This paper defines the attributes of distributed data networks and outlines the data and analytic infrastructure needed to build and maintain a successful network. We use examples from one successful ...implementation of a large‐scale, multisite, healthcare‐related distributed data network, the U.S. Food and Drug Administration–sponsored Sentinel Initiative. Analytic infrastructure–development concepts are discussed from the perspective of promoting six pillars of analytic infrastructure: consistency, reusability, flexibility, scalability, transparency, and reproducibility. This paper also introduces one use case for machine learning algorithm development to fully utilize and advance the portfolio of population health analytics, particularly those using multisite administrative data sources.
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BFBNIB, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Objective:The authors aimed to describe the development and testing of quality measures included in a public-facing addiction treatment facility search engine.Methods:An addiction treatment facility ...survey was created that queried providers in six U.S. states about whether they offered the services and used the processes identified by federal agencies and nonprofit organizations as signs of higher-quality addiction treatment. Four insurance claims–based quality measures were created to capture the percentage of a provider’s patients with opioid use disorder receiving opioid use disorder medications, who filled prescriptions for such medication for at least 180 days, who received follow-up care after treatment for substance use disorder in inpatient or residential settings, or who had a substance use disorder–related hospitalization or emergency department visit. A patient experience-of-care survey captured patients’ perceptions of the quality of the addiction treatment. The project was undertaken from November 2018 through July 2020.Results:The authors tested the measures by using 1,245 facility surveys, 7,970 patients’ experience-of-care surveys, and four claims-based measures submitted by 129, 136, 283, and 408 addiction treatment providers. Statistical testing demonstrated that the quality measures were reliable and valid. The quality measure scores varied among providers, capturing a wide performance range. A public website containing quality measures launched in July 2020 in the six states and has been accessed by thousands of consumers.Conclusions:This study developed valid, reliable, and useful addiction treatment quality measures. Dissemination of these measures may help consumers select among providers and help providers, policy makers, and payers improve quality.
Studies examining associations of early-life cat and dog ownership with childhood asthma have reported inconsistent results. Several factors could explain these inconsistencies, including type of ...pet, timing, and degree of exposure.
Our aim was to study associations of early-life cat and dog ownership with asthma in school-aged children, including the role of type (cat vs dog), timing (never, prenatal, or early childhood), and degree of ownership (number of pets owned), and the role of allergic sensitization.
We used harmonized data from 77,434 mother-child dyads from 9 birth cohorts in the European Union Child Cohort Network when the child was 5 to 11 years old. Associations were examined through the DataSHIELD platform by using adjusted logistic regression models, which were fitted separately for each cohort and combined by using random effects meta-analysis.
The prevalence of early-life cat and dog ownership ranged from 12% to 45% and 7% to 47%, respectively, and the prevalence of asthma ranged from 2% to 20%. There was no overall association between either cat or dog ownership and asthma (odds ratio OR = 0.97 95% CI = 0.87-1.09 and 0.92 95% CI = 0.85-1.01, respectively). Timing and degree of ownership did not strongly influence associations. Cat and dog ownership were also not associated with cat- and dog-specific allergic sensitization (OR = 0.92 95% CI = 0.75-1.13 and 0.93 95% CI = 0.57-1.54, respectively). However, cat- and dog-specific allergic sensitization was strongly associated with school-age asthma (OR = 6.69 95% CI = 4.91-9.10 and 5.98 95% CI = 3.14-11.36, respectively). There was also some indication of an interaction between ownership and sensitization, suggesting that ownership may exacerbate the risks associated with pet-specific sensitization but offer some protection against asthma in the absence of sensitization.
Our findings do not support early-life cat and dog ownership in themselves increasing the risk of school-age asthma, but they do suggest that ownership may potentially exacerbate the risks associated with cat- and dog-specific allergic sensitization.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPUK, ZAGLJ, ZRSKP
Nearly 90% of drugs dispensed in the US are generic products.
The aim of this study was to develop and implement a tool for analyzing manufacturer-level drug utilization and switching patterns within ...the US Food and Drug Administration's Sentinel system.
A descriptive tool was designed to analyze data in the Sentinel common data model and was tested with two case studies-metoprolol extended release (ER) and lamotrigine ER-using claims data from four Sentinel data partners. We plotted initiators of each brand and generic product over time. For metoprolol ER, we evaluated rates of switching from generics around the time of manufacturing issues. For lamotrigine ER, we examined rates of switching back to the brand among those who switched from brand to generic.
We identified 1,651,285 initiators of metoprolol ER products between July 2008 and September 2015. We observed a large decrease in monthly metoprolol ER initiators (from 25,465 in December 2008 to 13,128 in February 2009), corresponding to recalls by generic manufacturers. We observed simultaneous increases in utilization of the authorized generic and brand products. We identified 4266 initiators of lamotrigine ER with an epilepsy diagnosis between January 2012 and September 2015. Among those who switched from brand to generic, the cumulative incidence of switching back was close to 20% at 2 years. Switchback rates were higher for the first available generic products.
This developed tool was able to elucidate novel utilization and switching patterns in two case studies. Such information can be used to support surveillance of generic drugs and biosimilars.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
International sharing of cohort data for research is important and challenging. We explored the feasibility of multicohort federated analyses by examining associations between 3 pregnancy exposures ...(maternal education, exposure to green vegetation, and gestational diabetes) and offspring body mass index (BMI) from infancy to age 17 years. We used data from 18 cohorts (n = 206,180 mother-child pairs) from the EU Child Cohort Network and derived BMI at ages 0-1, 2-3, 4-7, 8-13, and 14-17 years. Associations were estimated using linear regression via 1-stage individual participant data meta-analysis using DataSHIELD. Associations between lower maternal education and higher child BMI emerged from age 4 and increased with age (difference in BMI z score comparing low with high education, at age 2-3 years = 0.03 (95% confidence interval (CI): 0.00, 0.05), at 4-7 years = 0.16 (95% CI: 0.14, 0.17), and at 8-13 years = 0.24 (95% CI: 0.22, 0.26)). Gestational diabetes was positively associated with BMI from age 8 years (BMI z score difference = 0.18, 95% CI: 0.12, 0.25) but not at younger ages; however, associations attenuated towards the null when restricted to cohorts that measured gestational diabetes via universal screening. Exposure to green vegetation was weakly associated with higher BMI up to age 1 year but not at older ages. Opportunities of cross-cohort federated analyses are discussed.
Turner syndrome affects 25–50 per 100,000 females and can involve multiple organs through all stages of life, necessitating multidisciplinary approach to care. Previous guidelines have highlighted ...this, but numerous important advances have been noted recently. These advances cover all specialty fields involved in the care of girls and women with TS. This paper is based on an international effort that started with exploratory meetings in 2014 in both Europe and the USA, and culminated with a Consensus Meeting held in Cincinnati, Ohio, USA in July 2016. Prior to this meeting, five groups each addressed important areas in TS care: 1) diagnostic and genetic issues, 2) growth and development during childhood and adolescence, 3) congenital and acquired cardiovascular disease, 4) transition and adult care, and 5) other comorbidities and neurocognitive issues. These groups produced proposals for the present guidelines. Additionally, four pertinent questions were submitted for formal GRADE (Grading of Recommendations, Assessment, Development and Evaluation) evaluation with a separate systematic review of the literature. These four questions related to the efficacy and most optimal treatment of short stature, infertility, hypertension, and hormonal replacement therapy. The guidelines project was initiated by the European Society of Endocrinology and the Pediatric Endocrine Society, in collaboration with the European Society for Paediatric Endocrinology, the Endocrine Society, the European Society of Human Reproduction and Embryology, the American Heart Association, the Society for Endocrinology, and the European Society of Cardiology. The guideline has been formally endorsed by the European Society of Endocrinology, the Pediatric Endocrine Society, the European Society for Paediatric Endocrinology, the European Society of Human Reproduction and Embryology and the Endocrine Society. Advocacy groups appointed representatives who participated in pre-meeting discussions and in the consensus meeting.
Objective. To describe the impact of arthritis and other rheumatic conditions on hospitals by describing the magnitude and characteristics of these hospitalizations. Methods. Data from the 1997 ...National Hospital Discharge Survey were used to examine this impact. Arthritis was defined using International Classification of Diseases, 9th Revision, Clinical Modification, codes specified by the National Arthritis Data Workgroup. Arthritis-related hospitalizations were analyzed by principal diagnosis of arthritis and by any-listed arthritis diagnosis. Results. In 1997, there were an estimated 744,000 hospitalizations with a principal arthritis diagnosis (3% of hospitalizations). Compared with nonarthritis hospitalizations, persons hospitalized with a principal arthritis diagnosis were older, had fewer comorbidities, had shorter hospital stays, were more likely to undergo a procedure, and were more likely to be discharged to short- and long-term care facilities. The most common diagnoses and procedures related to osteoarthritis. This profile was consistent with a healthier-than-average hospital population electively admitted for specific procedures and subsequent rehabilitation. There were an estimated 2.5 million hospitalizations with an any-listed arthritis diagnosis (>9% of hospitalizations). Persons hospitalized with an any-listed arthritis diagnosis were older, had more comorbidities, and had longer hospital stays than those with principal arthritis or nonarthritis hospitalizations. This profile was consistent with a sicker-than-average hospital population nonelectively admitted for reasons other than their arthritis, especially cardiovascular disease. Conclusion. Arthritis has a sizable impact on the hospital care system. As our population ages, this impact, in both human and economic terms, is likely to increase.
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BFBNIB, CMK, INZLJ, NMLJ, NUK, PNG, UL, UM, UPUK, ZRSKP
BackgroundPreterm birth is the leading cause of perinatal morbidity and mortality and is associated with adverse developmental and long-term health outcomes, including several cardiometabolic risk ...factors and outcomes. However, evidence about the association of preterm birth with later body size derives mainly from studies using birth weight as a proxy of prematurity rather than an actual length of gestation. We investigated the association of gestational age (GA) at birth with body size from infancy through adolescence.Methods and findingsWe conducted a two-stage individual participant data (IPD) meta-analysis using data from 253,810 mother-child dyads from 16 general population-based cohort studies in Europe (Denmark, Finland, France, Italy, Norway, Portugal, Spain, the Netherlands, United Kingdom), North America (Canada), and Australasia (Australia) to estimate the association of GA with body mass index (BMI) and overweight (including obesity) adjusted for the following maternal characteristics as potential confounders: education, height, prepregnancy BMI, ethnic background, parity, smoking during pregnancy, age at child's birth, gestational diabetes and hypertension, and preeclampsia. Pregnancy and birth cohort studies from the LifeCycle and the EUCAN-Connect projects were invited and were eligible for inclusion if they had information on GA and minimum one measurement of BMI between infancy and adolescence. Using a federated analytical tool (DataSHIELD), we fitted linear and logistic regression models in each cohort separately with a complete-case approach and combined the regression estimates and standard errors through random-effects study-level meta-analysis providing an overall effect estimate at early infancy (>0.0 to 0.5 years), late infancy (>0.5 to 2.0 years), early childhood (>2.0 to 5.0 years), mid-childhood (>5.0 to 9.0 years), late childhood (>9.0 to 14.0 years), and adolescence (>14.0 to 19.0 years). GA was positively associated with BMI in the first decade of life, with the greatest increase in mean BMI z-score during early infancy (0.02, 95% confidence interval (CI): 0.00; 0.05, p < 0.05) per week of increase in GA, while in adolescence, preterm individuals reached similar levels of BMI (0.00, 95% CI: -0.01; 0.01, p 0.9) as term counterparts. The association between GA and overweight revealed a similar pattern of association with an increase in odds ratio (OR) of overweight from late infancy through mid-childhood (OR 1.01 to 1.02) per week increase in GA. By adolescence, however, GA was slightly negatively associated with the risk of overweight (OR 0.98 95% CI: 0.97; 1.00, p 0.1) per week of increase in GA. Although based on only four cohorts (n = 32,089) that reached the age of adolescence, data suggest that individuals born very preterm may be at increased odds of overweight (OR 1.46 95% CI: 1.03; 2.08, p < 0.05) compared with term counterparts. Findings were consistent across cohorts and sensitivity analyses despite considerable heterogeneity in cohort characteristics. However, residual confounding may be a limitation in this study, while findings may be less generalisable to settings in low- and middle-income countries.ConclusionsThis study based on data from infancy through adolescence from 16 cohort studies found that GA may be important for body size in infancy, but the strength of association attenuates consistently with age. By adolescence, preterm individuals have on average a similar mean BMI to peers born at term.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK