Positive Ratio of Polymerase Chain Reaction (PCR) and Validity of Pre-Screening Criteria at an Outpatient Screening Center during the Early Phase of the COVID-19 Epidemic in Japan.

Despite the increase in COVID-19 cases globally, the number of cases in Japan has been relatively low, and an explosive surge in the prevalence has not occurred. In March 2020, the Ministry of Health, Labour and Welfare (MHLW) in Japan recommended the original criteria for polymerase chain reaction (PCR) testing, although there was a lack of evidence for appropriate targets for COVID-19 testing. This study aimed to evaluate the COVID-19 positive ratio and pre-screening criteria in Tokyo immediately after the insurance-covered SARS-CoV-2 PCR testing became available in Japan. We subjected 277 individuals with mild symptoms in metropolitan Tokyo (positive: 9.0%) from March 9 to 29, 2020, to SARS-CoV-2 PCR testing. The results revealed that 25 (9.0%) of them were PCR-positive. The sensitivity and specificity of the MHLW criteria were 100% and 10.7%, respectively. When the criteria excluded nonspecific symptoms, fatigue, and dyspnea, the sensitivity slightly decreased to 92%, and the specificity increased to 22.2%. The specificity was highest when the fever criterion was ≥37.5°C for ≥4 days, and exposure/travel history, including age and underlying comorbidities, was considered. Our findings suggest that the MHLW criteria, including the symptoms and exposure/travel history, may be useful for COVID-19 pre-screening.

Mass screening for neuroblastoma in infants.

Neuroblastoma (NB) is the only pediatric tumor that is screened for nationwide by detecting the urinary levels of homovanillic acid and/or vanillylmandelic acid; however, whether NB screening reduces the mortality rate has not been established. This review compared the incidence and mortality rates among data from international mass screening for NB, as well as an analysis of differences in age of screening, detection methods, and diagnostic biomarkers. A well-designed trial exploring possible benefits and hazards is warranted prior to resuming mass screening for NB.

Impact of the Centers for Disease Control and Prevention Recommendation and State Law on Birth Cohort Hepatitis C Screening of New York City Medicaid Recipients.

INTRODUCTION: The Centers for Disease Control and Prevention estimated that, during 1999-2008, people born in 1945-1965 (the baby boomer generation) represented approximately 75% of people infected with hepatitis C virus and 73% of hepatitis C virus-associated deaths and are at greatest risk for hepatocellular carcinoma and liver disease. In 2012, the Centers for Disease Control and Prevention recommended one-time hepatitis C virus screening for people born during 1945-1965. In addition, New York State enacted a Hepatitis C Virus Testing Law in 2014. This analysis assesses the impacts of the 2012 recommendation and 2014 New York State Testing Law on hepatitis C virus screening rates among New York City Medicaid-enrolled recipients born during 1945-1965. METHODS: The eligible population was determined quarterly as the number of Medicaid recipients continuously enrolled for 12 months with neither a prior hepatitis C virus diagnosis nor antibody test since 2005. Quarterly screening rates during 2010-2017 were examined using interrupted time series analysis. Data were analyzed in 2018-2019. RESULTS: In 2010-2017, the highest screening rate occurred in the quarter immediately after the law (33.64 per 1,000 Medicaid recipients). There was no change in screening rates after the Centers for Disease Control and Prevention recommendation and a significant increase after the New York State Law, which was not sustained. CONCLUSIONS: Hepatitis C virus screening rates increased in the quarter after the 2014 New York State Hepatitis C Virus Testing Law became effective. Additional efforts are needed to screen baby boomers and people who were recently infected with hepatitis C virus related to opioid use.

Characteristics of Students Identified With Dyslexia Within the Context of State Legislation.

All but seven U.S. states have laws that govern some aspects of dyslexia screening, intervention, or teacher training in public schools. However, in the three states that mandate child-level reporting, data indicate lower than expected rates of dyslexia identification when compared with commonly accepted dyslexia prevalence rates. To better understand this apparent mismatch, this study explores factors that might predict the school-assigned identification of individuals with dyslexia. Deidentified data on 7,947 second-grade students in 126 schools from one U.S. state included a universal screening measure of literacy skills indicative of dyslexia (i.e., reading and spelling), school-assigned dyslexia classification, and demographic characteristics. As expected, behavioral characteristics of dyslexia from universal screening were associated with school-assigned dyslexia classification. However, dyslexia classification was less likely for minority students and individuals attending schools with a higher percentage of minority students. Students who showed behavioral characteristics of dyslexia and attended schools with a higher proportion of other students with similar poor literacy skills were more likely not to receive a school-assigned dyslexia classification. The findings suggest systematic demographic differences in whether a student is identified with dyslexia by schools even when using universal screening.

Electronic personal protective equipment: A strategy to protect emergency department providers in the age of COVID-19.

Emergent policy changes related to telemedicine and the Emergency Medical Treatment and Labor Act during the novel coronavirus disease 2019 (COVID-19) pandemic have created opportunities for technology-based clinical evaluation, which serves to conserve personal protective equipment (PPE) and protect emergency providers. We define electronic PPE as an approach using telemedicine tools to perform electronic medical screening exams while satisfying the Emergency Medical Treatment and Labor Act. We discuss the safety, legal, and technical factors necessary for implementing such a pathway. This approach has the potential to conserve PPE and protect providers while maintaining safe standards for medical screening exams in the emergency department for low-risk patients in whom COVID-19 is suspected.

Screening Breast Ultrasound: Update After 10 Years of Breast Density Notification Laws.

OBJECTIVE. Breast density notification laws have grown from the first state legislation in Connecticut in 2009 to a federally mandated update to the Mammography Quality Standards Act in 2019. CONCLUSION. The increasing recognition of limited mammographic sensitivity in women with dense breasts has led to greater utilization of supplemental screening ultrasound. Robust data support improved detection of small node-negative invasive breast cancers with adjunctive ultrasound. Digital breast tomosynthesis and other emerging modalities may also play a role in screening guidelines.

Policy Implications of Artificial Intelligence and Machine Learning in Diabetes Management.

PURPOSE OF REVIEW: Machine learning (ML) is increasingly being studied for the screening, diagnosis, and management of diabetes and its complications. Although various models of ML have been developed, most have not led to practical solutions for real-world problems. There has been a disconnect between ML developers, regulatory bodies, health services researchers, clinicians, and patients in their efforts. Our aim is to review the current status of ML in various aspects of diabetes care and identify key challenges that must be overcome to leverage ML to its full potential. RECENT FINDINGS: ML has led to impressive progress in development of automated insulin delivery systems and diabetic retinopathy screening tools. Compared with these, use of ML in other aspects of diabetes is still at an early stage. The Food & Drug Administration (FDA) is adopting some innovative models to help bring technologies to the market in an expeditious and safe manner. ML has great potential in managing diabetes and the future is in furthering the partnership of regulatory bodies with health service researchers, clinicians, developers, and patients to improve the outcomes of populations and individual patients with diabetes.

introduce nationwide pulse oximetry screening for the detection of critical congenital heart disease and other hypoxaemic conditions in the newborn.

The mortality risk for infants with critical congenital heart disease (CCHD) unrecognised at the time of birth is high. Pulse oximetry has been utilised as a screening tool for the detection of these anomalies in the newborn as the majority will have a degree of hypoxaemia. This screening strategy has a moderate sensitivity and excellent specificity for the detection of CCHD, and a low false-positive rate. Respiratory and infective diseases are responsible for a large number of positive test results. The early recognition of these diseases can also improve health outcomes. Different approaches have been taken to introduce screening, ranging from hospital-led initiatives to mandatory state-wide policies. A study conducted in New Zealand demonstrated that sector-led screening initiatives are unlikely to result in equitable outcomes. In this midwifery-led maternity setting a nationwide pulse oximetry screening programme with adequate human and material resources should be introduced.

Physician Ordering of Screening Ultrasound: National Rates and Association With State-Level Breast Density Reporting Laws.

PURPOSE: To describe factors associated with screening ultrasound ordering and determine whether adoption of state-level breast density reporting laws was associated with changes in ordering rates. MATERIALS AND METHODS: We performed a cohort study using National Ambulatory Medical Care Survey data for 2007 to 2015. We included preventive office visits for women aged 40 to 74 years without breast symptoms and signs or additional reasons requiring ultrasound ordering. Multivariate logistic regression was used to identify changes in ultrasound ordering rates pre- versus post-state-level density reporting laws, accounting for patient-, physician-, and practice-level characteristics. Analyses were weighted to account for the multistage probability sampling design of National Ambulatory Medical Care Survey. RESULTS: Our sample included 12,787 visits over the 9-year study period. Overall, 28.9% (3,370 of 12,787) of women underwent a breast examination and 22.1% (2,442 of 12,787) had a screening mammogram ordered. Only 3.3% (379 of 12,787) had screening ultrasound ordered. Screening ultrasounds were ordered more frequently for younger women (rate ratio [RR] 0.8 per 10-year increase in age, 95% confidence interval [CI]: 0.6-0.9, P = .003) and at urban practices (RR 2.3, 95% CI: 1.1-5.0, P = .028), and less frequently in practices with computer reminders for ordering screening tests (RR 0.6, 95% CI: 0.3-0.9, P = .024). In multivariate analyses, the rate of ultrasound ordering did not change after adoption of density notification laws (RR 0.7, 95% CI: 0.3-2.0, P = .57). CONCLUSION: The rate of screening ultrasound ordering remains low over time. There was no observed association between adoption of state-level density reporting laws and overall changes in ultrasound ordering.

Supplemental Breast Imaging Utilization After Breast Density Legislation in North Carolina.

PURPOSE: Breast density notification laws are increasingly common but little is known of how they affect supplemental screening use. The aim of this study was to investigate supplemental screening before and after density notification in North Carolina, where notification has been required since 2014. METHODS: Breast screening data from Carolina Mammography Registry participants aged 40 to 79 years with no personal histories of breast cancer or breast implants were evaluated. Supplemental screening was defined as a nondiagnostic digital breast tomosynthesis (DBT), whole-breast ultrasound, or breast MRI performed within 3 months of negative or benign results on screening mammography (2-D or DBT). Supplemental screening before (2012-2013) and after (2014-2016) the notification law was compared using logistic regression. RESULTS: During the study period, 78,967 women underwent 145,279 index screening mammographic examinations. Supplemental screening use was similar before and after the notification law, regardless of breast density (dense breasts: adjusted odds ratio [aOR], 1.01; 95% confidence interval [CI], 0.58-1.75; nondense breasts: aOR, 0.63; 95% CI, 0.38-1.04). Although there was no change in supplemental screening, new use of any screening DBT from 2014 to 2016 was greater for women with dense breasts (versus nondense breasts; aOR, 1.15; 95% CI, 1.08-1.23). CONCLUSIONS: Data suggest that supplemental screening use in North Carolina did not change after enactment of a breast density notification law, though the increase in new use of any screening DBT was greater for women with dense breasts. The short-term lack of change in supplemental screening should be considered as additional notification laws are developed.

Building RAFT: Trafficking Screening Tool Derivation and Validation Methods.

BACKGROUND: Labor and sex trafficking have long impacted the patients who seek care in emergency departments (ED) across the United States. Increasing social and legislative pressures have led to multiple calls for screening for trafficking in the clinical care setting, but adoption of unvalidated screening tools for trafficking recognition is unwise for individual patient care and population-level data. Development of a valid screening tool for a social malady that is largely "invisible" to most clinicians requires significant investments. Valid screening tool development is largely a poorly understood process in the antitrafficking field and among clinicians who would use the tools. METHODS: The authors describe the study design and procedures for reliable data collection and analysis in the development of RAFT (Rapid Appraisal for Trafficking). In a five-ED, randomized, prospective study, RAFT will be derived and validated as a labor and sex trafficking screening tool for use among adult ED patients. Using a novel method of ED patient-participant randomization, intensively trained data collectors use qualitative data to assess subjects for a lifetime experience of human trafficking. CONCLUSION: Study methodology transparency encourages investigative rigor and integrity and will allow other sites to reproduce and externally validate this study's findings.

Falling short: When testing is mandated and follow-up is not.

In 1999, the Texas Legislature mandated acanthosis nigricans (AN) screening in primary schools in designated regions of the state through the passage of House Bill 1860 to identify children at risk for diabetes by identifying the skin condition AN. AN is related to insulin resistance, and, thus, is associated with type 2 diabetes (diabetes mellitus type 2 [DMT2]), a growing concern among school-aged children. Since 1999, millions of children have been screened and hundreds of thousands have been screened positive. No data are available about the effectiveness of the program in identifying DMT2 among the school-aged population because no follow-up is mandated. The current practice is to send a letter to the parents of the child who screens positive, advising the parents to take the child to a health care provider for further assessment. Hence, children within the state may have diabetes or are developing diabetes but have yet to be diagnosed. In light of the presence of a law mandating AN screening, mandating a follow-up to identify those who have diabetes or are developing the condition of diabetes can provide early intervention and decrease costs of care. It is not known why the follow-up of those who screen positive was not included in the initial legislation. It may have been due to the cost of the necessary blood tests that are used to assess an individual for diabetes. Related to this is the reality that blood tests are invasive procedures, whereas screening for a skin disorder is not, thereby possibly explaining the omission of mandated follow-up from the legislation .

Supplemental screening in the dense breast: does molecular breast imaging have a role?

With the passage of a 2019 US federal law directing FDA to ensure that mammography facilities provide a summary to patients categorizing their breast density and explaining how it can influence mammography accuracy, providers will increasingly be called on to discuss the options for supplemental screening. Numerous studies have elucidated the extent of masking that occurs with mammography screening in dense breasts when mammography is compared with other supplemental screening modalities. Despite this evidence, there is currently no consensus among experts or imaging societies as to whether or with what supplemental screening should be performed, leaving providers to counsel patients regarding the balance of benefits and harms.

Managing women who decline HIV testing in pregnancy and their infants? A multidisciplinary team guideline.

OBJECTIVES: The management of women at high risk of HIV infection who repeatedly decline HIV testing in pregnancy is not covered in any national guideline. In Leeds, we had a case which prompted us to consider maternal rights plus our duty of care to the infant once born. METHODS: Leeds has an established HIV and Syphilis in Pregnancy Multidisciplinary Team (MDT). The main issues pertaining to a pregnant woman persistently declining HIV testing were discussed within the MDT: identification of pregnant women declining testing; universal testing versus testing by risk stratification of their infants; calculation of vertical transmission risk; definition of unacceptable risk; timing of the decision to request court authority to test the infant; advanced preparation of court authority request papers. RESULTS: It was decided that an HIV transmission risk > 1 in 1000 justified testing an infant at birth. The MDT decision to request court authority for infant HIV testing would be made at 32-34 weeks of gestation, allowing the court papers to be prepared in advance of delivery. The Leeds Obstetrics and Paediatric Guidelines were reviewed, amended and approved by the Trust Guideline Group, Risk Management team and legal team. These guidelines are outlined within the article. The Neonatal guideline also is accessible via this link: http://nww.lhp.leedsth.nhs.uk/common/guidelines/detail.aspx?ID=177 CONCLUSIONS: If a woman at high risk declines HIV testing in pregnancy, it remains possible to significantly reduce the risk of vertical transmission once the child is born, but the window of opportunity is small. Therefore, it is vital to have pathways already in place to address this prior to delivery.