Comparison of management strategies for neonates with symptomatic tetralogy of Fallot and weight <2.5 kg.

OBJECTIVE: To compare management strategies for neonates <2.5 kg with tetralogy of Fallot and symptomatic cyanosis who either undergo staged repair (SR) (initial palliation followed by later complete repair) or primary repair (PR). METHODS: Consecutive neonates with tetralogy of Fallot and symptomatic cyanosis weighing <2.5 kg at initial intervention and between 2005 and 2017 were retrospectively reviewed from the Congenital Cardiac Research Collaborative. Primary outcome was mortality and secondary outcomes included component (eg, initial palliation, complete repair, or primary repair) and cumulative (SR: initial palliation followed by later complete repair) hospital and intensive care unit lengths of stay, durations of ventilation, inotrope use, cardiopulmonary bypass time, procedural complications, and reintervention. Outcomes were compared with propensity score adjustments with PR as the reference group. RESULTS: The cohort included 76 SR (initial palliation: 53 surgical and 23 transcatheter) and 44 PR patients. The observed risk of overall mortality was similar between SR and PR groups (15.8% vs 18.2%: P = .735). The adjusted hazard of mortality remained similar between groups overall (hazard ratio, 0.59; 95% confidence interval, 0.26-1.36; P = .214), as well as during short-term (<4 months: hazard ratio, 0.37; 95% confidence interval, 0.13-1.09; P = .071) and midterm (>4 months: hazard ratio, 1.32; 95% confidence interval, 0.30-5.79; P = .717) follow-up. Reintervention in the first 18 months was common in both groups (53.2% vs 48.4%; hazard ratio, 1.69; 95% confidence interval, 0.96-2.28; P = .072). Adjusted procedural complications and neonatal morbidity burden were overall lower in the SR group. Cumulative secondary outcome burdens largely favored the PR group. CONCLUSIONS: In this study comparing SR and PR treatment strategies for neonates with tetralogy of Fallot and symptomatic cyanosis and weight <2.5 kg, mortality and reintervention burden was high and independent of treatment strategy. Other potential advantages were observed with each approach.

Frequency of juvenile idiopathic arthritis and associated uveitis in pediatric rheumatology clinics in Turkey: A retrospective study, JUPITER.

BACKGROUND: Juvenile idiopathic arthritis (JIA), is the most common pediatric rheumatologic disorder with unknown etiology. Currently, no population-based data are available regarding the distribution of categories and frequency of uveitis in patients with JIA in Turkey. The purpose of this study was to evaluate the frequency of JIA-associated uveitis (JIAU) and distribution of JIA categories in a Turkish JIA cohort. METHODS: This was a retrospective study of 500 randomized patients in four pediatric rheumatology clinics in Turkey. RESULTS: Oligoarticular JIA (oJIA) was the most common JIA disease category in this study cohort (38.8%). The frequencies of the other categories were as follows: enthesitis-related arthritis (ERA), 23.2%; rheumatoid factor (RF)-negative polyarthritis, 15.6%; systemic arthritis, 12.2%; juvenile psoriatic arthritis, 5.2%; undifferentiated arthritis, 2.8%; and RF-positive polyarthritis, 2.2%. JIA-associated uveitis was observed in 6.8% of patients at a mean (Standard Deviation, SD) age of 9.1 (3.8) years over a mean JIA disease duration of 4 (1.9) years. Uveitis developed after joint disease, with a mean (SD) duration of 1.8 (1.9) years. Patients with oJIA had the highest rate of uveitis (12.9%) followed by patients with ERA (5.2%) and polyarticular RF-negative disease (3.8%). Compared with persistent oJIA, the extended oJIA category had a > 3-fold higher risk of uveitis (11.3% vs 27.7%; odds ratio, 3.38 [95% Confidence Interval, 1.09-10.4]). The most frequently administered drug after development of uveitis was tumor necrosis factor-alpha inhibitors (38.2%). Five patients (14.7%) had uveitis-related complications that required surgical intervention. CONCLUSIONS: Turkish pediatric patients with JIA experience a lower frequency of oJIA and higher frequency of ERA than their white European counterparts; the occurrence of uveitis is also somewhat lower than expected. Geographic and ethnic factors may affect these differences and need further investigation.

Effect of interprofessional collaboration among nursing home professionals on end-of-life care in nursing homes.

As end-of-life (EOL) care in nursing homes is gradually increasing, interprofessional collaboration in EOL care in nursing homes is becoming important. However, a method for measuring interprofessional collaboration has not been established. Therefore, this study aimed to clarify the effect of interprofessional collaboration on EOL care in nursing homes. Questionnaires were mailed to the facility directors of 378 nursing homes in Kanagawa Prefecture, Japan, and distributed to nurses, care managers, and professional caregivers. Three professionals from each nursing home completed the same questionnaire, which included 9 items on EOL care: shared facility policy, residents' wishes, each professional's roles, person in charge of the facility, residents' conditions, mental status of residents' families, emergency codes, residents' key people, and sufficient discussion among professionals. Based on the professionals' responses, interprofessional collaboration was assessed. We used multivariable analysis, with interprofessional collaboration as an independent factor. The outcome was the amount of EOL care in the nursing home. A total of 180 (47.6%) nursing homes participated. Multivariable analysis showed that interprofessional collaboration (beta [ß] coefficient 2.5, 95% confidence interval [CI] 0.45-4.48; p = 0.017), availability of EOL care bonuses (ß coefficient 4.4, 95% CI 1.41-7.38; p = 0.004), physician support for emergency care during off time (ß coefficient 5.4, 95% CI 1.86-8.94; p = 0.003), and EOL care conferences (ß coefficient 4.1, 95% CI 1.19-6.99; p = 0.006) were significant factors associated with the amount of EOL care in the nursing homes. We found evidence in the adjusted model that interprofessional collaboration among facility professionals is effective for EOL care in nursing homes.

Telemedicine for adult congenital heart disease patients during the first wave of COVID-19 era: a single center experience.

AIM: To summarize our experience on the implementation of a telemedicine service dedicated to adult congenital heart disease (ACHD) patients during the lockdown for the first wave of Coronavirus disease 2019 (COVID-19). METHODS: This is a prospective study enrolling all ACHD patients who answered a questionnaire dedicated telematic cardiovascular examination. RESULTS: A total of 289 patients were enrolled, 133 (47%) were male, 25 (9%) were affected by a genetic syndrome. The median age was 38 (29-51) years, whereas the median time interval between the last visit and the telematic follow-up was 9.5 (7.5-11.5) months. Overall, 35 patients (12%) reported a worsening of fatigue in daily life activity, 17 (6%) experienced chest pain, 42 (15%) had presyncope and 2 (1%) syncope; in addition, 28 patients (10%) presented peripheral edema and 14 (5%) were orthopneic. A total of 116 (40%) patients reported palpitations and 12 had at least one episode of atrial fibrillation and underwent successful electrical (8) or pharmacological (4) cardioversion. One patient was admitted to the emergency department for uncontrolled arterial hypertension, five for chest pain, and one for heart failure. Two patients presented fever but both had negative COVID-19 nasal swab. CONCLUSION: During the COVID-19 pandemic, the use of telemedicine dramatically increased and here we report a positive experience in ACHD patients. The postpandemic role of telemedicine will depend on permanent regulatory solutions and this early study might encourage a more systematic telematic approach for ACHD patients.

Pericarditis in patients with COVID-19: a systematic review.

AIMS: We performed a systematic review to summarize the clinical features, diagnostic methods, treatment, and outcomes of coronavirus disease 2019 (COVID-19) patients with pericarditis. METHODS: We searched electronic databases from inception to 17 December 2020. Studies that reported clinical data on patients with COVID-19 and pericarditis were included. Descriptive statistics were used for categorical and continuous variables [mean ±â€Šstandard deviation or median (interquartile range)]. As an exploratory analysis, differences between patients with acute pericarditis and myopericarditis were compared. RESULTS: A total of 33 studies (32 case reports and 1 case series) involving 34 patients were included. The mean age was 51.6 ±â€Š19.5 years and 62% of patients were men. Sixty-two percentage of patients were diagnosed with myopericarditis. The most frequent electrocardiographic pattern (56%) was diffuse ST-elevation and PR depression. Pericardial effusion and cardiac tamponade were reported in 76 and 35% of cases, respectively. The median values of C-reactive protein [77 mg/dl (12-177)] and white blood cells [12 335 cells/µl (5625-16 500)] were above the normal range. Thirty-eight percent and 53% of patients were treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine, respectively. These drugs were more frequently used in patients with acute pericarditis compared with myopericarditis. The in-hospital mortality was 6% without a significant difference between both groups. CONCLUSION: Our review shows that COVID-19 patients with pericarditis had similar clinical features to other viral cardiotropic infections. However, NSAIDs and colchicine were used in half or less of the cases. Overall, the short-term prognosis was good across groups.

Health-Related Quality of Life in Testicular Cancer Survivors in Japan: A Multi-Institutional, Cross-Sectional Study Using the EORTC QLQ-TC26.

OBJECTIVE: To evaluate the health-related quality of life (QOL) of testicular cancer (TC) survivors using the Japanese version of the EORTC QLQ-TC26 questionnaire in a multi-institutional, cross-sectional study. METHODS: This study recruited TC survivors who were followed after treatment for TC at eight high-volume institutions between January, 2018 and March, 2019. The participants completed the EORTC QLQ-TC26 questionnaire and mailed the completed questionnaires to a central institution. The QOL scores were assessed according to therapeutic modality (watchful waiting, WW; chemotherapy, CT; and CT followed by retroperitoneal lymph node dissection, CT+RPLND) and follow-up period and compared using analysis of variance and Student's t-test. RESULTS: A total of 567 TC survivors responded to the questionnaire. The median age at response was 43 years (IQR 35-51 years), and the median follow-up was 5.2 years (IQR 2.2-10.0 years). As for treatment side effects and physical limitations, the scores of the CT+RPLND group were significantly higher than those of the WW group, especially within one year after treatment. In addition, TC survivors in the CT+RPLND group reported high impairment related to job and education problems and future perspective less than 5 years after treatment. Even TC survivors in the WW group were anxious about job and education issues within one year after treatment. CONCLUSION: TC survivors were anxious about not only cancer recurrence, but also their jobs and education. TC patients should be given appropriate information on QOL after treatment for TC to attenuate post-treatment anxiety and improve their health-related QOL.

Clinicopathological and prognostic characteristics of acral metastases in patients with malignant disease: A retrospective study.

OBJECTIVE: This study aimed to investigate the clinical, pathological, and prognostic characteristics of acral metastases in patients with malignant disease and to determine the impact of different types of acral metastasis treatment on patient survival. METHODS: In this retrospective study, 64 acral metastatic lesions in 46 patients (17 women, 29 men; mean age, 61.5 years; age range, 35-82 years) who were evaluated by the Bone and Soft Tissue Tumors Council of our institute from 2015 to 2019 were included. The patients' primary tumor site, tumor type, localization of acral metastases, main symptom, duration from the diagnosis of the primary tumor to the diagnosis of acral metastasis, duration from the diagnosis of acral metastasis to death, and survival data were analyzed. The diagnosis of acral metastasis was confirmed by histopathological evaluation in 38 patients and clinical and radiological assessment of the lesions in 8 patients. The treatment type for each acral metastasis was individualized by the institutional Bone and Soft Tissue Tumors Council and categorized into 3 groups: excisional surgery (amputations and resections), palliative surgery (prophylactic fixation, intralesional curettage, and bone cement augmentation), and non-surgical treatment (chemotherapy, radiotherapy, and hormone therapy). RESULTS: A total of 16 acral metastases (25%) were identified in the upper extremity and 48 (75%) in the lower extremity. The most common primary tumor site was the lungs (32.6%), and the most common tumor type was adenocarcinoma (43.2%). The most frequent symptom and the primary reason for admission was pain (58.7%). The mean duration between the diagnosis of primary tumor and the diagnosis of acral metastasis was 19.1 (range, 0-124) months. No significant correlation was determined between the primary tumor types and duration from the diagnosis of primary tumor to the diagnosis of acral metastasis (p=0.278). Acral metastases were treated by excisional surgery in 15 (32.6%) patients, palliative surgery combined with non-surgical treatment in 10 (21.7%) patients, and only non-surgical treatment modalities in 21 (45.7%) patients. No significant correlation existed between the treatment types and patient survival (p=0.058). At the final follow-up, 30 (65.2%) patients were dead owing to the disease. The mean overall survival of the entire study group was 24.9 (range, 3-55) months. The mean duration between the diagnosis of acral metastasis and death was 7.6 (range, 3-24) months in patients who were dead owing to the disease (p=0.012). CONCLUSION: When the diagnosis of acral metastasis is established, it should be borne in mind that the most common primary tumor site and type are most likely the lungs and adenocarcinoma, respectively. The treatment type for acral metastasis may have no significant impact on patient survival, but the extensiveness of the disease may be a critical factor for survival. LEVEL OF EVIDENCE: Level IV, Prognostic study.

Characteristics and Risk Factors of Hospitalized and Nonhospitalized COVID-19 Patients, Atlanta, Georgia, USA, March-April 2020.

We compared the characteristics of hospitalized and nonhospitalized patients who had coronavirus disease in Atlanta, Georgia, USA. We found that risk for hospitalization increased with a patient's age and number of concurrent conditions. We also found a potential association between hospitalization and high hemoglobin A1c levels in persons with diabetes.

Access to cardiac surgery centers for cardiac and non-cardiac hospitalizations in adolescents and adults with congenital heart defects- a descriptive case series study.

BACKGROUND: Individuals with congenital heart defects (CHDs) are recommended to receive all inpatient cardiac and noncardiac care at facilities that can offer specialized care. We describe geographic accessibility to such centers in New York State and determine several factors associated with receiving care there. METHODS: We used inpatient hospitalization data from the Statewide Planning and Research Cooperative System (SPARCS) in New York State 2008-2013. In the absence of specific adult CHD care center designations during our study period, we identified pediatric/adult and adult-only cardiac surgery centers through the Cardiac Surgery Reporting System to estimate age-based specialized care. We calculated one-way drive and public transit time (in minutes) from residential address to centers using R gmapsdistance package and the Google Maps Distance Application Programming Interface (API). We calculated prevalence ratios using modified Poisson regression with model-based standard errors, fit with generalized estimating equations clustered at the hospital level and subclustered at the individual level. RESULTS: Individuals with CHDs were more likely to seek care at pediatric/adult or adult-only cardiac surgery centers if they had severe CHDs, private health insurance, higher severity of illness at encounter, a surgical procedure, cardiac encounter, and shorter drive time. These findings can be used to increase care receipt (especially for noncardiac care) at pediatric/adult or adult-only cardiac surgery centers, identify areas with limited access, and reduce disparities in access to specialized care among this high-risk population.

Demographic and Socioeconomic Factors Associated with Urinary Stone Disease Management in a Large Urban US Population.

OBJECTIVE: To determine the influence of socioeconomic parameters on urinary stone surgeries. METHODS: A retrospective cohort study analyzed patients undergoing urolithiasis surgery in our community network hospital in North Carolina from 2005-2018. RESULTS: Of 7731 patients, 2160 (28%), 5,174 (67%), and 397 (5%) underwent SWL, URS, and PCNL, respectively. A higher proportion of Whites underwent URS (67%) and SWL (74%) than PCNL (56%); whereas a larger percentage of Blacks underwent PCNL (24%) than URS (20%) and SWL (15%) groups (P <.001). Private insurance payers were greater in the SWL (95%) group than URS (80%) and PCNL (81%) (P <.001). The distribution of median income was significantly different amongst the 3 surgeries with higher income classes overutilizing SWL and underutilizing PCNL compared to lower income classes (P <.001). In linear regression modeling, the proportion of SWL in a postal code was positively associated with median income (R2=0.55, P <.001); URS and PCNL were negatively associated with median income (R2=0.40, P <.001 and R2=0.41, P <.001, respectively). On multivariate logistic regression modeling, Blacks were significantly more likely to undergo PCNL than Whites (aOR 1.32, 95% CI 1.01-1.74 P <.050). Private insurance payers were more likely to undergo SWL (aOR 11.0, 95% CI 7.26-16.8, P <.0001) than public insurance payers. Patients in higher median income brackets are significantly less likely to undergo PCNL than those in the <$40,000 income bracket (P <.0001). CONCLUSION: Our study suggests that socioeconomic status impacts urolithiasis surgical management, underscoring disparity recognition importance in endourologic care and ensuring appropriate surgical care regardless of socioeconomic status.

Impact of early Coronavirus Disease 2019 pandemic on pediatric cardiac surgery in China.

OBJECTIVE: This study aimed to provide an insight into the impact of the early outbreak of the novel Coronavirus Disease 2019 on the care management for patients with congenital heart disease. METHODS: This study respectively enrolled a cohort of surgical patients who underwent surgery in 2018 (group I), 2019 (group II), and 2020 (group III) and a cohort of follow-up patients who had follow-up in 2017 (group A), 2018 (group B), and 2019 (group C) in 13 children hospitals. RESULTS: During the Coronavirus Disease 2019 era, there was a significant decrease in total surgical volume and a change in case mix in terms of an increase in the proportion of emergency operations. Decrease in migration scale index was correlated to the decrease in both surgical volume (r = 0.64, P = .02) and outpatient visit volume (r = 0.61, P = .03). There was a significantly higher proportion of patients who had follow-up through the internet or phone in group C (26.4% vs 9.6% in group B and 8.9% in group A; P < .0001). There was no statistical difference in death or rehospitalization among the 3 follow-up groups (P = .49). There was higher parents' anxiety score (P < .0001) and more use of telemedicine (P = .004) in group C compared with groups A and B. CONCLUSIONS: The Coronavirus Disease 2019 pandemic has resulted in a considerable decrease in total surgical volume and a change of case mix, which seems to be related to the strict traffic ban. Follow-up through the online medical service appears to be an effective alternative to the conventional method.

Five-year disease-related risk of mortality in ambulatory frail older Japanese.

Objectives　We investigated the 5-year disease-related mortality risk, including that associated with neoplasms, mental/behavioral/neurodevelopmental disorders, and diseases of the circulatory system and respiratory system,in ambulatory frail Japanese older adults.Methods　We retrospectively analyzed long-term care and health insurance claims data in this cohort study performed between April 2012 and March 2017. The primary outcome was mortality, and the secondary outcome was care-need level decline. Risk factors were determined based on the International Statistical Classification of Disease and Related Health Problems, 10th Revision codes, hospitalization, and institutionalization. The study included 1,239 ambulatory frail older adults newly certified as needing Support-Level care at baseline (April 2012-March 2013) across three Japanese municipalities.Results　Of the 1,239 participants, 454 (36.6%) died. Neoplasms (hazard ratio [HR] 2.69, 95% confidence interval [CI] 1.97-3.68) or respiratory system diseases (HR 1.62, 95%CI 1.26-2.08) were independently associated with mortality. Mental/behavioral/neurodevelopmental disorders (HR 1.39, 95%CI 1.17-1.66) or diseases of the respiratory system(HR 86, 95%CI 75-99) were independently associated with care-need level decline.Conclusions　This study suggests that neoplasms or respiratory system diseases were associated with a high mortality risk and that mental/behavioral/neurodevelopmental disorders were associated with care-need level decline among ambulatory frail older adults. Optimal disease management and effective long-term care are important to delay the onset of these events in older adults certified as needing Support-Level care.

Medical Treatment in Coronary Patients: Is there Still a Gender Gap? Results from European Society of Cardiology EUROASPIRE V Registry.

PURPOSE: This study is aimed at investigating gender differences in the medical management of patients with coronary heart disease (CHD). METHODS: Analyses were based on the ESC EORP EUROASPIRE V (European Survey Of Cardiovascular Disease Prevention And Diabetes) survey. Consecutive patients between 18 and 80 years, hospitalized for a coronary event, were included in the study. Information on cardiovascular medication intake at hospital discharge and at follow-up (≥ 6 months to < 2 years after hospitalization) was collected. RESULTS: Data was available for 8261 patients (25.8% women). Overall, no gender differences were observed in the prescription and use of cardioprotective medication like aspirin, beta-blockers, and ACE-I/ARBs (P > 0.01) at discharge and follow-up respectively. However, a statistically significant difference was found in the use of statins at follow-up, in disfavor of women (82.8% vs. 77.7%; P < 0.001). In contrast, at follow-up, women were more likely to use diuretics (31.5% vs. 39.5%; P < 0.001) and calcium channel blockers (21.2% vs. 28.8%; P < 0.001), whereas men were more likely to use anticoagulants (8.8% vs. 7.0%; P < 0.001). Overall, no gender differences were found in total daily dose intake (P > 0.01). Furthermore, women were less likely than men to have received a CABG (20.4% vs. 13.2%; P < 0.001) or PCI (82.1% vs. 74.9%; P < 0.001) at follow-up. No gender differences were observed in prescribed (P = 0.10) and attended (P = 0.63) cardiac rehabilitation programs. CONCLUSION: The EUROASPIRE V results show only limited gender differences in the medical management of CHD patients. Current findings suggest growing awareness about risk in female CHD patients.

Evaluation of the Cherokee Nation Hepatitis C Virus Elimination Program in the First 22 Months of Implementation.

Importance: In 2019, hepatitis C virus (HCV) infection contributed to more deaths in the US than 60 other notifiable infectious diseases combined. The incidence of and mortality associated with HCV infection are highest among American Indian and Alaska Native individuals. Objective: To evaluate the association of the Cherokee Nation (CN) HCV elimination program with each element of the cascade of care: HCV screening, linkage to care, treatment, and cure. Design, Setting, and Participants: This cohort study used data from the CN Health Services (CNHS), which serves approximately 132 000 American Indian and Alaska Native individuals residing in the 14-county CN reservation in rural northeastern Oklahoma. Data from the first 22 months of implementation (November 1, 2015, to August 31, 2017) of an HCV elimination program were compared with those from the pre-elimination program period (October 1, 2012, to October 31, 2015). The analysis included American Indian and Alaska Native individuals aged 20 to 69 years who accessed care through the CNHS between October 1, 2012, and August 31, 2017. Cure data were recorded through April 15, 2018. Exposure: The CN HCV elimination program. Main Outcomes and Measures: The main outcomes were the proportions of the population screened for HCV, diagnosed with current HCV infection, linked to care, treated, and cured during the initial 22 months of the elimination program period and the pre-elimination program period. Data from electronic health records and an HCV treatment database were analyzed. The cumulative incidence of HCV infection in this population was estimated using bayesian analyses. Results: Among the 74 039 eligible individuals accessing care during the elimination program period, the mean (SD) age was 36.0 (13.5) years and 55.9% were women. From the pre-elimination program period to the elimination program period, first-time HCV screening coverage increased from 20.9% to 38.2%, and identification of current HCV infection and treatment in newly screened individuals increased from a mean (SD) of 170 (40) per year to 244 (4) per year and a mean of 95 (133) per year to 215 (9) per year, respectively. During the implementation period, of the 793 individuals with current HCV infection accessing the CNHS, 664 were evaluated (83.7%), 394 (59.3%) initiated treatment, and 335 (85.0%) had documented cure. In less than 2 years, the 85% 3-year goal was reached for cure (85.0%), and the goal for linkage to care was nearly reached (83.7%), whereas screening (44.1%) and treatment initiation (59.3%) required more time and resources. Conclusions and Relevance: This cohort study found that after 22 months of implementation, the CNHS community-based HCV elimination program was associated with an improved cascade of care. The facilitators and lessons learned in this program may be useful to other organizations planning similar programs.

United States' Emergency Department Visits for Fever by Young Children 2007-2017.

INTRODUCTION: Our goal in this study was to estimate rates of emergency department (ED) visits for fever by children <2 years of age, and evaluate frequencies of testing and treatment during these visits. METHODS: We performed a cross-sectional study of ED encounters from 2007-2017 using the National Hospital Ambulatory Medical Care Survey, a cross-sectional, multi-stage probability sample survey of visits to nonfederal United States EDs. We included encounters with a visit reason of "fever" or recorded fever in the ED. We report demographics and management strategies in two groups: infants ≤90 days in age; and children 91 days to <2 years old. For patients 91 days to <2 years, we compared testing and treatment strategies between general and pediatric EDs using chi-squared tests. RESULTS: Of 1.5 billion encounters over 11 years, 2.1% (95% confidence interval [CI], 1.9-2.2%) were by children <2 years old with fever. Two million encounters (95% CI, 1.7-2.4 million) were by infants ≤90 days, and 28.4 million (95% CI, 25.5-31.4 million) were by children 91 days to <2 years. Among infants ≤90 days, 27.6% (95% CI, 21.1-34.1%) had blood and 21.3% (95% CI, 13.6-29.1%) had urine cultures; 26.8% (95% CI, 20.9-32.7%) were given antibiotics, and 21.1% (95% CI, 15.3-26.9%) were admitted or transferred. Among patients 91 days to <2 years in age, 6.8% (95% CI, 5.8-7.8%) had blood and 7.7% (95% CI 6.1-9.4%) had urine cultures; 40.5% (95% CI, 40.5-40.5%) were given antibiotics, and 4.4% (95% CI, 3.5-5.3%) were admitted or transferred. Patients 91 days to <2 years who were evaluated in general EDs had higher rates of radiography (27.1% vs 15.2%; P<0.01) and antibiotic utilization (42.3% vs 34.2%; P<0.01), but lower rates of urine culture testing (6.4% vs 11.6%, p = 0.03), compared with patients evaluated in pediatric EDs. CONCLUSION: Approximately 180,000 patients ≤90 days old and 2.6 million patients 91 days to <2 years in age with fever present to US EDs annually. Given existing guidelines, blood and urine culture performance was low for infants ≤90 days old. For children 91 days to <2 years, rates of radiography and antibiotic use were higher in general EDs compared to pediatric EDs. These findings suggest opportunities to improve care among febrile young children in the ED.

Selecting appropriate endpoints for assessing treatment effects in comparative clinical studies for COVID-19.

To evaluate the efficacy and safety of a new treatment for COVID-19 vs. standard care, certain key endpoints are related to the duration of a specific event, such as hospitalization, ICU stay, or receipt of supplemental oxygen. However, since patients may die in the hospital during study follow-up, using, for example, the duration of hospitalization to assess treatment efficacy can be misleading. If the treatment tends to prolong patients' survival compared with standard care, patients in the new treatment group may spend more time in hospital. This can lead to a "survival bias" issue, where a treatment that is effective for preventing death appears to prolong an undesirable outcome. On the other hand, by using hospital-free survival time as the endpoint, we can circumvent the survival bias issue. In this article, we use reconstructed data from a recent, large clinical trial for COVID-19 to illustrate the advantages of this approach. For the analysis of ICU stay or oxygen usage, where the initiating event is potentially an outcome of treatment, standard survival analysis techniques may not be appropriate. We also discuss issues with analyzing the durations of such events.

Which patients to sample in clinical cohort studies when the number of events is high and measurement of additional markers is constrained by limited resources.

PURPOSE: We consider an existing clinical cohort with events but limited resources for the investigation of a further potentially expensive marker. Biological material of the patients is stored in a biobank, but only a limited number of samples can be analyzed with respect to the marker. The question arises as to which patients to sample, if the number of events preclude standard sampling designs. METHODS: Modifications of the nested case-control and the case-cohort design for the proportional hazards model are applied, that allow efficient sampling in situations where standard nested case-control and case-cohort are not feasible. These sampling designs are compared to simple random sampling and extreme group sampling, the latter including only patients with extreme outcomes, ie either with an event early in time or without an event until at least a point later in time. RESULTS: The modified nested case-control design and the modified case-cohort design provide powerful methods for sampling in a clinical cohort with many events. The simple random sampling usually is less efficient. If focus is on precise estimation of a potential effect in terms of a hazard ratio, extreme group sampling is not competitive. If focus is on screening for important biomarkers, extreme group sampling markedly outperforms the other sampling designs. CONCLUSIONS: When it is not feasible to sample all events, a modified nested case-control design or case-cohort design leads to efficient effect estimates in the proportional hazards model. If screening for important biomarkers is the primary objective, extreme group sampling is preferable.

Early Impact of the COVID-19 Pandemic on Congenital Heart Surgery Programs Across the World: Assessment by a Global Multi-Societal Consortium.

The coronavirus disease 2019 (COVID-19) pandemic currently gripping the globe is impacting the entire health care system with rapidly escalating morbidities and mortality. Although the infectious risk to the pediatric population appears low, the effects on children with congenital heart disease (CHD) remain poorly understood. The closure of congenital heart surgery programs worldwide to address the growing number of infected individuals could have an unintended impact on future health for COVID-19-negative patients with CHD. Pediatric and congenital heart surgeons, given their small numbers and close relationships, are uniquely positioned to collectively assess the impact of the pandemic on surgical practice and care of children with CHD. We present the results of an international survey sent to pediatric and congenital heart surgeons characterizing the early impact of COVID-19 on the care of patients with CHD.

The completeness and accuracy of the Norwegian Female Incontinence Registry.

INTRODUCTION: Medical quality registries have gained popularity as tools for monitoring the quality of medical treatments and they serve as data sources for research. The Norwegian Female Incontinence Registry (NFIR) was established in 1998 to monitor and improve the quality of surgery for women with stress and mixed urinary incontinence in Norway and to collect data for research. This study aimed to assess the completeness and accuracy of the Norwegian Female Incontinence Registry, and potential differences in data accuracy over time and according to surgical volume of the reporting hospitals. MATERIAL AND METHODS: A random selection of 300 women from a total of 20 610 operated for urinary incontinence between 1998 and 2016 reported to the Norwegian Female Incontinence Registry from 28 public hospitals were selected for validation. The database completeness was estimated for 2008-2017 by comparing surgical procedures registered both in the Norwegian Female Incontinence Registry and the Norwegian National Patient Registry. Historical data recorded in the Registry for 10 selected key variables were extracted and compared with the patients' individual medical records at the reporting hospitals as reference. The reviewers were blinded to the previously stored information. The intraclass correlation coefficient for continuous variables and Cohen's kappa for categorical variables were calculated. RESULTS: Primary source data on 285 of the 300 women selected from Norwegian Female Incontinence Registry were successfully retrieved. The completeness of the registry has increased from 61% in 2008 to 99% in 2017. The national coverage has increased from 12 reporting departments in 1998 to all 38 public departments performing female incontinence surgery in 2017. Excellent accuracy was found for both continuous variables (intraclass correlation coefficient >0.94) and categorical variables (Cohen's kappa >0.86). No differences in data accuracy were found comparing high-volume hospitals with low-volume hospitals, or when comparing data accuracy over time. CONCLUSIONS: The Norwegian Female Incontinence Registry is a reliable tool for quality assessment of incontinence surgery and research. The registry completeness has improved over time and now contains data on nearly all women undergoing incontinence surgery in Norway.