Automatic patient dose registry and clinical audit on line for mammography.

PubMed

Ten, J I; Vano, E; Sánchez, R; Fernandez-Soto, J M

2015-07-01

The use of automatic registry systems for patient dose in digital mammography allows clinical audit and patient dose analysis of the whole sample of individual mammography exposures while fulfilling the requirements of the European Directives and other international recommendations. Further parameters associated with radiation exposure (tube voltage, X-ray tube output and HVL values for different kVp and target/filter combinations, breast compression, etc.) should be periodically verified and used to evaluate patient doses. This study presents an experience in routine clinical practice for mammography using automatic systems. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

RENAC: National Registry of Congenital Anomalies of Argentina.

PubMed

Groisman, Boris; Bidondo, María Paz; Barbero, Pablo; Gili, Juan A; Liascovich, Rosa

2013-12-01

The National Registry of Congenital Anomalies (Registro Nacional de Anomalías Congénitas, RENAC) is a hospital-based surveillance system for newborn infants with major morphological congenital anomalies (CAs). The objective of this study was to describe the characteristics and operation of the RENAC registry and the prevalence at birth of 56 specifc selected CAs, compared to other registries. The organization of the RENAC registry was initiated in public hospitals with 1000 or more births per year or which are the referral hospitals in a determined health region. Neonatologists are in charge of data collection, and a central coordination department is in charge of encoding, statistical analyses and regular reports. The RENAC registry uses an online forum for data submission and for guidance and interaction regarding the initial management of cases. Between November 1st, 2009 and June 30th, 2012, 98 hospitals were included in the registry, the annual coverage of these hospitals is 65% in the public sector and 35% of births in Argentina. In this period, 294 005 newborn infants were examined, and 5165 cases with major CAs were detected (1.76%; 95% CI: 1.71-1.80). The most frequent CAs were septal heart defects (prevalence per 10 000: 28.6), Down's syndrome (prevalence per 10 000: 19.2), cleft lip +/- palate (prevalence per 10 000: 12), and a set of neural tube defects (prevalence per 10 000: 11.9). The RENAC has reached a high coverage in the public sector and the differences in prevalence with other registries can be related to operational aspects or actual differences, depending on the case. The RENAC deals with the collection, analysis and dissemination of information about CAs in Argentina, and also contributes with local interventions.

Great Valley Riparian Habitats and the National Registry of Natural Landmarks

Treesearch

Robert F. Holland; Cynthia L. Roye

1989-01-01

The National Registry of Natural Landmarks is a program established by the National Park Service that seeks to recognize nationally significant examples of the Nation's natural history. Nearly 100 Great Valley riparian sites were evaluated using Park Service criteria. Three sites illustrative of the range of this biotic theme were recommended to the National Park...

Transatlantic Comparison of CT Radiation Doses in the Era of Radiation Dose-Tracking Software.

PubMed

Parakh, Anushri; Euler, Andre; Szucs-Farkas, Zsolt; Schindera, Sebastian T

2017-12-01

The purpose of this study is to compare diagnostic reference levels from a local European CT dose registry, using radiation-tracking software from a large patient sample, with preexisting European and North American diagnostic reference levels. Data (n = 43,761 CT scans obtained over the course of 2 years) for the European local CT dose registry were obtained from eight CT scanners at six institutions. Means, medians, and interquartile ranges of volumetric CT dose index (CTDI vol ), dose-length product (DLP), size-specific dose estimate, and effective dose values for CT examinations of the head, paranasal sinuses, thorax, pulmonary angiogram, abdomen-pelvis, renal-colic, thorax-abdomen-pelvis, and thoracoabdominal angiogram were obtained using radiation-tracking software. Metrics from this registry were compared with diagnostic reference levels from Canada and California (published in 2015), the American College of Radiology (ACR) dose index registry (2015), and national diagnostic reference levels from local CT dose registries in Switzerland (2010), the United Kingdom (2011), and Portugal (2015). Our local registry had a lower 75th percentile CTDI vol for all protocols than did the individual internationally sourced data. Compared with our study, the ACR dose index registry had higher 75th percentile CTDI vol values by 55% for head, 240% for thorax, 28% for abdomen-pelvis, 42% for thorax-abdomen-pelvis, 128% for pulmonary angiogram, 138% for renal-colic, and 58% for paranasal sinus studies. Our local registry had lower diagnostic reference level values than did existing European and North American diagnostic reference levels. Automated radiation-tracking software could be used to establish and update existing diagnostic reference levels because they are capable of analyzing large datasets meaningfully.

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.

Cost of Operating Central Cancer Registries and Factors That Affect Cost: Findings From an Economic Evaluation of Centers for Disease Control and Prevention National Program of Cancer Registries.

PubMed

Tangka, Florence K L; Subramanian, Sujha; Beebe, Maggie Cole; Weir, Hannah K; Trebino, Diana; Babcock, Frances; Ewing, Jean

2016-01-01

The Centers for Disease Control and Prevention (CDC) evaluated the economics of the National Program of Cancer Registries to provide the CDC, the registries, and policy makers with the economics evidence-base to make optimal decisions about resource allocation. Cancer registry budgets are under increasing threat, and, therefore, systematic assessment of the cost will identify approaches to improve the efficiencies of this vital data collection operation and also justify the funding required to sustain registry operations. To estimate the cost of cancer registry operations and to assess the factors affecting the cost per case reported by National Program of Cancer Registries-funded central cancer registries. We developed a Web-based cost assessment tool to collect 3 years of data (2009-2011) from each National Program of Cancer Registries-funded registry for all actual expenditures for registry activities (including those funded by other sources) and factors affecting registry operations. We used a random-effects regression model to estimate the impact of various factors on cost per cancer case reported. The cost of reporting a cancer case varied across the registries. Central cancer registries that receive high-quality data from reporting sources (as measured by the percentage of records passing automatic edits) and electronic data submissions, and those that collect and report on a large volume of cases had significantly lower cost per case. The volume of cases reported had a large effect, with low-volume registries experiencing much higher cost per case than medium- or high-volume registries. Our results suggest that registries operate with substantial fixed or semivariable costs. Therefore, sharing fixed costs among low-volume contiguous state registries, whenever possible, and centralization of certain processes can result in economies of scale. Approaches to improve quality of data submitted and increasing electronic reporting can also reduce cost.

36 CFR § 704.1 - Films selected for inclusion in the National Film Registry.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 36 Parks, Forests, and Public Property 3 2013-07-01 2012-07-01 true Films selected for inclusion in the National Film Registry. § 704.1 Section § 704.1 Parks, Forests, and Public Property LIBRARY OF CONGRESS NATIONAL FILM REGISTRY OF THE LIBRARY OF CONGRESS § 704.1 Films selected for inclusion in...

Cost of Operating Central Cancer Registries and Factors That Affect Cost: Findings From an Economic Evaluation of Centers for Disease Control and Prevention National Program of Cancer Registries

PubMed Central

Tangka, Florence K. L.; Subramanian, Sujha; Beebe, Maggie Cole; Weir, Hannah K.; Trebino, Diana; Babcock, Frances; Ewing, Jean

2016-01-01

Context The Centers for Disease Control and Prevention evaluated the economics of the National Program of Cancer Registries to provide the Centers for Disease Control and Prevention, the registries, and policy makers with the economic evidence-base to make optimal decisions about resource allocation. Cancer registry budgets are under increasing threat, and, therefore, systematic assessment of the cost will identify approaches to improve the efficiencies of this vital data collection operation and also justify the funding required to sustain registry operations. Objectives To estimate the cost of cancer registry operations and to assess the factors affecting the cost per case reported by National Program of Cancer Registries–funded central cancer registries. Methods We developed a Web-based cost assessment tool to collect 3 years of data (2009-2011) from each National Program of Cancer Registries–funded registry for all actual expenditures for registry activities (including those funded by other sources) and factors affecting registry operations. We used a random-effects regression model to estimate the impact of various factors on cost per cancer case reported. Results The cost of reporting a cancer case varied across the registries. Central cancer registries that receive high-quality data from reporting sources (as measured by the percentage of records passing automatic edits) and electronic data submissions, and those that collect and report on a large volume of cases had significantly lower cost per case. The volume of cases reported had a large effect, with low-volume registries experiencing much higher cost per case than medium- or high-volume registries. Conclusions Our results suggest that registries operate with substantial fixed or semivariable costs. Therefore, sharing fixed costs among low-volume contiguous state registries, whenever possible, and centralization of certain processes can result in economies of scale. Approaches to improve quality of

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.

76 FR 14366 - National Registry of Certified Medical Examiners

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... [Docket No. FMCSA-2008-0363] RIN 2126-AA97 National Registry of Certified Medical Examiners AGENCY... Certified Medical Examiners (NRCME) published on December 1, 2008. In the comments on the NPRM, a commenter inquired as to what a motor carrier had to do to verify that a medical examiner's certificate had been...

75 FR 65629 - Modification of the Annual National Registry Fee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

... FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL [Docket No. AS10-7] Modification of the Annual National Registry Fee AGENCY: Appraisal Subcommittee (ASC) of the Federal Financial Institutions... Financial Institutions Reform, Recovery and Enforcement Act of 1989 (Title XI), as amended, requires the ASC...

National Suicide Registry Malaysia (NSRM).

PubMed

Hayati, A N; Kamarul, A K

2008-09-01

To create a nationwide system to capture data on completed suicide in Malaysia i.e. the morbidity, geographic and temporal trends and the population at high risk of suicide. Data from this registry can later be used to stimulate and facilitate further research on suicide. This paper describes the rationale and processes involved in developing a national suicide registry in 2007. The diagnosis of suicide is based on the ICD-10 codes for fatal intentional self-harm (X60-X84). A case report form with an accompanying instruction manual had been prepared to ensure systematic and uniform data collection. State Forensic Pathologist's offices are responsible for data collection in their respective states, and in turn will submit the data to a central data management unit. Data collection began in July 2007 and currently in data cleaning process. Training for source data producers is ongoing. In 2008, the NSRM plans to involve university hospitals into its network as currently only Ministry of Health hospitals are involved. The NSRM will be launching its online application for case registration this year while an overview of results will be available via its public domain at www.nsrm.gov.my beginning 20 April 2008. To efficiently capture the data on suicide, a concerted effort between various agencies is needed. A lot of conceptual work and data base development remains to be done in order to position preventive efforts on a more solid foundation.

A survey of national and multi-national registries and cohort studies in juvenile idiopathic arthritis: challenges and opportunities.

PubMed

Beukelman, Timothy; Anink, Janneke; Berntson, Lillemor; Duffy, Ciaran; Ellis, Justine A; Glerup, Mia; Guzman, Jaime; Horneff, Gerd; Kearsley-Fleet, Lianne; Klein, Ariane; Klotsche, Jens; Magnusson, Bo; Minden, Kirsten; Munro, Jane E; Niewerth, Martina; Nordal, Ellen; Ruperto, Nicolino; Santos, Maria Jose; Schanberg, Laura E; Thomson, Wendy; van Suijlekom-Smit, Lisette; Wulffraat, Nico; Hyrich, Kimme

2017-04-19

To characterize the existing national and multi-national registries and cohort studies in juvenile idiopathic arthritis (JIA) and identify differences as well as areas of potential future collaboration. We surveyed investigators from North America, Europe, and Australia about existing JIA cohort studies and registries. We excluded cross-sectional studies. We captured information about study design, duration, location, inclusion criteria, data elements and collection methods. We received survey results from 18 studies, including 11 national and 7 multi-national studies representing 37 countries in total. Study designs included inception cohorts, prevalent disease cohorts, and new treatment cohorts (several of which contribute to pharmacosurveillance activities). Despite numerous differences, the data elements collected across the studies was quite similar, with most studies collecting at least 5 of the 6 American College of Rheumatology core set variables and the data needed to calculate the 3-variable clinical juvenile disease activity score. Most studies were collecting medication initiation and discontinuation dates and were attempting to capture serious adverse events. There is a wide-range of large, ongoing JIA registries and cohort studies around the world. Our survey results indicate significant potential for future collaborative work using data from different studies and both combined and comparative analyses.

Improving Interoperability between Registries and EHRs

PubMed Central

Blumenthal, Seth

2018-01-01

National performance measurement needs clinical data that track the performance of multi disciplinary teams across episodes of care. Clinical registries are ideal platforms for this work due to their capture of structured, specific data across specialties. Because registries collect data at a national level, and registry data are captured in a consistent structure and format within each registry, registry data are useful for measurement and analysis “out of the box”. Registry business models are hampered by the cost of collecting data from EHRs and other source systems and abstracting or mapping them to fit registry data models. The National Quality Registry Network (NQRN) has launched Registries on FHIR, an initiative to lower barriers to achieving semantic interoperability between registries and source data systems. In 2017 Registries on FHIR conducted an information gathering campaign to learn where registries want better interoperability, and how to go about improving it. PMID:29888033

Positive predictive value of infective endocarditis in the Danish National Patient Registry: a validation study.

PubMed

Østergaard, Lauge; Adelborg, Kasper; Sundbøll, Jens; Pedersen, Lars; Loldrup Fosbøl, Emil; Schmidt, Morten

2018-05-30

The positive predictive value of an infective endocarditis diagnosis is approximately 80% in the Danish National Patient Registry. However, since infective endocarditis is a heterogeneous disease implying long-term intravenous treatment, we hypothesiszed that the positive predictive value varies by length of hospital stay. A total of 100 patients with first-time infective endocarditis in the Danish National Patient Registry were identified from January 2010 - December 2012 at the University hospital of Aarhus and regional hospitals of Herning and Randers. Medical records were reviewed. We calculated the positive predictive value according to admission length, and separately for patients with a cardiac implantable electronic device and a prosthetic heart valve using the Wilson score method. Among the 92 medical records available for review, the majority of the patients had admission length ⩾2 weeks. The positive predictive value increased with length of admission. In patients with admission length <2 weeks the positive predictive value was 65% while it was 90% for admission length ⩾2 weeks. The positive predictive value was 81% for patients with a cardiac implantable electronic device and 87% for patients with a prosthetic valve. The positive predictive value of the infective endocarditis diagnosis in the Danish National Patient Registry is high for patients with admission length ⩾2 weeks. Using this algorithm, the Danish National Patient Registry provides a valid source for identifying infective endocarditis for research.

Factors facilitating a national quality registry to aid clinical quality improvement: findings of a national survey.

PubMed

Eldh, Ann Catrine; Wallin, Lars; Fredriksson, Mio; Vengberg, Sofie; Winblad, Ulrika; Halford, Christina; Dahlström, Tobias

2016-11-09

While national quality registries (NQRs) are suggested to provide opportunities for systematic follow-up and learning opportunities, and thus clinical improvements, features in registries and contexts triggering such processes are not fully known. This study focuses on one of the world's largest stroke registries, the Swedish NQR Riksstroke, investigating what aspects of the registry and healthcare organisations facilitate or hinder the use of registry data in clinical quality improvement. Following particular qualitative studies, we performed a quantitative survey in an exploratory sequential design. The survey, including 50 items on context, processes and the registry, was sent to managers, physicians and nurses engaged in Riksstroke in all 72 Swedish stroke units. Altogether, 242 individuals were presented with the survey; 163 responded, representing all but two units. Data were analysed descriptively and through multiple linear regression. A majority (88%) considered Riksstroke data to facilitate detection of stroke care improvement needs and acknowledged that their data motivated quality improvements (78%). The use of Riksstroke for quality improvement initiatives was associated (R 2 =0.76) with 'Colleagues' call for local results' (p=<0.001), 'Management Request of Registry data' (p=<0.001), and it was said to be 'Simple to explain the results to colleagues' (p=0.02). Using stepwise regression, 'Colleagues' call for local results' was identified as the most influential factor. Yet, while 73% reported that managers request registry data, only 39% reported that their colleagues call for the unit's Riksstroke results. While an NQR like Riksstroke demonstrates improvement needs and motivates stakeholders to make progress, local stroke care staff and managers need to engage to keep the momentum going in terms of applying registry data when planning, performing and evaluating quality initiatives. Published by the BMJ Publishing Group Limited. For permission to use

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

Registry of Hypogonadism in Men (RHYME): design of a multi-national longitudinal, observational registry of exogenous testosterone use in hypogonadal men.

PubMed

Rosen, Raymond C; Wu, Frederick C W; Behre, Hermann M; Roehrborn, Claus G; Schröder, Fritz H; Siami, Flora S; Martha, Julia F; Finn, Joseph D; Araujo, Andre B

2013-03-01

Despite the prevalence of hypogonadism (HG) and widespread use of testosterone therapy, little is known about the safety/effectiveness of long-term testosterone use. The Registry of Hypogonadism in Men (RHYME) is a multi-national patient registry assessing prostate health and other outcomes associated with testosterone treatment in men. Observational patient disease registry. RHYME is a non-interventional disease registry with longitudinal data collection on a large sample (N = 999) of well-characterized, hypogonadal men aged 18 years or older. The Registry will prospectively evaluate male patients diagnosed with HG, who have not previously been treated with testosterone therapy. Key design features include: (1) broad inclusion/exclusion criteria, (2) standardized central laboratory hormone assays, (3) independent adjudication of prostate biopsies and mortalities, (4) standard of care treatment, (5) comprehensive medical record and questionnaire data at six months and annually post-enrollment and (6) adequate statistical power for assessing prostate endpoints at 36 months. A total of 25 clinical sites in six European countries (Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom) have completed recruitment for the study. Recruitment was initiated in May 2009, and completed in December 2011. Data collection is ongoing with a minimum of two years of follow-up on all patients.

[Decision process of Notification Value by the Dose Index Registry system in X-ray computed tomography].

PubMed

Shinozaki, Masafumi; Muramatsu, Yoshihisa; Sasaki, Toru

2014-01-01

A new technical standard for X-ray computed tomography (CT) has been published by the National Electrical Manufacturers Association (NEMA) that allows the Alert Value and Notification Value for cumulative dose to be configurable by CT systems operators in conjunction with the XR-25 (Dose check) standard. In this study, a decision method of the Notification Values for reducing the radiation dose was examined using the dose index registry (DIR) system, during 122 continuous days from August 1, 2012 to November 30, 2012. CT images were obtained using the Discovery CT 750HD (GE Healthcare) and the dose index was calculated using the DoseWatch DIR system. The CT dose index-volume (CTDIvol) and dose-length product (DLP) were output from the DIR system in comma-separated value (CSV) file format for each examination protocol. All data were shown as a schematic boxplot using statistical processing software. The CTDIvol of a routine chest examination showed the following values (maximum: 23.84 mGy; minimum: 2.55 mGy; median: 7.60 mGy; 75% tile: 10.01 mGy; 25% tile: 6.54 mGy). DLP showed the following values (maximum: 944.56 mGy·cm; minimum: 97.25 mGy·cm; median: 307.35 mGy·cm; 75% tile: 406.87 mGy·cm; 25% tile: 255.75 mGy·cm). These results indicate that the 75% tile of CTDIvol and DLP as an initial value proved to be safe and efficient for CT examination and operation. We have thus established one way of determining the Notification Value from the output of the DIR system. Transfer back to the protocol of the CT and automated processing each numeric value in the DIR system is desired.

National registry of hemoglobinopathies in Spain (REPHem).

PubMed

Cela, Elena; Bellón, José M; de la Cruz, María; Beléndez, Cristina; Berrueco, Rubén; Ruiz, Anna; Elorza, Izaskun; Díaz de Heredia, Cristina; Cervera, Aurea; Vallés, Griselda; Salinas, J Antonio; Coll, M Teresa; Bermúdez, Mar; Prudencio, Marta; Argilés, Bienvenida; Vecilla, Cruz

2017-07-01

Although highly prevalent throughout the world, the accurate prevalence of hemoglobinopathies in Spain is unknown. This study presents data on the national registry of hemoglobinopathies of patients with thalassemia major (TM), thalassemia intermedia (TI), and sickle cell disease (SCD) in Spain created in 2014. Fifty centers reported cases retrospectively. Data were registered from neonatal screening or from the first contact at diagnosis until last follow-up or death. Data of the 715 eligible patients were collected: 615 SCD (497 SS, 64 SC, 54 SBeta phenotypes), 73 thalassemia, 9 CC phenotype, and 18 other variants. Most of the SCD patients were born in Spain (65%), and 51% of these were diagnosed at newborn screening. Median age at the first diagnosis was 0.4 years for thalassemia and 1.0 years for SCD. The estimated incidence was 0.002 thalassemia cases and 0.03 SCD cases/1,000 live births. Median age was 8.9 years (0.2-33.7) for thalassemia and 8.1 years (0.2-32.8) for SCD patients. Stroke was registered in 16 SCD cases. Transplantation was performed in 43 TM and 23 SCD patients at a median age of 5.2 and 7.8 years, respectively. Twenty-one patients died (3 TM, 17 SCD, 1 CC) and 200 were lost to follow-up. Causes of death were related to transplantation in three patients with TM and three patients with SCD. Death did not seem to be associated with SCD in six patients, but nine patients died secondary to disease complications. Overall survival was 95% at 15 years of age. The registry provides data about the prevalence of hemoglobinopathies in Spain and will permit future cohort studies and the possibility of comparison with other registries. © 2016 Wiley Periodicals, Inc.

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...

Emergency Department Intubation Success With Succinylcholine Versus Rocuronium: A National Emergency Airway Registry Study.

PubMed

April, Michael D; Arana, Allyson; Pallin, Daniel J; Schauer, Steven G; Fantegrossi, Andrea; Fernandez, Jessie; Maddry, Joseph K; Summers, Shane M; Antonacci, Mark A; Brown, Calvin A

2018-05-07

Although both succinylcholine and rocuronium are used to facilitate emergency department (ED) rapid sequence intubation, the difference in intubation success rate between them is unknown. We compare first-pass intubation success between ED rapid sequence intubation facilitated by succinylcholine versus rocuronium. We analyzed prospectively collected data from the National Emergency Airway Registry, a multicenter registry collecting data on all intubations performed in 22 EDs. We included intubations of patients older than 14 years who received succinylcholine or rocuronium during 2016. We compared the first-pass intubation success between patients receiving succinylcholine and those receiving rocuronium. We also compared the incidence of adverse events (cardiac arrest, dental trauma, direct airway injury, dysrhythmias, epistaxis, esophageal intubation, hypotension, hypoxia, iatrogenic bleeding, laryngoscope failure, laryngospasm, lip laceration, main-stem bronchus intubation, malignant hyperthermia, medication error, pharyngeal laceration, pneumothorax, endotracheal tube cuff failure, and vomiting). We conducted subgroup analyses stratified by paralytic weight-based dose. There were 2,275 rapid sequence intubations facilitated by succinylcholine and 1,800 by rocuronium. Patients receiving succinylcholine were younger and more likely to undergo intubation with video laryngoscopy and by more experienced providers. First-pass intubation success rate was 87.0% with succinylcholine versus 87.5% with rocuronium (adjusted odds ratio 0.9; 95% confidence interval 0.6 to 1.3). The incidence of any adverse event was also comparable between these agents: 14.7% for succinylcholine versus 14.8% for rocuronium (adjusted odds ratio 1.1; 95% confidence interval 0.9 to 1.3). We observed similar results when they were stratified by paralytic weight-based dose. In this large observational series, we did not detect an association between paralytic choice and first-pass rapid sequence

Monitoring of timely and delayed vaccinations: a nation-wide registry-based study of Norwegian children aged < 2 years.

PubMed

Riise, Øystein Rolandsen; Laake, Ida; Bergsaker, Marianne Adeleide Riise; Nøkleby, Hanne; Haugen, Inger Lise; Storsæter, Jann

2015-11-13

Delayed vaccinations increase the risk for vaccine preventable diseases (VPDs). Monitoring of delayed vaccinations by using a national immunisation registry has not been studied in countries recommending a two-dose (3 and 5 months of age) primary series of e.g., pertussis vaccine. Surveillance/monitoring of all vaccinations may improve vaccination programmes functioning. We obtained information from the Norwegian immunisation registry (SYSVAK) on all programme vaccinations received at age up to 730 days in children born in 2010 (n = 63,382). Timely vaccinations were received up to 7 days after the recommended age. Vaccinations were considered delayed if they were received more than one month after the recommended age in the schedule. In vaccinated children, timely administration of the subsequent three doses of pertussis and one dose of measles occurred in 73.8, 47.6, 53.6 and 43.5 % respectively. Delay for one or more programme vaccinations (diphtheria, tetanus, pertussis, polio, Haemophilus influenza type B, invasive pneumococcal disease, measles, mumps or rubella) was present in 28,336 (44.7 %) children. Among those who were delayed the mean duration was 139 days. The proportion of children that had vaccinations delayed differed among counties (range 37.4 %-57.8 %). Immigrant children were more frequently delayed 52.3 % vs. 43.1 %, RR 1.21 (95 % CI 1.19, 1.24). Children scheduled for vaccines in the summer holiday month (July) were more frequently delayed than others (1(st) dose pertussis vaccine 6.5 % vs. 3.9 % RR 1.65 (95 % CI 1.48, 1.85). Priming against pertussis (2(nd) dose), pneumococcal (2(nd) dose) and measles (1(st) dose) was delayed in 16.8, 18.6 and 29.3 % respectively. Vaccinations were frequently delayed. Delayed vaccinations differed among counties and occurred more frequently during the summer vacation (July) and in the immigrant population. Monitoring improves programme surveillance and may be used on an annual basis.

Physical Activity Patterns in the National Weight Control Registry

PubMed Central

Catenacci, Victoria A.; Ogden, Lorraine G.; Stuht, Jennifer; Phelan, Suzanne; Wing, Rena R.; Hill, James O.; Wyatt, Holly R.

2015-01-01

Objective The National Weight Control Registry (NWCR) was established in 1993 to examine the characteristics of those who are successful at weight loss: individuals maintaining a 13.6-kg weight loss for >1 year. The size of the registry has increased substantially since the early descriptions of this group a decade ago. The purpose of this study was to describe in detail the weekly physical activity habits of NWCR members, to examine the relationship between amount of activity and demographic characteristics, and to determine if changes in activity parameters have occurred over time. Methods and Procedures Participants were 887 men and 2,796 women who enrolled in the NWCR between 1993 and 2004. Physical activity was evaluated at registry entry using the Paffenbarger Physical Activity Questionnaire. Results NWCR entrants report an average of 2,621 ± 2,252 kcal/week in physical activity. There is considerable variability in the amount of activity reported: 25.3% report <1,000 kcal/week and 34.9% report >3,000 kcal/week. Activity level on registry entry is related to the magnitude but not the duration of weight loss. The amount of activity reported by men has decreased over time while no significant change was observed in women. Changes in the types of activities most frequently reported were also observed. Discussion Overall, NWCR participants are an extremely physically active group. However, the amount of activity reported is highly variable, making it difficult to develop a single recommendation for the optimum amount of physical activity for weight loss maintenance. A better understanding of individual-specific determinants of how much activity is required for weight loss maintenance ought to be a high research priority. PMID:18223628

Addressing the challenges of cross-jurisdictional data linkage between a national clinical quality registry and government-held health data.

PubMed

Andrew, Nadine E; Sundararajan, Vijaya; Thrift, Amanda G; Kilkenny, Monique F; Katzenellenbogen, Judith; Flack, Felicity; Gattellari, Melina; Boyd, James H; Anderson, Phil; Grabsch, Brenda; Lannin, Natasha A; Johnston, Trisha; Chen, Ying; Cadilhac, Dominique A

2016-10-01

To describe the challenges of obtaining state and nationally held data for linkage to a non-government national clinical registry. We reviewed processes negotiated to achieve linkage between the Australian Stroke Clinical Registry (AuSCR), the National Death Index, and state held hospital data. Minutes from working group meetings, national workshop meetings, and documented communications with health department staff were reviewed and summarised. Time from first application to receipt of data was more than two years for most state data-sets. Several challenges were unique to linkages involving identifiable data from a non-government clinical registry. Concerns about consent, the re-identification of data, duality of data custodian roles and data ownership were raised. Requirements involved the development of data flow methods, separating roles and multiple governance and ethics approvals. Approval to link death data presented the fewest barriers. To our knowledge, this is the first time in Australia that person-level data from a clinical quality registry has been linked to hospital and mortality data across multiple Australian jurisdictions. Implications for Public Health: The administrative load of obtaining linked data makes projects such as this burdensome but not impossible. An improved national centralised strategy for data linkage in Australia is urgently needed. © 2016 Public Health Association of Australia.

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.

75 FR 38145 - Announcing the New National Electronic Job Registry for Use in the H-2A Temporary Agricultural...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

...The Employment and Training Administration (ETA) is announcing that the National Electronic Job Registry (job registry) in which H-2A job orders will be posted and available to the public will be operational on July 8, 2010.

Characteristics of national registries for occupational diseases: international development and validation of an audit tool (ODIT).

PubMed

Spreeuwers, Dick; de Boer, Angela G E M; Verbeek, Jos H A M; van Dijk, Frank J H

2009-10-23

The aim of the study was to develop quality indicators that can be used for quality assessment of registries of occupational diseases in relation to preventive policy on a national level. The research questions were: 1. Which indicators determine the quality of national registries of occupational diseases with respect to their ability to provide appropriate information for preventive policy? 2. What are the criteria that can distinguish low quality from high quality? First, we performed a literature search to assess which output of registries can be considered appropriate for preventive policy and to develop a set of preliminary indicators and criteria. Second, final indicators and criteria were assessed and their content validity was tested in a Delphi study, for which experts from the 25 EU Member States were invited. The literature search revealed two different types of information output to be appropriate for preventive policy: monitor and alert information. For the evaluation of the quality of the monitor and alert function we developed ten indicators and criteria. Sixteen of the twenty-five experts responded in the first round of the Delphi study, and eleven in the second round. Based on their comments, we assessed the final nine indicators: the completeness of the notification form, coverage of registration, guidelines or criteria for notification, education and training of reporting physicians, completeness of registration, statistical methods used, investigation of special cases, presentation of monitor information, and presentation of alert information. Except for the indicator "coverage of registration" for the alert function, all the indicators met the preset requirements of content validity. We have developed quality indicators and criteria to evaluate registries for occupational diseases on the ability to provide appropriate information for preventive policy on a national level. Together, these indicators form a tool which can be used for quality

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.

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

PubMed

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

75 FR 53953 - The National Saltwater Angler Registry Program; Designation of Exempted States for Anglers, Spear...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XX66 The National Saltwater Angler Registry Program; Designation of Exempted States for Anglers, Spear Fishers, and For-Hire... as exempted states for anglers, spear fishers and for-hire fishing vessels. NMFS has designated the...

The new opt-out Dutch National Breast Implant Registry - Lessons learnt from the road to implementation.

PubMed

Rakhorst, Hinne A; Mureau, Marc A M; Cooter, Rodney D; McNeil, John; van Hooff, Miranda; van der Hulst, René; Hommes, Juliette; Hoornweg, Marije; Moojen-Zaal, Laura; Liem, Patricia; Mathijssen, Irene M J

2017-10-01

An estimated 1-3% of all women in the Netherlands carry breast implants. Since the introduction five decades ago, problems with a variety of breast implants have emerged with direct consequences for the patients' health. Plastic surgeons worldwide reacted through campaigning for auditing on long-term implant quality, surgeon performance, and institutional outcomes in implant registries. Especially, the PIP implant scandal of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness in our ability to even 'track and trace' patients. In addition, a recent report of the Dutch Institute of National Health showed a lack of compliance of 100% of breast implant producers to CE requirements. These arguments stress the need for an independent implant registry. Insufficient capture rates or dependence from the implant producers made the variety of national and international patient registries unreliable. The Dutch Breast Implant Registry (DBIR) is unique because it is an opt-out registry without the need for informed consent and thus a high capture rate. Furthermore, an estimated 95% of breast implants are implanted by board-certified plastic surgeons. Funding was received from a non-governmental organisation to increase the quality of health care in the Netherlands, and maintenance is gathered by 25 euros per implant inserted. This article describes the way the Dutch have set up their system, with special attention to the well-known hurdles of starting a patient registry. Examples include: funding, medical ethical issues, opt out system, benchmarking, quality assurance as well as governance and collaboration. The Dutch consider their experience and data shareware for others to be used globally to the benefit of patient safety and quality improvement. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

High intensity focused ultrasound ablation for atrial fibrillation: results from the National Spanish Registry.

PubMed

Reyes, Guillermo; Ruyra, Xavier; Valderrama, Francisco; Jimenez, Antonio; Duran, Dario; Perez, Enrique; Daroca, Tomas; Moya, Javier; Ramirez, Ulises; Aldamiz, Gonzalo

2016-10-01

A National Spanish Registry to compile all patients treated with high intensity focused ultrasound (HIFU) energy for atrial fibrillation (AF) was created to evaluate the safety and efficacy of AF surgical ablation. A national Spanish registry was created, and ten hospitals using HIFU to ablate AF joined it. A total of 412 patients undergoing cardiac surgery between 2006 and February 2013 were included. AF was divided between paroxysmal AF (33%) and persistent AF (67%) with a mean AF duration of 29.3±108.2 months. Mean left atrial diameter was 51.2±6.5 mm. Mean underlying heart disease were aortic valve disease (49.3%), ischemic disease (25.2%) and mitral disease (33.2%) Clinical follow-up of patients and a 6 months postoperative echocardiogram were performed in all patients. A pacemaker implantation was needed in 4.9% of patients with a perioperative stroke in 2.5%. Rhythm at discharge from hospital was sinus rhythm in 58%, AF in 35.9% and atrial flutter in 0.8% of patients. Sinus rhythm restoration at 6, 12, 24 and 36 months follow-up was achieved in 66.1%, 63.8%, 63.9% and 45.9% of patients respectively. Multivariate analysis showed paroxysmal AF and sinus rhythm restoration in the operating theatre as factors related to sinus rhythm long term restoration. The Spanish national registry showed an efficacy of AF ablation with the HIFU Epicor system of 66.1%, 63.8%, 63.9% and 45.9% at 6, 12, 24 and 36 months follow-up. There were no device-related complications.

Immunisation Registries at regional level in Italy and the roadmap for a future Italian National Registry.

PubMed

D'Ancona, F; Gianfredi, V; Riccardo, F; Iannazzo, S

2018-01-01

Immunization Information Systems, or Immunisation registries (IRs), are essential to monitor and evaluate the accessibility, quality and outcomes of immunisation programmes both at local and national level. We conducted a cross-sectional survey in order to investigate and map the level of IRs implementation obtained by the 21 Italian Regional Health Authorities. On this basis we defined a roadmap towards implementing an Italian National IR. We designed an online questionnaire. Data were collected from July to September 2016 from all the 21 Regional Health Authorities in charge of infectious diseases control and immunization management. 18/21 Italian Regions have fully implemented an IR, out of them, 11 use the same software for all Local Health Units. Two Regions have partially implemented their IRs and one Region is not yet computerised. The decentralization of the Italian Health System is reflected also on the IRs characteristics and functionalities in terms of fragmented implementation of IRs and diversity in the software systems and data flows in place. Future efforts should not only aim not only to clarify the functionalities of Regional IRs, but should also aim to define how aggregation of data at national level can be optimised.

National Kidney Registry: 213 transplants in three years.

PubMed

Veale, Jeffrey; Hil, Garet

2010-01-01

Since its establishment in 2008, the National Kidney Registry has facilitated 213 kidney transplants between unrelated living donors and recipients at 28 transplant centers. Rapid innovations in matching strategies, advanced computer technologies, good communication and an evolving understanding of the processes at participating transplant centers and histocompatibility laboratories are among the factors driving the success of the NKR. Virtual cross match accuracy has improved from 43% to 91% as a result of changes to the HLA typing requirements for potential donors and improved mechanisms to list unacceptable HLA antigens for sensitized patients. A uniform financial agreement among participating centers eliminated a major roadblock to facilitate unbalanced donor kidney exchanges among centers. The NKR transplanted 64% of the patients registered since 2008 and the average waiting time for those transplanted in 2010 was 11 months.

eRegistries: Electronic registries for maternal and child health.

PubMed

Frøen, J Frederik; Myhre, Sonja L; Frost, Michael J; Chou, Doris; Mehl, Garrett; Say, Lale; Cheng, Socheat; Fjeldheim, Ingvild; Friberg, Ingrid K; French, Steve; Jani, Jagrati V; Kaye, Jane; Lewis, John; Lunde, Ane; Mørkrid, Kjersti; Nankabirwa, Victoria; Nyanchoka, Linda; Stone, Hollie; Venkateswaran, Mahima; Wojcieszek, Aleena M; Temmerman, Marleen; Flenady, Vicki J

2016-01-19

information. More mature country capacity reflected by published health registry based research is emerging in settings reaching regional or national scale, increasingly with electronic solutions. 66 scientific publications were identified based on 32 registry systems in 23 countries over a period of 10 years; this reflects a challenging experience and capacity gap for delivering sustainable high quality registries. Registries are being developed and used in many high burden countries, but their potential benefits are far from realized as few countries have fully transitioned from paper-based health information to integrated electronic backbone systems. Free tools and frameworks exist to facilitate progress in health information for women and children.

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.

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

Cancer incidence and mortality in Mongolia - National Registry Data.

PubMed

Sandagdorj, Tuvshingerel; Sanjaajamts, Erdenechimeg; Tudev, Undarmaa; Oyunchimeg, Dondov; Ochir, Chimedsuren; Roder, David

2010-01-01

The National Cancer Registry of Mongolia began as a hospital-based registry in the early 1960s but then evolved to have a population-wide role. The Registry provides the only cancer data available from Mongolia for international comparison. The descriptive data presented in this report are the first to be submitted on cancer incidence in Mongolia to a peer-reviewed journal. The purpose was to describe cancer incidence and mortality for all invasive cancers collectively, individual primary sites, and particularly leading sites, and consider cancer control opportunities. This study includes data on new cancer cases registered in Mongolia in 2003-2007. Incidence and mortality rates were calculated as mean annual numbers per 100,000 residents. Age-standardized incidence (ASR) and age-standardized mortality (ASMR) rates were calculated from age-specific rates by weighting directly to the World Population standard. Between 2003 and 2007, 17,271 new cases of invasive cancer were recorded (52.2% in males, 47.7% in females). The five leading primary sites in males were liver, stomach, lung, esophagus, and colon/rectum; whereas in females they were liver, cervix, stomach, esophagus and breast. ASRs were lower in females than males for cancers of the liver at 63.0 and 99.1 per 100,000 respectively; cancers of the stomach at 19.1 and 42.1 per 100,000 respectively; and cancers of the lung at 8.3 and 33.2 per 100,000 respectively. Liver cancer was the most common cause of death in each gender, the ASMR being lower for females than males at 60.6 compared with 94.8 per 100,000. In females the next most common sites of cancer death were the stomach and esophagus, whereas in males, they were the stomach and lung. Available data indicate that ASRs of all cancers collectively have increased over the last 20 years. Rates are highest for liver cancer, at about four times the world average. The most common cancers are those with a primary site of liver, stomach and esophagus, for which

Rheumatology Informatics System for Effectiveness: A National Informatics-Enabled Registry for Quality Improvement.

PubMed

Yazdany, Jinoos; Bansback, Nick; Clowse, Megan; Collier, Deborah; Law, Karen; Liao, Katherine P; Michaud, Kaleb; Morgan, Esi M; Oates, James C; Orozco, Catalina; Reimold, Andreas; Simard, Julia F; Myslinski, Rachel; Kazi, Salahuddin

2016-12-01

The Rheumatology Informatics System for Effectiveness (RISE) is a national electronic health record (EHR)-enabled registry. RISE passively collects data from EHRs of participating practices, provides advanced quality measurement and data analytic capacities, and fulfills national quality reporting requirements. Here we report the registry's architecture and initial data, and we demonstrate how RISE is being used to improve the quality of care. RISE is a certified Centers for Medicare and Medicaid Services Qualified Clinical Data Registry, allowing collection of data without individual patient informed consent. We analyzed data between October 1, 2014 and September 30, 2015 to characterize initial practices and patients captured in RISE. We also analyzed medication use among rheumatoid arthritis (RA) patients and performance on several quality measures. Across 55 sites, 312 clinicians contributed data to RISE; 72% were in group practice, 21% in solo practice, and 7% were part of a larger health system. Sites contributed data on 239,302 individuals. Among the subset with RA, 34.4% of patients were taking a biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD) at their last encounter, and 66.7% were receiving a nonbiologic DMARD. Examples of quality measures include that 55.2% had a disease activity score recorded, 53.6% a functional status score, and 91.0% were taking a DMARD in the last year. RISE provides critical infrastructure for improving the quality of care in rheumatology and is a unique data source to generate new knowledge. Data validation and mapping are ongoing and RISE is available to the research and clinical communities to advance rheumatology. © 2016, American College of Rheumatology.

The National Kidney Registry: 175 transplants in one year.

PubMed

Veale, Jeffrey; Hil, Garet

2011-01-01

Since organizing its first swap in 2008, the National Kidney Registry had facilitated 389 kidney transplants by the end of 2011 across 45 U.S. transplant centers. Rapid innovations, advanced computer technologies, and an evolving understanding of the processes at participating transplant centers and histocompatibility laboratories are among the factors driving the success of the NKR. Virtual cross match accuracy has improved from 43% to 94% as a result of improvements in the HLA typing process for donor antigens and enhanced mechanisms to list unacceptable HLA antigens for sensitized patients. By the end of 2011, the NKR had transplanted 66% of the patients enrolled since 2008. The 2011 wait time (from enrollment to transplant) for the 175 patients transplanted that year averaged 5 months.

An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

PubMed

Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita

2015-05-01

The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

Quality of data collected for severity of illness scores in the Dutch National Intensive Care Evaluation (NICE) registry.

PubMed

Arts, Daniëlle; de Keizer, Nicolette; Scheffer, Gert-Jan; de Jonge, Evert

2002-05-01

To analyse the quality of data used to measure severity of illness in the Dutch National Intensive Care Evaluation (NICE) registry, after implementation of quality improving procedures. Data were re-abstracted from the paper records of patients or the Patient Data Management System and compared to the data contained in the registry. The re-abstracted data were considered to be the gold standard. ICUs of nine Dutch hospitals that had been collecting data for the NICE registry for at least 1 year. The mean percentages of inaccurate and incomplete data, per hospital, over all variables, were 6.1%+/-4.4 (SD) and 2.7%+/-4.4 (SD), respectively. The mean difference in severity of illness scores between registry data and re-abstracted data was 0.2 points for APACHE II and 0.4 points for SAPS II. The mean difference in predicted mortality according to APACHE II and SAPS II between registry data and re-abstracted data was 0.4% and 0.02%, respectively. The current data quality of the NICE registry is good and justifies evaluative research. These positive results might be explained by the implementation of several quality assurance procedures in the NICE registry, such as training and automatic data checks. Electronic supplementary material to this paper can be obtained by using the Springer LINK server located at http://dx.doi.org/10.1007/s00134-002-1272-z

Epidemiology of atlas fractures--a national registry-based cohort study of 1,537 cases.

PubMed

Matthiessen, Christian; Robinson, Yohan

2015-11-01

The epidemiology of fractures of the first cervical vertebra-the atlas-has not been well documented. Previous studies concerning atlas fractures focus on treatment and form a weak platform for epidemiologic study. This study aims to provide reliable epidemiologic data on atlas fractures. This was a national registry-based cohort study. A total of 1,537 cases of atlas fractures between 1997 and 2011 from the Swedish National Patient Registry (NPR). The outcome measures were annual incidence and mortality. Data from the NPR and the Swedish Cause of Death Registry were extracted, including age, gender, diagnosis, comorbidity, treatment codes, and date of death. The Charlson Comorbidity Index was calculated and a survival analysis performed. A total of 869 (56.5%) cases were men, and 668 (43.5%) were women. The mean age of the entire population was 64 years. The proportion of atlas fractures of all registered cervical fractures was 10.6%. In 19% of all cases, there was an additional fracture of the axis, and 7% of all cases had additional subaxial cervical fractures. Patients with fractures of the axis were older than patients with isolated atlas fractures. The annual incidence almost doubled during the study period, and in 2011, it was 17 per million inhabitants. The greatest increase in incidence occurred in the elderly population. Atlas fractures occurred predominantly in the elderly population. Further study is needed to determine the cause of the increasing incidence. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

78 FR 33853 - Announcement for the National Registry of Evidence-Based Programs and Practices (NREPP): Open...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-05

... Practices (NREPP): Open Submission Period for Fiscal Year 2014 Background The Substance Abuse and Mental... DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration (SAMHSA) Announcement for the National Registry of Evidence-Based Programs and Practices (NREPP): Open...

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.

Validation of Stroke Diagnosis in the National Registry of Hospitalized Patients in the Czech Republic.

PubMed

Sedova, Petra; Brown, Robert D; Zvolsky, Miroslav; Kadlecova, Pavla; Bryndziar, Tomas; Volny, Ondrej; Weiss, Viktor; Bednarik, Josef; Mikulik, Robert

2015-09-01

Stroke is a common cause of mortality and morbidity in Eastern Europe. However, detailed epidemiological data are not available. The National Registry of Hospitalized Patients (NRHOSP) is a nationwide registry of prospectively collected data regarding each hospitalization in the Czech Republic since 1998. As a first step in the evaluation of stroke epidemiology in the Czech Republic, we validated stroke cases in NRHOSP. Any hospital in the Czech Republic with a sufficient number of cases was included. We randomly selected 10 of all 72 hospitals and then 50 patients from each hospital in 2011 stratified according to stroke diagnosis (International Classification of Diseases Tenth Revision [ICD-10] cerebrovascular codes I60, I61, I63, I64, and G45). Discharge summaries from hospitalization were reviewed independently by 2 reviewers and compared with NRHOSP for accuracy of discharge diagnosis. Any disagreements were adjudicated by a third reviewer. Of 500 requested discharge summaries, 484 (97%) were available. Validators confirmed diagnosis in NRHOSP as follows: transient ischemic attack (TIA) or any stroke type in 82% (95% confidence interval [CI], 79-86), any stroke type in 85% (95% CI, 81-88), I63/cerebral infarction in 82% (95% CI, 74-89), I60/subarachnoid hemorrhage in 91% (95% CI, 85-97), I61/intracerebral hemorrhage in 91% (95% CI, 85-96), and G45/TIA in 49% (95% CI, 39-58). The most important reason for disagreement was use of I64/stroke, not specified for patients with I63. The accuracy of coding of the stroke ICD-10 codes for subarachnoid hemorrhage (I60) and intracerebral hemorrhage (I61) included in a Czech Republic national registry was high. The accuracy of coding for I63/cerebral infarction was somewhat lower than for ICH and SAH. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A Good Idea May Not Be Good Enough: Stakeholder Buy In to QuitConnect, a National Smokers' Registry.

PubMed

Macauda, Mark M; Thrasher, James F; Saul, Jessie E; Celestino, Paula; Cummings, K Michael; Strayer, Scott M

2017-01-01

To examine interest and concerns among those who fund and operate state-run smoking cessation helplines (quitlines) about the concept of creating a centralized smokers' registry that could be used to reengage smokers after they receive initial quitline support services. We conducted 3, hour-long focus groups with stakeholders, covering the perceived benefits and barriers to creating a smokers' registry. The focus groups were conducted via telephone. Three groups participated: quitline service providers (n = 14), quitline funders (n = 9), and national quitline partners (n = 8). Data collection: Focus groups were recorded, transcribed, and coded for major relevant themes. Analysis Strategies: We used a grounded theory approach. Stakeholders were generally positive about the concept of a centralized smokers' registry (ie, QuitConnect), especially with its potential to link relapsed smokers to ongoing research studies designed to help smokers achieve abstinence from tobacco. However, stakeholders expressed concern about QuitConnect duplicating services already offered by state quitlines. Despite a common goal, many state quitline stakeholders had strong reservations about the creation of a centralized smokers' registry unless they could see clear evidence that the registry added value and was not duplicative of their existing services.

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.

Epinephrine Dosing Period and Survival after In-Hospital Cardiac Arrest

PubMed Central

Warren, Sam A.; Huszti, Ella; Bradley, Steven M.; Chan, Paul S.; Bryson, Chris L.; Fitzpatrick, Annette L.; Nichol, Graham

2015-01-01

Background Expert guidelines for treatment of cardiac arrest recommend administration of epinephrine every three to five minutes. However, different dosing periods of epinephrine have not been systematically assessed. Objective We evaluated the association between epinephrine dosing frequency and survival to hospital discharge in adults with an in-hospital cardiac arrest (IHCA). Methods Using data from 2000–2009 in the Get With the Guidelines(GWTG)-Resuscitation IHCA registry (formerly the National Registry of Cardiopulmonary Resuscitation [NRCPR]), we examined the association between epinephrine dosing period and survival to hospital discharge. Epinephrine dosing period was defined as the time between the first epinephrine dose and the resuscitation endpoint, divided by the total number of epinephrine doses received subsequent to the first epinephrine dose. Generalized estimating equations were used to construct multivariable logistic regression models, adjusted for patient and arrest characteristics. Results Included were 20,909 eligible IHCA events from 505 GWTG-Resuscitation participating hospitals. Compared to an epinephrine dosing period of 4 to <5 minutes per dose, survival to hospital discharge was significantly higher in patients with an epinephrine dosing period of 6 to <10 minutes per dose: for 6 to <7 min/dose, adjusted odds ratio [OR], 1.41 (95% CI: 1.12, 1.78); for 7 to <8 min/dose, adjusted OR, 1.30 (95%CI: 1.02, 1.65); for 8 to <9 min/dose, adjusted OR, 1.79 (95%CI: 1.38, 2.32); for 9 to <10 min/dose, adjusted OR, 2.17 (95%CI: 1.62, 2.92). This pattern was consistent for both shockable and non-shockable cardiac arrest rhythms. Moreover, for the majority (87%) of cardiac arrests due to non-shockable rhythms, an epinephrine dosing period of 1 to <3 minutes/dose was associated with lower rates of survival. Conclusion In this large, observational, national registry of in-hospital cardiac arrest, we found that epinephrine dosing at a less frequent

Gastric Cancer Incidence Estimation in a Resource-Limited Nation: Use of Endoscopy Registry Methodology

PubMed Central

Dominguez, Ricardo L.; Crockett, Seth D.; Lund, Jennifer L.; Suazo, Lia P.; Heidt-Davis, Paris; Martin, Christopher; Morgan, Douglas R.

2013-01-01

Purpose Cancer epidemiology is challenging in developing nations, in the absence of reliable pathology-based cancer registries. Clinical experience suggests that the incidence of gastric cancer is high in Honduras, in contrast to the limited available national statistics at the time of study initiation (IARC GLOBOCAN 2002: males 15.2, females 10.8). We estimate the incidence of gastric cancer for Honduras using an endoscopy registry as a complimentary resource. Methods We conducted a retrospective analysis of incident noncardia gastric adenocarcinoma cases in Western Honduras for the period 2000–2009. This region is well circumscribed geopolitically with a single district hospital and established referral patterns, to provide a unique epidemiological niche to facilitate estimation of incidence rates. A prospective, comprehensive database of all endoscopy procedures from this hospital was utilized at the primary data source. The catchment area for gastroenterology services for the at-risk population was validated by calculating the overall endoscopy utilization rates for each municipality in western Honduras. Incident cases of gastric adenocarcinoma were determined by the endoscopic diagnosis. Pathology services are not financed by the Ministry of Health, and histology data was incorporated when available. Population statistics were obtained from the Honduras National Statistics Institute (INE). Age standardized incidence rates (ASIRs) were calculated using world standard population fractions. Results The catchment area for Western Honduras was validated with the municipality threshold of 30 endoscopies per 106 person-years, with inclusion of a total of 40 municipalities. In the Western Honduras catchment area, there were 670 incident cases (439 M, 231 F) of noncardia gastric adenocarcinoma during the study decade 2000–2009. Notably, 67 (10.0%) and 165 (24.6%) of cases were under the ages of 45 and 55, respectively. The case-finding rate was 5.1 endoscopies

Architecture for Variable Data Entry into a National Registry.

PubMed

Goossen, William

2017-01-01

The Dutch perinatal registry required a new architecture due to the large variability of the submitted data from midwives and hospitals. The purpose of this article is to describe the healthcare information architecture for the Dutch perinatal registry. requirements analysis, design, development and testing. The architecture is depicted for its components and preliminary test results. The data entry and storage work well, the Data Marts are under preparation.

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.

Building a National Heritage Registry for the Sudan: the Friedrich W. Hinkel Archive Digitization Project

NASA Astrophysics Data System (ADS)

Lawrenz, S.

2017-08-01

The Republic of the Sudan is home to outstanding and diverse cultural heritage ranging from Neolithic sites of human activity and settlement to historic sites of the 19th and 20th century. While certain phases of the Sudan's cultural heritage such as the period of Egyptian influence during the second and first millennium B.C. have been the focus of archaeological research since the 19th century, other aspects of the country's rich history have remained largely unknown locally and internationally due to a lack of documentation and registration of such sites. Since 2014, the German Archaeological Institute (DAI) has been engaged in an effort to support the creation of a national heritage registry in close cooperation with the National Corporation for Antiquities and Museums (NCAM) by digitizing the archive of German architect Friedrich W. Hinkel and engaging in capacity building measures focusing on analog and digital data curation. The archive contains structured information (photos, drawings, maps and assembled written documentation) regarding over 14,000 archaeological and historical sites in the Sudan using an alphanumeric coding system that allows for easy integration of data in a digital environment such as the DAI's IT infrastructure, the iDAI.world. As such the data assembled by Hinkel will serve as the basis of the national heritage registry currently in development.

[Respiratory disease registries in Spain: fundamentals and organization].

PubMed

Lara, Beatriz; Morales, Pilar; Blanco, Ignacio; Vendrell, Montserrat; de Gracia Roldán, Javier; Monreal, Manel; Orriols, Ramón; Isidro, Isabel; Abú-Shams, Khalil; Escribano, Pilar; Villena, Victoria; Rodrigo, Teresa; Vidal Plà, Rafael; García-Yuste, Mariano; Miravitlles, Marc

2011-08-01

This present paper describes the general characteristics, objectives and organizational aspects of the respiratory disease registries in Spain with the aim to report their activities and increase their diffusion. The document compiles information on the following registries: the Spanish Registry of Patients with Alpha-1 Antitrypsin Deficiency, Spanish Registry of Bronchiectasis, International Registry of Thromboembolic Disease, Spanish Registry of Occupational Diseases, Spanish Registry of Pulmonary Artery Hypertension, Registry of Pleural Mesothelioma, Spanish Registry of Tuberculosis and Spanish Multi-center Study of Neuroendocrine Pulmonary Tumors. Our paper provides information on each of the registries cited. Each registry has compiled specific clinical information providing data in real situations, and completes the results obtained from clinical assays. Said information has been published both in national as well as international publications and has lead to the creation of various guidelines. Therefore, the activities of the professionals involved in the registries have spread the knowledge about the diseases studied, promoting the exchange of information among workgroups. Copyright © 2010 SEPAR. Published by Elsevier Espana. All rights reserved.

Implant and clinical characteristics for pediatric and congenital heart patients in the national cardiovascular data registry implantable cardioverter defibrillator registry.

PubMed

Jordan, Christopher P; Freedenberg, Vicki; Wang, Yongfei; Curtis, Jeptha P; Gleva, Marye J; Berul, Charles I

2014-12-01

In 2010, the National Cardiovascular Data Registry enhanced pediatric, nonatherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter defibrillator implantation. In this article, we report implantable cardioverter defibrillator procedures (April 2010 to December 2012) in the registry for 2 cohorts: (1) all patients with CHD (atrial septal defect, ventricular septal defect, tetralogy of Fallot, Ebstein anomaly, transposition of the great vessels, and common ventricle) and (2) patients <21 years. We evaluated indications and characteristics to include transvenous and nontransvenous lead implants, CHD type, and New York Heart Association class. There were 3139 CHD procedures, 1601 for patients <21 years and 126 for CHD <21 years. Implantable cardioverter defibrillator indications for patients with CHD were primary prevention in 1943 (61.9%) and secondary prevention in 1107 (35.2%). Pediatric patients had 935 (58.4%) primary prevention and 588 (36.7%) secondary prevention devices. Primary prevention had higher New York Heart Association class. Nontransvenous age (35.9 ± 23.2 versus 40.1 ± 24.6 years; P=0.05) and nontransvenous height (167.1 ± 18.9 cm; range, 53-193 cm versus 170.4 ± 13.1 cm; range, 61-203 cm; P<0.01) were lower than for transvenous patients. CHD and pediatrics had similar rates of transvenous (97%) and nontransvenous (3%) leads and did not differ from the overall registry. Transposition of the great vessels and common ventricle had higher rates of nontransvenous leads. Primary prevention exceeds secondary prevention for CHD and pediatrics. Nontransvenous lead patients were younger, with higher rates of transposition of the great vessels and common ventricle patients compared with transvenous lead patients. © 2014 American Heart Association, Inc.

A Suggested Model for Building Robust Biomedical Implants Registries.

PubMed

Aloufi, Bader; Alshagathrah, Fahad; Househ, Mowafa

2017-01-01

Registries are an essential source of information for clinical and non-clinical decision-makers; because they provide evidence for post-market clinical follow-up and early detection of safety signals for biomedical implants. Yet, many of todays biomedical implants registries are facing a variety of challenges relating to a poorly designed dataset, the reliability of inputted data and low clinician and patient participation. The purpose of this paper is to present a best practice model for the implementation and use of biomedical implants registries to monitor the safety and effectiveness of implantable medical devices. Based on a literature review and an analysis of multiple national relevant registries, we identified six factors that address contemporary challenges and are believed to be the keys for building a successful biomedical implants registry, which include: sustainable development, international comparability, data reliability, purposeful design, ease of patient participation, and collaborative development at the national level.

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.

The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies.

PubMed

Kayıkçıoğlu, Meral; Tokgözoğlu, Lale

2017-04-01

Familial hypercholesterolemia (FH) is a genetic disease characterized by extremely high levels of cholesterol, leading to premature atherosclerosis. Although many countries have already addressed the burden of FH by means of national registries, Turkey has no national FH registry or national screening program to detect FH. Creation of a series of FH registries is planned as part of Turkish FH Initiative endorsed by the Turkish Society of Cardiology to meet this need. This article provides detailed information on the rationale and design of the first 2 FH registries (A-HIT1 and A-HIT2). A-HIT1 is a nationwide survey of adult homozygous FH (HoFH) patients undergoing low-density lipoprotein (LDL) apheresis (LA) in Turkey. A-HIT1 will provide insight into the clinical status of HoFH patients undergoing LA. Primary objective of this cross-sectional study is to identify how HoFH patients on LA are managed. Inclusion criteria are age >12 years, diagnosis of HoFH, and regular LA treatment. All available apheresis centers were electronically invited to participate in the study. The principal physicians of each center will respond to a questionnaire regarding their attitude toward LA. For each patient, another questionnaire will be used to collect data on clinical status, medication use, and disease data. In addition, patients will be asked to complete self-report questionnaires that provide information on quality of life, disease-related anxiety, and depression. A-HIT2 is a registry of adult FH patients presenting at outpatient clinics. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 statistical regions in Turkey based on the EU NUTS classification. Sites specializing in cardiology, internal medicine, and endocrinology were invited to participate. The primary objective of this cross-sectional study is to determine clinical status and management of patients in Turkey diagnosed with FH. Eligibility for screening was defined as having

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.

REAC/TS Radiation Accident Registry: An Overview

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

Doran M. Christensen, DO, REAC /TS Associate Director and Staff Physician Becky Murdock, REAC/TS Registry and Health Physics Technician

2012-12-12

Over the past four years, REAC/TS has presented a number of case reports from its Radiation Accident Registry. Victims of radiological or nuclear incidents must meet certain dose criteria for an incident to be categorized as an “accident” and be included in the registry. Although the greatest numbers of “accidents” in the United States that have been entered into the registry involve radiation devices, the greater percentage of serious accidents have involved sealed sources of one kind or another. But if one looks at the kinds of accident scenarios that have resulted in extreme consequence, i.e., death, the greater sharemore » of deaths has occurred in medical settings.« less

National reference doses for dental cephalometric radiography.

PubMed

Holroyd, J R

2011-12-01

Diagnostic reference levels (DRLs) are an important tool in the optimisation of clinical radiography. Although national DRLs are provided for many diagnostic procedures including dental intra-oral radiography, there are currently no national DRLs set for cephalometric radiography. In the absence of formal national DRLs, the Health Protection Agency (HPA) has previously published National Reference Doses (NRDs) covering a wide range of diagnostic X-ray examinations. The aim of this study was to determine provisional NRDs for cephalometric radiography. Measurements made by the Dental X-ray Protection Service (DXPS) of the HPA, as part of the cephalometric X-ray equipment testing service provided to dentists and dental trade companies throughout the UK, were used to derive provisional NRDs. Dose-area product measurements were made on 42 X-ray sets. Third quartile dose-area product values for adult and child lateral cephalometric radiography were found to be 41 mGy cm² and 25 mGy cm², respectively, with individual measurements ranging from 3 mGy cm² to 108 mGy cm². This report proposes provisional NRDs of 40 mGy cm² and 25 mGy cm² for adult and child lateral cephalometric radiographs, respectively; these doses could be considered by employers when establishing their local DRLs.

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.

Inter-rater reliability of data elements from a prototype of the Paul Coverdell National Acute Stroke Registry

PubMed Central

Reeves, Mathew J; Mullard, Andrew J; Wehner, Susan

2008-01-01

Background The Paul Coverdell National Acute Stroke Registry (PCNASR) is a U.S. based national registry designed to monitor and improve the quality of acute stroke care delivered by hospitals. The registry monitors care through specific performance measures, the accuracy of which depends in part on the reliability of the individual data elements used to construct them. This study describes the inter-rater reliability of data elements collected in Michigan's state-based prototype of the PCNASR. Methods Over a 6-month period, 15 hospitals participating in the Michigan PCNASR prototype submitted data on 2566 acute stroke admissions. Trained hospital staff prospectively identified acute stroke admissions, abstracted chart information, and submitted data to the registry. At each hospital 8 randomly selected cases were re-abstracted by an experienced research nurse. Inter-rater reliability was estimated by the kappa statistic for nominal variables, and intraclass correlation coefficient (ICC) for ordinal and continuous variables. Factors that can negatively impact the kappa statistic (i.e., trait prevalence and rater bias) were also evaluated. Results A total of 104 charts were available for re-abstraction. Excellent reliability (kappa or ICC > 0.75) was observed for many registry variables including age, gender, black race, hemorrhagic stroke, discharge medications, and modified Rankin Score. Agreement was at least moderate (i.e., 0.75 > kappa ≥; 0.40) for ischemic stroke, TIA, white race, non-ambulance arrival, hospital transfer and direct admit. However, several variables had poor reliability (kappa < 0.40) including stroke onset time, stroke team consultation, time of initial brain imaging, and discharge destination. There were marked systematic differences between hospital abstractors and the audit abstractor (i.e., rater bias) for many of the data elements recorded in the emergency department. Conclusion The excellent reliability of many of the data elements

Factors Associated with Mobility Outcomes in a National Spina Bifida Patient Registry

PubMed Central

Dicianno, Brad E.; Karmarkar, Amol; Houtrow, Amy; Crytzer, Theresa M.; Cushanick, Katelyn M.; McCoy, Andrew; Wilson, Pamela; Chinarian, James; Neufeld, Jacob; Smith, Kathryn; Collins, Diane M.

2017-01-01

Objective To provide descriptive data on ambulatory ability and muscle strength in a large cohort of individuals with spina bifida enrolled in a National Spina Bifida Patient Registry (NSBPR) and to investigate factors associated with ambulatory status. Design Cross-sectional analysis of data from a multi-site patient registry Results Descriptive analysis of mobility variables for 2604 individuals with spina bifida age 5 and above are presented from 19 sites in the United States. Analysis of a subset of NSBPR data from 380 individuals from three sites accompanied by data from a specialized spina bifida electronic medical record revealed that those with no history of a shunt, lower motor level, and no history of hip or knee contracture release surgery were more likely to be ambulatory at the community level than at the household or wheelchair level. Conclusion This study is the first to examine factors associated with ambulatory status in a large sample of individuals with myelomeningocele and non-myelomeningocele subtypes of SB. Results of this study delineate the breadth of strength and functional abilities within the different age groups and subtypes of SB. The results may inform clinicians of the characteristics of those with varying ambulatory abilities. PMID:26488146

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.

Developing Statistical Models to Assess Transplant Outcomes Using National Registries: The Process in the United States.

PubMed

Snyder, Jon J; Salkowski, Nicholas; Kim, S Joseph; Zaun, David; Xiong, Hui; Israni, Ajay K; Kasiske, Bertram L

2016-02-01

Created by the US National Organ Transplant Act in 1984, the Scientific Registry of Transplant Recipients (SRTR) is obligated to publicly report data on transplant program and organ procurement organization performance in the United States. These reports include risk-adjusted assessments of graft and patient survival, and programs performing worse or better than expected are identified. The SRTR currently maintains 43 risk adjustment models for assessing posttransplant patient and graft survival and, in collaboration with the SRTR Technical Advisory Committee, has developed and implemented a new systematic process for model evaluation and revision. Patient cohorts for the risk adjustment models are identified, and single-organ and multiorgan transplants are defined, then each risk adjustment model is developed following a prespecified set of steps. Model performance is assessed, the model is refit to a more recent cohort before each evaluation cycle, and then it is applied to the evaluation cohort. The field of solid organ transplantation is unique in the breadth of the standardized data that are collected. These data allow for quality assessment across all transplant providers in the United States. A standardized process of risk model development using data from national registries may enhance the field.

[Evaluation of Organ Dose Estimation from Indices of CT Dose Using Dose Index Registry].

PubMed

Iriuchijima, Akiko; Fukushima, Yasuhiro; Ogura, Akio

Direct measurement of each patient organ dose from computed tomography (CT) is not possible. Most methods to estimate patient organ dose is using Monte Carlo simulation with dedicated software. However, dedicated software is too expensive for small scale hospitals. Not every hospital can estimate organ dose with dedicated software. The purpose of this study was to evaluate the simple method of organ dose estimation using some common indices of CT dose. The Monte Carlo simulation software Radimetrics (Bayer) was used for calculating organ dose and analysis relationship between indices of CT dose and organ dose. Multidetector CT scanners were compared with those from two manufactures (LightSpeed VCT, GE Healthcare; SOMATOM Definition Flash, Siemens Healthcare). Using stored patient data from Radimetrics, the relationships between indices of CT dose and organ dose were indicated as each formula for estimating organ dose. The accuracy of estimation method of organ dose was compared with the results of Monte Carlo simulation using the Bland-Altman plots. In the results, SSDE was the feasible index for estimation organ dose in almost organs because it reflected each patient size. The differences of organ dose between estimation and simulation were within 23%. In conclusion, our estimation method of organ dose using indices of CT dose is convenient for clinical with accuracy.

Malaysian Twin Registry.

PubMed

Jahanfar, Shayesteh; Jaffar, Sharifah Halimah

2013-02-01

The National Malaysian Twin Registry was established in Royal College of Medicine, Perak, University Kuala Lumpur (UniKL) in June 2008 through a grant provided by UniKL. The general objective is to facilitate scientific research involving participation of twins and their family members in order to answer questions of health and wellbeing relevant to Malaysians. Recruitment is done via mass media, poster, and pamphlets. We now have 266 adult and 204 children twins registered. Several research projects including reproductive health study of twins and the role of co-bedding on growth and development of children are carried out. Registry holds annual activities for twins and seeks to provide health-related information for twins. We seek international collaboration.

Predictable And SuStainable Implementation Of National Cardiovascular Registries Infrastructure: A Think Tank Report from MDEpiNet

PubMed Central

Zeitler, Emily P.; Al-Khatib, Sana M.; Drozda, Joseph P.; Kessler, Larry G.; Kirtane, Ajay J.; Kong, David F.; Laschinger, John; Marinac-Dabic, Danica; Morice, Marie-Claude; Reed, Terrie; Sedrakyan, Art; Stein, Kenneth M.; Tcheng, James; Krucoff, Mitchell W.

2015-01-01

The Medical Device Epidemiological Network Initiative (MDEpiNet) is a public-private partnership between the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and participating partners. The Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) program is an MDEpiNet-sponsored program which aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle (TPLC). To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included four areas of cardiovascular medicine intended to cultivate interest in four MDEpiNet Disease Specific/Device Specific Working Groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the Working Groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program. PMID:26699602

EPA Facility Registry System (FRS): NEPT

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 Environmental Performance Track (NEPT) Program dataset. 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. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs

EPA Facility Registry Service (FRS): NEI

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 National Emissions Inventory (NEI) Program dataset. 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. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs

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

[Survey on computerized immunization registries in Italy].

PubMed

Alfonsi, V; D'Ancona, F; Ciofi degli Atti, M L

2008-01-01

Computerized immunization registries are essential for conducting and monitoring vaccination programs. In fact, they enable to improve vaccine offering to target population, generating needed-immunization lists and assessing levels of vaccination coverage. In 2007, a national survey on immunization registries was conducted in Italy. In February 2007, all the 21 Regional Health Authorities (RHAs) completed and returned an ad hoc questionnaire. In June 2007, RHAs were further contacted by telephone in order to verify and update the information provided in questionnaires. In 9 Italian Regions (42.8%), vaccination registries are computerized in all Local Health Units (LHUs). In five of these Regions, all LHUs use the same software, while in the remaining four Regions, different softwares are in use. In six additional Regions (28.6%), only some LHUs use computerized immunization registries (range 61.5%-95%). In the remaining 6 Regions (28.6%), which are all in Southern Italy, there are no computerised immunization registries at all. In total, computerised immunization registries cover 126/180 Italian LHUs (70%); in 76/126 (60%) of these LUHs, immunization registries are linked with population registries. This survey shows the need to improve the implementation of computerised immunization registries in Italy, especially in Southern Regions.

Reported Numbers of Patients with Rare Diseases Based on Ten-Year Longitudinal National Disability Registries in Taiwan

ERIC Educational Resources Information Center

Lin, Jin-Ding; Lin, Lan-Ping; Hung, Wen-Jiu

2013-01-01

This paper aims to describe a general demographic picture of patients with rare diseases in Taiwan and particularly focuses on the prevalence of rare diseases over time, age and gender distributions. We analyzed data mainly from the national disability registry from 2002 to 2011 in Taiwan, Republic of China. The results showed that the number of…

Ultraviolet Radiation Dose National Standard of México

NASA Astrophysics Data System (ADS)

Cardoso, R.; Rosas, E.

2006-09-01

We present the Ultraviolet (UV) Radiation Dose National Standard for México. The establishment of this measurement reference at Centro Nacional de Metrología (CENAM) eliminates the need of contacting foreign suppliers in the search for traceability towards the SI units when calibrating instruments at 365 nm. Further more, the UV Radiation Dose National Standard constitutes a highly accurate and reliable source for the UV radiation dose measurements performed in medical and cosmetic treatments as in the the food and pharmaceutics disinfection processes, among other.

Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L; Nc, Durham; Md, Silver Spring; Japan, Tokyo; Ny, New York; Ri, Providence; Vt, Burlington; Mass, Newton; Colo, Denver; Ariz, Tempe; Calif, Santa Clara; Minn, Minneapolis; Nh, Lebanon

2018-01-25

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert A; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L

2018-02-01

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators. Copyright © 2017 Society for Vascular Surgery. All rights reserved.

Monitoring, documenting and reporting the quality of antibiotic use in the Netherlands: a pilot study to establish a national antimicrobial stewardship registry.

PubMed

Berrevoets, Marvin Ah; Ten Oever, Jaap; Sprong, Tom; van Hest, Reinier M; Groothuis, Ingeborg; van Heijl, Inger; Schouten, Jeroen A; Hulscher, Marlies E; Kullberg, Bart-Jan

2017-08-15

The Dutch Working Party on Antibiotic Policy is developing a national antimicrobial stewardship registry. This registry will report both the quality of antibiotic use in hospitals in the Netherlands and the stewardship activities employed. It is currently unclear which aspects of the quality of antibiotic use are monitored by antimicrobial stewardship teams (A-teams) and can be used as indicators for the stewardship registry. In this pilot study we aimed to determine which stewardship objectives are eligible for the envisioned registry. We performed an observational pilot study among five Dutch hospitals. We assessed which of the 14 validated stewardship objectives (11 process of care recommendations and 3 structure of care recommendations) the A-teams monitored and documented in individual patients. They provided, where possible, data to compute quality indicator (QI) performance scores in line with recently developed QIs to measure appropriate antibiotic use in hospitalized adults for the period of January 2015 through December 2015 RESULTS: All hospitals had a local antibiotic guideline describing recommended antimicrobial use. All A-teams monitored the performance of bedside consultations in Staphylococcus aureus bacteremia and the prescription of restricted antimicrobials. Documentation and reporting were the best for the use of restricted antimicrobials: 80% of the A-teams could report data. Lack of time and the absence of an electronic medical record system enabling documentation during the daily work flow were the main barriers hindering documentation and reporting. Five out of 11 stewardship objectives were actively monitored by A-teams. Without extra effort, 4 A-teams could report on the quality of use of restricted antibiotics. Therefore, this aspect of antibiotic use should be the starting point of the national antimicrobial stewardship registry. Our registry is expected to become a powerful tool to evaluate progress and impact of antimicrobial

The Cystic Fibrosis Foundation Patient Registry. Design and Methods of a National Observational Disease Registry.

PubMed

Knapp, Emily A; Fink, Aliza K; Goss, Christopher H; Sewall, Ase; Ostrenga, Josh; Dowd, Christopher; Elbert, Alexander; Petren, Kristofer M; Marshall, Bruce C

2016-07-01

The Cystic Fibrosis Foundation Patient Registry (CFFPR) is an ongoing patient registry study that collects longitudinal demographic, clinical, and treatment information about persons with cystic fibrosis (CF) in the United States. CF is a life-shortening genetic disorder that occurs in approximately 1 in 3,500 births in the United States. High-quality observational data is important for clinical research, quality improvement, and clinical management. To describe the data collection, patient population, and key limitations of the CFFPR. Inclusion criteria for the CFFPR include diagnosis with CF or a CFTR-associated disorder, care at an accredited care center program, and provision of informed consent. Data from clinic visits and hospitalizations are collected through a secure website. Loss to follow-up and generalizability were examined using several methods. The accuracy of CFFPR data was evaluated with an audit of 2012 CFFPR data compared to the medical record. Since 1986, the CFFPR contains the records of 48,463 individuals with CF. Participation among individuals seen at accredited care centers is high, and loss to follow-up is low. An audit of 2012 CFFPR data suggests that the CFFPR contains 95% of clinic visits and 90% of hospitalizations found in the medical record for these patients, and nearly all of the audited fields were highly accurate. Registries such as the CFFPR are important tools for research, clinical care, and tracking incidence, mortality and population trends.

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.

National Hematopoietic Stem Cells Transplant Registry in Poland: Nationwide Internet Reporting System and Results.

PubMed

Łęczycka, A; Dudkiewicz, M; Czerwiński, J; Malanowski, P; Żalikowska-Hołoweńko, J; Danielewicz, R

2016-06-01

History of hematopoietic stem cell transplantations in Poland begins in early 1980s; the 1st bone marrow allotransplantation was performed in 1983 in the Central Clinical Hospital of the Military Medical Academy in Warsaw. Following years brought the 1st autologous stem cell transplantations. Ten years later, unrelated bone marrow transplantation was performed for the 1st time by the team of the Hematology and Blood and Marrow Transplantation Unit in Katowice. Since then, hematopoietic stem cell transplantation developed to be standard procedure and one of the most important therapies applied in leukemia treatment. The number of allotransplantations in Poland has grown significantly in the past 2 decades, which generated new needs and problems. In 2005, based on a new Transplant Law, a National Transplants Registry was created. Its main role is to collect data (registration of procedures and follow-up data) related to every transplantation case for stem cells and tissues as well as for organs. We present statistics concerning stem cell transplantations performed in Poland, as collected in the National Transplants Registry in the years 2006-2014. There are 18 centers transplanting hematopoietic stem cells in Poland. The total number of hematopoietic stem cell transplantations performed in 2006-2014 was 3,537, with allotransplantations from relatives accounted for 1,491 and from unrelated donors for 2,046. The main indication for allotransplantation in past years was acute leukemia. Copyright © 2016 Elsevier Inc. All rights reserved.

Big Data in Organ Transplantation: Registries and Administrative Claims

PubMed Central

Massie, Allan B.; Kucirka, Lauren; Segev, Dorry L.

2015-01-01

The field of organ transplantation benefits from large, comprehensive, transplant-specific national datasets available to researchers. In addition to the widely-used OPTN-based registries (the UNOS and SRTR datasets) and USRDS datasets, there are other publicly available national datasets, not specific to transplantation, which have historically been underutilized in the field of transplantation. Of particular interest are the Nationwide Inpatient Sample (NIS) and State Inpatient Databases (SID), produced by the Agency for Healthcare Research and Quality (AHRQ). The United States Renal Data System (USRDS) database provides extensive data relevant to studies of kidney transplantation. Linkage of publicly available datasets to external data sources such as private claims or pharmacy data provides further resources for registry-based research. Although these resources can transcend some limitations of OPTN-based registry data, they come with their own limitations, which must be understood to avoid biased inference. This review discusses different registry-based data sources available in the United States, as well as the proper design and conduct of registry-based research. PMID:25040084

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.

United States transuranium and uranium registries - 25 years of growth, research, and service. Annual report, April 1992--September 1993

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

Kathren, R.L.; Harwick, L.A.; Toohey, R.E.

The Registries originated in 1968 as the National Plutonium Registry with the name changed to the United States Transuranium Registry the following year to reflect a broader concern with the heavier actinides as well. Initially, the scientific effort of the USTR was directed towards study of the distribution and dose of plutonium and americium in occupationally exposed persons, and to assessment of the effects of exposure to the transuranium elements on health. This latter role was reassessed during the 1970`s when it was recognized that the biased cohort of the USTR was inappropriate for epidemiologic analysis. In 1978, the administrativelymore » separate but parallel United States Uranium Registry was created to carry out similar work among persons exposed to uranium and its decay products. A seven member scientific advisory committee provided guidance and scientific oversight. In 1992, the two Registries were administratively combined and transferred from the purview of a Department of Energy contractor to Washington State University under the provisions of a grant. Scientific results for the first twenty-five years of the Registries are summarized, including the 1985 publication of the analysis of the first whole body donor. Current scientific work in progress is summarized along with administrative activities for the period.« less

Temporal Trends in the Risk Profile of Patients Undergoing Outpatient Percutaneous Coronary Intervention: A Report from the National Cardiovascular Data Registry's CathPCI Registry.

PubMed

Vora, Amit N; Dai, Dadi; Gurm, Hitinder; Amin, Amit P; Messenger, John C; Mahmud, Ehtisham; Mauri, Laura; Wang, Tracy Y; Roe, Matthew T; Curtis, Jeptha; Patel, Manesh R; Dauerman, Harold L; Peterson, Eric D; Rao, Sunil V

2016-03-01

Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality. Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care. © 2016 American Heart Association, Inc.

The natural history of Leydig cell testicular tumours: an analysis of the National Cancer Registry.

PubMed

Nason, G J; Redmond, E J; Considine, S W; Omer, S I; Power, D; Sweeney, P

2018-05-01

Leydig cell tumour (LCT) of the testis is a rare histological subtype of stromal tumours, accounting for 1 to 3% of testicular neoplasms. The natural history of LCT is poorly understood. The aim of this study was to assess the incidence and natural history of Leydig cell tumours (LCT) of the testes. A search of the National Cancer Registry of Ireland database was performed regarding Leydig cell testicular tumours. Recurrence free survival (RFS) and disease-specific survival (DSS) were analysed. Between 1994 and 2013, 2755 new cases of testicular cancer were diagnosed in Ireland. Of these, 22 (0.79%) were Leydig cell tumours. Nineteen were invasive (stage T1) and three were in situ (stage Tis). One patient developed a local recurrence following an organ preserving procedure and underwent a completion orchidectomy 107 days after initial diagnosis. No further treatment was required. There have been no disease-specific deaths. The 1-, 3- and 5-year overall survival (OS) rates were 95.5, 88.2 and 73.3%, respectively. The 5-year disease-specific survival (DSS) was 100% and the 5-year recurrence free survival (RFS) was 93.3%. From the National Cancer Registry, LCT has been shown to be a rare subtype of testicular tumour. Due to the relatively favourable natural history, it may be possible to tailor less aggressive surveillance regimens in these patients.

The cost of cancer registry operations: Impact of volume on cost per case for core and enhanced registry activities

PubMed Central

Subramanian, Sujha; Tangka, Florence K.L.; Beebe, Maggie Cole; Trebino, Diana; Weir, Hannah K.; Babcock, Frances

2016-01-01

Background Cancer registration data is vital for creating evidence-based policies and interventions. Quantifying the resources needed for cancer registration activities and identifying potential efficiencies are critically important to ensure sustainability of cancer registry operations. Methods Using a previously validated web-based cost assessment tool, we collected activity-based cost data and report findings using 3 years of data from 40 National Program of Cancer Registry grantees. We stratified registries by volume: low-volume included fewer than 10,000 cases, medium-volume included 10,000–50,000 cases, and high-volume included >50,000 cases. Results Low-volume cancer registries incurred an average of $93.11 to report a case (without in-kind contributions) compared with $27.70 incurred by high-volume registries. Across all registries, the highest cost per case was incurred for data collection and abstraction ($8.33), management ($6.86), and administration ($4.99). Low- and medium-volume registries have higher costs than high-volume registries for all key activities. Conclusions Some cost differences by volume can be explained by the large fixed costs required for administering and performing registration activities, but other reasons may include the quality of the data initially submitted to the registries from reporting sources such as hospitals and pathology laboratories. Automation or efficiency improvements in data collection can potentially reduce overall costs. PMID:26702880

Voluntary Health Registry of French Nationals after the Great East Japan Earthquake, Tsunami, and Fukushima Daiichi Nuclear Power Plant Accident: Methods, Results, Implications, and Feedback.

PubMed

Motreff, Yvon; Pirard, Philippe; Lagrée, Céline; Roudier, Candice; Empereur-Bissonnet, Pascal

2016-06-01

Introduction The 11th of March 2011, a magnitude 9.0 earthquake struck alongside the north-east coast of Honshu Island, Japan, causing a tsunami and a major nuclear accident. The French Institute for Public Health Surveillance (InVS) set up, within one week after the triple catastrophe, an Internet-based registry for French nationals who were in Japan at the time of the disasters. In this string of disasters, in this context of uncertainties about the nuclear risks, the aim of this registry was to facilitate the: (1) realization of further epidemiologic studies, if needed; and (2) contact of people if a medical follow-up was needed. The purpose of this report was to describe how the health registry was set up, what it was used for, and to discuss further utilization and improvements to health registries after disasters. The conception of the questionnaire to register French nationals was based on a form developed as part of the Steering Committee for the management of the post-accident phase in the event of nuclear accident or a radiological emergency situation (CODIRPA) work. The questionnaire was available online. The main objective was achieved since it was theoretically possible to contact again the 1,089 persons who completed the form. According to the data collected on their space-time budget, to the result of internal contamination measured by the French Institute for Radiological Protection and Nuclear Safety (IRSN) and dosimetric expertise published by the World Health Organization (WHO), it was not suitable to conduct an epidemiologic follow-up of adverse effects of exposure to ionizing radiations among them. However, this registry was used to launch a qualitative study on exposure to stress and psychosocial impact of the Great East Japan Earthquake on French nationals who were in Japan in March 2011. Setting a registry after a disaster is a very important step in managing the various consequences of a disaster. This experience showed that it is quickly

Vaccination coverage among children under two years of age based on electronic immunization registry in Southern Brazil.

PubMed

Luhm, Karin Regina; Cardoso, Maria Regina Alves; Waldman, Eliseu Alves

2011-02-01

To evaluate the immunization program for 12 and 24-month-old children based on electronic immunization registry. A descriptive study of a random sample of 2,637 children born in 2002 living in the city of Curitiba, Southern Brazil was performed. Data was collected from local electronic immunization registers and the National Live Birth Information System, as well as from a household survey for cases with incomplete records. Coverage at 12 and 24 months was estimated and analyzed according to the socioeconomic characteristics of each administrative district and the child's enrollment status in the health care service. The coverage, completeness, and record duplication in the registry were analyzed. Coverage of immunization was 95.3% at 12 months, with no disparities among administrative districts, and 90.3% at 24 months, with higher coverage in a district with lower socioeconomic conditions (p < 0.01). The proportion of vaccines, according to type, given before and after the recommended age reached 0.9% and 32.2%, respectively. In the surveyed sample, electronic immunization registry coverage was 98%, underreporting of vaccine doses was 11%, and record duplication was 20.6%. Groups with highest coverage included children with permanent records, children with three or more appointments through the National Unified Health Care System, and children seen within Primary Health Care Facilities fully adopting the Family Health Strategy. Vaccination coverage in Curitiba was high and homogeneous among districts, and health service enrollment status was an important factor in these results. The electronic immunization registry was a useful tool for monitoring vaccine coverage; however, it will be important to determine cost-effectiveness prior to wide-scale adoption by the National Immunization Program.

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

Vaccination coverage according to doses received and timely administered based on an electronic immunization registry, Araraquara-SP, Brazil, 2012-2014.

PubMed

Tauil, Márcia de Cantuária; Sato, Ana Paula Sayuri; Costa, Ângela Aparecida; Inenami, Marta; Ferreira, Vinícius Leati de Rossi; Waldman, Eliseu Alves

2017-01-01

to describe vaccine coverage by type of vaccine at 12 and 24 months of age. descriptive cohort study with children born in 2012, living in Araraquara-SP, Brazil, recorded in the Information System on Live Births (Sinasc); a manual linkage of Sinasc data with an electronic immunization registry (EIR) was performed; the assessment was based on vaccination status according to São Paulo State recommendations, and on doses received and timely administered. 2,740 children were registered on Sinasc and 99.6% of them were included into EIR; among the 2,612 (95.3%) children studied, the triple viral vaccine (measles, mumps and rubella) had the lowest coverage at 12 months for received dose (74.8%) and at 24 months for timely vaccination (53.5%) and received doses (88.0%). coverage was higher than 90% for most vaccines; however, delayed vaccination was observed, which indicates the need to intensify actions aimed at timely vaccination.

Local politico-administrative perspectives on quality improvement based on national registry data in Sweden: a qualitative study using the Consolidated Framework for Implementation Research.

PubMed

Fredriksson, Mio; Eldh, Ann Catrine; Vengberg, Sofie; Dahlström, Tobias; Halford, Christina; Wallin, Lars; Winblad, Ulrika

2014-12-28

Through a national policy agreement, over 167 million Euros will be invested in the Swedish National Quality Registries (NQRs) between 2012 and 2016. One of the policy agreement's intentions is to increase the use of NQR data for quality improvement (QI). However, the evidence is fragmented as to how the use of medical registries and the like lead to quality improvement, and little is known about non-clinical use. The aim was therefore to investigate the perspectives of Swedish politicians and administrators on quality improvement based on national registry data. Politicians and administrators from four county councils were interviewed. A qualitative content analysis guided by the Consolidated Framework for Implementation Research (CFIR) was performed. The politicians' and administrators' perspectives on the use of NQR data for quality improvement were mainly assigned to three of the five CFIR domains. In the domain of intervention characteristics, data reliability and access in reasonable time were not considered entirely satisfactory, making it difficult for the politico-administrative leaderships to initiate, monitor, and support timely QI efforts. Still, politicians and administrators trusted the idea of using the NQRs as a base for quality improvement. In the domain of inner setting, the organizational structures were not sufficiently developed to utilize the advantages of the NQRs, and readiness for implementation appeared to be inadequate for two reasons. Firstly, the resources for data analysis and quality improvement were not considered sufficient at politico-administrative or clinical level. Secondly, deficiencies in leadership engagement at multiple levels were described and there was a lack of consensus on the politicians' role and level of involvement. Regarding the domain of outer setting, there was a lack of communication and cooperation between the county councils and the national NQR organizations. The Swedish experiences show that a government

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.

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.

Suboptimal MMR2 vaccine coverage in six counties in Norway detected through the national immunisation registry, April 2014 to April 2017

PubMed Central

Hagerup-Jenssen, Maria; Kongsrud, Sigrun; Riise, Øystein Rolandsen

2017-01-01

In 2014, Norway became aware of potential low vaccination coverage for the second dose of measles-mumps-rubella vaccine (MMR2) in six of 19 counties. This was detected by comparing the national coverage (NC) for 16-year-olds extracted from the national immunisation registry SYSVAK with the annual status update for elimination of measles and rubella (ASU) reported to the World Health Organization (WHO). The existing method for calculating NC in 2014 did not show MMR2 coverage. ASU reporting on MMR2 was significantly lower then the NC and below the WHO-recommended 95% coverage. SYSVAK is based on the Norwegian personal identification numbers, which allows monitoring of vaccinations at aggregateded as well as individual level. It is an important tool for active surveillance of the performance of the Norwegian Childhood Immunisation Programme (NCIP). The method for calculating NC was improved in 2015 to reflect MMR2 coverage for 16-year-olds. As a result, Norway has improved its real-time surveillance and monitoring of the actual MMR2 coverage also through SYSVAK (the annual publication of NC). Vaccinators receive feedback for follow-up if 15-year-olds are missing MMR2. In 2017, only three counties had an MMR2 coverage below 90%. PMID:28489000

Suboptimal MMR2 vaccine coverage in six counties in Norway detected through the national immunisation registry, April 2014 to April 2017.

PubMed

Hagerup-Jenssen, Maria; Kongsrud, Sigrun; Riise, Øystein Rolandsen

2017-04-27

In 2014, Norway became aware of potential low vaccination coverage for the second dose of measles-mumps-rubella vaccine (MMR2) in six of 19 counties. This was detected by comparing the national coverage (NC) for 16-year-olds extracted from the national immunisation registry SYSVAK with the annual status update for elimination of measles and rubella (ASU) reported to the World Health Organization (WHO). The existing method for calculating NC in 2014 did not show MMR2 coverage. ASU reporting on MMR2 was significantly lower then the NC and below the WHO-recommended 95% coverage. SYSVAK is based on the Norwegian personal identification numbers, which allows monitoring of vaccinations at aggregateded as well as individual level. It is an important tool for active surveillance of the performance of the Norwegian Childhood Immunisation Programme (NCIP). The method for calculating NC was improved in 2015 to reflect MMR2 coverage for 16-year-olds. As a result, Norway has improved its real-time surveillance and monitoring of the actual MMR2 coverage also through SYSVAK (the annual publication of NC). Vaccinators receive feedback for follow-up if 15-year-olds are missing MMR2. In 2017, only three counties had an MMR2 coverage below 90%. This article is copyright of The Authors, 2017.

Estimated radiation exposure of German commercial airline cabin crew in the years 1960-2003 modeled using dose registry data for 2004-2015.

PubMed

Wollschläger, Daniel; Hammer, Gaël Paul; Schafft, Thomas; Dreger, Steffen; Blettner, Maria; Zeeb, Hajo

2018-05-01

Exposure to ionizing radiation of cosmic origin is an occupational risk factor in commercial aircrew. In a historic cohort of 26,774 German aircrew, radiation exposure was previously estimated only for cockpit crew using a job-exposure matrix (JEM). Here, a new method for retrospectively estimating cabin crew dose is developed. The German Federal Radiation Registry (SSR) documents individual monthly effective doses for all aircrew. SSR-provided doses on 12,941 aircrew from 2004 to 2015 were used to model cabin crew dose as a function of age, sex, job category, solar activity, and male pilots' dose; the mean annual effective dose was 2.25 mSv (range 0.01-6.39 mSv). In addition to an inverse association with solar activity, exposure followed age- and sex-dependent patterns related to individual career development and life phases. JEM-derived annual cockpit crew doses agreed with SSR-provided doses for 2004 (correlation 0.90, 0.40 mSv root mean squared error), while the estimated average annual effective dose for cabin crew had a prediction error of 0.16 mSv, equaling 7.2% of average annual dose. Past average annual cabin crew dose can be modeled by exploiting systematic external influences as well as individual behavioral determinants of radiation exposure, thereby enabling future dose-response analyses of the full aircrew cohort including measurement error information.

TREatment of ATopic eczema (TREAT) Registry Taskforce: An international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries.

PubMed

Gerbens, L A A; Apfelbacher, C J; Irvine, A D; Barbarot, S; de Booij, R J; Boyce, A E; Deleuran, M; Eichenfield, L F; Hof, M H; Middelkamp-Hup, M A; Roberts, A; Schmitt, J; Vestergaard, C; Wall, D; Weidinger, S; Williamson, P R; Flohr, C; Spuls, P I

2018-05-15

Evidence of immunomodulatory therapies to guide clinical management for atopic eczema (AE) is scarce, despite frequent and often off-label use. Patient registries provide valuable evidence for the effects of treatments under real world conditions which can inform treatment guidelines, give the opportunity for health economic evaluation and the evaluation of quality of care, as well as pharmacogenetic and -dynamic research which cannot be adequately addressed in clinical trials. The TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek international consensus on a core set of domains and items ('what to measure') for AE research registries, using a Delphi approach. Participants from six stakeholder groups were included: doctors, nurses, non-clinical researchers, patients, industry and regulatory body representatives. The eDelphi comprised 3 sequential online rounds, requesting participants to rate the importance of each proposed domain item. Participants could add domain items to the proposed list in round 1. A final consensus meeting was held to ratify the core set. 479 participants from 36 countries accessed the eDelphi platform, of whom 86%, 79% and 74% completed rounds 1, 2, and 3 respectively. At the face-to-face consensus meeting attended by 42 participants the final core set was established containing 19 domains with 69 domain items (49 baseline and 20 follow-up items). This core set of domains and items to be captured by national AE systemic therapy registries will standardise data collection and thereby allow direct comparability across registries and facilitate data pooling between countries. Ultimately, it will provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Dietary habits and weight maintenance success in high versus low exercisers in the National Weight Control Registry

PubMed Central

Ogden, Lorraine G.; Phelan, Suzanne; Thomas, J. Graham; Hill, James O; Wing, Rena R.; Wyatt, Holly R.

2015-01-01

Background The National Weight Control Registry (NWCR) was established to examine characteristics of successful weight loss maintainers. This study compares the diet and behavioral characteristics and weight regain trajectories of NWCR members with differing physical activity (PA) levels at baseline. Methods Participants (n=3591) were divided into 4 levels of self-reported PA at registry entry (<1000, 1000 to <2250, 2250 to <3500, and ≥3500 kcals/week). We compared self-reported energy intake (EI), macronutrient composition, eating behaviors (dietary restraint, hunger, and disinhibition), weight loss maintenance strategies, and 3 year weight regain between these 4 activity groups. Results Those with the highest PA at registry entry had lost the most weight, and reported lower fat intake, more dietary restraint, and greater reliance on several specific dietary strategies to maintain weight loss. Those in the lowest PA category maintained weight loss despite low levels of PA and without greater reliance on dietary strategies. There were no differences in odds of weight regain at year 3 between PA groups. Conclusions These findings suggest that there is not a “one size fits all strategy” for successful weight loss maintenance and that weight loss maintenance may require the use of more strategies by some individuals than others. PMID:24385447

Quality control and assurance in hematopoietic stem cell transplantation data registries in Japan and other countries.

PubMed

Kuwatsuka, Yachiyo

2016-01-01

Observational studies from national and international registries with large volumes of patients are commonly performed to identify superior strategies for hematopoietic stem cell transplantation. Major international and national stem cell transplant registries collect outcome data using electronic data capture systems, and a systematic study support process has been developed. Statistical support for studies is available from some major international registries, and international and national registries also mutually collaborate to promote stem cell transplant outcome studies and transplant-related activities. Transplant registries additionally take measures to improve data quality to further improve the quality of outcome studies by utilizing data capture systems and manual data management. Data auditing can potentially even further improve data quality; however, human and budgetary resources can be limiting factors in system construction and audits of the Japanese transplant registry are not currently performed.

Defining incidental perineural invasion: the need for a national registry.

PubMed

Buchanan, Lauren; De'Ambrosis, Brian; DeAmbrosis, Kathryn; Warren, Timothy; Huilgol, Shyamala; Soyer, H Peter; Panizza, Benedict

2014-05-01

This article by the Perineural Invasion (PNI) Registry Group aims to clarify clinical and histopathological ambiguities surrounding PNI in non-melanoma skin cancer (NMSC). PNI is reportedly present in approximately 2-6% of cases of NMSC and is associated with greater rates of morbidity and mortality. The distinction between clinical PNI and incidental PNI is somewhat unclear, especially in regard to management and prognosis. One important objective of the PNI Registry is to develop a standardised method of classifying perineural invasion. Hence, in this article we propose a definition for PNI and for its sub-classification. This article also provides a critical analysis of the current literature on the treatment of incidental PNI by evaluating the key cohort studies that have investigated the use of surgery or radiotherapy in the management of incidental PNI. At present, there are no universal clinical guidelines that specify the acceptable treatment of NMSC exhibiting incidental PNI. Consequently, patients often receive surgery with varying wider margins, or radiotherapy despite the limited evidence substantiating such management options. It is evident from the existing literature that current opinion is divided over the benefit of adjuvant radiotherapy. Certain prognostic factors have been proposed, such as the size and depth of tumour invasion, nerve diameter, the presence of multifocal PNI and the type of tumour. The PNI Registry is a web-based registry that has been developed to assist in attaining further data pertaining to incidental PNI in NMSC. It is envisaged that this information will provide the foundation for identifying and defining best practice in managing incidental PNI. © 2013 The Australasian College of Dermatologists.

Iliac Arteries: How Registries Can Help Improve Outcomes

PubMed Central

Tapping, Charles Ross; Uberoi, Raman

2014-01-01

There are many publications reporting excellent short and long-term results with endovascular techniques. Patients included in trials are often highly selected and may not represent real world practice. Registries are important to interventional radiologists for several reasons; they reflect prevailing practice and can be used to establish real world standards of care and safety profiles. This information allows individuals and centers to evaluate their outcomes compared with national norms. The British Iliac Angioplasty and Stenting (BIAS) registry is an example of a mature registry that has been collecting data since 2000 and has been reporting outcomes since 2001. This article discusses the evidence to support both endovascular and surgical intervention for aortoiliac occlusive disease, the role of registries, and optimal techniques for aortoiliac intervention. PMID:25435659

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.

Development of noise dose/visitor response relationships for the national parks overflight rule : Bryce Canyon National Park Study

DOT National Transportation Integrated Search

1998-07-01

This research was conducted in support of the National Parks Overflight Rule (National Rule). The foundation of the research program for the National Rule is the performance of noise dose/visitor response (dose-response) studies in several National P...

The Global Network Maternal Newborn Health Registry: a multi-national, community-based registry of pregnancy outcomes

PubMed Central

2015-01-01

Background The Global Network for Women's and Children's Health Research (Global Network) supports and conducts clinical trials in resource-limited countries by pairing foreign and U.S. investigators, with the goal of evaluating low-cost, sustainable interventions to improve the health of women and children. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to efforts to discover strategies for improving pregnancy outcomes in resource-limited settings. Because most of the sites in the Global Network have weak registration within their health care systems, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnancies at the Global Network sites to provide precise data on health outcomes and measures of care. Methods Pregnant women are enrolled in the MNHR if they reside in or receive healthcare in designated groups of communities within sites in the Global Network. For each woman, demographic, health characteristics and major outcomes of pregnancy are recorded. Data are recorded at enrollment, the time of delivery and at 42 days postpartum. Results From 2010 through 2013 Global Network sites were located in Argentina, Guatemala, Belgaum and Nagpur, India, Pakistan, Kenya, and Zambia. During this period, 283,496 pregnant women were enrolled in the MNHR; this number represented 98.8% of all eligible women. Delivery data were collected for 98.8% of women and 42-day follow-up data for 98.4% of those enrolled. In this supplement, there are a series of manuscripts that use data gathered through the MNHR to report outcomes of these pregnancies. Conclusions Developing public policy and improving public health in countries with poor perinatal outcomes is, in part, dependent upon understanding the outcome of every pregnancy. Because the worst pregnancy outcomes typically occur in countries with limited health registration

RSA and registries: the quest for phased introduction of new implants.

PubMed

Nelissen, Rob G H H; Pijls, Bart G; Kärrholm, Johan; Malchau, Henrik; Nieuwenhuijse, Marc J; Valstar, Edward R

2011-12-21

Although the overall survival of knee and hip prostheses at ten years averages 90%, recent problems with several hip and knee prostheses have illustrated that the orthopaedic community, industry, and regulators can still further improve patient safety. Given the early predictive properties of roentgen stereophotogrammetric analysis (RSA) and the meticulous follow-up of national joint registries, these two methods are ideal tools for such a phased clinical introduction. In this paper, we elaborate on the predictive power of RSA within a two-year follow-up after arthroplasty and its relationship to national joint registries. The association between RSA prosthesis-migration data and registry data is evaluated. The five-year rate of revision of RSA-tested total knee replacements was compared with that of non-RSA-tested total knee replacements. Data were extracted from the published results of the national joint registries of Sweden, Australia, and New Zealand. There was a 22% to 35% reduction in the number of revisions of RSA-tested total knee replacements as compared with non-RSA-tested total knee replacements in the national joint registries. Assuming that the total cost of total knee arthroplasty is $37,000 in the United States, a 22% to 35% reduction in the number of revisions (currently close to 55,000 annually) could lead to an estimated annual savings of over $400 million to the health-care system. The phased clinical introduction of new prostheses with two-year RSA results as a qualitative tool could lead to better patient care and could reduce the costs associated with revision total knee arthroplasty. Follow-up in registries is necessary to substantiate these results and to improve post-market surveillance.

Vascular surgical data registries for small computers.

PubMed

Kaufman, J L; Rosenberg, N

1984-08-01

Recent designs for computer-based vascular surgical registries and clinical data bases have employed large centralized systems with formal programming and mass storage. Small computers, of the types created for office use or for word processing, now contain sufficient speed and memory storage capacity to allow construction of decentralized office-based registries. Using a standardized dictionary of terms and a method of data organization adapted to word processing, we have created a new vascular surgery data registry, "VASREG." Data files are organized without programming, and a limited number of powerful logical statements in English are used for sorting. The capacity is 25,000 records with current inexpensive memory technology. VASREG is adaptable to computers made by a variety of manufacturers, and interface programs are available for conversion of the word processor formated registry data into forms suitable for analysis by programs written in a standard programming language. This is a low-cost clinical data registry available to any physician. With a standardized dictionary, preparation of regional and national statistical summaries may be facilitated.

Dose tracking and dose auditing in a comprehensive computed tomography dose-reduction program.

PubMed

Duong, Phuong-Anh; Little, Brent P

2014-08-01

Implementation of a comprehensive computed tomography (CT) radiation dose-reduction program is a complex undertaking, requiring an assessment of baseline doses, an understanding of dose-saving techniques, and an ongoing appraisal of results. We describe the role of dose tracking in planning and executing a dose-reduction program and discuss the use of the American College of Radiology CT Dose Index Registry at our institution. We review the basics of dose-related CT scan parameters, the components of the dose report, and the dose-reduction techniques, showing how an understanding of each technique is important in effective auditing of "outlier" doses identified by dose tracking. Copyright © 2014 Elsevier Inc. All rights reserved.

Private provider participation in statewide immunization registries

PubMed Central

Clark, Sarah J; Cowan, Anne E; Bartlett, Diana L

2006-01-01

Background Population-based registries have been promoted as an effective method to improve childhood immunization rates, yet rates of registry participation in the private sector are low. We sought to describe, through a national overview, the perspectives of childhood immunization providers in private practice regarding factors associated with participation or non-participation in immunization registries. Methods Two mailed surveys, one for 264 private practices identified as registry non-participants and the other for 971 identified as registry participants, from 15 of the 31 states with population-based statewide immunization registries. Frequency distributions were calculated separately for non-participants and participants regarding the physician-reported factors that influenced decisions related to registry participation. Pearson chi-square tests of independence were used to assess associations among categorical variables. Results Overall response rate was 62% (N = 756). Among non-participants, easy access to records of vaccines provided at other sites (N = 101, 68%) and printable immunization records (N = 82, 55%) were most often cited as "very important" potential benefits of a registry, while the most commonly cited barriers to participation were too much cost/staff time (N = 36, 38%) and that the practice has its own system for recording and monitoring immunizations (N = 35, 37%). Among registry participants, most reported using the registry to input data on vaccines administered (N = 326, 87%) and to review immunization records of individual patients (N = 302, 81%). A minority reported using it to assess their practice's immunization coverage (N = 110, 29%) or generate reminder/recall notices (N = 54, 14%). Few participants reported experiencing "significant" problems with the registry; the most often cited was cost/staff time to use the registry (N = 71, 20%). Conclusion Most registry participants report active participation with few problems. The

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

The development of registries for surveillance of adult lead exposure, 1981 to 1992.

PubMed

Baser, M E

1992-08-01

Since 1981, 15 states have established registries for surveillance of adult lead absorption, primarily based on reports of elevated blood lead levels from clinical laboratories. I review the status of the registries and recommend steps for further development. Companies reported to the New York registry are compared with those cited by the Occupational Safety and Health Administration (OSHA). I present data on US workers and plants with potential lead exposures and blood tests, as well as review registries' reporting requirements. Registries identify many companies not cited by the Occupational Safety and Health Administration, but underreporting occurs because (1) reporting is usually not required from laboratories outside the state, (2) most registries use a blood lead reporting level of 1.21 mumol/L, which excludes many exposed workers, and (3) many companies with potential exposures do not have routine monitoring programs. Registries' reporting requirements and procedures should be standardized, including a blood lead reporting level of 0.72 mumol/L. Elevated blood lead levels should be a reportable condition nationwide, and a comprehensive national surveillance system should be established: clinical laboratories should be required to report cases to those states with lead registries or directly to the national adult lead registry.

Gender and Geographic Differences in Developmental Delays among Young Children: Analysis of the Data from the National Registry in Taiwan

ERIC Educational Resources Information Center

Lai, Der-Chung; Tseng, Yen-Cheng; Guo, How-Ran

2011-01-01

Although developmental delays are not uncommon in children, the incidence is seldom assessed, and the reported prevalence varies widely. In Taiwan, the government mandates the reporting of suspected cases. Using the national registry data, we conducted a study to estimate the incidence and prevalence of developmental delays in young children in…

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

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

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

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.

Toward the Turkish National Registry System: A Prevalence Study of Total Knee Arthroplasty in Turkey.

PubMed

Ceyhan, Erman; Gursoy, Safa; Akkaya, Mustafa; Ugurlu, Mahmut; Koksal, Ismet; Bozkurt, Murat

2016-09-01

The aim of this pilot study was to analyze the data obtained from a retrospective examination of the records of the existing reimbursement system and through the identification of gaps in the data to create a foundation for a reliable, descriptive national registry system for our country. The Social Security Institution Medical Messenger (MEDULA) records were scanned for the years 2010-2014, and the numbers of total knee arthroplasty applied for a diagnosis of gonarthrosis and the numbers of revision knee arthroplasty were recorded for the country in general. The patients were classified according to age, gender, and bilateral or unilateral surgery. The institution where the surgery was applied, the geographic region and the province were also recorded. A total of 283,400 primary and 9900 revision knee arthroplasty operations were applied in Turkey between 2010 and 2014. Numbers were recorded for each year, and there was found to be an increase between years. For primary knee arthroplasty, the female:male ratio was 67 of 33, and surgery was applied most often between the ages of 60-69 years. Both types of surgery were determined to have been applied most often in second-stage state hospitals. Geographically, both types of surgery were applied most in the Marmara region, with the highest frequency of primary knee arthroplasty in Istanbul and the highest frequency of revision surgery in Ankara. The data obtained from this study will contribute to the creation of the basis for a National Registry System and thereby define more scientific treatment approaches. Copyright © 2016 Elsevier Inc. All rights reserved.

The Turkish Neonatal Jaundice Online Registry: A national root cause analysis

PubMed Central

Erdeve, Omer; Olukman, Ozgur; Ulubas, Dilek; Buyukkale, Gokhan; Narter, Fatma; Tunc, Gaffari; Atasay, Begum; Gultekin, Nazli Dilay; Arsan, Saadet; Koc, Esin

2018-01-01

Background Neonatal jaundice (NNJ) is common, but few root cause analyses based on national quality registries have been performed. An online registry was established to estimate the incidence of NNJ in Turkey and to facilitate a root cause analysis of NNJ and its complications. Methods A multicenter prospective study was conducted on otherwise healthy newborns born at ≥35 weeks of gestation and hospitalized for only NNJ in 50 collaborator neonatal intensive care units across Turkey over a 1-year period. Patients were analyzed for their demographic and clinical characteristics, treatment options, and complications. Results Of the 5,620 patients enrolled, 361 (6.4%) had a bilirubin level ≥25 mg/dL on admission and 13 (0.23%) developed acute bilirubin encephalopathy. The leading cause of hospital admission was hemolytic jaundice, followed by dehydration related to a lack of proper feeding. Although all infants received phototherapy, 302 infants (5.4%) received intravenous immunoglobulin in addition to phototherapy and 132 (2.3%) required exchange transfusion. The infants who received exchange transfusion were more likely to experience hemolytic causes (60.6% vs. 28.1%) and a longer duration of phototherapy (58.5 ± 31.7 vs. 29.4 ± 18.8 h) compared to infants who were not transfused (p < 0.001). The incidence of short-term complications among discharged patients during follow-up was 8.5%; rehospitalization was the most frequent (58%), followed by jaundice for more than 2 weeks (39%), neurological abnormality (0.35%), and hearing loss (0.2%). Conclusions Severe NNJ and bilirubin encephalopathy are still problems in Turkey. Means of identifying at-risk newborns before discharge during routine postnatal care, such as bilirubin monitoring, blood group analysis, and lactation consultations, would reduce the frequency of short- and long-term complications of severe NNJ. PMID:29474382

Supplement use by women during pregnancy: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

PubMed

Freeman, Marlene P; Sosinsky, Alexandra Z; Moustafa, Danna; Viguera, Adele C; Cohen, Lee S

2016-06-01

Women of reproductive age commonly use integrative treatments. However, the reproductive safety for most complementary products lacks systematic study. We aimed to study the use of supplements by women in a prospective pregnancy registry. The Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics was established to evaluate the reproductive safety of atypical antipsychotics. Exposed and control participants were systematically queried about the use of vitamins and supplements. Slightly greater than half (53.2 %) of the participants eligible for analysis (N = 534) were using at least one vitamin or supplement at the time of enrollment, not including prenatal vitamins or folic acid. The most common supplements used were omega-3 fatty acids (38.0 %), vitamin D (11.0 %), calcium (8.2 %), and iron (4.7 %). Probiotics and melatonin were used by 2.6 and 0.9 %, respectively. In this prospective pregnancy registry, we found that over half of the participants were taking supplements or vitamins other than prenatal vitamins and folic acid. These findings underscore the need for active query on the part of health care providers about the use of supplements during pregnancy, and the need to obtain rigorous reproductive safety and efficacy data for supplements used by pregnant women and reproductive aged women.

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.

Factors for short-term outcomes in patients with a minor stroke: results from China National Stroke Registry.

PubMed

Wu, Lingyun; Wang, Anxin; Wang, Xianwei; Zhao, Xingquan; Wang, Chunxue; Liu, Liping; Zheng, Huaguang; Wang, Yongjun; Cao, Yibin; Wang, Yilong

2015-12-09

Stroke recurrence and disability in patients with a minor stroke is one of the most depressing medical situations. In this study, we aimed to identify which factors were associated with adverse outcomes of a minor stroke. The China National Stroke Registry (CNSR) is a nationwide prospective registry for patients presented to hospitals with acute cerebrovascular events between September 2007 and August 2008. The 3-month follow-up was completed in 4669 patients with a minor stroke defined as the initial neurological severity lower than 4 in the National Institutes of Health Stroke Scale (NIHSS). Multivariate model was used to determine the association between risk factors and clinical outcomes. Of 4669 patients with a minor stroke during 3-month follow-up, 459 (9.8 %) patients experienced recurrent stroke, 679 (14.5 %) had stroke disability and 168 (3.6 %) died. Multivariate model identified hypertension, diabetes mellitus, atrial fibrillation, coronary heart disease and previous stroke as independent predictors for the recurrent stroke. Age, diabetes mellitus, atrial fibrillation, previous stroke and time from onset to admission < 24 h were independent predictors for stroke disability. The independent predictors for the all-caused death were age, atrial fibrillation, and coronary heart disease. The short-term risk of poor clinical outcome in Chinese patients with a minor stroke was substantial. Therefore, patients with a minor stroke should be given expeditious assessment and urgent aggressive intervention.

Complications of Non-Operating Room Procedures: Outcomes From the National Anesthesia Clinical Outcomes Registry.

PubMed

Chang, Beverly; Kaye, Alan D; Diaz, James H; Westlake, Benjamin; Dutton, Richard P; Urman, Richard D

2015-04-07

This study examines the impact of procedural locations and types of anesthetics on patient outcomes in non-operating room anesthesia (NORA) locations. The National Anesthesia Clinical Outcomes Registry database was examined to compare OR to NORA anesthetic complications and patient demographics. The National Anesthesia Clinical Outcomes Registry database was examined for all patient procedures from 2010 to 2013. A total of 12,252,846 cases were analyzed, with 205 practices contributing information, representing 1494 facilities and 7767 physician providers. Cases were separated on the basis of procedure location, OR, or NORA. Subgroup analysis examined outcomes from specific subspecialties. Non-OR anesthesia procedures were performed on a higher percentage of patients older than 50 years (61.92% versus 55.56%, P < 0.0001). Monitored anesthesia care (MAC) (20.15%) and sedation (2.05%) were more common in NORA locations. The most common minor complications were postoperative nausea and vomiting (1.06%), inadequate pain control (1.01%), and hemodynamic instability (0.62%). The most common major complications were serious hemodynamic instability (0.10%) and upgrade of care (0.10%). There was a greater incidence of complications in cardiology and radiology locations. Overall mortality was higher in OR versus NORA (0.04% versus 0.02%, P < 0.0001). Subcategory analysis showed increased incidence of death in cardiology and radiology locations (0.05%). Non-OR anesthesia procedures have lower morbidity and mortality rates than OR procedures, contrary to some previously published studies. However, the increased complication rates in both the cardiology and radiology locations may need to be the target of future safety investigations. Providers must ensure proper monitoring of patients, and NORA locations need to be held to the same standard of care as the main operating room. Further studies need to identify at-risk patients and procedures that may predispose patients to

Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry.

PubMed

Kaiser, Daniel W; Tsai, Vivian; Heidenreich, Paul A; Goldstein, Mary K; Wang, Yongfei; Curtis, Jeptha; Turakhia, Mintu P

2015-10-01

Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria. We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs. Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT). Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4). Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance. Published by Elsevier Inc.

Agreement between Rheumatologist and Patient-reported Adherence to Methotrexate in a US Rheumatoid Arthritis Registry.

PubMed

Curtis, Jeffrey R; Bharat, Aseem; Chen, Lang; Greenberg, Jeffrey D; Harrold, Leslie; Kremer, Joel M; Sommers, Tanya; Pappas, Dimitrios

2016-06-01

Rheumatologists have limited tools to assess medication adherence. The extent to which methotrexate (MTX) adherence is overestimated by rheumatologists is unknown. We deployed an Internet survey to patients with rheumatoid arthritis (RA) participating in a US registry. Patient self-report was the gold standard compared to MTX recorded in the registry. Response rate to the survey was 44%. Of 228 patients whose rheumatologist reported current MTX at the time of the most recent registry visit, 45 (19.7%) had discontinued (n = 19, 8.3%) or missed ≥ 1 dose in the last month (n = 26, 11.4%). For the subgroup whose rheumatologist also confirmed at the next visit that they were still taking MTX (n = 149), only 2.6% reported not taking it, and 10.7% had missed at least 1 dose. MTX use was misclassified for 13%-20% of patients, mainly because of 1 or more missed doses rather than overt discontinuation. Clinicians should be aware of suboptimal adherence when assessing MTX response.

Oral cancer in Libya and development of regional oral cancer registries: A review.

PubMed

BenNasir, E; El Mistiri, M; McGowan, R; Katz, R V

2015-10-01

The aims of this paper are three-fold: (1) to summarize the current epidemiological data on oral cancer in Libya as reported in the published literature and as compared to other national oral cancer rates in the region; (2) to present both the history of the early development, and future goals, of population-based oral cancer tumor registries in Libya as they partner with the more established regional and international population-based cancer tumor registries; and, (3) to offer recommendations that will likely be required in the near future if these nascent, population-based Libyan oral cancer registries are to establish themselves as on-going registries for describing the oral cancer disease patterns and risk factors in Libya as well as for prevention and treatment. This comprehensive literature review revealed that the current baseline incidence of oral cancer in Libya is similar to those of other North Africa countries and China, but is relatively low compared to the United Kingdom, the United States, and India. The recently established Libyan National Cancer Registry Program, initiated in 2007, while envisioning five cooperating regional cancer registries, continues to operate at a relatively suboptimal level. Lack of adequate levels of national funding continue to plague its development…and the accompanying quality of service that could be provided to the Libyan people.

Positive predictive value of cardiac examination, procedure and surgery codes in the Danish National Patient Registry: a population-based validation study

PubMed Central

Adelborg, Kasper; Sundbøll, Jens; Munch, Troels; Frøslev, Trine; Sørensen, Henrik Toft; Bøtker, Hans Erik; Schmidt, Morten

2016-01-01

Objective Danish medical registries are widely used for cardiovascular research, but little is known about the data quality of cardiac interventions. We computed positive predictive values (PPVs) of codes for cardiac examinations, procedures and surgeries registered in the Danish National Patient Registry during 2010–2012. Design Population-based validation study. Setting We randomly sampled patients from 1 university hospital and 2 regional hospitals in the Central Denmark Region. Participants 1239 patients undergoing different cardiac interventions. Main outcome measure PPVs with medical record review as reference standard. Results A total of 1233 medical records (99% of the total sample) were available for review. PPVs ranged from 83% to 100%. For examinations, the PPV was overall 98%, reflecting PPVs of 97% for echocardiography, 97% for right heart catheterisation and 100% for coronary angiogram. For procedures, the PPV was 98% overall, with PPVs of 98% for thrombolysis, 92% for cardioversion, 100% for radiofrequency ablation, 98% for percutaneous coronary intervention, and 100% for both cardiac pacemakers and implantable cardiac defibrillators. For cardiac surgery, the overall PPVs was 99%, encompassing PPVs of 100% for mitral valve surgery, 99% for aortic valve surgery, 98% for coronary artery bypass graft surgery, and 100% for heart transplantation. The accuracy of coding was consistent within age, sex, and calendar year categories, and the agreement between independent reviewers was high (99%). Conclusions Cardiac examinations, procedures and surgeries have high PPVs in the Danish National Patient Registry. PMID:27940630

Registries in orthopaedics.

PubMed

Delaunay, C

2015-02-01

The first nationwide orthopaedic registry was created in Sweden in 1975 to collect data on total knee arthroplasty (TKA). Since then, several countries have established registries, with varying degrees of success. Managing a registry requires time and money. Factors that contribute to successful registry management include the use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants. The effects of registries on practice patterns should be evaluated. The high cost of registries raises issues of independence and content ownership. Scandinavian countries have been maintaining orthopaedic registries for nearly four decades (since 1975). The first English-language orthopaedic registry was not created until 1998 (in New Zealand), and both the US and many European countries are still struggling to establish orthopaedic registries. To date, there are 11 registered nationwide registries on total knee and total hip replacement. The data they contain are often consistent, although contradictions occur in some cases due to major variations in cultural and market factors. The future of registries will depend on the willingness of health authorities and healthcare professionals to support the creation and maintenance of these tools. Surgeons feel that registries should serve merely to compare implants. Health authorities, in contrast, have a strong interest in practice patterns and healthcare institution performances. Striking a balance between these objectives should allow advances in registry development in the near future. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry.

PubMed

Pappas, Dimitrios A; John, Ani; Curtis, Jeffrey R; Reed, George W; Karki, Chitra; Magner, Robert; Kremer, Joel M; Shewade, Ashwini; Greenberg, Jeffrey D

2016-06-01

In the United States, the recommended starting dose of intravenous tocilizumab (TCZ) is 4 mg/kg every 4 weeks, with an increase to 8 mg/kg based on clinical response for patients with moderate to severe rheumatoid arthritis; however, data on how TCZ dose is escalated in real life are missing. The objective of this analysis was to describe patterns of early intravenous TCZ dose escalation in a real-world setting using data from the Corrona registry. All patients enrolled in the comparative effectiveness substudy (CERTAIN) nested within Corrona who initiated TCZ and completed 3- and 6-month study visits were eligible for inclusion. Patients who initiated TCZ 4 mg/kg were categorized into 1 of 2 groups: those who remained on TCZ 4 mg/kg at 3 months (Group 1) and those who escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Changes in clinical disease activity measures were provided. Of the 213 patients who were eligible for analysis, 86 (40.4%) remained on their initial dose of TCZ 4 mg/kg (Group 1) and 110 (51.6%) were escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Baseline demographic and clinical characteristics were similar between the 2 groups; except in Group 2, patients were older (58.3 vs. 54.0 years) and a lower proportion was female (75.5% vs. 89.4%) than in Group 1. Significant improvements in disease activity measures were observed at 3 and 6 months in both groups, with the majority of patients in both groups achieving moderate or good European League Against Rheumatism response. Real-world data demonstrated that physicians escalate TCZ dose at varying frequencies. The ability to administer TCZ in varying doses allows physicians to tailor TCZ therapy to disease activity. ClinicalTrials.gov identifier, NCT01625650.

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

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.

Benefits of an automatic patient dose registry system for interventional radiology and cardiology at five hospitals of the Madrid area.

PubMed

Fernandez-Soto, J M; Ten, J I; Sanchez, R M; España, M; Pifarre, X; Vano, E

2015-07-01

The purpose of this article is to present the results of connecting the interventional radiology and cardiology laboratories of five university hospitals to a unique server using an automatic patient dose registry system (Dose On Line for Interventional Radiology, DOLIR) developed in-house, and to evaluate its feasibility more than a year after its introduction. The system receives and stores demographic and dosimetric parameters included in the MPPS DICOM objects sent by the modalities to a database. A web service provides a graphical interface to analyse the information received. During 2013, the system processed 10 788 procedures (6874 cardiac, 2906 vascular and 1008 neuro interventional). The percentages of patients requiring clinical follow-up due to potential tissue reactions before and after the use of DOLIR are presented. The system allowed users to verify in real-time, if diagnostic (or interventional) reference levels are fulfilled. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Clinical features of sarcoidosis associated pulmonary hypertension: Results of a multi-national registry.

PubMed

Baughman, Robert P; Shlobin, Oksana A; Wells, Athol U; Alhamad, Esam H; Culver, Daniel A; Barney, Joseph; Cordova, Francis C; Carmona, Eva M; Scholand, Mary Beth; Wijsenbeek, Marlies; Ganesh, Sivagini; Birring, Surinder S; Kouranos, Vasilis; O'Hare, Lanier; Baran, Joanne M; Cal, Joseph G; Lower, Elyse E; Engel, Peter J; Nathan, Steven D

2018-06-01

Pulmonary hypertension (PH) is a significant cause of morbidity and mortality in sarcoidosis. We established a multi-national registry of sarcoidosis associated PH (SAPH) patients. Sarcoidosis patients with PH confirmed by right heart catheterization (RHC) were studied. Patients with pulmonary artery wedge pressure (PAWP) of 15 mmHg or less and a mean pulmonary artery pressure (mPAP) ≥ 25 Hg were subsequently analyzed. Data collected included hemodynamics, forced vital capacity (FVC), diffusion capacity of carbon monoxide (DL CO ), chest x-ray, and 6-min walk distance (6MWD). A total of 176 patients were analyzed. This included 84 (48%) cases identified within a year of entry into the registry and 94 (53%) with moderate to severe PH. There was a significant correlation between DL CO percent predicted (% pred) andmPAP (Rho = -0.228, p = 0.0068) and pulmonary vascular resistance (PVR) (Rho = -0.362, p < 0.0001). PVR was significantly higher in stage 4 disease than in stage 0 or 1 disease (p < 0.05 for both comparisons). About two-thirds of the SAPH patients came from the United States (US). There was a significant difference in the rate of treatment between US (67.5%) versus non-US (86%) (Chi Square 11.26, p = 0.0008) sites. The clinical features of SAPH were similar across multiple centers in the US, Europe, and the Middle East. The severity of SAPH was related to reduced DLCO. There were treatment differences between the US and non-US centers. Copyright © 2018. Published by Elsevier Ltd.

[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.

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.

Central venous catheter infections in home parenteral nutrition patients: Outcomes from Sustain: American Society for Parenteral and Enteral Nutrition's National Patient Registry for Nutrition Care.

PubMed

Ross, Vicki M; Guenter, Peggi; Corrigan, Mandy L; Kovacevich, Debra; Winkler, Marion F; Resnick, Helaine E; Norris, Tina L; Robinson, Lawrence; Steiger, Ezra

2016-12-01

Home parenteral nutrition (HPN) is a high-cost, complex nutrition support therapy that requires the use of central venous catheters. Central line-associated bloodstream infections (CLABSIs) are among the most serious risks of this therapy. Sustain: American Society for Parenteral and Enteral Nutrition's National Patient Registry for Nutrition Care (Sustain registry) provides the most current and comprehensive data for studying CLABSI among a national cohort of HPN patients in the United States. This is the first Sustain registry report detailing longitudinal data on CLABSI among HPN patients. To describe CLABSI rates for HPN patients followed in the Sustain registry from 2011-2014. Descriptive, χ 2 , and t tests were used to analyze data from the Sustain registry. Of the 1,046 HPN patients from 29 sites across the United States, 112 (10.7%) experienced 194 CLABSI events during 223,493 days of HPN exposure, for an overall CLABSI rate of 0.87 episodes/1,000 parenteral nutrition-days. Although the majority of patients were female (59%), adult (87%), white (75%), and with private insurance or Medicare (69%), CLABSI episodes per 1,000 parenteral nutrition-days were higher for men (0.69 vs 0.38), children (1.17 vs 0.35), blacks (0.91 vs 0.41), and Medicaid recipients (1.0 vs 0.38 or 0.39). Patients with implanted ports or double-lumen catheters also had more CLABSIs than those with peripherally inserted or central catheters or single-lumen catheters. Staphylococci were the most commonly reported pathogens. These data support findings of smaller studies about CLABSI risk for children and by catheter type and identify new potential risk factors, including gender, race, and insurance type. Additional studies are needed to determine effective interventions that will reduce HPN-associated CLABSI. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

The National Marrow Donor Program and Be The Match Registry | NIH MedlinePlus the Magazine

MedlinePlus

... Registry Past Issues / Summer 2011 Table of Contents Creating connections. Saving lives. Founded in 1987 by the ... The Match Registry are nonprofit organizations dedicated to creating an opportunity for all patients to receive the ...

Interventional Procedures Outside of the Operating Room: Results From the National Anesthesia Clinical Outcomes Registry.

PubMed

Chang, Beverly; Kaye, Alan D; Diaz, James H; Westlake, Benjamin; Dutton, Richard P; Urman, Richard D

2018-03-01

This study examines the impact of procedural locations and types of anesthetics on patient outcomes in non-operating room anesthesia (NORA) locations. The National Anesthesia Clinical Outcomes Registry database was examined to compare OR to NORA anesthetic complications and patient demographics. The National Anesthesia Clinical Outcomes Registry database was examined for all patient procedures from 2010 to 2013. A total of 12,252,846 cases were analyzed, with 205 practices contributing information, representing 1494 facilities and 7767 physician providers. Cases were separated on the basis of procedure location, OR, or NORA. Subgroup analysis examined outcomes from specific subspecialties. NORA procedures were performed on a higher percentage of patients older than 50 years (61.92% versus 55.56%, P < 0.0001). Monitored anesthesia care (MAC) (20.15%) and sedation (2.05%) were more common in NORA locations. The most common minor complications were postoperative nausea and vomiting (1.06%), inadequate pain control (1.01%), and hemodynamic instability (0.62%). The most common major complications were serious hemodynamic instability (0.10%) and upgrade of care (0.10%). There was a greater incidence of complications in cardiology and radiology locations. Overall mortality was higher in OR versus NORA (0.04% versus 0.02%, P < 0.0001). Subcategory analysis showed increased incidence of death in cardiology and radiology locations (0.05%). NORA procedures have lower morbidity and mortality rates than OR procedures, contrary to some previously published studies. However, the increased complication rates in both the cardiology and radiology locations may need to be the target of future safety investigations. Providers must ensure proper monitoring of patients, and NORA locations need to be held to the same standard of care as the main operating room. Further studies need to identify at-risk patients and procedures that may predispose patients to complications.

Are Cancer Registries Unconstitutional?

PubMed Central

McLaughlin, Robert H; Clarke, Christina A; Crawley, LaVera M; Glaser, Sally L

2010-01-01

Population-based cancer registration, mandated throughout the United States, is central to quantifying the breadth and impact of cancer. It facilitates research to learn what causes cancer to develop and, in many cases, lead to death. However, as concerns about privacy increase, cancer registration has come under question. Recently, its constitutionality was challenged on the basis of 1) the vagueness of statutory aims to pursue public health versus the individual privacy interests of cancer patients, and 2) the alleged indignity of one's individual medical information being transmitted to government authorities. Examining cancer registry statutes in states covered by the US National Cancer Institute's SEER Program and the US Centers for Disease Control and Prevention's National Program of Cancer Registries, we found that cancer registration laws do state specific public health benefits, and offer reasonable limits and safeguards on the government's possession of private medical information. Thus, we argue that cancer registration would survive constitutional review, is compatible with the civil liberties protected by privacy rights in the U.S., satisfies the conditions that justify public health expenditures, and serves human rights to enjoy the highest attainable standards of health, the advances of science, and the benefits of government efforts to prevent and control disease. PMID:20199835

Medical Specialty Society Sponsored Data Registries – Opportunities in Plastic Surgery

PubMed Central

Hume, Keith M.; Crotty, Catherine A.; Simmons, Christopher J.; Neumeister, Michael W.; Chung, Kevin C.

2014-01-01

Clinical data registries are commonly used worldwide and are implemented for a variety of purposes ranging from physician or facility clinic logs for tracking patients, collecting outcomes data, to measuring quality improvement or safety of medical devices. In the United States, the Food and Drug Administration has used data collected through registries to facilitate the drug and device regulatory process, ongoing surveillance during the product life-cycle, and for disease appraisals. Furthermore, the Centers for Medicare and Medicaid Services, in certain instances, base registry participation and submitting data to registries as factors for reimbursement decisions. The purpose of this article is to discuss the use of clinical data registries, the role that medical specialty societies, in particular the American Society of Plastic Surgeons and The Plastic Surgery Foundation, can have in the development and management of registries, and the opportunities for registry use in Plastic Surgery. As outcomes data are becoming essential measures of quality healthcare delivery, participating in registry development and centralized data collection has become a critical effort for Plastic Surgery to engage in to proactively participate in the national quality and performance measurement agenda. PMID:23806935

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.

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.

Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry.

PubMed

Lenguerrand, E; Whitehouse, M R; Beswick, A D; Jones, S A; Porter, M L; Blom, A W

2017-06-01

We used the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) to investigate the risk of revision due to prosthetic joint infection (PJI) for patients undergoing primary and revision hip arthroplasty, the changes in risk over time, and the overall burden created by PJI. We analysed revision total hip arthroplasties (THAs) performed due to a diagnosis of PJI and the linked index procedures recorded in the NJR between 2003 and 2014. The cohort analysed consisted of 623 253 index primary hip arthroplasties, 63 222 index revision hip arthroplasties and 7585 revision THAs performed due to a diagnosis of PJI. The prevalence, cumulative incidence functions and the burden of PJI (total procedures) were calculated. Overall linear trends were investigated with log-linear regression. We demonstrated a prevalence of revision THA due to prosthetic joint infection of 0.4/100 procedures following primary and 1.6/100 procedures following revision hip arthroplasty. The prevalence of revision due to PJI in the three months following primary hip arthroplasty has risen 2.3-fold (95% confidence interval (CI) 1.3 to 4.1) between 2005 and 2013, and 3.0-fold (95% CI 1.1 to 8.5) following revision hip arthroplasty. Over 1000 procedures are performed annually as a consequence of hip PJI, an increase of 2.6-fold between 2005 and 2013. Although the risk of revision due to PJI following hip arthroplasty is low, it is rising and, coupled with the established and further predicted increased incidence of both primary and revision hip arthroplasty, this represents a growing and substantial treatment burden. Cite this article : E. Lenguerrand, M. R. Whitehouse, A. D. Beswick, S. A. Jones, M. L. Porter, A. W. Blom. Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry. Bone Joint Res 2017;6:391-398. DOI: 10.1302/2046-3758.66.BJR-2017-0003.R1. © 2017 Lenguerrand et al.

Protocol and pilot data for establishing the Australian Stroke Clinical Registry.

PubMed

Cadilhac, Dominique A; Lannin, Natasha A; Anderson, Craig S; Levi, Christopher R; Faux, Steven; Price, Chris; Middleton, Sandy; Lim, Joyce; Thrift, Amanda G; Donnan, Geoffrey A

2010-06-01

Disease registries assist with clinical practice improvement. The Australian Stroke Clinical Registry aims to provide national, prospective, systematic data on processes and outcomes for stroke. We describe the methods of establishment and initial experience of operation. Australian Stroke Clinical Registry conforms to new national operating principles and technical standards for clinical quality registers. Features include: online data capture from acute public and private hospital sites; opt-out consent; expert consensus agreed core minimum dataset with standard definitions; outcomes assessed at 3 months poststroke; formal governance oversight; and formative evaluations for improvements. Qualitative feedback from sites indicates that the web-tool is simple to use and the user manuals, data dictionary, and training are appropriate. However, sites desire automated data-entry methods for routine demography variables and the opt-out consent protocol has sometimes been problematic. Data from 204 patients (median age 71 years, 54% males, 60% Australian) were collected from four pilot hospitals from June to October 2009 (mean, 50 cases per month) including ischaemic stroke (in 72%), intracerebral haemorrhage (16%), transient ischaemic attack (9%), and undetermined (3%), with only one case opting out. Australian Stroke Clinical Registry has been well established, but further refinements and broad roll-out are required before realising its potential of improving patient care through clinician feedback and allowance of local, national, and international comparative data.

The National Cardiovascular Data Registry Voluntary Public Reporting Program: An Interim Report From the NCDR Public Reporting Advisory Group.

PubMed

Dehmer, Gregory J; Jennings, Jonathan; Madden, Ruth A; Malenka, David J; Masoudi, Frederick A; McKay, Charles R; Ness, Debra L; Rao, Sunil V; Resnic, Frederic S; Ring, Michael E; Rumsfeld, John S; Shelton, Marc E; Simanowith, Michael C; Slattery, Lara E; Weintraub, William S; Lovett, Ann; Normand, Sharon-Lise

2016-01-19

Public reporting of health care data continues to proliferate as consumers and other stakeholders seek information on the quality and outcomes of care. Medicare's Hospital Compare website, the U.S. News & World Report hospital rankings, and several state-level programs are well known. Many rely heavily on administrative data as a surrogate to reflect clinical reality. Clinical data are traditionally more difficult and costly to collect, but more accurately reflect patients' clinical status, thus enhancing the validity of quality metrics. We describe the public reporting effort being launched by the American College of Cardiology and partnering professional organizations using clinical data from the National Cardiovascular Data Registry (NCDR) programs. This hospital-level voluntary effort will initially report process of care measures from the percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries of the NCDR. Over time, additional process, outcomes, and composite performance metrics will be reported. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The History and Use of Cancer Registry Data by Public Health Cancer Control Programs in the United States

PubMed Central

White, Mary C.; Babcock, Frances; Hayes, Nikki S.; Mariotto, Angela B.; Wong, Faye L.; Kohler, Betsy A.; Weir, Hannah K.

2018-01-01

Because cancer registry data provide a census of cancer cases, registry data can be used to: 1) define and monitor cancer incidence at the local, state, and national levels; 2) investigate patterns of cancer treatment; and 3) evaluate the effectiveness of public health efforts to prevent cancer cases and improve cancer survival. The purpose of this article is to provide a broad overview of the history of cancer surveillance programs in the United States, and illustrate the expanding ways in which cancer surveillance data are being made available and contributing to cancer control programs. The article describes the building of the cancer registry infrastructure and the successful coordination of efforts among the 2 federal agencies that support cancer registry programs, the Centers for Disease Control and Prevention and the National Cancer Institute, and the North American Association of Central Cancer Registries. The major US cancer control programs also are described, including the National Comprehensive Cancer Control Program, the National Breast and Cervical Cancer Early Detection Program, and the Colorectal Cancer Control Program. This overview illustrates how cancer registry data can inform public health actions to reduce disparities in cancer outcomes and may be instructional for a variety of cancer control professionals in the United States and in other countries. PMID:29205307

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

The Brazilian Twin Registry.

PubMed

Ferreira, Paulo H; Oliveira, Vinicius C; Junqueira, Daniela R; Cisneros, Lígia C; Ferreira, Lucas C; Murphy, Kate; Ordoñana, Juan R; Hopper, John L; Teixeira-Salmela, Luci F

2016-12-01

The Brazilian Twin Registry (BTR) was established in 2013 and has impelled twin research in South America. The main aim of the initiative was to create a resource that would be accessible to the Brazilian scientific community as well as international researchers interested in the investigation of the contribution of genetic and environmental factors in the development of common diseases, phenotypes, and human behavior traits. The BTR is a joint effort between academic and governmental institutions from Brazil and Australia. The collaboration includes the Federal University of Minas Gerais (UFMG) in Brazil, the University of Sydney and University of Melbourne in Australia, the Australian Twin Registry, as well as the research foundations CNPq and CAPES in Brazil. The BTR is a member of the International Network of Twin Registries. Recruitment strategies used to register twins have been through participation in a longitudinal study investigating genetic and environmental factors for low back pain occurrence, and from a variety of sources including media campaigns and social networking. Currently, 291 twins are registered in the BTR, with data on demographics, zygosity, anthropometrics, and health history having been collected from 151 twins using a standardized self-reported questionnaire. Future BTR plans include the registration of thousands of Brazilian twins identified from different sources and collaborate nationally and internationally with other research groups interested on twin studies.

Developing a national radiation oncology registry: From acorns to oaks.

PubMed

Palta, Jatinder R; Efstathiou, Jason A; Bekelman, Justin E; Mutic, Sasa; Bogardus, Carl R; McNutt, Todd R; Gabriel, Peter E; Lawton, Colleen A; Zietman, Anthony L; Rose, Christopher M

2012-01-01

The National Radiation Oncology Registry (NROR) is a collaborative initiative of the Radiation Oncology Institute and the American Society of Radiation Oncology, with input and guidance from other major stakeholders in oncology. The overarching mission of the NROR is to improve the care of cancer patients by capturing reliable information on treatment delivery and health outcomes. The NROR will collect patient-specific radiotherapy data electronically to allow for rapid comparison of the many competing treatment modalities and account for effectiveness, outcome, utilization, quality, safety, and cost. It will provide benchmark data and quality improvement tools for individual practitioners. The NROR steering committee has determined that prostate cancer provides an appropriate model to test the concept and the data capturing software in a limited number of sites. The NROR pilot project will begin with this disease-gathering treatment and outcomes data from a limited number of treatment sites across the range of practice; once feasibility is proven, it will scale up to more sites and diseases. When the NROR is fully implemented, all radiotherapy facilities, along with their radiation oncologists, will be solicited to participate in it. With the broader participation of the radiation oncology community, NROR has the potential to serve as a resource for determining national patterns of care, gaps in treatment quality, comparative effectiveness, and hypothesis generation to identify new linkages between therapeutic processes and outcomes. The NROR will benefit radiation oncologists and other care providers, payors, vendors, policy-makers, and, most importantly, cancer patients by capturing reliable information on population-based radiation treatment delivery. Copyright © 2012 (c) 2010 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved. Published by Elsevier Inc. All rights reserved.

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

Second generation registry framework.

PubMed

Bellgard, Matthew I; Render, Lee; Radochonski, Maciej; Hunter, Adam

2014-01-01

Information management systems are essential to capture data be it for public health and human disease, sustainable agriculture, or plant and animal biosecurity. In public health, the term patient registry is often used to describe information management systems that are used to record and track phenotypic data of patients. Appropriate design, implementation and deployment of patient registries enables rapid decision making and ongoing data mining ultimately leading to improved patient outcomes. A major bottleneck encountered is the static nature of these registries. That is, software developers are required to work with stakeholders to determine requirements, design the system, implement the required data fields and functionality for each patient registry. Additionally, software developer time is required for ongoing maintenance and customisation. It is desirable to deploy a sophisticated registry framework that can allow scientists and registry curators possessing standard computing skills to dynamically construct a complete patient registry from scratch and customise it for their specific needs with little or no need to engage a software developer at any stage. This paper introduces our second generation open source registry framework which builds on our previous rare disease registry framework (RDRF). This second generation RDRF is a new approach as it empowers registry administrators to construct one or more patient registries without software developer effort. New data elements for a diverse range of phenotypic and genotypic measurements can be defined at any time. Defined data elements can then be utilised in any of the created registries. Fine grained, multi-level user and workgroup access can be applied to each data element to ensure appropriate access and data privacy. We introduce the concept of derived data elements to assist the data element standards communities on how they might be best categorised. We introduce the second generation RDRF that

Second generation registry framework

PubMed Central

2014-01-01

Background Information management systems are essential to capture data be it for public health and human disease, sustainable agriculture, or plant and animal biosecurity. In public health, the term patient registry is often used to describe information management systems that are used to record and track phenotypic data of patients. Appropriate design, implementation and deployment of patient registries enables rapid decision making and ongoing data mining ultimately leading to improved patient outcomes. A major bottleneck encountered is the static nature of these registries. That is, software developers are required to work with stakeholders to determine requirements, design the system, implement the required data fields and functionality for each patient registry. Additionally, software developer time is required for ongoing maintenance and customisation. It is desirable to deploy a sophisticated registry framework that can allow scientists and registry curators possessing standard computing skills to dynamically construct a complete patient registry from scratch and customise it for their specific needs with little or no need to engage a software developer at any stage. Results This paper introduces our second generation open source registry framework which builds on our previous rare disease registry framework (RDRF). This second generation RDRF is a new approach as it empowers registry administrators to construct one or more patient registries without software developer effort. New data elements for a diverse range of phenotypic and genotypic measurements can be defined at any time. Defined data elements can then be utilised in any of the created registries. Fine grained, multi-level user and workgroup access can be applied to each data element to ensure appropriate access and data privacy. We introduce the concept of derived data elements to assist the data element standards communities on how they might be best categorised. Conclusions We introduce the

The Three Mile Island Population Registry.

PubMed

Goldhaber, M K; Tokuhata, G K; Digon, E; Caldwell, G G; Stein, G F; Lutz, G; Gur, D

1983-01-01

Shortly after the March 28, 1979, accident at the Three Mile Island (TMI) nuclear plant outside Harrisburg, Pa., the Pennsylvania Department of Health, in conjunction with the Centers for Disease Control and the U.S. Bureau of the Census, conducted a census of the 35,930 persons residing within 5 miles of the plant. With the help of 150 enumerators, demographic and health-related information was collected on each person to provide baseline data for future short- and long-term epidemiologic studies of the effects of the accident. Individual radiation doses were estimated on the basis of residential location and the amount of time each person spent in the 5-mile area during the 10 days after the accident. Health and behavioral resurveys of the population will be conducted approximately every 5 years. Population-mobility, morbidity, and mortality will be studied yearly by matching the TMI Population Registry with postal records, cancer registry records, and death certificate data. Because the radiation dose from TMI was extremely small, any increase in morbidity or mortality attributable to the accident would be so small as not to be measurable by present methods; however, adverse health effects as a result of psychological stress may occur. Also, a temporary increase in reporting of disease could occur because of increased surveillance and attention to health.

The Three Mile Island Population Registry.

PubMed Central

Goldhaber, M K; Tokuhata, G K; Digon, E; Caldwell, G G; Stein, G F; Lutz, G; Gur, D

1983-01-01

Shortly after the March 28, 1979, accident at the Three Mile Island (TMI) nuclear plant outside Harrisburg, Pa., the Pennsylvania Department of Health, in conjunction with the Centers for Disease Control and the U.S. Bureau of the Census, conducted a census of the 35,930 persons residing within 5 miles of the plant. With the help of 150 enumerators, demographic and health-related information was collected on each person to provide baseline data for future short- and long-term epidemiologic studies of the effects of the accident. Individual radiation doses were estimated on the basis of residential location and the amount of time each person spent in the 5-mile area during the 10 days after the accident. Health and behavioral resurveys of the population will be conducted approximately every 5 years. Population-mobility, morbidity, and mortality will be studied yearly by matching the TMI Population Registry with postal records, cancer registry records, and death certificate data. Because the radiation dose from TMI was extremely small, any increase in morbidity or mortality attributable to the accident would be so small as not to be measurable by present methods; however, adverse health effects as a result of psychological stress may occur. Also, a temporary increase in reporting of disease could occur because of increased surveillance and attention to health. PMID:6419276

The Establishment of an Inflammatory Breast Cancer Registry and Biospecimen Repository

DTIC Science & Technology

2004-08-01

will be presented at the San Antonio Breast Cancer Conference in December, 2004. The clinical data include the observation that approximately one third...of IBC patients are initially diagnosed as having mastitis and are treated with up to five months of antibiotics before the diagnosis of cancer is...developed a national registry of patients with IBC which contains standardized clinical , epidemiological and pathological information. Our registry includes

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.

Modest Associations Between Electronic Health Record Use and Acute Myocardial Infarction Quality of Care and Outcomes: Results From the National Cardiovascular Data Registry.

PubMed

Enriquez, Jonathan R; de Lemos, James A; Parikh, Shailja V; Simon, DaJuanicia N; Thomas, Laine E; Wang, Tracy Y; Chan, Paul S; Spertus, John A; Das, Sandeep R

2015-11-01

In 2009, national legislation promoted wide-spread adoption of electronic health records (EHRs) across US hospitals; however, the association of EHR use with quality of care and outcomes after acute myocardial infarction (AMI) remains unclear. Data on EHR use were collected from the American Hospital Association Annual Surveys (2007-2010) and data on AMI care and outcomes from the National Cardiovascular Data Registry Acute Coronary Treatment and Interventions Outcomes Network Registry-Get With The Guidelines. Comparisons were made between patients treated at hospitals with fully implemented EHR (n=43 527), partially implemented EHR (n=72 029), and no EHR (n=9270). Overall EHR use increased from 82.1% (183/223) hospitals in 2007 to 99.3% (275/277) hospitals in 2010. Patients treated at hospitals with fully implemented EHRs had fewer heparin overdosing errors (45.7% versus 72.8%; P<0.01) and a higher likelihood of guideline-recommended care (adjusted odds ratio, 1.40 [confidence interval, 1.07-1.84]) compared with patients treated at hospitals with no EHR. In non-ST-segment-elevation AMI, fully implemented EHR use was associated with lower risk of major bleeding (adjusted odds ratio, 0.78 [confidence interval, 0.67-0.91]) and mortality (adjusted odds ratio, 0.82 [confidence interval, 0.69-0.97]) compared with no EHR. In ST-segment-elevation MI, outcomes did not significantly differ by EHR status. EHR use has risen to high levels among hospitals in the National Cardiovascular Data Registry. EHR use was associated with less frequent heparin overdosing and modestly greater adherence to acute MI guideline-recommended therapies. In non-ST-segment-elevation MI, slightly lower adjusted risk of major bleeding and mortality were seen in hospitals implemented with full EHRs; however, in ST-segment-elevation MI, differences in outcomes were not seen. © 2015 American Heart Association, Inc.

Perioperative Mortality, 2010 to 2014: A Retrospective Cohort Study Using the National Anesthesia Clinical Outcomes Registry.

PubMed

Whitlock, Elizabeth L; Feiner, John R; Chen, Lee-Lynn

2015-12-01

The National Anesthesia Clinical Outcomes Registry collects demographic and outcome data from anesthesia cases, with the goal of improving safety and quality across the specialty. The authors present a preliminary analysis of the National Anesthesia Clinical Outcomes Registry database focusing on the rates of and associations with perioperative mortality (within 48 h of anesthesia induction). The authors retrospectively analyzed 2,948,842 cases performed between January 1, 2010, and May 31, 2014. Cases without procedure information and vaginal deliveries were excluded. Mortality and other outcomes were reported by the anesthesia provider. Hierarchical logistic regression was performed on cases with complete information for patient age group, sex, American Society of Anesthesiologists physical status, emergency case status, time of day, and surgery type, controlling for random effects within anesthesia practices. The final analysis included 2,866,141 cases and 944 deaths (crude mortality rate, 33 per 100,000). Increasing American Society of Anesthesiologists physical status, emergency case status, cases beginning between 4:00 PM and 6:59 AM, and patient age less than 1 yr or greater than or equal to 65 yr were independently associated with higher perioperative mortality. A post hoc subgroup analysis of 279,154 patients limited to 22 elective case types, post hoc models incorporating either more granular estimate of surgical risk or work relative value units, and a post hoc propensity score-matched cohort confirmed the association with time of day. Several factors were associated with increased perioperative mortality. A case start time after 4:00 PM was associated with an adjusted odds ratio of 1.64 (95% CI, 1.22 to 2.21) for perioperative death, which suggests a potentially modifiable target for perioperative risk reduction. Limitations of this study include nonstandardized mortality reporting and limited ability to adjust for missing data.

National and international registries of rare bleeding disorders.

PubMed

Peyvandi, Flora; Spreafico, Marta

2008-09-01

Rare bleeding disorders (RBDs) are autosomal recessive disorders, representing 3-5% of all the inherited deficiencies of coagulation factors. Their frequency in the general population ranges from 1:500,000 to 1:2 millions. In countries with a high rate of consanguineous marriages RBDs occur more frequently, representing a significant clinical and social problem. Patients affected by RBDs have a wide spectrum of clinical symptoms that vary from a mild or moderate bleeding tendency to potentially serious or life-threatening haemorrhages. Current treatment is based on both replacement therapy and non-transfusional treatment. However, despite the existence of several concentrates, there is no Factor V concentrate available for the treatment of Factor V deficiency, yet. In 2004, to improve the understanding of RBDs prevalence, diagnosis and treatments, the Rare Bleeding Disorders database (RBDD, www.rbdd.org) was developed. The RBDD project allowed the collection of epidemiological information on 3,230 patients from 66 Centres scattered all over the world. Epidemiological data can also be derived from the annual survey of the World Federation of Hemophilia (www.wfh.org) and from other existing national registries. However, these data are not homogenous and global surveys provide a non-real picture of the distribution of RBDs, as about 50% of data refers to European patients. Hence, we focused on Europe and, thanks to a European project (EN-RBD), we set up a network of 10 Treatment Centres to develop a homogeneous communication tool for inserting, managing and viewing information on RBD patients (www.rbdd.eu). This on-line database resulted to be a powerful tool to improve the quality of data collection. Preliminary results showed that a homogeneous and harmonized data collection using a unique model will help to have more accurate data for statistical analysis.

Linked Registries: Connecting Rare Diseases Patient Registries through a Semantic Web Layer

PubMed Central

González-Castro, Lorena; Carta, Claudio; van der Horst, Eelke; Lopes, Pedro; Kaliyaperumal, Rajaram; Thompson, Mark; Thompson, Rachel; Queralt-Rosinach, Núria; Lopez, Estrella; Wood, Libby; Robertson, Agata; Lamanna, Claudia; Gilling, Mette; Orth, Michael; Merino-Martinez, Roxana; Taruscio, Domenica; Lochmüller, Hanns

2017-01-01

Patient registries are an essential tool to increase current knowledge regarding rare diseases. Understanding these data is a vital step to improve patient treatments and to create the most adequate tools for personalized medicine. However, the growing number of disease-specific patient registries brings also new technical challenges. Usually, these systems are developed as closed data silos, with independent formats and models, lacking comprehensive mechanisms to enable data sharing. To tackle these challenges, we developed a Semantic Web based solution that allows connecting distributed and heterogeneous registries, enabling the federation of knowledge between multiple independent environments. This semantic layer creates a holistic view over a set of anonymised registries, supporting semantic data representation, integrated access, and querying. The implemented system gave us the opportunity to answer challenging questions across disperse rare disease patient registries. The interconnection between those registries using Semantic Web technologies benefits our final solution in a way that we can query single or multiple instances according to our needs. The outcome is a unique semantic layer, connecting miscellaneous registries and delivering a lightweight holistic perspective over the wealth of knowledge stemming from linked rare disease patient registries. PMID:29214177

Linked Registries: Connecting Rare Diseases Patient Registries through a Semantic Web Layer.

PubMed

Sernadela, Pedro; González-Castro, Lorena; Carta, Claudio; van der Horst, Eelke; Lopes, Pedro; Kaliyaperumal, Rajaram; Thompson, Mark; Thompson, Rachel; Queralt-Rosinach, Núria; Lopez, Estrella; Wood, Libby; Robertson, Agata; Lamanna, Claudia; Gilling, Mette; Orth, Michael; Merino-Martinez, Roxana; Posada, Manuel; Taruscio, Domenica; Lochmüller, Hanns; Robinson, Peter; Roos, Marco; Oliveira, José Luís

2017-01-01

Patient registries are an essential tool to increase current knowledge regarding rare diseases. Understanding these data is a vital step to improve patient treatments and to create the most adequate tools for personalized medicine. However, the growing number of disease-specific patient registries brings also new technical challenges. Usually, these systems are developed as closed data silos, with independent formats and models, lacking comprehensive mechanisms to enable data sharing. To tackle these challenges, we developed a Semantic Web based solution that allows connecting distributed and heterogeneous registries, enabling the federation of knowledge between multiple independent environments. This semantic layer creates a holistic view over a set of anonymised registries, supporting semantic data representation, integrated access, and querying. The implemented system gave us the opportunity to answer challenging questions across disperse rare disease patient registries. The interconnection between those registries using Semantic Web technologies benefits our final solution in a way that we can query single or multiple instances according to our needs. The outcome is a unique semantic layer, connecting miscellaneous registries and delivering a lightweight holistic perspective over the wealth of knowledge stemming from linked rare disease patient registries.

The Italian Registry of Antiphospholipid Antibodies.

PubMed

Finazzi, G

1997-01-01

The clinical importance of antiphospholipid antibodies (APA) derives from their association with a syndrome of venous and arterial thrombosis, recurrent fetal loss and thrombocytopenia known as the antiphospholipid syndrome (APS). The Italian Registry of Antiphospholipid Antibodies was set up in 1989 for the purpose of collecting a large number of patients with lupus anticoagulant (LA) or anticardiolipin antibodies (ACA) for clinical studies in order to obtain more information on the clinical features of APS. The Italian Registry has completed two clinical studies and proposed an international trial on the treatment of APS patients. These activities of the Registry are reviewed herein. Additional information has been obtained from pertinent articles and abstracts published in journals covered by the Science Citation Index and Medline. The first study of the Registry was a retrospective analysis of enrolled patients which showed that: a) the prevalence of thrombosis and thrombocytopenia was similar in cases with idiopathic APA or APA secondary to systemic lupus erythematosus, and b) the rate of thrombosis was significantly reduced in patients with severe thrombocytopenia but not in those with only a mild reduction of the platelet count. The second study was a prospective survey of the natural history of the disease, showing that a) previous thrombosis and ACA titer > 40 units were independent predictors of subsequent vascular complications; b) a history of miscarriage or thrombosis is significantly associated with adverse pregnancy outcome; c) hematological malignancies can develop during follow-up and patients with APA should be considered at increased risk of developing NHL. Thus the possibility of a hematologic neoplastic disease should be borne in mind in the initial evaluation and during the follow-up of these patients. The latest initiative of the Registry was the proposal of an international, randomized clinical trial (WAPS study) aimed at assessing the

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 ...

Establishing a harmonized haemophilia registry for countries with developing health care systems.

PubMed

Alzoebie, A; Belhani, M; Eshghi, P; Kupesiz, A O; Ozelo, M; Pompa, M T; Potgieter, J; Smith, M

2013-09-01

Over recent decades tremendous progress has been made in diagnosing and treating haemophilia and, in resource-rich countries, life expectancy of people with haemophilia (PWH) is now close to that of a healthy person. However, an estimated 70% of PWH are not diagnosed or are undertreated; the majority of whom live in countries with developing health care systems. In these countries, designated registries for people with haemophilia are often limited and comprehensive information on the natural history of the disease and treatment outcomes is lacking. Taken together, this means that planning efforts for future treatment and care of affected individuals is constrained in countries where it is most needed. Establishment of standardized national registries in these countries would be a step towards obtaining reliable sociodemographic and clinical data for an entire country. A series of consensus meetings with experts from widely differing countries with different health care systems took place to discuss concerns specific to countries with developing health care systems. As a result of these discussions, recommendations are made on parameters to include when establishing and harmonizing national registries. Such recommendations should enable countries with developing health care systems to establish standardized national haemophilia registries. Although not a primary objective, the recommendations should also help standardized data collation on an international level, enabling treatment and health care trends to be monitored across groups of countries and providing data for advocacy purposes. Greater standardization of data collation should have implications for optimizing resources for haemophilia care both nationally and internationally. © 2013 John Wiley & Sons Ltd.

Evaluation of data quality at the National Cancer Registry of Ukraine.

PubMed

Ryzhov, Anton; Bray, Freddie; Ferlay, Jacques; Fedorenko, Zoya; Goulak, Liudmyla; Gorokh, Yevgeniy; Soumkina, Olena; Znaor, Ariana

2018-04-01

Cancer notification has been mandatory in Ukraine since 1953, with the National Cancer Registry of Ukraine (NCRU) established in 1996. The aim of this study was to provide a comprehensive evaluation of the data quality at the NCRU. Qualitative and semi-quantitative methods were used to assess the comparability, completeness, validity and timeliness of cancer incidence data from the NCRU for the period 2002-2012. Cancer registration procedures at the NCRU are in accordance with international standards and recommendations. Semi-quantitative methods suggested the NCRU's data was reasonably complete, although decreases in age-specific incidence and mortality rates in the elderly indicated some missing cases at older ages. The proportion of microscopically-verified cases increased from 73.6% in 2002 to 82.3% in 2012, with death-certificate-only (DCO) proportions stable at around 0.1% and unknown stage recorded in 9.6% of male and 7.5% of female solid tumours. Timeliness was considered acceptable, with reporting >99% complete within a turn-around time of 15 months. While timely reporting of national data reflects the advantages of a mandatory data collection system, a low DCO% and observed age-specific declines suggest possible underreporting of incidence and mortality data, particularly at older ages. Overall, the evaluation indicates that the data are reasonably comparable and thus may be used to describe the magnitude of the cancer burden in Ukraine. Given its central role in monitoring and evaluation of cancer control activities, ensuring the sustainability of NCRU operations throughout the process of healthcare system reform is of utmost importance. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

Gender and geographic differences in the prevalence of autism spectrum disorders in children: analysis of data from the national disability registry of Taiwan.

PubMed

Lai, Der-Chung; Tseng, Yen-Cheng; Hou, Yuh-Ming; Guo, How-Ran

2012-01-01

The prevalence of autism spectrum disorders (ASD) in the world has increased dramatically in the recent decades. However, data at the national level are limited, and geographic differences are seldom evaluated. According to the law, the local governments in Taiwan began to certify disabled residents and provide various services in 1980, and the central government maintains a registry of certified cases. The registry started to enroll cases of ASD in 1990, providing a unique opportunity for studying ASD at the national level. Because the government discourages the certification under 3 years of age, we limited our analyses to those who were at least 3 years old. Using the registry data from 2004 to 2010, we calculated the prevalence of ASD by age, gender, and geographic area and assessed the changes over time. From 2004 to 2010, the registered cases between 3 and 17 years old increased from 3995 to 8072 annually, and the prevalence generally increased every year in all age groups (p<0.01). In each year there were more boy cases than girl cases, and the prevalence rate ratio ranged from 5.64:1 to 6.06:1 (p<0.01 in all years), with an increasing trend over time (p<0.01). A higher prevalence was observed in the urban areas over the years, and the prevalence rate ratio ranged from 2.24:1 to 2.72:1 (p<0.01 in all years), with a decreasing trend over time (p<0.01). Copyright © 2011 Elsevier Ltd. All rights reserved.

Intravenous contrast extravasation during CT: a national data registry and practice quality improvement initiative.

PubMed

Dykes, Thomas M; Bhargavan-Chatfield, Mythreyi; Dyer, Raymond B

2015-02-01

Establish 3 performance benchmarks for intravenous contrast extravasation during CT examinations: extravasation frequency, distribution of extravasation volumes, and severity of injury. Evaluate the effectiveness of implementing practice quality improvement (PQI) methodology in improving performance for these 3 benchmarks. The Society of Abdominal Radiology and ACR developed a registry collecting data for contrast extravasation events. The project includes a PQI initiative allowing for process improvement. As of December 2013, a total of 58 radiology practices have participated in this project, and 32 practices have completed the 2-cycle PQI. There were a total of 454,497 contrast-enhanced CT exams and 1,085 extravasation events. The average extravasation rate is 0.24%. The median extravasation rate is 0.21%. Most extravasations (82.9%) were between 10 mL and 99 mL. The majority of injuries, 94.6%, are mild in severity, with 4.7% having moderate and 0.8% having severe injuries. Data from practices that completed the PQI process showed a change in the average extravasation rate from 0.28% in the first 6 months to 0.23% in the second 6 months, and the median extravasation rate dropped from 0.25% to 0.16%, neither statistically significant. The distribution of extravasation volumes and the severity of injury did not change between the first and second measurement periods. National performance benchmarks for contrast extravasation rate, distribution of volumes of extravasate, and distribution of severity of injury are established through this multi-institutional practice registry. The application of PQI failed to have a statistically significant positive impact on any of the 3 benchmarks. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

On-line data collection platform for national dose surveys in diagnostic and interventional radiology.

PubMed

Vassileva, J; Simeonov, F; Avramova-Cholakova, S

2015-07-01

According to the Bulgarian regulation for radiation protection at medical exposure, the National Centre of Radiobiology and Radiation Protection (NCRRP) is responsible for performing national dose surveys in diagnostic and interventional radiology and nuclear medicine and for establishing of national diagnostic reference levels (DRLs). The next national dose survey is under preparation to be performed in the period of 2015-16, with the aim to cover conventional radiography, mammography, conventional fluoroscopy, interventional and fluoroscopy guided procedures and CT. It will be performed electronically using centralised on-line data collection platform established by the NCRRP. The aim is to increase the response rate and to improve the accuracy by reducing human errors. The concept of the on-line dose data collection platform is presented. Radiological facilities are provided with a tool to determine local typical patient doses, and the NCRRP to establish national DRLs. Future work will include automatic retrieval of dose data from hospital picture archival and communicating system. The on-line data collection platform is expected to facilitate the process of dose audit and optimisation of radiological procedures in Bulgarian hospitals. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Encouraging Health Information Management Graduates to Pursue Cancer Registry Careers.

PubMed

Peterson, Jennifer

2016-01-01

The cancer registry profession has grown dramatically since its inception in 1926. Certified tumor registrars (CTRs) have become an integral part of the cancer care team by providing quality cancer data for research, statistical purposes, public health, and cancer control. In addition, CTRs have been found to be valuable in other cancer and health-related fields. Based on the need for high-quality, accurate data, the National Cancer Registrars Association (NCRA), the certification body for CTRs, has increased the educational requirement for eligibility for the CTR certification exam. This has resulted in fewer individuals who are able to meet the requirements for CTR certification. In addition, the existing cancer registry workforce is, on average, older than other allied health professions, and therefore will face an increasing number of retirements in the next few years. The high demand for CTRs, the decreased pool of CTR-eligible applicants, and the aging cancer registry workforce has resulted in an existing shortage that will only get worse as the population ages and the incidence of cancer increases. Health information management (HIM) students are well suited to pursuing further training in the cancer registry field and gaining the CTR credential. HIM students or new graduates have the needed skill set and education to pursue a cancer registry career. There are many avenues HIM educational programs can take to encourage students to pursue CTR certification and a cancer registry career. Including cancer registry functions in courses throughout the HIM curriculum, bringing in cancer registry speakers, encouraging networking, and promoting the cancer registry field and profession in general are just a few of the methods that HIM programs can use to raise awareness of and promote a cancer registry career to their students. Illinois State University has used these methods and has found them to be successful in encouraging a percentage of their graduates to pursue

Understanding the patient perspective on research access to national health records databases for conduct of randomized registry trials.

PubMed

Avram, Robert; Marquis-Gravel, Guillaume; Simard, François; Pacheco, Christine; Couture, Étienne; Tremblay-Gravel, Maxime; Desplantie, Olivier; Malhamé, Isabelle; Bibas, Lior; Mansour, Samer; Parent, Marie-Claude; Farand, Paul; Harvey, Luc; Lessard, Marie-Gabrielle; Ly, Hung; Liu, Geoffrey; Hay, Annette E; Marc Jolicoeur, E

2018-07-01

Use of health administrative databases is proposed for screening and monitoring of participants in randomized registry trials. However, access to these databases raises privacy concerns. We assessed patient's preferences regarding use of personal information to link their research records with national health databases, as part of a hypothetical randomized registry trial. Cardiology patients were invited to complete an anonymous self-reported survey that ascertained preferences related to the concept of accessing government health databases for research, the type of personal identifiers to be shared and the type of follow-up preferred as participants in a hypothetical trial. A total of 590 responders completed the survey (90% response rate), the majority of which were Caucasians (90.4%), male (70.0%) with a median age of 65years (interquartile range, 8). The majority responders (80.3%) would grant researchers access to health administrative databases for screening and follow-up. To this end, responders endorsed the recording of their personal identifiers by researchers for future record linkage, including their name (90%), and health insurance number (83.9%), but fewer responders agreed with the recording of their social security number (61.4%, p<0.05 with date of birth as reference). Prior participation in a trial predicted agreement for granting researchers access to the administrative databases (OR: 1.69, 95% confidence interval: 1.03-2.90; p=0.04). The majority of Cardiology patients surveyed were supportive of use of their personal identifiers to access administrative health databases and conduct long-term monitoring in the context of a randomized registry trial. Copyright © 2018 Elsevier Ireland Ltd. All rights reserved.

Validity of Race, Ethnicity, and National Origin in Population-based Cancer Registries and Rapid Case Ascertainment Enhanced With a Spanish Surname List.

PubMed

Clarke, Lisa C; Rull, Rudolph P; Ayanian, John Z; Boer, Robert; Deapen, Dennis; West, Dee W; Kahn, Katherine L

2016-01-01

Accurate information regarding race, ethnicity, and national origins is critical for identifying disparities in the cancer burden. To examine the use of a Spanish surname list to improve the quality of race-related information obtained from rapid case ascertainment (RCA) and to estimate the accuracy of race-related information obtained from cancer registry records collected by routine reporting. Self-reported survey responses of 3954 participants from California enrolled in the Cancer Care Outcomes Research and Surveillance Consortium. Sensitivity, specificity, positive predictive value, and percent agreement. We used logistic regression to identify predictors of underreporting and overreporting of a race/ethnicity. Use of the Spanish surname list increased the sensitivity of RCA for Latino ethnicity from 37% to 83%. Sensitivity for cancer registry records collected by routine reporting was ≥95% for whites, blacks, and Asians, and specificity was high for all groups (86%-100%). However, patterns of misclassification by race/ethnicity were found that could lead to biased cancer statistics for specific race/ethnicities. Discordance between self-reported and registry-reported race/ethnicity was more likely for women, Latinos, and Asians. Methods to improve race and ethnicity data, such as using Spanish surnames in RCA and instituting data collection guidelines for hospitals, are needed to ensure minorities are accurately represented in clinical and epidemiological research.

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.

Adjuvant high-dose chemotherapy with autologous hematopoietic stem cell support for high-risk primary breast cancer: results from the Italian national registry.

PubMed

Pedrazzoli, Paolo; Martinelli, Giovanni; Gianni, Alessandro Massimo; Da Prada, Gian Antonio; Ballestrero, Alberto; Rosti, Giovanni; Frassineti, Giovanni Luca; Aieta, Michele; Secondino, Simona; Cinieri, Saverio; Fedele, Roberta; Bengala, Carmelo; Bregni, Marco; Grasso, Donatella; De Giorgi, Ugo; Lanza, Francesco; Castagna, Luca; Bruno, Barbara; Martino, Massimo

2014-04-01

The efficacy of high-dose chemotherapy (HDC) and autologous hemopoietic progenitor cell transplantation (AHPCT) for breast cancer (BC) patients has been an area of intense controversy among the medical oncology community. The aim of this study was to assess toxicity and efficacy of this procedure in a large cohort of high-risk primary BC patients who underwent AHPCT in Italy. A total of 1183 patients receiving HDC for high-risk BC (HRBC) (>3 positive nodes) were identified in the Italian registry. The median age was 46 years, 62% of patients were premenopausal at treatment, 60.1% had endocrine-responsive tumors, and 20.7% had a human epidermal growth factor receptor 2 (HER2)-positive tumor. The median number of positive lymph nodes (LN) at surgery was 15, with 71.5% of patients having ≥ 10 positive nodes. Seventy-three percent received an alkylating agent-based HDC as a single procedure, whereas 27% received epirubicin or mitoxantrone-containing HDC, usually within a multitransplantation program. The source of stem cells was peripheral blood in the vast majority of patients. Transplantation-related mortality was .8%, whereas late cardiac and secondary tumor-related mortality were around 1%, overall. With a median follow-up of 79 months, median disease-free and overall survival (OS) in the entire population were 101 and 134 months, respectively. Subgroup analysis demonstrated that OS was significantly better in patients with endocrine-responsive tumors and in patients receiving multiple transplantation procedures. HER2 status did not affect survival probability. The size of the primary tumor and number of involved LN negatively affected OS. Adjuvant HDC with AHPCT has a low mortality rate and provides impressive long-term survival rates in patients with high-risk primary BC. Our results suggest that this treatment modality should be proposed in selected HRBC patients and further investigated in clinical trials. Copyright © 2014 American Society for Blood and

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

The history and use of cancer registry data by public health cancer control programs in the United States.

PubMed

White, Mary C; Babcock, Frances; Hayes, Nikki S; Mariotto, Angela B; Wong, Faye L; Kohler, Betsy A; Weir, Hannah K

2017-12-15

Because cancer registry data provide a census of cancer cases, registry data can be used to: 1) define and monitor cancer incidence at the local, state, and national levels; 2) investigate patterns of cancer treatment; and 3) evaluate the effectiveness of public health efforts to prevent cancer cases and improve cancer survival. The purpose of this article is to provide a broad overview of the history of cancer surveillance programs in the United States, and illustrate the expanding ways in which cancer surveillance data are being made available and contributing to cancer control programs. The article describes the building of the cancer registry infrastructure and the successful coordination of efforts among the 2 federal agencies that support cancer registry programs, the Centers for Disease Control and Prevention and the National Cancer Institute, and the North American Association of Central Cancer Registries. The major US cancer control programs also are described, including the National Comprehensive Cancer Control Program, the National Breast and Cervical Cancer Early Detection Program, and the Colorectal Cancer Control Program. This overview illustrates how cancer registry data can inform public health actions to reduce disparities in cancer outcomes and may be instructional for a variety of cancer control professionals in the United States and in other countries. Cancer 2017;123:4969-76. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

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.

Assessing the readiness of precision medicine interoperabilty: An exploratory study of the National Institutes of Health genetic testing registry.

PubMed

Ronquillo, Jay G; Weng, Chunhua; Lester, William T

2017-11-17

  Precision medicine involves three major innovations currently taking place in healthcare:  electronic health records, genomics, and big data.  A major challenge for healthcare providers, however, is understanding the readiness for practical application of initiatives like precision medicine.   To better understand the current state and challenges of precision medicine interoperability using a national genetic testing registry as a starting point, placed in the context of established interoperability formats.   We performed an exploratory analysis of the National Institutes of Health Genetic Testing Registry.  Relevant standards included Health Level Seven International Version 3 Implementation Guide for Family History, the Human Genome Organization Gene Nomenclature Committee (HGNC) database, and Systematized Nomenclature of Medicine - Clinical Terms (SNOMED CT).  We analyzed the distribution of genetic testing laboratories, genetic test characteristics, and standardized genome/clinical code mappings, stratified by laboratory setting. There were a total of 25472 genetic tests from 240 laboratories testing for approximately 3632 distinct genes.  Most tests focused on diagnosis, mutation confirmation, and/or risk assessment of germline mutations that could be passed to offspring.  Genes were successfully mapped to all HGNC identifiers, but less than half of tests mapped to SNOMED CT codes, highlighting significant gaps when linking genetic tests to standardized clinical codes that explain the medical motivations behind test ordering.  Conclusion:  While precision medicine could potentially transform healthcare, successful practical and clinical application will first require the comprehensive and responsible adoption of interoperable standards, terminologies, and formats across all aspects of the precision medicine pipeline.

Workload and time management in central cancer registries: baseline data and implication for registry staffing.

PubMed

Chapman, Susan A; Mulvihill, Linda; Herrera, Carolina

2012-01-01

The Workload and Time Management Survey of Central Cancer Registries was conducted in 2011 to assess the amount of time spent on work activities usually performed by cancer registrars. A survey including 39 multi-item questions,together with a work activities data collection log, was sent by email to the central cancer registry (CCR) manager in each of the 50 states and the District of Columbia. Twenty-four central cancer registries (47%) responded to the survey.Results indicate that registries faced reductions in budgeted staffing from 2008-2009. The number of source records and total cases were important indicators of workload. Four core activities, including abstracting at the registry, visual editing,case consolidation, and resolving edit reports, accounted for about half of registry workload. We estimate an average of 12.4 full-time equivalents (FTEs) are required to perform all cancer registration activities tracked by the survey; however,estimates vary widely by registry size. These findings may be useful for registries as a benchmark for their own registry workload and time-management data and to develop staffing guidelines.

Workload and Time Management in Central Cancer Registries: Baseline Data and Implication for Registry Staffing

PubMed Central

Chapman, Susan A.; Mulvihill, Linda; Herrera, Carolina

2015-01-01

The Workload and Time Management Survey of Central Cancer Registries was conducted in 2011 to assess the amount of time spent on work activities usually performed by cancer registrars. A survey including 39 multi-item questions, together with a work activities data collection log, was sent by email to the central cancer registry (CCR) manager in each of the 50 states and the District of Columbia. Twenty-four central cancer registries (47%) responded to the survey. Results indicate that registries faced reductions in budgeted staffing from 2008–2009. The number of source records and total cases were important indicators of workload. Four core activities, including abstracting at the registry, visual editing, case consolidation, and resolving edit reports, accounted for about half of registry workload. We estimate an average of 12.4 full-time equivalents (FTEs) are required to perform all cancer registration activities tracked by the survey; however, estimates vary widely by registry size. These findings may be useful for registries as a benchmark for their own registry workload and time-management data and to develop staffing guidelines. PMID:23493024

Paul Coverdell National Acute Stroke Registry Surveillance - four states, 2005-2007.

PubMed

George, Mary G; Tong, Xin; McGruder, Henraya; Yoon, Paula; Rosamond, Wayne; Winquist, Andrea; Hinchey, Judith; Wall, Hilary K; Pandey, Dilip K

2009-11-06

Each year, approximately 795,000 persons in the United States experience a new or recurrent stroke. Data from the prototype phase (2001-2004) of the Paul Coverdell National Acute Stroke Registry (PCNASR) suggested that numerous acute stroke patients did not receive treatment according to established guidelines. This report summarizes PCNASR data collected during 2005-2007 from Georgia, Illinois, Massachusetts, and North Carolina, the first states to have PCNASRs implemented in and led by state health departments. PCNASR was established by CDC in 2001 to track and improve the quality of hospital-based acute stroke care. The prototype phase (2001-2004) registries were led by CDC-funded clinical investigators in academic and medical institutions, whereas the full implementation of the 2005-2007 statewide registries was led by CDC-funded state health departments. Health departments in each state recruit hospitals to collect data. To be included in PCNASR, patients must be aged >or=18 years and have a clinical diagnosis of acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (TIA) or an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code indicative of a stroke or TIA. Data for patients who are already hospitalized at the time of stroke are not included. The following 10 performance measures of care, based on established guidelines for care of acute stroke patients, were developed by CDC in partnership with neurologists who specialize in stroke care: 1) received deep venous thrombosis prophylaxis, 2) received antithrombotic therapy at discharge, 3) received anticoagulation therapy for atrial fibrillation, 4) received tissue plasminogen activator (among eligible patients), 5) received antithrombotic therapy within 48 hours of admission or by the end of the second hospital day, 6) received lipid level testing, 7) received dysphagia screening, 8) received stroke education, 9

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.

Comparative effectiveness of ceramic-on-ceramic implants in stemmed hip replacement: a multinational study of six national and regional registries.

PubMed

Sedrakyan, Art; Graves, Stephen; Bordini, Barbara; Pons, Miquel; Havelin, Leif; Mehle, Susan; Paxton, Elizabeth; Barber, Thomas; Cafri, Guy

2014-12-17

The rapid decline in use of conventional total hip replacement with a large femoral head size and a metal-on-metal bearing surface might lead to increased popularity of ceramic-on-ceramic bearings as another hard-on-hard alternative that allows implantation of a larger head. We sought to address comparative effectiveness of ceramic-on-ceramic and metal-on-HXLPE (highly cross-linked polyethylene) implants by utilizing the distributed health data network of the ICOR (International Consortium of Orthopaedic Registries), an unprecedented collaboration of national and regional registries and the U.S. FDA (Food and Drug Administration). A distributed health data network was developed by the ICOR and used in this study. The data from each registry are standardized and provided at a level of aggregation most suitable for the detailed analysis of interest. The data are combined across registries for comprehensive assessments. The ICOR coordinating center and study steering committee defined the inclusion criteria for this study as total hip arthroplasty performed without cement from 2001 to 2010 in patients forty-five to sixty-four years of age with osteoarthritis. Six national and regional registries (Kaiser Permanente and HealthEast in the U.S., Emilia-Romagna region in Italy, Catalan region in Spain, Norway, and Australia) participated in this study. Multivariate meta-analysis was performed with use of linear mixed models, with survival probability as the unit of analysis. We present the results of the fixed-effects model and include the results of the random-effects model in an appendix. SAS version 9.2 was used for all analyses. We first compared femoral head sizes of >28 mm and ≤28 mm within ceramic-on-ceramic implants and then compared ceramic-on-ceramic with metal-on-HXLPE. A total of 34,985 patients were included; 52% were female. We found a lower risk of revision associated with use of ceramic-on-ceramic implants when a larger head size was used (HR [hazard

Analyses of Radiation and Mesothelioma in the US Transuranium and Uranium Registries

PubMed Central

Fulcher, Keri; Nagarajan, Sumitha; McCord, Stacey; Fallahian, Naz Afarin; Hoffman, Heather J.; Haver, Cary; Tolmachev, Sergei

2013-01-01

Objectives. We examined the relationship between radiation and excess deaths from mesothelioma among deceased nuclear workers who were part of the US Transuranium and Uranium Registries. Methods. We performed univariate analysis with SAS Version 9.1 software. We conducted proportionate mortality ratio (PMR) and proportionate cancer mortality ratio (PCMR) analyses using the National Institute for Occupational Safety and Health Life Table Analysis System with the referent group being all deaths in the United States. Results. We found a PMR of 62.40 (P < .05) and a PCMR of 46.92 (P < .05) for mesothelioma. PMRs for the 4 cumulative external radiation dose quartiles were 61.83, 57.43, 74.46, and 83.31. PCMRs were 36.16, 47.07, 51.35, and 67.73. The PMR and PCMR for trachea, bronchus, and lung cancer were not significantly elevated. Conclusions. The relationship between cumulative external radiation dose and the PMR and PCMR for mesothelioma suggests that external radiation at nuclear facilities is associated with an increased risk of mesothelioma. The lack of a significantly elevated PMR and PCMR for trachea, bronchus, and lung cancer suggests that asbestos did not confound this relationship. PMID:23409888

[The year 2003 National Registry of Home-based Parenteral Nutrition].

PubMed

Moreno, J M; Planas, M; de Cos, A I; Virgili, N; Gómez-Enterría, P; Ordóñez, J; de la Cuerda, C; Martí, E; Apezetxea, A; Forga, M T; Pérez de la Cruz, A; Muñoz, A; Rodríguez, A; Cardona, D; Pedrón, C; Luengo, L M; Garde, C; Parés, R M

2006-01-01

To report the results of the Home-based Parenteral Nutrition (HBPN) registry of the NADYA-SENPE working group, for the year 2003. Gathering of registry data introduced by all units responsible of HBPN patient care. This an on-line registry available for authorized users of the working group web page (www.nadya-senpe.com). Epidemiological data, diagnosis, access route, complications, hospital admissions, disability degree, and course at December 31st, 2003 Data from 86 patients (62% female and 38% male) from 17 hospitals were gathered. Mean age of adult patients was 50.7 +/- 15.0 years, whereas for patients younger than 14 years was 2.4 +/- 1.5 years (n = 5 patients). Diseases that prone HBPN were neoplasm (21%), followed by mesenteric ischemia (20%), radiation enteritis (16.3%), motility impairments (10.5%), and Crohn's disease (4.6%). Tunneled catheters were used in 66.3% of the cases versus 29.1% of subcutaneous reservoirs. Mean treatment duration has been 8.5 +/- 4.6 months; 67.4% of patients had been on HBPN for a period of time longer than 6 months. Patient follow-up was mostly done from the reference area hospital (88.4%). In no case patient follow-up was done by the primary care team or by specialists other than those prescribing nutritional support. Nutritional support-related complications were seen in 98 occasions. The most frequent complications were infectious ones. They represented 1.60 hospital admissions per patient. The mean number of visits was 7.9 per patient (6.4 for scheduled visits and 1.5 for emergency visits). By the end of the year, we observed that 73.3% of the patients were still on the program, whereas in 23.3% HBPN had been withdrawn. The main reasons for withdrawal were decease (11 patients), and advancing to oral diet (9 patients). As for the disability degree, 13% were confined to a wheelchair or bed, and only 28% had no disability degree or only mild social disability. We observed a mild increase in HBPN prevalence rate in Spain (2

On the Effect of Triplet or Doublet Chemotherapy in Advanced Gastric Cancer: Results From a National Cancer Registry.

PubMed

Carmona-Bayonas, Alberto; Jiménez-Fonseca, Paula; Lorenzo, Maria Luisa Sánchez; Ramchandani, Avinash; Martínez, Elena Asensio; Custodio, Ana; Garrido, Marcelo; Echavarría, Isabel; Cano, Juana María; Barreto, Jose Enrique Lorenzo; García, Teresa García; Manceñido, Felipe Álvarez; Lacalle, Alejandra; Cardona, Marta Ferrer; Mangas, Monserrat; Visa, Laura; Buxó, Elvira; Azkarate, Aitor; Díaz-Serrano, Asunción; Montes, Ana Fernández; Rivera, Fernando

2016-11-01

There is currently no consensus regarding first-line chemotherapy for patients with advanced gastric cancer (AGC) who are ineligible to receive trastuzumab. The objective of this study was to evaluate the efficacy and tolerance of triplets versus doublets by analyzing a national gastric cancer registry. Patients with AGC treated with polychemotherapy without associating trastuzumab were included from 2008 through 2016. The effect of triplets versus doublets was compared using 3 methods: Cox proportional hazards regression, propensity score matching (PSM), and coarsened exact matching (CEM). A total of 970 patients were recruited (doublets: n=569; triplets: n=401). In the multivariate Cox model, the use of triplets was associated with better overall survival (OS), with a hazard ratio (HR) of 0.84 (95% CI, 0.72-0.98; P=.035). After PSM, the sample contained 340 pairs. A significant increase in OS, 11.14 months (95% CI, 9.60-12.68) versus 9.60 months (95% CI, 8.44-10.75), was seen in favor of triplets (HR, 0.77; 95% CI, 0.65-0.92; stratified log-rank test, P=.004). The effect appeared to be comparable for anthracycline-based (HR, 0.78; 95% CI, 0.64-0.94) or docetaxel-based triplets (HR, 0.78; 95% CI, 0.60-1.009). The trend was similar after applying the CEM algorithm, with an HR of 0.78 (95% CI, 0.63-0.97; P=.03). Triplet therapy was viable and relative dose intensities exceeded 85%, except for cisplatin in DCX (docetaxel, cisplatin, capecitabine). Triplets had more severe toxicity overall, especially hematologic, hepatic, and mucosal adverse events. With the limitations of a retrospective study that examines a heterogeneous set of chemotherapy regimens, we found that triplets are feasible in daily practice and are associated with a discreet benefit in efficacy at the expense of a moderate increase in toxicity. Copyright © 2016 by the National Comprehensive Cancer Network.

CARESS: the Canadian registry of palivizumab.

PubMed

Mitchell, Ian; Paes, Bosco A; Li, Abby; Lanctôt, Krista L

2011-08-01

Palivizumab is indicated for respiratory syncytial virus (RSV) prophylaxis in high-risk children. However, relatively little is known about the current use, compliance, and outcomes associated with this medication. A prospective, observational, registry based on 27 sites, with monthly follow-up of infants at high risk for RSV who received at least 1 dose of palivizumab during the 2005-2009 RSV seasons. A total of 5286 children were enrolled (56.6% male; 71.7% white; average gestational age, 32.1 ± 5.5 weeks). Of them, 3741 patients (70.8%) were prophylaxed for prematurity only, 449 (8.5%) for bronchopulmonary dysplasia/chronic lung disease, 508 (9.6%) for congenital heart disease, and 588 (11.1%) for other reasons. Overall, 19,485 doses were given. On average, infants received 86.0% ± 28.4% of their expected number of injections; 71.2% of infants received their injections in the recommended time periods. Of the 5286 participants enrolled, 308 patients were hospitalized for respiratory tract illness (hospitalization rate, 5.8%). The RSV-hospitalization rate was calculated as 1.38%. Having siblings increased likelihood of hospitalization (66.9% vs. 55.7%, P < 0.005), and was significantly correlated with time to hospitalization in this cohort (P = 0.050). The overall RSV-hospitalization rate in our study was within the range found in previous reports (1.3%-5.3%), although it did not mimic the declining rates of the US Palivizumab Outcomes Registry. This could be due to increased testing for RSV when hospitalized and increasing rates of prophylaxis of infants with underlying medical disorders.

Review of patient registries in dermatology.

PubMed

DiMarco, Gabriella; Hill, Dane; Feldman, Steven R

2016-10-01

Patient registries are datasets containing information on patients with a particular disease or patients who are undergoing a specific treatment. Our objective was to search for and catalog the types of registries being used in dermatology and investigate their characteristics and uses. We searched Google, the Registry of Patient Registries, Orphanet, and ClinicalTrials.gov to compile a list of dermatology disease registries. We also conducted a literature review on the uses of dermatology registries using PubMed. We identified 48 dermatology patient registries, with 23 distinct diseases represented. We also identified 11 registries used for postmarketing surveillance of skin disease. Our search was limited to registries in English. Registries are commonly used for the study of rare dermatologic diseases and for postsurveillance monitoring of systemic therapies in more common dermatologic diseases, such as psoriasis. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Immune tolerance: critical issues of factor dose, purity and treatment complications.

PubMed

DiMichele, D M

2006-12-01

The current practice of immune tolerance induction (ITI) therapy has been largely influenced by the results of small institutional studies and three large registries. However, many questions remain. Successful outcome predictors for ITI in haemophilia A have been suggested by the analyses of two of these registries. Among these predictors, factor VIII (FVIII) dose/dosing regimen remains a controversial outcome parameter, demonstrating a strong direct relationship to ITI success in the international registry and a weaker inverse relationship in the North American registry. There is an international multicentre prospective randomized trial underway to further study the role of FVIII dose in successful ITI induction in a good risk haemophilia A inhibitor patient cohort. FVIII purity also remains an unproved ITI outcome predictor. Institutional experience with von-Willebrand-factor-containing products has suggested its therapeutic advantage in both inhibitor development and eradication. The International ITI Study, although not designed to answer this particular question, may be able to determine an impact on outcome depending on the final distribution of investigator choice of product among the study subjects. Much less is known about the influence of factor IX (FIX) dose and purity on ITI success in haemophilia B. Importantly, nephrotic syndrome has been a major determinant of ITI failure in FIX inhibitor patients, particularly those with the allergic phenotype. Unfortunately, large prospective randomized trials in this group will not be feasible. Rather, we will have to rely on prospectively collected registry data to build our knowledge base of inhibitors and ITI in haemophilia B.

Standardising trauma monitoring: the development of a minimum dataset for trauma registries in Australia and New Zealand.

PubMed

Palmer, Cameron S; Davey, Tamzyn M; Mok, Meng Tuck; McClure, Rod J; Farrow, Nathan C; Gruen, Russell L; Pollard, Cliff W

2013-06-01

Trauma registries are central to the implementation of effective trauma systems. However, differences between trauma registry datasets make comparisons between trauma systems difficult. In 2005, the collaborative Australian and New Zealand National Trauma Registry Consortium began a process to develop a bi-national minimum dataset (BMDS) for use in Australasian trauma registries. This study aims to describe the steps taken in the development and preliminary evaluation of the BMDS. A working party comprising sixteen representatives from across Australasia identified and discussed the collectability and utility of potential BMDS fields. This included evaluating existing national and international trauma registry datasets, as well as reviewing all quality indicators and audit filters in use in Australasian trauma centres. After the working party activities concluded, this process was continued by a number of interested individuals, with broader feedback sought from the Australasian trauma community on a number of occasions. Once the BMDS had reached a suitable stage of development, an email survey was conducted across Australasian trauma centres to assess whether BMDS fields met an ideal minimum standard of field collectability. The BMDS was also compared with three prominent international datasets to assess the extent of dataset overlap. Following this, the BMDS was encapsulated in a data dictionary, which was introduced in late 2010. The finalised BMDS contained 67 data fields. Forty-seven of these fields met a previously published criterion of 80% collectability across respondent trauma institutions; the majority of the remaining fields either could be collected without any change in resources, or could be calculated from other data fields in the BMDS. However, comparability with international registry datasets was poor. Only nine BMDS fields had corresponding, directly comparable fields in all the national and international-level registry datasets evaluated. A

Maternal nationality and developmental delays in young children: Analysis of the data from the national registry in Taiwan.

PubMed

Tseng, Yen-Cheng; Guo, How-Ran; Lai, Der-Chung

2016-01-01

With globalization, transnational marriages become more and more common around the world. Children born to immigrant mothers might be more likely to have developmental delays, but studies on this topic are limited and with inconsistent results. To determine whether children born to immigrant mothers are more likely to have developmental delays. We analyzed the data from the national registry of children with developmental delays from 2009 to 2013 and compared the incidence of developmental delays between children born to immigrant mothers and native mothers. We also performed stratified analyses by age, sex, and geographic area. From 2009 to 2013, 78,946 new cases of developmental delays under 6 years of age were registered, including 5619 (7.1%) born to immigrant mothers. The incidence was higher in children born to native mothers in every year with rate ratios ranging from 1.32 to 1.48, and the differences reached statistical significance even after stratification by age, sex, and geographic area. Children born to immigrant mothers had lower incidence of developmental delays in Taiwan. The result may help reduce the discrimination of foreign spouses and their children. Copyright © 2016 Elsevier Ltd. All rights reserved.

The first report of a 5-year period cancer registry in Greece (2009-2013): a pathology-based cancer registry.

PubMed

Patsea, Eleni; Kaklamanis, Loukas; Batistatou, Anna

2018-04-01

Cancer registries are essential in health care, since they allow more accurate planning of necessary health services and evaluation of programs for cancer prevention and control. The Hellenic Society of Pathology (HSP) having recognized the lack of such information in Greece has undertaken the task of a 5-year pathology-based cancer registry in Greece (2009-2013). In this study, > 95% of all pathology laboratories in the national health system hospitals and 100% of pathology laboratories in private hospitals, as well as > 80% of private pathology laboratories have contributed their data. The most common cancer types overall were as follows: breast cancer (18.26%), colorectal cancer (15.49%), prostate cancer (13.49%), and lung cancer (10.24% of all registered cancers). In men, the most common neoplasms were as follows: prostate cancer, colorectal cancer, lung cancer, and gastric cancer. In women, the most common neoplasms were as follows: breast cancer, colorectal cancer, thyroid cancer, and lung cancer. The data on cancer burden in Greece, presented herein, fill the void of cancer information in Greece that affects health care not only nationally but Europe-wise.

Low/No Calorie Sweetened Beverage Consumption in the National Weight Control Registry

PubMed Central

Catenacci, Victoria A.; Pan, Zhaoxing; Thomas, J. Graham; Ogden, Lorraine G.; Roberts, Susan A.; Wyatt, Holly R.; Wing, Rena R.; Hill, James O.

2015-01-01

Objective The aim of this cross-sectional study was to evaluate prevalence of and strategies behind low/no calorie sweetened beverage (LNCSB) consumption in successful weight loss maintainers. Methods An online survey was administered to 434 members of the National Weight Control Registry (NWCR, individuals who have lost ≥13.6 kg and maintained weight loss for > 1 year). Results While few participants (10%) consume sugar-sweetened beverages on a regular basis, 53% regularly consume LNCSB. The top five reasons for choosing LNCSB were for taste (54%), to satisfy thirst (40%), part of routine (27%), to reduce calories (22%) and to go with meals (21%). The majority who consume LNCSB (78%) felt they helped control total calorie intake. Many participants considered changing patterns of beverage consumption to be very important in weight loss (42%) and maintenance (40%). Increasing water was by far the most common strategy, followed by reducing regular calorie beverages. Conclusions Regular consumption of LNCSB is common in successful weight loss maintainers for various reasons including helping individuals to limit total energy intake. Changing beverage consumption patterns was felt to be very important for weight loss and maintenance by a substantial percentage of successful weight loss maintainers in the NWCR. PMID:25044563

Low/no calorie sweetened beverage consumption in the National Weight Control Registry.

PubMed

Catenacci, Victoria A; Pan, Zhaoxing; Thomas, J Graham; Ogden, Lorraine G; Roberts, Susan A; Wyatt, Holly R; Wing, Rena R; Hill, James O

2014-10-01

The aim of this cross-sectional study was to evaluate prevalence of and strategies behind low/no calorie sweetened beverage (LNCSB) consumption in successful weight loss maintainers. An online survey was administered to 434 members of the National Weight Control Registry (NWCR, individuals who have lost ≥13.6 kg and maintained weight loss for > 1 year). While few participants (10%) consume sugar-sweetened beverages on a regular basis, 53% regularly consume LNCSB. The top five reasons for choosing LNCSB were for taste (54%), to satisfy thirst (40%), part of routine (27%), to reduce calories (22%) and to go with meals (21%). The majority who consume LNCSB (78%) felt they helped control total calorie intake. Many participants considered changing patterns of beverage consumption to be very important in weight loss (42%) and maintenance (40%). Increasing water was by far the most common strategy, followed by reducing regular calorie beverages. Regular consumption of LNCSB is common in successful weight loss maintainers for various reasons including helping individuals to limit total energy intake. Changing beverage consumption patterns was felt to be very important for weight loss and maintenance by a substantial percentage of successful weight loss maintainers in the NWCR. Copyright © 2014 The Obesity Society.

Ensuring quality in studies linking cancer registries and biobanks.

PubMed

Langseth, Hilde; Luostarinen, Tapio; Bray, Freddie; Dillner, Joakim

2010-04-01

The Nordic countries have a long tradition of providing comparable and high quality cancer data through the national population-based cancer registries and the capability to link the diverse large-scale biobanks currently in operation. The joining of these two infrastructural resources can provide a study base for large-scale studies of etiology, treatment and early detection of cancer. Research projects based on combined data from cancer registries and biobanks provides great opportunities, but also presents major challenges. Biorepositories have become an important resource in molecular epidemiology, and the increased interest in performing etiological, clinical and gene-environment-interaction studies, involving information from biological samples linked to population-based cancer registries, warrants a joint evaluation of the quality aspects of the two resources, as well as an assessment of whether the resources can be successfully combined into a high quality study. While the quality of biospecimen handling and analysis is commonly considered in different studies, the logistics of data handling including the linkage of the biobank with the cancer registry is an overlooked aspect of a biobank-based study. It is thus the aim of this paper to describe recommendations on data handling, in particular the linkage of biobank material to cancer registry data and the quality aspects thereof, based on the experience of Nordic collaborative projects combining data from cancer registries and biobanks. We propose a standard documentation with respect to the following topics: the quality control aspects of cancer registration, the identification of cases and controls, the identification and use of data confounders, the stability of serum components, historical storage conditions, aliquoting history, the number of freeze/thaw cycles and available volumes.

Initial Report of the Korean Organ Transplant Registry (KOTRY): Heart Transplantation.

PubMed

Lee, Hae Young; Jeon, Eun Seok; Kang, Seok Min; Kim, Jae Joong

2017-11-01

The Korean Organ Transplant Registry (KOTRY), which was the first national transplant registry in Korea, was founded by the Korean Society for Transplantation and the Korean Center for Disease Control in 2014. Here, we present the initial report of the Korean Heart Transplant Registry. A total of 183 heart transplantation (HTPL) patients performed at 4 nationally representative hospitals were collected from April 2014 to December 2015. We analyzed donor and recipient characteristics, treatment patterns, and immediate post-transplantation outcomes. One hundred and eighty-three patients were enrolled. The mean age of the patients was 50.5±13.5 years. The mean age of the male recipients was 4 years greater than that of the female recipients (51.7±13.3 years vs. 47.9±13.7 years, p<0.050). The mean age of donors was more than 12 years younger than that of heart recipients (37.6±10.1 years). Dilated cardiomyopathy was the predominant cause (69%) of heart failure in recipients, followed by ischemic heart diseases (14%) and valvular heart disease (4%). Rejection episodes were most frequent in the 1-6-month period after transplantation (48%), and rarely required intensive treatment. Infection episodes were most frequent <1 month after transplantation (66%) and bacterial and viral infections were equally reported. The 1-year survival rate was 91.6% and most mortality cases occurred during the perioperative period within 1 month after transplantation. With the establishment of the KOTRY in 2014, it is now possible to present nationwide epidemiological data for HTPL in Korea for the first time. The KOTRY is the first national HTPL registry in Korea, and will continue until 2023. Copyright © 2017. The Korean Society of Cardiology

ULTRAVIOLET RADIATION DOSE AND AMPHIBIAN DISTRIBUTIONS IN NATIONAL PARKS

EPA Science Inventory

Ultraviolet Radiation Dose and Amphibian Distributions in National Parks. Diamond, S. A., Detenbeck, N. E., USEPA, Duluth, MN, USA, Bradford, D. F., USEPA, Las Vegas, NV, USA, Trenham, P. C., University of California, Davis, CA., USA, Adams, M. J., Corn, P. S., Hossack, B., USGS,...

Cluster analysis of the national weight control registry to identify distinct subgroups maintaining successful weight loss.

PubMed

Ogden, Lorraine G; Stroebele, Nanette; Wyatt, Holly R; Catenacci, Victoria A; Peters, John C; Stuht, Jennifer; Wing, Rena R; Hill, James O

2012-10-01

The National Weight Control Registry (NWCR) is the largest ongoing study of individuals successful at maintaining weight loss; the registry enrolls individuals maintaining a weight loss of at least 13.6 kg (30 lb) for a minimum of 1 year. The current report uses multivariate latent class cluster analysis to identify unique clusters of individuals within the NWCR that have distinct experiences, strategies, and attitudes with respect to weight loss and weight loss maintenance. The cluster analysis considers weight and health history, weight control behaviors and strategies, effort and satisfaction with maintaining weight, and psychological and demographic characteristics. The analysis includes 2,228 participants enrolled between 1998 and 2002. Cluster 1 (50.5%) represents a weight-stable, healthy, exercise conscious group who are very satisfied with their current weight. Cluster 2 (26.9%) has continuously struggled with weight since childhood; they rely on the greatest number of resources and strategies to lose and maintain weight, and report higher levels of stress and depression. Cluster 3 (12.7%) represents a group successful at weight reduction on the first attempt; they were least likely to be overweight as children, are maintaining the longest duration of weight loss, and report the least difficulty maintaining weight. Cluster 4 (9.9%) represents a group less likely to use exercise to control weight; they tend to be older, eat fewer meals, and report more health problems. Further exploration of the unique characteristics of these clusters could be useful for tailoring future weight loss and weight maintenance programs to the specific characteristics of an individual.

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.

The utility of heart failure registries: a descriptive and comparative study of two heart failure registries.

PubMed

Trullàs, Joan Carles; Miró, Òscar; Formiga, Francesc; Martín-Sánchez, Francisco Javier; Montero-Pérez-Barquero, Manuel; Jacob, Javier; Quirós-López, Raúl; Herrero Puente, Pablo; Manzano, Luís; Llorens, Pere

2016-05-01

Registries are useful to address questions that are difficult to answer in clinical trials. The objective of this study was to describe and compare two heart failure (HF) cohorts from two Spanish HF registries. We compared the RICA and EAHFE registries, both of which are prospective multicentre cohort studies including patients with decompensated HF consecutively admitted to internal medicine wards (RICA) or attending the emergency department (EAHFE). From the latter registry we only included patients who were admitted to internal medicine wards. A total of 5137 patients admitted to internal medicine wards were analysed (RICA: 3287 patients; EAHFE: 1850 patients). Both registries included elderly patients (RICA: mean (SD) age 79 (9) years; EAHFE: mean (SD) age 81 (9) years), with a slight predominance of female gender (52% and 58%, respectively, in the RICA and EAHFE registries) and with a high proportion of patients with preserved ejection fraction (58% and 62%, respectively). Some differences in comorbidities were noted, with diabetes mellitus, dyslipidaemia, chronic renal failure and atrial fibrillation being more frequent in the RICA registry while cognitive and functional impairment predominated in the EAHFE registry. The 30-day mortality after discharge was 3.4% in the RICA registry and 4.8% in the EAHFE registry (p<0.05) and the 30-day readmission rate was 7.5% in the RICA registry (readmission to hospital) and 24.0% in the EAHFE registry (readmission to emergency department) (p<0.001). We found differences in the clinical characteristics of patients admitted to Spanish internal medicine wards for decompensated HF depending on inclusion in either the RICA or EAHFE registry. 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/

A web-based, patient driven registry for Angelman syndrome: the global Angelman syndrome registry.

PubMed

Napier, Kathryn R; Tones, Megan; Simons, Chloe; Heussler, Helen; Hunter, Adam A; Cross, Meagan; Bellgard, Matthew I

2017-08-01

Angelman syndrome (AS) is a rare neurodevelopmental disorder that is characterised by severe global developmental delays, ataxia, loss of speech, epilepsy, sleep disorders, and a happy disposition. There is currently no cure for AS, though several pharmaceutical companies are anticipating drug trials for new therapies to treat AS. The Foundation for Angelman Therapeutics (FAST) Australia therefore identified a need for a global AS patient registry to identify patients for recruitment for clinical trials.The Global AS Registry was deployed in September 2016 utilising the Rare Disease Registry Framework, an open-source tool that enables the efficient creation and management of patient registries. The Global AS Registry is web-based and allows parents and guardians worldwide to register, provide informed consent, and enter data on individuals with AS. 286 patients have registered in the first 8 months since deployment.We demonstrate the successful deployment of the first patient-driven global registry for AS. The data generated from the Global AS Registry will be crucial in identifying patients suitable for clinical trials and in informing research that will identify treatments for AS, and ultimately improve the lives of individuals and their families living with AS.

Increasing Use of Dose-Escalated External Beam Radiation Therapy for Men With Nonmetastatic Prostate Cancer

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

Swisher-McClure, Samuel, E-mail: Swisher-Mcclure@uphs.upenn.edu; Leonard Davis Institute of Health Economics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Mitra, Nandita

Purpose: To examine recent practice patterns, using a large national cancer registry, to understand the extent to which dose-escalated external beam radiation therapy (EBRT) has been incorporated into routine clinical practice for men with prostate cancer. Methods and Materials: We conducted a retrospective observational cohort study using the National Cancer Data Base, a nationwide oncology outcomes database in the United States. We identified 98,755 men diagnosed with nonmetastatic prostate cancer between 2006 and 2011 who received definitive EBRT and classified patients into National Comprehensive Cancer Network (NCCN) risk groups. We defined dose-escalated EBRT as total prescribed dose of ≥75.6 Gy. Usingmore » multivariable logistic regression, we examined the association of patient, clinical, and demographic characteristics with the use of dose-escalated EBRT. Results: Overall, 81.6% of men received dose-escalated EBRT during the study period. The use of dose-escalated EBRT did not vary substantially by NCCN risk group. Use of dose-escalated EBRT increased from 70.7% of patients receiving treatment in 2006 to 89.8% of patients receiving treatment in 2011. On multivariable analysis, year of diagnosis and use of intensity modulated radiation therapy were significantly associated with receipt of dose-escalated EBRT. Conclusions: Our study results indicate that dose-escalated EBRT has been widely adopted by radiation oncologists treating prostate cancer in the United States. The proportion of patients receiving dose-escalated EBRT increased nearly 20% between 2006 and 2011. We observed high utilization rates of dose-escalated EBRT within all disease risk groups. Adoption of intensity modulated radiation therapy was strongly associated with use of dose-escalated treatment.« less

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.

Modeling Major Adverse Outcomes of Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Catheterization: Observations From the NCDR IMPACT Registry (National Cardiovascular Data Registry Improving Pediatric and Adult Congenital Treatment).

PubMed

Jayaram, Natalie; Spertus, John A; Kennedy, Kevin F; Vincent, Robert; Martin, Gerard R; Curtis, Jeptha P; Nykanen, David; Moore, Phillip M; Bergersen, Lisa

2017-11-21

Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment). Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%. The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95). The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk

Meta-analysis of individual registry results enhances international registry collaboration.

PubMed

Paxton, Elizabeth W; Mohaddes, Maziar; Laaksonen, Inari; Lorimer, Michelle; Graves, Stephen E; Malchau, Henrik; Namba, Robert S; Kärrholm, John; Rolfson, Ola; Cafri, Guy

2018-03-28

Background and purpose - Although common in medical research, meta-analysis has not been widely adopted in registry collaborations. A meta-analytic approach in which each registry conducts a standardized analysis on its own data followed by a meta-analysis to calculate a weighted average of the estimates allows collaboration without sharing patient-level data. The value of meta-analysis as an alternative to individual patient data analysis is illustrated in this study by comparing the risk of revision of porous tantalum cups versus other uncemented cups in primary total hip arthroplasties from Sweden, Australia, and a US registry (2003-2015). Patients and methods - For both individual patient data analysis and meta-analysis approaches a Cox proportional hazard model was fit for time to revision, comparing porous tantalum (n = 23,201) with other uncemented cups (n = 128,321). Covariates included age, sex, diagnosis, head size, and stem fixation. In the meta-analysis approach, treatment effect size (i.e., Cox model hazard ratio) was calculated within each registry and a weighted average for the individual registries' estimates was calculated. Results - Patient-level data analysis and meta-analytic approaches yielded the same results with the porous tantalum cups having a higher risk of revision than other uncemented cups (HR (95% CI) 1.6 (1.4-1.7) and HR (95% CI) 1.5 (1.4-1.7), respectively). Adding the US cohort to the meta-analysis led to greater generalizability, increased precision of the treatment effect, and similar findings (HR (95% CI) 1.6 (1.4-1.7)) with increased risk of porous tantalum cups. Interpretation - The meta-analytic technique is a viable option to address privacy, security, and data ownership concerns allowing more expansive registry collaboration, greater generalizability, and increased precision of treatment effects.

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.

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

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.

[Clinical trials registry].

PubMed

Ryder, Elena

2004-12-01

Authors and journals are more enthusiastic about the publication of trials with positive results than those negative or inconclusive trials. The International Committee of Medical Journal Editors proposed comprehensive trials registration as a solution to the problem of selective awareness and announces that the ICMJE member journals will adopt a trial-registration policy to promote this goal. They establish as a condition of consideration for publication, registration in a public trials registry. They recommend registries that meet certain criteria as www.clinicaltrials.com. Among those criteria is that the registry must be supported by a non-profit organization. On the other hand, people from Current Controlled Trials Ltd. being a commercial company, but meeting all the other criteria established by the ICMJE, feel that is being put aside. We wonder if clinical trials in our country are being registered in some of these International Registries. If not, would it be time to do so?

eRegistries: governance for electronic maternal and child health registries.

PubMed

Myhre, Sonja L; Kaye, Jane; Bygrave, Lee A; Aanestad, Margunn; Ghanem, Buthaina; Mechael, Patricia; Frøen, J Frederik

2016-09-23

The limited availability of maternal and child health data has limited progress in reducing mortality and morbidity among pregnant women and children. Global health agencies, leaders, and funders are prioritizing strategies that focus on acquiring high quality health data. Electronic maternal and child health registries (eRegistries) offer a systematic data collection and management approach that can serve as an entry point for preventive, curative and promotive health services. Due to the highly sensitive nature of reproductive health information, careful consideration must be accorded to privacy, access, and data security. In the third paper of the eRegistries Series, we report on the current landscape of ethical and legal governance for maternal and child health registries in developing countries. This research utilizes findings from two web-based surveys, completed in 2015 that targeted public health officials and health care providers in 76 countries with high global maternal and child mortality burden. A sample of 298 public health officials from 64 countries and 490 health care providers from 59 countries completed the online survey. Based on formative research in the development of the eRegistries Governance Guidance Toolkit, the surveys were designed to investigate topics related to maternal and child health registries including ethical and legal issues. According to survey respondents, the prevailing legal landscape is characterized by inadequate data security safeguards and weak support for core privacy principles. Respondents from the majority of countries indicated that health information from medical records is typically protected by legislation although legislation dealing specifically or comprehensively with data privacy may not be in place. Health care provider trust in the privacy of health data at their own facilities is associated with the presence of security safeguards. Addressing legal requirements and ensuring that privacy and data security

Registry data for cross-country comparisons of migrants' healthcare utilization in the EU: a survey study of availability and content

PubMed Central

2009-01-01

Background Cross-national comparable data on migrants' use of healthcare services are important to address problems in access to healthcare; to identify high risk groups for prevention efforts; and to evaluate healthcare systems comparatively. Some of the main obstacles limiting analyses of health care utilization are lack of sufficient coverage and availability of reliable and valid healthcare data which includes information allowing for identification of migrants. The objective of this paper was to reveal which registry data on healthcare utilization were available in the EU countries in which migrants can be identified; and to determine to what extent data were comparable between the EU countries. Methods A questionnaire survey on availability of healthcare utilization registries in which migrants can be identified was carried out among all national statistic agencies and other relevant national health authorities in the 27 EU countries in 2008-9 as part of the Migrant and Ethnic Minority Health Observatory-project (MEHO). The information received was compared with information from a general survey on availability of survey and registry data on migrants conducted by Agency of Public Health, Lazio Region, Italy within the MEHO-project; thus, the information on registries was double-checked to assure accuracy and verification. Results Available registry data on healthcare utilization which allow for identification on migrants on a national/regional basis were only reported in 11 EU countries: Austria, Belgium, Denmark, Finland, Greece, Italy, Luxembourg, the Netherlands, Poland, Slovenia, and Sweden. Data on hospital care, including surgical procedures, were most frequently available whereas only few countries had data on care outside the hospital. Regarding identification of migrants, five countries reported having information on both citizenship and country of birth, one reported availability of information on country of birth, and five countries reported

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

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.

Establishment of the Pediatric Obesity Weight Evaluation Registry: A National Research Collaborative for Identifying the Optimal Assessment and Treatment of Pediatric Obesity.

PubMed

Kirk, Shelley; Armstrong, Sarah; King, Eileen; Trapp, Christine; Grow, Mollie; Tucker, Jared; Joseph, Madeline; Liu, Lenna; Weedn, Ashley; Sweeney, Brooke; Fox, Claudia; Fathima, Samreen; Williams, Ronald; Kim, Roy; Stratbucker, William

2017-02-01

Prospective patient registries have been successfully utilized in several disease states with a goal of improving treatment approaches through multi-institutional collaboration. The prevalence of youth with severe obesity is at a historic high in the United States, yet evidence to guide effective weight management is limited. The Pediatric Obesity Weight Evaluation Registry (POWER) was established in 2013 to identify and promote effective intervention strategies for pediatric obesity. Sites in POWER provide multicomponent pediatric weight management (PWM) care for youth with obesity and collect a defined set of demographic and clinical parameters, which they regularly submit to the POWER Data Coordinating Center. A program profile survey was completed by sites to describe characteristics of the respective PWM programs. From January 2014 through December 2015, 26 US sites were enrolled in POWER and had submitted data on 3643 youth with obesity. Ninety-five percent were 6-18 years of age, 54% female, 32% nonwhite, 32% Hispanic, and 59% publicly insured. Over two-thirds had severe obesity. All sites included a medical provider and used weight status in their referral criteria. Other program characteristics varied widely between sites. POWER is an established national registry representing a diverse sample of youth with obesity participating in multicomponent PWM programs across the United States. Using high-quality data collection and a collaborative research infrastructure, POWER aims to contribute to the development of evidence-based guidelines for multicomponent PWM programs.

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.

Premature trial discontinuation often not accurately reflected in registries: comparison of registry records with publications.

PubMed

Alturki, Reem; Schandelmaier, Stefan; Olu, Kelechi Kalu; von Niederhäusern, Belinda; Agarwal, Arnav; Frei, Roy; Bhatnagar, Neera; Hooft, Lotty; von Elm, Erik; Briel, Matthias

2017-01-01

One quarter of randomized clinical trials (RCTs) are prematurely discontinued and frequently remain unpublished. Trial registries can document whether a trial is ongoing, suspended, discontinued, or completed and therefore represent an important source for trial status information. The accuracy of this information is unclear. To examine the accuracy of completion status and reasons for discontinuation documented in trial registries as compared to corresponding publications of discontinued RCTs and to investigate potential predictors for accurate trial status information in registries. We conducted a cross-sectional study comparing information provided in publications (reference standard) to corresponding registry entries. First, we reviewed publications of RCTs providing information on both discontinuation and registration. We identified eligible publications through systematic searches of MEDLINE and EMBASE (2010-2014) and an international cohort of 1,017 RCTs initiated between 2000 and 2003. Second, pairs of investigators independently and in duplicate extracted data from publications and corresponding registry records. Third, for each discontinued RCT, we compared publication information to registry information. We used multivariable regression to examine whether accurate labeling of trials as discontinued (vs. other status) in the registry was associated with recent initiation of RCT, industry sponsorship, multicenter design, or larger sample size. We identified 173 publications of RCTs that were discontinued due to slow recruitment (55%), harm (16%), futility (11%), benefit (5%), other reasons (3%), or multiple reasons (9%). Trials were registered with clinicaltrials.gov (77%), isrctn.com (14%), or other registries (8%). Of the 173 corresponding registry records, 77 (45%) trials were labeled as discontinued and 57 (33%) provided a reason for discontinuation (of which 53, 93%, provided the same reason as in the publication). Labeling of discontinued trials as

The antiretrovirals in pregnancy registry: a fifteenth anniversary celebration.

PubMed

Tilson, Hugh H; Doi, Peggy A; Covington, Deborah L; Parker, Artist; Shields, Kristine; White, Alice

2007-02-01

The year 2007 marks the fifteenth anniversary year of the founding of a landmark effort in drug safety risk management, the formation of the first monitoring effort of an antiretroviral (ARV) drug in pregnancy which has become the Antiretrovirals in Pregnancy Registry, the APR. This multicompany, multi-national voluntary collaborative registry monitors pregnancy exposure to a class of highly important drugs for any indication of an increase in the postexposure incidence of birth defects in the offspring of these pregnancies. To recognize the anniversary, the Steering Committee of the APR has commissioned this review of the contributions and lessons learned over the past decade and a half and, in the spirit of continuous process improvement, has committed to apply these lessons for the next fifteen years. This retrospective examines the antecedents to this registry and the context in which the APR was formed; the early efforts to establish technical and organizational procedures and policies; the evolving experiences with enrollment and follow-up, patient and participant protections, information management and oversight; public and regulatory dissemination; and of course, the accomplishments and lessons learned. Obstetricians & Gynecologists, Family Physicians. After completion of this article, the reader should be able to explain the value of a drug registry in determining safety risk management; summarize that the Antiretroviral (ARV) drugs in Pregnancy Registry (APR) is a very successful multinational, multicompany collaborative effort that has been in place for 15 years; and state that it has been an ideal public interest effort dealing with the devastating pandemic of human immunodeficiency viral disease.

Paving pathways: Brazil's implementation of a national human papillomavirus immunization campaign.

PubMed

Baker, Misha L; Figueroa-Downing, Daniella; Chiang, Ellen Dias De Oliveira; Villa, Luisa; Baggio, Maria Luiza; Eluf-Neto, José; Bednarczyk, Robert A; Evans, Dabney P

2015-08-01

In 2014, Brazil introduced an HPV immunization program for girls 9-13 years of age as part of the Unified Health System's (SUS) National Immunization Program. The first doses were administered in March 2014; the second ones, in September 2014. In less than 3 months more than 3 million girls received the first dose of quadrivalent HPV vaccine, surpassing the target rate of 80%. This paper examines three elements that may influence the program's long-term success in Brazil: sustaining effective outreach, managing a large technology-transfer collaboration, and developing an electronic immunization registry, with a focus on the State of São Paulo. If these three factors are managed, the Government of Brazil is primed to serve as a model of success for other countries interested in implementing a national HPV vaccination program to decrease HPV-related morbidity and mortality.

Comparison of consolidation strategies in acute myeloid leukemia: high-dose cytarabine alone versus intermediate-dose cytarabine combined with anthracyclines.

PubMed

Kim, Dae Sik; Kang, Ka-Won; Lee, Se Ryeon; Park, Yong; Sung, Hwa Jung; Kim, Seok Jin; Choi, Chul Won; Kim, Byung Soo

2015-09-01

We compared the efficacy of high-dose cytarabine alone to that of intermediate-dose cytarabine combined with anthracyclines as consolidation therapy. Patients enrolled in the Korea University acute myeloid leukemia (AML) registry received remission induction chemotherapy with the same standard induction regimen (idarubicin and cytarabine 3 + 7). Postremission therapy was performed for three or four cycles according to one of the following regimens: high-dose cytarabine (3 g/m(2)) or combination of intermediate-dose cytarabine (1 g/m(2)) with anthracyclines (idarubicin or mitoxantrone). Among the 443 AML patients enrolled in the registry, 145 patients received consolidation chemotherapy. The median overall survival (OS) and relapse-free survival (RFS) in the high-dose cytarabine group were significantly longer than those in the anthracycline combination group (OS, not reached vs. 16.6 months, p = 0.045; RFS, 38.6 months vs. 11.0 months, p = 0.011). The median duration of neutropenia was longer in the anthracycline combination group than in the high-dose cytarabine group (8 vs. 10 days, p = 0.001). This study suggests that high-dose cytarabine consolidation may produce superior outcomes than combination treatment with intermediate-dose cytarabine and anthracyclines and that the addition of anthracyclines during AML consolidation has limited value as compared to cytarabine intensification.

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.

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

GCK-MODY in the US National Monogenic Diabetes Registry: frequently misdiagnosed and unnecessarily treated.

PubMed

Carmody, David; Naylor, Rochelle N; Bell, Charles D; Berry, Shivani; Montgomery, Jazzmyne T; Tadie, Elizabeth C; Hwang, Jessica L; Greeley, Siri Atma W; Philipson, Louis H

2016-10-01

GCK-MODY leads to mildly elevated blood glucose typically not requiring therapy. It has been described in all ethnicities, but mainly in Caucasian Europeans. Here we describe our US cohort of GCK-MODY. We examined the rates of detection of heterozygous mutations in the GCK gene in individuals referred to the US Monogenic Diabetes Registry with a phenotype consistent with GCK-MODY. We also assessed referral patterns, treatment and demography, including ethnicity, of the cohort. Deleterious heterozygous GCK mutations were found in 54.7 % of Registry probands selected for GCK sequencing for this study. Forty-nine percent were previously unnecessarily treated with glucose-lowering agents, causing hypoglycemia and other adverse effects in some of the subjects. The proportion of probands found to have a GCK mutation through research-based testing was similar across each ethnic group. However, together African-American, Latino and Asian subjects represented only 20.5 % of screened probands and 17.2 % of those with GCK-MODY, despite higher overall diabetes prevalence in these groups. Our data show that a high detection rate of GCK-MODY is possible based on clinical phenotype and that prior to genetic diagnosis, a large percentage are inappropriately treated with glucose-lowering therapies. We also find low minority representation in our Registry, which may be due to disparities in diagnostic diabetes genetic testing and is an area needing further investigation.

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.

Use of electronic immunization registry in the surveillance of adverse events following immunization.

PubMed

Sato, Ana Paula Sayuri; Ferreira, Vinícius Leati de Rossi; Tauil, Márcia de Cantuária; Rodrigues, Laura Cunha; Barros, Mariana Bernardes; Martineli, Edmar; Costa, Ângela Aparecida; Inenami, Marta; Waldman, Eliseu Alves

2018-02-05

To describe adverse events following vaccination (AEFV) of children under two years old and analyze trend of this events from 2000 to 2013, in the city of Araraquara (SP), Brazil. This is a descriptive study conducted with data of the passive surveillance system of AEFV that is available in the electronic immunization registry (EIR) of the computerized medical record of the municipal health service (Juarez System). The study variables were: age, gender, vaccine, dose, clinical manifestations and hospitalization. We estimated rates using AEFV as numerator and administered doses of vaccines as denominator. The surveillance sensitivity was estimated by applying the method proposed by the Centers for Disease Control and Prevention. We used Prais-Winsten regression with a significance level of 5.0%. The average annual rate of AEFV was 11.3/10,000 administered doses, however without a trend in the study period (p=0.491). Most cases occurred after the first dose (41.7%) and among children under one year of age (72.6%). Vaccines with pertussis component, yellow fever and measles-mumps-rubella were the most reactogenic. We highlighted the rates of hypotonic-hyporesponsive episodes and convulsion that were 4.1/10,000 and 1.5/10,000 doses of vaccines with pertussis component, respectively, most frequently in the first dose; 60,0% of cases presented symptoms in the first 24 hours after vaccination, however, 18.6% showed after 96 hours. The sensitivity of surveillance was 71.9% and 78.9% for hypotonic-hyporesponsive episodes and convulsion, respectively. The EIR-based AEFV surveillance system proved to be useful and highly sensitive to describe the safety profile of vaccines in a medium-sized city. It was also shown that the significant increase of the vaccines included in the basic vaccination schedule in childhood in the last decade did not alter the high safety standard of the National Immunization Program.

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.

EPA Facility Registry Service (FRS): RCRA

EPA Pesticide Factsheets

This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of hazardous waste facilities that link to the Resource Conservation and Recovery Act Information System (RCRAInfo). EPA's comprehensive information system in support of the Resource Conservation and Recovery Act (RCRA) of 1976 and the Hazardous and Solid Waste Amendments (HSWA) of 1984, RCRAInfo tracks many types of information about generators, transporters, treaters, storers, and disposers of hazardous waste. 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 RCRAInfo hazardous waste facilities once the RCRAInfo 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

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.

Implications for registry-based vaccine effectiveness studies from an evaluation of an immunization registry: a cross-sectional study.

PubMed

Mahon, Barbara E; Shea, Kimberly M; Dougherty, Nancy N; Loughlin, Anita M

2008-05-14

Population-based electronic immunization registries create the possibility of using registry data to conduct vaccine effectiveness studies which could have methodological advantages over traditional observational studies. For study validity, the base population would have to be clearly defined and the immunization status of members of the population accurately recorded in the registry. We evaluated a city-wide immunization registry, focusing on its potential as a tool to study pertussis vaccine effectiveness, especially in adolescents. We conducted two evaluations - one in sites that were active registry participants and one in sites that had implemented an electronic medical record with plans for future direct data transfer to the registry - of the ability to match patients' medical records to registry records and the accuracy of immunization records in the registry. For each site, records from current pediatric patients were chosen randomly. Data regarding pertussis-related immunizations, clinic usage, and demographic and identifying information were recorded; for 11-17-year-old subjects, information on MMR, hepatitis B, and varicella immunizations was also collected. Records were then matched, when possible, to registry records. For records with a registry match, immunization data were compared. Among 350 subjects from sites that were current registry users, 307 (87.7%) matched a registry record. Discrepancies in pertussis-related data were common for up-to-date status (22.6%), number of immunizations (34.7%), dates (10.2%), and formulation (34.4%). Among 442 subjects from sites that planned direct electronic transfer of immunization data to the registry, 393 (88.9%) would have matched a registry record; discrepancies occurred frequently in number of immunizations (11.9%), formulation (29.1%), manufacturer (94.4%), and lot number (95.1%.) Inability to match and immunization discrepancies were both more common in subjects who were older at their first visit to

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.

Prospects for research in haemophilia with real-world data-An analysis of German registry and secondary data.

PubMed

Schopohl, D; Bidlingmaier, C; Herzig, D; Klamroth, R; Kurnik, K; Rublee, D; Schramm, W; Schwarzkopf, L; Berger, K

2018-02-28

Open questions in haemophilia, such as effectiveness of innovative therapies, clinical and patient-reported outcomes (PROs), epidemiology and cost, await answers. The aim was to identify data attributes required and investigate the availability, appropriateness and accessibility of real-world data (RWD) from German registries and secondary databases to answer the aforementioned questions. Systematic searches were conducted in BIOSIS, EMBASE and MEDLINE to identify non-commercial secondary healthcare databases and registries of patients with haemophilia (PWH). Inclusion of German patients, type of patients, data elements-stratified by use in epidemiology, safety, outcomes and health economics research-and accessibility were investigated by desk research. Screening of 676 hits, identification of four registries [national PWH (DHR), national/international paediatric (GEPARD, PEDNET), international safety monitoring (EUHASS)] and seven national secondary databases. Access was limited to participants in three registries and to employees in one secondary database. One registry asks for PROs. Limitations of secondary databases originate from the ICD-coding system (missing: severity of haemophilia, presence of inhibitory antibodies), data protection laws and need to monitor reliability. Rigorous observational analysis of German haemophilia RWD shows that there is potential to supplement current knowledge and begin to address selected policy goals. To improve the value of existing RWD, the following efforts are proposed: ethical, legal and methodological discussions on data linkage across different sources, formulation of transparent governance rules for data access, redefinition of the ICD-coding, standardized collection of outcome data and implementation of incentives for treatment centres to improve data collection. © 2018 John Wiley & Sons Ltd.

Clinical decision-making tools for exam selection, reporting and dose tracking.

PubMed

Brink, James A

2014-10-01

Although many efforts have been made to reduce the radiation dose associated with individual medical imaging examinations to "as low as reasonably achievable," efforts to ensure such examinations are performed only when medically indicated and appropriate are equally if not more important. Variations in the use of ionizing radiation for medical imaging are concerning, regardless of whether they occur on a local, regional or national basis. Such variations among practices can be reduced with the use of decision support tools at the time of order entry. These tools help reduce radiation exposure among practices through the appropriate use of medical imaging. Similarly, adoption of best practices among imaging facilities can be promoted through tracking the radiation exposure among imaging patients. Practices can benchmark their aggregate radiation exposures for medical imaging through the use of dose index registries. However several variables must be considered when contemplating individual patient dose tracking. The specific dose measures and the variation among them introduced by variations in body habitus must be understood. Moreover the uncertainties in risk estimation from dose metrics related to age, gender and life expectancy must also be taken into account.

High Mortality without ESCAPE: The Registry of Heart Failure Patients Receiving Pulmonary Artery Catheters without Randomization

PubMed Central

Allen, Larry A.; Rogers, Joseph G.; Warnica, J. Wayne; DiSalvo, Thomas G.; Tasissa, Gudaye; Binanay, Cynthia; O’Connor, Christopher M.; Califf, Robert M.; Leier, Carl V.; Shah, Monica R.; Stevenson, Lynne W.

2008-01-01

Background In ESCAPE, there was no difference in days alive and out of the hospital for patients with decompensated heart failure (HF) randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes as compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial, while measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs. 6 days, p <0.001) and higher 6-month mortality (34% vs. 20%, p < 0.001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials. PMID:18926438

Quality indicators and their regular use in clinical practice: results from a survey among users of two cardiovascular National Registries in Sweden.

PubMed

Algurén, Beatrix; Andersson-Gäre, Boel; Thor, Johan; Andersson, Ann-Christine

2018-05-14

To examine the regular use of quality indicators from Swedish cardiovascular National Quality Registries (NQRs) by clinical staff; particularly differences in use between the two NQRs and between nurses and physicians. Cross-sectional online survey study. Two Swedish cardiovascular NQRs: (a) Swedish Heart Failure Registry and (b) Swedeheart. Clinicians (n =185; 70% nurses, 26% physicians) via the NQRs' email networks. Frequency of NQR use for (a) producing healthcare activity statistics; (b) comparing results between similar departments; (c) sharing results with colleagues; (d) identifying areas for quality improvement (QI); (e) surveilling the impact of QI efforts; (f) monitoring effects of implementation of new treatment methods; (g) doing research and (h) educating and informing healthcare professionals and patients. Median use of NQRs was 10 times a year (25th and 75th percentiles range: 3-23 times/year). Quality indicators from the NQRs were used mainly for producing healthcare activity statistics. Median use of Swedeheart was six times greater than Swedish Heart Failure Registry (SwedeHF; P < 0.000). Physicians used the NQRs more than twice as often as nurses (18 vs. 7.5 times/year; P < 0.000) and perceived NQR work more often as meaningful. Around twice as many Swedeheart users had the role to participate in data analysis and in QI efforts compared to SwedeHF users. Most respondents used quality indicators from the two cardiovascular NQRs infrequently (<3 times/year). The results indicate that linking registration of quality indicators to using them for QI activities increases their routine use and makes them meaningful tools for professionals.

The NeuroAiD Safe Treatment (NeST) Registry: a protocol

PubMed Central

Venketasubramanian, Narayanaswamy; Kumar, Ramesh; Soertidewi, Lyna; Abu Bakar, Azizi; Laik, Carine; Gan, Robert

2015-01-01

Introduction NeuroAiD (MLC601, MLC901), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries. The NeuroAiD Safe Treatment (NeST) Registry aims to assess its use and safety in the real-world setting. Methods and analysis The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional and cognitive state, compliance, concomitant medications, and side effects, if any, among patients on NeuroAiD. Patients who are taking or have been prescribed NeuroAiD may be included. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialisation of NeuroAiD) and during subsequent visits. The primary outcome assessed is safety (ie, non-serious and serious adverse event), while compliance and neurological status over time are secondary outcomes. The in-person follow-up assessments are timed with clinical appointments. Anonymised data will be extracted and collectively analysed. Initial target sample size for the registry is 2000. Analysis will be performed after every 500 participants entered with completed follow-up information. Ethics and dissemination Doctors who prescribe NeuroAiD will be introduced to the registry by local partners. The central coordinator of the registry will discuss the protocol and requirements for implementation with doctors who show interest. Currently, the registry has been approved by the Ethics Committees of Universiti Kebangsaan Malaysia (Malaysia) and National Brain Center (Indonesia). In addition, for other countries, Ethics Committee approval will be obtained in accordance with local requirements. Trial

[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).

Implications for registry-based vaccine effectiveness studies from an evaluation of an immunization registry: A cross-sectional study

PubMed Central

Mahon, Barbara E; Shea, Kimberly M; Dougherty, Nancy N; Loughlin, Anita M

2008-01-01

Background Population-based electronic immunization registries create the possibility of using registry data to conduct vaccine effectiveness studies which could have methodological advantages over traditional observational studies. For study validity, the base population would have to be clearly defined and the immunization status of members of the population accurately recorded in the registry. We evaluated a city-wide immunization registry, focusing on its potential as a tool to study pertussis vaccine effectiveness, especially in adolescents. Methods We conducted two evaluations – one in sites that were active registry participants and one in sites that had implemented an electronic medical record with plans for future direct data transfer to the registry – of the ability to match patients' medical records to registry records and the accuracy of immunization records in the registry. For each site, records from current pediatric patients were chosen randomly. Data regarding pertussis-related immunizations, clinic usage, and demographic and identifying information were recorded; for 11–17-year-old subjects, information on MMR, hepatitis B, and varicella immunizations was also collected. Records were then matched, when possible, to registry records. For records with a registry match, immunization data were compared. Results Among 350 subjects from sites that were current registry users, 307 (87.7%) matched a registry record. Discrepancies in pertussis-related data were common for up-to-date status (22.6%), number of immunizations (34.7%), dates (10.2%), and formulation (34.4%). Among 442 subjects from sites that planned direct electronic transfer of immunization data to the registry, 393 (88.9%) would have matched a registry record; discrepancies occurred frequently in number of immunizations (11.9%), formulation (29.1%), manufacturer (94.4%), and lot number (95.1%.) Inability to match and immunization discrepancies were both more common in subjects who were

Epidemiology of Inherited Epidermolysis Bullosa Based on Incidence and Prevalence Estimates From the National Epidermolysis Bullosa Registry.

PubMed

Fine, Jo-David

2016-11-01

Accurate estimation of the incidence and prevalence of each subtype of epidermolysis bullosa (EB) is essential before clinical trials can be designed and sufficient funding allocated by government agencies and third-party insurers for the care of these individuals. To determine the incidence and prevalence of inherited EB stratified by subtype in the United States during a 16-year period. Prospective cross-sectional and longitudinal study. Data were obtained from 3271 patients consecutively enrolled in the National Epidermolysis Bullosa Registry from January 1, 1986, through December 31, 2002, using a detailed instrument created with the assistance of the National Institutes of Health. Analyses were performed in January 1999 and April 2015. Participants were patients of all ages with EB. Extensive clinical and laboratory data were collected on patients who were subclassified and serially revalidated based on published diagnostic recommendations by an international panel of experts. Pertinent to this report, estimates were made of the incidence and prevalence during 2 time frames. During the first 5 years of funding of the registry, the overall incidence and prevalence of inherited EB were 19.60 and 8.22 per 1 million live births, respectively. When reassessed over the entire 16 years of the study, the prevalence rose to 11.07, whereas the overall incidence remained unchanged at 19.57 cases. Changes were also observed within some disease subsets as increased numbers of patients were identified, recruited, followed up longitudinally, and resubclassified as needed over time. For example, in 2002, the prevalence of EBS overall and localized EBS had increased considerably by 30.4% and 25.5%, respectively, whereas the prevalence of generalized intermediate EBS declined by 76.7% as a result of later subclassification of some of those patients into other subtypes. In contrast, no significant change was noted in the overall prevalence of JEB or generalized severe JEB

Cardiac arrest and clinical characteristics, treatments and outcomes among patients hospitalized with ST-elevation myocardial infarction in contemporary practice: A report from the National Cardiovascular Data Registry.

PubMed

Kontos, Michael C; Scirica, Benjamin M; Chen, Anita Y; Thomas, Laine; Anderson, Monique L; Diercks, Deborah B; Jollis, James G; Roe, Matthew T

2015-04-01

Cardiac arrest (CA) is a major complication of patients with ST-elevation myocardial infarction (STEMI). Its prevalence and prognostic impact in contemporary US practice has not been well assessed. We evaluated STEMI patients included in the National Cardiovascular Data Registry (NCDR) Acute Coronary Treatment Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) from 4/1/11 to 6/30/12. Patient clinical characteristics, treatments, and inhospital outcomes were compared by the presence or absence of CA on first medical contact-either before hospital arrival or upon presentation to the ACTION hospital. Of the 49,279 STEMI patients included, 3,716 (7.5%) had CA. Cardiac arrest patients were more likely to have heart failure (15.5% vs 6.9%) and shock (42.9% vs 4.9%) on presentation and higher median (25th and 75th percentiles) ACTION Registry-GWTG mortality risk scores (42 [32, 54] vs 32 [26, 38]) than non-CA patients (all P < .001). Primary percutaneous coronary intervention was performed in most patients with and without CA (76.7% vs 79.1%). Inhospital mortality was significantly higher in patients with than without CA (28.8% vs 4.0%; P < .001), both in patients who presented with cardiogenic shock (46.9% vs 27.1%; P < .001) and those without shock (15.4% vs 2.9%; P < .001). The ACTION Registry-GWTG inhospital mortality model underestimated mortality risk in CA patients; however, prediction significantly improved after adding CA to the model. Almost 8% of STEMI patients present with CA. More than 25% die during the hospitalization, despite high use of primary percutaneous coronary intervention. Cardiogenic shock and CA frequently coexist. Our results suggest that development of systems of care and treatments for both STEMI and CA is needed to reduce the high mortality in these patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluation of Kidney Stones with Reduced-Radiation Dose CT: Progress from 2011-2012 to 2015-2016-Not There Yet.

PubMed

Weisenthal, Karrin; Karthik, Priyadarshini; Shaw, Melissa; Sengupta, Debapriya; Bhargavan-Chatfield, Mythreyi; Burleson, Judy; Mustafa, Adel; Kalra, Mannudeep; Moore, Christopher

2018-02-01

Purpose To determine if the use of reduced-dose computed tomography (CT) for evaluation of kidney stones increased in 2015-2016 compared with that in 2011-2012, to determine variability in radiation exposure according to facility for this indication, and to establish a current average radiation dose for CT evaluation for kidney stones by querying a national dose registry. Materials and Methods This cross-sectional study was exempt from institutional review board approval. Data were obtained from the American College of Radiology dose registry for CT examinations submitted from July 2015 to June 2016. Study descriptors consistent with single-phase unenhanced CT for evaluation of kidney stones and associated RadLex® Playbook identifiers (RPIDs) were retrospectively identified. Facilities actively submitting data on kidney stone-specific CT examinations were included. Dose metrics including volumetric CT dose index, dose-length product, and size-specific dose estimate, when available, were reported, and a random effects model was run to account for clustering of CT examinations at facilities. A z-ratio was calculated to test for a significant difference between the proportion of reduced-radiation dose CT examinations (defined as those with a dose-length product of 200 mGy · cm or less) performed in 2015-2016 and the proportion performed in 2011-2012. Results Three hundred four study descriptors for kidney stone CT corresponding to data from 328 facilities that submitted 105 334 kidney stone CT examinations were identified. Reduced-dose CT examinations accounted for 8040 of 105 334 (7.6%) CT examinations, a 5.6% increase from the 1010 of 49 903 (2%) examinations in 2011-2012 (P < .001). Mean overall dose-length product was 689 mGy · cm (95% confidence interval: 667, 712), decreased from the mean of 746 mGy · cm observed in 2011-2012. Median facility dose-length product varied up to sevenfold, from less than 200 mGy · cm to greater than 1600 mGy · cm. Conclusion

Characterization of Tako-tsubo Cardiomyopathy in Spain: Results from the RETAKO National Registry.

PubMed

Núñez Gil, Iván J; Andrés, Mireia; Almendro Delia, Manuel; Sionis, Alessandro; Martín, Ana; Bastante, Teresa; Córdoba Soriano, Juan Gabriel; Linares Vicente, José A; González Sucarrats, Silvia; Sánchez-Grande Flecha, Alejandro

2015-06-01

The etiology and epidemiology of tako-tsubo cardiomyopathy remain uncertain. The symptoms of this condition are often similar to those of myocardial infarction and, although it usually has a good prognosis, it is not without complications. Our aim was to characterize this disease in our setting using a dedicated registry (Spanish REgistry for TAKOtsubo cardiomyopathy). The prospective registry included 202 incident patients in 23 hospitals from 2012 to 2013. The patients' clinical characteristics and analytical, echocardiographic, and imaging results were recorded, as were the events during follow-up. Patients were included when the attending physician considered the case proven, and incidence was calculated relative to the catheterizations requested for a presumptive diagnosis of acute coronary syndrome. The patients were predominantly women (90%), with a mean age of 70 years, and many had cardiovascular risk factors, such as hypertension (67%), dyslipidemia (41%), diabetes mellitus (15%), and smoking (15%). The incidence of tako-tsubo cardiomyopathy was 1.2%, and there was no clear weekly or seasonal distribution pattern. Chest pain was the predominant symptom, a triggering factor (emotional, physical, or both) was present in 72%, and most patients consulted within the first 6h after symptom onset. The median duration of hospitalization was 7 days. There were heart failure symptoms in 34.0%, arrhythmia in 26.7%, and 2.4% of patients died. The incidence of tako-tsubo cardiomyopathy is low. This disease primarily affects postmenopausal women, and occurs after a situation of emotional stress in more than half of affected individuals. It is characterized by anginal pain, shows no seasonal distribution, and has a good prognosis, although it is not without morbidity and mortality. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

eXtended MetaData Registry

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

2006-10-25

The purpose of the eXtended MetaData Registry (XMDR) prototype is to demonstrate the feasibility and utility of constructing an extended metadata registry, i.e., one which encompasses richer classification support, facilities for including terminologies, and better support for formal specification of semantics. The prototype registry will also serve as a reference implementation for the revised versions of ISO 11179, Parts 2 and 3 to help guide production implementations.

The New Zealand Major Trauma Registry: the foundation for a data-driven approach in a contemporary trauma system.

PubMed

Isles, Siobhan; Christey, Grant; Civil, Ian; Hicks, Peter

2017-10-06

To describe the development of the New Zealand Major Trauma Registry (NZ-MTR) and the initial experiences of its use. The background to the development of the NZ-MTR was reviewed and the processes undertaken to implement a single-instance of a web-based national registry described. A national minimum dataset was defined and utilised. Key structures to support the Registry such as a data governance group were established. The NZ-MTR was successfully implemented and is the foundation for a new, data-driven model of quality improvement. In its first year of operation over 1,300 patients were entered into the Registry although coverage is not yet universal. Overall incidence is 40.8 major trauma cases/100,000 population. The incidence in the Māori population was 69/100,000 compared with 31/100,000 in the non-Māori population. Case fatality rate was 9%. Three age peaks were observed at 20-24 years, 50-59 years and above 85 years. Road traffic crashes accounted for 50% of all caseload. A significant proportion of major trauma patients (21%) were transferred to one or more hospitals before reaching a definitive care facility. Despite the challenges working across multiple jurisdictions, initiation of a single-instance web-based registry has been achieved. The NZ-MTR enables New Zealand to have a national view of trauma treatment and outcomes for the first time. It will inform quality improvement and injury prevention initiatives and potentially decrease the burden of injury on all New Zealanders.

Design characteristics of the Corrona Japan rheumatoid arthritis registry.

PubMed

Yamanaka, Hisashi; Kishimoto, Mitsumasa; Pappas, Dimitrios A; Greenberg, Jeffrey D; Kremer, Joel M; Tanaka, Yoshiya

2018-01-01

The primary objective is to prospectively study the comparative safety and effectiveness of older and newer classes of nonbiologic DMARDs (Disease-modifying antirheumatic drugs), biologic DMARDs and targeted synthetic therapies approved for rheumatoid arthritis (RA) in a real-world patient population in Japan. Prospective, multicenter, noninterventional, observational study across geographic distribution of both private and public institutions for patients with RA who are newly prescribed one of the following medications: (1) methotrexate; (2) anti-TNF biologic DMARDs; (3) non-TNF biologic DMARDs; and (4) approved JAK inhibitors at the time of enrollment into the registry. Target enrollment is currently 2000 subjects. Baseline and follow-up data on patient demographics, medical history, disease activity, laboratory results, comorbidities, hospitalizations, and targeted safety events are obtained via Physician and Patient Questionnaires. Fifty sites are anticipated to participate with 40 sites ethics committee (EC) approved at the time of submission consisting of 23% clinics, 21% private academic hospitals, 29% private mid-sized to large hospitals, 15% national academic hospitals, and 12% national hospitals. The Corrona Japan RA Registry will provide real-world evidence from both private and public institutions on the comparative effectiveness and safety of recently approved RA therapies in Japan.

Proving Value in Radiology: Experience Developing and Implementing a Shareable Open Source Registry Platform Driven by Radiology Workflow.

PubMed

Gichoya, Judy Wawira; Kohli, Marc D; Haste, Paul; Abigail, Elizabeth Mills; Johnson, Matthew S

2017-10-01

Numerous initiatives are in place to support value based care in radiology including decision support using appropriateness criteria, quality metrics like radiation dose monitoring, and efforts to improve the quality of the radiology report for consumption by referring providers. These initiatives are largely data driven. Organizations can choose to purchase proprietary registry systems, pay for software as a service solution, or deploy/build their own registry systems. Traditionally, registries are created for a single purpose like radiation dosage or specific disease tracking like diabetes registry. This results in a fragmented view of the patient, and increases overhead to maintain such single purpose registry system by requiring an alternative data entry workflow and additional infrastructure to host and maintain multiple registries for different clinical needs. This complexity is magnified in the health care enterprise whereby radiology systems usually are run parallel to other clinical systems due to the different clinical workflow for radiologists. In the new era of value based care where data needs are increasing with demand for a shorter turnaround time to provide data that can be used for information and decision making, there is a critical gap to develop registries that are more adapt to the radiology workflow with minimal overhead on resources for maintenance and setup. We share our experience of developing and implementing an open source registry system for quality improvement and research in our academic institution that is driven by our radiology workflow.

[The Murcia Twin Registry. A resource for research on health-related behaviour].

PubMed

Ordoñana, Juan R; Sánchez Romera, Juan F; Colodro-Conde, Lucía; Carrillo, Eduvigis; González-Javier, Francisca; Madrid-Valero, Juan J; Morosoli-García, José J; Pérez-Riquelme, Francisco; Martínez-Selva, José M

Genetically informative designs and, in particular, twin studies, are the most widely used methodology to analyse the relative contribution of genetic and environmental factors to inter-individual variability. These studies basically compare the degree of phenotypical similarity between monozygotic and dizygotic twin pairs. In addition to the traditional estimate of heritability, this kind of registry enables a wide variety of analyses which are unique due to the characteristics of the sample. The Murcia Twin Registry is population-based and focused on the analysis of health-related behaviour. The observed prevalence of health problems is comparable to that of other regional and national reference samples, which guarantees its representativeness. Overall, the characteristics of the Registry facilitate developing various types of research as well as genetically informative designs, and collaboration with different initiatives and consortia. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

PubMed

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V

2013-01-01

The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate

Update of literature from cystic fibrosis registries 2012-2015. Part 6: Epidemiology, nutrition and complications.

PubMed

Salvatore, Donatello; Buzzetti, Roberto; Mastella, Gianni

2017-03-01

Patient registries provide useful information to afford more knowledge on rare diseases like Cystic Fibrosis (CF). Twenty-two studies originating from national CF registries, focusing on demographics, survival, genetics, nutritional status, and non-pulmonary complications, were published between December 2011 and March 2015. The purpose of this review article is to examine these reports, aiming attention to the clinical characteristics of CF patients included in the registries, current, and estimated future epidemiological data, the role of gender gap, the increasing survival in different countries. Some studies offer insights into pubertal growth and non-pulmonary complications, such as liver disease, nephropathy, and cancer. Pediatr Pulmonol. 2017;52:390-398. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Who are the people in your neighborhood? A descriptive analysis of individuals on public sex offender registries.

PubMed

Ackerman, Alissa R; Harris, Andrew J; Levenson, Jill S; Zgoba, Kristen

2011-01-01

Despite growing focus on registration and notification systems as central elements of national sex offender management practice, there has been remarkably little systematic analysis of the content of these registries and the diversity of individuals contained within them. Specifically, little research attention has been paid to examining the heterogeneity of the population of registered sex offenders - a circumstance that may obscure important distinctions within the population and, in turn, may undermine the ostensible purpose of SORN to prevent sexual victimization. Addressing this significant gap in our current knowledge, this article sets forth a national profile of the registered sex offender (RSO) population, drawn from an analysis of data on 445,127 RSOs obtained from the public registries of 49 states, Washington, DC, Puerto Rico and Guam. In contrast with the homogenized perception about registered sex offenders that permeates much public discourse, the analysis illuminates the wide diversity of registrants across a range of demographic, offense-related, registry status, and risk-oriented variables. Policy and practice implications concerning risk, prevention, and the public safety utility of sex offender registries are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

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.

20 CFR 655.34 - Electronic job registry.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 3 2014-04-01 2014-04-01 false Electronic job registry. 655.34 Section 655... Electronic job registry. (a) Location of and placement in the electronic job registry. Upon acceptance of the... copy of the job order posted by the SWA on the Department's electronic job registry, including any...

20 CFR 655.34 - Electronic job registry.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 3 2013-04-01 2013-04-01 false Electronic job registry. 655.34 Section 655... Electronic job registry. (a) Location of and placement in the electronic job registry. Upon acceptance of the... copy of the job order posted by the SWA on the Department's electronic job registry, including any...

20 CFR 655.144 - Electronic job registry.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 3 2013-04-01 2013-04-01 false Electronic job registry. 655.144 Section 655... Certification § 655.144 Electronic job registry. (a) Location of and placement in the electronic job registry... promptly place for public examination a copy of the job order on an electronic job registry maintained by...

20 CFR 655.144 - Electronic job registry.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Electronic job registry. 655.144 Section 655... Certification § 655.144 Electronic job registry. (a) Location of and placement in the electronic job registry... promptly place for public examination a copy of the job order on an electronic job registry maintained by...

20 CFR 655.144 - Electronic job registry.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 3 2014-04-01 2014-04-01 false Electronic job registry. 655.144 Section 655... Certification § 655.144 Electronic job registry. (a) Location of and placement in the electronic job registry... promptly place for public examination a copy of the job order on an electronic job registry maintained by...

20 CFR 655.144 - Electronic job registry.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Electronic job registry. 655.144 Section 655... Certification § 655.144 Electronic job registry. (a) Location of and placement in the electronic job registry... promptly place for public examination a copy of the job order on an electronic job registry maintained by...

20 CFR 655.144 - Electronic job registry.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Electronic job registry. 655.144 Section 655... Certification § 655.144 Electronic job registry. (a) Location of and placement in the electronic job registry... promptly place for public examination a copy of the job order on an electronic job registry maintained by...

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.

The pot calling the kettle black: the extent and type of errors in a computerized immunization registry and by parent report.

PubMed

MacDonald, Shannon E; Schopflocher, Donald P; Golonka, Richard P

2014-01-04

Accurate classification of children's immunization status is essential for clinical care, administration and evaluation of immunization programs, and vaccine program research. Computerized immunization registries have been proposed as a valuable alternative to provider paper records or parent report, but there is a need to better understand the challenges associated with their use. This study assessed the accuracy of immunization status classification in an immunization registry as compared to parent report and determined the number and type of errors occurring in both sources. This study was a sub-analysis of a larger study which compared the characteristics of children whose immunizations were up to date (UTD) at two years as compared to those not UTD. Children's immunization status was initially determined from a population-based immunization registry, and then compared to parent report of immunization status, as reported in a postal survey. Discrepancies between the two sources were adjudicated by review of immunization providers' hard-copy clinic records. Descriptive analyses included calculating proportions and confidence intervals for errors in classification and reporting of the type and frequency of errors. Among the 461 survey respondents, there were 60 discrepancies in immunization status. The majority of errors were due to parent report (n = 44), but the registry was not without fault (n = 16). Parents tended to erroneously report their child as UTD, whereas the registry was more likely to wrongly classify children as not UTD. Reasons for registry errors included failure to account for varicella disease history, variable number of doses required due to age at series initiation, and doses administered out of the region. These results confirm that parent report is often flawed, but also identify that registries are prone to misclassification of immunization status. Immunization program administrators and researchers need to institute measures to identify

The pot calling the kettle black: the extent and type of errors in a computerized immunization registry and by parent report

PubMed Central

2014-01-01

Background Accurate classification of children’s immunization status is essential for clinical care, administration and evaluation of immunization programs, and vaccine program research. Computerized immunization registries have been proposed as a valuable alternative to provider paper records or parent report, but there is a need to better understand the challenges associated with their use. This study assessed the accuracy of immunization status classification in an immunization registry as compared to parent report and determined the number and type of errors occurring in both sources. Methods This study was a sub-analysis of a larger study which compared the characteristics of children whose immunizations were up to date (UTD) at two years as compared to those not UTD. Children’s immunization status was initially determined from a population-based immunization registry, and then compared to parent report of immunization status, as reported in a postal survey. Discrepancies between the two sources were adjudicated by review of immunization providers’ hard-copy clinic records. Descriptive analyses included calculating proportions and confidence intervals for errors in classification and reporting of the type and frequency of errors. Results Among the 461 survey respondents, there were 60 discrepancies in immunization status. The majority of errors were due to parent report (n = 44), but the registry was not without fault (n = 16). Parents tended to erroneously report their child as UTD, whereas the registry was more likely to wrongly classify children as not UTD. Reasons for registry errors included failure to account for varicella disease history, variable number of doses required due to age at series initiation, and doses administered out of the region. Conclusions These results confirm that parent report is often flawed, but also identify that registries are prone to misclassification of immunization status. Immunization program administrators and

Evidence and practice in spine registries

PubMed Central

van Hooff, Miranda L; Jacobs, Wilco C H; Willems, Paul C; Wouters, Michel W J M; de Kleuver, Marinus; Peul, Wilco C; Ostelo, Raymond W J G; Fritzell, Peter

2015-01-01

Background and purpose We performed a systematic review and a survey in order to (1) evaluate the evidence for the impact of spine registries on the quality of spine care, and with that, on patient-related outcomes, and (2) evaluate the methodology used to organize, analyze, and report the “quality of spine care” from spine registries. Methods To study the impact, the literature on all spinal disorders was searched. To study methodology, the search was restricted to degenerative spinal disorders. The risk of bias in the studies included was assessed with the Newcastle-Ottawa scale. Additionally, a survey among registry representatives was performed to acquire information about the methodology and practice of existing registries. Results 4,273 unique references up to May 2014 were identified, and 1,210 were eligible for screening and assessment. No studies on impact were identified, but 34 studies were identified to study the methodology. Half of these studies (17 of the 34) were judged to have a high risk of bias. The survey identified 25 spine registries, representing 14 countries. The organization of these registries, methods used, analytical approaches, and dissemination of results are presented. Interpretation We found a lack of evidence that registries have had an impact on the quality of spine care, regardless of whether intervention was non-surgical and/or surgical. To improve the quality of evidence published with registry data, we present several recommendations. Application of these recommendations could lead to registries showing trends, monitoring the quality of spine care given, and ultimately improving the value of the care given to patients with degenerative spinal disorders. PMID:25909475

Health, social and economic consequences of hypersomnia: a controlled national study from a national registry evaluating the societal effect on patients and their partners.

PubMed

Jennum, Poul; Ibsen, Rikke; Avlund, Kirsten; Kjellberg, Jakob

2014-04-01

Hypersomnia causes significant socioeconomic burden, but there is insufficient information about the time course and the effect on the partner. The aim of this study was to estimate the factual direct and productivity costs of hypersomnia in a controlled study including all national patients and their partners. Using records from the Danish National Patient Registry (1997-2009), we identified all patients with a diagnosis of hypersomnia and compared these patients and their partners with randomly chosen controls matched for age, gender, geographic area and marital status. Direct and productivity costs, including frequencies of primary and sector contacts and procedures, medication, labour supply and social transfer payments were extracted from the national databases. A total of 2,855 national patients was compared to 11,382 controls. About 70 % of patients and controls were married or cohabiting. Patients with hypersomnia had significantly higher rates of health-related contact, medication use and socioeconomic cost. Furthermore, they had slightly lower employment rates, and those in employment had a lower income level than control subjects. The annual mean excess health-related cost including social transfers was 3,498 for patients with hypersomnia and 3,851 for their partners. The social and health-related consequences could be identified up to 11 years before the first diagnosis among both the patients and their partners and became more pronounced as the disease advanced. The health effects were present in all age groups and in both genders. On the basis of this retrospective controlled study in the Danish population, symptoms and findings of hypersomnia are associated with major socioeconomic consequences for patients, their partners and society.

Incidence of Hospitalized Stroke in the Czech Republic: The National Registry of Hospitalized Patients.

PubMed

Sedova, Petra; Brown, Robert D; Zvolsky, Miroslav; Kadlecova, Pavla; Bryndziar, Tomas; Kubelka, Tomáš; Weiss, Viktor; Volný, Ondřej; Bednarik, Josef; Mikulik, Robert

2017-05-01

Contemporary stroke incidence data are not available in some countries and regions, including in Eastern Europe. Based on previous validation of the accuracy of the National Registry of Hospitalized Patients (NRHOSP), we report the incidence of hospitalized stroke in the Czech Republic (CR) using the NRHOSP. The results of the prior validation study assessing the accuracy of coding of stroke diagnoses in the NRHOSP were applied, and we calculated (1) the overall incidence of hospitalized stroke and (2) the incidence rates of hospitalized stroke for the three main stroke types: cerebral infarction (International Classification of Diseases Tenth Revision, CI I63), subarachnoid hemorrhage (SAH I60), and intracerebral hemorrhage (ICH I61). We calculated the average annual age- and sex-standardized incidence. The overall incidence of hospitalized stroke was 241 out of 100,000 individuals. The incidence of hospitalized stroke for the main stroke types was 8.2 cases in SAH, 29.5 in ICH, and 211 in CI per 100,000 individuals. The standardized annual stroke incidence adjusted to the 2000 World Health Organization population for overall stroke incidence of hospitalized stroke was 131 per 100,000 individuals. Standardized stroke incidence for stroke subtypes was 5.7 cases in SAH, 16.7 in ICH, and 113 in CI per 100,000 individuals. These studies provide an initial assessment of the burden of stroke in this part of the world. The estimates of hospitalized stroke in the CR and Eastern Europe suggest that ICH is about three times more common than SAH, and hemorrhagic stroke makes up about 18% of strokes. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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.

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.

27 CFR 24.115 - Registry number.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Registry number. 24.115... OF THE TREASURY ALCOHOL WINE Establishment and Operations Application § 24.115 Registry number. Upon approval of the application, the appropriate TTB officer will assign a registry number to the bonded winery...

27 CFR 24.115 - Registry number.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Registry number. 24.115... OF THE TREASURY ALCOHOL WINE Establishment and Operations Application § 24.115 Registry number. Upon approval of the application, the appropriate TTB officer will assign a registry number to the bonded winery...

27 CFR 24.115 - Registry number.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Registry number. 24.115... OF THE TREASURY LIQUORS WINE Establishment and Operations Application § 24.115 Registry number. Upon approval of the application, the appropriate TTB officer will assign a registry number to the bonded winery...

How complete are immunization registries? The Philadelphia story.

PubMed

Kolasa, Maureen S; Chilkatowsky, Andrew P; Clarke, Kevin R; Lutz, James P

2006-01-01

To assess accuracy and completeness of Philadelphia, Pa, registry data among children served by providers in areas at risk for underimmunization. Philadelphia's Department of Public Health selected a simple random sample of 45 children age 19-35 months (or all children age 19-35 months if there were <45 children in the practice) from each of 30 private practices receiving government-funded vaccine and located in zip codes where children are at risk for underimmunization. Chart and registry data were compared with determine the proportion of children missing from the registry and assess differences in immunization coverage. Of 620 children reviewed, 567 (92%) were in the registry. Significant differences (P < .05) were observed in immunization coverage for 4 diphtheria-tetanus-acellular pertussis vaccinations, 3 polio vaccinations, 1 measles-mumps-rubella vaccination, and 3 Haemophilus influenzae type b vaccinations between the chart (80% coverage) and registry (62% coverage). Providers submitting electronic medical records or directly transferring electronic data to the registry had significantly more children in the registry and higher registry-reported immunization coverage than those whose data were entered from billing records or log forms. All practice types experienced difficulties in transferring complete data to the registry. Although 92% of study children were in the registry, immunization coverage was significantly lower when registry data were compared with chart data. Because electronic medical records and direct electronic data transfer resulted in more complete registry data, these methods should be encouraged in linking providers with immunization registries.

National registry of patients with systemic lupus erythematosus of the Spanish Society of Rheumatology: objectives and methodology.

PubMed

Rúa-Figueroa, Iñigo; López-Longo, Francisco Javier; Calvo-Alén, Jaime; Galindo-Izquierdo, María; Loza, Estíbaliz; García de Yebenes, M Jesús; Pego-Reigosa, José M

2014-01-01

To describe the objectives, design and methods of the Spanish Society of Rheumatology systemic lupus erythematosus (SLE) registry (RELESSER). Multicenter, hospital-based registry, with retrospective collection of data from a large representative sample of adult patients with SLE (1997 ACR criteria) attending Spanish rheumatology services. The registry includes demographic data, frequent and infrequent (<1%) clinical manifestations, information about activity, damage, severity, comorbidity, treatments and mortality, collecting 359 variables per patient, with highly standardized definitions. We performed a preliminary descriptive analysis of the data. Forty-five centers were involved and 4,024 SLE patients (91% with ≥ 4 ACR criteria) have been included; 90% are women and 93% caucasians, with a median age at diagnosis of 33 years, median disease duration: 120 months, median follow-up duration: 104 months; 3,222 (81%) of the patients are in active follow-up and 591 (14%) were lost to follow-up. The median values of the SELENA-SLEDAI score, SLICC/ACR damage index and Katz severity index have been 2, 1 and 2, respectively. A total of 211 patients (6%) died. RELESSER represents the largest European SLE registry built to date, providing comprehensive and reliable information on SLE manifestations, disease status, comorbid conditions and treatments in daily clinical practice. RELESSER is constituted as a tool of great potential for multicenter clinical research in SLE. Copyright © 2013 Elsevier España, S.L. All rights reserved.

A Prototype Publishing Registry for the Virtual Observatory

NASA Astrophysics Data System (ADS)

Williamson, R.; Plante, R.

2004-07-01

In the Virtual Observatory (VO), a registry helps users locate resources, such as data and services, in a distributed environment. A general framework for VO registries is now under development within the International Virtual Observatory Alliance (IVOA) Registry Working Group. We present a prototype of one component of this framework: the publishing registry. The publishing registry allows data providers to expose metadata descriptions of their resources to the VO environment. Searchable registries can harvest the metadata from many publishing registries and make them searchable by users. We have developed a prototype publishing registry that data providers can install at their sites to publish their resources. The descriptions are exposed using the Open Archive Initiative (OAI) Protocol for Metadata Harvesting. Automating the input of metadata into registries is critical when a provider wishes to describe many resources. We illustrate various strategies for such automation, both currently in use and planned for the future. We also describe how future versions of the registry can adapt automatically to evolving metadata schemas for describing resources.

Estimated ultraviolet radiation doses in wetlands in six national parks

USGS Publications Warehouse

Diamond, S.A.; Trenham, P.C.; Adams, Michael J.; Hossack, B.R.; Knapp, R.A.; Stark, L.; Bradford, D.; Corn, P.S.; Czarnowski, K.; Brooks, P.D.; Fagre, D.B.; Breen, B.; Dentenbeck, N.E.; Tonnessen, K.

2005-01-01

Ultraviolet-B radiation (UV-B, 280–320-nm wavelengths) doses were estimated for 1024 wetlands in six national parks: Acadia (Acadia), Glacier (Glacier), Great Smoky Mountains (Smoky), Olympic (Olympic), Rocky Mountain (Rocky), and Sequoia/Kings Canyon (Sequoia). Estimates were made using ground-based UV-B data (Brewer spectrophotometers), solar radiation models, GIS tools, field characterization of vegetative features, and quantification of DOC concentration and spectral absorbance. UV-B dose estimates were made for the summer solstice, at a depth of 1 cm in each wetland. The mean dose across all wetlands and parks was 19.3 W-h m−2 (range of 3.4–32.1 W-h m−2). The mean dose was lowest in Acadia (13.7 W-h m−2) and highest in Rocky (24.4 W-h m−2). Doses were significantly different among all parks. These wetland doses correspond to UV-B flux of 125.0 μW cm−2 (range 21.4–194.7 μW cm−2) based on a day length, averaged among all parks, of 15.5 h. Dissolved organic carbon (DOC), a key determinant of water-column UV-B flux, ranged from 0.6 (analytical detection limit) to 36.7 mg C L−1 over all wetlands and parks, and reduced potential maximal UV-B doses at 1-cm depth by 1%–87 %. DOC concentration, as well as its effect on dose, was lowest in Sequoia and highest in Acadia (DOC was equivalent in Acadia, Glacier, and Rocky). Landscape reduction of potential maximal UV-B doses ranged from zero to 77% and was lowest in Sequoia. These regional differences in UV-B wetland dose illustrate the importance of considering all aspects of exposure in evaluating the potential impact of UV-B on aquatic organisms.

The FOP Connection Registry: Design of an international patient-sponsored registry for Fibrodysplasia Ossificans Progressiva.

PubMed

Mantick, Neal; Bachman, Eric; Baujat, Genevieve; Brown, Matt; Collins, Oliver; De Cunto, Carmen; Delai, Patricia; Eekhoff, Marelise; Zum Felde, Roger; Grogan, Donna Roy; Haga, Nobuhiko; Hsiao, Edward; Kantanie, Sharon; Kaplan, Frederick; Keen, Richard; Milosevic, Jelena; Morhart, Rolf; Pignolo, Robert; Qian, Xiaobing; di Rocco, Maja; Scott, Christiaan; Sherman, Adam; Wallace, Marin; Williams, Nicky; Zhang, Keqin; Bogard, Betsy

2018-04-01

The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry is an international, voluntary, observational study that directly captures demographic and disease information initially from patients with FOP (the patient portal) and in the near future from treating physicians (the physician portal) via a secure web-based tool. It was launched by the International FOP Association (IFOPA) with a guiding vision to develop and manage one unified, global, and coordinated Registry allowing the assembly of the most comprehensive data on FOP. This will ultimately facilitate greater access and sharing of patient data and enable better and faster development of therapies and tracking their long-term treatment effectiveness and safety. This report outlines the FOP Connection Registry's design and procedures for data collection and reporting, as well as the long-term sustainability of Registry. Patient-reported, aggregate data are summarized for the first 196 enrolled patients, representing participation from 42 countries and approximately 25% of the world's known FOP population. Fifty-seven percent of the current Registry participants are female with a mean age of 23.8years (median=21years, range=1, 76years). Among the Registry participants who provided their FOP type, 51% reported FOP Classic (R206H), 41% reported FOP Type Unknown, and 8% reported FOP Variant. Patients reported 5.4years (median=3.0years, range=0, 45.8years) as the mean age at which they noticed their first FOP symptoms and a mean age at final FOP diagnosis of 7.5years (median=5.0years, range=0.1, 48.4years). Information on the patients' diagnostic journeys in arriving at a correct diagnosis of FOP is also presented. These early patient-reported data suggest that the IFOPA's vision of one, unified, global, and coordinated approach to the FOP Connection Registry is well underway to being realized. In addition, the positive response from the FOP patient community to the initial launch of the Registry

Meeting the Privacy Requirements for the Development of a Multi-Centre Patient Registry in Canada: The Rick Hansen Spinal Cord Injury Registry

PubMed Central

Noonan, Vanessa K.; Thorogood, Nancy P.; Joshi, Phalgun B.; Fehlings, Michael G.; Craven, B. Catharine; Linassi, Gary; Fourney, Daryl R.; Kwon, Brian K.; Bailey, Christopher S.; Tsai, Eve C.; Drew, Brian M.; Ahn, Henry; Tsui, Deborah; Dvorak, Marcel F.

2013-01-01

Privacy legislation addresses concerns regarding the privacy of personal information; however, its interpretation by research ethics boards has resulted in significant challenges to the collection, management, use and disclosure of personal health information for multi-centre research studies. This paper describes the strategy used to develop the national Rick Hansen Spinal Cord Injury Registry (RHSCIR) in accordance with privacy statutes and benchmarked against best practices. An analysis of the regional and national privacy legislation was conducted to determine the requirements for each of the 31 local RHSCIR sites and the national RHSCIR office. A national privacy and security framework was created for RHSCIR that includes a governance structure, standard operating procedures, training processes, physical and technical security and privacy impact assessments. The framework meets a high-water mark in ensuring privacy and security of personal health information nationally and may assist in the development of other national or international research initiatives. PMID:23968640

Meeting the privacy requirements for the development of a multi-centre patient registry in Canada: the Rick Hansen Spinal Cord Injury Registry.

PubMed

Noonan, Vanessa K; Thorogood, Nancy P; Joshi, Phalgun B; Fehlings, Michael G; Craven, B Catharine; Linassi, Gary; Fourney, Daryl R; Kwon, Brian K; Bailey, Christopher S; Tsai, Eve C; Drew, Brian M; Ahn, Henry; Tsui, Deborah; Dvorak, Marcel F

2013-05-01

Privacy legislation addresses concerns regarding the privacy of personal information; however, its interpretation by research ethics boards has resulted in significant challenges to the collection, management, use and disclosure of personal health information for multi-centre research studies. This paper describes the strategy used to develop the national Rick Hansen Spinal Cord Injury Registry (RHSCIR) in accordance with privacy statutes and benchmarked against best practices. An analysis of the regional and national privacy legislation was conducted to determine the requirements for each of the 31 local RHSCIR sites and the national RHSCIR office. A national privacy and security framework was created for RHSCIR that includes a governance structure, standard operating procedures, training processes, physical and technical security and privacy impact assessments. The framework meets a high-water mark in ensuring privacy and security of personal health information nationally and may assist in the development of other national or international research initiatives. Copyright © 2013 Longwoods Publishing.

Client interfaces to the Virtual Observatory Registry

NASA Astrophysics Data System (ADS)

Demleitner, M.; Harrison, P.; Taylor, M.; Normand, J.

2015-04-01

The Virtual Observatory Registry is a distributed directory of information systems and other resources relevant to astronomy. To make it useful, facilities to query that directory must be provided to humans and machines alike. This article reviews the development and status of such facilities, also considering the lessons learnt from about a decade of experience with Registry interfaces. After a brief outline of the history of the standards development, it describes the use of Registry interfaces in some popular clients as well as dedicated UIs for interrogating the Registry. It continues with a thorough discussion of the design of the two most recent Registry interface standards, RegTAP on the one hand and a full-text-based interface on the other hand. The article finally lays out some of the less obvious conventions that emerged in the interaction between providers of registry records and Registry users as well as remaining challenges and current developments.

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.

Pattern of suicides in 2009: data from the National Suicide Registry Malaysia.

PubMed

Ali, Nor Hayati; Zainun, Khairul Anuar; Bahar, Norharlina; Haniff, Jamaiyah; Hamid, Abdul Muneer; Bujang, Mohamad Adam Hj; Mahmood, Mohd Shah

2014-06-01

The National Suicide Registry Malaysia (NSRM) is a nationwide system that captures data on completed suicides in Malaysia from all forensic departments under the purview of the Ministry of Health Malaysia. This paper examines all suicidal deaths reported to the NSRM from 1 January 2009 to 31 December 2009. The relevant variables were recorded in the paper-based Case Report Form (CRF) and then entered into the online reporting system for analysis. The overall suicide rate for 2009 was 1.18 per 100,000 population (n = 328). The age range was 14-94 years, with a median of 37 (IQR 24) years. There were more men than women, the gender ratio being 2.9:1 (males : females), and the majority (89% or 293/328) were Malaysian citizens. Ethnicity-wise, Indians had the highest suicide rate of 3.67 per 100,000. The Malays and Bumiputera of Sabah and Sarawak had lower rates of 0.32 to 0.37 per 100,000. Mental illness was reported in 22% (72/328) of the cases and physical illnesses in 20.4% (67/328). Previous suicide attempts were reported in 15.5% (51/328) of cases. History of substance abuse was present in 28.7% (83/328). Life events were positive in 41.2% (135/328) of cases. Malaysia is able to generate statistics on suicide by enhancing the collaboration between forensic, psychiatry and clinical research agencies. These trends should be monitored to gain a better understanding of suicide trends. Copyright © 2012 Wiley Publishing Asia Pty Ltd.

Effect of increasing radiation dose on pathologic complete response in rectal cancer patients treated with neoadjuvant chemoradiation therapy.

PubMed

Hall, Matthew D; Schultheiss, Timothy E; Smith, David D; Fakih, Marwan G; Wong, Jeffrey Y C; Chen, Yi-Jen

2016-12-01

Neoadjuvant chemoradiation therapy (CRT) increases pathological complete response (pCR) rates compared to radiotherapy alone in patients with stage II-III rectal cancer. Limited evidence addresses whether radiotherapy dose escalation further improves pCR rates. Our purpose is to measure the effects of radiotherapy dose and other factors on post-therapy pathologic tumor (ypT) and nodal stage in rectal cancer patients treated with neoadjuvant CRT followed by mesorectal excision. A non-randomized comparative effectiveness analysis was performed of rectal cancer patients treated in 2000-2013 from the National Oncology Data Alliance™ (NODA), a pooled database of cancer registries from >150 US hospitals. The NODA contains the same data submitted to state cancer registries and SEER combined with validated radiotherapy and chemotherapy records. Eligible patients were treated with neoadjuvant CRT followed by proctectomy and had complete data on treatment start dates, radiotherapy dose, clinical tumor (cT) and ypT stage, and number of positive nodes at surgery (n = 3298 patients). Multivariable logistic regression was used to assess the predictive value of independent variables on achieving a pCR. On multivariable regression, radiotherapy dose, cT stage, and time interval between CRT and surgery were significant predictors of achieving a pCR. After adjusting for the effect of other variates, patients treated with higher radiotherapy doses were also more likely to have negative nodes at surgery and be downstaged from cT3-T4 and/or node positive disease to ypT0-T2N0 after neoadjuvant CRT. Our study suggests that increasing dose significantly improved pCR rates and downstaging in rectal cancer patients treated with neoadjuvant CRT followed by surgery.

Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

PubMed Central

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V.

2013-01-01

Background The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Purpose Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. Methods and Results We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. Conclusion This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework

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.

Childhood cancer registration in New Zealand: A registry collaboration to assess and improve data quality.

PubMed

Ballantine, Kirsten R; Hanna, Susan; Macfarlane, Scott; Bradbeer, Peter; Teague, Lochie; Hunter, Sarah; Cross, Siobhan; Skeen, Jane

2018-06-11

To evaluate the completeness and accuracy of child cancer registration in New Zealand. Registrations for children aged 0-14 diagnosed between 1/1/2010 and 31/12/2014 were obtained from the New Zealand Cancer Registry (NZCR) and the New Zealand Children's Cancer Registry (NZCCR). Six key data fields were matched using National Health Index numbers in order to identify and resolve registration discrepancies. Capture-recapture methods were used to assess the completeness of cancer registration. 794 unique cases were reported; 718 from the NZCR, 721 from the NZCCR and 643 from both registries. 27 invalid cancer registrations were identified, including 19 residents of the Pacific Islands who had travelled to New Zealand for treatment. The NZCCR provided 55 non-malignant central nervous system tumour and 16 Langerhans cell histiocytosis cases which were not registered by the NZCR. The NZCR alerted the NZCCR to 18 cases missed due to human error and 23 cases that had not been referred to the specialist paediatric oncology centres. 762 cases were verified as true incident cases, an incidence rate of 166.8 per million. Registration accuracy for six key data fields was 98.6%. According to their respective inclusion criteria case completeness was 99.3% for the NZCR and 94.4% for the NZCCR. For childhood malignancies covered by both registries, capture-recapture methods estimated case ascertainment at greater than 99.9%. With two national registries covering childhood cancers, New Zealand is uniquely positioned to undertake regular cooperative activities to ensure high quality data is available for research and patient care. Copyright © 2018 Elsevier Ltd. All rights reserved.

Low dose intranasal oxytocin delivered with Breath Powered device dampens amygdala response to emotional stimuli: A peripheral effect-controlled within-subjects randomized dose-response fMRI trial.

PubMed

Quintana, Daniel S; Westlye, Lars T; Alnæs, Dag; Rustan, Øyvind G; Kaufmann, Tobias; Smerud, Knut T; Mahmoud, Ramy A; Djupesland, Per G; Andreassen, Ole A

2016-07-01

It is unclear if and how exogenous oxytocin (OT) reaches the brain to improve social behavior and cognition and what is the optimal dose for OT response. To better understand the delivery routes of intranasal OT administration to the brain and the dose-response, we compared amygdala response to facial stimuli by means of functional magnetic resonance imaging (fMRI) in four treatment conditions, including two different doses of intranasal OT using a novel Breath Powered device, intravenous (IV) OT, which provided similar concentrations of blood plasma OT, and placebo. We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults administering a single-dose of these four treatments. We observed a treatment effect on right amygdala activation during the processing of angry and happy face stimuli, with pairwise comparisons revealing reduced activation after the 8IU low dose intranasal treatment compared to placebo. These data suggest the dampening of amygdala activity in response to emotional stimuli occurs via direct intranasal delivery pathways rather than across the blood-brain barrier via systemically circulating OT. This trial is registered at the U.S. National Institutes of Health clinical trial registry (www.clinicaltrials.gov; NCT01983514) and as EudraCT no. 2013-001608-12. Copyright © 2016 Elsevier Ltd. All rights reserved.

HLA Match Likelihoods for Hematopoietic Stem-Cell Grafts in the U.S. Registry

PubMed Central

Gragert, Loren; Eapen, Mary; Williams, Eric; Freeman, John; Spellman, Stephen; Baitty, Robert; Hartzman, Robert; Rizzo, J. Douglas; Horowitz, Mary; Confer, Dennis; Maiers, Martin

2018-01-01

Background Hematopoietic stem-cell transplantation (HSCT) is a potentially lifesaving therapy for several blood cancers and other diseases. For patients without a suitable related HLA-matched donor, unrelated-donor registries of adult volunteers and banked umbilical cord–blood units, such as the Be the Match Registry operated by the National Marrow Donor Program (NMDP), provide potential sources of donors. Our goal in the present study was to measure the likelihood of finding a suitable donor in the U.S. registry. Methods Using human HLA data from the NMDP donor and cord-blood-unit registry, we built population-based genetic models for 21 U.S. racial and ethnic groups to predict the likelihood of identifying a suitable donor (either an adult donor or a cord-blood unit) for patients in each group. The models incorporated the degree of HLA matching, adult-donor availability (i.e., ability to donate), and cord-blood-unit cell dose. Results Our models indicated that most candidates for HSCT will have a suitable (HLA-matched or minimally mismatched) adult donor. However, many patients will not have an optimal adult donor — that is, a donor who is matched at high resolution at HLA-A, HLA-B, HLA-C, and HLA-DRB1. The likelihood of finding an optimal donor varies among racial and ethnic groups, with the highest probability among whites of European descent, at 75%, and the lowest probability among blacks of South or Central American descent, at 16%. Likelihoods for other groups are intermediate. Few patients will have an optimal cord-blood unit — that is, one matched at the antigen level at HLA-A and HLA-B and matched at high resolution at HLA-DRB1. However, cord-blood units mismatched at one or two HLA loci are available for almost all patients younger than 20 years of age and for more than 80% of patients 20 years of age or older, regardless of racial and ethnic background. Conclusions Most patients likely to benefit from HSCT will have a donor. Public investment in

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.

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.

Characteristics of clinical trial websites: information distribution between ClinicalTrials.gov and 13 primary registries in the WHO registry network.

PubMed

Ogino, Daisuke; Takahashi, Kunihiko; Sato, Hajime

2014-11-05

It is well known that information about clinical trials is not easily accessible by the public. In Japan, clinical trial information can be accessed by the general public through online registries; however, many people find these registries difficult to use. To improve current clinical trial registries, we propose that combining them with clinical information phrased in lay terms would be beneficial to other interested professionals such as journalists and clinicians, as well as the general public. Therefore, this study aimed to examine the current pattern of distribution of clinical trial information from the primary World Health Organization (WHO) registries. Based on the results of this assessment, we then aimed to build and evaluate a prototype of the Japan Primary Registries Network (JPRN) portal that would be easily accessible to patients and the public, while still remaining useful for professionals. We assessed a total of 14 primary clinical trial registries listed on the WHO International Clinical Trials Registry Platform between January and February 2013. Website content was accessed and checked against a series of items that looked at usability, communication, design and accessibility of the sites. We excluded registries that were not active or were not on the approved WHO registry list at the time of our assessment. We also examined only the English versions of the websites as native-language registries may offer more functionality or different content than the English version of the same website. All registries examined had a function allowing users to search the registry data and that displayed the related information from the search, including the clinical trial registration data. However, few websites were found to be user-friendly, and there was little integration with social media. We confirmed that there are few websites providing useful clinical trial information to patients and their families. However, information gleaned from some of the more

Use of electronic immunization registry in the surveillance of adverse events following immunization

PubMed Central

Sato, Ana Paula Sayuri; Ferreira, Vinícius Leati de Rossi; Tauil, Márcia de Cantuária; Rodrigues, Laura Cunha; Barros, Mariana Bernardes; Martineli, Edmar; Costa, Ângela Aparecida; Inenami, Marta; Waldman, Eliseu Alves

2018-01-01

ABSTRACT OBJECTIVE To describe adverse events following vaccination (AEFV) of children under two years old and analyze trend of this events from 2000 to 2013, in the city of Araraquara (SP), Brazil. METHODS This is a descriptive study conducted with data of the passive surveillance system of AEFV that is available in the electronic immunization registry (EIR) of the computerized medical record of the municipal health service (Juarez System). The study variables were: age, gender, vaccine, dose, clinical manifestations and hospitalization. We estimated rates using AEFV as numerator and administered doses of vaccines as denominator. The surveillance sensitivity was estimated by applying the method proposed by the Centers for Disease Control and Prevention. We used Prais-Winsten regression with a significance level of 5.0%. RESULTS The average annual rate of AEFV was 11.3/10,000 administered doses, however without a trend in the study period (p=0.491). Most cases occurred after the first dose (41.7%) and among children under one year of age (72.6%). Vaccines with pertussis component, yellow fever and measles-mumps-rubella were the most reactogenic. We highlighted the rates of hypotonic-hyporesponsive episodes and convulsion that were 4.1/10,000 and 1.5/10,000 doses of vaccines with pertussis component, respectively, most frequently in the first dose; 60,0% of cases presented symptoms in the first 24 hours after vaccination, however, 18.6% showed after 96 hours. The sensitivity of surveillance was 71.9% and 78.9% for hypotonic-hyporesponsive episodes and convulsion, respectively. CONCLUSIONS The EIR-based AEFV surveillance system proved to be useful and highly sensitive to describe the safety profile of vaccines in a medium-sized city. It was also shown that the significant increase of the vaccines included in the basic vaccination schedule in childhood in the last decade did not alter the high safety standard of the National Immunization Program. PMID:29412373

A Dutch Nationwide Bariatric Quality Registry: DATO.

PubMed

Poelemeijer, Youri Q M; Liem, Ronald S L; Nienhuijs, Simon W

2017-12-22

In the Netherlands, the number of bariatric procedures increased exponentially in the 90s. To ensure and improve the quality of bariatric surgery, the nationwide Dutch Audit for Treatment of Obesity (DATO) was established in 2014. The audit was coordinated by the Dutch Institute for Clinical Auditing (DICA). This article provides a review of the aforementioned process in establishing a nationwide registry in the Netherlands. In collaboration with the DATO's scientific committee and other stakeholders, an annual list of several external quality indicators was formulated. This list consists of volume, process, and outcome indicators. In addition to the annual external indicators, the database permits individual hospitals to analyze their own data. The dashboard provides several standardized reports and detailed quality indicators, which are updated on a weekly base. Since the start, all 18 Dutch bariatric centers participated in the nationwide audit. A total of 21,941 cases were registered between 2015 and 2016. By 2016, the required variables were registered in 94.3% of all cases. A severe complicated course was seen in 2.87%, and mortality in 0.05% in 2016. The first-year follow-up shows a > 20% TWL in 86.1% of the registered cases. The DATO has become rapidly a mature registry. The well-organized structure of the national audit institution DICA and governmental funding were essential. However, most important were the bariatric teams themselves. The authors believe reporting the results from the registry has already contributed to more knowledge and acceptance by other health care providers.

Burden of Rotavirus Disease in Norway: Using National Registries for Public Health Research.

PubMed

Bruun, Tone; Salamanca, Beatriz Valcarcel; Bekkevold, Terese; Vainio, Kirsti; Gibory, Moustafa; Haugstad, Kirsti Egge; Rojahn, Astrid; Jakobsen, Kirsti; Størvold, Gunnar; Lunde, Anette; Størdal, Ketil; Kanestrøm, Anita; Eidem, Magnhild Owesen; Døllner, Henrik; Skanke, Lars Høsøien; Nordbø, Svein Arne; Sivertsen, Heidi Christin; Gilje, Ann Marit; Haarr, Elisebet; Flem, Elmira

2016-04-01

Norway introduced routine rotavirus immunization for all children born on or after September 1, 2014. We estimated the healthcare burden of all-cause gastroenteritis and rotavirus disease in children <5 years old to establish the prevaccine baseline and support the ongoing immunization program. We examined national registry data on gastroenteritis-associated primary care consultations and hospitalizations for 2009-2013 and data on all deaths in children <5 years old reported during 2000-2013. We also established rotavirus hospital surveillance from February 2014 through January 2015. Before vaccine introduction, 114.5 cases per 1000 children <5 years old were treated in primary care and 11.8 children per 1000 were hospitalized with gastroenteritis annually. During hospital surveillance, rotavirus was detected in 65% (95% confidence interval: 60-70) of inpatient gastroenteritis cases. We estimated that 4.0 inpatient and 2.3 outpatient cases per 1000 children were seen in hospital with rotavirus disease annually, suggesting that 1 in 32 children was hospitalized by age 5. Additional 30.6 rotavirus cases per 1000 children consulted primary care annually or 1 in every 7 children by the age of 5 years. Rotavirus-associated mortality was estimated at 0.17 deaths per 100,000 children <5 years old, corresponding to 1 death every second year. Rotavirus remains the primary cause of severe gastroenteritis in children in Norway. The unique population-based registers, in combination with an established rotavirus surveillance platform, provide a well-suited setting to evaluate the impact of rotavirus vaccination.

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

PubMed

Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

2017-06-01

The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

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.

Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women).

PubMed

Hess, Connie N; Rao, Sunil V; Kong, David F; Aberle, Laura H; Anstrom, Kevin J; Gibson, C Michael; Gilchrist, Ian C; Jacobs, Alice K; Jolly, Sanjit S; Mehran, Roxana; Messenger, John C; Newby, L Kristin; Waksman, Ron; Krucoff, Mitchell W

2013-09-01

Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry CathPCI Registry through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization. © 2013.

A brief review of vaccination coverage in immunization registries.

PubMed

Goldstein, Neal D; Maiese, Brett A

2011-01-01

Immunization registries are effective electronic tools for assessing vaccination coverage, but are only as good as the information reported to them. This review summarizes studies through August 2010 on vaccination coverage in registries and identifies key characteristics of successful registries. Based on the current state of registries, paper-based charts combined with electronic registry reporting provide the most cohesive picture of coverage. To ultimately supplant paper charts, registries must exhibit increased coverage and participation.

Treatment outcomes for Hodgkin lymphoma: First report from the Brazilian Prospective Registry.

PubMed

Biasoli, Irene; Castro, Nelson; Delamain, Marcia; Silveira, Talita; Farley, James; Simões, Belinda Pinto; Solza, Cristiana; Praxedes, Monica; Baiocchi, Otávio; Gaiolla, Rafael; Franceschi, Fernanda; Sola, Caroline Bonamin; Boquimpani, Carla; Clementino, Nelma; Perini, Guilherme; Pagnano, Kátia; Steffenello, Giovanna; Tabacof, Jacques; de Freitas Colli, Gilberto; Soares, Andrea; de Souza, Carmino; Chiattone, Carlos Sérgio; Milito, Cristiane; Morais, José Carlos; Spector, Nelson

2018-02-01

Data about Hodgkin lymphoma (HL) in developing countries are scarce and suggest the existence of substantial disparities in healthcare and outcomes in large areas of the world. In 2009, a prospective registry of HL was implemented in Brazil. Web-based data were contributed by 20 institutions across the country participating in the Brazilian Prospective Hodgkin's Lymphoma Registry. The aim of this study was to present the clinical features and outcomes of newly diagnosed patients with HL aged 13 to 90 years. Multivariate Cox regression models were used to estimate progression-free (PFS) and overall survival (OS) by clinical factors. A total of 674 patients with classical HL were analysed, with a median follow-up of 37 months. Median age was 30 years (13-90). The median time from the onset of symptoms to diagnosis was 6 months (0-60). Only 6% of patients had early favourable disease, while 65% had advanced disease. Stage IVB was present in 26% and a high-risk International Prognostic Score in 38%. Doxorubicin, bleomycin, vinblastine, and dacarbazine was used in 93%. The median dose of radiotherapy was 36 Gy for localized disease and 32 Gy for advanced disease. The 3 year PFS in early favourable, early unfavourable, and advanced disease were 95%, 88%, and 66%, respectively. High-risk International Prognostic Score, advanced disease, and age greater than or equal to 60 were independently associated with poorer PFS and OS; performance status greater than or equal to 2 was also associated with a poorer OS. Poor-risk patients predominated. Radiation doses for localized disease appear higher than current recommendations. Outcomes appear inferior in developing countries than in developed countries. Delayed diagnosis is probably a major factor underlying these findings. Scattered reports from developing nations suggest that many aspects of standard care in developed countries remain unmet needs for populations living in developing countries. The present report

Coding completeness and quality of relative survival-related variables in the National Program of Cancer Registries Cancer Surveillance System, 1995-2008.

PubMed

Wilson, Reda J; O'Neil, M E; Ntekop, E; Zhang, Kevin; Ren, Y

2014-01-01

Calculating accurate estimates of cancer survival is important for various analyses of cancer patient care and prognosis. Current US survival rates are estimated based on data from the National Cancer Institute's (NCI's) Surveillance, Epidemiology, and End RESULTS (SEER) program, covering approximately 28 percent of the US population. The National Program of Cancer Registries (NPCR) covers about 96 percent of the US population. Using a population-based database with greater US population coverage to calculate survival rates at the national, state, and regional levels can further enhance the effective monitoring of cancer patient care and prognosis in the United States. The first step is to establish the coding completeness and coding quality of the NPCR data needed for calculating survival rates and conducting related validation analyses. Using data from the NPCR-Cancer Surveillance System (CSS) from 1995 through 2008, we assessed coding completeness and quality on 26 data elements that are needed to calculate cancer relative survival estimates and conduct related analyses. Data elements evaluated consisted of demographic, follow-up, prognostic, and cancer identification variables. Analyses were performed showing trends of these variables by diagnostic year, state of residence at diagnosis, and cancer site. Mean overall percent coding completeness by each NPCR central cancer registry averaged across all data elements and diagnosis years ranged from 92.3 percent to 100 percent. RESULTS showing the mean percent coding completeness for the relative survival-related variables in NPCR data are presented. All data elements but 1 have a mean coding completeness greater than 90 percent as was the mean completeness by data item group type. Statistically significant differences in coding completeness were found in the ICD revision number, cause of death, vital status, and date of last contact variables when comparing diagnosis years. The majority of data items had a coding

14 CFR 47.19 - Registry.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Registry. 47.19 Section 47.19 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA...

14 CFR 47.19 - Registry.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Registry. 47.19 Section 47.19 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA...

14 CFR 47.19 - Registry.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Registry. 47.19 Section 47.19 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA...

14 CFR 47.19 - Registry.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Registry. 47.19 Section 47.19 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA...

37 CFR 201.25 - Visual Arts Registry.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Visual Arts Registry. 201.25... OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.25 Visual Arts Registry. (a) General. This section prescribes the procedures relating to the submission of Visual Arts Registry Statements by visual artists and...

37 CFR 201.25 - Visual Arts Registry.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Visual Arts Registry. 201.25... AND PROCEDURES GENERAL PROVISIONS § 201.25 Visual Arts Registry. (a) General. This section prescribes the procedures relating to the submission of Visual Arts Registry Statements by visual artists and...

37 CFR 201.25 - Visual Arts Registry.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Visual Arts Registry. 201.25... AND PROCEDURES GENERAL PROVISIONS § 201.25 Visual Arts Registry. (a) General. This section prescribes the procedures relating to the submission of Visual Arts Registry Statements by visual artists and...

37 CFR 201.25 - Visual Arts Registry.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Visual Arts Registry. 201.25... AND PROCEDURES GENERAL PROVISIONS § 201.25 Visual Arts Registry. (a) General. This section prescribes the procedures relating to the submission of Visual Arts Registry Statements by visual artists and...

37 CFR 201.25 - Visual Arts Registry.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Visual Arts Registry. 201.25... AND PROCEDURES GENERAL PROVISIONS § 201.25 Visual Arts Registry. (a) General. This section prescribes the procedures relating to the submission of Visual Arts Registry Statements by visual artists and...

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective

PubMed Central

Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

2017-01-01

Aim The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. Methods A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. Results The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Conclusions Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers. PMID:28276780

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

Quality registry, a tool for patient advantages - from a preventive caring perspective.

PubMed

Rosengren, Kristina; Höglund, Pär J; Hedberg, Berith

2012-03-01

The aim of this study was to describe nurses' experiences of a recently implemented quality register, Senior Alert, at two hospitals in Sweden. In Sweden, in recent decades, a system of national quality registries has been established in health and medical services for better outcomes for patients, professional development and a better functioning system. Senior Alert (SA) is one quality registry, aimed at preventing malnutrition, pressure ulcers and falls in elderly care. The study comprised a total of eight interviews with nurses working with SA at the ward level. The interviews were analysed using manifest qualitative content analysis. Respect for the individuals was a main concern in the study. All persons who were asked to participate in the study consented to do so. One category 'Patient Advantages' and three subcategories 'Conscious Persevering', 'Supporting Structure' and 'Committed Leadership' were identified to describe staff experiences of implementing SA. Implementation processes need to be sustainable at both staff and managerial levels. A key factor in implementing and using a quality registry in prevention care could be described as keeping the flame burning. However, further research is needed on how patient advantages could be developed using other quality registries in order to improve care from a patient perspective. The results of this study could help other organizations implement quality registries or other change processes, for example new guidelines and treatment. Strategies concerning organizational structure and committed leadership could increase the usefulness of knowledge systems on all levels, which could enable continuous learning and quality improvement in health care. © 2012 Blackwell Publishing Ltd.

Urological procedures in Central Europe and the current reality based on the national registries of Czech Republic, Hungary, and Poland (2012 status).

PubMed

Adamczyk, Przemysław; Juszczak, Kajetan; Drewa, Tomasz; Hora, Milan; Nyirády, Peter; Sosnowski, Marek

2016-01-01

In recent years, the laparoscopic approach in oncologic urology seems more attractable to the surgeons. It is considered to have the same oncologic quality as open surgery, but is less invasive in patients. It is used widely in all of Europe, but with various frequency. The aim of the study was to present a various amount of oncourological procedures from three neighbouring countries - Poland, Czech Republic and Hungary. Prostatectomy, cystectomy, nephrectomy and tumorectomy (Nephron Sparing Procedures - NSS) were presented as a list of procedures prepared from the national registry. The total amount of procedures was presented, as well as the LO (Lap to Open procedures) index, P/P (procedures/population) index, ratio of cystectomy/population, and cystectomy/TURBT. In the Czech Republic, the most complex procedures are performed (laparoscopic/robotic prostatectomy, NSS LAP, LAP nephrectomy) in the majority when analysing the country's population. In Hungary and Czech Republic, there are more laparoscopic/robotic radical prostatectomies performed, than open ones. In Poland the largest number of cystectomies is performed when analysing the country's population, but it is difficult to explain the much higher ratio of 6.57 TUR/one cystectomy. In the Czech Republic this procedure is performed in almost one quarter of the patients (23.36%). Interestingly, in Hungary the cystectomy with pouch creation is performed in about 67.65% cases. The highest reimbursement for surgical procedure is present in the Czech Republic with approximately 20-40% more than when compared to Poland or Hungary. The definitive leader in Central Europe (based on the national registry) is the Czech Republic, where the most complex procedures are performed (laparoscopic/robotic prostatectomy, NSS LAP, LAP nephrectomy) in biggest amounts when analysing the country's population. Explanation of such circumstances, can be the higher reimbursement rate for surgical procedure in this country.

Measuring Adolescent Human Papillomavirus Vaccine Coverage: A Match of Sexually Transmitted Disease Clinic and Immunization Registry Data.

PubMed

Pathela, Preeti; Jamison, Kelly; Papadouka, Vikki; Kabir, Rezaul; Markowitz, Lauri E; Dunne, Eileen F; Schillinger, Julia A

2016-12-01

Human papillomavirus (HPV) vaccine is recommended for adolescents. By the end of 2013, 64% of female and 40% of male New York City residents aged 13-18 years had received ≥1 HPV vaccine dose. Adolescents attending sexually transmitted disease (STD) clinics are at high risk for HPV exposure and could benefit from vaccination. Our objective was to estimate HPV vaccination coverage for this population. We matched records of New York City's STD clinic patients aged 13-18 years during 2010-2013 with the Citywide Immunization Registry. We assessed HPV vaccine initiation (≥1 dose) and series completion (≥3 doses among those who initiated) as of clinic visit date and by patient demographics. We compared receipt of ≥1 dose for HPV, tetanus-diphtheria-acellular pertussis, and meningococcal conjugate vaccine. Eighty-two percent of clinic attendees (13,505/16,364) had records in the Citywide Immunization Registry. Receipt of ≥1 HPV dose increased during 2010-2013 (females: 57.6%-69.7%; males: 1.5%-36.3%). Among females, ≥1-dose coverage was lowest among whites (53.4%) and highest among Hispanics (73.3%); among males, ≥1-dose coverage was lowest among whites (6.9%) and highest among Asians (20.9%). Series completion averaged 57.7% (females) and 28.0% (males), with little variation by race/ethnicity or poverty level. Receipt of ≥1 dose was 59.7% for HPV, 82% for tetanus-diphtheria-acellular pertussis, and 76% for meningococcal conjugate vaccines. HPV vaccine initiation and completion were low among adolescent STD clinic patients; coverage was lower compared with other recommended vaccines. STD clinics may be good venues for delivering HPV vaccine, thereby enhancing efforts to improve HPV vaccination. Copyright © 2016 Society for Adolescent Health and Medicine. All rights reserved.

Achieving interoperability for metadata registries using comparative object modeling.

PubMed

Park, Yu Rang; Kim, Ju Han

2010-01-01

Achieving data interoperability between organizations relies upon agreed meaning and representation (metadata) of data. For managing and registering metadata, many organizations have built metadata registries (MDRs) in various domains based on international standard for MDR framework, ISO/IEC 11179. Following this trend, two pubic MDRs in biomedical domain have been created, United States Health Information Knowledgebase (USHIK) and cancer Data Standards Registry and Repository (caDSR), from U.S. Department of Health & Human Services and National Cancer Institute (NCI), respectively. Most MDRs are implemented with indiscriminate extending for satisfying organization-specific needs and solving semantic and structural limitation of ISO/IEC 11179. As a result it is difficult to address interoperability among multiple MDRs. In this paper, we propose an integrated metadata object model for achieving interoperability among multiple MDRs. To evaluate this model, we developed an XML Schema Definition (XSD)-based metadata exchange format. We created an XSD-based metadata exporter, supporting both the integrated metadata object model and organization-specific MDR formats.

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

Resolution No. 598-87, Regulations for the Functioning of the Land Tenure Registry, 27 October 1987.

PubMed

1988-01-01

This Resolution sets forth Regulations for the Land Tenancy Registry of Cuba. It provides that the Registry is part of a scheme for exercising control over legal land tenure and has the following objectives: maintaining control of national land; determining the legal situation of holders of land; recognizing the number of legal holders of land; furnishing information on acquisition, exploitation, and buildings; issuing certificates; and analyzing and processing records in appeals. Further provisions of the Resolution lay down details about these functions. full text

Artificial Nutritional Support Registries: systematic review.

PubMed

Castelló-Botía, I; Wanden-Berghe, C; Sanz-Valero, J

2009-01-01

The nutritional registries are data bases through which we obtain the information to understand the nutrition of populations. Several main nutrition societies of the world have these types of registries, outstanding the NADYA (Home artificial and Ambulatory nutrition) group in Spain. The object of this study is to determine by means of a systematic review, the existent scientific production in the international data bases referred to nutritional support registries. Descriptive transversal study of the results of a critical bibliographic research done in the bioscience data bases: MEDLINE, EMBASE, The Cochrane Library, ISI (Web of Sciences), LILACS, CINHAL. A total of 20 original articles related to nutritional registries were found and recovered. Eleven registries of eight countries were identified: Australia, Germany, Italy, Japan, Spain, Sweden, United Status and United Kingdom. The Price Index was of 65% and all the articles were published in the last 20 years. The Price Index highlights the innovativeness of this practice. The articles related to nutritional support are heterogeneous with respect to data and population, which exposes this as a limitation for a combined analysis.

Renal replacement therapy in Europe: a summary of the 2011 ERA-EDTA Registry Annual Report.

PubMed

Noordzij, Marlies; Kramer, Anneke; Abad Diez, José M; Alonso de la Torre, Ramón; Arcos Fuster, Emma; Bikbov, Boris T; Bonthuis, Marjolein; Bouzas Caamaño, Encarnación; Čala, Svetlana; Caskey, Fergus J; Castro de la Nuez, Pablo; Cernevskis, Harijs; Collart, Frederic; Díaz Tejeiro, Rafael; Djukanovic, Ljubica; Ferrer-Alamar, Manuel; Finne, Patrik; García Bazaga, María de Los Angelos; Garneata, Liliana; Golan, Eliezer; Gonzalez Fernández, Raquel; Heaf, James G; Hoitsma, Andries; Ioannidis, George A; Kolesnyk, Mykola; Kramar, Reinhard; Lasalle, Mathilde; Leivestad, Torbjørn; Lopot, Frantisek; van de Luijtgaarden, Moniek W M; Macário, Fernando; Magaz, Ángela; Martín Escobar, Eduardo; de Meester, Johan; Metcalfe, Wendy; Ots-Rosenberg, Mai; Palsson, Runolfur; Piñera, Celestino; Pippias, Maria; Prütz, Karl G; Ratkovic, Marina; Resić, Halima; Rodríguez Hernández, Aurelio; Rutkowski, Boleslaw; Spustová, Viera; Stel, Vianda S; Stojceva-Taneva, Olivera; Süleymanlar, Gültekin; Wanner, Christoph; Jager, Kitty J

2014-04-01

This article provides a summary of the 2011 ERA-EDTA Registry Annual Report (available at www.era-edta-reg.org). Data on renal replacement therapy (RRT) for end-stage renal disease (ESRD) from national and regional renal registries in 30 countries in Europe and bordering the Mediterranean Sea were used. From 27 registries, individual patient data were received, whereas 17 registries contributed data in aggregated form. We present the incidence and prevalence of RRT, and renal transplant rates in 2011. In addition, survival probabilities and expected remaining lifetimes were calculated for those registries providing individual patient data. The overall unadjusted incidence rate of RRT in 2011 among all registries reporting to the ERA-EDTA Registry was 117 per million population (pmp) (n = 71.631). Incidence rates varied from 24 pmp in Ukraine to 238 pmp in Turkey. The overall unadjusted prevalence of RRT for ESRD on 31 December 2011 was 692 pmp (n = 425 824). The highest prevalence was reported by Portugal (1662 pmp) and the lowest by Ukraine (131 pmp). Among all registries, a total of 22 814 renal transplantations were performed (37 pmp). The highest overall transplant rate was reported from Spain, Cantabria (81 pmp), whereas the highest rate of living donor transplants was reported from Turkey (39 pmp). For patients who started RRT between 2002 and 2006, the unadjusted 5-year patient survival on RRT was 46.8% [95% confidence interval (CI) 46.6-47.0], and on dialysis 39.3% (95% CI 39.2-39.4). The unadjusted 5-year patient survival after the first renal transplantation performed between 2002 and 2006 was 86.7% (95% CI 86.2-87.2) for kidneys from deceased donors and 94.3% (95% CI 93.6-95.0) for kidneys from living donors.

Renal replacement therapy in Europe: a summary of the 2011 ERA–EDTA Registry Annual Report

PubMed Central

Noordzij, Marlies; Kramer, Anneke; Abad Diez, José M.; Alonso de la Torre, Ramón; Arcos Fuster, Emma; Bikbov, Boris T.; Bonthuis, Marjolein; Bouzas Caamaño, Encarnación; Čala, Svetlana; Caskey, Fergus J.; Castro de la Nuez, Pablo; Cernevskis, Harijs; Collart, Frederic; Díaz Tejeiro, Rafael; Djukanovic, Ljubica; Ferrer-Alamar, Manuel; Finne, Patrik; García Bazaga, María de los Angelos; Garneata, Liliana; Golan, Eliezer; Gonzalez Fernández, Raquel; Heaf, James G.; Hoitsma, Andries; Ioannidis, George A.; Kolesnyk, Mykola; Kramar, Reinhard; Lasalle, Mathilde; Leivestad, Torbjørn; Lopot, Frantisek; van de Luijtgaarden, Moniek W.M.; Macário, Fernando; Magaz, Ángela; Martín Escobar, Eduardo; de Meester, Johan; Metcalfe, Wendy; Ots-Rosenberg, Mai; Palsson, Runolfur; Piñera, Celestino; Pippias, Maria; Prütz, Karl G.; Ratkovic, Marina; Resić, Halima; Rodríguez Hernández, Aurelio; Rutkowski, Boleslaw; Spustová, Viera; Stel, Vianda S.; Stojceva-Taneva, Olivera; Süleymanlar, Gültekin; Wanner, Christoph; Jager, Kitty J.

2014-01-01

Background This article provides a summary of the 2011 ERA–EDTA Registry Annual Report (available at www.era-edta-reg.org). Methods Data on renal replacement therapy (RRT) for end-stage renal disease (ESRD) from national and regional renal registries in 30 countries in Europe and bordering the Mediterranean Sea were used. From 27 registries, individual patient data were received, whereas 17 registries contributed data in aggregated form. We present the incidence and prevalence of RRT, and renal transplant rates in 2011. In addition, survival probabilities and expected remaining lifetimes were calculated for those registries providing individual patient data. Results The overall unadjusted incidence rate of RRT in 2011 among all registries reporting to the ERA–EDTA Registry was 117 per million population (pmp) (n = 71.631). Incidence rates varied from 24 pmp in Ukraine to 238 pmp in Turkey. The overall unadjusted prevalence of RRT for ESRD on 31 December 2011 was 692 pmp (n = 425 824). The highest prevalence was reported by Portugal (1662 pmp) and the lowest by Ukraine (131 pmp). Among all registries, a total of 22 814 renal transplantations were performed (37 pmp). The highest overall transplant rate was reported from Spain, Cantabria (81 pmp), whereas the highest rate of living donor transplants was reported from Turkey (39 pmp). For patients who started RRT between 2002 and 2006, the unadjusted 5-year patient survival on RRT was 46.8% [95% confidence interval (CI) 46.6–47.0], and on dialysis 39.3% (95% CI 39.2–39.4). The unadjusted 5-year patient survival after the first renal transplantation performed between 2002 and 2006 was 86.7% (95% CI 86.2–87.2) for kidneys from deceased donors and 94.3% (95% CI 93.6–95.0) for kidneys from living donors. PMID:25852881

Thrombus aspiration in patients with ST-elevation myocardial infarction: results of a national registry of interventional cardiology.

PubMed

Pereira, Hélder; Caldeira, Daniel; Teles, Rui Campante; Costa, Marco; da Silva, Pedro Canas; da Gama Ribeiro, Vasco; Brandão, Vítor; Martins, Dinis; Matias, Fernando; Pereira-Machado, Francisco; Baptista, José; Abreu, Pedro Farto E; Santos, Ricardo; Drummond, António; de Carvalho, Henrique Cyrne; Calisto, João; Silva, João Carlos; Pipa, João Luís; Marques, Jorge; Sousa, Paulino; Fernandes, Renato; Ferreira, Rui Cruz; Ramos, Sousa; Oliveira, Eduardo Infante; de Sousa Almeida, Manuel

2018-04-24

We aimed to evaluate the impact of thrombus aspiration (TA) during primary percutaneous coronary intervention (P-PCI) in 'real-world' settings. We performed a retrospective study, using data from the National Registry of Interventional Cardiology (RNCI 2006-2012, Portugal) with ST-elevation myocardial infarction (STEMI) patients treated with P-PCI. The primary outcome, in-hospital mortality, was analysed through adjusted odds ratio (aOR) and 95% confidence intervals (95%CI). We assessed data for 9458 STEMI patients that undergone P-PCI (35% treated with TA). The risk of in-hospital mortality with TA (aOR 0.93, 95%CI:0.54-1.60) was not significantly decreased. After matching patients through the propensity score, TA reduced significantly the risk of in-hospital mortality (OR 0.58, 95%CI:0.35-0.98; 3500 patients). The whole cohort data does not support the routine use of TA in P-PCI, but the results of the propensity-score matched cohort suggests that the use of selective TA may improve the short-term risks of STEMI.

Use of emergency medical service transport among patients with ST-segment-elevation myocardial infarction: findings from the National Cardiovascular Data Registry Acute Coronary Treatment Intervention Outcomes Network Registry-Get With The Guidelines.

PubMed

Mathews, Robin; Peterson, Eric D; Li, Shuang; Roe, Matthew T; Glickman, Seth W; Wiviott, Stephen D; Saucedo, Jorge F; Antman, Elliott M; Jacobs, Alice K; Wang, Tracy Y

2011-07-12

Activation of emergency medical services (EMS) is critical for the early triage and treatment of patients experiencing ST-segment-elevation myocardial infarction, yet data regarding EMS use and its association with subsequent clinical care are limited. We performed an observational analysis of 37 634 ST-segment-elevation myocardial infarction patients treated at 372 US hospitals participating in the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines between January 2007 and September 2009, and examined independent patient factors associated with EMS transportation versus patient self-transportation. We found that EMS transport was used in only 60% of ST-segment-elevation myocardial infarction patients. Older patients, those living farther from the hospital, and those with hemodynamic compromise were more likely to use EMS transport. In contrast, race, income, and education level did not appear to be associated with the mode of transport. Compared with self-transported patients, EMS-transported patients had significantly shorter delays in both symptom-onset-to-arrival time (median, 89 versus 120 minutes; P<0.0001) and door-to-reperfusion time (median door-to-balloon time, 63 versus 76 minutes; P<0.0001; median door-to-needle time, 23 versus 29 minutes; P<0.0001). Emergency medical services transportation to the hospital is underused among contemporary ST-segment-elevation myocardial infarction patients. Nevertheless, use of EMS transportation is associated with substantial reductions in ischemic time and treatment delays. Community education efforts are needed to improve the use of emergency transport as part of system-wide strategies to improve ST-segment-elevation myocardial infarction reperfusion care.

The Infection Rate of Metal-on-Metal Total Hip Replacement Is Higher When Compared to Other Bearing Surfaces as Documented by the Australian Orthopaedic Association National Joint Replacement Registry.

PubMed

Huang, Phil; Lyons, Matt; O'Sullivan, Michael

2018-02-01

Despite the well-documented decline in the use of metal-on-metal (MoM) implants over the last decade, there are still controversies regarding whether all MoM implants are created equally. Complications such as elevated serum metal ion levels, aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) and pseudotumours have all been well documented, but recent studies suggest increased risk of infection with MoM bearing surfaces. Most of these studies however have small patient numbers. The purpose of this study was to examine the cumulative incidence of revision for infection of MoM bearing surfaces in primary hip arthroplasty at a national and single-surgeon level. Data was collected from the Australian Orthopaedic Association National Joint Replacement Registry, which contains over 98% of all arthroplasties performed in Australia since 2001. The cumulative incidence of revision for infection was extracted at a national level and single-surgeon level. Two hundred seventy-six thousand eight hundred seventy-eight subjects were documented in the Australian registry. The 10-year cumulative percent revision for infection of MoM bearing surfaces in primary total hip replacement (THR) was 2.5% at a national level, compared to 0.8% for other bearing surfaces. The senior author contributed 1755 subjects with 7-year follow-up and a cumulative percent revision for infection of MoM bearing surfaces in primary THR of 36.9%, compared to 2.0% for other bearing surfaces. The cumulative percent of revision of MoM bearing surfaces is higher compared to other bearing surfaces; this is especially pronounced in cumulative percent of revision for infection. There was a higher cumulative percent of revision for infection in MoM bearings surfaces (in particular, large-head MoM) compared to other bearing surfaces at both the national and individual-surgeon level.

Occupational Disease Registries-Characteristics and Experiences.

PubMed

Davoodi, Somayeh; Haghighi, Khosro Sadeghniat; Kalhori, Sharareh Rostam Niakan; Hosseini, Narges Shams; Mohammadzadeh, Zeinab; Safdari, Reza

2017-06-01

Due to growth of occupational diseases and also increase of public awareness about their consequences, attention to various aspects of diseases and improve occupational health and safety has found great importance. Therefore, there is the need for appropriate information management tools such as registries in order to recognitions of diseases patterns and then making decision about prevention, early detection and treatment of them. These registries have different characteristics in various countries according to their occupational health priorities. Aim of this study is evaluate dimensions of occupational diseases registries including objectives, data sources, responsible institutions, minimum data set, classification systems and process of registration in different countries. In this study, the papers were searched using the MEDLINE (PubMed) Google scholar, Scopus, ProQuest and Google. The search was done based on keyword in English for all motor engines including "occupational disease", "work related disease", "surveillance", "reporting", "registration system" and "registry" combined with name of the countries including all subheadings. After categorizing search findings in tables, results were compared with each other. Important aspects of the registries studied in ten countries including Finland, France, United Kingdom, Australia, Czech Republic, Malaysia, United States, Singapore, Russia and Turkey. The results show that surveyed countries have statistical, treatment and prevention objectives. Data sources in almost the rest of registries were physicians and employers. The minimum data sets in most of them consist of information about patient, disease, occupation and employer. Some of countries have special occupational related classification systems for themselves and some of them apply international classification systems such as ICD-10. Finally, the process of registration system was different in countries. Because occupational diseases are often

The Survival of Total Knee Arthroplasty: Current Data from Registries on Tribology: Review Article.

PubMed

Civinini, Roberto; Carulli, Christian; Matassi, Fabrizio; Lepri, Andrea Cozzi; Sirleo, Luigi; Innocenti, Massimo

2017-02-01

Polyethylene (PE) wear is a major contributor to implant loosening following total knee arthroplasty (TKA), and advanced bearings in TKA are being investigated with hopes of reducing or eliminate wear-related loosening. Currently, information on knee tribology is available from national joint registries and may be the best tools to evaluate the efficacy and safety of design innovations in joint arthroplasty. We performed a review of national joint registries trying to answer the following questions: "Which is the main factor directly related to revisions rate in TKA?" and "Are there new bearing options better than conventional ones?" A review was performed of all published annual reports of National Joint Registers, as well as of the literature. The search was carried out using and comparing the National Joint Registers. Current data from registries for total knee arthroplasty indicates that age is the major factor affecting the outcome of primary total knee replacement. The 10-year cumulative revision rate for non-cross-linked PE was 5.8% and for XLPE it was 3.5%. The effect of cross-linked polyethylene was more evident in the younger patients. The survival of the oxidized zirconium (OxZr) femoral component appears better when compared to a similar age group of patients with conventional group of prostheses. Our review suggests that the revision rates are half for the OxZr components compared to conventional CoCr femoral components. Age is the most relevant single factor related to revision rate. Cross-linked PE has a statistical lower revision rate at 10 years compared to conventional PE and, in the OxZr group, the revision rate is 2 times lower than Co-Cr in the same group of age.

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.

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

Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

PubMed

Wolf, William M; Vlachos, Helen A; Marroquin, Oscar C; Lee, Joon S; Smith, Conrad; Anderson, William D; Schindler, John T; Holper, Elizabeth M; Abbott, J Dawn; Williams, David O; Laskey, Warren K; Kip, Kevin E; Kelsey, Sheryl F; Mulukutla, Suresh R

2010-02-01

Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.

Oral cancer statistics in India on the basis of first report of 29 population-based cancer registries

PubMed Central

Sharma, Swati; Satyanarayana, L; Asthana, Smitha; Shivalingesh, KK; Goutham, Bala Subramanya; Ramachandra, Sujatha

2018-01-01

Objectives: To summarize and provide an overview of age-specific oral cancer incidence reported in 29 population-based cancer registry in India. Materials and Methods: Secondary data on age-adjusted rates (AARs) of incidence of oral cancer and other associated sites for all ages (0–75 years) were collected from the report of the National Cancer Registry Programme 2012–2014 in 29 population-based control registries. Results: Among both males and females, mouth cancer had maximum Age adjusted incidence rates (64.8) in the central zone, while oropharynx cancer had minimum AAR (0) in all regions. Conclusion: Oral cancer incidence increases with age with typical pattern of cancer of associated sites of oral cavity seen in the northeast region. PMID:29731552

Governing stem cell banks and registries: emerging issues.

PubMed

Isasi, Rosario M; Knoppers, Bartha M

2009-01-01

The expansion of national and international research efforts in stem cell research is increasingly paired with the trend of establishing stem cell banks and registries. In jurisdictions crossing the spectrum of restrictive to liberal stem cell policies, banks and registries are emerging as an essential resource for transnational access to quality-controlled and ethically sourced stem cell lines. In this study, we report the preliminary findings of a survey of stem cell banks participating in the International Stem Cell Forum's International Stem Cell Banking Initiative (ISCBI). The questionnaire circulated to all ISCBI members addressed both general issues surrounding research policies (e.g., national policies regulating the permissibility of conducting embryonic stem cell research (hESCR)) and, more specifically, issues relating to the governance of stem cell banking projects. The results of the questionnaire were complemented by scholarly research conducted by the authors. This article provides an overview of the current international hESC banking landscape (I). For this purpose, the policy and governance approaches adopted in the surveyed stem cell banks at the national level will be analyzed and areas of convergence and variance will be identified (II). It is beyond the scope of this paper to provide a comprehensive analysis of the wide range of possible governance approaches, policy responses, and their implications. However, we want to provide a starting point for discussion surrounding key questions and challenges as concerns provenance, access, and deposit of hESC lines (III). Finally, while our analysis is focused on research grade hESCs, the lessons to be gleaned from this examination will encourage further thought, analysis, and research into the issues raised in the banking and governance of other sources of stem cell lines (e.g., SCNT, parthenogenesis, iPs) (IV).

Clinical patient registry recruitment and retention: a survey of patients in two chronic disease registries.

PubMed

Solomon, Daniel H; Shadick, Nancy A; Weinblatt, Michael E; Frits, Michelle; Iannaccone, Christine; Zak, Agnes; Korzenik, Joshua R

2017-04-17

The collection of routine clinical data in the setting of research registries can serve an important role in understanding real world care. However, relatively little is known about the patient experience in registries, motivating us to survey patients enrolled in two chronic disease registries. We conducted similar surveys in two disease-based registries based at one academic medical center in the US. One group of patients with rheumatoid arthritis (RA) had been enrolled in a registry, and we focused on retention factors. In a second group of patients with inflammatory bowel disease (IBD) recently enrolled or considering enrollment, we examined factors that would influence their enrollment and willingness to answer frequent questionnaires and give biospecimens. The surveys were analyzed using descriptive statistics and the two cohorts were compared using nonparametric and chi-square tests. We received 150 (50%) completed surveys from RA and 169 (63%) from IBD patients. Mean age of subjects was 62 years in RA and 43 in IBD with more women respondents with RA (83%) than IBD (62%). The two groups described very similar factors as the top three motivations for participation: desire to help others, desire to improve care of own disease, and ease of volunteering. Preferred methods of surveying included mail, e-mail, but telephone was not favored; age was an important correlate of this preference. Respondents preferred surveys either every 1-3 months (28.7% RA and 55.0% IBD) or every 4-6 months (50.7% RA and 29.0% IBD). They differed in the preference for payment for answering surveys with 68.0% with RA answering that no payment was necessary but only 36.1% with IBD felt similarly. Patients engaged in clinical registries demonstrate a high level of commitment to improve care and many report a willingness to answer questions relatively frequently.

Cloud-Based CT Dose Monitoring using the DICOM-Structured Report: Fully Automated Analysis in Regard to National Diagnostic Reference Levels.

PubMed

Boos, J; Meineke, A; Rubbert, C; Heusch, P; Lanzman, R S; Aissa, J; Antoch, G; Kröpil, P

2016-03-01

To implement automated CT dose data monitoring using the DICOM-Structured Report (DICOM-SR) in order to monitor dose-related CT data in regard to national diagnostic reference levels (DRLs). We used a novel in-house co-developed software tool based on the DICOM-SR to automatically monitor dose-related data from CT examinations. The DICOM-SR for each CT examination performed between 09/2011 and 03/2015 was automatically anonymized and sent from the CT scanners to a cloud server. Data was automatically analyzed in accordance with body region, patient age and corresponding DRL for volumetric computed tomography dose index (CTDIvol) and dose length product (DLP). Data of 36,523 examinations (131,527 scan series) performed on three different CT scanners and one PET/CT were analyzed. The overall mean CTDIvol and DLP were 51.3% and 52.8% of the national DRLs, respectively. CTDIvol and DLP reached 43.8% and 43.1% for abdominal CT (n=10,590), 66.6% and 69.6% for cranial CT (n=16,098) and 37.8% and 44.0% for chest CT (n=10,387) of the compared national DRLs, respectively. Overall, the CTDIvol exceeded national DRLs in 1.9% of the examinations, while the DLP exceeded national DRLs in 2.9% of the examinations. Between different CT protocols of the same body region, radiation exposure varied up to 50% of the DRLs. The implemented cloud-based CT dose monitoring based on the DICOM-SR enables automated benchmarking in regard to national DRLs. Overall the local dose exposure from CT reached approximately 50% of these DRLs indicating that DRL actualization as well as protocol-specific DRLs are desirable. The cloud-based approach enables multi-center dose monitoring and offers great potential to further optimize radiation exposure in radiological departments. • The newly developed software based on the DICOM-Structured Report enables large-scale cloud-based CT dose monitoring • The implemented software solution enables automated benchmarking in regard to national DRLs • The

ISHKS joint registry: A preliminary report.

PubMed

Pachore, Jawahir A; Vaidya, Shrinand V; Thakkar, Chandrasekhar J; Bhalodia, Haresh Kumar P; Wakankar, Hemant M

2013-09-01

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are the most widely practiced surgical options for arthritis all over the world and its application is rising in India. Indian Society of Hip and Knee Surgeons (ISHKS) has established a joints registry and has been collecting data for last 6 years. All members of ISHKS are encouraged to actively participate in the registry. A simple two page knee and hip form can be downloaded from the website www.ishks.com. The information collected includes patient demographics, indication for surgery, implant details and in case of revision arthroplasty: the details of implants removed and the cause of failure of primary arthroplasty. These forms are mailed to the central registry office and the data is fed in computerized registry. Data collection started in October 2006. Joint registry is a very important initiative of ISHKS and till date, have data of 34,478 TKAs and 3604 THAs, contributed by 42 surgeons across India. Some important observations have emerged. Data of 34,478 TKAs was assessed: These included 8612 males (25%) and 25,866 females (75%). Average age was 64.4 years (Osteoarthritis range: 45 to 88 years; Rheumatoid arthritis range: 22 to 74 years). Average body mass index was 29.1 (Range: 18.1 to 42.9). The indication for TKA was osteoarthritis in 33,444 (97%) and rheumatoid arthritis in 759 (2.2%). Total of 3604 THA procedures were recorded. These included 2162 (60%) male patients and 1442 (40%) female patients. Average age was 52 years (Range 17 to 85 years) and average BMI was 25.8 (Range: 17.3 to 38.5). The indications for THA was AVN in 49%. The registry will become more meaningful in years to come. Active participation of all arthroplasty surgeons across India is vital for the success of the joints registry.

77 FR 16471 - Pipeline Safety: Implementation of the National Registry of Pipeline and Liquefied Natural Gas...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... Registry of Pipeline and Liquefied Natural Gas Operators AGENCY: Pipeline and Hazardous Materials Safety... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts... Register (75 FR 72878) titled: ``Pipeline Safety: Updates to Pipeline and Liquefied Natural Gas Reporting...

The impact of smoke exposure on the clinical phenotype of alpha-1 antitrypsin deficiency in Ireland: exploiting a national registry to understand a rare disease.

PubMed

O'Brien, M Emmet; Pennycooke, Kevin; Carroll, Tomás P; Shum, Jonathan; Fee, Laura T; O'Connor, Catherine; Logan, P Mark; Reeves, Emer P; McElvaney, Noel G

2015-05-01

Individuals with Alpha-1 antitrypsin deficiency (AATD) have mutations in the SERPINA1 gene causing genetic susceptibility to early onset lung and liver disease that may result in premature death. Environmental interactions have a significant impact in determining the disease phenotype and outcome in AATD. The aim of this study was to assess the impact of smoke exposure on the clinical phenotype of AATD in Ireland. Clinical demographics and available thoracic computerised tomography (CT) imaging were detected from 139 PiZZ individuals identified from the Irish National AATD Registry. Clinical information was collected by questionnaire. Data was analysed to assess AATD disease severity and evaluate predictors of clinical phenotype. Questionnaires were collected from 107/139 (77%) and thoracic CT evaluation was available in 72/107 (67.2%). 74% of respondents had severe Chronic Obstructive Pulmonary Disease (COPD) (GOLD stage C or D). Cigarette smoking was the greatest predictor of impairment in FEV1 and DLCO (%predicted) and the extent of emphysema correlated most significantly with DLCO. Interestingly the rate of FEV1 decline was similar in ex-smokers when compared to never-smokers. Passive smoke exposure in childhood resulted in a greater total pack-year smoking history. Radiological evidence of bronchiectasis was a common finding and associated with increasing age. The Irish National AATD Registry facilitates clinical and basic science research of this condition in Ireland. This study illustrates the detrimental effect of smoke exposure on the clinical phenotype of AATD in Ireland and the benefit of immediate smoking cessation at any stage of lung disease.

Weight-loss maintenance for 10 years in the National Weight Control Registry.

PubMed

Thomas, J Graham; Bond, Dale S; Phelan, Suzanne; Hill, James O; Wing, Rena R

2014-01-01

The challenge of weight-loss maintenance is well known, but few studies have followed successful weight losers over an extended period or evaluated the effect of behavior change on weight trajectories. To study the weight-loss trajectories of successful weight losers in the National Weight Control Registry (NWCR) over a 10-year period, and to evaluate the effect of behavior change on weight-loss trajectories. A 10-year observational study of self-reported weight loss and behavior change in 2886 participants (78% female; mean age 48 years) in the NWCR who at entry had lost at least 30 lbs (13.6 kg) and kept it off for at least one year. Data were collected in 1993-2010; analysis was conducted in 2012. Weight loss (kilograms; percent weight loss from maximum weight). Mean weight loss was 31.3 kg (95% CI=30.8, 31.9) at baseline, 23.8 kg (95% CI=23.2, 24.4) at 5 years and 23.1±0.4 kg (95% CI=22.3, 23.9) at 10 years. More than 87% of participants were estimated to be still maintaining at least a 10% weight loss at Years 5 and 10. Larger initial weight losses and longer duration of maintenance were associated with better long-term outcomes. Decreases in leisure-time physical activity, dietary restraint, and frequency of self-weighing and increases in percentage of energy intake from fat and disinhibition were associated with greater weight regain. The majority of weight lost by NWCR members is maintained over 10 years. Long-term weight-loss maintenance is possible and requires sustained behavior change. © 2013 American Journal of Preventive Medicine Published by American Journal of Preventive Medicine All rights reserved.

Population-based incidence and patterns of cancer in Kamrup Urban Cancer Registry, India.

PubMed

Sharma, Jagannath D; Kataki, Amal C; Vijay, C R

2013-01-01

Cancer is not a notifiable disease in India. The Indian Council of Medical Research (ICMR) initiated the National Cancer Registry Programme in 1982 to measure the burden and pattern of cancer in India. However, no data were available from the northeastern region till 2001 when a WHO- sponsored, ICMR project showed a relatively high frequency of microscopically diagnosed cases of cancer in the region. A population-based cancer registry was established in January 2003 in Guwahati to cover the Kamrup Urban district in the northeastern region of India. We report the data generated in the first 6 years of the registry (2003-08). Information on cancer was obtained by voluntary participation of different sources including major hospitals, diagnostic centres, state referral board and birth and death registry centres within the registry area. A total of 6608 cases were registered during the 6-year period (1 January 2003- 31 December 2008); 3927 were men and 2681 women. The age-adjusted incidence rates were 167.9 per 100000 among men and 133.8 per 100000 among women. The oesophagus was the leading site of cancer among men, comprising 18.3% of all cancers with an age-adjusted rate of 30.7 per 100000. Among women, the breast followed by the cervix uteri were the leading sites of cancer. These two cancers comprised 30% of all cancers among women. Tobacco-related cancers accounted for 58.2% of cancers among men and 26.9% of cancers among women. The patterns observed from the analysis of data from the cancer registry at Guwahati provide comprehensive information on occurrence of cancer and can be valuable for planning cancer control programmes in the region. Copyright 2013, NMJI.

Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol.

PubMed

Bautista-Hernandez, Victor; Cal-Purriños, Natalia; Arribas-Leal, Jose M; Carnero-Alcazar, Manuel; Gutierrez-Diez, Jose F; Cuenca-Castillo, Jose J

2017-01-10

Rapid deployment valves (RDV) represent a newly introduced approach to aortic valve replacement which facilitates surgical implantation and minimally invasive techniques, shortens surgical times and shows excellent haemodynamic performance. However, evidence on their safety, efficacy and potential complications is mostly fitted with small-volume and retrospective studies. Moreover, no current guidelines exist. To improve our knowledge on this technology, The Rapid Deployment Aortic Replacement (RADAR) Registry will be established across Spain with the aim of assessing RDV outcomes in the real-world setting. The RADAR Registry is designed as a product registry that would provide information on its use and outcomes in clinical practice. This multicentre, prospective, national effort will initially involve 4 centres in Spain. Any patient undergoing cardiac surgery for aortic valve replacement and receiving an RDV as an isolated operation or in combination with other cardiac procedures may be included. Participation is voluntary. Data collection is equal to information obtained during standard care and is prospectively entered by the participating physicians perioperatively and during subsequent follow-up visits. The primary outcome assessed is in-hospital and up to 5 years of follow-up, prosthetic valve functioning and clinical status. Secondary outcomes are to perform subgroup analysis, to compare outcomes with other existing approaches and to develop future clinical guidelines. The follow-up assessments are timed with routine clinical appointments. Dissociated data will be extracted and collectively analysed. Initial target sample size for the registry is 500 participants entered with complete follow-up information. Different substudies will be implemented within the registry to investigate specific populations undergoing aortic valve replacement. The protocol is approved by all local institutional ethics committees. Findings will be shared by the participant

[Pain registries and similar data collections : A systematic review].

PubMed

Freytag, A; Scriba, B; Kaiser, U; Meißner, W

2016-12-01

Registries and similar data collections are a valuable addition to prospective studies as they provide data from real life treatment. In pain medicine only few such data collections exist so far. Aim of the study was to identify German-language registries or similar data collections that record patient-reported and pain-associated outcomes together with other data. A systematic search was carried out, which included the following sources: the data bases PubMed/MEDLINE and Embase, the German Registry for Clinical Trials (DRKS), ClinicalTrials.gov and registry portals known to us. Furthermore, an extended internet search was carried out via Google Scholar. References from personal scientific contacts and from operators of registries were also included. Questionnaires regarding registry items were sent to registry operators. Out of 381 search hits, 37 potentially relevant projects received a questionnaire and 35 answered. From the 35 responders 23 registries or similar data collections fulfilling inclusion criteria could be identified: 5 primarily pain-associated, 3 therapy-associated, 2 population-associated and 13 disease-associated (rheumatism/arthritis 5, joints/spine 4, hernias 1 and cancer 3). The reader obtains contact information on relevant data collections associated with pain, the contents, objectives and the pain assessment instruments applied. This review could give an important impulse for increased networking in health services research on pain. A limitation of the study was that identification of registries was made difficult due to an inconsistent definition and application of the term "registry", incomplete or insufficiently updated registry portals, missing scientific publications as well as two non-responders.

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.

Positive predictive value of peptic ulcer diagnosis codes in the Danish National Patient Registry.

PubMed

Viborg, Søren; Søgaard, Kirstine Kobberøe; Jepsen, Peter

2017-01-01

Diagnoses of peptic ulcer are registered in the Danish National Patient Registry (DNPR) for administrative as well as research purposes, but it is unknown whether the coding validity depends on the location of the ulcer. To validate the International Classification of Diseases, 10 th revision diagnosis codes of peptic ulcer in the DNPR by estimating positive predictive values (PPVs) for gastric and duodenal ulcer diagnoses. We identified all patients registered with a hospital discharge diagnosis of peptic ulcer from Aarhus University Hospital, Denmark, in 1995-2006. Among them, we randomly selected 200 who had an outpatient gastroscopy at the time of ulcer diagnosis. We reviewed the findings from these gastroscopies to confirm the presence of peptic ulcer and its location. We calculated PPVs and corresponding 95% confidence intervals (CIs) of gastric and duodenal ulcer diagnoses, using descriptions from the gastroscopic examinations as standard reference. In total, 182 records (91%) were available for review. The overall PPV of peptic ulcer diagnoses in DNPR was 95.6% (95% CI 91.5-98.1), with PPVs of 90.3% (95% CI 82.4-95.5) for gastric ulcer diagnoses, and 94.4% (95% CI 87.4-98.2) for duodenal ulcer diagnoses. PPVs were constant over time. The PPV of uncomplicated peptic ulcer diagnoses in the DNPR is high, and the location of the ulcers is registered correctly in most cases, indicating that the diagnoses are useful for research purposes.

The use of a national transplant registry to benchmark transplant outcome for patients undergoing autologous and allogeneic stem cell transplantation in the United Kingdom and Ireland.

PubMed

Russell, N H; Szydlo, R; McCann, S; Potter, M N; Craddock, C; Towlson, K; Apperley, J F

2004-02-01

As part of its clinical governance programme the British Society for Blood and Marrow Transplantation (BSBMT) undertook an analysis of transplant outcome for adults undergoing human leucocyte antigen - identical sibling allogeneic transplantation for chronic myeloid leukaemia (CML) in first chronic phase (CP1) or autologous transplantation for Hodgkin's disease (HD). The study aimed to compare transplant-related mortality (TRM) and survival for patients reported to the BSBMT with patients transplanted in the rest of Europe, reported to the European Group for Blood and Marrow Transplantation (EBMT). The outcomes for 104 allogeneic transplants for CML in 24 UK/Irish centres were compared with 775 allografts in 145 other European centres. For HD, 241 autografts from 38 UK/Irish centres were compared with 1145 transplants in 239 other European centres. For both diseases, the cohorts were broadly matched with the exception of CML, where 85% of patients were transplanted <1 year from diagnosis in the UK/Ireland compared with 68% in the EBMT (P = 0.001). Cox regression analysis was undertaken using known delineated variables affecting transplant outcome in addition to the registry of origin. The adjusted survival curves for CML showed no significant differences between the two groups, with 3-year survival probabilities of 70.2% and 67.1% for the EBMT and BSBMT cohorts respectively. Likewise, the analysis for HD showed overlapping survival curves, with 3-year survival probabilities of 71.8% (EBMT) and 70.8% (BSBMT). TRM was not statistically different in either disease. This study demonstrates the potential for using national registries to benchmark transplant outcome against the EBMT registry.

Frequent Questions about the Manifest Registry

EPA Pesticide Factsheets

FAQs Including Can I submit multiple form samples to the EPA Registry for approval? Must I submit a continuation sheet sample to the Manifest Registry under section 262.21(d)? Can I typeset the form after I am approved to print the manifest?

Protecting Confidentiality in Cancer Registry Data With Geographic Identifiers.

PubMed

Yu, Mandi; Reiter, Jerome Phillip; Zhu, Li; Liu, Benmei; Cronin, Kathleen A; Feuer, Eric J Rocky

2017-07-01

The National Cancer Institute's Surveillance, Epidemiology, and End Results Program releases research files of cancer registry data. These files include geographic information at the county level, but no finer. Access to finer geography, such as census tract identifiers, would enable richer analyses-for example, examination of health disparities across neighborhoods. To date, tract identifiers have been left off the research files because they could compromise the confidentiality of patients' identities. We present an approach to inclusion of tract identifiers based on multiply imputed, synthetic data. The idea is to build a predictive model of tract locations, given patient and tumor characteristics, and randomly simulate the tract of each patient by sampling from this model. For the predictive model, we use multivariate regression trees fitted to the latitude and longitude of the population centroid of each tract. We implement the approach in the registry data from California. The method results in synthetic data that reproduce a wide range (but not all) of analyses of census tract socioeconomic cancer disparities and have relatively low disclosure risks, which we assess by comparing individual patients' actual and synthetic tract locations. We conclude with a discussion of how synthetic data sets can be used by researchers with cancer registry data. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

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).

Development of National Program of Cancer Registries SAS Tool for Population-Based Cancer Relative Survival Analysis.

PubMed

Dong, Xing; Zhang, Kevin; Ren, Yuan; Wilson, Reda; O'Neil, Mary Elizabeth

2016-01-01

Studying population-based cancer survival by leveraging the high-quality cancer incidence data collected by the Centers for Disease Control and Prevention's National Program of Cancer Registries (NPCR) can offer valuable insight into the cancer burden and impact in the United States. We describe the development and validation of a SASmacro tool that calculates population-based cancer site-specific relative survival estimates comparable to those obtained through SEER*Stat. The NPCR relative survival analysis SAS tool (NPCR SAS tool) was developed based on the relative survival method and SAS macros developed by Paul Dickman. NPCR cancer incidence data from 25 states submitted in November 2012 were used, specifically cases diagnosed from 2003 to 2010 with follow-up through 2010. Decennial and annual complete life tables published by the National Center for Health Statistics (NCHS) for 2000 through 2009 were used. To assess comparability between the 2 tools, 5-year relative survival rates were calculated for 25 cancer sites by sex, race, and age group using the NPCR SAS tool and the National Cancer Institute's SEER*Stat 8.1.5 software. A module to create data files for SEER*Stat was also developed for the NPCR SAS tool. Comparison of the results produced by both SAS and SEER*Stat showed comparable and reliable relative survival estimates for NPCR data. For a majority of the sites, the net differences between the NPCR SAS tool and SEER*Stat-produced relative survival estimates ranged from -0.1% to 0.1%. The estimated standard errors were highly comparable between the 2 tools as well. The NPCR SAS tool will allow researchers to accurately estimate cancer 5-year relative survival estimates that are comparable to those produced by SEER*Stat for NPCR data. Comparison of output from the NPCR SAS tool and SEER*Stat provided additional quality control capabilities for evaluating data prior to producing NPCR relative survival estimates.

Electronic health records and disease registries to support integrated care in a health neighbourhood: an ontology-based methodology.

PubMed

Liaw, Siaw-Teng; Taggart, Jane; Yu, Hairong; Rahimi, Alireza

2014-01-01

Disease registries derived from Electronic Health Records (EHRs) are widely used for chronic disease management (CDM). However, unlike national registries which are specialised data collections, they are usually specific to an EHR or organization such as a medical home. We approached registries from the perspective of integrated care in a health neighbourhood, considering data quality issues such as semantic interoperability (consistency), accuracy, completeness and duplication. Our proposition is that a realist ontological approach is required to systematically and accurately identify patients in an EHR or data repository of EHRs, assess intrinsic data quality and fitness for use by members of the multidisciplinary integrated care team. We report on this approach as applied to routinely collected data in an electronic practice based research network in Australia.

Modest familial risks for multiple sclerosis: a registry-based study of the population of Sweden

PubMed Central

Westerlind, Helga; Ramanujam, Ryan; Uvehag, Daniel; Kuja-Halkola, Ralf; Boman, Marcus; Bottai, Matteo; Lichtenstein, Paul

2014-01-01

Data on familial recurrence rates of complex diseases such as multiple sclerosis give important hints to aetiological factors such as the importance of genes and environment. By linking national registries, we sought to avoid common limitations of clinic-based studies such as low numbers, poor representation of the population and selection bias. Through the Swedish Multiple Sclerosis Registry and a nationwide hospital registry, a total of 28 396 patients with multiple sclerosis were identified. We used the national Multi-Generation Registry to identify first and second degree relatives as well as cousins, and the Swedish Twin Registry to identify twins of patients with multiple sclerosis. Crude and age corrected familial risks were estimated for cases and found to be in the same range as previously published figures. Matched population-based controls were used to calculate relative risks, revealing lower estimates of familial multiple sclerosis risks than previously reported, with a sibling recurrence risk (λs = 7.1; 95% confidence interval: 6.42–7.86). Surprisingly, despite a well-established lower prevalence of multiple sclerosis amongst males, the relative risks were equal among maternal and paternal relations. A previously reported increased risk in maternal relations could thus not be replicated. An observed higher transmission rate from fathers to sons compared with mothers to sons suggested a higher transmission to offspring from the less prevalent sex; therefore, presence of the so-called ‘Carter effect’ could not be excluded. We estimated the heritability of multiple sclerosis using 74 757 twin pairs with known zygosity, of which 315 were affected with multiple sclerosis, and added information from 2.5 million sibling pairs to increase power. The heritability was estimated to be 0.64 (0.36–0.76), whereas the shared environmental component was estimated to be 0.01 (0.00–0.18). In summary, whereas multiple sclerosis is to a great extent an

[Taxonomy and definition of clinical registries].

PubMed

Costa, Giuseppe

2015-09-01

In order to assess the needs of knowledge about surveillance and registries in Italy and to prepare a proposal for the advancement of monitoring and recording capacity, a working group led by the Italian Association of Epidemiology and composed by the University of Turin, the Institute of Health and Agenas, carried out a survey of definitions and approaches used in public health and consulted the main Italian experts in surveillance and registries. Some of the reflections developed in this project are presented, to assess to which extent they are adaptable to the prospects the program PRIER aims to. Different aspects of the issue are analyzed: from the frame work necessary to identify information needs and how to improve the ability to measure and types of definitions and taxonomies of the registers, to the implications of the choices about what to include in registries on regulation of the instruments and investment priorities for new registries and surveillance.

75 FR 51075 - National Registry of Evidence-Based Programs and Practices (NREPP): Open Submission Period for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-18

... and pre- and post-intervention assessments; this category includes longitudinal/multiple time series... Registry of Evidence-based Programs and Practices (NREPP) is a voluntary rating system designed to provide... acceptance status at that time. The number of reviews conducted will depend on the availability of funds...

Reprint of: Client interfaces to the Virtual Observatory Registry

NASA Astrophysics Data System (ADS)

Demleitner, M.; Harrison, P.; Taylor, M.; Normand, J.

2015-06-01

The Virtual Observatory Registry is a distributed directory of information systems and other resources relevant to astronomy. To make it useful, facilities to query that directory must be provided to humans and machines alike. This article reviews the development and status of such facilities, also considering the lessons learnt from about a decade of experience with Registry interfaces. After a brief outline of the history of the standards development, it describes the use of Registry interfaces in some popular clients as well as dedicated UIs for interrogating the Registry. It continues with a thorough discussion of the design of the two most recent Registry interface standards, RegTAP on the one hand and a full-text-based interface on the other hand. The article finally lays out some of the less obvious conventions that emerged in the interaction between providers of registry records and Registry users as well as remaining challenges and current developments.

The role of registries in rare genetic lipid disorders: Review and introduction of the first global registry in lipoprotein lipase deficiency.

PubMed

Steinhagen-Thiessen, Elisabeth; Stroes, Erik; Soran, Handrean; Johnson, Colin; Moulin, Philippe; Iotti, Giorgio; Zibellini, Marco; Ossenkoppele, Bas; Dippel, Michaela; Averna, Maurizio R

2017-07-01

A good understanding of the natural history of rare genetic lipid disorders is a pre-requisite for successful patient management. Disease registries have been helpful in this regard. Lipoprotein Lipase Deficiency (LPLD) is a rare, autosomal-recessive lipid disorder characterized by severe hypertriglyceridemia and a very high risk for recurrent acute pancreatitis, however, only limited data are available on its natural course. Alipogene tiparvovec (Glybera ® ) is the first gene therapy to receive Marketing Authorization in the European Union; GENIALL (GENetherapy In the MAnagement of Lipoprotein Lipase Deficiency), a 15-year registry focusing on LPLD was launched in 2014 as part of its Risk Management Plan. The aim of this publication is to introduce the GENIALL Registry within a structured literature review of registries in rare genetic lipid disorders. A total of 11 relevant initiatives/registries were identified (homozygous Familial Hypercholesterolemia (hoFH) [n = 5]; LPLD [n = 1]; Lysosomal Acid Lipase Deficiency [LALD, n = 1], detection of mutations in genetic lipid disorders [n = 4]). Besides one product registry in hoFH and the LALD registry, all other initiatives are local or country-specific. GENIALL is the first global prospective registry in LPLD that will collect physician and patient generated data on the natural course of LPLD, as well as long-term outcomes of gene therapy. There is a limited number of international initiatives focusing on the natural course of specific rare genetic lipid disorders. The GENIALL LPLD Registry could be the first step towards a future broader global initiative that collects data related to familial chylomicronemia syndrome and their underlying genetic causes. Copyright © 2016. Published by Elsevier B.V.

UK Renal Registry 16th annual report: chapter 9 adequacy of haemodialysis in UK adult patients in 2012: national and centre-specific analyses.

PubMed

Shaw, Catriona; Steenkamp, Retha; Davenport, Andrew

2013-01-01

Outcomes in patients treated with haemodialysis (HD) are influenced by the delivered dose of dialysis. The UK Renal Association (RA) publishes clinical practice guidelines which include recommendations for dialysis dose. The urea reduction ratio (URR) is a widely used measure of dialysis dose and has historically been the measure of adequacy reported by the UKRR. This chapter aims to determine the extent to which patients achieved the recommended UK target. All 71 UK renal centres submitted data to the UK Renal Registry (UKRR). Two groups of patients were included in the analyses: the prevalent HD patient population on 30st September 2012 and the incident HD patient population for 2011. Centres returning data on <50% of their patient population or centres with <20 patients were excluded from centrespecific comparisons. Data regarding URR were available from 63 renal centres in the UK. Forty nine centres provided URR data on more than 90% of prevalent HD patients. The proportion of patients in the UK who met the UK clinical practice guideline for URR (>65%) increased from 69% in 2000 to 88% in 2012. There was persistent variation observed between centres, with 21 centres attaining the RA clinical practice guideline in >90% of patients, 38 centres attaining the guideline in 70-90% of patients and one centre in less than 70% of patients. The overall proportion of prevalent HD patients with a URR >65% has continued to improve over time. The delivered dose of HD, as measured by URR for patients with established renal failure, has increased over the last decade. Whilst the majority of UK patients achieved the target URR there was considerable variation between centres in the percentage of patients achieving the current guideline. © 2014 S. Karger AG, Basel.

42 CFR 483.156 - Registry of nurse aides.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Registry of nurse aides. 483.156 Section 483.156... That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants § 483.156 Registry of nurse aides. (a) Establishment of registry. The State must...

42 CFR 483.156 - Registry of nurse aides.

Code of Federal Regulations, 2011 CFR

2011-10-01

... That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants § 483.156 Registry of nurse aides. (a) Establishment of registry. The State must... 42 Public Health 5 2011-10-01 2011-10-01 false Registry of nurse aides. 483.156 Section 483.156...

42 CFR 483.156 - Registry of nurse aides.

Code of Federal Regulations, 2014 CFR

2014-10-01

... That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants § 483.156 Registry of nurse aides. (a) Establishment of registry. The State must... 42 Public Health 5 2014-10-01 2014-10-01 false Registry of nurse aides. 483.156 Section 483.156...

42 CFR 483.156 - Registry of nurse aides.

Code of Federal Regulations, 2012 CFR

2012-10-01

... That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants § 483.156 Registry of nurse aides. (a) Establishment of registry. The State must... 42 Public Health 5 2012-10-01 2012-10-01 false Registry of nurse aides. 483.156 Section 483.156...

42 CFR 483.156 - Registry of nurse aides.

Code of Federal Regulations, 2013 CFR

2013-10-01

... That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants § 483.156 Registry of nurse aides. (a) Establishment of registry. The State must... 42 Public Health 5 2013-10-01 2013-10-01 false Registry of nurse aides. 483.156 Section 483.156...

Acute injuries in soccer, ice hockey, volleyball, basketball, judo, and karate: analysis of national registry data.

PubMed

Kujala, U M; Taimela, S; Antti-Poika, I; Orava, S; Tuominen, R; Myllynen, P

1995-12-02

To determine the acute injury profile in each of six sports and compare the injury rates between the sports. Analysis of national sports injury insurance registry data. Finland during 1987-91. 621,691 person years of exposure among participants in soccer, ice hockey, volleyball, basketball, judo, or karate. Acute sports injuries requiring medical treatment and reported to the insurance company on structured forms by the patients and their doctors. 54,186 sports injuries were recorded. Injury rates were low in athletes aged under 15, while 20-24 year olds had the highest rates. Differences in injury rates between the sports were minor in this adult age group. Overall injury rates were higher in sports entailing more frequent and powerful body contact. Each sport had a specific injury profile. Fractures and dental injuries were most common in ice hockey and karate and least frequent in volleyball. Knee injuries were the most common cause of permanent disability. Based on the defined injury profiles in the different sports it is recommended that sports specific preventive measures should be employed to decrease the number of violent contacts between athletes, including improved game rules supported by careful refereeing. To prevent dental injuries the wearing of mouth guards should be encouraged, especially in ice hockey, karate, and basketball.

77 FR 58141 - Public Buildings Service; Information Collection; Art-in-Architecture Program National Artist...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... Buildings Service; Information Collection; Art-in- Architecture Program National Artist Registry (GSA Form... regarding Art-in Architecture Program National Artist Registry (GSA Form 7437). The Art-in-Architecture...-Architecture & Fine Arts Division (PCAC), 1800 F Street NW., Room 3305, Washington, DC 20405, at telephone(202...

Psychotropic Medication Use among Children with Autism Spectrum Disorders Enrolled in a National Registry, 2007-2008

ERIC Educational Resources Information Center

Rosenberg, Rebecca E.; Mandell, David S.; Farmer, Janet E.; Law, J. Kiely; Marvin, Alison R.; Law, Paul A.

2010-01-01

Patterns of current psychotropic medication use among 5,181 children with autism spectrum disorders (ASD) enrolled in a Web-based registry were examined. Overall, 35% used at least one psychotropic medication, most commonly stimulants, neuroleptics, and/or antidepressants. Those who were uninsured or exclusively privately insured were less likely…

Diffusion, outcomes and implementation of minimally invasive liver surgery: a snapshot from the I Go MILS (Italian Group of Minimally Invasive Liver Surgery) Registry.

PubMed

Aldrighetti, Luca; Ratti, Francesca; Cillo, Umberto; Ferrero, Alessandro; Ettorre, Giuseppe Maria; Guglielmi, Alfredo; Giuliante, Felice; Calise, Fulvio

2017-09-01

The Italian Group of MILS (I Go MILS) prospective registry was established in 2014 with the goals to create a hub for data and projects on a national basis and to promote the diffusion and implementation of MILS programs on a national scale. The primary endpoint of the present study is to give a snapshot of the real diffusion and outcomes of MILS in Italy, while analyzing the role of the registry in the implementation of MILS programs nationwide. The I Go MILS Registry is a prospective and intention-to-treat registry opened to any Italian center performing MILS, without restriction criteria based on number of procedures. The Registry is developed through the eClinical, an electronic platform for the management of clinical trials and is based on 34 clinical variables, regarding indication, intra- and postoperative course. Clinical outcomes and data regarding implementation of MILS activity have been analyzed for the aim of the study. Between November 2014 and June 2017, data from 1678 MILS performed in 48 centers have been collected (mean number of procedures per center 35, range 1-302). 22% of procedures were performed for benign and 78% for malignant disease (HCC constituted the 49.1% and CRLM the 31.2% of malignant tumors). Major liver resections (>3 liver segments), including right and left hepatectomies, trisectionectomies and ALPPS procedures were 10% of the series. Mean blood loss was 200 ± 230 mL Morbidity rate was 20.5% and mortality was 0.3%. 10.4% of cases were converted to open approach. Median length of stay was 5 days. MILS/total resections ratio in 13 experienced centers increased from 14 to 30% after Registry establishment. MILS programs are well established in Italy, with progressive increase both in the number of cases and in the numerosity of centers. The I Go MILS Registry is playing a crucial role in monitoring the development of MILS in the real world on a national basis while giving a significant contribution to the implementation of MILS

Agency for Toxic Substances and Disease Registry

MedlinePlus

... fact sheet. Hexachlorobenzene Learn important information about Hexachlorobenzene. ALS Registry 7th Anniversary Read how the Registry has been working to better understand ALS for 7 years now. Protect the Health of ...

Occupational radiation procedures and doses in South Korean dentists.

PubMed

Kim, Yoon-Ji; Cha, Eun Shil; Lee, Won Jin

2016-10-01

Dentistry is among the occupations involving chronic exposure to ionizing radiation. Although several cohort studies on medical radiation workers have been conducted in some countries, only a few epidemiological studies on dentists have been performed to examine occupational radiation exposure worldwide. The aim of this study was to investigate occupational characteristics and radiation exposures in South Korean dentists. A total of 658 dentists were surveyed from April 2012 to May 2013, and survey data were linked with dosimetry data from the National Dose Registry. Multiple linear regression analysis was used to identify the relationship between demographic or occupational factors and individual radiation doses. Of the dentists sampled, 78% were men, 51% were younger than age 40, and 61% began employment after 2000. The most frequent procedures performed by dentists were panoramic radiography, followed by intraoral and portable dental radiography. Male dentists were more frequently involved in radiation procedures, and a higher proportion of male than female dentists wore a lead apron for diagnostic radiology. The average annual effective dose was 0.18 mSv for male and 0.13 mSv for female dentists. Female dentists working in provincial areas had significantly higher average annual and cumulative effective doses than those in metropolitan areas. The cumulative effective doses were significantly greater for older dentists, those who entered the field in the 1990s, and those with longer employment duration. Our findings provided detailed information on work practices, number of procedures performed on a weekly basis, and occupational radiation doses, which enabled in-depth evaluation of occupational radiation exposure and work status among dentists. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A description and comparison of selected forest carbon registries: a guide for States considering the development of a forest carbon registry

Treesearch

Jessica Call; Jennifer Hayes

2007-01-01

There is increasing interest in tools for measuring and reducing emissions of carbon dioxide, a major greenhouse gas. Two tools that have been receiving a lot of attention include carbon markets and carbon registries. Carbon registries are established to record and track net carbon emission levels over time. These registries provide quantifiable and verifiable carbon...

Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

PubMed

Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

2013-05-07

Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care

Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry.

PubMed

Kramer, Daniel B; Reynolds, Matthew R; Normand, Sharon-Lise; Parzynski, Craig S; Spertus, John A; Mor, Vincent; Mitchell, Susan L

2017-02-01

To evaluate the incidence and characteristics of nursing home (NH) use after implantable cardioverter-defibrillator (ICD) implantation. Cohort study. Medicare beneficiaries in the National Cardiovascular Data Registry-ICD Registry. Individuals aged 65 and older receiving ICDs between January 1, 2006, and March 31, 2010 (N = 192,483). Proportion of ICD recipients discharged to NHs directly after device placement, cumulative incidence of long-term NH admission, and factors associated with immediate discharge to a NH and time to long-term NH admission. Over 4 years, 40.6% of the cohort died, and 35,939 (18.7%) experienced at least one NH admission, including 4.0% directly discharged to a NH after ICD implantation and 2.8% admitted to long-term NH care during follow-up. The cumulative incidence of long-term NH admission, accounting for the competing risk of death, was 1.7% at 1 year, 3.8% at 3 years, and 4.6% at 4 years; 20.1% of individuals admitted to a NH died there. Factors most strongly associated with direct NH discharge and time to long-term NH care were older age (adjusted odds ratio (AOR) = 2.09, 95% confidence interval (CI) = 2.01-2.17 per 10-year increment; adjusted hazard ratio (AHR) = 1.88, 95% CI = 1.80-1.97, respectively), dementia (AOR = 2.60, 95% CI = 2.25-3.01; AHR = 2.50, 95% CI = 2.14-2.93, respectively), and Medicare Part A claim for NH stay in prior 6 months (AOR = 3.96, 95% CI = 3.70-4.25; AHR = 2.88, 95% CI = 2.65-3.14, respectively). Nearly one in five individuals are admitted to NHs over a median of 1.6 years of follow-up after ICD implantation. Understanding these outcomes may help inform the clinical care of these individuals. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

15 CFR 995.21 - Registry of data users.

Code of Federal Regulations, 2011 CFR

2011-01-01

... information about the type and size of vessel that the NOAA ENC data has been provided for as well as an... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Registry of data users. 995.21 Section... § 995.21 Registry of data users. (a) CED or CEVAD shall maintain a registry of customers receiving NOAA...

Positive predictive value of peptic ulcer diagnosis codes in the Danish National Patient Registry

PubMed Central

Viborg, Søren; Søgaard, Kirstine Kobberøe; Jepsen, Peter

2017-01-01

Background Diagnoses of peptic ulcer are registered in the Danish National Patient Registry (DNPR) for administrative as well as research purposes, but it is unknown whether the coding validity depends on the location of the ulcer. Objective To validate the International Classification of Diseases, 10th revision diagnosis codes of peptic ulcer in the DNPR by estimating positive predictive values (PPVs) for gastric and duodenal ulcer diagnoses. Methods We identified all patients registered with a hospital discharge diagnosis of peptic ulcer from Aarhus University Hospital, Denmark, in 1995–2006. Among them, we randomly selected 200 who had an outpatient gastroscopy at the time of ulcer diagnosis. We reviewed the findings from these gastroscopies to confirm the presence of peptic ulcer and its location. We calculated PPVs and corresponding 95% confidence intervals (CIs) of gastric and duodenal ulcer diagnoses, using descriptions from the gastroscopic examinations as standard reference. Results In total, 182 records (91%) were available for review. The overall PPV of peptic ulcer diagnoses in DNPR was 95.6% (95% CI 91.5–98.1), with PPVs of 90.3% (95% CI 82.4–95.5) for gastric ulcer diagnoses, and 94.4% (95% CI 87.4–98.2) for duodenal ulcer diagnoses. PPVs were constant over time. Conclusion The PPV of uncomplicated peptic ulcer diagnoses in the DNPR is high, and the location of the ulcers is registered correctly in most cases, indicating that the diagnoses are useful for research purposes. PMID:28503076

Cancer Registries and Monitoring the Impact of Prophylactic Human Papillomavirus Vaccines: The Potential Role

PubMed Central

Saraiya, Mona; Goodman, Marc T.; Datta, S. Deblina; Chen, Vivien W.; Wingo, Phyllis A.

2009-01-01

The recent US Food and Drug Administration licensure of a prophylactic vaccine against oncogenic human papillomavirus (HPV) types 16 and 18, the first of its kind, poses unique challenges in postmarketing vaccine surveillance, especially in measuring vaccine effectiveness against biologic endpoints of HPV infection. Historically, the national system of population-based cancer registries in the US has provided high-quality data on cancer incidence and mortality for the most important biologic endpoints, namely, anogenital cancers and some oral cavity/oropharyngeal cancers. There also has been some data collection on cancer precursors; however, this activity has been inconsistent and of lower priority. Because effectiveness against HPV-associated cancers will not be measurable for several decades, strengthening and possibly expanding the capacity of registries to collect precancer data, which are earlier manifestations of infection, must be considered. Collecting type-specific data on HPV-associated precancers and cancers. While keeping in mind the current limitations of registry operations, they discuss resources that may be needed to implement and sustain these types of activities. PMID:18980287

Stroke Trials Registry

MedlinePlus

... Trials News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions ... UT Southwestern Medical Center. Copyright © 1997-2011 - The Internet Stroke Center. All rights reserved. The information contained ...

Designing exposure registries for improved tracking of occupational exposure and disease.

PubMed

Arrandale, Victoria H; Bornstein, Stephen; King, Andrew; Takaro, Timothy K; Demers, Paul A

2016-06-27

Registries are one strategy for collecting information on occupational exposure and disease in populations. Recently leaders in the Canadian occupational health and safety community have shown an interest in the use of occupational exposure registries. The primary goal of this study was to review a series of Canadian exposure registries to identify their strengths and weaknesses as a tool for tracking occupational exposure and disease in Canada. A secondary goal was to identify the features of an exposure registry needed to specifically contribute to prevention, including the identification of new exposure-disease relationships. A documentary review of five exposure registries from Canada was completed. Strengths and limitations of the registries were compared and key considerations for designing new registries were identified. The goals and structure of the exposure registries varied considerably. Most of the reviewed registries had voluntary registration, which presents challenges for the use of the data for either surveillance or epidemiology. It is recommended that eight key issues be addressed when planning new registries: clear registry goal(s), a definition of exposure, data to be collected (and how it will be used), whether enrolment will be mandatory, as well as ethical, privacy and logistical considerations. When well constructed, an exposure registry can be a valuable tool for surveillance, epidemiology and ultimately the prevention of occupational disease. However, exposure registries also have a number of actual and potential limitations that need to be considered.

Focal cryotherapy for localized prostate cancer: a report from the national Cryo On-Line Database (COLD) Registry.

PubMed

Ward, John F; Jones, J Stephen

2012-06-01

Study Type - Therapy (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Selective destruction of targeted prostate tissue is now technically feasible. Much has been theorized but little is known about the proper patient selection or treatment outcomes to determine if this organ preserving approach to prostate cancer has merit for further study and diffusion into wider practice. Herein we present the largest retrospective registry report of men treated with sub-total prostate cryotherapy in order to begin to understand how this treatment is being applied despite the paucity of data. •  To identify recent trends in focal cryotherapy from a prospectively maintained treatment registry. •  To describe treatment outcomes after uncontrolled application of focally ablative techniques within community practice. •  We conducted an analysis of the COLD Registry to identify patients treated with partial gland prostate cryoablation between 1997 and 2007. •  Preoperative characteristics and postoperative cancer-specific and functional outcomes were assembled for analysis. •  The COLD Registry contained information for 5853 patients and focal cryotherapy was the codified procedure in 1160 patients (19.8%). •  A dramatic increase in focal treatments was observed, from 46 in 1999 to 567 in 2005 (P < 0.01). •  The biochemical recurrence-free rate (ASTRO definition) at 36 months was 75.7%. •  Prostate biopsy, performed in 164/1160 of patients (14.1%), was positive in 43 (26.3%) of those suspected of cancer recurrence, but in only 3.7% (43/1160) of treated patients. •  Urinary continence (defined as use of 0 pads) was 98.4%. Maintenance of spontaneous erections was 58.1%. Prolonged urinary retention (>30 days) occurred in six (1.1%) patients. Rectourethral fistula was observed in one (0.1%) patient. •  Focal cryoablation is increasingly used for selected patients with prostate cancer. •  Oncological

Lung Transplantation in the Management of Patients with LAM:Baseline Data from the NHLBI LAM Registry

PubMed Central

Ryu, Jay; Beck, Gerald; Moss, Joel; Lee, Jar-Chi; Finlay, Geraldine; Brown, Kevin; Chapman, Jeffrey; McMahan, June; Olson, Eric; Ruoss, Stephen; Sherer, Susan; Maurer, Janet R; Ryu, Jay; Beck, Gerald; Moss, Joel; Lee, Jar-Chi; Finlay, Geraldine; Brown, Kevin; Chapman, Jeffrey; McMahan, June; Olson, Eric; Ruoss, Steven

2008-01-01

Background In 1997, the National Heart, Lung, and Blood Institute of the National Institutes of Health established a Registry to better characterize the demographic, clinical, physiologic and radiographic features of patients with LAM. We report here data collected at enrollment from patients who had either undergone transplant prior to enrollment, underwent transplant during the 5-year study, or were evaluated/waitlisted for lung transplant during the 5-year study. Methods The LAM Registry enrolled patients from six clinical centers between August 1998 and October 2001. On entry patients filled out questionnaires covering medical history, symptoms, treatment and quality of life (SF-36 and St. George’s Respiratory Questionnaire). Enrollees underwent blood laboratory work, arterial blood gases and pulmonary function testing. Follow-up was at six month and/or yearly intervals. Diagnoses were confirmed by biopsy or typical clinical presentation plus CT findings confirmed by independent expert radiologists. A total of 243 women were enrolled. Of those 13 (5.3%) had been transplanted at time of entry (Group A), 21 (8.6%) were transplanted during the study (Group B) and 48 (19.8%) were either waitlisted for transplant or underwent evaluation after enrollment during the study period (Group C). The remaining 161 (66.3%) registrants were neither considered for nor listed for transplant during the Registry period (Group D). Results One-third of patients in a large sample of LAM patients had either been transplanted or were being considered for transplant. At enrollment, patients who had already been transplanted and those not in need of transplant (Groups A and D) had better pulmonary function and quality of life scores compared to patients who subsequently underwent lung transplant during the Registry period (Group B). Conclusion In this large registry of LAM patients, lung transplantation appears to be associated both with significantly improved lung function and quality

Design of a framework for the deployment of collaborative independent rare disease-centric registries: Gaucher disease registry model.

PubMed

Bellgard, Matthew I; Napier, Kathryn R; Bittles, Alan H; Szer, Jeffrey; Fletcher, Sue; Zeps, Nikolajs; Hunter, Adam A; Goldblatt, Jack

2018-02-01

Orphan drug clinical trials often are adversely affected by a lack of high quality treatment efficacy data that can be reliably compared across large patient cohorts derived from multiple governmental and country jurisdictions. It is critical that these patient data be captured with limited corporate involvement. For some time, there have been calls to develop collaborative, non-proprietary, patient-centric registries for post-market surveillance of aspects related to orphan drug efficacy. There is an urgent need for the development and sustainable deployment of these 'independent' registries that can capture comprehensive clinical, genetic and therapeutic information on patients with rare diseases. We therefore extended an open-source registry platform, the Rare Disease Registry Framework (RDRF) to establish an Independent Rare Disease Registry (IRDR). We engaged with an established rare disease community for Gaucher disease to determine system requirements, methods of data capture, consent, and reporting. A non-proprietary IRDR model is presented that can serve as autonomous data repository, but more importantly ensures that the relevant data can be made available to appropriate stakeholders in a secure, timely and efficient manner to improve clinical decision-making and the lives of those with a rare disease. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Adult congenital heart disease in Greece: Preliminary data from the CHALLENGE registry.

PubMed

Giannakoulas, G; Vasiliadis, K; Frogoudaki, A; Ntellos, C; Tzifa, A; Brili, S; Manginas, A; Papaphylactou, M; Parcharidou, D; Kampouridis, N; Pitsis, A; Chamaidi, A; Kolios, M; Papadopoulos, G; Douras, A; Davlouros, P; Ntiloudi, D; Karvounis, H; Kalangos, A; Tsioufis, C; Rammos, S

2017-10-15

The majority of patients with congenital heart disease (CHD), nowadays, survives into adulthood and is faced with long-term complications. We aimed to study the basic demographic and clinical characteristics of adult patients with congenital heart disease (ACHD) in Greece. A registry named CHALLENGE (Adult Congenital Heart Disease Registry. A registry from Hellenic Cardiology Society) was initiated in January 2012. Patients with structural CHD older than 16years old were enrolled by 16 specialized centers nationwide. Out of a population of 2115 patients with ACHD, who have been registered, (mean age 38years (SD 16), 52% women), 47% were classified as suffering from mild, 37% from moderate and 15% from severe ACHD. Atrial septal defect (ASD) was the most prevalent diagnosis (33%). The vast majority of ACHD patients (92%) was asymptomatic or mildly symptomatic (NYHA class I/II). The most symptomatic patients were suffering from an ASD, most often the elderly or those under targeted therapy for pulmonary arterial hypertension. Elderly patients (>60years old) accounted for 12% of the ACHD population. Half of patients had undergone at least one open-heart surgery, while 39% were under cardiac medications (15% under antiarrhythmic drugs, 16% under anticoagulants, 16% under medications for heart failure and 4% under targeted therapy for pulmonary arterial hypertension). ACHD patients are an emerging patient population and national prospective registries such as CHALLENGE are of unique importance in order to identify the ongoing needs of these patients and match them with the appropriate resource allocation. Copyright © 2017 Elsevier B.V. All rights reserved.

The cost of doing business: cost structure of electronic immunization registries.

PubMed

Fontanesi, John M; Flesher, Don S; De Guire, Michelle; Lieberthal, Allan; Holcomb, Kathy

2002-10-01

To predict the true cost of developing and maintaining an electronic immunization registry, and to set the framework for developing future cost-effective and cost-benefit analysis. Primary data collected at three immunization registries located in California, accounting for 90 percent of all immunization records in registries in the state during the study period. A parametric cost analysis compared registry development and maintenance expenditures to registry performance requirements. Data were collected at each registry through interviews, reviews of expenditure records, technical accomplishments development schedules, and immunization coverage rates. The cost of building immunization registries is predictable and independent of the hardware/software combination employed. The effort requires four man-years of technical effort or approximately $250,000 in 1998 dollars. Costs for maintaining a registry were approximately $5,100 per end user per three-year period. There is a predictable cost structure for both developing and maintaining immunization registries. The cost structure can be used as a framework for examining the cost-effectiveness and cost-benefits of registries. The greatest factor effecting improvement in coverage rates was ongoing, user-based administrative investment.

RItA: The Italian severe/uncontrolled asthma registry.

PubMed

Maio, S; Baldacci, S; Bresciani, M; Simoni, M; Latorre, M; Murgia, N; Spinozzi, F; Braschi, M; Antonicelli, L; Brunetto, B; Iacovacci, P; Roazzi, P; Pini, C; Pata, M; La Grasta, L; Paggiaro, P; Viegi, G

2018-03-01

The Italian severe/uncontrolled asthma (SUA) web-based registry encompasses demographic, clinical, functional, and inflammatory data; it aims to raise SUA awareness, identifying specific phenotypes and promoting optimal care. Four hundred and ninety three adult patients from 27 Italian centers (recruited in 2011-2014) were analyzed. Mean age was 53.8 years. SUA patients were more frequently female (60.6%), with allergic asthma (83.1%). About 30% showed late onset of asthma diagnosis/symptoms (>40 years); the mean age for asthma symptoms onset was 30.2 years and for asthma diagnosis 34.4 years. 97.1% used ICS (dose 2000 BDP), 93.6% LABA in association with ICS, 53.3% LTRAs, 64.1% anti-IgE, 10.7% theophylline, and 16.0% oral corticosteroids. Mean FEV 1 % pred of 75.1%, median values of 300/mm 3 of blood eosinophil count, 323 kU/L of serum total IgE, and 24 ppb of FENO were shown. Most common comorbidities were allergic rhinitis (62.4%), gastroesophageal reflux (42.1%), sinusitis (37.9%), nasal polyposis (30.2%), and allergic conjunctivitis (30.2%). 55.7% of SUA patients had exacerbations in the last 12 months, 9.7% emergency department visits, and 7.3% hospitalizations. Factors associated with exacerbation risk were obesity (OR, 95% CI 2.46, 1.11-5.41), psychic disorders (2.87, 0.89-9.30-borderline), nasal polyps (1.86, 0.88-3.89-borderline), partial/poor asthma treatment adherence (2.54, 0.97-6.67-borderline), and anti-IgE use in a protective way (0.26, 0.12-0.53). Comparisons to severe asthma multicenter studies and available registries showed data consistency across European and American populations. An international effort in the implementation of SUA patients' registries could help to better understand the clinical features and to manage severe asthma, representing a non-negligible socioeconomic burden for health services. © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

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.

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.

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.

Comparative effectiveness of commonly used devices for carotid artery stenting: an NCDR Analysis (National Cardiovascular Data Registry).

PubMed

Giri, Jay; Kennedy, Kevin F; Weinberg, Ido; Hawkins, Beau M; Press, Marcella Calfon; Drachman, Douglas; McCormick, Daniel J; Aronow, Herbert D; White, Christopher J; Rosenfield, Kenneth; Yeh, Robert W

2014-02-01

This study sought to characterize usage and outcomes of carotid stenting platforms. A variety of stents and embolic protection devices (EPDs) are used for carotid artery stenting. Little is known about current usage patterns and differences in outcomes with these devices. We analyzed 12,135 consecutive carotid stent procedures in the NCDR (National Cardiovascular Data Registry) CARE (Carotid Artery Revascularization and Endarterectomy) registry performed between January 1, 2007 and March 31, 2012. We compared baseline characteristics and crude and multivariable-adjusted rates of in-hospital combined death/stroke among patients treated with Acculink/Accunet (Abbott Laboratories, Abbott Park, Illinois), Xact/Emboshield (Abbott), and Precise/Angioguard (Cordis Corporation, Bridgewater, New Jersey) stent/EPD combinations. In 78.2% of cases, stents were used in conjunction with their specific, corresponding U.S. Food and Drug Administration-approved EPD. The Acculink/Accunet (n = 2,617, 21.6%), Xact/Emboshield (n = 3,507, 28.9%), and Precise/Angioguard (n = 2,696, 22.2%) stent/EPD combinations were used in 72.7% of all cases. The Protégé/SpiderFx (ev3 Endovascular Inc., Plymouth, Minnesota) (n = 453, 3.7%) and Wallstent/Filterwire (Boston Scientific, Natick, Massachusetts) (n = 213, 1.8%) devices were used in a minority of cases. In unadjusted analyses, the Precise/Angioguard system was associated with higher rates of the primary outcome than were the Acculink/Accunet (2.5% vs. 1.8%; p = 0.058) and Xact/Emboshield (2.5% vs. 1.9%; p = 0.14) systems that were not statistically different. In adjusted analyses, differences between Precise/Angioguard and Accunet/Acculink (odds ratio [OR]: 1.48, 95% confidence interval [CI]: 0.89 to 2.47; p = 0.065), Precise/Angioguard and Xact/Emboshield (OR: 1.16, 95% CI: 0.77 to 1.76; p = 0.38), and Xact/Emboshield and Accunet/Acculink (OR: 1.28, 95% CI: 0.82 to 1.97; p = 0.18) remained nonsignificant. In modern U.S. practice, the

A UK medical devices regulator's perspective on registries.

PubMed

Wilkinson, John; Crosbie, Andy

2016-04-01

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

[Individual linkage of primary data with secondary and registry data within large cohort studies - capabilities and procedural proposals].

PubMed

Stallmann, C; Ahrens, W; Kaaks, R; Pigeot, I; Swart, E; Jacobs, S

2015-02-01

Some German cohort studies have already linked secondary and registry data with primary data from interviews and medical examinations. This offers the opportunity to obtain more valid information by taking advantage of the strengths of these data synergistically and overcome their individual weaknesses at the same time. The potential and the requirements for linking secondary and registry data with primary data from cohort studies is described generally and illustrated by the example of the "German National Cohort" (GNC). The transfer and usage of secondary and registry data require that administrative and logistic efforts be made over the whole study period. In addition, rigid data protection regulations for using social data have to be observed. The particular strengths of secondary and registry data, namely their objectivity and independence from recall bias, add to the strengths of newly collected primary data and improve the assessment of morbidity endpoints, exposure history and need of patient care. Moreover, new insights on quality and on the added value of linking different data sources may be obtained. © Georg Thieme Verlag KG Stuttgart · New York.

Pregnancy, Birth, and Infant Health Outcomes from the National Smallpox Health Vaccine in Pregnancy Registry, 2003-2006

DTIC Science & Technology

2008-01-01

PREGNANCY REGISTRY TEAM From the US Department of Defense: Ava Conlin, Brianna Alexander, Rosha Aran- Loach , Katherine Campbell, Shirley Chow, Renata Engler...Sonja S. Hutchins, Kristin Ken - yan, Sheryl B. Lyss, and Joseph Mulinare. Acknowledgments We gratefully acknowledge the support of all of the

The spectrum of glomerulonephritis in saudi arabia: the results of the saudi registry.

PubMed

Huraib, S; Al Khader, A; Shaheen, F A; Abu Aisha, H; Souqiyyeh, M Z; Al Mohana, F; Soliman, M; Al Wakeel, J; Mitwalli, A; Al Mohaya, S; Said, R; Al Menawy, L; Sohaibani, M; Chan, N

2000-01-01

Only few studies regarding glomerulonephritis, with relatively small numbers of patients, have so far been published from different centers in Saudi Arabia, and have reported conflicting results regarding the patterns, even in the same city. The possible reasons for these differences include the small number of patients in the different studies, differences in the indications for renal biopsies, referral bias, geographical differences, and, sometimes, the non-availability of the necessary diagnostic facilities in the reporting centers. In order to overcome these problems, a registry for glomerulonephropathy was attempted in Saudi Arabia. Six large referral hospitals from different regions of Saudi Arabia participated in this registry. Biopsy reports and clinical information of 1294 renal biopsies were obtained. There were 782 renal biopsies due to glomerulonephritis (GN) accounting for 77.2% of the total biopsies. Five hundred eighty seven (72.6%) were primary glomerulonephritidis. Focal and segmental glomerulosclerosis (FSGS) (21.3%) and membrano-proliferative glomerulonephritis (MPGN) (20.7%) were the most common types found in the primary glomerulonephritidis. Membranous glomerulonephritis (MGN) was present in only 10.6% of the cases. IgA nephropathy was found in 6.5% of the cases. Of the secondary glomerulo-nephritides, systemic lupus erythematosus (SLE) was the most common indication for biopsy (57.0%) and amyloidosis was found in only 3.2% of the biopsies. In conclusion, FSGS and MPGN were the most common forms of primary glomerulonephritis in adult patients in Saudi Arabia. MGN was not as common as in the western world. SLE was the commonest cause of secondary GN. Amyloidosis was not as common as in other Arab countries. There is a need for more centers from Saudi Arabia to join this national GN registry. Similar registries can be established in different Arab countries, which all would, hopefully, lead to a Pan-Arab GN registry.

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

United States Transuranium and Uranium Registries

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

Kathren, R.L.; Filipy, R.E.; Dietert, S.E.

1991-06-01

This report summarizes the primary scientific activities of the United States Transuranium and Uranium Registries for the period October 1, 1989 through September 30, 1990. The Registries are parallel human tissue research programs devoted to the study of the actinide elements in humans. To date there have been 261 autopsy or surgical specimen donations, which include 11 whole bodies. The emphasis of the Registry was directed towards quality improvement and the development of a fully computerized data base that would incorporate not only the results of postmortem radiochemical analysis, but also medical and monitoring information obtained during life. Human subjectsmore » reviews were also completed. A three compartment biokinetic model for plutonium distribution is proposed. 2 tabs.« less

External Validation of the Prestroke Independence, Sex, Age, National Institutes of Health Stroke Scale Score for Predicting Pneumonia After Stroke Using Data From the China National Stroke Registry.

PubMed

Zhang, Runhua; Ji, Ruijun; Pan, Yuesong; Jiang, Yong; Liu, Gaifen; Wang, Yilong; Wang, Yongjun

2017-05-01

Pneumonia is an important risk factor for mortality and morbidity after stroke. The Prestroke Independence, Sex, Age, National Institutes of Health Stroke Scale (ISAN) score was shown to be a useful tool for predicting stroke-associated pneumonia based on UK multicenter cohort study. We aimed to externally validate the score using data from the China National Stroke Registry (CNSR). Eligible patients with acute ischemic stroke (AIS) and intracerebral hemorrhage (ICH) in the CNSR from 2007 to 2008 were included. The area under the receiver operating characteristic (AUC) curve was used to evaluate discrimination. The Hosmer-Lemeshow goodness of fit test and Pearson correlation coefficient were performed to assess calibration of the model. A total of 19,333 patients (AIS = 14400; ICH = 4933) were included and the overall pneumonia rate was 12.7%. The AUC was .76 (95% confidence interval [CI]: .75-.78) for the subgroup of AIS and .70 (95% CI: .68-.72) for the subgroup of ICH. The Hosmer-Lemeshow test showed the ISAN score with the good calibration for AIS and ICH (P = .177 and .405, respectively). The plot of observed versus predicted pneumonia rates suggested higher correlation for patients with AIS than with ICH (Pearson correlation coefficient = .99 and .83, respectively). The ISAN score was a useful tool for predicting in-hospital pneumonia after acute stroke, especially for patients with AIS. Further validations need to be done in different populations. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Chronobiology of Acute Aortic Dissection in the Marfan Syndrome (from the National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions and the International Registry of Acute Aortic Dissection).

PubMed

Siddiqi, Hasan K; Luminais, Steven N; Montgomery, Dan; Bossone, Eduardo; Dietz, Harry; Evangelista, Arturo; Isselbacher, Eric; LeMaire, Scott; Manfredini, Roberto; Milewicz, Dianna; Nienaber, Christoph A; Roman, Mary; Sechtem, Udo; Silberbach, Michael; Eagle, Kim A; Pyeritz, Reed E

2017-03-01

Marfan syndrome (MFS) is an autosomal dominant connective tissue disease associated with acute aortic dissection (AAD). We used 2 large registries that include patients with MFS to investigate possible trends in the chronobiology of AAD in MFS. We queried the International Registry of Acute Aortic Dissection (IRAD) and the Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) registry to extract data on all patients with MFS who had suffered an AAD. The group included 257 patients with MFS who suffered an AAD from 1980 to 2012. The chi-square tests were used for statistical testing. Mean subject age at time of AAD was 38 years, and 61% of subjects were men. AAD was more likely in the winter/spring season (November to April) than the other half of the year (57% vs 43%, p = 0.05). Dissections were significantly more likely to occur during the daytime hours, with 65% of dissections occurring from 6 a.m. to 6 p.m. (p = 0.001). Men were more likely to dissect during the daytime hours (6 a.m. to 6 p.m.) than women (74% vs 51%, p = 0.01). These insights offer a glimpse of the times of greatest vulnerability for patients with MFS who suffer from this catastrophic event. In conclusion, the chronobiology of AAD in MFS reflects that of AAD in the general population. Copyright © 2016 Elsevier Inc. All rights reserved.

The Cost of Doing Business: Cost Structure of Electronic Immunization Registries

PubMed Central

Fontanesi, John M; Flesher, Don S; De Guire, Michelle; Lieberthal, Allan; Holcomb, Kathy

2002-01-01

Objective To predict the true cost of developing and maintaining an electronic immunization registry, and to set the framework for developing future cost-effective and cost-benefit analysis. Data Sources/Study Setting Primary data collected at three immunization registries located in California, accounting for 90 percent of all immunization records in registries in the state during the study period. Study Design A parametric cost analysis compared registry development and maintenance expenditures to registry performance requirements. Data Collection/Extraction Methods Data were collected at each registry through interviews, reviews of expenditure records, technical accomplishments development schedules, and immunization coverage rates. Principal Findings The cost of building immunization registries is predictable and independent of the hardware/software combination employed. The effort requires four man-years of technical effort or approximately $250,000 in 1998 dollars. Costs for maintaining a registry were approximately $5,100 per end user per three-year period. Conclusions There is a predictable cost structure for both developing and maintaining immunization registries. The cost structure can be used as a framework for examining the cost-effectiveness and cost-benefits of registries. The greatest factor effecting improvement in coverage rates was ongoing, user-based administrative investment. PMID:12479497

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

Patient-reported outcome measures in arthroplasty registries

PubMed Central

Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill

2016-01-01

The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175

RECONSTRUCTION OF INDIVIDUAL DOSES DUE TO MEDICAL EXPOSURES FOR MEMBERS OF THE TECHA RIVER COHORT

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

Shagina, N. B.; Golikov, V.; Degteva, M. O.

Purpose: To describe a methodology for reconstruction of doses due to medical exposures for members of the Techa River Cohort (TRC) who received diagnostic radiation at the clinic of the Urals Research Center for Radiation Medicine (URCRM) in 1952–2005. To calculate doses of medical exposure for the TRC members and compare with the doses that resulted from radioactive contamination of the Techa River. Material and Methods: Reconstruction of individual medical doses is based on data on x-ray diagnostic procedures available for each person examined at the URCRM clinics and values of absorbed dose in 12 organs per typical x-ray proceduremore » calculated with the use of a mathematical phantom. Personal data on x-ray diagnostic examinations have been complied in the computerized “Registry of x-ray diagnostic procedures.” Sources of information are archival registry books from the URCRM x-ray room (available since 1956) and records on x-ray diagnostic procedures in patient-case histories (since 1952). The absorbed doses for 12 organs of interest have been evaluated per unit typical x-ray procedure with account taken of the x-ray examination parameters characteristic for the diagnostic machines used at the URCRM clinics. These parameters have been evaluated from published data on technical characteristics of the x-ray diagnostic machines used at the URCRM clinics in 1952–1988 and taken from the x-ray room for machines used at the URCRM in 1989–2005. Absorbed doses in the 12 organs per unit typical x-ray procedure have been calculated with use of a special computer code, EDEREX, developed at the Saint-Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev. Individual accumulated doses of medical exposure have been calculated with a computer code, MEDS (Medical Exposure Dosimetry System), specifically developed at the URCRM. Results: At present, the “Registry of x-ray diagnostic procedures” contains information on individual x

Characteristics of small areas with high rates of hospital-treated self-harm: deprived, fragmented and urban or just close to hospital? A national registry study.

PubMed

O'Farrell, I B; Corcoran, P; Perry, I J

2015-02-01

Previous research has shown an inconsistent relationship between the spatial distribution of hospital treated self-harm and area-level factors such as deprivation and social fragmentation. However, many of these studies have been confined to urban centres, with few focusing on rural settings and even fewer studies carried out at a national level. Furthermore, no previous research has investigated if travel time to hospital services can explain the area-level variation in the incidence of hospital treated self-harm. From 2009 to 2011, the Irish National Registry of Deliberate Self Harm collected data on self-harm presentations to all hospital emergency departments in the country. The Registry uses standard methods of case ascertainment and also geocodes patient addresses to small area geographical level. Negative binomial regression was used to explore the ecological relationship between area-level self-harm rates and various area-level factors. Deprivation, social fragmentation and population density had a positive linear association with self-harm, with deprivation having the strongest independent effect. Furthermore, self-harm incidence was found to be elevated in areas that had shorter journey times to hospital. However, while this association became attenuated after controlling for other area-level factors it still remained statistically significant. A subgroup analysis examining the effect of travel time on specific methods of self-harm, found that this effect was most marked for self-harm acts involving minor self-cutting. Self-harm incidence was influenced by proximity to hospital services, population density and social fragmentation; however, the strongest area-level predictor of self-harm was deprivation. 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.

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.

14 CFR 47.19 - FAA Aircraft Registry.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false FAA Aircraft Registry. 47.19 Section 47.19 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.19 FAA Aircraft Registry. Each application, request, notification, or other...

Association of Pulmonary Tuberculosis and Diabetes in Mexico: Analysis of the National Tuberculosis Registry 2000-2012.

PubMed

Delgado-Sánchez, Guadalupe; García-García, Lourdes; Castellanos-Joya, Martín; Cruz-Hervert, Pablo; Ferreyra-Reyes, Leticia; Ferreira-Guerrero, Elizabeth; Hernández, Andrés; Ortega-Baeza, Victor Manuel; Montero-Campos, Rogelio; Sulca, José Antonio; Martínez-Olivares, Ma de Lourdes; Mongua-Rodríguez, Norma; Baez-Saldaña, Renata; González-Roldán, Jesús Felipe; López-Gatell, Hugo; Ponce-de-León, Alfredo; Sifuentes-Osornio, José; Jiménez-Corona, María Eugenia

2015-01-01

Tuberculosis (TB) remains a public health problem in Mexico while the incidence of diabetes mellitus type 2 (DM) has increased rapidly in recent years. To describe the trends of incidence rates of pulmonary TB associated with DM and not associated with DM and to compare the results of treatment outcomes in patients with and without DM. We analysed the National Tuberculosis Registry from 2000 to 2012 including patients with pulmonary TB among individuals older than 20 years of age. The association between DM and treatment failure was analysed using logistic regression, accounting for clustering due to regional distribution. In Mexico from 2000 to 2012, the incidence rates of pulmonary TB associated to DM increased by 82.64%, (p<0.001) in contrast to rates of pulmonary TB rate without DM, which decreased by 26.77%, (p<0.001). Patients with a prior diagnosis of DM had a greater likelihood of failing treatment (adjusted odds ratio, 1.34 (1.11-1.61) p<0.002) compared with patients who did not have DM. There was statistical evidence of interaction between DM and sex. The odds of treatment failure were increased in both sexes. Our data suggest that the growing DM epidemic has an impact on the rates of pulmonary TB. In addition, patients who suffer from both diseases have a greater probability of treatment failure.

Acute injuries in soccer, ice hockey, volleyball, basketball, judo, and karate: analysis of national registry data.

PubMed Central

Kujala, U. M.; Taimela, S.; Antti-Poika, I.; Orava, S.; Tuominen, R.; Myllynen, P.

1995-01-01

OBJECTIVE--To determine the acute injury profile in each of six sports and compare the injury rates between the sports. DESIGN--Analysis of national sports injury insurance registry data. SETTING--Finland during 1987-91. SUBJECTS--621,691 person years of exposure among participants in soccer, ice hockey, volleyball, basketball, judo, or karate. MAIN OUTCOME MEASURES--Acute sports injuries requiring medical treatment and reported to the insurance company on structured forms by the patients and their doctors. RESULTS--54,186 sports injuries were recorded. Injury rates were low in athletes aged under 15, while 20-24 year olds had the highest rates. Differences in injury rates between the sports were minor in this adult age group. Overall injury rates were higher in sports entailing more frequent and powerful body contact. Each sport had a specific injury profile. Fractures and dental injuries were most common in ice hockey and karate and least frequent in volleyball. Knee injuries were the most common cause of permanent disability. CONCLUSIONS--Based on the defined injury profiles in the different sports it is recommended that sports specific preventive measures should be employed to decrease the number of violent contacts between athletes, including improved game rules supported by careful refereeing. To prevent dental injuries the wearing of mouth guards should be encouraged, especially in ice hockey, karate, and basketball. PMID:8520333

45 CFR 2540.202 - What two search components of the National Service Criminal History Check must I satisfy to...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Affecting the Selection and Treatment of Participants § 2540.202 What two search components of the National...; and (b) National Sex Offender Public Registry. A name-based search of the Department of Justice (DOJ) National Sex Offender Public Registry (NSOPR). [72 FR 48582, Aug. 24, 2007] ...

Decision counseling and participation in a pancreas cancer registry.

PubMed

Myers, Ronald; Lavu, Harish; Keith, Scott W; Kelly, Heidi; O'Rourke, Nadine; Cocroft, James; Quinn, Anna; Potluri, Vishnu; Yeo, Charles J

2014-01-01

Cancer registries play a vital role in research, as they provide important data that can be used to assess disease etiology and risk. Specialty registries can help to address the need for information on defined cancer types. However, achieving high rates of participation in such registries is problematic.We studied the impact of decision support on patient participation in a hospital-based pancreas cancer registry, the Jefferson Pancreas Tumor Registry (JPTR). In this study, we assembled a nonrandomized cohort of 40 patients, of whom 20 were exposed to the intervention and 20 were exposed to routine recruiting methods. Patients in the control group were invited to join the JPTR; while those in the intervention group were also invited to join the JPTR, and received decision support related to participation. Registry participation was assessed at 90 days. At baseline, patient gender, race, and stage of pancreatic cancer did not vary significantly between study groups. Overall, participation in the intervention group was significantly higher (P = 0.01) than in the control group (55% and 10%, respectively). In the intervention group, altruism was the major factor motivating patient participation, while patient concerns related to treatment recovery, registration time and complexity, and the confidentiality of registry data discouraged participation.

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

PubMed

Homedes, Núria; Ugalde, Antonio

2015-06-01

To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. 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.

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

Using Israel's National Cancer Registry Database to Track Progress in the War against Cancer: A Challenge for Health Services.

PubMed

Robinson, Eliezer; Silverman, Barbara G; Keinan-Boker, Lital

2017-04-01

The number of cancer survivors has been increasing worldwide and is now approximately 32.6 million and growing. Cancer survivors present a challenge to health care providers because of their higher susceptibility to long-term health outcomes related to their primary disease and treatment. To report on the number of cancer survivors and incident cancer cases in the period 1960-2009 in Israel, in order to provide data on the scope of the challenge Israel's health care funds face. The Israel National Cancer Registry (INCR) database was used to identify new cancer cases diagnosed during the period 1960-2009. Lifetable analysis was used to assess changes in cumulative survival and population prevalence of cancer survivors throughout the 50 year study period. Almost 600,000 invasive cancer cases were diagnosed during the period 1960-2009 (overall absolute survival rate 54%). Within this time period, the number of new patients diagnosed with cancer increased fivefold and that of cancer survivors ninefold. The absolute survival of cancer patients and the prevalence of cancer survivors in the general population significantly increased with time from 34% and 0.5%, respectively (1960-1969), to 62% and 1.9%, respectively (2000-2009). Cumulative absolute survival for 5, 10 and 15 years following diagnosis increased with time as well. The INCR database is useful to assess progress in the war against cancer. The growing numbers of cancer survivors in Israel present a challenge to the national health and social services system.

[History of the cancer registry in Mexico].

PubMed

Allende-López, Aldo; Fajardo-Gutiérrez, Arturo

2011-01-01

A cancer registry is to record the data which let us to know the epidemiology of neoplasm, but led us take a decision in medical policy about this health problem that benefit patients. In this paper we did a brief historical review about models and attempts for having a cancer registry in Mexico. However, since 1940 "the fight against cancer" was declared, we have not had a confident cancer registry today validated and built with data from whole the country. In 1982, the Registro Nacional del Cancer was created. The design and validation of a registration card in four hospitals were the main results. In 1988, the Registro Nacional del Cancer was reinforced with a computerized system for facilitation the data capture. In 1994, it was signed the first interinstitutional agreement that led to Registro Histopatol6gico de Neoplasias Malignas. In 1996, the Instituto Mexicano del Seguro Social established a cancer registry in children in Mexico with the intention to have data from this population.

Integrating data from multiple sources for data completeness in a web-based registry for pediatric renal transplantation--the CERTAIN Registry.

PubMed

Köster, Lennart; Krupka, Kai; Höcker, Britta; Rahmel, Axel; Samuel, Undine; Zanen, Wouter; Opelz, Gerhard; Süsal, Caner; Döhler, Bernd; Plotnicki, Lukasz; Kohl, Christian D; Knaup, Petra; Tönshoff, Burkhard

2015-01-01

Patient registries are a useful tool to measure outcomes and compare the effectiveness of therapies in a specific patient population. High data quality and completeness are therefore advantageous for registry analysis. Data integration from multiple sources may increase completeness of the data. The pediatric renal transplantation registry CERTAIN identified Eurotransplant (ET) and the Collaborative Transplant Study (CTS) as possible partners for data exchange. Import and export interfaces with CTS and ET were implemented. All parties reached their projected goals and benefit from the exchange.

A registry for exposure and population health in the Altai region affected by fallout from the Semipalatinsk nuclear test site.

PubMed

Shoikhet, Y N; Kiselev, V I; Zaitsev, E V; Kolyado, I B; Konovalov, B Y; Bauer, S; Grosche, B; Burkart, W

1999-09-01

A registry of the rural population in the Altai region exposed to fallout from nuclear tests at the Semipalatinsk test site (STS) was established more than four decades after the first Soviet nuclear explosion on August 29, 1949. Information about individuals living in an exposed and a control area was collected using all available local sources, such as kolkhoz documentation, school registries, medical treatment records and interviews with residents. As a result, a database comprising an exposed group of 39 179 individuals from 53 Altai region villages, 6769 external and 3303 internal controls was compiled. For several settlements, effective dose estimates reached the level of 1.5 Sv, while the average effective dose estimate in the exposed group was 340 mSv. Dosimetric data, vital status information and health records gathered at rayon and village medical facilities are held in the registry. Cause-of-death information for deceased residents is obtained from death registration forms archived at the Altai region vital statistics office. At present, a follow-up of approximately 40% of the population exposed in 1949 has been done. More will be added by searching for migrants to the larger towns of the Altai region, i.e. Barnaul, Rubtsovsk and Biisk. In order to assess the influence of radiation exposure, analytical studies with a case-control design for stomach and lung cancer are currently being prepared. The number of known cases is sufficient to detect an odds ratio of 1.5 at the 95% confidence level. Epidemiological studies in populations affected by fallout from STS may be equally important to the atomic bomb survivors' study for the direct quantification of radiation effects. The range of exposure rates experienced will extend the acute high-dose-rate findings from Hiroshima/Nagasaki towards acute and protracted lower exposures, which are more relevant for radiation protection issues.

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

Differences in the Korea Acute Myocardial Infarction Registry Compared with Western Registries

PubMed Central

2017-01-01

The Korea Acute Myocardial Infarction Registry (KAMIR) is the first nationwide registry that reflects current therapeutic approaches and acute myocardial infarction (AMI) management in Korea. The results of the KAMIR demonstrated different risk factors and responses to medical and interventional treatments. The results indicated that the incidence of ST-elevation myocardial infarction (STEMI) was relatively high, and that the prevalence of dyslipidemia was relatively low with higher triglyceride and lower high-density lipoprotein cholesterol levels. Percutaneous coronary intervention (PCI) rates were high for both STEMI and non-ST-elevation myocardial infarction (NSTEMI) with higher use of drug-eluting stents (DESs). DES were effective and safe without increased risk of stent thrombosis in Korean AMI patients. Triple antiplatelet therapy, consisting of aspirin, clopidogrel, and cilostazol, was effective in preventing adverse clinical outcomes after PCI. Statin therapy was effective in Korean AMI patients, including those with very low levels of low-density lipoprotein cholesterol and those with cardiogenic shock. The KAMIR score had a greater predictive value than Thrombolysis in Myocardial Infarction (TIMI) and Global Registry of Acute Coronary Events (GRACE) scores for long-term mortality in AMI patients. Based on these results, the KAMIR will be instrumental for establishing new therapeutic strategies and effective methods for secondary prevention of AMI and guidelines for Asian patients. PMID:29035427

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 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.

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.

77 FR 73657 - Public Buildings Service; Submission for OMB Review; Art-in-Architecture Program National Artist...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... Buildings Service; Submission for OMB Review; Art-in- Architecture Program National Artist Registry (GSA... Architecture Program National Artist Registry (GSA Form 7437). A notice was published in the Federal Register at 77 FR 58141, on September 19, 2012. No comments were received. The Art-in-Architecture Program is...

The New ADL Registry. ADL Registry Web Portal Changes

DTIC Science & Technology

2009-08-19

Questions or Comments? Jason Haag Learning Technology Analyst jason.haag.ctr@adlnet.gov +1.850.471.1300 ...PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Advanced Decision Learning (ADL),Joint ADL Co-Lab,13501 Ingenuity Drive Suite 248,Orlando,FL,32826 8... Technologies /adlr/  News and Announcements  Frequently Asked Questions (FAQ)  Documentation  Events and Event Registration 4 ADL Registry Functional

Ten years and 100,000 participants later: occupational and other factors influencing participation in US Gulf War health registries.

PubMed

Smith, Tyler C; Smith, Besa; Ryan, Margaret A K; Gray, Gregory C; Hooper, Tomoko I; Heller, Jack M; Dalager, Nancy A; Kang, Han K; Gackstetter, Gary D

2002-08-01

For more than a decade after the Gulf War, there has been concern that wartime exposures have resulted in significant morbidity among Gulf War veterans. After the end of the war, the Department of Veterans Affairs (VA) and the Department of Defense (DoD) initiated health registries to provide systematic clinical evaluations of Gulf War veterans who chose to participate. By September 1999, there were 32,876 participants in the DoD Comprehensive Clinical Evaluation Program and 70,385 participants in the VA Gulf War Registry Health Examination Program. We identified demographic and military service factors, as well as potential war-related exposures associated with subsequent registry participation after 10 years of observation. Veterans potentially exposed to oil well fire smoke, those near Khamisiyah, Reserve and National Guard, Army veterans, and veterans in the theater of operations during intense combat periods were most likely to elect to participate in a registry. These findings support the hypothesis that certain occupational factors and wartime exposures may influence subsequent health care-seeking behavior.

Analysis of the Spanish national registry for pediatric home enteral nutrition (NEPAD): implementation rates and observed trends during the past 8 years.

PubMed