school testing programs to facilitate in-person learning. Additionally, COVID-19 vaccines became available to all school-aged children and many were infected with SARS-CoV-2. There are limited studies evaluating the impacts of these testing programs on SARS-CoV-2 cases in elementary and secondary school settings. The aim of this state-wide, retrospective cohort study was to assess the impact of testing programs and immunity on SARS-CoV-2 case rates in elementary and secondary students.MethodsCommunity-level vaccination and cumulative incidence rates were combined with data about participation in and results of in-school testing programs (test-to-stay, pooled surveillance testing). School-level impacts of surveillance testing programs on SARS-CoV-2 cases in students were estimated using generalized estimating equations within a target trial emulation approach stratified by school type (elementary/middle/high). Impacts of immunity and vaccination were estimated using random effects linear regression.ResultsHere we show that among N = 652,353 students at 2141 schools participating in in-school testing programs, surveillance testing is associated with a small but measurable decrease in in-school positivity rates. During delta, pooled testing positivity rates are higher in communities with higher cumulative incidence of infection. During omicron, when immunity from prior infection became more prevalent, the effect reversed, such that communities with lower burden of infection during the earlier phases of the pandemic had higher infection rates.ConclusionsTesting programs are an effective strategy for supporting in-person learning. Fluctuating levels of immunity acquired via natural infection or vaccination are a major determinant of SARS-CoV-2 cases in schools.

The kinetics of nucleolar precursor bodies clustering at the pronuclei interface: Positive correlations with the morphokinetic characteristics of cleaving embryos and euploidy in preimplantation genetic testing programs

Objective: This study investigated potential relationships between the kinetics of nucleolar precursor bodies (NPBs) in the pronucleus and developmental morphokinetics and euploidy in human preimplantation genetic testing for aneuploidy (PGT-A) cycles.Methods: The morphokinetic analysis of 200 blastocysts obtained from 53 PGT-A cycles was performed retrospectively in a time-lapse incubator. At the time of pronuclear breakdown (PNBD), we categorized the blastocysts into two groups based on the kinetic degree of clustering NPBs at the interface of the two pronuclei: clustered NPBs (CL) and non-clustered NPBs (NCL). We then compared morphokinetic parameters, abnormal behavioral events, and the rate of aneuploidy between the two groups.Results: Pronuclear fading and the first cleavage occurred earlier in the NCL group than in the CL group. However, the initiation of blastocyst formation and blastocyst expansion was delayed in the NCL group relative to the CL group. No differences were found in the rate of abnormal cleavage events, such as multinucleation at the 2-cell stage, direct cleavage from one to three cells, and from two to five cells between the CL and NCL groups. However, the fragmentation rate at the 8-cell stage was higher in the NCL group than in the CL group (10.3% vs. 1.9%, p<0.05). Additionally, the euploid rate in the CL group was significantly higher than in the NCL group (37.9% vs. 12.4%, p<0.05).Conclusion: These results demonstrate the effectiveness of combining NPB clustering at PNBD with morphokinetics as a parameter for selecting embryos with higher developmental potential in in vitro fertilization.

Model risk management in stress testing: The road up to here

This paper reviews the historical evolution of the quantitative models, model usage and model risk management (MRM) in large US banks since the 1980s. It comments on the most significant model-related events through this period. Some of these events were associated with contexts of great stress to the financial system. The paper identifies the main features of modelling in finance and economics that distinguish it from its application in the natural sciences. Then it presents the different types of models used in the large banks' stress testing programmes, the specific characteristics and risks of each type of model and the best practices for the implementation of sound model risk management, and it suggests a proper way to interpret the results of stress testing and capital assessment in the presence of model risks. The paper discusses the future evolution of MRM towards the implementation of a `fully fledged risk management framework` along the lines of other risk management disciplines, including risk identification, measurement, monitoring, reporting, limiting and capitalisation. It acknowledges the enhancements and opportunities offered by advances in the use of artificial intelligence and machine learning as well as increases in computational power. The paper concludes by noting that the model risk management framework that has been enforced by the Federal Reserve's stress testing and capital planning programmes has substantially strengthened the capital position, profitability and resilience of the large banks in the US.

Tracing HIV Infection among high-risk Tuberculosis Patients in Hodiedah Referral Center, Yemen

Background: HIV and tuberculosis [TB] are major public health concerns in Yemen. However, in this population, there is limited information on the prevalence of HIV infection among TB patients. This study aims to trace and describe cases of HIV infection among high-risk tuberculosis patients attending the Hodiedah referral center in Yemen. Methods: A cross-sectional study design was employed, and a convenience sampling method was used to select 40 high-risk tuberculosis patients out of 164 confirmed cases. Data was collected through a questionnaire regarding sociodemographic features and clinical signs. Results: Of 40 high-risk TB patients, only 4 tested positive for HIV, indicating a 10% prevalence. More than half [55.0%] were aged between 18 and 40 years, with the majority [57.5%] being male. Over half [57.5%] resided in urban areas, and approximately two-thirds [62.5%] had no formal education. Most participants [87.5%] belonged to a low socioeconomic status, with a monthly income of less than 50,000 Yemeni Riyals. The age group of 18–40 years had the highest frequency of HIV-positive cases [50.0%]. All HIV-positive cases occurred in males. Younger age and travel history showed higher odds of HIV positivity. Diarrhea, bone pain, and abdominal pain were associated with HIV-TB co-infection. Conclusion: A relatively high HIV prevalence points to an urgent need to scale up integrated screening, testing, and treatment programs within existing TB clinics to address this unmet HIV/TB burden. Males, younger ages, and travel outside the country emerged as potential high-risk groups that could be prioritized for screening; incorporating symptom-based algorithms into clinical protocols may help front-line workers recognize and refer to suspected co-infection cases for testing. Larger studies are warranted to validate the findings and better inform control programs.

Development of an affordable light emitting diode spectrophotometer paired with a Python program for calibration and linearity testing and the measurement of uranium(VI).

Uranium (U) is a radiologically and chemically toxic element that occurs naturally in water, soil, and rock at generally low levels. However, anthropogenic uranium can also leach into groundwater sources due to mining, ore refining, and improper nuclear waste management. Over the last few decades, various methods for measuring uranium have emerged; however, most of these techniques require skilled scientists to run samples on expensive instrumentation for detection or require the pretreatment of samples in complex procedures. In this work, a Schiff base ligand (P1) is used to develop a simple spectrophotometric method for measuring the concentration of uranium (VI) with an accurate and affordable light-emitting diode (LED) spectrophotometer. A test for a higher-order polynomial relationship was used to objectively determine the calibration data's linearity. This test was done with a Python program on a Raspberry Pi computer that captured the spectrophotometer's calibration and sample measurement data.

A Mark-Recapture Approach to Estimating Item Pool Compromise.

Testing organizations routinely investigate if secure exam material has been compromised and is consequently invalid for scoring and inclusion on future assessments. Beyond identifying individual compromised items, knowing the degree to which a form is compromised can inform decisions on whether the form can no longer be administered or when an item pool is compromised to such an extent that serious action on a broad scale must be taken to ensure the validity of score interpretations. Previous research on estimating the population of item compromise is sparse; however, this is a more generally long-studied problem in ecological research. In this note, we exemplify the utility of the mark-recapture technique to estimate the population of compromised items, first through a brief demonstration to introduce the fundamental concepts and then a more realistic scenario to illustrate applicability to large-scale testing programs. An effective use of this technique would be to longitudinally track changes in the estimated population to inform operational test security strategies. Many variations on mark-recapture exist and interpretation of the estimated population depends on several factors. Thus, this note is only meant to introduce the concept of mark-recapture as a useful application to evaluate a testing organization's compromise mitigation procedures.

Implementation and Evaluation Strategies for Pharmacogenetic Testing in Hospital Settings: A Scoping Review.

Pharmacogenetic testing in clinical settings has improved the safety and efficacy of drug treatment. There is a growing number of studies evaluating pharmacogenetic implementation and identifying barriers and facilitators. However, no review has focused on bridging the gap between identifying barriers and facilitators of testing and the clinical strategies adopted in response. This review was conducted to understand the implementation and evaluation strategies of pharmacogenetic testing programs. A PRISMA-compliant scoping review was conducted. The included studies discussed pharmacogenetic testing programs implemented in a hospital setting. Quantitative, qualitative, and mixed design methods were included. A total of 232 of the 7043 articles that described clinical pharmacogenetic programs were included. The most common specialties that described pharmacogenetic implementation were psychiatry (26%) and oncology (16%), although many studies described institutional programs implemented across multiple specialties (19%). Different specialties reported different clinical outcomes, but all reported similar program performance indicators, such as test uptake and the number of times the test recommendations were followed. There were benefits and drawbacks to delivering test results through research personnel, pharmacists, and electronic alerts, but active engagement of physicians was necessary for the incorporation of pharmacogenetic results into clinical decision making. Further research is required on the maintenance and sustainability of pharmacogenetic testing initiatives. These findings provide an overview of the implementation and evaluation strategies of different specialties that can be used to improve pharmacogenetic testing.

Relationships between soil test phosphorus and county-level agricultural surplus phosphorus.

National nutrient inventories provide surplus phosphorus (P) estimates derived from county-scale mass balance calculations using P inputs from manure and fertilizer sales and P outputs from crop yield data. Although bioavailable P and surplus P are often correlated at the field scale, few studies have investigated the relationship between measured soil P concentrations of large-scale soil testing programs and inventory-based surplus P estimates. In this study, we assessed the relationship between national surplus P data from the NuGIS dataset and laboratory-measured soil test phosphorus (STP) at the county scale for Arkansas, North Carolina, and Oklahoma. For optimal periods of surplus P aggregation, surplus P was positively correlated with STP based on both Pearson (Arkansas: r=0.65, North Carolina: r=0.45, Oklahoma: r=0.52) and Spearman correlation coefficients (Arkansas: ρ=0.57, North Carolina: ρ=0.28, and Oklahoma: ρ=0.66). Based on Pearson correlations, the optimal surplus P aggregation periods were 10, 30, and 4 years for AR, NC, and OK, respectively. On average, STP was more strongly correlated with surplus P than with individual P inventory components (fertilizer, manure, and crop removal), except in North Carolina. In Arkansas and North Carolina, manure P was positively correlated with STP, and fertilizer P was negatively correlated with STP. Altogether, results suggest that surplus P moderately correlates with STP concentrations, but aggregation period and location-specific factors influence the strength of the relationship.

Communication Disparities and Trusted Sources of COVID-19 Information in Massachusetts School Districts.

The COVID-19 pandemic led to the closure of prekindergarten to grade 12 schools and an inequitable return to full-time in-person learning. To explore how ethnic and racial differences across school districts in Massachusetts correlate with parents' attitudes, beliefs, and trusted sources of information about COVID-19 and mitigation strategies. An electronic survey was distributed by school administrators to parents and guardians in November and December 2021 using existing school district contact lists and established methods of communication (email in 2 school districts; email and text message in 1 district). Three school districts in Massachusetts (Chelsea, Medford, and Somerville). Parents of prekindergarten to grade 12 school students attending public schools. Parental attitudes and beliefs regarding mitigation strategies for COVID-19 (surveillance testing, masking, and vaccination); trusted information sources about COVID-19; preferred methods of communication from schools. A total of 1496 survey responses were analyzed. Chelsea respondents were predominantly Hispanic/LatinX (88%); Medford and Somerville were predominantly White/non-Hispanic (80% and 68%, respectively). Testing, masks, and vaccination were supported by >80% of parents/guardians across districts. However, there were statistically significant differences between school districts regarding participation in testing programs, implications of a child testing positive, vaccination of young children, communication preferences, and trusted sources of information. Although primarily focused on COVID-19, these results highlight opportunities for public health personnel and school administrators to work directly with parents and guardians in their school districts to improve communication strategies and be a trusted source of information for a variety of public health issues.

Associations between socioeconomic factors and PSA testing in a population-based organised testing programme and routine healthcare: a register-based study of 50-year-old men

ObjectivePopulation-based, organised prostate cancer testing (OPT) programmes were started in Sweden in 2020. The influence of socioeconomic factors on prostate cancer testing in this setting is not known. We examined...

Cannabinoid Therapy in Athletics: A Review of Current Cannabis Research to Evaluate Potential Real-World Cannabinoid Applications in Sport.

The increasing legalization of Cannabis sativa plant products has sparked growing interest in their therapeutic applications. Prohibition laws established in 1937 hindered formal research on cannabis, a plant with cultural and medicinal roots dating back to 2700 BC in Chinese history. Despite regulatory hurdles, published research on cannabis has emerged; yet elite athletes remain an underrepresented population in these studies. Athletes, known for exploring diverse substances to optimize performance, are drawn to the potential benefits of cannabinoid therapy, with anecdotal reports suggesting positive effects on issues ranging from anxiety to brain injuries. This review aims to evaluate empirical published cannabis research with a specific focus on its potential applications in athletics. The changing legal landscape, especially the removal of cannabis from drug testing programs in leagues such as the National Basketball Association (NBA), and endorsements by Major League Baseball (MLB) for cannabinoid products and the National Football League (NFL) for cannabis research, reflects a shift in the acceptability of such substances in sports. However, stigma, confusion, and a lack of education persist, hindering a cohesive understanding among sports organizations, including business professionals, policymakers, coaches, and medical/training staff, in addition to athletes themselves. Adding to the confusion is the lack of consistency with cannabinoid regulations from sport to sport, within or out of competition, and with cannabis bioactive compounds. The need for this review is underscored by the evolving attitudes toward cannabinoids in professional sports and the potential therapeutic benefits or harms they may offer. By synthesizing current cannabis research, this review aims to provide a comprehensive understanding of the applications and implications of cannabinoid use in the realm of athletics.

Investigations into the Concentrations and Metabolite Profiles of Doping Agents and Antidepressants in Human Seminal Fluid Using Liquid Chromatography-Mass Spectrometry.

Exogenous substances, including drugs and chemicals, can transfer into human seminal fluid and influence male fertility and reproduction. In addition, substances relevant in the context of sports drug testing programs, can be transferred into the urine of a female athlete (after unprotected sexual intercourse) and trigger a so-called adverse analytical finding. Here, the question arises as to whether it is possible to distinguish analytically between intentional doping offenses and unintentional contamination of urine by seminal fluid. To this end, 480 seminal fluids from nonathletes were analyzed to identify concentration ranges and metabolite profiles of therapeutic drugs that are also classified as doping agents. Therefore, a screening procedure was developed using liquid chromatography connected to a triple quadrupole mass spectrometer, and suspect samples (i.e., samples indicating the presence of relevant compounds) were further subjected to liquid chromatography-high-resolution accurate mass (tandem) mass spectrometry. The screening method yielded 90 findings (including aromatase inhibitors, selective estrogen receptor modulators, diuretics, stimulants, glucocorticoids, beta-blockers, antidepressants, and the nonapproved proliferator-activated receptor delta agonist GW1516) in a total of 81 samples, with 91% of these suspected cases being verified by the confirmation method. In addition to the intact drug, phase-I and -II metabolites were also occasionally observed in the seminal fluid. This study demonstrated that various drugs including those categorized as doping agents partition into seminal fluid. Monitoring substances and metabolites may contribute to a better understanding of the distribution and metabolism of exogenous substances in seminal fluid that may be responsible for the impairment of male fertility. SIGNIFICANCE STATEMENT: This study demonstrates that doping agents as well as clinically relevant substances are transferred/eliminated into seminal fluid to a substantial extent and that knowledge about drug levels (and potential consequences for the male fertility and female exposure) is limited. The herein generated new dataset provides new insights into an important and yet little explored area of drug deposition and elimination, and hereby a basis for the assessment of contamination cases by seminal fluid in sports drug testing.

Patient perspective on the elimination mother-to-child transmission of HIV, syphilis, and hepatitis B in Bali, Indonesia: a qualitative study

BackgroundThis study aimed to explore the facilitators and barriers to the elimination of human immunodeficiency virus (HIV), syphilis, and hepatitis B transmission based on the perspectives of mothers living with HIV, syphilis, and hepatitis B.MethodsThis study employed a descriptive, qualitative design. Semi-structured interviews were conducted with mothers living with HIV, syphilis, and/or hepatitis B virus. A total of 25 participants were included in the study. This study used a triangulation method conducted by members to enhance the validity and dependability of the findings. The study was conducted at referral hospitals and community health centers between September 2022 and February 2023. Data analysis utilized deductive content analysis and categorized themes based on a socio-ecological framework.ResultsThe findings revealed facilitators and barriers across five levels of the socio-ecological framework and 21 subcategories. The findings included the following: (1) At the policy level, facilitators were mandatory testing programs, and barriers were separating testing services from antenatal care facilities. (2) At the community level, facilitators included the involvement of non-governmental organizations (NGOs) and cross-sector support. Barriers included challenges faced by non-residents and fear of stigma and discrimination. (3) At the healthcare system level, facilitators included tracking and follow-up by midwives, positive relationships with healthcare providers, and satisfaction with healthcare services. Barriers included prolonged waiting times, insufficient information from healthcare providers, and administrative limitations. (4) At the interpersonal level, facilitators included partner and family support, open communication, and absence of stigma. Barriers included the reluctance of sexual partners to undergo screening. (5) At the individual level, facilitators included the desire for a healthy baby, adequate knowledge, self-acceptance, and commitment to a healthy lifestyle; barriers included the lack of administrative discipline.ConclusionMothers living with HIV, syphilis, or hepatitis B require tailored healthcare approaches. Healthcare professionals must understand and meet the needs of mothers within a comprehensive care continuum. The findings of this study advocate for the development and implementation of integrated care models that are responsive to the specific challenges and preferences of affected mothers, aiming to improve health outcomes for both mothers and their children.

Utilization of Machine Learning Algorithms for the Strengthening of HIV Testing: A Systematic Review

Several machine learning (ML) techniques have demonstrated efficacy in precisely forecasting HIV risk and identifying the most eligible individuals for HIV testing in various countries. Nevertheless, there is a data gap on the utility of ML algorithms in strengthening HIV testing worldwide. This systematic review aimed to evaluate how effectively ML algorithms can enhance the efficiency and accuracy of HIV testing interventions and to identify key outcomes, successes, gaps, opportunities, and limitations in their implementation. This review was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A comprehensive literature search was conducted via PubMed, Google Scholar, Web of Science, Science Direct, Scopus, and Gale OneFile databases. Out of the 845 identified articles, 51 studies were eligible. More than 75% of the articles included in this review were conducted in the Americas and various parts of Sub-Saharan Africa, and a few were from Europe, Asia, and Australia. The most common algorithms applied were logistic regression, deep learning, support vector machine, random forest, extreme gradient booster, decision tree, and the least absolute shrinkage selection operator model. The findings demonstrate that ML techniques exhibit higher accuracy in predicting HIV risk/testing compared to traditional approaches. Machine learning models enhance early prediction of HIV transmission, facilitate viable testing strategies to improve the efficiency of testing services, and optimize resource allocation, ultimately leading to improved HIV testing. This review points to the positive impact of ML in enhancing early prediction of HIV spread, optimizing HIV testing approaches, improving efficiency, and eventually enhancing the accuracy of HIV diagnosis. We strongly recommend the integration of ML into HIV testing programs for efficient and accurate HIV testing.

Prevalence and predictors of HIV testing among young men in Papua New Guinea: A cross-sectional analysis of a nationally representative sample.

HIV testing is an important component of HIV prevention and serves as a gateway to other HIV-related services. However, the uptake remains suboptimal among young people, particularly in highly prevalent settings such as Papua New Guinea (PNG). This study aimed to assess the prevalence and determine the predictors of HIV testing uptake among young men aged 15-24 years in PNG. The 2016-2018 PNG Demographic and Health Survey (DHS) data was used. A total of 1,275 young men aged 15-24 years were included in the final analysis. Descriptive, bivariate, and multivariable logistic regression analyses were performed to determine independent predictors of HIV testing. Adjusted odds ratios (AORs) with 95% confidence intervals (CIs) were reported. All analyses were adjusted using survey weights to account for unequal sampling probabilities. The overall prevalence of HIV testing among young men was 17.1% (95% CI: 15-19). Of those who were tested for HIV, about one-third (32.9%) had experienced a sexual debut at age <15 years, and 33.9% inconsistently used condoms during sex. In multivariable analysis, men aged 20-24 years (AOR 1.18, 95% CI: 1.00-2.31), who owned mobile phones (AOR 1.43, 95% CI: 1.00-2.55), who were aware that consistent condom use during sex can reduce HIV risk (AOR 2.18, 95% CI: 1.18-4.04), who had paid for sex (AOR 1.75, 95% CI: 1.01-5.83), and who had two or more sexual partners (AOR 1.37, 95% CI: 1.01-3.14) had increased odds of HIV testing. However, decreased odds of HIV testing were found among men who were never married (AOR 0.51, 95% CI: 0.29-0.88), lived in rural areas (AOR 0.54, 95% CI: 0.32-0.92), and consistently used condoms during sex (AOR 0.59, 95% CI: 0.34-1.01). The findings show that HIV testing is low among young men in PNG. To increase HIV testing uptake among young men, it is crucial to implement comprehensive youth-friendly HIV/STI education and tailored sensitization programs and enable more accessible and affordable HIV testing services. Also, outreach and community-based testing programs for young men in rural and prioritized areas requiring urgent prevention interventions are feasible options in PNG.

Evaluation of an Italian Population-Based Programme for Risk Assessment and Genetic Counselling and Testing for BRCA1/2-Related Hereditary Breast and Ovarian Cancer after 10 Years of Operation: An Observational Study Protocol.

Hereditary breast/ovarian cancer (HBOC) syndrome is caused by the inheritance of monoallelic germline BRCA1/2 gene mutations. If BRCA1/2 mutation carriers are identified before the disease develops, effective actions against HBOC can be taken, including intensive screening, risk-reducing mastectomy and salpingo-oophorectomy, and risk-reducing medications. The Italian National Prevention Plan mandates the creation of regional BRCA genetic testing programmes. So far, however, only informal data have been reported on their implementation. We have designed a study aimed at evaluating the results of a population-based programme for risk assessment and genetic counselling and testing for BRCA1/2-related HBOC that is underway in the Emilia-Romagna region (northern Italy). The programme-which is entirely free-includes basic screening with an estimate of the likelihood of carrying a BRCA1/2 mutation using a familial risk assessment tool, a closer examination of women with suspected risk increase, an assessment of the need for further genetic counselling and, if needed, genetic testing and risk-reducing interventions. In this paper, the design of the programme and the protocol of the study are presented. The study has an observational, historical cohort design. Eligible are the women found to be at an increased risk of HBOC (profile 3 women). The main objectives are (i) to determine the precision of the programme in measuring the level of risk of HBOC for profile 3 women; (ii) to determine the characteristics of profile 3 women and their association with the risk management strategy chosen; (iii) to compare the age at onset, histologic type, tumour stage, molecular subtype, and prognosis of breast/ovarian cancers observed in the cohort of profile 3 women with the features of sporadic cancers observed in the general female population; (iv) to determine the level and the determinants of adherence to recommendations; and (v) to determine the appropriateness and timing of risk-reducing surgery and medications. Investigating the quality and results of the programme is necessary because the best practices in risk assessment and genetic counselling and testing for BRCA1/2-related cancer and the challenges they encounter should be identified and shared. The study has the potential to provide sound empirical evidence for the factors affecting the effectiveness of this type of service.

Outcomes of a 1-Year Pilot Study Implementing Universal Hepatitis Delta Virus Testing Among Veterans With Chronic Hepatitis B.

Current US guidelines recommend risk-based testing for hepatitis delta virus (HDV) in persons with chronic hepatitis B (CHB). While there is debate as to whether a risk-based or universal testing approach is most effective, limited data exist on universal HDV testing programs in the United States. We performed a 1-year pilot study evaluating the outcomes of a universal HDV testing approach among US veterans with CHB. All consecutive adults with CHB receiving care at hepatology clinics at a single-centre Veterans Affairs Health System from 1 October 2022 to 30 September 2023 were prospectively tested for anti-HDV antibody (anti-HDV). Patients who were anti-HDV Ab-positive were subsequently tested for HDV RNA. Comparison of HDV testing between groups utilised chi-square testing. A total of 91 consecutive CHB patients (90.0% male, mean age 60.9 ± 14.1 years, 73.9% Asian, 26.1% non-Asia, 16.5% cirrhosis and 17.1% with active or past history of drug use) had anti-HDV ordered. Overall, 76.9% (n = 70) completed anti-HDV testing; 4.3% (n = 3) were positive. HDV RNA testing was ordered in all three patients; two patients completed HDV RNA testing and one had detectable HDV RNA. No significant differences in completion of anti-HDV testing was observed by age, sex, race/ethnicity, cirrhosis status or drug use history. Among a single-centre prospective cohort study piloting a universal HDV testing approach, one patient with viremic HDV was identified. Implementing true reflex testing of all CHB patients with anti-HDV, followed by automated HDV RNA testing for anti-HDV-positive patients would improve the HDV testing cascade and timely diagnosis of HDV.