Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus.

Background: This study investigated the real-world efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in Korean adults with type 2 diabetes mellitus (T2DM), whose insulin treatment was switched to IDegAsp. Methods: This was a multicenter, retrospective, observational study comprising two 26-week treatment periods, before and after switching to IDegAsp, respectively. Korean adults with uncontrolled T2DM treated with basal or premix insulin (±oral antidiabetic drugs) were enrolled. The primary objective was to compare the degree of glycosylated hemoglobin (HbA1c) change in each 26-week observation period. The analyses included changes in HbA1c, fasting plasma glucose (FPG), body weight, proportion of participants achieving HbA1c <7.0%, hypoglycemic events, and total daily insulin dose (ClinicalTrials.gov, number NCT04656106). Results: In total, 196 adults (mean age, 65.95 years; mean T2DM duration, 18.99 years) were analyzed. The change in both HbA1c and FPG were significantly different between the pre-switching and the post-switching period (0.28% vs. -0.51%, P<0.001; 5.21 mg/dL vs. -23.10 mg/dL, P=0.005), respectively. After switching, the rate of achieving HbA1c <7.0% was significantly improved (5.10% at baseline vs. 11.22% with IDegAsp, P=0.012). No significant differences (before vs. after switching) were observed in body weight change, and total daily insulin dose. The rates of overall and severe hypoglycemia were similar in the two periods. Conclusion: In real-world clinical practice in Korea, the change of insulin regimen to IDegAsp was associated with an improvement in glycemic control without increase of hypoglycemia, supporting the use of IDegAsp for patients with T2DM uncontrolled with basal or premix insulin.

Big Data Research in the Field of Endocrine Diseases Using the Korean National Health Information Database.

The Korean National Health Information Database (NHID) contains big data combining information obtained from the National Health Insurance Service and health examinations. Data are provided in the form of a cohort, and the NHID can be used to conduct longitudinal studies and research on rare diseases. Moreover, data on the cause and date of death are provided by Statistics Korea. Research and publications based on the NHID have increased explosively in the field of endocrine disorders. However, because the data were not collected for research purposes, studies using the NHID have limitations, particularly the need for the operational definition of diseases. In this review, we describe the characteristics of the Korean NHID, operational definitions of endocrine diseases used for research, and an overview of recent studies in endocrinology using the Korean NHID.

A 25 años de la implementación del identificador de objeto digital / Twenty-five years after the implementation of the Digital Object Identifier

RESUMEN El identificador de objeto digital, conocido en inglés como digital object identifier y abreviado DOI, surgido en 1997, es una cadena alfanumérica única que identifica un contenido electrónico y proporciona un enlace permanente a su ubicación en internet. A 25 años de la implementación de esta herramienta, todavía quedan muchas revistas con un impacto considerable que no cuentan con DOI. Cuba no lo tiene porque le es negado por las grandes agencias registradoras. Fue objetivo de los autores de esta comunicación destacar la importancia del DOI como herramienta básica para el control de la documentación digital. Se concluyó que su principal aporte es asegurar la identificación persistente y unívoca de un documento, a través de un registro sistemático central de sus metadatos. Se recomienda que siempre que esté disponible el DOI en línea, se utilice en la cita bibliográfica, para mejorar la visibilidad de las revistas y los propios investigadores.

ABSTRACT The Digital Object Identifier, abbreviated as DOI and emerged in 1997, is a unique alphanumeric string that identifies electronic content and provides a permanent link to its location on the Internet. Twenty-five years after the implementation of this tool, there are still many journals with a considerable impact which do not have DOIs. Cuba does not have it because it is denied by the big registration agencies. The objective of this article was to highlight the importance of the DOI as a basic tool for the control of digital documentation. We concluded that its main contribution is to ensure the persistent and unique identification of a document, through a central systematic record of its metadata. It is recommended that whenever the DOI is available online, it is used in the bibliographic citation, to improve the visibility of the journals and the researchers themselves.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data

ABSTRACT OBJECTIVE To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

Citation Analysis of the Journal of Bone Metabolism from Korean Citation Index, Web of Science, and Scopus.

BACKGROUND: Nine years have passed since the Journal of Bone Metabolism (JBM) was launched as an English journal in 2012; it was finally included in Scopus in January 2019. Therefore, this study aimed to provide evidence of increased international recognition based on journal metrics and reflect on its efforts to be recognized as a top-notch journal. METHODS: Databases, such as the Web of Science (WoS), Scopus, Korean Citation Index (KCI), and citation indicators, including the impact factor (IF) and SCImago journal rank (SJR) were reviewed and calculated according to years, and the results were drawn. Furthermore, country-wise contributions and top-cited articles were also investigated. RESULTS: The JBM 2020 IF was 2.17 in the WoS. The 2020 SJR in Scopus was 0.334, with a ranking of 165/219 (75.3%) in the Endocrinology, Diabetes, and Metabolism category. The 2020 KCI was 0.42. Of 263 articles, 260 were citable (98.9%), and of 176 original articles, 15 (8.5%) were supported by research grants. The total citation of JBM has increased from 16 in 2014 to 141 in 2020; however, its KCI remained stationary from 0.29 in 2015 to 0.42 in 2020. CONCLUSIONS: Currently, JBM is increasingly cited by international researchers than Korean researchers, indicating that the journal's content is valued at an international level. Its inclusion in PubMed Central appears to have increased its international relevance; however, publishing English-only articles may hinder its use domestically. Therefore, efforts should be made to increase citation rates and enhance domestic readership.

Evaluating Quality in Adult Cardiac Surgery.

National and institutional quality initiatives provide benchmarks for evaluating the effectiveness of medical care. However, the dramatic growth in the number and type of medical and organizational quality-improvement standards creates a challenge to identify and understand those that most accurately determine quality in cardiac surgery. It is important that surgeons have knowledge and insight into valid, useful indicators for comparison and improvement. We therefore reviewed the medical literature and have identified improvement initiatives focused on cardiac surgery. We discuss the benefits and drawbacks of existing methodologies, such as comprehensive regional and national databases that aid self-evaluation and feedback, volume-based standards as structural indicators, process measurements arising from evidence-based research, and risk-adjusted outcomes. In addition, we discuss the potential of newer methods, such as patient-reported outcomes and composite measurements that combine data from multiple sources.

Rapid Response to Drive COVID-19 Research in a Learning Health Care System: Rationale and Design of the Houston Methodist COVID-19 Surveillance and Outcomes Registry (CURATOR).

BACKGROUND: The COVID-19 pandemic has exacerbated the challenges of meaningful health care digitization. The need for rapid yet validated decision-making requires robust data infrastructure. Organizations with a focus on learning health care (LHC) systems tend to adapt better to rapidly evolving data needs. Few studies have demonstrated a successful implementation of data digitization principles in an LHC context across health care systems during the COVID-19 pandemic. OBJECTIVE: We share our experience and provide a framework for assembling and organizing multidisciplinary resources, structuring and regulating research needs, and developing a single source of truth (SSoT) for COVID-19 research by applying fundamental principles of health care digitization, in the context of LHC systems across a complex health care organization. METHODS: Houston Methodist (HM) comprises eight tertiary care hospitals and an expansive primary care network across Greater Houston, Texas. During the early phase of the pandemic, institutional leadership envisioned the need to streamline COVID-19 research and established the retrospective research task force (RRTF). We describe an account of the structure, functioning, and productivity of the RRTF. We further elucidate the technical and structural details of a comprehensive data repository-the HM COVID-19 Surveillance and Outcomes Registry (CURATOR). We particularly highlight how CURATOR conforms to standard health care digitization principles in the LHC context. RESULTS: The HM COVID-19 RRTF comprises expertise in epidemiology, health systems, clinical domains, data sciences, information technology, and research regulation. The RRTF initially convened in March 2020 to prioritize and streamline COVID-19 observational research; to date, it has reviewed over 60 protocols and made recommendations to the institutional review board (IRB). The RRTF also established the charter for CURATOR, which in itself was IRB-approved in April 2020. CURATOR is a relational structured query language database that is directly populated with data from electronic health records, via largely automated extract, transform, and load procedures. The CURATOR design enables longitudinal tracking of COVID-19 cases and controls before and after COVID-19 testing. CURATOR has been set up following the SSoT principle and is harmonized across other COVID-19 data sources. CURATOR eliminates data silos by leveraging unique and disparate big data sources for COVID-19 research and provides a platform to capitalize on institutional investment in cloud computing. It currently hosts deeply phenotyped sociodemographic, clinical, and outcomes data of approximately 200,000 individuals tested for COVID-19. It supports more than 30 IRB-approved protocols across several clinical domains and has generated numerous publications from its core and associated data sources. CONCLUSIONS: A data-driven decision-making strategy is paramount to the success of health care organizations. Investment in cross-disciplinary expertise, health care technology, and leadership commitment are key ingredients to foster an LHC system. Such systems can mitigate the effects of ongoing and future health care catastrophes by providing timely and validated decision support.

[A New Paradigm in Health Research: FAIR Data (Findable, Accessible, Interoperable, Reusable)]. / Um Novo Paradigma em Investigação em Saúde: Dados FAIR (Localizáveis, Acessíveis, Interoperáveis, Reutilizáveis).

The digital era, that we are living nowadays, is transforming health, health care models and services, and the role of society in this new reality. We currently have a large amount of stored health data, including clinical, biometric, and scientific research data. Nonetheless, its potential is not being fully exploited. It is essential to foster the sharing and reuse of this data not only in research but also towards the development of health technologies in order to improve health care efficiency, as well as products, services or digital health apps, to promote preventive and individualized medicine and to empower citizens in health literacy and self-management. In this sense, the FAIR concept has emerged, which implies that health data is findable, accessible, shared and reusable, facilitating interoperability between systems, ensuring the protection of personal and sensitive data. In this paper we review the FAIR concept, 'FAIRification' process, FAIR data versus open access data, ethical issues and the general data protection regulation, and digital health and citizen science.

Vivemos uma nova era digital que está a transformar a saúde, os modelos de cuidados e serviços de saúde, e o próprio papel da sociedade nesta realidade. Atualmente dispomos de uma grande quantidade de dados de saúde armazenados, incluindo dados clínicos, biométricos e de investigação científica, cuja potencialidade não está a ser devidamente explorada. É essencial favorecer a partilha e reutilização destes dados não só na investigação, como também para o desenvolvimento de tecnologias para melhorar a eficiência dos cuidados de saúde, de produtos ou serviços de saúde digitais, promover uma medicina preventiva e individualizada, mas também o empoderamento da população em literacia em saúde e na gestão da doença. Recentemente, surgiu o conceito FAIR que implica que os dados de saúde sejam facilmente localizáveis, acessíveis, partilhados e reutilizáveis, facilitando desta forma a interoperacionalidade entre sistemas e assegurando a proteção de dados pessoais e sensíveis. Neste artigo é feita uma revisão do conceito FAIR, processo de 'FAIRificação', dados FAIR versus dados de acesso livre, questões de éticas e o regulamento geral de proteção de dados, e saúde digital e ciência cidadã.

Database of the alumni performance of the Ophthalmology Stricto sensu Postgraduate Program at Escola Paulista de Medicina, UNIFESP

Abstract Purpose To develop a database with social, demographic and professional information of all graduates of the two post-graduate programs in Ophthalmology of EPM-UNIFESP, including their opinions on quality, application, and contribution of the courses received in their professional careers. Methods The survey was conducted in the digital and physical archives of the University and by telephone contact. When the graduates' e-mails were all collected, the electronic questionnaire was applied. The responses were compiled. Descriptive analysis of the results obtained in this cross-sectional study was performed, and analyzed by the authors and by statistical professionals, through Excel graphs. Results The database suggests that most graduates were born and work in the state of São Paulo. A significant fraction of 66.77% is dedicated to academic work, but only 36.2% hold management positions. Most of them receive amounts of one to 56 minimum wages monthly. The main motivation was to improve their professional careers. Conclusion For post-graduate programs, a database with information of its graduates can elucidate whether the goals were achieved based on the proposed teaching, as well as can generate reflections to improve the quality, the courses expectations and the vision that students have of the University.

Clinical Presentation and Long-Term Outcomes of Systemic Sclerosis Portuguese Patients from a Single Centre Cohort: A EUSTAR Registration Initiative.

INTRODUCTION: Systemic sclerosis is a complex disorder that requires systematic screening. Our objective is to report the European Scleroderma Trials and Research group centre affiliation and its impact in our clinical practice. MATERIAL AND METHODS: The European Scleroderma Trials and Research group affiliation process, database update and current patient evaluation, with respect to demographic and clinical features. Cumulative mortality was analysed. RESULTS: We identified 19 female patients (which met all the American College of Rheumatology/ European League Against Rheumatism 2013 criteria for systemic sclerosis) under current follow-up, divided according to the LeRoy classification into diffuse cutaneous (n = 5), limited cutaneous (n = 11) and limited (n = 3) types, followed for a median period of 5, 12 and 6 years, respectively. Raynaud´s phenomenon and abnormal nailfold capillaries were universally present. Interstitial lung disease was absent in the limited cutaneous form but present in 100% of the diffuse subtype. Pitting scars were more common in the diffuse form. Active disease was also more frequent in the diffuse form, and most patients with active disease were treated with anti-endothelin receptor antagonists. Over 21 years (from 1994 to 2015) the mortality rate was 55% (n = 23/42). Age at time of death was significantly lower in the diffuse subtype. DISCUSSION: Our single centre cohort shares many features with larger and international reports and more specifically is in accordance with patient characteristics described in the European Scleroderma Trials and Research group registries. CONCLUSION: The European Scleroderma Trials and Research group registration motivated our systematic patient characterization and may be used as a tool for homogenous disease registries.

Introdução: A esclerose sistémica é uma doença complexa que requer uma vigilância regular e sistemática. Este estudo teve como objetivo divulgar a afiliação da nossa Unidade no registo Europeu Scleroderma Trials and Research group e o seu impacto na prática clínica. Material e Métodos: Processo de afiliação Scleroderma Trials and Research group, atualização da base de dados, avaliação sistemática das características demográficas e clínicas dos doentes em seguimento e análise da mortalidade cumulativa. Resultados: Foram identificados 19 doentes do sexo feminino (com preenchimento completo dos critérios de classificação de esclerose sistémica do American College of Rheumatology/ European League Against Rheumatism 2013), seguidas no momento atual e divididas pela classificação de LeRoy em três formas: cutânea difusa (n = 5), cutânea limitada (n = 11) e limitada (n = 3), com um período de seguimento com uma duração mediana de 5, 12 e 6 anos, respetivamente. O fenómeno de Raynaud e as anomalias nos capilares peri-ungueais estavam presentes em todas as doentes. Todas as doentes com a forma difusa apresentavam doença intersticial pulmonar, ausente na forma cutânea limitada. As pitting scars foram mais frequentes na forma difusa. A doença ativa foi mais frequente na forma difusa, na sua maioria tratada com antagonistas dos recetores da endotelina. Num período de 21 anos (de 1994 a 2015), a mortalidade foi de 55% (n = 23/42). A expectativa de vida nos doentes com a forma difusa estava significativamente reduzida quando comparada com a forma localizada. Discussão: O nosso grupo de doentes é semelhante a outros de maiores dimensões e cariz internacional e, mais especificamente, enquadra-se nas características dos doentes registados nos registos Scleroderma Trials and Research group. Conclusão: O registo Scleroderma Trials and Research group incentivou uma caracterização sistemática e pode revelar-se um veículo para a criação de registos mais homogéneos.

[Analysis on the trend of innovation and development in the field of ophthalmology].

Objective: To systematically analyze the innovation and development trend in the field of ophthalmology. Methods: The latest ophthalmology funding program from the National Eye Institute and National Natural Science Foundation of China, and funding project for 2012 to 2016 from the National Institutes of Health, National Natural Science Foundation of China and National key research and development plan of China was collected. Using the comparative analysis method, the major ophthalmology funding areas at home and abroad were analyzed. Papers published in 2012 to 2016 in the field of ophthalmology were collected from the Web of Science Core Collection, among which ESI highly cited papers and hot papers were particularly selected. Using bibliometric methods, the time trend of the number of papers and the citation frequency were analyzed. Using the co-occurrence cluster analysis method, the continued focuses and emerging concerns of ophthalmology papers was analyzed. Results: The funding plan of the National Eye Institute mainly covers nine major diseases in ophthalmology. NSFC focuses on retinal damage and repair mechanisms. The National Key Research and Development Program of China focuses on research on high-end ophthalmic implants. NIH continues to focus on the molecular mechanisms of blinding eye disease such as diabetic retinopathy, age-related macular degeneration, glaucoma, corneal disease and cataracts, basic research in genetics, and advanced diagnostic techniques such as imaging. Latest areas of interest involve gene editing techniques and the application of stem cell technology in ophthalmology. In China, research and application of stem cells in ophthalmic diseases, intraocular sustained-release drug carrier, and precision medicine research in ophthalmology are emerging areas of funding. In 2012 to 2016, research topics of 168 papers collected by ESI focused on macular degeneration, retinal diseases, glaucoma and other eye diseases. How to quickly promote new drugs and new technological achievements to the clinical application is a problem in the field of ophthalmology. How to change the ophthalmology clinic model, so as to provide patients with convenient and quality service, has become a research topic that needs to be given attention to. Conclusions: Based on the multidimensional analysis of innovation and development in the field of ophthalmology, cross application and integration of ophthalmology and high - tech fields such as advanced imaging technology, stem cell technology, gene editing technology, molecular targeting, and artificial intelligence will provide a strong basis for the enhancement of China's ophthalmology research innovation and international competitiveness. Research efforts for ophthalmic transformation should be strengthened, in order to realize the clinical application of the achievements as soon as possible. (Chin J Ophthalmol, 2018, 54: 452-463).

Establishment of neonatal homogeneity platform for clinical and scientific research / 中华围产医学杂志

Neonatal medicine in China has been developing rapidly in recent years,but there is a considerable gap in clinical statistics and studies between China and developed countries.Since 1990s,some international neonatal homogeneity platforms such as the Vermont-Oxford Network and the Canadian Neonatal Network,in which a unified collaboration network database was applied,have been established to share the homogeneous data of all network databases in neonatal clinical and scientific research.These platforms have greatly promoted the progress of neonatal clinical studies in both Europe and America.Yet,we have not seen great breakthroughs in clinical big data analysis in neonatal medicine in China.Here,we discussed the critical role of establishing neonatal homogeneity platform in clinical and scientific research.

Educación continua: bases de datos biomédicas II: Medline/PubMed / Continuing education: biomedical databases II: Medline/PubMed

MEDLINE/PubMed es una de las bases de datos de bibliografía biomédica más grandes e importantes y el principal componente de PUbMed que cubre las áreas de medicina, enfermería, odontología, veterinaria, sistemas de salud y ciencias preclínicas. La interfaz de PubMed permite realizar búsquedas, no solamente en Medline, sino también en otras 35 bases de datos del NCBI (Centro Nacional para la Información Biotecnológica). Medline fue desarrollado por la Biblioteca Nacional de Medicina de los Estados Unidos (NLM), que forma parte del Instituto Nacional de Salud (NIH). En esta sexta entrega de educación continua se describen la estructura, el funcionamiento y las características de los principales componentes de Medline/PubMed que permitirán al usuario realizar una búsqueda bibliográfica más eficiente.

MEDLINE / PubMed is one of the largest and most important biomedical bibliographic databases and the main component of PUbMed that covers the areas of medicine, nursing, dentistry, veterinary, health systems and preclinical sciences. The PubMed interface allows searching not only of Medline, but also of another 35 NCBI (National Center for Biotechnology Information) databases. Medline was developed by the National Library of Medicine of the United States (NLM), which is part of the National Institute of Health (NIH). This sixth edition of continuing education describes the structure, operation and characteristics of the main components of Medline / PubMed that will allow the user to perform a more efficient bibliographic search.

The 'One in a Million' study: creating a database of UK primary care consultations.

BACKGROUND: Around 1 million primary care consultations happen in England every day. Despite this, much of what happens in these visits remains a 'black box'. AIM: To create an archive of videotaped consultations and linked data based on a large sample of routine face-to-face doctor-patient consultations with consent for use in future research and training. DESIGN AND SETTING: Cross-sectional study in 12 general practices in the west of England, UK. METHOD: Up to two GPs from each practice took part in the study. Over 1 to 2 days, consecutive patients were approached until up to 20 eligible patients for each GP consented to be videotaped. Eligible patients were aged ≥18 years, consulting on their own behalf, fluent in English, and with capacity to consent. GP questionnaires were self-administered. Patient questionnaires were self-administered immediately pre-consultation and post-consultation, and GPs filled in a checklist after each recording. A follow-up questionnaire was sent to patients after 10 days, and data about subsequent related consultations were collected from medical records 3 months later. RESULTS: Of the 485 patients approached, 421 (86.8%) were eligible. Of the eligible patients, 334 (79.3%) consented to participate and 327 consultations with 23 GPs were successfully taped (307 video, 20 audio-only). Most patients (n = 300, 89.8%) consented to use by other researchers, subject to specific ethical approval. CONCLUSION: Most patients were willing to allow their consultations to be videotaped, and, with very few exceptions, to allow recordings and linked data to be stored in a data repository for future use for research and training.

Review of the Registration in the Clinical Research Information Service.

Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement.

Review of the Registration in the Clinical Research Information Service

Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement.

Comparison of the short-term risk of bleeding and arterial thromboembolic events in nonvalvular atrial fibrillation patients newly treated with dabigatran or rivaroxaban versus vitamin K antagonists: a French nationwide propensity-matched cohort study.

BACKGROUND: The safety and effectiveness of non-vitamin K antagonist (VKA) oral anticoagulants, dabigatran or rivaroxaban, were compared with VKA in anticoagulant-naive patients with nonvalvular atrial fibrillation during the early phase of anticoagulant therapy. METHODS AND RESULTS: With the use of the French medico-administrative databases (SNIIRAM and PMSI), this nationwide cohort study included patients with nonvalvular atrial fibrillation who initiated dabigatran or rivaroxaban between July and November 2012 or VKA between July and November 2011. Patients presenting a contraindication to oral anticoagulants were excluded. Dabigatran and rivaroxaban new users were matched to VKA new users by the use of 1:2 matching on the propensity score. Patients were followed for up to 90 days until outcome, death, loss to follow-up, or December 31 of the inclusion year. Hazard ratios of hospitalizations for bleeding and arterial thromboembolic events were estimated in an intent-to-treat analysis using Cox regression models. The population was composed of 19 713 VKA, 8443 dabigatran, and 4651 rivaroxaban new users. All dabigatran- and rivaroxaban-treated patients were matched to 16 014 and 9301 VKA-treated patients, respectively. Among dabigatran-, rivaroxaban-, and their VKA-matched-treated patients, 55 and 122 and 31 and 68 bleeding events and 33 and 58 and 12 and 28 arterial thromboembolic events were observed during follow-up, respectively. After matching, no statistically significant difference in bleeding (hazard ratio, 0.88; 95% confidence interval, 0.64-1.21) or thromboembolic (hazard ratio, 1.10; 95% confidence interval, 0.72-1.69) risk was observed between dabigatran and VKA new users. Bleeding (hazard ratio, 0.98; 95% confidence interval, 0.64-1.51) and ischemic (hazard ratio, 0.93; 95% confidence interval, 0.47-1.85) risks were comparable between rivaroxaban and VKA new users. CONCLUSIONS: In this propensity-matched cohort study, our findings suggest that physicians should exercise caution when initiating either non-VKA oral anticoagulants or VKA in patients with nonvalvular atrial fibrillation.

Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data.

BACKGROUND: Linking patient registries with administrative databases can enhance the utility of the databases for epidemiological and comparative effectiveness research. However, registries often lack direct personal identifiers, and the validity of record linkage using multiple indirect personal identifiers is not well understood. METHODS AND RESULTS: Using a large contemporary national cardiovascular device registry and 100% Medicare inpatient data, we linked hospitalization-level records. The main outcomes were the validity measures of several deterministic linkage rules using multiple indirect personal identifiers compared with rules using both direct and indirect personal identifiers. Linkage rules using 2 or 3 indirect, patient-level identifiers (ie, date of birth, sex, admission date) and hospital ID produced linkages with sensitivity of 95% and specificity of 98% compared with a gold standard linkage rule using a combination of both direct and indirect identifiers. CONCLUSIONS: Ours is the first large-scale study to validate the performance of deterministic linkage rules without direct personal identifiers. When linking hospitalization-level records in the absence of direct personal identifiers, provider information is necessary for successful linkage.

Validation of congenital anomaly coding in Canada's administrative databases compared with a congenital anomaly registry.

BACKGROUND: Congenital anomaly (CA) surveillance provides epidemiologic data that are necessary for health planning. Approaches to CA surveillance vary; however, an increasing number of jurisdictions rely on administrative health databases for case ascertainment. This study aimed to assess the validity of CA coding in three administrative databases compared with a CA registry. METHODS: A cohort of 5862 live and stillborn infants from Calgary Alberta Canada was created through linking 12 clinical and administrative databases. Diagnostic codes for all health care contacts (hospitalizations, emergency room visits, out-patient physician visits) in the first 3 months of life were examined for relevant International Classification of Disease codes. Sensitivity, positive predictive values, and kappa coefficients were calculated, and data from the Alberta Congenital Anomalies Surveillance System was used as the reference standard. RESULTS: The ability of administrative data to accurately ascertain CAs varied by data source and the specificity of the diagnosis. Consistently, hospitalization data out-performed other administrative data sources in terms of sensitivity, positive predictive values, and kappa. Kappa scores for CAs easily visible at birth ranged from moderate (0.62 for emergency room visits and 0.65 for out-patient physician claims) to good (0.83 for hospitalization data) depending on the data source. CONCLUSION: The validity of CA coding in administrative databases compared with a CA registry varies by database used and by CA studied. This has important implications for national surveillance efforts. Condition-specific validity should be assessed locally before use of these data sources for research or planning purposes.