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Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients.
Chang HC, Tzou DT, Usawachintachit M, Duty BD, Hsi RS, Harper JD, Sorensen MD, Stoller ML, Sur RL, Chi T
(2016) J Endourol 30: 1332-1338
MeSH Terms: Automation, Biomedical Research, Canada, China, Data Collection, Databases, Factual, Female, Humans, International Cooperation, Japan, Kidney, Kidney Calculi, Male, Middle Aged, Outcome Assessment (Health Care), Prospective Studies, Registries, United States, Ureter, Ureteral Calculi, Ureterolithiasis, Urolithiasis
Show Abstract · Added January 16, 2018
OBJECTIVES - Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database-the Registry for Stones of the Kidney and Ureter (ReSKU™)-was developed, and herein we describe our implementation outcomes.
MATERIALS AND METHODS - Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU.
RESULTS - The number of variables within each instrument includes the following: New patient-60, Surgery-80, Postoperative-64, and Follow-up-64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient-12.06 ± 2.30, Postoperative-7.18 ± 1.02, and Follow-up-8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient-4.09 ± 1.73, Postoperative-1.41 ± 0.41, and Follow-up-0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated.
CONCLUSIONS - ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease.
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22 MeSH Terms
RePORT International: Advancing Tuberculosis Biomarker Research Through Global Collaboration.
Hamilton CD, Swaminathan S, Christopher DJ, Ellner J, Gupta A, Sterling TR, Rolla V, Srinivasan S, Karyana M, Siddiqui S, Stoszek SK, Kim P
(2015) Clin Infect Dis 61Suppl 3: S155-9
MeSH Terms: Biological Specimen Banks, Biomarkers, Biomedical Research, Brazil, Humans, India, Indonesia, International Cooperation, Prospective Studies, Specimen Handling, Tuberculosis
Show Abstract · Added February 17, 2016
Progress in tuberculosis clinical research is hampered by a lack of reliable biomarkers that predict progression from latent to active tuberculosis, and subsequent cure, relapse, or failure. Regional Prospective Observational Research in Tuberculosis (RePORT) International represents a consortium of regional cohorts (RePORT India, RePORT Brazil, and RePORT Indonesia) that are linked through the implementation of a Common Protocol for data and specimen collection, and are poised to address this critical research need. Each RePORT network is designed to support local, in-country tuberculosis-specific data and specimen biorepositories, and associated research. Taken together, the expected results include greater global clinical research capacity in high-burden settings, and increased local access to quality data and specimens for members of each network and their domestic and international collaborators. Additional networks are expected to be added, helping to spur tuberculosis treatment and prevention research around the world.
© The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
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11 MeSH Terms
World Molecular Imaging Congress 2015: precision medicine visualized.
Manning HC
(2015) Mol Imaging Biol 17: 295-6
MeSH Terms: Congresses as Topic, Hawaii, Humans, International Cooperation, Molecular Imaging, Precision Medicine
Added September 30, 2015
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6 MeSH Terms
The Society for Vascular Medicine: the first quarter century.
Creager MA, Hiatt WR, Hirsch AT, Olin JW, Jaff MR, Cooke JP, Rooke T, Beckman JA, Froehlich JB
(2015) Vasc Med 20: 60-8
MeSH Terms: Anniversaries and Special Events, Biomedical Research, Cardiology, Cooperative Behavior, History, 20th Century, History, 21st Century, Humans, Interdisciplinary Communication, International Cooperation, Societies, Medical, Vascular Diseases
Show Abstract · Added January 15, 2016
The Society for Vascular Medicine was founded in 1989. During the subsequent 25 years, the Society has grown to approximately 500 members and has achieved international recognition while making important contributions to vascular disease education, clinical vascular medicine and biology research, and patient care. In celebration of the Society's 25th anniversary, its past and current presidents reflect on the Society's history, challenges, and achievements, and emphasize the vital role of the SVM in the discipline of vascular medicine.
© The Author(s) 2015.
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11 MeSH Terms
Training programs within global networks: lessons learned in the Fogarty International Clinical Research Scholars and Fellows Program.
Carothers CL, Heimburger DC, Schlachter S, Gardner P, Primack A, Warner TL, Vermund SH
(2014) Am J Trop Med Hyg 90: 173-9
MeSH Terms: Biomedical Research, Fellowships and Scholarships, Humans, International Cooperation, National Institutes of Health (U.S.), United States
Show Abstract · Added March 28, 2014
The Fogarty International Clinical Research Scholars and Fellows Support Center at Vanderbilt describes administrative lessons learned from the management of 436 scholars (American students or host country junior trainees) and 122 post-doctoral fellows (Americans or host country nationals). Trainees spent 10-11 months working on mentored research projects at 61 well-vetted sites in 27 low- or middle-income host countries (LMICs) with strong US partners. Economies of scale, strong centralized information exchange, and effective standardized operations linking US institutions with LMIC field sites were achieved in a program that minimized administrative overhead. Advantages and drawbacks of this approach are presented and discussed. Training of a new generation of global research leaders is greatly facilitated by an overseas mentored research experience that is administratively streamlined to optimize the use of resources for training, research, and capacity building.
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6 MeSH Terms
The usefulness of a yearly head and neck surgery trip to rural Kenya.
Pearce EC, Mainthia R, Freeman KL, Mueller JL, Rohde SL, Netterville JL
(2013) Otolaryngol Head Neck Surg 149: 727-32
MeSH Terms: Adolescent, Adult, Aged, 80 and over, Child, Child, Preschool, Cleft Lip, Cleft Palate, Developing Countries, Female, Follow-Up Studies, Health Services Needs and Demand, Humans, Incidence, Infant, International Cooperation, Kenya, Male, Middle Aged, Neck, Prospective Studies, Reconstructive Surgical Procedures, Rural Population, Time Factors, Travel, Young Adult
Show Abstract · Added March 7, 2014
OBJECTIVE - Surgical specialty trips to third world countries have been praised and criticized. Our objective was to learn the usefulness of a yearly head and neck surgery trip through initial analysis of 2 years of patient data.
METHODS - We reviewed data from a prospectively maintained repository of surgical patients treated during head and neck surgical trips to Malindi, Kenya, in 2010 and 2011. Basic demographics, distance traveled for care, access to physicians, preoperative diagnosis, surgical procedure(s), and pathology were recorded when available.
RESULTS - In 2 years, 226 surgeries were performed. Patient age ranged between 3 months and 85 years, and gender was evenly split. Half of patients came from outside the town of Malindi, and a third traveled over 100 kilometers for care. The majority reported access to a local physician, yet very few patients were offered prior surgical treatment. The most common operations performed were adenotonsillectomy and hemithyroidectomy. A wide variety of cases were performed, including parotidectomies, maxillectomies, mandibulectomies, cleft lip and palate repair, and free flap reconstructions. Local and national visiting otolaryngologist-head and neck surgeons participated or observed throughout our visits with teaching emphasis based on their skills and specific learning goals.
CONCLUSIONS - Annual surgical specialty trips to rural, resource-limited regions are useful and worthwhile and offer procedures not otherwise available. On such trips, it is important to collect patient, surgical, and pathology data to help visiting surgeons determine the best procedures to teach local physicians and provide needed resources.
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25 MeSH Terms
Data set for reporting of lung carcinomas: recommendations from International Collaboration on Cancer Reporting.
Jones KD, Churg A, Henderson DW, Hwang DM, Ma Wyatt J, Nicholson AG, Rice AJ, Washington MK, Butnor KJ
(2013) Arch Pathol Lab Med 137: 1054-62
MeSH Terms: Australasia, Canada, Cooperative Behavior, Databases, Factual, Female, Humans, International Cooperation, Lung Neoplasms, Male, Pathology, Clinical, Research Design, Societies, Medical, United Kingdom, United States
Show Abstract · Added April 12, 2016
CONTEXT - The International Collaboration on Cancer Reporting (ICCR) is a quadripartite alliance formed by the Royal College of Pathologists of Australasia, the Royal College of Pathologists of the United Kingdom, the College of American Pathologists, and the Canadian Partnership Against Cancer. The ICCR was formed with a view to reducing the global burden of cancer data set development and reduplication of effort by different international institutions that commission, publish, and maintain standardized cancer-reporting data sets. The resultant standardization of cancer reporting would be expected to benefit not only those countries directly involved in the collaboration but also others not in a position to develop their own data sets.
OBJECTIVES - To develop an evidence-based reporting data set for each cancer site.
DESIGN - A project to develop data sets for prostate, endometrium, and lung cancers and malignant melanoma was piloted by the quadripartite group.
RESULTS - A set of required and recommended data elements and appropriate responses for each element were agreed upon for the reporting of lung cancer.
CONCLUSIONS - This review describes the process of development of the lung cancer data set.
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14 MeSH Terms
Genome-wide association study of Tourette's syndrome.
Scharf JM, Yu D, Mathews CA, Neale BM, Stewart SE, Fagerness JA, Evans P, Gamazon E, Edlund CK, Service SK, Tikhomirov A, Osiecki L, Illmann C, Pluzhnikov A, Konkashbaev A, Davis LK, Han B, Crane J, Moorjani P, Crenshaw AT, Parkin MA, Reus VI, Lowe TL, Rangel-Lugo M, Chouinard S, Dion Y, Girard S, Cath DC, Smit JH, King RA, Fernandez TV, Leckman JF, Kidd KK, Kidd JR, Pakstis AJ, State MW, Herrera LD, Romero R, Fournier E, Sandor P, Barr CL, Phan N, Gross-Tsur V, Benarroch F, Pollak Y, Budman CL, Bruun RD, Erenberg G, Naarden AL, Lee PC, Weiss N, Kremeyer B, Berrío GB, Campbell DD, Cardona Silgado JC, Ochoa WC, Mesa Restrepo SC, Muller H, Valencia Duarte AV, Lyon GJ, Leppert M, Morgan J, Weiss R, Grados MA, Anderson K, Davarya S, Singer H, Walkup J, Jankovic J, Tischfield JA, Heiman GA, Gilbert DL, Hoekstra PJ, Robertson MM, Kurlan R, Liu C, Gibbs JR, Singleton A, North American Brain Expression Consortium, Hardy J, UK Human Brain Expression Database, Strengman E, Ophoff RA, Wagner M, Moessner R, Mirel DB, Posthuma D, Sabatti C, Eskin E, Conti DV, Knowles JA, Ruiz-Linares A, Rouleau GA, Purcell S, Heutink P, Oostra BA, McMahon WM, Freimer NB, Cox NJ, Pauls DL
(2013) Mol Psychiatry 18: 721-8
MeSH Terms: Adolescent, Adult, Attention Deficit Disorder with Hyperactivity, Case-Control Studies, Chromosomes, Human, Pair 9, European Continental Ancestry Group, Female, Fibrillar Collagens, Genetic Predisposition to Disease, Genome-Wide Association Study, Genotype, Humans, International Cooperation, Male, Meta-Analysis as Topic, Obsessive-Compulsive Disorder, Polymorphism, Single Nucleotide, Tourette Syndrome, Young Adult
Show Abstract · Added February 22, 2016
Tourette's syndrome (TS) is a developmental disorder that has one of the highest familial recurrence rates among neuropsychiatric diseases with complex inheritance. However, the identification of definitive TS susceptibility genes remains elusive. Here, we report the first genome-wide association study (GWAS) of TS in 1285 cases and 4964 ancestry-matched controls of European ancestry, including two European-derived population isolates, Ashkenazi Jews from North America and Israel and French Canadians from Quebec, Canada. In a primary meta-analysis of GWAS data from these European ancestry samples, no markers achieved a genome-wide threshold of significance (P<5 × 10(-8)); the top signal was found in rs7868992 on chromosome 9q32 within COL27A1 (P=1.85 × 10(-6)). A secondary analysis including an additional 211 cases and 285 controls from two closely related Latin American population isolates from the Central Valley of Costa Rica and Antioquia, Colombia also identified rs7868992 as the top signal (P=3.6 × 10(-7) for the combined sample of 1496 cases and 5249 controls following imputation with 1000 Genomes data). This study lays the groundwork for the eventual identification of common TS susceptibility variants in larger cohorts and helps to provide a more complete understanding of the full genetic architecture of this disorder.
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19 MeSH Terms
"Global networks, alliances and consortia" in global health education-the case for south-to-south partnerships.
Eichbaum Q, Nyarango P, Bowa K, Odonkor P, Ferrão J, Mashalla Y, Vainio O, Vermund SH
(2012) J Acquir Immune Defic Syndr 61: 263-4
MeSH Terms: Africa, Education, Medical, HIV Infections, Humans, International Cooperation, United States
Added March 5, 2014
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6 MeSH Terms
Measuring the quality of observational study data in an international HIV research network.
Duda SN, Shepherd BE, Gadd CS, Masys DR, McGowan CC
(2012) PLoS One 7: e33908
MeSH Terms: Adult, Anti-HIV Agents, Cohort Studies, Data Collection, Databases, Factual, Female, HIV, HIV Infections, Humans, International Cooperation, Latin America, Male, Medical Audit, Observation, Quality Control, United States
Show Abstract · Added January 20, 2015
Observational studies of health conditions and outcomes often combine clinical care data from many sites without explicitly assessing the accuracy and completeness of these data. In order to improve the quality of data in an international multi-site observational cohort of HIV-infected patients, the authors conducted on-site, Good Clinical Practice-based audits of the clinical care datasets submitted by participating HIV clinics. Discrepancies between data submitted for research and data in the clinical records were categorized using the audit codes published by the European Organization for the Research and Treatment of Cancer. Five of seven sites had error rates >10% in key study variables, notably laboratory data, weight measurements, and antiretroviral medications. All sites had significant discrepancies in medication start and stop dates. Clinical care data, particularly antiretroviral regimens and associated dates, are prone to substantial error. Verifying data against source documents through audits will improve the quality of databases and research and can be a technique for retraining staff responsible for clinical data collection. The authors recommend that all participants in observational cohorts use data audits to assess and improve the quality of data and to guide future data collection and abstraction efforts at the point of care.
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16 MeSH Terms