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• W2893327716 abstract "Glomerular kidney disorders account for a significant proportion of chronic kidney disease and end-stage renal disease worldwide. Nevertheless, major obstacles make breakthrough progress in diagnosis and cure an ongoing challenge. Here we report the creation of a “grassroots” initiative that aims to provide new opportunities for nephrologists, pathologists, basic and clinical scientists, patients, and industry partners to collaborate in the field of glomerular kidney disease. Members of the medical community, including trainees, nephrologists, and nephropathologists, can participate in the open-access, Web-based, multidisciplinary clinical video case conferences, which provide “peer-to-peer” exchange of clinical and pathological expertise combined with a formal didactic curriculum. Participants can also join other aspects of the broader initiative. These include the participation in a multisite research study to facilitate enrollment of patients into a longitudinal clinical data and biorepository for glomerular kidney disorders. Items included in this prospective registry include the following: an ontology-based patient medical history, which is regularly updated; interval collection and storage of blood and urine samples; DNA collection; and a contact registry for patients who wish to participate in clinical trials. Participating sites and external scientists can leverage access to the database to pursue genetic, biomarker, epidemiological, and observational clinical effectiveness studies. Patients can independently sign up for a supplementary contact registry to participate in clinical trials if eligible. The broad spectrum of activities within this initiative will foster closer collaboration among trainees, practicing nephrologists, pathologists, and researchers, and may help to overcome some of the barriers to progress in the field of glomerular kidney disease. Glomerular kidney disorders account for a significant proportion of chronic kidney disease and end-stage renal disease worldwide. Nevertheless, major obstacles make breakthrough progress in diagnosis and cure an ongoing challenge. Here we report the creation of a “grassroots” initiative that aims to provide new opportunities for nephrologists, pathologists, basic and clinical scientists, patients, and industry partners to collaborate in the field of glomerular kidney disease. Members of the medical community, including trainees, nephrologists, and nephropathologists, can participate in the open-access, Web-based, multidisciplinary clinical video case conferences, which provide “peer-to-peer” exchange of clinical and pathological expertise combined with a formal didactic curriculum. Participants can also join other aspects of the broader initiative. These include the participation in a multisite research study to facilitate enrollment of patients into a longitudinal clinical data and biorepository for glomerular kidney disorders. Items included in this prospective registry include the following: an ontology-based patient medical history, which is regularly updated; interval collection and storage of blood and urine samples; DNA collection; and a contact registry for patients who wish to participate in clinical trials. Participating sites and external scientists can leverage access to the database to pursue genetic, biomarker, epidemiological, and observational clinical effectiveness studies. Patients can independently sign up for a supplementary contact registry to participate in clinical trials if eligible. The broad spectrum of activities within this initiative will foster closer collaboration among trainees, practicing nephrologists, pathologists, and researchers, and may help to overcome some of the barriers to progress in the field of glomerular kidney disease. Diabetic glomerulopathy together, with other, less common forms of glomerular disorders, account for ∼64% of the prevalent end-stage renal disease (ESRD) patient population in China,1Zuo L. Wang M. Chinese Association of Blood Purification Management of Chinese Hospital Association. Current burden and probable increasing incidence of ESRD in China.Clin. Nephrol. 2010; 74 (S20-22)PubMed Google Scholar ∼60% in India,2Sakhuja V. Jha V. Ghosh A.K. et al.Chronic renal failure in India.Nephrol Dial Transplant. 1994; 9: 871-872PubMed Google Scholar ∼59% Australia/New Zealand,3Australia and New Zealand Dialysis and Transplant Registry, 37th Annual Report. Adelaide: 2014.Google Scholar ∼54% in the United States,4United States Renal Data System2017 USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD2017Google Scholar and ∼38% in Europe.5Kramer A. Pippias M. Noordzij M. et al.The European Renal Association–European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report 2015: a summary.Clin Kidney J. 2018; 11: 108-122Crossref PubMed Scopus (146) Google Scholar Yet, even this majority of glomerulopathies among all causes of ESRD is still likely to be an underestimate. Not all patients are formally diagnosed through a biopsy, leading to a high degree of uncertainty with regard to the underlying cause of ESRD in registry data.4United States Renal Data System2017 USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD2017Google Scholar Furthermore, a positive relationship between the rate of renal biopsy and the number of glomerulonephritis diagnoses was shown by Fiorentino et al,.6Fiorentino M. Bolignano D. Tesar V. et al.Renal biopsy in 2015—from epidemiology to evidence-based indications.Am J Nephrol. 2016; 43: 1-19Crossref PubMed Scopus (80) Google Scholar suggesting that prevalence reports are influenced by practice pattern (sampling bias) and that the actual disease prevalence may indeed be higher than widely assumed. In addition, a sizeable portion of patients are likely misclassified as having “hypertensive nephropathy” (or the equivalent tissue diagnosis of “hypertensive nephrosclerosis”), when indeed the primary cause of ESRD is due to a focal segmental glomerulosclerosis lesion related to the presence of high-risk APOL1 alleles, or other yet poorly understood glomerulopathies.4United States Renal Data System2017 USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD2017Google Scholar, 7Longenkecker J.C. Coresh J. Klag M.J. et al.Validation of comorbid conditions on the End-Stage Renal Disease Medical Evidence Report: the CHOICE Study.J Am Soc Nephrol. 2000; 11: 520-529PubMed Google Scholar Within the wider group of glomerulopathies, diabetic nephropathy, although responsible for a sizeable portion of ESRD cases, has repeatedly been shown to be overestimated as the underlying cause of kidney disease, masking the true prevalence of other less common primary and secondary forms of glomerulonephritis.8Fiorentino M. Bolignano D. Tesar V. et al.Renal biopsy in patients with diabetes: a pooled meta-analysis of 48 studies.Nephrol Dial Transplant. 2017; 32: 97-110PubMed Google Scholar These less common forms of glomerulopathies include IgA nephropathy, focal segmental glomerulosclerosis, membranous nephropathy, lupus nephritis, pauci-immune glomerulonephritis, immunotactoid and fibrillary glomerulonephritis, and a plethora of other, newly described inherited or acquired disorders.9Hebert L.A. Parikh S. Prosek J. et al.Differential diagnosis of glomerular disease: a systematic and inclusive approach.Am J Nephrol. 2013; 38: 253-256Crossref PubMed Scopus (0) Google Scholar Each individual disease has a reported incidence of <0.1 to 2.5 per 100,000 and a prevalence of approximately 3 to 20 patients per million population.10McGrogan A. Franssen C.F.M. de Vries C.S. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature.Nephrol Dial Transplant. 2011; 26: 414-430Crossref PubMed Scopus (316) Google Scholar, 11Braun N. Schweisfurth A. Lohöfener C. et al.Epidemiology of glomerulonephritis in northern Germany.Int Urol Nephrol. 2011; 43: 1117-1126Crossref PubMed Scopus (31) Google Scholar Therefore, each represents a rare disorder according to the Orphan Drug Act from 1983 and the Rare Disease Act of 2002.12US Congress. Orphan Drug Act. 96 Stat. 2, Public Law 97-414; 1983.Google Scholar, 13US Congress. An act to amend the Public Health Service Act to establish an Office of Rare Diseases at the National Institutes of Health, and for other purposes. H.R. 4013, Public Law 107-280; 2002.Google Scholar This designation highlights the unmet need in understanding and treating glomerulopathies, and makes the research and drug development for these disorders a priority for the medical community.14Griggs R.C. Batshaw M. Dunkle M. et al.Clinical research for rare disease: opportunities, challenges, and solutions.Mol Genet Metab. 2009; 96: 20-26Crossref PubMed Scopus (255) Google Scholar These rare and highly heterogeneous presentations of glomerular disorders are not only a challenge during the clinical and pathology training years, but they also pose a significant barrier to the conduct of large observational studies and clinical trials. Here we report the creation of a platform in which nephrologists, nephropathologists, and basic scientists come together to share experiences, to participate in medical education, and to conduct translational research activities in the field of glomerular kidney disorders. This study aims to create a network of clinicians and pathologists who can share their experience to increase each one’s exposure to rare glomerular disorders, enhance trainees’ education, and combine their patients to establish large patient cohorts to overcome challenges in glomerular disease research. This international initiative, referred to as the “Glomerular Disease Study and Trial Consortium,” is not restricted to any a priori selected center(s), but goes beyond the institutional framework to encourage the active participation of small nonacademic medical centers, community practices, and individual physicians. The Glomerular Disease Study and Trial Consortium has 3 focus areas: Clinical practice support, education, and research. Several interconnected platforms aim to create opportunities for members to participate in any of the 3 focus areas. Membership is open to trainees, nephrologists, nephropathologists, scientists, and industry partners. Projects within the consortium are initiated and shaped by the members (Figure 1). Platforms within this consortium include:•Tumor board−like case reviews and continuing medical education•Public awareness campaigns•Creation of interconnected patient registries and biorepositories•Supporting design and conduct of long-term observational studies•Contact registry for enrollment of patients into clinical trials•Synchronized treatment protocols In their day-to-day practice, clinicians often consult informally with their peers on diagnostic and therapeutic questions. Commonly referred to as “curbside consultation,” this informal yet case-based interaction with colleagues enjoys broad approval among physicians.15Keating N.L. Zaslavsky A.M. Ayanian J.Z. Physicians’ experiences and beliefs regarding informal consultation.JAMA. 1998; 280 (900–194)Crossref PubMed Scopus (78) Google Scholar “Curbsiding” colleagues is not only considered helpful in diagnostic and therapeutic decision making, and hence improving patient care, but is also considered an important opportunity for professional development and medical education, and is an enjoyable aspect of a physician’s work activity.15Keating N.L. Zaslavsky A.M. Ayanian J.Z. Physicians’ experiences and beliefs regarding informal consultation.JAMA. 1998; 280 (900–194)Crossref PubMed Scopus (78) Google Scholar, 16Kuo D. Gifford D.R. Stein M.D. Curbside consultation practices and attitudes among primary care physicians and medical subspecialists.JAMA. 1998; 280: 905-909Crossref PubMed Scopus (120) Google Scholar, 17Cook D.A. Sorensen K.J. Wilkinson J.M. Value and process of curbside consultations in clinical practice: a grounded theory study.Mayo Clin Proc. 2014; 89: 602-614Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar It is especially necessary for those in lone practice. Because of the inherent diagnostic and therapeutic uncertainties, the management of patients with glomerular kidney disorders is especially conducive to curbside consultations. In this field, colleagues with a similar level of experience often seek each other’s opinion when caring for patients either with a challenging presentation, or a rare entity that a given nephrologist may only see a handful of times over the course of a career. Frequent and ongoing communication with nephropathologists also provides vital support for nuanced decision making. Similarly, nephropathologists seek each other’s informal opinion on specific cases. In this initiative, we have created an opportunity for the participation in live Web-based video case conferences, which aim to bring together nephrologists and nephropathologists to review cases from their day-to-day clinical practice (Figure 2). The goal is to promote evidence-based, rather “expert-based” case-based discussions, to access pathology curbside consultation, and to provide an opportunity for all participants to stay up to date with the latest developments in the field of glomerular kidney disorders through case-based, formalized medical education. As of April 2018, nearly 600 nephrologists and nephropathologists from 51 counties have signed up to participate in the twice-monthly virtual online case conferences. Session attendance ranges between 35 and 75 participants. Access to the online conferences are open, and health care professionals wishing to join this initiative are encouraged to sign up through the main Web portal (www.glomcon.org). Cases and discussion topics are proposed by the open community on an informal basis and presented according to the order received. In recent years, several medical research areas have seen an increase in public and private funding, while funding for kidney disease research has steadily declined.18Bryan L. Ibrahim T. Zent R. Fischer M.J. The kidney research predicament.J Am Soc Nephrol. 2014; 25: 898-903Crossref PubMed Scopus (11) Google Scholar A decline in funding is considered to be a major contributor to the steady decline in the number of physicians entering a research career.19Bluestone J, Beier D, Glimcher L. The NIH is in danger of losing its edge in creating biomedical innovations. STAT News. Available at: https://www.statnews.com/2018/01/03/nih-biomedical-research-funding/. Accessed January 3, 2018.Google Scholar Because medical trainees choose their careers based on role models and available opportunities,20Reynolds E.E. Influencing career choice during residency.J Gen Intern Med. 1999; 14: 512-513Crossref PubMed Scopus (5) Google Scholar depriving the profession of such may be a contributor to the declining numbers of fellowship applicants, and overall may be eroding a profession in its ability to innovate and rejuvenate. HIV/AIDS and cancer are examples of diseases that have shown that the amount of funding for research does not correlate with disease burden.21Moses III, H. Matheson D.H. Cairns-Smith S. et al.The anatomy of medical research: US and international comparisons.JAMA. 2015; 313: 174-189Crossref PubMed Scopus (292) Google Scholar, 22Carter A.J.R. Nguyen C.N. A comparison of cancer burden and research spending reveals discrepancies in the distribution of research funding.BMC Public Health. 2007; 12: 526Crossref Scopus (97) Google Scholar Evidence for why such discrepancies among various medical fields exist is lacking, and one can only speculate whether funding opportunities are influenced by public awareness and disease advocacy.23Increasing public awareness.Nat Immunol. 2007; 8: 109Crossref PubMed Scopus (1) Google Scholar Medical research areas that have received outsized public awareness have also historically drawn a disproportionate amount of public and private funding. Using Google trends in search queries for example, one may find that public interest in “kidney disease” is dwarfed by “breast cancer” (Figure 3). This interest is not reflective of their prevalence and socioeconomic burden.4United States Renal Data System2017 USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD2017Google Scholar, 21Moses III, H. Matheson D.H. Cairns-Smith S. et al.The anatomy of medical research: US and international comparisons.JAMA. 2015; 313: 174-189Crossref PubMed Scopus (292) Google Scholar, 24GBD 2016 DALYs and HALE CollaboratorsGlobal, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.Lancet (London, England). 2017; 390: 1260-1344Abstract Full Text Full Text PDF PubMed Scopus (1315) Google Scholar Although public awareness and perception about disease morbidity and mortality may be an important determinant for public and private funding, it is also likely to be an important aspect in inspiring trainees toward a career in nephrology and a desire to join the force for research and innovation. This initiative aims to raise awareness about glomerular kidney disease. Through a steady stream of open-access teaching materials and ample opportunity to interact with experts in the field of glomerular kidney disease, we hope to spark curiosity and to inspire medical graduates and trainees to explore nephrology as a career choice. We have created various online portals (World Wide Web: www.glomcon.org) and social media (https://twitter.com/GlomCon and https://www.facebook.com/glomcon) through which trainees are given the opportunity to connect with senior nephrologists, nephropathologists, and scientists to discuss all matters related to glomerular kidney disease, to build a professional network, and to participate in medical education. Through this, we also hope that this platform will be a positive force for “Creating a Culture of Research”25Avins A.L. Goldberg H. Creating a culture of research.Contemp Clin Trials. 2007; 28: 557-562Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar and will provide opportunity for nephrology fellows to connect and aspire for a research- and education-oriented career. A dedicated teaching series for trainees, called GlomCon Interactive Fellows' Curriculum, has been created to enable nephrology training programs to connect and to engage in a collective learning experience. Currently, 18 training programs have signed up to provide a didactic seminar each month on a rotating basis. This initiative was awarded the 2017 American Society in Nephrology Innovations in Education Award. The low prevalence of each individual glomerular kidney disorder (except diabetic glomerulopathy), together with their highly variable clinical presentations, has made the systemic study of this disease category extremely challenging. This is not unique to glomerular disease, but applies to all rare disease conditions. Over the past several decades, disease specific human subject biorepositories and genome databases have created tremendous research opportunities for rare diseases.26De Souza Y.G. Greenspan J.S. Biobanking past, present and future: responsibilities and benefits.AIDS. 2013; 27: 303-312Crossref PubMed Scopus (158) Google Scholar, 27Groft S.C. Rubinstein Y.R. New and evolving rare diseases research programs at the National Institutes of Health.Public Health Genomics. 2013; 16: 259-267Crossref PubMed Scopus (16) Google Scholar, 28Aymé S. State of the art of rare disease activities in Europe: a EUCERD perspective.Orphanet J Rare Dis. 2012; 7: A1Crossref PubMed Scopus (4) Google Scholar Their availability to basic scientists has helped to facilitate the understanding of disease mechanisms and to identify potential therapeutic targets.14Griggs R.C. Batshaw M. Dunkle M. et al.Clinical research for rare disease: opportunities, challenges, and solutions.Mol Genet Metab. 2009; 96: 20-26Crossref PubMed Scopus (255) Google Scholar Furthermore, national and international rare disease patient registries and contact registries have made the enrollment of patients into multicenter clinical trials possible.28Aymé S. State of the art of rare disease activities in Europe: a EUCERD perspective.Orphanet J Rare Dis. 2012; 7: A1Crossref PubMed Scopus (4) Google Scholar, 29Field M.J. Boat T.F. Rare Diseases and Orphan Products. Accelerating Research and Development. National Academies Press, Washington, DC2011Google Scholar In the field of glomerular disease research, the Nephrotic Syndrome Study Network (NEPTUNE),30Gadegbeku C.A. Gipson D.S. Holzman L.B. et al.Design of the Nephrotic Syndrome Study Network (NEPTUNE) to evaluate primary glomerular nephropathy by a multidisciplinary approach.Kidney Int. 2013; 83: 749-756Abstract Full Text Full Text PDF PubMed Scopus (185) Google Scholar and the Cure Glomerulopathy Network (CureGN, https://curegn.org) have been the “trailblazers” in implementing basic and clinical research through the use of prospective patient registries and biorepositories for a select number of glomerular disorders. The British Columbia Glomerulonephritis Network and Registry (BCGN Network) is enrolling a broad category of patients with biopsy-proven glomerulonephritis into a clinical data registry.31Barbour S. Beaulieu M. Gill J. et al.An overview of the British Columbia Glomerulonephritis Network and Registry: integrating knowledge generation and translation within a single framework.BMC Nephrol. 2013; 14: 236Crossref PubMed Scopus (21) Google Scholar The aims of the BCGN Network include clinical and administrative patient care support, provider and patient education, clinical trial registration, and longitudinal observational studies. The Glomerular Disease Study and Trial Consortium will build on these efforts, and expand the enrollment into a prospective observational study of all forms of glomerular kidney disease, as defined by clinical parameters, even in the absence of a kidney biopsy (Figure 4). Our broad inclusion criteria will circumvent the inherent selection bias of biopsy registries and allow for the study of patients with glomerular disorders beginning at a much earlier disease stage. Based on level of diagnostic certainty (adjudicated consensus diagnosis among study investigators > single report, biopsy-based diagnosis > clinical diagnosis), the Glomerular Disease Study and Trial Consortium can provide distinct cohorts for “real-world” observations and validation studies in collaboration with other glomerular kidney disease registries. As opposed to a centralized database and biorepository, we are creating a spoke-and-hub pattern of participating sites, whereby centers and large clinical practices can join the initiative in a decentralized fashion. The clinical research database for this initiative is created using the Research Electronic Data Capture (REDCap) application.32Harris P.A. Taylor R. Thielke R. et al.Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support.J Biomed Inform. 2009; 42: 377-381Crossref PubMed Scopus (23149) Google Scholar This application is a Health Insurance Portability and Accountability Act (HIPAA)−compliant, Web-based platform specifically developed to support clinical research data entry and maintenance across networks. It provides user-level access control, enabling simultaneous data entry, retrieval, and exchange within multiple investigators and study sites. REDCap also allows for different levels of restricted and privileged access to the data repository, which may contain identifiable information or be removed of all personal identifiers based on level of access, nature of consent, and purpose of the query. More than 1700 data fields are included in 26 data collection forms to allow for the storage of relevant clinical data (see Supplementary Study Protocol). The Unified Medical Language System (UMLS)33Lindberg D.A. Humphreys B.L. McCray A.T. The Unified Medical Language System.Methods Inf Med. 1993; 32: 281-291Crossref PubMed Scopus (889) Google Scholar and other biomedical research ontologies34Smith B. Ashburner M. Rosse C. et al.The OBO Foundry: coordinated evolution of ontologies to support biomedical data integration.Nat Biotechnol. 2007; 25: 1251-1255Crossref PubMed Scopus (1866) Google Scholar are used to maintain consistency across sites. This standardized, ontology-driven approach to data storage will further enhance the interoperability with other research registries or observational research initiatives such as the Observational Health Data Sciences and Informatics (OHDSI).35Hripcsak G. Duke J.D. Shah N.H. et al.Observational Health Data Sciences and Informatics (OHDSI): opportunities for observational researchers.Stud Health Technol Inform. 2015; 216: 574-578PubMed Google Scholar Larger academic centers and smaller group practices with research infrastructures can adopt and implement this standardized clinical data repository and can rely on a select group of partner sites for collection and maintenance of biospecimens. This will allow for the flexible expansion of the initiative at lower cost. A contact registry will allow for inclusion of patients interested in clinical trial participation. Strong collaboration with private industry partners will not only serve clinical trial collaborations but will facilitate translational studies at an earlier stage. A steering committee composed of site Principal Investigators and sponsors (representatives of prospective funding entities, including industry sponsors or not-for-profit organizations) will guide the direction of this initiative, ensure consensus among investigators and sponsors, and oversee the scientific integrity. Currently 43 patients from a single center (Beth Israel Deaconess Medical Center, Boston, MA) are enrolled in this clinical data and biorepository, and have consented for longitudinal prospective clinical data, biospecimen, and DNA collection. Any individual or center providing care for patients with glomerular disorders who is interested in joining this study is invited to reach out to the authors for protocol solicitation, site feasibility review, and guidance for local protocol implementation. Currently, the Beth Israel Deaconess Medical Center and the University of Wisconsin (Madison, WI) are active study sites where the protocol has been implemented. This dual partnership has created a framework for further interested centers to join this collaborative effort. The overarching requirements within this framework include compliance at an organizational and individual level with all the requirements as stipulated by the regulations for human research protection, and training and compliance with the Good Clinical Practice Guidelines as outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.36International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline for Good Clinical Practice E6(R1), Step 4 version, 10 June 1996. U.S. Federal Register; 2018:83;41:8882-3.Google Scholar To satisfy the National Institutes of Health requirement of “Single IRB” (single institutional review board) policy for multisite studies,37Ervin A.M. Taylor H.A. Ehrhardt S. NIH Policy on single-IRB review—a new era in multicenter studies.N Engl J Med. 2016; 375: 2315-2317Crossref PubMed Scopus (23) Google Scholar this initiative has been implemented through the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB; https://smartirb.org), which is funded by the National Institutes of Health Clinical and Translational Science Awards (CTSA) Program, and serves to accelerate the implementation of multisite clinical studies (IRB Protocol #: 2016P000414). A steering committee, composed of site Principal Investigator, is in charge of scientific and strategic decisions pertaining to protocol development, ancillary research activities, and the future direction of this study. This study is being conducted in accordance with the Declaration of Helsinki and has been approved by the Institutional Review Board (Protocol Nr. 2016P000414). The widespread adoption of electronic health records has provided an opportunity to conduct retrospective clinical studies in a more efficient and cost-effective manner. Nevertheless, retrospective studies conducted using medical records designed for patient care are inherently prone to biases and errors.38Hripcsak G. Knirsch C. Zhou L. et al.Bias associated with mining electronic health records.J Biomed Discov Collab. 2011; 6: 48-52Crossref PubMed Google Scholar, 39Hogan W.R. Wagner M.M. Accuracy of data in computer-based patient records.J Am Med Inform Assoc. 1997; 4: 342-355Crossref PubMed Scopus (274) Google Scholar Prospectively collected clinical information, which has been obtained through patients’ medical records, is manually reviewed by study members, and predefined clinical information and patient history is entered into online accessible electronic case report forms. This process of manual review, curation, and standardized categorization can pr" @default.
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