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Revisado por pares
International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF): Rationale, Design, and Initial Descriptives
2016; Wiley; Volume: 5; Issue: 11 Linguagem: Inglês
10.1161/jaha.116.004037
ISSN2047-9980
AutoresJonathan C. Hsu, Masaharu Akao, Mitsuru Abe, Karen Anderson, Álvaro Avezum, Nathan Glusenkamp, Shun Kohsaka, Deirdre A. Lane, Gregory Y.H. Lip, Chang‐Sheng Ma, Frederick A. Masoudi, Tatjana Potpara, Teo Wee Siong, Mintu P. Turakhia, Hung‐Fat Tse, John S. Rumsfeld, Thomas M. Maddox,
Tópico(s)Cardiac Arrhythmias and Treatments
ResumoHomeJournal of the American Heart AssociationVol. 5, No. 11International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF): Rationale, Design, and Initial Descriptives Open AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessResearch ArticlePDF/EPUBInternational Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF): Rationale, Design, and Initial Descriptives Jonathan C. Hsu, MD, MAS, Masaharu Akao, MD, PhD, Mitsuru Abe, PhD, Karen L. Anderson, MA, Alvaro Avezum, MD, Nathan Glusenkamp, BA, MA, Shun Kohsaka, MD, Deirdre A. Lane, PhD, Gregory Y. H. Lip, MD, Chang‐Sheng Ma, MD, Frederick A. Masoudi, MD, MSPH, Tatjana S. Potpara, MD, PhD, Teo Wee Siong, MD, Mintu P. Turakhia, MD, MAS, Hung‐Fat Tse, MD, John S. Rumsfeld, MD, PhD and Thomas M. Maddox, MD, MSc Jonathan C. HsuJonathan C. Hsu Section of Cardiac Electrophysiology, Division of Cardiology, University of California, San Diego, La Jolla, CA , Masaharu AkaoMasaharu Akao Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan , Mitsuru AbeMitsuru Abe Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan Kanai Hospital, Kyoto, Japan , Karen L. AndersonKaren L. Anderson American College of Cardiology, Washington, DC , Alvaro AvezumAlvaro Avezum Instituto Dante Pazzanese de Cardiologia ‐ Fundação Adib Jatene, Sao Paulo, Brazil , Nathan GlusenkampNathan Glusenkamp American College of Cardiology, Washington, DC , Shun KohsakaShun Kohsaka Keio University, Tokyo, Japan , Deirdre A. LaneDeirdre A. Lane University of Birmingham Institute of Cardiovascular Science, City Hospital, Birmingham, United Kingdom , Gregory Y. H. LipGregory Y. H. Lip University of Birmingham Institute of Cardiovascular Science, City Hospital, Birmingham, United Kingdom Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark , Chang‐Sheng MaChang‐Sheng Ma Beijing Anzhen Hospital, Beijing, China , Frederick A. MasoudiFrederick A. Masoudi Department of Medicine (Cardiology), University of Colorado School of Medicine, Denver, CO Colorado Cardiovascular Outcomes Research (CCOR) Consortium, Denver, CO , Tatjana S. PotparaTatjana S. Potpara School of Medicine, Clinical Center of Serbia, Belgrade University, Belgrade, Serbia , Teo Wee SiongTeo Wee Siong The Heart Specialist Clinic, Singapore , Mintu P. TurakhiaMintu P. Turakhia VA Palo Alto Health Care System, Palo Alto, CA Stanford University School of Medicine, Stanford, CA , Hung‐Fat TseHung‐Fat Tse Cardiology Department, Department of Medicine, University of Hong Kong, HKSAR, China , John S. RumsfeldJohn S. Rumsfeld American College of Cardiology, Washington, DC Department of Medicine (Cardiology), University of Colorado School of Medicine, Denver, CO Colorado Cardiovascular Outcomes Research (CCOR) Consortium, Denver, CO and Thomas M. MaddoxThomas M. Maddox Department of Medicine (Cardiology), University of Colorado School of Medicine, Denver, CO Colorado Cardiovascular Outcomes Research (CCOR) Consortium, Denver, CO Cardiology Section, VA Eastern Colorado Health Care System, Denver, CO Originally published2 Nov 2016https://doi.org/10.1161/JAHA.116.004037Journal of the American Heart Association. 2016;5:e004037IntroductionAtrial fibrillation (AF) is a global problem with a significant impact on health outcomes, affecting up to 1% to 2% of the global adult population, and is projected to increase in both developed and developing countries over the coming decades.1 AF is associated with higher mortality and morbidity, as well as decreased quality of life, and increases the risk of thromboembolic events (including stroke), heart failure (HF), myocardial infarction, dementia, and chronic kidney disease. The mainstays of AF treatment are arrhythmia management (with pharmacologic or mechanical rate or rhythm control) and prevention of thromboembolism.2 The field of AF treatment is dynamic, with the recent development of new procedures to restore sinus rhythm (catheter and surgical ablation) and new treatments to reduce thromboembolism (target‐specific oral anticoagulants and catheter‐based exclusion of the left atrial appendage). However, there is significant global variation in use of these therapies, particularly in developing countries, and the global implementation, diffusion, and anticipated real‐world effectiveness of these technologies is uncertain.3 Therefore, a better understanding of global AF treatments, barriers and facilitators to its optimal use, and its subsequent outcomes is needed.As AF incidence and its arsenal of treatments continue to expand globally, the longitudinal and comprehensive nature of clinical registries can provide important insights into the clinical management of AF. Registries are observational databases of clinical conditions and/or therapies in which there are no mandated approaches to therapy and relatively few inclusion or exclusion criteria.4 In addition, registries can continuously collect longitudinal data on their target population, which allows them to monitor current and emerging clinical practices over time and associate them with clinical outcomes. Accordingly, current AF management practices and their associated outcomes can be measured, benchmarked to current best practices and clinical practice guidelines, and compared across different countries, populations, and healthcare systems. As novel AF treatments emerge, their dissemination globally and effect on outcomes, both intended and unintended, can be assessed.Currently, multiple AF databases and registries spanning a variety of countries, patients, treatments, and outcomes exist.5 However, coordination among these data sources is minimal. In addition, the variations in patient enrollment, data definitions, and characterization of AF therapies in each of the registries prevent effective comparison between registries and limit their ability to track changes over time. Finally, many of the current registries are sponsored by pharmaceutical or device companies, which can limit their focus on those patients and treatments associated with their products.The potential value of coordinating these disparate registry efforts is significant. More accurate and complete assessment of the treatment and outcomes of AF in various countries and populations around the world could occur. As the arsenal of AF treatments continues to expand, such a registry would allow for comparative effectiveness studies between treatments. Additionally, a global registry would allow for understanding of the impact of treatments in various patient populations and within the context of their local healthcare environments. Large registries could also utilize their size to detect infrequent, but important, safety signals of both AF and its treatment. Thus, the insights from such a registry effort could allow for richer insights into AF and sharing of best practices for its management. In addition, these insights could inform ongoing research efforts, supporting a "learning healthcare system" iterative cycle of knowledge generation from clinical practice insights.6To respond to this need, we present the International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF). This worldwide partnership, with initial participants from the United States, Europe, China, Brazil, South Korea, Taiwan, Singapore, Japan, and the Balkan countries, provides a common platform for investigators and countries to study AF populations, treatments, and outcomes. In order to allow for the integration of registries from a wide variety of countries, INTERAF utilizes a distributed data and analytic platform, rather than a single, combined registry structure. The INTERAF leadership provides general data requirements, standards, and governance policies for existing and future country‐ and region‐specific registries. This design allows for easier integration of pre‐existing registries and greater flexibility in data collection, which can lower barriers to participation, allow for an expansive view of global AF treatment and outcome patterns, and support country‐specific and international efforts to optimize the care for the large and growing population of AF patients.In this report, we present the current knowledge and gaps in global AF management and outcomes, and discuss how INTERAF can fill these gaps. We also outline the organizing principles and structure of the INTERAF partnership, and introduce its initial research agenda and future directions. Finally, we provide initial descriptive data of the participating registries and their AF populations.Global AF Prevalence and Projections for GrowthAF is a global problem, with projections for significant growth in the coming years. Although comprehensive data are lacking, the 2010 Global Burden of Disease study provides some insights, suggesting that the total number of AF patients is ≈33 million, with an age‐adjusted prevalence of 596 per 100 000 men and 373 per 100 000 women, with significant regional variation (Figure 1).1, 7Download PowerPointFigure 1. International age‐adjusted AF prevalence rates (per 100 000 population) in the 21 Global Burden of Disease regions, 2010. Figure reproduced from Chugh et al7 with permission from Wolters Kluwer Health, Inc. AF indicates atrial fibrillation.Over the coming years, AF prevalence is expected to grow significantly. Current census projections for 2050 suggest that the number of Americans, Europeans, and Japanese with AF will increase by 2‐ to 3‐fold.1 In addition, the number of people in the developing world who are older than 60 years, where AF incidence is concentrated, is projected to double by 2050 (Figure 2).1Download PowerPointFigure 2. Global AF prevalence and projected increases. Figure reproduced from Rahman et al1 with permission from Nature Publishing Group. AF indicates atrial fibrillation.Associations Between AF and Mortality, Morbidity, and Quality of LifeAF is associated with increased mortality. As AF prevalence and average lifespan increases over time, this burden will likely increase as well. In adjusted analyses from the Framingham Heart Study in the United States, AF was associated with a 50% higher risk of death among men (odds ratio 1.5, 95% CI 1.2–1.8) and a 90% higher risk of death among women (odds ratio 1.9, 95% CI 1.5–2.2).8 Globally, the age‐adjusted mortality rate, per 100 000 individuals, from AF in 2010 was 1.6 (95% CI 1–2.4) among men and 1.7 (95% CI 1.4–2.2) among women, representing a 2‐fold increase since the previous survey conducted in 1990.7 Perhaps surprisingly, AF mortality rates in the developed world were 3 to 4 times higher than the developing world (Figure 3).Download PowerPointFigure 3. Mortality associated with atrial fibrillation (AF) stratified by sex and type of region (developed vs developing). Figure reproduced from Chugh et al7 with permission from Wolters Kluwer Health, Inc.AF is also associated with significant morbidity. One of the most devastating consequences of AF is arterial thromboembolism. AF is associated with a 4 to 5 times higher risk of stroke, even after accounting for standard stroke risk factors (eg, hypertension, congestive HF, etc).9, 10 However, this risk of thromboembolism and its subsequent outcomes vary significantly among ethnic groups and geographies. For example, Americans of either Hispanic ethnicity or African‐American race appear to have higher stroke risks, despite a lower prevalence of AF relative to white individuals.8, 11 Asians with AF may have particularly high risks for stroke, potentially due to variations in both anticoagulant prescribing practices and variable genetic‐based responses to anticoagulation with warfarin.12, 13, 14, 15 Similar variation in thromboembolism risk and outcomes may also occur in other regions, but comprehensive global assessments of thromboembolism outcomes, particularly in developing countries, are lacking.AF is also associated with other causes of morbidity, including coronary artery disease, dementia, chronic kidney disease, and HF. Coronary artery disease has been associated with AF across a wide variety of ethnicities and countries.3, 10, 16, 17, 18 A US‐based study found that AF was associated with a 70% increased risk of incident myocardial infarction (hazard ratio, 1.96; 95% CI, 1.52, 2.52), with higher risks in women and blacks.19 AF has also been associated with cognitive decline and dementia. A meta‐analysis of 21 studies found decreased cognitive scores associated with AF in different populations.11 In Brazil, AF patients were 2.8 times more likely to have dementia, relative to those without AF.14 AF also is associated with chronic kidney disease. A US‐based study noted that the development of new‐onset AF in chronic kidney disease patients was associated with a 1.7 times increased risk of developing end‐stage renal disease, relative to those without AF.15 Similarly, a Japanese study found the incidence of kidney dysfunction was 18.2 per 1000 person‐years in AF patients, compared to 6.8 per 1000 person‐years in patients without AF.20 Finally, HF among AF patients is common, occurring in ≈40% of patients, and associated with increased morbidity and mortality.12 These associations between AF and HF in the developed world have also been demonstrated in the developing world. In particular, African studies have documented a 10% to 20% prevalence of AF among patients admitted to hospitals with HF.13These associations between AF, mortality, and morbidity impair overall quality of life. This effect can be estimated by a disability‐adjusted life years calculation, which adds up the years lost due to the condition with the years lived with the condition, weighted for its impact on quality of life.9 As illustrated in Figure 4, AF‐associated DALYs have consistently increased over the past 2 decades and continued increases are projected for the coming year.7Download PowerPointFigure 4. Disability‐adjusted life years (DALYs) related to AF. Estimated global age‐adjusted DALYs (per 100 000) related to atrial fibrillation: 1990 to 2010. UI indicates uncertainty index. Figure reproduced from Chugh et al7 with permission from Wolters Kluwer Health, Inc.Although these data underscore the impact that AF has on mortality, morbidity, and quality of life, a full assessment of its worldwide impact is lacking. The INTERAF initiative can address these gaps, and uncover additional insights into the impact of AF globally.Global Trends and Differences in AF TreatmentsThere are notable variations in AF treatment and outcomes between different patient and country populations. Some of this variation is due to the availability of medications and interventions that, in turn, are dependent on resource availability and differences in healthcare systems (eg, national healthcare systems, private health insurance, or a mixture of both). In general, AF treatments are directed towards symptom reduction, typically via heart rate or rhythm control, and the prevention of complications, such as arterial thromboembolism. Rate and/or rhythm‐control treatments include heart rate controlling medications, antiarrhythmic medications, electrical cardioversion, or AF ablation. Thromboembolism prevention treatments include antithrombotic medications and mechanical left atrial appendage occlusion devices.The use of rate and rhythm‐control treatments varies globally, both in the developed and developing world. In the Euro Heart Survey, 65% of AF patients received rate‐control medication, 40% received antiarrhythmic medication, and 12% received neither.21 In contrast, a German AF registry—the Central Registry of German Competence Network on Atrial Fibrillation (AFNET)—demonstrated that only 21.3% of patients received antiarrhythmic medication, but 53.4% received electrical or pharmacologic cardioversion and 5% underwent AF ablation.22 Chinese data demonstrated variable use of rate‐control treatments, partly dependent on the AF phenotype.23, 24 Among those with paroxysmal AF, 44% of patients received rate‐control treatment, compared to 83% of patients with permanent AF. These differences likely result from a variety of factors, including availability of more advanced and technically complex treatments, such as AF ablation.25 In the developing world, rate‐control treatments, particularly digoxin, dominate the use of antiarrhythmic medications, given their low cost and wide availability. For example, recent surveys of AF treatments in Cameroon found that 83% of patients were being treated with rate‐control medications, with over 60% receiving digoxin.26 Similarly, over 50% of Kenyan patients on rate‐control therapy were receiving digoxin.27 However, better characterization of rate‐control treatments, especially in developing countries, is needed. In addition, as newer technologies such as AF ablation gain traction in these countries, registries will be needed to guide their safe and effective deployment.Thromboembolic events related to AF are significantly reduced with the use of anticoagulation therapies. However, large variations occur in its provision and effect among various populations. For example, despite the recommendation that patients at moderate to high risk for thromboembolism receive anticoagulation, large numbers of patients, across multiple countries, do not.3, 21, 28 Furthermore, even among those patients receiving anticoagulation with warfarin, its use is often suboptimal, with several studies demonstrating significant rates of subtherapeutic warfarin levels globally, particularly in developing countries.29, 30 Finally, certain populations appear to have higher risks of significant bleeding with anticoagulation, thus diminishing its benefit. In particular, Asian, Hispanic, and black populations all appear to have higher rates of intracranial hemorrhage on oral anticoagulation (OAC), relative to white populations.31, 32In recent years, 2 new modalities for thromboembolism prevention have emerged: direct oral anticoagulants (DOACs) and left atrial appendage occlusion devices. There is a need to understand how these new therapies will diffuse into global practice, and their impact on both thromboembolic event prevention and bleeding outcomes. DOACs have similar or better efficacy than warfarin, and have a dose‐dependent, predictable anticoagulant effect, thus enabling fixed dosing that does not require laboratory monitoring of anticoagulation intensity. In addition, DOACs have a favorable safety profile, particularly for intracranial hemorrhage. All of these characteristics are potentially attractive to regions with relatively underdeveloped healthcare systems. However, DOACs are more expensive than warfarin and, with the exception of dabigatran, cannot be easily reversed.33 These factors may limit their dissemination to the developing world. Left atrial appendage occlusion devices are an option for those patients who have absolute contraindications to OAC or completely refuse OAC, and appear to have similar efficacy to OAC in thromboembolism prevention.34 However, the safety of left atrial appendage occlusion device implantation is largely operator dependent, with better outcomes in those who perform a high number of procedures. Thus, technical complexity, as well as cost, will likely slow its dissemination to the developing world. Registries to monitor its dissemination and safety of these new therapies are needed.35The International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF)In response to this need for a more coordinated approach to AF registries, the International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF) was established. Organized by an international group of AF and clinical registry experts, INTERAF is a collaborative, international consortium of AF registries to characterize worldwide AF care and establish a foundation for ongoing efforts to optimize AF care. The goals of INTERAF are 4‐fold: Build the foundation for a sustained international collaboration to identify and address meaningful questions related to AF management and improve AF patient outcomes.Explore ways to harmonize existing and future AF registries in order to compare AF care across countries, identify gaps, and to influence and change global practice to close those gaps.Prioritize research projects focused on international quality improvement.Develop a roadmap for global AF quality improvement and educational initiatives, informed by best practices.The initial partners of INTERAF include representatives from the United States, Europe, China, Brazil, South Korea, Taiwan, Singapore, Japan, and the Balkan countries (Figure 5). Each of the partners oversees country‐ or region‐specific AF registries, and can thus inform efforts to unify their respective registries. In addition, the countries represent a variety of patient populations and healthcare systems, which can inform the technical challenges inherent in creating a unified, global AF registry. Table 1 lists the participating registries and their various characteristics.Download PowerPointFigure 5. Initial INTERAF partners, by country. APHRS indicates Asia‐Pacific Heart Rhythm Society; CAFR, Chinese Atrial Fibrillation Registry; EORP, EURObservational Research Programme, INTERAF, International Collaborative Partnership for the Study of Atrial Fibrillation; KiCs, Keio Interhospital Cardiovascular Studies; PINNACLE, Practice Innovation and Clinical Excellence.Table 1. Characteristics of the Current INTERAF Registries, as of December 31, 2015United States NCDR PINNACLE AF RegistryEuropean Society of Cardiology EURObservational Research Program (EORP) AF General RegistryChinese AF Registry (CAFR)Brazil PINNACLE AF RegistryAsia Pacific Heart Rhythm SocietyJapanese Fushimi AF RegistryJapanese Keio Interhospital Cardiovascular Studies (KiCS) AF RegistryBalkan AF RegistryPatient settingOutpatientsOutpatientsInpatients and outpatientsInpatients and outpatientsInpatients and outpatientsInpatients and outpatientsOutpatientsInpatients and outpatientsGeographic locationUnited StatesAlbania, Belgium, Czech Republic, Denmark, France, Georgia, Ireland, Israel, Italy, Kyrgystan, Kazakhstan, Lativa, Libya, Macedonia, Malta, Poland, Portugal, Romania, Russia, Serbia, Spain, Switzerland, UKChinaBrazilHong Kong, South Korea, Singapore, Japan, TaiwanJapanJapanAlbania, Bosnia & Herzegovina, Bulgaria, Croatia, Montenegro, Romania and SerbiaNumber of patients, providers, and healthcare settings927 511 patients at 1400 practice locations10 000 patients (Target enrollment: 23 000 patients)15 000 patients at 31 hospitals (Target enrollment: 20 000 patients)Target enrollment 10 000 patients (to begin enrolling in late 2015)Target enrollment 5000 patients with at least 5 centers in each country (to begin enrolling in early 2016)4426 patients at 79 participating institutions (2 cardiovascular centers, 10 rehab hospitals, 67 private clinics)1284 patients at 10 cardiovascular centers2712 patients in 49 centers (university and non‐university hospitals and health centers)Registry dates of collection2008–present2014–20162011–present2015–20172016–20172011–present2012–presentDecember 2015–February 2015Data collection methodAutomated EHR data collectionPaper‐based case report formEHR and paper data collectionEHR and paper data collectionEHR and paper data collectionEHR and paper data collectionEHR and paper data collectionElectronic case report form, backed up with paper data sourceData elements and qualityComplete data on comorbidities, medications, vital signs, and labs; partial data on event history, events between visits; CHADS2 and CHA2DS2‐VASc score calcuationComplete data on comorbidities, medications, vital signs, CHADS2 and CHA2DS2‐VASc score calculations; partial data on events at 1 yearData elements similar to US PINNACLEData elements similar to US PINNACLEComplete data on comorbidities, medications, vital signs, CHADS2 and CHA2DS2‐VASc score calculations; partial data on events at 1 yearComplete data on comorbidities, medications, vital signs, CHADS2 and CHA2DS2‐VASc score calculationsComplete data on comorbidities, medications, vital signs, CHADS2 score, CHA2DS2‐VASc score, treatment strategy, and baseline QoL data; partial data embolic events, bleeding events, and QoL at 1 and 2 yearsComplete data on patient characteristics, presentation, healthcare setting, AF management strategies, and diagnostic proceduresAvailability and characteristics of longitudinal dataLinked to longitudinal US Medicare claims dataAnnual follow‐up assessment over 3 yearsLongitudinal follow‐up assessment every 6 monthsPlanned longitudinal follow‐up assessmentAnnual follow‐up over 2 yearsAnnual follow‐up assessmentAnnual follow‐up over 2 yearsNoneOAC assessment and qualityAssessment of OAC use, including both VKA and DOACsAssessment of OAC useAssessment of OAC use, including both VKA and DOACsAssessment of OAC useAssessment of OAC useAssessment of OAC use, including both VKA and DOACsAssessment of OAC use, including both VKA and DOACsAssessment of OAC use, including both VKA and DOACsIRB approvalaNational IRB waiver; no individual patient consentPatients individually consentedPatients individually consentedNational IRB waiver; some individual patient consentPatients individually consentedInstitutional IRB waiver; no individual patient consentPatients individually consentedPatients individually consentedFeedback to registry participantsFeedback given to participating practices via performance reportsFeedback and some data monitoringFeedback to hospitals twice a yearFeedback given to participating practices via performance reportsFeedback and some data monitoringFeedback and some data monitoringFeedback provided to participating hospitals twice a yearRegular feedback to participating sitesParticipation in prospective research studiesSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededSites can participate in cohort studies, but consent neededIncentives for registry participationReceipt of feedback reports and automatic submission to Medicare for quality bonus paymentsNoneCAFR funding to hospitalsReceipt of feedback reports and quality of care certification via the American College of Cardiology and São Paulo Society of CardiologyNoneNoneFeedback reports and research projectsNoneAF indicates atrial fibrillation; DOACs, direct oral anticoagulants; EHR, electronic health record; INTERAF, International Collaborative Partnership for the Study of Atrial Fibrillation; IRB, institutional review board; OAC, oral anticoagulant; PINNACLE, Practice Innovation and Clinical Excellence; QoL, quality of life; VKA, vitamin K antagonist.aAn institutional waiver of consent has been obtained for collective analyses as all data are de‐identified and of minimal risk to any patient.A challenge for all clinical registries, particularly those that are global in scope, is organizing data collection and analytic efforts to gain meaningful insights. Simply establishing a single registry that collects the same data elements in every participating country is not feasible, given the enormous costs and logistical difficulties associated with such an effort. Instead, INTERAF will be organized as a distributed research network, similar to the National Heart, Lung, and Blood Institute–supported Cardiovascular Research Network and the Patient‐Centered Outcomes Research Institute (PCORI)‐supported PCORnet.36, 37 A distributed research network allows for data collection and local analyses to be conducted within each participating partner's infrastructure. These data are then aggregated and analyzed across partner registries. This distributed structure thus avoids the difficulties with data security, patient privacy, and governance inherent in a single registry structure. At the same time, the structure allows for greater size and power of the overall registry, an ability to assess and compare partner practice patterns, greater diversity in studied patient populations, and an opportunity to assess the heterogeneity of treatment effect in various real‐world settings. It also lowers barriers to participation in INTERAF and engages with local AF experts to best identify partner‐specific characteristics and challenges in AF management for analysis.In order to effectively manage this distributed research network, a governance structure will be established to determine the minimal data elements and standards needed for partner participation in INTERAF and the technical specifications necessary to integrate registries. Examples of necessary data elements include patient and clinical demographics, AF phenotype (eg, paroxysmal, persistent, permanent) characteristics, relevant clinical comorbidities, stroke and bleeding risk scores, AF therapies (eg, rate control, rhythm control, anticoagulation), and relevant concurrent medications. In addition, efforts to link to other longitudinal outcomes data will occur to help in understanding the impact of AF on mortality, quality of life, healthcare utilization, and costs. Once the individual registry analyses are completed, a dedicated analytic center will utilize informatics tools to merge individual analyses into an aggregated result.Ensuring effective data harmonization and quality across the partner
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