The Virginia Henderson International Nursing Library: resource for nurse administrators.

PubMed

Graves, J R

1997-01-01

This article describes the major knowledge resource of the Virginia Henderson International Nursing Library, The Registry of Nursing. The first part of this article examines informatics issues and is accompanied by examples of retrieval from a typical bibliographic database and a retrieval from the Registry of Nursing Research using case mix, both as a subject heading and as a research variable. The second part of the article examines the interaction of informatics and technology used in the Registry and presents some other Library resources.

Resource Disambiguator for the Web: Extracting Biomedical Resources and Their Citations from the Scientific Literature.

PubMed

Ozyurt, Ibrahim Burak; Grethe, Jeffrey S; Martone, Maryann E; Bandrowski, Anita E

2016-01-01

The NIF Registry developed and maintained by the Neuroscience Information Framework is a cooperative project aimed at cataloging research resources, e.g., software tools, databases and tissue banks, funded largely by governments and available as tools to research scientists. Although originally conceived for neuroscience, the NIF Registry has over the years broadened in the scope to include research resources of general relevance to biomedical research. The current number of research resources listed by the Registry numbers over 13K. The broadening in scope to biomedical science led us to re-christen the NIF Registry platform as SciCrunch. The NIF/SciCrunch Registry has been cataloging the resource landscape since 2006; as such, it serves as a valuable dataset for tracking the breadth, fate and utilization of these resources. Our experience shows research resources like databases are dynamic objects, that can change location and scope over time. Although each record is entered manually and human-curated, the current size of the registry requires tools that can aid in curation efforts to keep content up to date, including when and where such resources are used. To address this challenge, we have developed an open source tool suite, collectively termed RDW: Resource Disambiguator for the (Web). RDW is designed to help in the upkeep and curation of the registry as well as in enhancing the content of the registry by automated extraction of resource candidates from the literature. The RDW toolkit includes a URL extractor from papers, resource candidate screen, resource URL change tracker, resource content change tracker. Curators access these tools via a web based user interface. Several strategies are used to optimize these tools, including supervised and unsupervised learning algorithms as well as statistical text analysis. The complete tool suite is used to enhance and maintain the resource registry as well as track the usage of individual resources through an innovative literature citation index honed for research resources. Here we present an overview of the Registry and show how the RDW tools are used in curation and usage tracking.

Resource Disambiguator for the Web: Extracting Biomedical Resources and Their Citations from the Scientific Literature

PubMed Central

Ozyurt, Ibrahim Burak; Grethe, Jeffrey S.; Martone, Maryann E.; Bandrowski, Anita E.

2016-01-01

The NIF Registry developed and maintained by the Neuroscience Information Framework is a cooperative project aimed at cataloging research resources, e.g., software tools, databases and tissue banks, funded largely by governments and available as tools to research scientists. Although originally conceived for neuroscience, the NIF Registry has over the years broadened in the scope to include research resources of general relevance to biomedical research. The current number of research resources listed by the Registry numbers over 13K. The broadening in scope to biomedical science led us to re-christen the NIF Registry platform as SciCrunch. The NIF/SciCrunch Registry has been cataloging the resource landscape since 2006; as such, it serves as a valuable dataset for tracking the breadth, fate and utilization of these resources. Our experience shows research resources like databases are dynamic objects, that can change location and scope over time. Although each record is entered manually and human-curated, the current size of the registry requires tools that can aid in curation efforts to keep content up to date, including when and where such resources are used. To address this challenge, we have developed an open source tool suite, collectively termed RDW: Resource Disambiguator for the (Web). RDW is designed to help in the upkeep and curation of the registry as well as in enhancing the content of the registry by automated extraction of resource candidates from the literature. The RDW toolkit includes a URL extractor from papers, resource candidate screen, resource URL change tracker, resource content change tracker. Curators access these tools via a web based user interface. Several strategies are used to optimize these tools, including supervised and unsupervised learning algorithms as well as statistical text analysis. The complete tool suite is used to enhance and maintain the resource registry as well as track the usage of individual resources through an innovative literature citation index honed for research resources. Here we present an overview of the Registry and show how the RDW tools are used in curation and usage tracking. PMID:26730820

Quality assessment and improvement of nationwide cancer registration system in Taiwan: a review.

PubMed

Chiang, Chun-Ju; You, San-Lin; Chen, Chien-Jen; Yang, Ya-Wen; Lo, Wei-Cheng; Lai, Mei-Shu

2015-03-01

Cancer registration provides core information for cancer surveillance and control. The population-based Taiwan Cancer Registry was implemented in 1979. After the Cancer Control Act was promulgated in 2003, the completeness (97%) and data quality of cancer registry database has achieved at an excellent level. Hospitals with 50 or more beds, which provide outpatient and hospitalized cancer care, are recruited to report 20 items of information on all newly diagnosed cancers to the central registry office (called short-form database). The Taiwan Cancer Registry is organized and funded by the Ministry of Health and Welfare. The National Taiwan University has been contracted to operate the registry and organized an advisory board to standardize definitions of terminology, coding and procedures of the registry's reporting system since 1996. To monitor the cancer care patterns and evaluate the cancer treatment outcomes, central cancer registry has been reformed since 2002 to include detail items of the stage at diagnosis and the first course of treatment (called long-form database). There are 80 hospitals, which count for >90% of total cancer cases, involved in the long-form registration. The Taiwan Cancer Registry has run smoothly for >30 years, which provides essential foundation for academic research and cancer control policy in Taiwan. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Construction and management of ARDS/sepsis registry with REDCap.

PubMed

Pang, Xiaoqing; Kozlowski, Natascha; Wu, Sulong; Jiang, Mei; Huang, Yongbo; Mao, Pu; Liu, Xiaoqing; He, Weiqun; Huang, Chaoyi; Li, Yimin; Zhang, Haibo

2014-09-01

The study aimed to construct and manage an acute respiratory distress syndrome (ARDS)/sepsis registry that can be used for data warehousing and clinical research. The workflow methodology and software solution of research electronic data capture (REDCap) was used to construct the ARDS/sepsis registry. Clinical data from ARDS and sepsis patients registered to the intensive care unit (ICU) of our hospital formed the registry. These data were converted to the electronic case report form (eCRF) format used in REDCap by trained medical staff. Data validation, quality control, and database management were conducted to ensure data integrity. The clinical data of 67 patients registered to the ICU between June 2013 and December 2013 were analyzed. Of the 67 patients, 45 (67.2%) were classified as sepsis, 14 (20.9%) as ARDS, and eight (11.9%) as sepsis-associated ARDS. The patients' information, comprising demographic characteristics, medical history, clinical interventions, daily assessment, clinical outcome, and follow-up data, was properly managed and safely stored in the ARDS/sepsis registry. Data efficiency was guaranteed by performing data collection and data entry twice weekly and every two weeks, respectively. The ARDS/sepsis database that we constructed and manage with REDCap in the ICU can provide a solid foundation for translational research on the clinical data of interest, and a model for development of other medical registries in the future.

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

PubMed

Paxton, Elizabeth W; Kiley, Mary-Lou; Love, Rebecca; Barber, Thomas C; Funahashi, Tadashi T; Inacio, Maria C S

2013-06-01

In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

Down syndrome: national conference on patient registries, research databases, and biobanks.

PubMed

Oster-Granite, Mary Lou; Parisi, Melissa A; Abbeduto, Leonard; Berlin, Dorit S; Bodine, Cathy; Bynum, Dana; Capone, George; Collier, Elaine; Hall, Dan; Kaeser, Lisa; Kaufmann, Petra; Krischer, Jeffrey; Livingston, Michelle; McCabe, Linda L; Pace, Jill; Pfenninger, Karl; Rasmussen, Sonja A; Reeves, Roger H; Rubinstein, Yaffa; Sherman, Stephanie; Terry, Sharon F; Whitten, Michelle Sie; Williams, Stephen; McCabe, Edward R B; Maddox, Yvonne T

2011-01-01

A December 2010 meeting, "Down Syndrome: National Conference on Patient Registries, Research Databases, and Biobanks," was jointly sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) in Bethesda, MD, and the Global Down Syndrome Foundation (GDSF)/Linda Crnic Institute for Down Syndrome based in Denver, CO. Approximately 70 attendees and organizers from various advocacy groups, federal agencies (Centers for Disease Control and Prevention, and various NIH Institutes, Centers, and Offices), members of industry, clinicians, and researchers from various academic institutions were greeted by Drs. Yvonne Maddox, Deputy Director of NICHD, and Edward McCabe, Executive Director of the Linda Crnic Institute for Down Syndrome. They charged the participants to focus on the separate issues of contact registries, research databases, and biobanks through both podium presentations and breakout session discussions. Among the breakout groups for each of the major sessions, participants were asked to generate responses to questions posed by the organizers concerning these three research resources as they related to Down syndrome and then to report back to the group at large with a summary of their discussions. This report represents a synthesis of the discussions and suggested approaches formulated by the group as a whole. Copyright © 2011. Published by Elsevier Inc. All rights reserved.

Conference Proceedings: “Down Syndrome: National Conference on Patient Registries, Research Databases, and Biobanks”

PubMed Central

Oster-Granite, Mary Lou; Parisi, Melissa A.; Abbeduto, Leonard; Berlin, Dorit S.; Bodine, Cathy; Bynum, Dana; Capone, George; Collier, Elaine; Hall, Dan; Kaeser, Lisa; Kaufmann, Petra; Krischer, Jeffrey; Livingston, Michelle; McCabe, Linda L.; Pace, Jill; Pfenninger, Karl; Rasmussen, Sonja A.; Reeves, Roger H.; Rubinstein, Yaffa; Sherman, Stephanie; Terry, Sharon F.; Whitten, Michelle Sie; Williams, Stephen; McCabe, Edward R.B.; Maddox, Yvonne T.

2011-01-01

A December 2010 meeting, “Down Syndrome: National Conference on Patient Registries, Research Databases, and Biobanks,” was jointly sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) in Bethesda, MD, and the Global Down Syndrome Foundation (GDSF)/Linda Crnic Institute for Down Syndrome based in Denver, CO. Approximately 70 attendees and organizers from various advocacy groups, federal agencies (Centers for Disease Control and Prevention, and various NIH Institutes, Centers, and Offices), members of industry, clinicians, and researchers from various academic institutions were greeted by Drs. Yvonne Maddox, Deputy Director of NICHD, and Edward McCabe, Executive Director of the Linda Crnic Institute for Down Syndrome. They charged the participants to focus on the separate issues of contact registries, research databases, and biobanks through both podium presentations and breakout session discussions. Among the breakout groups for each of the major sessions, participants were asked to generate responses to questions posed by the organizers concerning these three research resources as they related to Down syndrome and then to report back to the group at large with a summary of their discussions. This report represents a synthesis of the discussions and suggested approaches formulated by the group as a whole. PMID:21835664

FORWARD: A Registry and Longitudinal Clinical Database to Study Fragile X Syndrome

PubMed Central

Sherman, Stephanie L.; Kidd, Sharon A.; Riley, Catharine; Berry-Kravis, Elizabeth; Andrews, Howard F.; Miller, Robert M.; Lincoln, Sharyn; Swanson, Mark; Kaufmann, Walter E.; Brown, W. Ted

2017-01-01

BACKGROUND AND OBJECTIVE Advances in the care of patients with fragile X syndrome (FXS) have been hampered by lack of data. This deficiency has produced fragmentary knowledge regarding the natural history of this condition, healthcare needs, and the effects of the disease on caregivers. To remedy this deficiency, the Fragile X Clinic and Research Consortium was established to facilitate research. Through a collective effort, the Fragile X Clinic and Research Consortium developed the Fragile X Online Registry With Accessible Research Database (FORWARD) to facilitate multisite data collection. This report describes FORWARD and the way it can be used to improve health and quality of life of FXS patients and their relatives and caregivers. METHODS FORWARD collects demographic information on individuals with FXS and their family members (affected and unaffected) through a 1-time registry form. The longitudinal database collects clinician- and parent-reported data on individuals diagnosed with FXS, focused on those who are 0 to 24 years of age, although individuals of any age can participate. RESULTS The registry includes >2300 registrants (data collected September 7, 2009 to August 31, 2014). The longitudinal database includes data on 713 individuals diagnosed with FXS (data collected September 7, 2012 to August 31, 2014). Longitudinal data continue to be collected on enrolled patients along with baseline data on new patients. CONCLUSIONS FORWARD represents the largest resource of clinical and demographic data for the FXS population in the United States. These data can be used to advance our understanding of FXS: the impact of cooccurring conditions, the impact on the day-today lives of individuals living with FXS and their families, and short-term and long-term outcomes. PMID:28814539

FORWARD: A Registry and Longitudinal Clinical Database to Study Fragile X Syndrome.

PubMed

Sherman, Stephanie L; Kidd, Sharon A; Riley, Catharine; Berry-Kravis, Elizabeth; Andrews, Howard F; Miller, Robert M; Lincoln, Sharyn; Swanson, Mark; Kaufmann, Walter E; Brown, W Ted

2017-06-01

Advances in the care of patients with fragile X syndrome (FXS) have been hampered by lack of data. This deficiency has produced fragmentary knowledge regarding the natural history of this condition, healthcare needs, and the effects of the disease on caregivers. To remedy this deficiency, the Fragile X Clinic and Research Consortium was established to facilitate research. Through a collective effort, the Fragile X Clinic and Research Consortium developed the Fragile X Online Registry With Accessible Research Database (FORWARD) to facilitate multisite data collection. This report describes FORWARD and the way it can be used to improve health and quality of life of FXS patients and their relatives and caregivers. FORWARD collects demographic information on individuals with FXS and their family members (affected and unaffected) through a 1-time registry form. The longitudinal database collects clinician- and parent-reported data on individuals diagnosed with FXS, focused on those who are 0 to 24 years of age, although individuals of any age can participate. The registry includes >2300 registrants (data collected September 7, 2009 to August 31, 2014). The longitudinal database includes data on 713 individuals diagnosed with FXS (data collected September 7, 2012 to August 31, 2014). Longitudinal data continue to be collected on enrolled patients along with baseline data on new patients. FORWARD represents the largest resource of clinical and demographic data for the FXS population in the United States. These data can be used to advance our understanding of FXS: the impact of cooccurring conditions, the impact on the day-to-day lives of individuals living with FXS and their families, and short-term and long-term outcomes. Copyright © 2017 by the American Academy of Pediatrics.

The Danish Schizophrenia Registry

PubMed Central

Baandrup, Lone; Cerqueira, Charlotte; Haller, Lea; Korshøj, Lene; Voldsgaard, Inge; Nordentoft, Merete

2016-01-01

Aim of database To systematically monitor and improve the quality of treatment and care of patients with schizophrenia in Denmark. In addition, the database is accessible as a resource for research. Study population Patients diagnosed with schizophrenia and receiving mental health care in psychiatric hospitals or outpatient clinics. During the first year after the diagnosis, patients are classified as incident patients, and after this period as prevalent patients. Main variables The registry currently contains 21 clinical quality measures in relation to the following domains: diagnostic evaluation, antipsychotic treatment including adverse reactions, cardiovascular risk factors including laboratory values, family intervention, psychoeducation, postdischarge mental health care, assessment of suicide risk in relation to discharge, and assessment of global functioning. Descriptive data The recorded data are available electronically for the reporting clinicians and responsible administrative personnel, and they are updated monthly. The registry publishes the national and regional results of all included quality measures in the annual audit reports. External researchers may obtain access to the data for use in specific research projects by applying to the steering committee. Conclusion The Danish Schizophrenia Registry represents a valuable source of informative data to monitor and improve the quality of care of patients with schizophrenia in Denmark. However, continuous resources and time devoted is necessary to maintain the integrity of the registry and the validity of the data. PMID:27843348

Feasibility of Linking Population-Based Cancer Registries and Cancer Center Biorepositories

PubMed Central

McCusker, Margaret E.; Allen, Mark; Fernandez-Ami, Allyn; Gandour-Edwards, Regina

2012-01-01

Purpose: Biospecimen-based research offers tremendous promise as a way to increase understanding of the molecular epidemiology of cancers. Population-based cancer registries can augment this research by providing more clinical detail and long-term follow-up information than is typically available from biospecimen annotations. In order to demonstrate the feasibility of this concept, we performed a pilot linkage between the California Cancer Registry (CCR) and the University of California, Davis Cancer Center Biorepository (UCD CCB) databases to determine if we could identify patients with records in both databases. Methods: We performed a probabilistic data linkage between 2180 UCD CCB biospecimen records collected during the years 2005–2009 and all CCR records for cancers diagnosed from 1988–2009 based on standard data linkage procedures. Results: The 1040 UCD records with a unique medical record number, tissue site, and pathology date were linked to 3.3 million CCR records. Of these, 844 (81.2%) were identified in both databases. Overall, record matches were highest (100%) for cancers of the cervix and testis/other male genital system organs. For the most common cancers, matches were highest for cancers of the lung and respiratory system (93%), breast (91.7%), and colon and rectum (89.5%), and lower for prostate (72.9%). Conclusions: This pilot linkage demonstrated that information on existing biospecimens from a cancer center biorepository can be linked successfully to cancer registry data. Linkages between existing biorepositories and cancer registries can foster productive collaborations and provide a foundation for virtual biorepository networks to support population-based biospecimen research. PMID:24845042

Coding of obesity in administrative hospital discharge abstract data: accuracy and impact for future research studies.

PubMed

Martin, Billie-Jean; Chen, Guanmin; Graham, Michelle; Quan, Hude

2014-02-13

Obesity is a pervasive problem and a popular subject of academic assessment. The ability to take advantage of existing data, such as administrative databases, to study obesity is appealing. The objective of our study was to assess the validity of obesity coding in an administrative database and compare the association between obesity and outcomes in an administrative database versus registry. This study was conducted using a coronary catheterization registry and an administrative database (Discharge Abstract Database (DAD)). A Body Mass Index (BMI) ≥30 kg/m2 within the registry defined obesity. In the DAD obesity was defined by diagnosis codes E65-E68 (ICD-10). The sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of an obesity diagnosis in the DAD was determined using obesity diagnosis in the registry as the referent. The association between obesity and outcomes was assessed. The study population of 17380 subjects was largely male (68.8%) with a mean BMI of 27.0 kg/m2. Obesity prevalence was lower in the DAD than registry (2.4% vs. 20.3%). A diagnosis of obesity in the DAD had a sensitivity 7.75%, specificity 98.98%, NPV 80.84% and PPV 65.94%. Obesity was associated with decreased risk of death or re-hospitalization, though non-significantly within the DAD. Obesity was significantly associated with an increased risk of cardiac procedure in both databases. Overall, obesity was poorly coded in the DAD. However, when coded, it was coded accurately. Administrative databases are not an optimal datasource for obesity prevalence and incidence surveillance but could be used to define obese cohorts for follow-up.

Validation of the 'United Registries for Clinical Assessment and Research' [UR-CARE], a European Online Registry for Clinical Care and Research in Inflammatory Bowel Disease.

PubMed

Burisch, Johan; Gisbert, Javier P; Siegmund, Britta; Bettenworth, Dominik; Thomsen, Sandra Bohn; Cleynen, Isabelle; Cremer, Anneline; Ding, Nik John Sheng; Furfaro, Federica; Galanopoulos, Michail; Grunert, Philip Christian; Hanzel, Jurij; Ivanovski, Tamara Knezevic; Krustins, Eduards; Noor, Nurulamin; O'Morain, Neil; Rodríguez-Lago, Iago; Scharl, Michael; Tua, Julia; Uzzan, Mathieu; Ali Yassin, Nuha; Baert, Filip; Langholz, Ebbe

2018-04-27

The 'United Registries for Clinical Assessment and Research' [UR-CARE] database is an initiative of the European Crohn's and Colitis Organisation [ECCO] to facilitate daily patient care and research studies in inflammatory bowel disease [IBD]. Herein, we sought to validate the database by using fictional case histories of patients with IBD that were to be entered by observers of varying experience in IBD. Nineteen observers entered five patient case histories into the database. After 6 weeks, all observers entered the same case histories again. For each case history, 20 key variables were selected to calculate the accuracy for each observer. We assumed that the database was such that ≥ 90% of the entered data would be correct. The overall proportion of correctly entered data was calculated using a beta-binomial regression model to account for inter-observer variation and compared to the expected level of validity. Re-test reliability was assessed using McNemar's test. For all case histories, the overall proportion of correctly entered items and their confidence intervals included the target of 90% (Case 1: 92% [88-94%]; Case 2: 87% [83-91%]; Case 3: 93% [90-95%]; Case 4: 97% [94-99%]; Case 5: 91% [87-93%]). These numbers did not differ significantly from those found 6 weeks later [NcNemar's test p > 0.05]. The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR-CARE has the potential to enhance future European collaborations regarding clinical research in IBD.

The Québec BCG Vaccination Registry (1956-1992): assessing data quality and linkage with administrative health databases.

PubMed

Rousseau, Marie-Claude; Conus, Florence; Li, Jun; Parent, Marie-Élise; El-Zein, Mariam

2014-01-09

Vaccination registries have undoubtedly proven useful for estimating vaccination coverage as well as examining vaccine safety and effectiveness. However, their use for population health research is often limited. The Bacillus Calmette-Guérin (BCG) Vaccination Registry for the Canadian province of Québec comprises some 4 million vaccination records (1926-1992). This registry represents a unique opportunity to study potential associations between BCG vaccination and various health outcomes. So far, such studies have been hampered by the absence of a computerized version of the registry. We determined the completeness and accuracy of the recently computerized BCG Vaccination Registry, as well as examined its linkability with demographic and administrative medical databases. Two systematically selected verification samples, each representing ~0.1% of the registry, were used to ascertain accuracy and completeness of the electronic BCG Vaccination Registry. Agreement between the paper [listings (n = 4,987 records) and vaccination certificates (n = 4,709 records)] and electronic formats was determined along several nominal and BCG-related variables. Linkage feasibility with the Birth Registry (probabilistic approach) and provincial Healthcare Registration File (deterministic approach) was examined using nominal identifiers for a random sample of 3,500 individuals born from 1961 to 1974 and BCG vaccinated between 1970 and 1974. Exact agreement was observed for 99.6% and 81.5% of records upon comparing, respectively, the paper listings and vaccination certificates to their corresponding computerized records. The proportion of successful linkage was 77% with the Birth Registry, 70% with the Healthcare Registration File, 57% with both, and varied by birth year. Computerization of this Registry yielded excellent results. The registry was complete and accurate, and linkage with administrative databases was highly feasible. This study represents the first step towards assembling large scale population-based epidemiological studies which will enable filling important knowledge gaps on the potential health effects of early life non-specific stimulation of the immune function, as resulting from BCG vaccination.

Describing the linkages of the immigration, refugees and citizenship Canada permanent resident data and vital statistics death registry to Ontario's administrative health database.

PubMed

Chiu, Maria; Lebenbaum, Michael; Lam, Kelvin; Chong, Nelson; Azimaee, Mahmoud; Iron, Karey; Manuel, Doug; Guttmann, Astrid

2016-10-21

Ontario, the most populous province in Canada, has a universal healthcare system that routinely collects health administrative data on its 13 million legal residents that is used for health research. Record linkage has become a vital tool for this research by enriching this data with the Immigration, Refugees and Citizenship Canada Permanent Resident (IRCC-PR) database and the Office of the Registrar General's Vital Statistics-Death (ORG-VSD) registry. Our objectives were to estimate linkage rates and compare characteristics of individuals in the linked versus unlinked files. We used both deterministic and probabilistic linkage methods to link the IRCC-PR database (1985-2012) and ORG-VSD registry (1990-2012) to the Ontario's Registered Persons Database. Linkage rates were estimated and standardized differences were used to assess differences in socio-demographic and other characteristics between the linked and unlinked records. The overall linkage rates for the IRCC-PR database and ORG-VSD registry were 86.4 and 96.2 %, respectively. The majority (68.2 %) of the record linkages in IRCC-PR were achieved after three deterministic passes, 18.2 % were linked probabilistically, and 13.6 % were unlinked. Similarly the majority (79.8 %) of the record linkages in the ORG-VSD were linked using deterministic record linkage, 16.3 % were linked after probabilistic and manual review, and 3.9 % were unlinked. Unlinked and linked files were similar for most characteristics, such as age and marital status for IRCC-PR and sex and most causes of death for ORG-VSD. However, lower linkage rates were observed among people born in East Asia (78 %) in the IRCC-PR database and certain causes of death in the ORG-VSD registry, namely perinatal conditions (61.3 %) and congenital anomalies (81.3 %). The linkages of immigration and vital statistics data to existing population-based healthcare data in Ontario, Canada will enable many novel cross-sectional and longitudinal studies to be conducted. Analytic techniques to account for sub-optimal linkage rates may be required in studies of certain ethnic groups or certain causes of death among children and infants.

Connecting communities to health research: development of the Project CONNECT minority research registry.

PubMed

Green, Melissa A; Kim, Mimi M; Barber, Sharrelle; Odulana, Abedowale A; Godley, Paul A; Howard, Daniel L; Corbie-Smith, Giselle M

2013-05-01

Prevention and treatment standards are based on evidence obtained in behavioral and clinical research. However, racial and ethnic minorities remain relatively absent from the science that develops these standards. While investigators have successfully recruited participants for individual studies using tailored recruitment methods, these strategies require considerable time and resources. Research registries, typically developed around a disease or condition, serve as a promising model for a targeted recruitment method to increase minority participation in health research. This study assessed the tailored recruitment methods used to populate a health research registry targeting African-American community members. We describe six recruitment methods applied between September 2004 and October 2008 to recruit members into a health research registry. Recruitment included direct (existing studies, public databases, community outreach) and indirect methods (radio, internet, and email) targeting the general population, local universities, and African American communities. We conducted retrospective analysis of the recruitment by method using descriptive statistics, frequencies, and chi-square statistics. During the recruitment period, 608 individuals enrolled in the research registry. The majority of enrollees were African American, female, and in good health. Direct and indirect methods were identified as successful strategies for subgroups. Findings suggest significant associations between recruitment methods and age, presence of existing health condition, prior research participation, and motivation to join the registry. A health research registry can be a successful tool to increase minority awareness of research opportunities. Multi-pronged recruitment approaches are needed to reach diverse subpopulations. Copyright © 2013. Published by Elsevier Inc.

Connecting Communities to Health Research: Development of the Project CONNECT Minority Research Registry

PubMed Central

Green, Melissa A.; Kim, Mimi M.; Barber, Sharrelle; Odulana, Abedowale A.; Godley, Paul A.; Howard, Daniel L.; Corbie-Smith, Giselle M.

2013-01-01

Introduction Prevention and treatment standards are based on evidence obtained in behavioral and clinical research. However, racial and ethnic minorities remain relatively absent from the science that develops these standards. While investigators have successfully recruited participants for individual studies using tailored recruitment methods, these strategies require considerable time and resources. Research registries, typically developed around a disease or condition, serve as a promising model for a targeted recruitment method to increase minority participation in health research. This study assessed the tailored recruitment methods used to populate a health research registry targeting African-American community members. Methods We describe six recruitment methods applied between September 2004 and October 2008 to recruit members into a health research registry. Recruitment included direct (existing studies, public databases, community outreach) and indirect methods (radio, internet, and email) targeting the general population, local universities, and African American communities. We conducted retrospective analysis of the recruitment by method using descriptive statistics, frequencies, and chi-square statistics. Results During the recruitment period, 608 individuals enrolled in the research registry. The majority of enrollees were African American, female, and in good health. Direct and indirect methods were identified as successful strategies for subgroups. Findings suggest significant associations between recruitment methods and age, presence of existing health condition, prior research participation, and motivation to join the registry. Conclusions A health research registry can be a successful tool to increase minority awareness of research opportunities. Multi-pronged recruitment approaches are needed to reach diverse subpopulations. PMID:23340183

Use of large healthcare databases for rheumatology clinical research.

PubMed

Desai, Rishi J; Solomon, Daniel H

2017-03-01

Large healthcare databases, which contain data collected during routinely delivered healthcare to patients, can serve as a valuable resource for generating actionable evidence to assist medical and healthcare policy decision-making. In this review, we summarize use of large healthcare databases in rheumatology clinical research. Large healthcare data are critical to evaluate medication safety and effectiveness in patients with rheumatologic conditions. Three major sources of large healthcare data are: first, electronic medical records, second, health insurance claims, and third, patient registries. Each of these sources offers unique advantages, but also has some inherent limitations. To address some of these limitations and maximize the utility of these data sources for evidence generation, recent efforts have focused on linking different data sources. Innovations such as randomized registry trials, which aim to facilitate design of low-cost randomized controlled trials built on existing infrastructure provided by large healthcare databases, are likely to make clinical research more efficient in coming years. Harnessing the power of information contained in large healthcare databases, while paying close attention to their inherent limitations, is critical to generate a rigorous evidence-base for medical decision-making and ultimately enhancing patient care.

A breast cancer clinical registry in an Italian comprehensive cancer center: an instrument for descriptive, clinical, and experimental research.

PubMed

Baili, Paolo; Torresani, Michele; Agresti, Roberto; Rosito, Giuseppe; Daidone, Maria Grazia; Veneroni, Silvia; Cavallo, Ilaria; Funaro, Francesco; Giunco, Marco; Turco, Alberto; Amash, Hade; Scavo, Antonio; Minicozzi, Pamela; Bella, Francesca; Meneghini, Elisabetta; Sant, Milena

2015-01-01

In clinical research, many potentially useful variables are available via the routine activity of cancer center-based clinical registries (CCCR). We present the experience of the breast cancer clinical registry at Fondazione IRCCS "Istituto Nazionale dei Tumori" to give an example of how a CCCR can be planned, implemented, and used. Five criteria were taken into consideration while planning our CCCR: (a) available clinical and administrative databases ought to be exploited to the maximum extent; (b) open source software should be used; (c) a Web-based interface must be designed; (d) CCCR data must be compatible with population-based cancer registry data; (e) CCCR must be an open system, able to be connected with other data repositories. The amount of work needed for the implementation of a CCCR is inversely linked with the amount of available coded data: the fewer data are available in the input databases as coded variables, the more work will be necessary, for information technology staff, text mining analysis, and registrars (for collecting data from clinical records). A cancer registry in a comprehensive cancer center can be used for several research aspects, such as estimate of the number of cases needed for clinical studies, assessment of biobank specimens with specific characteristics, evaluation of clinical practice and adhesion to clinical guidelines, comparative studies between clinical and population sets of patients, studies on cancer prognosis, and studies on cancer survivorship.

Current concepts in clinical research: web-based, automated, arthroscopic surgery prospective database registry.

PubMed

Lubowitz, James H; Smith, Patrick A

2012-03-01

In 2011, postsurgical patient outcome data may be compiled in a research registry, allowing comparative-effectiveness research and cost-effectiveness analysis by use of Health Insurance Portability and Accountability Act-compliant, institutional review board-approved, Food and Drug Administration-approved, remote, Web-based data collection systems. Computerized automation minimizes cost and minimizes surgeon time demand. A research registry can be a powerful tool to observe and understand variations in treatment and outcomes, to examine factors that influence prognosis and quality of life, to describe care patterns, to assess effectiveness, to monitor safety, and to change provider practice through feedback of data. Registry of validated, prospective outcome data is required for arthroscopic and related researchers and the public to advocate with governments and health payers. The goal is to develop evidence-based data to determine the best methods for treating patients. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Web resources for rare auto-inflammatory diseases: towards a common patient registry.

PubMed

Touitou, Isabelle; Hentgen, Véronique; Koné-Paut, Isabelle

2009-06-01

To review information resources on rare auto-inflammatory disorders (AIDs) for use by health care professionals, focusing particularly on patient registries. Using relevant key words, we surveyed the websites of several scientific societies of immunology, paediatrics and rheumatology, as well as Pubmed and specialized databases for AIDs. The Internet provides a wide variety of information related to AIDs. Moreover, several other initiatives have been undertaken to create new resources for professionals. We reviewed six patient registries for rare AIDs, taking a special interest in the submission questionnaire. We revealed a wide overlap between the items used in the questionnaires, whereas the currently available registries appeared inappropriate for AIDs patients with complex or undefined diagnosis. AIDs share common clinical features, pathophysiological pathways and therapeutic approaches. Although several resources are now available for rare AIDs, a unique and dedicated site gathering all aspects of these diseases as a whole is still lacking, i.e. covering research as well as the needs of AIDs patients and health care professionals. Our study thus advocates a merging of existing patient registries or the creation of a common database.

Early Detection Research Network Registry for Hereditary Cancer — EDRN Public Portal

Cancer.gov

The EDRN High Risk Registry (HRR)recruits individuals that carry germline mutations for hereditary cancer syndromes, who are willing to participate in biomarker studies. Recruitment is pursued through distribution of recruitment packets. The recruitment packet includes a cover letter, EDRN HRR brochure, consent form, HIPAA authorization, and baseline questionnaire. Upon completion of enrollment materials, each Registry member is provided a Certificate of Confidentiality, which has been issued by the NCI for the EDRN HRR. The EDRN HRR has a website (http://medicine2.creighton.edu/EDRN-Registry). It provides eligibilty, enrollment educational information for individuals who are at high risk of developing hereditary cancer. The EDRN HRR newsletter is published twice each year. These are distributed to EDRN HRR members on an annual basis. Follow-up questionnaires are sent to Registry participants each year. An EDRN HRR database has been established to store demographic data, personal and family history of cancer diagnoses, personal smoking history, female specific history, as well as cancer prevention, detection and treatment information collected on questionnaires. All EDRN HRR questionnaires and database use the EDRN CDEs.

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

The Québec BCG Vaccination Registry (1956–1992): assessing data quality and linkage with administrative health databases

PubMed Central

2014-01-01

Background Vaccination registries have undoubtedly proven useful for estimating vaccination coverage as well as examining vaccine safety and effectiveness. However, their use for population health research is often limited. The Bacillus Calmette-Guérin (BCG) Vaccination Registry for the Canadian province of Québec comprises some 4 million vaccination records (1926-1992). This registry represents a unique opportunity to study potential associations between BCG vaccination and various health outcomes. So far, such studies have been hampered by the absence of a computerized version of the registry. We determined the completeness and accuracy of the recently computerized BCG Vaccination Registry, as well as examined its linkability with demographic and administrative medical databases. Methods Two systematically selected verification samples, each representing ~0.1% of the registry, were used to ascertain accuracy and completeness of the electronic BCG Vaccination Registry. Agreement between the paper [listings (n = 4,987 records) and vaccination certificates (n = 4,709 records)] and electronic formats was determined along several nominal and BCG-related variables. Linkage feasibility with the Birth Registry (probabilistic approach) and provincial Healthcare Registration File (deterministic approach) was examined using nominal identifiers for a random sample of 3,500 individuals born from 1961 to 1974 and BCG vaccinated between 1970 and 1974. Results Exact agreement was observed for 99.6% and 81.5% of records upon comparing, respectively, the paper listings and vaccination certificates to their corresponding computerized records. The proportion of successful linkage was 77% with the Birth Registry, 70% with the Healthcare Registration File, 57% with both, and varied by birth year. Conclusions Computerization of this Registry yielded excellent results. The registry was complete and accurate, and linkage with administrative databases was highly feasible. This study represents the first step towards assembling large scale population-based epidemiological studies which will enable filling important knowledge gaps on the potential health effects of early life non-specific stimulation of the immune function, as resulting from BCG vaccination. PMID:24400924

Usefulness of a centralized system of data collection for the development of an international multicentre registry of spondyloarthritis

PubMed Central

Schiotis, Ruxandra; Font, Pilar; Zarco, Pedro; Almodovar, Raquel; Gratacós, Jordi; Mulero, Juan; Juanola, Xavier; Montilla, Carlos; Moreno, Estefanía; Ariza Ariza, Rafael; Collantes-Estevez, Eduardo

2011-01-01

Objective. To present the usefulness of a centralized system of data collection for the development of an international multicentre registry of SpA. Method. The originality of this registry consists in the creation of a virtual network of researchers in a computerized Internet database. From its conception, the registry was meant to be a dynamic acquiring system. Results. REGISPONSER has two developing phases (Conception and Universalization) and gathers several evolving secondary projects (REGISPONSER-EARLY, REGISPONSER-AS, ESPERANZA and RESPONDIA). Each sub-project answered the necessity of having more specific and complete data of the patients even from the onset of the disease so, in the end, obtaining a well-defined picture of SpAs spectrum in the Spanish population. Conclusion. REGISPONSER is the first dynamic SpA database composed of cohorts with a significant number of patients distributed by specific diagnosis, which provides basic specific information of the sub-cohorts useful for patients’ evaluation in rheumatology ambulatory consulting. PMID:20823095

SEER Bibliography

Cancer.gov

Search this database of articles and other publications produced by cancer registry staff and Surveillance Research Program staff. Search by author, title, date, and organization. Provides links to PubMed and abstracts.

A novel approach for medical research on lymphomas

PubMed Central

Conte, Cécile; Palmaro, Aurore; Grosclaude, Pascale; Daubisse-Marliac, Laetitia; Despas, Fabien; Lapeyre-Mestre, Maryse

2018-01-01

Abstract The use of claims database to study lymphomas in real-life conditions is a crucial issue in the future. In this way, it is essential to develop validated algorithms for the identification of lymphomas in these databases. The aim of this study was to assess the validity of diagnosis codes in the French health insurance database to identify incident cases of lymphomas according to results of a regional cancer registry, as the gold standard. Between 2010 and 2013, incident lymphomas were identified in hospital data through 2 algorithms of selection. The results of the identification process and characteristics of incident lymphomas cases were compared with data from the Tarn Cancer Registry. Each algorithm's performance was assessed by estimating sensitivity, predictive positive value, specificity (SPE), and negative predictive value. During the period, the registry recorded 476 incident cases of lymphomas, of which 52 were Hodgkin lymphomas and 424 non-Hodgkin lymphomas. For corresponding area and period, algorithm 1 provides a number of incident cases close to the Registry, whereas algorithm 2 overestimated the number of incident cases by approximately 30%. Both algorithms were highly specific (SPE = 99.9%) but moderately sensitive. The comparative analysis illustrates that similar distribution and characteristics are observed in both sources. Given these findings, the use of claims database can be consider as a pertinent and powerful tool to conduct medico-economic or pharmacoepidemiological studies in lymphomas. PMID:29480830

Measurement of the Inter-Rater Reliability Rate Is Mandatory for Improving the Quality of a Medical Database: Experience with the Paulista Lung Cancer Registry.

PubMed

Lauricella, Leticia L; Costa, Priscila B; Salati, Michele; Pego-Fernandes, Paulo M; Terra, Ricardo M

2018-06-01

Database quality measurement should be considered a mandatory step to ensure an adequate level of confidence in data used for research and quality improvement. Several metrics have been described in the literature, but no standardized approach has been established. We aimed to describe a methodological approach applied to measure the quality and inter-rater reliability of a regional multicentric thoracic surgical database (Paulista Lung Cancer Registry). Data from the first 3 years of the Paulista Lung Cancer Registry underwent an audit process with 3 metrics: completeness, consistency, and inter-rater reliability. The first 2 methods were applied to the whole data set, and the last method was calculated using 100 cases randomized for direct auditing. Inter-rater reliability was evaluated using percentage of agreement between the data collector and auditor and through calculation of Cohen's κ and intraclass correlation. The overall completeness per section ranged from 0.88 to 1.00, and the overall consistency was 0.96. Inter-rater reliability showed many variables with high disagreement (>10%). For numerical variables, intraclass correlation was a better metric than inter-rater reliability. Cohen's κ showed that most variables had moderate to substantial agreement. The methodological approach applied to the Paulista Lung Cancer Registry showed that completeness and consistency metrics did not sufficiently reflect the real quality status of a database. The inter-rater reliability associated with κ and intraclass correlation was a better quality metric than completeness and consistency metrics because it could determine the reliability of specific variables used in research or benchmark reports. This report can be a paradigm for future studies of data quality measurement. Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Quebec Trophoblastic Disease Registry: how to make an easy-to-use dynamic database.

PubMed

Sauthier, Philippe; Breguet, Magali; Rozenholc, Alexandre; Sauthier, Michaël

2015-05-01

To create an easy-to-use dynamic database designed specifically for the Quebec Trophoblastic Disease Registry (RMTQ). It is now well established that much of the success in managing trophoblastic diseases comes from the development of national and regional reference centers. Computerized databases allow the optimal use of data stored in these centers. We have created an electronic data registration system by producing a database using FileMaker Pro 12. It uses 11 external tables associated with a unique identification number for each patient. Each table allows specific data to be recorded, incorporating demographics, diagnosis, automated staging, laboratory values, pathological diagnosis, and imaging parameters. From January 1, 2009, to December 31, 2013, we used our database to register 311 patients with 380 diseases and have seen a 39.2% increase in registrations each year between 2009 and 2012. This database allows the automatic generation of semilogarithmic curves, which take into account β-hCG values as a function of time, complete with graphic markers for applied treatments (chemotherapy, radiotherapy, or surgery). It generates a summary sheet for a synthetic vision in real time. We have created, at a low cost, an easy-to-use database specific to trophoblastic diseases that dynamically integrates staging and monitoring. We propose a 10-step procedure for a successful trophoblastic database. It improves patient care, research, and education on trophoblastic diseases in Quebec and leads to an opportunity for collaboration on a national Canadian registry.

12 CFR 1008.1 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-01-01

... participate in a nationwide mortgage licensing system and registry database of residential mortgage loan... requirements, the Bureau is charged with establishing and maintaining a licensing and registry database for... administration of the Nationwide Mortgage Licensing System and Registry. (5) Subpart E clarifies the Bureau's...

12 CFR 1008.1 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-01-01

... participate in a nationwide mortgage licensing system and registry database of residential mortgage loan... requirements, the Bureau is charged with establishing and maintaining a licensing and registry database for... administration of the Nationwide Mortgage Licensing System and Registry. (5) Subpart E clarifies the Bureau's...

12 CFR 1008.1 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-01-01

... participate in a nationwide mortgage licensing system and registry database of residential mortgage loan... requirements, the Bureau is charged with establishing and maintaining a licensing and registry database for... administration of the Nationwide Mortgage Licensing System and Registry. (5) Subpart E clarifies the Bureau's...

RTECS database (on the internet). Online data

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The Registry of Toxic Effects of Chemical Substances (RTECS (trademark)) is a database of toxicological information compiled, maintained, and updated by the National Institute for Occupational Safety and Health. The program is mandated by the Occupational Safety and Health Act of 1970. The original edition, known as the `Toxic Substances List,` was published on June 28, 1971, and included toxicologic data for approximately 5,000 chemicals. Since that time, the list has continuously grown and been updated, and its name changed to the current title, `Registry of Toxic Effects of Chemical Substances.` RTECS (trademark) now contains over 133,000 chemicals as NIOSHmore » strives to fulfill the mandate to list `all known toxic substances...and the concentrations at which...toxicity is known to occur.` This database is now available for searching through the Gov. Research-Center (GRC) service. GRC is a single online web-based search service to well known Government databases. Featuring powerful search and retrieval software, GRC is an important research tool. The GRC web site is at http://grc.ntis.gov.« less

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.

PubMed

Chang, Helena C; Tzou, David T; Usawachintachit, Manint; Duty, Brian D; Hsi, Ryan S; Harper, Jonathan D; Sorensen, Mathew D; Stoller, Marshall L; Sur, Roger L; Chi, Thomas

2016-12-01

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. 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. 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. 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.

Database structure for the Laser Accident and Incident Registry (LAIR)

NASA Astrophysics Data System (ADS)

Ness, James W.; Hoxie, Stephen W.; Zwick, Harry; Stuck, Bruce E.; Lund, David J.; Schmeisser, Elmar T.

1997-05-01

The ubiquity of laser radiation in military, medical, entertainment, telecommunications and research industries and the significant risk, of eye injury from this radiation are firmly established. While important advances have been made in understanding laser bioeffects using animal analogues and clinical data, the relationships among patient characteristics, exposure conditions, severity of the resulting injury, and visual function are fragmented, complex and varied. Although accident cases are minimized through laser safety regulations and control procedures, accumulated accident case information by the laser eye injury evaluation center warranted the development of a laser accident and incident registry. The registry includes clinical data for validating and refining hypotheses on injury and recovery mechanisms; a means for analyzing mechanisms unique to human injury; and a means for identifying future areas of investigation. The relational database supports three major sections: (1) the physics section defines exposure circumstances, (2) the clinical/ophthalmologic section includes fundus and scanning laser ophthalmoscope images, and (3) the visual functions section contains specialized visual function exam results. Tools are available for subject-matter experts to estimate parameters like total intraocular energy, ophthalmic lesion grade, and exposure probability. The database is research oriented to provide a means for generating empirical relationships to identify symptoms for definitive diagnosis and treatment of laser induced eye injuries.

A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery.

PubMed

Dodd, Susanna; Clarke, Mike; Becker, Lorne; Mavergames, Chris; Fish, Rebecca; Williamson, Paula R

2018-04-01

There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

The First 500 Registrations to the Research Registry®: Advancing Registration of Under-Registered Study Types.

PubMed

Agha, Riaz; Fowler, Alexander J; Limb, Christopher; Al Omran, Yasser; Sagoo, Harkiran; Koshy, Kiron; Jafree, Daniyal J; Anwar, Mohammed Omer; McCullogh, Peter; Orgill, Dennis Paul

2016-01-01

The Declaration of Helsinki 2013 encourages the registration of all research studies involving human participants. However, emphasis has been placed on prospective clinical trials, and it is estimated that only 10% of observational studies are registered. In response, Research Registry ® was launched in February 2015; a retrospectively curated registry that is free and easy to use. Research Registry ® enables prospective or retrospective registration of studies, including those study types that cannot be registered on existing registries. In this study, we describe the first 500 registrations on Research Registry ® . Since the launch of Research Registry ® in February 2015, data of registrations have been collected, including type of studies registered, country of origin, and data curation activity. Inappropriate registrations, such as duplicates, were identified by the data curation process. These were removed from the database or modified as required. A quality score was assigned for each registration, based on Sir Austin Bradford Hill's criteria on what research studies should convey. Changes in quality scores over time were assessed. A total of 500 studies were registered on Research Registry ® from February 2015 to October 2015, with a total of 1.7 million patients enrolled. The most common study types were retrospective cohort studies (37.2%), case series (14.8%), and first-in-man case reports (10.4%). Registrations were received from 57 different countries; the most submissions were received from Turkey, followed by China and the United Kingdom. Retrospective data curation identified 80 studies that were initially registered as the incorrect study type, and were subsequently correct. The Kruskal-Wallis test identified a significant improvement in quality scores for registrations from February 2015 to October 2015 ( p  < 0.0001). Since its conception in February 2015, Research Registry ® has established itself as a new registry that is free, easy to use, and enables the registration of various study types, including observational studies and first-in-man case reports. Going forward, our plan is to continue developing Research Registry ® in line with user feedback and usability studies. We plan to further promote Research Registry ® to advance the cause of registration of research, to increase compliance with the Declaration of Helsinki 2013.

Big data and ophthalmic research.

PubMed

Clark, Antony; Ng, Jonathon Q; Morlet, Nigel; Semmens, James B

2016-01-01

Large population-based health administrative databases, clinical registries, and data linkage systems are a rapidly expanding resource for health research. Ophthalmic research has benefited from the use of these databases in expanding the breadth of knowledge in areas such as disease surveillance, disease etiology, health services utilization, and health outcomes. Furthermore, the quantity of data available for research has increased exponentially in recent times, particularly as e-health initiatives come online in health systems across the globe. We review some big data concepts, the databases and data linkage systems used in eye research-including their advantages and limitations, the types of studies previously undertaken, and the future direction for big data in eye research. Copyright © 2016 Elsevier Inc. All rights reserved.

The value of trauma registries.

PubMed

Moore, Lynne; Clark, David E

2008-06-01

Trauma registries are databases that document acute care delivered to patients hospitalised with injuries. They are designed to provide information that can be used to improve the efficiency and quality of trauma care. Indeed, the combination of trauma registry data at regional or national levels can produce very large databases that allow unprecedented opportunities for the evaluation of patient outcomes and inter-hospital comparisons. However, the creation and upkeep of trauma registries requires a substantial investment of money, time and effort, data quality is an important challenge and aggregated trauma data sets rarely represent a population-based sample of trauma. In addition, trauma hospitalisations are already routinely documented in administrative hospital discharge databases. The present review aims to provide evidence that trauma registry data can be used to improve the care dispensed to victims of injury in ways that could not be achieved with information from administrative databases alone. In addition, we will define the structure and purpose of contemporary trauma registries, acknowledge their limitations, and discuss possible ways to make them more useful.

Use of Patient Registries and Administrative Datasets for the Study of Pediatric Cancer

PubMed Central

Rice, Henry E.; Englum, Brian R.; Gulack, Brian C.; Adibe, Obinna O.; Tracy, Elizabeth T.; Kreissman, Susan G.; Routh, Jonathan C.

2015-01-01

Analysis of data from large administrative databases and patient registries is increasingly being used to study childhood cancer care, although the value of these data sources remains unclear to many clinicians. Interpretation of large databases requires a thorough understanding of how the dataset was designed, how data were collected, and how to assess data quality. This review will detail the role of administrative databases and registry databases for the study of childhood cancer, tools to maximize information from these datasets, and recommendations to improve the use of these databases for the study of pediatric oncology. PMID:25807938

The ClinicalTrials.gov results database--update and key issues.

PubMed

Zarin, Deborah A; Tse, Tony; Williams, Rebecca J; Califf, Robert M; Ide, Nicholas C

2011-03-03

The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.

The Italian Twin Project: from the personal identification number to a national twin registry.

PubMed

Stazi, Maria Antonietta; Cotichini, Rodolfo; Patriarca, Valeria; Brescianini, Sonia; Fagnani, Corrado; D'Ippolito, Cristina; Cannoni, Stefania; Ristori, Giovanni; Salvetti, Marco

2002-10-01

The unique opportunity given by the "fiscal code", an alphanumeric identification with demographic information on any single person residing in Italy, introduced in 1976 by the Ministry of Finance, allowed a database of all potential Italian twins to be created. This database contains up to now name, surname, date and place of birth and home address of about 1,300,000 "possible twins". Even though we estimated an excess of 40% of pseudo-twins, this still is the world's largest twin population ever collected. The database of possible twins is currently used in population-based studies on multiple sclerosis, Alzheimer's disease, celiac disease, and type 1 diabetes. A system is currently being developed for linking the database with data from mortality and cancer registries. In 2001, the Italian Government, through the Ministry of Health, financed a broad national research program on twin studies, including the establishment of a national twin registry. Among all the possible twins, a sample of 500,000 individuals are going to be contacted and we expect to enrol around 120,000 real twin pairs in a formal Twin Registry. According to available financial resources, a sub sample of the enrolled population will be asked to donate DNA. A biological bank from twins will be then implemented, guaranteeing information on future etiological questions regarding genetic and modifiable factors for physical impairment and disability, cancers, cardiovascular diseases and other age related chronic illnesses.

Integrated image data and medical record management for rare disease registries. A general framework and its instantiation to theGerman Calciphylaxis Registry.

PubMed

Deserno, Thomas M; Haak, Daniel; Brandenburg, Vincent; Deserno, Verena; Classen, Christoph; Specht, Paula

2014-12-01

Especially for investigator-initiated research at universities and academic institutions, Internet-based rare disease registries (RDR) are required that integrate electronic data capture (EDC) with automatic image analysis or manual image annotation. We propose a modular framework merging alpha-numerical and binary data capture. In concordance with the Office of Rare Diseases Research recommendations, a requirement analysis was performed based on several RDR databases currently hosted at Uniklinik RWTH Aachen, Germany. With respect to the study management tool that is already successfully operating at the Clinical Trial Center Aachen, the Google Web Toolkit was chosen with Hibernate and Gilead connecting a MySQL database management system. Image and signal data integration and processing is supported by Apache Commons FileUpload-Library and ImageJ-based Java code, respectively. As a proof of concept, the framework is instantiated to the German Calciphylaxis Registry. The framework is composed of five mandatory core modules: (1) Data Core, (2) EDC, (3) Access Control, (4) Audit Trail, and (5) Terminology as well as six optional modules: (6) Binary Large Object (BLOB), (7) BLOB Analysis, (8) Standard Operation Procedure, (9) Communication, (10) Pseudonymization, and (11) Biorepository. Modules 1-7 are implemented in the German Calciphylaxis Registry. The proposed RDR framework is easily instantiated and directly integrates image management and analysis. As open source software, it may assist improved data collection and analysis of rare diseases in near future.

The International Collaboration for Autism Registry Epidemiology (iCARE): multinational registry-based investigations of autism risk factors and trends.

PubMed

Schendel, Diana E; Bresnahan, Michaeline; Carter, Kim W; Francis, Richard W; Gissler, Mika; Grønborg, Therese K; Gross, Raz; Gunnes, Nina; Hornig, Mady; Hultman, Christina M; Langridge, Amanda; Lauritsen, Marlene B; Leonard, Helen; Parner, Erik T; Reichenberg, Abraham; Sandin, Sven; Sourander, Andre; Stoltenberg, Camilla; Suominen, Auli; Surén, Pål; Susser, Ezra

2013-11-01

The International Collaboration for Autism Registry Epidemiology (iCARE) is the first multinational research consortium (Australia, Denmark, Finland, Israel, Norway, Sweden, USA) to promote research in autism geographical and temporal heterogeneity, phenotype, family and life course patterns, and etiology. iCARE devised solutions to challenges in multinational collaboration concerning data access security, confidentiality and management. Data are obtained by integrating existing national or state-wide, population-based, individual-level data systems and undergo rigorous harmonization and quality control processes. Analyses are performed using database federation via a computational infrastructure with a secure, web-based, interface. iCARE provides a unique, unprecedented resource in autism research that will significantly enhance the ability to detect environmental and genetic contributions to the causes and life course of autism.

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

PubMed

Setoguchi, Soko; Zhu, Ying; Jalbert, Jessica J; Williams, Lauren A; Chen, Chih-Ying

2014-05-01

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. 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. 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. © 2014 American Heart Association, Inc.

24 CFR 3400.1 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-04-01

... participate in a nationwide mortgage licensing system and registry database of residential mortgage loan... charged with establishing and maintaining a licensing and registry database for loan originators. (b...

The HOPE (Helping to Outline Paediatric Eating Disorders) Project: development and debut of a paediatric clinical eating disorder registry

PubMed Central

2013-01-01

Background The HOPE (Helping to Outline Paediatric Eating Disorders) Project is an ongoing registry study made up of a sequential cross-sectional sample prospectively recruited over 17 years, and is designed to answer empirical questions about paediatric eating disorders. This paper introduces the HOPE Project, describes the registry sample to-date, and discusses future directions and challenges and accomplishments. The project and clinical service were established in a tertiary academic hospital in Western Australia in 1996 with a service development grant. Research processes were inbuilt into the initial protocols and data collection was maintained in the following years. Recognisable progress with the research agenda accelerated only when dedicated research resources were obtained. The registry sample consists of consecutive children and adolescents assessed at the eating disorder program from 1996 onward. Standardised multidisciplinary data collected from family intake interview, parent and child clinical interviews, medical review, parent, child and teacher psychometric assessments, and inpatient admission records populate the HOPE Project database. Results The registry database to-date contains 941 assessments, of whom 685 met DSM-IV diagnostic criteria for an eating disorder at admission. The majority of the sample were females (91%) from metropolitan Perth (83%). The cases with eating disorders consist of eating disorders not otherwise specified (68%), anorexia nervosa (25%) and bulimia nervosa (7%). Among those with eating disorders, a history of weight loss since illness onset was almost universal (96%) with fear of weight gain (71%) common, and the median duration of illness was 8 months. Conclusions Over the next five years and more, we expect that the HOPE Project will make a strong scientific contribution to paediatric eating disorders research and will have important real-world applications to clinical practice and policy as the research unfolds. PMID:24999409

Incidence of Appendicitis over Time: A Comparative Analysis of an Administrative Healthcare Database and a Pathology-Proven Appendicitis Registry

PubMed Central

Clement, Fiona; Zimmer, Scott; Dixon, Elijah; Ball, Chad G.; Heitman, Steven J.; Swain, Mark; Ghosh, Subrata

2016-01-01

Importance At the turn of the 21st century, studies evaluating the change in incidence of appendicitis over time have reported inconsistent findings. Objectives We compared the differences in the incidence of appendicitis derived from a pathology registry versus an administrative database in order to validate coding in administrative databases and establish temporal trends in the incidence of appendicitis. Design We conducted a population-based comparative cohort study to identify all individuals with appendicitis from 2000 to2008. Setting & Participants Two population-based data sources were used to identify cases of appendicitis: 1) a pathology registry (n = 8,822); and 2) a hospital discharge abstract database (n = 10,453). Intervention & Main Outcome The administrative database was compared to the pathology registry for the following a priori analyses: 1) to calculate the positive predictive value (PPV) of administrative codes; 2) to compare the annual incidence of appendicitis; and 3) to assess differences in temporal trends. Temporal trends were assessed using a generalized linear model that assumed a Poisson distribution and reported as an annual percent change (APC) with 95% confidence intervals (CI). Analyses were stratified by perforated and non-perforated appendicitis. Results The administrative database (PPV = 83.0%) overestimated the incidence of appendicitis (100.3 per 100,000) when compared to the pathology registry (84.2 per 100,000). Codes for perforated appendicitis were not reliable (PPV = 52.4%) leading to overestimation in the incidence of perforated appendicitis in the administrative database (34.8 per 100,000) as compared to the pathology registry (19.4 per 100,000). The incidence of appendicitis significantly increased over time in both the administrative database (APC = 2.1%; 95% CI: 1.3, 2.8) and pathology registry (APC = 4.1; 95% CI: 3.1, 5.0). Conclusion & Relevance The administrative database overestimated the incidence of appendicitis, particularly among perforated appendicitis. Therefore, studies utilizing administrative data to analyze perforated appendicitis should be interpreted cautiously. PMID:27820826

A unique linkage of administrative and clinical registry databases to expand analytic possibilities in pediatric heart transplantation research.

PubMed

Godown, Justin; Thurm, Cary; Dodd, Debra A; Soslow, Jonathan H; Feingold, Brian; Smith, Andrew H; Mettler, Bret A; Thompson, Bryn; Hall, Matt

2017-12-01

Large clinical, research, and administrative databases are increasingly utilized to facilitate pediatric heart transplant (HTx) research. Linking databases has proven to be a robust strategy across multiple disciplines to expand the possible analyses that can be performed while leveraging the strengths of each dataset. We describe a unique linkage of the Scientific Registry of Transplant Recipients (SRTR) database and the Pediatric Health Information System (PHIS) administrative database to provide a platform to assess resource utilization in pediatric HTx. All pediatric patients (1999-2016) who underwent HTx at a hospital enrolled in the PHIS database were identified. A linkage was performed between the SRTR and PHIS databases in a stepwise approach using indirect identifiers. To determine the feasibility of using these linked data to assess resource utilization, total and post-HTx hospital costs were assessed. A total of 3188 unique transplants were identified as being present in both databases and amenable to linkage. Linkage of SRTR and PHIS data was successful in 3057 (95.9%) patients, of whom 2896 (90.8%) had complete cost data. Median total and post-HTx hospital costs were $518,906 (IQR $324,199-$889,738), and $334,490 (IQR $235,506-$498,803) respectively with significant differences based on patient demographics and clinical characteristics at HTx. Linkage of the SRTR and PHIS databases is feasible and provides an invaluable tool to assess resource utilization. Our analysis provides contemporary cost data for pediatric HTx from the largest US sample reported to date. It also provides a platform for expanded analyses in the pediatric HTx population. Copyright © 2017 Elsevier Inc. All rights reserved.

Measuring hospital performance in congenital heart surgery: Administrative vs. clinical registry data

PubMed Central

Pasquali, Sara K.; He, Xia; Jacobs, Jeffrey P.; Jacobs, Marshall L.; Gaies, Michael G.; Shah, Samir S.; Hall, Matthew; Gaynor, J. William; Peterson, Eric D.; Mayer, John E.; Hirsch-Romano, Jennifer C.

2015-01-01

Background In congenital heart surgery, hospital performance has historically been assessed using widely available administrative datasets. Recent studies have demonstrated inaccuracies in case ascertainment (coding and inclusion of eligible cases) in administrative vs. clinical registry data, however it is unclear whether this impacts assessment of performance on a hospital-level. Methods Merged data from the Society of Thoracic Surgeons (STS) Database (clinical registry), and Pediatric Health Information Systems Database (administrative dataset) on 46,056 children undergoing heart surgery (2006–2010) were utilized to evaluate in-hospital mortality for 33 hospitals based on their administrative vs. registry data. Standard methods to identify/classify cases were used: Risk Adjustment in Congenital Heart Surgery (RACHS-1) in the administrative data, and STS–European Association for Cardiothoracic Surgery (STAT) methodology in the registry. Results Median hospital surgical volume based on the registry data was 269 cases/yr; mortality was 2.9%. Hospital volumes and mortality rates based on the administrative data were on average 10.7% and 4.7% lower, respectively, although this varied widely across hospitals. Hospital rankings for mortality based on the administrative vs. registry data differed by ≥ 5 rank-positions for 24% of hospitals, with a change in mortality tertile classification (high, middle, or low mortality) for 18%, and change in statistical outlier classification for 12%. Higher volume/complexity hospitals were most impacted. Agency for Healthcare Quality and Research methods in the administrative data yielded similar results. Conclusions Inaccuracies in case ascertainment in administrative vs. clinical registry data can lead to important differences in assessment of hospital mortality rates for congenital heart surgery. PMID:25624057

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

PubMed Central

Travers, Karin; Sallum, Rachel H; Burns, Meghan D; Barr, Charles E; Beattie, Mary S; Pashos, Chris L; Luce, Bryan R

2015-01-01

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25079108

Prognosis and management of myocardial infarction: Comparisons between the French FAST-MI 2010 registry and the French public health database.

PubMed

Massoullié, Grégoire; Wintzer-Wehekind, Jérome; Chenaf, Chouki; Mulliez, Aurélien; Pereira, Bruno; Authier, Nicolas; Eschalier, Alain; Clerfond, Guillaume; Souteyrand, Géraud; Tabassome, Simon; Danchin, Nicolas; Citron, Bernard; Lusson, Jean-René; Puymirat, Étienne; Motreff, Pascal; Eschalier, Romain

2016-05-01

Multicentre registries of myocardial infarction management show a steady improvement in prognosis and greater access to myocardial revascularization in a more timely manner. While French registries are the standard references, the question arises: are data stemming solely from the activity of French cardiac intensive care units (ICUs) a true reflection of the entire French population with ST-segment elevation myocardial infarction (STEMI)? To compare data on patients hospitalized for STEMI from two French registries: the French registry of acute ST-elevation or non-ST-elevation myocardial infarction (FAST-MI) and the Échantillon généraliste des bénéficiaires (EGB) database. We compared patients treated for STEMI listed in the FAST-MI 2010 registry (n=1716) with those listed in the EGB database, which comprises a sample of 1/97th of the French population, also from 2010 (n=403). Compared with the FAST-MI 2010 registry, the EGB database population were older (67.2±15.3 vs 63.3±14.5 years; P<0.001), had a higher percentage of women (36.0% vs 24.7%; P<0.001), were less likely to undergo emergency coronary angiography (75.2% vs 96.3%; P<0.001) and were less often treated in university hospitals (27.1% vs 37.0%; P=0.001). There were no significant differences between the two registries in terms of cardiovascular risk factors, comorbidities and drug treatment at admission. Thirty-day mortality was higher in the EGB database (10.2% vs 4.4%; P<0.001). Registries such as FAST-MI are indispensable, not only for assessing epidemiological changes over time, but also for evaluating the prognostic effect of modern STEMI management. Meanwhile, exploitation of data from general databases, such as EGB, provides additional relevant information, as they include a broader population not routinely admitted to cardiac ICUs. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

The ClinicalTrials.gov Results Database — Update and Key Issues

PubMed Central

Zarin, Deborah A.; Tse, Tony; Williams, Rebecca J.; Califf, Robert M.; Ide, Nicholas C.

2011-01-01

BACKGROUND The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data. PMID:21366476

The value of patient registries in advancing pediatric surgical care.

PubMed

Skarsgard, Erik D

2018-05-01

Pediatric surgeons treat a variety of conditions that are distinguished by their low occurrence rate, complexity, and need for integrated multidisciplinary care. Although randomized controlled trials (RCTs) are considered the gold standard for generating evidence to inform best practice, they are poorly suited to rare diseases based on the variability of illness severity, unpredictability in clinical course, and the impact limitations of studying a single intervention at a time. An alternative to RCTs for comparative effectiveness research for rare diseases in pediatric surgery is the patient registry, which collects detailed and condition-specific patient level data related to illness severity, treatment, and outcome, and allows a large, disease-specific database to be created for the dual purposes of collaborative research and quality improvement across participating sites. This review discusses the various functions of a patient registry in fulfilling its mandate of evidence-based practice and outcome improvement using examples from a variety of existing pediatric surgical registries. The value proposition of patient registries as sources of knowledge, facilitators of practice standardization, and enablers of continuous quality improvement is discussed. Copyright © 2018 Elsevier Inc. All rights reserved.

The relational clinical database: a possible solution to the star wars in registry systems.

PubMed

Michels, D K; Zamieroski, M

1990-12-01

In summary, having data from other service areas available in a relational clinical database could resolve many of the problems existing in today's registry systems. Uniting sophisticated information systems into a centralized database system could definitely be a corporate asset in managing the bottom line.

From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results.

PubMed

Cepeda, M Soledad; Lobanov, Victor; Berlin, Jesse A

2013-04-01

The ClinicalTrials.gov web site provides a convenient interface to look up study results, but it does not allow downloading data in a format that can be readily used for quantitative analyses. To develop a system that automatically downloads study results from ClinicalTrials.gov and provides an interface to retrieve study results in a spreadsheet format ready for analysis. Sherlock(®) identifies studies by intervention, population, or outcome of interest and in seconds creates an analytic database of study results ready for analyses. The outcome classification algorithms used in Sherlock were validated against a classification by an expert. Having a database ready for analysis that can be updated automatically, dramatically extends the utility of the ClinicalTrials.gov trial registry. It increases the speed of comparative research, reduces the need for manual extraction of data, and permits answering a vast array of questions.

Existing data sources for clinical epidemiology: Aarhus University Clinical Trial Candidate Database, Denmark.

PubMed

Nørrelund, Helene; Mazin, Wiktor; Pedersen, Lars

2014-01-01

Denmark is facing a reduction in clinical trial activity as the pharmaceutical industry has moved trials to low-cost emerging economies. Competitiveness in industry-sponsored clinical research depends on speed, quality, and cost. Because Denmark is widely recognized as a region that generates high quality data, an enhanced ability to attract future trials could be achieved if speed can be improved by taking advantage of the comprehensive national and regional registries. A "single point-of-entry" system has been established to support collaboration between hospitals and industry. When assisting industry in early-stage feasibility assessments, potential trial participants are identified by use of registries to shorten the clinical trial startup times. The Aarhus University Clinical Trial Candidate Database consists of encrypted data from the Danish National Registry of Patients allowing an immediate estimation of the number of patients with a specific discharge diagnosis in each hospital department or outpatient specialist clinic in the Central Denmark Region. The free access to health care, thorough monitoring of patients who are in contact with the health service, completeness of registration at the hospital level, and ability to link all databases are competitive advantages in an increasingly complex clinical trial environment.

Publication proportions for registered breast cancer trials: before and following the introduction of the ClinicalTrials.gov results database.

PubMed

Asiimwe, Innocent Gerald; Rumona, Dickson

2016-01-01

To limit selective and incomplete publication of the results of clinical trials, registries including ClinicalTrials.gov were introduced. The ClinicalTrials.gov registry added a results database in 2008 to enable researchers to post the results of their trials as stipulated by the Food and Drug Administration Amendment Act of 2007. This study aimed to determine the direction and magnitude of any change in publication proportions of registered breast cancer trials that occurred since the inception of the ClinicalTrials.gov results database. A cross-sectional study design was employed using ClinicalTrials.gov, a publicly available registry/results database as the primary data source. Registry contents under the subcategories 'Breast Neoplasms' and 'Breast Neoplasms, Male' were downloaded on 1 August 2015. A literature search for included trials was afterwards conducted using MEDLINE and DISCOVER databases to determine publication status of the registered breast cancer trials. Nearly half (168/340) of the listed trials had been published, with a median time to publication of 24 months (Q1 = 14 months, Q3 = 42 months). Only 86 trials were published within 24 months of completion. There was no significant increase in publication proportions of trials that were completed before the introduction of the results database compared to those completed after (OR = 1.00, 95 % CI = .61 to 1.63; adjusted OR = 0.84, 95 % CI = .51 to 1.39). Characteristics associated with publication included trial type (observational versus interventional adjusted OR = .28, 95 % CI = .10 to .74) and completion/termination status (terminated versus completed adjusted OR = .22, 95 % CI = .09 to .51). Less than a half of breast cancer trials registered in ClinicalTrials.gov are published in peer-reviewed journals.

The CERTAIN Registry: a novel, web-based registry and research platform for pediatric renal transplantation in Europe.

PubMed

Plotnicki, L; Kohl, C D; Höcker, B; Krupka, K; Rahmel, A; Pape, L; Hoyer, P; Marks, S D; Webb, N J A; Söylemezoglu, O; Topaloglu, R; Szabo, A J; Seeman, T; Marlies Cornelissen, E A; Knops, N; Grenda, R; Tönshoff, B

2013-05-01

The results of pediatric renal transplantation have improved markedly in the last decade. However, a number of relevant clinical problems remain, such as organ damage caused by chronic rejection, long-term toxicity of immunosuppressive therapy, difficulty in developing tolerance-inducing protocols, secondary cardiovascular comorbidity, post-transplantation lymphoproliferative disease, suboptimal longitudinal growth, quality of life, adherence to immunosuppressive medication, and structured transition programs to adult care. These unmet clinical needs require intense collaborative and interdisciplinary clinical research. We recently founded the Cooperative European Paediatric Renal TransplAnt INitiative (CERTAIN; www.certain-registry.eu) as a research network and platform built on a novel, web-based registry. The registry's dataset provides essential information on generic kidney transplantation-related topics and also captures pediatric-specific topics, such as growth, physical and psychosocial development, and adherence. Due to its flexibility the system can be used as follows: (1) as a registry capturing a minimal or an extended dataset; (2) as a center and/or country-specific transplantation database; or (3) as a patient-specific electronic transplantation chart. The data can be exported directly from the CERTAIN web application into statistical software packages for scientific analyses. The rights regarding data ownership, evaluation, and publications are regulated in the registry's rules of procedure. Data quality is ensured by automatic software validation and a manual data review process. To avoid redundant data entry, CERTAIN has established interfaces for data change with Eurotransplant, the Collaborative Transplant Study (CTS), and the registry of the European Society of Pediatric Nephrology (ESPN) and European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) (ESPN/ERA-EDTA registry). CERTAIN fulfils all regulatory and ethical requirements of the European Union and Germany, in particular, regarding patients' data privacy and security. Using modern information technology, the recently established multinational CERTAIN Registry fills a gap in Europe for collaborative 5 research and quality assurance in the field of pediatric renal transplantation. Copyright © 2013 Elsevier Inc. All rights reserved.

Measuring hospital performance in congenital heart surgery: administrative versus clinical registry data.

PubMed

Pasquali, Sara K; He, Xia; Jacobs, Jeffrey P; Jacobs, Marshall L; Gaies, Michael G; Shah, Samir S; Hall, Matthew; Gaynor, J William; Peterson, Eric D; Mayer, John E; Hirsch-Romano, Jennifer C

2015-03-01

In congenital heart surgery, hospital performance has historically been assessed using widely available administrative data sets. Recent studies have demonstrated inaccuracies in case ascertainment (coding and inclusion of eligible cases) in administrative versus clinical registry data; however, it is unclear whether this impacts assessment of performance on a hospital level. Merged data from The Society of Thoracic Surgeons (STS) database (clinical registry) and the Pediatric Health Information Systems (PHIS) database (administrative data set) for 46,056 children undergoing cardiac operations (2006-2010) were used to evaluate in-hospital mortality for 33 hospitals based on their administrative versus registry data. Standard methods to identify/classify cases were used: Risk Adjustment in Congenital Heart Surgery, version 1 (RACHS-1) in the administrative data and STS-European Association for Cardiothoracic Surgery (STAT) methodology in the registry. Median hospital surgical volume based on the registry data was 269 cases per year; mortality was 2.9%. Hospital volumes and mortality rates based on the administrative data were on average 10.7% and 4.7% lower, respectively, although this varied widely across hospitals. Hospital rankings for mortality based on the administrative versus registry data differed by 5 or more rank positions for 24% of hospitals, with a change in mortality tertile classification (high, middle, or low mortality) for 18% and a change in statistical outlier classification for 12%. Higher volume/complexity hospitals were most impacted. Agency for Healthcare Quality and Research (AHRQ) methods in the administrative data yielded similar results. Inaccuracies in case ascertainment in administrative versus clinical registry data can lead to important differences in assessment of hospital mortality rates for congenital heart surgery. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Establishing of National Birth Defects Registry in Thailand.

PubMed

Pangkanon, Suthipong; Sawasdivorn, Siraporn; Kuptanon, Chulaluck; Chotigeat, Uraiwan; Vandepitte, Warunee

2014-06-01

Deaths attributed to birth defects are a major cause of infant and under-five mortality as well as lifetime disabilities among those who survive. In Thailand, birth defects contribute to 21% of neonatal deaths. There is currently no systematic registry for congenital anomalies in Thailand. Queen Sirikit National Institute of Child Health has initiated a Thailand Birth Defects Registry to capture birth defects among newborn infants. To establish the national birth defects registry in order to determine the burden of birth defects in Thailand. The birth defects data come from four main sources: National Birth Registry Database; National Health Security Office's reimbursement database; Online Birth Defect Registry Database designed to capture new cases that were detected later; and birth defects data from 20 participated hospitals. All data are linked by unique 13-digit national identification number and International Classification of Diseases (ICD)-10 codes. This registry includes 19 common structural birth defects conditions and pilots in 20 hospitals. The registry is hospital-based, hybrid reporting system, including only live births whose information was collected up to 1 year of age. 3,696 infants out of 67,813 live births (8.28% of total live births in Thailand) were diagnosed with congenital anomalies. The prevalence rate of major anomalies was 26.12 per 1,000 live births. The five most common birth defects were congenital heart defects, limb anomalies, cleft lip/cleft palate, Down syndrome, and congenital hydrocephalus respectively. The present study established the Birth Defects Registry by collecting data from four databases in Thailand. Information obtained from this registry and surveillance is essential in the planning for effective intervention programs for birth defects. The authors suggest that this program should be integrated in the existing public health system to ensure sustainability.

Systematic Review of Cerebral Palsy Registries/Surveillance Groups: Relationships between Registry Characteristics and Knowledge Dissemination

PubMed Central

Hurley, Donna S; Sukal-Moulton, Theresa; Gaebler-Spira, Deborah; Krosschell, Kristin J; Pavone, Larissa; Mutlu, Akmer; Dewald, Julius PA; Msall, Michael E

2016-01-01

The aims of this study were to provide a comprehensive summary of the body of research disseminated by Cerebral Palsy (CP) registries and surveillance programs from January 2009 through May 2014 in order to describe the influence their results have on our overall understanding of CP. Secondly, registries/surveillance programs and the work they produced were evaluated and grouped using standardized definitions and classification systems. Method A systematic review search in PubMed, CINAH and Embase for original articles published from 1 January 2009 to 20 May 2014 originating from or supported by population based CP registries and surveillance programs or population based national registries including CP were included. Articles were grouped by 2009 World CP Registry Congress aim, registry/surveillance program classification, geographical region, and the International Classification of Function, Disability and Health (ICF) domain. Registry variables were assessed using the ICF-CY classification. Results Literature searches returned 177 articles meeting inclusion criteria. The majority (69%) of registry/surveillance program productivity was related to contributions as a Resource for CP Research. Prevention (23%) and Surveillance (22%) articles were other areas of achievement, but fewer articles were published in the areas of Planning (17%) and Raising the Profile of CP (2%). There was a range of registry/surveillance program classifications contributing to this productivity, and representation from multiple areas of the globe, although most of the articles originated in Europe, Australia, and Canada. The domains of the ICF that were primarily covered included body structures and function at the early stages of life. Encouragingly, a variety of CP registry/surveillance program initiatives included additional ICF domains of participation and environmental and personal factors. Interpretation CP registries and surveillance programs, including novel non-traditional ones, have significantly contributed to the understanding of how CP affects individuals, families and society. Moving forward, the global CP registry/surveillance program community should continue to strive for uniformity in CP definitions, variables collected and consistency with international initiatives like the ICF so that databases can be consolidated for research use. Adaptation to new technologies can improve access, reduce cost and facilitate information transfer between registrants, researchers and registries/surveillance programs. Finally, increased efforts in documenting variables of individuals with CP into adulthood should be made in order to expand our understanding of CP across the lifespan. PMID:27790626

The Danish Schizophrenia Registry.

PubMed

Baandrup, Lone; Cerqueira, Charlotte; Haller, Lea; Korshøj, Lene; Voldsgaard, Inge; Nordentoft, Merete

2016-01-01

To systematically monitor and improve the quality of treatment and care of patients with schizophrenia in Denmark. In addition, the database is accessible as a resource for research. Patients diagnosed with schizophrenia and receiving mental health care in psychiatric hospitals or outpatient clinics. During the first year after the diagnosis, patients are classified as incident patients, and after this period as prevalent patients. The registry currently contains 21 clinical quality measures in relation to the following domains: diagnostic evaluation, antipsychotic treatment including adverse reactions, cardiovascular risk factors including laboratory values, family intervention, psychoeducation, postdischarge mental health care, assessment of suicide risk in relation to discharge, and assessment of global functioning. The recorded data are available electronically for the reporting clinicians and responsible administrative personnel, and they are updated monthly. The registry publishes the national and regional results of all included quality measures in the annual audit reports. External researchers may obtain access to the data for use in specific research projects by applying to the steering committee. The Danish Schizophrenia Registry represents a valuable source of informative data to monitor and improve the quality of care of patients with schizophrenia in Denmark. However, continuous resources and time devoted is necessary to maintain the integrity of the registry and the validity of the data.

[Databases for surgical specialists in Cancún, Quintana Roo].

PubMed

Contla-Hosking, Jorge Eduardo; Ceballos-Martínez, Zoila Inés; Peralta-Bahena, Mónica Esther

2004-01-01

Our aim was to identify the level of knowledge of surgical health-area specialists in Cancún, Quintana Roo, Mexico, from the personal productivity database. We carried out an investigation of 37 surgical specialists: 24 belonged to the Mexican Social Security Institute (IMSS), while 13 belonged to the Mexican Health Secretariat (SSA). In our research, we found that 61% of surgical health-area specialist physicians were familiar with some aspects of the institutional surgical registry, including the following: 54% knew of the existence of a personal registry of surgeries carried out, and 43% keep a record of their personal activities. From the latter percentage, 69% of surgical health-area specialist physicians mentioned keeping their records manually, while 44% used the computer. Results of the research suggest that these physicians would like to have some kind of record of the surgeries carried out by each. An important percentage of these specialists do not keep a personal record on a database; due to this lack of knowledge, we obtain incorrect information in institutional records of the reality of what is actually done. We consider it important to inform surgical specialists concerning the existence of personal institutional records in database form or even of record done manually, as well as correct terminology for the International Codification (CIE-9 & 10). We inform here of the need to encourage a culture in records and databases in the formative stage of surgeon specialists.

Development of the Lymphoma Enterprise Architecture Database: A caBIG(tm) Silver level compliant System

PubMed Central

Huang, Taoying; Shenoy, Pareen J.; Sinha, Rajni; Graiser, Michael; Bumpers, Kevin W.; Flowers, Christopher R.

2009-01-01

Lymphomas are the fifth most common cancer in United States with numerous histological subtypes. Integrating existing clinical information on lymphoma patients provides a platform for understanding biological variability in presentation and treatment response and aids development of novel therapies. We developed a cancer Biomedical Informatics Grid™ (caBIG™) Silver level compliant lymphoma database, called the Lymphoma Enterprise Architecture Data-system™ (LEAD™), which integrates the pathology, pharmacy, laboratory, cancer registry, clinical trials, and clinical data from institutional databases. We utilized the Cancer Common Ontological Representation Environment Software Development Kit (caCORE SDK) provided by National Cancer Institute’s Center for Bioinformatics to establish the LEAD™ platform for data management. The caCORE SDK generated system utilizes an n-tier architecture with open Application Programming Interfaces, controlled vocabularies, and registered metadata to achieve semantic integration across multiple cancer databases. We demonstrated that the data elements and structures within LEAD™ could be used to manage clinical research data from phase 1 clinical trials, cohort studies, and registry data from the Surveillance Epidemiology and End Results database. This work provides a clear example of how semantic technologies from caBIG™ can be applied to support a wide range of clinical and research tasks, and integrate data from disparate systems into a single architecture. This illustrates the central importance of caBIG™ to the management of clinical and biological data. PMID:19492074

Development of the Lymphoma Enterprise Architecture Database: a caBIG Silver level compliant system.

PubMed

Huang, Taoying; Shenoy, Pareen J; Sinha, Rajni; Graiser, Michael; Bumpers, Kevin W; Flowers, Christopher R

2009-04-03

Lymphomas are the fifth most common cancer in United States with numerous histological subtypes. Integrating existing clinical information on lymphoma patients provides a platform for understanding biological variability in presentation and treatment response and aids development of novel therapies. We developed a cancer Biomedical Informatics Grid (caBIG) Silver level compliant lymphoma database, called the Lymphoma Enterprise Architecture Data-system (LEAD), which integrates the pathology, pharmacy, laboratory, cancer registry, clinical trials, and clinical data from institutional databases. We utilized the Cancer Common Ontological Representation Environment Software Development Kit (caCORE SDK) provided by National Cancer Institute's Center for Bioinformatics to establish the LEAD platform for data management. The caCORE SDK generated system utilizes an n-tier architecture with open Application Programming Interfaces, controlled vocabularies, and registered metadata to achieve semantic integration across multiple cancer databases. We demonstrated that the data elements and structures within LEAD could be used to manage clinical research data from phase 1 clinical trials, cohort studies, and registry data from the Surveillance Epidemiology and End Results database. This work provides a clear example of how semantic technologies from caBIG can be applied to support a wide range of clinical and research tasks, and integrate data from disparate systems into a single architecture. This illustrates the central importance of caBIG to the management of clinical and biological data.

24 CFR 3400.1 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-04-01

... participate in a nationwide mortgage licensing system and registry database of residential mortgage loan... charged with establishing and maintaining a licensing and registry database for loan originators. (b.... Subpart D provides minimum requirements for the administration of the Nationwide Mortgage Licensing System...

24 CFR 3400.1 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-04-01

... participate in a nationwide mortgage licensing system and registry database of residential mortgage loan... charged with establishing and maintaining a licensing and registry database for loan originators. (b.... Subpart D provides minimum requirements for the administration of the Nationwide Mortgage Licensing System...

Delphi Technique Used in Laser Incident Surveillance

DTIC Science & Technology

2004-01-01

Registry (LAIR), and the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health ( CDRH ) [10]. Other databases were consulted...for collecting laser incident reports such as training (RLI), reporting equipment problems ( CDRH ), or for research and accident prevention (LAIR

The utility of international shoulder joint replacement registries and databases: a comparative analytic review of two hundred and sixty one thousand, four hundred and eighty four cases.

PubMed

Bayona, Carlos Eduardo Afanador; Somerson, Jeremy S; Matsen, Frederick A

2018-02-01

National registries are valuable tools for understanding the results of shoulder arthroplasty across populations. These databases provide an unselected view of shoulder joint replacement within geographical areas that cannot be obtained from case series or prospective studies. They can be particularly helpful in determining which diagnoses, patients, procedures, and prostheses have higher than expected rates of revision. In an attempt to determine the generalizability of registry data, we asked, 'how similar are the patients and procedures among the different national registries?' We analyzed national shoulder arthroplasty registries and databases accessed via Internet portals and through a PubMed literature search. Seven national/regional registries and five publications regarding national shoulder arthroplasty data were identified; these sources contained a combined total of 261,484 shoulder arthroplasty cases. The percentages of hemiarthroplasty, anatomic (aTSA) and reverse total shoulders (rTSA), the diagnoses leading to arthroplasty, the mean patient age, and the distribution of patient gender varied significantly among these different databases. This study indicates that the indications for and application of shoulder arthroplasty have important geographical variations and that these variations must be considered when comparing outcomes of shoulder arthroplasty from different locations. Without controlling for age, gender, diagnosis and procedure type, the results from one national registry may not be applicable to patients from a different location. In that national data provide the opportunity to reduce costs by identifying implants and procedures with higher failure rates, the funding of registries needs to be free of conflicts of interest.

RADIUS: Research Archive on Disability in the United States. [CD-ROMs].

ERIC Educational Resources Information Center

Sociometrics Corp., Los Altos, CA.

This Research Archive on Disability in the United States (RADIUS), a database on CD-ROM, contains 19 data sets on the prevalence, incidence, correlates, and consequences of disability in the United States. The 19 data sets are: (1) 1991 National Maternal and Infant Health Follow-Up Survey; (2) National Pediatric Trauma Registry, 1988-1994; (3)…

Is Mammography Useful in Older Women

DTIC Science & Technology

1999-06-01

mammography in women age 70 and older . Using the Linked Medicare-SEER Tumor Registry Database, created by the National Cancer Institute and the Health Care... Health Interview Survey) have documented that mammography use decreases with advancing age (11,21,22). In 1993, only 25% of women age 65 and older ...related health services research. The linked database contains cancer information on patients 65 years of age and older from NCI’s SEER Program and

The foundation of NCVD PCI Registry: the Malaysia's first multi-centre interventional cardiology project.

PubMed

Liew, H B; Rosli, M A; Wan Azman, W A; Robaayah, Z; Sim, K H

2008-09-01

The National Cardiovascular Database for Percutaneous Coronary Intervention (NCVD PCI) Registry is the first multicentre interventional cardiology project, involving the main cardiac centres in the country. The ultimate goal of NCVD PCI is to provide a contemporary appraisal of PCI in Malaysia. This article introduces the foundation, the aims, methodology, database collection and preliminary results of the first six-month database.

Setting up of the Indian HIPEC Registry: A Registry for Indian Patients with Peritoneal Surface Malignancies.

PubMed

Bhatt, Aditi; Mehta, Sanket; Ramakrishnan As; Pande, Pankaj; Rajan, Firoz; Rangole, Ashvin; Saklani, Avanish; Sethna, Kayomarz; Singh, Shivendra; Zaveri, Shabber; Gopinath, K S

2017-12-01

There are various registries for patients with peritoneal metastases (PM) that aid pooling of data and generate evidence that dictates current clinical practice. This manuscript describes the setting up of the Indian HIPEC registry that was set up with a similar goal by a group of Indian surgeons. This is a registry for patients with PM treated with CRS and HIPEC in India. It also acts as a database for storing treatment-related information. Patients with PM from colorectal ovarian, gastric, appendiceal tumors, and other rare peritoneal tumors/metastases from rare tumors are enrolled in the registry. A coordinator updates the disease status of patients on a yearly basis. A private organization maintains the database. A non-disclosure agreement is signed between the company and each surgeon contributing to the registry to maintain confidentiality. For enrolling patients, securing institutional permission depends on the requirement of each institute; patient consent is mandatory. Data entry can be prospective or retrospective. To propose and conduct a study, the approval of a scientific committee linked to the registry is required. The Indian HIPEC registry is a practical database for Indian surgeons. There is no regulatory body that mandates collection and publication of scientific data in India. The onus is on each surgeon to capture valuable information pertaining to these common and rare diseases that could contribute to the existing scientific knowledge and guide the treatment of these patients in the future. The next challenge will be to enter data into the registry.

Developing a national quality registry for hand surgery: challenges and opportunities

PubMed Central

Arner, Marianne

2016-01-01

The Scandinavian National Healthcare Quality Registries (NQRs) have brought about considerable improvements since their introduction in the 1970s. One such registry – HAKIR (‘hand surgery’) – was established in 2010 and was likely the first NQR for hand surgery. Patient-reported outcome and reoperations due to post-operative complications are registered in HAKIR, as well as hand function in selected groups of surgical procedures. Creating simple logistics for collecting data and careful planning are important factors when establishing a new NQR. Continuous surveillance of data validity and coverage are crucial for success. With perseverance, large databases for clinical research can be created, along with the establishment of national multi-professional collaboration in healthcare improvement work. Cite this article: Arner, M. Developing a national quality registry for hand surgery: challenges and opportunities. EFORT Open Rev 2016;1:100-106. DOI: 10.1302/2058-5241.1.000045. PMID:28461935

A Directory of Sources of Information and Data Bases on Education and Training.

DTIC Science & Technology

1980-09-01

ACADO07 National Opinion Research Center (NORC) ... ............. ... ACADOO8 U of California Union Catalog Supp. (1963-1967...Records (RSR) ...... .................. ... ARMYO30 Union Central Registry System (UCRSYS) .... .............. ... ARMY032 Training Control Card Report...research. Your query directs a computer search of the Compre- hensive Dissertation Database. The search produces a list of all titles matching your

A comparative study of the risk profile of hemodialysis patients in a for profit network and in two regional registries of the Italian Society of Nephrology.

PubMed

Postorino, Maurizio; Amato, Claudia; Mancini, Elena; Carioni, Paola; D'Arrigo, Graziella; Di Benedetto, Attilio; Cerino, Fabrizio; Marino, Carmela; Vilasi, Antonio; Tripepi, Giovanni; Stuard, Stefano; Capasso, Giovanbattista; Santoro, Antonio; Zoccali, Carmine

2018-02-01

In 2013, the Italian Society of Nephrology joined forces with Nephrocare-Italy to create a clinical research cohort of patients on file in the data-rich clinical management system (EUCLID) of this organization for the performance of observational studies in the hemodialysis (HD) population. To see whether patients in EUCLID are representative of the HD population in Italy, we set out to compare the whole EUCLID population with patients included in the regional HD registries in Emilia-Romagna (Northern Italy) and in Calabria (Southern Italy), the sole regions in Italy which have systematically collected an enlarged clinical data set allowing comparison with the data-rich EUCLID system. An analysis of prevalent and incident patients in 2010 and 2011 showed that EUCLID patients had a lower prevalence of coronary heart disease, peripheral vascular disease, heart failure, valvular heart disease, liver disease, peptic ulcer and other comorbidities and risk factors and a higher fractional urea clearance (Kt/V) than those in the Emilia Romagna and Calabria registries. Accordingly, survival analysis showed a lower mortality risk in the EUCLID 2010 and 2011 cohorts than in the combined two regional registries in the corresponding years: for 2010, hazard ratio (HR) EUCLID vs. Regional registries: 0.80 [95% confidence interval: 0.71-0.90]; for 2011, HR: 0.76 [0.65-0.90]. However, this difference was nullified by statistical adjustment for the difference in comorbidities and risk factors, indicating that the longer survival in the EUCLID database was attributable to the lower risk profile of patients included in that database. This preliminary analysis sets the stage for future observational studies and indicates that appropriate adjustment for difference in comorbidities and risk factors is needed to generalize to the Italian HD population analyses based on the data-rich EUCLID database.

Central diabetes insipidus: a previously unreported side effect of temozolomide.

PubMed

Faje, Alexander T; Nachtigall, Lisa; Wexler, Deborah; Miller, Karen K; Klibanski, Anne; Makimura, Hideo

2013-10-01

Temozolomide (TMZ) is an alkylating agent primarily used to treat tumors of the central nervous system. We describe 2 patients with apparent TMZ-induced central diabetes insipidus. Using our institution's Research Patient Database Registry, we identified 3 additional potential cases of TMZ-induced diabetes insipidus among a group of 1545 patients treated with TMZ. A 53-year-old male with an oligoastrocytoma and a 38-year-old male with an oligodendroglioma each developed symptoms of polydipsia and polyuria approximately 2 months after the initiation of TMZ. Laboratory analyses demonstrated hypernatremia and urinary concentrating defects, consistent with the presence of diabetes insipidus, and the patients were successfully treated with desmopressin acetate. Desmopressin acetate was withdrawn after the discontinuation of TMZ, and diabetes insipidus did not recur. Magnetic resonance imaging of the pituitary and hypothalamus was unremarkable apart from the absence of a posterior pituitary bright spot in both of the cases. Anterior pituitary function tests were normal in both cases. Using the Research Patient Database Registry database, we identified the 2 index cases and 3 additional potential cases of diabetes insipidus for an estimated prevalence of 0.3% (5 cases of diabetes insipidus per 1545 patients prescribed TMZ). Central diabetes insipidus is a rare but reversible side effect of treatment with TMZ.

Central Diabetes Insipidus: A Previously Unreported Side Effect of Temozolomide

PubMed Central

Nachtigall, Lisa; Wexler, Deborah; Miller, Karen K.; Klibanski, Anne; Makimura, Hideo

2013-01-01

Context: Temozolomide (TMZ) is an alkylating agent primarily used to treat tumors of the central nervous system. We describe 2 patients with apparent TMZ-induced central diabetes insipidus. Using our institution's Research Patient Database Registry, we identified 3 additional potential cases of TMZ-induced diabetes insipidus among a group of 1545 patients treated with TMZ. Case Presentations: A 53-year-old male with an oligoastrocytoma and a 38-year-old male with an oligodendroglioma each developed symptoms of polydipsia and polyuria approximately 2 months after the initiation of TMZ. Laboratory analyses demonstrated hypernatremia and urinary concentrating defects, consistent with the presence of diabetes insipidus, and the patients were successfully treated with desmopressin acetate. Desmopressin acetate was withdrawn after the discontinuation of TMZ, and diabetes insipidus did not recur. Magnetic resonance imaging of the pituitary and hypothalamus was unremarkable apart from the absence of a posterior pituitary bright spot in both of the cases. Anterior pituitary function tests were normal in both cases. Using the Research Patient Database Registry database, we identified the 2 index cases and 3 additional potential cases of diabetes insipidus for an estimated prevalence of 0.3% (5 cases of diabetes insipidus per 1545 patients prescribed TMZ). Conclusions: Central diabetes insipidus is a rare but reversible side effect of treatment with TMZ. PMID:23928668

Introduction of Transplant Registry Unified Management Program 2 (TRUMP2): scripts for TRUMP data analyses, part I (variables other than HLA-related data).

PubMed

Atsuta, Yoshiko

2016-01-01

Collection and analysis of information on diseases and post-transplant courses of allogeneic hematopoietic stem cell transplant recipients have played important roles in improving therapeutic outcomes in hematopoietic stem cell transplantation. Efficient, high-quality data collection systems are essential. The introduction of the Second-Generation Transplant Registry Unified Management Program (TRUMP2) is intended to improve data quality and more efficient data management. The TRUMP2 system will also expand possible uses of data, as it is capable of building a more complex relational database. The construction of an accessible data utilization system for adequate data utilization by researchers would promote greater research activity. Study approval and management processes and authorship guidelines also need to be organized within this context. Quality control of processes for data manipulation and analysis will also affect study outcomes. Shared scripts have been introduced to define variables according to standard definitions for quality control and improving efficiency of registry studies using TRUMP data.

A medical birth registry at Kilimanjaro Christian Medical Centre.

PubMed

Bergsjø, Per; Mlay, Joseph; Lie, Rolv T; Lie-Nielsen, E; Shao, John F

2007-04-01

To establish a medical birth registry intended to serve clinical, administrative and research purposes. Starting in July 2000, every birth at Kilimanjaro Christian Medical Centre (KCMC) in Moshi, Tanzania has been recorded in a separate database. The information is obtained through personal interviews with each mother, conducted by specially trained midwives, and supplied with data from the medical records. A secretary enters the data into the electronic file. Data are collected about the mother and father: education, occupation and living conditions, mother's health before and during present pregnancy, expected date of delivery, smoking and drinking (alcohol) habits, use of drugs, plus HIV and syphilis status (if known). This is followed by particulars on the delivery: spontaneous or induced, and complications; the child or children: weight, height and Apgar score, malformations and other diagnoses. Mode of birth: spontaneous or operative intervention. If perinatal death: when? Transfer to intensive neonatal unit? The mother's reproductive history (births, miscarriages, ectopic pregnancies) is also recorded, with outcomes. We describe the process based on more than six years' experience, including obstacles and how they were overcome. The registry serves as a monitoring tool, with a set of key activities and events being issued monthly, indicating changes and trends in, e.g., bleeding complications, caesarean section rates and perinatal mortality, as early warning signs. Monthly reports on key issues are presented. Confidentiality and data protection are key issues. Day-to-day recording of births is vulnerable to personnel shortage, whether from disease or holidays. Validation and quality checks leave the overall impression that the database is largely accurate and credible. There are plenty of opportunities for research. Clinicians and epidemiologists will profit from using the database to test hypotheses and clarify problem issues, to the ultimate benefit of labouring women and their children.

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries.

PubMed

Gerbens, Louise A A; Boyce, Aaron E; Wall, Dmitri; Barbarot, Sebastien; de Booij, Richard J; Deleuran, Mette; Middelkamp-Hup, Maritza A; Roberts, Amanda; Vestergaard, Christian; Weidinger, Stephan; Apfelbacher, Christian J; Irvine, Alan D; Schmitt, Jochen; Williamson, Paula R; Spuls, Phyllis I; Flohr, Carsten

2017-02-27

Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinical management is small, despite the frequent and often off-label use of these treatments. Registries of patients on photo- and systemic immunomodulatory therapies could fill this gap, and the collection of a core set concerning these therapies in AE will allow direct comparisons across registries as well as data sharing and pooling. Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies. Participants from six stakeholder groups will be invited: doctors, nurses, non-clinical researchers, patients, as well as industry and regulatory body representatives. The eDelphi will comprise three sequential online rounds, requesting participants to rate the importance of each proposed domain and domain items. Participants will be able to add domains and domain items to the proposed list in round 1. A final consensus meeting will be held with representatives of each stakeholder group. Identifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders. Not applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database.

Report of a workshop on research gaps in the treatment of cerebral palsy

PubMed Central

Hirtz, Deborah; Damiano, Diane; Gross, Paul; Mink, Jonathan W.

2016-01-01

Cerebral palsy (CP) is heterogeneous in etiology and manifestations, making research into relevant therapies difficult and limiting the generalizability of the results. We report here on the NIH CP symposium, where stakeholders from academic, clinical, regulatory, and advocacy backgrounds discussed the major challenges and needs for moving forward with clinical research in CP, and outlined priorities and action items. New information is constantly generated through research into pathogenesis and etiology. Clinical research and new therapeutic approaches need to keep pace, through large data registry integration and new research designs. Development of standardized data collection, increasing academic focus on CP research, and iterative approaches to treatment throughout the patients' lives, have all been identified as areas of focus. The workshop identified critical gaps and areas of focus to increase the evidence base for therapeutic approaches to determine which treatments work best for which patients in the near future. These include consolidation and optimization of databases and registries, updates to the research methodology, and better integration of resources and stakeholders. PMID:27558377

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register.

PubMed

Fleminger, Jessica; Goldacre, Ben

2018-01-01

Trial registries are a key source of information for clinicians and researchers. While building OpenTrials, an open database of public trial information, we identified errors and omissions in registries, including discrepancies between descriptions of the same trial in different registries. We set out to ascertain the prevalence of discrepancies in trial completion status using a cohort of trials registered on both the European Union Clinical Trials Register (EUCTR) and ClinicalTrials.gov. We used matching titles and registry IDs provided by both registries to build a cohort of dual-registered trials. Completion statuses were compared; we calculated descriptive statistics on the prevalence of discrepancies. 11,988 dual-registered trials were identified. 1,496 did not provide a comparable completion status, leaving 10,492 trials. 16.2% were discrepant on completion status. The majority of discrepancies (90.5%) were a 'completed' trial on ClinicalTrials.gov inaccurately marked as 'ongoing' on EUCTR. Overall, 33.9% of dual-registered trials described as 'ongoing' on EUCTR were listed as 'completed' on ClinicalTrials.gov. Completion status on registries is commonly inaccurate. Previous work on publication bias may underestimate non-reporting. We describe simple steps registry owners and trialists could take to improve accuracy.

78 FR 29349 - Applications for New Awards; National Institute on Disability and Rehabilitation Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... System (DUNS) number and a Taxpayer Identification Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR)--and, after July 24, 2012, with the System for Award Management (SAM), the Government's primary registrant database; c. Provide your DUNS number and TIN on your...

United States Transuranium and Uranium Registries. Annual report, February 1, 2003 - January 31, 2004

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alldredge, J. R.; Brumbaugh, T. L.; Ehrhart, Susan M.

2004-01-31

This year was my fourteenth year with the U. S. Transuranium and Uranium Registries (USTUR). How time flies! Since I became the director of the program five years ago, one of my primary goals was to increase the usefulness of the large USTUR database that consists of six tables containing personal information, medical histories, radiation exposure histories, causes of death, and the results of radiochemical analysis of organ samples collected at autopsy. It is essential that a query of one or more of these tables by USTUR researchers or by collaborating researchers provides complete and reliable information. Also, some ofmore » the tables (those without personal identifiers) are destined to appear on the USTUR website for the use of the scientific community. I am pleased to report that most of the data in the database have now been verified and formatted for easy query. It is important to note that no data were discarded; copies of the original tables were retained and the original paper documents are still available for further verification of values as needed.« less

Reference Standards for Cardiorespiratory Fitness Measured With Cardiopulmonary Exercise Testing Using Cycle Ergometry: Data From the Fitness Registry and the Importance of Exercise National Database (FRIEND) Registry.

PubMed

Kaminsky, Leonard A; Imboden, Mary T; Arena, Ross; Myers, Jonathan

2017-02-01

The importance of cardiorespiratory fitness (CRF) is well established. This report provides newly developed standards for CRF reference values derived from cardiopulmonary exercise testing (CPX) using cycle ergometry in the United States. Ten laboratories in the United States experienced in CPX administration with established quality control procedures contributed to the "Fitness Registry and the Importance of Exercise: A National Database" (FRIEND) Registry from April 2014 through May 2016. Data from 4494 maximal (respiratory exchange ratio, ≥1.1) cycle ergometer tests from men and women (20-79 years) from 27 states, without cardiovascular disease, were used to develop these references values. Percentiles of maximum oxygen consumption (VO 2max ) for men and women were determined for each decade from age 20 years through age 79 years. Comparisons of VO 2max were made to reference data established with CPX data from treadmill data in the FRIEND Registry and previously published reports. As expected, there were significant differences between sex and age groups for VO 2max (P<.01). For cycle tests within the FRIEND Registry, the 50th percentile VO 2max of men and women aged 20 to 29 years declined from 41.9 and 31.0 mLO 2 /kg/min to 19.5 and 14.8 mLO 2 /kg/min for ages 70 to 79 years, respectively. The rate of decline in this cohort was approximately 10% per decade. The FRIEND Registry reference data will be useful in providing more accurate interpretations for the US population of CPX-measured VO 2max from exercise tests using cycle ergometry compared with previous approaches based on estimations of standard differences from treadmill testing reference values. Copyright © 2016 Mayo Foundation for Medical Education and Research. All rights reserved.

Health data research in New Zealand: updating the ethical governance framework.

PubMed

Ballantyne, Angela; Style, Rochelle

2017-10-27

Demand for health data for secondary research is increasing, both in New Zealand and worldwide. The New Zealand government has established a large research database, the Integrated Data Infrastructure (IDI), which facilitates research, and an independent ministerial advisory group, the Data Futures Partnership (DFP), to engage with citizens, the private sector and non-government organisations (NGOs) to facilitate trusted data use and strengthen the data ecosystem in New Zealand. We commend these steps but argue that key strategies for effective health-data governance remain absent in New Zealand. In particular, we argue in favour of the establishment of: (1) a specialist Health and Disability Ethics Committee (HDEC) to review applications for secondary-use data research; (2) a public registry of approved secondary-use research projects (similar to a clinical trials registry); and (3) detailed guidelines for the review and approval of secondary-use data research. We present an ethical framework based on the values of public interest, trust and transparency to justify these innovations.

Development and Implementation of a Registry of Patients Attending Multidisciplinary Pain Treatment Clinics: The Quebec Pain Registry

PubMed Central

Lanctôt, H.; Beaudet, N.; Boulanger, A.; Bourgault, P.; Cloutier, C.; De Koninck, Y.; Dion, D.; Dolbec, P.; Germain, L.; Sarret, P.; Shir, Y.; Taillefer, M.-C.; Trépanier, A.; Truchon, R.

2017-01-01

The Quebec Pain Registry (QPR) is a large research database of patients suffering from various chronic pain (CP) syndromes who were referred to one of five tertiary care centres in the province of Quebec (Canada). Patients were monitored using common demographics, identical clinical descriptors, and uniform validated outcomes. This paper describes the development, implementation, and research potential of the QPR. Between 2008 and 2013, 6902 patients were enrolled in the QPR, and data were collected prior to their first visit at the pain clinic and six months later. More than 90% of them (mean age ± SD: 52.76 ± 4.60, females: 59.1%) consented that their QPR data be used for research purposes. The results suggest that, compared to patients with serious chronic medical disorders, CP patients referred to tertiary care clinics are more severely impaired in multiple domains including emotional and physical functioning. The QPR is also a powerful and comprehensive tool for conducting research in a “real-world” context with 27 observational studies and satellite research projects which have been completed or are underway. It contains data on the clinical evolution of thousands of patients and provides the opportunity of answering important research questions on various aspects of CP (or specific pain syndromes) and its management. PMID:28280406

The making of a pan-European organ transplant registry.

PubMed

Smits, Jacqueline M; Niesing, Jan; Breidenbach, Thomas; Collett, Dave

2013-03-01

A European patient registry to track the outcomes of organ transplant recipients does not exist. As knowledge gleaned from large registries has already led to the creation of standards of care that gained widespread support from patients and healthcare providers, the European Union initiated a project that would enable the creation of a European Registry linking currently existing national databases. This report contains a description of all functional, technical, and legal prerequisites, which upon fulfillment should allow for the seamless sharing of national longitudinal data across temporal, geographical, and subspecialty boundaries. To create a platform that can effortlessly link multiple databases and maintain the integrity of the existing national databases crucial elements were described during the project. These elements are: (i) use of a common dictionary, (ii) use of a common database and refined data uploading technology, (iii) use of standard methodology to allow uniform protocol driven and meaningful long-term follow-up analyses, (iv) use of a quality assurance mechanism to guarantee completeness and accuracy of the data collected, and (v) establishment of a solid legal framework that allows for safe data exchange. © 2012 The Authors Transplant International © 2012 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

Description of OPRA: A Danish database designed for the analyses of risk factors associated with 30-day hospital readmission of people aged 65+ years.

PubMed

Pedersen, Mona K; Nielsen, Gunnar L; Uhrenfeldt, Lisbeth; Rasmussen, Ole S; Lundbye-Christensen, Søren

2017-08-01

To describe the construction of the Older Person at Risk Assessment (OPRA) database, the ability to link this database with existing data sources obtained from Danish nationwide population-based registries and to discuss its research potential for the analyses of risk factors associated with 30-day hospital readmission. We reviewed Danish nationwide registries to obtain information on demographic and social determinants as well as information on health and health care use in a population of hospitalised older people. The sample included all people aged 65+ years discharged from Danish public hospitals in the period from 1 January 2007 to 30 September 2010. We used personal identifiers to link and integrate the data from all events of interest with the outcome measures in the OPRA database. The database contained records of the patients, admissions and variables of interest. The cohort included 1,267,752 admissions for 479,854 unique people. The rate of 30-day all-cause acute readmission was 18.9% ( n=239,077) and the overall 30-day mortality was 5.0% ( n=63,116). The OPRA database provides the possibility of linking data on health and life events in a population of people moving into retirement and ageing. Construction of the database makes it possible to outline individual life and health trajectories over time, transcending organisational boundaries within health care systems. The OPRA database is multi-component and multi-disciplinary in orientation and has been prepared to be used in a wide range of subgroup analyses, including different outcome measures and statistical methods.

Innovative measures to combat rare diseases in China: The national rare diseases registry system, larger-scale clinical cohort studies, and studies in combination with precision medicine research.

PubMed

Song, Peipei; He, Jiangjiang; Li, Fen; Jin, Chunlin

2017-02-01

China is facing the great challenge of treating the world's largest rare disease population, an estimated 16 million patients with rare diseases. One effort offering promise has been a pilot national project that was launched in 2013 and that focused on 20 representative rare diseases. Another government-supported special research program on rare diseases - the "Rare Diseases Clinical Cohort Study" - was launched in December 2016. According to the plan for this research project, the unified National Rare Diseases Registry System of China will be established as of 2020, and a large-scale cohort study will be conducted from 2016 to 2020. The project plans to develop 109 technical standards, to establish and improve 2 national databases of rare diseases - a multi-center clinical database and a biological sample library, and to conduct studies on more than 50,000 registered cases of 50 different rare diseases. More importantly, this study will be combined with the concept of precision medicine. Chinese population-specific basic information on rare diseases, clinical information, and genomic information will be integrated to create a comprehensive predictive model with a follow-up database system and a model to evaluate prognosis. This will provide the evidence for accurate classification, diagnosis, treatment, and estimation of prognosis for rare diseases in China. Numerous challenges including data standardization, protecting patient privacy, big data processing, and interpretation of genetic information still need to be overcome, but research prospects offer great promise.

77 FR 37012 - Applications for New Awards: Disability and Rehabilitation Research Projects and Centers Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d..., agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are...

[Concordance in the registry of dementia among the main sources of clinical information].

PubMed

Marta-Moreno, Javier; Obón-Azuara, Blanca; Gimeno-Felíu, Luis; Achkar-Tuglaman, Nesib Nicolás; Poblador-Plou, Beatriz; Calderón-Larrañaga, Amaia; Prados-Torres, Alexandra

2016-01-01

The objective of this work was to analyse the concordance in the registry of dementia among the main sources of clinical information, with the aim of determining their usefulness for epidemiological and clinical research. Descriptive study of patients assigned to the Aragon Health Service in 2010 (n=1,344,891). (i)the pharmacy billing database (n=9,392); (ii)Primary Care electronic health records (EHR) (n=9,471), and (iii)the hospital minimum basic data set (n=3,289). When studying the concordance of the databases, the group of patients with a specific treatment for dementia (i.e., acetylcholinesterase inhibitors and/or memantine) was taken as the reference. The diagnosis in Primary Care was missing for 47.3% of patients taking anti-dementia drugs. The same occurred with 38.3% of dementia patients admitted to hospital during the study year. Among patients with a diagnosis of dementia in the EHR, only half (52.3%) was under treatment for this condition. This percentage decreased to 34.4% in patients with the diagnosis registered in the hospital database. The weak concordance in the registry of the dementia diagnosis between the main health information systems makes their use and analysis more complex, and supports the need to include all available health data sources in order to gain a global picture of the epidemiological and clinical reality of this health condition. Copyright © 2015 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

Data Quality in Institutional Arthroplasty Registries: Description of a Model of Validation and Report of Preliminary Results.

PubMed

Bautista, Maria P; Bonilla, Guillermo A; Mieth, Klaus W; Llinás, Adolfo M; Rodríguez, Fernanda; Cárdenas, Laura L

2017-07-01

Arthroplasty registries are a relevant source of information for research and quality improvement in patient care and its value depends on the quality of the recorded data. The purpose of this study is to describe a model of validation and present the findings of validation of an Institutional Arthroplasty Registry (IAR). Information from 209 primary arthroplasties and revision surgeries of the hip, knee, and shoulder recorded in the IAR between March and September 2015 were analyzed in the following domains. Adherence is defined as the proportion of patients included in the registry, completeness is defined as the proportion of data effectively recorded, and accuracy is defined as the proportion of data consistent with medical records. A random sample of 53 patients (25.4%) was selected to assess the latest 2 domains. A direct comparison between the registry's database and medical records was performed. In total, 324 variables containing information on demographic data, surgical procedure, clinical outcomes, and key performance indicators were analyzed. Two hundred nine of 212 patients who underwent surgery during the study period were included in the registry, accounting for an adherence of 98.6%. Completeness was 91.7% and accuracy was 85.8%. Most errors were found in the preoperative range of motion and timely administration of prophylactic antibiotics and thromboprophylaxis. This model provides useful information regarding the quality of the recorded data since it identified deficient areas within the IAR. We recommend that institutional arthroplasty registries be constantly monitored for data quality before using their information for research or quality improvement purposes. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed Central

Chang, Helena C.; Tzou, David T.; Usawachintachit, Manint; Duty, Brian D.; Hsi, Ryan S.; Harper, Jonathan D.; Sorensen, Mathew D.; Stoller, Marshall L.; Sur, Roger L.

2016-01-01

Abstract 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. PMID:27758162

Schwannomatosis

MedlinePlus

... Schwannomatosis Database Schwannomatosis Resources NF Registry International Schwannomatosis Database Because of the small number of people that ... and how to treat it, the International Schwannomatosis Database (ISD) project is proposing to bring together people ...

Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

PubMed Central

Mitchell, Ian; Lanctôt, Krista L.

2013-01-01

Respiratory syncytial virus (RSV) infection occurs commonly in infants aged ≤2 years, and severe infection results in hospitalization with accompanying morbidity and mortality. Palivizumab has been available for prophylaxis for the past 15 years. Prospective data on patients who received palivizumab from 2005 to 2012 has been assembled in the Canadian registry (CARESS) to document utilization, compliance, and health outcomes in both hospital and community settings. Long-term data is necessary to evaluate the impact of palivizumab on the incidence of RSV infections, minimize healthcare resources, and identify which infant subpopulations are receiving prophylaxis. A database search was also conducted for similar information from published registries, and hospitalization rates were compared to results from randomized clinical trials (RCTs).Overall hospitalization rates (percent; range) for respiratory-related illnesses and RSV-specific infection in infants who meet standard indications for prophylaxis were 6.6 (3.3–7.7) and 1.55 (0.3–2.06), respectively, in CARESS, which closely aligns with registry data from 4 other countries, despite the former comprising the largest cohort of complex patients internationally. Overall RSV-related hospitalization rates were lower across registries compared to equivalent patients in RCTs. Registry data provides valuable information regarding real-world experience with palivizumab, while facilitating the genesis of new research themes. PMID:23861694

BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciences.

PubMed

McQuilton, Peter; Gonzalez-Beltran, Alejandra; Rocca-Serra, Philippe; Thurston, Milo; Lister, Allyson; Maguire, Eamonn; Sansone, Susanna-Assunta

2016-01-01

BioSharing (http://www.biosharing.org) is a manually curated, searchable portal of three linked registries. These resources cover standards (terminologies, formats and models, and reporting guidelines), databases, and data policies in the life sciences, broadly encompassing the biological, environmental and biomedical sciences. Launched in 2011 and built by the same core team as the successful MIBBI portal, BioSharing harnesses community curation to collate and cross-reference resources across the life sciences from around the world. BioSharing makes these resources findable and accessible (the core of the FAIR principle). Every record is designed to be interlinked, providing a detailed description not only on the resource itself, but also on its relations with other life science infrastructures. Serving a variety of stakeholders, BioSharing cultivates a growing community, to which it offers diverse benefits. It is a resource for funding bodies and journal publishers to navigate the metadata landscape of the biological sciences; an educational resource for librarians and information advisors; a publicising platform for standard and database developers/curators; and a research tool for bench and computer scientists to plan their work. BioSharing is working with an increasing number of journals and other registries, for example linking standards and databases to training material and tools. Driven by an international Advisory Board, the BioSharing user-base has grown by over 40% (by unique IP address), in the last year thanks to successful engagement with researchers, publishers, librarians, developers and other stakeholders via several routes, including a joint RDA/Force11 working group and a collaboration with the International Society for Biocuration. In this article, we describe BioSharing, with a particular focus on community-led curation.Database URL: https://www.biosharing.org. © The Author(s) 2016. Published by Oxford University Press.

Validation of a case definition to define chronic dialysis using outpatient administrative data.

PubMed

Clement, Fiona M; James, Matthew T; Chin, Rick; Klarenbach, Scott W; Manns, Braden J; Quinn, Robert R; Ravani, Pietro; Tonelli, Marcello; Hemmelgarn, Brenda R

2011-03-01

Administrative health care databases offer an efficient and accessible, though as-yet unvalidated, approach to studying outcomes of patients with chronic kidney disease and end-stage renal disease (ESRD). The objective of this study is to determine the validity of outpatient physician billing derived algorithms for defining chronic dialysis compared to a reference standard ESRD registry. A cohort of incident dialysis patients (Jan. 1-Dec. 31, 2008) and prevalent chronic dialysis patients (Jan 1, 2008) was selected from a geographically inclusive ESRD registry and administrative database. Four administrative data definitions were considered: at least 1 outpatient claim, at least 2 outpatient claims, at least 2 outpatient claims at least 90 days apart, and continuous outpatient claims at least 90 days apart with no gap in claims greater than 21 days. Measures of agreement of the four administrative data definitions were compared to a reference standard (ESRD registry). Basic patient characteristics are compared between all 5 patient groups. 1,118,097 individuals formed the overall population and 2,227 chronic dialysis patients were included in the ESRD registry. The three definitions requiring at least 2 outpatient claims resulted in kappa statistics between 0.60-0.80 indicating "substantial" agreement. "At least 1 outpatient claim" resulted in "excellent" agreement with a kappa statistic of 0.81. Of the four definitions, the simplest (at least 1 outpatient claim) performed comparatively to other definitions. The limitations of this work are the billing codes used are developed in Canada, however, other countries use similar billing practices and thus the codes could easily be mapped to other systems. Our reference standard ESRD registry may not capture all dialysis patients resulting in some misclassification. The registry is linked to on-going care so this is likely to be minimal. The definition utilized will vary with the research objective.

National Databases for Neurosurgical Outcomes Research: Options, Strengths, and Limitations.

PubMed

Karhade, Aditya V; Larsen, Alexandra M G; Cote, David J; Dubois, Heloise M; Smith, Timothy R

2017-08-05

Quality improvement, value-based care delivery, and personalized patient care depend on robust clinical, financial, and demographic data streams of neurosurgical outcomes. The neurosurgical literature lacks a comprehensive review of large national databases. To assess the strengths and limitations of various resources for outcomes research in neurosurgery. A review of the literature was conducted to identify surgical outcomes studies using national data sets. The databases were assessed for the availability of patient demographics and clinical variables, longitudinal follow-up of patients, strengths, and limitations. The number of unique patients contained within each data set ranged from thousands (Quality Outcomes Database [QOD]) to hundreds of millions (MarketScan). Databases with both clinical and financial data included PearlDiver, Premier Healthcare Database, Vizient Clinical Data Base and Resource Manager, and the National Inpatient Sample. Outcomes collected by databases included patient-reported outcomes (QOD); 30-day morbidity, readmissions, and reoperations (National Surgical Quality Improvement Program); and disease incidence and disease-specific survival (Surveillance, Epidemiology, and End Results-Medicare). The strengths of large databases included large numbers of rare pathologies and multi-institutional nationally representative sampling; the limitations of these databases included variable data veracity, variable data completeness, and missing disease-specific variables. The improvement of existing large national databases and the establishment of new registries will be crucial to the future of neurosurgical outcomes research. Copyright © 2017 by the Congress of Neurological Surgeons

Report of a workshop on research gaps in the treatment of cerebral palsy.

PubMed

Lungu, Codrin; Hirtz, Deborah; Damiano, Diane; Gross, Paul; Mink, Jonathan W

2016-09-20

Cerebral palsy (CP) is heterogeneous in etiology and manifestations, making research into relevant therapies difficult and limiting the generalizability of the results. We report here on the NIH CP symposium, where stakeholders from academic, clinical, regulatory, and advocacy backgrounds discussed the major challenges and needs for moving forward with clinical research in CP, and outlined priorities and action items. New information is constantly generated through research into pathogenesis and etiology. Clinical research and new therapeutic approaches need to keep pace, through large data registry integration and new research designs. Development of standardized data collection, increasing academic focus on CP research, and iterative approaches to treatment throughout the patients' lives, have all been identified as areas of focus. The workshop identified critical gaps and areas of focus to increase the evidence base for therapeutic approaches to determine which treatments work best for which patients in the near future. These include consolidation and optimization of databases and registries, updates to the research methodology, and better integration of resources and stakeholders. © 2016 American Academy of Neurology.

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics.

PubMed

Russo, Rennie; Coultas, David; Ashmore, Jamile; Peoples, Jennifer; Sloan, John; Jackson, Bradford E; Uhm, Minyong; Singh, Karan P; Blair, Steven N; Bae, Sejong

2015-03-01

To describe the recruitment methods, study participation rate, and baseline characteristics of a representative sample of outpatients with COPD eligible for pulmonary rehabilitation participating in a trial of a lifestyle behavioral intervention to increase physical activity. A patient registry was developed for recruitment using an administrative database from primary care and specialty clinics of an academic medical center in northeast Texas for a parallel group randomized trial. The registry was comprised of 5582 patients and over the course of the 30 month recruitment period 325 patients were enrolled for an overall study participation rate of 35.1%. After a 6-week COPD self-management education period provided to all enrolled patients, 305 patients were randomized into either usual care (UC; n=156) or the physical activity self-management intervention (PASM; n=149). There were no clinically significant differences in demographics, clinical characteristics, or health status indicators between the randomized groups. The results of this recruitment process demonstrate the successful use of a patient registry for enrolling a representative sample of outpatients eligible for pulmonary rehabilitation with COPD from primary and specialty care. Moreover, this approach to patient recruitment provides a model for future studies utilizing administrative databases and electronic health records. Published by Elsevier Inc.

Review of U.S. registries for psoriasis.

PubMed

Amin, Mina; No, Daniel J; Wu, Jashin J

2017-12-01

Patient registries are databases comprised of standardized clinical data for a specific population of patients with a particular disease or medical condition. Information from patient registries allows clinicians to assess long-lasting outcomes in patients with a specific disease, such as psoriasis. Our primary objective was to identify available psoriasis registries in the United States (U.S.) and evaluate the application of patient registries compared to clinical trials. We searched Google, the Registry of Patient Registries, Orphanet and ClinicalTrials.gov to create a list of U.S. psoriasis registries. We also performed a literature review on the application of psoriasis registries using PubMed. We identified 6 psoriasis patient registries in the United States. Patient registries are frequently used for psoriasis in the U.S. and provide important information about the safety, efficacy and long-term effects of systemic therapies.

NORDCAN--a Nordic tool for cancer information, planning, quality control and research.

PubMed

Engholm, Gerda; Ferlay, Jacques; Christensen, Niels; Bray, Freddie; Gjerstorff, Marianne L; Klint, Asa; Køtlum, Jóanis E; Olafsdóttir, Elínborg; Pukkala, Eero; Storm, Hans H

2010-06-01

The NORDCAN database and program ( www.ancr.nu ) include detailed information and results on cancer incidence, mortality and prevalence in each of the Nordic countries over five decades and has lately been supplemented with predictions of cancer incidence and mortality; future extensions include the incorporation of cancer survival estimates. The data originates from the national cancer registries and causes of death registries in Denmark, Finland, Iceland, Norway, Sweden, and Faroe Islands and is regularly updated. Presently 41 cancer entities are included in the common dataset, and conversions of the original national data according to international rules ensure comparability. With 25 million inhabitants in the Nordic countries, 130 000 incident cancers are reported yearly, alongside nearly 60 000 cancer deaths, with almost a million persons living with a cancer diagnosis. This web-based application is available in English and in each of the five Nordic national languages. It includes comprehensive and easy-to-use descriptive epidemiology tools that provide tabulations and graphs, with further user-specified options available. The NORDCAN database aims to provide comparable and timely data to serve the varying needs of policy makers, cancer societies, the public, and journalists, as well as the clinical and research community.

JBEI Registry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ham, Timothy

2008-12-01

The JBEI Registry is a software to store and manage to a database of biological parts. It is intended to be used as a web service that is accessed via a web browser. It is also capable of running as a desktop program for a single user. The registry software stores, indexes, categories, and allows users to enter, search, retrieve, and contruct biological constructs in silico. It is also able to communicate with other Registries for data sharing and exchange.

The Illinois Women’s Health Registry: advancing women’s health research and education in Illinois, USA

PubMed Central

Bristol-Gould, Sarah; Desjardins, Michelle; Woodruff, Teresa K

2010-01-01

To achieve the goal of personalized medicine, we must first improve our understanding of the differences in health and illness between men and women. The purpose of the Illinois Women’s Health Registry (USA) is to provide a research and education tool that advances scientific knowledge of sex- and gender-based differences in health and disease. Specifically, the Registry is a confidential 30-min health and lifestyle survey for female residents of Illinois over the age of 18 years. The survey includes questions regarding health, environment, health-related behaviors, symptoms and illnesses or conditions that a participant may have now or has had in the past. By enrolling in the Registry, women throughout the state are provided with information and access to clinical research studies that they may be eligible for, based on their self-reported health information. The Registry not only serves as a platform for recruitment into pivotal research studies, but also represents the beginning of a state-wide database that enables researchers to examine the collective de-identified health information provided by women living in Illinois. Ultimately, a cross-sectional and longitudinal analysis of these data will help to clarify the issues that women themselves identify as their main health concerns. In response to these concerns, specific research studies can be designed and launched, allowing us to eventually deliver tailored treatment and prevention options to women. Finally, by creating a reliable state-focused research tool, developed by staff that are trained in women’s health research, we can compare health issues across the state and apply strategies for improvement where it is needed most. This article will provide examples of sex differences in disease, the lack of federal enforcement for inclusion of women in studies, researcher-perceived burdens and sex-based reasons as to why recruitment of women is considered to be more challenging. In addition, this article will discuss what a women’s health registry is and why we need one in Illinois, how we have recruited women and our successes and challenges. Our goal is to inform the reader about the utility of a state-based tool and to provide a discussion regarding the lessons learned in order to aid other states in implementing this kind of program. PMID:20187725

Bigger Data, Bigger Problems.

PubMed

Slobogean, Gerard P; Giannoudis, Peter V; Frihagen, Frede; Forte, Mary L; Morshed, Saam; Bhandari, Mohit

2015-12-01

Clinical studies frequently lack the ability to reliably answer their research questions because of inadequate sample sizes. Underpowered studies are subject to multiple sources of bias, may not represent the larger population, and are regularly unable to detect differences between treatment groups. Most importantly, an underpowered study can lead to incorrect conclusions. Big data can be used to address many of these concerns, enabling researchers to answer questions with increased certainty and less likelihood of bias. Big datasets, such as The National Hip Fracture Database in the United Kingdom and the Swedish Hip Arthroplasty Registry, collect valuable clinical information that can be used by researchers to guide patient care and inform policy makers, chief executives, commissioners, and clinical staff. The range of research questions that can be examined is directly related to the quality and complexity of the data, which is positively associated with the cost of the data. However, technological advancements have unlocked new possibilities for efficient data capture and widespread opportunities to merge massive datasets, particularly in the setting of national registries and administrative data.

Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

PubMed

Ito, Tatsuya

2016-01-01

Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs). In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs. The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries. Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data. New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants. There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

Quality and Safety in Health Care, Part XXIX: The Transcatheter Valve Therapy Registry.

PubMed

Harolds, Jay A

2017-11-01

The American College of Cardiology, the Society of Thoracic Surgeons, and other organizations cooperated to form the Transcatheter Valve Therapy Registry. This registry studies information on the outcome of valve therapy device placement with a transcatheter approach. The companies that manufacture these devices can use the registry to meet the post-product sale surveillance requirements of the US Food and Drug Administration. There will also be linkage to the registry information from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, which has information on open cardiac valve surgery.

Integration of immunological aspects in the European Human Embryonic Stem Cell Registry.

PubMed

Borstlap, Joeri; Kurtz, Andreas

2008-05-01

The immunological properties of stem cells are of increasing importance in regenerative medicine. Immunomodulatory mechanisms seem to play an important role not only with respect to the understanding of underlying mechanisms of autologous versus allogenic therapeutic approaches, but also for endogeneous tissue regeneration. The newly established European human embryonic stem cell registry (hESCreg) offers an international database for the registration, documentation and characterisation of human embryonic stem cells (hESC) and their use. By doing so, hESCreg aims to develop a model procedure for further standardisation efforts in the field of stem cell research and regenerative medicine, and eventually the registry may lead to a repository of therapy-related information. Currently the stem cell characterisation data acquired by the registry are divided into several categories such as cell derivation, culture conditions, genetic constitution, stem cell marker expression and degree of modification. This article describes immunological aspects of stem cell characterisation and explores the layout and relevance of a possible additional section to the hESCreg repository to include immunological characteristics of human embryonic stem cells.

Patients with advanced and metastatic renal cell carcinoma treated with targeted therapy in the Czech Republic: twenty cancer centres, six agents, one database.

PubMed

Poprach, Alexandr; Bortlíček, Zbyněk; Büchler, Tomáš; Melichar, Bohuslav; Lakomý, Radek; Vyzula, Rostislav; Brabec, Petr; Svoboda, Marek; Dušek, Ladislav; Gregor, Jakub

2012-12-01

The incidence and mortality of renal cell carcinoma (RCC) in the Czech Republic are among the highest in the world. Several targeted agents have been recently approved for the treatment of advanced/metastatic RCC. Presentation of a national clinical database for monitoring and assessment of patients with advanced/metastatic RCC treated with targeted therapy. The RenIS (RENal Information System, http://renis.registry.cz ) registry is a non-interventional post-registration database of epidemiological and clinical data of patients with RCC treated with targeted therapies in the Czech Republic. Twenty cancer centres eligible for targeted therapy administration participate in the project. As of November 2011, six agents were approved and reimbursed from public health insurance, including bevacizumab, everolimus, pazopanib, sorafenib, sunitinib, and temsirolimus. As of 10 October 2011, 1,541 patients with valid records were entered into the database. Comparison with population-based data from the Czech National Cancer Registry revealed that RCC patients treated with targeted therapy are significantly younger (median age at diagnosis 59 vs. 66 years). Most RenIS registry patients were treated with sorafenib and sunitinib, many patients sequentially with both agents. Over 10 % of patients were also treated with everolimus in the second or third line. Progression-free survival times achieved were comparable to phase III clinical trials. The RenIS registry has become an important tool and source of information for the management of cancer care and clinical practice, providing comprehensive data on monitoring and assessment of RCC targeted therapy on a national level.

Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health.

PubMed

Cho, Jahyang; Kim, Bo Bae; Bae, Chong-Woo; Cha, Sung-Ho

2013-01-01

PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators. Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group. Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.

Use of hormonal contraceptives among immigrant and native women in Norway: data from the Norwegian Prescription Database

PubMed Central

Omland, G; Ruths, S; Diaz, E

2014-01-01

Objective To examine the use of hormonal contraceptives among immigrant and native women in Norway. Design Nationwide registry-based study based on merged data from the Norwegian Prescription Database, the Norwegian Population Registry, the Regular General Practitioner Database and the Medical Birth Registry. Setting Norway. Sample All women born abroad to two foreign-born parents (immigrants), or born in Norway to two Norwegian-born parents (natives) aged 16–45 years, who lived in Norway in 2008. Methods Data on all collected supplies of hormonal contraceptives in 2008 were merged with demographic, socio-economic and immigration data, information on any delivery and women's general practitioners. Main outcome measures User rates of hormonal contraception and predictors of contraceptive use. Results A total of 893 073 women were included, of whom 130 080 were immigrants. More native women (38%) used hormonal contraceptives compared with all immigrant groups (15–24%). The odds ratios for any use of hormonal contraceptives for immigrants compared with Norwegian-born women were; Nordic countries 0.53, South and Central America 0.53, Western countries 0.39, Asia 0.30, Eastern Europe 0.29, Africa 0.29. Work, education, long stay in Norway and young age of immigration predicted the use of hormonal contraceptives among immigrants. Conclusions The use of hormonal contraceptives varies between natives and immigrant groups. Further work is needed to ascertain whether these differences can be explained by higher desires for fertility, preferential use of non-hormonal contraceptives or other reasons identified through qualitative research. PMID:24931487

The national database of hospital-based cancer registries: a nationwide infrastructure to support evidence-based cancer care and cancer control policy in Japan.

PubMed

Higashi, Takahiro; Nakamura, Fumiaki; Shibata, Akiko; Emori, Yoshiko; Nishimoto, Hiroshi

2014-01-01

Monitoring the current status of cancer care is essential for effective cancer control and high-quality cancer care. To address the information needs of patients and physicians in Japan, hospital-based cancer registries are operated in 397 hospitals designated as cancer care hospitals by the national government. These hospitals collect information on all cancer cases encountered in each hospital according to precisely defined coding rules. The Center for Cancer Control and Information Services at the National Cancer Center supports the management of the hospital-based cancer registry by providing training for tumor registrars and by developing and maintaining the standard software and continuing communication, which includes mailing lists, a customizable web site and site visits. Data from the cancer care hospitals are submitted annually to the Center, compiled, and distributed as the National Cancer Statistics Report. The report reveals the national profiles of patient characteristics, route to discovery, stage distribution, and first-course treatments of the five major cancers in Japan. A system designed to follow up on patient survival will soon be established. Findings from the analyses will reveal characteristics of designated cancer care hospitals nationwide and will show how characteristics of patients with cancer in Japan differ from those of patients with cancer in other countries. The database will provide an infrastructure for future clinical and health services research and will support quality measurement and improvement of cancer care. Researchers and policy-makers in Japan are encouraged to take advantage of this powerful tool to enhance cancer control and their clinical practice.

Attitudes of people with osteoarthritis towards their conservative management: a systematic review and meta-ethnography.

PubMed

Smith, Toby O; Purdy, Rachel; Lister, Sarah; Salter, Charlotte; Fleetcroft, Robert; Conaghan, Philip G

2014-03-01

This paper determines the perceptions of people diagnosed with osteoarthritis towards their conservative management strategies. A systematic review of the published (AMED, CINAHL, EMBASE, PsychINFO, SportsDisc, MEDLINE, Cochrane Clinical Trials Registry, PubMed) and unpublished/trial registry databases (WHO International Clinical Trials Registry Platform, Current Controlled Trials, the United States National Institute of Health Trials Registry, NIHR Clinical Research Portfolio Database) searched from their inception to July 2013. Eligible studies included those which presented the attitudes or perceptions of people with osteoarthritis towards non-operative management strategies. Study quality was appraised using the CASP and the Gough's weight of evidence appraisal tools. Data were analysed through a meta-ethnography approach. Thirty-three studies including 1,314 people with osteoarthritis were sampled; the majority diagnosed with knee osteoarthritis. The overarching themes indicated people with osteoarthritis delay their diagnosis, opting for self-management and informal information gathering. This informal rather than health professional-led guidance is sought and maintained as an important resource throughout the care of this population and is valued. Diagnosis is sought at a 'critical point'. Healthcare interventions largely provided are poorly perceived. The period of subsequent self-management is an expectation before the inevitable requirement for joint replacement. There remains uncertainty regarding when this is required, but the expected failure of conservative treatment to manage pain and symptoms is common. In conclusion, patients should be enthused towards the principles of self-management and clinicians should not trivialise osteoarthritis. This may provide a more valuable perception of non-operative management to promote its adoption and adherence in managing osteoarthritis.

The German national registry for primary immunodeficiencies (PID)

PubMed Central

Gathmann, B; Goldacker, S; Klima, M; Belohradsky, B H; Notheis, G; Ehl, S; Ritterbusch, H; Baumann, U; Meyer-Bahlburg, A; Witte, T; Schmidt, R; Borte, M; Borte, S; Linde, R; Schubert, R; Bienemann, K; Laws, H-J; Dueckers, G; Roesler, J; Rothoeft, T; Krüger, R; Scharbatke, E C; Masjosthusmann, K; Wasmuth, J-C; Moser, O; Kaiser, P; Groß-Wieltsch, U; Classen, C F; Horneff, G; Reiser, V; Binder, N; El-Helou, S M; Klein, C; Grimbacher, B; Kindle, G

2013-01-01

In 2009, a federally funded clinical and research consortium (PID–NET, http://www.pid-net.org) established the first national registry for primary immunodeficiencies (PID) in Germany. The registry contains clinical and genetic information on PID patients and is set up within the framework of the existing European Database for Primary Immunodeficiencies, run by the European Society for Primary Immunodeficiencies. Following the example of other national registries, a central data entry clerk has been employed to support data entry at the participating centres. Regulations for ethics approvals have presented a major challenge for participation of individual centres and have led to a delay in data entry in some cases. Data on 630 patients, entered into the European registry between 2004 and 2009, were incorporated into the national registry. From April 2009 to March 2012, the number of contributing centres increased from seven to 21 and 738 additional patients were reported, leading to a total number of 1368 patients, of whom 1232 were alive. The age distribution of living patients differs significantly by gender, with twice as many males than females among children, but 15% more women than men in the age group 30 years and older. The diagnostic delay between onset of symptoms and diagnosis has decreased for some PID over the past 20 years, but remains particularly high at a median of 4 years in common variable immunodeficiency (CVID), the most prevalent PID. PMID:23607573

Project VALOR: design and methods of a longitudinal registry of post-traumatic stress disorder (PTSD) in combat-exposed veterans in the Afghanistan and Iraqi military theaters of operations.

PubMed

Rosen, Raymond C; Marx, Brian P; Maserejian, Nancy N; Holowka, Darren W; Gates, Margaret A; Sleeper, Lynn A; Vasterling, Jennifer J; Kang, Han K; Keane, Terence M

2012-03-01

Few studies have investigated the natural history of post-traumatic stress disorder (PTSD). Project VALOR (Veterans' After-discharge Longitudinal Registry) was designed as a longitudinal patient registry assessing the course of combat-related PTSD among 1600 male and female Veterans who served in Operation Enduring Freedom (OEF) in Afghanistan or Operation Iraqi Freedom (OIF). Aims of the study include investigating patterns and predictors of progression or remission of PTSD and treatment utilization. The study design was based on recommendations from the Agency for Healthcare Quality and Research for longitudinal disease registries and used a pre-specified theoretical model to select the measurement domains for data collection and interpretation of forthcoming results. The registry will include 1200 male and female Veterans with a recent diagnosis of PTSD in the Department of Veteran Affairs (VA) electronic medical record and a comparison group of 400 Veterans without a medical record-based PTSD diagnosis, to also allow for case-control analyses. Data are collected from administrative databases, electronic medical records, a self-administered questionnaire, and a semi-structured diagnostic telephone interview. Project VALOR is a unique and timely registry study that will evaluate the clinical course of PTSD, psychosocial correlates, and health outcomes in a carefully selected cohort of returning OEF/OIF Veterans. Copyright © 2011 John Wiley & Sons, Ltd.

The pooling of manpower and resources through the establishment of European reference networks and rare disease patient registries is a necessary area of collaboration for rare renal disorders.

PubMed

Parker, Samantha

2014-09-01

This review aims to provide guidance on emerging concepts and policy related to European reference networks (ERNs) for rare diseases (RDs) and the development and management of RD patient registries. A major problem facing many RDs including rare renal disorders is that patients do not have a specialist centre that they can attend where clinicians, working as a multidisciplinary team, are experts in the particular disease. Furthermore, for most RDs, no single centre, and in many cases no single country, has sufficient numbers of patients and resources to fully understand the natural history or to conduct clinical and translational research. Therefore, the pooling of manpower and resources through the establishment of ERN and RD patient registries is a common and necessary area of collaboration. The concept of European networks for RDs dates back to the early 2000s and the Commission launch of a call for European pilot reference networks for RDs. These networks of expert centres have been brought together through the desire for further knowledge and innovation in RD areas. Networks demand a holistic approach and long-term vision with close collaboration between clinicians, diagnostic laboratories, scientists, patients and their families. The development of legal measures for ERNs is in progress at the Commission and these networks will be a shared responsibility of the Commission and member states. In the context of ERNs, an essential activity is the patient registries. Patient registries are organized databases where patient information, including demographic, medical and family history, are collected, stored and available for retrieval via standardized and secure methods. Patient registries are increasingly recognized as crucial tools for RD research for which international collaboration is absolutely essential to understand the pathogenesis of rare genotypes, achieve a unified collection of phenotypic data, foster natural history studies providing the foundation for successful orphan drug development, facilitate studies to identify appropriate clinical endpoints or biomarkers, identify participants for research and clinical trials and support discussions with regulators including the safety and efficacy evaluation of potential therapies. Furthermore, patient registries are often used as part of regulatory decisions and post-marketing surveillance requirements. Data can be entered into a registry by patients, clinicians, researchers or directly imported from patient's health records. The major concern in maintaining the dynamic of these networks and registries is sustainability, as the infrastructures and coordination have a cost. © The Author 2014. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Semi-Automated Annotation of Biobank Data Using Standard Medical Terminologies in a Graph Database.

PubMed

Hofer, Philipp; Neururer, Sabrina; Goebel, Georg

2016-01-01

Data describing biobank resources frequently contains unstructured free-text information or insufficient coding standards. (Bio-) medical ontologies like Orphanet Rare Diseases Ontology (ORDO) or the Human Disease Ontology (DOID) provide a high number of concepts, synonyms and entity relationship properties. Such standard terminologies increase quality and granularity of input data by adding comprehensive semantic background knowledge from validated entity relationships. Moreover, cross-references between terminology concepts facilitate data integration across databases using different coding standards. In order to encourage the use of standard terminologies, our aim is to identify and link relevant concepts with free-text diagnosis inputs within a biobank registry. Relevant concepts are selected automatically by lexical matching and SPARQL queries against a RDF triplestore. To ensure correctness of annotations, proposed concepts have to be confirmed by medical data administration experts before they are entered into the registry database. Relevant (bio-) medical terminologies describing diseases and phenotypes were identified and stored in a graph database which was tied to a local biobank registry. Concept recommendations during data input trigger a structured description of medical data and facilitate data linkage between heterogeneous systems.

The Danish Neuro-Oncology Registry: establishment, completeness and validity.

PubMed

Hansen, Steinbjørn; Nielsen, Jan; Laursen, René J; Rasmussen, Birthe Krogh; Nørgård, Bente Mertz; Gradel, Kim Oren; Guldberg, Rikke

2016-08-30

The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database completeness of patient registration and validity of data. The completeness of the number of patients registered in the database was evaluated in the study period from January 2009 through December 2014 by comparing cases reported to the DNOR with the Danish National Patient Registry and the Danish Pathology Registry. The data validity of important clinical variables was evaluated by a random sample of 100 patients from the DNOR using the medical records as reference. A total of 2241 patients were registered in the DNOR by December 2014 with an overall patient completeness of 92 %, which increased during the study period (from 78 % in 2009 to 96 % in 2014). Medical records were available for all patients in the validity analyses. Most variables showed a high agreement proportion (56-100 %), with a fair to good chance-corrected agreement (k = 0.43-1.0). The completeness of patient registration was very high (92 %) and the validity of the most important patient data was good. The DNOR is a newly established national database, which is a reliable source for future scientific studies and clinical quality assessments among patients with gliomas.

Validity of cancer diagnosis in the National Health Insurance database compared with the linked National Cancer Registry in Taiwan.

PubMed

Kao, Wei-Heng; Hong, Ji-Hong; See, Lai-Chu; Yu, Huang-Ping; Hsu, Jun-Te; Chou, I-Jun; Chou, Wen-Chi; Chiou, Meng-Jiun; Wang, Chun-Chieh; Kuo, Chang-Fu

2017-08-16

We aimed to evaluate the validity of cancer diagnosis in the National Health Insurance (NHI) database, which has routinely collected the health information of almost the entire Taiwanese population since 1995, compared with the Taiwan National Cancer Registry (NCR). There were 26,542,445 active participants registered in the NHI database between 2001 and 2012. National Cancer Registry and NHI database records were compared for cancer diagnosis; date of cancer diagnosis; and 1, 2, and 5 year survival. In addition, the 10 leading causes of cancer deaths in Taiwan were analyzed. There were 908,986 cancer diagnoses in NCR and NHI database and 782,775 (86.1%) in both, with 53,192 (5.9%) in the NHI database only and 73,019 (8.0%) in the NCR only. The positive predictive value of the NHI database cancer diagnoses was 94% for all cancers; the positive predictive value of the 10 specific cancers ranged from 95% (lung cancer) to 82% (cervical cancer). The date of diagnosis in the NHI database was generally delayed by a median of 15 days (interquartile range 8-18) compared with the NCR. The 1, 2, and 5 year survival rates were 71.21%, 60.85%, and 47.44% using the NHI database and were 71.18%, 60.17%, and 46.09% using NCR data. Recording of cancer diagnoses and survival estimates based on these diagnosis codes in the NHI database are generally consistent with the NCR. Studies using NHI database data must pay careful attention to eligibility and record linkage; use of both sources is recommended. Copyright © 2017 John Wiley & Sons, Ltd.

[Predictive value and sensibility of hospital discharge system (PMSI) compared to cancer registries for thyroïd cancer (1999-2000)].

PubMed

Carré, N; Uhry, Z; Velten, M; Trétarre, B; Schvartz, C; Molinié, F; Maarouf, N; Langlois, C; Grosclaude, P; Colonna, M

2006-09-01

Cancer registries have a complete recording of new cancer cases occurring among residents of a specific geographic area. In France, they cover only 13% of the population. For thyroid cancer, where incidence rate is highly variable according to the district conversely to mortality, national incidence estimates are not accurate. A nationwide database, such as hospital discharge system, could improve this estimate but its positive predictive value and sensibility should be evaluated. The positive predictive value and the sensitivity for thyroid cancer case ascertainment (ICD-10) of the national hospital discharge system in 1999 and 2000 were estimated using the cancer registries database of 10 French districts as gold standard. The linkage of the two databases required transmission of nominative information from the health facilities of the study. From the registries database, a logistic regression analysis was carried out to identify factors related to being missed by the hospital discharge system. Among the 973 standardized discharge charts selected from the hospital discharge system, 866 were considered as true positive cases, and 107 as false positive. Forty five of the latter group were prevalent cases. The predictive positive value was 89% (95% confidence interval (CI): 87-91%) and did not differ according to the district (p=0,80). According to the cancer registries, 322 thyroid cancer cases diagnosed in 1999 or 2000 were missed by the hospital discharge system. Thus, the sensitivity of this latter system was 73% (70-76%) and varied significantly from 62% to 85% across districts (p<0.001) and according to the type of health facility (p<0.01). Predictive positive value of the French hospital discharge system for ascertainment of thyroid cancer cases is high and stable across districts. Sensitivity is lower and varies significantly according to the type of health facility and across districts, which limits the interest of this database for a national estimate of thyroid cancer incidence rate.

Automated Tumor Registry for Oncology. A VA-DHCP MUMPS application.

PubMed

Richie, S

1992-01-01

The VA Automated Tumor Registry for Oncology, Version 2, is a multifaceted, completely automated user-friendly cancer database. Easy to use modules include: Automatic Casefinding; Suspense Files; Abstracting and Printing; Follow-up; Annual Reports; Statistical Reports; Utility Functions.

Pediatric Contact Dermatitis Registry Inaugural Case Data.

PubMed

Goldenberg, Alina; Mousdicas, Nico; Silverberg, Nanette; Powell, Douglas; Pelletier, Janice L; Silverberg, Jonathan I; Zippin, Jonathan; Fonacier, Luz; Tosti, Antonella; Lawley, Leslie; Wu Chang, Mary; Scheman, Andrew; Kleiner, Gary; Williams, Judith; Watsky, Kalman; Dunnick, Cory A; Frederickson, Rachel; Matiz, Catalina; Chaney, Keri; Estes, Tracy S; Botto, Nina; Draper, Michelle; Kircik, Leon; Lugo-Somolinos, Aida; Machler, Brian; Jacob, Sharon E

2016-01-01

Little is known about the epidemiology of allergic contact dermatitis (ACD) in US children. More widespread diagnostic confirmation through epicutaneous patch testing is needed. The aim was to quantify patch test results from providers evaluating US children. The study is a retrospective analysis of deidentified patch test results of children aged 18 years or younger, entered by participating providers in the Pediatric Contact Dermatitis Registry, during the first year of data collection (2015-2016). One thousand one hundred forty-two cases from 34 US states, entered by 84 providers, were analyzed. Sixty-five percent of cases had one or more positive patch test (PPT), with 48% of cases having 1 or more relevant positive patch test (RPPT). The most common PPT allergens were nickel (22%), fragrance mix I (11%), cobalt (9.1%), balsam of Peru (8.4%), neomycin (7.2%), propylene glycol (6.8%), cocamidopropyl betaine (6.4%), bacitracin (6.2%), formaldehyde (5.7%), and gold (5.7%). This US database provides multidisciplinary information on pediatric ACD, rates of PPT, and relevant RPPT reactions, validating the high rates of pediatric ACD previously reported in the literature. The registry database is the largest comprehensive collection of US-only pediatric patch test cases on which future research can be built. Continued collaboration between patients, health care providers, manufacturers, and policy makers is needed to decrease the most common allergens in pediatric consumer products.

Clinical research in a hospital--from the lone rider to teamwork.

PubMed

Hannisdal, E

1996-01-01

Clinical research of high international standard is very demanding and requires clinical data of high quality, software, hardware and competence in research design and statistical treatment of data. Most busy clinicians have little time allocated for clinical research and this increases the need for a potent infrastructure. This paper describes how the Norwegian Radium Hospital, a specialized cancer hospital, has reorganized the clinical research process. This includes a new department, the Clinical Research Office, which serves the formal framework, a central Diagnosis Registry, clinical databases and multicentre studies. The department assists about 120 users, mainly clinicians. Installation of a network software package with over 10 programs has strongly provided an internal standardization, reduced the costs and saved clinicians a great deal of time. The hospital is building up about 40 diagnosis-specific clinical databases with up to 200 variables registered. These databases are shared by the treatment group and seem to be important tools for quality assurance. We conclude that the clinical research process benefits from a firm infrastructure facilitating teamwork through extensive use of modern information technology. We are now ready for the next phase, which is to work for a better external technical framework for cooperation with other institutions throughout the world.

The Toxicology Investigators Consortium Case Registry--the 2011 experience.

PubMed

Wiegand, Timothy J; Wax, Paul M; Schwartz, Tayler; Finkelstein, Yaron; Gorodetsky, Rachel; Brent, Jeffrey

2012-12-01

In 2010, the American College of Medical Toxicology established its Case Registry, the Toxicology Investigators Consortium (ToxIC). ToxIC is a prospective registry, which exclusively compiles suspected and confirmed toxic exposure cases cared for at the bedside by medical toxicologists at its participating sites. The Registry aims to fulfill two important gaps in the field: a real-time toxicosurveillance system to identify current poisoning trends and a powerful research tool in toxicology. ToxIC allows extraction of information from medical records making it the most robust multicenter database on chemical toxicities in existence. All cases seen by medical toxicologists at participating institutions were entered in a database. Information characterizing patients entered in 2011 was tabulated. 2010 data was also included so that cumulative total numbers could be described as well. The current report is a summary of the data collected in 2011 in comparison to 2010 entries and also includes cumulative data through December 31st, 2011. During 2011, 28 sites with 49 specific institutions contributed a total of 6,456 cases to the Registry. The total number of cases entered into the registry at the end of 2011 was 10,392. Emergency departments remained the most common source of consultations in 2011, accounting for 53 % of cases. The most common reason for consultation was for pharmaceutical overdoses, which occurred in 48 % of patients, including intentional (37 %) and unintentional (11 %) exposures. The most common classes of agents were sedative-hypnotics (1,492 entries in 23 % of cases), non-opioid analgesics (1,368 cases in 21 % of cases), opioids (17 %), antidepressants (16 %), stimulants/sympathomimetics (12 %), and ethanol (8 %). N-acetylcysteine was the most commonly administered antidote during 2011, similar to 2010, followed by the opioid antagonist naloxone, sodium bicarbonate, physostigmine and flumazenil. Anti-crotalid Fab fragments (CroFab) were administered in 106 out of 131 cases in which an envenomation occurred. There were 35 deaths recorded in the Registry during 2011. The most common associated agents, including when reported as sole agent or in combination with other agents, were opioids and analgesics (acetaminophen, aspirin, NSAIDS) with ten and eight deaths, respectively. Oxycodone was reported in six of the ten opioid-related deaths and heroin in three. Acetaminophen was the most common single agent reported overall being identified in all eight of the death cases attributed to analgesics. There were significant trends identified during 2011. Cases involving designer drugs including psychoactive bath salts and synthetic cannabinoids increased substantially from 2010 to 2011. The psychoactive bath salts were responsible for a large increase in stimulant/sympathomimetic-related cases reported to the Registry in 2011 with overall numbers doubling from 6 % of all Registry entries in 2010 to 12 % in 2011. Entries involving psychoactive drugs of abuse also increased twofold from 2010 to 2011 jumping 3 to 6 %, primarily due to increasing frequency of synthetic cannabinoid ("K2") related intoxications as 2011 progressed. The 2011 Registry included over 600 ADR's (10 % of Registry Cases) with 115 agents causing at least 2 ADR's. This is up from only 3 % of cases (116 total cases) in 2010. The ToxIC Case Registry continues to grow. At the end of 2011, over 10,000 cases had been entered into the Registry. As demonstrated by the trends identified in psychoactive bath salt and synthetic cannabinoid reports, the Registry is a valuable toxicosurveillance and research tool. The ToxIC Registry is a unique tool for identifying and characterizing confirmed cases of significant or potential toxicity or complexity to require bedside consultation by a medical toxicologist.

The Odense University Pharmacoepidemiological Database (OPED)

Cancer.gov

The Odense University Pharmacoepidemiological Database is one of two large prescription registries in Denmark and covers a stable population that is representative of the Danish population as a whole.

Adequate Security Protocols Adopt in a Conceptual Model in Identity Management for the Civil Registry of Ecuador

NASA Astrophysics Data System (ADS)

Toapanta, Moisés; Mafla, Enrique; Orizaga, Antonio

2017-08-01

We analyzed the problems of security of the information of the civil registries and identification at world level that are considered strategic. The objective is to adopt the appropriate security protocols in a conceptual model in the identity management for the Civil Registry of Ecuador. In this phase, the appropriate security protocols were determined in a Conceptual Model in Identity Management with Authentication, Authorization and Auditing (AAA). We used the deductive method and exploratory research to define the appropriate security protocols to be adopted in the identity model: IPSec, DNSsec, Radius, SSL, TLS, IEEE 802.1X EAP, Set. It was a prototype of the location of the security protocols adopted in the logical design of the technological infrastructure considering the conceptual model for Identity, Authentication, Authorization, and Audit management. It was concluded that the adopted protocols are appropriate for a distributed database and should have a direct relationship with the algorithms, which allows vulnerability and risk mitigation taking into account confidentiality, integrity and availability (CIA).

Australian Twin Registry: a nationally funded resource for medical and scientific research, incorporating match and WATCH.

PubMed

Hopper, John L; Treloar, Susan A; de Klerk, Nicholas H; Morley, Ruth

2006-12-01

The Australian Twin Registry (ATR) has, since the late 1970s, enrolled more than 30,000 pairs of all zygosity types and ages willing to consider participation in approved research studies. Its core functions are the recruitment to, and maintenance of, an up-to-date database containing contact details and baseline information, and the management of fair and equitable access so as to enhance medical and scientific research. The ATR has facilitated more than 430 studies producing 525 peer-reviewed publications using a variety of designs including classic biometrical twin and twin family studies, co-twin control studies, intervention studies, longitudinal studies, and studies of issues relevant specifically to twins. The ATR is supported for 2004 to 2009 by an Australian National Health and Medical Research Council (NHMRC) Enabling Grant, a new form of funding which recognizes the importance of long-term support for shared national resources. New initiatives include: integration with the Western Australian Twin Child Health (WATCH) cohort and the new Western Australian Twin Registry (WATR); foundation of a cohort of mothers and their twin children recruited from the time of diagnosis of the multiple gestation (match); a national Twins Festival run in collaboration with the Australian Multiple Birth Association (AMBA); promotion of the ATR at medical conferences; and fostering an active network of researchers from a range of disciplines and providing financial support for new researchers to attend international twin research workshops. Consistent with its mission statement, the long-term goal of the ATR is to make twin studies a standard component of medical and scientific research.

EPA Facility Registry Service (FRS): OIL

EPA Pesticide Factsheets

This dataset contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link to the Oil database. The Oil database contains information on Spill Prevention, Control, and Countermeasure (SPCC) and Facility Response Plan (FRP) subject facilities to prevent and respond to oil spills. FRP facilities are referred to as substantial harm facilities due to the quantities of oil stored and facility characteristics. FRS identifies and geospatially locates facilities, sites or places subject to environmental regulations or of environmental interest. Using vigorous verification and data management procedures, FRS integrates facility data from EPA's national program systems, other federal agencies, and State and tribal master facility records and provides EPA with a centrally managed, single source of comprehensive and authoritative information on facilities. This data set contains the subset of FRS integrated facilities that link to Oil facilities once the Oil data has been integrated into the FRS database. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs.

Automated Tumor Registry for Oncology. A VA-DHCP MUMPS application.

PubMed Central

Richie, S.

1992-01-01

The VA Automated Tumor Registry for Oncology, Version 2, is a multifaceted, completely automated user-friendly cancer database. Easy to use modules include: Automatic Casefinding; Suspense Files; Abstracting and Printing; Follow-up; Annual Reports; Statistical Reports; Utility Functions. PMID:1482866

49 CFR 390.101 - Scope.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 5 2012-10-01 2012-10-01 false Scope. 390.101 Section 390.101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Registry Program is the registry itself, which is a national database of names and contact information for...

49 CFR 390.101 - Scope.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false Scope. 390.101 Section 390.101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Registry Program is the registry itself, which is a national database of names and contact information for...

49 CFR 390.101 - Scope.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Scope. 390.101 Section 390.101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Registry Program is the registry itself, which is a national database of names and contact information for...

Genetic Testing Registry

MedlinePlus

... Splign Vector Alignment Search Tool (VAST) All Data & Software Resources... Domains & Structures BioSystems Cn3D Conserved Domain Database (CDD) Conserved Domain Search Service (CD Search) Structure (Molecular Modeling Database) Vector Alignment ...

Design and implementation of the first nationwide, web-based Chinese Renal Data System (CNRDS)

PubMed Central

2012-01-01

Background In April 2010, with an endorsement from the Ministry of Health of the People's Republic of China, the Chinese Society of Nephrology launched the first nationwide, web-based prospective renal data registration platform, the Chinese Renal Data System (CNRDS), to collect structured demographic, clinical, and laboratory data for dialysis cases, as well as to establish a kidney disease database for researchers and policy makers. Methods The CNRDS program uses information technology to facilitate healthcare professionals to create a blood purification registry and to deliver an evidence-based care and education protocol tailored to chronic kidney disease, as well as online forum for communication between nephrologists. The online portal https://www.cnrds.net is implemented as a Java web application using an Apache Tomcat web server and a MySQL database. All data are stored in a central databank to establish a Chinese renal database for research and publication purposes. Results Currently, over 270,000 clinical cases, including general patient information, diagnostics, therapies, medications, and laboratory tests, have been registered in CNRDS by 3,669 healthcare institutions qualified for hemodialysis therapy. At the 2011 annual blood purification forum of the Chinese Society of Nephrology, the CNRDS 2010 annual report was reviewed and accepted by the society members and government representatives. Conclusions CNRDS is the first national, web-based application for collecting and managing electronic medical records of patients with dialysis in China. It provides both an easily accessible platform for nephrologists to store and organize their patient data and acts as a communication platform among participating doctors. Moreover, it is the largest database for treatment and patient care of end-stage renal disease (ESRD) patients in China, which will be beneficial for scientific research and epidemiological investigations aimed at improving the quality of life of such patients. Furthermore, it is a model nationwide disease registry, which could potentially be used for other diseases. PMID:22369692

Design and implementation of the first nationwide, web-based Chinese Renal Data System (CNRDS).

PubMed

Xie, Fengbo; Zhang, Dong; Wu, Jinzhao; Zhang, Yunfeng; Yang, Qing; Sun, Xuefeng; Cheng, Jing; Chen, Xiangmei

2012-02-28

In April 2010, with an endorsement from the Ministry of Health of the People's Republic of China, the Chinese Society of Nephrology launched the first nationwide, web-based prospective renal data registration platform, the Chinese Renal Data System (CNRDS), to collect structured demographic, clinical, and laboratory data for dialysis cases, as well as to establish a kidney disease database for researchers and policy makers. The CNRDS program uses information technology to facilitate healthcare professionals to create a blood purification registry and to deliver an evidence-based care and education protocol tailored to chronic kidney disease, as well as online forum for communication between nephrologists. The online portal https://www.cnrds.net is implemented as a Java web application using an Apache Tomcat web server and a MySQL database. All data are stored in a central databank to establish a Chinese renal database for research and publication purposes. Currently, over 270,000 clinical cases, including general patient information, diagnostics, therapies, medications, and laboratory tests, have been registered in CNRDS by 3,669 healthcare institutions qualified for hemodialysis therapy. At the 2011 annual blood purification forum of the Chinese Society of Nephrology, the CNRDS 2010 annual report was reviewed and accepted by the society members and government representatives. CNRDS is the first national, web-based application for collecting and managing electronic medical records of patients with dialysis in China. It provides both an easily accessible platform for nephrologists to store and organize their patient data and acts as a communication platform among participating doctors. Moreover, it is the largest database for treatment and patient care of end-stage renal disease (ESRD) patients in China, which will be beneficial for scientific research and epidemiological investigations aimed at improving the quality of life of such patients. Furthermore, it is a model nationwide disease registry, which could potentially be used for other diseases.

Use of hormonal contraceptives among immigrant and native women in Norway: data from the Norwegian Prescription Database.

PubMed

Omland, G; Ruths, S; Diaz, E

2014-09-01

To examine the use of hormonal contraceptives among immigrant and native women in Norway. Nationwide registry-based study based on merged data from the Norwegian Prescription Database, the Norwegian Population Registry, the Regular General Practitioner Database and the Medical Birth Registry. Norway. All women born abroad to two foreign-born parents (immigrants), or born in Norway to two Norwegian-born parents (natives) aged 16-45 years, who lived in Norway in 2008. Data on all collected supplies of hormonal contraceptives in 2008 were merged with demographic, socio-economic and immigration data, information on any delivery and women's general practitioners. User rates of hormonal contraception and predictors of contraceptive use. A total of 893,073 women were included, of whom 130,080 were immigrants. More native women (38%) used hormonal contraceptives compared with all immigrant groups (15-24%). The odds ratios for any use of hormonal contraceptives for immigrants compared with Norwegian-born women were; Nordic countries 0.53, South and Central America 0.53, Western countries 0.39, Asia 0.30, Eastern Europe 0.29, Africa 0.29. Work, education, long stay in Norway and young age of immigration predicted the use of hormonal contraceptives among immigrants. The use of hormonal contraceptives varies between natives and immigrant groups. Further work is needed to ascertain whether these differences can be explained by higher desires for fertility, preferential use of non-hormonal contraceptives or other reasons identified through qualitative research. © 2014 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Improving Hospital Reporting of Patient Race and Ethnicity--Approaches to Data Auditing.

PubMed

Zingmond, David S; Parikh, Punam; Louie, Rachel; Lichtensztajn, Daphne Y; Ponce, Ninez; Hasnain-Wynia, Romana; Gomez, Scarlett Lin

2015-08-01

To investigate new metrics to improve the reporting of patient race and ethnicity (R/E) by hospitals. California Patient Discharge Database (PDD) and birth registry, 2008-2009, Healthcare and Cost Utilization Project's State Inpatient Database, 2008-2011, cancer registry 2000-2008, and 2010 US Census Summary File 2. We examined agreement between hospital reported R/E versus self-report among mothers delivering babies and a cancer cohort in California. Metrics were created to measure root mean squared differences (RMSD) by hospital between reported R/E distribution and R/E estimates using R/E distribution within each patient's zip code of residence. RMSD comparisons were made to corresponding "gold standard" facility-level measures within the maternal cohort for California and six comparison states. Maternal birth hospitalization (linked to the state birth registry) and cancer cohort records linked to preceding and subsequent hospitalizations. Hospital discharges were linked to the corresponding Census zip code tabulation area using patient zip code. Overall agreement between the PDD and the gold standard for the maternal cohort was 86 percent for the combined R/E measure and 71 percent for race alone. The RMSD measure is modestly correlated with the summary level gold standard measure for R/E (r = 0.44). The RMSD metric revealed general improvement in data agreement and completeness across states. "Other" and "unknown" categories were inconsistently applied within inpatient databases. Comparison between reported R/E and R/E estimates using zip code level data may be a reasonable first approach to evaluate and track hospital R/E reporting. Further work should focus on using more granular geocoded data for estimates and tracking data to improve hospital collection of R/E data. © Health Research and Educational Trust.

Clinical trial resources on the internet must be designed to reach underrepresented minorities.

PubMed

Wilson, John J; Mick, Rosemarie; Wei, S Jack; Rustgi, Anil K; Markowitz, Sanford D; Hampshire, Maggie; Metz, James M

2006-01-01

Internet-based clinical trial information services are being developed to increase recruitment to studies. However, there are limited data that evaluate their ability to reach elderly and underrepresented minority populations. This study was designed to evaluate the ability of an established clinical trials registry to reach these populations based on expected Internet use. This study compares general Internet users to participants who enrolled in an Internet based colorectal cancer clinical trials registry established by OncoLink (www.oncolink.org) and the National Colorectal Cancer Research Alliance. Observed rates of demographic groupings were compared to those established for general Internet users. Two thousand, four hundred and thirty-seven participants from the continental United States used the Internet to register for the database. New England, the Mid-Atlantic region, and the Southeast had the highest relative frequency of participation in the database, whereas the Upper Midwest, California, and the South had the lowest rates. Compared to general Internet users, there was an overrepresentation of women (73% vs. 50%) and participants over 55 years old (27% vs. 14%). However, there was an underrepresentation of minorities (10.3% vs. 22%), particularly African Americans (3.1% vs. 8%) and Hispanics (2.8% vs. 9%). The Internet is a growing medium for registry into clinical trials databases. However, even taking into account the selection bias of Internet accessibility, there are still widely disparate demographics between general Internet users and those registering for clinical trials, particularly the underrepresentation of minorities. Internet-based educational and recruitment services for clinical trials must be designed to reach these underrepresented minorities to avoid selection biases in future clinical trials.

Comprehensive computerized diabetes registry. Serving the Cree of Eeyou Istchee (eastern James Bay).

PubMed Central

Dannenbaum, D.; Verronneau, M.; Torrie, J.; Smeja, H.; Robinson, E.; Dumont, C.; Kovitch, I.; Webster, T.

1999-01-01

PROBLEM BEING ADDRESSED: Diabetes is rapidly evolving as a major health concern in the Cree population of eastern James Bay (Eeyou Istchee). The Cree Board of Health and Social Services of James Bay (CBHSSJB) diabetes registry was the initial phase in the development of a comprehensive program for diabetes in this region. OBJECTIVE OF PROGRAM: The CBHSSJB diabetes registry was developed to provide a framework to track the prevalence of diabetes and the progression of diabetic complications. The database will also identify patients not receiving appropriate clinical and laboratory screening for diabetic complications, and will provide standardized clinical flow sheets for routine patient management. MAIN COMPONENTS OF PROGRAM: The CBHSSJB diabetes registry uses a system of paper registration forms and clinical flow sheets kept in the nine community clinics. Information from these sheets is entered into a computer database annually. The flow sheets serve as a guideline for appropriate management of patients with diabetes, and provide a one-page summary of relevant clinical and laboratory information. CONCLUSIONS: A diabetes registry is vital to follow the progression of diabetes and diabetic complications in the region served by the CBHSSJB. The registry system incorporates both a means for regional epidemiologic monitoring of diabetes mellitus and clinical tools for managing patients with the disease. PMID:10065310

The use of a medico economic database as a part of French apheresis registry.

PubMed

Kanouni, T; Aubas, P; Heshmati, F

2017-02-01

An apheresis registry is a part of each learned apheresis society. The interest in this is obvious, in terms of knowledge of the practice of apheresis, adverse events, and technical issues. However, because of the weight of data entry it could never be exhaustive and some data will be missing. While continuing our registry efforts and our efforts to match with other existing registries, we decided to extend the data collection to a medico-economic database that is available in France, the Programme de Médicalisation du Système d'Information (PMSI) that has covered reimbursement information for each public or private hospital since 2007. It contains almost all apheresis procedures in all apheresis fields, demographic patient data, and primary and related diagnoses, among other data. Although this data does not include technical apheresis issues or other complications of the procedures, its interest is great and it is complementary to the registry. From 2003-2014, we have recorded 250,585 apheresis procedures, for 48,428 patients. We showed that the data are reliable and exhaustive. The information shows a perfect real life practice in apheresis, regarding indications, the rhythm and the duration of apheresis treatment. This prospective data collection is sustainable and allows us to assess the impact of healthcare guidelines. Our objective is to extend the data collection and match it to other existing databases; this will allow us to conduct, for example, a cohort study specifically for ECP. Copyright © 2016 Elsevier Ltd. All rights reserved.

16th IHIW: Global analysis of registry HLA haplotypes from 20 Million individuals: Report from the IHIW Registry Diversity Group

PubMed Central

Maiers, M; Gragert, L; Madbouly, A; Steiner, D; Marsh, S G E; Gourraud, P-A; Oudshoorn, M; Zanden, H; Schmidt, A H; Pingel, J; Hofmann, J; Müller, C; Eberhard, H-P

2013-01-01

This project has the goal to validate bioinformatics methods and tools for HLA haplotype frequency analysis specifically addressing unique issues of haematopoietic stem cell registry data sets. In addition to generating new methods and tools for the analysis of registry data sets, the intent is to produce a comprehensive analysis of HLA data from 20 million donors from the Bone Marrow Donors Worldwide (BMDW) database. This report summarizes the activity on this project as of the 16IHIW meeting in Liverpool. PMID:23280139

Verification of Data Accuracy in Japan Congenital Cardiovascular Surgery Database Including Its Postprocedural Complication Reports.

PubMed

Takahashi, Arata; Kumamaru, Hiraku; Tomotaki, Ai; Matsumura, Goki; Fukuchi, Eriko; Hirata, Yasutaka; Murakami, Arata; Hashimoto, Hideki; Ono, Minoru; Miyata, Hiroaki

2018-03-01

Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.

The Chinese Cardiac Surgery Registry: Design and Data Audit.

PubMed

Rao, Chenfei; Zhang, Heng; Gao, Huawei; Zhao, Yan; Yuan, Xin; Hua, Kun; Hu, Shengshou; Zheng, Zhe

2016-04-01

In light of the burgeoning volume and certain variation of in-hospital outcomes of cardiac operations in China, a large patient-level registry was needed. We generated the Chinese Cardiac Surgery Registry (CCSR) database in 2013 to benchmark, continuously monitor, and provide feedback of the quality of adult cardiac operations. We report on the design of this database and provide an overview of participating sites and quality of data. We established a network of participating sites with an adult cardiac surgery volume of more than 100 operations per year for continuous web-based registry of in-hospital and follow-up data of coronary artery bypass grafting (CABG) and valve operations. After a routine data quality audit, we report the performance and quality of care back to the participating sites. In total, 87 centers participated and submitted 46,303 surgical procedures from January 2013 to December 2014. The timeliness rates of the short-list and in-hospital data submitted were 73.6% and 70.2%, respectively. The completeness and accuracy rates of the in-hospital data were 97.6% and 95.1%, respectively. We have provided 2 reports for each site and 1 national report regarding the performance of isolated CABG and valve operations. The newly launched CCSR with a national representativeness network and good data quality has the potential to act as an important platform for monitoring and improving cardiac surgical care in mainland China, as well as facilitating research projects, establishing benchmarking standards, and identifying potential areas for quality improvements (ClinicalTrials.gov No. NCT02400125). Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

California’s Parkinson’s Disease Registry Pilot Project - Coordination Center and Northern California Ascertainment

DTIC Science & Technology

2011-03-01

project effort is being directed to investigate possible associations between PD and toxicant exposure using state databases, to define disease ... prevalence and care patterns among registrants, and to assess the value of the registry to stakeholders.

California’s Parkinson’s Disease Registry Pilot Project - Coordination Center and Northern California Ascertainment

DTIC Science & Technology

2012-03-01

project effort is being directed to investigate possible associations between PD and toxicant exposure using state databases, to define disease ... prevalence and care patterns among registrants, and to assess the value of the registry to stakeholders.

Towards a Global Service Registry for the World-Wide LHC Computing Grid

NASA Astrophysics Data System (ADS)

Field, Laurence; Alandes Pradillo, Maria; Di Girolamo, Alessandro

2014-06-01

The World-Wide LHC Computing Grid encompasses a set of heterogeneous information systems; from central portals such as the Open Science Grid's Information Management System and the Grid Operations Centre Database, to the WLCG information system, where the information sources are the Grid services themselves. Providing a consistent view of the information, which involves synchronising all these informations systems, is a challenging activity that has lead the LHC virtual organisations to create their own configuration databases. This experience, whereby each virtual organisation's configuration database interfaces with multiple information systems, has resulted in the duplication of effort, especially relating to the use of manual checks for the handling of inconsistencies. The Global Service Registry aims to address this issue by providing a centralised service that aggregates information from multiple information systems. It shows both information on registered resources (i.e. what should be there) and available resources (i.e. what is there). The main purpose is to simplify the synchronisation of the virtual organisation's own configuration databases, which are used for job submission and data management, through the provision of a single interface for obtaining all the information. By centralising the information, automated consistency and validation checks can be performed to improve the overall quality of information provided. Although internally the GLUE 2.0 information model is used for the purpose of integration, the Global Service Registry in not dependent on any particular information model for ingestion or dissemination. The intention is to allow the virtual organisation's configuration databases to be decoupled from the underlying information systems in a transparent way and hence simplify any possible future migration due to the evolution of those systems. This paper presents the Global Service Registry architecture, its advantages compared to the current situation and how it can support the evolution of information systems.

The trauma registry compared to All Patient Refined Diagnosis Groups (APR-DRG).

PubMed

Hackworth, Jodi; Askegard-Giesmann, Johanna; Rouse, Thomas; Benneyworth, Brian

2017-05-01

Literature has shown there are significant differences between administrative databases and clinical registry data. Our objective was to compare the identification of trauma patients using All Patient Refined Diagnosis Related Groups (APR-DRG) as compared to the Trauma Registry and estimate the effects of those discrepancies on utilization. Admitted pediatric patients from 1/2012-12/2013 were abstracted from the trauma registry. The patients were linked to corresponding administrative data using the Pediatric Health Information System database at a single children's hospital. APR-DRGs referencing trauma were used to identify trauma patients. We compared variables related to utilization and diagnosis to determine the level of agreement between the two datasets. There were 1942 trauma registry patients and 980 administrative records identified with trauma-specific APR-DRG during the study period. Forty-two percent (816/1942) of registry records had an associated trauma-specific APR-DRG; 69% of registry patients requiring ICU care had trauma APR-DRGs; 73% of registry patients with head injuries had trauma APR-DRGs. Only 21% of registry patients requiring surgical management had associated trauma APR-DRGs, and 12.5% of simple fractures had associated trauma APR-DRGs. APR-DRGs appeared to only capture a fraction of the entire trauma population and it tends to be the more severely ill patients. As a result, the administrative data was not able to accurately answer hospital or operating room utilization as well as specific information on diagnosis categories regarding trauma patients. APR-DRG administrative data should not be used as the only data source for evaluating the needs of a trauma program. Copyright © 2016 Elsevier Ltd. All rights reserved.

ClinicalTrials.gov

MedlinePlus

... Terms and Conditions Disclaimer ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted ... world. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of ...

Healthcare Databases in Thailand and Japan: Potential Sources for Health Technology Assessment Research.

PubMed

Saokaew, Surasak; Sugimoto, Takashi; Kamae, Isao; Pratoomsoot, Chayanin; Chaiyakunapruk, Nathorn

2015-01-01

Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases' characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. Forty databases- 20 from Thailand and 20 from Japan-were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed.

A Five-Tier System for Improving the Categorization of Transplant Program Performance.

PubMed

Wey, Andrew; Salkowski, Nicholas; Kasiske, Bertram L; Israni, Ajay K; Snyder, Jon J

2018-06-01

To better inform health care consumers by better identifying differences in transplant program performance. Adult kidney transplants performed in the United States, January 1, 2012-June 30, 2014. In December 2016, the Scientific Registry of Transplant Recipients instituted a five-tier system for reporting transplant program performance. We compare the differentiation of program performance and the simulated misclassification rate of the five-tier system with the previous three-tier system based on the 95 percent credible interval. Scientific Registry of Transplant Recipients database. The five-tier system improved differentiation and maintained a low misclassification rate of less than 22 percent for programs differing by two tiers. The five-tier system will better inform health care consumers of transplant program performance. © Health Research and Educational Trust.

Dementia registries around the globe and their applications: A systematic review.

PubMed

Krysinska, Karolina; Sachdev, Perminder S; Breitner, John; Kivipelto, Miia; Kukull, Walter; Brodaty, Henry

2017-09-01

Patient registries are valuable tools helping to address significant challenges in research, care, and policy. Registries, well embedded in many fields of medicine and public health, are relatively new in dementia. This systematic review presents the current situation in regards to dementia registries worldwide. We identified 31 dementia registries operating on an international, national, or local level between 1986 and 2016. More than half of the registries aimed to conduct or facilitate research, including preclinical research registries and registries recruiting research volunteers. Other dementia registries collected epidemiological or quality of care data. We present evidence of practical and economic outcomes of registries for research, clinical practice and policy, and recommendations for future development. Global harmonization of recruitment methods and minimum data would facilitate international comparisons. Registries provide a positive return on investment; their establishment and maintenance require ongoing support by government, policy makers, research funding bodies, clinicians, and individuals with dementia and their caregivers. Copyright © 2017 the Alzheimer's Association. All rights reserved.

Accuracy of a state immunization registry in the pediatric emergency department.

PubMed

Stecher, Dawn S; Adelman, Raymond; Brinkman, Traci; Bulloch, Blake

2008-02-01

The purpose of this study was to ascertain whether either parental recall or a state immunization registry was as accurate as the medical record in determining immunization status in the emergency department (ED). A convenience sample of children younger than 5 years who presented to the ED between July 2004 and May 2005 were enrolled prospectively. After obtaining informed consent, parents were asked about their child's immunization status. All children then had their immunization data accessed in the Arizona State Immunization Information System. The information obtained from the state registry, as well as the information from the parental interview, was then compared with the information on the medical record obtained from the primary care physician (PCP). Data were analyzed using simple descriptive statistics. A total of 332 children were enrolled in the study. A total of 302 (91%) children enrolled were found in the state database, and 222 (74%) of these had a medical record available for comparison. The database agreed with the PCP record in 130 (59%) cases; parental report agreed with the PCP record in 149 (62%) cases. Although most children can be found in the state immunization registry, it seems to be similar in accuracy to parental recall of immunization status when each is compared with the medical record. This may have been due to either underreporting of immunizations from the community or a delay in updating the state database. At this time, neither parental recall nor the database would accurately determine a child's immunization status during an ED visit.

Analysis and visualization of disease courses in a semantically-enabled cancer registry.

PubMed

Esteban-Gil, Angel; Fernández-Breis, Jesualdo Tomás; Boeker, Martin

2017-09-29

Regional and epidemiological cancer registries are important for cancer research and the quality management of cancer treatment. Many technological solutions are available to collect and analyse data for cancer registries nowadays. However, the lack of a well-defined common semantic model is a problem when user-defined analyses and data linking to external resources are required. The objectives of this study are: (1) design of a semantic model for local cancer registries; (2) development of a semantically-enabled cancer registry based on this model; and (3) semantic exploitation of the cancer registry for analysing and visualising disease courses. Our proposal is based on our previous results and experience working with semantic technologies. Data stored in a cancer registry database were transformed into RDF employing a process driven by OWL ontologies. The semantic representation of the data was then processed to extract semantic patient profiles, which were exploited by means of SPARQL queries to identify groups of similar patients and to analyse the disease timelines of patients. Based on the requirements analysis, we have produced a draft of an ontology that models the semantics of a local cancer registry in a pragmatic extensible way. We have implemented a Semantic Web platform that allows transforming and storing data from cancer registries in RDF. This platform also permits users to formulate incremental user-defined queries through a graphical user interface. The query results can be displayed in several customisable ways. The complex disease timelines of individual patients can be clearly represented. Different events, e.g. different therapies and disease courses, are presented according to their temporal and causal relations. The presented platform is an example of the parallel development of ontologies and applications that take advantage of semantic web technologies in the medical field. The semantic structure of the representation renders it easy to analyse key figures of the patients and their evolution at different granularity levels.

Healthcare Databases in Thailand and Japan: Potential Sources for Health Technology Assessment Research

PubMed Central

Saokaew, Surasak; Sugimoto, Takashi; Kamae, Isao; Pratoomsoot, Chayanin; Chaiyakunapruk, Nathorn

2015-01-01

Background Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. Method Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases’ characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. Results Forty databases– 20 from Thailand and 20 from Japan—were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. Conclusion Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed. PMID:26560127

Trials, tricks and transparency: how disclosure rules affect clinical knowledge.

PubMed

Dahm, Matthias; González, Paula; Porteiro, Nicolás

2009-12-01

Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined the need for more transparency in clinical trials. We provide a theoretical framework which reproduces incentives for selective reporting and yields three key implications concerning regulation. First, a compulsory clinical trial registry complemented through a voluntary clinical trial results database can implement full transparency (the existence of all trials as well as their results is known). Second, full transparency comes at a price. It has a deterrence effect on the incentives to conduct clinical trials, as it reduces the firms' gains from trials. Third, in principle, a voluntary clinical trial results database without a compulsory registry is a superior regulatory tool; but we provide some qualified support for additional compulsory registries when medical decision-makers cannot anticipate correctly the drug companies' decisions whether to conduct trials.

How Big Data Informs Us About Cataract Surgery: The LXXII Edward Jackson Memorial Lecture.

PubMed

Coleman, Anne Louise

2015-12-01

To characterize the role of Big Data in evaluating quality of care in ophthalmology, to highlight opportunities for studying quality improvement using data available in the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) Registry, and to show how Big Data informs us about rare events such as endophthalmitis after cataract surgery. Review of published studies, analysis of public-use Medicare claims files from 2010 to 2013, and analysis of IRIS Registry from 2013 to 2014. Statistical analysis of observational data. The overall rate of endophthalmitis after cataract surgery was 0.14% in 216 703 individuals in the Medicare database. In the IRIS Registry the endophthalmitis rate after cataract surgery was 0.08% among 511 182 individuals. Endophthalmitis rates tended to be higher in eyes with combined cataract surgery and anterior vitrectomy (P = .051), although only 0.08% of eyes had this combined procedure. Visual acuity (VA) in the IRIS Registry in eyes with and without postoperative endophthalmitis measured 1-7 days postoperatively were logMAR 0.58 (standard deviation [SD]: 0.84) (approximately Snellen acuity of 20/80) and logMAR 0.31 (SD: 0.34) (approximately Snellen acuity of 20/40), respectively. In 33 547 eyes with postoperative VA after cataract surgery, 18.3% had 1-month-postoperative VA worse than 20/40. Big Data drawing on Medicare claims and IRIS Registry records can help identify additional areas for quality improvement, such as in the 18.3% of eyes in the IRIS Registry having 1-month-postoperative VA worse than 20/40. The ability to track patient outcomes in Big Data sets provides opportunities for further research on rare complications such as postoperative endophthalmitis and outcomes from uncommon procedures such as cataract surgery combined with anterior vitrectomy. But privacy and data-security concerns associated with Big Data should not be taken lightly. Copyright © 2015 Elsevier Inc. All rights reserved.

The CRAC cohort model: A computerized low cost registry of interventional cardiology with daily update and long-term follow-up.

PubMed

Rangé, G; Chassaing, S; Marcollet, P; Saint-Étienne, C; Dequenne, P; Goralski, M; Bardiére, P; Beverilli, F; Godillon, L; Sabine, B; Laure, C; Gautier, S; Hakim, R; Albert, F; Angoulvant, D; Grammatico-Guillon, L

2018-05-01

To assess the reliability and low cost of a computerized interventional cardiology (IC) registry to prospectively and systematically collect high-quality data for all consecutive coronary patients referred for coronary angiogram or/and coronary angioplasty. Rigorous clinical practice assessment is a key factor to improve prognosis in IC. A prospective and permanent registry could achieve this goal but, presumably, at high cost and low level of data quality. One multicentric IC registry (CRAC registry), fully integrated to usual coronary activity report software, started in the centre Val-de-Loire (CVL) French region in 2014. Quality assessment of CRAC registry was conducted on five IC CathLab of the CVL region, from January 1st to December 31st 2014. Quality of collected data was evaluated by measuring procedure exhaustivity (comparing with data from hospital information system), data completeness (quality controls) and data consistency (by checking complete medical charts as gold standard). Cost per procedure (global registry operating cost/number of collected procedures) was also estimated. CRAC model provided a high-quality level with 98.2% procedure completeness, 99.6% data completeness and 89% data consistency. The operating cost per procedure was €14.70 ($16.51) for data collection and quality control, including ST-segment elevation myocardial infarction (STEMI) preadmission information and one-year follow-up after angioplasty. This integrated computerized IC registry led to the construction of an exhaustive, reliable and costless database, including all coronary patients entering in participating IC centers in the CVL region. This solution will be developed in other French regions, setting up a national IC database for coronary patients in 2020: France PCI. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Construction and validation of a list of common Middle Eastern surnames for epidemiological research

PubMed Central

Nasseri, Kiumarss

2007-01-01

Purpose Middle Eastern (ME) population is rapidly growing in the US but cannot be easily identified in cancer registry or other databases for epidemiological research. The purpose of this study was to develop a list of common Middle Eastern surnames and validate it by linking with a cancer registry incidence files. Methods Surnames and place of birth in the Middle East were obtained from various sources. After exclusion of the non-specific entries, the final combined list included 49,610 surnames and was matched with the California Cancer Registry incidence file for 1988-2003. Results Overall, 1.4% of all registered cases were positively identified as ME that is similar to the proportion of ME population in California. Two third of the identified cases had known place of birth in the Middle East and of those, 70% were non-Arabs. The sensitivity of the list in detecting ME birth in men and women are 91% and 86%, respectively. The positive predictive values for men and women are 72% and 65%. The specificity and negative predictive values are universally over 99 percent. Conclusion The high accuracy reported for this Middle Eastern surname list (MESL) makes it a valuable tool for epidemiological studies of this ethnic population. PMID:18023539

Toward an integrated knowledge environment to support modern oncology.

PubMed

Blake, Patrick M; Decker, David A; Glennon, Timothy M; Liang, Yong Michael; Losko, Sascha; Navin, Nicholas; Suh, K Stephen

2011-01-01

Around the world, teams of researchers continue to develop a wide range of systems to capture, store, and analyze data including treatment, patient outcomes, tumor registries, next-generation sequencing, single-nucleotide polymorphism, copy number, gene expression, drug chemistry, drug safety, and toxicity. Scientists mine, curate, and manually annotate growing mountains of data to produce high-quality databases, while clinical information is aggregated in distant systems. Databases are currently scattered, and relationships between variables coded in disparate datasets are frequently invisible. The challenge is to evolve oncology informatics from a "systems" orientation of standalone platforms and silos into an "integrated knowledge environments" that will connect "knowable" research data with patient clinical information. The aim of this article is to review progress toward an integrated knowledge environment to support modern oncology with a focus on supporting scientific discovery and improving cancer care.

Validation of diagnosis of aplastic anaemia in La Rioja (Spain) by International Classification of Diseases codes for case ascertainment for the Spanish National Rare Diseases Registry.

PubMed

Ruiz, Elena; Ramalle-Gómara, Enrique; Quiñones, Carmen; Rabasa, Pilar; Pisón, Carlos

2015-05-01

To analyse the validity of diagnosis of aplastic anaemia (AA) by International Classification of Diseases codes in hospital discharge data (MBDS) and the mortality registry (MR) of La Rioja to detect cases to be included in the Spanish National Rare Diseases Registry. International Classification of Diseases (ICD) codes were used to detect AA cases during the period 2007-2012 from two administrative databases: the MBDS and the MR of La Rioja (Spain). Medical records of population selected by merging both databases were used to confirm true AA cases. The annual mean incidence rate of AA was calculated using confirmed incident cases. By merging both databases, 62 hypothetical AA incident patients were detected during the period 2007-2012. The medical records of the 89% of them could be revised, and they confirmed that only the 15% of the patients actually suffered AA. The annual mean AA incidence in La Rioja was 4.17 per million inhabitants (6.23 per million, males; 2.10 per million, females). The MBDS and the MR are not in themselves sufficient to ascertain AA cases in La Rioja and medical records should be reviewed to confirm true AA cases to be included in the Spanish National Rare Diseases Registry. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Hospital pharmacy workforce in Brazil.

PubMed

Santos, Thiago R; Penm, Jonathan; Baldoni, André O; Ayres, Lorena Rocha; Moles, Rebekah; Sanches, Cristina

2018-01-04

This study aims to describe the distribution of the hospital pharmacy workforce in Brazil. Data were acquired, during 2016, through the Brazilian National Database of Healthcare Facilities (CNES). The following variables were extracted: hospital name, registry number, telephone, e-mail, state, type of institution, subtype, management nature, ownership, presence of research/teaching activities, complexity level, number of hospital beds, presence of pharmacists, number of pharmacists, pharmacist specialization. All statistical analyses were performed by IBM SPSS v.19. The number of hospitals with a complete registry in the national database was 4790. The majority were general hospitals (77.9%), managed by municipalities (66.1%), under public administration (44.0%), had no research/teaching activities (90.5%), classified as medium complexity (71.6%), and had no pharmacist in their team (50.6%). Furthermore, almost 60.0% of hospitals did not comply with the minimum recommendations of having a pharmacist per 50 hospital beds. The Southeast region had the highest prevalence of pharmacists, with 64.4% of hospitals having a pharmaceutical professional. This may have occurred as this region had the highest population to hospital ratio. Non-profit hospitals were more likely to have pharmacists compared to those under public administration and private hospitals. This study mapped the hospital pharmacy workforce in Brazil, showing a higher prevalence of hospital pharmacists in the Southeast region, and in non-profit specialized hospitals.

French brain tumor database: 5-year histological results on 25 756 cases.

PubMed

Rigau, Valérie; Zouaoui, Sonia; Mathieu-Daudé, Hélène; Darlix, Amélie; Maran, Aurélie; Trétarre, Brigitte; Bessaoud, Faiza; Bauchet, Fabienne; Attaoua, Redha; Fabbro-Peray, Pascale; Fabbro, Michel; Kerr, Christine; Taillandier, Luc; Duffau, Hugues; Figarella-Branger, Dominique; Costes, Valérie; Bauchet, Luc

2011-11-01

This work aimed to prospectively record all primary central nervous system tumor (PCNST) cases in France, for which histological diagnosis is available. The objectives were to (i) create a national registry and a network to perform epidemiological studies; (ii) implement clinical and basic research protocols; and (iii) harmonize the health care of patients affected by PCNST. For 5 years, 25 756 cases of newly diagnosed and histologically confirmed PCNST have been recorded. Histological diagnoses included glioma (48.9%), all other neuroepithelial tumors (5%), meningioma (28.8%), nerve sheath tumors (8.4%), lymphoma (3.2%) and others (5.7%). Cryopreservation was reported for 6018 PCNST specimens. Tumor resections (R) were performed in 78% cases, while biopsies accounted for 22%. Median age (MA), sex, percentage R and number of cryopreserved tumors were detailed for each histology; for example, out of 6053 glioblastomas (MA 63 years, male 59.4%, R 62%, 1611 were cryopreserved), and out of 37 atypical teratoid/rhabdoid tumors (MA 2 years, male 56.8%, R 94%, 17 were cryopreserved). This database or databank dedicated to PCNST cases contains detailed data on clinical, histological and other characteristics, such as the inclusion of data on cryopreserved specimens that are not available in other European registries. Therefore, this is a valuable resource that can be used for planning future epidemiological and clinical research. © 2011 The Authors; Brain Pathology © 2011 International Society of Neuropathology.

An international registry for primary ciliary dyskinesia.

PubMed

Werner, Claudius; Lablans, Martin; Ataian, Maximilian; Raidt, Johanna; Wallmeier, Julia; Große-Onnebrink, Jörg; Kuehni, Claudia E; Haarman, Eric G; Leigh, Margaret W; Quittner, Alexandra L; Lucas, Jane S; Hogg, Claire; Witt, Michal; Priftis, Kostas N; Yiallouros, Panayiotis; Nielsen, Kim G; Santamaria, Francesca; Ückert, Frank; Omran, Heymut

2016-03-01

Primary ciliary dyskinesia (PCD) is a rare autosomal recessive disorder leading to chronic upper and lower airway disease. Fundamental data on epidemiology, clinical presentation, course and treatment strategies are lacking in PCD. We have established an international PCD registry to realise an unmet need for an international platform to systematically collect data on incidence, clinical presentation, treatment and disease course.The registry was launched in January 2014. We used internet technology to ensure easy online access using a web browser under www.pcdregistry.eu. Data from 201 patients have been collected so far. The database is comprised of a basic data form including demographic and diagnostic information, and visit forms designed to monitor the disease course.To establish a definite PCD diagnosis, we used strict diagnostic criteria, which required two to three diagnostic methods in addition to classical clinical symptoms. Preliminary analysis of lung function data demonstrated a mean annual decline of percentage predicted forced expiratory volume in 1 s of 0.59% (95% CI 0.98-0.22).Here, we present the development of an international PCD registry as a new promising tool to advance the understanding of this rare disorder, to recruit candidates for research studies and ultimately to improve PCD care. Copyright ©ERS 2016.

Multicenter breast cancer collaborative registry.

PubMed

Sherman, Simon; Shats, Oleg; Fleissner, Elizabeth; Bascom, George; Yiee, Kevin; Copur, Mehmet; Crow, Kate; Rooney, James; Mateen, Zubeena; Ketcham, Marsha A; Feng, Jianmin; Sherman, Alexander; Gleason, Michael; Kinarsky, Leo; Silva-Lopez, Edibaldo; Edney, James; Reed, Elizabeth; Berger, Ann; Cowan, Kenneth

2011-01-01

The Breast Cancer Collaborative Registry (BCCR) is a multicenter web-based system that efficiently collects and manages a variety of data on breast cancer (BC) patients and BC survivors. This registry is designed as a multi-tier web application that utilizes Java Servlet/JSP technology and has an Oracle 11g database as a back-end. The BCCR questionnaire has accommodated standards accepted in breast cancer research and healthcare. By harmonizing the controlled vocabulary with the NCI Thesaurus (NCIt) or Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), the BCCR provides a standardized approach to data collection and reporting. The BCCR has been recently certified by the National Cancer Institute's Center for Biomedical Informatics and Information Technology (NCI CBIIT) as a cancer Biomedical Informatics Grid (caBIG(®)) Bronze Compatible product.The BCCR is aimed at facilitating rapid and uniform collection of critical information and biological samples to be used in developing diagnostic, prevention, treatment, and survivorship strategies against breast cancer. Currently, seven cancer institutions are participating in the BCCR that contains data on almost 900 subjects (BC patients and survivors, as well as individuals at high risk of getting BC).

Multicenter Breast Cancer Collaborative Registry

PubMed Central

Sherman, Simon; Shats, Oleg; Fleissner, Elizabeth; Bascom, George; Yiee, Kevin; Copur, Mehmet; Crow, Kate; Rooney, James; Mateen, Zubeena; Ketcham, Marsha A.; Feng, Jianmin; Sherman, Alexander; Gleason, Michael; Kinarsky, Leo; Silva-Lopez, Edibaldo; Edney, James; Reed, Elizabeth; Berger, Ann; Cowan, Kenneth

2011-01-01

The Breast Cancer Collaborative Registry (BCCR) is a multicenter web-based system that efficiently collects and manages a variety of data on breast cancer (BC) patients and BC survivors. This registry is designed as a multi-tier web application that utilizes Java Servlet/JSP technology and has an Oracle 11g database as a back-end. The BCCR questionnaire has accommodated standards accepted in breast cancer research and healthcare. By harmonizing the controlled vocabulary with the NCI Thesaurus (NCIt) or Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), the BCCR provides a standardized approach to data collection and reporting. The BCCR has been recently certified by the National Cancer Institute’s Center for Biomedical Informatics and Information Technology (NCI CBIIT) as a cancer Biomedical Informatics Grid (caBIG®) Bronze Compatible product. The BCCR is aimed at facilitating rapid and uniform collection of critical information and biological samples to be used in developing diagnostic, prevention, treatment, and survivorship strategies against breast cancer. Currently, seven cancer institutions are participating in the BCCR that contains data on almost 900 subjects (BC patients and survivors, as well as individuals at high risk of getting BC). PMID:21918596

Prioritising sewerage maintenance using inferred sewer age: a case study for Edinburgh.

PubMed

Arthur, S; Burkhard, R

2010-01-01

The reported research project focuses on using a database which contains details of customer contacts and CCTV data for a key Scottish catchment to construct a GIS based sewer condition model. Given the nature of the asset registry, a key research challenge was estimating the age of individual lengths of pipe. Within this context, asset age was inferred using the estimated age of surface developments-this involved overlaying the network in a GIS with historical digital maps. The paper illustrates that inferred asset age can reliably be used to highlight assets which are more likely to fail.

Transforming the Army Central Registry Family Violence File into a Relational Database for the Purpose of Facilitating Epidemiological Research

DTIC Science & Technology

2005-07-01

child abuse events. ACR data were originally collected for administrative purposes and, without significant adaptation, are not immediately suitable for epidemiological analyses. Our ultimate research goal is to link ACR data for individuals involved in single or multiple events as victims, perpetrators, or both to health behavior, health outcome and demographic data. This will allow us to identity precipitating factors,follow individuals after an event, and understand how different events are related. This report details the steps taken to transform the ACR data into a

[Virtual clinical diagnosis support system of degenerative stenosis of the lumbar spinal canal].

PubMed

Shevelev, I N; Konovalov, N A; Cherkashov, A M; Molodchenkov, A A; Sharamko, T G; Asiutin, D S; Nazarenko, A G

2013-01-01

The aim of the study was to develop a virtual clinical diagnostic support system of degenerative lumbar spinal stenosis on database of spine registry. Choice of criteria's for diagnostic system was made on symptom analysis of 298 patients with lumbar spinal stenosis. Also was analysed a group of patient with disc herniation's for sensitivity and specify assessment of developed diagnostic support system. Represented clinical diagnostic support system allows identifying patients with degenerative lumbar spinal stenosis on stage of patient's primary visit. System sensitivity and specify are 90 and 71% respectively. "Online" mode of diagnostic system in structure of spine registry provides maximal availability for specialists, regardless of their locations. Development of tools "medicine 2.0" is the actual direction for carrying out further researches with which carrying out the centralized baea collection by means of specialized registers helps.

National Cancer Patient Registry--a patient registry/clinical database to evaluate the health outcomes of patients undergoing treatment for cancers in Malaysia.

PubMed

Lim, G C C; Azura, D

2008-09-01

Cancer burden in Malaysia is increasing. Although there have been improvements in cancer treatment, these new therapies may potentially cause an exponential increase in the cost of cancer treatment. Therefore, justification for the use of these treatments is mandated. Availability of local data will enable us to evaluate and compare the outcome of our patients. This will help to support our clinical decision making and local policy, improve access to treatment and improve the provision and delivery of oncology services in Malaysia. The National Cancer Patient Registry was proposed as a database for cancer patients who seek treatment in Malaysia. It will be a valuable tool to provide timely and robust data on the actual setting in oncology practice, safety and cost effectiveness of treatment and most importantly the outcome of these patients.

Visual outcome of cataract surgery; study from the European Registry of Quality Outcomes for Cataract and Refractive Surgery.

PubMed

Lundström, Mats; Barry, Peter; Henry, Ype; Rosen, Paul; Stenevi, Ulf

2013-05-01

To analyze the visual outcome after cataract surgery. Cataract surgery clinics in 15 European countries. Database study. Data were drawn from case series of cataract extractions reported to the European Registry of Quality Outcomes for Cataract and Refractive Surgery database. These data were entered into the database via the Web by surgeons or by transfer from existing national registries or electronic medical record systems. The database contains individual anonymous data on preoperative, intraoperative, and postoperative measurements. Data on 368,256 cataract extractions were available for analysis. The best visual outcome was achieved in age groups 40 to 74 years, and men showed a higher percentage of excellent vision (1.0 [20/20] or better) than women. A corrected distance visual acuity (CDVA) of 0.5 (20/40) or better and of 1.0 (20/20) or better was achieved in 94.3% and 61.3% of cases, respectively. Ocular comorbidity and postoperative complications were the strongest influences on the visual outcome; however, surgical complications and ocular changes requiring complex surgery also had a negative influence. Deterioration of visual acuity after the surgery (n= 6112 [1.7% of all cases]) was most common in patients with a good preoperative visual acuity. The visual outcomes of cataract surgery were excellent, with 61.3% of patients achieving a corrected distance visual acuity of 1.0 (20/20) or better. Age and sex influenced the visual outcomes, but the greatest influences were short-term postoperative complications, ocular comorbidity, surgical complications, and complex surgery. A weakness of the study could be that some of the data is self-reported to the registry. Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Use of health plan combined with registry data to predict clinical trial recruitment.

PubMed

Curtis, Jeffrey R; Wright, Nicole C; Xie, Fenglong; Chen, Lang; Zhang, Jie; Saag, Kenneth G; Bharat, Aseem; Kremer, Joel; Cofield, Stacey; Winthrop, Kevin; Delzell, Elizabeth

2014-02-01

Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients' treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.

[Development and validation of an algorithm to identify cancer recurrences from hospital data bases].

PubMed

Manzanares-Laya, S; Burón, A; Murta-Nascimento, C; Servitja, S; Castells, X; Macià, F

2014-01-01

Hospital cancer registries and hospital databases are valuable and efficient sources of information for research into cancer recurrences. The aim of this study was to develop and validate algorithms for the detection of breast cancer recurrence. A retrospective observational study was conducted on breast cancer cases from the cancer registry of a third level university hospital diagnosed between 2003 and 2009. Different probable cancer recurrence algorithms were obtained by linking the hospital databases and the construction of several operational definitions, with their corresponding sensitivity, specificity, positive predictive value and negative predictive value. A total of 1,523 patients were diagnosed of breast cancer between 2003 and 2009. A request for bone gammagraphy after 6 months from the first oncological treatment showed the highest sensitivity (53.8%) and negative predictive value (93.8%), and a pathology test after 6 months after the diagnosis showed the highest specificity (93.8%) and negative predictive value (92.6%). The combination of different definitions increased the specificity and the positive predictive value, but decreased the sensitivity. Several diagnostic algorithms were obtained, and the different definitions could be useful depending on the interest and resources of the researcher. A higher positive predictive value could be interesting for a quick estimation of the number of cases, and a higher negative predictive value for a more exact estimation if more resources are available. It is a versatile and adaptable tool for other types of tumors, as well as for the needs of the researcher. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

PubMed Central

Tasneem, Asba; Aberle, Laura; Ananth, Hari; Chakraborty, Swati; Chiswell, Karen; McCourt, Brian J.; Pietrobon, Ricardo

2012-01-01

Background The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. Methods/Principal Results The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. Conclusions/Significance The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups. PMID:22438982

The database for aggregate analysis of ClinicalTrials.gov (AACT) and subsequent regrouping by clinical specialty.

PubMed

Tasneem, Asba; Aberle, Laura; Ananth, Hari; Chakraborty, Swati; Chiswell, Karen; McCourt, Brian J; Pietrobon, Ricardo

2012-01-01

The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups.

National Dyslipidemia Registry of the Spanish Arteriosclerosis Society: Current status.

PubMed

Pérez-Calahorra, Sofía; Sánchez-Hernández, Rosa M; Plana, Núria; Valdivielso, Pedro; Civeira, Fernando

Clinical registries are a very effective tool to verify the usual clinical practice, to compare clinical strategies and to improve the knowledge of diagnostic and therapeutic new procedures. The National Registry of Dyslipemias of the Spanish Society of Arteriosclerosis (SEA) is an on-line, retrospective and prospective database where the different Spanish lipid units accredited by the SEA introduce data from patients with disorders of lipid metabolism. The registry was created in 2013, and since then clinical, analytical, genetic and evolutionary data of 4,449 patients have been introduced until June 2017. In the last year the registry has given rise to a considerable number of international publications and there are several more in progress. An ambitious incentive plan for inclusion of patients has been initiated to get the SEA registry as a global reference that helps to improve the knowledge and clinical management of these patients. From the coordinating group of the registry we encourage all SEA partners to collaborate in the multiple forms that the registry allows, and to make it an international scientific reference. Copyright © 2017. Publicado por Elsevier España, S.L.U.

Acoustic Neuroma Educational Video

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Informatics and data quality at collaborative multicenter Breast and Colon Cancer Family Registries.

PubMed

McGarvey, Peter B; Ladwa, Sweta; Oberti, Mauricio; Dragomir, Anca Dana; Hedlund, Erin K; Tanenbaum, David Michael; Suzek, Baris E; Madhavan, Subha

2012-06-01

Quality control and harmonization of data is a vital and challenging undertaking for any successful data coordination center and a responsibility shared between the multiple sites that produce, integrate, and utilize the data. Here we describe a coordinated effort between scientists and data managers in the Cancer Family Registries to implement a data governance infrastructure consisting of both organizational and technical solutions. The technical solution uses a rule-based validation system that facilitates error detection and correction for data centers submitting data to a central informatics database. Validation rules comprise both standard checks on allowable values and a crosscheck of related database elements for logical and scientific consistency. Evaluation over a 2-year timeframe showed a significant decrease in the number of errors in the database and a concurrent increase in data consistency and accuracy.

Informatics and data quality at collaborative multicenter Breast and Colon Cancer Family Registries

PubMed Central

McGarvey, Peter B; Ladwa, Sweta; Oberti, Mauricio; Dragomir, Anca Dana; Hedlund, Erin K; Tanenbaum, David Michael; Suzek, Baris E

2012-01-01

Quality control and harmonization of data is a vital and challenging undertaking for any successful data coordination center and a responsibility shared between the multiple sites that produce, integrate, and utilize the data. Here we describe a coordinated effort between scientists and data managers in the Cancer Family Registries to implement a data governance infrastructure consisting of both organizational and technical solutions. The technical solution uses a rule-based validation system that facilitates error detection and correction for data centers submitting data to a central informatics database. Validation rules comprise both standard checks on allowable values and a crosscheck of related database elements for logical and scientific consistency. Evaluation over a 2-year timeframe showed a significant decrease in the number of errors in the database and a concurrent increase in data consistency and accuracy. PMID:22323393

Clinical Databases and Registries in Congenital and Pediatric Cardiac Surgery, Cardiology, Critical Care, and Anesthesiology Worldwide.

PubMed

Vener, David F; Gaies, Michael; Jacobs, Jeffrey P; Pasquali, Sara K

2017-01-01

The growth in large-scale data management capabilities and the successful care of patients with congenital heart defects have coincidentally paralleled each other for the last three decades, and participation in multicenter congenital heart disease databases and registries is now a fundamental component of cardiac care. This manuscript attempts for the first time to consolidate in one location all of the relevant databases worldwide, including target populations, specialties, Web sites, and participation information. Since at least 1,992 cardiac surgeons and cardiologists began leveraging this burgeoning technology to create multi-institutional data collections addressing a variety of specialties within this field. Pediatric heart diseases are particularly well suited to this methodology because each individual care location has access to only a relatively limited number of diagnoses and procedures in any given calendar year. Combining multiple institutions data therefore allows for a far more accurate contemporaneous assessment of treatment modalities and adverse outcomes. Additionally, the data can be used to develop outcome benchmarks by which individual institutions can measure their progress against the field as a whole and focus quality improvement efforts in a more directed fashion, and there is increasing utilization combining clinical research efforts within existing data structures. Efforts are ongoing to support better collaboration and integration across data sets, to improve efficiency, further the utility of the data collection infrastructure and information collected, and to enhance return on investment for participating institutions.

Assessment of Confounders in Comparative Effectiveness Studies From Secondary Databases.

PubMed

Franklin, Jessica M; Schneeweiss, Sebastian; Solomon, Daniel H

2017-03-15

Secondary clinical databases are an important and growing source of data for comparative effectiveness research (CER) studies. However, measurement of confounders, such as biomarker values or patient-reported health status, in secondary clinical databases may not align with the initiation of a new treatment. In many published CER analyses of registry data, investigators assessed confounders based on the first questionnaire in which the new exposure was recorded. However, it is known that adjustment for confounders measured after the start of exposure can lead to biased treatment effect estimates. In the present study, we conducted simulations to compare assessment strategies for a dynamic clinical confounder in a registry-based comparative effectiveness study of 2 therapies. As expected, we found that adjustment for the confounder value at the time of the first questionnaire after the start of exposure creates a biased estimate the total effect of exposure choice on outcome when the confounder mediates part of the effect. However, adjustment for the prior value can also be badly biased when measured long before exposure initiation. Thus, investigators should carefully consider the timing of confounder measurements relative to exposure initiation and the rate of change in the confounder in order to choose the most relevant measure for each patient. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Standard Nomenclature for Referencing and Authentication of Pluripotent Stem Cells.

PubMed

Kurtz, Andreas; Seltmann, Stefanie; Bairoch, Amos; Bittner, Marie-Sophie; Bruce, Kevin; Capes-Davis, Amanda; Clarke, Laura; Crook, Jeremy M; Daheron, Laurence; Dewender, Johannes; Faulconbridge, Adam; Fujibuchi, Wataru; Gutteridge, Alexander; Hei, Derek J; Kim, Yong-Ou; Kim, Jung-Hyun; Kokocinski, Anja Kolb-; Lekschas, Fritz; Lomax, Geoffrey P; Loring, Jeanne F; Ludwig, Tenneille; Mah, Nancy; Matsui, Tohru; Müller, Robert; Parkinson, Helen; Sheldon, Michael; Smith, Kelly; Stachelscheid, Harald; Stacey, Glyn; Streeter, Ian; Veiga, Anna; Xu, Ren-He

2018-01-09

Unambiguous cell line authentication is essential to avoid loss of association between data and cells. The risk for loss of references increases with the rapidity that new human pluripotent stem cell (hPSC) lines are generated, exchanged, and implemented. Ideally, a single name should be used as a generally applied reference for each cell line to access and unify cell-related information across publications, cell banks, cell registries, and databases and to ensure scientific reproducibility. We discuss the needs and requirements for such a unique identifier and implement a standard nomenclature for hPSCs, which can be automatically generated and registered by the human pluripotent stem cell registry (hPSCreg). To avoid ambiguities in PSC-line referencing, we strongly urge publishers to demand registration and use of the standard name when publishing research based on hPSC lines. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Eye Care Professionals' Perspectives on Eye Donation and an Eye Donation Registry for Research: A Single-Institution, Cross-Sectional Study.

PubMed

Williams, Andrew M; Allingham, R Rand; Stamer, W Daniel; Muir, Kelly W

2016-06-01

A centralized eye donation registry for research could help to bridge the gap between patients interested in donating their eyes to science and scientists who conduct research on human eye tissue. Previous research has demonstrated patient and family support for such a registry. In this study, we assessed the views that eye care professionals have toward an eye donation registry for research. Surveys were distributed to all 46 clinical faculty members of the Duke University Eye Center. In addition to collecting demographic information, the surveys assessed clinicians' experience with discussing eye donation with patients, described the proposed eye donation registry for research and asked how the registry would affect the clinicians' practice. A total of 21 eye care professionals returned the survey. Thirty-three percent reported discussing eye donation with patients, and 43% reported that a patient has asked about donating their eyes for research on their disease. Eighty-six percent of eye care professionals reported that a centralized registry would improve the way they work with patients who express a desire to donate their eyes for research. The majority of eye care professionals at our academic institution indicated that an eye donation registry for research would improve how they work with patients who are interested in donating their eyes for research on their disease. Future research should examine how best to communicate this registry to ophthalmic patients.

[The significance of introducing registry study in the post-marketing safety research for Chinese medicine and pharmacy].

PubMed

Liao, Xing; Xie, Yan-Ming; Yang, Wei; Chang, Yan-Peng

2014-03-01

There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.

Analysis of Outcomes After TKA: Do All Databases Produce Similar Findings?

PubMed

Bedard, Nicholas A; Pugely, Andrew J; McHugh, Michael; Lux, Nathan; Otero, Jesse E; Bozic, Kevin J; Gao, Yubo; Callaghan, John J

2018-01-01

Use of large clinical and administrative databases for orthopaedic research has increased exponentially. Each database represents unique patient populations and varies in their methodology of data acquisition, which makes it possible that similar research questions posed to different databases might result in answers that differ in important ways. (1) What are the differences in reported demographics, comorbidities, and complications for patients undergoing primary TKA among four databases commonly used in orthopaedic research? (2) How does the difference in reported complication rates vary depending on whether only inpatient data or 30-day postoperative data are analyzed? Patients who underwent primary TKA during 2010 to 2012 were identified within the National Surgical Quality Improvement Programs (NSQIP), the Nationwide Inpatient Sample (NIS), the Medicare Standard Analytic Files (MED), and the Humana Administrative Claims database (HAC). NSQIP is a clinical registry that captures both inpatient and outpatient events up to 30 days after surgery using clinical reviewers and strict definitions for each variable. The other databases are administrative claims databases with their comorbidity and adverse event data defined by diagnosis and procedure codes used for reimbursement. NIS is limited to inpatient data only, whereas HAC and MED also have outpatient data. The number of patients undergoing primary TKA from each database was 48,248 in HAC, 783,546 in MED, 393,050 in NIS, and 43,220 in NSQIP. NSQIP definitions for comorbidities and surgical complications were matched to corresponding International Classification of Diseases, 9 Revision/Current Procedural Terminology codes and these coding algorithms were used to query NIS, MED, and HAC. Age, sex, comorbidities, and inpatient versus 30-day postoperative complications were compared across the four databases. Given the large sample sizes, statistical significance was often detected for small, clinically unimportant differences; thus, the focus of comparisons was whether the difference reached an absolute difference of twofold to signify an important clinical difference. Although there was a higher proportion of males in NIS and NSQIP and patients in NIS were younger, the difference was slight and well below our predefined threshold for a clinically important difference. There was variation in the prevalence of comorbidities and rates of postoperative complications among databases. The prevalence of chronic obstructive pulmonary disease (COPD) and coagulopathy in HAC and MED was more than twice that in NIS and NSQIP (relative risk [RR] for COPD: MED versus NIS 3.1, MED versus NSQIP 4.5, HAC versus NIS 3.6, HAC versus NSQIP 5.3; RR for coagulopathy: MED versus NIS 3.9, MED versus NSQIP 3.1, HAC versus NIS 3.3, HAC versus NSQIP 2.7; p < 0.001 for all comparisons). NSQIP had more than twice the obesity as NIS (RR 0.35). Rates of stroke within 30 days of TKA had more than a twofold difference among all databases (p < 0.001). HAC had more than twice the rates of 30-day complications at all endpoints compared with NSQIP and more than twice the 30-day infections as MED. A comparison of inpatient and 30-day complications rates demonstrated more than twice the amount of wound infections and deep vein thromboses is captured when data are analyzed out to 30 days after TKA (p < 0.001 for all comparisons). When evaluating research utilizing large databases, one must pay particular attention to the type of database used (administrative claims, clinical registry, or other kinds of databases), time period included, definitions utilized for specific variables, and the population captured to ensure it is best suited for the specific research question. Furthermore, with the advent of bundled payments, policymakers must meticulously consider the data sources used to ensure the data analytics match historical sources. Level III, therapeutic study.

Transcatheter aortic valve replacement and vascular complications definitions.

PubMed

Van Mieghem, Nicolas M; Généreux, Philippe; van der Boon, Robert M A; Kodali, Susheel; Head, Stuart; Williams, Matthew; Daneault, Benoit; Kappetein, Arie-Pieter; de Jaegere, Peter P; Leon, Martin B; Serruys, Patrick W

2014-03-20

Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting. We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (k 0.80), the UK registry (k 0.82) the Italian registry (k 0.72) and "FRANCE" registry (k 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry ( 0.47) and the 18 Fr Safety and Efficacy study (k 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (k 0.54). Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint definitions and should be universally adopted to obtain better insights into global TAVR experience.

Characterization and utilization of an international neurofibromatosis web-based, patient–entered registry: An observational study

PubMed Central

Korf, Bruce; Rangel Miller, Vanessa; Viskochil, David

2017-01-01

The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis) are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF) is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children’s Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015) who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes. PMID:28644838

Characterization and utilization of an international neurofibromatosis web-based, patient-entered registry: An observational study.

PubMed

Seidlin, Mindell; Holzman, Robert; Knight, Pamela; Korf, Bruce; Rangel Miller, Vanessa; Viskochil, David; Bakker, Annette

2017-01-01

The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis) are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF) is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children's Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015) who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes.

Objectives and Design of the Russian Acute Coronary Syndrome Registry (RusACSR).

PubMed

Gridnev, Vladimir I; Kiselev, Anton R; Posnenkova, Olga M; Popova, Yulia V; Dmitriev, Viktor A; Prokhorov, Mikhail D; Dovgalevsky, Pavel Ya; Oschepkova, Elena V

2016-01-01

The Russian Acute Coronary Syndrome Registry (RusACSR) is a retrospective, continuous, nationwide, Web-based registry of patients with acute coronary syndromes (ACS). The RusACSR is a database that uses a secure Web-based interface for data entry by individual users. Participation in the RusACSR is voluntary. Any clinical center that provides health care to ACS patients can take part in the RusACSR. The RusACSR enrolls ACS patients who have undergone care in Russian hospitals from February 2008 to the present. Key data elements and methods of data analysis in the RusACSR are presented in this article. Up to 2015, 213 clinical centers from 36 regions of Russia had participated in the RusACSR. Currently, the database contains data on more than 250 000 ACS patients who underwent care from 2008 to 2015. Some current problems are highlighted in this article. The RusACSR is a perspective project for different epidemiologic studies in Russian ACS patients. © 2015 Wiley Periodicals, Inc.

Toolbox for Research, or how to facilitate a central data management in small-scale research projects.

PubMed

Bialke, Martin; Rau, Henriette; Thamm, Oliver C; Schuldt, Ronny; Penndorf, Peter; Blumentritt, Arne; Gött, Robert; Piegsa, Jens; Bahls, Thomas; Hoffmann, Wolfgang

2018-01-25

In most research projects budget, staff and IT infrastructures are limiting resources. Especially for small-scale registries and cohort studies professional IT support and commercial electronic data capture systems are too expensive. Consequently, these projects use simple local approaches (e.g. Excel) for data capture instead of a central data management including web-based data capture and proper research databases. This leads to manual processes to merge, analyze and, if possible, pseudonymize research data of different study sites. To support multi-site data capture, storage and analyses in small-scall research projects, corresponding requirements were analyzed within the MOSAIC project. Based on the identified requirements, the Toolbox for Research was developed as a flexible software solution for various research scenarios. Additionally, the Toolbox facilitates data integration of research data as well as metadata by performing necessary procedures automatically. Also, Toolbox modules allow the integration of device data. Moreover, separation of personally identifiable information and medical data by using only pseudonyms for storing medical data ensures the compliance to data protection regulations. This pseudonymized data can then be exported in SPSS format in order to enable scientists to prepare reports and analyses. The Toolbox for Research was successfully piloted in the German Burn Registry in 2016 facilitating the documentation of 4350 burn cases at 54 study sites. The Toolbox for Research can be downloaded free of charge from the project website and automatically installed due to the use of Docker technology.

An overview of multidisciplinary research resources at the Osaka University Center for Twin Research.

PubMed

Hayakawa, Kazuo; Iwatani, Yoshinori

2013-02-01

Osaka University Center for Twin Research is currently organizing a government-funded, multidisciplinary research project using a large registry of aged twins living in Japan. The purpose of the project is to collect various information as well as biological resources from registered twins, and to establish a biobank and databases for preserving and managing these data and resources. The Center is collecting data from twin pairs, both of whom have agreed to participate in a one-day comprehensive medical examination. The following data are being collected: physical data (e.g., height, body mass, blood pressure, theoretical visceral fat, pulse wave velocity, and bone density), data regarding epidemiology (e.g., medical history, lifestyle, quality of life, mood status, cognitive function, and nutrition), electrocardiogram, ultrasonography (carotid artery and thyroid), dentistry, plastic surgery, positron emission tomography, magnetoencephalogram, and magnetic resonance imaging of brain. These data are then aggregated and systematically stored in specific databases. In addition, peripheral blood is obtained from the participants, and then genomic DNA is purified and sera are stored. A wide variety of studies are ongoing, and more are in the planning stage.

Chinese SLE Treatment and Research group (CSTAR) registry: II. Prevalence and risk factors of pulmonary arterial hypertension in Chinese patients with systemic lupus erythematosus.

PubMed

Li, M; Wang, Q; Zhao, J; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Tian, Z; Liu, Y; He, J; Zhang, F; Zhao, Y; Zeng, X

2014-09-01

To estimate the prevalence of pulmonary arterial hypertension (PAH) and risk factors for PAH in patients registered in the Chinese SLE Treatment and Research group (CSTAR) database, the first online registry of Chinese patients with systemic lupus erythematosus (SLE). A prospective cross-sectional study of patients with SLE was conducted using the CSTAR registry. Resting transthoracic echocardiography was used to estimate pulmonary artery pressure (PAP); PAH was defined as systolic PAP (PASP)≥40 mmHg. Patients with interstitial lung disease, valvular disease or cardiomyopathy were excluded because of disease influence on PAP. We explored potential risk factors for PAH including patient characteristics, organ involvement, laboratory findings and SLE disease activity. Of 1934 patients with SLE, 74 had PASP with 54.2±17.1 (40,106) mmHg and were diagnosed with probable PAH. The incidences of lupus nephritis, pleuritis, pericarditis, hypocomplementemia, anti-SSA, and anti-ribonucleoprotein (RNP) were significantly higher in patients with PAH than in those without (p<0.05). SLE disease activity was significantly higher in patients with PAH than in unaffected patients (p<0.05). Multivariate analysis indicated that pericarditis (odds ratio (OR)=4.248), pleuritis (OR=3.061) and anti-RNP (OR=2.559) were independent risk factors for PAH in patients with SLE (p<0.05). The possible prevalence of PAH was 3.8% in Chinese patients with SLE in the CSTAR registry. The significant association of pericarditis, pleuritis and anti-RNP positivity with PAH suggests that higher disease activity and vasculopathy may both contribute to the development of PAH in SLE, which need be treated aggressively to improve prognosis. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Preliminary Results of National Amyotrophic Lateral Sclerosis (ALS) Registry Risk Factor Survey Data

PubMed Central

2016-01-01

Background The National ALS Registry is made up of two components to capture amyotrophic lateral sclerosis (ALS) cases: national administrative databases (Medicare, Medicaid, Veterans Health Administration and Veterans Benefits Administration) and self-identified cases captured by the Registry’s web portal. This study describes self-reported characteristics of U.S. adults with ALS using the data collected by the National ALS Registry web portal risk factor surveys only from October 19, 2010 through December 31, 2013. Objective To describe findings from the National ALS Registry’s web portal risk factor surveys. Measurements The prevalence of select risk factors among adults with ALS was determined by calculating the frequencies of select risk factors—smoking and alcohol (non, current and former) histories, military service and occupational history, and family history of neurodegenerative diseases such as ALS, Alzheimer’s and/or Parkinson’s. Results Nearly half of survey respondents were ever smokers compared with nearly 41% of adults nationally. Most respondents were ever drinkers which is comparable to national estimates. The majority were light drinkers. Nearly one-quarter of survey respondents were veterans compared with roughly 9% of US adults nationally. Most respondents were retired or disabled. The industries in which respondents were employed for the longest time were Professional and Scientific and Technical Services. When family history of neurodegenerative diseases in first degree relatives was evaluated against our comparison group, the rates of ALS were similar, but were higher for Parkinson’s disease, Alzheimer’s disease and any neurodegenerative diseases. Conclusions The National ALS Registry web portal, to our knowledge, is the largest, most geographically diverse collection of risk factor data about adults living with ALS. Various characteristics were consistent with other published studies on ALS risk factors and will allow researchers to generate hypotheses for future research. PMID:27124833

Development of a statewide trauma registry using multiple linked sources of data.

PubMed Central

Clark, D. E.

1993-01-01

In order to develop a cost-effective method of injury surveillance and trauma system evaluation in a rural state, computer programs were written linking records from two major hospital trauma registries, a statewide trauma tracking study, hospital discharge abstracts, death certificates, and ambulance run reports. A general-purpose database management system, programming language, and operating system were used. Data from 1991 appeared to be successfully linked using only indirect identifying information. Familiarity with local geography and the idiosyncracies of each data source were helpful in programming for effective matching of records. For each individual case identified in this way, data from all available sources were then merged and imported into a standard database format. This inexpensive, population-based approach, maintaining flexibility for end-users with some database training, may be adaptable for other regions. There is a need for further improvement and simplification of the record-linkage process for this and similar purposes. PMID:8130556

Clinical Case Registries: Simultaneous Local and National Disease Registries for Population Quality Management

PubMed Central

Backus, Lisa I.; Gavrilov, Sergey; Loomis, Timothy P.; Halloran, James P.; Phillips, Barbara R.; Belperio, Pamela S.; Mole, Larry A.

2009-01-01

The Department of Veterans Affairs (VA) has a system-wide, patient-centric electronic medical record system (EMR) within which the authors developed the Clinical Case Registries (CCR) to support population-centric delivery and evaluation of VA medical care. To date, the authors have applied the CCR to populations with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Local components use diagnosis codes and laboratory test results to identify patients who may have HIV or HCV and support queries on local care delivery with customizable reports. For each patient in a local registry, key EMR data are transferred via HL7 messaging to a single national registry. From 128 local registry systems, over 60,000 and 320,000 veterans in VA care have been identified as having HIV and HCV, respectively, and entered in the national database. Local and national reports covering demographics, resource usage, quality of care metrics and medication safety issues have been generated. PMID:19717794

Development of a Web-Based Nationwide Korean Pediatric Dental Sedation Registry.

PubMed

Choi, Sung Chul; Yang, Yeonmi; Yoo, Seunghoon; Kim, Jiyeon; Jeong, Taesung; Shin, Teo Jeon

Finding a balance between sedation efficacy and safety remains an ongoing challenge. In children, the risk of sedation-related complications is relatively high. It is of utmost importance to determine the factors related to improved overall sedation outcomes. However, most previous reports have been based on small samples at single institutions. The Korean Academy of Pediatric Dentistry (KAPD) developed a Korean Pediatric Dental Sedation Registry using a web-based platform. Specialists in pediatric dental sedation selected the itemized list included within the registry through an extensive literature review. The web-based registry was built into the KAPD homepage to facilitate easy access to the sedation data. All teaching and university hospitals agreed to participate in the Korean Pediatric Dental Sedation Registry. This is the first attempt to collect sedation data on a nationwide scale in the field of pediatric dentistry. The sedation database established with the registry may facilitate standardizing and improving pediatric dental sedation clinical practices.

Trauma scoring systems and databases.

PubMed

Lecky, F; Woodford, M; Edwards, A; Bouamra, O; Coats, T

2014-08-01

This review considers current trauma scoring systems and databases and their relevance to improving patient care. Single physiological measures such as systolic arterial pressure have limited ability to diagnose severe trauma by reflecting raised intracranial pressure, or significant haemorrhage. The Glasgow coma score has the greatest prognostic value in head-injured and other trauma patients. Trauma triage tools and imaging decision rules-using combinations of physiological cut-off measures with mechanism of injury and other categorical variables-bring both increased sophistication and increased complexity. It is important for clinicians and managers to be aware of the diagnostic properties (over- and under-triage rates) of any triage tool or decision rule used in their trauma system. Trauma registries are able to collate definitive injury descriptors and use survival prediction models to guide trauma system governance, through individual patient review and case-mix-adjusted benchmarking of hospital and network performance with robust outlier identification. Interrupted time series allow observation in the changes in care processes and outcomes at national level, which can feed back into clinical quality-based commissioning of healthcare. Registry data are also a valuable resource for trauma epidemiological and comparative effectiveness research studies. © The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The National Anesthesia Clinical Outcomes Registry.

PubMed

Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

2015-12-01

The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses.

A Practical Introduction to Non-Bibliographic Database Searching.

ERIC Educational Resources Information Center

Rocke, Hans J.; And Others

This guide comprises four reports on the Laboratory Animal Data Bank (LADB), the National Institute of Health Environmental Protection Agency (NIH/EPA) Chemical Information System (CIS), nonbibliographic databases for the social sciences, and the Toxicology Data Bank (TDB) and Registry of Toxic Effects of Chemical Substances (RTECS). The first…

50 CFR 600.1415 - Procedures for designating exempted states-general provisions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE MAGNUSON-STEVENS ACT PROVISIONS...-hire vessel license holder data to NMFS for inclusion in a national or regional registry database; or.... 1417; (iii) A description of the database in which the data exists and will be transmitted; and (iv...

Validity of a computerized population registry of dementia based on clinical databases.

PubMed

Mar, J; Arrospide, A; Soto-Gordoa, M; Machón, M; Iruin, Á; Martinez-Lage, P; Gabilondo, A; Moreno-Izco, F; Gabilondo, A; Arriola, L

2018-05-08

The handling of information through digital media allows innovative approaches for identifying cases of dementia through computerized searches within the clinical databases that include systems for coding diagnoses. The aim of this study was to analyze the validity of a dementia registry in Gipuzkoa based on the administrative and clinical databases existing in the Basque Health Service. This is a descriptive study based on the evaluation of available data sources. First, through review of medical records, the diagnostic validity was evaluated in 2 samples of cases identified and not identified as dementia. The sensitivity, specificity and positive and negative predictive value of the diagnosis of dementia were measured. Subsequently, the cases of living dementia in December 31, 2016 were searched in the entire Gipuzkoa population to collect sociodemographic and clinical variables. The validation samples included 986 cases and 327 no cases. The calculated sensitivity was 80.2% and the specificity was 99.9%. The negative predictive value was 99.4% and positive value was 95.1%. The cases in Gipuzkoa were 10,551, representing 65% of the cases predicted according to the literature. Antipsychotic medication were taken by a 40% and a 25% of the cases were institutionalized. A registry of dementias based on clinical and administrative databases is valid and feasible. Its main contribution is to show the dimension of dementia in the health system. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Rationale and design of a multidisciplinary national real-world registry on carotid stenting: the Italian Registry for Carotid Stenting (RISC).

PubMed

Biasi, Giorgio M; Deleo, Gaetano; Froio, Alberto; Cremonesi, Alberto; Inglese, Luigi; Lavitrano, Marialuisa; Setacci, Carlo

2006-04-01

The Registro Italiano per lo Stenting Carotideo (RISC, Italian Registry for Carotid Stenting) has been organized by Italian specialists from different disciplines directly involved in the prevention of stroke due to carotid plaques through stenting of carotid lesions. The Registry has been endorsed by the national societies of 4 different specialties: vascular surgery, interventional cardiology, radiology, and neuroradiology. Each society contributed in the planning stage. The basis for the registry is to collect data on carotid stenting procedures performed by different specialists with different techniques in a "real-world" setting without the limitations of a randomized clinical trial. The Registry was funded to enroll at least 1200 patients over a minimum period of 36 months. The results will be analyzed using the intention-to-treat principle and are anticipated in late 2006. Primary endpoints of the registry are the 30-day combined death and stroke rate and the occurrence of restenosis and ipsilateral neurological deficit at 12 and 24 months. Considerable attention has been paid to the registry's quality control program to ensure scientific validation. An online database facilitates the collection of data with speed and accuracy.

Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.

PubMed

Rimland, Joseph M; Abraha, Iosief; Luchetta, Maria Laura; Cozzolino, Francesco; Orso, Massimiliano; Cherubini, Antonio; Dell'Aquila, Giuseppina; Chiatti, Carlos; Ambrosio, Giuseppe; Montedori, Alessandro

2016-06-01

Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases. CRD42015029204. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Evaluation of the national tuberculosis surveillance program in Haiti

PubMed Central

Salyer, S. J.; Fitter, D. L.; Milo, R.; Blanton, C.; Ho, J. L.; Geffrard, H.; Morose, W.; Marston, B. J.

2015-01-01

OBJECTIVE To assess the quality of tuberculosis (TB) surveillance in Haiti, including whether underreporting from facilities to the national level contributes to low national case registration. METHODS We collected 2010 and 2012 TB case totals, reviewed laboratory registries, and abstracted individual TB case reports from 32 of 263 anti-tuberculosis treatment facilities randomly selected after stratification/weighting toward higher-volume facilities. We compared site results to national databases maintained by a non-governmental organization partner (International Child Care [ICC]) for 2010 and 2012, and the National TB Program (Programme National de Lutte contre la Tuberculose, PNLT) for 2012 only. RESULTS Case registries were available at 30/32 facilities for 2010 and all 32 for 2012. Totals of 3711 (2010) and 4143 (2012) cases were reported at the facilities. Case totals per site were higher in site registries than in the national databases by 361 (9.7%) (ICC 2010), 28 (0.8%) (ICC 2012), and 31 (0.8%) cases (PNLT 2012). Of abstracted individual cases, respectively 11.8% and 6.8% were not recorded in national databases for 2010 (n = 323) and 2012 (n = 351). CONCLUSIONS The evaluation demonstrated an improvement in reporting registered TB cases to the PNLT in Haiti between 2010 and 2012. Further improvement in case notification will require enhanced case detection and diagnosis. PMID:26260822

Process improvement: a multi-registry database abstraction success story.

PubMed

Abrich, Victor; Rokey, Roxann; Devadas, Christopher; Uebel, Julie

2014-01-01

The St. Joseph Hospital/Marshfield Clinic Cardiac Database Registry submits data to the National Cardiovascular Data Registry (NCDR) and to the Society of Thoracic Surgeons (STS) National Database. Delayed chart abstraction is problematic, since hospital policy prohibits patient care clarifications made to the medical record more than 1 month after hospital discharge. This can also lead to late identification of missed care opportunities and untimely notification to providers. Our institution was 3.5 months behind in retrospective postdischarge case abstraction. A process improvement plan was implemented to shorten this delay to 1 month postdischarge. Daily demand of incoming cases and abstraction capacity were determined for 4 employees. Demand was matched to capacity, with the remaining time allocated to reducing backlog. Daily demand of new cases was 17.1 hours. Daily abstraction capacity was 24 hours, assuming 6 hours of effective daily abstraction time per employee, leaving 7 hours per day for backlogged case abstraction. The predicted time to reach abstraction target was 10 weeks. This was accomplished after 10 weeks, as predicted, leading to a 60% reduction of backlogged cases. The delay of postdischarge chart abstraction was successfully shortened from 3.5 months to 1 month. We intend to maintain same-day abstraction efficiency without reaccumulating substantial backlog.

CNS sites cooperate to detect duplicate subjects with a clinical trial subject registry.

PubMed

Shiovitz, Thomas M; Wilcox, Charles S; Gevorgyan, Lilit; Shawkat, Adnan

2013-02-01

To report the results of the first 1,132 subjects in a pilot project where local central nervous system trial sites collaborated in the use of a subject database to identify potential duplicate subjects. Central nervous system sites in Los Angeles and Orange County, California, were contacted by the lead author to seek participation in the project. CTSdatabase, a central nervous system-focused trial subject registry, was utilized to track potential subjects at pre-screen. Subjects signed an institutional review board-approved authorization prior to participation, and site staff entered their identifiers by accessing a website. Sites were prompted to communicate with each other or with the database administrator when a match occurred between a newly entered subject and a subject already in the database. Between October 30, 2011, and August 31, 2012, 1,132 subjects were entered at nine central nervous system sites. Subjects continue to be entered, and more sites are anticipated to begin participation by the time of publication. Initially, there were concerns at a few sites over patient acceptance, financial implications, and/or legal and privacy issues, but these were eventually overcome. Patient acceptance was estimated to be above 95 percent. Duplicate Subjects (those that matched several key identifiers with subjects at different sites) made up 7.78 percent of the sample and Certain Duplicates (matching identifiers with a greater than 1 in 10 million likelihood of occurring by chance in the general population) accounted for 3.45 percent of pre-screens entered into the database. Many of these certain duplicates were not consented for studies because of the information provided by the registry. The use of a clinical trial subject registry and cooperation between central nervous system trial sites can reduce the number of duplicate and professional subjects entering clinical trials. To be fully effective, a trial subject database could be integrated into protocols across pharmaceutical companies, thereby mandating site participation and increasing the likelihood that duplicate subjects will be removed before they enter (and negatively affect) clinical trials.

Astrophysics Source Code Library -- Now even better!

NASA Astrophysics Data System (ADS)

Allen, Alice; Schmidt, Judy; Berriman, Bruce; DuPrie, Kimberly; Hanisch, Robert J.; Mink, Jessica D.; Nemiroff, Robert J.; Shamir, Lior; Shortridge, Keith; Taylor, Mark B.; Teuben, Peter J.; Wallin, John F.

2015-01-01

The Astrophysics Source Code Library (ASCL, ascl.net) is a free online registry of codes used in astronomy research. Indexed by ADS, it now contains nearly 1,000 codes and with recent major changes, is better than ever! The resource has a new infrastructure that offers greater flexibility and functionality for users, including an easier submission process, better browsing, one-click author search, and an RSS feeder for news. The new database structure is easier to maintain and offers new possibilities for collaboration. Come see what we've done!

Ethical aspects of registry-based research in the Nordic countries.

PubMed

Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

2015-01-01

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.

Ethical aspects of registry-based research in the Nordic countries

PubMed Central

Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

2015-01-01

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies. PMID:26648756

Generational differences in the age at diagnosis with Ibd: genetic anticipation, bias, or temporal effects.

PubMed

Faybush, E M; Blanchard, J F; Rawsthorne, P; Bernstein, C N

2002-03-01

Previous cross-sectional research has demonstrated generational differences in age at diagnosis (AAD) in inflammatory bowel disease (IBD). This observation has at times been ascribed to genetic anticipation, but could also be due to biases related to case ascertainment or follow-up or to temporal changes in IBD epidemiology. We aimed to explore this issue using a population-based database. In 1995 we used the comprehensive administrative databases in the province of Manitoba, Canada to establish a population-based IBD Research Registry that includes clinical and demographic information for persons. We contacted those subjects within our Research Registry who reported having any family members with IBD and their family members for verification of diagnosis and AAD. Differences in AAD between familial pairs were calculated. In addition, to assess whether duration of follow-up accounted for generational differences in AAD, we computed the mean AAD for subjects with and without family histories of IBD based on age at the time of interview (i.e., < 45 and > or = 45 yr of age). Of the 2445 persons with IBD in the Research Registry, 548 reported positive family histories, and 315 of these (58%) were reached by telephone. There were 169 Crohn's disease and 146 ulcerative colitis subjects with positive family histories. The mean AADs for the parents, aunts/uncles, and grandparents were significantly greater than the mean AADs for the children, nieces/nephews, and grandchildren, respectively. There was a doubling of the mean AAD when comparing the grandparent/grandchild cases with the parent/child or aunt/uncle-niece/nephew cases. No statistically significant difference in anticipation was observed, whether or not the older generation was male or female or had Crohn's disease or ulcerative colitis. The AAD was substantially greater for those interviewed at > or = 45 yr of age for subjects with and without family histories. However, there was no substantial difference in mean AAD between familial and nonfamilial subjects. The present study has demonstrated that there is a tendency for children to be younger than their parents at the time of diagnosis of familial IBD, and that this difference in mean AAD is almost doubled for grandparent/grandchild pairs. However, we conclude that these differences are most likely due to a bias based on length of follow-up or recent multigenerational temporal changes in the risk of IBD, or both.

Demonstration of SLUMIS: a clinical database and management information system for a multi organ transplant program.

PubMed Central

Kurtz, M.; Bennett, T.; Garvin, P.; Manuel, F.; Williams, M.; Langreder, S.

1991-01-01

Because of the rapid evolution of the heart, heart/lung, liver, kidney and kidney/pancreas transplant programs at our institution, and because of a lack of an existing comprehensive database, we were required to develop a computerized management information system capable of supporting both clinical and research requirements of a multifaceted transplant program. SLUMIS (ST. LOUIS UNIVERSITY MULTI-ORGAN INFORMATION SYSTEM) was developed for the following reasons: 1) to comply with the reporting requirements of various transplant registries, 2) for reporting to an increasing number of government agencies and insurance carriers, 3) to obtain updates of our operative experience at regular intervals, 4) to integrate the Histocompatibility and Immunogenetics Laboratory (HLA) for online test result reporting, and 5) to facilitate clinical investigation. PMID:1807741

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

PubMed Central

Jang, Jae-Sik; Han, Kyoo-Rok; Moon, Keon-Woong; Jeon, Dong Woon; Shin, Dong-Ho; Kim, Jung-Sun; Park, Duk-Woo; Kang, Hyun-Jae; Kim, Juhan; Bae, Jang-Whan; Hur, Seung-Ho; Kim, Byung Ok; Choi, Donghoon; Gwon, Hyeon-Cheol

2017-01-01

Background and Objectives Although several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country. Materials and Methods Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data. Results A total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively. Conclusion These data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research. PMID:28567083

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry.

PubMed

Jang, Jae-Sik; Han, Kyoo-Rok; Moon, Keon-Woong; Jeon, Dong Woon; Shin, Dong-Ho; Kim, Jung-Sun; Park, Duk-Woo; Kang, Hyun-Jae; Kim, Juhan; Bae, Jang-Whan; Hur, Seung-Ho; Kim, Byung Ok; Choi, Donghoon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo

2017-05-01

Although several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country. Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data. A total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively. These data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research.

Cohort profile: the TrueNTH Global Registry - an international registry to monitor and improve localised prostate cancer health outcomes.

PubMed

Evans, Sue M; Millar, Jeremy L; Moore, Caroline M; Lewis, John D; Huland, Hartwig; Sampurno, Fanny; Connor, Sarah E; Villanti, Paul; Litwin, Mark S

2017-11-28

Globally, prostate cancer treatment and outcomes for men vary according to where they live, their race and the care they receive. The TrueNTH Global Registry project was established as an international registry monitoring care provided to men with localised prostate cancer (CaP). Sites with existing CaP databases in Movember fundraising countries were invited to participate in the international registry. In total, 25 Local Data Centres (LDCs) representing 113 participating sites across 13 countries have nominated to contribute to the project. It will collect a dataset based on the International Consortium for Health Outcome Measures (ICHOM) standardised dataset for localised CaP. A governance strategy has been developed to oversee registry operation, including transmission of reversibly anonymised data. LDCs are represented on the Project Steering Committee, reporting to an Executive Committee. A Project Coordination Centre and Data Coordination Centre (DCC) have been established. A project was undertaken to compare existing datasets, understand capacity at project commencement (baseline) to collect the ICHOM dataset and assist in determining the final data dictionary. 21/25 LDCs provided data dictionaries for review. Some ICHOM data fields were well collected (diagnosis, treatment start dates) and others poorly collected (complications, comorbidities). 17/94 (18%) ICHOM data fields were relegated to non-mandatory fields due to poor capture by most existing registries. Participating sites will transmit data through a web interface biannually to the DCC. Recruitment to the TrueNTH Global Registry-PCOR project will commence in late 2017 with sites progressively contributing reversibly anonymised data following ethical review in local regions. Researchers will have capacity to source deidentified data after the establishment phase. Quality indicators are to be established through a modified Delphi approach in later 2017, and it is anticipated that reports on performance against quality indicators will be provided to LDCs. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Improving Cardiac Surgical Site Infection Reporting and Prevention By Using Registry Data for Case Ascertainment.

PubMed

Nayar, Vaidehi; Kennedy, Andrea; Pappas, Janine; Atchley, Krista D; Field, Cynthia; Smathers, Sarah; Teszner, Eva E; Sammons, Julia S; Coffin, Susan E; Gerber, Jeffrey S; Spray, Thomas L; Steven, James M; Bell, Louis M; Forrer, Joan; Gonzalez, Fernando; Chi, Albert; Nieczpiel, William J; Martin, John N; Gaynor, J William

2016-01-01

The use of administrative data for surgical site infection (SSI) surveillance leads to inaccurate reporting of SSI rates [1]. A quality improvement (QI) initiative was conducted linking clinical registry and administrative databases to improve reporting and reduce the incidence of SSI [2]. At our institution, The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) and infection surveillance database (ISD) were linked to the enterprise data warehouse containing electronic health record (EHR) billing data. A data visualization tool was created to (1) use the STS-CHSD for case ascertainment, (2) resolve discrepancies between the databases, and (3) assess impact of QI initiatives, including wound alert reports, bedside reviews, prevention bundles, and billing coder education. Over the 24-month study period, 1,715 surgical cases were ascertained according to the STS-CHSD clinical criteria, with 23 SSIs identified through the STS-CHSD, 20 SSIs identified through the ISD, and 32 SSIs identified through the billing database. The rolling 12-month STS-CHSD SSI rate decreased from 2.73% (21 of 769 as of January 2013) to 1.11% (9 of 813 as of December 2014). Thirty reporting discrepancies were reviewed to ensure accuracy. Workflow changes facilitated communication and improved adjudication of suspected SSIs. Billing coder education increased coding accuracy and narrowed variation between the 3 SSI sources. The data visualization tool demonstrated temporal relationships between QI initiatives and SSI rate reductions. Linkage of registry and infection control surveillance data with the EHR improves SSI surveillance. The visualization tool and workflow changes facilitated communication, SSI adjudication, and assessment of the QI initiatives. Implementation of these initiatives was associated with decreased SSI rates. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Evaluation of algorithms to identify incident cancer cases by using French health administrative databases.

PubMed

Ajrouche, Aya; Estellat, Candice; De Rycke, Yann; Tubach, Florence

2017-08-01

Administrative databases are increasingly being used in cancer observational studies. Identifying incident cancer in these databases is crucial. This study aimed to develop algorithms to estimate cancer incidence by using health administrative databases and to examine the accuracy of the algorithms in terms of national cancer incidence rates estimated from registries. We identified a cohort of 463 033 participants on 1 January 2012 in the Echantillon Généraliste des Bénéficiaires (EGB; a representative sample of the French healthcare insurance system). The EGB contains data on long-term chronic disease (LTD) status, reimbursed outpatient treatments and procedures, and hospitalizations (including discharge diagnoses, and costly medical procedures and drugs). After excluding cases of prevalent cancer, we applied 15 algorithms to estimate the cancer incidence rates separately for men and women in 2012 and compared them to the national cancer incidence rates estimated from French registries by indirect age and sex standardization. The most accurate algorithm for men combined information from LTD status, outpatient anticancer drugs, radiotherapy sessions and primary or related discharge diagnosis of cancer, although it underestimated the cancer incidence (standardized incidence ratio (SIR) 0.85 [0.80-0.90]). For women, the best algorithm used the same definition of the algorithm for men but restricted hospital discharge to only primary or related diagnosis with an additional inpatient procedure or drug reimbursement related to cancer and gave comparable estimates to those from registries (SIR 1.00 [0.94-1.06]). The algorithms proposed could be used for cancer incidence monitoring and for future etiological cancer studies involving French healthcare databases. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Building a Diabetes Registry from the Veterans Health Administration's Computerized Patient Record System

PubMed Central

F. O. Kern, Elizabeth; Beischel, Scott; Stalnaker, Randal; Aron, David C.; Kirsh, Susan R.; Watts, Sharon A.

2008-01-01

Background Little information is available describing how to implement a disease registry from an electronic patient record system. The aim of this report is to describe the technology, methods, and utility of a diabetes registry populated by the Veterans Health Information Systems Architecture (VistA), which underlies the computerized patient record system of the Veterans Health Administration (VHA) in Veteran Affairs Integrated Service Network 10 (VISN 10). Methods VISN 10 data from VistA were mapped to a relational SQL-based data system using KB_SQL software. Operational definitions for diabetes, active clinical management, and responsible providers were used to create views of patient-level data in the diabetes registry. Query Analyzer was used to access the data views directly. Semicustomizable reports were created by linking the diabetes registry to a Web page using Microsoft asp.net2. A retrospective observational study design was used to analyze trends in the process of care and outcomes. Results Since October 2001, 81,227 patients with diabetes have enrolled in VISN 10: approximately 42,000 are currently under active management by VISN 10 providers. By tracking primary care visits, we assigned 91% to a clinic group responsible for diabetes care. In the Cleveland Veterans Affairs Medical Center (VAMC), the frequency of mean annual hemoglobin A1c levels ≥9% has declined significantly over 5 years. Almost 4000 patients have been seen in diabetes intervention programs in the Cleveland VAMC over the past 4 years. Conclusions A diabetes registry can be populated from the database underlying the VHA electronic patient record database system and linked to Web-based and ad hoc queries useful for quality improvement. PMID:19885172

Measuring the effect of improvement in methodological techniques on data collection in the Gharbiah population-based cancer registry in Egypt: Implications for other Low- and Middle-Income Countries.

PubMed

Smith, Brittney L; Ramadan, Mohamed; Corley, Brittany; Hablas, Ahmed; Seifeldein, Ibrahim A; Soliman, Amr S

2015-12-01

The purpose of this study was to describe and quantify procedures and methods that maximized the efficiency of the Gharbiah Cancer Registry (GPCR), the only population-based cancer registry in Egypt. The procedures and measures included a locally-developed software program to translate names from Arabic to English, a new national ID number for demographic and occupational information, and linkage of cancer cases to new electronic mortality records of the Ministry of Health. Data was compiled from the 34,058 cases from the registry for the years 1999-2007. Cases and registry variables about demographic and clinical information were reviewed by year to assess trends associated with each new method or procedure during the study period. The introduction of the name translation software in conjunction with other demographic variables increased the identification of detected duplicates from 23.4% to 78.1%. Use of the national ID increased the proportion of cases with occupation information from 27% to 89%. Records with complete mortality information increased from 18% to 43%. Proportion of cases that came from death certificate only, decreased from 9.8% to 4.7%. Overall, the study revealed that introducing and utilizing local and culture-specific methodological changes, software, and electronic non-cancer databases had a significant impact on data quality and completeness. This study may have translational implications for improving the quality of cancer registries in LMICs considering the emerging advances in electronic databases and utilization of health software and computerization of data. Copyright © 2015 Elsevier Ltd. All rights reserved.

Toxic substances registry system: Index of material safety data sheets

NASA Technical Reports Server (NTRS)

1991-01-01

The Material Safety Data Sheets (MSDSs) listed in this index reflect product inventories and associated MSDSs which have been submitted to the Toxic Substance Registry database maintained by the Base Operations Contractor at the Kennedy Space Center. The purpose of this index is to provide a means to access information on the hazards associated with the toxic and otherwise hazardous chemicals stored and used at the Kennedy Space Center.

[Healthcare services research on pain in Germany. A survey].

PubMed

Häuser, W; Neugebauer, E; Petzke, F

2015-10-01

Within the last ten years healthcare services research has developed into an independent interdisciplinary field of research. A selective search of the literature was conducted in the database Google Scholar and the database on healthcare services research in Germany (http://versorgungsforschung-deutschland.de) for healthcare services research projects on pain in Germany. Healthcare services research projects were conducted by pharmaceutical companies, patient self-help organizations, scientific societies, statutory health insurance companies and university departments on acute and chronic pain. Valid data on the epidemiology, grading and treatment of chronic pain are available. There was an overuse of opioids and invasive procedures in patients with chronic low back pain, fibromyalgia syndrome and somatoform pain disorders. Databases for patients with chronic pain are currently constructed by pain societies. The fragmentation of data from health insurance companies, old age pension insurances, clinical institutions and population surveys and inconsistencies in diagnosing or encoding chronic pain impede the carrying out of significant longitudinal studies. Based on the data available, the needs of care for patients with chronic pain and the necessary care services cannot be derived. Important topics of future healthcare services research on pain are longitudinal studies on the cost efficacy and risks of inpatient and outpatient pain therapy based on routine data of health insurance companies, old age pension insurances and pain registries, longitudinal studies on "patient careers" (i.e. sequences of healthcare) and the identification of potential starting points for control of healthcare.

Immunization registries in the EMR Era

PubMed Central

Stevens, Lindsay A.; Palma, Jonathan P.; Pandher, Kiran K.; Longhurst, Christopher A.

2013-01-01

Background: The CDC established a national objective to create population-based tracking of immunizations through regional and statewide registries nearly 2 decades ago, and these registries have increased coverage rates and reduced duplicate immunizations. With increased adoption of commercial electronic medical records (EMR), some institutions have used unidirectional links to send immunization data to designated registries. However, access to these registries within a vendor EMR has not been previously reported. Purpose: To develop a visually integrated interface between an EMR and a statewide immunization registry at a previously non-reporting hospital, and to assess subsequent changes in provider use and satisfaction. Methods: A group of healthcare providers were surveyed before and after implementation of the new interface. The surveys addressed access of the California Immunization Registry (CAIR), and satisfaction with the availability of immunization information. Information Technology (IT) teams developed a “smart-link” within the electronic patient chart that provides a single-click interface for visual integration of data within the CAIR database. Results: Use of the tool has increased in the months since its initiation, and over 20,000 new immunizations have been exported successfully to CAIR since the hospital began sharing data with the registry. Survey data suggest that providers find this tool improves workflow and overall satisfaction with availability of immunization data. (p=0.009). Conclusions: Visual integration of external registries into a vendor EMR system is feasible and improves provider satisfaction and registry reporting. PMID:23923096

The Era of the Large Databases: Outcomes After Gastroesophageal Surgery According to NSQIP, NIS, and NCDB Databases. Systematic Literature Review.

PubMed

Batista Rodríguez, Gabriela; Balla, Andrea; Fernández-Ananín, Sonia; Balagué, Carmen; Targarona, Eduard M

2018-05-01

The term big data refers to databases that include large amounts of information used in various areas of knowledge. Currently, there are large databases that allow the evaluation of postoperative evolution, such as the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), the Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS), and the National Cancer Database (NCDB). The aim of this review was to evaluate the clinical impact of information obtained from these registries regarding gastroesophageal surgery. A systematic review using the Meta-analysis of Observational Studies in Epidemiology guidelines was performed. The research was carried out using the PubMed database identifying 251 articles. All outcomes related to gastroesophageal surgery were analyzed. A total of 34 articles published between January 2007 and July 2017 were included, for a total of 345 697 patients. Studies were analyzed and divided according to the type of surgery and main theme in (1) esophageal surgery and (2) gastric surgery. The information provided by these databases is an effective way to obtain levels of evidence not obtainable by conventional methods. Furthermore, this information is useful for the external validation of previous studies, to establish benchmarks that allow comparisons between centers and have a positive impact on the quality of care.

Launching Effectiveness Research to Guide Practice in Neurosurgery: A National Institute Neurological Disorders and Stroke Workshop Report

PubMed Central

Walicke, Patricia; Abosch, Aviva; Asher, Anthony; Barker, Fred G.; Ghogawala, Zoher; Harbaugh, Robert; Jehi, Lara; Kestle, John; Koroshetz, Walter; Little, Roderick; Rubin, Donald; Valadka, Alex; Wisniewski, Stephen

2017-01-01

Abstract This workshop addressed challenges of clinical research in neurosurgery. Randomized controlled clinical trials (RCTs) have high internal validity, but often insufficiently generalize to real-world practice. Observational studies are inclusive but often lack sufficient rigor. The workshop considered possible solutions, such as (1) statistical methods for demonstrating causality using observational data; (2) characteristics required of a registry supporting effectiveness research; (3) trial designs combining advantages of observational studies and RCTs; and (4) equipoise, an identified challenge for RCTs. In the future, advances in information technology potentially could lead to creation of a massive database where clinical data from all neurosurgeons are integrated and analyzed, ending the separation of clinical research and practice and leading to a new “science of practice.” PMID:28362926

A review of schizophrenia research in malaysia.

PubMed

Chee, K Y; Salina, A A

2014-08-01

Research in schizophrenia has advanced tremendously. One hundred and seventy five articles related to Schizophrenia were found from a search through a database dedicated to indexing all original data relevant to medicine published in Malaysia between the years 2000-2013. This project aims to examine published research articles, in local and international journals in order to provide a glimpse of the research interest in Malaysia with regards to schizophrenia. Single case study, case series report, reviews and registry reports were not included in this review. Medication trial, unless it concerned a wider scope of psychopharmacology was also excluded from this review. A total of 105 articles were included in this review. Despite numerous genetics studies conducted and published, a definitive conclusion on the aetiology or mechanism underlying schizophrenia remains elusive. The National Mental Health - Schizophrenia Registry (NMHR) proved to be an important platform for many studies and publications. Studies stemmed from NMHR have provided significant insight into the baseline characteristic of patients with schizophrenia, pathway to care, and outcomes of the illness. International and regional collaborations have also encouraged important work involving stigma and discrimination in schizophrenia. Ministry of Health's hospitals (MOH) are the main research sites in the country with regards to schizophrenia research. Numbers of schizophrenia research are still low in relation to the number of universities and hospitals in the country. Some of the weaknesses include duplication of studies, over-emphasising clinical trials and ignoring basic clinical research, and the lack of publications in international and regional journals.

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research.

PubMed

Rider, Lisa G; Dankó, Katalin; Miller, Frederick W

2014-11-01

Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers' collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here, we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways.

Disaster Debris Recovery Database - Recovery

EPA Pesticide Factsheets

The US EPA Region 5 Disaster Debris Recovery Database includes public datasets of over 6,000 composting facilities, demolition contractors, transfer stations, landfills and recycling facilities for construction and demolition materials, electronics, household hazardous waste, metals, tires, and vehicles in the states of Illinois, Indiana, Iowa, Kentucky, Michigan, Minnesota, Missouri, North Dakota, Ohio, Pennsylvania, South Dakota, West Virginia and Wisconsin.In this update, facilities in the 7 states that border the EPA Region 5 states were added to assist interstate disaster debris management. Also, the datasets for composters, construction and demolition recyclers, demolition contractors, and metals recyclers were verified and source information added for each record using these sources: AGC, Biocycle, BMRA, CDRA, ISRI, NDA, USCC, FEMA Debris Removal Contractor Registry, EPA Facility Registry System, and State and local listings.

Disaster Debris Recovery Database - Landfills

EPA Pesticide Factsheets

The US EPA Region 5 Disaster Debris Recovery Database includes public datasets of over 6,000 composting facilities, demolition contractors, transfer stations, landfills and recycling facilities for construction and demolition materials, electronics, household hazardous waste, metals, tires, and vehicles in the states of Illinois, Indiana, Iowa, Kentucky, Michigan, Minnesota, Missouri, North Dakota, Ohio, Pennsylvania, South Dakota, West Virginia and Wisconsin.In this update, facilities in the 7 states that border the EPA Region 5 states were added to assist interstate disaster debris management. Also, the datasets for composters, construction and demolition recyclers, demolition contractors, and metals recyclers were verified and source information added for each record using these sources: AGC, Biocycle, BMRA, CDRA, ISRI, NDA, USCC, FEMA Debris Removal Contractor Registry, EPA Facility Registry System, and State and local listings.

Enhancement and Validation of an Arab Surname Database

PubMed Central

Schwartz, Kendra; Beebani, Ganj; Sedki, Mai; Tahhan, Mamon; Ruterbusch, Julie J.

2015-01-01

Objectives Arab Americans constitute a large, heterogeneous, and quickly growing subpopulation in the United States. Health statistics for this group are difficult to find because US governmental offices do not recognize Arab as separate from white. The development and validation of an Arab- and Chaldean-American name database will enhance research efforts in this population subgroup. Methods A previously validated name database was supplemented with newly identified names gathered primarily from vital statistic records and then evaluated using a multistep process. This process included 1) review by 4 Arabic- and Chaldean-speaking reviewers, 2) ethnicity assessment by social media searches, and 3) self-report of ancestry obtained from a telephone survey. Results Our Arab- and Chaldean-American name algorithm has a positive predictive value of 91% and a negative predictive value of 100%. Conclusions This enhanced name database and algorithm can be used to identify Arab Americans in health statistics data, such as cancer and hospital registries, where they are often coded as white, to determine the extent of health disparities in this population. PMID:24625771

Beyond MEDLINE for literature searches.

PubMed

Conn, Vicki S; Isaramalai, Sang-arun; Rath, Sabyasachi; Jantarakupt, Peeranuch; Wadhawan, Rohini; Dash, Yashodhara

2003-01-01

To describe strategies for a comprehensive literature search. MEDLINE searches result in limited numbers of studies that are often biased toward statistically significant findings. Diversified search strategies are needed. Empirical evidence about the recall and precision of diverse search strategies is presented. Challenges and strengths of each search strategy are identified. Search strategies vary in recall and precision. Often sensitivity and specificity are inversely related. Valuable search strategies include examination of multiple diverse computerized databases, ancestry searches, citation index searches, examination of research registries, journal hand searching, contact with the "invisible college," examination of abstracts, Internet searches, and contact with sources of synthesized information. Extending searches beyond MEDLINE enables researchers to conduct more systematic comprehensive searches.

Facility Registry Service (FRS)

EPA Pesticide Factsheets

This is a centrally managed database that identifies facilities either subject to environmental regulations or of environmental interest, providing an integrated source of air, water, and waste environmental data.

Rationale and design of the extracranial carotid artery aneurysm registry.

PubMed

Welleweerd, J C; Bots, M L; Kappelle, L J; Rinkel, G J; Ruigrok, Y M; Baas, A F; van der Worp, H B; Vergouwen, M D; Bleys, R L; Hendrikse, J; Lo, T H; Moll, F L; de Borst, G J

2015-02-06

Aneurysms of the extracranial carotid artery (ECAA) are rare. Although most ECAA are identified in asymptomatic patients, serious neurological complications may occur. Current literature on treatment outcome contains mainly case reports and small case series with incomplete data and lack of long--term follow--up. There is clear lack on natural follow--up data, and there is no clear treatment algorithm. An international web--based registry to collect data on patients with ECAA is designed to provide clinical guidance on this scarce pathology. The Carotid Aneurysm Registry (CAR) is open for inclusion of all patients with a fusiform or saccular ECAA. Patients with primary or secondary ECAA can be enrolled in CAR independent of the type of treatment (conservative or invasive). CAR participation does not interfere with the local physician's treatment policy. Follow--up and imaging can also be scheduled according to local clinical practice. The primary endpoint of the CAR in conservative patients is occurrence of symptoms related to the aneurysm at 30 days, one, three, and five years. The primary endpoint in invasively treated patients is freedom from symptoms of the aneurysm at 30 days, one, three, and five years. Analyses will relate outcome to etiology, imaging characteristics, ECAA growth patterns, and (if applicable) revascularization technique applied. The aim of the registry is to prospectively collect follow--up data on patients with an ECAA, being either treated conservatively or by invasive aneurysm exclusion strategies. The CAR database will be used to address diagnostic and therapeutic research questions. Collecting and analyzing the data gained from the registry could be the first step towards development of treatment guidelines and expert consensus for the management of ECAA.

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

PubMed

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical preparations. Copyright © 2017 John Wiley & Sons, Ltd.

Searching ClinicalTrials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches?

PubMed

Glanville, Julie M; Duffy, Steven; McCool, Rachael; Varley, Danielle

2014-07-01

Since 2005, International Committee of Medical Journal Editors (ICMJE) member journals have required that clinical trials be registered in publicly available trials registers before they are considered for publication. The research explores whether it is adequate, when searching to inform systematic reviews, to search for relevant clinical trials using only public trials registers and to identify the optimal search approaches in trials registers. A search was conducted in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) for research studies that had been included in eight systematic reviews. Four search approaches (highly sensitive, sensitive, precise, and highly precise) were performed using the basic and advanced interfaces in both resources. On average, 84% of studies were not listed in either resource. The largest number of included studies was retrieved in ClinicalTrials.gov and ICTRP when a sensitive search approach was used in the basic interface. The use of the advanced interface maintained or improved sensitivity in 16 of 19 strategies for Clinicaltrials.gov and 8 of 18 for ICTRP. No single search approach was sensitive enough to identify all studies included in the 6 reviews. Trials registers cannot yet be relied upon as the sole means to locate trials for systematic reviews. Trials registers lag behind the major bibliographic databases in terms of their search interfaces. For systematic reviews, trials registers and major bibliographic databases should be searched. Trials registers should be searched using sensitive approaches, and both the registers consulted in this study should be searched.

Rare disease registries: a call to action.

PubMed

Lacaze, Paul; Millis, Nicole; Fookes, Megan; Zurynski, Yvonne; Jaffe, Adam; Bellgard, Matthew; Winship, Ingrid; McNeil, John; Bittles, Alan H

2017-09-01

When registries collect accurate clinical data over time, they can act as fundamental support structures for patients and their families and powerful cost-effective instruments to support clinical trials and translational research to improve quality of care, quality of life and survival. Registries are critical for rare diseases (RD) with low prevalence and propensity for variation in treatment and outcomes. Rare Voices Australia is leading a call for action to the research and clinical community to prioritise RD data collection and develop an integrated RD Registry strategy for Australia. Financial, operational and governance challenges exist for establishing and maintaining RD registries. As a multidisciplinary team whose interests converge on RD, we highlight the need for the establishment of an Australian RD Registry Alliance. This 'umbrella' organisation will: (i) bring together existing RD registries across Australia; (ii) establish National RD Registry Standards to support interoperability and cohesion across registries; (iii) develop strategies to attract sustainable funding from government and other sources to maximise the utility of existing RD registries and support the development of new RD registries. The most important role for the Alliance would be to use the RD registries for translational research to address current knowledge gaps about RD and to improve the care for the over 1.4 million Australians estimated to live with RD. © 2017 Royal Australasian College of Physicians.

Pregnancy Registries

MedlinePlus

... is compared with women who have not taken medicine during pregnancy. Enrolling in a pregnancy exposure registry can help ... help. Pregnant Women Health Professionals Find a Registry Medicine and Pregnancy More in Women's Health Research OWH Research and ...

The Registry of Knowledge Translation Methods and Tools: a resource to support evidence-informed public health.

PubMed

Peirson, Leslea; Catallo, Cristina; Chera, Sunita

2013-08-01

This paper examines the development of a globally accessible online Registry of Knowledge Translation Methods and Tools to support evidence-informed public health. A search strategy, screening and data extraction tools, and writing template were developed to find, assess, and summarize relevant methods and tools. An interactive website and searchable database were designed to house the registry. Formative evaluation was undertaken to inform refinements. Over 43,000 citations were screened; almost 700 were full-text reviewed, 140 of which were included. By November 2012, 133 summaries were available. Between January 1 and November 30, 2012 over 32,945 visitors from more than 190 countries accessed the registry. Results from 286 surveys and 19 interviews indicated the registry is valued and useful, but would benefit from a more intuitive indexing system and refinements to the summaries. User stories and promotional activities help expand the reach and uptake of knowledge translation methods and tools in public health contexts. The National Collaborating Centre for Methods and Tools' Registry of Methods and Tools is a unique and practical resource for public health decision makers worldwide.

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research

PubMed Central

Rider, Lisa G.; Dankó, Katalin; Miller, Frederick W.

2016-01-01

Purpose of review Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers’ collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. Recent findings We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Summary Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways. PMID:25225838

Review article: Use of renal registry data for research, health-care planning and quality improvement: what can we learn from registry data in the Asia-Pacific region?

PubMed

Lim, Teck-Onn; Goh, Adrian; Lim, Yam-Ngo; Morad, Zaki

2008-12-01

We review renal registry data from the Asia-Pacific region with an emphasis on their uses in health care and in dialysis care in particular. The review aims to demonstrate the information value of registry data. While renal registry provides a useful data resource for epidemiological research, there are severe methodological limitations in its application for analytical or therapeutic research. However, it is the use of renal registry data for public health and health-care management purposes that registry really comes into its own, and it is primarily for these that governments have invested in national patient and disease registries. We apply data from several renal registries in the Asia-Pacific region to illustrate its wide application for planning dialysis services, for evaluating dialysis practices and health outcomes, with a view to improving the quality of dialysis care. In the course of preparing the review, we have found that the quality and accessibility of renal registry data were highly variable across the region. Given the value of renal registry, every country in the Asia-Pacific region should establish one or should ensure that their current registries are better resourced and developed. Greater data sharing and collaboration among registries in the region could help advance the nephrology to serve our patients better.

TMDB: a literature-curated database for small molecular compounds found from tea.

PubMed

Yue, Yi; Chu, Gang-Xiu; Liu, Xue-Shi; Tang, Xing; Wang, Wei; Liu, Guang-Jin; Yang, Tao; Ling, Tie-Jun; Wang, Xiao-Gang; Zhang, Zheng-Zhu; Xia, Tao; Wan, Xiao-Chun; Bao, Guan-Hu

2014-09-16

Tea is one of the most consumed beverages worldwide. The healthy effects of tea are attributed to a wealthy of different chemical components from tea. Thousands of studies on the chemical constituents of tea had been reported. However, data from these individual reports have not been collected into a single database. The lack of a curated database of related information limits research in this field, and thus a cohesive database system should necessarily be constructed for data deposit and further application. The Tea Metabolome database (TMDB), a manually curated and web-accessible database, was developed to provide detailed, searchable descriptions of small molecular compounds found in Camellia spp. esp. in the plant Camellia sinensis and compounds in its manufactured products (different kinds of tea infusion). TMDB is currently the most complete and comprehensive curated collection of tea compounds data in the world. It contains records for more than 1393 constituents found in tea with information gathered from 364 published books, journal articles, and electronic databases. It also contains experimental 1H NMR and 13C NMR data collected from the purified reference compounds or collected from other database resources such as HMDB. TMDB interface allows users to retrieve tea compounds entries by keyword search using compound name, formula, occurrence, and CAS register number. Each entry in the TMDB contains an average of 24 separate data fields including its original plant species, compound structure, formula, molecular weight, name, CAS registry number, compound types, compound uses including healthy benefits, reference literatures, NMR, MS data, and the corresponding ID from databases such as HMDB and Pubmed. Users can also contribute novel regulatory entries by using a web-based submission page. The TMDB database is freely accessible from the URL of http://pcsb.ahau.edu.cn:8080/TCDB/index.jsp. The TMDB is designed to address the broad needs of tea biochemists, natural products chemists, nutritionists, and members of tea related research community. The TMDB database provides a solid platform for collection, standardization, and searching of compounds information found in tea. As such this database will be a comprehensive repository for tea biochemistry and tea health research community.

EPA Facility Registry Service (FRS): TRI

EPA Pesticide Factsheets

This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link to the Toxic Release Inventory (TRI) System. TRI is a publicly available EPA database reported annually by certain covered industry groups, as well as federal facilities. It contains information about more than 650 toxic chemicals that are being used, manufactured, treated, transported, or released into the environment, and includes information about waste management and pollution prevention activities. FRS identifies and geospatially locates facilities, sites or places subject to environmental regulations or of environmental interest. Using vigorous verification and data management procedures, FRS integrates facility data from EPA's national program systems, other federal agencies, and State and tribal master facility records and provides EPA with a centrally managed, single source of comprehensive and authoritative information on facilities. This data set contains the subset of FRS integrated facilities that link to TRI facilities once the TRI data has been integrated into the FRS database. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs.

Database resources of the National Center for Biotechnology Information.

PubMed

2016-01-04

The National Center for Biotechnology Information (NCBI) provides a large suite of online resources for biological information and data, including the GenBank(®) nucleic acid sequence database and the PubMed database of citations and abstracts for published life science journals. Additional NCBI resources focus on literature (PubMed Central (PMC), Bookshelf and PubReader), health (ClinVar, dbGaP, dbMHC, the Genetic Testing Registry, HIV-1/Human Protein Interaction Database and MedGen), genomes (BioProject, Assembly, Genome, BioSample, dbSNP, dbVar, Epigenomics, the Map Viewer, Nucleotide, Probe, RefSeq, Sequence Read Archive, the Taxonomy Browser and the Trace Archive), genes (Gene, Gene Expression Omnibus (GEO), HomoloGene, PopSet and UniGene), proteins (Protein, the Conserved Domain Database (CDD), COBALT, Conserved Domain Architecture Retrieval Tool (CDART), the Molecular Modeling Database (MMDB) and Protein Clusters) and chemicals (Biosystems and the PubChem suite of small molecule databases). The Entrez system provides search and retrieval operations for most of these databases. Augmenting many of the web applications are custom implementations of the BLAST program optimized to search specialized datasets. All of these resources can be accessed through the NCBI home page at www.ncbi.nlm.nih.gov. Published by Oxford University Press on behalf of Nucleic Acids Research 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Database resources of the National Center for Biotechnology Information.

PubMed

2015-01-01

The National Center for Biotechnology Information (NCBI) provides a large suite of online resources for biological information and data, including the GenBank(®) nucleic acid sequence database and the PubMed database of citations and abstracts for published life science journals. Additional NCBI resources focus on literature (Bookshelf, PubMed Central (PMC) and PubReader); medical genetics (ClinVar, dbMHC, the Genetic Testing Registry, HIV-1/Human Protein Interaction Database and MedGen); genes and genomics (BioProject, BioSample, dbSNP, dbVar, Epigenomics, Gene, Gene Expression Omnibus (GEO), Genome, HomoloGene, the Map Viewer, Nucleotide, PopSet, Probe, RefSeq, Sequence Read Archive, the Taxonomy Browser, Trace Archive and UniGene); and proteins and chemicals (Biosystems, COBALT, the Conserved Domain Database (CDD), the Conserved Domain Architecture Retrieval Tool (CDART), the Molecular Modeling Database (MMDB), Protein Clusters, Protein and the PubChem suite of small molecule databases). The Entrez system provides search and retrieval operations for many of these databases. Augmenting many of the Web applications are custom implementations of the BLAST program optimized to search specialized data sets. All of these resources can be accessed through the NCBI home page at http://www.ncbi.nlm.nih.gov. Published by Oxford University Press on behalf of Nucleic Acids Research 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

[Real-world data on novel oral anticoagulants: the added value of registries and observational studies. Focus on apixaban].

PubMed

Pelliccia, Francesco; Tanzilli, Gaetano; Schiariti, Michele; Viceconte, Nicola; Greco, Cesare; Gaudio, Carlo

2016-12-01

Anticoagulant therapy has been used with great effect for decades for the prevention of stroke among patients with atrial fibrillation. In recent years, the therapeutic armamentarium has been strengthened considerably, with the addition of anticoagulants acting through novel pathways. The currently available novel agents are apixaban, rivaroxaban and dabigatran. These novel oral anticoagulants (NOACs) were approved for use on the basis of major clinical trials clearly demonstrating improved risk reductions compared to warfarin for stroke and/or major bleeding events. In these studies, apixaban and dabigatran 150 mg each significantly reduced the risk of stroke, while apixaban and dabigatran 110 mg reduced the risk of major bleeding compared to warfarin. Extrapolating the results of the randomized clinical trials on NOACs to all patients is not possible, as the strict design of clinical trials yields information that is directly applicable to a relatively narrow spectrum of patients. To control for confounding variables, randomized studies restrict enrolment to a prespecified set of criteria that do not necessarily reflect the profiles of all those who could potentially benefit from these agents. Research continues using the trial databases, in an attempt to better identify patient subgroups who do or do not benefit from each of the agents. At the European Society of Cardiology (ESC) annual meetings in London in 2015 and in Rome in 2016, there were several presentations and posters providing this type of evidence. Perhaps more important, as real-world experience with these agents grows, we are beginning to obtain meaningful new information about the NOACs in everyday use. This has involved the study of large databases including patients receiving these medications in clinical situations less stringently defined than in the randomized clinical trials. These include purpose-built registries, observational studies, and analyses of healthcare administrative databases. At both ESC meetings in 2015 and 2016, a wealth of information was presented using these types of sources. In many cases, these new data reinforce the key learnings from the randomized clinical trials. The following report provides highlights of registry and other post-marketing data presented at both ESC meetings in 2015 and 2016.

[Ethics guidelines for the creation and use of registries for biomedical research purposes].

PubMed

Abajo Iglesias, Francisco J de; Feito Grande, Lydia; Júdez Gutiérrez, Javier; Martín Arribas, M Concepción; Terracini, Benedetto; Pàmpols Ros, Teresa; Campos Castelló, Jaime; Martín Uranga, Amelia; Abascal Alonso, Moisés; Herrera Carranza, Joaquín; Sánchez Martínez, María José

2008-01-01

The clinical information stored in registries and records of different types is a fundamental tool for biomedical research. Up until just a few years ago, hardly any limitations existed on the creation and use of epidemiological registries or the use of information from pre-existing records for research purposes. This situation has changed substantially due mainly to the growing importance current laws place upon the safeguarding of the privacy and confidentiality of personal data. Although the legal framework is already quite explicit, a certain degree of leeway exists for ethical debate and prudence advice for the purpose of conducting valid, useful research with this information which will also respect the rights of the subjects and the laws in force. These guidelines deal with those aspects which have been considered relevant from an ethical standpoint in the handling of records and registries for research-related purposes, including not only the use but also the creation proper of the registries. A total of twenty-four recommendations are provided, grouped into ten sections: warranting of the creation of registry, organization and definition of responsibilities, scientific validity of the research project, ethical requirements of the collections of anonymous and anonymized data, ethical requirements of the registries including personal data, uses of medical records for research purposes, use of historical records of deceased individuals, contact with the research subjects, notification of results and review by a Research Ethics Committee.

The Rare Diseases Clinical Research Network's organization and approach to observational research and health outcomes research.

PubMed

Krischer, Jeffrey P; Gopal-Srivastava, Rashmi; Groft, Stephen C; Eckstein, David J

2014-08-01

Established in 2003 by the Office of Rare Diseases Research (ORDR), in collaboration with several National Institutes of Health (NIH) Institutes/Centers, the Rare Diseases Clinical Research Network (RDCRN) consists of multiple clinical consortia conducting research in more than 200 rare diseases. The RDCRN supports longitudinal or natural history, pilot, Phase I, II, and III, case-control, cross-sectional, chart review, physician survey, bio-repository, and RDCRN Contact Registry (CR) studies. To date, there have been 24,684 participants enrolled on 120 studies from 446 sites worldwide. An additional 11,533 individuals participate in the CR. Through a central data management and coordinating center (DMCC), the RDCRN's platform for the conduct of observational research encompasses electronic case report forms, federated databases, and an online CR for epidemiological and survey research. An ORDR-governed data repository (through dbGaP, a database for genotype and phenotype information from the National Library of Medicine) has been created. DMCC coordinates with ORDR to register and upload study data to dbGaP for data sharing with the scientific community. The platform provided by the RDCRN DMCC has supported 128 studies, six of which were successfully conducted through the online CR, with 2,352 individuals accrued and a median enrollment time of just 2 months. The RDCRN has built a powerful suite of web-based tools that provide for integration of federated and online database support that can accommodate a large number of rare diseases on a global scale. RDCRN studies have made important advances in the diagnosis and treatment of rare diseases.

Cardiovascular safety of biologic therapies for the treatment of RA.

PubMed

Greenberg, Jeffrey D; Furer, Victoria; Farkouh, Michael E

2011-11-15

Cardiovascular disease represents a major source of extra-articular comorbidity in patients with rheumatoid arthritis (RA). A combination of traditional cardiovascular risk factors and RA-related factors accounts for the excess risk in RA. Among RA-related factors, chronic systemic inflammation has been implicated in the pathogenesis and progression of atherosclerosis. A growing body of evidence--mainly derived from observational databases and registries--suggests that specific RA therapies, including methotrexate and anti-TNF biologic agents, can reduce the risk of future cardiovascular events in patients with RA. The cardiovascular profile of other biologic therapies for the treatment of RA has not been adequately studied, including of investigational drugs that improve systemic inflammation but alter traditional cardiovascular risk factors. In the absence of large clinical trials adequately powered to detect differences in cardiovascular events between biologic drugs in RA, deriving firm conclusions on cardiovascular safety is challenging. Nevertheless, observational research using large registries has emerged as a promising approach to study the cardiovascular risk of emerging RA biologic therapies.

Participation in Clinical Research Registries: A Focus Group Study Examining Views From Patients With Arthritis and Other Chronic Illnesses.

PubMed

Lee, Sara B; Zak, Agnes; Iversen, Maura D; Polletta, Valerie L; Shadick, Nancy A; Solomon, Daniel H

2016-07-01

Patient registries have contributed substantially to progress in clinical research in rheumatic diseases. However, not much is known about how to optimize the patient experience in such registries. We assessed patient views, motivations, and potential barriers towards participation in registry research to better understand how registries can be improved to maximize patient engagement. Focus groups were held with 23 patients (mean ± SD age 59 ± 13 years) from the Boston area and led by a bilingual moderator trained in focus group methodology, using a semistructured moderator guide. Three separate focus groups were conducted to thematic saturation: patients with rheumatoid arthritis (RA) who had registry experience, patients with any chronic illness, and Spanish-speaking patients with RA or osteoarthritis. Patients in the latter 2 groups had no prior registry experience. Focus groups were audiotaped and transcribed. Four researchers independently analyzed transcripts using open data coding to identify themes. A normative group process was used to consolidate and refine themes. Seven major themes were identified, including personalization/convenience of data collection, trust and confidentiality, camaraderie, learning about yourself and your disease, altruism, material motivators, and capturing mental health and other elements of the lived experience. We observed distinct differences in the discussion content of the Spanish-speaking patients compared to the English-speaking patients. This study identified patient attitudes towards registry research among those with and without prior experience in a registry. The results provide insight into strategies for registry design to maximize patient engagement, which can lead to more robust registry data. © 2016, American College of Rheumatology.

A national registry for juvenile dermatomyositis and other paediatric idiopathic inflammatory myopathies: 10 years' experience; the Juvenile Dermatomyositis National (UK and Ireland) Cohort Biomarker Study and Repository for Idiopathic Inflammatory Myopathies

PubMed Central

Martin, Neil; Krol, Petra; Smith, Sally; Murray, Kevin; Pilkington, Clarissa A.; Davidson, Joyce E.

2011-01-01

Objectives. The paediatric idiopathic inflammatory myopathies (IIMs) are a group of rare chronic inflammatory disorders of childhood, affecting muscle, skin and other organs. There is a severe lack of evidence base for current treatment protocols in juvenile myositis. The rarity of these conditions means that multicentre collaboration is vital to facilitate studies of pathogenesis, treatment and disease outcomes. We have established a national registry and repository for childhood IIM, which aims to improve knowledge, facilitate research and clinical trials, and ultimately to improve outcomes for these patients. Methods. A UK-wide network of centres and research group was established to contribute to the study. Standardized patient assessment, data collection forms and sample protocols were agreed. The Biobank includes collection of peripheral blood mononuclear cells, serum, genomic DNA and biopsy material. An independent steering committee was established to oversee the use of data/samples. Centre training was provided for patient assessment, data collection and entry. Results. Ten years after inception, the study has recruited 285 children, of which 258 have JDM or juvenile PM; 86% of the cases have contributed the biological samples. Serial sampling linked directly to the clinical database makes this a highly valuable resource. The study has been a platform for 20 sub-studies and attracted considerable funding support. Assessment of children with myositis in contributing centres has changed through participation in this study. Conclusions. This establishment of a multicentre registry and Biobank has facilitated research and contributed to progress in the management of a complex group of rare muscloskeletal conditions. PMID:20823094

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis.

PubMed

Papachristou, Georgios I; Machicado, Jorge D; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C; Singh, Vikesh K; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O; Triantafyllou, Konstantinos; Barbu, Sorin T; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch; Nawaz, Haq; Park, Walter G; de-Madaria, Enrique; Lee, Peter J; Wu, Bechien U; Greer, Phil J; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

An overview and online registry of microvillus inclusion disease patients and their MYO5B mutations.

PubMed

van der Velde, K Joeri; Dhekne, Herschel S; Swertz, Morris A; Sirigu, Serena; Ropars, Virginie; Vinke, Petra C; Rengaw, Trebor; van den Akker, Peter C; Rings, Edmond H H M; Houdusse, Anne; van Ijzendoorn, Sven C D

2013-12-01

Microvillus inclusion disease (MVID) is one of the most severe congenital intestinal disorders and is characterized by neonatal secretory diarrhea and the inability to absorb nutrients from the intestinal lumen. MVID is associated with patient-, family-, and ancestry-unique mutations in the MYO5B gene, encoding the actin-based motor protein myosin Vb. Here, we review the MYO5B gene and all currently known MYO5B mutations and for the first time methodologically categorize these with regard to functional protein domains and recurrence in MYO7A associated with Usher syndrome and other myosins. We also review animal models for MVID and the latest data on functional studies related to the myosin Vb protein. To congregate existing and future information on MVID geno-/phenotypes and facilitate its quick and easy sharing among clinicians and researchers, we have constructed an online MOLGENIS-based international patient registry (www.MVID-central.org). This easily accessible database currently contains detailed information of 137 MVID patients together with reported clinical/phenotypic details and 41 unique MYO5B mutations, of which several unpublished. The future expansion and prospective nature of this registry is expected to improve disease diagnosis, prognosis, and genetic counseling. © 2013 WILEY PERIODICALS, INC.

[Potential for the survey of quality indicators based on a national emergency department registry : A systematic literature search].

PubMed

Hörster, A C; Kulla, M; Brammen, D; Lefering, R

2018-06-01

Emergency department processes are often key for successful treatment. Therefore, collection of quality indicators is demanded. A basis for the collection is systematic, electronic documentation. The development of paper-based documentation into an electronic and interoperable national emergency registry is-besides the establishment of quality management for emergency departments-a target of the AKTIN project. The objective of this research is identification of internationally applied quality indicators. For the investigation of the current status of quality management in emergency departments based on quality indicators, a systematic literature search of the database PubMed, the Cochrane Library and the internet was performed. Of the 170 internationally applied quality indicators, 25 with at least two references are identified. A total of 10 quality indicators are ascertainable by the data set. An enlargement of the data set will enable the collection of seven further quality indicators. The implementation of data of care behind the emergency processes will provide eight additional quality indicators. This work was able to show that the potential of a national emergency registry for the establishment of quality indicators corresponds with the international systems taken into consideration and could provide a comparable collection of quality indicators.

Database Comparison of the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) and the SRTR U.S. Transplant Registry1,2,3

PubMed Central

Gillespie, BW; Merion, RM; Ortiz-Rios, E; Tong, L; Shaked, A; Brown, RS; Ojo, AO; Hayashi, PH; Berg, CL; Abecassis, MM; Ashworth, AS; Friese, CE; Hong, JC; Trotter, JF; Everhart, JE

2010-01-01

Data submitted by transplant programs to the Organ Procurement and Transplantation Network (OPTN) are used by the Scientific Registry of Transplant Recipients (SRTR) for policy development, performance evaluation, and research. This study compared OPTN/SRTR data with data extracted from medical records by research coordinators from the nine-center A2ALL study. A2ALL data were collected independently of OPTN data submission (48 data elements among 785 liver transplant candidates/recipients; 12 data elements among 386 donors). At least 90% agreement occurred between OPTN/SRTR and A2ALL for 11/29 baseline recipient elements, 4/19 recipient transplant or follow-up elements, and 6/12 donor elements. For the remaining recipient and donor elements, >10% of values were missing in OPTN/SRTR but present in A2ALL, confirming that missing data were largely avoidable. Other than variables required for allocation, the percentage missing varied widely by center. These findings support an expanded focus on data quality control by OPTN/SRTR for a broader variable set than those used for allocation. Center-specific monitoring of missing values could substantially improve the data. PMID:20199501

[Computerization and the importance of information in health system, as in health care resources registry].

PubMed

Troselj, Mario; Fanton, Davor

2005-01-01

The possibilities of creating a health care resources registry and its operating in Croatia as well as the importance of information in health system are described. At the Croatian Institute of Public Health, monitoring of human resources is performed through the national Health Workers Registry. It also covers basic data on all health units, bed capacities of health facilities included. The initiated health care computerization has urged the idea of forming one more database on physical resources, i.e. on registered medical devices and equipment, more complete. Linking these databases on health resources would produce a single Health Care Resources Registry. The concept views Health Care Resources Registry as part of the overall health information system with centralized information on the health system. The planned development of segments of a single health information system is based on the implementation of the accepted international standards and common network services. Network services that are based on verified Internet technologies are used within a safe, reliable and closed health computer network, which makes up the health intranet (WAN--Wide Area Network). The resource registry is a software solution based on the relational database that monitors history, thus permitting the data collected over a longer period to be analyzed. Such a solution assumes the existence of a directory service, which would replace the current independent software for the Health Workers Registry. In the Health Care Resources Registry, the basic data set encompasses data objects and attributes from the directory service. The directory service is compatible with the LDAP protocol (Lightweight Directory Access Protocol), providing services uniformly to the current records on human and physical resources. Through the storage of attributes defined according to the HL7 (Health Level Seven) standard, directory service is accessible to all applications of the health information system. Directory service does not follow the history of attribute changes, and is optimized for a large number of authorizing inquiries. With it, one follows the following objects and attributes: persons, groups of people (patients, physicians, other personnel), roles (right of access and administrator permissions), organizational units, unit locations, devices and services (according to the list of services and procedures). One can add to the Health Care Resource Registry such attributes as are nonessential for inclusion in the directory service, but are of public health value. Authentication, authorization and digital signature are done by means of Smart Cards, which are used as protective elements against access to system functions, and simultaneously as a physical medium for the storage of the official certificate with which documents are signed digitally. As FINA (state financial control agency) has completed a system for certificate issuance and verification, the option of official digital signature is also available as a computer network service. Any changes taking place in the directory service are transferred by XML messages to a separate part of the Registry that reads them and automatically modifies records in the relational database. Because data input and data changes are made in health units, this makes the data updated and directly connected with health working operations. This avoids all one-time data collection campaigns using form filling about the devices and equipment in the future. As it is very difficult to monitor from a central standpoint how accurate and update the information is, it is necessary to delegate the permissions and duties associated with making changes to the directory service. By this organizational setup, the time needed to ensure data quality control is reduced. In the case described, the Health Care Resource Registry becomes an indicator of change, acquiring certain characteristics of an analytical system. An analysis of topical data renders possible proactive action and makes more effective the planning and utilization of available resources. Providing answers on the current data quickly could also be important to solution-seeking in emergencies. The present proposal to establish the Registry is intended to facilitate the future process of planning and striking a balance between investments in human and physical resources. For health expenditure control, having reliable information related to the use and purchase of new medical technology is particularly important. World Health Organization and European Union have also emphasized the need to develop new indicators in this area.

Fostering International Collaboration in Birth Defects Research and Prevention: A Perspective From the International Clearinghouse for Birth Defects Surveillance and Research

PubMed Central

Botto, Lorenzo D.; Robert-Gnansia, Elisabeth; Siffel, Csaba; Harris, John; Borman, Barry; Mastroiacovo, Pierpaolo

2006-01-01

The International Clearing-house for Birth Defects Surveillance and Research, formerly known as International Clearinghouse of Birth Defects Monitoring Systems, consists of 40 registries worldwide that collaborate in monitoring 40 types of birth defects. Clearinghouse activities include the sharing and joint monitoring of birth defect data, epidemiologic and public health research, and capacity building, with the goal of reducing disease and promoting healthy birth outcomes through primary prevention. We discuss 3 of these activities: the collaborative assessment of the potential teratogenicity of first-trimester use of medications (the MADRE project), an example of the intersection of surveillance and research; the international databases of people with orofacial clefts, an example of the evolution from surveillance to outcome research; and the study of genetic polymorphisms, an example of collaboration in public health genetics. PMID:16571708

The Cerebral Palsy Research Registry: Development and Progress Toward National Collaboration in the United States

PubMed Central

Hurley, Donna S.; Sukal-Moulton, Theresa; Msall, Michael E.; Gaebler-Spira, Deborah; Krosschell, Kristin J.; Dewald, Julius P.

2011-01-01

Cerebral palsy is the most common neurodevelopmental motor disability in children. The condition requires medical, educational, social, and rehabilitative resources throughout the life span. Several countries have developed population-based registries that serve the purpose of prospective longitudinal collection of etiologic, demographic, and functional severity. The United States has not created a comprehensive program to develop such a registry. Barriers have been large population size, poor interinstitution collaboration, and decentralized medical and social systems. The Cerebral Palsy Research Registry was created to fill the gap between population and clinical-based cerebral palsy registries and promote research in the field. This is accomplished by connecting persons with cerebral palsy, as well as their families, to a network of regional researchers. This article describes the development of an expandable cerebral palsy research registry, its current status, and the potential it has to affect families and persons with cerebral palsy in the United States and abroad. PMID:21677201

For 481 biomedical open access journals, articles are not searchable in the Directory of Open Access Journals nor in conventional biomedical databases.

PubMed

Liljekvist, Mads Svane; Andresen, Kristoffer; Pommergaard, Hans-Christian; Rosenberg, Jacob

2015-01-01

Background. Open access (OA) journals allows access to research papers free of charge to the reader. Traditionally, biomedical researchers use databases like MEDLINE and EMBASE to discover new advances. However, biomedical OA journals might not fulfill such databases' criteria, hindering dissemination. The Directory of Open Access Journals (DOAJ) is a database exclusively listing OA journals. The aim of this study was to investigate DOAJ's coverage of biomedical OA journals compared with the conventional biomedical databases. Methods. Information on all journals listed in four conventional biomedical databases (MEDLINE, PubMed Central, EMBASE and SCOPUS) and DOAJ were gathered. Journals were included if they were (1) actively publishing, (2) full OA, (3) prospectively indexed in one or more database, and (4) of biomedical subject. Impact factor and journal language were also collected. DOAJ was compared with conventional databases regarding the proportion of journals covered, along with their impact factor and publishing language. The proportion of journals with articles indexed by DOAJ was determined. Results. In total, 3,236 biomedical OA journals were included in the study. Of the included journals, 86.7% were listed in DOAJ. Combined, the conventional biomedical databases listed 75.0% of the journals; 18.7% in MEDLINE; 36.5% in PubMed Central; 51.5% in SCOPUS and 50.6% in EMBASE. Of the journals in DOAJ, 88.7% published in English and 20.6% had received impact factor for 2012 compared with 93.5% and 26.0%, respectively, for journals in the conventional biomedical databases. A subset of 51.1% and 48.5% of the journals in DOAJ had articles indexed from 2012 and 2013, respectively. Of journals exclusively listed in DOAJ, one journal had received an impact factor for 2012, and 59.6% of the journals had no content from 2013 indexed in DOAJ. Conclusions. DOAJ is the most complete registry of biomedical OA journals compared with five conventional biomedical databases. However, DOAJ only indexes articles for half of the biomedical journals listed, making it an incomplete source for biomedical research papers in general.

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

PubMed

Turner, Leigh

2017-09-01

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Use of ClinicalTrials.gov to estimate condition-specific nocebo effects and other factors affecting outcomes of analgesic trials.

PubMed

Cepeda, M Soledad; Lobanov, Victor; Berlin, Jesse A

2013-04-01

ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted worldwide. We sought to answer: what are the characteristics of pain trials; how frequently are these trials stopped and why; what is the magnitude of attrition due to lack of efficacy or adverse events; and whether the withdrawal rates depend on pain syndrome. To facilitate this and subsequent studies, we have developed a system called Sherlock that automatically downloads data from ClinicalTrials.gov into a relational database. We included pain interventional trials. To evaluate attrition, we restricted consideration to prospective randomized, parallel, double-blind, placebo-controlled trials. Of the 82,867 trials, 6% reported results and 5.6% terminated before the planned number of subjects was accrued. Of these early terminations, 38% were due to enrollment difficulties. In the placebo arms, 3.8% of participants withdrew due to lack of efficacy and 4.9% due to adverse events, with proportions differing among pain conditions. Compared with migraine trials, in fibromyalgia trials 5.1% more participants withdrew due to lack of efficacy (95% confidence interval [CI], 2.5-7.8%), and 6.4% more withdrew due to adverse events (95% CI, 4.3-8.6%). Nonsteroidal anti-inflammatory drugs were the treatment class with the lowest adverse events withdrawals. Recruitment challenges account for the largest proportion of noncompleted trials. Attrition rates differ across pain conditions. Migraine studies had the lowest withdrawal rate. Tools like Sherlock facilitate conducting research in the ClinicalTrials.gov registry. ClinicalTrials.gov registry enables researchers to get a snapshot of a specific field and observe changes over time in trial design, including numbers of subjects accrued, and it can inform clinical trial design. We learned that recruitment challenges account for the largest proportion of noncompleted trials, attrition rates differed across pain conditions, and migraine studies had the lowest withdrawal rate. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

Building a Patient-Reported Outcome Metric Database: One Hospital's Experience.

PubMed

Rana, Adam J

2016-06-01

A number of provisions exist within the Patient Protection and Affordable Care Act that focus on improving the delivery of health care in the United States, including quality of care. From a total joint arthroplasty perspective, the issue of quality increasingly refers to quantifying patient-reported outcome metrics (PROMs). This article describes one hospital's experience in building and maintaining an electronic PROM database for a practice of 6 board-certified orthopedic surgeons. The surgeons advocated to and worked with the hospital to contract with a joint registry database company and hire a research assistant. They implemented a standardized process for all surgical patients to fill out patient-reported outcome questionnaires at designated intervals. To date, the group has collected patient-reported outcome metric data for >4500 cases. The data are frequently used in different venues at the hospital including orthopedic quality metric and research meetings. In addition, the results were used to develop an annual outcome report. The annual report is given to patients and primary care providers, and portions of it are being used in discussions with insurance carriers. Building an electronic database to collect PROMs is a group undertaking and requires a physician champion. A considerable amount of work needs to be done up front to make its introduction a success. Once established, a PROM database can provide a significant amount of information and data that can be effectively used in multiple capacities. Copyright © 2016 Elsevier Inc. All rights reserved.

[Retrospective census of cancers between 1994 and 2002 around the municipal solid waste incinerator of Gilly-sur-Isère].

PubMed

Thabuis, A; Schmitt, M; Megas, F; Fabres, B

2007-12-01

The retrospective cancer incidence study carried out around the municipal solid waste incinerator of Gilly-sur-Isère (Savoie, France) was ordered in a context of crisis during its closing in the late 2001. Its purpose was to determine whether or not there was an excessive number of cancers around the incinerator. In the absence of cancer registry in Savoie, this study consisted in counting as exhaustively as possible the cancers that occurred between 1994 and 2002 in the study area, which was exposed to the atmospheric fallouts from the incinerator. Thus, it was planned to compare the observed cancer incidence to the French cancer registries'. This work describes the main difficulties encountered as well as the solutions found during the census of cancer cases; the results of the incidence study are not included. The collection of medical data was carried out thanks to multiple sources of information: pathology and hematology laboratories, hospitals' and clinics' departments of medical information, health insurance funds, liberal practitioners or specialised cancer registries. The collected medical data files were dealt with: looking for the missing addresses, selecting patients from the study area, homogenizing cancers coding, merging files into a single database, analysing available information on each cancer and de-duplicating the database. Most cancers were validated by consulting medical folders so as to exclude the false cases like metastasises of a known primary cancer or recurrences. Two thousand eight hundred and forty-five cancers were initially collected, and 28% of them were excluded because they did not correspond to the case definition (no proof of cancer, diagnosis date before the study period...); the final database was made of 2055 cancer cases. Quality indicators showed that the database could be considered as exhaustive and valid as a registry's. Three types of sources allowed to identify 94% of cases: laboratories, hospitals' departments of medical information and health insurance funds. Using administrative data and consulting medical folders turned out to be necessary considering uncertainties about: the patients' residence at the time of the diagnosis, errors in coding cancers in some databases that were collected and difficulties to identify false cases. This census required very important means.

Next-generation registries: fusion of data for care, and research.

PubMed

Mandl, Kenneth D; Edge, Stephen; Malone, Chad; Marsolo, Keith; Natter, Marc D

2013-01-01

Disease-based registries are a critical tool for electronic data capture of high-quality, gold standard data for clinical research as well as for population management in clinical care. Yet, a legacy of significant operational costs, resource requirements, and poor data liquidity have limited their use. Research registries have engendered more than $3 Billion in HHS investment over the past 17 years. Health delivery systems and Accountable Care Organizations are investing heavily in registries to track care quality and follow-up of patient panels. Despite the investment, regulatory and financial models have often enforced a "single purpose" limitation on each registry, restricting the use of data to a pre-defined set of protocols. The need for cost effective, multi-sourced, and widely shareable registry data sets has never been greater, and requires next-generation platforms to robustly support multi-center studies, comparative effectiveness research, post-marketing surveillance and disease management. This panel explores diverse registry efforts, both academic and commercial, that have been implemented in leading-edge clinical, research, and hybrid use cases. Panelists present their experience in these areas as well as lessons learned, challenges addressed, and near innovations and advances.

Improved characterization of combat injury.

PubMed

Champion, Howard R; Holcomb, John B; Lawnick, Mary M; Kelliher, Timothy; Spott, Mary Ann; Galarneau, Michael R; Jenkins, Donald H; West, Susan A; Dye, Judy; Wade, Charles E; Eastridge, Brian J; Blackbourne, Lorne H; Shair, Ellen Kalin

2010-05-01

Combat injury patterns differ from civilian trauma in that the former are largely explosion-related, comprising multiple mechanistic and fragment injuries and high-kinetic-energy bullets. Further, unlike civilians, U.S. armed forces combatants are usually heavily protected with helmets and Kevlar body armor with ceramic plate inserts. Searchable databases providing actionable, statistically valid knowledge of body surface entry wounds and resulting organ injury severity are essential to understanding combat trauma. Two tools were developed to address these unique aspects of combat injury: (1) the Surface Wound Mapping (SWM) database and Surface Wound Analysis Tool (SWAT) software that were developed to generate 3D density maps of point-of-surface wound entry and resultant anatomic injury severity; and (2) the Abbreviated Injury Scale (AIS) 2005-Military that was developed by a panel of military trauma surgeons to account for multiple injury etiology from explosions and other high-kinetic- energy weapons. Combined data from the Joint Theater Trauma Registry, Navy/Marine Combat Trauma Registry, and the Armed Forces Medical Examiner System Mortality Trauma Registry were coded in AIS 2005-Military, entered into the SWM database, and analyzed for entrance site and wounding path. When data on 1,151 patients, who had a total of 3,500 surface wounds and 12,889 injuries, were entered into SWM, surface wounds averaged 3.0 per casualty and injuries averaged 11.2 per casualty. Of the 3,500 surface wounds, 2,496 (71%) were entrance wounds with 6,631 (51%) associated internal injuries, with 2.2 entrance wounds and 5.8 associated injuries per casualty (some details cannot be given because of operational security). Crude deaths rates were calculated using Maximum AIS-Military. These new tools have been successfully implemented to describe combat injury, mortality, and distribution of wounds and associated injuries. AIS 2005-Military is a more precise assignment of severity to military injuries. SWM has brought data from all three combat registries together into one analyzable database. SWM and SWAT allow visualization of wounds and associated injuries by region on a 3D model of the body.

For 481 biomedical open access journals, articles are not searchable in the Directory of Open Access Journals nor in conventional biomedical databases

PubMed Central

Andresen, Kristoffer; Pommergaard, Hans-Christian; Rosenberg, Jacob

2015-01-01

Background. Open access (OA) journals allows access to research papers free of charge to the reader. Traditionally, biomedical researchers use databases like MEDLINE and EMBASE to discover new advances. However, biomedical OA journals might not fulfill such databases’ criteria, hindering dissemination. The Directory of Open Access Journals (DOAJ) is a database exclusively listing OA journals. The aim of this study was to investigate DOAJ’s coverage of biomedical OA journals compared with the conventional biomedical databases. Methods. Information on all journals listed in four conventional biomedical databases (MEDLINE, PubMed Central, EMBASE and SCOPUS) and DOAJ were gathered. Journals were included if they were (1) actively publishing, (2) full OA, (3) prospectively indexed in one or more database, and (4) of biomedical subject. Impact factor and journal language were also collected. DOAJ was compared with conventional databases regarding the proportion of journals covered, along with their impact factor and publishing language. The proportion of journals with articles indexed by DOAJ was determined. Results. In total, 3,236 biomedical OA journals were included in the study. Of the included journals, 86.7% were listed in DOAJ. Combined, the conventional biomedical databases listed 75.0% of the journals; 18.7% in MEDLINE; 36.5% in PubMed Central; 51.5% in SCOPUS and 50.6% in EMBASE. Of the journals in DOAJ, 88.7% published in English and 20.6% had received impact factor for 2012 compared with 93.5% and 26.0%, respectively, for journals in the conventional biomedical databases. A subset of 51.1% and 48.5% of the journals in DOAJ had articles indexed from 2012 and 2013, respectively. Of journals exclusively listed in DOAJ, one journal had received an impact factor for 2012, and 59.6% of the journals had no content from 2013 indexed in DOAJ. Conclusions. DOAJ is the most complete registry of biomedical OA journals compared with five conventional biomedical databases. However, DOAJ only indexes articles for half of the biomedical journals listed, making it an incomplete source for biomedical research papers in general. PMID:26038727

The Danish Testicular Cancer database.

PubMed

Daugaard, Gedske; Kier, Maria Gry Gundgaard; Bandak, Mikkel; Mortensen, Mette Saksø; Larsson, Heidi; Søgaard, Mette; Toft, Birgitte Groenkaer; Engvad, Birte; Agerbæk, Mads; Holm, Niels Vilstrup; Lauritsen, Jakob

2016-01-01

The nationwide Danish Testicular Cancer database consists of a retrospective research database (DaTeCa database) and a prospective clinical database (Danish Multidisciplinary Cancer Group [DMCG] DaTeCa database). The aim is to improve the quality of care for patients with testicular cancer (TC) in Denmark, that is, by identifying risk factors for relapse, toxicity related to treatment, and focusing on late effects. All Danish male patients with a histologically verified germ cell cancer diagnosis in the Danish Pathology Registry are included in the DaTeCa databases. Data collection has been performed from 1984 to 2007 and from 2013 onward, respectively. The retrospective DaTeCa database contains detailed information with more than 300 variables related to histology, stage, treatment, relapses, pathology, tumor markers, kidney function, lung function, etc. A questionnaire related to late effects has been conducted, which includes questions regarding social relationships, life situation, general health status, family background, diseases, symptoms, use of medication, marital status, psychosocial issues, fertility, and sexuality. TC survivors alive on October 2014 were invited to fill in this questionnaire including 160 validated questions. Collection of questionnaires is still ongoing. A biobank including blood/sputum samples for future genetic analyses has been established. Both samples related to DaTeCa and DMCG DaTeCa database are included. The prospective DMCG DaTeCa database includes variables regarding histology, stage, prognostic group, and treatment. The DMCG DaTeCa database has existed since 2013 and is a young clinical database. It is necessary to extend the data collection in the prospective database in order to answer quality-related questions. Data from the retrospective database will be added to the prospective data. This will result in a large and very comprehensive database for future studies on TC patients.

Computer algorithms in the search for unrelated stem cell donors.

PubMed

Steiner, David

2012-01-01

Hematopoietic stem cell transplantation (HSCT) is a medical procedure in the field of hematology and oncology, most often performed for patients with certain cancers of the blood or bone marrow. A lot of patients have no suitable HLA-matched donor within their family, so physicians must activate a "donor search process" by interacting with national and international donor registries who will search their databases for adult unrelated donors or cord blood units (CBU). Information and communication technologies play a key role in the donor search process in donor registries both nationally and internationaly. One of the major challenges for donor registry computer systems is the development of a reliable search algorithm. This work discusses the top-down design of such algorithms and current practice. Based on our experience with systems used by several stem cell donor registries, we highlight typical pitfalls in the implementation of an algorithm and underlying data structure.

Czech Registry of Monoclonal Gammopathies - Technical Solution, Data Collection and Visualisation.

PubMed

Brozova, L; Schwarz, D; Snabl, I; Kalina, J; Pavlickova, B; Komenda, M; Jarkovský, J; Němec, P; Horinek, D; Stefanikova, Z; Pour, L; Hájek, R; Maisnar, V

2017-01-01

The Registry of Monoclonal Gammopathies (RMG) was established by the Czech Myeloma Group in 2007. RMG is a registry designed for the collection of clinical data concerning diagnosis, treatment, treatment results and survival of patients with monoclonal gammopathies. Data on patients with monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinaemia (WM), multiple myeloma (MM) or primary AL ("amyloid light-chain") amyloidosis are collected in the registry. Nineteen Czech centres and four Slovak centres currently contribute to the registry. The registry currently contains records on more than 5,000 patients with MM, almost 3,000 patients with MGUS, 170 patients with WM and 26 patients with primary AL amyloidosis, i.e. more than 8,000 records on patients with monoclonal gammopathies altogether. This paper describes technology employed for the collection, storage and subsequent online visualisation of data. The CLADE-IS platform is introduced as a new system for the collection and storage of data from the registry. The form structure and functions of the new system are described for all diagnoses in general; these functions facilitate data entry to the registry and minimise the error rate in data. Publicly available online visualisations of data on patients with MGUS, WM, MM or primary AL amyloidosis from all Czech or Slovak centres are introduced, together with authenticated visualisations of data on patients with MM from selected centres. The RMG represents a data basis that makes it possible to monitor the disease course in patients with monoclonal gammopathies on the population level.Key words: Registry of Monoclonal Gammopathies - RMG - registries - monoclonal gammopathies - CLADE-IS - data visualisation - database.

State Trauma Registries as a Resource for Occupational Injury Surveillance and Research

PubMed Central

Bowman, Stephen M.

2016-01-01

Objectives: Work-related traumatic injury is a leading cause of death and disability among US workers. Occupational injury surveillance is necessary for effective prevention planning and assessing progress toward Healthy People 2020 objectives. Our objectives were to (1) describe the Washington State Trauma Registry (WTR) as a resource for occupational injury surveillance and research, (2) compare the WTR with 2 population-based data sources more widely used for these purposes, and (3) compare the number of injuries ascertained by the WTR with other data sources. Methods: We linked WTR records to hospital discharge records in the Comprehensive Hospital Abstract Reporting System for 2009 and to workers’ compensation claims from the Washington State Department of Labor and Industries for 1998 to 2008. We assessed the 3 data sources for overlap, concordance, and case ascertainment. Results: Of 9185 work-related injuries in the WTR, 3380 (37%) did not link to workers’ compensation claims. Use of payer information in hospital discharge records along with the WTR work-relatedness field identified 20% more linked injuries as work related (n = 720) than did use of payer information alone (n = 602). The WTR identified substantial numbers of work-related injuries that were not identified through workers’ compensation or hospital discharge records. Conclusions: Workers’ compensation and hospital discharge databases are important but incomplete data sources for work-related injuries; many work-related injuries are not billed to, reported to, or covered by workers’ compensation. Trauma registries are well positioned to capture severe work-related injuries and should be included in comprehensive injury surveillance efforts. PMID:28123225

The implementation of a national trauma registry in Greece. Methodology and preliminary results.

PubMed

Katsaragakis, Stylianos; Theodoraki, Maria E; Toutouzas, Kostas; Drimousis, Panagiotis G; Larentzakis, Antreas; Stergiopoulos, Spiros; Aggelakis, Christos; Lapidakis, George; Massalis, Ioannis; Theodorou, Dimitrios

2009-12-01

Trauma is a leading cause of death worldwide and a major health problem of the modern society. Trauma systems are considered the gold standard of managing patients with trauma. An integral part of any trauma system is a trauma registry. In Europe, and particularly in Greece, trauma registries and systems are in an embryonic stage. In this study, we present an attempt to record trauma in Greece. The Hellenic Society of Trauma and Emergency Surgery invited all the official representatives of the society throughout the country to participate in the study. In succeeding meetings of the representatives, the reporting form was developed and the inclusion criteria were defined meticulously. Inclusion criteria were defined as patients with trauma requiring admission, transfer to a higher level center, or arrived dead or died in the emergency department of the reporting hospital. All reports were accumulated by the Hellenic Trauma society, imported in an electronic database, and analyzed. Thirty-two hospitals receiving patients with trauma participated in the country, representing 40% of the country's healthcare facilities and serving 40% of the country's population. In 12 months time, (October 2005 to September 2006), 8,862 patients were included in the study. Of them, 66.9% were men and 31.3% were women. The compilation rate of the reporting forms was surprisingly high, considering that the final reporting form included 150 data points and that there were no independent personnel in charge of filling the forms. Trauma registries are feasible even in health care systems where funding of medical research is sparse.

Primary CNS germ cell tumors in Japan and the United States: an analysis of 4 tumor registries

PubMed Central

McCarthy, Bridget J.; Shibui, Soichiro; Kayama, Takamasa; Miyaoka, Etsuo; Narita, Yoshitaka; Murakami, Michiko; Matsuda, Ayako; Matsuda, Tomohiro; Sobue, Tomotaka; Palis, Bryan E.; Dolecek, Therese A.; Kruchko, Carol; Engelhard, Herbert H.; Villano, J. Lee

2012-01-01

Intracranial germ cell tumors (GCTs) are relatively rare. Their incidence has been considered to be higher in East Asia than in the United States. This study estimates the incidence of CNS GCTs in Japan and the United States, investigates gender discrepancies in each country, and describes treatment outcomes. Data on primary CNS GCTs from 4 databases were utilized: population-based malignant incidence data from (1) the Japan Cancer Surveillance Research Group (2004–2006; 14 registries), malignant and nonmalignant incidence data from (2) the Surveillance, Epidemiology, and End Results Program (2004–2008; 17 registries), and hospital-based observed survival data from (3) the Brain Tumor Registry of Japan (1984–2000) and (4) the US National Cancer Data Base (1990–2003). Incidence rates per 100 000 for malignant GCTs were not statistically significantly different between Japan (males = 0.143, females = 0.046) and the United States (males = 0.118, females = 0.030). The malignant incidence-rate ratio was higher for pineal GCTs versus nonpineal (ie, the rest of the brain) GCTs in Japan (11.5:1 vs 1.9:1, respectively) and the United States (16.0:1 vs 1.7:1, respectively). In general, 5-year survival estimates were high: over 75% for all GCTs, and over 81% for germinomas, regardless of the type of treatment in either Japan or the United States. The incidence of primary GCTs is similar between Japan and the United States and has the same gender-based patterns by location. High rates of survival were observed in both countries. PMID:22869621

R2 REGULATED FACILITIES

EPA Science Inventory

The Facility Registry System (FRS) is a centrally managed database that identifies facilities, sites or places subject to environmental regulations or of environmental interest. FRS creates high-quality, accurate, and authoritative facility identification records through rigorous...

The Vietnam Era Twin Registry: a resource for medical research.

PubMed Central

Henderson, W G; Eisen, S; Goldberg, J; True, W R; Barnes, J E; Vitek, M E

1990-01-01

The Vietnam Era Twin Registry consists of 4,774 male-male twin pairs born between 1939 and 1957 with both brothers having served in the United States military during the Vietnam War. The registry was originally developed to provide the best control group for Vietnam-exposed servicemen to study the long-term health consequences of service in Vietnam. Recognizing the potential value of the registry for other areas of medical research, the Department of Veterans Affairs in 1988 opened the registry for use by both VA and non-VA investigators. The existence of centralized VA data bases for deaths and VA hospitalizations will strengthen future followup of the twins. This article describes the characteristics of the registry population and the process for accessing the registry. PMID:2116638

Creation of a pediatric mature B-cell non-Hodgkin lymphoma cohort within the Pediatric Health Information System Database.

PubMed

Citrin, Rebecca; Horowitz, Joseph P; Reilly, Anne F; Li, Yimei; Huang, Yuan-Shung; Getz, Kelly D; Seif, Alix E; Fisher, Brian T; Aplenc, Richard

2017-01-01

Mature B-cell non-Hodgkin lymphoma (B-NHL) constitutes a collection of relatively rare pediatric malignancies. In order to utilize administrative data to perform large-scale epidemiologic studies within this population, a two-step process was used to assemble a 12-year cohort of B-NHL patients treated between 2004 and 2015 within the Pediatric Health Information System database. Patients were identified by ICD-9 codes, and their chemotherapy data were then manually reviewed against standard B-NHL treatment regimens. A total of 1,409 patients were eligible for cohort inclusion. This process was validated at a single center, utilizing both an institutional tumor registry and medical record review as the gold standards. The validation demonstrated appropriate sensitivity (91.5%) and positive predictive value (95.1%) to allow for the future use of this cohort for epidemiologic and comparative effectiveness research.

[Trauma and accident documentation in Germany compared with elsewhere in Europe].

PubMed

Probst, C; Richter, M; Haasper, C; Lefering, R; Otte, D; Oestern, H J; Krettek, C; Hüfner, T

2008-07-01

The role of trauma documentation has grown continuously since the 1970s. Prevention and management of injuries were adapted according to the results of many analyses. Since 1993 there have been two different trauma databases in Germany: the German trauma registry (TR) and the database of the Accident Research Unit (UFO). Modern computer applications improved the data processing. Our study analysed the pros and cons of each system and compared them with those of our European neighbours. We compared the TR and the UFO databases with respect to aims and goals, advantages and disadvantages, and current status. Results were reported as means +/- standard errors of the mean. The level of significance was set at P<0.05. There were differences between the two databases concerning number and types of items, aims and goals, and demographics. The TR documents care for severely injured patients and the clinical course of different types of accidents. The UFO describes traffic accidents, accident conditions, and interrelations. The German and British systems are similar, and the French system shows interesting differences. The German trauma documentation systems focus on different points. Therefore both can be used for substantiated analyses of different hypotheses. Certain intersections of both databases may help to answer very special questions in the future.

The Toxicology Investigators Consortium Case Registry--the 2012 experience.

PubMed

Wiegand, Timothy; Wax, Paul; Smith, Eric; Hart, Katherine; Brent, Jeffrey

2013-12-01

In 2010, the American College of Medical Toxicology (ACMT) established its Case Registry, the Toxicology Investigators Consortium (ToxIC). All cases are entered prospectively and include only suspected and confirmed toxic exposures cared for at the bedside by board-certified or board-eligible medical toxicologists at its participating sites. The primary aims of establishing this Registry include the development of a realtime toxico-surveillance system in order to identify and describe current or evolving trends in poisoning and to develop a research tool in toxicology. ToxIC allows for extraction of data from medical records from multiple sites across a national and international network. All cases seen by medical toxicologists at participating institutions were entered into the database. Information characterizing patients entered in 2012 was tabulated and data from the previous years including 2010 and 2011 were included so that cumulative numbers and trends could be described as well. The current report includes data through December 31st, 2012. During 2012, 38 sites with 68 specific institutions contributed a total of 7,269 cases to the Registry. The total number of cases entered into the Registry at the end of 2012 was 17,681. Emergency departments remained the most common source of consultation in 2012, accounting for 61 % of cases. The most common reason for consultation was for pharmaceutical overdose, which occurred in 52 % of patients including intentional (41 %) and unintentional (11 %) exposures. The most common classes of agents were sedative-hypnotics (1,422 entries in 13 % of cases) non-opioid analgesics (1,295 entries in 12 % of cases), opioids (1,086 entries in 10 % of cases) and antidepressants (1,039 entries in 10 % of cases). N-acetylcysteine (NAC) was the most common antidote administered in 2012, as it was in previous years, followed by the opioid antagonist naloxone, sodium bicarbonate, physostigmine and flumazenil. Anti-crotalid Fab fragments were administered in 109 cases or 82 % of cases in which a snake envenomation occurred. There were 57 deaths reported in the Registry in 2012. The most common associated agent alone or in combination was the non-opioid analgesic acetaminophen, being reported in 10 different cases. Other common agents and agent classes involved in death cases included ethanol, opioids, the anti-diabetic agent metformin, sedatives-hypnotics and cardiovascular agents, in particular amlodipine. There were significant trends identified during 2012. Abuse of over-the-counter medications such as dextromethorphan remains prevalent. Cases involving dextromethorphan continued to be reported at frequencies higher than other commonly abused drugs including many stimulants, phencyclidine, synthetic cannabinoids and designer amphetamines such as bath salts. And, while cases involving synthetic cannabinoids and psychoactive bath salts remained relatively constant from 2011 to 2012 several designer amphetamines and novel psychoactive substances were first reported in the Registry in 2012 including the NBOME compounds or "N-bomb" agents. LSD cases also spiked dramatically in 2012 with an 18-fold increase from 2011 although many of these cases are thought to be ultra-potent designer amphetamines misrepresented as "synthetic" LSD. The 2012 Registry included over 400 Adverse Drug Reactions (ADRs) involving 4 % of all Registry cases with 106 agents causing at least 2 ADRs. Additional data including supportive cares, decontamination, and chelating agent use are also included in the 2012 annual report. The Registry remains a valuable toxico-surveillance and research tool. The ToxIC Registry is a unique tool for identifying and characterizing confirmed cases of significant or potential toxicity or complexity to require bedside care by a medical toxicologist.

Balancing the need for big data and patient data privacy--an IT infrastructure for a decentralized emergency care research database.

PubMed

Ahlbrandt, Janko; Brammen, Dominik; Majeed, Raphael W; Lefering, Rolf; Semler, Sebastian C; Thun, Sylvia; Walcher, Felix; Röhrig, Rainer

2014-01-01

Emergency rooms of hospitals provide care to a lot of patients and have great impact on their outcome, so researching the quality of care seems important. Research using registries has yielded impressive results in other areas of medicine. However centralized data-storage has its pitfalls, especially regarding data privacy. We therefore drafted an IT infrastructure that uses decentralized storage to ensure data privacy, but still enables data transfer between participating hospitals. It implements an independent information broker to ensure anonymity of patients. Still it provides a way for researchers to request data and hospitals to contribute data on an opt-in basis. Although not an entirely new approach, the emphasis on data privacy throughout the design is a novel aspect providing a better balance between the need for big sample sizes and patient privacy.

Differences among Major Taxa in the Extent of Ecological Knowledge across Four Major Ecosystems

PubMed Central

Fisher, Rebecca; Knowlton, Nancy; Brainard, Russell E.; Caley, M. Julian

2011-01-01

Existing knowledge shapes our understanding of ecosystems and is critical for ecosystem-based management of the world's natural resources. Typically this knowledge is biased among taxa, with some taxa far better studied than others, but the extent of this bias is poorly known. In conjunction with the publically available World Registry of Marine Species database (WoRMS) and one of the world's premier electronic scientific literature databases (Web of Science®), a text mining approach is used to examine the distribution of existing ecological knowledge among taxa in coral reef, mangrove, seagrass and kelp bed ecosystems. We found that for each of these ecosystems, most research has been limited to a few groups of organisms. While this bias clearly reflects the perceived importance of some taxa as commercially or ecologically valuable, the relative lack of research of other taxonomic groups highlights the problem that some key taxa and associated ecosystem processes they affect may be poorly understood or completely ignored. The approach outlined here could be applied to any type of ecosystem for analyzing previous research effort and identifying knowledge gaps in order to improve ecosystem-based conservation and management. PMID:22073172

Challenges in translating endpoints from trials to observational cohort studies in oncology

PubMed Central

Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

2016-01-01

Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

The pancreatic surgery registry (StuDoQ|Pancreas) of the German Society for General and Visceral Surgery (DGAV) - presentation and systematic quality evaluation.

PubMed

Wellner, Ulrich F; Klinger, Carsten; Lehmann, Kai; Buhr, Heinz; Neugebauer, Edmund; Keck, Tobias

2017-04-05

Pancreatic resections are among the most complex procedures in visceral surgery. While mortality has decreased substantially over the past decades, morbidity remains high. The volume-outcome correlation in pancreatic surgery is among the strongest in the field of surgery. The German Society for General and Visceral Surgery (DGAV) established a national registry for quality control, risk assessment and outcomes research in pancreatic surgery in Germany (DGAV SuDoQ|Pancreas). Here, we present the aims and scope of the DGAV StuDoQ|Pancreas Registry. A systematic assessment of registry quality is performed based on the recommendations of the German network for outcomes research (DNVF). The registry quality was assessed by consensus criteria of the DNVF in regard to the domains Systematics and Appropriateness, Standardization, Validity of the sampling procedure, Validity of data collection, Validity of statistical analysis and reports, and General demands for registry quality. In summary, DGAV StuDoQ|Pancreas meets most of the criteria of a high-quality clinical registry. The DGAV StuDoQ|Pancreas provides a valuable platform for quality assessment, outcomes research as well as randomized registry trials in pancreatic surgery.

EPA Facility Registry Service (FRS): Facility Interests Dataset - Intranet

EPA Pesticide Factsheets

This web feature service consists of location and facility identification information from EPA's Facility Registry Service (FRS) for all sites that are available in the FRS individual feature layers. The layers comprise the FRS major program databases, including:Assessment Cleanup and Redevelopment Exchange System (ACRES) : brownfields sites ; Air Facility System (AFS) : stationary sources of air pollution ; Air Quality System (AQS) : ambient air pollution data from monitoring stations; Bureau of Indian Affairs (BIA) : schools data on Indian land; Base Realignment and Closure (BRAC) facilities; Clean Air Markets Division Business System (CAMDBS) : market-based air pollution control programs; Comprehensive Environmental Response, Compensation, and Liability Information System (CERCLIS) : hazardous waste sites; Integrated Compliance Information System (ICIS) : integrated enforcement and compliance information; National Compliance Database (NCDB) : Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA); National Pollutant Discharge Elimination System (NPDES) module of ICIS : NPDES surface water permits; Radiation Information Database (RADINFO) : radiation and radioactivity facilities; RACT/BACT/LAER Clearinghouse (RBLC) : best available air pollution technology requirements; Resource Conservation and Recovery Act Information System (RCRAInfo) : tracks generators, transporters, treaters, storers, and disposers of haz

EPA Facility Registry Service (FRS): Facility Interests Dataset - Intranet Download

EPA Pesticide Factsheets

This downloadable data package consists of location and facility identification information from EPA's Facility Registry Service (FRS) for all sites that are available in the FRS individual feature layers. The layers comprise the FRS major program databases, including:Assessment Cleanup and Redevelopment Exchange System (ACRES) : brownfields sites ; Air Facility System (AFS) : stationary sources of air pollution ; Air Quality System (AQS) : ambient air pollution data from monitoring stations; Bureau of Indian Affairs (BIA) : schools data on Indian land; Base Realignment and Closure (BRAC) facilities; Clean Air Markets Division Business System (CAMDBS) : market-based air pollution control programs; Comprehensive Environmental Response, Compensation, and Liability Information System (CERCLIS) : hazardous waste sites; Integrated Compliance Information System (ICIS) : integrated enforcement and compliance information; National Compliance Database (NCDB) : Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA); National Pollutant Discharge Elimination System (NPDES) module of ICIS : NPDES surface water permits; Radiation Information Database (RADINFO) : radiation and radioactivity facilities; RACT/BACT/LAER Clearinghouse (RBLC) : best available air pollution technology requirements; Resource Conservation and Recovery Act Information System (RCRAInfo) : tracks generators, transporters, treaters, storers, and disposers

EPA Facility Registry Service (FRS): Facility Interests Dataset Download

EPA Pesticide Factsheets

This downloadable data package consists of location and facility identification information from EPA's Facility Registry Service (FRS) for all sites that are available in the FRS individual feature layers. The layers comprise the FRS major program databases, including:Assessment Cleanup and Redevelopment Exchange System (ACRES) : brownfields sites ; Air Facility System (AFS) : stationary sources of air pollution ; Air Quality System (AQS) : ambient air pollution data from monitoring stations; Bureau of Indian Affairs (BIA) : schools data on Indian land; Base Realignment and Closure (BRAC) facilities; Clean Air Markets Division Business System (CAMDBS) : market-based air pollution control programs; Comprehensive Environmental Response, Compensation, and Liability Information System (CERCLIS) : hazardous waste sites; Integrated Compliance Information System (ICIS) : integrated enforcement and compliance information; National Compliance Database (NCDB) : Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA); National Pollutant Discharge Elimination System (NPDES) module of ICIS : NPDES surface water permits; Radiation Information Database (RADINFO) : radiation and radioactivity facilities; RACT/BACT/LAER Clearinghouse (RBLC) : best available air pollution technology requirements; Resource Conservation and Recovery Act Information System (RCRAInfo) : tracks generators, transporters, treaters, storers, and disposers

EPA Facility Registry Service (FRS): Facility Interests Dataset

EPA Pesticide Factsheets

This web feature service consists of location and facility identification information from EPA's Facility Registry Service (FRS) for all sites that are available in the FRS individual feature layers. The layers comprise the FRS major program databases, including:Assessment Cleanup and Redevelopment Exchange System (ACRES) : brownfields sites ; Air Facility System (AFS) : stationary sources of air pollution ; Air Quality System (AQS) : ambient air pollution data from monitoring stations; Bureau of Indian Affairs (BIA) : schools data on Indian land; Base Realignment and Closure (BRAC) facilities; Clean Air Markets Division Business System (CAMDBS) : market-based air pollution control programs; Comprehensive Environmental Response, Compensation, and Liability Information System (CERCLIS) : hazardous waste sites; Integrated Compliance Information System (ICIS) : integrated enforcement and compliance information; National Compliance Database (NCDB) : Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA); National Pollutant Discharge Elimination System (NPDES) module of ICIS : NPDES surface water permits; Radiation Information Database (RADINFO) : radiation and radioactivity facilities; RACT/BACT/LAER Clearinghouse (RBLC) : best available air pollution technology requirements; Resource Conservation and Recovery Act Information System (RCRAInfo) : tracks generators, transporters, treaters, storers, and disposers of haz

Acute Toxicity Grade 3 and 4 After Irradiation in Children and Adolescents: Results From the IPPARCA Collaboration

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pixberg, Caroline; Koch, Raphael; Eich, Hans Theodor, E-mail: Hans.Eich@ukmuenster.de

Purpose: In the context of oncologic therapy for children, radiation therapy is frequently indicated. This study identified the frequency of and reasons for the development of high-grade acute toxicity and possible sequelae. Materials and Methods: Irradiated children have been prospectively documented since 2001 in the Registry for the Evaluation of Side Effects After Radiation in Childhood and Adolescence (RiSK) database in Germany and since 2008 in the registry for radiation therapy toxicity (RADTOX) in Sweden. Data were collected using standardized, published forms. Toxicity classification was based on Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer criteria. Results: Asmore » of June 2013, 1500 children have been recruited into the RiSK database and 485 into the RADTOX registry leading to an analysis population of 1359 patients (age range 0-18). A total of 18.9% (n=257) of all investigated patients developed high-grade acute toxicity (grades 3/4). High-grade toxicity of the bone marrow was documented for 63.8% (n=201) of those patients, oral mucositis for 7.6% (n=24), and dermatitis for 7.6% (n=24). Patients with high-grade acute toxicity received concomitant chemotherapy more frequently (56%) than patients with no or lower acute toxicity (31.5%). In multivariate analyses, concomitant chemotherapy, diagnosis of Ewing sarcoma, and total radiation dose showed a statistically noticeable effect (P≤.05) on acute toxicity, whereas age, concomitant chemotherapy, Hodgkin lymphoma, Ewing sarcoma, total radiation dose, and acute toxicity influenced the time until maximal late toxicity. Conclusions: Generally, high-grade acute toxicity after irradiation in children and adolescence occurs in a moderate proportion of patients (18.9%). As anticipated, the probability of acute toxicity appeared to depend on the prescribed dose as well as concomitant chemotherapy. The occurrence of chronic toxicity correlates with the prior acute toxicity grade. Age seems to influence the time until maximal late toxicity but not the development of acute toxicity.« less

Result Publication of Chinese Trials in World Health Organization Primary Registries

PubMed Central

Xuemei, Liu; Youping, Li; Senlin, Yin; Shangqi, Song

2010-01-01

Background Result publication is the key step to improve the transparency of clinical trials. Objective To investigate the result publication rate of Chinese trials registered in World Health Organization (WHO) primary registries. Method We searched 11 WHO primary registries for Chinese trials records. The progress of each trial was analyzed. We searched for the full texts of result publications cited in the registration records. For completed trials without citations, we searched PubMed, Embase, Chinese Biomedical Literature Database (Chinese), China Knowledge Resource Integrated Database, and Chinese Science and Technology Periodicals Database for result publications. The search was conducted on July 14, 2009. We also called the investigators of completed trials to ask about results publication. Results We identified 1294 Chinese trials records (428 in ChiCTR,743 in clinicaltrials.gov,55 in ISRCTN, 21 in ACTRN). A total of 443 trials had been completed. The publication rate of the Chinese trials in WHO primary registries is 35.2%(156/443).The publication rate of Chinese trials in clinicaltrials.gov, ChiCTR, ISRCTN, and ACRTN was 36.5% (53/145), 36.3% (89/245), 26.0%(9/44), and 55.6%(5/9), respectively. The publication rate of trials sponsored by industry(23.8%) was lower than that of sponsored by central and local government(31.7%), hospital(35.1%), and universities (40.7%). The publication rate for randomized trials was higher than that of cohort study and case-control study (33.2% versus 16.7%, 22.2%). The publication rate for interventional studies and observational studies was similar(33.4% versus 33.3%). Conclusion The publication rate of the registered Chinese trials was low, with no significant difference between ChiCTR and clinicaltrials.gov. An effective mechanism is needed to promote publication of results for registered trials in China. PMID:20856888

An Innovative Approach to Improve Completeness of Treatment and Other Key Data Elements in a Population-Based Cancer Registry: A15-Month Data Submission.

PubMed

Hsieh, Mei-Chin; Mumphrey, Brent; Pareti, Lisa; Yi, Yong; Wu, Xiao-Cheng

2017-01-01

BACKGROUND: In order to comply with the Louisiana legislative obligation and meet funding agencies’ requirement of case completeness for 12-month data submission, hospital cancer registries are mandated to submit cancer incidence data to the Louisiana Tumor Registry (LTR) within 6 months of diagnosis. However, enforcing compliance with timely reporting may result in incomplete data on adjuvant treatment received by the LTR. Although additional treatment information can be obtained via retransmission of the North American Association of Central Cancer Registries (NAACCR)–modified abstracts, consolidating multiple NAACCR-modified abstracts for the same case is extremely time consuming. To avoid a huge amount of work while obtaining timely and complete data, the LTR has requested hospital cancer registries resubmit their data 15 months after the close of the diagnosis year. The purpose of this report is to assess the improvement in the completeness of data items related to treatment, staging and site specific factors. METHODS: The LTR requested that hospital cancer registries resubmit 15-month data between April 1, 2016 and April 15, 2016 for cases diagnosed in 2014. Microsoft Visual Studio Visual Basic script was used to link and compare resubmitted data with existing data in the LTR database. Data elements used for matching same patient/tumor were name, Social Security number, date of birth, primary site, laterality, and hospital identifier number. Treatment data items were compared as known vs none/ unknown and known vs known with different code. Matched records with updated information were imported into the LTR database and flagged as modified abstract records for manual consolidation. Nonmatched records were also loaded in the LTR database as potential new cases for further investigation. RESULTS: A total of 25,207 resubmitted NAACCR abstracts were received from 38 hospitals and freestanding radiation centers. About 11.1% had at least 1 update related to treatment and/or other data item; an average of 3.3 updates per updated abstract. The majority of the updates (45.7%) for treatment were changes from none/unknown to known value and 42.6% of the updates were related to radiation treatment fields. In addition, 172 potential new cases were identified. Approximately 10.5% (18 cases) of these new cases were confirmed to be truly missed cases after investigation. CONCLUSION: The 15-month data resubmission is a cost-effective approach to obtaining complete information on treatment and other key data items from reporting facilities and can also be used to identify potential missed cases.

Implementation of Medical Information Exchange System Based on EHR Standard

PubMed Central

Han, Soon Hwa; Kim, Sang Guk; Jeong, Jun Yong; Lee, Bi Na; Choi, Myeong Seon; Kim, Il Kon; Park, Woo Sung; Ha, Kyooseob; Cho, Eunyoung; Kim, Yoon; Bae, Jae Bong

2010-01-01

Objectives To develop effective ways of sharing patients' medical information, we developed a new medical information exchange system (MIES) based on a registry server, which enabled us to exchange different types of data generated by various systems. Methods To assure that patient's medical information can be effectively exchanged under different system environments, we adopted the standardized data transfer methods and terminologies suggested by the Center for Interoperable Electronic Healthcare Record (CIEHR) of Korea in order to guarantee interoperability. Regarding information security, MIES followed the security guidelines suggested by the CIEHR of Korea. This study aimed to develop essential security systems for the implementation of online services, such as encryption of communication, server security, database security, protection against hacking, contents, and network security. Results The registry server managed information exchange as well as the registration information of the clinical document architecture (CDA) documents, and the CDA Transfer Server was used to locate and transmit the proper CDA document from the relevant repository. The CDA viewer showed the CDA documents via connection with the information systems of related hospitals. Conclusions This research chooses transfer items and defines document standards that follow CDA standards, such that exchange of CDA documents between different systems became possible through ebXML. The proposed MIES was designed as an independent central registry server model in order to guarantee the essential security of patients' medical information. PMID:21818447

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis

PubMed Central

Papachristou, Georgios I.; Machicado, Jorge D.; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C.; Singh, Vikesh K.; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A.; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O.; Triantafyllou, Konstantinos; Barbu, Sorin T.; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A.; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch.; Nawaz, Haq; Park, Walter G.; de-Madaria, Enrique; Lee, Peter J.; Wu, Bechien U.; Greer, Phil J.; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

Background We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. Methods The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Results Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. Conclusion APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials. PMID:28042246

Implementation of Medical Information Exchange System Based on EHR Standard.

PubMed

Han, Soon Hwa; Lee, Min Ho; Kim, Sang Guk; Jeong, Jun Yong; Lee, Bi Na; Choi, Myeong Seon; Kim, Il Kon; Park, Woo Sung; Ha, Kyooseob; Cho, Eunyoung; Kim, Yoon; Bae, Jae Bong

2010-12-01

To develop effective ways of sharing patients' medical information, we developed a new medical information exchange system (MIES) based on a registry server, which enabled us to exchange different types of data generated by various systems. To assure that patient's medical information can be effectively exchanged under different system environments, we adopted the standardized data transfer methods and terminologies suggested by the Center for Interoperable Electronic Healthcare Record (CIEHR) of Korea in order to guarantee interoperability. Regarding information security, MIES followed the security guidelines suggested by the CIEHR of Korea. This study aimed to develop essential security systems for the implementation of online services, such as encryption of communication, server security, database security, protection against hacking, contents, and network security. The registry server managed information exchange as well as the registration information of the clinical document architecture (CDA) documents, and the CDA Transfer Server was used to locate and transmit the proper CDA document from the relevant repository. The CDA viewer showed the CDA documents via connection with the information systems of related hospitals. This research chooses transfer items and defines document standards that follow CDA standards, such that exchange of CDA documents between different systems became possible through ebXML. The proposed MIES was designed as an independent central registry server model in order to guarantee the essential security of patients' medical information.

Astrophysics Source Code Library Enhancements

NASA Astrophysics Data System (ADS)

Hanisch, R. J.; Allen, A.; Berriman, G. B.; DuPrie, K.; Mink, J.; Nemiroff, R. J.; Schmidt, J.; Shamir, L.; Shortridge, K.; Taylor, M.; Teuben, P. J.; Wallin, J.

2015-09-01

The Astrophysics Source Code Library (ASCL)1 is a free online registry of codes used in astronomy research; it currently contains over 900 codes and is indexed by ADS. The ASCL has recently moved a new infrastructure into production. The new site provides a true database for the code entries and integrates the WordPress news and information pages and the discussion forum into one site. Previous capabilities are retained and permalinks to ascl.net continue to work. This improvement offers more functionality and flexibility than the previous site, is easier to maintain, and offers new possibilities for collaboration. This paper covers these recent changes to the ASCL.

Stroke/Death Rates Following Carotid Artery Stenting and Carotid Endarterectomy in Contemporary Administrative Dataset Registries: A Systematic Review.

PubMed

Paraskevas, K I; Kalmykov, E L; Naylor, A R

2016-01-01

Randomised trials have reported higher stroke/death rates after carotid artery stenting (CAS) versus carotid endarterectomy (CEA). Despite this, the 2011 American Heart Association (AHA) guidelines expanded CAS indications, partly because of the Carotid Revascularization Endarterectomy versus Stenting Trial, but also because of improving outcomes in industry sponsored CAS Registries. The aim of this systematic review was: (i) to compare stroke/death rates after CAS/CEA in contemporary dataset registries, (ii) to examine whether published stroke/death rates after CAS fall within AHA thresholds, and, (iii) to see if there had been a decline (over time) in procedural risk after CAS/CEA. PubMed/Medline, Embase, and Cochrane databases were systematically searched according to the recommendations of the PRISMA statement from January 1, 2008 until February 23, 2015 for administrative dataset registries reporting outcomes after both CEA and CAS. Twenty-one registries reported outcomes involving more than 1,500,000 procedures. Stroke/death after CAS was significantly higher than after CEA in 11/21 registries (52%) involving "average risk for CEA" asymptomatic patients and in 11/18 registries (61%) involving "average risk for CEA" symptomatic patients. In another five registries, CAS was associated with higher stroke/death rates than CEA for both symptomatic and asymptomatic patients, but formal statistical comparison was not reported. CAS was associated with stroke/death rates that exceeded risk thresholds recommended by the AHA in 9/21 registries (43%) involving "average risk for CEA" asymptomatic patients and in 13/18 registries (72%) involving "average risk for CEA" symptomatic patients. In 5/18 registries (28%), the procedural risk after CAS in "average risk" symptomatic patients exceeded 10%. Data from contemporary administrative dataset registries suggest that stroke/death rates following CAS remain significantly higher than after CEA and often exceed accepted AHA thresholds. There was no evidence of a sustained decline in procedural risk after CAS. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Data Quality in Rare Diseases Registries.

PubMed

Kodra, Yllka; Posada de la Paz, Manuel; Coi, Alessio; Santoro, Michele; Bianchi, Fabrizio; Ahmed, Faisal; Rubinstein, Yaffa R; Weinbach, Jérôme; Taruscio, Domenica

2017-01-01

In the field of rare diseases, registries are considered power tool to develop clinical research, to facilitate the planning of appropriate clinical trials, to improve patient care and healthcare planning. Therefore high quality data of rare diseases registries is considered to be one of the most important element in the establishment and maintenance of a registry. Data quality can be defined as the totality of features and characteristics of data set that bear on its ability to satisfy the needs that result from the intended use of the data. In the context of registries, the 'product' is data, and quality refers to data quality, meaning that the data coming into the registry have been validated, and ready for use for analysis and research. Determining the quality of data is possible through data assessment against a number of dimensions: completeness, validity; coherence and comparability; accessibility; usefulness; timeliness; prevention of duplicate records. Many others factors may influence the quality of a registry: development of standardized Case Report Form and security/safety controls of informatics infrastructure. With the growing number of rare diseases registries being established, there is a need to develop a quality validation process to evaluate the quality of each registry. A clear description of the registry is the first step when assessing data quality or the registry evaluation system. Here we report a template as a guide for helping registry owners to describe their registry.

[Obstacles and facilitators of conducting studies - the perspective of colorectal cancer centers' coordinators].

PubMed

Kowalski, C; Ferencz, J; Benz, S; Post, S; Seufferlein, T; Stinner, B; Penzes, O; Wesselmann, S

2016-05-01

Clinical trials and health services research are crucial pillars for improving patient care. This paper examines factors inhibiting and promoting the study activity and the knowledge and use of trial registries (e. g. DRKS, StudyBox) as an opportunity to learn about existing studies. The coordinators of 274 cancer center sites certified according to the requirements of the German Cancer Society were surveyed using a standardized online questionnaire. Data were analyzed using descriptive and bivariate statistics to identify associations with characteristics of the sites (e. g. patient volume, ownership, teaching status). 176 sites participated in the survey (64.2 %). The central obstacle to study participa-tion from the centers' view is the low number of existing studies. General knowledge of the population about studies was considered low. Trial registries are known to almost all respondents, but are rarely used. The results of the survey suggest that comprehensive measures are needed to sustainably increase the study activity. These include, for example, better information about studies, for example through appropriate databases, and (industry-independent) research funding. One possible way to sensitize patients for studies could be the comprehensive education of the population about the purpose of studies. © Georg Thieme Verlag KG Stuttgart · New York.

National Mesothelioma Virtual Bank: a standard based biospecimen and clinical data resource to enhance translational research.

PubMed

Amin, Waqas; Parwani, Anil V; Schmandt, Linda; Mohanty, Sambit K; Farhat, Ghada; Pople, Andrew K; Winters, Sharon B; Whelan, Nancy B; Schneider, Althea M; Milnes, John T; Valdivieso, Federico A; Feldman, Michael; Pass, Harvey I; Dhir, Rajiv; Melamed, Jonathan; Becich, Michael J

2008-08-13

Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. The National Mesothelioma Virtual Bank architecture is based on three major components: (a) common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards), (b) clinical and epidemiologic data annotation, and (c) data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid (caBIG, see http://cabig.nci.nih.gov). This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational research. Furthermore, it protects patient privacy by disclosing only de-identified datasets to assure that biospecimens can be made accessible to researchers.

[Obligatory vaccination reporting in Saxony-Anhalt. Possibilities and limitations of establishing a computerized vaccination registry].

PubMed

Oppermann, H; Wahl, G; Borrmann, M; Fleischer, J

2009-11-01

Vaccination registries are databases intended to assess and manage complete vaccination data of as many individuals as possible in a population under survey. The task of these registries is to identify low vaccination rates on the individual and population level, to enable systems of reminding individuals, to focus vaccination campaigns and to maximize overall vaccination coverage. Saxony-Anhalt is the only federal state of Germany to have a law that prescribes the reporting of vaccinations. Vaccinations of children up to the age of 7 are reported to the regional public health services. However, as the law provides no regulations as to how the data should be registered and processed, the development of a vaccination registry depends entirely on the initiative and cooperation of the "players in vaccination". The key players in vaccination in Saxony-Anhalt have recently created a Vaccination-Committee, which set out to develop the theoretical standards and a software prototype for the establishment of a computerized vaccination registry. Recent developments in the public health reporting system of Saxony-Anhalt (which strives to modernize its computerized assessment of child and adolescent health) are now opening the possibility to integrate the vaccination registry into the commercially available child health software.

Quality criteria for medical device registries: best practice approaches for improving patient safety - a systematic review of international experiences.

PubMed

Niederländer, Charlotte Susanne; Kriza, Christine; Kolominsky-Rabas, Peter

2017-01-01

As the benefit of medical device registries (MDRs) depends on their content and quality, it is important to ensure that MDRs have a robust and adequate structure to fulfill their objectives. However, no requirements are specified for the design and content of MDRs. The aim of this work is to analyze different MDRs in the field of implants and to give best practice recommendations for quality criteria regarding their design and development. Areas covered: A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified 66 articles describing either a general MDR structure or the development process of specific registries. Extracted information about MDRs served as the basis for recommendations: MDRs should deliver a minimal data set and report information about the geographical area, data collection, numbers of patients enrolled, registry staff, and security and confidentiality of data. Expert commentary: Well-structured registries are a cornerstone of the regulatory process of medical devices and a major tool for decision makers. A future goal is to establish agreed minimal data sets for different devices - overcoming national borders. By establishing clear guidelines, the outcomes as well as registry comparability can be fundamentally improved.

Tools and data services registry: a community effort to document bioinformatics resources

PubMed Central

Ison, Jon; Rapacki, Kristoffer; Ménager, Hervé; Kalaš, Matúš; Rydza, Emil; Chmura, Piotr; Anthon, Christian; Beard, Niall; Berka, Karel; Bolser, Dan; Booth, Tim; Bretaudeau, Anthony; Brezovsky, Jan; Casadio, Rita; Cesareni, Gianni; Coppens, Frederik; Cornell, Michael; Cuccuru, Gianmauro; Davidsen, Kristian; Vedova, Gianluca Della; Dogan, Tunca; Doppelt-Azeroual, Olivia; Emery, Laura; Gasteiger, Elisabeth; Gatter, Thomas; Goldberg, Tatyana; Grosjean, Marie; Grüning, Björn; Helmer-Citterich, Manuela; Ienasescu, Hans; Ioannidis, Vassilios; Jespersen, Martin Closter; Jimenez, Rafael; Juty, Nick; Juvan, Peter; Koch, Maximilian; Laibe, Camille; Li, Jing-Woei; Licata, Luana; Mareuil, Fabien; Mičetić, Ivan; Friborg, Rune Møllegaard; Moretti, Sebastien; Morris, Chris; Möller, Steffen; Nenadic, Aleksandra; Peterson, Hedi; Profiti, Giuseppe; Rice, Peter; Romano, Paolo; Roncaglia, Paola; Saidi, Rabie; Schafferhans, Andrea; Schwämmle, Veit; Smith, Callum; Sperotto, Maria Maddalena; Stockinger, Heinz; Vařeková, Radka Svobodová; Tosatto, Silvio C.E.; de la Torre, Victor; Uva, Paolo; Via, Allegra; Yachdav, Guy; Zambelli, Federico; Vriend, Gert; Rost, Burkhard; Parkinson, Helen; Løngreen, Peter; Brunak, Søren

2016-01-01

Life sciences are yielding huge data sets that underpin scientific discoveries fundamental to improvement in human health, agriculture and the environment. In support of these discoveries, a plethora of databases and tools are deployed, in technically complex and diverse implementations, across a spectrum of scientific disciplines. The corpus of documentation of these resources is fragmented across the Web, with much redundancy, and has lacked a common standard of information. The outcome is that scientists must often struggle to find, understand, compare and use the best resources for the task at hand. Here we present a community-driven curation effort, supported by ELIXIR—the European infrastructure for biological information—that aspires to a comprehensive and consistent registry of information about bioinformatics resources. The sustainable upkeep of this Tools and Data Services Registry is assured by a curation effort driven by and tailored to local needs, and shared amongst a network of engaged partners. As of November 2015, the registry includes 1785 resources, with depositions from 126 individual registrations including 52 institutional providers and 74 individuals. With community support, the registry can become a standard for dissemination of information about bioinformatics resources: we welcome everyone to join us in this common endeavour. The registry is freely available at https://bio.tools. PMID:26538599

EPA Facility Registry Service (FRS): CERCLIS

EPA Pesticide Factsheets

This data provides location and attribute information on Facilities regulated under the Comprehensive Environmental Responsibility Compensation and Liability Information System (CERCLIS) for a intranet web feature service . The data provided in this service are obtained from EPA's Facility Registry Service (FRS). The FRS is an integrated source of comprehensive (air, water, and waste) environmental information about facilities, sites or places. This service connects directly to the FRS database to provide this data as a feature service. FRS creates high-quality, accurate, and authoritative facility identification records through rigorous verification and management procedures that incorporate information from program national systems, state master facility records, data collected from EPA's Central Data Exchange registrations and data management personnel. Additional Information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs.

The International Collaboration for Autism Registry Epidemiology (iCARE): Multinational Registry-Based Investigations of Autism Risk Factors and Trends

ERIC Educational Resources Information Center

Schendel, Diana E.; Bresnahan, Michaeline; Carter, Kim W.; Francis, Richard W.; Gissler, Mika; Grønborg, Therese K.; Gross, Raz; Gunnes, Nina; Hornig, Mady; Hultman, Christina M.; Langridge, Amanda; Lauritsen, Marlene B.; Leonard, Helen; Parner, Erik T.; Reichenberg, Abraham; Sandin, Sven; Sourander, Andre; Stoltenberg, Camilla; Suominen, Auli; Surén, Pål; Susser, Ezra

2013-01-01

The International Collaboration for Autism Registry Epidemiology (iCARE) is the first multinational research consortium (Australia, Denmark, Finland, Israel, Norway, Sweden, USA) to promote research in autism geographical and temporal heterogeneity, phenotype, family and life course patterns, and etiology. iCARE devised solutions to challenges in…

Identifying types and causes of errors in mortality data in a clinical registry using multiple information systems.

PubMed

Koetsier, Antonie; Peek, Niels; de Keizer, Nicolette

2012-01-01

Errors may occur in the registration of in-hospital mortality, making it less reliable as a quality indicator. We assessed the types of errors made in in-hospital mortality registration in the clinical quality registry National Intensive Care Evaluation (NICE) by comparing its mortality data to data from a national insurance claims database. Subsequently, we performed site visits at eleven Intensive Care Units (ICUs) to investigate the number, types and causes of errors made in in-hospital mortality registration. A total of 255 errors were found in the NICE registry. Two different types of software malfunction accounted for almost 80% of the errors. The remaining 20% were five types of manual transcription errors and human failures to record outcome data. Clinical registries should be aware of the possible existence of errors in recorded outcome data and understand their causes. In order to prevent errors, we recommend to thoroughly verify the software that is used in the registration process.

Incidence of esophageal cancer in Sri Lanka: Analysis of cancer registry data and comparison with other South Asian populations.

PubMed

Wickramasinghe, Dakshitha P; Samarasekera, Dharmabandhu N

2017-10-01

The objectives of this study were to report the incidence of Carcinoma of Esophagus (CaE) in Sri Lanka and to compare these values with other cancer registry data of the region and with migrant populations. We compared the data published by the National Cancer Control Program over the last two decades with data from the National Cancer Registry Programme of the Indian Council of Medical Research and Karachi Cancer Registry. SEERstat was used to analyze the surveillance, epidemiology and end results database to analyze data on Indian migrant population. CaE was the fourth most common cancer overall and among females and third most common cancer among males. The incidence of CaE rises with age in both sexes, with a peak in the 70-74 year age group. There was a disproportionately higher number of CaE in the Tamil population (chi-square test, P < 0.00001). The commonest type of CaE in Sri Lanka was squamous cell carcinoma, Not otherwise specified (NOS) (n = 750, 70.5%), followed by adenocarcinoma, NOS (n = 83, 7.8%). India, Pakistan and Sri Lanka have comparable age-adjusted incidence and age distribution of CaE. All migrant populations had lower incidence of CaE than original population or population in their present country. Both cigarette smoking and alcohol consumption are more prevalent in Sri Lankan males than females. The incidence of CaE and its distribution among age groups in Sri Lanka was comparable to other countries of the region. Persons of Tamil ethnicity have a higher risk of developing CaE. © 2016 John Wiley & Sons Australia, Ltd.

The Molecular Registry of Pituitary Adenomas (REMAH): A bet of Spanish Endocrinology for the future of individualized medicine and translational research.

PubMed

Luque, Raúl M; Ibáñez-Costa, Alejandro; Sánchez-Tejada, Laura; Rivero-Cortés, Esther; Robledo, Mercedes; Madrazo-Atutxa, Ainara; Mora, Mireia; Álvarez, Clara V; Lucas-Morante, Tomás; Álvarez-Escolá, Cristina; Fajardo, Carmen; Castaño, Luis; Gaztambide, Sonia; Venegas-Moreno, Eva; Soto-Moreno, Alfonso; Gálvez, María Ángeles; Salvador, Javier; Valassi, Elena; Webb, Susan M; Picó, Antonio; Puig-Domingo, Manel; Gilabert, Montserrat; Bernabéu, Ignacio; Marazuela, Mónica; Leal-Cerro, Alfonso; Castaño, Justo P

2016-01-01

Pituitary adenomas are uncommon, difficult to diagnose tumors whose heterogeneity and low incidence complicate large-scale studies. The Molecular Registry of Pituitary Adenomas (REMAH) was promoted by the Andalusian Society of Endocrinology and Nutrition (SAEN) in 2008 as a cooperative clinical-basic multicenter strategy aimed at improving diagnosis and treatment of pituitary adenomas by combining clinical, pathological, and molecular information. In 2010, the Spanish Society of Endocrinology and Nutrition (SEEN) extended this project to national level and established 6 nodes with common protocols and methods for sample and clinical data collection, molecular analysis, and data recording in a common registry (www.remahnacional.com). The registry combines clinical data with molecular phenotyping of the resected pituitary adenoma using quantitative real-time PCR of expression of 26 genes: Pituitary hormones (GH-PRL-LH-FSH-PRL-ACTH-CGA), receptors (somatostatin, dopamine, GHRH, GnRH, CRH, arginine-vasopressin, ghrelin), other markers (Ki67, PTTG1), and control genes. Until 2015, molecular information has been collected from 704 adenomas, out of 1179 patients registered. This strategy allows for comparative and relational analysis between the molecular profile of the different types of adenoma and the clinical phenotype of patients, which may provide a better understanding of the condition and potentially help in treatment selection. The REMAH is therefore a unique multicenter, interdisciplinary network founded on a shared database that provides a far-reaching translational approach for management of pituitary adenomas, and paves the way for the conduct of combined clinical-basic innovative studies on large patient samples. Copyright © 2016 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

Drug safety analyses in a rheumatoid arthritis registry: application of different approaches regarding timing of exposure and confounder measurement.

PubMed

Solomon, Daniel H; Shadick, Nancy A; Weinblatt, Michael E; Zak, Agnes; Frits, Michelle; Franklin, Jessica M

2017-06-13

Patient registry data serves an increasing role in drug safety and comparative effectiveness research, but registry databases often do not contain confounder information measured at the same time that treatments begin. This study evaluated a set of approaches for estimating confounder values at treatment initiation using actual data from a rheumatoid arthritis (RA) registry to examine the risk of infection associated with different biologic DMARDs (bDMARDs). We examined the risk of infection associated with starting a TNF inhibitor (TNFi) versus any of the other non-TNFi bDMARDs. Different confounder assessment approaches were tested. All approaches were tested in Cox proportional hazard regression models that used a propensity score (PS). The confounder of interest was the disease activity score (DAS28-CRP). The confounder assessment approaches utilized different temporal relationships between the DAS28-CRP measurement and the start of the treatments of interest. We included 219 subjects with RA with 269 initiations of either a TNFi or a different bDMARD or both. Among this group, 305 infections were reported and confirmed through chart review. The hazard ratio (HR) for the risk of infection associated with use of a non-TNFi bDMARD ranged from 1.17 to 3.03 using 13 different approaches; only the approach with the highest HR produced results significantly different than one, but this approach included the fewest subjects and infections. The relative risk of infection for TNFi and other non-TNFi bDMARDs was similar using various approaches regarding which DAS28-CRP score should be used as the baseline measure in adjusted analyses.

Quality of race, Hispanic ethnicity, and immigrant status in population-based cancer registry data: implications for health disparity studies.

PubMed

Clegg, Limin X; Reichman, Marsha E; Hankey, Benjamin F; Miller, Barry A; Lin, Yi D; Johnson, Norman J; Schwartz, Stephen M; Bernstein, Leslie; Chen, Vivien W; Goodman, Marc T; Gomez, Scarlett L; Graff, John J; Lynch, Charles F; Lin, Charles C; Edwards, Brenda K

2007-03-01

Population-based cancer registry data from the Surveillance, Epidemiology, and End Results (SEER) Program at the National Cancer Institute are based on medical records and administrative information. Although SEER data have been used extensively in health disparities research, the quality of information concerning race, Hispanic ethnicity, and immigrant status has not been systematically evaluated. The quality of this information was determined by comparing SEER data with self-reported data among 13,538 cancer patients diagnosed between 1973-2001 in the SEER--National Longitudinal Mortality Study linked database. The overall agreement was excellent on race (kappa = 0.90, 95% CI = 0.88-0.91), moderate to substantial on Hispanic ethnicity (kappa = 0.61, 95% CI = 0.58-0.64), and low on immigrant status (kappa = 0.21. 95% CI = 0.10, 0.23). The effect of these disagreements was that SEER data tended to under-classify patient numbers when compared to self-identifications, except for the non-Hispanic group which was slightly over-classified. These disagreements translated into varying racial-, ethnic-, and immigrant status-specific cancer statistics, depending on whether self-reported or SEER data were used. In particular, the 5-year Kaplan-Meier survival and the median survival time from all causes for American Indians/Alaska Natives were substantially higher when based on self-classification (59% and 140 months, respectively) than when based on SEER classification (44% and 53 months, respectively), although the number of patients is small. These results can serve as a useful guide to researchers contemplating the use of population-based registry data to ascertain disparities in cancer burden. In particular, the study results caution against evaluating health disparities by using birthplace as a measure of immigrant status and race information for American Indians/Alaska Natives.

Chinese Systemic Lupus Erythematosus Treatment and Research Group Registry VI: Effect of Cigarette Smoking on the Clinical Phenotype of Chinese Patients with Systemic Lupus Erythematosus.

PubMed

Xu, Dong; You, Xin; Wang, Zhengang; Zeng, Qingyu; Xu, Jianhua; Jiang, Lindi; Gong, Lu; Wu, Fengqi; Gu, Jieruo; Tao, Yi; Chen, Jinwei; Zhao, Jiuliang; Li, Mengtao; Zhao, Yan; Zeng, Xiaofeng

2015-01-01

Our study aimed to investigate the effect of cigarette smoking on the clinical phenotype of patients registered in the Chinese Systemic Lupus Erythematosus (SLE) Treatment and Research (CSTAR) group registry database, the first online registry of Chinese patients with SLE. A prospective cross-sectional study of Chinese SLE patients was conducted using the CSTAR. Our case-control analysis was performed on age- and gender-matched subjects to explore the potential effect of cigarette smoking on the clinical manifestation of SLE. Smokers comprised 8.9% (65/730) of patients, and the ratio of females/males was 19/46. Thirty-nine patients were current smokers, and 26 were ex-smokers. Data showed significant differences between smokers and nonsmokers in the following areas: nephropathy (58.5% vs. 39.2%; p = 0.003), microscopic hematuria (30.8% vs. 19.1%; p = 0.025), proteinuria (53.8% vs. 34.4%; p = 0.002), and SLE Disease Activity Index(DAI) scores (12.38±8.95 vs. 9.83±6.81; p = 0.028). After adjusting for age and gender, significant differences between smokers and nonsmokers were found with photosensitivity (35.9% vs. 18%; p = 0.006), nephropathy (59.4% vs. 39.8%; p = 0.011), and proteinuria (54.7% vs. 35.2%). Although smokers tended to have greater disease severity compared with nonsmokers (SLEDAI scores: 12.58±8.89 vs.10.5±7.09), the difference was not significant (p = 0.081). Cigarette smoking triggers the development and exacerbation of SLE, especially with respect to renal involvement. Chinese smokers with SLE should be advised to discontinue cigarette use.

76 FR 36896 - Notice of Establishment of a New Plant Protection and Quarantine Stakeholder Registry

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-23

... subscription service and advises current subscribers on how to continue receiving emails on topics of interest... Requirements database. Subscribers may also select how often to receive emails, Really Simple Syndication (RSS...

A basis for translational cancer research on aetiology, pathogenesis and prognosis: Guideline for standardised and population-based linkages of biobanks to cancer registries.

PubMed

Dillner, Joakim

2015-06-01

Population-based cancer research is paramount for controlling cancer. Cancer research is increasingly dependent on access to biospecimens from subjects that have been followed-up for future health outcomes. This is achieved using longitudinal follow-up of cohorts and biobanks using cancer registry linkages. All over the world, more and more large population-based cohorts and advanced biobanking facilities are established. International standardisation and networking in the linkage of cohorts and biobanks to cancer registries is required in order to enable international cancer research and comparability of research results. An international operating procedure and standard minimum dataset for linkages of biobanks, cohorts and cancer registries is proposed. An internationally comparable provision of well characterised study bases for molecular cancer research will be an essential prerequisite for the success of translational medicine. Copyright © 2013 Elsevier Ltd. All rights reserved.

From a paper-based to an electronic registry in physiotherapy.

PubMed

Buyl, Ronald; Nyssen, Marc

2008-01-01

During the past decade the healthcare industry has evolved from paper-based storage of clinical data into the digital era. Electronic healthcare records play a crucial role to meet the growing need for integrated data-storage and data communication. In this context a new law was issued in Belgium on December 7th, 2005, which requires physiotherapists (but also nurses and speech therapists) to keep an electronic version of the registry. This (electronic) registry contains all physiotherapeutic acts, starting from January 1, 2007. Up until that day, a paper version of the registry had to be created every month.This article describes the development of an electronic version of the registry that not only meets all legal constraints, but also enables to verify the traceability and inalterability of the generated documents, by means of SHA-256 codes. One of the major concerns of the process was that the rationale behind the electronic registry would conform well to the common practice of the physiotherapist. Therefore we opted for a periodic recording of a standardized "image" of the controllable data, in the patient database of the software-system, into the XML registry messages. The proposed XSLT schema can also form a basis for the development of tools that can be used by the controlling authorities. Hopefully the electronic registry for physiotherapists will be a first step towards the future development of a fully integrated electronic physiotherapy record.By means of a certification procedure for the software systems, we succeeded in developing a user friendly system that enables end-users that use a quality labeled software package, to automatically produce all the legally necessary documents concerning the registry. Moreover, we hope that this development will be an incentive for non-users to start working in an electronic way.

Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks.

PubMed

Gibson, Elaine; Brazil, Kevin; Coughlin, Michael D; Emerson, Claudia; Fournier, Francois; Schwartz, Lisa; Szala-Meneok, Karen V; Weisbaum, Karen M; Willison, Donald J

2008-11-14

The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Strengthening Renal Registries and ESRD Research in Africa.

PubMed

Davids, M Razeen; Caskey, Fergus J; Young, Taryn; Balbir Singh, Gillian K

2017-05-01

In Africa, the combination of noncommunicable diseases, infectious diseases, exposure to environmental toxins, and acute kidney injury related to trauma and childbirth are driving an epidemic of chronic kidney disease and end-stage renal disease (ESRD). Good registry data can inform the planning of renal services and can be used to argue for better resource allocation, audit the delivery and quality of care, and monitor the impact of interventions. Few African countries have established renal registries and most have failed owing to resource constraints. In this article we briefly review the burden of chronic kidney disease and ESRD in Africa, and then consider the research questions that could be addressed by renal registries. We describe examples of the impact of registry data and summarize the sparse primary literature on country-wide renal replacement therapy in African countries over the past 20 years. Finally, we highlight some initiatives and opportunities for strengthening research on ESRD and renal replacement therapy in Africa. These include the establishment of the African Renal Registry and the availability of new areas for research. We also discuss capacity building, collaboration, open-access publication, and the strengthening of local journals, all measures that may improve the quantity, visibility, and impact of African research outputs. Copyright © 2017 Elsevier Inc. All rights reserved.

Assessment of immunization registry databases as supplemental sources of data to improve ascertainment of vaccination coverage estimates in the national immunization survey.

PubMed

Khare, Meena; Piccinino, Linda; Barker, Lawrence E; Linkins, Robert W

2006-08-01

To evaluate the use of immunization registry data to supplement missing or incomplete vaccination data reported by immunization providers (referred to as "providers" hereafter) in the National Immunization Survey. Cross-sectional, random-digit-dialing, telephone survey to measure vaccination coverage among children aged 19 to 35 months in the United States. Four sites with mature (with >67% of provider participation in the area) immunization registries. Of the 639 children with complete household interviews, interviewers had consent from the respondents for 569 (89.0%) children to contact their providers and for 556 (87.0%) children to contact both providers and registries. Percentages of children up-to-date for vaccines based on data from providers, registries, and both sources combined. According to provider-reported data, weighted estimates of coverage for the recommended childhood vaccine series 4:3:1:3 at the 4 sites were 65.6%, 78.8%, 81.6%, and 77.0%. According to registry data, these coverage rates were consistently lower: 31.7% (P<.05), 65.4%, 71.9%, and 61.8%, respectively. When all unique vaccine doses were combined from both sources, the pooled 4:3:1:3 coverage rates increased to 72.0%, 92.0%, 88.7%, and 80.2%, respectively. The quality and completeness of vaccination histories from the registries were inconsistent and varied by sites. Vaccination coverage estimates were the lowest when only registry-reported data were used and were the highest when provider- and registry-reported histories were combined. Although registries enrolled and matched more children, vaccination histories were missing, incomplete, and inconsistent. The quality and completeness of the registry data must be improved and must be comparable across all states before further consideration may be given to supplement or replace the provider-reported National Immunization Survey data.

Characteristics of medical professional liability claims in patients treated by family medicine physicians.

PubMed

Flannery, Frank T; Parikh, Parul Divya; Oetgen, William J

2010-01-01

This study describes a large database of closed medical professional liability (MPL) claims involving family physicians in the United States. The purpose of this report is to provide information for practicing family physicians that will be useful in improving the quality of care, thereby reducing the incidence of patient injury and the consequent frequency of MPL claims. The Physician Insurers Association of America (PIAA) established a registry of closed MPL claims in 1985. This registry contains data describing 239,756 closed claims in the United States through 2008. The registry is maintained for educational programs that are designed to improve quality of care and reduce patient injury MPL claims. We summarized this closed claims database. Of 239,756 closed claims, 27,556 (11.5%) involved family physicians. Of these 27,556 closed claims, 8797 (31.9%) resulted in a payment, and the average payment was $164,107. In the entire registry, 29.5% of closed claims were paid, and the average payment was $209,156. The most common allegation among family medicine closed claims was diagnostic error, and the most prevalent diagnosis was acute myocardial infarction, which represented 24.1% of closed claims with diagnostic errors. Diagnostic errors related to patients with breast cancer represented the next most common condition, accounting for 21.3% of closed claims with diagnostic errors. MPL issues are common and are important to all practicing family physicians. Knowledge of the details of liability claims should assist practicing family physicians in improving quality of care, reducing patient injury, and reducing the incidence of MPL claims.

Functional requirements regarding medical registries--preliminary results.

PubMed

Oberbichler, Stefan; Hörbst, Alexander

2013-01-01

The term medical registry is used to reference tools and processes to support clinical or epidemiologic research or provide a data basis for decisions regarding health care policies. In spite of this wide range of applications the term registry and the functional requirements which a registry should support are not clearly defined. This work presents preliminary results of a literature review to discover functional requirements which form a registry. To extract these requirements a set of peer reviewed articles was collected. These set of articles was screened by using methods from qualitative research. Up to now most discovered functional requirements focus on data quality (e. g. prevent transcription error by conducting automatic domain checks).

Cohort Profile: The National Academy of Sciences-National Research Council Twin Registry (NAS-NRC Twin Registry)

PubMed Central

Gatz, Margaret; Harris, Jennifer R; Kaprio, Jaakko; McGue, Matt; Smith, Nicholas L; Snieder, Harold; Spiro, Avron; Butler, David A

2015-01-01

The National Academy of Sciences-National Research Council Twin Registry (NAS-NRC Twin Registry) is a comprehensive registry of White male twin pairs born in the USA between 1917 and 1927, both of the twins having served in the military. The purpose was medical research and ultimately improved clinical care. The cohort was assembled in the early 1960s with identification of approximately 16 000 twin pairs, review of service records, a brief mailed questionnaire assessing zygosity, and a health survey largely comparable to questionnaires used at that time with Scandinavian twin registries. Subsequent large-scale data collection occurred in 1974, 1985 and 1998, repeating the health survey and including information on education, employment history and earnings. Self-reported data have been supplemented with mortality, disability and medical data through record linkage. Potential collaborators should access the study website [http://www.iom.edu/Activities/Veterans/TwinsStudy.aspx] or e-mail the Medical Follow-up Agency at [Twins@nas.edu]. Questionnaire data are being prepared for future archiving with the National Archive of Computerized Data on Aging (NACDA) at the Inter-University Consortium for Political and Social Research (ICPSR), University of Michigan, MI. PMID:25183748

The German registry for natural orifice translumenal endoscopic surgery: report of the first 551 patients.

PubMed

Lehmann, Kai S; Ritz, Jörg P; Wibmer, Andreas; Gellert, Klaus; Zornig, Carsten; Burghardt, Jens; Büsing, Martin; Runkel, Norbert; Kohlhaw, Kay; Albrecht, Roland; Kirchner, Tom G; Arlt, Georg; Mall, Julian W; Butters, Michael; Bulian, Dirk R; Bretschneider, Jörgen; Holmer, Christoph; Buhr, Heinz J

2010-08-01

To analyze patient outcome in the first 14 months of the German natural orifice translumenal endoscopic surgery (NOTES) registry (GNR). NOTES is a new surgical concept, which permits scarless intra-abdominal operations through natural orifices, such as the mouth, vagina, rectum, or urethra. The GNR was established as a nationwide outcome database to allow the monitoring and safe introduction of this technique in Germany. The GNR was designed as a voluntary database with online access. All surgeons in Germany who performed NOTES procedures were requested to participate in the registry. The GNR recorded demographical and therapy data as well as data on the postoperative course. A total of 572 target organs were operated in 551 patients. Cholecystectomies accounted for 85.3% of all NOTES procedures. All procedures were performed in female patients using transvaginal hybrid technique. Complications occurred in 3.1% of all patients, conversions to laparoscopy or open surgery in 4.9%. In cholecystectomies, institutional case volume, obesity, and age had substantial effect on conversion rate, operation length, and length of hospital stay, but no effect on complications. Despite the fact that NOTES has just recently been introduced, the technique has already gained considerable clinical application. Transvaginal hybrid NOTES cholecystectomy is a practicable and safe alternative to laparoscopic resection even in obese or older patients.

The Generation Challenge Programme Platform: Semantic Standards and Workbench for Crop Science

PubMed Central

Bruskiewich, Richard; Senger, Martin; Davenport, Guy; Ruiz, Manuel; Rouard, Mathieu; Hazekamp, Tom; Takeya, Masaru; Doi, Koji; Satoh, Kouji; Costa, Marcos; Simon, Reinhard; Balaji, Jayashree; Akintunde, Akinnola; Mauleon, Ramil; Wanchana, Samart; Shah, Trushar; Anacleto, Mylah; Portugal, Arllet; Ulat, Victor Jun; Thongjuea, Supat; Braak, Kyle; Ritter, Sebastian; Dereeper, Alexis; Skofic, Milko; Rojas, Edwin; Martins, Natalia; Pappas, Georgios; Alamban, Ryan; Almodiel, Roque; Barboza, Lord Hendrix; Detras, Jeffrey; Manansala, Kevin; Mendoza, Michael Jonathan; Morales, Jeffrey; Peralta, Barry; Valerio, Rowena; Zhang, Yi; Gregorio, Sergio; Hermocilla, Joseph; Echavez, Michael; Yap, Jan Michael; Farmer, Andrew; Schiltz, Gary; Lee, Jennifer; Casstevens, Terry; Jaiswal, Pankaj; Meintjes, Ayton; Wilkinson, Mark; Good, Benjamin; Wagner, James; Morris, Jane; Marshall, David; Collins, Anthony; Kikuchi, Shoshi; Metz, Thomas; McLaren, Graham; van Hintum, Theo

2008-01-01

The Generation Challenge programme (GCP) is a global crop research consortium directed toward crop improvement through the application of comparative biology and genetic resources characterization to plant breeding. A key consortium research activity is the development of a GCP crop bioinformatics platform to support GCP research. This platform includes the following: (i) shared, public platform-independent domain models, ontology, and data formats to enable interoperability of data and analysis flows within the platform; (ii) web service and registry technologies to identify, share, and integrate information across diverse, globally dispersed data sources, as well as to access high-performance computational (HPC) facilities for computationally intensive, high-throughput analyses of project data; (iii) platform-specific middleware reference implementations of the domain model integrating a suite of public (largely open-access/-source) databases and software tools into a workbench to facilitate biodiversity analysis, comparative analysis of crop genomic data, and plant breeding decision making. PMID:18483570

The CSB Incident Screening Database: description, summary statistics and uses.

PubMed

Gomez, Manuel R; Casper, Susan; Smith, E Allen

2008-11-15

This paper briefly describes the Chemical Incident Screening Database currently used by the CSB to identify and evaluate chemical incidents for possible investigations, and summarizes descriptive statistics from this database that can potentially help to estimate the number, character, and consequences of chemical incidents in the US. The report compares some of the information in the CSB database to roughly similar information available from databases operated by EPA and the Agency for Toxic Substances and Disease Registry (ATSDR), and explores the possible implications of these comparisons with regard to the dimension of the chemical incident problem. Finally, the report explores in a preliminary way whether a system modeled after the existing CSB screening database could be developed to serve as a national surveillance tool for chemical incidents.

Infrastructure resources for clinical research in amyotrophic lateral sclerosis.

PubMed

Sherman, Alexander V; Gubitz, Amelie K; Al-Chalabi, Ammar; Bedlack, Richard; Berry, James; Conwit, Robin; Harris, Brent T; Horton, D Kevin; Kaufmann, Petra; Leitner, Melanie L; Miller, Robert; Shefner, Jeremy; Vonsattel, Jean Paul; Mitsumoto, Hiroshi

2013-05-01

Clinical trial networks, shared clinical databases, and human biospecimen repositories are examples of infrastructure resources aimed at enhancing and expediting clinical and/or patient oriented research to uncover the etiology and pathogenesis of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that leads to the paralysis of voluntary muscles. The current status of such infrastructure resources, as well as opportunities and impediments, were discussed at the second Tarrytown ALS meeting held in September 2011. The discussion focused on resources developed and maintained by ALS clinics and centers in North America and Europe, various clinical trial networks, U.S. government federal agencies including the National Institutes of Health (NIH), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC), and several voluntary disease organizations that support ALS research activities. Key recommendations included 1) the establishment of shared databases among individual ALS clinics to enhance the coordination of resources and data analyses; 2) the expansion of quality-controlled human biospecimen banks; and 3) the adoption of uniform data standards, such as the recently developed Common Data Elements (CDEs) for ALS clinical research. The value of clinical trial networks such as the Northeast ALS (NEALS) Consortium and the Western ALS (WALS) Consortium was recognized, and strategies to further enhance and complement these networks and their research resources were discussed.

The Pediatric Emergency Care Applied Research Network Registry: A Multicenter Electronic Health Record Registry of Pediatric Emergency Care.

PubMed

Deakyne Davies, Sara J; Grundmeier, Robert W; Campos, Diego A; Hayes, Katie L; Bell, Jamie; Alessandrini, Evaline A; Bajaj, Lalit; Chamberlain, James M; Gorelick, Marc H; Enriquez, Rene; Casper, T Charles; Scheid, Beth; Kittick, Marlena; Dean, J Michael; Alpern, Elizabeth R

2018-04-01

 Electronic health record (EHR)-based registries allow for robust data to be derived directly from the patient clinical record and can provide important information about processes of care delivery and patient health outcomes.  A data dictionary, and subsequent data model, were developed describing EHR data sources to include all processes of care within the emergency department (ED). ED visit data were deidentified and XML files were created and submitted to a central data coordinating center for inclusion in the registry. Automated data quality control occurred prior to submission through an application created for this project. Data quality reports were created for manual data quality review.  The Pediatric Emergency Care Applied Research Network (PECARN) Registry, representing four hospital systems and seven EDs, demonstrates that ED data from disparate health systems and EHR vendors can be harmonized for use in a single registry with a common data model. The current PECARN Registry represents data from 2,019,461 pediatric ED visits, 894,503 distinct patients, more than 12.5 million narrative reports, and 12,469,754 laboratory tests and continues to accrue data monthly.  The Registry is a robust harmonized clinical registry that includes data from diverse patients, sites, and EHR vendors derived via data extraction, deidentification, and secure submission to a central data coordinating center. The data provided may be used for benchmarking, clinical quality improvement, and comparative effectiveness research. Schattauer.

Outpatient-shopping behavior and survival rates in newly diagnosed cancer patients.

PubMed

Chiou, Shang-Jyh; Wang, Shiow-Ing; Liu, Chien-Hsiang; Yaung, Chih-Liang

2012-09-01

To evaluate the appropriateness of the definition of outpatient-shopping behavior in Taiwanese patients. Linked study of 3 databases (Taiwan Cancer Registry, National Health Insurance [NHI] claim database, and death registry database). Outpatient shopping behavior was defined as making at least 4 or 5 physician visits to confirm a cancer diagnosis. We analyzed patient-related factors and the 5-year overall survival rate of the outpatient-shopping group compared with a nonshopping group. Using the household registration database and NHI database, we determined the proportion of outpatient shopping, characteristics of patients who did and did not shop for outpatient therapy, time between diagnosis and start of regular treatment, and medical service utilization in the shopping versus the nonshopping group. Patients with higher incomes were significantly more likely to shop for outpatient care. Patients with higher comorbidity scores were 1.4 times more likely to shop for outpatient care than patients with lower scores. Patients diagnosed with more advanced cancer were more likely to shop than those who were not. Patients might be more trusting of cancer diagnoses given at higher-level hospitals. The nonshopping groups had a longer duration of survival over 5 years. Health authorities should consider charging additional fees after a specific outpatient- shopping threshold is reached to reduce this behavior. The government may need to reassess the function of the medical sources network by shrinking it from the original 4 levels to 2 levels, or by enhancing the referral function among different hospital levels.

Constructing a Local Potential Participant Registry to Improve Alzheimer's Disease Clinical Research Recruitment.

PubMed

Grill, Joshua D; Hoang, Dan; Gillen, Daniel L; Cox, Chelsea G; Gombosev, Adrijana; Klein, Kirsten; O'Leary, Steve; Witbracht, Megan; Pierce, Aimee

2018-01-01

Potential participant registries are tools to address the challenge of slow recruitment to clinical research. In particular, registries may aid recruitment to secondary prevention clinical trials for Alzheimer's disease (AD), which enroll cognitively normal older individuals meeting specific genetic or biomarker criteria. Evidence of registry effectiveness is sparse, as is guidance on optimal designs or methods of conduct. We report our experiences of developing a novel local potential participant registry that implemented online enrollment and data collection. In the first year of operation, 957 individuals submitted email addresses to the registry, of whom 592 self-reported demographic, family history, and medical data. In addition, registrants provided information related to their interest and willingness to be contacted about studies. Local earned media and community education were the most effective methods of recruitment into the registry. Seventy-six (26%) of 298 registrants contacted about studies in the first year enrolled in those studies. One hundred twenty-nine registrants were invited to enroll in a preclinical AD trial, of whom 25 (18%) screened and 6 were randomized. These results indicate that registries can aid recruitment and provide needed guidance for investigators initiating new local registries.

Creation of an international registry to support discovery in schwannomatosis.

PubMed

Ostrow, K L; Bergner, A L; Blakeley, J; Evans, D G; Ferner, R; Friedman, J M; Harris, G J; Jordan, J T; Korf, B; Langmead, S; Leschziner, G; Mautner, V; Merker, V L; Papi, L; Plotkin, S R; Slopis, J M; Smith, M J; Stemmer-Rachamimov, A; Yohay, K; Belzberg, A J

2017-02-01

Schwannomatosis is a tumor suppressor syndrome that causes multiple tumors along peripheral nerves. Formal diagnostic criteria were first published in 2005. Variability in clinical presentation and a relative lack of awareness of the syndrome have contributed to difficulty recognizing affected individuals and accurately describing the natural history of the disorder. Many critical questions such as the mutations underlying schwannomatosis, genotype-phenotype correlations, inheritance patterns, pathologic diagnosis of schwannomatosis-associated schwannomas, tumor burden in schwannomatosis, the incidence of malignancy, and the effectiveness of current, or new treatments remain unanswered. A well-curated registry of schwannomatosis patients is needed to facilitate research in field. An international consortium of clinicians and scientists across multiple disciplines with expertise in schwannomatosis was established and charged with the task of designing and populating a schwannomatosis patient registry. The International Schwannomatosis Registry (ISR) was built around key data points that allow confirmation of the diagnosis and identification of potential research subjects to advance research to further the knowledge base for schwannomatosis. A registry with 389 participants enrolled to date has been established. Twenty-three additional subjects are pending review. A formal process has been established for scientific investigators to propose research projects, identify eligible subjects, and seek collaborators from ISR sites. Research collaborations have been created using the information collected by the registry and are currently being conducted. The ISR is a platform from which multiple research endeavors can be launched, facilitating connections between affected individuals interested in participating in research and researchers actively investigating a variety of aspects of schwannomatosis. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Applying openEHR's Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study.

PubMed

Anani, Nadim; Mazya, Michael V; Chen, Rong; Prazeres Moreira, Tiago; Bill, Olivier; Ahmed, Niaz; Wahlgren, Nils; Koch, Sabine

2017-01-10

Interoperability standards intend to standardise health information, clinical practice guidelines intend to standardise care procedures, and patient data registries are vital for monitoring quality of care and for clinical research. This study combines all three: it uses interoperability specifications to model guideline knowledge and applies the result to registry data. We applied the openEHR Guideline Definition Language (GDL) to data from 18,400 European patients in the Safe Implementation of Treatments in Stroke (SITS) registry to retrospectively check their compliance with European recommendations for acute stroke treatment. Comparing compliance rates obtained with GDL to those obtained by conventional statistical data analysis yielded a complete match, suggesting that GDL technology is reliable for guideline compliance checking. The successful application of a standard guideline formalism to a large patient registry dataset is an important step toward widespread implementation of computer-interpretable guidelines in clinical practice and registry-based research. Application of the methodology gave important results on the evolution of stroke care in Europe, important both for quality of care monitoring and clinical research.

Matching study to registry data: maintaining data privacy in a study on family based colorectal cancer.

PubMed

Nasseh, Daniel; Engel, Jutta; Mansmann, Ulrich; Tretter, Werner; Stausberg, Jürgen

2014-01-01

Confidentiality of patient data in the field of medical informatics is an important task. Leaked sensitive information within this data can be adverse to and being abused against a patient. Therefore, when working with medical data, appropriate and secure models which serve as guidelines for different applications are needed. Consequently, this work presents a model for performing a privacy preserving record linkage between study and registry data. The model takes into account seven requirements related to data privacy. Furthermore, this model is exemplified with a study on family based colorectal cancer in Germany. The model is very strict and excludes possible violations towards data privacy protection to a reasonable degree. It should be applicable to similar use cases which are in need of a mapping between medical data of a study and a registry database.

An i2b2-based, generalizable, open source, self-scaling chronic disease registry

PubMed Central

Quan, Justin; Ortiz, David M; Bousvaros, Athos; Ilowite, Norman T; Inman, Christi J; Marsolo, Keith; McMurry, Andrew J; Sandborg, Christy I; Schanberg, Laura E; Wallace, Carol A; Warren, Robert W; Weber, Griffin M; Mandl, Kenneth D

2013-01-01

Objective Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. Materials and methods Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. Results The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. Discussion We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. Conclusions The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases. PMID:22733975

An i2b2-based, generalizable, open source, self-scaling chronic disease registry.

PubMed

Natter, Marc D; Quan, Justin; Ortiz, David M; Bousvaros, Athos; Ilowite, Norman T; Inman, Christi J; Marsolo, Keith; McMurry, Andrew J; Sandborg, Christy I; Schanberg, Laura E; Wallace, Carol A; Warren, Robert W; Weber, Griffin M; Mandl, Kenneth D

2013-01-01

Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases.

The Epimed Monitor ICU Database®: a cloud-based national registry for adult intensive care unit patients in Brazil.

PubMed

Zampieri, Fernando Godinho; Soares, Márcio; Borges, Lunna Perdigão; Salluh, Jorge Ibrain Figueira; Ranzani, Otávio Tavares

2017-01-01

To describe the Epimed Monitor Database®, a Brazilian intensive care unit quality improvement database. We described the Epimed Monitor® Database, including its structure and core data. We presented aggregated informative data from intensive care unit admissions from 2010 to 2016 using descriptive statistics. We also described the expansion and growth of the database along with the geographical distribution of participating units in Brazil. The core data from the database includes demographic, administrative and physiological parameters, as well as specific report forms used to gather detailed data regarding the use of intensive care unit resources, infectious episodes, adverse events and checklists for adherence to best clinical practices. As of the end of 2016, 598 adult intensive care units in 318 hospitals totaling 8,160 intensive care unit beds were participating in the database. Most units were located at private hospitals in the southeastern region of the country. The number of yearly admissions rose during this period and included a predominance of medical admissions. The proportion of admissions due to cardiovascular disease declined, while admissions due to sepsis or infections became more common. Illness severity (Simplified Acute Physiology Score - SAPS 3 - 62 points), patient age (mean = 62 years) and hospital mortality (approximately 17%) remained reasonably stable during this time period. A large private database of critically ill patients is feasible and may provide relevant nationwide epidemiological data for quality improvement and benchmarking purposes among the participating intensive care units. This database is useful not only for administrative reasons but also for the improvement of daily care by facilitating the adoption of best practices and use for clinical research.

[Preparation of the database and the Internet (WWW) homepage for regulations on chemicals in Japan].

PubMed

Yamamoto, M; Morita, M; Kaminuma, T

1999-01-01

We prepared a database on chemical regulations in Japan. The regulations consist of "The Law concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances", "Poisonous and Deleterious Substances", Control Law", "Waterworks Law", "Law for the Control of Household Products containing Harmful Substances", and Pesticide Residues in Food Sanitation Law". We also set up a World Wide Web (WWW) homepage containing an explanation of the law as well as chemical names, CAS registry numbers, and standards. The WWW pages contain lists of chemicals and the retrieval page for the database.

The international dystrophic epidermolysis bullosa patient registry: an online database of dystrophic epidermolysis bullosa patients and their COL7A1 mutations.

PubMed

van den Akker, Peter C; Jonkman, Marcel F; Rengaw, Trebor; Bruckner-Tuderman, Leena; Has, Cristina; Bauer, Johann W; Klausegger, Alfred; Zambruno, Giovanna; Castiglia, Daniele; Mellerio, Jemima E; McGrath, John A; van Essen, Anthonie J; Hofstra, Robert M W; Swertz, Morris A

2011-10-01

Dystrophic epidermolysis bullosa (DEB) is a heritable blistering disorder that can be inherited autosomal dominantly (DDEB) or recessively (RDEB) and covers a group of several distinctive phenotypes. A large number of unique COL7A1 mutations have been shown to underlie DEB. Although general genotype-phenotype correlation rules have emerged, many exceptions to these rules exist, compromising disease diagnosing and genetic counseling. We therefore constructed the International DEB Patient Registry (http://www.deb-central.org), aimed at worldwide collection and sharing of phenotypic and genotypic information on DEB. As of May 2011, this MOLGENIS-based registry contains detailed information on 508 published and 71 unpublished patients and their 388 unique COL7A1 mutations, and includes all combinations of mutations. The current registry RDEB versus DDEB ratio of 4:1, if compared to prevalence figures, suggests underreporting of DDEB in the literature. Thirty-eight percent of mutations stored introduce a premature termination codon (PTC) and 43% an amino acid change. Submission wizards allow users to quickly and easily share novel information. This registry will be of great help in disease diagnosing and genetic counseling and will lead to novel insights, especially in the rare phenotypes of which there is often lack of understanding. Altogether, this registry will greatly benefit the DEB patients. © 2011 Wiley-Liss, Inc.

Data that empower: The success and promise of CF patient registries.

PubMed

Fink, Aliza K; Loeffler, Deena R; Marshall, Bruce C; Goss, Christopher H; Morgan, Wayne J

2017-11-01

In this article, we describe existing CF registries with a focus on US registry data collected through the CF Foundation Patient Registry (CFFPR) and the Epidemiologic Study of CF (ESCF); highlight what registries have taught us regarding epidemiology of CF; showcase the impact of registries on research and clinical care; and discuss future directions. This manuscript complements the plenary address given by Dr Wayne Morgan at the 2016 North American CF Conference by summarizing the key points from the presentation and providing additional detail and information. © 2017 Wiley Periodicals, Inc.

Informatics Tools and Methods to Enhance U.S. Cancer Surveillance Research, UG3/UH3 | Informatics Technology for Cancer Research (ITCR)

Cancer.gov

The goal of this Funding Opportunity Announcement (FOA) is to advance surveillance science by supporting the development of new and innovative tools and methods for more efficient, detailed, timely, and accurate data collection by cancer registries. Specifically, the FOA seeks applications for projects to develop, adapt, apply, scale-up, and validate tools and methods to improve the collection and integration cancer registry data and to expand the data items collected. Population-based central cancer registries (a partnership must involve at least two different registries).

How TAVI registries report clinical outcomes—A systematic review of endpoints based on VARC-2 definitions

PubMed Central

Kolominsky-Rabas, Peter L.

2017-01-01

Introduction Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed. Materials and methods A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients’ characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry’s publications. Results This review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation. Conclusion Since the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers. PMID:28910289

First results of Liguria-Trento transplant network project: a model for a macroregional network and real-time registry in Italy.

PubMed

Valente, R; Cambiaso, F; Santori, G; Ghirelli, R; Gianelli, A; Valente, U

2004-04-01

In Italy, health-care telematic is funded and supported at the level of national government or regional institutions. In 1999, the Italian Ministry of Health started to fund the Liguria-Trento Transplant Network (LTTN) project, a health research project with the aim to build an informative system for donor management and transplantation activity in a macroregional area. At the time of LTTN project proposal, no published Transplant Network Informative System fulfilled Italian rules on telematic management of electronic documentation concerning transplantation activity. Partnership of LTTN project were two Regional Transplant Coordinating Centres, Nord Italia Transplant Interregional Coordinating Centre and the Italian Institute of Health/National Transplant Coordinating Centre. Project Total Quality Management methods were adopted. Technological and case analysis followed ANSI-HL7, CEN-TC251, and Object-Oriented Software Engineering standards. A low-tech prototype powered by a web access relational database is running on a transplant network including web-based clients located in 17 intensive care units, in Nord Italia Transplant Interregional Coordinating Centre, and at the Italian Institute of Health/National Transplant Coordinating Centre. LTTN registry includes pretransplant, surgical, and posttransplant phases regarding liver, kidney, pancreas, and kidney-pancreas transplantation in adult and pediatric recipients. Clinical specifications were prioritized in agreement with the RAND/UCLA appropriateness method. Further implementation will include formal rules for data access and output release, fault tolerance, and a continuous registry evolution plan.

Nationwide incidence of motor neuron disease using the French health insurance information system database.

PubMed

Kab, Sofiane; Moisan, Frédéric; Preux, Pierre-Marie; Marin, Benoît; Elbaz, Alexis

2017-08-01

There are no estimates of the nationwide incidence of motor neuron disease (MND) in France. We used the French health insurance information system to identify incident MND cases (2012-2014), and compared incidence figures to those from three external sources. We identified incident MND cases (2012-2014) based on three data sources (riluzole claims, hospitalisation records, long-term chronic disease benefits), and computed MND incidence by age, gender, and geographic region. We used French mortality statistics, Limousin ALS registry data, and previous European studies based on administrative databases to perform external comparisons. We identified 6553 MND incident cases. After standardisation to the United States 2010 population, the age/gender-standardised incidence was 2.72/100,000 person-years (males, 3.37; females, 2.17; male:female ratio = 1.53, 95% CI1.46-1.61). There was no major spatial difference in MND distribution. Our data were in agreement with the French death database (standardised mortality ratio = 1.01, 95% CI = 0.96-1.06) and Limousin ALS registry (standardised incidence ratio = 0.92, 95% CI = 0.72-1.15). Incidence estimates were in the same range as those from previous studies. We report French nationwide incidence estimates of MND. Administrative databases including hospital discharge data and riluzole claims offer an interesting approach to identify large population-based samples of patients with MND for epidemiologic studies and surveillance.

Persian Registry Of cardioVascular diseasE (PROVE): Design and methodology.

PubMed

Givi, Mahshid; Sarrafzadegan, Nizal; Garakyaraghi, Mohammad; Yadegarfar, Ghasem; Sadeghi, Masoumeh; Khosravi, Alireza; Azhari, Amir Hossein; Samienasab, Mohammad Reza; Shafie, Davood; Saadatnia, Mohammad; Roohafza, Hamidreza; Paydari, Navid; Soleimani, Azam; Hosseinzadeh, Mohsen; Ahmadi, Seyed Abdulah; Dehghani, Leila; Najafian, Jamshid; Andalib, Elham; Shahabi, Javad; Sabri, Mohammad Reza

2017-09-01

Our aim was to create and establish a database called "Persian Registry Of cardioVascular diseasE (PROVE)" in order to be used for future research and in addition, as a tool to develop national guidelines for diagnosis, treatment, and prevention of cardiovascular disease (CVD). In this paper, the design and methodology of the PROVE pilot study will be discussed, launched in Isfahan, Iran, in 2015-2016. Through establishing PROVE, patients' data were collected from hospitals and outpatient clinics prospectively or retrospectively and followed up for a maximum of three years based on the type of CVDs. The inclusion criteria were as patients with acute coronary syndrome (ACS), ST elevation myocardial infarction (STEMI), stroke, atrial fibrillation (AF), heart failure (HF), congenital heart disease (CHD), percutaneous coronary intervention (PCI), and chronic ischemic cardiovascular disease (CICD). Specific protocols, questionnaires, and glossaries were developed for each registry. In order to ensure the validation of the protocols, questionnaires, data collection, management, and analysis, a well-established quality control (QC) protocol was developed and implemented. Data confidentiality was considered. In order to register patients with ACS, STEMI, stroke, HF, PCI, and CICD, the hospital recorded data were used, whereas, in case of AF and CHD registries, the data were collected from hospitals and outpatient clinics. During the pilot phase of the study in Isfahan, from March 2015 to September 2016, 9427 patients were registered as ACS including 809 as STEMI, 1195 patients with HF, 363 with AF, 761 with stroke, 1136 with CHD, 1200 with PCI, and 9 with CICD. Data collection and management were performed under the supervision of the QC group. PROVE was developed and implemented in Isfahan as a pilot study, in order to be implemented at national level in future. It provides a valuable source of valid data that could be used for future research, re-evaluation of current CVD management and more specifically, gap analysis and as a tool for assessment of the type of CVDs, prevention, treatment, and control by health care decision makers.

The Impact of Multiple Malignancies on Patients with Bladder Carcinoma: A Population-Based Study Using the SEER Database

PubMed Central

Ehrlich, Joshua R.; Schwartz, Michael J.; Ng, Casey K.; Kauffman, Eric C.; Scherr, Douglas S.

2009-01-01

Purpose. To date, no study has examined a population-based registry to determine the impact of multiple malignancies on survival of bladder cancer patients. Our experience suggests that bladder cancer patients with multiple malignancies may have relatively positive outcomes. Materials & Methods. We utilized data from the Surveillance Epidemiology and End Results (SEERs) database to examine survival between patients with only bladder cancer (BO) and with bladder cancer and additional cancer(s) antecedent (AB), subsequent (BS), or antecedent and subsequent to bladder cancer (ABS). Results. Analyses demonstrated diminished survival among AB and ABS cohorts. However, when cohorts were substratified by stage, patients in the high-stage BS cohort appeared to have a survival advantage over high-stage BO patients. Conclusions. Bladder cancer patients with multiple malignancies have diminished survival. The survival advantage of high-stage BS patients is likely a statistical phenomenon. Such findings are important to shape future research and to improve our understanding of patients with multiple malignancies. PMID:20069054

From design to implementation--the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program.

PubMed

Ko, Gary T; So, Wing-Yee; Tong, Peter C; Le Coguiec, Francois; Kerr, Debborah; Lyubomirsky, Greg; Tamesis, Beaver; Wolthers, Troels; Nan, Jennifer; Chan, Juliana

2010-05-13

The Joint Asia Diabetes Evaluation (JADE) Program is a web-based program incorporating a comprehensive risk engine, care protocols, and clinical decision support to improve ambulatory diabetes care. The JADE Program uses information technology to facilitate healthcare professionals to create a diabetes registry and to deliver an evidence-based care and education protocol tailored to patients' risk profiles. With written informed consent from participating patients and care providers, all data are anonymized and stored in a databank to establish an Asian Diabetes Database for research and publication purpose. The JADE electronic portal (e-portal: http://www.jade-adf.org) is implemented as a Java application using the Apache web server, the mySQL database and the Cocoon framework. The JADE e-portal comprises a risk engine which predicts 5-year probability of major clinical events based on parameters collected during an annual comprehensive assessment. Based on this risk stratification, the JADE e-portal recommends a care protocol tailored to these risk levels with decision support triggered by various risk factors. Apart from establishing a registry for quality assurance and data tracking, the JADE e-portal also displays trends of risk factor control at each visit to promote doctor-patient dialogues and to empower both parties to make informed decisions. The JADE Program is a prototype using information technology to facilitate implementation of a comprehensive care model, as recommended by the International Diabetes Federation. It also enables health care teams to record, manage, track and analyze the clinical course and outcomes of people with diabetes.

NIH Pain Consortium

MedlinePlus

... Did You Know? Infographics on Pain Topics Resource Library Health Care Systems Research Collaboratory Pain Registries IOM Report: Relieving Pain ... Did You Know? Infographics on Pain Topics Resource Library Health Care Systems Research Collaboratory Pain Registries IOM Report: Relieving Pain ...

Brief Report: Databases in the Asia-Pacific Region: The Potential for a Distributed Network Approach.

PubMed

Lai, Edward Chia-Cheng; Man, Kenneth K C; Chaiyakunapruk, Nathorn; Cheng, Ching-Lan; Chien, Hsu-Chih; Chui, Celine S L; Dilokthornsakul, Piyameth; Hardy, N Chantelle; Hsieh, Cheng-Yang; Hsu, Chung Y; Kubota, Kiyoshi; Lin, Tzu-Chieh; Liu, Yanfang; Park, Byung Joo; Pratt, Nicole; Roughead, Elizabeth E; Shin, Ju-Young; Watcharathanakij, Sawaeng; Wen, Jin; Wong, Ian C K; Yang, Yea-Huei Kao; Zhang, Yinghong; Setoguchi, Soko

2015-11-01

This study describes the availability and characteristics of databases in Asian-Pacific countries and assesses the feasibility of a distributed network approach in the region. A web-based survey was conducted among investigators using healthcare databases in the Asia-Pacific countries. Potential survey participants were identified through the Asian Pharmacoepidemiology Network. Investigators from a total of 11 databases participated in the survey. Database sources included four nationwide claims databases from Japan, South Korea, and Taiwan; two nationwide electronic health records from Hong Kong and Singapore; a regional electronic health record from western China; two electronic health records from Thailand; and cancer and stroke registries from Taiwan. We identified 11 databases with capabilities for distributed network approaches. Many country-specific coding systems and terminologies have been already converted to international coding systems. The harmonization of health expenditure data is a major obstacle for future investigations attempting to evaluate issues related to medical costs.

A Model-Driven, Science Data Product Registration Service

NASA Astrophysics Data System (ADS)

Hardman, S.; Ramirez, P.; Hughes, J. S.; Joyner, R.; Cayanan, M.; Lee, H.; Crichton, D. J.

2011-12-01

The Planetary Data System (PDS) has undertaken an effort to overhaul the PDS data architecture (including the data model, data structures, data dictionary, etc.) and to deploy an upgraded software system (including data services, distributed data catalog, etc.) that fully embraces the PDS federation as an integrated system while taking advantage of modern innovations in information technology (including networking capabilities, processing speeds, and software breakthroughs). A core component of this new system is the Registry Service that will provide functionality for tracking, auditing, locating, and maintaining artifacts within the system. These artifacts can range from data files and label files, schemas, dictionary definitions for objects and elements, documents, services, etc. This service offers a single reference implementation of the registry capabilities detailed in the Consultative Committee for Space Data Systems (CCSDS) Registry Reference Model White Book. The CCSDS Reference Model in turn relies heavily on the Electronic Business using eXtensible Markup Language (ebXML) standards for registry services and the registry information model, managed by the OASIS consortium. Registries are pervasive components in most information systems. For example, data dictionaries, service registries, LDAP directory services, and even databases provide registry-like services. These all include an account of informational items that are used in large-scale information systems ranging from data values such as names and codes, to vocabularies, services and software components. The problem is that many of these registry-like services were designed with their own data models associated with the specific type of artifact they track. Additionally these services each have their own specific interface for interacting with the service. This Registry Service implements the data model specified in the ebXML Registry Information Model (RIM) specification that supports the various artifacts above as well as offering the flexibility to support customer-defined artifacts. Key features for the Registry Service include: - Model-based configuration specifying customer-defined artifact types, metadata attributes to capture for each artifact type, supported associations and classification schemes. - A REST-based external interface that is accessible via the Hypertext Transfer Protocol (HTTP). - Federation of Registry Service instances allowing associations between registered artifacts across registries as well as queries for artifacts across those same registries. A federation also enables features such as replication and synchronization if desired for a given deployment. In addition to its use as a core component of the PDS, the generic implementation of the Registry Service facilitates its applicability as a core component in any science data archive or science data system.

What Information Does Your EHR Contain? Automatic Generation of a Clinical Metadata Warehouse (CMDW) to Support Identification and Data Access Within Distributed Clinical Research Networks.

PubMed

Bruland, Philipp; Doods, Justin; Storck, Michael; Dugas, Martin

2017-01-01

Data dictionaries provide structural meta-information about data definitions in health information technology (HIT) systems. In this regard, reusing healthcare data for secondary purposes offers several advantages (e.g. reduce documentation times or increased data quality). Prerequisites for data reuse are its quality, availability and identical meaning of data. In diverse projects, research data warehouses serve as core components between heterogeneous clinical databases and various research applications. Given the complexity (high number of data elements) and dynamics (regular updates) of electronic health record (EHR) data structures, we propose a clinical metadata warehouse (CMDW) based on a metadata registry standard. Metadata of two large hospitals were automatically inserted into two CMDWs containing 16,230 forms and 310,519 data elements. Automatic updates of metadata are possible as well as semantic annotations. A CMDW allows metadata discovery, data quality assessment and similarity analyses. Common data models for distributed research networks can be established based on similarity analyses.

The Clinical Research Landscape in Rhode Island.

PubMed

Mao, George; Ramratnam, Bharat

2017-01-06

To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

Arthroplasty knee registry of Catalonia: What scientific evidence supports the implantation of our prosthesis?

PubMed

Samaniego Alonso, R; Gaviria Parada, E; Pons Cabrafiga, M; Espallargues Carreras, M; Martinez Cruz, O

2018-02-28

In our environment, it is increasingly necessary to perform an activity based on scientific evidence and the field of prosthetic surgery should be governed by the same principles. The national arthroplasty registries allow us to obtain a large amount of data in order to evaluate this technique. The aim of our study is to analyse the scientific evidence that supports the primary total knee arthroplasties implanted in Catalonian public hospitals, based on the Arthoplasty Registry of Catalonia (RACat) MATERIAL AND METHODS: A review of the literature was carried out on knee prostheses (cruciate retaining, posterior stabilized, constricted and rotational) recorded in RACat between the period 2005-2013 in the following databases: Orthopedic Data Evaluation Panel, PubMed, TripDatabase and Google Scholar. The prostheses implanted in fewer than 10 units (1,358 prostheses corresponding to 62 models) were excluded. 41,947 prostheses (96.86%) were analysed out of 43,305 implanted, corresponding to 74 different models. In 13 models (n = 4,715) (11.24%) no clinical evidence to support their use was found. In the remaining 36 models (n = 13,609) (32.45%), level iv studies were the most predominant evidence. There was a significant number of implanted prostheses (11.24%) for which no clinical evidence was found. The number of models should be noted, 36 out of 110, with fewer than 10 units implanted. The use of arthroplasty registries has proved an extremely useful tool that allows us to analyse and draw conclusions in order to improve the efficiency of this surgical technique. Copyright © 2018 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

A new data management system for the French National Registry of human alveolar echinococcosis cases.

PubMed

Charbonnier, Amandine; Knapp, Jenny; Demonmerot, Florent; Bresson-Hadni, Solange; Raoul, Francis; Grenouillet, Frédéric; Millon, Laurence; Vuitton, Dominique Angèle; Damy, Sylvie

2014-01-01

Alveolar echinococcosis (AE) is an endemic zoonosis in France due to the cestode Echinococcus multilocularis. The French National Reference Centre for Alveolar Echinococcosis (CNR-EA), connected to the FrancEchino network, is responsible for recording all AE cases diagnosed in France. Administrative, epidemiological and medical information on the French AE cases may currently be considered exhaustive only on the diagnosis time. To constitute a reference data set, an information system (IS) was developed thanks to a relational database management system (MySQL language). The current data set will evolve towards a dynamic surveillance system, including follow-up data (e.g. imaging, serology) and will be connected to environmental and parasitological data relative to E. multilocularis to better understand the pathogen transmission pathway. A particularly important goal is the possible interoperability of the IS with similar European and other databases abroad; this new IS could play a supporting role in the creation of new AE registries. © A. Charbonnier et al., published by EDP Sciences, 2014.

EPA Facility Registry System (FRS): NCES

EPA Pesticide Factsheets

This web feature service contains location and facility identification information from EPA's Facility Registry System (FRS) for the subset of facilities that link to the National Center for Education Statistics (NCES). The primary federal database for collecting and analyzing data related to education in the United States and other Nations, NCES is located in the U.S. Department of Education, within the Institute of Education Sciences. FRS identifies and geospatially locates facilities, sites or places subject to environmental regulations or of environmental interest. Using vigorous verification and data management procedures, FRS integrates facility data from EPA00e2??s national program systems, other federal agencies, and State and tribal master facility records and provides EPA with a centrally managed, single source of comprehensive and authoritative information on facilities. This data set contains the subset of FRS integrated facilities that link to NCES school facilities once the NCES data has been integrated into the FRS database. Additional information on FRS is available at the EPA website http://www.epa.gov/enviro/html/fii/index.html.

A new data management system for the French National Registry of human alveolar echinococcosis cases

PubMed Central

Charbonnier, Amandine; Knapp, Jenny; Demonmerot, Florent; Bresson-Hadni, Solange; Raoul, Francis; Grenouillet, Frédéric; Millon, Laurence; Vuitton, Dominique Angèle; Damy, Sylvie

2014-01-01

Alveolar echinococcosis (AE) is an endemic zoonosis in France due to the cestode Echinococcus multilocularis. The French National Reference Centre for Alveolar Echinococcosis (CNR-EA), connected to the FrancEchino network, is responsible for recording all AE cases diagnosed in France. Administrative, epidemiological and medical information on the French AE cases may currently be considered exhaustive only on the diagnosis time. To constitute a reference data set, an information system (IS) was developed thanks to a relational database management system (MySQL language). The current data set will evolve towards a dynamic surveillance system, including follow-up data (e.g. imaging, serology) and will be connected to environmental and parasitological data relative to E. multilocularis to better understand the pathogen transmission pathway. A particularly important goal is the possible interoperability of the IS with similar European and other databases abroad; this new IS could play a supporting role in the creation of new AE registries. PMID:25526544

Therapeutic priorities for solitary large hepatocellular carcinoma in a hepatitis B virus endemic area; an analysis of a nationwide cancer registry database.

PubMed

Jin, Young-Joo; Lee, Jin-Woo

2017-03-01

We compared overall survival (OS) of patients with a solitary large (>5 cm) hepatocellular carcinoma (HCC) treated surgically or by transarterial chemoembolization (TACE). The archived records of HCC patients registered at the Korean Central Cancer Registry from 2003 through 2005 (registry A, n = 4 520) or from 2008 through 2010 (registry B, n = 4 596) were retrospectively analyzed. In these registries, 578 and 315 patients had a single large HCC, respectively. In registry A, 442 (cohort A) underwent surgery (n = 96) or TACE (n = 346). In registry B, 253 (cohort B) underwent surgery (n = 110) or TACE (n = 143). Cohort C (n = 695) was constructed by combining cohorts A and B, and thus, 206 and 489 patients received surgery and TACE, respectively. In cohort C, cumulative OS rates at 1-, 3-, and 5-years were significantly higher for surgery than TACE (89.3%, 67.4%, and 58.0% vs 67.7%, 38.2%, and 27.2%, respectively, P < 0.001). Similar results were obtained for cohorts A and B, even after propensity-score matching in three cohorts (P values for all <0.05). TACE (HR 2.18, P < 0.001), serum albumin (HR 0.77, P = 0.015), and tumor size (HR 1.06, P < 0.001) were predictors of post-treatment mortality. Surgery is associated with improved OS for a solitary large HCC of BCLC stage A. © 2016 Wiley Periodicals, Inc.

Patient registries: useful tools for clinical research in myasthenia gravis.

PubMed

Baggi, Fulvio; Mantegazza, Renato; Antozzi, Carlo; Sanders, Donald

2012-12-01

Clinical registries may facilitate research on myasthenia gravis (MG) in several ways: as a source of demographic, clinical, biological, and immunological data on large numbers of patients with this rare disease; as a source of referrals for clinical trials; and by allowing rapid identification of MG patients with specific features. Physician-derived registries have the added advantage of incorporating diagnostic and treatment data that may allow comparison of outcomes from different therapeutic approaches, which can be supplemented with patient self-reported data. We report the demographic analysis of MG patients in two large physician-derived registries, the Duke MG Patient Registry, at the Duke University Medical Center, and the INNCB MG Registry, at the Istituto Neurologico Carlo Besta, as a preliminary study to assess the consistency of the two data sets. These registries share a common structure, with an inner core of common data elements (CDE) that facilitate data analysis. The CDEs are concordant with the MG-specific CDEs developed under the National Institute of Neurological Disorders and Stroke Common Data Elements Project. © 2012 New York Academy of Sciences.

76 FR 20690 - International Consortium of Orthopedic Registries; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... orthopedic implant information and create a research network to advance the methodology and conduct of research related to orthopedic device performance. Date and Time: The public workshop will be held on May 9... discussion among FDA and international orthopedic registries and develop a research consortium (ICOR) that...

Peutz-Jeghers syndrome: data from the Singapore Polyposis Registry and a shifting paradigm in management.

PubMed

Tan, Veronique Km; Koh, Poh Koon; Loi, Carol Tt; Eu, Kong Weng; Tang, Choong Leong

2010-01-01

Peutz-Jeghers Syndrome (PJS) is an uncommon autosomal dominant hamartomatous polyposis syndrome. Morbidity arises from polyp-related complications and increased risks of malignancy. We report on PJS patients registered in the Singapore Polyposis Registry, identified principal causes of morbidity and appraised current management strategies. A followup protocol based on recent literature has been proposed. A search of a prospectively collected database in the Singapore Polyposis Registry was made. Only patients who fulfilled the diagnostic criteria of PJS were included. The clinical records were retrieved for review. Information on affected family members was obtained from the Registry's pedigree records. Seven unrelated patients fulfilled the criteria of having PJS. Principal causes of morbidity include recurrent bouts of abdominal colic, episodes of intestinal obstruction, gastrointestinal bleeding and the need for repeated laparotomies. Six out of 7 patients had initial presentation with acute intestinal obstruction requiring emergency laparotomy. Management was mostly problem-oriented and marked inter-surgeon variation with regard to cancer screening and genetic counselling was observed. Patients with PJS suffer gastrointestinal complications from polyposis and are at increased risks for developing cancers. A move towards surveillance and planned comprehensive care may reduce the morbidity of the condition. A protocol driven approach conducted in the setting of a Polyposis Registry is ideally suited to facilitate such care.

Should we all go to the PROM? The first two years of the British Spine Registry.

PubMed

Breakwell, L M; Cole, A A; Birch, N; Heywood, C

2015-07-01

The effective capture of outcome measures in the healthcare setting can be traced back to Florence Nightingale's investigation of the in-patient mortality of soldiers wounded in the Crimean war in the 1850s. Only relatively recently has the formalised collection of outcomes data into Registries been recognised as valuable in itself. With the advent of surgeon league tables and a move towards value based health care, individuals are being driven to collect, store and interpret data. Following the success of the National Joint Registry, the British Association of Spine Surgeons instituted the British Spine Registry. Since its launch in 2012, over 650 users representing the whole surgical team have registered and during this time, more than 27 000 patients have been entered onto the database. There has been significant publicity regarding the collection of outcome measures after surgery, including patient-reported scores. Over 12 000 forms have been directly entered by patients themselves, with many more entered by the surgical teams. Questions abound: who should have access to the data produced by the Registry and how should they use it? How should the results be reported and in what forum? ©2015 The British Editorial Society of Bone & Joint Surgery.

The design and evaluation of an antimicrobial resistance surveillance system for neonatal intensive care units in Iran.

PubMed

Rezaei-Hachesu, Peyman; Samad-Soltani, Taha; Yaghoubi, Sajad; GhaziSaeedi, Marjan; Mirnia, Kayvan; Masoumi-Asl, Hossein; Safdari, Reza

2018-07-01

Neonatal intensive care units (NICUs) have complex patients in terms of their diagnoses and required treatments. Antimicrobial treatment is a common therapy for patients in NICUs. To solve problems pertaining to empirical therapy, antimicrobial stewardship programs have recently been introduced. Despite the success of these programs in terms of data collection, there is still inefficiency in terms of analyzing and reporting the data. Thus, to successfully implement these stewardship programs, the design of antimicrobial resistance (AMR) surveillance systems is recommended as a first step. As a result, this study aimed to design an AMR surveillance system for use in the NICUs in northwestern Iranian hospitals to cover these information gaps. The recommended system is compatible with the World Health Organization (WHO) guidelines. The business intelligence (BI) requirements were extracted in an interview with a product owner (PO) using a valid and reliable checklist. Following this, an AMR surveillance system was designed and evaluated in relation to user experiences via a user experience questionnaire (UEQ). Finally, an association analysis was performed on the database, and the results were reported by identifying the important multidrug resistances in the database. A customized software development methodology was proposed. The three major modules of the AMR surveillance are the data registry, dashboard, and decision support modules. The data registry module was implemented based on a three-tier architecture, and the Clinical Decision Support System (CDSS) and dashboard modules were designed based on the BI requirements of the Scrum product owner (PO). The mean values of UEQ measures were in a good range. This measures showed the suitable usability of the AMR surveillance system. Applying efficient software development methodologies allows for the systems' compatibility with users' opinions and requirements. In addition, the construction of interdisciplinary communication models for research and software engineering allows for research and development concepts to be used in operational environments. Copyright © 2018 Elsevier B.V. All rights reserved.

METADATA REGISTRY, ISO/IEC 11179

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pon, R K; Buttler, D J

2008-01-03

ISO/IEC-11179 is an international standard that documents the standardization and registration of metadata to make data understandable and shareable. This standardization and registration allows for easier locating, retrieving, and transmitting data from disparate databases. The standard defines the how metadata are conceptually modeled and how they are shared among parties, but does not define how data is physically represented as bits and bytes. The standard consists of six parts. Part 1 provides a high-level overview of the standard and defines the basic element of a metadata registry - a data element. Part 2 defines the procedures for registering classification schemesmore » and classifying administered items in a metadata registry (MDR). Part 3 specifies the structure of an MDR. Part 4 specifies requirements and recommendations for constructing definitions for data and metadata. Part 5 defines how administered items are named and identified. Part 6 defines how administered items are registered and assigned an identifier.« less

Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

PubMed

Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

2017-11-01

Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Occupational exposure in the removal and disposal of asbestos-containing materials in Italy.

PubMed

Scarselli, Alberto; Corfiati, Marisa; Di Marzio, Davide

2016-07-01

A great variety of asbestos-containing materials are present in both residential and work settings because of the widespread use made in the past, and many occupational activities still entail the risk of asbestos exposure in Italy, more than 2 decades after the total national ban, mainly those involved in the removal and disposal of asbestos. The aim of the study was to evaluate the level and extent of asbestos exposure in Italy between the years 1996-2013 in the sector of asbestos abatement. Data were collected from firm registries of asbestos-exposed workers and descriptive statistics were calculated for exposure-related variables. Overall, 15,860 measurements of asbestos exposure were selected from the national database of registries, mostly referring to the construction sector (N = 11,353). Despite the mean exposure levels are low, the air concentration of asbestos fibers measured during these activities may overcome the action level established by the Italian legislation and, in a limited number of cases, can exceed even the occupational limit value. Among occupations at higher risk, there are also garbage collectors and insulation workers. Starting from the analysis of the Italian database of occupational exposure registries, this study outlines the current levels of asbestos exposure in abatement-related sectors, discussing their possible implications for public health policies and surveillance programs.

Integrating cancer survivors' experiences into UK cancer registries: design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors)

PubMed Central

Ashley, L; Jones, H; Thomas, J; Forman, D; Newsham, A; Morris, E; Johnson, O; Velikova, G; Wright, P

2011-01-01

Background: Understanding the psychosocial challenges of cancer survivorship, and identifying which patients experience ongoing difficulties, is a key priority. The ePOCS (electronic patient-reported outcomes from cancer survivors) project aims to develop and evaluate a cost-efficient, UK-scalable electronic system for collecting patient-reported outcome measures (PROMs), at regular post-diagnostic timepoints, and linking these with clinical data in cancer registries. Methods: A multidisciplinary team developed the system using agile methods. Design entailed process mapping the system's constituent parts, data flows and involved human activities, and undertaking usability testing. Informatics specialists built new technical components, including a web-based questionnaire tool and tracking database, and established component-connecting data flows. Development challenges were overcome, including patient usability and data linkage and security. Results: We have developed a system in which PROMs are completed online, using a secure questionnaire administration tool, accessed via a public-facing website, and the responses are linked and stored with clinical registry data. Patient monitoring and communications are semiautomated via a tracker database, and patient correspondence is primarily Email-based. The system is currently honed for clinician-led hospital-based patient recruitment. Conclusions: A feasibility test study is underway. Although there are possible challenges to sustaining and scaling up ePOCS, the system has potential to support UK epidemiological PROMs collection and clinical data linkage. PMID:22048035

The European Cystic Fibrosis Society Patient Registry: valuable lessons learned on how to sustain a disease registry.

PubMed

Viviani, Laura; Zolin, Anna; Mehta, Anil; Olesen, Hanne Vebert

2014-06-07

Disease registries have the invaluable potential to provide an insight into the natural history of the disease under investigation, to provide useful information (e.g. through health indicators) for planning health care services and to identify suitable groups of patients for clinical trials enrolment. However, the establishment and maintenance of disease registries is a burdensome initiative from economical and organisational points of view and experience sharing on registries management is important to avoid waste of resources. The aim of this paper is to discuss the problems embedded in the institution and management of an international disease registry to warn against common mistakes that can derail the best of intentions: we share the experience of the European Cystic Fibrosis Society Patient Registry, which collects data on almost 30,000 patients from 23 countries. We discuss the major problems that researchers often encounter in the creation and management of disease registries: definition of the aims the registry has to reach, definition of the criteria for patients referral to the registry, definition of the information to record, set up of a data quality process, handling of missing data, maintenance of data confidentiality, regulation of data use and dissemination of research results. We give examples on how many crucial aspects were solved by the European Cystic Fibrosis Society Patient Registry regarding objectives, inclusion criteria and variables definition, data management, data quality controls, missing data handling, confidentiality maintenance, data use and results dissemination. We suggest an extensive literature research and discussions in working groups with different stake holders, including patient representatives, on the objectives, inclusion criteria and the information to record. We propose to pilot the recording of few variables and test the applicability of their definition first. The use of a shared electronic platform for data collection that automatically computes derived variables, and automatically performs basic data quality controls is a good data management practice, that also helps in reducing missing data. We found crucial for success the collaboration with existing national and international registries, cystic fibrosis organisations and patients' associations.

The European Cystic Fibrosis Society Patient Registry: valuable lessons learned on how to sustain a disease registry

PubMed Central

2014-01-01

Background Disease registries have the invaluable potential to provide an insight into the natural history of the disease under investigation, to provide useful information (e.g. through health indicators) for planning health care services and to identify suitable groups of patients for clinical trials enrolment. However, the establishment and maintenance of disease registries is a burdensome initiative from economical and organisational points of view and experience sharing on registries management is important to avoid waste of resources. The aim of this paper is to discuss the problems embedded in the institution and management of an international disease registry to warn against common mistakes that can derail the best of intentions: we share the experience of the European Cystic Fibrosis Society Patient Registry, which collects data on almost 30,000 patients from 23 countries. Methods We discuss the major problems that researchers often encounter in the creation and management of disease registries: definition of the aims the registry has to reach, definition of the criteria for patients referral to the registry, definition of the information to record, set up of a data quality process, handling of missing data, maintenance of data confidentiality, regulation of data use and dissemination of research results. Results We give examples on how many crucial aspects were solved by the European Cystic Fibrosis Society Patient Registry regarding objectives, inclusion criteria and variables definition, data management, data quality controls, missing data handling, confidentiality maintenance, data use and results dissemination. Conclusions We suggest an extensive literature research and discussions in working groups with different stake holders, including patient representatives, on the objectives, inclusion criteria and the information to record. We propose to pilot the recording of few variables and test the applicability of their definition first. The use of a shared electronic platform for data collection that automatically computes derived variables, and automatically performs basic data quality controls is a good data management practice, that also helps in reducing missing data. We found crucial for success the collaboration with existing national and international registries, cystic fibrosis organisations and patients’ associations. PMID:24908055

Current situation and challenge of registry in China.

PubMed

Zhang, Yang; Feng, Yuji; Qu, Zhi; Qi, Yali; Zhan, Siyan

2014-09-01

Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30,400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.

[Epidemiology of war injuries, about two conflicts: Iraq and Afghanistan].

PubMed

Pasquier, P; de Rudnicki, S; Donat, N; Auroy, Y; Merat, S

2011-11-01

Since March 2003, military operations in Iraq "Operation Iraqi Freedom" (OIF) and in Afghanistan "Operation Enduring Freedom" (OEF), have made many wounded and killed in action (KIA). This article proposes to highlight the specific epidemiology of combat casualties, met in these both non-conventional and asymmetric conflicts. Personal protective equipments, Kevlar helmet and body armor, proved their efficiency in changing features of war injuries. Health Force Services organized trauma care system in different levels, with three main objectives: immediate basic medical care in battalion aid station, forward surgery and early aeromedical evacuation. The Joint Theater Trauma Registry (JTTR), a war injury registry, provides medical data, analyzed from the combat theater to the military hospital in United States. This analysis concluded that during modern conflicts, most injuries are caused by explosive devices; injuries are more severe and interestingly more specifically the head region and extremities than the trunk. Hemorrhage is the first cause of death, leading to the concept of avoidable death. Specific databases focused on mechanisms and severity of injuries, diagnostic and treatment difficulties, outcomes can guide research programs to improve war injuries prevention and treatment. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

PEP725 Pan European Phenological Database

NASA Astrophysics Data System (ADS)

Koch, E.; Lipa, W.; Ungersböck, M.; Zach-Hermann, S.

2012-04-01

PEP725 is a 5 years project with the main object to promote and facilitate phenological research by delivering a pan European phenological database with an open, unrestricted data access for science, research and education. PEP725 is funded by EUMETNET (the network of European meteorological services), ZAMG and the Austrian ministry for science & research bm:w_f. So far 16 European national meteorological services and 7 partners from different nati-onal phenological network operators have joined PEP725. The data access is very easy via web-access from the homepage www.pep725.eu. Ha-ving accepted the PEP725 data policy and registry the data download can be done by different criteria as for instance the selection of a specific plant or all data from one country. At present more than 300 000 new records are available in the PEP725 data-base coming from 31 European countries and from 8150 stations. For some more sta-tions (154) META data (location and data holder) are provided. Links to the network operators and data owners are also on the webpage in case you have more sophisticated questions about the data. Another objective of PEP725 is to bring together network-operators and scientists by organizing workshops. In April 2012 the second of these workshops will take place on the premises of ZAMG. Invited speakers will give presentations spanning the whole study area of phenology starting from observations to modelling. Quality checking is also a big issue. At the moment we study the literature to find ap-propriate methods.

[Population-based cancer registration in Germany. Essentials and perspectives].

PubMed

Katalinic, A

2004-05-01

Although cancer registration has a long tradition in Germany, wide areas remained blank spaces on the map concerning population-based cancer registration. The situation changed completely when a federal law on cancer registration (KRG, 1995-1999) took effect. Now all federal states have established population-based cancer registries on a legal basis. In spite of the uniform model of cancer registration anchored in the KRG, 16 different models have developed in Germany. Completeness of cancer registration was constantly improved over the last several years. In addition to the Saarland cancer registry, further registries can now provide a high grade of registration for all cancer sites. Essential tasks, such as public reporting and support of cancer research, can now be better fulfilled. Even taking the great developments in cancer registration in Germany into consideration, some deficits still continue to exist. These deficits are mostly caused by heterogeneity and missing compatibility of the cancer registry laws of the federal states. After the focus of cancer registration was on developing valid registries,now the focus has to be changed to the usability of cancer registry data. These data can be used e. g. for research on etiology and evaluation of programs on early cancer detection. Scientists in the field of cancer epidemiology, public health, and cancer care are invited to use data of cancer registries for research and evaluation projects intensively.

Probability of Finding Marrow Unrelated Donor (MUD) for an Indian patient in a Multi-national Human Leukocyte Antigen (HLA) Registry.

PubMed

Tiwari, Aseem K; Bhati-Kushwaha, Himakshi; Kukreja, Pooja; Mishra, Vikash C; Tyagi, Neetu; Sharma, Ashish; Raina, Vimarsh

2015-06-01

With an increase in the number of transplants happening globally, hematopoietic stem cells (HSC) transplantation from matched unrelated donor (MUD) has begun. The increasing trend of MUD transplants across countries has been largely facilitated with the conspicuous growth of volunteer HSC donor noted in the last decade i.e. 8 million HSC donors in 2002 to more than 22 million in 2013 registered in 71 member registries of the Bone Marrow Donor Worldwide (BMDW). Some populations of the world are still very poorly represented in these registries. Since, the chances of successful engraftment and disease free survival are directly proportional to the HLA compatibility between the recipient and the prospective donor, the diversity of the HLA system at the antigenic and allelic level and the heterogeneity of HLA data of the registered donors has a bearing on the probability of finding a volunteer unrelated HSC donor for patients from such populations. In the present study 126 patients were identified suffering from hematological diseases requiring MUD transplant. Their HLA typing was performed and search was done using BMDW database. The search results for these Indian patients in the multinational registry as well as in the Indian Registries were analyzed using mean, range, standard deviation and finally evaluated in terms of probability for finding matched donor (MUD). Total Asian population is only 11 % in the BMDW making it difficult to find a MUD for an Asian patient. The current study supports this, experimentally; revealing that the probability of finding an allele match for an Indian patient in the multinational Human Leukocyte Antigen (HLA) registries is 16 % and a dismal 0.008 % in the Indian registries (donors in Indian registries is just 33,678 as compared to 22.5 million in BMDW). This greatly, emphasizes on enhancing the number of Indian donors in Indian and multi-national registries.

FAA Registry - Aircraft - N-Number Inquiry

Science.gov Websites

Skip to page content Federal Aviation Administration Aircraft Inquiries N-number Serial Number -Number Online In Writing Reserved N-Number Renewal Online Request for Aircraft Records Online Help Main Menu Aircraft Registration Aircraft Downloadable Database Definitions N-Number Format Registrations at

Australia and New Zealand Dialysis and Transplant Registry.

PubMed

McDonald, Stephen P

2015-06-01

The ANZDATA Registry includes all patients treated with renal replacement therapy (RRT) throughout Australia and New Zealand. Funding is predominantly from government sources, together with the non-government organization Kidney Health Australia. Registry operations are overseen by an Executive committee, and a Steering Committee with wide representation. Data is collected from renal units throughout Australia and New Zealand on a regular basis, and forwarded to the Registry. Areas covered include demographic details, primary renal disease, type of renal replacement therapy, process measures, and a variety of outcomes. From this data collection a number of themes of work are produced. These include production of Registry reports with an extensive range of national and regional data, a suite of quality assurance reports, key process indicator (KPI) reports, and data sets for a variety of audit and research purposes. The various types of information from the ANZDATA Registry are used in a wide variety of areas, including health services planning, safety and quality programs, and clinical research projects.

Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation: results of the German STARR registry.

PubMed

Schwandner, Oliver; Fürst, Alois

2010-06-01

Internal rectal prolapse and rectocele are frequent clinical findings in patients with obstructed defecation syndrome (ODS). However, there is still no evidence whether stapled transanal rectal resection (STARR) provides a safe and effective surgical option. Therefore, the German STARR registry was initiated to assess safety, effectiveness, and quality of life. The German STARR registry was designed as an interventional, prospective, multicenter audit. Primary outcomes include safety (morbidity and adverse events), effectiveness (ODS, symptom severity, and incontinence scores), and quality of life (PAC-QoL and EQ-5D) documented at baseline and at 6 and 12 months. Statistical evaluation was performed by an independent research organization of clinical epidemiology. Complete data of 379 patients (78% females, mean age 57.8 years) were entered into the registry database. Mean operative time was 40 min, mean hospitalization was 5.5 days. A total of 103 complications and adverse events were reported in 80 patients (21.1%) including staple line complications (minor bleeding, infection, or partial dehiscence; 7.1%), major bleeding (2.9%), and postsurgical stenosis (2.1%). Comparisons of ODS and symptom severity scores (SSS) demonstrated a significant reduction in ODS score between baseline (mean 11.14) and 6 months (mean 6.43), which was maintained at 12 months (mean 6.45), and SSS at preoperative and at 6- and 12-month follow-up (13.02 vs. 7.34 vs. 6.59; paired t test, p < 0.001). Significant reduction in ODS symptoms was matched by an improvement in quality of life as judged by symptom-specific PAC-QoL and generic ED-5Q (utility and visual analog scale) scores and was not associated with an impairment of incontinence score following STARR (p > 0.05). However, 11 patients (2.9%) showed de novo incontinence, and new-onset symptoms of fecal urgency were observed in 25.3% of patients. These data indicate that STARR is a safe and effective procedure. However, conclusions are limited due to the selection and reporting bias of a registry. The problem of fecal urgency needs cautious reassessment.

University of TX Bureau of Economic Geology's Core Research Centers: The Time is Right for Registering Physical Samples and Assigning IGSN's - Workflows, Stumbling Blocks, and Successes.

NASA Astrophysics Data System (ADS)

Averett, A.; DeJarnett, B. B.

2016-12-01

The University Of Texas Bureau Of Economic Geology (BEG) serves as the geological survey for Texas and operates three geological sample repositories that house well over 2 million boxes of geological samples (cores and cuttings) and an abundant amount of geoscience data (geophysical logs, thin sections, geochemical analyses, etc.). Material is accessible and searchable online, and it is publically available to the geological community for research and education. Patrons access information about our collection by using our online core and log database (SQL format). BEG is currently undertaking a large project to: 1) improve the internal accuracy of metadata associated with the collection; 2) enhance the capabilities of the database for both BEG curators and researchers as well as our external patrons; and 3) ensure easy and efficient navigation for patrons through our online portal. As BEG undertakes this project, BEG is in the early stages of planning to export the metadata for its collection into SESAR (System for Earth Sample Registration) and have IGSN's (International GeoSample Numbers) assigned to its samples. Education regarding the value of IGSN's and an external registry (SESAR) has been crucial to receiving management support for the project because the concept and potential benefits of registering samples in a registry outside of the institution were not well-known prior to this project. Potential benefits such as increases in discoverability, repository recognition in publications, and interoperability were presented. The project was well-received by management, and BEG fully supports the effort to register our physical samples with SESAR. Since BEG is only in the initial phase of this project, any stumbling blocks, workflow issues, successes/failures, etc. can only be predicted at this point, but by mid-December, BEG expects to have several concrete issues to present in the session. Currently, our most pressing issue involves establishing the most efficient workflow for exporting of large amounts of metadata in a format that SESAR can easily ingest, and how this can be best accomplished with very few BEG staff assigned to the project.

Feasibility of evaluating quality cancer care using registry data and electronic health records: a population-based study.

PubMed

Caldarella, Adele; Amunni, Gianni; Angiolini, Catia; Crocetti, Emanuele; Di Costanzo, Francesco; Di Leo, Angelo; Giusti, Francesco; Pegna, Andrea Lopes; Mantellini, Paola; Luzzatto, Lucio; Paci, Eugenio

2012-08-01

To evaluate the quality of patients care, a set of indicators of the standards of cancer care were defined. We developed a set of indicators to assess the implementation in daily practice of recommendation produced by a regional network (Istituto Toscano Tumori). This set was tested in a retrospective study in the resident population of the Tuscany Region; the regional health system is organized on 12 local health authorities which refer to three macro areas (Area Vasta). The study included incident colorectal, lung and breast cancer cases listed in 2004 for the Tuscan Cancer Registry, a population-based registry which collected tumor cases diagnosed in all residents in Tuscany. Electronic data from registry database were used to determine the compliance with each indicator for patients in 2004. To validate the results, an ad hoc clinical survey including the same geographical area for the year 2006 was performed. None. The proportion of patients who fulfilled each of the indicators. Our study showed the feasibility of the evaluation of the quality of cancer care using cancer registry population-based data and major computerized information systems. The estimation of the selected indicators confirmed a good homogeneity among areas, and globally revealed a good intraregional performance. Further work is needed to develop specific quality measures, particularly about structural data and to continually revise indicators of quality of care. Data from a cancer registry, however, can be useful to evaluate quality of cancer care.

The European Narcolepsy Network (EU-NN) database.

PubMed

Khatami, Ramin; Luca, Gianina; Baumann, Christian R; Bassetti, Claudio L; Bruni, Oliviero; Canellas, Francesca; Dauvilliers, Yves; Del Rio-Villegas, Rafael; Feketeova, Eva; Ferri, Raffaele; Geisler, Peter; Högl, Birgit; Jennum, Poul; Kornum, Birgitte R; Lecendreux, Michel; Martins-da-Silva, Antonio; Mathis, Johannes; Mayer, Geert; Paiva, Teresa; Partinen, Markku; Peraita-Adrados, Rosa; Plazzi, Guiseppe; Santamaria, Joan; Sonka, Karel; Riha, Renata; Tafti, Mehdi; Wierzbicka, Aleksandra; Young, Peter; Lammers, Gert Jan; Overeem, Sebastiaan

2016-06-01

Narcolepsy with cataplexy is a rare disease with an estimated prevalence of 0.02% in European populations. Narcolepsy shares many features of rare disorders, in particular the lack of awareness of the disease with serious consequences for healthcare supply. Similar to other rare diseases, only a few European countries have registered narcolepsy cases in databases of the International Classification of Diseases or in registries of the European health authorities. A promising approach to identify disease-specific adverse health effects and needs in healthcare delivery in the field of rare diseases is to establish a distributed expert network. A first and important step is to create a database that allows collection, storage and dissemination of data on narcolepsy in a comprehensive and systematic way. Here, the first prospective web-based European narcolepsy database hosted by the European Narcolepsy Network is introduced. The database structure, standardization of data acquisition and quality control procedures are described, and an overview provided of the first 1079 patients from 18 European specialized centres. Due to its standardization this continuously increasing data pool is most promising to provide a better insight into many unsolved aspects of narcolepsy and related disorders, including clear phenotype characterization of subtypes of narcolepsy, more precise epidemiological data and knowledge on the natural history of narcolepsy, expectations about treatment effects, identification of post-marketing medication side-effects, and will contribute to improve clinical trial designs and provide facilities to further develop phase III trials. © 2016 European Sleep Research Society.

An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry.

PubMed

Woodward, Len; Johnson, Sally; Walle, Johan Vande; Beck, Joran; Gasteyger, Christoph; Licht, Christoph; Ariceta, Gema

2016-11-21

Patients are becoming increasingly involved in research which can promote innovation through novel ideas, support patient-centred actions, and facilitate drug development. For rare diseases, registries that collect data from patients can increase knowledge of the disease's natural history, evaluate clinical therapies, monitor drug safety, and measure quality of care. The active participation of patients is expected to optimise rare-disease management and improve patient outcomes. However, few reports address the type and frequency of interactions involving patients, and what research input patient groups have. Here, we describe a collaboration between an international group of patient organisations advocating for patients with atypical haemolytic uraemic syndrome (aHUS), the aHUS Alliance, and an international aHUS patient registry (ClinicalTrials.gov NCT01522183). The aHUS Registry Scientific Advisory Board (SAB) invited the aHUS Alliance to submit research ideas important to patients with aHUS. This resulted in 24 research suggestions from patients and patient organisations being presented to the SAB. The proposals were classified under seven categories, the most popular of which were understanding factors that cause disease manifestations and learning more about the clinical and psychological/social impact of living with the disease. Subsequently, aHUS Alliance members voted for up to five research priorities. The top priority was: "What are the outcomes of a transplant without eculizumab and what non-kidney damage is likely in patients with aHUS?". This led directly to the initiation of an ongoing analysis of the data collected in the Registry on patients with kidney transplants. This collaboration resulted in several topics proposed by the aHUS Alliance being selected as priority activities for the aHUS Registry, with one new analysis already underway. A clear pathway was established for engagement between a patient advocacy group and an international research network. This should ensure the development of a long-term partnership which clearly benefits both groups.

The Research Implications of Prostate Specific Antigen Registry Errors: Data from the Veterans Health Administration.

PubMed

Guo, David P; Thomas, I-Chun; Mittakanti, Harsha R; Shelton, Jeremy B; Makarov, Danil V; Skolarus, Ted A; Cooperberg, Mathew R; Sonn, Geoffrey A; Chung, Benjamin I; Brooks, James D; Leppert, John T

2018-04-06

We sought to characterize the effects of prostate specific antigen registry errors on clinical research by comparing cohorts based on cancer registry prostate specific antigen values with those based directly on results in the electronic health record. We defined sample cohorts of men with prostate cancer using data from the VHA (Veterans Health Administration), including those with a prostate specific antigen value less than 4.0, 4.0 to 10.0, 10.0 to 20.0 and 20.0 to 98.0 ng/ml, respectively. We compared the composition of each cohort and overall patient survival when using PSA values from the VACCR (Veteran Affairs Central Cancer Registry) vs the gold standard electronic health record laboratory file results. There was limited agreement among cohorts when defined by cancer registry PSA values vs the laboratory file of the electronic health record. The least agreement of 58% was seen in patients with PSA less than 4.0 ng/ml and greatest agreement of 89% was noted among patients with PSA between 4.0 and 10.0 ng/ml. In each cohort patients assigned to a cohort based only on the cancer registry PSA value had significantly different overall survival when compared with patients assigned based on registry and laboratory file PSA values. Cohorts based exclusively on cancer registry PSA values may have high rates of misclassification that can introduce concerning differences in key characteristics and result in measurable differences in clinical outcomes. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Using State Early Care and Education Workforce Registry Data to Inform Training-Related Questions: Issues to Consider. Research Report. ETS RR-16-31

ERIC Educational Resources Information Center

Ackerman, Debra J.

2016-01-01

The current early care and education (ECE) policy context is bringing increased attention to the training completed by the child care workforce and to the use of registries to track such training. Although ECE workforce registries are designed to record individuals' data, aggregate registry data have the potential to shed light on the workforce's…

Identification of biomedical journals in Spain and Latin America.

PubMed

Bonfill, Xavier; Osorio, Dimelza; Posso, Margarita; Solà, Ivan; Rada, Gabriel; Torres, Ania; García Dieguez, Marcelo; Piña-Pozas, Maricela; Díaz-García, Luisa; Tristán, Mario; Gandarilla, Omar; Rincón-Valenzuela, David A; Martí, Arturo; Hidalgo, Ricardo; Simancas-Racines, Daniel; López, Luis; Correa, Ricardo; Rojas-De-Arias, Antonieta; Loza, César; Gianneo, Óscar; Pardo, Hector

2015-12-01

Journals in languages other than English that publish original clinical research are often not well covered in the main biomedical databases and therefore often not included in systematic reviews. This study aimed to identify Spanish language biomedical journals from Spain and Latin America and to describe their main features. Journals were identified in electronic databases, publishers' catalogues and local registries. Eligibility was determined by assessing data from these sources or the journals' websites, when available. A total of 2457 journals were initially identified; 1498 met inclusion criteria. Spain (27.3%), Mexico (16.0%), Argentina (15.1%) and Chile (11.9%) had the highest number of journals. Most (85.8%) are currently active; 87.8% have an ISSN. The median and mean length of publication were 22 and 29 years, respectively. A total of 66.0% were indexed in at least one database; 3.0% had an impact factor in 2012. A total of 845 journals had websites (56.4%), of which 700 (82.8%) were searchable and 681 (80.6%) free of charge. Most of the identified journals have no impact factor or are not indexed in any of the major databases. The list of identified biomedical journals can be a useful resource when conducting hand searching activities and identifying clinical trials that otherwise would not be retrieved. © 2015 Health Libraries Group.

BGDMdocker: a Docker workflow for data mining and visualization of bacterial pan-genomes and biosynthetic gene clusters.

PubMed

Cheng, Gong; Lu, Quan; Ma, Ling; Zhang, Guocai; Xu, Liang; Zhou, Zongshan

2017-01-01

Recently, Docker technology has received increasing attention throughout the bioinformatics community. However, its implementation has not yet been mastered by most biologists; accordingly, its application in biological research has been limited. In order to popularize this technology in the field of bioinformatics and to promote the use of publicly available bioinformatics tools, such as Dockerfiles and Images from communities, government sources, and private owners in the Docker Hub Registry and other Docker-based resources, we introduce here a complete and accurate bioinformatics workflow based on Docker. The present workflow enables analysis and visualization of pan-genomes and biosynthetic gene clusters of bacteria. This provides a new solution for bioinformatics mining of big data from various publicly available biological databases. The present step-by-step guide creates an integrative workflow through a Dockerfile to allow researchers to build their own Image and run Container easily.

BGDMdocker: a Docker workflow for data mining and visualization of bacterial pan-genomes and biosynthetic gene clusters

PubMed Central

Cheng, Gong; Zhang, Guocai; Xu, Liang

2017-01-01

Recently, Docker technology has received increasing attention throughout the bioinformatics community. However, its implementation has not yet been mastered by most biologists; accordingly, its application in biological research has been limited. In order to popularize this technology in the field of bioinformatics and to promote the use of publicly available bioinformatics tools, such as Dockerfiles and Images from communities, government sources, and private owners in the Docker Hub Registry and other Docker-based resources, we introduce here a complete and accurate bioinformatics workflow based on Docker. The present workflow enables analysis and visualization of pan-genomes and biosynthetic gene clusters of bacteria. This provides a new solution for bioinformatics mining of big data from various publicly available biological databases. The present step-by-step guide creates an integrative workflow through a Dockerfile to allow researchers to build their own Image and run Container easily. PMID:29204317

Biliary atresia: unity in diversity.

PubMed

Petersen, Claus

2017-12-01

Biliary atresia (BA) is a rare disease of unknown origin and unsatisfying outcome. Single, multicenter and national evaluations of epidemiological and outcome data on BA have been periodically published over the course of decades. However, the diversity of the registered parameters and outcome measures impede comparability and cumulative analysis of these very worthwhile studies. Taking into account the fact that BA is a good example of translational research and transition of patients from pediatric surgery and hepatology to transplant surgery and hepatology in general, the interdisciplinary community should make every effort to develop a common platform upon which further activities are conducted. Extending this topic to BA-related diseases might increase the acceptance of research studies and enhance the effectiveness of any recommendations outlined therein. The use of the Internet-based communication platform and registry on http://www.bard-online.com represents the first step in this direction, and the database should be viewed as a helpful tool that guides further activities.

Pharmacology Portal: An Open Database for Clinical Pharmacologic Laboratory Services.

PubMed

Karlsen Bjånes, Tormod; Mjåset Hjertø, Espen; Lønne, Lars; Aronsen, Lena; Andsnes Berg, Jon; Bergan, Stein; Otto Berg-Hansen, Grim; Bernard, Jean-Paul; Larsen Burns, Margrete; Toralf Fosen, Jan; Frost, Joachim; Hilberg, Thor; Krabseth, Hege-Merete; Kvan, Elena; Narum, Sigrid; Austgulen Westin, Andreas

2016-01-01

More than 50 Norwegian public and private laboratories provide one or more analyses for therapeutic drug monitoring or testing for drugs of abuse. Practices differ among laboratories, and analytical repertoires can change rapidly as new substances become available for analysis. The Pharmacology Portal was developed to provide an overview of these activities and to standardize the practices and terminology among laboratories. The Pharmacology Portal is a modern dynamic web database comprising all available analyses within therapeutic drug monitoring and testing for drugs of abuse in Norway. Content can be retrieved by using the search engine or by scrolling through substance lists. The core content is a substance registry updated by a national editorial board of experts within the field of clinical pharmacology. This ensures quality and consistency regarding substance terminologies and classification. All laboratories publish their own repertoires in a user-friendly workflow, adding laboratory-specific details to the core information in the substance registry. The user management system ensures that laboratories are restricted from editing content in the database core or in repertoires within other laboratory subpages. The portal is for nonprofit use, and has been fully funded by the Norwegian Medical Association, the Norwegian Society of Clinical Pharmacology, and the 8 largest pharmacologic institutions in Norway. The database server runs an open-source content management system that ensures flexibility with respect to further development projects, including the potential expansion of the Pharmacology Portal to other countries. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Instructor Quality Affecting Emergency Medical Technician (EMT) Preparedness: A LEADS Project

ERIC Educational Resources Information Center

Russ-Eft, Darlene F.; Dickison, Philip D.; Levine, Roger

2005-01-01

This represents one of a series of studies of the Longitudinal Emergency Medical Technician Attributes and Demographics Study (LEADS) being undertaken by the National Registry of Emergency Medical Technicians and the National Highway Traffic Safety Administration (NHTSA). This secondary analysis of the LEADS database, which provides a…

Cyberspace as a Theater of Conflict: Federal Law, National Strategy and the Departments of Defense and Homeland Security

DTIC Science & Technology

2007-06-01

short period of time. When web search organizations canvas the web looking for sites to catalog, they will discover your systems and create registry... Fingerprint & DNA Databases, INTERPOL & National Law Enforcement Communication Systems, Firearms Registration Records, Drivers License, Birth

Child Care: State Requirements for Background Checks.

ERIC Educational Resources Information Center

Fagnoni, Cynthia

Background checks involve gathering information from state and federal databases to determine if child care providers have a history of child abuse or other criminal convictions that would make them unacceptable for working with children. Background checks include state criminal history checks, state child abuse registry checks, and Federal Bureau…

Impact of Inclusion of Industry Trial Results Registries as an Information Source for Systematic Reviews

PubMed Central

Potthast, Regine; Vervölgyi, Volker; McGauran, Natalie; Kerekes, Michaela F.; Wieseler, Beate; Kaiser, Thomas

2014-01-01

Background Clinical trial results registries may contain relevant unpublished information. Our main aim was to investigate the potential impact of the inclusion of reports from industry results registries on systematic reviews (SRs). Methods We identified a sample of 150 eligible SRs in PubMed via backward selection. Eligible SRs investigated randomized controlled trials of drugs and included at least 2 bibliographic databases (original search date: 11/2009). We checked whether results registries of manufacturers and/or industry associations had also been searched. If not, we searched these registries for additional trials not considered in the SRs, as well as for additional data on trials already considered. We reanalysed the primary outcome and harm outcomes reported in the SRs and determined whether results had changed. A “change” was defined as either a new relevant result or a change in the statistical significance of an existing result. We performed a search update in 8/2013 and identified a sample of 20 eligible SRs to determine whether mandatory results registration from 9/2008 onwards in the public trial and results registry ClinicalTrials.gov had led to its inclusion as a standard information source in SRs, and whether the inclusion rate of industry results registries had changed. Results 133 of the 150 SRs (89%) in the original analysis did not search industry results registries. For 23 (17%) of these SRs we found 25 additional trials and additional data on 31 trials already included in the SRs. This additional information was found for more than twice as many SRs of drugs approved from 2000 as approved beforehand. The inclusion of the additional trials and data yielded changes in existing results or the addition of new results for 6 of the 23 SRs. Of the 20 SRs retrieved in the search update, 8 considered ClinicalTrials.gov or a meta-registry linking to ClinicalTrials.gov, and 1 considered an industry results registry. Conclusion The inclusion of industry and public results registries as an information source in SRs is still insufficient and may result in publication and outcome reporting bias. In addition to an essential search in ClinicalTrials.gov, authors of SRs should consider searching industry results registries. PMID:24743113

Digital Management and Curation of the National Rock and Ore Collections at NMNH, Smithsonian

NASA Astrophysics Data System (ADS)

Cottrell, E.; Andrews, B.; Sorensen, S. S.; Hale, L. J.

2011-12-01

The National Museum of Natural History, Smithsonian Institution, is home to the world's largest curated rock collection. The collection houses 160,680 physical rock and ore specimen lots ("samples"), all of which already have a digital record that can be accessed by the public through a searchable web interface (http://collections.mnh.si.edu/search/ms/). In addition, there are 66 accessions pending that when catalogued will add approximately 60,000 specimen lots. NMNH's collections are digitally managed on the KE EMu° platform which has emerged as the premier system for managing collections in natural history museums worldwide. In 2010 the Smithsonian released an ambitious 5 year Digitization Strategic Plan. In Mineral Sciences, new digitization efforts in the next five years will focus on integrating various digital resources for volcanic specimens. EMu sample records will link to the corresponding records for physical eruption information housed within the database of Smithsonian's Global Volcanism Program (GVP). Linkages are also planned between our digital records and geochemical databases (like EarthChem or PetDB) maintained by third parties. We anticipate that these linkages will increase the use of NMNH collections as well as engender new scholarly directions for research. Another large project the museum is currently undertaking involves the integration of the functionality of in-house designed Transaction Management software with the EMu database. This will allow access to the details (borrower, quantity, date, and purpose) of all loans of a given specimen through its catalogue record. We hope this will enable cross-referencing and fertilization of research ideas while avoiding duplicate efforts. While these digitization efforts are critical, we propose that the greatest challenge to sample curation is not posed by digitization and that a global sample registry alone will not ensure that samples are available for reuse. We suggest instead that the ability of the Earth science community to identify and preserve important collections and make them available for future study is limited by personnel and space resources from the level of the individual PI to the level of national facilities. Moreover, when it comes to specimen "estate planning," the cultural attitudes of scientists, institutions, and funding agencies are often inadequate to provide for long-term specimen curation - even if specimen discovery is enabled by digital registry. Timely access to curated samples requires that adequate resources be devoted to the physical care of specimens (facilities) and to the personnel costs associated with curation - from the conservation, storage, and inventory management of specimens, to the dispersal of samples for research, education, and exhibition.

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank.

PubMed

Al-Khatib, Sana M; Calkins, Hugh; Eloff, Benjamin C; Kowey, Peter; Hammill, Stephen C; Ellenbogen, Kenneth A; Marinac-Dabic, Danica; Waldo, Albert L; Brindis, Ralph G; Wilbur, David J; Jackman, Warren M; Yaross, Marcia S; Russo, Andrea M; Prystowsky, Eric; Varosy, Paul D; Gross, Thomas; Pinnow, Ellen; Turakhia, Mintu P; Krucoff, Mitchell W

2010-10-01

Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry. Copyright © 2010 Mosby, Inc. All rights reserved.

Presenting an evaluation model of the trauma registry software.

PubMed

Asadi, Farkhondeh; Paydar, Somayeh

2018-04-01

Trauma is a major cause of 10% death in the worldwide and is considered as a global concern. This problem has made healthcare policy makers and managers to adopt a basic strategy in this context. Trauma registry has an important and basic role in decreasing the mortality and the disabilities due to injuries resulted from trauma. Today, different software are designed for trauma registry. Evaluation of this software improves management, increases efficiency and effectiveness of these systems. Therefore, the aim of this study is to present an evaluation model for trauma registry software. The present study is an applied research. In this study, general and specific criteria of trauma registry software were identified by reviewing literature including books, articles, scientific documents, valid websites and related software in this domain. According to general and specific criteria and related software, a model for evaluating trauma registry software was proposed. Based on the proposed model, a checklist designed and its validity and reliability evaluated. Mentioned model by using of the Delphi technique presented to 12 experts and specialists. To analyze the results, an agreed coefficient of %75 was determined in order to apply changes. Finally, when the model was approved by the experts and professionals, the final version of the evaluation model for the trauma registry software was presented. For evaluating of criteria of trauma registry software, two groups were presented: 1- General criteria, 2- Specific criteria. General criteria of trauma registry software were classified into four main categories including: 1- usability, 2- security, 3- maintainability, and 4-interoperability. Specific criteria were divided into four main categories including: 1- data submission and entry, 2- reporting, 3- quality control, 4- decision and research support. The presented model in this research has introduced important general and specific criteria of trauma registry software and sub criteria related to each main criteria separately. This model was validated by experts in this field. Therefore, this model can be used as a comprehensive model and a standard evaluation tool for measuring efficiency and effectiveness and performance improvement of trauma registry software. Copyright © 2018 Elsevier B.V. All rights reserved.

Strategies for successful trauma registry implementation in low- and middle-income countries-protocol for a systematic review.

PubMed

Paradis, Tiffany; St-Louis, Etienne; Landry, Tara; Poenaru, Dan

2018-02-21

The benefits of trauma registries have been well described. The crucial data they provide may guide injury prevention strategies, inform resource allocation, and support advocacy and policy. This has been shown to reduce trauma-related mortality in various settings. Trauma remains a leading cause of mortality in low- and middle-income countries (LMICs). However, the implementation of trauma registries in LMICs can be challenging due to lack of funding, specialized personnel, and infrastructure. This study explores strategies for successful trauma registry implementation in LMICs. The protocol was registered a priori (CRD42017058586). A peer-reviewed search strategy of multiple databases will be developed with a senior librarian. As per PRISMA guidelines, first screen of references based on abstract and title and subsequent full-text review will be conducted by two independent reviewers. Disagreements that cannot be resolved by discussion between reviewers shall be arbitrated by the principal investigator. Data extraction will be performed using a pre-defined data extraction sheet. Finally, bibliographies of included articles will be hand-searched. Studies of any design will be included if they describe or review development and implementation of a trauma registry in LMICs. No language or period restrictions will be applied. Summary statistics and qualitative meta-narrative analyses will be performed. The significant burden of trauma in LMIC environments presents unique challenges and limitations. Adapted strategies for deployment and maintenance of sustainable trauma registries are needed. Our methodology will systematically identify recommendations and strategies for successful trauma registry implementation in LMICs and describe threats and barriers to this endeavor. The protocol was registered on the PROSPERO international prospective register of systematic reviews ( CRD42017058586 ).

The registry case finding engine: an automated tool to identify cancer cases from unstructured, free-text pathology reports and clinical notes.

PubMed

Hanauer, David A; Miela, Gretchen; Chinnaiyan, Arul M; Chang, Alfred E; Blayney, Douglas W

2007-11-01

The American College of Surgeons mandates the maintenance of a cancer registry for hospitals seeking accreditation. At the University of Michigan Health System, more than 90% of all registry patients are identified by manual review, a method common to many institutions. We hypothesized that an automated computer system could accurately perform this time- and labor-intensive task. We created a tool to automatically scan free-text medical documents for terms relevant to cancer. We developed custom-made lists containing approximately 2,500 terms and phrases and 800 SNOMED codes. Text is processed by the Case Finding Engine (CaFE), and relevant terms are highlighted for review by a registrar and used to populate the registry database. We tested our system by comparing results from the CaFE to those by trained registrars who read through 2,200 pathology reports and marked relevant cases for the registry. The clinical documentation (eg, electronic chart notes) of an additional 476 patients was also reviewed by registrars and compared with the automated process by the CaFE. For pathology reports, the sensitivity for automated case identification was 100%, but specificity was 85.0%. For clinical documentation, sensitivity was 100% and specificity was 73.7%. Types of errors made by the CaFE were categorized to direct additional improvements. Use of the CaFE has resulted in a considerable increase in the number of cases added to the registry each month. The system has been well accepted by our registrars. CaFE can improve the accuracy and efficiency of tumor registry personnel and helps ensure that cancer cases are not overlooked.

Developing a standardized healthcare cost data warehouse.

PubMed

Visscher, Sue L; Naessens, James M; Yawn, Barbara P; Reinalda, Megan S; Anderson, Stephanie S; Borah, Bijan J

2017-06-12

Research addressing value in healthcare requires a measure of cost. While there are many sources and types of cost data, each has strengths and weaknesses. Many researchers appear to create study-specific cost datasets, but the explanations of their costing methodologies are not always clear, causing their results to be difficult to interpret. Our solution, described in this paper, was to use widely accepted costing methodologies to create a service-level, standardized healthcare cost data warehouse from an institutional perspective that includes all professional and hospital-billed services for our patients. The warehouse is based on a National Institutes of Research-funded research infrastructure containing the linked health records and medical care administrative data of two healthcare providers and their affiliated hospitals. Since all patients are identified in the data warehouse, their costs can be linked to other systems and databases, such as electronic health records, tumor registries, and disease or treatment registries. We describe the two institutions' administrative source data; the reference files, which include Medicare fee schedules and cost reports; the process of creating standardized costs; and the warehouse structure. The costing algorithm can create inflation-adjusted standardized costs at the service line level for defined study cohorts on request. The resulting standardized costs contained in the data warehouse can be used to create detailed, bottom-up analyses of professional and facility costs of procedures, medical conditions, and patient care cycles without revealing business-sensitive information. After its creation, a standardized cost data warehouse is relatively easy to maintain and can be expanded to include data from other providers. Individual investigators who may not have sufficient knowledge about administrative data do not have to try to create their own standardized costs on a project-by-project basis because our data warehouse generates standardized costs for defined cohorts upon request.

The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients.

PubMed

Gomes, Walter J; Moreira, Rita Simone; Zilli, Alexandre Cabral; Bettiati, Luiz Carlos; Figueira, Fernando Augusto Marinho Dos Santos; D' Azevedo, Stephanie Steremberg Pires; Soares, Marcelo José Ferreira; Fernandes, Marcio Pimentel; Ardito, Roberto Vito; Bogdan, Renata Andrea Barberio; Campagnucci, Valquíria Pelisser; Nakasako, Diana; Kalil, Renato Abdala Karam; Rodrigues, Clarissa Garcia; Rodrigues, Anilton Bezerra; Cascudo, Marcelo Matos; Atik, Fernando Antibas; Lima, Elson Borges; Nina, Vinicius José da Silva; Heluy, Renato Albuquerque; Azeredo, Lisandro Gonçalves; Henrique, Odilon Silva; Mendonça, José Teles de; Silva, Katharina Kelly de Oliveira Gama; Pandolfo, Marcelo; Lima, José Dantas de; Faria, Renato Max; Santos, Jonas Pereira Dos; Paez, Rodrigo Pereira; Coelho, Guilherme Henrique Biachi; Pereira, Sergio Nunes; Senger, Roberta; Buffolo, Enio; Caputi, Guido Marco; Santo, José Amalth do Espírito; Oliveira, Juliana Aparecida Borges de; Berwanger, Otavio; Cavalcanti, Alexandre Biasi; Jatene, Fabio B

2017-01-01

To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.

Promoting Awareness of Key Resources for Evidence-Informed Decision-making in Public Health: An Evaluation of a Webinar Series about Knowledge Translation Methods and Tools

PubMed Central

Yost, Jennifer; Mackintosh, Jeannie; Read, Kristin; Dobbins, Maureen

2016-01-01

The National Collaborating Centre for Methods and Tools (NCCMT) has developed several resources to support evidence-informed decision-making – the process of distilling and disseminating best available evidence from research, context, and experience – and knowledge translation, applying best evidence in practice. One such resource, the Registry of Methods and Tools, is a free online database of 195 methods and tools to support knowledge translation. Building on the identification of webinars as a strategy to improve the dissemination of information, NCCMT launched the Spotlight on Knowledge Translation Methods and Tools webinar series in 2012 to promote awareness and use of the Registry. To inform continued implementation of this webinar series, NCCMT conducted an evaluation of the series’ potential to improve awareness and use of the methods/tools within the Registry, as well as identify areas for improvement and “what worked.” For this evaluation, the following data were analyzed: electronic follow-up surveys administered immediately following each webinar; an additional electronic survey administered 6 months after two webinars; and Google Analytics for each webinar. As of November 2015, there have been 22 webinars conducted, reaching 2048 people in multiple sectors across Canada and around the world. Evaluation results indicate that the webinars increase awareness about the Registry and stimulate use of the methods/tools. Although webinar attendees were significantly less likely to have used the methods/tools 6 months after webinars, this may be attributed to the lack of an identified opportunity in their work to use the method/tool. Despite technological challenges and requests for further examples of how the methods/tools have been used, there is overwhelming positive feedback that the format, presenters, content, and interaction across webinars “worked.” This evaluation supports that webinars are a valuable strategy for increasing awareness and stimulating use of resources for evidence-informed decision-making and knowledge translation in public health practice. PMID:27148518

Disease-related costs of care and survival among Medicare-enrolled patients with myelodysplastic syndromes.

PubMed

Zeidan, Amer M; Wang, Rong; Davidoff, Amy J; Ma, Shuangge; Zhao, Yinjun; Gore, Steven D; Gross, Cary P; Ma, Xiaomei

2016-05-15

Although newer treatments for myelodysplastic syndromes (MDS), particularly hypomethylating agents (HMAs), are expensive, it is unclear whether MDS-related costs of care are associated with overall survival. This study evaluated the relation between MDS-related costs and survival among Medicare beneficiaries with MDS. Eligible patients were identified from the Surveillance, Epidemiology, and End Results-Medicare database with codes for MDS from International Classification of Diseases for Oncology, 3rd edition. The patients were diagnosed between January 1, 2005 and December 31, 2011, were 66 years old or older, and were followed through death or the end of study (December 31, 2012). Medicare payments were used to estimate costs. Cumulative costs in a propensity score-matched group of cancer-free Medicare beneficiaries were subtracted from costs in the MDS cohort in each registry to estimate MDS-related costs. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived from multivariate Cox proportional hazards models adjusted for patient and disease characteristics. There were 8580 eligible patients, and 1,267 (14.7%) received HMAs. The overall 2-year survival rate was 48.7%, and the 2-year registry-specific MDS-related cost per patient ranged from $40,793 to $78,156 across 16 registries. The 2-year MDS-related cost was not associated with survival in the overall study population (first tertile, reference; second tertile, HR, 0.96; 95% CI, 0.89-1.04; P = .29; third tertile, HR, 0.98; 95% CI, 0.91-1.06; P = .64) or in subgroups of patients who did or did not receive HMAs. Medicare expenditures for elderly patients with MDS varied across registries but were not associated with survival. A lack of an association between costs and outcomes warrants additional research because it may help to identify potential areas for cost-saving interventions without compromising patient outcomes. Cancer 2016;122:1598-607. © 2016 American Cancer Society. © 2016 American Cancer Society.

Cancer registration, public health and the reform of the European data protection framework: Abandoning or improving European public health research?

PubMed

Andersen, Mette Rye; Storm, Hans H

2015-06-01

The importance of cancer- and other disease registries for planning, management and evaluation of healthcare systems has been shown repeatedly during the last 50 years. Complete and unbiased population-level analyses on routinely collected, individual data concerning health and personal characteristics can address significant concerns about risk factors for cancer and provide sound evidence about public health and the effectiveness of healthcare systems. The existence of quality controlled and comprehensive data in registries, allowed to be used for quality control, research and public health purposes are taken as granted by most health professionals and researchers. However, the current revision of the European Union (EU) data protection framework suggests a harmonisation of requirements for confidentiality and individual consent to data processing, likely at the expense of proper use of registry data in the health sector. Consequences of excessive confidentiality rules that may lead to missed data linkages have been simulated. The simulations provide one possible explanation for observed heterogeneity among some cancer incidence data. Further, public health, quality control and epidemiological research on large populations can no longer provide evidence for health interventions, if requirements for consent renders research impossible or where attempts to obtain consent from each data subject generates biased results. Health professionals should engage in the on-going debate on the Commission's proposal for a General Data Protection Regulation. The nature and use of registry data in public health research must be explained and known to policy-makers and the public. Use of cancer registry data and other epidemiological activity will terminate abruptly if an unnecessarily strict EU data protection regulation is adopted. Research based interventions, as well as the international recognised standing of cancer registries and register-based research institutions in Europe are at stake. Copyright © 2013 Elsevier Ltd. All rights reserved.

The CNDR: collaborating to translate new therapies for Canadians.

PubMed

Korngut, Lawrence; Campbell, Craig; Johnston, Megan; Benstead, Timothy; Genge, Angela; Mackenzie, Alex; McCormick, Anna; Biggar, Douglas; Bourque, Pierre; Briemberg, Hannah; O'Connell, Colleen; Dojeiji, Suzan; Dooley, Joseph; Grant, Ian; Hogan, Gillian; Johnston, Wendy; Kalra, Sanjay; Katzberg, Hans D; Mah, Jean K; McAdam, Laura; McMillan, Hugh J; Melanson, Michel; Selby, Kathryn; Shoesmith, Christen; Smith, Garth; Venance, Shannon L; Wee, Joy

2013-09-01

Patient registries represent an important method of organizing "real world" patient information for clinical and research purposes. Registries can facilitate clinical trial planning and recruitment and are particularly useful in this regard for uncommon and rare diseases. Neuromuscular diseases (NMDs) are individually rare but in aggregate have a significant prevalence. In Canada, information on NMDs is lacking. Barriers to performing Canadian multicentre NMD research exist which can be overcome by a comprehensive and collaborative NMD registry. We describe the objectives, design, feasibility and initial recruitment results for the Canadian Neuromuscular Disease Registry (CNDR). The CNDR is a clinic-based registry which launched nationally in June 2011, incorporates paediatric and adult neuromuscular clinics in British Columbia, Alberta, Ontario, Quebec, New Brunswick and Nova Scotia and, as of December 2012, has recruited 1161 patients from 12 provinces and territories. Complete medical datasets have been captured on 460 "index disease" patients. Another 618 "non-index" patients have been recruited with capture of physician-confirmed diagnosis and contact information. We have demonstrated the feasibility of blended clinic and central office-based recruitment. "Index disease" patients recruited at the time of writing include 253 with Duchenne and Becker muscular dystrophy, 161 with myotonic dystrophy, and 71 with ALS. The CNDR is a new nationwide registry of patients with NMDs that represents an important advance in Canadian neuromuscular disease research capacity. It provides an innovative platform for organizing patient information to facilitate clinical research and to expedite translation of recent laboratory findings into human studies.

Clinical disease registries in acute myocardial infarction.

PubMed

Ashrafi, Reza; Hussain, Hussain; Brisk, Robert; Boardman, Leanne; Weston, Clive

2014-06-26

Disease registries, containing systematic records of cases, have for nearly 100 years been valuable in exploring and understanding various aspects of cardiology. This is particularly true for myocardial infarction, where such registries have provided both epidemiological and clinical information that was not readily available from randomised controlled trials in highly-selected populations. Registries, whether mandated or voluntary, prospective or retrospective in their analysis, have at their core a common study population and common data definitions. In this review we highlight how registries have diversified to offer information on epidemiology, risk modelling, quality assurance/improvement and original research-through data mining, transnational comparisons and the facilitation of enrolment in, and follow-up during registry-based randomised clinical trials.

ISS groups: are we speaking the same language?

PubMed

Rozenfeld, Michael; Radomislensky, Irina; Freedman, Laurence; Givon, Adi; Novikov, Iliya; Peleg, Kobi

2014-10-01

Despite ISS being a widely accepted tool for measuring injury severity, many researchers and practitioners use different partition of ISS into severity groups. The lack of uniformity in ISS use inhibits proper comparisons between different studies. Creation of ISS group boundaries based on single AIS value squares and their sums was proposed in 1988 during Major Trauma Study (MTOS) in the USA, but was not validated by analysis of large databases. A validation study analysing 316,944 patients in the Israeli National Trauma registry (INTR) and 249,150 patients in the American National Trauma Data Bases (NTDB). A binary algorithm (Classification and Regression Trees (CART)) was used to detect the most significantly different ISS groups and was also applied to original MTOS data. The division of ISS into groups by the CART algorithm was identical in both Trauma Registries and very similar to original division in the MTOS. For most samples, the recommended groups are 1-8, 9-14, 16-24 and 25-75, while in very large samples or in studies specifically targeting critical patients there is a possibility to divide the last group into 25-48 and 50-75 groups, with an option for further division into 50-66 and 75 groups. Using a statistical analysis of two very large databases of trauma patients, we have found that partitioning of ISS into groups based on their association with patient mortality enables us to establish clear cut-off points for these groups. We propose that the suggested partition of ISS into severity groups would be adopted as a standard in order to have a common language when discussing injury severity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

From design to implementation - The Joint Asia Diabetes Evaluation (JADE) program: A descriptive report of an electronic web-based diabetes management program

PubMed Central

2010-01-01

Background The Joint Asia Diabetes Evaluation (JADE) Program is a web-based program incorporating a comprehensive risk engine, care protocols, and clinical decision support to improve ambulatory diabetes care. Methods The JADE Program uses information technology to facilitate healthcare professionals to create a diabetes registry and to deliver an evidence-based care and education protocol tailored to patients' risk profiles. With written informed consent from participating patients and care providers, all data are anonymized and stored in a databank to establish an Asian Diabetes Database for research and publication purpose. Results The JADE electronic portal (e-portal: http://www.jade-adf.org) is implemented as a Java application using the Apache web server, the mySQL database and the Cocoon framework. The JADE e-portal comprises a risk engine which predicts 5-year probability of major clinical events based on parameters collected during an annual comprehensive assessment. Based on this risk stratification, the JADE e-portal recommends a care protocol tailored to these risk levels with decision support triggered by various risk factors. Apart from establishing a registry for quality assurance and data tracking, the JADE e-portal also displays trends of risk factor control at each visit to promote doctor-patient dialogues and to empower both parties to make informed decisions. Conclusions The JADE Program is a prototype using information technology to facilitate implementation of a comprehensive care model, as recommended by the International Diabetes Federation. It also enables health care teams to record, manage, track and analyze the clinical course and outcomes of people with diabetes. PMID:20465815

Impact of work-related cancers in Taiwan-Estimation with QALY (quality-adjusted life year) and healthcare costs.

PubMed

Lee, Lukas Jyuhn-Hsiarn; Lin, Cheng-Kuan; Hung, Mei-Chuan; Wang, Jung-Der

2016-12-01

This study estimates the annual numbers of eight work-related cancers, total losses of quality-adjusted life years (QALYs), and lifetime healthcare expenditures that possibly could be saved by improving occupational health in Taiwan. Three databases were interlinked: the Taiwan Cancer Registry, the National Mortality Registry, and the National Health Insurance Research Database. Annual numbers of work-related cancers were estimated based on attributable fractions (AFs) abstracted from a literature review. The survival functions for eight cancers were estimated and extrapolated to lifetime using a semi-parametric method. A convenience sample of 8846 measurements of patients' quality of life with EQ-5D was collected for utility values and multiplied by survival functions to estimate quality-adjusted life expectancies (QALEs). The loss-of-QALE was obtained by subtracting the QALE of cancer from age- and sex-matched referents simulated from national vital statistics. The lifetime healthcare expenditures were estimated by multiplying the survival probability with mean monthly costs paid by the National Health Insurance for cancer diagnosis and treatment and summing this for the expected lifetime. A total of 3010 males and 726 females with eight work-related cancers were estimated in 2010. Among them, lung cancer ranked first in terms of QALY loss, with an annual total loss-of-QALE of 28,463 QALYs and total lifetime healthcare expenditures of US$36.6 million. Successful prevention of eight work-related cancers would not only avoid the occurrence of 3736 cases of cancer, but would also save more than US$70 million in healthcare costs and 46,750 QALYs for the Taiwan society in 2010.

The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry.

PubMed

Cooperberg, Matthew R; Broering, Jeanette M; Litwin, Mark S; Lubeck, Deborah P; Mehta, Shilpa S; Henning, James M; Carroll, Peter R

2004-04-01

The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes. The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes. Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother. The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.

OpenTrials: towards a collaborative open database of all available information on all clinical trials.

PubMed

Goldacre, Ben; Gray, Jonathan

2016-04-08

OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.

Why does primary angioplasty not work in registries? Quantifying the susceptibility of real-world comparative effectiveness data to allocation bias.

PubMed

Sen, Sayan; Davies, Justin E; Malik, Iqbal S; Foale, Rodney A; Mikhail, Ghada W; Hadjiloizou, Nearchos; Hughes, Alun; Mayet, Jamil; Francis, Darrel P

2012-11-01

Meta-analysis of registries (comparative effectiveness research) shows that primary angioplasty and fibrinolysis have equivalent real-world survival. Yet, randomized, controlled trials consistently find primary angioplasty superior. Can unequal allocation of higher-risk patients in registries have masked primary angioplasty benefit? First, we constructed a model to demonstrate the potential effect of allocation bias. We then analyzed published registries (55022 patients) for allocation of higher-risk patients (Killip class ≥1) to determine whether the choice of reperfusion therapy was affected by the risk level of the patient. Meta-regression was used to examine the relationship between differences in allocation of high-risk patient to primary angioplasty or fibrinolysis and mortality. Initial modeling suggested that registry outcomes are sensitive to allocation bias of high-risk patients. Across the registries, the therapy receiving excess high-risk patients had worse mortality. Unequal distribution of high-risk status accounted for most of the between-registry variance (adjusted R(2)(meta)=83.1%). Accounting for differential allocation of higher-risk patients, primary angioplasty gave 22% lower mortality (odds ratio, 0.78; 95% confidence interval, 0.64-0.97; P=0.029). We derive a formula, called the number needed to abolish, highlighting situations in which comparative effectiveness studies are particularly vulnerable to this bias. In ST-segment elevation myocardial infarction, clinicians' preference for management of a few high-risk patients can shift mortality substantially. Comparative effectiveness research in any disease is vulnerable to this, especially diseases with an immediately identifiable high-risk subgroup that clinicians prefer to allocate to 1 therapy. For this reason, preliminary indications from registry-based comparative effectiveness research should be definitively tested by randomized, controlled trials.

Development of a Web-based Glaucoma Registry at King Khaled Eye Specialist Hospital, Saudi Arabia: A Cost-Effective Methodology

PubMed Central

Zaman, Babar; Khandekar, Rajiv; Al Shahwan, Sami; Song, Jonathan; Al Jadaan, Ibrahim; Al Jiasim, Leyla; Owaydha, Ohood; Asghar, Nasira; Hijazi, Amar; Edward, Deepak P.

2014-01-01

In this brief communication, we present the steps used to establish a web-based congenital glaucoma registry at our institution. The contents of a case report form (CRF) were developed by a group of glaucoma subspecialists. Information Technology (IT) specialists used Lime Survey softwareTM to create an electronic CRF. A MY Structured Query Language (MySQL) server was used as a database with a virtual machine operating system. Two ophthalmologists and 2 IT specialists worked for 7 hours, and a biostatistician and a data registrar worked for 24 hours each to establish the electronic CRF. Using the CRF which was transferred to the Lime survey tool, and the MYSQL server application, data could be directly stored in spreadsheet programs that included Microsoft Excel, SPSS, and R-Language and queried in real-time. In a pilot test, clinical data from 80 patients with congenital glaucoma were entered into the registry and successful descriptive analysis and data entry validation was performed. A web-based disease registry was established in a short period of time in a cost-efficient manner using available resources and a team-based approach. PMID:24791112

Development of a web-based glaucoma registry at King Khaled Eye Specialist Hospital, Saudi Arabia: a cost-effective methodology.

PubMed

Zaman, Babar; Khandekar, Rajiv; Al Shahwan, Sami; Song, Jonathan; Al Jadaan, Ibrahim; Al Jiasim, Leyla; Owaydha, Ohood; Asghar, Nasira; Hijazi, Amar; Edward, Deepak P

2014-01-01

In this brief communication, we present the steps used to establish a web-based congenital glaucoma registry at our institution. The contents of a case report form (CRF) were developed by a group of glaucoma subspecialists. Information Technology (IT) specialists used Lime Survey softwareTM to create an electronic CRF. A MY Structured Query Language (MySQL) server was used as a database with a virtual machine operating system. Two ophthalmologists and 2 IT specialists worked for 7 hours, and a biostatistician and a data registrar worked for 24 hours each to establish the electronic CRF. Using the CRF which was transferred to the Lime survey tool, and the MYSQL server application, data could be directly stored in spreadsheet programs that included Microsoft Excel, SPSS, and R-Language and queried in real-time. In a pilot test, clinical data from 80 patients with congenital glaucoma were entered into the registry and successful descriptive analysis and data entry validation was performed. A web-based disease registry was established in a short period of time in a cost-efficient manner using available resources and a team-based approach.

[Mortality and survival analysis of liver cancer in China].

PubMed

Zheng, Rongshou; Zuo, Tingting; Zeng, Hongmei; Zhang, Siwei; Chen, Wanqing

2015-09-01

Based on the cancer registry data to analyze the mortality and survival of liver cancer in China. Liver cancer data of 2011 were retrieved from the National Cancer Registry Database.Liver cancer deaths were estimated using age-specific rate by areas and gender according to the national population in 2011. Mortality data from 22 cancer registries during 2000-2011 were used to analyze the mortality trend, and data from 17 cancer registries during 2003-2005 were used for survival analysis. The estimates of liver cancer deaths were about 322 thousand in 2011 with a crude mortality rate of 23.93/10(5).There was an increasing trend of crude mortality rate of liver cancer during 2000-2011 in 22 Chinese cancer registries with an average annual percentage change of 0.7% (95%CI: 0.2%-1.2%), 1.1% in urban and 0.4% in rural areas. After age standardization with Segi's population, the mortality rate was significantly decreased, with an APC of -2.3%, -1.9% in urban and -2.2% in rural populations. The 5-year age standardized relative survival was 10.1% (95%CI: 9.5% to 10.7%), and the 1-, 3- and the 5-year observed survival rates were 27.2%, 12.7%, and 8.9%, respectively. Liver cancer is a major cancer threatening people's lives and health in China, and the liver cancer burden is still high.

Electronic Patient Registries Improve Diabetes Care and Clinical Outcomes in Rural Community Health Centers

ERIC Educational Resources Information Center

Pollard, Cecil; Bailey, Kelly A.; Petitte, Trisha; Baus, Adam; Swim, Mary; Hendryx, Michael

2009-01-01

Context: Diabetes care is challenging in rural areas. Research has shown that the utilization of electronic patient registries improves care; however, improvements generally have been described in combination with other ongoing interventions. The level of basic registry utilization sufficient for positive change is unknown. Purpose: The goal of…

ResearchMatch: A National Registry to Recruit Volunteers for Clinical Research

PubMed Central

Harris, Paul A.; Scott, Kirstin W; Lebo, Laurie; Hassan, NikNik; Lighter, Chad; Pulley, Jill

2013-01-01

The authors designed ResearchMatch, a disease-neutral, web-based recruitment registry to help match individuals who wish to participate in clinical research studies with researchers actively searching for volunteers throughout the United States. In this article, they describe ResearchMatch’s stakeholders, workflow model, technical infrastructure, and, for the registry’s first 19 months of operation, utilization metrics. Having launched volunteer registration tools in November 2009 and researcher registration tools in March 2010, ResearchMatch had, as of June 2011, registered 15,871 volunteer participants from all 50 states. The registry was created as a collaborative project for institutions in the Clinical and Translational Science Awards (CTSA) consortium. Also as of June 2011, a total of 751 researchers from 61 participating CTSA institutions had registered to use the tool to recruit participants into 540 active studies and trials. ResearchMatch has proven successful in connecting volunteers with researchers, and the authors are currently evaluating regulatory and workflow options to open access to researchers at non-CTSA institutions. PMID:22104055

[Drug registries: post-marketing evaluation of the benefit-risk profile and promotion of appropriateness. The regional point of view].

PubMed

Martelli, Luisa; Venegoni, Mauro

2013-06-01

Italian Regions and the Italian regulatory agency share a common interest in promoting the appropriateness of drug use, containing drug expenditure and acquiring additional evidence on the effectiveness and safety of drugs. Drug registries can help attaining these objectives. Specifically, the registries implemented in Italy were able to cover the first two objectives, whereas some critical issues were raised on the third one. For instance, the data recorded in the registries are not available at regional level to conduct safety and effectiveness investigations. This is a paradox, when considering that drugs included in the registries have a risk-benefit profile that is only partially defined at the moment of marketing. Currently, researchers and regions can conduct epidemiological research (cohort and case control studies), on the basis of record-linkage procedures, on all drugs prescribed in general practice (which are older drugs with a better defined risk-benefit profile). The expected outcomes of registries should be more clearly defined: when the main aim is to promote appropriateness, the recording of only a very limited amount of data should be required (to avoid a bureaucratic burden on clinicians).The Italian centers of the ENCePP network might play an important role in planning and conducting drug registries: through the presence in the steering committees of the registries, and in conducting epidemiological studies that make the most of this powerful instrument.

Enhancing Cancer Registry Data for Comparative Effectiveness Research (CER) Project: Overview and Methodology

PubMed Central

Chen, Vivien W.; Eheman, Christie R.; Johnson, Christopher J.; Hernandez, Monique N.; Rousseau, David; Styles, Timothy S.; West, Dee W.; Hsieh, Meichin; Hakenewerth, Anne M.; Celaya, Maria O.; Rycroft, Randi K.; Wike, Jennifer M.; Pearson, Melissa; Brockhouse, Judy; Mulvihill, Linda G.; Zhang, Kevin B.

2015-01-01

Following the Institute of Medicine's 2009 report on the national priorities for comparative effectiveness research (CER), funding for support of CER became available in 2009 through the American Recovery and Reinvestment Act. The Centers for Disease Control and Prevention (CDC) received funding to enhance the infrastructure of population-based cancer registries and to expand registry data collection to support CER. The CDC established 10 specialized registries within the National Program of Cancer Registries (NPCR) to enhance data collection for all cancers and to address targeted CER questions, including the clinical use and prognostic value of specific biomarkers. The project also included a special focus on detailed first course of treatment for cancers of the breast, colon, and rectum, as well as chronic myeloid leukemia (CML) diagnosed in 2011. This paper describes the methodology and the work conducted by the CDC and the NPCR specialized registries in collecting data for the 4 special focused cancers, including the selection of additional data variables, development of data collection tools and software modifications, institutional review board approvals, training, collection of detailed first course of treatment, and quality assurance. It also presents the characteristics of the study population and discusses the strengths and limitations of using population-based cancer registries to support CER as well as the potential future role of population-based cancer registries in assessing the quality of patient care and cancer control. PMID:25419602

Enhancing cancer registry data for comparative effectiveness research (CER) project: overview and methodology.

PubMed

Chen, Vivien W; Eheman, Christie R; Johnson, Christopher J; Hernandez, Monique N; Rousseau, David; Styles, Timothy S; West, Dee W; Hsieh, Meichin; Hakenewerth, Anne M; Celaya, Maria O; Rycroft, Randi K; Wike, Jennifer M; Pearson, Melissa; Brockhouse, Judy; Mulvihill, Linda G; Zhang, Kevin B

2014-01-01

Following the Institute of Medicine's 2009 report on the national priorities for comparative effectiveness research (CER), funding for support of CER became available in 2009 through the American Recovery and Re-investment Act. The Centers for Disease Control and Prevention (CDC) received funding to enhance the infrastructure of population-based cancer registries and to expand registry data collection to support CER. The CDC established 10 specialized registries within the National Program of Cancer Registries (NPCR) to enhance data collection for all cancers and to address targeted CER questions, including the clinical use and prognostic value of specific biomarkers. The project also included a special focus on detailed first course of treatment for cancers of the breast, colon, and rectum, as well as chronic myeloid leukemia (CML) diagnosed in 2011. This paper describes the methodology and the work conducted by the CDC and the NPCR specialized registries in collecting data for the 4 special focused cancers, including the selection of additional data variables, development of data collection tools and software modifications, institutional review board approvals, training, collection of detailed first course of treatment, and quality assurance. It also presents the characteristics of the study population and discusses the strengths and limitations of using population-based cancer registries to support CER as well as the potential future role of population-based cancer registries in assessing the quality of patient care and cancer control.

Nordic registry-based cohort studies: Possibilities and pitfalls when combining Nordic registry data.

PubMed

Maret-Ouda, John; Tao, Wenjing; Wahlin, Karl; Lagergren, Jesper

2017-07-01

All five Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) have nationwide registries with similar data structure and validity, as well as personal identity numbers enabling linkage between registries. These resources provide opportunities for medical research that is based on large registry-based cohort studies with long and complete follow-up. This review describes practical aspects, opportunities and challenges encountered when setting up all-Nordic registry-based cohort studies. Relevant articles describing registries often used for medical research in the Nordic countries were retrieved. Further, our experiences of conducting this type of study, including planning, acquiring permissions, data retrieval and data cleaning and handling, and the possibilities and challenges we have encountered are described. Combining data from the Nordic countries makes it possible to create large and powerful cohorts. The main challenges include obtaining all permissions within each country, usually in the local language, and retrieving the data. These challenges emphasise the importance of having experienced collaborators within each country. Following the acquisition of data, data management requires the understanding of the differences between the variables to be used in the various countries. A concern is the long time required between initiation and completion. Nationwide Nordic registries can be combined into cohorts with high validity and statistical power, but the considerable expertise, workload and time required to complete such cohorts should not be underestimated.

The importance of international collaboration for rare diseases research: a European perspective

PubMed Central

Julkowska, D; Austin, C P; Cutillo, C M; Gancberg, D; Hager, C; Halftermeyer, J; Jonker, A H; Lau, L P L; Norstedt, I; Rath, A; Schuster, R; Simelyte, E; van Weely, S

2017-01-01

Over the last two decades, important contributions were made at national, European and international levels to foster collaboration into rare diseases research. The European Union (EU) has put much effort into funding rare diseases research, encouraging national funding organizations to collaborate together in the E-Rare program, setting up European Reference Networks for rare diseases and complex conditions, and initiating the International Rare Diseases Research Consortium (IRDiRC) together with the National Institutes of Health in the USA. Co-ordination of the activities of funding agencies, academic researchers, companies, regulatory bodies, and patient advocacy organizations and partnerships with, for example, the European Research Infrastructures maximizes the collective impact of global investments in rare diseases research. This contributes to accelerating progress, for example, in faster diagnosis through enhanced discovery of causative genes, better understanding of natural history of rare diseases through creation of common registries and databases and boosting of innovative therapeutic approaches. Several examples of funded pre-clinical and clinical gene therapy projects show that integration of multinational and multidisciplinary expertize generates new knowledge and can result in multicentre gene therapy trials. International collaboration in rare diseases research is key to improve the life of people living with a rare disease. PMID:28440796

The importance of international collaboration for rare diseases research: a European perspective.

PubMed

Julkowska, D; Austin, C P; Cutillo, C M; Gancberg, D; Hager, C; Halftermeyer, J; Jonker, A H; Lau, L P L; Norstedt, I; Rath, A; Schuster, R; Simelyte, E; van Weely, S

2017-09-01

Over the last two decades, important contributions were made at national, European and international levels to foster collaboration into rare diseases research. The European Union (EU) has put much effort into funding rare diseases research, encouraging national funding organizations to collaborate together in the E-Rare program, setting up European Reference Networks for rare diseases and complex conditions, and initiating the International Rare Diseases Research Consortium (IRDiRC) together with the National Institutes of Health in the USA. Co-ordination of the activities of funding agencies, academic researchers, companies, regulatory bodies, and patient advocacy organizations and partnerships with, for example, the European Research Infrastructures maximizes the collective impact of global investments in rare diseases research. This contributes to accelerating progress, for example, in faster diagnosis through enhanced discovery of causative genes, better understanding of natural history of rare diseases through creation of common registries and databases and boosting of innovative therapeutic approaches. Several examples of funded pre-clinical and clinical gene therapy projects show that integration of multinational and multidisciplinary expertize generates new knowledge and can result in multicentre gene therapy trials. International collaboration in rare diseases research is key to improve the life of people living with a rare disease.

Clinical presentation and management of stable coronary artery disease in Austria.

PubMed

Pichlhöfer, Otto; Maier, Manfred; Badr-Eslam, Roza; Ristl, Robin; Zebrowska, Magdalena; Lang, Irene M

2017-01-01

Cardiovascular disease is the main cause of death in Austria. However, no systematic information exists regarding characteristics and treatments of contemporary patients with stable coronary artery disease (CAD) in Austria. We assembled two retrospective physicians' databases to describe demographics, clinical profiles, and therapeutic strategies in patients with stable CAD. In addition, we compared patient profiles of secondary care internists and hospital-based cardiologists with those of general practitioners in a primary care setting outside of hospital. The study population was identified from retrospective chart review of 1020 patients from 106 primary care physicians in Austria (ProCor II registry), and was merged with a previous similar database of 1280 patients under secondary care (ProCor I registry) to yield a total patient number of 2300. Female patients with stable CAD were older, had more angina and/or heart failure symptoms, and more depression than males. Female gender, type 2 diabetes mellitus, higher CCS class and asthma/COPD were predictors of elevated heart rate, while previous coronary events/revascularization predicted a lower heart rate in multivariate analysis. There were no significant differences with regard to characteristics and management of patients of general practitioners in the primary care setting versus internists in secondary care. Characteristics and treatments of unselected patients with stable ischemic heart disease in Austria resemble the pattern of large international registries of stable ischemic heart disease, with the exception that diabetes and systemic hypertension were more prevalent.

Increased risk of cardiovascular perforation during ECMO with a bicaval, wire-reinforced cannula.

PubMed

Johnson, Sidney M; Itoga, Nathan; Garnett, Gwendolyn M; Kilcommons, Melody; Puapong, Devin P; Woo, Russell K

2014-01-01

Cardiac or major vascular perforation is a rare but serious risk of ECMO. We sought to determine if perforation rates are related to cannula design. We utilized three methods to evaluate perforation on ECMO. 1. The ELSO registry was queried to establish the historical rate of hemorrhagic pericardial tamponade. 2. ELSO centers were surveyed regarding cannula related perforation events and brands of cannulas used over a four year time period (January 2008-March 2012). 3. The FDA's MAUDE database was reviewed looking for adverse events related to ECMO cannulas. The historical rate of hemorrhagic pericardial tamponade in the ELSO registry was 0.53% (~1985-2010, ELSO registry). In the survey there were eleven reports of cannula-related perforation, 0.74% (11/1482 p-value=0.29) at 7 different ELSO centers with 23 ELSO centers responding (17% response rate). The incidence of perforation was much higher for the wire-reinforced bicaval design 3.6% (10/279) as compared to catheters designed for the atrial position, 0.1% (1/1203, p-value<0.0001). Review of the FDA's MAUDE database revealed 19 adverse events related to the bicaval cannula design, 16 of which were hemorrhagic pericardial effusions or tamponade. These findings suggest a relatively high rate of cardiac perforation associated with the dual lumen bicaval cannula. This may be related to inherent differences in cannula design or the IVC positioning required by the design. © 2014.

Implementation of the trauma registry as a tool for quality improvement in trauma care in a brazilian hospital: the first 12 months.

PubMed

Parreira, José Gustavo; de Campos, Tércio; Perlingeiro, Jacqueline A Gianinni; Soldá, Silvia C; Assef, José Cesar; Gonçalves, Augusto Canton; Zuffo, Bruno Malteze; Floriano, Caio Gomes; de Oliveira, Erik Haruk; de Oliveira, Renato Vieira Rodrigues; Oliveira, Amanda Lima; de Melo, Caio Gullo; Below, Cristiano; Miranda, Dino R Pérez; Santos, Gabriella Colasuonno; de Almeida, Gabriele Madeira; Brianti, Isabela Campos; Votto, Karina Baruel de Camargo; Schues, Patrick Alexander Sauer; dos Santos, Rafael Gomes; de Figueredo, Sérgio Mazzola Poli; de Araujo, Tatiani Gonçalves; Santos, Bruna do Nascimento; Ferreira, Laura Cardoso Manduca; Tanaka, Giuliana Olivi; Matos, Thiara; da Sousa, Maria Daiana; Augusto, Samara de Souza

2015-01-01

to analyze the implementation of a trauma registry in a university teaching hospital delivering care under the unified health system (SUS), and its ability to identify points for improvement in the quality of care provided. the data collection group comprised students from medicine and nursing courses who were holders of FAPESP scholarships (technical training 1) or otherwise, overseen by the coordinators of the project. The itreg (ECO Sistemas-RJ/SBAIT) software was used as the database tool. Several quality "filters" were proposed to select those cases for review in the quality control process. data for 1344 trauma patients were input to the itreg database between March and November 2014. Around 87.0% of cases were blunt trauma patients, 59.6% had RTS>7.0 and 67% ISS<9. Full records were available for 292 cases, which were selected for review in the quality program. The auditing filters most frequently registered were laparotomy four hours after admission and drainage of acute subdural hematomas four hours after admission. Several points for improvement were flagged, such as control of overtriage of patients, the need to reduce the number of negative imaging exams, the development of protocols for achieving central venous access, and management of major TBI. the trauma registry provides a clear picture of the points to be improved in trauma patient care, however, there are specific peculiarities for implementing this tool in the Brazilian milieu.

[Establishement for regional pelvic trauma database in Hunan Province].

PubMed

Cheng, Liang; Zhu, Yong; Long, Haitao; Yang, Junxiao; Sun, Buhua; Li, Kanghua

2017-04-28

To establish a database for pelvic trauma in Hunan Province, and to start the work of multicenter pelvic trauma registry.
 Methods: To establish the database, literatures relevant to pelvic trauma were screened, the experiences from the established trauma database in China and abroad were learned, and the actual situations for pelvic trauma rescue in Hunan Province were considered. The database for pelvic trauma was established based on the PostgreSQL and the advanced programming language Java 1.6.
 Results: The complex procedure for pelvic trauma rescue was described structurally. The contents for the database included general patient information, injurious condition, prehospital rescue, conditions in admission, treatment in hospital, status on discharge, diagnosis, classification, complication, trauma scoring and therapeutic effect. The database can be accessed through the internet by browser/servicer. The functions for the database include patient information management, data export, history query, progress report, video-image management and personal information management.
 Conclusion: The database with whole life cycle pelvic trauma is successfully established for the first time in China. It is scientific, functional, practical, and user-friendly.

Making Research Data Repositories Visible: The re3data.org Registry

PubMed Central

Pampel, Heinz; Vierkant, Paul; Scholze, Frank; Bertelmann, Roland; Kindling, Maxi; Klump, Jens; Goebelbecker, Hans-Jürgen; Gundlach, Jens; Schirmbacher, Peter; Dierolf, Uwe

2013-01-01

Researchers require infrastructures that ensure a maximum of accessibility, stability and reliability to facilitate working with and sharing of research data. Such infrastructures are being increasingly summarized under the term Research Data Repositories (RDR). The project re3data.org–Registry of Research Data Repositories–has begun to index research data repositories in 2012 and offers researchers, funding organizations, libraries and publishers an overview of the heterogeneous research data repository landscape. In July 2013 re3data.org lists 400 research data repositories and counting. 288 of these are described in detail using the re3data.org vocabulary. Information icons help researchers to easily identify an adequate repository for the storage and reuse of their data. This article describes the heterogeneous RDR landscape and presents a typology of institutional, disciplinary, multidisciplinary and project-specific RDR. Further the article outlines the features of re3data.org, and shows how this registry helps to identify appropriate repositories for storage and search of research data. PMID:24223762

Making research data repositories visible: the re3data.org Registry.

PubMed

Pampel, Heinz; Vierkant, Paul; Scholze, Frank; Bertelmann, Roland; Kindling, Maxi; Klump, Jens; Goebelbecker, Hans-Jürgen; Gundlach, Jens; Schirmbacher, Peter; Dierolf, Uwe

2013-01-01

Researchers require infrastructures that ensure a maximum of accessibility, stability and reliability to facilitate working with and sharing of research data. Such infrastructures are being increasingly summarized under the term Research Data Repositories (RDR). The project re3data.org-Registry of Research Data Repositories-has begun to index research data repositories in 2012 and offers researchers, funding organizations, libraries and publishers an overview of the heterogeneous research data repository landscape. In July 2013 re3data.org lists 400 research data repositories and counting. 288 of these are described in detail using the re3data.org vocabulary. Information icons help researchers to easily identify an adequate repository for the storage and reuse of their data. This article describes the heterogeneous RDR landscape and presents a typology of institutional, disciplinary, multidisciplinary and project-specific RDR. Further the article outlines the features of re3data.org, and shows how this registry helps to identify appropriate repositories for storage and search of research data.

Regional Cancer Registries – 20 Years and Growing

Cancer.gov

The NCI, Center for Global Health (CGH), the University of California at Irvine, the Middle East Cancer Consortium, and the International Agency for Research on Cancer partnered in support of the training course, held in Ankara, Turkey this past October, on The Uses of Cancer Registry Data in Cancer Control Research.

76 FR 57742 - National Registry of Evidence-Based Programs and Practices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... research in these areas more effectively and more rapidly into the general health care system. The National... registry undergo two independent review processes in which their (1) Quality of research and (2) readiness... presents ratings and descriptive information about the intervention. Anyone that consents to a review is...

Cancer Reporting: Timeliness Analysis and Process Reengineering

ERIC Educational Resources Information Center

Jabour, Abdulrahman M.

2016-01-01

Introduction: Cancer registries collect tumor-related data to monitor incident rates and support population-based research. A common concern with using population-based registry data for research is reporting timeliness. Data timeliness have been recognized as an important data characteristic by both the Centers for Disease Control and Prevention…

Arthroplasty Implant Registries Over the Past Five Decades: Development, Current, and Future Impact.

PubMed

Malchau, Henrik; Garellick, Göran; Berry, Daniel; Harris, William H; Robertson, Otto; Kärrlholm, Johan; Lewallen, David; Bragdon, Charles R; Lidgren, Lars; Herberts, Peter

2018-04-16

Local, regional and national registries have played an important role the development of hip and knee arthroplasty and the treatment of patients with various maladies of these joints. Four arthroplasty registries stand out as leading forces behind the drive to popularize the use of registries and pursue the concept of evidence based medicine. The Mayo registry, started by Mark Coventry, is recognized as the oldest continuing registry for arthroplasty. The Harris Registry at Massachusetts General Hospital, along with the Mayo Registry, has greatly contributed to the advancement of arthroplasty surgery and have served an important role of identifying poorly performing implants and techniques in the United States. The Swedish Knee Arthroplasty Registry is the oldest national registry dedicated to joint arthroplasty and along with the Swedish Hip Arthroplasty Registry have established the infrastructure, analysis and reporting mechanisms and leadership that has enabled other countries to subsequently develop national registries around the world. As more countries have adopted the concept of national registries, a new area of research is possible by pooling the resources of large registries as is now occurring with the Nordic countries. Several international organizations have been formed to promote future collaboration and develop international standards. The process of globalization of registries is a result of continued efforts over the past 50 years in improving and disseminating the knowledge gained from the early registries. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Systematic review of discharge coding accuracy

PubMed Central

Burns, E.M.; Rigby, E.; Mamidanna, R.; Bottle, A.; Aylin, P.; Ziprin, P.; Faiz, O.D.

2012-01-01

Introduction Routinely collected data sets are increasingly used for research, financial reimbursement and health service planning. High quality data are necessary for reliable analysis. This study aims to assess the published accuracy of routinely collected data sets in Great Britain. Methods Systematic searches of the EMBASE, PUBMED, OVID and Cochrane databases were performed from 1989 to present using defined search terms. Included studies were those that compared routinely collected data sets with case or operative note review and those that compared routinely collected data with clinical registries. Results Thirty-two studies were included. Twenty-five studies compared routinely collected data with case or operation notes. Seven studies compared routinely collected data with clinical registries. The overall median accuracy (routinely collected data sets versus case notes) was 83.2% (IQR: 67.3–92.1%). The median diagnostic accuracy was 80.3% (IQR: 63.3–94.1%) with a median procedure accuracy of 84.2% (IQR: 68.7–88.7%). There was considerable variation in accuracy rates between studies (50.5–97.8%). Since the 2002 introduction of Payment by Results, accuracy has improved in some respects, for example primary diagnoses accuracy has improved from 73.8% (IQR: 59.3–92.1%) to 96.0% (IQR: 89.3–96.3), P= 0.020. Conclusion Accuracy rates are improving. Current levels of reported accuracy suggest that routinely collected data are sufficiently robust to support their use for research and managerial decision-making. PMID:21795302

76 FR 2091 - Indian Education Formula Grants to Local Educational Agencies; Office of Elementary and Secondary...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

... System (DUNS) number and a Taxpayer Identification Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d. Maintain an active CCR registration with...

77 FR 27031 - Applications for New Awards; Centers for Independent Living

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d..., agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are...

78 FR 55689 - Applications for Fiscal Year 2014 Awards; Impact Aid Section 8002 Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

... System (DUNS) number and a Taxpayer Identification Number (TIN); b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry (CCR)), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d...

76 FR 80351 - Application for New Awards; Indian Education Formula Grants to Local Educational Agencies

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-23

... Numbering System (DUNS) number and a Taxpayer Identification Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d. Maintain an active CCR registration with...

76 FR 780 - Office of Special Education and Rehabilitative Services Overview Information; National Institute...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-06

... Numbering System (DUNS) number and a Taxpayer Identification Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d. Maintain an active CCR registration with...

75 FR 49484 - Office of Postsecondary Education; Overview Information; Jacob K. Javits Fellowship Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-13

... Associated States. Applicants must also either: Be entering into a doctoral program in academic year 2011... study for which they are seeking support; or be entering a Master of Fine Arts program in academic year... with the Central Contractor Registry (CCR), the Government's primary registrant database; and (3) you...

The Matchmaker Exchange API: automating patient matching through the exchange of structured phenotypic and genotypic profiles

PubMed Central

Buske, Orion J.; Schiettecatte, François; Hutton, Benjamin; Dumitriu, Sergiu; Misyura, Andriy; Huang, Lijia; Hartley, Taila; Girdea, Marta; Sobreira, Nara; Mungall, Chris; Brudno, Michael

2016-01-01

Despite the increasing prevalence of clinical sequencing, the difficulty of identifying additional affected families is a key obstacle to solving many rare diseases. There may only be a handful of similar patients worldwide, and their data may be stored in diverse clinical and research databases. Computational methods are necessary to enable finding similar patients across the growing number of patient repositories and registries. We present the Matchmaker Exchange Application Programming Interface (MME API), a protocol and data format for exchanging phenotype and genotype profiles to enable matchmaking among patient databases, facilitate the identification of additional cohorts, and increase the rate with which rare diseases can be researched and diagnosed. We designed the API to be straightforward and flexible in order to simplify its adoption on a large number of data types and workflows. We also provide a public test data set, curated from the literature, to facilitate implementation of the API and development of new matching algorithms. The initial version of the API has been successfully implemented by three members of the Matchmaker Exchange and was immediately able to reproduce previously-identified matches and generate several new leads currently being validated. The API is available at https://github.com/ga4gh/mme-apis. PMID:26255989

The Matchmaker Exchange API: automating patient matching through the exchange of structured phenotypic and genotypic profiles.

PubMed

Buske, Orion J; Schiettecatte, François; Hutton, Benjamin; Dumitriu, Sergiu; Misyura, Andriy; Huang, Lijia; Hartley, Taila; Girdea, Marta; Sobreira, Nara; Mungall, Chris; Brudno, Michael

2015-10-01

Despite the increasing prevalence of clinical sequencing, the difficulty of identifying additional affected families is a key obstacle to solving many rare diseases. There may only be a handful of similar patients worldwide, and their data may be stored in diverse clinical and research databases. Computational methods are necessary to enable finding similar patients across the growing number of patient repositories and registries. We present the Matchmaker Exchange Application Programming Interface (MME API), a protocol and data format for exchanging phenotype and genotype profiles to enable matchmaking among patient databases, facilitate the identification of additional cohorts, and increase the rate with which rare diseases can be researched and diagnosed. We designed the API to be straightforward and flexible in order to simplify its adoption on a large number of data types and workflows. We also provide a public test data set, curated from the literature, to facilitate implementation of the API and development of new matching algorithms. The initial version of the API has been successfully implemented by three members of the Matchmaker Exchange and was immediately able to reproduce previously identified matches and generate several new leads currently being validated. The API is available at https://github.com/ga4gh/mme-apis. © 2015 WILEY PERIODICALS, INC.

Nailfold capillaroscopy in systemic sclerosis: data from the EULAR scleroderma trials and research (EUSTAR) database.

PubMed

Ingegnoli, Francesca; Ardoino, Ilaria; Boracchi, Patrizia; Cutolo, Maurizio

2013-09-01

The aims of this study were to obtain cross-sectional data on capillaroscopy in an international multi-center cohort of Systemic Sclerosis (SSc) and to investigate the frequency of the capillaroscopic patterns and their disease-phenotype associations. Data collected between June 2004 and October 2011 in the EULAR Scleroderma Trials and Research (EUSTAR) registry were examined. Patients' profiles based on clinical and laboratory data were obtained by cluster analysis and the association between profiles and capillaroscopy was investigated by multinomial logistic regression. 62 of the 110 EUSTAR centers entered data on capillaroscopy in the EUSTAR database. 376 of the 2754 patients (13.65%) were classified as scleroderma pattern absent, but non-specific capillary abnormalities were noted in 55.48% of the cases. Four major patients' profiles were identified characterized by a progressive severity for skin involvement, as well as an increased number of systemic manifestations. The "early" and "active" scleroderma patterns were generally observed in patients with mild/moderate skin involvement and a low number of disease manifestations, while the "late" scleroderma pattern was found more frequently in the more severe forms of the disease. These data indicate the importance of capillaroscopy in SSc management and that capillaroscopic patterns are directly related to the extent of organ involvement. Copyright © 2013 Elsevier Inc. All rights reserved.

Optimization of Inflammatory Bowel Disease Cohort Studies in Asia.

PubMed

Leung, Wai K

2015-07-01

With the incidence of inflammatory bowel disease (IBD) increasing rapidly in many Asian countries, including Hong Kong, it is important that patient characteristics are better understood. For example, are the phenotypes, behaviors, complications, and even treatment responses found in Asian patients similar to those of their Western counterparts? To formally address these questions, a properly designed local cohort study is needed. Whilst IBD is still relatively uncommon in Asia, the establishment of a local IBD registry will significantly contribute to the answering of these questions. The Hong Kong IBD registry was established to fill the gap in the understanding of IBD patients, and to foster research into IBD in Hong Kong. The Hong Kong IBD registry is a territory-wide registry that includes all public hospitals in Hong Kong. We included all IBD patients who were currently receiving medical care at these hospitals. With the help of the central computer medical record system of the Hospital Authority of Hong Kong, all clinical events, medications usage, endoscopy records, and laboratory results of patients in the registry were captured. Apart from data collection, the registry is also establishing a bio-specimen bank of blood and stool samples of IBD patients for future research. The IBD registry is a very useful platform for population-based studies on IBD in Asia.

My Retina Tracker™: An On-line International Registry for People Affected with Inherited Orphan Retinal Degenerative Diseases and their Genetic Relatives - A New Resource.

PubMed

Fisher, Joan K; Bromley, Russell L; Mansfield, Brian C

2016-01-01

My Retina Tracker™ is a new on-line registry for people affected with inherited orphan retinal degenerative diseases, and their unaffected, genetic relatives. Created and supported by the Foundation Fighting Blindness, it is an international resource designed to capture the disease from the perspective of the registry participant and their retinal health care providers. The registry operates under an Institutional Review Board (IRB)-approved protocol and allows sharing of de-identified data with participants, researchers and clinicians. All participants sign an informed consent that includes selecting which data they wish to share. There is no minimum age of participation. Guardians must sign on behalf of minors, and children between the ages of 12 to 17 also sign an informed assent. Participants may compare their disease to others in the registry using graphical interpretations of the aggregate registry data. Researchers and clinicians have two levels of access. The first provides an interface to interrogate all data fields registrants have agreed to share based on their answers in the IRB informed consent. The second provides a route to contact people in the registry who may be eligible for studies or trials, through the Foundation.

Implementation of customized health information technology in diabetes self management programs.

PubMed

Alexander, Susan; Frith, Karen H; O'Keefe, Louise; Hennigan, Michael A

2011-01-01

The project was a nurse-led implementation of a software application, designed to combine clinical and demographic records for a diabetes education program, which would result in secure, long-term record storage. Clinical information systems may be prohibitively expensive for small practices and require extensive training for implementation. A review of the literature suggests that the use of simple, practice-based registries offer an economical method of monitoring the outcomes of diabetic patients. The database was designed using a common software application, Microsoft Access. The theory used to guide implementation and staff training was Rogers' Diffusion of Innovations theory (1995). Outcomes after a 3-month period included incorporation of 100% of new clinical and demographic patient records into the database and positive changes in staff attitudes regarding software applications used in diabetes self-management training. These objectives were met while keeping project costs under budgeted amounts. As a function of the clinical nurse specialist (CNS) researcher role, there is a need for CNSs to identify innovative and economical methods of data collection. The success of this nurse-led project reinforces suggestions in the literature for less costly methods of data maintenance in small practice settings. Ongoing utilization and enhancement have resulted in the creation of a robust database that could aid in the research of multiple clinical issues. Clinical nurse specialists can use existing evidence to guide and improve both their own practice and outcomes for patients and organizations. Further research regarding specific factors that predict efficient transition of informatics applications, how these factors vary according to practice settings, and the role of the CNS in implementation of such applications is needed.

Respiratory diseases registries in the national registry of rare diseases.

PubMed

Lara Gallego, Beatriz; Abaitua Borda, Ignacio; Galán Gil, Genaro; Castillo Villegas, Diego; Casanova Espinosa, Álvaro; Cano Jiménez, Esteban; Ojanguren Arranz, Iñigo; Posada de la Paz, Manuel

2014-09-01

This report describes the general characteristics, objectives and organizational aspects of the registries of rare respiratory diseases included in the National Registry of Rare Diseases of the Research Institute for Rare Diseases (ISCIII), in order to publicize their existence and encourage the participation of professionals. Information is collected on the following conditions: alpha-1 antitrypsin deficiency, idiopathic tracheal stenosis, adult pulmonary Langerhans' cell histiocytosis, lymphangioleiomyomatosis, alveolar proteinosis, and sarcoidosis. Copyright © 2013 SEPAR. Published by Elsevier Espana. All rights reserved.

Considerations Before Establishing an Environmental Health Registry

PubMed Central

Muravov, Oleg I.; Sapp, James; Larson, Theodore C.; Pallos, L. Laszlo; Sanchez, Marchelle E.; Williamson, G. David; Horton, D. Kevin

2015-01-01

Public health registries can provide valuable information when health consequences of environmental exposures are uncertain or will likely take long to develop. They can also aid research on diseases that may have environmental causes that are not completely well defined. We discuss factors to consider when deciding whether to create an environmental health registry. Those factors include public health significance, purpose and outcomes, duration and scope of data collection and availability of alternative data sources, timeliness, availability of funding and administrative capabilities, and whether the establishment of a registry can adequately address specific health concerns. We also discuss difficulties, limitations, and benefits of exposure and disease registries, based on the experience of the Agency for Toxic Substances and Disease Registry. PMID:26066912

Living with Spina Bifida (at different ages)

MedlinePlus

... School-Aged Adolescents & Teens Young Adults Videos My Story Data and Statistics Research & Tracking Spina Bifida Patient Registry Clinic Map Findings from Patient Registry Articles & Key Findings Free ...

EPA Facility Registry Service (FRS): CAMDBS

EPA Pesticide Factsheets

This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link to the Clean Air Markets Division Business System (CAMDBS). Administered by the EPA Clean Air Markets Division, within the Office of Air and Radiation, CAMDBS supports the implementation of market-based air pollution control programs, including the Acid Rain Program and regional programs designed to reduce the transport of ozone. FRS identifies and geospatially locates facilities, sites or places subject to environmental regulations or of environmental interest. Using vigorous verification and data management procedures, FRS integrates facility data from EPA's national program systems, other federal agencies, and State and tribal master facility records and provides EPA with a centrally managed, single source of comprehensive and authoritative information on facilities. This data set contains the subset of FRS integrated facilities that link to CAMDBS facilities once the CAMDBS data has been integrated into the FRS database. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs.

Toxic substances registry system: Index of material safety data sheets

NASA Technical Reports Server (NTRS)

1993-01-01

The Material Safety Data Sheets (MSDS's) listed in this index reflect product inventories and associated MSDS's which were submitted to the Toxic Substances Registry database maintained by the Base Operations Contractor at the Kennedy Space Center. The purpose of this index is to provide KSC government, contractor, and tenant organizations a means to access information on the hazards associated with these chemicals. The Toxic Substance Registry Service (TSRS) was established to manage information dealing with the storage and use of toxic and otherwise hazardous materials at KSC. As a part of this service, the BOC Environmental Health Services maintains a central repository of MSDS's which were provided to TSRS. The data on the TSRS are obtained from NASA, contractor, and tenant organizations who use or store hazardous materials at KSC. It is the responsibility of these organizations to conduct inventories, obtain MSDS's, distribute Hazard Communication information to their employees, and otherwise implement compliance with appropriate Federal, State, and NASA Hazard Communication and Worker Right-to-Know regulations and policies.

The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases.

PubMed

Lundström, Mats; Goh, Pik-Pin; Henry, Ype; Salowi, Mohamad A; Barry, Peter; Manning, Sonia; Rosen, Paul; Stenevi, Ulf

2015-01-01

The aim of this study was to describe changes over time in the indications and outcomes of cataract surgery and to discuss optimal timing for the surgery. Database study. Patients who had undergone cataract extraction in the Netherlands, Sweden, or Malaysia from 2008 through 2012. We analyzed preoperative, surgical, and postoperative data from 2 databases: the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) and the Malaysian National Cataract Registry. The EUREQUO contains complete data from the national cataract registries in the Netherlands and Sweden. Preoperative and postoperative corrected distance visual acuity, preoperative ocular comorbidity in the surgery eye, and capsule complications during surgery. There were substantial differences in indication for surgery between the 3 national data sets. The percentage of eyes with a preoperative best-corrected visual acuity of 20/200 or worse varied from 7.1% to 72%. In all 3 data sets, the visual thresholds for cataract surgery decreased over time by 6% to 28% of the baseline values. The frequency of capsule complications varied between the 3 data sets, from 1.1% to 3.7% in 2008 and from 0.6% to 2.7% in 2012. An increasing postoperative visual acuity was also seen for all 3 data sets. A high frequency of capsule complication was related significantly to poor preoperative visual acuity, and a high frequency of decreased visual acuity after surgery was related significantly to excellent preoperative visual acuity. The 5-year trend in all 3 national data sets showed decreasing visual thresholds for surgery, decreasing surgical complication rates, and increasing visual outcomes regardless of the initial preoperative visual level. Cataract surgery on eyes with poor preoperative visual acuity was related to surgical complications, and cataract surgery on eyes with excellent preoperative visual acuity was related to adverse visual results. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

PubMed

Laville, Martine; Segrestin, Berenice; Alligier, Maud; Ruano-Rodríguez, Cristina; Serra-Majem, Lluis; Hiesmayr, Michael; Schols, Annemie; La Vecchia, Carlo; Boirie, Yves; Rath, Ana; Neugebauer, Edmund A M; Garattini, Silvio; Bertele, Vittorio; Kubiak, Christine; Demotes-Mainard, Jacques; Jakobsen, Janus C; Djurisic, Snezana; Gluud, Christian

2017-09-11

Evidence-based clinical research poses special barriers in the field of nutrition. The present review summarises the main barriers to research in the field of nutrition that are not common to all randomised clinical trials or trials on rare diseases and highlights opportunities for improvements. Systematic academic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Many nutrients occur in multiple forms that differ in biological activity, and several factors can alter their bioavailability which raises barriers to their assessment. These include specific difficulties with blinding procedures, with assessments of dietary intake, and with selecting appropriate outcomes as patient-centred outcomes may occur decennia into the future. The methodologies and regulations for drug trials are, however, applicable to nutrition trials. Research on clinical nutrition should start by collecting clinical data systematically in databases and registries. Measurable patient-centred outcomes and appropriate study designs are needed. International cooperation and multistakeholder engagement are key for success.

Scandinavian epidemiological research in gastroenterology and hepatology.

PubMed

Björnsson, Einar S; Ekbom, Anders

2015-06-01

In the last decades, a large number of epidemiological studies in gastroenterology and hepatology have originated from the Scandinavian countries. With the help of large health databases, with good validity and other registries related to patient outcomes, researchers from the Scandinavian countries have been able to make some very important contributions to the field. These countries, Sweden, Norway, Finland, Denmark and Iceland, have all universal access to health care and have shown to be ideal for epidemiological research. Population-based studies have been frequent and follow-up studies have been able to describe the temporal trends and changes in phenotypes. Our ability in Scandinavia to follow up defined groups of patients over time has been crucial to learn the natural history of many gastrointestinal and liver diseases and often in a population-based setting. Patient-related outcomes measures will probably gain increasing importance in the future, but Scandinavian gastroenterologists and surgeons are likely to have a better infrastructure for such endeavors compared to most other populations. Thus, there is a bright future for international competitive research within the field of gastrointestinal and liver diseases in Scandinavia.

Standardization of Questions in Rare Disease Registries: The PRISM Library Project.

PubMed

Richesson, Rachel Lynn; Shereff, Denise; Andrews, James Everett

2012-10-10

Patient registries are often a helpful first step in estimating the impact and understanding the etiology of rare diseases - both requisites for the development of new diagnostics and therapeutics. The value and utility of patient registries rely on the use of both well-constructed structured research questions and relevant answer sets accompanying them. There are currently no clear standards or specifications for developing registry questions, and there are no banks of existing questions to support registry developers. This paper introduces the [Rare Disease] PRISM (Patient Registry Item Specifications and Metadata for Rare Disease) project, a library of standardized questions covering a broad spectrum of rare diseases that can be used to support the development of new registries, including Internet-based registries. A convenience sample of questions was identified from well-established (>5 years) natural history studies in various diseases and from several existing registries. Face validity of the questions was determined by review by many experts (both terminology experts at the College of American Pathologists (CAP) and research and informatics experts at the University of South Florida (USF)) for commonality, clarity, and organization. Questions were re-worded slightly, as needed, to make the full semantics of the question clear and to make the questions generalizable to multiple diseases where possible. Questions were indexed with metadata (structured and descriptive information) using a standard metadata framework to record such information as context, format, question asker and responder, and data standards information. At present, PRISM contains over 2,200 questions, with content of PRISM relevant to virtually all rare diseases. While the inclusion of disease-specific questions for thousands of rare disease organizations seeking to develop registries would present a challenge for traditional standards development organizations, the PRISM library could serve as a platform to liaison between rare disease communities and existing standardized controlled terminologies, item banks, and coding systems. If widely used, PRISM will enable the re-use of questions across registries, reduce variation in registry data collection, and facilitate a bottom-up standardization of patient registries. Although it was initially developed to fulfill an urgent need in the rare disease community for shared resources, the PRISM library of patient-directed registry questions can be a valuable resource for registries in any disease - whether common or rare. N/A.

Standardization of Questions in Rare Disease Registries: The PRISM Library Project

PubMed Central

Shereff, Denise; Andrews, James Everett

2012-01-01

Background Patient registries are often a helpful first step in estimating the impact and understanding the etiology of rare diseases - both requisites for the development of new diagnostics and therapeutics. The value and utility of patient registries rely on the use of both well-constructed structured research questions and relevant answer sets accompanying them. There are currently no clear standards or specifications for developing registry questions, and there are no banks of existing questions to support registry developers. Objective This paper introduces the [Rare Disease] PRISM (Patient Registry Item Specifications and Metadata for Rare Disease) project, a library of standardized questions covering a broad spectrum of rare diseases that can be used to support the development of new registries, including Internet-based registries. Methods A convenience sample of questions was identified from well-established (>5 years) natural history studies in various diseases and from several existing registries. Face validity of the questions was determined by review by many experts (both terminology experts at the College of American Pathologists (CAP) and research and informatics experts at the University of South Florida (USF)) for commonality, clarity, and organization. Questions were re-worded slightly, as needed, to make the full semantics of the question clear and to make the questions generalizable to multiple diseases where possible. Questions were indexed with metadata (structured and descriptive information) using a standard metadata framework to record such information as context, format, question asker and responder, and data standards information. Results At present, PRISM contains over 2,200 questions, with content of PRISM relevant to virtually all rare diseases. While the inclusion of disease-specific questions for thousands of rare disease organizations seeking to develop registries would present a challenge for traditional standards development organizations, the PRISM library could serve as a platform to liaison between rare disease communities and existing standardized controlled terminologies, item banks, and coding systems. Conclusions If widely used, PRISM will enable the re-use of questions across registries, reduce variation in registry data collection, and facilitate a bottom-up standardization of patient registries. Although it was initially developed to fulfill an urgent need in the rare disease community for shared resources, the PRISM library of patient-directed registry questions can be a valuable resource for registries in any disease – whether common or rare. Trial Registration N/A PMID:23611924

Validation of Carotid Artery Revascularization Coding in Ontario Health Administrative Databases.

PubMed

Hussain, Mohamad A; Mamdani, Muhammad; Saposnik, Gustavo; Tu, Jack V; Turkel-Parrella, David; Spears, Julian; Al-Omran, Mohammed

2016-04-02

The positive predictive value (PPV) of carotid endarterectomy (CEA) and carotid artery stenting (CAS) procedure and post-operative complication coding were assessed in Ontario health administrative databases. Between 1 April 2002 and 31 March 2014, a random sample of 428 patients were identified using Canadian Classification of Health Intervention (CCI) procedure codes and Ontario Health Insurance Plan (OHIP) billing codes from administrative data. A blinded chart review was conducted at two high-volume vascular centers to assess the level of agreement between the administrative records and the corresponding patients' hospital charts. PPV was calculated with 95% confidence intervals (CIs) to estimate the validity of CEA and CAS coding, utilizing hospital charts as the gold standard. Sensitivity of CEA and CAS coding were also assessed by linking two independent databases of 540 CEA-treated patients (Ontario Stroke Registry) and 140 CAS-treated patients (single-center CAS database) to administrative records. PPV for CEA ranged from 99% to 100% and sensitivity ranged from 81.5% to 89.6% using CCI and OHIP codes. A CCI code with a PPV of 87% (95% CI, 78.8-92.9) and sensitivity of 92.9% (95% CI, 87.4-96.1) in identifying CAS was also identified. PPV for post-admission complication diagnosis coding was 71.4% (95% CI, 53.7-85.4) for stroke/transient ischemic attack, and 82.4% (95% CI, 56.6-96.2) for myocardial infarction. Our analysis demonstrated that the codes used in administrative databases accurately identify CEA and CAS-treated patients. Researchers can confidently use administrative data to conduct population-based studies of CEA and CAS.

Pediatric Tuina for promoting growth and development of preterm infants: A protocol for the systematic review of randomized controlled trail.

PubMed

Zhang, Xinghe; Guo, Taipin; Zhu, Bowen; Gao, Qing; Wang, Hourong; Tai, Xiantao; Jing, Fujie

2018-05-01

Preterm infants are babies born alive before 37 weeks. Many survived infants concomitant with defects of growth and development, a lifetime of disability usually as following when insufficient intervention. In early intervention of preterm infants, pediatric Tuina shows good effect in many Chinese and some English clinical trials. This systematic review is aimed to evaluate the efficacy and safety of pediatric Tuina for promoting growth and development of preterm infants. The electronic databases of Cochrane Library, MEDLINE, EBASE, Web of Science, Springer, World Health Organization International Clinical Trials Registry Platform, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wan-fang database, Chinese Scientific Journal Database, and other databases will be searched from establishment to April 1, 2018. All published randomized controlled trials (RCTs) about this topic will be included. Two independent researchers will operate article retrieval, screening, quality evaluation, and data analyses by Review Manager (V.5.3.5). Meta-analyses, subgroup analysis, and/or descriptive analysis will be performed based on included data conditions. High-quality synthesis and/or descriptive analysis of current evidence will be provided from weight increase, motor development, neuropsychological development, length of stay, days of weight recovery to birthweight, days on supplemental oxygen, daily sleep duration, and side effects. This study will provide the evidence of whether pediatric Tuina is an effective early intervention for preterm infants. There is no requirement of ethical approval and informed consent, and it will be in print or published by electronic copies. This systematic review protocol has been registered in the PROSPERO network (No. CRD42018090563).

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians.

PubMed

Ryerson, A Blythe; Eheman, Christie; Styles, Timothy; Rycroft, Randi; Snyder, Claire

2015-12-01

Cancer survivors, the medical community, public health professionals, researchers, and policymakers all need information about newly diagnosed cancer cases and deaths to better understand and address the disease burden. CDC collects cancer data on 96% of the U.S. population through the National Program of Cancer Registries. The National Program of Cancer Registries routinely collects data on all cancer occurrences, deaths, and the types of initial treatment received by the patients, and recently CDC has made advances in its cancer surveillance activities that have direct applicability to cancer survivorship research and care. This article examines CDC's innovative uses of the National Program of Cancer Registries infrastructure and data as a recruitment source for survivorship research studies and behavioral interventions; comparative effectiveness and patient-centered outcomes research; and the collection, consolidation, and dissemination of treatment summaries for cancer survivors and their providers. This paper also discusses long-term, idealistic plans for additional data linkages and sharing among public health, providers, and the cancer survivor through innovative concepts such as patient portals and rapid-learning health care. Published by Elsevier Inc.

The accuracy of burn diagnosis codes in health administrative data: A validation study.

PubMed

Mason, Stephanie A; Nathens, Avery B; Byrne, James P; Fowler, Rob; Gonzalez, Alejandro; Karanicolas, Paul J; Moineddin, Rahim; Jeschke, Marc G

2017-03-01

Health administrative databases may provide rich sources of data for the study of outcomes following burn. We aimed to determine the accuracy of International Classification of Diseases diagnoses codes for burn in a population-based administrative database. Data from a regional burn center's clinical registry of patients admitted between 2006-2013 were linked to administrative databases. Burn total body surface area (TBSA), depth, mechanism, and inhalation injury were compared between the registry and administrative records. The sensitivity, specificity, and positive and negative predictive values were determined, and coding agreement was assessed with the kappa statistic. 1215 burn center patients were linked to administrative records. TBSA codes were highly sensitive and specific for ≥10 and ≥20% TBSA (89/93% sensitive and 95/97% specific), with excellent agreement (κ, 0.85/κ, 0.88). Codes were weakly sensitive (68%) in identifying ≥10% TBSA full-thickness burn, though highly specific (86%) with moderate agreement (κ, 0.46). Codes for inhalation injury had limited sensitivity (43%) but high specificity (99%) with moderate agreement (κ, 0.54). Burn mechanism had excellent coding agreement (κ, 0.84). Administrative data diagnosis codes accurately identify burn by burn size and mechanism, while identification of inhalation injury or full-thickness burns is less sensitive but highly specific. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

CKD.QLD: establishment of a chronic kidney disease [CKD] registry in Queensland, Australia.

PubMed

Venuthurupalli, Sree K; Hoy, Wendy E; Healy, Helen G; Cameron, Anne; Fassett, Robert G

2017-06-07

Chronic kidney disease [CKD] is recognised as a global public health problem. Until recently, the majority of information informing on CKD has been generated from renal registries reporting on patients with end-stage kidney disease [ESKD] and on renal replacement therapy [RRT]. There has been a paucity of information on pre-dialysis CKD cohorts, and many issues related to these poorly described populations are unresolved. To this end, international organizations have called for CKD surveillance systems across all countries. In Australia, we have responded by developing the Chronic Kidney Disease in Queensland [CKD.QLD] with three main platforms consisting of CKD Registry, clinical trials and development of biobank. This registry which is the core component of CKD surveillance was conceptualized specifically for the pre-dialysis population in the public health system in Queensland, Australia. Recruitment started in May 2011, and to date the Registry has evolved as one of the largest CKD cohorts in the world with recruitment close to 7000 patients. The Registry has had many outcomes, including being the nidus for Australia's first National Health and Medical Research Council [NHMRC] CKD Centre of Research Excellence [CKD.CRE]. The Registry, with its linkage to Queensland Health datasets, is reporting, and is expected to continue generating, significant information on multiple aspects of CKD, its trajectory, management and patient outcomes. Intent of the CKD.CRE is to facilitate an expanded Registry network that has representation from health services, both public and private, across Australia.

Patient selection and volume in the era surrounding implementation of Medicare conditions of participation for transplant programs.

PubMed

White, Sarah L; Zinsser, Dawn M; Paul, Matthew; Levine, Gregory N; Shearon, Tempie; Ashby, Valarie B; Magee, John C; Li, Yi; Leichtman, Alan B

2015-04-01

To evaluate evidence of practice changes affecting kidney transplant program volumes, and donor, recipient and candidate selection in the era surrounding the introduction of Centers for Medicare and Medicaid Services (CMS) conditions of participation (CoPs) for organ transplant programs. Scientific Registry of Transplant Recipients; CMS ESRD and Medicare claims databases. Retrospective analysis of national registry data. A Cox proportional hazards model of 1-year graft survival was used to derive risks associated with deceased-donor kidney transplants performed from 2001 to 2010. Among programs with ongoing noncompliance with the CoPs, kidney transplant volumes declined by 38 percent (n = 766) from 2006 to 2011, including a 55 percent drop in expanded criteria donor transplants. Volume increased by 6 percent (n = 638) among programs remaining in compliance. Aggregate risk of 1-year graft failure increased over time due to increasing recipient age and obesity, and longer ESRD duration. Although trends in aggregate risk of 1-year kidney graft loss do not indicate that the introduction of the CoPs has systematically reduced opportunities for marginal candidates or that there has been a systematic shift away from utilization of higher risk deceased donor kidneys, total volume and expanded criteria donor utilization decreased overall among programs with ongoing noncompliance. © Health Research and Educational Trust.

[Types of medical registries - definitions, methodological aspects and quality of the scientific work with registries].

PubMed

Mathis-Edenhofer, Stefan; Piso, Brigitte

2011-12-01

This work presents a comprehensive list of registry definitions including broader and narrower definitions. Compared to each other different methodological issues can be identified. Some of these issues are common for all registry types; some can be assigned more easily to a specific registry type. Instruments for evaluating the quality of registers reflect many of the mentioned aspects. Generally, and especially at registers with a descriptive or exploratory research dimension it is important to consider their intended purpose and in about it was achieved. This includes, for instance, whether the purpose and the methodology are coordinated. From the start of registration an initiator should be - based on the purpose - aware of the methodological dimension of the registry. This helps to apply the correct type of the registry, the appropriate guidance and, ultimately, the arguments for the effort (cost-benefit ratio).

Disease registries on the nationwide health information network.

PubMed

Russler, Daniel

2011-05-01

Donation by individuals of their protected health information (PHI) for evidence-based research potentially benefits all individuals with disease through improved understandings of disease patterns. In the future, a better understanding of how disease features combine into unique patterns of disease will generate new disease classifications, supporting greater specificity in health management techniques. However, without large numbers of people who donate their PHI to disease registries designed for research, it is difficult for researchers to discover the existence of complex patterns or to create more specific evidence-based management techniques. In order to identify new opportunities in disease registry design, an analysis of the current stage of maturity of the newly created U.S. Nationwide Health Information Network (NwHIN) related to large-scale consumer donation of PHI is presented. Utilizing a use-case analysis methodology, the consumer-centric designs of the policies and technologies created for the NwHIN were examined for the potential to support consumer donations of PHI to research. The NwHIN design has placed the enforcement point for the policy-based release of PHI over the Internet into a specialized gateway accessible to consumer authorization. However, current NwHIN policies leave the final decision regarding release of PHI for research to the health care providers rather than to the consumers themselves. Should disease registries designed for research be established on the NwHIN, consumers might then directly authorize the donation of their PHI to these disease registries. However, under current NwHIN policies, consumer authorization does not guarantee release of PHI by health providers. © 2011 Diabetes Technology Society.

Published intimate partner violence studies often differ from their trial registration records.

PubMed

Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

2017-12-27

Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

pClone: Synthetic Biology Tool Makes Promoter Research Accessible to Beginning Biology Students

PubMed Central

Eckdahl, Todd; Cronk, Brian; Andresen, Corinne; Frederick, Paul; Huckuntod, Samantha; Shinneman, Claire; Wacker, Annie; Yuan, Jason

2014-01-01

The Vision and Change report recommended genuine research experiences for undergraduate biology students. Authentic research improves science education, increases the number of scientifically literate citizens, and encourages students to pursue research. Synthetic biology is well suited for undergraduate research and is a growing area of science. We developed a laboratory module called pClone that empowers students to use advances in molecular cloning methods to discover new promoters for use by synthetic biologists. Our educational goals are consistent with Vision and Change and emphasize core concepts and competencies. pClone is a family of three plasmids that students use to clone a new transcriptional promoter or mutate a canonical promoter and measure promoter activity in Escherichia coli. We also developed the Registry of Functional Promoters, an open-access database of student promoter research results. Using pre- and posttests, we measured significant learning gains among students using pClone in introductory biology and genetics classes. Student posttest scores were significantly better than scores of students who did not use pClone. pClone is an easy and affordable mechanism for large-enrollment labs to meet the high standards of Vision and Change. PMID:26086659

Developing a list of reference chemicals for testing alternatives to whole fish toxicity tests.

PubMed

Schirmer, Kristin; Tanneberger, Katrin; Kramer, Nynke I; Völker, Doris; Scholz, Stefan; Hafner, Christoph; Lee, Lucy E J; Bols, Niels C; Hermens, Joop L M

2008-11-11

This paper details the derivation of a list of 60 reference chemicals for the development of alternatives to animal testing in ecotoxicology with a particular focus on fish. The chemicals were selected as a prerequisite to gather mechanistic information on the performance of alternative testing systems, namely vertebrate cell lines and fish embryos, in comparison to the fish acute lethality test. To avoid the need for additional experiments with fish, the U.S. EPA fathead minnow database was consulted as reference for whole organism responses. This database was compared to the Halle Registry of Cytotoxicity and a collation of data by the German EPA (UBA) on acute toxicity data derived from zebrafish embryos. Chemicals that were present in the fathead minnow database and in at least one of the other two databases were subject to selection. Criteria included the coverage of a wide range of toxicity and physico-chemical parameters as well as the determination of outliers of the in vivo/in vitro correlations. While the reference list of chemicals now guides our research for improving cell line and fish embryo assays to make them widely applicable, the list could be of benefit to search for alternatives in ecotoxicology in general. One example would be the use of this list to validate structure-activity prediction models, which in turn would benefit from a continuous extension of this list with regard to physico-chemical and toxicological data.

Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers.

PubMed

Dear, Rachel; Barratt, Alexandra; Askie, Lisa; McGeechan, Kevin; Arora, Sheena; Crossing, Sally; Currow, David; Tattersall, Martin

2011-02-01

Clinical trials registries are now operating in the USA, Europe, Australia, China, and India and more are planned. Trial registries could be an excellent source of information about clinical trials for patients and others affected by cancer as well as health care professionals, but may be difficult for patients to navigate and use. An opportunity arose in Australia to develop a consumer friendly cancer clinical trials website (Australian Cancer Trials Online (ACTO), www.australiancancertrials.gov.au) using an automated data feed from two large clinical trial registries. In this article, we describe aspects of this new website, and explore ways in which such a website may add value to clinical trial data which are already collected and held by trial registries. The development of ACTO was completed by a Web company working in close association with staff at the Australian New Zealand Clinical Trials Registry (ANZCTR), and with consumer representatives. Data for the website were sourced directly and only from clinical trial registries, thus avoiding the creation of an additional trials database. It receives an automated, daily data feed of newly registered cancer clinical trials from both the ANZCTR and Clinical Trials.gov. The development of ACTO exemplifies the advantage of a local clinical trial registry working with consumers to provide accessible information about cancer clinical trials to meet consumers' information needs. We found that the inclusion of a lay summary added substantial value for consumers, and recommend that consideration be given to adding a lay summary to the mandatory data items collected by all trial registries. Furthermore, improved navigation, decision support tools, and consistency in data collection between clinical trial registries will also enable consumer websites to provide additional value for users. Clinical trial registration is not compulsory in Australia. If the additional cancer items (including a lay summary) are not provided by registrants of cancer trials on ANZCTR, this can compromise the quality and usefulness of the data for the end-user, in this case consumers, as they may encounter gaps in the data. Expanding the World Health Organization Trial Registration Data Set to include this additional information, particularly the lay summary, would be valuable. A well-coordinated system of clinical trial registration is critical to the success of efforts to provide better access for all to inform about clinical trials.

The Impact of Coexisting Asthma, Chronic Obstructive Pulmonary Disease and Tuberculosis on Survival in Patients with Lung Squamous Cell Carcinoma.

PubMed

Huang, Jing-Yang; Jian, Zhi-Hong; Ndi Nfor, Oswald; Jhang, Kai-Ming; Ku, Wen-Yuan; Ko, Pei-Chieh; Jan, Shiou-Rung; Ho, Chien-Chang; Lung, Chia-Chi; Pan, Hui-Hsien; Liang, Yu-Chiu; Liaw, Yung-Po

2015-01-01

Pulmonary diseases [asthma, chronic obstructive pulmonary disease (COPD), and tuberculosis (TB)] are associated with lung cancer mortality. However, the relationship between coexisting pulmonary diseases and survival in patients with lung squamous cell carcinoma (SqCC) has not been well defined. Patients newly diagnosed with SqCC between 2003 and 2008 were identified by linking the National Health Insurance Research Database and Taiwan Cancer Registry Database. Cases with SqCC were followed up until death, loss to follow-up, or study end in 2010. Information on health status, date of death and the main causes of death was ascertained from the National Death Registry Database. Cox proportional hazard regression was used to calculate the hazard ratio (HR) of coexisting asthma, COPD and/or TB. During the study period, a total of 5406 cases with SqCC were enrolled. For all cause-mortality, HRs were 1.08 [95% confidence interval (CI), 0.99-1.18], 1.04 (95% CI, 0.97-1.12), and 1.14 (95% CI, 1.00-1.31) for individuals with asthma, COPD, and TB, respectively. Specifically, among men with coexisting pulmonary diseases, the HRs were 1.56 (95% CI, 1.23-1.97) and 1.11 (95% CI, 1.00-1.24) for individuals with asthma+COPD+TB and asthma+COPD, respectively. Among male patients with stage III SqCC, HRs were 3.41 (95%CI, 1.27-9.17) and 1.65 (95%CI, 1.10-2.47) for individuals with asthma+TB and asthma+COPD+TB, respectively. Among male patients with stage IV SqCC, HRs were 1.40 (95%CI, 1.00-1.97) and 1.25 (95%CI, 1.03-1.52) for individuals with asthma+ COPD+TB and asthma. Among female patients with stage I and II, HR was 0.19 (95%CI, 005-0.77) for individuals with asthma. Coexisting pulmonary diseases increased the risk of mortality from SqCC in male patients. For female patients with early stage SqCC, pre-existing asthma decreased mortality. These patients deserve greater attention while undergoing cancer treatment.

Online Registries for Researchers: Using ORCID and SciENcv.

PubMed

Vrabel, Mark

2016-12-01

The Open Researcher and Contributor ID (ORCID) registry helps resolve name ambiguity by assigning persistent unique identifiers that automatically link to a researcher's publications, grants, and other activities. This article provides an overview of ORCID and its benefits, citing several examples of its use in cancer and nursing journals. The article also briefly describes My NCBI and the Science Experts Network Curriculum Vitae (SciENcv) and its connection to ORCID.

Behavioral Health Services Utilization among Older Adults Identified within a State Abuse Hotline Database

ERIC Educational Resources Information Center

Schonfeld, Lawrence; Larsen, Rebecca G.; Stiles, Paul G.

2006-01-01

Purpose: This study examined the extent to which older adults identified in a statewide abuse hotline registry utilized behavioral health services. This is important as mental health issues have been identified as a high priority for filling gaps in services for victims of mistreatment. Design and Methods: We compared Medicaid and Medicare claims…

76 FR 17391 - Applications for New Awards; United States-Brazil Higher Education Consortia Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

... Number (TIN); b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database; c. Provide your DUNS number and TIN on your application; and d..., agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are...

To amend title 5, United States Code, to permit access to databases maintained by the Federal Emergency Management Agency for purposes of complying with sex offender registry and notification laws, and for other purposes.

THOMAS, 111th Congress

Rep. Poe, Ted [R-TX-2

2009-01-09

House - 02/24/2009 Referred to the Subcommittee on Information Policy, Census, and National Archives. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Are all metal-on-metal hip revision operations contributing to the National Joint Registry implant survival curves? : a study comparing the London Implant Retrieval Centre and National Joint Registry datasets.

PubMed

Sabah, S A; Henckel, J; Koutsouris, S; Rajani, R; Hothi, H; Skinner, J A; Hart, A J

2016-01-01

The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records. We analysed metal-on-metal hip revision procedures performed between 2003 and 2013. A total of 69 929 revision procedures from the NJR and 929 revised pairs of components from the LIRC were included. We were able to link 716 (77.1%) revision procedures on the NJR to the LIRC. This meant that 213 (22.9%) revision procedures at the LIRC could not be identified on the NJR. We found that 349 (37.6%) explants at the LIRC completed the full linkage process to both NJR primary and revision databases. Data completion was excellent (> 99.9%) for revision procedures reported to the NJR. This study has shown that only approximately one third of retrieved components at the LIRC, contributed to survival curves on the NJR. We recommend prospective registry-retrieval linkage as a tool to feedback missing and erroneous data to the NJR and improve data quality. Prospective Registry - retrieval linkage is a simple tool to evaluate and improve data quality on the NJR. ©2016 Sabah et al.

The Prevalence of Congenital Hand and Upper Extremity Anomalies Based Upon the New York Congenital Malformations Registry.

PubMed

Goldfarb, Charles A; Shaw, Neil; Steffen, Jennifer A; Wall, Lindley B

2017-03-01

There have been few publications regarding the prevalence of congenital upper extremity anomalies and no recent reports from the United States. The purpose of this investigation was to examine the prevalence of congenital upper extremity anomalies in the total birth population of New York State over a 19-year period utilizing the New York Congenital Malformations Registry (NYCMR) database. The NYCMR includes children with at least 1 birth anomaly diagnosed by 2 years of age and listed by diagnosis code. We scrutinized these codes for specific upper extremity anomalies, including polydactyly, syndactyly, reduction defects, clubhand malformations, and syndromes with upper limb anomalies. We included children born between 1992 and 2010. There were a total of 4,883,072 live births in New York State during the study period. The overall prevalence of congenital upper extremity anomalies was 27.2 cases per 10,000 live births. Polydactyly was most common with 12,418 cases and a prevalence rate of 23.4 per 10,000 live births. The next most common anomalies included syndactyly with 627 cases affecting the hands (1498 total) and reduction defects (1111 cases). Specific syndromes were quite rare and were noted in a total of 215 live births. The prevalence of anomalies was higher in New York City compared with New York State populations at 33.0 and 21.9 per 10,000 live births, respectively. The NYCMR data demonstrate that congenital upper extremity anomalies are more common than previously reported. This is in large part due to the high prevalence of polydactyly. Although registries are imperfect, such data are helpful in monitoring prevalence rates over time, identifying potential causes or associations, and guiding health care planning and future research. Level I-diagnostic.

The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients

PubMed Central

Gomes, Walter J.; Moreira, Rita Simone; Zilli, Alexandre Cabral; Bettiati Jr, Luiz Carlos; Figueira, Fernando Augusto Marinho dos Santos; D'Azevedo, Stephanie Steremberg Pires; Soares, Marcelo José Ferreira; Fernandes, Marcio Pimentel; Ardito, Roberto Vito; Bogdan, Renata Andrea Barberio; Campagnucci, Valquíria Pelisser; Nakasako, Diana; Kalil, Renato Abdala Karam; Rodrigues, Clarissa Garcia; Rodrigues Junior, Anilton Bezerra; Cascudo, Marcelo Matos; Atik, Fernando Antibas; Lima, Elson Borges; Nina, Vinicius José da Silva; Heluy, Renato Albuquerque; Azeredo, Lisandro Gonçalves; Henrique Junior, Odilon Silva; de Mendonça, José Teles; Silva, Katharina Kelly de Oliveira Gama; Pandolfo, Marcelo; de Lima Júnior, José Dantas; Faria, Renato Max; dos Santos, Jonas Pereira; Paez, Rodrigo Pereira; Coelho, Guilherme Henrique Biachi; Pereira, Sergio Nunes; Senger, Roberta; Buffolo, Enio; Caputi, Guido Marco; Santo, José Amalth do Espírito; de Oliveira, Juliana Aparecida Borges; Berwanger, Otavio; Cavalcanti, Alexandre Biasi; Jatene, Fabio B.

2017-01-01

Objective To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. Conclusion This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols. PMID:28492786

Streamlining cardiovascular clinical trials to improve efficiency and generalisability.

PubMed

Zannad, Faiez; Pfeffer, Marc A; Bhatt, Deepak L; Bonds, Denise E; Borer, Jeffrey S; Calvo-Rojas, Gonzalo; Fiore, Louis; Lund, Lars H; Madigan, David; Maggioni, Aldo Pietro; Meyers, Catherine M; Rosenberg, Yves; Simon, Tabassome; Stough, Wendy Gattis; Zalewski, Andrew; Zariffa, Nevine; Temple, Robert

2017-08-01

Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Does Breast Cancer Drive the Building of Survival Probability Models among States? An Assessment of Goodness of Fit for Patient Data from SEER Registries

PubMed

Khan, Hafiz; Saxena, Anshul; Perisetti, Abhilash; Rafiq, Aamrin; Gabbidon, Kemesha; Mende, Sarah; Lyuksyutova, Maria; Quesada, Kandi; Blakely, Summre; Torres, Tiffany; Afesse, Mahlet

2016-12-01

Background: Breast cancer is a worldwide public health concern and is the most prevalent type of cancer in women in the United States. This study concerned the best fit of statistical probability models on the basis of survival times for nine state cancer registries: California, Connecticut, Georgia, Hawaii, Iowa, Michigan, New Mexico, Utah, and Washington. Materials and Methods: A probability random sampling method was applied to select and extract records of 2,000 breast cancer patients from the Surveillance Epidemiology and End Results (SEER) database for each of the nine state cancer registries used in this study. EasyFit software was utilized to identify the best probability models by using goodness of fit tests, and to estimate parameters for various statistical probability distributions that fit survival data. Results: Statistical analysis for the summary of statistics is reported for each of the states for the years 1973 to 2012. Kolmogorov-Smirnov, Anderson-Darling, and Chi-squared goodness of fit test values were used for survival data, the highest values of goodness of fit statistics being considered indicative of the best fit survival model for each state. Conclusions: It was found that California, Connecticut, Georgia, Iowa, New Mexico, and Washington followed the Burr probability distribution, while the Dagum probability distribution gave the best fit for Michigan and Utah, and Hawaii followed the Gamma probability distribution. These findings highlight differences between states through selected sociodemographic variables and also demonstrate probability modeling differences in breast cancer survival times. The results of this study can be used to guide healthcare providers and researchers for further investigations into social and environmental factors in order to reduce the occurrence of and mortality due to breast cancer. Creative Commons Attribution License

Retinoblastoma incidence patterns in the US Surveillance, Epidemiology, and End Results program.

PubMed

Wong, Jeannette R; Tucker, Margaret A; Kleinerman, Ruth A; Devesa, Susan S

2014-04-01

IMPORTANCE Several studies have found no temporal or demographic differences in the incidence of retinoblastoma except for age at diagnosis, whereas other studies have reported variations in incidence by sex and race/ethnicity. OBJECTIVE To examine updated US retinoblastoma incidence patterns by sex, age at diagnosis, laterality, race/ethnicity, and year of diagnosis. DESIGN, SETTING, AND PARTICIPANTS The Surveillance, Epidemiology, and End Results (SEER) databases were examined for retinoblastoma incidence patterns by demographic and tumor characteristics. We studied 721 children in SEER 18 registries, 659 in SEER 13 registries, and 675 in SEER 9 registries. MAIN OUTCOMES AND MEASURES Incidence rates, incidence rate ratios (IRRs), and annual percent changes in rates. RESULTS During 2000-2009 in SEER 18, there was a significant excess of total retinoblastoma among boys compared with girls (IRR, 1.18; 95% CI, 1.02 to 1.36), in contrast to earlier reports of a female predominance. Bilateral retinoblastoma among white Hispanic boys was significantly elevated relative to white non-Hispanic boys (IRR, 1.81; 95% CI, 1.22 to 2.79) and white Hispanic girls (IRR, 1.75; 95% CI, 1.11 to 2.91) because of less rapid decreases in bilateral rates since the 1990s among white Hispanic boys than among the other groups. Retinoblastoma rates among white non-Hispanics decreased significantly since 1992 among those younger than 1 year and since 1998 among those with bilateral disease. CONCLUSIONS AND RELEVANCE Although changes in the availability of prenatal screening practices for retinoblastoma may have contributed to these incidence patterns, further research is necessary to determine their actual effect on the changing incidence of retinoblastoma in the US population. In addition, consistent with other cancers, an excess of retinoblastoma diagnosed in boys suggests a potential effect of sex on cancer origin.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

Enhancing requirements engineering for patient registry software systems with evidence-based components.

PubMed

Lindoerfer, Doris; Mansmann, Ulrich

2017-07-01

Patient registries are instrumental for medical research. Often their structures are complex and their implementations use composite software systems to meet the wide spectrum of challenges. Commercial and open-source systems are available for registry implementation, but many research groups develop their own systems. Methodological approaches in the selection of software as well as the construction of proprietary systems are needed. We propose an evidence-based checklist, summarizing essential items for patient registry software systems (CIPROS), to accelerate the requirements engineering process. Requirements engineering activities for software systems follow traditional software requirements elicitation methods, general software requirements specification (SRS) templates, and standards. We performed a multistep procedure to develop a specific evidence-based CIPROS checklist: (1) A systematic literature review to build a comprehensive collection of technical concepts, (2) a qualitative content analysis to define a catalogue of relevant criteria, and (3) a checklist to construct a minimal appraisal standard. CIPROS is based on 64 publications and covers twelve sections with a total of 72 items. CIPROS also defines software requirements. Comparing CIPROS with traditional software requirements elicitation methods, SRS templates and standards show a broad consensus but differences in issues regarding registry-specific aspects. Using an evidence-based approach to requirements engineering for registry software adds aspects to the traditional methods and accelerates the software engineering process for registry software. The method we used to construct CIPROS serves as a potential template for creating evidence-based checklists in other fields. The CIPROS list supports developers in assessing requirements for existing systems and formulating requirements for their own systems, while strengthening the reporting of patient registry software system descriptions. It may be a first step to create standards for patient registry software system assessments. Copyright © 2017 Elsevier Inc. All rights reserved.

Novel Method for Recruiting Representative At-Risk Individuals into Cancer Prevention Trials: Online Health Risk Assessment in Employee Wellness Programs.

PubMed

Hui, Siu-Kuen Azor; Miller, Suzanne M; Hazuda, Leah; Engelman, Kimberly; Ellerbeck, Edward F

2016-09-01

Participation in cancer prevention trials (CPT) is lower than 3 % among high-risk healthy individuals, and racial/ethnic minorities are the most under-represented. Novel recruitment strategies are therefore needed. Online health risk assessment (HRA) serves as a gateway component of nearly all employee wellness programs (EWPs) and may be a missed opportunity. This study aimed to explore employees' interest, willingness, motivators, and barriers of releasing their HRA responses to an external secure research database for recruitment purpose. We used qualitative research methods (focus group and individual interviews) to examine employees' interest and willingness in releasing their online HRA responses to an external, secure database to register as potential CPT participants. Fifteen structured interviews (40 % of study participants were of racial/ethnic minority) were conducted, and responses reached saturation after four interviews. All employees showed interest and willingness to release their online HRA responses to register as a potential CPT participant. Content analyses revealed that 91 % of participants were motivated to do so, and the major motivators were to (1) obtain help in finding personally relevant prevention trials, (2) help people they know who are affected by cancer, and/or (3) increase knowledge about CPT. A subset of participants (45 %) expressed barriers of releasing their HRA responses due to concerns about credibility and security of the external database. Online HRA may be a feasible but underutilized recruitment method for cancer prevention trials. EWP-sponsored HRA shows promise for the development of a large, centralized registry of racially/ethnically representative CPT potential participants.

Novel method for recruiting representative at-risk individuals into cancer prevention trials: on-line health risk assessment in employee wellness programs

PubMed Central

Hui, Siu-kuen Azor; Miller, Suzanne M.; Hazuda, Leah; Engelman, Kimberly; Ellerbeck, Edward F.

2015-01-01

Participation in cancer prevention trials (CPT) is lower than 3% among high-risk healthy individuals, and racial/ethnic minorities are the most under-represented. Novel recruitment strategies are therefore needed. On-line health risk assessment (HRA) serves as a gateway component of nearly all employee wellness programs (EWP) and may be a missed opportunity. This study aimed to explore employees’ interest, willingness, motivators, and barriers of releasing their HRA responses to an external secure research database for recruitment purpose. We used qualitative research methods (focus group and individual interviews) to examine employees’ interest and willingness in releasing their on-line HRA responses to an external, secure database to register as potential CPT participants. Fifteen structured interviews (40% of study participants were of racial/ethnic minority) were conducted and responses reached saturation after four interviews. All employees showed interest and willingness to release their on-line HRA responses to register as a potential CPT participant. Content analyses revealed that 91% of participants were motivated to do so, and the major motivators were to: 1) obtain help in finding personally relevant prevention trials, 2) help people they know who are affected by cancer, and/or 3) increase knowledge about CPT. A subset of participants (45%) expressed barriers of releasing their HRA responses due to concerns about credibility and security of the external database. On-line HRA may be a feasible but underutilized recruitment method for cancer prevention trials. EWP-sponsored HRA shows promise for the development of a large, centralized registry of racially/ethnically representative CPT potential participants. PMID:26507744

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records.

PubMed

Fife, Caroline E; Eckert, Kristen A

2017-04-01

The United States Food and Drug Administration will consider the expansion of coverage indications for some drugs and devices based on real-world data. Real-world data accrual in patient registries has historically been via manual data entry from the medical chart at a time distant from patient care, which is fraught with systematic error. The efficient automated transmission of data directly from electronic health records is replacing this labor-intensive paradigm. However, real-world data collection is unfamiliar. The potential sources of bias arising from the source of data and data accrual, documentation, and aggregation have not been well defined. Furthermore, the technological aspects of data acquisition and transmission are less transparent. We explore opportunities for harnessing direct-from-electronic health record registry reporting and propose the ABCs of Registries (Analysis of Bias Criteria of Registries), which are an evaluation framework for publications to minimize potential bias of real-world data obtained directly from an electronic health record method. These standards are based on a point-of-care data documentation process using a common definitional framework and data dictionaries. By way of example, we describe a wound registry obtained directly from electronic health records. This qualified clinical data registry minimizes bias by ensuring complete and accurate point-of-care data capture, standardizes usual care linked to quality reporting, and prevents post-hoc vetting of outcomes. The resulting data are of high quality and integrity and can be used for comparative effectiveness research in wound care. In this way, the effort needed to succeed with the Quality Payment Program is leveraged to obtain the real-world data needed for comparative effectiveness research. © 2017 by the Wound Healing Society.

Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease.

PubMed

Lee, Michael S; Canan, Timothy; Rha, Seung-Woon; Mustapha, Jihad; Adams, George L

2015-02-01

To compare the acute procedure and angiographic outcomes of peripheral artery disease (PAD) patients treated with orbital atherectomy stratified by gender. The CONFIRM I, II, and III registries are US multicenter, nonrandomized, all-comers registries of PAD patients who were treated with orbital atherectomy. All patients with gender specified in the registry database were included in the current analysis, which compared the final residual stenosis achieved after atherectomy and the rate of acute complications in female and male patients. The 3 registries included 3131 patients with 4761 lesions: 1261 women (mean age 73.2 ± 10.7 years) with 1874 lesions and 1870 men (mean age 70.4 ± 10.2) with 2887 lesions. The women were older (p < 0.001) and had a higher but nonsignificant prevalence of critical limb ischemia (p = 0.075). After treatment, the final residual stenosis in women vs. men was 9% ± 11% vs. 11% ± 11%, respectively (p < 0.001). Women had a higher rate of all types of dissection (13.3% vs. 9.9%, p<0.001). However, both genders had similar rates of flow-limiting dissections (1.6% vs. 1.4%, p = 0.61), perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation. The gender analysis of the CONFIRM registries revealed that there was successful lesion modification with orbital atherectomy in both men and women; however, women had a higher rate of dissection (all types). This difference is likely because of the older age and higher percentage of critical limb ischemia in women in this cohort. These results, however, suggest that additional studies should be completed to further understand the increased risks for women vs. men during endovascular procedures. © The Author(s) 2015.

Effects of automated immunization registry reporting via an electronic health record deployed in community practice settings.

PubMed

Merrill, J; Phillips, A; Keeling, J; Kaushal, R; Senathirajah, Y

2013-01-01

Among the expected benefits of electronic health records (EHRs) is increased reporting of public health information, such as immunization status. State and local immunization registries aid control of vaccine-preventable diseases and help offset fragmentation in healthcare, but reporting is often slow and incomplete. The Primary Care Information Project (PCIP), an initiative of the NYC Department of Health and Mental Hygiene, has implemented EHRs with immunization reporting capability in community settings. To evaluate the effect of automated reporting via an EHR on use and efficiency of reporting to the NY Citywide Immunization Registry, we conducted a secondary analysis of 1.7 million de-identified records submitted between January 2007 and June 2011 by 217 primary care practices enrolled in PCIP, pre and post launch of automated reporting via an EHR. We examined differences in records submitted per day, lag time, and documentation of eligibility for subsidized vaccines. Mean submissions per day did not change. Automated submissions of new and historical records increased by 18% and 98% respectively. Submissions within 14 days increased from 84% to 87%, and within 2 days increased from 60% to 77%. Median lag time decreased from 13 to 10 days. Documentation of eligibility decreased. Results are significant at p<0.001. Significant improvements in registry use and efficiency of reporting were found after launch of automated reporting via an EHR. A decrease in eligibility documentation was attributed to EHR workflow. The limitations to comprehensive evaluation found in these data, which were extracted from a registry initiated prior to widespread EHR implementation suggests that reliable evaluation of immunization reporting via the EHR may require modifications to legacy registry databases.

Development and validation of a registry-based definition of eosinophilic esophagitis in Denmark

PubMed Central

Dellon, Evan S; Erichsen, Rune; Pedersen, Lars; Shaheen, Nicholas J; Baron, John A; Sørensen, Henrik T; Vyberg, Mogens

2013-01-01

AIM: To develop and validate a case definition of eosinophilic esophagitis (EoE) in the linked Danish health registries. METHODS: For case definition development, we queried the Danish medical registries from 2006-2007 to identify candidate cases of EoE in Northern Denmark. All International Classification of Diseases-10 (ICD-10) and prescription codes were obtained, and archived pathology slides were obtained and re-reviewed to determine case status. We used an iterative process to select inclusion/exclusion codes, refine the case definition, and optimize sensitivity and specificity. We then re-queried the registries from 2008-2009 to yield a validation set. The case definition algorithm was applied, and sensitivity and specificity were calculated. RESULTS: Of the 51 and 49 candidate cases identified in both the development and validation sets, 21 and 24 had EoE, respectively. Characteristics of EoE cases in the development set [mean age 35 years; 76% male; 86% dysphagia; 103 eosinophils per high-power field (eos/hpf)] were similar to those in the validation set (mean age 42 years; 83% male; 67% dysphagia; 77 eos/hpf). Re-review of archived slides confirmed that the pathology coding for esophageal eosinophilia was correct in greater than 90% of cases. Two registry-based case algorithms based on pathology, ICD-10, and pharmacy codes were successfully generated in the development set, one that was sensitive (90%) and one that was specific (97%). When these algorithms were applied to the validation set, they remained sensitive (88%) and specific (96%). CONCLUSION: Two registry-based definitions, one highly sensitive and one highly specific, were developed and validated for the linked Danish national health databases, making future population-based studies feasible. PMID:23382628

Utilizing a diabetic registry to manage diabetes in a low-income Asian American population.

PubMed

Seto, Winnie; Turner, Barbara S; Champagne, Mary T; Liu, Lynn

2012-08-01

Racial and income disparities persist in diabetes management in America. One third of African and Hispanic Americans with diabetes receive the recommended diabetes services (hemoglobin A1c [A1c] testing, retinal and foot examinations) shown to reduce diabetes complications and mortality, compared to half of whites with diabetes. National data for Asian Americans are limited, but studies suggest that those with language and cultural barriers have difficulty accessing health services. A diabetic registry has been shown to improve process and clinical outcomes in a population with diabetes. This study examined whether a community center that serves primarily low-income Asian American immigrants in Santa Clara County, California, could improve diabetes care and outcomes by implementing a diabetic registry. The registry was built using the Access 2007 software program. A total of 580 patients with diabetes were identified by reviewing charts, the appointment database, and reimbursement records from Medicaid, Medicare, and private insurance companies. Utilizing the registry, medical assistants contacted patients for follow-up appointments, and medical providers checked and tracked the patients' A1c results. Among the 431 patients who returned for treatment, the mean A1c was reduced from 7.27% to 6.97% over 8 months (P<0.001). Although 10.8% of the patients changed from controlled to uncontrolled diabetes post intervention, 32.6% of patients with uncontrolled diabetes converted to controlled diabetes (P<0.001). The diabetes control rate improved from 47% to 59% at the end of the study. This study demonstrated that a diabetic registry is an effective tool to manage an underserved population with diabetes, thereby reducing disparities in diabetes management.

Feasibility of creating a National ALS Registry using administrative data in the United States

PubMed Central

KAYE, WENDY E.; SANCHEZ, MARCHELLE; WU, JENNIFER

2015-01-01

Uncertainty about the incidence and prevalence of amyotrophic lateral sclerosis (ALS), as well as the role of the environment in the etiology of ALS, supports the need for a surveillance system/registry for this disease. Our aim was to evaluate the feasibility of using existing administrative data to identify cases of ALS. The Agency for Toxic Substances and Disease Registry (ATSDR) funded four pilot projects at tertiary care facilities for ALS, HMOs, and state based organizations. Data from Medicare, Medicaid, the Veterans Health Administration, and Veterans Benefits Administration were matched to data available from site-specific administrative and clinical databases for a five-year time-period (1 January 2001–31 December 2005). Review of information in the medical records by a neurologist was considered the gold standard for determining an ALS case. We developed an algorithm using variables from the administrative data that identified true cases of ALS (verified by a neurologist). Individuals could be categorized into ALS, possible ALS, and not ALS. The best algorithm had sensitivity of 87% and specificity of 85%. We concluded that administrative data can be used to develop a surveillance system/ registry for ALS. These methods can be explored for creating surveillance systems for other neurodegenerative diseases. PMID:24597459

The Polish National Registry for Fetal Cardiac Pathology: organization, diagnoses, management, educational aspects and telemedicine endeavors.

PubMed

Slodki, Maciej; Szymkiewicz-Dangel, Joanna; Tobota, Zdzislaw; Seligman, Neil S; Weiner, Stuart; Respondek-Liberska, Maria

2012-05-01

We describe the National Registry for Fetal Cardiac Pathology, a program under the Polish Ministry of Health aimed at improving the prenatal diagnosis, care, and management of congenital heart disease (CHD). An online database was created to prospectively record diagnosis, prenatal care, delivery, follow-up, and still images and video for fetuses with CHD. A certification program in fetal cardiac ultrasound was also implemented. Optimal screening and referral centers were identified by number of fetuses entered in the Registry yearly by each center. From 2004 to 2009, 2910 fetuses with CHD were registered (2473 structural, 437 functional anomalies). The most common reasons for referral for fetal echocardiography were abnormal four-chamber view (56.0%) and extra-cardiac anomalies (8.2% ), while the most common diagnoses were atrioventricular septal defects (10.2%) and hypoplastic left heart syndrome (9.7%). Prenatal diagnosis increased yearly, from 10.0% of neonatal diagnoses in 2003 to 38.0% in 2008. From inception of the registry up to 2009 there has been a fourfold increase in the number of neonates referred for cardiac surgery in whom the condition was prenatally diagnosed. Equally important achievements include the establishment of a certification program for fetal echocardiography and the organization of prenatal and neonatal management. © 2012 John Wiley & Sons, Ltd.

Uses of cancer registries for public health and clinical research in Europe: Results of the European Network of Cancer Registries survey among 161 population-based cancer registries during 2010-2012.

PubMed

Siesling, S; Louwman, W J; Kwast, A; van den Hurk, C; O'Callaghan, M; Rosso, S; Zanetti, R; Storm, H; Comber, H; Steliarova-Foucher, E; Coebergh, J W

2015-06-01

To provide insight into cancer registration coverage, data access and use in Europe. This contributes to data and infrastructure harmonisation and will foster a more prominent role of cancer registries (CRs) within public health, clinical policy and cancer research, whether within or outside the European Research Area. During 2010-12 an extensive survey of cancer registration practices and data use was conducted among 161 population-based CRs across Europe. Responding registries (66%) operated in 33 countries, including 23 with national coverage. Population-based oncological surveillance started during the 1940-50s in the northwest of Europe and from the 1970s to 1990s in other regions. The European Union (EU) protection regulations affected data access, especially in Germany and France, but less in the Netherlands or Belgium. Regular reports were produced by CRs on incidence rates (95%), survival (60%) and stage for selected tumours (80%). Evaluation of cancer control and quality of care remained modest except in a few dedicated CRs. Variables evaluated were support of clinical audits, monitoring adherence to clinical guidelines, improvement of cancer care and evaluation of mass cancer screening. Evaluation of diagnostic imaging tools was only occasional. Most population-based CRs are well equipped for strengthening cancer surveillance across Europe. Data quality and intensity of use depend on the role the cancer registry plays in the politico, oncomedical and public health setting within the country. Standard registration methodology could therefore not be translated to equivalent advances in cancer prevention and mass screening, quality of care, translational research of prognosis and survivorship across Europe. Further European collaboration remains essential to ensure access to data and comparability of the results. Copyright © 2014 Elsevier Ltd. All rights reserved.