Pruebas diagnósticas de tamizaje / Diagnostic screening tests

Introducción. Las pruebas diagnósticas de tamizaje son aquellas pruebas que son capaces de identificar un factor de riesgo o mutaciones genéticas que predicen el inicio ulterior de la enfermedad, así como también las pruebas que ponen de manifiesto alteraciones estructurales de la enfermedad antes que la enfermedad progrese y se vuelva sintomática. Métodos. Se hizo una revisión de la literatura para establecer los fundamentos teóricos científicos que sustentan a las pruebas de diagnóstico de tamizaje y las condiciones y requisitos que se deben cumplir para introducirlas en el ámbito clínico o como programas de salud pública. Resultados. Se estableció la diferencia conceptual entre la detección precoz y el diagnóstico temprano y la diferencia entre tamizaje de prevalencia y tamizaje de incidencia. Se dieron a conocer las indicaciones y criterios científicos para la realización de las pruebas de tamizaje. Se puntualizó la importancia de la duración del tiempo de adelanto en la eficacia de las pruebas diagnósticas de detección precoz. Se argumentaron las razones por las cuales era necesario la realización de experimentos clínicos aleatorizados para evaluar la eficacia de las pruebas diagnósticas de detección precoz en la prevención secundaria de la enfermedad. Conclusiones. Las pruebas diagnósticas de tamizaje hacen posible la introducción de intervenciones en el ámbito de la prevención primaria, como también en el escenario de la prevención secundaria de las enfermedades.

Introduction. Screening diagnostic tests are those tests that help to identify a risk factor or genetic mutations that predict the subsequent onset of the disease, as well as tests that reveal structural alterations of the disease before the disease progresses and becomes symptomatic. Methods. A literature review was performed to establish the scientific theoretical fundamentals that support diagnostic screening tests and the conditions and requirements that must be met to introduce them in the clinical setting or as public health programs. Results. The conceptual difference between early detection and early diagnosis and the difference between prevalence screening and incidence screening was established. Indications and scientific criteria for conducting screening tests were presented. The importance of the duration of the lead time in the efficacy of early detection diagnostic tests was pointed out. The reasons why it was necessary to carry out a randomized clinical experiment to evaluate the efficacy of early detection diagnostic tests for early diagnosis in the secondary prevention of the disease were confronted. Conclusions. Screening diagnostic tests make it possible to introduce interventions in the field of primary prevention, as well as in the setting of secondary prevention of diseases.

Modified multiple marker aneuploidy screening as a primary screening test for preeclampsia.

BACKGROUND: Abnormal levels of maternal biochemical markers used in multiple marker aneuploidy screening have been associated with adverse pregnancy outcomes. This study aims to assess if a combination of maternal characteristics and biochemical markers in the first and second trimesters can be used to screen for preeclampsia (PE). The secondary aim was to assess this combination in identifying pregnancies at risk for gestational hypertension and preterm birth. METHODS: This case-control study used information on maternal characteristics and residual blood samples from pregnant women who have undergone multiple marker aneuploidy screening. The median multiple of the median (MoM) of first and second trimester biochemical markers in cases (women with PE, gestational hypertension and preterm birth) and controls were compared. Biochemical markers included pregnancy-associated plasma protein A (PAPP-A), placental growth factor (PlGF), human chorionic gonadotropin (hCG), alpha feto-protein (AFP), unconjugated estriol (uE3) and Inhibin A. Logistic regression analysis was used to estimate screening performance using different marker combinations. Screening performance was defined as detection rate (DR) and false positive rate (FPR). Preterm and early-onset preeclampsia PE were defined as women with PE who delivered at < 37 and < 34 weeks of gestation, respectively. RESULTS: There were 147 pregnancies with PE (81 term, 49 preterm and 17 early-onset), 295 with gestational hypertension, and 166 preterm birth. Compared to controls, PE cases had significantly lower median MoM of PAPP-A (0.77 vs 1.10, p < 0.0001), PlGF (0.76 vs 1.01, p < 0.0001) and free-ß hCG (0.81 vs. 0.98, p < 0.001) in the first trimester along with PAPP-A (0.82 vs 0.99, p < 0.01) and PlGF (0.75 vs 1.02, p < 0.0001) in the second trimester. The lowest first trimester PAPP-A, PlGF and free ß-hCG were seen in those with preterm and early-onset PE. At a 20% FPR, 67% of preterm and 76% of early-onset PE cases can be predicted using a combination of maternal characteristics with PAPP-A and PlGF in the first trimester. The corresponding DR was 58% for gestational hypertension and 36% for preterm birth cases. CONCLUSIONS: Maternal characteristics with first trimester PAPP-A and PlGF measured for aneuploidy screening provided reasonable accuracy in identifying women at risk of developing early onset PE, allowing triage of high-risk women for further investigation and risk-reducing therapy. This combination was less accurate in predicting women who have gestational hypertension or preterm birth.

Identificação de alterações auditivas em crianças pré-escolares / Identification of hearing disorders in preschool children / Identificación de trastornos auditivos en niños en edad preescolar

Programas de saúde auditiva estão voltados predominantemente para crianças entre 0 e 3 anos de idade ou para os maiores de 7. As crianças entre estas duas faixas etárias não estão em nenhum destes programas, porém é neste grupo que mais ocorrem problemas de orelha média, e, é, neste grupo, possível detectar as perdas auditivas mínimas, leves ou unilaterais que não foram identificadas nos programas de triagem auditiva neonatal. Objetivo: Identificar alterações auditivas em crianças pré-escolares por meio de um programa de triagem auditiva. Método: Trata-se de estudo descritivo, transversal e observacional realizado em duas escolas municipais do município de Mauá. A amostra foi composta por crianças de cinco e seis anos de idade. O programa de triagem auditiva foi composto: a. otoscopia; b. timpanometria, e c. registro das emissões otoacústicas transiente (EOAT) e produto de distorção (EOAPD). Em vista da pandemia iniciada em março de 2020, não foi possível avaliar as crianças de três e quatro anos. Resultados: 28,44% (n= 31) de crianças falharam na otoscopia. Das 78 (71,55%) crianças que passaram na otoscopia, 30,8% falharam na timpanometria; 16,7% nas Emissões Otoacústicas Produto de Distorção (DPOAE) e 19,2% nas Emissões Otoacústicas por estímulo Transiente (TPOAE); 30,76% (n= 24) das crianças falharam em pelo menos um dos três procedimentos. Conclusão: foram identificadas 30,76% de crianças com risco de alteração auditiva que devem ser encaminhadas para avaliação médica e audiológica.

Hearing health programs are predominantly aimed at children between 0 and 3 years of age or those older than 7. Children between these two age groups are not in any of these programs, but it is in this group that the most middle ear problems occur, and, it is in this group, possible to detect minimal, mild, or unilateral hearing loss that was not identified in neonatal hearing screening programs. Objective: To identify hearing alterations in preschool children through a hearing screening program. Method: This is a descriptive, cross-sectional, and observational study conducted in two municipal schools in the municipality of Mauá. The sample consisted of children aged five and six years. The hearing screening program was composed of a. otoscopy; b. tympanometry and, c. recording of transient otoacoustic emissions (TOAE) and distortion product (DPOAE). In view of the pandemic that began in March 2020, it was not possible to evaluate the three and four-year-old children. Results: 28.44% (n= 31) of the children failed otoscopy. Of the 78 (71.55%) children who underwent otoscopy, 30.8% failed tympanometry: 16.7% in Distortion Product Otoacoustic Emissions (DPOAE) and 19.2% in Transient Stimulus Otoacoustic Emissions (TPOAE); 30.76% (n= 24) of the children failed at least one of the three procedures. Conclusion: 30.76% of children at risk of hearing impairment were identified and should be referred for medical and audiological evaluation.

Los programas de salud auditiva están dirigidos principalmente a niños entre 0 y 3 años o mayores de 7 años. Los niños entre estos dos grupos de edad no están en ninguno de estos programas, pero es en este grupo que ocurren la mayoría de los problemas del oído medio, y, es en este grupo, posible detectar la pérdida de audición mínima, leve o unilateral que no se identificó en los programas de cribado auditivo neonatal. Objetivo: Identificar las alteraciones auditivas en niños en edad preescolar a través de un programa de detección auditiva. Método: Se trata de un estudio descriptivo, transversal y observacional realizado en dos colegios municipales del municipio de Mauá. La muestra estuvo constituida por niños de cinco y seis años y sus padres/tutores. El programa de detección de audición estuvo compuesto por: a. Cuestionario para padres/tutores sobre la historia de la salud auditiva de los niños; b. otoscopia; c. timpanometria y, d. Registro de emisiones otoacústicas transitorias (EOT) y producto de distorsión (DPOAE). Ante la pandemia que comenzó en marzo de 2020, no fue posible realizar los reexámenes ni evaluar a los niños de tres y cuatro años. Resultados: 28,44% (n= 31) de los niños no pasaron la otoscopia. De los 78 (71,55%) niños que se sometieron a otoscopia, 30,8% fallaron la timpanometria; 16,7% en emisiones otoacústicas de productos de distorsión (DPOAE) y 19,2% en emisiones otoacústicas de estímulo transitorio (TPOAE); 30,76% (n= 24) de los niños fallaron por lo menos uno de los tres procedimientos. Conclusión: 30,76% de los niños con riesgo de deficiencia auditiva fueron identificados y deben ser referidos para evaluación médica y audiológica.

Detection of SARS-CoV-2 infection prevalence in 860 cancer patients with a combined screening procedure including triage, molecular nasopharyngeal swabs and rapid serological test. A report from the first epidemic wave.

INTRODUCTION: Even if now we have available the weapon of vaccination against SARS-CoV-2, the patients with cancer remains a very frail population in which frequently the immunologic response to vaccination may be impaired. In this setting, the SARS-CoV-2 infection screening retains a great value. However, there are still limited data on the feasibility and efficacy of combined screening procedures to assess the prevalence of SARS-CoV-2 infection (including asymptomatic cases) in cancer outpatients undergoing antineoplastic therapy. PATIENTS AND RESULTS: From May 1, 2020, to June 15, 2020, during the first wave of SARS-CoV-2 pandemic, 860 consecutive patients, undergoing active anticancer therapy, were evaluated and tested for SARS-CoV-2 with a combined screening procedure, including a self-report questionnaire, a molecular nasopharyngeal swab (NPS) and a rapid serological immunoassay (for anti-SARS-CoV-2 IgG/IgM antibodies). The primary endpoint of the study was to estimate the prevalence of SARS-CoV-2 infection (including asymptomatic cases) in consecutive and unselected cancer outpatients by a combined screening modality. A total of 2955 SARS-CoV-2 NPS and 860 serological tests, in 475 patients with hematologic cancers and in 386 with solid tumors, were performed. A total of 112 (13%) patients self-reported symptoms potentially COVID-19 related. In 1/860 cases (< 1%) SARS-CoV-2 NPS was positive and in 14 cases (1.62%) the specific serological test was positive (overall prevalence of SARS-CoV-2 infection 1.62%). Of the 112 cases who declared symptoms potentially COVID-19-related, only 2.7% (3/112) were found SARS-CoV-2 positive. CONCLUSIONS: This is the largest study reporting the feasibility of a combined screening procedure (including triage, NPS and serologic test) to evaluate the prevalence of SARS-CoV-2 infection in cancer patients receiving active therapy, during the first epidemic wave and under the restrictive lockdown measures, in one of the active areas of the SARS-CoV-2 circulation. Lacking specific recommendations for the detection of asymptomatic SARS-CoV-2 cases, a combined diagnostic screening might be more effective to detect the exact prevalence of SARS-CoV-2 in neoplastic patient population. The prevalence can obviously change according to the territorial context, the entity of the restrictive measures adopted and the phase of the epidemic curve. However, its exact and real-time knowledge could be important to balance risks/benefits of oncologic treatments, avoiding (if the prevalence is low) the reduction of dose intensity or the selection of less intensive (but also less effective) anti-cancer therapies.

Implementation of a COVID-19 Screening Testing Program in a Rural, Tribal Nation: Experience of the San Carlos Apache Tribe, January-February 2021.

The COVID-19 pandemic has disproportionately affected tribal populations, including the San Carlos Apache Tribe. Universal screening testing in a community using rapid antigen tests could allow for near-real-time identification of COVID-19 cases and result in reduced SARS-CoV-2 transmission. Published experiences of such testing strategies in tribal communities are lacking. Accordingly, tribal partners, with support from the Centers for Disease Control and Prevention, implemented a serial testing program using the Abbott BinaxNOW rapid antigen test in 2 tribal casinos and 1 detention center on the San Carlos Apache Indian Reservation for a 4-week pilot period from January to February 2021. Staff members at each setting, and incarcerated adults at the detention center, were tested every 3 or 4 days with BinaxNOW. During the 4-week period, 3834 tests were performed among 716 participants at the sites. Lessons learned from implementing this program included demonstrating (1) the plausibility of screening testing programs in casino and prison settings, (2) the utility of training non-laboratory personnel in rapid testing protocols that allow task shifting and reduce the workload on public health employees and laboratory staff, (3) the importance of building and strengthening partnerships with representatives from the community and public and private sectors, and (4) the need to implement systems that ensure confidentiality of test results and promote compliance among participants. Our experience and the lessons learned demonstrate that a serial rapid antigen testing strategy may be useful in work settings during the COVID-19 pandemic as schools and businesses are open for service.

Clinical and laboratory characteristics in outpatient diagnosis of COVID-19 in healthcare professionals in Rio de Janeiro, Brazil.

AIMS: This study aimed to identify the symptoms associated with early stage SARS-CoV-2 (COVID-19) infections in healthcare professionals (HCPs) using both clinical and laboratory data. METHODS: A total of 1297 patients, admitted between 18 March and 8 April 2020, were stratified according to their risk of developing COVID-19 using their responses to a questionnaire designed to evaluate symptoms and risk conditions. RESULTS: Anosmia/hyposmia (p<0.0001), fever (p<0.0001), body pain (p<0.0001) and chills (p=0.001) were all independent predictors for COVID-19, with a 72% estimated probability for detecting COVID-19 in nasopharyngeal swab samples. Leucopenia, relative monocytosis, decreased eosinophil values, C reactive protein (CRP) and platelets were also shown to be significant independent predictors for COVID-19. CONCLUSIONS: The significant clinical features for COVID-19 were identified as anosmia, fever, chills and body pain. Elevated CRP, leucocytes under 5400×109/L and relative monocytosis (>9%) were common among patients with a confirmed COVID-19 diagnosis. These variables may help, in the absence of reverse transcriptase PCR tests, to identify possible COVID-19 infections during pandemic outbreaks. SUMMARY: From 19 March to 8 April 2020, 1297 patients attended the Polyclinic Piquet Carneiro for COVID-19 detection. HCP data were analysed, and significant clinical features were anosmia, fever, chills and body pain. Elevated CRP, leucopenia and monocytosis were common in COVID-19.

Overview of screening eligibility in patients undergoing ruptured AAA repair from 2003 to 2019 in the Vascular Quality Initiative.

OBJECTIVE: Although efforts such as the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act have improved access to abdominal aortic aneurysm (AAA) screening, certain high-risk populations are currently excluded from the guidelines yet may benefit from screening. We therefore examined all patients who underwent repair of ruptured AAA (rAAA) to characterize those who are ineligible for screening under current guidelines and evaluate the potential impact of these restrictions on their disease. METHODS: We identified patients undergoing rAAA repair in the Vascular Quality Initiative (VQI) database between 2003 and 2019. These patients were stratified by AAA screening eligibility according to the Centers for Medicare and Medicaid reimbursement guidelines. We then described baseline characteristics to identify high-risk features of these cohorts. Groups with disproportionate representation in the screening-ineligible cohort were identified as potential targets of screening expansion. Trends over time in screening eligibility and the proportion of AAA repairs performed for rAAA were also analyzed. RESULTS: A total of 5340 patients underwent rAAA repair. The majority (66%) were screening-ineligible. When characterizing the screening-ineligible group by sex and risk factors (smoking history or family history of AAA), the largest contributors to screening ineligibility were males less than 65 years of age with a smoking history or family history of AAA (25%), males greater than 75 years of age with a smoking history (25%), and females older than 65 years of age with a smoking history (19%). In comparison with rAAAs prior to implementation of the SAAAVE act, the proportion of AAA repair performed for rupture among males undergoing AAA repair in the VQI decreased from 12% to 8% (P < .001), whereas in females, there was no change (P = .990). There was no statically significant difference in screening eligibility for either males (P = .762) or females (P = .335). CONCLUSIONS: Most patients who underwent rAAA repair were ineligible for initial AAA screening or aged out of the screening window. Furthermore, rAAA rates and screening ineligibility have not improved as much as expected since the passage of the SAAAVE Act. Our data suggest that three high-risk populations may benefit from expansion of AAA screening guidelines: males with a smoking history or family history of AAA between ages 55 and 64 years, female smokers older than 65 years, and male smokers older than 75 years who are otherwise in good health. Increased efforts to screen these high-risk populations may increase elective AAA repair and minimize the morbidity and mortality associated with rAAAs.

Retinografia como forma de rastreio de retinopatia diabética em hospital terciário do Sistema Único de Saúde / Color retinography as a means of screening for diabetic retinopathy in the tertiary hospital of Unified Health System

RESUMO Objetivo Avaliar o impacto da triagem de retinopatia diabética de paciente diabéticos realizada com retinografia colorida. Métodos Estudo retrospectivo, de caráter descritivo, avaliando laudos de retinografias realizadas desde a implementação do protocolo da triagem de retinopatia diabética de paciente diabéticos acompanhados no Ambulatório de Endocrinologia de um hospital terciário do Sistema Único de Saúde, de maio de 2018 até maio de 2020. Resultados Realizaram retinografia 727 pacientes diabéticos, que tinham entre 14 e 91 anos, sendo a maioria com 60 anos ou mais (53,2%), do sexo feminino (68%) e brancos (87,6%). Não apresentavam retinopatia diabética 467 (64,2%) pacientes, 125 (17,2%) tinham retinopatia diabética não proliferativa, 37 (5,1%) retinopatia diabética não proliferativa grave e/ou suspeita de edema macular, 65 (8,9%) retinopatia diabética proliferativa, 21 (2,9%) suspeita de outras patologias, e as imagens de 12 (1,7%) pacientes eram insatisfatórias. Foram considerados de alto risco (aqueles com retinopatia diabética não proliferativa grave e/ou edema macular, retinopatia diabética proliferativa ou imagem insatisfatória) 114 (15,68%) pacientes. Conclusão O rastreio de retinopatia diabética com retinografia colorida possibilitou a detecção de pacientes diabéticos de alto risco que necessitavam atendimento com brevidade, permitindo o acesso deles à consulta oftalmológica e diminuindo a morbidade da doença relacionada ao tratamento tardio. Os demais foram encaminhados à Atenção Primária para regulamentação, por meio do Sistema de Regulação.

ABSTRACT Objective To evaluate the impact of diabetic retinopathy (DR) screening using color retinography in diabetic patients. Methods Retrospective descriptive study, evaluating reports of all retinographs performed since the implementation of the protocol for screening for diabetic retinopathy in diabetic patients followed up at the endocrinology outpatient clinic of a tertiary hospital of the Unified Health System, from May 2018 to May 2020. Results 727 diabetic with age range from 14 to 91 years old, the majority being 60 years old or older (53.2%), female (68%) and white (87.6%), patients underwent retinography. Of the patients, 467 (64.2%) did not have DR, 125 (17.2%) had non-proliferative DR, 37 (5.1%) had severe non-proliferative DR and/or suspected macular edema, 65 (8.9%) had proliferative DR, 21 (2.9%) had suspicion signs of other pathologies and 12 (1.7%) had unsatisfactory images. A total of 114 (15.68%) patients were considered at high risk (those with severe non-proliferative NP and/or EM, proliferative DR or poor image) and were referred for comprehensive ophthalmic evaluation. Conclusion The screening of RD with color retinography enabled the detection of high-risk diabetic patients who needed assistance sooner and enabled their access to ophthalmologic consultation, which decreased disease morbidity. The others were referred to primary care for regulation through the Regulation System (SISREG).

A method for campus-wide SARS-CoV-2 surveillance at a large public university.

The systematic screening of asymptomatic and pre-symptomatic individuals is a powerful tool for controlling community transmission of infectious disease on college campuses. Faced with a paucity of testing in the beginning of the COVID-19 pandemic, many universities developed molecular diagnostic laboratories focused on SARS-CoV-2 diagnostic testing on campus and in their broader communities. We established the UC Santa Cruz Molecular Diagnostic Lab in early April 2020 and began testing clinical samples just five weeks later. Using a clinically-validated laboratory developed test (LDT) that avoided supply chain constraints, an automated sample pooling and processing workflow, and a custom laboratory information management system (LIMS), we expanded testing from a handful of clinical samples per day to thousands per day with the testing capacity to screen our entire campus population twice per week. In this report we describe the technical, logistical, and regulatory processes that enabled our pop-up lab to scale testing and reporting capacity to thousands of tests per day.

Economic evaluation of population-based type 2 diabetes mellitus screening at different healthcare settings in Vietnam.

INTRODUCTION: Few economic evaluations have assessed the cost-effectiveness of screening type-2 diabetes mellitus (T2DM) in different healthcare settings. This study aims to evaluate the value for money of various T2DM screening strategies in Vietnam. METHODS: A decision analytical model was constructed to compare costs and quality-adjusted life years (QALYs) of T2DM screening in different health care settings, including (1) screening at commune health station (CHS) and (2) screening at district health center (DHC), with no screening as the current practice. We further explored the costs and QALYs of different initial screening ages and different screening intervals. Cost and utility data were obtained by primary data collection in Vietnam. Incremental cost-effectiveness ratios were calculated from societal and payer perspectives, while uncertainty analysis was performed to explore parameter uncertainties. RESULTS: Annual T2DM screening at either CHS or DHC was cost-effective in Vietnam, from both societal and payer perspectives. Annual screening at CHS was found as the best screening strategy in terms of value for money. From a societal perspective, annual screening at CHS from initial age of 40 years was associated with 0.40 QALYs gained while saving US$ 186.21. Meanwhile, one-off screening was not cost-effective when screening for people younger than 35 years old at both CHS and DHC. CONCLUSIONS: T2DM screening should be included in the Vietnamese health benefits package, and annual screening at either CHS or DHC is recommended.

Diagnostic Yield of Population-Based Screening for Chronic Kidney Disease in Low-Income, Middle-Income, and High-Income Countries.

Importance: Population-based screening for chronic kidney disease (CKD) is sometimes recommended based on the assumption that detecting CKD is associated with beneficial changes in treatment. However, the treatment of CKD is often similar to the treatment of hypertension or diabetes, which commonly coexist with CKD. Objective: To determine the frequency with which population-based screening for CKD is associated with a change in recommended treatment compared with a strategy of measuring blood pressure and assessing glycemia. Design, Setting, and Participants: This cohort study was conducted using data obtained from studies that evaluated CKD in population-based samples from China (2007-2010), India (2010-2014), Mexico (2007-2008), Senegal (2012), and the United States (2009-2014), including a total of 126 242 adults screened for CKD. Data were analyzed from January 2020 to March 2021. Main Outcomes and Measures: The primary definition of CKD was estimated glomerular filtration rate less than 60 mL/min/1.73 m2. For individuals with CKD, the need for a treatment change was defined as not taking an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker or having blood pressure levels of 140/90 mm Hg or greater. For individuals with CKD who also had diabetes, the need for a treatment change was also defined as having hemoglobin A1c levels of 8% or greater or fasting glucose levels of 178.4 mg/dL (9.9 mmol/L) or greater. Case finding was defined as testing for CKD only in adults with hypertension or diabetes. Results: Among 126 242 adults screened for CKD, there were 47 204 patients in the China cohort, 9817 patients in the India cohort, 51 137 patients in the Mexico cohort, 2441 patients in the Senegal cohort, and 15 643 patients in the US cohort. The mean age of participants was 49.6 years (95% CI, 49.5-49.7 years) in the China cohort, 42.9 years (95% CI, 42.6-43.2 years) in the India cohort, 51.6 years (95% CI, 51.5-51.7 years) in the Mexico cohort, 48.2 years (95% CI, 47.5-48.9 years) in the Senegal cohort, and 47.3 years (95% CI, 46.6-48.0 years) in the US cohort. The proportion of women was 57.3% (95% CI, 56.9%-57.7%) in the China cohort, 53.4% (95% CI, 52.4%-54.4%) in the India cohort, 68.8% (95% CI, 68.4%-69.2%) in the Mexico cohort, 56.0% (95% CI, 54.0%-58.0%) in the Senegal cohort, and 51.9% (51.0%-52.7%) in the US cohort. The prevalence of CKD was 2.5% (95% CI, 2.4%-2.7%) in the China cohort, 2.3% (95% CI, 2.0%-2.6%) in the India cohort, 10.6% (95% CI, 10.3%-10.9%) in the Mexico cohort, 13.1% (95% CI, 11.7%-14.4%) in the Senegal cohort, and 6.8% (95% CI, 6.2%-7.5%) in the US cohort. Screening for CKD was associated with the identification of additional adults whose treatment would change (beyond those identified by measuring blood pressure and glycemia) per 1000 adults: China: 8 adults (95% CI, 8-9 adults); India: 5 adults (95% CI, 4-7 adults); Mexico: 26 adults (95% CI, 24-27 adults); Senegal: 59 adults (95% CI, 50-69 adults); and the US: 19 adults (95% CI, 16-23 adults). Case finding was associated with the identification of 46.2% (95% CI, 45.1%-47.4%) to 86.4% (95% CI, 85.4%-87.3%) of individuals with CKD depending on the country, an increase in the proportion of individuals requiring a treatment change by as much 89.6% (95% CI, 80.4%-99.3%) in the US, and a decrease in the proportion of individuals needing GFR measurements by as much as 57.8% (95% CI, 56.3%-59.3%) in the US. Conclusions and Relevance: This study found that most additional individuals with CKD identified by population-based screening programs did not need a change in treatment compared with a strategy of measuring blood pressure and assessing glycemia and that case finding was more efficient than screening for early detection of CKD.

Women's attitudes, beliefs and values about tests, and management for hypertensive disorders of pregnancy.

BACKGROUND: Advances in research suggest the possibility of improving routine clinical care for preeclampsia using screening (predictive) and diagnostic tests. The views of women should be incorporated into the way in which such tests are used. Therefore, we explored the views of women with experience of preeclampsia and other hypertensive disorders in pregnancy (HDPs) about predictive and diagnostic tests, treatment risks, and expectant management. METHOD: Eight hundred and seven women with experience of preeclampsia or other HDPs completed an online questionnaire. These women were participants in the Preeclampsia Registry (USA). The questionnaire contained 22 items to elicit women's views about predictive tests (n = 8); diagnostic tests (n = 5); treatment risks (n = 7), and expectant management (n = 2). An optional text box allowed participants to add qualitative open-ended comments. Levels of agreement with the statements were reported descriptively for the sample as a whole, and a preliminary investigation of the role of lived experience in shaping women's views was conducted by comparing subgroups within the sample based on time of HDP delivery (preterm/term). The qualitative data provided in the optional text box was analysed using inductive thematic analysis to examine participants' responses. RESULTS: Women generally favored predictive and diagnostic testing, although not because they would opt for termination of pregnancy. Participants generally disagreed that taking daily low-dose aspirin (LDA) would make them nervous, with disagreement significantly higher in the preterm delivery subgroup. A high proportion of participants, especially in the preterm delivery subgroup, would take LDA throughout pregnancy. The majority of participants would be more worried about the possibility of preeclampsia than about the risks of treatments to their health (60%), and that proportion was significantly higher in the preterm delivery subgroup. There were no differences between subgroups in the views expressed about expectant management, although opinion was divided in both groups. Overall, most participants opted to put the baby's interests first. CONCLUSION: Women with experience of hypertensive disorders were enthusiastic about improved predictive and diagnostic tests. However, varied views about treatment options and expectant management suggest the need for a shared decision-making tool to enable healthcare professionals to support pregnant women's decision-making to maximize the utility of these tests and interventions.

Cost-effectiveness of the adherence with recommendations for clinical monitoring of patients with diabetes.

BACKGROUND AND AIMS: To validate a set of indicators for monitoring the quality of care of patients with diabetes in 'real-life' practice through its relationship with measurable clinical outcomes and healthcare costs. METHODS AND RESULTS: A population-based cohort study was carried out by including the 20,635 patients, residents in the Lombardy Region (Italy), who in the year 2012 were newly taken-in-care for diabetes. Adherence with clinical recommendations (i.e., controls for glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine) was recorded during the first year after the patient was taken-in-care, and categorized according whether he/she complied with none or almost none (0 or 1), just some (2) or all or almost all (3 or 4) the recommendations, respectively denoted as poor, intermediate and high adherence. Short- and long-term complications of diabetes, and healthcare cost incurred by the National Health Service, were assessed during follow-up. Compared with patients with poor adherence, those with intermediate and high adherence respectively showed (i) a delay in outcome occurrence of 13 days (95% CI, -2 to 27) and 23 days (9-38), and (ii) a lower healthcare cost of 54 € and 77 €. In average, a gain of 18 Euros and 15 Euros for each day free from diabetic complication by increasing adherence respectively from poor to intermediate and from poor to high were observed. CONCLUSION: Close control of patients with diabetes through regular clinical examinations must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Insulin-like growth factor-1 level is a poor diagnostic indicator of growth hormone deficiency.

We evaluated the diagnostic accuracy of insulin-like growth factor-1 (IGF-1) for screening growth hormone deficiency (GHD) to determine the usefulness of IGF-1 as a screening test. Among 298 consecutive children who had short stature or decreased height velocity, we measured IGF-1 levels and performed growth hormone (GH) secretion test using clonidine, arginine, and, in cases with different results of the two tests, L-dopa. Patients with congenital abnormalities were excluded. GHD was defined as peak GH ≤ 6.0 ng/mL in the two tests. We identified 60 and 238 patients with and without GHD, respectively. The mean IGF-1 standard deviation (SD) was not significantly different between the GHD and non-GHD groups (p = 0.23). Receiver operating characteristic curve analysis demonstrated the best diagnostic accuracy at an IGF-1 cutoff of - 1.493 SD, with 0.685 sensitivity, 0.417 specificity, 0.25 positive and 0.823 negative predictive values, and 0.517 area under the curve. Correlation analysis revealed that none of the items of patients' characteristics increased the diagnostic power of IGF-1. IGF-1 level had poor diagnostic accuracy as a screening test for GHD. Therefore, IGF-1 should not be used alone for GHD screening. A predictive biomarker for GHD should be developed in the future.

Coronary artery disease surveillance among childhood, adolescent and young adult cancer survivors: A systematic review and recommendations from the International Late Effects of Childhood Cancer Guideline Harmonization Group.

BACKGROUND: Coronary artery disease (CAD) is a concerning late outcome for cancer survivors. However, uniform surveillance guidelines are lacking. AIM: To harmonise international recommendations for CAD surveillance for survivors of childhood, adolescent and young adult (CAYA) cancers. METHODS: A systematic literature review was performed and evidence graded using the Grading of Recommendations, Assessment, Development and Evaluation criteria. Eligibility included English language studies, a minimum of 20 off-therapy cancer survivors assessed for CAD, and 75% diagnosed prior to age 35 years. All study designs were included, and a multidisciplinary guideline panel formulated and graded recommendations. RESULTS: 32 of 522 identified articles met eligibility criteria. The prevalence of CAD ranged from 0 to 72% and was significantly increased compared to control populations. The risk of CAD was increased among survivors who received radiotherapy exposing the heart, especially at doses ≥15 Gy (moderate-quality evidence). The guideline panel agreed that healthcare providers and CAYA cancer survivors treated with radiotherapy exposing the heart should be counselled about the increased risk for premature CAD. While the evidence is insufficient to support primary screening, monitoring and early management of modifiable cardiovascular risk factors are recommended. Initiation and frequency of surveillance should be based on the intensity of treatment exposures, family history, and presence of co-morbidities but at least by age 40 years and at a minimum of every 5 years. All were strong recommendations. CONCLUSION: These systematically assessed and harmonised recommendations for CAD surveillance will inform care and guide research concerning this critical outcome for CAYA cancer survivors.

Targeting Hypertension Screening in Low- and Middle-Income Countries: A Cross-Sectional Analysis of 1.2 Million Adults in 56 Countries.

Background As screening programs in low- and middle-income countries (LMICs) often do not have the resources to screen the entire population, there is frequently a need to target such efforts to easily identifiable priority groups. This study aimed to determine (1) how hypertension prevalence in LMICs varies by age, sex, body mass index, and smoking status, and (2) the ability of different combinations of these variables to accurately predict hypertension. Methods and Results We analyzed individual-level, nationally representative data from 1 170 629 participants in 56 LMICs, of whom 220 636 (18.8%) had hypertension. Hypertension was defined as systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥90 mm Hg, or reporting to be taking blood pressure-lowering medication. The shape of the positive association of hypertension with age and body mass index varied across world regions. We used logistic regression and random forest models to compute the area under the receiver operating characteristic curve in each country for different combinations of age, body mass index, sex, and smoking status. The area under the receiver operating characteristic curve for the model with all 4 predictors ranged from 0.64 to 0.85 between countries, with a country-level mean of 0.76 across LMICs globally. The mean absolute increase in the area under the receiver operating characteristic curve from the model including only age to the model including all 4 predictors was 0.05. Conclusions Adding body mass index, sex, and smoking status to age led to only a minor increase in the ability to distinguish between adults with and without hypertension compared with using age alone. Hypertension screening programs in LMICs could use age as the primary variable to target their efforts.

Systematic screening for a proximal DVT in COVID-19 hospitalized patients: Results of a comparative study.

INTRODUCTION: The COVID-19 pandemic is associated with a high incidence of venous thromboembolism questioning the utility of a systematic screening for deep venous thrombosis (DVT) in hospitalised patients. METHODS: In this prospective bicentric controlled study, 4-point ultrasound using a pocket device was used to screen for DVT, in patients with SARS-CoV-2 infection and controls admitted for acute medical illness not related to COVID-19 hospitalised in general ward, in order to assess the utility of a routine screening and to estimate the prevalence of VTE among those patients. RESULTS: Between April and May 2020, 135 patients were screened, 69 in the COVID+ group and 66 in the control one. There was no significant difference in the rate of proximal DVT between the two groups (2.2% vs. 1.5%; P=0.52), despite the high rate of PE diagnosed among COVID-19 infected patients (10.1% vs. 1.5%, P=0.063). No isolated DVT was detected, 37.5% of PE was associated with DVT. Mortality (7.2% vs. 1.5%) was not different (P=0.21) between COVID-19 patients and controls. CONCLUSION: The systematic screening for proximal DVT was not found to be relevant among COVID-19 patients hospitalized in general ward despite the increase of VTE among this population. Further studies are needed to confirm the hypothesis of a local pulmonary thrombosis which may lead to new therapeutic targets.

The effect of empirical and laboratory-confirmed tuberculosis on treatment outcomes.

The World Health Organization (WHO) criteria for diagnosing and treating Tuberculosis (TB) includes clinical signs, therefore not requiring bacteriological laboratory confirmation. In resource-limited settings, including Kenya, this empirical TB treatment is routine practice however limited data exist on patient clinical outcomes when comparing the method of diagnosis. We evaluated TB treatment outcomes comparing clinically diagnosed and bacteriologically confirmed TB, 6 months after starting treatment of TB in a rural county in Kenya. Our analysis compared patients with a clinical versus a bacteriologically confirmed TB diagnosis. In this retrospective analysis, we included all adults (≥ 18 years) starting treatment of TB and followed up for 6 months, within the County TB surveillance database from 2012 to 2018. Patients included from both public and private facilities. The TB treatment outcomes assessed included treatment success, treatment failure, death, defaulted and transferred out. We used survival regression models to assess effect of type of diagnosis on TB treatment outcome defining time at risk from date of starting treatment to experiencing one of the treatment outcomes or completing 6-months of treatment. A total of 12,856 patients; median age 37 [IQR 28 - 50] years were included. 7639 (59%) were male while 11,339 (88%) were pulmonary TB cases. Overall, 11,633 (90%) were given first-line TB treatment and 3791 (29%) were HIV infected. 6472 (50%) of the patients were clinically diagnosed of whom 4521/6472 (70%) had a negative sputum/GeneXpert test. During the study 5565 person-years (PYs) observed, treatment success was 82% and 83% amongst clinically and bacteriologically diagnosed patients (P = 0.05). There were no significant differences in defaulting (P = 0.70) or transfer out (P = 0.19) between clinically and bacteriologically diagnosed patients. Mortality was significantly higher among clinically diagnosed patients: 639 (9.9%) deaths compared to 285 (4.5%) amongst the bacteriologically diagnosed patients; aHR 5.16 (95%CI 2.17 - 12.3) P < 0.001. Our study suggests survival during empirical TB treatment is significantly lower compared to patients with laboratory evidence, irrespective of HIV status and age. To improve TB treatment outcomes amongst clinically diagnosed patients, we recommend systematic screening for comorbidities, prompt diagnosis and management of other infections.

Cost-effectiveness analysis of ankle-brachial index screening in patients with coronary artery disease to optimize medical management.

INTRODUCTION: Screening for peripheral artery disease (PAD) with the ankle-brachial index (ABI) test is currently not recommended in the general population; however, previous studies advocate screening in high-risk populations. Although providers may be hesitant to prescribe low-dose rivaroxaban to patients with coronary artery disease (CAD) alone, given the reduction in cardiovascular events and death associated with rivaroxaban, screening for PAD with the ABI test and accordingly prescribing rivaroxaban may provide additional benefits. We sought to describe the cost-effectiveness of screening for PAD in patients with CAD to optimize this high-risk populations' medical management. METHODS: We used a Markov model to evaluate the ABI test in patients with CAD. We assumed that all patients screened would be candidates for low-dose rivaroxaban. We assessed the cost of ABI screening at $100 per patient and added additional charges for physician visits ($100) and rivaroxaban cost ($470 per month). We used a 30-day cycle and performed analysis over 35 years. We evaluated quality-adjusted life years (QALYs) from previous studies and determined the incremental cost-effectiveness ratio (ICER) according to our model. We performed a deterministic and probabilistic sensitivity analyses of variables with uncertainty and reported them in a Tornado diagram showing the variables with the greatest effect on the ICER. RESULTS: Our model estimates decision costs to screen or not screen at $94,953 and $82,553, respectively. The QALYs gained from screening was 0.060, generating an ICER of $207,491 per QALY. Factors most influential on the ICER were the reduction in all-cause mortality associated with rivaroxaban and the prohibitively high cost of rivaroxaban. If rivaroxaban cost less than $95 per month, this would make screening cost-effective based on a willingness to pay threshold of $50,000 per QALY. CONCLUSIONS: According to our model, screening patients with CAD for PAD to start low-dose rivaroxaban is not currently cost-effective due to insufficient reduction in all-cause mortality and high medication costs. Nevertheless, vascular surgeons have a unique opportunity to prescribe or advocate for low-dose rivaroxaban in patients with PAD to improve cardiovascular outcomes.