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Sample records for national disease registries

  1. Respiratory diseases registries in the national registry of rare diseases.

    PubMed

    Lara Gallego, Beatriz; Abaitua Borda, Ignacio; Galán Gil, Genaro; Castillo Villegas, Diego; Casanova Espinosa, Álvaro; Cano Jiménez, Esteban; Ojanguren Arranz, Iñigo; Posada de la Paz, Manuel

    2014-09-01

    This report describes the general characteristics, objectives and organizational aspects of the registries of rare respiratory diseases included in the National Registry of Rare Diseases of the Research Institute for Rare Diseases (ISCIII), in order to publicize their existence and encourage the participation of professionals. Information is collected on the following conditions: alpha-1 antitrypsin deficiency, idiopathic tracheal stenosis, adult pulmonary Langerhans' cell histiocytosis, lymphangioleiomyomatosis, alveolar proteinosis, and sarcoidosis. Copyright © 2013 SEPAR. Published by Elsevier Espana. All rights reserved.

  2. Establishment of an Australian National Genetic Heart Disease Registry.

    PubMed

    Ingles, Jodie; McGaughran, Julie; Vohra, Jitendra; Weintraub, Robert G; Davis, Andrew; Atherton, John; Semsarian, Christopher

    2008-12-01

    A National Genetic Heart Disease Registry has recently been established, with the aim to enroll every family in Australia with a genetically determined cardiomyopathy or primary arrhythmic disorder. The Registry seeks to further our understanding of the impact and burden of disease in this population; increase awareness and provide education to health professionals and families; and establish a large cardiac genetic cohort as a resource for approved research studies. The Registry is currently recruiting families with inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy) and primary arrhythmogenic disorders (e.g. long QT syndrome), with scope to expand this in the future. Affected individuals, as well as their first-degree (at-risk) family members are eligible to enroll. Participants are currently being recruited from cardiac genetics clinics in approved recruitment sites and hope to expand to other Australian centres including general cardiology practice in the future. A significant focus of the Registry is to improve understanding and create awareness of inherited heart diseases, which includes ensuring families are aware of genetic testing options and current clinical screening recommendations for at-risk family members. A Registry Advisory Committee has been established under the NHMRC Guidelines, and includes a representative from each major recruitment centre. This committee approves all decisions relating to the Registry including approval of research studies. A National Genetic Heart Disease Registry will provide a valuable resource to further our knowledge of the clinical and genetic aspects of these diseases. Since most of the current data about the prevalence, natural history and outcomes of genetic heart diseases has emanated from the United States and Europe, characterising these Australian populations will be of significant benefit, allowing for more informed and specific health care planning and resource provision.

  3. National Registry of Designated Intractable Diseases in Japan: Present Status and Future Prospects

    PubMed Central

    KANATANI, Yasuhiro; TOMITA, Naoko; SATO, Yoko; ETO, Akiko; OMOE, Hiroe; MIZUSHIMA, Hiroshi

    2017-01-01

    Japan promotes research related to intractable diseases and financially supports patients with these diseases. Intractable diseases are designated as those that fulfill the following criteria: (1) rarity (affecting less than 0.1% of the population in Japan), (2) unknown etiology, (3) lack of effective treatment, (4) necessity of long-term treatment, and (5) existence of objective diagnostic criteria and not necessarily equal to rare diseases in other countries. The construction of a national database is required to promote research to clarify the pathogenesis of these diseases and to develop pharmaceutical products and medical devices. The Ministry of Health, Labor, and Welfare launched an online registration system in 2001, but many problems associated with gathering and utilizing information on patients with intractable diseases remain. In this paper, we describe the present status of the national registry of designated intractable diseases in Japan and discuss future prospects. PMID:27666154

  4. Record linkage between hospital discharges and mortality registries for motor neuron disease case ascertainment for the Spanish National Rare Diseases Registry.

    PubMed

    Ruiz, Elena; Ramalle-Gómara, Enrique; Quiñones, Carmen

    2014-06-01

    Our objective was to analyse the coverage of hospital discharge data and the mortality registry (MR) of La Rioja to ascertain motor neuron disease (MND) cases to be included in the Spanish National Rare Diseases Registry. MND cases that occurred in La Rioja during the period 1996-2011 were selected from hospital discharge data and the MR by means of the International Classification of Diseases. Review of the medical histories was carried out to confirm the causes of death reported. Characteristics of the population with MND were analysed. A total of 133 patients with MND were detected in La Rioja during the period 1996-2011; 30.1% were only recorded in the hospital discharges data, 12.0% only in the MR, and 57.9% were recorded by both databases. Medical records revealed a miscoding of patients who had been diagnosed with progressive supranuclear palsy but were recorded in the MR with an MND code. In conclusion, the hospital discharges data and the MR appear to be complementary and are valuable databases for the Spanish National Rare Diseases Registry when MNDs are properly codified. Nevertheless, it would be advisable to corroborate the validity of the MR as data source since the miscoding of progressive supranuclear palsy has been corrected.

  5. The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease

    PubMed Central

    Larsen, Lone; Jensen, Michael Dam; Larsen, Michael Due; Nielsen, Rasmus Gaardskær; Thorsgaard, Niels; Vind, Ida; Wildt, Signe; Kjeldsen, Jens

    2016-01-01

    Aim The aims of The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease are to ensure that biological therapy and the clinical management of patients with inflammatory bowel disease (IBD) receiving biological treatment are in accordance with the national clinical guidelines and, second, the database allows register-based clinical epidemiological research. Study population The study population comprises all Danish patients with IBD (both children and adults) with ulcerative colitis, Crohn’s disease, and IBD unclassified who receive biological therapy. Patients will be enrolled consecutively when biological treatment is initiated. Main variables The variables in the database are: diagnosis, time of diagnosis, disease manifestation, indication for biological therapy, previous biological and nonbiological therapy, date of visit, clinical indices, physician’s global assessment, pregnancy and breastfeeding (women), height (children), weight, dosage (current biological agent), adverse events, surgery, endoscopic procedures, and radiology. Descriptive data Eleven clinical indicators have been selected to monitor the quality of biological treatment. For each indicator, a standard has been defined based on the available evidence. National results will be published in an annual report and local results on a quarterly basis. The indicators will be reported as department-specific proportions with 95% confidence intervals, and the national average will be provided for comparison. An estimated 1,200–1,300 new biological therapies are initiated each year in Danish patients with IBD. Conclusion The database will be available for research during 2016. Data will be made available by The Danish Clinical Registries (www.rkkp.dk). PMID:27822107

  6. 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…

  7. 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…

  8. Validation of diagnostic codes for Charcot–Marie–Tooth disease in the Danish National Patient Registry

    PubMed Central

    Vaeth, Signe; Jensen, Uffe Birk; Christensen, Rikke; Andersen, Henning

    2016-01-01

    Purpose To validate the diagnostic codes for Charcot–Marie–Tooth disease (CMT) in the Danish National Patient Registry (DNPR) using positive predictive value (PPV) as a measure of validity. Patients and methods We used the DNPR to identify all patients diagnosed with at least one primary CMT diagnosis at a specialized department in the Central Denmark Region during the period 1977–2012. From this population, we randomly selected 123 patients for the validation study. Medical files were reviewed and used as reference standard. We estimated the PPV of the CMT diagnoses and stratified the analysis according to age at diagnosis, gender, and calendar time. Results In the DNPR, 275 patients were identified. We were able to retrieve 96 medical files from the random sample of 123 patients, and 85 CMT diagnoses were confirmed. The average age at diagnosis was 42.5 years, and 34% were female. The PPV was 88.5% (95% confidence interval: 80.4–94.1). Conclusion The CMT diagnoses in the DNPR have high validity. The DNPR can be used as a data source for epidemiologic research on CMT. PMID:27920579

  9. Pregnancy outcome for women with Crohn's disease: a follow-up study based on linkage between national registries.

    PubMed

    Fonager, K; Sørensen, H T; Olsen, J; Dahlerup, J F; Rasmussen, S N

    1998-12-01

    Crohn's disease, characterized by chronic intestinal inflammation, is sometimes followed by malabsorption, which may interfere with embryogenesis and fetal growth. Therefore we examined birthweight, the frequency of preterm birth, and other reproductive outcomes in the offspring of women with Crohn's disease. We used a historical registry-based study, with linkage between the Danish National Registry of Patients and the Danish Medical Birth Registry. Included were 510 newborns to mothers with Crohn's disease and 3018 controls in the study period from 1982 to 1992. The average birthweight of newborns to mothers with Crohn's disease was 185 g, 134 g less than expected for primiparas and multiparas. After adjusting for potential confounders the differences were 142 g (95% confidence interval [CI95%] = 76, 208) and 105 g (CI95% = 37, 173), respectively. The risk of low birthweight was increased in Crohn patients (odds ratio [OR] = 2.4; CI95% = 1.6-3.7), as was the risk of preterm birth (OR = 1.6; CI95% = 1.1-2.3). We found a lower birthweight in newborns of patients with Crohn's disease, indicating that Crohn's disease or its treatment may influence fetal growth.

  10. If you build a rare disease registry, will they enroll and will they use it? Methods and data from the National Registry of Myotonic Dystrophy (DM) and Facioscapulohumeral Muscular Dystrophy (FSHD)

    PubMed Central

    Hilbert, James E.; Kissel, John T.; Luebbe, Elizabeth A.; Martens, William B.; McDermott, Michael P.; Sanders, Donald B.; Tawil, Rabi; Thornton, Charles A.; Moxley, Richard T.

    2011-01-01

    Introduction Registries are becoming increasingly important for rare diseases as experimental therapies develop. This report describes the methodology behind the National Registry of Myotonic Dystrophy (DM) and Facioscapulohumeral Muscular Dystrophy (FSHD) Patients and Family Members to facilitate the development of other rare disease registries. We also highlight data about the pathophysiology and select burdens of DM and FSHD reported at baseline and longitudinally. Methods The Registry consists of de-identified, patient reported information collected at baseline and annually and information from review of medical records. Investigators can use the Registry to analyze de-identified data and to facilitate recruitment into clinical studies. Results To date, the Registry has enrolled 1611 members, facilitated 24 studies, and collected data annually for up to 8 years. Genetic test results were obtained in 56.2% of enrollees. Approximately one-third of members used assistive devices and another one-third reported psychological problems at baseline. Wheelchair use was reported for both short and long distances by 7.0% of DM and 18.1% of FSHD members. Approximately 60% of members reported their employment was affected by their disease. Conclusions Strengths of the Registry include large sample sizes, stringent review of clinical and molecular data, annually updated information, and regular interactions between patients and investigators. Registry data provide new insights into the burdens of DM and FSHD, such as, psychological problems and reduced employment. Opportunities abound for investigators to utilize Registry resources to assess the impact of these and other burdens on health care costs, progression of symptoms, and quality of life. PMID:22155025

  11. 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.

  12. Iranian Joint Registry (Iranian National Hip and Knee Arthroplasty Registry)

    PubMed Central

    Aslani, Hamidreza; Nourbakhsh, Seyed Taghi; Lahiji, Farivar A.; Heydarian, Keykavoos; Jabalameli, Mahmood; Ghazavi, Mohammad Taghi; Tahmasebi, Mohammad Naghi; Fayyaz, Mahmoud Reza; Sazegari, Mohammad Ali; Mohaddes, Maziar; Rajabpour, Mojtaba; Emami, Mohammad; Jazayeri, Seyyed Mohammad; Madadi, Firooz; Farahini, Hossein; Mirzatoloee, Fardin; Gharahdaghi, Mohammad; Ebrahimzadeh, Mohammad Hossein; Ebrahimian, Mohammadreza; Mirvakili, Hossein; Bashti, Kaveh; Almasizadeh, Mohtasham; Abolghasemian, Mansour; Taheriazam, Afshin; Motififard, Mehdi; Yazdi, Hamidreza; Mobarakeh, Mahmood Karimi; Shayestehazar, Masoud; Moghtadae, Mehdi; Siavashi, Babak; Sajjadi, Mohammadreza M.; Rasi, Alireza Manafi; Chabok, Seyyed Kazem; Zafarani, Zohreh; Salehi, Shahin; Ahmadi, Monireh; Mohammadi, Amin; Shahsavand, Mohammad Ebrahim

    2016-01-01

    Periodic evaluation and monitoring the health and economic outcome of joint replacement surgery is a common and popular process under the territory of joint registries in many countries. In this article we introduce the methodology used for the foundation of the National Iranian Joint Registry (IJR) with a joint collaboration of the Social Security Organization (SSO) and academic research departments considering the requirements of the Iran’s Ministry of Health and Education. PMID:27200403

  13. Iranian Joint Registry (Iranian National Hip and Knee Arthroplasty Registry).

    PubMed

    Aslani, Hamidreza; Nourbakhsh, Seyed Taghi; Lahiji, Farivar A; Heydarian, Keykavoos; Jabalameli, Mahmood; Ghazavi, Mohammad Taghi; Tahmasebi, Mohammad Naghi; Fayyaz, Mahmoud Reza; Sazegari, Mohammad Ali; Mohaddes, Maziar; Rajabpour, Mojtaba; Emami, Mohammad; Jazayeri, Seyyed Mohammad; Madadi, Firooz; Farahini, Hossein; Mirzatoloee, Fardin; Gharahdaghi, Mohammad; Ebrahimzadeh, Mohammad Hossein; Ebrahimian, Mohammadreza; Mirvakili, Hossein; Bashti, Kaveh; Almasizadeh, Mohtasham; Abolghasemian, Mansour; Taheriazam, Afshin; Motififard, Mehdi; Yazdi, Hamidreza; Mobarakeh, Mahmood Karimi; Shayestehazar, Masoud; Moghtadae, Mehdi; Siavashi, Babak; Sajjadi, Mohammadreza M; Rasi, Alireza Manafi; Chabok, Seyyed Kazem; Zafarani, Zohreh; Salehi, Shahin; Ahmadi, Monireh; Mohammadi, Amin; Shahsavand, Mohammad Ebrahim

    2016-04-01

    Periodic evaluation and monitoring the health and economic outcome of joint replacement surgery is a common and popular process under the territory of joint registries in many countries. In this article we introduce the methodology used for the foundation of the National Iranian Joint Registry (IJR) with a joint collaboration of the Social Security Organization (SSO) and academic research departments considering the requirements of the Iran's Ministry of Health and Education.

  14. 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.

  15. The Corrona US registry of rheumatic and autoimmune diseases.

    PubMed

    Kremer, Joel M

    2016-01-01

    The Corrona US national registry collects data concerning patient status from both the rheumatologist and patient at routine clinical encounters. Corrona has functioning disease registries in rheumatoid arthritis, psoriatic arthritis, spondyloarthropathies, psoriasis and inflammatory bowel disease. Corrona merges data concerning long-term effectiveness and safety, as well as comparative and cost effectiveness of agents to treat these autoimmune diseases.

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

    PubMed Central

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

    2017-01-01

    Summary China is facing the great challenge of treating the world's largest rare disease population, an estimated 16 million patients with rare diseases. One effort offering promise has been a pilot national project that was launched in 2013 and that focused on 20 representative rare diseases. Another government-supported special research program on rare diseases – the “Rare Diseases Clinical Cohort Study” – was launched in December 2016. According to the plan for this research project, the unified National Rare Diseases Registry System of China will be established as of 2020, and a large-scale cohort study will be conducted from 2016 to 2020. The project plans to develop 109 technical standards, to establish and improve 2 national databases of rare diseases – a multi-center clinical database and a biological sample library, and to conduct studies on more than 50,000 registered cases of 50 different rare diseases. More importantly, this study will be combined with the concept of precision medicine. Chinese population-specific basic information on rare diseases, clinical information, and genomic information will be integrated to create a comprehensive predictive model with a follow-up database system and a model to evaluate prognosis. This will provide the evidence for accurate classification, diagnosis, treatment, and estimation of prognosis for rare diseases in China. Numerous challenges including data standardization, protecting patient privacy, big data processing, and interpretation of genetic information still need to be overcome, but research prospects offer great promise. PMID:28357175

  17. Completeness and diagnostic validity of recording acute myocardial infarction events in primary care, hospital care, disease registry, and national mortality records: cohort study.

    PubMed

    Herrett, Emily; Shah, Anoop Dinesh; Boggon, Rachael; Denaxas, Spiros; Smeeth, Liam; van Staa, Tjeerd; Timmis, Adam; Hemingway, Harry

    2013-05-20

    To determine the completeness and diagnostic validity of myocardial infarction recording across four national health record sources in primary care, hospital care, a disease registry, and mortality register. Cohort study. 21 482 patients with acute myocardial infarction in England between January 2003 and March 2009, identified in four prospectively collected, linked electronic health record sources: Clinical Practice Research Datalink (primary care data), Hospital Episode Statistics (hospital admissions), the disease registry MINAP (Myocardial Ischaemia National Audit Project), and the Office for National Statistics mortality register (cause specific mortality data). One country (England) with one health system (the National Health Service). Recording of acute myocardial infarction, incidence, all cause mortality within one year of acute myocardial infarction, and diagnostic validity of acute myocardial infarction compared with electrocardiographic and troponin findings in the disease registry (gold standard). Risk factors and non-cardiovascular coexisting conditions were similar across patients identified in primary care, hospital admission, and registry sources. Immediate all cause mortality was highest among patients with acute myocardial infarction recorded in primary care, which (unlike hospital admission and disease registry sources) included patients who did not reach hospital, but at one year mortality rates in cohorts from each source were similar. 5561 (31.0%) patients with non-fatal acute myocardial infarction were recorded in all three sources and 11 482 (63.9%) in at least two sources. The crude incidence of acute myocardial infarction was underestimated by 25-50% using one source compared with using all three sources. Compared with acute myocardial infarction defined in the disease registry, the positive predictive value of acute myocardial infarction recorded in primary care was 92.2% (95% confidence interval 91.6% to 92.8%) and in hospital

  18. A national registry of thalassemia in Turkey; demographic and disease characteristics of patients, achievements and challenges in prevention.

    PubMed

    Aydınok, Yeşim; Oymak, Yeşim; Atabay, Berna; Aydoğan, Gönül; Yeşilipek, Akif; Ünal, Selma; Kılınç, Yurdanur; Oflaz, Banu; Akın, Mehmet; Vergin, Canan; Sezgin Evim, Melike; Çalışkan, Ümran; Ünal, Şule; Bay, Ali; Kazancı, Elif; İleri, Dilber Talia; Atay, Didem; Patıroğlu, Türkan; Kahraman, Selda; Söker, Murat; Akcan, Mediha; Akdeniz, Aydan; Büyükavcı, Mustafa; Alanoğlu, Güçhan; Bör, Özcan; Soyer, Nur; Özdemir Karadaş, Nihal; Uysalol, Ezgi; Türker, Meral; Akçay, Arzu; Ocak, Süheyla; Güneş, Adalet Meral; Tokgöz, Hüseyin; Uysal, Zümrüt; Tiftik, Naci; Karakaş, Zeynep

    2017-04-13

    Turkish Society of Pediatric Hematology set up a National Hemoglobinopathy Registry to demonstrate demographic and disease characteristics of patients, and assessed the efficacy of hemoglobinopathy control program (HCP) over 10 years in Turkey. A total of 2046 patients from 27 Thalassemia Centers were registered in which 1988 were eligible for analysis. This cohort mainly comprised patients with β-thalassemia major (n=1658, 83.4%) and intermedia (n=215, 10.8%). The majority of patients were accumulated into the costal areas of Turkey. The high number of patients in South Eastern Anatolia would be contributed by the highest rate of consanguinity marriage and fertility. The most common 11 mutations represented 90% of all β-thalassemia alleles in which 47% of those was IVS1-110(G->A). The probability to undergo splenectomy within the first 10 years of life was 20% and unchanged since 1980s. The iron chelators were administered as monotherapy regimen in 95% of patients and deferasirox was prescribed in 81.3% of those. Deferasirox administration was the highest (93.6%) in patients aged <10 years. The overall 5.8% of thalassemia major patients had match-related hemopoietic stem cell transplantation (HSCT) with a success rate of 77%. Cardiac disease was detected as a major cause of deaths and didn't show a decreasing trend at 5 years' cohorts since 1999. While, HCP has been implemented since 2003, the affected births have shown a consistent decrease only after 2009, at lowest 34 cases per year. The program failure was resulted from missing premarital screening in the majority. Following problems were unawareness of the risk and misinformation of the risk couples. In addition, prenatal diagnosis was either not offered to or not accepted by the risk families. This study indicated that a continuous effort is needed for optimizing management of thalassemia and developing strategies are essential for further achievements in HCP in Turkey.

  19. 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.

  20. The Danish National Multiple Myeloma Registry

    PubMed Central

    Gimsing, Peter; Holmström, Morten O; Klausen, Tobias Wirenfelt; Andersen, Niels Frost; Gregersen, Henrik; Pedersen, Robert Schou; Plesner, Torben; Pedersen, Per Trøllund; Frederiksen, Mikael; Frølund, Ulf; Helleberg, Carsten; Vangsted, Annette; de Nully Brown, Peter; Abildgaard, Niels

    2016-01-01

    Aim The Danish National Multiple Myeloma Registry (DMMR) is a population-based clinical quality database established in January 2005. The primary aim of the database is to ensure that diagnosis and treatment of plasma cell dyscrasia are of uniform quality throughout the country. Another aim is to support research. Patients are registered with their unique Danish personal identification number, and the combined use of DMMR, other Danish National registries, and the Danish National Cancer Biobank offers a unique platform for population-based translational research. Study population All newly diagnosed patients with multiple myeloma (MM), smoldering MM, solitary plasmacytomas, and plasma cell leukemia in Denmark are registered annually; ~350 patients. Amyloid light-chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome), monoclonal gammopathy of undetermined significance and monoclonal gammopathy of undetermined significance with polyneuropathy have been registered since 2014. Main variables The main registered variables at diagnosis are patient demographics, baseline disease characteristics, myeloma-defining events, clinical complications, prognostics, first- and second-line treatments, treatment responses, progression free, and overall survival. Descriptive data Up to June 2015, 2,907 newly diagnosed patients with MM, 485 patients with smoldering MM, 64 patients with plasma cell leukemia, and 191 patients with solitary plasmacytomas were registered. Registration completeness of new patients is ~100%. A data validation study performed in 2013–2014 by the Danish Myeloma Study Group showed >95% data correctness. Conclusion The DMMR is a population-based data validated database eligible for clinical, epidemiological, and translational research. PMID:27822103

  1. Diagnosis features of pediatric Gaucher disease patients in the era of enzymatic therapy, a national-base study from the Spanish Registry of Gaucher Disease.

    PubMed

    Andrade-Campos, Marcio; Alfonso, Pilar; Irun, Pilar; Armstrong, Judith; Calvo, Carmen; Dalmau, Jaime; Domingo, Maria-Rosario; Barbera, Jose-Luis; Cano, Horacio; Fernandez-Galán, Maria-Angeles; Franco, Rafael; Gracia, Inmaculada; Gracia-Antequera, Miguel; Ibañez, Angela; Lendinez, Francisco; Madruga, Marcos; Martin-Hernández, Elena; O'Callaghan, Maria Del Mar; Del Soto, Alberto Pérez; Del Prado, Yolanda Ruiz; Sancho-Val, Ignacio; Sanjurjo, Pablo; Pocovi, Miguel; Giraldo, Pilar

    2017-05-03

    The enzymatic replacement therapy (ERT) availability for Gaucher disease (GD) has changed the landscape of the disease, several countries have screening programs. These actions have promoted the early diagnosis and avoided many complications in pediatric patients. In Spain ERT has been available since 1993 and 386 patients have been included in the Spanish Registry of Gaucher Disease (SpRGD). The aim of this study is to analyze the impact of ERT on the characteristics at time of diagnosis and initial complications in pediatric Gaucher disease patients. To analyze the impact of ERT on the characteristics at time of diagnosis and initial complications in pediatric Gaucher disease patients. A review of data in SpRGD from patients' diagnosed before 18 years old was performed. The cohort was split according the year of diagnosis (≤1994, cohort A; ≥1995, cohort B). A total of 98 pediatric patients were included, GD1: 80, GD3: 18; mean age: 7.2 (0.17-16.5) years, 58 (59.2%) males and 40 (40.8%) females. Forty-five were diagnosed ≤ 1994 and 53 ≥ 1995. Genotype: N370S/N370S: 2 (2.0%), N370S/L444P: 27 (27.5%), N370S/other: 47 (48%), L444P/L444P: 7 (7.1%), L444P/D409H: 2 (2.0%), L444P/other: 3 (6.2%), other/other: 10 (10.2%). The mean age at diagnosis was earlier in patients diagnosed after 1995 (p < 0.001) and different between the subtypes, GD1: 8.2 (0.2-16.5) years and GD3: 2.8 (0.17-10.2) years (p < 0.001). There were more severe patients in the group diagnosed before 1994 (p = 0.045) carrying L444P (2), D409H (2), G377S (1), G195W (1) or the recombinant mutation. The patients' diagnosed ≤1994 showed worse cytopenias, higher chance of bone vascular complications at diagnosis and previous spleen removal. The patients started ERT at a median time after diagnosis of 5.2 years [cohort A] and 1.6 years [cohort B] (p < 0.001). The early diagnosis of Gaucher disease in the era of ERT availability has permitted to reduce the incidence of

  2. 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

  3. 76 FR 4092 - National Saltwater Angler Registry Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-24

    ... National Oceanic and Atmospheric Administration RIN 0648-XA131 National Saltwater Angler Registry Program... INFORMATION: The final rule implementing the National Saltwater Angler Registry Program, 50 CFR part 600... registered under a qualifying State license and/or registry program, or to provide catch and effort data...

  4. 78 FR 49478 - National Saltwater Angler Registry Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... National Oceanic and Atmospheric Administration RIN 0648-XC403 National Saltwater Angler Registry Program... Angler Registry Program. DATES: The registration fee will be required effective August 1, 2013. ADDRESSES... final rule implementing the National Saltwater Angler Registry Program, 50 CFR part 600, subpart P,...

  5. The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry.

    PubMed

    Cooperberg, Matthew R; Broering, Jeanette M; Litwin, Mark S; Lubeck, Deborah P; Mehta, Shilpa S; Henning, James M; Carroll, Peter R

    2004-04-01

    The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes. The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes. Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother. The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.

  6. 76 FR 28403 - National Registry of Certified Medical Examiners

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-17

    ... Certified Medical Examiners ACTION: Notice of availability of draft guidance; request for comments. SUMMARY... Medical Examiners (National Registry) proposed rule. The National Registry is required by section 4116 of... Registry and the proposal included minimum training requirements for medical examiners. The draft...

  7. National registry of patients with juvenile idiopathic inflammatory myopathies in Hungary--clinical characteristics and disease course of 44 patients with juvenile dermatomyositis.

    PubMed

    Constantin, T; Ponyi, A; Orbán, I; Molnár, K; Dérfalvi, B; Dicso, F; Kálovics, T; Müller, J; Garami, M; Sallai, A; Balogh, Z; Szalai, Z; Fekete, G; Dankó, K

    2006-05-01

    Idiopathic inflammatory myopathies (IIMs) are systemic autoimmune diseases characterized by chronic muscle inflammation resulting in progressive weakness and frequent involvement of internal organs, mainly the pulmonary, gastrointestinal and cardiac systems which considerably contribute to the morbidity and mortality of the IIMs. Aim of this study was to present clinical characteristics, disease course, frequency of relapses and survival in patients with juvenile dermatomyositis (DM). A national registry of patients with juvenile IIMs was elaborated by the authors in Hungary. We have summarized data of the register according to signs and symptoms, disease course, frequency of relapses and survival of patients with juvenile IIM. Analysis was performed using data of 44 patients with juvenile DM diagnosed between 1976 and 2004 according to Bohan and Peter's criteria. Survival probability was calculated by Kaplan-Meier method. Data of patients with juvenile DM were compared with data of 66 patients with adult DM. The most frequent cutaneous features were facial erythema and heliotrope rash. Extramuscular and extraskeletal manifestations of the disease were more frequent in adult patients. The most common extramuscular feature was arthralgia in both groups of patients with juvenile or adult DM. Cardiac manifestation of the disease was not observed in juvenile patients. Respiratory muscle involvement and interstitial lung disease (ILD) were more frequent among adult DM patients than cardiac manifestation of the myositis. In view of the disease course, the authors found that frequency of polycyclic and monophasic subtypes of the disease were mainly similar. The hazard of relapse was found higher during the first year after the remission. None of the juvenile patients died. Among adult patients four disease-specific deaths occurred. There was no correlation between relapse free survival and initial therapeutic regimen. Many of our patients had polycyclic or chronic disease

  8. 76 FR 38619 - Proposed Information Collection; Comment Request; National Saltwater Angler Registry and State...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... Saltwater Angler Registry and State Exemption Program AGENCY: National Oceanic and Atmospheric... currently approved collection. The National Saltwater Angler Registry Program (Registry Program) was... fisheries surveys, including establishing a national saltwater angler and for-hire vessel registry,...

  9. Inherited Retinal Degenerative Disease Registry

    ClinicalTrials.gov

    2016-03-21

    Eye Diseases Hereditary; Retinal Disease; Achromatopsia; Bardet-Biedl Syndrome; Bassen-Kornzweig Syndrome; Batten Disease; Best Disease; Choroidal Dystrophy; Choroideremia; Cone Dystrophy; Cone-Rod Dystrophy; Congenital Stationary Night Blindness; Enhanced S-Cone Syndrome; Fundus Albipunctatus; Goldmann-Favre Syndrome; Gyrate Atrophy; Juvenile Macular Degeneration; Kearns-Sayre Syndrome; Leber Congenital Amaurosis; Refsum Syndrome; Retinitis Pigmentosa; Retinitis Punctata Albescens; Retinoschisis; Rod-Cone Dystrophy; Rod Dystrophy; Rod Monochromacy; Stargardt Disease; Usher Syndrome

  10. Positive predictive value of the International Classification of Diseases, 10th edition diagnosis codes for anemia caused by bleeding in the Danish National Registry of Patients.

    PubMed

    Zalfani, Jihen; Frøslev, Trine; Olsen, Morten; Ben Ghezala, Inès; Gammelager, Henrik; Arendt, Johan Fb; Erichsen, Rune

    2012-01-01

    Valid data on anemia caused by bleeding are needed for epidemiological research and monitoring health care. The Danish National Registry of Patients (DNRP) is a nationwide medical database with information on all Danish residents' hospital history. We aimed to assess the positive predictive value (PPV) of the diagnostic coding of anemia caused by bleeding in the DNRP. In the DNRP, we identified all patients with International Classification of Disease, 10th edition codes for anemia caused by bleeding (acute: D50.0; chronic: D62.6) at three Danish hospitals from 2000 through 2009. For these patients we computed the PPV using hemoglobin level data, from Aarhus University laboratory database, as reference standard. Anemia was defined by a hemoglobin level less than 7.0 mmol/L for women and less than 8.0 mmol/L for men. We identified 3391 patients in the DNRP with a diagnosis of anemia caused by bleeding. The overall PPV was 95.4% (95% confidence interval [CI]: 94.6%-96.0%). The PPV was 97.6% (95% CI: 96.6%-98.3%) for men and 94.0% (95% CI: 92.9%-94.9%) for women, and the PPV increased with age at diagnosis. The PPV varied according to type of discharging departments, from 89.2% (95% CI: 83.4%-93.4%) in gynecology to 96.8% (95% CI: 94.9%-98.2%) in surgery, and was lower for outpatients compared with inpatients. We found a high PPV of the coding for anemia caused by bleeding in the DNRP. The registry is a valid source of data on anemia caused by bleeding for various purposes including research and monitoring health care.

  11. 76 FR 9578 - National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... Health and Chemical Exposures Leadership Council. The National Conversation on Public Health and Chemical... an action agenda for strengthening the nation's approach to protecting the public's health from... National Conversation on Public Health and Chemical Exposures, visit this Web site: http://www.atsdr.cdc...

  12. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2010-11-01

    1-0001 Brian A Trimble, MD Alaska Native Parkinson’s Disease Registry Principal Investigator A. Introduction Parkinsonism (PS) is a syndrome...characterized by tremor , rigidity, slowness of movement, and problems with walking and balance. Parkinson’s disease is the most common form of PS... parkinsonism cases will be the Indian Health Service (IHS) provider database, called the Resource and Patient Management System (RPMS), but the protocol will

  13. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2009-11-01

    W81XWH-07-1-0001 Brian A Trimble, MD Alaska Native Parkinson’s Disease Registry Principal Investigator A. Introduction Parkinsonism (PS) is a...syndrome characterized by tremor , rigidity, slowness of movement, and problems with walking and balance. Parkinson’s disease is the most common form...protocol. The primary source of parkinsonism cases will be the Indian Health Service (IHS) provider database, called the Resource and Patient Management

  14. 75 FR 59727 - National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... sixth meeting of the National Conversation on Public ] Health and Chemical Exposures Leadership Council... approach to protecting the public's health from harmful chemical exposures. The Leadership Council provides... agenda. For additional information on the National Conversation on Public Health and Chemical Exposures...

  15. 75 FR 75474 - National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... seventh meeting of the National Conversation on Public Health and Chemical Exposures Leadership Council... approach to protecting the public's health from harmful chemical exposures. The Leadership Council provides... agenda. For additional information on the National Conversation on Public Health and Chemical Exposures...

  16. 75 FR 16488 - National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... National Conversation on Public Health and Chemical Exposures Leadership Council, which is convened by RESOLVE, a non-profit independent facilitator. The National Conversation on Public Health and Chemical... public's health from harmful chemical exposures. The Leadership Council provides overall guidance to...

  17. The National Film Registry: Acquiring Our Film Heritage.

    ERIC Educational Resources Information Center

    Ziegler, Roy A.

    The National Film Registry, which is primarily a designated list of films to be preserved by the Library of Congress, is also a valuable tool for selecting "films that are culturally, historically, and aesthetically significant." Following a brief discussion of the history and selection process of the National Film Registry, Southeast…

  18. 75 FR 41505 - National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... on Public Health and Chemical Exposures Leadership Council Meeting Time and Date: 1 p.m.-5 p.m. EDT... National Conversation on Public Health and Chemical Exposures Leadership Council, which is convened by... protecting the public's health from harmful chemical exposures. The Leadership Council provides...

  19. Towards a national trauma registry for the United Arab Emirates

    PubMed Central

    2010-01-01

    Background Trauma is a major health problem in the United Arab Emirates (UAE) as well as worldwide. Trauma registries provide large longitudinal databases for analysis and policy improvement. We aim in this paper to report on the development and evolution of a national trauma registry using a staged approach by developing a single-center registry, a two-center registry, and then a multi-center registry. The three registries were established by developing suitable data collection forms, databases, and interfaces to these databases. The first two registries collected data for a finite period of time and the third is underway. The steps taken to establish these registries depend on whether the registry is intended as a single-center or multi-center registry. Findings Several issues arose and were resolved during the development of these registries such as the relational design of the database, whether to use a standalone database management system or a web-based system, and the usability and security of the system. The inclusion of preventive medicine data elements is important in a trauma registry and the focus on road traffic collision data elements is essential in a country such as the UAE. The first two registries provided valuable data which has been analyzed and published. Conclusions The main factors leading to the successful establishment of a multi-center trauma registry are the development of a concise data entry form, development of a user-friendly secure web-based database system, the availability of a computer and Internet connection in each data collection center, funded data entry personnel well trained in extracting medical data from the medical record and entering it into the computer, and experienced personnel in trauma injuries and data analysis to continuously maintain and analyze the registry. PMID:20618988

  20. Policies and procedures for establishing a national registry of persons exposed to hazardous substances (National Exposure Registry)

    SciTech Connect

    Not Available

    1988-01-01

    In the document, the Agency for Toxic Substances and Disease Registry (ATSDR) procedures for meeting the statutory mandate for a registry of persons exposed to hazardous substances are described. The rationale for and purpose of the Exposure Registry is to address health issues at hazardous waste sites and emergency chemical spills. The registry activity specifically addresses long-term health issues related to the exposures of hazardous substances and/or mixtures of hazardous substances. The creation of the registry is meant to provide--through the creation of large, valid data files--information needed by researchers to elucidate the presence or absence of the long-term health effects.

  1. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2013-07-01

    07-1-0001 TITLE: Alaska Native Parkinson’s Disease Registry PRINCIPAL INVESTIGATOR: Caroline M. Tanner, M.D...The views, opinions and/or findings contained in this report are those of the author( s ) and should not be construed as an official Department...GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR( S ) 5d. PROJECT NUMBER 5e. TASK NUMBER E-Mail: 5f. WORK UNIT NUMBER 7. PERFORMING

  2. Cancer registries in Japan: National Clinical Database and site-specific cancer registries.

    PubMed

    Anazawa, Takayuki; Miyata, Hiroaki; Gotoh, Mitsukazu

    2015-02-01

    The cancer registry is an essential part of any rational program of evidence-based cancer control. The cancer control program is required to strategize in a systematic and impartial manner and efficiently utilize limited resources. In Japan, the National Clinical Database (NCD) was launched in 2010. It is a nationwide prospective registry linked to various types of board certification systems regarding surgery. The NCD is a nationally validated database using web-based data collection software; it is risk adjusted and outcome based to improve the quality of surgical care. The NCD generalizes site-specific cancer registries by taking advantage of their excellent organizing ability. Some site-specific cancer registries, including pancreatic, breast, and liver cancer registries have already been combined with the NCD. Cooperation between the NCD and site-specific cancer registries can establish a valuable platform to develop a cancer care plan in Japan. Furthermore, the prognosis information of cancer patients arranged using population-based and hospital-based cancer registries can help in efficient data accumulation on the NCD. International collaboration between Japan and the USA has recently started and is expected to provide global benchmarking and to allow a valuable comparison of cancer treatment practices between countries using nationwide cancer registries in the future. Clinical research and evidence-based policy recommendation based on accurate data from the nationwide database may positively impact the public.

  3. Clinical presentation and management of stable coronary artery disease: insights from the international prospective CLARIFY registry - results from the Greek national cohort.

    PubMed

    Sbarouni, Eftihia; Voudris, Vassilis; Georgiadou, Panagiota; Hamilos, Michalis; Steg, P Gabriel; Fox, Kim M; Greenlaw, Nicola; Ferrari, Roberto; Vardas, Panos E

    2014-01-01

    Coronary artery disease (CAD) is highly prevalent worldwide, yet there is a paucity of data regarding the clinical characteristics and management of outpatients with stable CAD. In this paper, we report the baseline data of the Greek cohort and we compare our national data with the global results of the entire registry, as well as the results from the western European countries. CLARIFY is an international, prospective, observational, longitudinal registry of outpatients with stable CAD, defined as prior myocardial infarction or revascularization procedure, evidence of coronary stenosis >50%, or chest pain associated with proven myocardial ischemia. A total of 33,283 patients from 45 countries in 4 continents were enrolled between November 2009 and July 2010; of these, 14,726 were from western European countries (Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland and the United Kingdom) and 559 patients were enrolled in Greece. Compared to their counterparts in western Europe and the entire cohort, Greeks were younger (p<0.0001, p<0.0001, respectively), more predominantly male (p<0.0039, p<0.0001), with a higher body mass index (p<0.0002, p<0.0001) and a larger waist circumference (p<0.0001, p<0.0001), as well as a higher prevalence of family history of CAD (p<0.0008, 0.0005), hyperlipidemia (p<0.0001, p<0.0001) and smoking (p<0.0001, p<0.0001). Noninvasive testing (p<0.0001, p<0.0001, respectively) and coronary angiography (p<0.0001, 0.0013) along with surgical revascularization (CABG) (p<0.0001, 0.0088) were performed more often in Greece. Antiplatelets, b-blockers and lipid lowering medications were used to an equal extent in Greece as in the other two cohorts. There are substantial differences in demographics, clinical profiles and treatment in patients with stable CAD within the data set, which are also observed for Greek data. Interestingly, these differences are consistent in relation to the global

  4. Ethnic differences in the occurrence of acute coronary syndrome: results of the Malaysian National Cardiovascular Disease (NCVD) Database Registry (March 2006 - February 2010)

    PubMed Central

    2013-01-01

    Background The National Cardiovascular Disease (NCVD) Database Registry represents one of the first prospective, multi-center registries to treat and prevent coronary artery disease (CAD) in Malaysia. Since ethnicity is an important consideration in the occurrence of acute coronary syndrome (ACS) globally, therefore, we aimed to identify the role of ethnicity in the occurrence of ACS among high-risk groups in the Malaysian population. Methods The NCVD involves more than 15 Ministry of Health (MOH) hospitals nationwide, universities and the National Heart Institute and enrolls patients presenting with ACS [ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI) and unstable angina (UA)]. We analyzed ethnic differences across socio-demographic characteristics, hospital medications and invasive therapeutic procedures, treatment of STEMI and in-hospital clinical outcomes. Results We enrolled 13,591 patients. The distribution of the NCVD population was as follows: 49.0% Malays, 22.5% Chinese, 23.1% Indians and 5.3% Others (representing other indigenous groups and non-Malaysian nationals). The mean age (SD) of ACS patients at presentation was 59.1 (12.0) years. More than 70% were males. A higher proportion of patients within each ethnic group had more than two coronary risk factors. Malays had higher body mass index (BMI). Chinese had highest rate of hypertension and hyperlipidemia. Indians had higher rate of diabetes mellitus (DM) and family history of premature CAD. Overall, more patients had STEMI than NSTEMI or UA among all ethnic groups. The use of aspirin was more than 94% among all ethnic groups. Utilization rates for elective and emergency percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) were low among all ethnic groups. In STEMI, fibrinolysis (streptokinase) appeared to be the dominant treatment options (>70%) for all ethnic groups. In-hospital mortality rates for STEMI across ethnicity ranges

  5. Ethnic differences in the occurrence of acute coronary syndrome: results of the Malaysian National Cardiovascular Disease (NCVD) Database Registry (March 2006 - February 2010).

    PubMed

    Lu, Hou Tee; Nordin, Rusli Bin

    2013-11-06

    The National Cardiovascular Disease (NCVD) Database Registry represents one of the first prospective, multi-center registries to treat and prevent coronary artery disease (CAD) in Malaysia. Since ethnicity is an important consideration in the occurrence of acute coronary syndrome (ACS) globally, therefore, we aimed to identify the role of ethnicity in the occurrence of ACS among high-risk groups in the Malaysian population. The NCVD involves more than 15 Ministry of Health (MOH) hospitals nationwide, universities and the National Heart Institute and enrolls patients presenting with ACS [ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI) and unstable angina (UA)]. We analyzed ethnic differences across socio-demographic characteristics, hospital medications and invasive therapeutic procedures, treatment of STEMI and in-hospital clinical outcomes. We enrolled 13,591 patients. The distribution of the NCVD population was as follows: 49.0% Malays, 22.5% Chinese, 23.1% Indians and 5.3% Others (representing other indigenous groups and non-Malaysian nationals). The mean age (SD) of ACS patients at presentation was 59.1 (12.0) years. More than 70% were males. A higher proportion of patients within each ethnic group had more than two coronary risk factors. Malays had higher body mass index (BMI). Chinese had highest rate of hypertension and hyperlipidemia. Indians had higher rate of diabetes mellitus (DM) and family history of premature CAD. Overall, more patients had STEMI than NSTEMI or UA among all ethnic groups. The use of aspirin was more than 94% among all ethnic groups. Utilization rates for elective and emergency percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) were low among all ethnic groups. In STEMI, fibrinolysis (streptokinase) appeared to be the dominant treatment options (>70%) for all ethnic groups. In-hospital mortality rates for STEMI across ethnicity ranges from 8.1% to 10.1% (p = 0

  6. 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.

  7. Portuguese National Registry on Cardiac Electrophysiology, 2013 and 2014.

    PubMed

    Cavaco, Diogo; Morgado, Francisco; Bonhorst, Daniel

    2016-01-01

    The authors present the results of the national registry of electrophysiology of the Portuguese Association for Arrhythmology, Pacing and Electrophysiology (APAPE) for 2013 and 2014. The registry is annual and voluntary, and data are collected retrospectively. Data for electrophysiological studies, ablations and cardioverter-defibrillator implantations for 2013 and 2014 are presented. Developments over the years and their implications are analyzed and discussed.

  8. Existing data sources for clinical epidemiology: Danish registries for studies of medical genetic diseases

    PubMed Central

    Nguyen-Nielsen, Mary; Svensson, Elisabeth; Vogel, Ida; Ehrenstein, Vera; Sunde, Lone

    2013-01-01

    Denmark has an extensive collection of national and regional medical registries. There are many advantages to registry-based research when investigating genetic diseases which, due to their rarity, can be difficult to identify. In this study, we aimed to provide an updated overview of Danish registries for medical genetic conditions and describe how data linkage across registries can be used to collect data on genetic diseases at the individual level and at the family level. We present a list of medical genetic registries in Denmark at the national level, data sources from the departments of clinical genetics and other specialized centers, and project-specific data sources. We also summarize key general registries, such as the Danish National Registry of Patients, the Danish Medical Birth Registry, and the Civil Registration System, which are renowned for their comprehensive and high quality data, and are useful supplemental data sources for genetic epidemiology research. We describe the potential for data linkage across multiple registries, which allows for access to medical histories with follow-up time spanning birth to death. Finally, we provide a brief introduction to the Danish epidemiological research setting and legalities related to data access. The Danish collection of medical registries is a valuable resource for genetic epidemiology research. PMID:23966801

  9. [Legislation of cancer registries in Japan- an outline of the national cancer registry].

    PubMed

    Nishino, Yoshikazu

    2015-04-01

    The national cancer registry in Japan will commence operations in January 2016 under the Cancer Registry Promotion Act, which was established in December 2013. Although data on cancer incidence and survival rates in Japan have been available for limited regions for a long time, accurate nationwide data obtained from the national cancer registry database will contribute to the planning and evaluation of cancer control in Japan. It is expected that this database will be utilized in evaluating the quality of medical care for cancer patients, in assessing the accuracy of cancer screening, and in follow-up surveys in nationwide cohort studies. Furthermore, under the Cancer Registry Promotion Act, hospitals will be permitted to obtain vital patient information from data registered in the national cancer registry database, which will promote the publication of survival rates for cancer patients and accelerate research at hospitals. The founding of the Japanese national cancer registry is a landmark development in the promotion of cancer control and cancer research in Japan and it is essential that the Japanese population benefits from the information obtained from this database.

  10. Are there gender differences in coronary artery disease? The Malaysian National Cardiovascular Disease Database - Percutaneous Coronary Intervention (NCVD-PCI) Registry.

    PubMed

    Lee, Chuey Yan; Hairi, Noran N; Wan Ahmad, Wan Azman; Ismail, Omar; Liew, Houng Bang; Zambahari, Robaayah; Ali, Rosli Mohd; Fong, Alan Yean Yip; Sim, Kui Hian

    2013-01-01

    To assess whether gender differences exist in the clinical presentation, angiographic severity, management and outcomes in patients with coronary artery disease (CAD). The study comprised of 1,961 women and 8,593 men who underwent percutaneous coronary intervention (PCI) and were included in the Malaysian NCVD-PCI Registry from 2007-2009. Significant stenosis was defined as ≥70% stenosis in at least one of the epicardial vessels. Women were significantly older and had significantly higher rates of diabetes mellitus, hypertension, chronic renal failure, new onset angina and prior history of heart failure whereas smokers and past history of myocardial infarction were higher in men. In the ST-elevation myocardial infarction (STEMI) cohort, more women were in Killip class III-IV, had longer door-to-balloon time (169.5 min. vs 127.3 min, p<0.052) and significantly longer transfer time (300.4 min vs 166.3 min, p<0.039). Overall, women had significantly more left main stem (LMS) disease (1.3% vs 0.6%, p<0.003) and smaller diameter vessels (<3.0 mm: 45.5% vs 34.8%, p<0.001). In-hospital mortality rates for all PCI, STEMI, Non-STEMI (NSTEMI) and unstable angina for women and men were 1.99% vs 0.98%, Odds ratio (OR): 2.06 (95% confidence interval (CI): 1.40 to 3.01), 6.19% vs 2.88%, OR: 2.23 (95% CI: 1.31 to 3.79), 2.90% vs 0.79%, OR: 3.75 (95% CI: 1.58 to 8.90) and 1.79% vs 0.29%, OR: 6.18 (95% CI: 0.56 to 68.83), respectively. Six-month adjusted OR for mortality for all PCI, STEMI and NSTEMI in women were 2.18 (95% CI: 0.97 to 4.90), 2.68 (95% CI: 0.37 to 19.61) and 2.66 (95% CI: 0.73 to 9.69), respectively. Women who underwent PCI were older with more co-morbidities. In-hospital and six-month mortality for all PCI, STEMI and NSTEMI were higher due largely to significantly more LMS disease, smaller diameter vessels, longer door-to-balloon and transfer time in women.

  11. National Stroke Registry (NSR): Terengganu and Seberang Jaya experience.

    PubMed

    Nazifah, S Norsima; Azmi, I Khairul; Hamidon, B B; Looi, I; Zariah, A A; Hanip, M R

    2012-06-01

    The National Stroke Registry (NSR) was established in 2009 under National Neurology Registry (NNeuR) . The main objectives of NSR were to describe the demographic and disease pattern of stroke patients in Malaysia, to examine the risk factors and evaluate the specified treatment and outcomes. This prospective observational study was carried out from August 2009 until December 2010 using a standardized case report form which involved two participating hospital, namely Hospital Sultanah Nur Zahirah, Kuala Terengganu and Hospital Seberang Jaya, Pulau Pinang. There were 1018 patients registered. Ischemic stroke accounted for the majority of cases (73.3%). The most common risk factor was hypertension (75.5 %), followed by diabetes mellitus, previous stroke or Transient Ischemic Attack (TIA), hyperlipidemia and active smoker: 45.6%, 25.1%, 22.4%, and 19.4%, respectively. Overall, our stroke management, based on nine stroke key performance indicators (KPI) still needs to be improved. There was a total of 121 mortality cases with the main contributing factor was massive cerebral bleed (21.6%). In conclusion, the findings highlight the important of primary and secondary stroke management. Further and continuous observation with more site date provider (SDP) involvement is needed to get a more comprehensive data on stroke in Malaysia.

  12. Positive predictive values of International Classification of Diseases, 10th revision codes for dermatologic events and hypersensitivity leading to hospitalization or emergency room visit among women with postmenopausal osteoporosis in the Danish and Swedish national patient registries

    PubMed Central

    Adelborg, Kasper; Christensen, Lotte Brix; Munch, Troels; Kahlert, Johnny; Trolle Lagerros, Ylva; Tell, Grethe S; Apalset, Ellen M; Xue, Fei; Ehrenstein, Vera

    2017-01-01

    Background Clinical epidemiology research studies, including pharmacoepidemiology and pharmacovigilance studies, use routinely collected health data, such as diagnoses recorded in national health and administrative registries, to assess clinical effectiveness and safety of treatments. We estimated positive predictive values (PPVs) of International Classification of Diseases, 10th revision (ICD-10) codes for primary diagnoses of dermatologic events and hypersensitivity recorded at hospitalization or emergency room visit in the national patient registries of Denmark and Sweden among women with postmenopausal osteoporosis (PMO). Methods This validation study included women with PMO identified from the Danish and Swedish national patient registries (2005–2014). Medical charts of the potential cases served as the gold standard for the diagnosis confirmation and were reviewed and adjudicated by physicians. Results We obtained and reviewed 189 of 221 sampled medical records (86%). The overall PPV was 92.4% (95% confidence interval [CI], 85.1%–96.3%) for dermatologic events, while the PPVs for bullous events and erythematous dermatologic events were 52.5% (95% CI, 37.5%–67.1%) and 12.5% (95% CI, 2.2%–47.1%), respectively. The PPV was 59.0% (95% CI, 48.3%–69.0%) for hypersensitivity; however, the PPV of hypersensitivity increased to 100.0% (95% CI, 67.6%–100.0%) when restricting to diagnostic codes for anaphylaxis. The overall results did not vary by country. Conclusion Among women with PMO, the PPV for any dermatologic event recorded as the primary diagnosis at hospitalization or at an emergency room visit was high and acceptable for epidemiologic research in the Danish and Swedish national patient registries. The PPV was substantially lower for hypersensitivity leading to hospitalization or emergency room visit.

  13. Positive predictive values of International Classification of Diseases, 10th revision codes for dermatologic events and hypersensitivity leading to hospitalization or emergency room visit among women with postmenopausal osteoporosis in the Danish and Swedish national patient registries.

    PubMed

    Adelborg, Kasper; Christensen, Lotte Brix; Munch, Troels; Kahlert, Johnny; Trolle Lagerros, Ylva; Tell, Grethe S; Apalset, Ellen M; Xue, Fei; Ehrenstein, Vera

    2017-01-01

    Clinical epidemiology research studies, including pharmacoepidemiology and pharmacovigilance studies, use routinely collected health data, such as diagnoses recorded in national health and administrative registries, to assess clinical effectiveness and safety of treatments. We estimated positive predictive values (PPVs) of International Classification of Diseases, 10th revision (ICD-10) codes for primary diagnoses of dermatologic events and hypersensitivity recorded at hospitalization or emergency room visit in the national patient registries of Denmark and Sweden among women with postmenopausal osteoporosis (PMO). This validation study included women with PMO identified from the Danish and Swedish national patient registries (2005-2014). Medical charts of the potential cases served as the gold standard for the diagnosis confirmation and were reviewed and adjudicated by physicians. We obtained and reviewed 189 of 221 sampled medical records (86%). The overall PPV was 92.4% (95% confidence interval [CI], 85.1%-96.3%) for dermatologic events, while the PPVs for bullous events and erythematous dermatologic events were 52.5% (95% CI, 37.5%-67.1%) and 12.5% (95% CI, 2.2%-47.1%), respectively. The PPV was 59.0% (95% CI, 48.3%-69.0%) for hypersensitivity; however, the PPV of hypersensitivity increased to 100.0% (95% CI, 67.6%-100.0%) when restricting to diagnostic codes for anaphylaxis. The overall results did not vary by country. Among women with PMO, the PPV for any dermatologic event recorded as the primary diagnosis at hospitalization or at an emergency room visit was high and acceptable for epidemiologic research in the Danish and Swedish national patient registries. The PPV was substantially lower for hypersensitivity leading to hospitalization or emergency room visit.

  14. Surveillance Evaluation of the National Cancer Registry in Sabah, Malaysia.

    PubMed

    Jeffree, Saffree Mohammad; Mihat, Omar; Lukman, Khamisah Awang; Ibrahim, Mohd Yusof; Kamaludin, Fadzilah; Hassan, Mohd Rohaizat; Kaur, Nirmal; Myint, Than

    2016-01-01

    Cancer is the fourth leading cause of death in Sabah Malaysia with a reported agestandardized incidence rate was 104.9 per 100,000 in 2007. The incidence rate depends on nonmandatory notification in the registry. Underreporting will provide the false picture of cancer control program effectiveness. The present study was to evaluate the performance of the cancer registry system in terms of representativeness, data quality, simplicity, acceptability and timeliness and provision of recommendations for improvement. The evaluation was conducted among key informants in the National Cancer Registry (NCR) and reporting facilities from FebMay 2012 and was based on US CDC guidelines. Representativeness was assessed by matching cancer case in the Health Information System (HIS) and state pathology records with those in NCR. Data quality was measured through case finding and reabstracting of medical records by independent auditors. The reabstracting portion comprised 15 data items. Selfadministered questionnaires were used to assess simplicity and acceptability. Timeliness was measured from date of diagnosis to date of notification received and data dissemination. Of 4613 cancer cases reported in HIS, 83.3% were matched with cancer registry. In the state pathology centre, 99.8% was notified to registry. Duplication of notification was 3%. Data completeness calculated for 104 samples was 63.4%. Registrars perceived simplicity in coding diagnosis as moderate. Notification process was moderately acceptable. Median duration of interval 1 was 5.7 months. The performances of registry's attributes are fairly positive in terms of simplicity, case reporting sensitivity, and predictive value positive. It is moderately acceptable, data completeness and inflexible. The usefulness of registry is the area of concern to achieve registry objectives. Timeliness of reporting is within international standard, whereas timeliness to data dissemination was longer up to 4 years. Integration between

  15. National Adult Cardiac Surgery Registry: past, present and future.

    PubMed

    Uva, Miguel Sousa; Mota, João Carlos

    2003-10-01

    A task force commission was created with the support of the Portuguese Society for Cardiothoracic and Vascular Surgery with the aim of organizing a National Adult Cardiac Surgery Registry, collecting clinical data and types of cardiac surgical procedure performed in Portugal. Selected variables include risk factors, cardiac status, preoperative hemodynamics, surgical procedure, hospital stay and mortality. Information is collected into a database in each institution and sent via the internet to a central database responsible for grouping and data analysis. It is hoped that this National Registry, through standardized data collection, will provide information on cardiac surgery activity in Portugal and its risk adjusted results.

  16. National exposure registry: Tichloroethylene (TCE) subregistry (on CD-ROM). Data file

    SciTech Connect

    Not Available

    1995-01-01

    The 1994 National Exposure Registry: Trichloroethylene (TCE) Subregistry' contains data on approximately 4,000 persons and is the first CD-ROM product released in the National Exposure Registry Series. This CD-ROM is composed of three files: Demographics and Health, Mortality, and Environmental. The CD-ROM includes access software, the Statistical Export and Tabulation System (SETS). The TCE subregistry is one of three (dioxin and benzene subregistries are the other two). The National Exposure Registry was created in response to a mandate given in the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980 to the Agency for Toxic Substances and Disease Registry (ATSDR) to create a registry of persons exposed to hazardous substances. This mandate was reiterated in the Superfund Amendments and Reauthorization Act (SARA) of 1986. The National Exposure Registry is a database composed of names of persons, along with additional information on these persons, with documented exposure to specific chemicals. The purpose of the Registry is to aid in assessing the long-term health consequences of low-level, long-term exposure to environmental contaminants. One of the goals is to establish a database that will furnish the information needed to generate appropriate and valid hypotheses for future activities such as epidemiological studies. When supplemented with additional data, the combined file can then be used to carry out hypothesis-testing epidemiological investigations. The data collected for each member of the Registry include environmental levels, demographic information, smoking and occupational history, and self-reported responses to 25 general health status questions. The files for each chemical-specific subregistry are established at the time baseline data are collected and are updated and maintained by ATSDR on an ongoing basis (annually the first year, biennially thereafter).

  17. 76 FR 14366 - National Registry of Certified Medical Examiners

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... Certified Medical Examiners AGENCY: Federal Motor Carrier Safety Administration, Transportation. ACTION... National Registry of 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...

  18. 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.

  19. The NAS-NRC Twin Registry of WWII military veteran twins. National Academy of Sciences-National Research Council.

    PubMed

    Page, William F

    2002-10-01

    The NAS-NRC Twin Registry is one of the oldest, national population based-twin registries in the United States. It consists of 15,924 white male twin pairs born in the years 1917-1927 (inclusive) both of whom served in the armed forces. The registry, which has been in operation more than 30 years, has collected data from a variety of sources. Records-based, computerized data have come largely from the Department of Veterans Affairs, and there have been three major epidemiologic questionnaires, undertaken roughly every 15 years. Classic twin studies on a variety of medical conditions were the early focus of the registry, which now has a strong focus on chronic disease epidemiology. Work on a DNA specimen bank has been proceeding slowly, but is now a top priority, due to the increasing force of mortality in this twin cohort.

  20. 148 Predictive Model for Return to Work After Elective Surgery for Lumbar Degenerative Disease: An Analysis From National Neurosurgery Quality Outcomes Database Registry.

    PubMed

    Asher, Anthony L; Chotai, Silky; Devin, Clinton J; Archer-Swygert, Kristen; Parker, Scott L; Bydon, Mohamad; Hui, Nian; Harrell, Frank; Speroff, Theodore; Dittus, Robert; Philips, Sharon; Shaffrey, Christopher I; Foley, Kevin T; McGirt, Matthew J

    2016-08-01

    The current costs associated with spine care are unsustainable. The productivity loss and time away from work in gainfully employed patients contributes greatly to the financial burden. Therefore, it is vital to identify the factors associated with returning to work after lumbar spine surgery. We present a predictive model of ability to return to work (RTW) after lumbar spine surgery for degenerative spine disease. Total 4694 patients undergoing elective spine surgery for degenerative lumbar disease who were employed were entered into a prospective multicenter registry (N2QOD). Baseline and 3-month postoperative patient-reported outcomes: Oswestry Disability Index (ODI), EQ-5D, NRS back and leg pain were recorded. The time to RTW was defined as the period between operation time and date of returning to work. A multivariable Cox proportional hazards regression model, including an array of preoperative factors, was fitted for RTW. The model performance was measured by the c-index. Eighty-two percent of patients (n = 3855) returned to work within 3 -months postoperatively. The risk-adjusted predictors of lower likelihood of RTW were preoperatively employed but not working at the time of presentation, those occupied with manual labor, on worker's compensation, on liability insurance, baseline ODI and NRS-BP scores, female sex, African American race, history of diabetes mellitus, and higher ASA grades. The likelihood of RTW within 3 months was higher in patients with higher education level compared with those with less than high school level education. The c-index of our model performance was 0.71. We present a novel predictive model for probability of RTW after lumbar spine surgery. Spine care providers can use this model to educate patients and encourage them in shared decision making regarding the RTW outcome. This will result in better communication between patients and clinicians and improve recovery expectations, which will ultimately increase the likelihood of a

  1. Percutaneous coronary intervention for older adults who present with syncope and coronary artery disease? Insights from the National Cardiovascular Data Registry.

    PubMed

    Anderson, Lindsay L; Dai, David; Miller, Amy Leigh; Roe, Matthew T; Messenger, John C; Wang, Tracy Y

    2016-06-01

    We explored the risks/benefits of revascularization versus medical management in syncope patients with obstructive coronary artery disease (CAD). We retrospectively examined Medicare patients ≥65 years undergoing percutaneous coronary intervention (PCI) for syncope at 539 CathPCI Registry hospitals with ≥70% stenosis in at least 1 coronary artery, excluding those with ST-segment elevation myocardial infarction (MI), cardiogenic shock, left main disease, and coronary artery bypass grafting. In a propensity-matched population, we compared short-term (90-day) all-cause readmission risk and long-term (3-year) risks of readmission for syncope and MI, as well as mortality in those receiving PCI versus medical management. Among 14,674 syncope patients, 9,549 (65%) had at least 1-vessel obstructive CAD. After exclusions, 3,196 of 7,338 patients (44%) underwent PCI. In the propensity-matched cohort, there was no significant difference in 90-day all-cause readmission risk (28.2% vs 30.3%, adjusted hazard ratio [HR] 0.92, 95% CI 0.83-1.02) or long-term risks of readmission for syncope (7.0% vs 6.1%, adjusted HR 1.06, 95% CI 0.83-1.35). PCI-treated patients had significantly higher risk of readmission for MI (5.6% vs 4.0%, adjusted HR 1.56, 95% CI 1.18-2.06) but lower risk of long-term mortality (27.0% vs 30.3%, adjusted HR 0.86, 95% CI 0.77-0.97) than medically managed patients. In patients presenting with syncope and obstructive CAD, PCI was not associated with significant improvements in the risk of readmission but was associated with lower long-term mortality compared with medical therapy, suggesting the need to more definitively assess the benefit of PCI among elderly syncope patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. 49 CFR 391.42 - Schedule for use of medical examiners listed on the National Registry of Certified Medical...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... the National Registry of Certified Medical Examiners. 391.42 Section 391.42 Transportation Other... examiners listed on the National Registry of Certified Medical Examiners. On and after May 21, 2014, each... the National Registry of Certified Medical Examiners....

  3. 49 CFR 391.42 - Schedule for use of medical examiners listed on the National Registry of Certified Medical...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... the National Registry of Certified Medical Examiners. 391.42 Section 391.42 Transportation Other... examiners listed on the National Registry of Certified Medical Examiners. On and after May 21, 2014, each... the National Registry of Certified Medical Examiners....

  4. 49 CFR 391.42 - Schedule for use of medical examiners listed on the National Registry of Certified Medical...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... the National Registry of Certified Medical Examiners. 391.42 Section 391.42 Transportation Other... examiners listed on the National Registry of Certified Medical Examiners. On and after May 21, 2014, each... the National Registry of Certified Medical Examiners....

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

    PubMed

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

    2015-06-01

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

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

    PubMed Central

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

    2015-01-01

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

  7. Inception of a national multidisciplinary registry for stereotactic radiosurgery.

    PubMed

    Sheehan, Jason P; Kavanagh, Brian D; Asher, Anthony; Harbaugh, Robert E

    2016-01-01

    Stereotactic radiosurgery (SRS) represents a multidisciplinary approach to the delivery of ionizing high-dose radiation to treat a wide variety of disorders. Much of the radiosurgical literature is based upon retrospective single-center studies along with a few randomized controlled clinical trials. More timely and effective evidence is needed to enhance the consistency and quality of and clinical outcomes achieved with SRS. The authors summarize the creation and implementation of a national SRS registry. The American Association of Neurological Surgeons (AANS) through NeuroPoint Alliance, Inc., started a successful registry effort with its lumbar spine initiative. Following a similar approach, the AANS and NeuroPoint Alliance collaborated with corporate partners and the American Society for Radiation Oncology to devise a data dictionary for an SRS registry. Through administrative and financial support from professional societies and corporate partners, a framework for implementation of the registry was created. Initial plans were devised for a 3-year effort encompassing 30 high-volume SRS centers across the country. Device-specific web-based data-extraction platforms were built by the corporate partners. Data uploaders were then used to port the data to a common repository managed by Quintiles, a national and international health care trials company. Audits of the data for completeness and veracity will be undertaken by Quintiles to ensure data fidelity. Data governance and analysis are overseen by an SRS board comprising equal numbers of representatives from the AANS and NeuroPoint Alliance. Over time, quality outcome assessments and post hoc research can be performed to advance the field of SRS. Stereotactic radiosurgery offers a high-technology approach to treating complex intracranial disorders. Improvements in the consistency and quality of care delivered to patients who undergo SRS should be afforded by the national registry effort that is underway.

  8. [Primary Spinal Tumor Registry at the National Centre for Spinal Disorders].

    PubMed

    Szövérfi, Zsolt; Lazáry, Aron; Varga, Péter Pál

    2014-05-11

    Primary spinal tumors are rare diseases. Primary spinal tumor registry would be useful to help decision making in this complex field of spine surgery. In this article the authors present the latest findings from the Primary Spinal Tumor Registry at the National Centre for Spinal Disorders, Hungary. The registry is based on a novel database management software, the REDCap electronic data capture system. It contains data of 323 patients treated surgically during an 18-year period. Among the 126 malignant tumors, the most frequent was chordoma (61 cases). In the case of benign tumors schwannoma showed the largest prevalence (45 cases). The authors conclude that due to the rarity of the disease and the complexity of the management, multicenter, prospective registries are required to provide high level of evidence. The structure of the Primary Spinal Tumor Registry in the National Centre for Spinal Disorders in Hungary is optimal for user-friendly, fast and secure data collection providing a prospective database for scientific researches and clinical follow-up.

  9. 49 CFR 390.115 - Procedure for removal from the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 5 2012-10-01 2012-10-01 false Procedure for removal from the National Registry... MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL National Registry of Certified Medical Examiners § 390.115 Procedure for removal from the National Registry of Certified...

  10. 49 CFR 390.115 - Procedure for removal from the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false Procedure for removal from the National Registry... MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL National Registry of Certified Medical Examiners § 390.115 Procedure for removal from the National Registry of Certified...

  11. 49 CFR 390.113 - Reasons for removal from the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 5 2013-10-01 2013-10-01 false Reasons for removal from the National Registry of... MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL National Registry of Certified Medical Examiners § 390.113 Reasons for removal from the National Registry of Certified...

  12. 49 CFR 390.113 - Reasons for removal from the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false Reasons for removal from the National Registry of... MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL National Registry of Certified Medical Examiners § 390.113 Reasons for removal from the National Registry of Certified...

  13. 75 FR 68604 - National Saltwater Angler Registry Program Designation of Exempted States

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-08

    ... National Oceanic and Atmospheric Administration RIN 0648-XZ91 National Saltwater Angler Registry Program... INFORMATION: The final rule implementing the National Saltwater Angler Registry Program, 50 CFR Subpart P, was... under a qualifying state license and/or registry program, or to provide catch and effort data from...

  14. 49 CFR 390.113 - Reasons for removal from the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 5 2012-10-01 2012-10-01 false Reasons for removal from the National Registry of... MOTOR CARRIER SAFETY REGULATIONS FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL National Registry of Certified Medical Examiners § 390.113 Reasons for removal from the National Registry of Certified...

  15. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2011-06-01

    Investigator Parkinsonism (PS) is a syndrome characterized by tremor , rigidity, slowness of movement, and problems with walking and balance...2. Developing an identification protocol. The primary source of parkinsonism cases will be the Indian Health Service (IHS) provider database, called...of parkinsonism among Alaska Natives. Status: Complete 3. Developing a secure Alaska Native parkinsonism registry database. Status: The database

  16. [National Registry of Cardiac Rehabilitation Programs in México].

    PubMed

    Ilarraza Lomelí, Hermes; Herrera Franco, Rodolfo; Lomelí Rivas, Alvaro; Zavala Ramírez, Juana; Martínez Ramírez, Leonel; Ramos Becerril, Francisco José; Romo Escamilla, Ricardo Elías; Pacheco Beltrán, Nancy; Alonso Sánchez, Jesús; Mendoza Díaz, Pedro Miguel; Alvarez Cerro, Margarita; Cassaigne Guasco, María Elena; Mayela Muñoz Gutiérrez, Luz María

    2009-01-01

    Cardiac Rehabilitation and secondary prevention programs are a group of therapeutic maneuvers that can reduce the adverse impact of cardiovascular disease, by using the cardiovascular risk factors reduction, through secondary prevention and exercise training therapy programs. This program started in Mexico in 1944, since then, several health institutions are working on a public or private basis, mainly in an isolated way. This article presents data about fourteen cardiac rehabilitation institutions that answered the first national registry of cardiac rehabilitation programs (RENAPREC) in 2007. On this study, we observed that these centers were mainly private; nevertheless, almost all of the referred population was attended in public health institutions. The core-components for an adequate cardiac rehabilitation attention were satisfied by almost all these centers. The patients used to pay, by their own, this kind of medical practice. In our country, only the 0.58% of the population, that needed to be included on a cardiac rehabilitation program, was covered. This phenomena is due, in one hand, to the reduced number of cardiac rehabilitation centers in Mexico, but on the other hand, it happens because the primary physician do not refer all the eligible patients to this kid of programs. RENAPREC can be one first attempt to consolidate all the activities around the inter-institutional cardiac rehabilitation and secondary prevention programs in our country.

  17. [Home Enteral Nutrition: National Registry 2001].

    PubMed

    Planas, M; Castellà, M; García Luna, P P; Parés, R M; Chamorro, J; Camarero, E; Calañas, A J; Bonada, A; Irles, J A; Adrio, G; Jiménez, M; Bobis, M A; Rodríguez, A; Pérez de la Cruz, A; Gómez Enterría, P; Zamarrón, I; Cos, A; Mancha, A; Martínez, I; Martí, E; de Luis, D; Virgili, N; Moreno, J M; Luengo, L M; de la Cuerda, C; Forga, M T; Goenaga, M A; Carrera, J A; Garde, C; Ordóñez, J; Pedrón, C

    2004-01-01

    The NADYA-SENPE Working Group analyzed the registered data of patients on Home Enteral Nutrition (HEN) in our country, during year 2001. The data were collected through a closed questionnaire included on our web site (www.nadya-senpe.com). Apart from epidemiological information, the form includes the indication to prescribe this treatment, the specific nutritional treatment used and its duration, access path, complications and readmission rate in hospital, follow-up of the treatment, patient's quality of life and progress. All data were processed and analyzed by the coordinating team. Twenty two hospitals participated and 3,458 patients, aged 5.6 +/- 4.0 y for those younger than 14 y, and 67.1 +/- 19.5 y for those older than 14 y, were enrolled. Of these patients, 43.4% were diagnosed with neurological diseases and 33.5% with cancer. The mean time on HEN was 6.5 +/- 4.5 months. Oral nutrition was the preferential route (54.5%), followed by nasoenteral tube (32.3%), and in 13.3% ostomy tubes were placed. Polymeric was the formula composition mainly used (85.9%). Patients were followed (71.1%) by the hospital reference Nutritional Support Unit. The complications related to nutrition included mainly the gastrointestinal (0.16 complications/patient), and the mechanical one (0.15 complications/patient). At the end for the year, 48.3% of the patients were in the HEN program, and in 33.3% HEN was finish due to different reasons. In 22.9% of the patients no, o light, discapacity degree was found. Neurological diseases and cancer were the more frequent diagnoses in HEN patients. Oral access was the higher feeding route due, probably, to the high prevalence of cancer patients. In spite of the elevated prevalence of neurological diseases, a few number of patients, as previous years, were feed with ostomy tube. Due to the few complications observed, HEN is a safe treatment in our country.

  18. Creating an effective clinical registry for rare diseases

    PubMed Central

    D’Agnolo, Hedwig MA; Kievit, Wietske; Andrade, Raul J; Karlsen, Tom Hemming; Wedemeyer, Heiner

    2015-01-01

    The exposure of clinicians to patients with rare gastrointestinal diseases is limited. This hurts clinical studies, which impedes accumulation of scientific knowledge on the natural disease course, treatment outcomes and prognosis in these patients. An excellent method to detect patterns on an aggregate level that would not be possible to discover in individual cases, is a registry study. This paper aims to describe a template to create a successful international registry for rare diseases. We focus mainly on rare hepatic diseases, but lessons from this paper serve other fields in medicine, as well. PMID:27403298

  19. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2012-07-01

    Investigator 4 A. Introduction Parkinsonism (PS) is a syndrome characterized by tremor , rigidity, slowness of movement, and problems with walking...2011. The aims of this project are: Specific Aim 1: Identify cases of parkinsonism among Alaska Native people and populate a secure electronic...registry database. Specific Aim 2: Provide education on parkinsonism and its treatment to primary care physicians and other health care providers

  20. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2007-11-01

    Questionable 0 DK f. seborrheic dermatitis 0 Yes 0 No 0 Questionable 0 DK Exclusion criteria O Prominent postural instability in the first 3...4 A. Introduction Parkinsonism (PS) is a syndrome characterized by tremor, rigidity, slowness of movement, and problems with walking and balance...the Alaska Native Medical Center. B. Body The intent of this proposal is to establish a registry of parkinsonism cases among Alaska native

  1. Interstitial Lung Disease in India. Results of a Prospective Registry.

    PubMed

    Singh, Sheetu; Collins, Bridget F; Sharma, Bharat B; Joshi, Jyotsna M; Talwar, Deepak; Katiyar, Sandeep; Singh, Nishtha; Ho, Lawrence; Samaria, Jai Kumar; Bhattacharya, Parthasarathi; Gupta, Rakesh; Chaudhari, Sudhir; Singh, Tejraj; Moond, Vijay; Pipavath, Sudhakar; Ahuja, Jitesh; Chetambath, Ravindran; Ghoshal, Aloke G; Jain, Nirmal K; Devi, H J Gayathri; Kant, Surya; Koul, Parvaiz; Dhar, Raja; Swarnakar, Rajesh; Sharma, Surendra K; Roy, Dhrubajyoti J; Sarmah, Kripesh R; Jankharia, Bhavin; Schmidt, Rodney; Katiyar, Santosh K; Jindal, Arpita; Mangal, Daya K; Singh, Virendra; Raghu, Ganesh

    2017-03-15

    Interstitial lung disease (ILD) is a heterogeneous group of acute and chronic inflammatory and fibrotic lung diseases. Existing ILD registries have had variable findings. Little is known about the clinical profile of ILDs in India. To characterize new-onset ILDs in India by creating a prospective ILD using multidisciplinary discussion (MDD) to validate diagnoses. Adult patients of Indian origin living in India with new-onset ILD (27 centers, 19 Indian cities, March 2012-June 2015) without malignancy or infection were included. All had connective tissue disease (CTD) serologies, spirometry, and high-resolution computed tomography chest. ILD pattern was defined by high-resolution computed tomography images. Three groups independently made diagnoses after review of clinical data including that from prompted case report forms: local site investigators, ILD experts at the National Data Coordinating Center (NDCC; Jaipur, India) with MDD, and experienced ILD experts at the Center for ILD (CILD; Seattle, WA) with MDD. Cohen's κ was used to assess reliability of interobserver agreement. A total of 1,084 patients were recruited. Final diagnosis: hypersensitivity pneumonitis in 47.3% (n = 513; exposure, 48.1% air coolers), CTD-ILD in 13.9%, and idiopathic pulmonary fibrosis in 13.7%. Cohen's κ: 0.351 site investigator/CILD, 0.519 site investigator/NDCC, and 0.618 NDCC/CILD. Hypersensitivity pneumonitis was the most common new-onset ILD in India, followed by CTD-ILD and idiopathic pulmonary fibrosis; diagnoses varied between site investigators and CILD experts, emphasizing the value of MDD in ILD diagnosis. Prompted case report forms including environmental exposures in prospective registries will likely provide further insight into the etiology and management of ILD worldwide.

  2. Third national registry of acute coronary syndromes (RENASICA III).

    PubMed

    Jerjes-Sanchez, Carlos; Martinez-Sanchez, Carlos; Borrayo-Sanchez, Gabriela; Carrillo-Calvillo, Jorge; Juarez-Herrera, Ursulo; Quintanilla-Gutierrez, Juan

    2015-01-01

    RENASICA III is a prospective, multicenter registry on acute coronary syndromes (ACS). The main objective will be to identify the outcome in tertiary and community hospitals and perform strategies to improve quality of care in Mexico. RENASICA III will enroll 8000 patients in public health and private hospitals. The registry began in November 2012 with a planned recruitment during 12 months and a 1-year follow-up. The study population will comprise a consecutive, prospective cohort of patients >18 years with ACS final diagnosis and evidence of ischemic heart disease. The structure, data collection and data analysis will be based on quality current recommendations for registries. The protocol has been approved by institutional ethics committees in all participant centers. All patients will sign an informed consent form. Currently in Mexico, there is a need of observational registries that include patients with treatment in the everyday clinical practice so the data could be validated and additional information could be obtained versus the one from the clinical trials. In this way, RENASICA III emerges as a link among randomized clinical trials developed by experts and previous Mexican experience. Copyright © 2014 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  3. 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

    ... National Oceanic and Atmospheric Administration RIN 0648-XX66 The National Saltwater Angler Registry... Registry Program, 50 CFR subpart P, was published in the Federal Register on December 30, 2008. The final... numbers of the persons licensed or registered under a qualifying state license and/or registry program,...

  4. The national alpha-1 antitrypsin deficiency registry in Poland.

    PubMed

    Chorostowska-Wynimko, Joanna; Struniawski, Radoslaw; Sliwinski, Paweł; Wajda, Beata; Czajkowska-Malinowska, Małgorzata

    2015-05-01

    The alpha-1 antitrypsin deficiency (AATD) targeted screening program, together with the National Registry, were established in Poland in 2010 soon after the AATD diagnostics became available. Between 2010 and 2014 a total of 2525 samples were collected from respiratory patients countrywide; 55 patients with severe AAT deficiency or rare mutations were identified and registered, including 36 PiZZ subjects (65%). The majority of AATD patients were diagnosed with COPD (40%) or emphysema (7%), but also with bronchial asthma (16%) and bronchiectasis (13%). Therefore, the registry has proved instrumental in setting-up the AATD-dedicated network of respiratory medical centres in Poland. Since augmentation therapy is not reimbursed in our country, the smoking cessation guidance, optimal pharmacotherapy of respiratory symptoms as well the early detection, and effective treatment of exacerbations is absolutely essential.

  5. 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

    2017-01-27

    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.

  6. Developing National Cancer Registration in Developing Countries – Case Study of the Nigerian National System of Cancer Registries

    PubMed Central

    Jedy-Agba, Elima E.; Oga, Emmanuel A.; Odutola, Michael; Abdullahi, Yusuf M.; Popoola, Abiodun; Achara, Peter; Afolayan, Enoch; Banjo, Adekunbiola Aina Fehintola; Ekanem, Ima-Obong; Erinomo, Olagoke; Ezeome, Emmanuel; Igbinoba, Festus; Obiorah, Christopher; Ogunbiyi, Olufemi; Omonisi, Abidemi; Osime, Clement; Ukah, Cornelius; Osinubi, Patience; Hassan, Ramatu; Blattner, William; Dakum, Patrick; Adebamowo, Clement A.

    2015-01-01

    The epidemiological transition in sub-Saharan Africa (SSA) has given rise to a concomitant increase in the incidence of non-communicable diseases including cancers. Worldwide, cancer registries have been shown to be critical for the determination of cancer burden, conduct of research, and in the planning and implementation of cancer control measures. Cancer registration though vital is often neglected in SSA owing to competing demands for resources for healthcare. We report the implementation of a system for representative nation-wide cancer registration in Nigeria – the Nigerian National System of Cancer Registries (NSCR). The NSCR coordinates the activities of cancer registries in Nigeria, strengthens existing registries, establishes new registries, complies and analyses data, and makes these freely available to researchers and policy makers. We highlight the key challenges encountered in implementing this strategy and how they were overcome. This report serves as a guide for other low- and middle-income countries (LMIC) wishing to expand cancer registration coverage in their countries and highlights the training, mentoring, scientific and logistic support, and advocacy that are crucial to sustaining cancer registration programs in LMIC. PMID:26284233

  7. 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.

  8. 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

  9. International Registry for Patients With Castleman Disease

    ClinicalTrials.gov

    2017-07-12

    Castleman Disease; Castleman's Disease; Giant Lymph Node Hyperplasia; Angiofollicular Lymph Hyperplasia; Angiofollicular Lymph Node Hyperplasia; Angiofollicular Lymphoid Hyperplasia; GLNH; Hyperplasia, Giant Lymph Node; Lymph Node Hyperplasia, Giant

  10. 16 CFR 310.8 - Fee for access to the National Do Not Call Registry.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Registry. 310.8 Section 310.8 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS... Call Registry. (a) It is a violation of this Rule for any seller to initiate, or cause any telemarketer... National Do Not Call Registry maintained by the Commission under § 310.4(b)(1)(iii)(B); provided,...

  11. 16 CFR 310.8 - Fee for access to the National Do Not Call Registry.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Registry. 310.8 Section 310.8 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS... Call Registry. (a) It is a violation of this Rule for any seller to initiate, or cause any telemarketer... National Do Not Call Registry maintained by the Commission under § 310.4(b)(1)(iii)(B); provided,...

  12. 16 CFR 310.8 - Fee for access to the National Do Not Call Registry.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Registry. 310.8 Section 310.8 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS... Call Registry. (a) It is a violation of this Rule for any seller to initiate, or cause any telemarketer... National Do Not Call Registry maintained by the Commission under § 310.4(b)(1)(iii)(B); provided,...

  13. 16 CFR 310.8 - Fee for access to the National Do Not Call Registry.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Registry. 310.8 Section 310.8 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS... Call Registry. (a) It is a violation of this Rule for any seller to initiate, or cause any telemarketer... National Do Not Call Registry maintained by the Commission under § 310.4(b)(1)(iii)(B); provided,...

  14. National Joint Registry data inaccuracy: a threat to proper reporting.

    PubMed

    Kosy, Jonathan D; Kassam, Al-Amin M; Hockings, Michael

    2013-12-01

    The authors set out to investigate the accuracy of the information their unit was inputting onto the National Joint Registry. This is important both in relation to implant surveillance and also to the use of these data to monitor the performance of surgeons. A single consultant's arthroplasty patients were audited over 12 months. Data taken from the National Joint Registry were compared to the operation notes and the hospital's computer system. Of 78 cases inputted, 27 (35%) were incorrect. Sixteen cases (21%) had the incorrect 'consultant in charge' recorded, eight cases (10%) had the incorrect 'operating surgeon' recorded and three cases (4%) had both errors. The most frequent inaccuracies resulted from listing by another consultant and incorrectly recorded trainee supervision. These errors were highlighted to the unit and a corrected process was designed. The intervention was to implement this process by presenting to the involved groups and displaying posters to prevent the error-producing process. The audit was repeated (after 6 months) showing eradication of the problem. It is the surgeon's duty to ensure data recorded under his/her name are accurate and justify any discrepancies when compared to other surgeons. Pooling of patients and supervision of trainees are sources of potential error.

  15. 49 CFR 390.111 - Requirements for continued listing on the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Registry of Certified Medical Examiners. 390.111 Section 390.111 Transportation Other Regulations Relating... National Registry of Certified Medical Examiners § 390.111 Requirements for continued listing on the National Registry of Certified Medical Examiners. (a) To continue to be listed on the National Registry...

  16. 49 CFR 390.111 - Requirements for continued listing on the National Registry of Certified Medical Examiners.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Registry of Certified Medical Examiners. 390.111 Section 390.111 Transportation Other Regulations Relating... National Registry of Certified Medical Examiners § 390.111 Requirements for continued listing on the National Registry of Certified Medical Examiners. (a) To continue to be listed on the National Registry...

  17. Acute Stroke Registry Malaysia, 2010-2014: Results from the National Neurology Registry.

    PubMed

    Aziz, Zariah A; Lee, Yvonne Y L; Ngah, Bahari Awang; Sidek, Norsima Nafizah; Looi, Irene; Hanip, Md Rafia; Basri, Hamidon B

    2015-12-01

    Stroke remains a major health burden worldwide. The incidence and prevalence rates of stroke are decreasing in developed countries, an opposite trend is taking place in the Asia Pacific, where an increasing number of patients are being diagnosed with acute stroke. The results of the present study on acute stroke in multi-ethnic Malaysia will significantly contribute to the global stroke epidemiological data. We aimed to present epidemiological data of stroke including incidence and prevalence rates as well as associated risk factors from a prospective nationwide hospital-based registry from 2010 to 2014. Patients diagnosed with stroke upon admission at the hospital were prospectively enrolled into the registry from January 1, 2010, to December 31, 2014. Descriptive analyses were performed. A total of 7668 patients were available for analysis. On average, patients were aged 62.7 years (standard deviation of 12.5). Ischemic stroke accounts for 79.4% of the cohort with a slightly higher proportion of male patients (55%). Ischemic stroke incidence is estimated to increase annually by 29.5% and hemorrhagic stroke by 18.7%. Hypertension is a major risk factor for both ischemic and hemorrhagic strokes regardless of stroke event with an excess of 8.4% hypertensive female compare to male patients (P ≤ .001). Majority of patients with ischemic and hemorrhagic strokes experienced mild and moderate stroke with 11.7% and 21.1%, respectively, documented as severe (P ≤ .001). The incidence and prevalence of stroke in Malaysia increased dramatically in the 5-year study period. Therefore, implementation of risk factor control strategies is important to prevent further increase of stroke burden in the country. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  18. Diabetes and poor outcomes within 6 months after acute ischemic stroke: the China National Stroke Registry.

    PubMed

    Jia, Qian; Zhao, Xingquan; Wang, Chunxue; Wang, Yilong; Yan, Yu; Li, Hao; Zhong, Liyong; Liu, Liping; Zheng, Huaguang; Zhou, Yong; Wang, Yongjun

    2011-10-01

    Diabetes mellitus (DM) is an independent risk factor for ischemic stroke. However, controversy exists with regard to the impact of DM on prognosis after ischemic stroke in the Chinese population. We investigated the associations between DM and death, dependency, and stroke recurrence in patients after ischemic stroke onset in a nationwide, prospective registry, the China National Stroke Registry. The China National Stroke Registry consecutively recruited patients hospitalized for acute ischemic stroke in 2007 to 2008 and who were prospectively followed up for clinical and functional outcomes (death, dependency, and stroke recurrence) at 3 and 6 months after disease onset. Multivariable logistic regression was performed to analyze the association between DM and stroke outcomes after adjusting for potential confounding including age, sex, National Institutes of Health Stroke Scale score, glucose level at admission, hypertension, coronary heart disease, smoking, urinary tract infection, and other factors. DM was identified in 3483 (27.0%) of stroke patients. Compared with stroke patients without DM, patients with DM had a significantly higher incidence of death or dependency and of recurrent stroke at 3 and 6 months after stroke onset. DM was an independent risk factor for death or dependency (adjusted odds ratio=1.23; 95% confidence interval, 1.10 to 1.37) in patients with ischemic stroke at 6 months after onset. DM independently predicted poor outcomes in Chinese patients after acute ischemic stroke.

  19. 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.

  20. Chronic disease management systems registries in rural health care.

    PubMed

    Skinner, Anne; Fraser-Maginn, Roslyn; Mueller, Keith J

    2006-05-01

    Health care quality is being addressed from a variety of policy perspectives. The 2001 Institute of Medicine report, Crossing the Quality Chasm, calls for sweeping action involving a five-part strategy for change in the U.S. health care system. This agenda for change includes use of evidence-based approaches to address common conditions, the majority of which are chronic. A Chronic Disease Management System (CDMS), or registry, is a tool that helps providers efficiently collect and analyze patient information to promote quality care for the rural population. CDMSs can provide a technological entry point for the impending use of Electronic Medical Records. A CDMS is a patient-centered electronic database tool that helps providers diagnose, treat, and manage chronic diseases. The purpose of this brief is to discuss the different types of CDMSs used by a sample of 14 state organizations and 19 local rural clinics in Maine, Nebraska, New Mexico, South Carolina, Washington, and Wisconsin. As part of a larger study examining the challenges and innovations in implementing disease management programs in rural areas, we conducted interviews with national, state, and local contacts. During interviews, respondents helped us understand the usefulness and functionalities of commonly used CDMSs in rural facilities. Our focus was on the use of CDMSs in the management of diabetes, a disease prevalent in rural populations. (1) CDMSs are readily available to rural clinics and are being implemented and maintained by clinic staff with minimal expenditures for technology. (2) Use of a standardized system in a collaborative helps provide data comparisons and share costs involved with technical assistance services across the group.

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

    PubMed Central

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

    2016-01-01

    Objectives 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. Methods 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. Results 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 (R2=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. Conclusions 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. PMID

  2. Disease Registries on the Nationwide Health Information Network

    PubMed Central

    Russler, Daniel

    2011-01-01

    Background: Donation by individuals of their protected health information (PHI) for evidence-based research potentially benefits all individuals with disease through improved understandings of disease patterns. In the future, a better understanding of how disease features combine into unique patterns of disease will generate new disease classifications, supporting greater specificity in health management techniques. However, without large numbers of people who donate their PHI to disease registries designed for research, it is difficult for researchers to discover the existence of complex patterns or to create more specific evidence-based management techniques. In order to identify new opportunities in disease registry design, an analysis of the current stage of maturity of the newly created U.S. Nationwide Health Information Network (NwHIN) related to large-scale consumer donation of PHI is presented. Methods: Utilizing a use–case analysis methodology, the consumer-centric designs of the policies and technologies created for the NwHIN were examined for the potential to support consumer donations of PHI to research. Results: The NwHIN design has placed the enforcement point for the policy-based release of PHI over the Internet into a specialized gateway accessible to consumer authorization. However, current NwHIN policies leave the final decision regarding release of PHI for research to the health care providers rather than to the consumers themselves. Conclusions: Should disease registries designed for research be established on the NwHIN, consumers might then directly authorize the donation of their PHI to these disease registries. However, under current NwHIN policies, consumer authorization does not guarantee release of PHI by health providers. PMID:21722569

  3. Dialysis modality, vascular access and mortality in end-stage kidney disease: A bi-national registry-based cohort study.

    PubMed

    Kasza, Jessica; Wolfe, Rory; McDonald, Stephen P; Marshall, Mark R; Polkinghorne, Kevan R

    2016-10-01

    There remains debate on which dialysis modality offers better survival outcomes for patients. We compare the survival of patients undergoing home haemodialysis (HD) with a permanent vascular access, facility HD with a permanent vascular access, facility HD with a central venous catheter or peritoneal dialysis. We considered adult patients from the Australia and New Zealand Dialysis and Transplant Registry who commenced dialysis between 1 October 2003 and 31 December 2011. Patients were followed until death, transplant, loss to follow-up or 31 December 2011. Marginal structural models for mortality were used to account for time-varying treatment, comorbidities and baseline covariates. Unmeasured differences between treatment groups may remain even after adjustment for measured differences, so the potential effects of unmeasured confounding were explicitly modelled. There were 20,191 patients who underwent ≥90 days of dialysis (median 2.25 years, interquartile range 1-3.75 years). There were significant differences in age, gender, comorbidities and other variables between treatment groups at baseline. Thirty per cent of patients had at least one treatment change. Relative to facility HD with permanent access, the risk of death for home HD patients with a permanent access was lower in the first year (at 9 months: hazard ratio 0.41, 95% CI 0.25-0.67, adjusted for all baseline covariates). Findings were robust to unmeasured confounding within plausible ranges. Relative to facility HD with permanent vascular access, home HD conferred better survival prospects, while peritoneal dialysis was associated with a higher risk and facility HD with a catheter the highest risk, especially within the first year of dialysis. © 2015 Asian Pacific Society of Nephrology.

  4. 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.

  5. Shedding Light on Alopecia Areata in Pediatrics: A Retrospective Analysis of Comorbidities in Children in the National Alopecia Areata Registry.

    PubMed

    Sorrell, Jennifer; Petukhova, Lynn; Reingold, Rachel; Christiano, Angela; Garzon, Maria

    2017-09-01

    Alopecia areata (AA) is a common autoimmune disease and it is challenging to predict which patients will have severe disease. The purpose of this retrospective study was to identify comorbidities in children enrolled in the National Alopecia Areata Registry. Atopic dermatitis was more common in patients with severe AA than in those with mild disease. The most common autoimmune comorbidities were vitiligo, psoriasis, thyroid disease, and juvenile idiopathic arthritis. © 2017 Wiley Periodicals, Inc.

  6. 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

    ... disclose on the job registry information or data subject to privacy, security, or privilege limitations... Employment and Training Administration Announcing the New National Electronic Job Registry for Use in the H... that the National Electronic Job Registry (job registry) in which H-2A job orders will be posted...

  7. Comparison of Body Habitus in Patients With Pulmonary Arterial Hypertension Enrolled in the Registry to Evaluate Early and Long-term PAH Disease Management With Normative Values From the National Health and Nutrition Examination Survey

    PubMed Central

    Burger, Charles D.; Foreman, Aimee J.; Miller, Dave P.; Safford, Robert E.; McGoon, Michael D.; Badesch, David B.

    2011-01-01

    OBJECTIVE: To investigate the correlation between body mass index (BMI) and pulmonary artery systolic pressure in a large population of patients with pulmonary arterial hypertension (PAH). PATIENTS AND METHODS: The BMI of patients with group 1 PAH enrolled in the Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) was compared with that of age- and sex-matched controls in the National Health and Nutrition Examination Survey (NHANES) to clarify whether obesity is linked with PAH. The diagnosis of PAH was defined in REVEAL by right-sided heart catheterization. Differences in BMI and the percentage of patients considered obese (BMI ≥30) and underweight (BMI <18.5) in various subgroups of patients enrolled in REVEAL from March 30, 2006, through September 11, 2007, were determined. RESULTS: Mean BMI was no different for patients with PAH (n=2141) than for the NHANES normal comparison group; however, the proportion of obese and underweight patients was increased in patients with PAH. Subgroup analysis demonstrated that subgroups with idiopathic PAH and those with PAH associated with drugs and toxins had both higher BMI and percentage of obese patients, whereas 3 other subgroups (those with PAH associated with congenital heart disease, connective tissue disease, and human immunodeficiency virus) had lower mean BMI. CONCLUSION: Mean BMI of the REVEAL patients was the same as that of the NHANES normal comparison group; however, there were higher percentages of obese and underweight patients in REVEAL. This discrepancy can be explained by the balancing effect of more overweight and underweight patients in different PAH subgroups. The reason for the increased frequency of obesity in idiopathic PAH is unknown, and additional study is needed. Trial Registration: clinicaltrials.gov Identifier: NCT00370214 PMID:21282484

  8. Observing Huntington’s Disease: the European Huntington’s Disease Network’s REGISTRY

    PubMed Central

    Orth, Michael; Handley, Olivia J; Schwenke, Carsten; Dunnett, Stephen B.; Craufurd, David; Ho, Aileen K; Wild, Edward; Tabrizi, Sarah J; Landwehrmeyer, G. Bernhard; Bonelli, Raphael M.; Herranhof, Brigitte; Hödl, Anna; Koppitz, Michael; Magnet, Markus; Otti, Daniela; Painold, Annamaria; Reisinger, Karin; Flamez, Anja; Morez, Vera; de Raedt, Sylvie; Ribaï, Pascale; Verellen-Dumoulin, Christine; Vandenberghe, Wim; van Reijen, Dimphna; Hasholt, Lis; Hjermind, Lena E.; Jakobsen, Oda; Nørremølle, Anne; Sørensen, Sven Asger; Stokholm, Jette; Peippo, Maarit; Sipponen, Marjatta; Hiivola, Heli; Martikainen, Kirsti; Tuuha, Katri; Kosinski, Christoph Michael; Probst, Daniela; Sass, Christian; Schiefer, Johannes; Schlangen, Christiane; Werner, Cornelius J.; Priller, Josef; Prüß, Harald; Andrich, Jürgen; Hoffmann, Rainer; Kraus, Peter; Prehn, Christian; Saft, Carsten; Salmen, Stephan; Straßburger, Katrin; Lange, Herwig; Hunger, Ulrike; Löhle, Matthias; Schmidt, Simone; Storch, Alexander; Wolz, Anett; Wolz, Martin; Lammbeck, Johann; Zucker, Birgit; Hidding, Ute; Münchau, Alexander; Orth, Michael; Stubbe, Lars; Heinicke, Walburgis; Orth, Michael; Longinus, Bernhard; Möller, Jens Carsten; Rissling, Ida; Peinemann, Alexander; Städtler, Michael; Weindl, Adolf; Bohlen, Stefan; Lange, Herwig; Reilmann, Ralf; Beister, Antonie; Dose, Matthias; Leythaeuser, Gabriele; Marquard, Ralf; Schrenk, Caroline; Schuierer, Michele; Wiedemann, Alexandra; Ecker, Daniel; Landwehrmeyer, Bernhard; Lezius, Franziska; Trautmann, Sonja; Bertini, Elisabetta; Mechi, Claudia; Paganini, Marco; Piacentini, Sivia; Romoli, Maria; Sorbi, Sandro; Abbruzzese, Giovanni; di Poggio, Monica Bandettini; Di Maria, Emilio; Ferrandes, Giovanna; Mandich, Paola; Marchese, Roberta; Albanese, Alberto; Di Donato, Stefano; Mariotti, Caterina; Soliveri, Paola; Carlo, Rinaldi; Luigi, Di Maio; De Michele, Giuseppe; Rinaldi, Carlo; Salvatore, Elena; Tucci, Tecla; Ciarmiello, Andrea; Martino, Tiziana; Simonelli, Maria; Squitieri, Ferdinando; Bentivoglio, Anna Rita; Fasano, Alfonso; Frontali, Marina; Guidubaldi, Arianna; Ialongo, Tamara; Jacopini, Gioia; Loria, Giovanna; Piano, Carla; Romano, Silvia; Soleti, Francesco; Spadaro, Maria; Zinzi, Paola; Heiberg, Arvid; van Walsem, Marleen R; Bjørgo, Kathrine; Fannemel, Madelein; Lars Retterstøl, Per Gørvell.; Bjørnevoll, Inga; Sando, Sigrid Botne; Sitek, Emilia Jadwiga; Slawek, Jaroslaw; Soltan, Witold; Boczarska-Jedynak, Magdalena; Jasinska-Myga, Barbara; Opala, Gregorz; Rudzińska, Monika; Szczudlik, Andrzej; Wójcik, Magdalena; Banaszkiewicz, Krzysztof; Bryl, Anna; Ciesielska, Anna; Klimberg, Aneta; Kozubski, Wojciech; Marcinkowski, Jerzy; Sempołowicz, Pani Justyna; Zielonka, Daniel; Janik, Piotr; Kalbarczyk, Anna; Kwiecinski, Hubert; Jamrozik, Zygmunt; Antczak, Jakub; Witkowski, Grzegorz; Rakowicz, Maryla; Richter, Przemyslaw; Ryglewicz, Danuta; Zaremba, Jacek; Zdzienicka, Elzbieta; Costa, Christina; Coelho, Miguel; Ferreira, Joaquim J; Mestre, Tiago; Rosa, Mário M; Valadas, Anabela; Gago, Miguel; Garrett, Carolina; Guerra, Maria Rosalia; Bas, Jordi; Calopa, Matilde; Barberà, Miquel Aguilar; Badenes, Dolores; Casas, Laura; Arroyo, Sonia Escalante; Vara, Jorge Hernández; Krupinski, Jerzy; López, Judith; Obdulia, Marta; Ferrer, Pilar Quilez; Sebastián, Ana Rojo; Contreras, Silvia Romero; Carruesco, Gemma Tome; Cubo, Esther; Mariscal, Natividad; Sánchez, Jesús; Barrero, Francisco J; Morales, Blas; López-Sendón Moreno, José Luis; García, Rocío García-Ramos; Quiroga, Purificacion Pin; Villanueva, Clara; Ruíz-Espiga, Pedro-José García; Martínez, Asunción; Artiga, María José Saiz; Sánchez, Vicenta; Bascuñana, Mónica; Fatas, Marta; Ribas, Guillermo García; de Yébenes, Justo García; López Moreno, José Luis; Schwarz, Christine; Cubillo, Patricia Trigo; Arques, Penelope Navas; Gorospe, Aranzazú; Legarda, Inés; Torres Rodríguez, María José; Gaston, Itziar; Ramos-Arroyo, Maria A.; del Val, Javier López; Martinez, Laura; Burgunder, Jean-Marc; Romero, Irene; Schüpbach, Michael; Zaugg, Sabine Weber; van Hout, Monique S.E.; van Vugt, Jeroen P.P.; de Weert, A. Marit; Bolwijn, J.J.W.; Dekker, Meike; Leenders, K.L.; van Oostrom, Joost.C.H.; Bos, Reineke; Dumas, Eve; Jurgens, Caroline K.; Roos, Raymund A.C.; Witjes-Ané, Marie-Noëlle; Matheson, Kirsty; Rae, Daniela; Simpson, Sheila; Summers, Fiona; Ure, Alexandra; Curtis, Adrienne; Keylock, Jenny; Rickards, Hugh; Wright, Jan; Barker, Roger A.; Fisher, Kate; Goodman, Anna Olivia Goyder; Hill, Susan; Kershaw, Ann; Mason, Sarah; Paterson, Nicole; Raymond, Lucy; Bisson, Jon; Busse, Monica; Ellison-Rose, Lynda; Handley, Olivia; Dunnett, SB; Naji, Jenny; Price, Kathy; Rosser, Anne; Edwards, Maureen; De Sousa, Paul A.; Hughes, Teresa; McGill, Marie; Pearson, Pauline; Porteous, Mary; Zema, Adam; Brockie, Peter; Foster, Jillian; Johns, Nicola; McKenzie, Sue; Thomas, Gareth; Burrows, Liz; Fletcher, Amy; Laver, Fiona; Silva, Mark; Thomson, Aileen; Chu, Carol; Hobson, Emma; Jamieson, Stuart; Toscano, Jean; Wild, Sue; Yardumian, Pam; Bourne, Colin; Clayton, Carole; Dipple, Heather; Grant, Janet; Gross, Diana; Hallam, Caroline; Middleton, Julia; Murch, Ann; Andrews, Thomasin; Dougherty, Andrew; Kavalier, Fred; Golding, Charlotte; Lashwood, Alison; Robertson, Dene; Ruddy, Deborah; Whaite, Anna; Andrews, Thomasin; Bruno, Stefania; Golding, Charlotte; Henley, Susie; Novak, Marianne; O'Driscoll, Christine; Patel, Aakta; Rosser, Elisabeth; Tabrizi, Sarah; Taylor, Rachel; Warner, Thomas; Wild, Edward; Arran, Natalie; Craufurd, David; Fullam, Ruth; Howard, Liz; Huson, Susan; Partington-Jones, Lucy; Ritchie, Nichola; Snowden, Julie; Solom, Annie; Stopford, Cheryl; Thompson, Jennifer; Westmoreland, Leann; Nemeth, Andrea H; Siuda, Gill; Bandmann, Oliver; Bradbury, Alyson; Fillingham, Kay; Foustanos, Isabella; Quarrell, Oliver; Reynders, Hazel; Robertson, Lisa; Tidswell, Katharine

    2011-01-01

    Background: Huntington’s disease (HD) is a rare triplet repeat (CAG) disorder. Advanced, multi-centre, multi-national research frameworks are needed to study simultaneously multiple complementary aspects of HD. This includes the natural history of HD, its management and the collection of clinical information and biosamples for research. Methods: We report on cross-sectional data of the first 1766 participants in REGISTRY, the European Huntington’s Disease Network’s (EHDN), multi-lingual, multi-national prospective observational study of HD in Europe. Data collection (demographics, phenotype, genotype, medication, co-morbidities, biosamples) followed a standard protocol. Results: Phenotype, and the HD genotype, of manifest HD participants across different European regions was similar. Motor onset was most common (48%) with a non-motor onset in more than a third of participants. Motor signs increased, and cognitive abilities and functional capacity declined as the disease burden (CAGn-35.5) X age) increased. A life-time history of behavioural symptoms was common, but the behavioural score was not related to disease burden. One fifth of participants had severe psychiatric problems, e.g. suicidal ideation and attempts, and/or irritability/aggression, with psychosis being less common. Participants on anti-dyskinetic medication had a higher motor and lower cognitive score, were older, and more prone to physical trauma. A higher motor and a lower cognitive score predicted more advanced disease. Conclusions: The unparalleled collection of clinical data and biomaterials within the EHDN’s REGISTRY can expedite the search for disease modifiers (genetic and environmental) of age at onset and disease progression that could be harnessed for the development of novel treatments. PMID:20890398

  9. Using registries to identify adverse events in rheumatic diseases.

    PubMed

    Lionetti, Geraldina; Kimura, Yukiko; Schanberg, Laura E; Beukelman, Timothy; Wallace, Carol A; Ilowite, Norman T; Winsor, Jane; Fox, Kathleen; Natter, Marc; Sundy, John S; Brodsky, Eric; Curtis, Jeffrey R; Del Gaizo, Vincent; Iyasu, Solomon; Jahreis, Angelika; Meeker-O'Connell, Ann; Mittleman, Barbara B; Murphy, Bernard M; Peterson, Eric D; Raymond, Sandra C; Setoguchi, Soko; Siegel, Jeffrey N; Sobel, Rachel E; Solomon, Daniel; Southwood, Taunton R; Vesely, Richard; White, Patience H; Wulffraat, Nico M; Sandborg, Christy I

    2013-11-01

    The proven effectiveness of biologics and other immunomodulatory products in inflammatory rheumatic diseases has resulted in their widespread use as well as reports of potential short- and long-term complications such as infection and malignancy. These complications are especially worrisome in children who often have serial exposures to multiple immunomodulatory products. Post-marketing surveillance of immunomodulatory products in juvenile idiopathic arthritis (JIA) and pediatric systemic lupus erythematosus is currently based on product-specific registries and passive surveillance, which may not accurately reflect the safety risks for children owing to low numbers, poor long-term retention, and inadequate comparators. In collaboration with the US Food and Drug Administration (FDA), patient and family advocacy groups, biopharmaceutical industry representatives and other stakeholders, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) and the Duke Clinical Research Institute (DCRI) have developed a novel pharmacosurveillance model (CARRA Consolidated Safety Registry [CoRe]) based on a multicenter longitudinal pediatric rheumatic diseases registry with over 8000 participants. The existing CARRA infrastructure provides access to much larger numbers of subjects than is feasible in single-product registries. Enrollment regardless of medication exposure allows more accurate detection and evaluation of safety signals. Flexibility built into the model allows the addition of specific data elements and safety outcomes, and designation of appropriate disease comparator groups relevant to each product, fulfilling post-marketing requirements and commitments. The proposed model can be applied to other pediatric and adult diseases, potentially transforming the paradigm of pharmacosurveillance in response to the growing public mandate for rigorous post-marketing safety monitoring.

  10. Using Registries to Identify Adverse Events in Rheumatic Diseases

    PubMed Central

    Lionetti, Geraldina; Kimura, Yukiko; Schanberg, Laura E.; Beukelman, Timothy; Wallace, Carol A.; Ilowite, Norman T.; Winsor, Jane; Fox, Kathleen; Natter, Marc; Sundy, John S.; Brodsky, Eric; Curtis, Jeffrey R.; Del Gaizo, Vincent; Iyasu, Solomon; Jahreis, Angelika; Meeker-O’Connell, Ann; Mittleman, Barbara B.; Murphy, Bernard M.; Peterson, Eric D.; Raymond, Sandra C.; Setoguchi, Soko; Siegel, Jeffrey N.; Sobel, Rachel E.; Solomon, Daniel; Southwood, Taunton R.; Vesely, Richard; White, Patience H.; Wulffraat, Nico M.; Sandborg, Christy I.

    2013-01-01

    The proven effectiveness of biologics and other immunomodulatory products in inflammatory rheumatic diseases has resulted in their widespread use as well as reports of potential short- and long-term complications such as infection and malignancy. These complications are especially worrisome in children who often have serial exposures to multiple immunomodulatory products. Post-marketing surveillance of immunomodulatory products in juvenile idiopathic arthritis (JIA) and pediatric systemic lupus erythematosus is currently based on product-specific registries and passive surveillance, which may not accurately reflect the safety risks for children owing to low numbers, poor long-term retention, and inadequate comparators. In collaboration with the US Food and Drug Administration (FDA), patient and family advocacy groups, biopharmaceutical industry representatives and other stakeholders, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) and the Duke Clinical Research Institute (DCRI) have developed a novel pharmacosurveillance model (CARRA Consolidated Safety Registry [CoRe]) based on a multicenter longitudinal pediatric rheumatic diseases registry with over 8000 participants. The existing CARRA infrastructure provides access to much larger numbers of subjects than is feasible in single-product registries. Enrollment regardless of medication exposure allows more accurate detection and evaluation of safety signals. Flexibility built into the model allows the addition of specific data elements and safety outcomes, and designation of appropriate disease comparator groups relevant to each product, fulfilling post-marketing requirements and commitments. The proposed model can be applied to other pediatric and adult diseases, potentially transforming the paradigm of pharmacosurveillance in response to the growing public mandate for rigorous post-marketing safety monitoring. PMID:24144710

  11. 36 CFR 704.1 - Films selected for inclusion in the National Film Registry.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 3 2012-07-01 2012-07-01 false 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 the...

  12. 36 CFR 704.1 - Films selected for inclusion in the National Film Registry.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false 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 the...

  13. 36 CFR 704.1 - Films selected for inclusion in the National Film Registry.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 3 2011-07-01 2011-07-01 false 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 the...

  14. 36 CFR 704.1 - Films selected for inclusion in the National Film Registry.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false 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...

  15. 16 CFR 310.8 - Fee for access to the National Do Not Call Registry.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Registry. 310.8 Section 310.8 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS TELEMARKETING SALES RULE § 310.8 Fee for access to the National Do Not Call Registry. (a... access to telephone numbers within that area code that are included in the National Do Not Call...

  16. 49 CFR 195.64 - National Registry of Pipeline and LNG Operators.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false National Registry of Pipeline and LNG Operators... Reporting § 195.64 National Registry of Pipeline and LNG Operators. (a) OPID Request. Effective January 1... Pipeline and LNG Operators in accordance with § 195.58. (b) OPID validation. An operator who has...

  17. 49 CFR 191.22 - National Registry of Pipeline and LNG operators.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 3 2014-10-01 2014-10-01 false National Registry of Pipeline and LNG operators...-RELATED CONDITION REPORTS § 191.22 National Registry of Pipeline and LNG operators. (a) OPID Request. Effective January 1, 2012, each operator of a gas pipeline, gas pipeline facility, LNG plant or LNG...

  18. 49 CFR 195.64 - National Registry of Pipeline and LNG Operators.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 false National Registry of Pipeline and LNG Operators... Reporting § 195.64 National Registry of Pipeline and LNG Operators. (a) OPID Request. Effective January 1... Pipeline and LNG Operators in accordance with § 195.58. (b) OPID validation. An operator who has...

  19. 49 CFR 191.22 - National Registry of Pipeline and LNG operators.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 false National Registry of Pipeline and LNG operators...-RELATED CONDITION REPORTS § 191.22 National Registry of Pipeline and LNG operators. (a) OPID Request. Effective January 1, 2012, each operator of a gas pipeline, gas pipeline facility, LNG plant or LNG...

  20. 49 CFR 191.22 - National Registry of Pipeline and LNG operators.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false National Registry of Pipeline and LNG operators...-RELATED CONDITION REPORTS § 191.22 National Registry of Pipeline and LNG operators. (a) OPID Request. Effective January 1, 2012, each operator of a gas pipeline, gas pipeline facility, LNG plant or LNG...

  1. 49 CFR 191.22 - National Registry of Pipeline and LNG operators.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false National Registry of Pipeline and LNG operators...-RELATED CONDITION REPORTS § 191.22 National Registry of Pipeline and LNG operators. (a) OPID Request. Effective January 1, 2012, each operator of a gas pipeline, gas pipeline facility, LNG plant or LNG...

  2. 49 CFR 195.64 - National Registry of Pipeline and LNG Operators.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false National Registry of Pipeline and LNG Operators... Reporting § 195.64 National Registry of Pipeline and LNG Operators. (a) OPID Request. Effective January 1... Pipeline and LNG Operators in accordance with § 195.58. (b) OPID validation. An operator who has...

  3. 49 CFR 195.64 - National Registry of Pipeline and LNG Operators.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 3 2014-10-01 2014-10-01 false National Registry of Pipeline and LNG Operators... Reporting § 195.64 National Registry of Pipeline and LNG Operators. (a) OPID Request. Effective January 1... Pipeline and LNG Operators in accordance with § 195.58. (b) OPID validation. An operator who has...

  4. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION... and liquefied natural gas (LNG) operators. New operators use the national registry to obtain an... LNG Facilities. Subject: Implementation of the National Registry of Pipeline and LNG Operators...

  5. A modular approach to disease registry design: successful adoption of an internet-based rare disease registry.

    PubMed

    Bellgard, Matthew I; Macgregor, Andrew; Janon, Fred; Harvey, Adam; O'Leary, Peter; Hunter, Adam; Dawkins, Hugh

    2012-10-01

    There is a need to develop Internet-based rare disease registries to support health care stakeholders to deliver improved quality patient outcomes. Such systems should be architected to enable multiple-level access by a range of user groups within a region or across regional/country borders in a secure and private way. However, this functionality is currently not available in many existing systems. A new approach to the design of an Internet-based architecture for disease registries has been developed for patients with clinical and genetic data in geographical disparate locations. The system addresses issues of multiple-level access by key stakeholders, security and privacy. The system has been successfully adopted for specific rare diseases in Australia and is open source. The results of this work demonstrate that it is feasible to design an open source Internet-based disease registry system in a scalable and customizable fashion and designed to facilitate interoperability with other systems. © 2012 Wiley Periodicals, Inc.

  6. Surveillance of the Incidence of Non-Communicable Diseases (NCDs) with Sparse Resources: A Simulation Study Using Data from a National Diabetes Registry, Denmark, 1995-2004.

    PubMed

    Brinks, Ralph; Hoyer, Annika; Landwehr, Sandra

    2016-01-01

    We propose two new methods to estimate secular trends in the incidence of a chronic disease from a series of prevalence studies and mortality data. One method is a direct inversion formula, the second method is a least squares estimation. Both methods are validated in a simulation study based on data from a diabetes register. The results of the validation show that the proposed methods may be useful in epidemiological settings with sparse resources, where running a register or a series of follow-up studies is difficult or impossible.

  7. Japan Renal Biopsy Registry and Japan Kidney Disease Registry: Committee Report for 2009 and 2010.

    PubMed

    Sugiyama, Hitoshi; Yokoyama, Hitoshi; Sato, Hiroshi; Saito, Takao; Kohda, Yukimasa; Nishi, Shinichi; Tsuruya, Kazuhiko; Kiyomoto, Hideyasu; Iida, Hiroyuki; Sasaki, Tamaki; Higuchi, Makoto; Hattori, Motoshi; Oka, Kazumasa; Kagami, Shoji; Kawamura, Tetsuya; Takeda, Tetsuro; Hataya, Hiroshi; Fukasawa, Yuichiro; Fukatsu, Atsushi; Morozumi, Kunio; Yoshikawa, Norishige; Shimizu, Akira; Kitamura, Hiroshi; Yuzawa, Yukio; Matsuo, Seiichi; Kiyohara, Yutaka; Joh, Kensuke; Nagata, Michio; Taguchi, Takashi; Makino, Hirofumi

    2013-04-01

    The Japan Renal Biopsy Registry (J-RBR) was started in 2007 and the Japan Kidney Disease Registry (J-KDR) was then started in 2009 by the Committee for Standardization of Renal Pathological Diagnosis and the Committee for the Kidney Disease Registry of the Japanese Society of Nephrology. The purpose of this report is to describe and summarize the registered data from 2009 and 2010. For the J-KDR, data were collected from 4,016 cases, including 3,336 (83.1 %) by the J-RBR and 680 (16.9 %) other cases from 59 centers in 2009, and from 4,681 cases including 4,106 J-RBR cases (87.7 %) and 575 other cases (12.3 %) from 94 centers in 2010, including the affiliate hospitals. In the J-RBR, 3,165 native kidneys (94.9 %) and 171 renal grafts (5.1 %) and 3,869 native kidneys (94.2 %) and 237 renal grafts (5.8 %) were registered in 2009 and 2010, respectively. Patients younger than 20 years of age comprised 12.1 % of the registered cases, and those 65 years and over comprised 24.5 % of the cases with native kidneys in 2009 and 2010. The most common clinical diagnosis was chronic nephritic syndrome (55.4 % and 50.0 % in 2009 and 2010, respectively), followed by nephrotic syndrome (22.4 % and 27.0 %); the most frequent pathological diagnosis as classified by the pathogenesis was IgA nephropathy (31.6 % and 30.4 %), followed by primary glomerular diseases (except IgA nephropathy) (27.2 % and 28.1 %). Among the primary glomerular diseases (except IgA nephropathy) in the patients with nephrotic syndrome, membranous nephropathy was the most common histopathology in 2009 (40.3 %) and minor glomerular abnormalities (50.0 %) were the most common in 2010 in native kidneys in the J-RBR. Five new secondary and longitudinal research studies by the J-KDR were started in 2009 and one was started in 2010.

  8. Existing data sources for clinical epidemiology: the Danish National Pathology Registry and Data Bank

    PubMed Central

    Erichsen, Rune; Lash, Timothy L; Hamilton-Dutoit, Stephen J; Bjerregaard, Beth; Vyberg, Mogens; Pedersen, Lars

    2010-01-01

    Diagnostic histological and cytological specimens are routinely stored in pathology department archives. These biobanks are a valuable research resource for many diseases, particularly if they can be linked to high quality population-based health registries, allowing large retrospective epidemiological studies to be carried out. Such studies are of significant importance, for example in the search for novel prognostic and predictive biomarkers in the era of personalized medicine. Denmark has a wealth of highly-regarded population-based registries that are ideally suited to conduct this type of epidemiological research. We describe two recent additions to these databases: the Danish National Pathology Registry (DNPR) and its underlying national online registration database, the Danish Pathology Data Bank (DPDB). The DNPR and the DPDB contain detailed nationwide records of all pathology specimens analyzed in Denmark since 1997, and an incomplete but nonetheless valuable record of specimens from some pathology departments dating back to the 1970s. The data are of high quality and completeness and are sufficient to allow precise and efficient localization of the specimens. We describe the relatively uncomplicated procedures required to use these pathology databases in clinical research and to gain access to the archived specimens. PMID:20865103

  9. Initial results of the National Registry of Incisional Hernia.

    PubMed

    Pereira, José Antonio; López-Cano, Manuel; Hernández-Granados, Pilar; Feliu, Xavier

    2016-12-01

    The aim of this study was to the data from the National Registry of Incisional Hernia (EVEREG) to determine the reality of the treatment of this condition in Spain. EVEREG is an online prospective database which has been functioning since July 2012; operations for incisional hernia are anonymously recorded. Up to March 2015, 4501 hernias from 95 of the 113 participating hospitals were registered. The mean age of the patients was 62.7, and 56.5% were women, with a mean BMI of 30.2kg/m(2); 29.8% presented a high surgical risk (ASA III-V). A total of 93.7% were scheduled surgeries, 88.3% open surgery and 22.2% were recurrent incisional hernias. There were 66.9% hernias after a midline laparotomy, and 81.4% of a transverse diameter of less than 10cm. A mesh was used in 96.2% of cases. Postoperative stay was 5.3 days and 29.1% presented a complication, with a mortality of 0.8%. After a median follow-up of 7.7 months a high rate of recurrence was detected (20.7% per year), especially in hernias that were operated on after a previous repair (18.1% primary vs. 30.6% recurrent; P=.004). the EVEREG registry is a useful tool to know the current situation of incisional hernia treatment. Analysis of the data shows several points that could be improved: a low rate of follow-up and high recurrence rate. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  10. Unmet palliative care needs among patients with end-stage kidney disease: a national registry study about the last week of life.

    PubMed

    Axelsson, Lena; Alvariza, Anette; Lindberg, Jenny; Öhlén, Joakim; Håkanson, Cecilia; Reimertz, Helene; Fürst, Carl-Johan; Årestedt, Kristofer

    2017-09-20

    End-stage kidney disease (ESKD) is characterized by high physical and psychological burden and therefore, more knowledge about the palliative care provided close to death is needed. To describe symptom prevalence, relief and management during the last week of life, as well as end-of-life communication, in patients with ESKD. This study was based on data from the Swedish Register of Palliative Care. Patients aged 18 or older who died from a chronic kidney disease, with or without dialysis treatment (ICD-10-SE; N18.5 or N18.9), during 2011 and 2012 were selected. 472 patients were included. Of six predefined symptoms, pain was the most prevalent (69%), followed by respiratory secretion (46%), anxiety (41%), confusion (30%), shortness of breath (22%), and nausea (17%). Of patients with pain and/or anxiety, 32% and 44% respectively were only partly relieved or not relieved at all. Of patients with the other symptoms, a majority (55%-84%) were partly relieved or not relieved at all. End-of-life discussions were reported in 41% of patients and 71% of families. A minority died in specialized palliative care: 8% in hospice/in-patient palliative care and 5% in palliative home care. Of all patients, 19% died alone. Bereavement support was offered to 38% of families. Even if death is expected, the majority of patients dying with ESKD had unmet palliative care needs regarding symptom management, advance care planning, and bereavement support. Copyright © 2017. Published by Elsevier Inc.

  11. The Danish National Patient Registry: a review of content, data quality, and research potential

    PubMed Central

    Schmidt, Morten; Schmidt, Sigrun Alba Johannesdottir; Sandegaard, Jakob Lynge; Ehrenstein, Vera; Pedersen, Lars; Sørensen, Henrik Toft

    2015-01-01

    Background The Danish National Patient Registry (DNPR) is one of the world’s oldest nationwide hospital registries and is used extensively for research. Many studies have validated algorithms for identifying health events in the DNPR, but the reports are fragmented and no overview exists. Objectives To review the content, data quality, and research potential of the DNPR. Methods We examined the setting, history, aims, content, and classification systems of the DNPR. We searched PubMed and the Danish Medical Journal to create a bibliography of validation studies. We included also studies that were referenced in retrieved papers or known to us beforehand. Methodological considerations related to DNPR data were reviewed. Results During 1977–2012, the DNPR registered 8,085,603 persons, accounting for 7,268,857 inpatient, 5,953,405 outpatient, and 5,097,300 emergency department contacts. The DNPR provides nationwide longitudinal registration of detailed administrative and clinical data. It has recorded information on all patients discharged from Danish nonpsychiatric hospitals since 1977 and on psychiatric inpatients and emergency department and outpatient specialty clinic contacts since 1995. For each patient contact, one primary and optional secondary diagnoses are recorded according to the International Classification of Diseases. The DNPR provides a data source to identify diseases, examinations, certain in-hospital medical treatments, and surgical procedures. Long-term temporal trends in hospitalization and treatment rates can be studied. The positive predictive values of diseases and treatments vary widely (<15%–100%). The DNPR data are linkable at the patient level with data from other Danish administrative registries, clinical registries, randomized controlled trials, population surveys, and epidemiologic field studies – enabling researchers to reconstruct individual life and health trajectories for an entire population. Conclusion The DNPR is a valuable

  12. The Danish National Patient Registry: a review of content, data quality, and research potential.

    PubMed

    Schmidt, Morten; Schmidt, Sigrun Alba Johannesdottir; Sandegaard, Jakob Lynge; Ehrenstein, Vera; Pedersen, Lars; Sørensen, Henrik Toft

    2015-01-01

    The Danish National Patient Registry (DNPR) is one of the world's oldest nationwide hospital registries and is used extensively for research. Many studies have validated algorithms for identifying health events in the DNPR, but the reports are fragmented and no overview exists. To review the content, data quality, and research potential of the DNPR. We examined the setting, history, aims, content, and classification systems of the DNPR. We searched PubMed and the Danish Medical Journal to create a bibliography of validation studies. We included also studies that were referenced in retrieved papers or known to us beforehand. Methodological considerations related to DNPR data were reviewed. During 1977-2012, the DNPR registered 8,085,603 persons, accounting for 7,268,857 inpatient, 5,953,405 outpatient, and 5,097,300 emergency department contacts. The DNPR provides nationwide longitudinal registration of detailed administrative and clinical data. It has recorded information on all patients discharged from Danish nonpsychiatric hospitals since 1977 and on psychiatric inpatients and emergency department and outpatient specialty clinic contacts since 1995. For each patient contact, one primary and optional secondary diagnoses are recorded according to the International Classification of Diseases. The DNPR provides a data source to identify diseases, examinations, certain in-hospital medical treatments, and surgical procedures. Long-term temporal trends in hospitalization and treatment rates can be studied. The positive predictive values of diseases and treatments vary widely (<15%-100%). The DNPR data are linkable at the patient level with data from other Danish administrative registries, clinical registries, randomized controlled trials, population surveys, and epidemiologic field studies - enabling researchers to reconstruct individual life and health trajectories for an entire population. The DNPR is a valuable tool for epidemiological research. However, both its

  13. Dispelling myths about rare disease registry system development

    PubMed Central

    2013-01-01

    Rare disease registries (RDRs) are an essential tool to improve knowledge and monitor interventions for rare diseases. If designed appropriately, patient and disease related information captured within them can become the cornerstone for effective diagnosis and new therapies. Surprisingly however, registries possess a diverse range of functionality, operate in different, often-times incompatible, software environments and serve various, and sometimes incongruous, purposes. Given the ambitious goals of the International Rare Diseases Research Consortium (IRDiRC) by 2020 and beyond, RDRs must be designed with the agility to evolve and efficiently interoperate in an ever changing rare disease landscape, as well as to cater for rapid changes in Information Communication Technologies. In this paper, we contend that RDR requirements will also evolve in response to a number of factors such as changing disease definitions and diagnostic criteria, the requirement to integrate patient/disease information from advances in either biotechnology and/or phenotypying approaches, as well as the need to adapt dynamically to security and privacy concerns. We dispel a number of myths in RDR development, outline key criteria for robust and sustainable RDR implementation and introduce the concept of a RDR Checklist to guide future RDR development. PMID:24131574

  14. Practice-Based Evidence to Evidence-Based Practice: Building the National Radiation Oncology Registry

    PubMed Central

    Efstathiou, Jason A.; Nassif, Deborah S.; McNutt, Todd R.; Bogardus, C. Bob; Bosch, Walter; Carlin, Jeffrey; Chen, Ronald C.; Chou, Henry; Eggert, Dave; Fraass, Benedick A.; Goldwein, Joel; Hoffman, Karen E.; Hotz, Ken; Hunt, Margie; Kessler, Marc; Lawton, Colleen A.F.; Mayo, Charles; Michalski, Jeff M.; Mutic, Sasa; Potters, Louis; Rose, Christopher M.; Sandler, Howard M.; Sharp, Gregory; Tomé, Wolfgang; Tran, Phuoc T.; Wall, Terry; Zietman, Anthony L.; Gabriel, Peter E.; Bekelman, Justin E.

    2013-01-01

    The National Radiation Oncology Registry (NROR), sponsored by the Radiation Oncology Institute and the American Society for Radiation Oncology, is designed to collect standardized information on cancer care delivery among patients treated with radiotherapy in the United States and will focus on patients with prostate cancer. Stakeholders were engaged through a forum that emphasized the need for patient-centered outcomes, minimal data burden, and maximal connectivity to existing registries and databases. An electronic infrastructure is under development to provide connectivity across radiation oncology and hospital information systems. The NROR Gateway features automatic abstraction as well as aggregation of treatment and outcome data. The prostate cancer data dictionary provides standardized elements in four domains: facility, physician, patient, and treatment. The pilot phase will consist of clinical centers chosen to provide a representative mix of radiation treatment modalities, facility types, population-based settings, and regional locations. The initial set of radiation practice metrics includes physician board certification and maintenance, ordering of staging scans, active surveillance discussion, dose prescriptions for low-risk/high-risk disease, radiation fields for low-risk/high-risk disease, image-guided radiation therapy use, androgen deprivation therapy use, post-brachytherapy implant computed tomography dosimetry, collection of toxicity assessments, and longitudinal patient follow-up. The NROR pilot study will provide the framework for expansion to a nationwide electronic registry for radiation oncology. PMID:23942508

  15. Need for a roadmap for development of a coordinated national registry programme.

    PubMed

    Wilkins, S; Best, R L; Evans, S M

    2015-11-01

    Clinical quality registries are an overlooked and under-funded arm of clinical research in Australia. Registries are databases for patients with a particular disease, or who undergo a procedure, or use a health resource. Registries, where properly funded and universally adopted, have provided substantial benefits to the quality of healthcare and, in some cases, have had demonstrable effect in reducing costs. There is a lack of a coordinated programme for both funding and development of registries in Australia. A coordinated effort is required to address key gaps in registry coverage and ensure registries comply with appropriate technical and operating principles, and target areas where registries can add value to the health system. This will ensure that Australia is competitive with its international peers in this dynamic environment.

  16. 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.

  17. National Registry on Cardiac Electrophysiology 2007 and 2008.

    PubMed

    da Silva, Manuel Nogueira; Bonhorst, Daniel; de Sousa, João

    2009-11-01

    Clinical electrophysiology remains one of the most dynamic areas of cardiology, with continuing developments in equipping centers with more modern mapping and navigation systems. This has enabled an increase in the number and variety of interventions, resulting in significant improvements in results of therapeutic ablation of arrhythmias and prevention of sudden cardiac death. In this phase of transition towards implementation of a computerized national registry with nationwide data transmitted via the internet, publication of the registry in its previous form, although requiring more work, still seems justified, in order to appraise and disseminate qualitative and quantitative developments in this activity and enable comparisons with what is being done internationally, assess the centers' training capacity and inform national and European health authorities of the activities and real needs in this sector. The authors analyze the number and type of procedures performed during 2007 and 2008 based on a survey sent to centers performing diagnostic and interventional electrophysiology (16 centers in 2007 and 2008) and/or implanting cardioverter-defibrillators (ICDs) (19 centers in 2007 and 21 in 2008). Compared to 2006, one more center began interventional electrophysiology in 2007 and two centers began implanting ICDs in 2008. In the years under review, 2060 electrophysiological studies were performed in 2007 and 2007 were performed in 2008, of which 74 and 79.5% respectively were followed by therapeutic ablation, making totals of 1523 and 1596 ablations (increases of 10.7 and 4.6% from previous years). Atrioventricular nodal reentrant tachycardia was the main indication for ablation (28.4 and 28.7%), followed by accessory pathways (26.8 and 25.4%), atrial flutter (20.8 and 19.7%), atrial fibrillation (13.9 and 14.6%), ventricular tachycardia (4.7 and 5.1%), atrial tachycardia (2.8 and 2.6%) and atrioventricular junction ablation (2.7 and 3.9%). Regarding ICDs, a

  18. Assessing Medicare Beneficiary Eligibility for Medication Therapy Management Programs Using PINNACLE, a National Cardiovascular Data Registry.

    PubMed

    Spinler, Sarah A; Cziraky, Mark J; Tang, Fengming; Dueñas, Gladys G; Thomas, Tyan; Reinhold, Jennifer A; Willey, Vincent J

    2013-09-01

    Medication therapy management (MTM) is a mandated component of the 2003 Medicare Modernization Act for Part D prescription drug plans and Medicare Advantage plans, authorizing the pharmacist or other qualified provider to identify, resolve, and prevent medication-related problems for patients with chronic diseases. MTM programs have been shown to improve medication adherence and reduce medication errors while reducing overall costs in patients with cardiovascular (CV) disease; however, MTM has been greatly underutilized for patients with chronic diseases. To identify the proportion of Medicare beneficiaries who are eligible for, and who could potentially benefit from, participating in MTM among patients enrolled in the National Cardiovascular Data Registry's PINNACLE Registry. Patient MTM eligibility is based on the presence of multiple chronic diseases and meeting a minimum annual insurance medication costs. We used patient data from 462 academic and private cardiology practices in the United States who participated in the PINNACLE Registry between May 1, 2008, and September 30, 2010, to determine Medicare beneficiaries' eligibility to participate in an MTM program for patients meeting the MTM criteria of (1) a number of chronic diseases (in this case, the number of CV conditions) and (2) an estimated minimum annual medication expenses, using a weighted average cost calculated based on the average wholesale price of the most often prescribed medications, by class, as extracted from the HealthCore Integrated Research Database and weighted according to prescribing frequency within a class. Among the Medicare beneficiaries in the PINNACLE Registry, 93,089 (58%) had ≥3 chronic CV conditions, and the median annual estimated medication expenditure per patient enrolled in the PINNACLE Registry was $1329. Of the total of 93,089 Medicare beneficiaries, 21.4% were eligible for MTM, based on the 2010 minimum eligibility criterion of an annual insurer medication expenditure

  19. Proposal for a Prospective Registry for Moyamoya Disease in Japan.

    PubMed

    Kazumata, Ken; Ito, Masaki; Uchino, Haruto; Nishihara, Hiroshi; Houkin, Kiyohiro

    2017-02-15

    The number of clinical research papers published worldwide on moyamoya disease (MMD) has increased recently. However, the majority of the literature comprises retrospective single-center studies collecting data on small numbers of patients. Several multi-center studies are ongoing in Japan; however, the current data are insufficient for comprehensively outlining the various characteristics of MMD. To enhance our knowledge on epidemiologic, vascular, and genetic aspects of MMD, a prospective multicenter registry will be established in Japan that will help to streamline clinical research as well as improve clinical treatments and long-term outcomes. Patients with MMD or secondary moyamoya syndrome referred to the participating centers will be invited to the registry. Demographic and physiological parameters, along with neuroimaging data will be collected chronologically. Clinical events, including neurological, medical, and surgical interventions will be recorded. Whole blood samples will be collected. Extra- and intra-cranial vascular tissue, and/or cerebrospinal fluid will also be collected from patients who undergo surgical revascularization. These biospecimens will be stored at the repositories and utilized for genome-wide association studies for identifying genetic variants, as well as tissue-specific proteomic, and/or molecular analyses. Ethics approval will be obtained at all facilities collecting biospecimens. The registry will provide descriptive statistics on functional outcomes, surgical techniques used, medications, and neurological events stratified according to patients' clinical characteristics. We expect this study to provide novel insights in the management of MMD patients and design better therapies.

  20. Proposal for a Prospective Registry for Moyamoya Disease in Japan

    PubMed Central

    KAZUMATA, Ken; ITO, Masaki; UCHINO, Haruto; NISHIHARA, Hiroshi; HOUKIN, Kiyohiro

    2017-01-01

    The number of clinical research papers published worldwide on moyamoya disease (MMD) has increased recently. However, the majority of the literature comprises retrospective single-center studies collecting data on small numbers of patients. Several multi-center studies are ongoing in Japan; however, the current data are insufficient for comprehensively outlining the various characteristics of MMD. To enhance our knowledge on epidemiologic, vascular, and genetic aspects of MMD, a prospective multicenter registry will be established in Japan that will help to streamline clinical research as well as improve clinical treatments and long-term outcomes. Patients with MMD or secondary moyamoya syndrome referred to the participating centers will be invited to the registry. Demographic and physiological parameters, along with neuroimaging data will be collected chronologically. Clinical events, including neurological, medical, and surgical interventions will be recorded. Whole blood samples will be collected. Extra- and intracranial vascular tissue, and/or cerebrospinal fluid will also be collected from patients who undergo surgical revascularization. These biospecimens will be stored at the repositories and utilized for genome-wide association studies for identifying genetic variants, as well as tissue-specific proteomic, and/or molecular analyses. Ethics approval will be obtained at all facilities collecting biospecimens. The registry will provide descriptive statistics on functional outcomes, surgical techniques used, medications, and neurological events stratified according to patients’ clinical characteristics. We expect this study to provide novel insights in the management of MMD patients and design better therapies. PMID:28070115

  1. Towards a European registry of severe allergic reactions: current status of national registries and future needs.

    PubMed

    Worm, M; Timmermans, F; Moneret-Vautrin, A; Muraro, A; Malmheden Yman, I I; Lövik, M; Hattersley, S; Crevel, R

    2010-06-01

    The incidence of severe allergic reactions is largely unknown and information about triggering allergens, aggravating factors, demography of patients and medical care is lacking. A European wide registry could provide a powerful tool to improve the management of severe allergic reactions from both a medical and a public health perspective. Analysis of existing registries regarding the type and quality of data being collected was used to develop a plan for a pan-European registry, including the type of system to be used and the range of data to be entered. Surveillance will provide evidence for the efficacy of risk management measures and may identify the emergence of new allergenic foods, and aid monitoring of novel foods, ingredients and technologies. Patients need a clear indication of factors that may increase their risk of having an adverse reaction, which such a registry can help compile. Based on the collected data, food businesses will be able to develop educational programmes for allergen risk assessment and allergen risk communication. Finally, and most importantly preventive measures can be developed and government agencies receive population based data which may be relevant for legislative purposes.

  2. National MS and Parkinson's Disease Registries Act

    THOMAS, 111th Congress

    Sen. Dorgan, Byron L. [D-ND

    2009-06-16

    Senate - 06/16/2009 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  3. 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...

  4. 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 (VO2max) for men and women were determined for each decade from age 20 years through age 79 years. Comparisons of VO2max 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 VO2max (P<.01). For cycle tests within the FRIEND Registry, the 50th percentile VO2max of men and women aged 20 to 29 years declined from 41.9 and 31.0 mLO2/kg/min to 19.5 and 14.8 mLO2/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 VO2max from exercise tests using cycle ergometry compared with previous approaches based on estimations of standard differences from treadmill testing reference values.

  5. National nephrectomy registries: Reviewing the need for population-based data.

    PubMed

    Pearson, John; Williamson, Timothy; Ischia, Joseph; Bolton, Damien M; Frydenberg, Mark; Lawrentschuk, Nathan

    2015-09-01

    Nephrectomy is the cornerstone therapy for renal cell carcinoma (RCC) and continued refinement of the procedure through research may enhance patient outcomes. A national nephrectomy registry may provide the key information needed to assess the procedure at a national level. The aim of this study was to review nephrectomy data available at a population-based level in Australia and to benchmark these data against data from the rest of the world as an examination of the national nephrectomy registry model. A PubMed search identified records pertaining to RCC nephrectomy in Australia. A similar search identified records relating to established nephrectomy registries internationally and other surgical registries of clinical importance. These records were reviewed to address the stated aims of this article. Population-based data within Australia for nephrectomy were lacking. Key issues identified were the difficulty in benchmarking outcomes and no ongoing monitoring of trends. The care centralization debate, which questions whether small-volume centers provide comparable outcomes to high-volume centers, is ongoing. Patterns of adherence and the effectiveness of existing protocols are uncertain. A review of established international registries demonstrated that the registry model can effectively address issues comparable to those identified in the Australian literature. A national nephrectomy registry could address deficiencies identified in a given nation's nephrectomy field. The model is supported by evidence from international examples and will provide the population-based data needed for studies. Scope exists for possible integration with other registries to develop a more encompassing urological or surgical registry. Need remains for further exploration of the feasibility and practicalities of initiating such a registry including a minimum data set, outcome indicators, and auditing of data.

  6. National nephrectomy registries: Reviewing the need for population-based data

    PubMed Central

    Pearson, John; Williamson, Timothy; Ischia, Joseph; Bolton, Damien M; Frydenberg, Mark

    2015-01-01

    Nephrectomy is the cornerstone therapy for renal cell carcinoma (RCC) and continued refinement of the procedure through research may enhance patient outcomes. A national nephrectomy registry may provide the key information needed to assess the procedure at a national level. The aim of this study was to review nephrectomy data available at a population-based level in Australia and to benchmark these data against data from the rest of the world as an examination of the national nephrectomy registry model. A PubMed search identified records pertaining to RCC nephrectomy in Australia. A similar search identified records relating to established nephrectomy registries internationally and other surgical registries of clinical importance. These records were reviewed to address the stated aims of this article. Population-based data within Australia for nephrectomy were lacking. Key issues identified were the difficulty in benchmarking outcomes and no ongoing monitoring of trends. The care centralization debate, which questions whether small-volume centers provide comparable outcomes to high-volume centers, is ongoing. Patterns of adherence and the effectiveness of existing protocols are uncertain. A review of established international registries demonstrated that the registry model can effectively address issues comparable to those identified in the Australian literature. A national nephrectomy registry could address deficiencies identified in a given nation's nephrectomy field. The model is supported by evidence from international examples and will provide the population-based data needed for studies. Scope exists for possible integration with other registries to develop a more encompassing urological or surgical registry. Need remains for further exploration of the feasibility and practicalities of initiating such a registry including a minimum data set, outcome indicators, and auditing of data. PMID:26366272

  7. 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.

  8. 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

  9. A national registry of haemoglobinopathies in Greece: deducted demographics, trends in mortality and affected births.

    PubMed

    Voskaridou, Ersi; Ladis, Vasilis; Kattamis, Antonis; Hassapopoulou, Eleni; Economou, Marina; Kourakli, Alexandra; Maragkos, Konstantinos; Kontogianni, Kalliopi; Lafioniatis, Stilianos; Vrettou, Eleni; Koutsouka, Freideriki; Papadakis, Alexandros; Mihos, Andreas; Eftihiadis, Eftihios; Farmaki, Kallistheni; Papageorgiou, Ourania; Tapaki, Georgia; Maili, Polixeni; Theohari, Maria; Drosou, Marouso; Kartasis, Zafeiris; Aggelaki, Maria; Basileiadi, Artemis; Adamopoulos, Ioannis; Lafiatis, Ioannis; Galanopoulos, Athanasios; Xanthopoulidis, Georgios; Dimitriadou, Efthimia; Mprimi, Agapi; Stamatopoulou, Maria; Haile, Elanso Damba; Tsironi, Maria; Anastasiadis, Athanasios; Kalmanti, Maria; Papadopoulou, Margarita; Panori, Evaggelia; Dimoxenou, Peristera; Tsirka, Antigoni; Georgakopoulos, Dimitrios; Drandrakis, Pantelis; Dionisopoulou, Dionisia; Ntalamaga, Androniki; Davros, Ioannis; Karagiorga, Markisia

    2012-09-01

    Haemoglobinopathies are the most common hereditary disorders in Greece. Although there is a successful national prevention program, established 35 years ago, there is lack of an official registry and collection of epidemiological data for haemoglobinopathies. This paper reports the results of the first National Registry for Haemoglobinopathies in Greece (NRHG), recently organized by the Greek Society of Haematology. NRHG records all patients affected by thalassaemia major (TM), thalassaemia intermedia (TI), "H" Haemoglobinopathy (HH) and sickle cell disease (SCD). Moreover, data about the annual rate of new affected births along with deaths, between 2000 and 2010, are reported. A total of 4,506 patients are registered all over the country while the number of affected newborns was significantly decreased during the last 3 years. Main causes for still having affected births are: (1) lack of medical care due to financial reasons or low educational level; (2) unawareness of time limitations for prenatal diagnosis (PD); due either to obstetricians' malpractice or to delayed demand of medical care of couples at risk; and (3) religious, social or bioethical reasons. Cardiac and liver disorders consist main causes for deaths while life expectancy of patients lengthened after 2005 (p < 0.01). The NRHG of patients affected by haemoglobinopathies in Greece provides useful data about the haemoglobinopathies in the Greek population and confirms the efficacy of the National Thalassaemia Prevention Program on impressively decreasing the incidence of TM and sickle cell syndromes.

  10. 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.

  11. Implementation of a population-based epidemiological rare disease registry: study protocol of the amyotrophic lateral sclerosis (ALS) - registry Swabia

    PubMed Central

    2013-01-01

    Background The social and medical impact of rare diseases is increasingly recognized. Amyotrophic lateral sclerosis (ALS) is the most prevalent of the motor neuron diseases. It is characterized by rapidly progressive damage to the motor neurons with a survival of 2–5 years for the majority of patients. The objective of this work is to describe the study protocol and the implementation steps of the amyotrophic lateral sclerosis (ALS) registry Swabia, located in the South of Germany. Methods/Design The ALS registry Swabia started in October 2010 with both, the retrospective (01.10.2008-30.09.2010) and prospective (from 01.10.2010) collection of ALS cases, in a target population of 8.6 million persons in Southern Germany. In addition, a population based case–control study was implemented based on the registry that also included the collection of various biological materials. Retrospectively, 420 patients (222 men and 198 women) were identified. Prospectively data of ALS patients were collected, of which about 70% agreed to participate in the population-based case–control study. All participants in the case–control study provided also a blood sample. The prospective part of the study is ongoing. Discussion The ALS registry Swabia has been implemented successfully. In rare diseases such as ALS, the collaboration of registries, the comparison with external samples and biorepositories will facilitate to identify risk factors and to further explore the potential underlying pathophysiological mechanisms. PMID:23414001

  12. National and international registries of rare bleeding disorders

    PubMed Central

    Peyvandi, Flora; Spreafico, Marta

    2008-01-01

    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 ofRBDs, 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. PMID:19115503

  13. Towards data integration automation for the French rare disease registry

    PubMed Central

    Maaroufi, Meriem; Choquet, Rémy; Landais, Paul; Jaulent, Marie-Christine

    2015-01-01

    Building a medical registry upon an existing infrastructure and rooted practices is not an easy task. It is the case for the BNDMR project, the French rare disease registry, that aims to collect administrative and medical data of rare disease patients seen in different hospitals. To avoid duplicating data entry for health professionals, the project plans to deploy connectors with the existing systems to automatically retrieve data. Given the data heterogeneity and the large number of source systems, the automation of connectors creation is required. In this context, we propose a methodology that optimizes the use of existing alignment approaches in the data integration processes. The generated mappings are formalized in exploitable mapping expressions. Following this methodology, a process has been experimented on specific data types of a source system: Boolean and predefined lists. As a result, effectiveness of the used alignment approach has been enhanced and more good mappings have been detected. Nonetheless, further improvements could be done to deal with the semantic issue and process other data types. PMID:26958224

  14. Towards data integration automation for the French rare disease registry.

    PubMed

    Maaroufi, Meriem; Choquet, Rémy; Landais, Paul; Jaulent, Marie-Christine

    2015-01-01

    Building a medical registry upon an existing infrastructure and rooted practices is not an easy task. It is the case for the BNDMR project, the French rare disease registry, that aims to collect administrative and medical data of rare disease patients seen in different hospitals. To avoid duplicating data entry for health professionals, the project plans to deploy connectors with the existing systems to automatically retrieve data. Given the data heterogeneity and the large number of source systems, the automation of connectors creation is required. In this context, we propose a methodology that optimizes the use of existing alignment approaches in the data integration processes. The generated mappings are formalized in exploitable mapping expressions. Following this methodology, a process has been experimented on specific data types of a source system: Boolean and predefined lists. As a result, effectiveness of the used alignment approach has been enhanced and more good mappings have been detected. Nonetheless, further improvements could be done to deal with the semantic issue and process other data types.

  15. Development of a disease registry for autoimmune bullous diseases: initial analysis of the pemphigus vulgaris subset.

    PubMed

    Shah, Amit Aakash; Seiffert-Sinha, Kristina; Sirois, David; Werth, Victoria P; Rengarajan, Badri; Zrnchik, William; Attwood, Kristopher; Sinha, Animesh A

    2015-01-01

    Pemphigus vulgaris (PV) is a rare, potentially life threatening, autoimmune blistering skin disease. The International Pemphigus and Pemphigoid Foundation (IPPF) has recently developed a disease registry with the aim to enhance our understanding of autoimmune bullous diseases with the long-term goal of acquiring information to improve patient care. Patients were recruited to the IPPF disease registry through direct mail, e-mail, advertisements, and articles in the IPPF-quarterly, -website, -Facebook webpage, and IPPF Peer Health Coaches to complete a 38-question survey. We present here the initial analysis of detailed clinical information collected on 393 PV patients. We report previously unrecognized gender differences in terms of lesion location, autoimmune comorbidity, and delay in diagnosis. The IPPF disease registry serves as a useful resource and guide for future clinical investigation.

  16. 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...

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

    PubMed

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

    2015-05-01

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

  18. The NIH Office of Rare Diseases Research Patient Registry Standard: A Report from the University of New Mexico’s Oculopharyngeal Muscular Dystrophy Patient Registry

    PubMed Central

    Daneshvari, Shamsi; Youssof, Sarah; Kroth, Philip J.

    2013-01-01

    Patient registries remove barriers to performing research by assembling patient cohorts and data in a systematic, efficient, and proactive manner. Consequently, registries are a valuable strategy for facilitating research and scientific discovery. Registries for rare diseases are arguably even more valuable since there is difficulty in assembling cohorts of adequate size for study. Recently, the NIH Office of Rare Diseases Research created a rare disease registry Standard to facilitate research across multiple registries. We implemented the Standard for the Oculopharyngeal Muscular Dystrophy patient registry created at the University of New Mexico Health Sciences Center. We performed a data element analysis for each Common Data Element defined in the Standard. Problems included the use of previous HL7 versions, non-structured data types, and a recent update to the Standard. Overall, the Standard is an excellent first step toward standardizing patient registries to facilitate work on broader questions and promote novel interdisciplinary collaborations. PMID:24551336

  19. [Computer tomography examination of the coronary system - National Plaque Registry and Database, Hungary].

    PubMed

    Bagyura, Zsolt; Kolossváry, Márton; Merkely, Béla; Maurovich-Horvat, Pál

    2017-01-01

    Coronary computer tomography angiography is a unique non-invasive imaging technique with the capability to provide information regarding plaque quantity, burden and structure. A reliable registry is required to use the data of these examinations in research projects. The difficulty is that registries need double data entry simultaneously to the hospital information system. Our registry solves this problem through a structured reporting tool, which generates clinical report and stores all data simultaneously. The automatically generated report is based on international guidelines. Between August 1. 2014 and September 1. 2015 we registered the data of 2866 patients. Coronary plaque was observed in 77.03% of the patients, 33.18% of the plaques were calcified. Severe stenosis was present in 13.71% of the patients. The structured reporting decreases reporting time, eliminates double data entry related errors. Our goal is to initiate a nationwide, unified registry, the National Plaque Registry and Database. Orv. Hetil., 2017, 158(3), 106-110.

  20. 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

  1. A comparison of survival between on-pump and off-pump left internal mammary artery bypass graft surgery for isolated left anterior descending coronary artery disease: an analysis of the UK National Adult Cardiac Surgery Audit Registry.

    PubMed

    Hickey, Graeme L; Pullan, Mark; Oo, Aung; Mediratta, Neeraj; Chalmers, John; Bridgewater, Ben; Poullis, Michael

    2016-05-01

    To determine if the use of cardiopulmonary bypass is associated with all-cause in-hospital and mid-term survival for patients undergoing left internal mammary artery (LIMA) to left anterior descending (LAD) coronary artery bypass grafting (CABG) for single coronary vessel disease. Data from the National Adult Cardiac Surgery Audit registry for all elective and urgent isolated CABG procedures performed between April 2003 and March 2013 in first-time cardiac surgery patients were extracted. Experienced surgeons (those with ≥300 records) were classified by their technique preference (as 'off-pump preference', 'mixed practice', 'on-pump preference') based on their entire isolated CABG data. In-hospital mortality and time to death were analysed using logistic and Cox proportional hazards regression models, respectively. From a total of 3402 records, 65.5% were performed off-pump. There were 16 (0.47%) in-hospital deaths: 6 (0.51%) in the on-pump group and 10 (0.45%) in the off-pump group. The risk-adjusted odds ratio of in-hospital mortality in the direction of on-pump was 1.09 [95% confidence interval (CI): 0.39-3.04; P = 0.86]. The overall 5-year survival in the on- and off-pump groups was 93.1 and 93.4%, respectively. The adjusted hazard ratio (HR) for mortality in the direction of on-pump CABG was 1.15 (95% CI: 0.89-1.49; P = 0.28). Comparing off-pump cases performed by experienced CABG surgeons with a preference for the off-pump technique with on-pump cases performed by surgeons with a preference for the on-pump technique indicated a significant difference (HR for on-pump = 1.72; 95% CI: 1.19-2.47; P = 0.004). Elective and urgent first-time CABG for isolated LAD disease is associated with excellent mid-term survival in the England and Wales population, conferring a 5-year survival rate of 93.1 and 93.4% in the on-pump and off-pump groups, respectively. There was no difference in risk-adjusted survival between the on-pump and off-pump techniques when analysing all

  2. Cerebral venous thrombosis in a Mexican multicenter registry of acute cerebrovascular disease: the RENAMEVASC study.

    PubMed

    Ruiz-Sandoval, José L; Chiquete, Erwin; Bañuelos-Becerra, L Jacqueline; Torres-Anguiano, Carolina; González-Padilla, Christian; Arauz, Antonio; León-Jiménez, Carolina; Murillo-Bonilla, Luis M; Villarreal-Careaga, Jorge; Barinagarrementería, Fernando; Cantú-Brito, Carlos

    2012-07-01

    Cerebral venous thrombosis (CVT) is a rare form of cerebrovascular disease that is usually not mentioned in multicenter registries on all-type acute stroke. We aimed to describe the experience on hospitalized patients with CVT in a Mexican multicenter registry on acute cerebrovascular disease. CVT patients were selected from the RENAMEVASC registry, which was conducted between 2002 and 2004 in 25 Mexican hospitals. Risk factors, neuroimaging, and 30-day outcome as assessed by the modified Rankin scale (mRS) were analyzed. Among 2000 all-type acute stroke patients, 59 (3%; 95% CI, 2.3-3.8%) had CVT (50 women; female:male ratio, 5:1; median age, 31 years). Puerperium (42%), contraceptive use (18%), and pregnancy (12%) were the main risk factors in women. In 67% of men, CVT was registered as idiopathic, but thrombophilia assessment was suboptimal. Longitudinal superior sinus was the most frequent thrombosis location (78%). Extensive (>5 cm) venous infarction occurred in 36% of patients. Only 81% of patients received anticoagulation since the acute phase, and 3% needed decompressive craniectomy. Mechanical ventilation (13.6%), pneumonia (10.2%) and systemic thromboembolism (8.5%) were the main in-hospital complications. The 30-day case fatality rate was 3% (2 patients; 95% CI, 0.23-12.2%). In a Cox proportional hazards model, only age <40 years was associated with a mRS score of 0 to 2 (functional independence; rate ratio, 3.46; 95% CI, 1.34-8.92). The relative frequency of CVT and the associated in-hospital complications were higher than in other registries. Thrombophilia assessment and acute treatment was suboptimal. Young age is the main determinant of a good short-term outcome. Copyright © 2012 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  3. [Treatment inertia in secondary prevention of cardiovascular disease. FRENA registry].

    PubMed

    Roa, Leonor; Monreal, Manuel; Carmona, José A; Aguilar, Eduardo; Coll, Ramón; Suárez, Carmen

    2010-01-30

    Although nowadays there are many cardiovascular disease (CVD) treatment protocols and evidence based guidelines, not many patients achieve the recommended levels for cardiovascular (CV) risk factor (RF) and management of disorders could be improved. Treatment inertia (TI) is the failure of health care providers to initiate or intensify therapy when indicated. The purpose of this study was to quantify TI in secondary CV prevention and identify factors influencing TI. Observational, transversal study with 1660 patients included in FRENA (The FRENA registry recruited Spanish patients in CVD secondary prevention treated by different specialists), aged 66,3 years, 74% males, 38,5% females, 38,5% coronary heart disease (CHD), 30,8% cerebrovascular disease and 32% peripheral artery disease (PAD). Final variable: TI; three types of inertia where described: treatment failure inertia, RF control inertia and the third one was at least one of the previous. Uni and multivariate analysis were done for each type of inertia. Inertia was detected in 81,5% of the patients. RF control inertia was 85,1% and treatment failure inertia 53%. Diabetic patients are likely to be treated with TI whereas patients with renal insufficiency (RI) or arterial hypertension (AHT) are more likely to be protected against it. There is less treatment failure inertia in cerebrovascular disease or coronary heart disease Vs PAD, AHT and Dyslipemia (DL) where the rate of treatment failure inertia is higher. RF control inertia increases with the coexistence of AHT, DL and diabetes mellitus (DM) and is lower in patients with previous CVD, cerebrovascular disease, AHT and DL. In high risk patient, TI is present in a high percentage of them. DM, PAD and the coexistence of cardiovascular risk factors are associated with a higher inertia. Copyright (c) 2009 Elsevier España, S.L. All rights reserved.

  4. A comparison of the cancer incidence rates between the national cancer registry and insurance claims data in Korea.

    PubMed

    Seo, Hee Jung; Oh, In-Hwan; Yoon, Seok-Jun

    2012-01-01

    Although much health services research has been conducted using national health insurance claims data in Korea, the validity of this method has not been ascertained. The objective of this study was to validate the use of claims data for health services research by comparing incidence rate of cancers found using insurance claims data against rates of the national cancer registry of Korea. An algorithm to estimate incidence rates using claims data was developed and applied. The claims data from 2005-2008 were acquired and the patients admitted to hospitals due to cancer in 2008 without admission to hospital from 2005- 2007 by the same diagnosis code were regarded as incident cases. The acquired results were compared with the values from the National Cancer Registry of Korea. The incidence rate of all cancers found using claims data was 363.1 per 100,000 people, which is very similar to the 361.9 per 100,000 rate of the national cancer registry. Also the age-, gender- and disease-specific rates between the two data sources were similar. Therefore, national health insurance claims data may be a worthwhile resource for health services research if appropriate algorithms are applied, especially considering the cost effectiveness of this method.

  5. Standardization of Questions in Rare Disease Registries: The PRISM Library Project.

    PubMed

    Richesson, Rachel Lynn; Shereff, Denise; Andrews, James Everett

    2012-10-10

    Patient registries are often a helpful first step in estimating the impact and understanding the etiology of rare diseases - both requisites for the development of new diagnostics and therapeutics. The value and utility of patient registries rely on the use of both well-constructed structured research questions and relevant answer sets accompanying them. There are currently no clear standards or specifications for developing registry questions, and there are no banks of existing questions to support registry developers. This paper introduces the [Rare Disease] PRISM (Patient Registry Item Specifications and Metadata for Rare Disease) project, a library of standardized questions covering a broad spectrum of rare diseases that can be used to support the development of new registries, including Internet-based registries. A convenience sample of questions was identified from well-established (>5 years) natural history studies in various diseases and from several existing registries. Face validity of the questions was determined by review by many experts (both terminology experts at the College of American Pathologists (CAP) and research and informatics experts at the University of South Florida (USF)) for commonality, clarity, and organization. Questions were re-worded slightly, as needed, to make the full semantics of the question clear and to make the questions generalizable to multiple diseases where possible. Questions were indexed with metadata (structured and descriptive information) using a standard metadata framework to record such information as context, format, question asker and responder, and data standards information. At present, PRISM contains over 2,200 questions, with content of PRISM relevant to virtually all rare diseases. While the inclusion of disease-specific questions for thousands of rare disease organizations seeking to develop registries would present a challenge for traditional standards development organizations, the PRISM library could

  6. Standardization of Questions in Rare Disease Registries: The PRISM Library Project

    PubMed Central

    Shereff, Denise; Andrews, James Everett

    2012-01-01

    Background Patient registries are often a helpful first step in estimating the impact and understanding the etiology of rare diseases - both requisites for the development of new diagnostics and therapeutics. The value and utility of patient registries rely on the use of both well-constructed structured research questions and relevant answer sets accompanying them. There are currently no clear standards or specifications for developing registry questions, and there are no banks of existing questions to support registry developers. Objective This paper introduces the [Rare Disease] PRISM (Patient Registry Item Specifications and Metadata for Rare Disease) project, a library of standardized questions covering a broad spectrum of rare diseases that can be used to support the development of new registries, including Internet-based registries. Methods A convenience sample of questions was identified from well-established (>5 years) natural history studies in various diseases and from several existing registries. Face validity of the questions was determined by review by many experts (both terminology experts at the College of American Pathologists (CAP) and research and informatics experts at the University of South Florida (USF)) for commonality, clarity, and organization. Questions were re-worded slightly, as needed, to make the full semantics of the question clear and to make the questions generalizable to multiple diseases where possible. Questions were indexed with metadata (structured and descriptive information) using a standard metadata framework to record such information as context, format, question asker and responder, and data standards information. Results At present, PRISM contains over 2,200 questions, with content of PRISM relevant to virtually all rare diseases. While the inclusion of disease-specific questions for thousands of rare disease organizations seeking to develop registries would present a challenge for traditional standards development

  7. Assessing the feasibility of a web-based registry for multiple orphan lung diseases: the Australasian Registry Network for Orphan Lung Disease (ARNOLD) experience.

    PubMed

    Casamento, K; Laverty, A; Wilsher, M; Twiss, J; Gabbay, E; Glaspole, I; Jaffe, A

    2016-04-18

    We investigated the feasibility of using an online registry to provide prevalence data for multiple orphan lung diseases in Australia and New Zealand. A web-based registry, The Australasian Registry Network of Orphan Lung Diseases (ARNOLD) was developed based on the existing British Paediatric Orphan Lung Disease Registry. All adult and paediatric respiratory physicians who were members of the Thoracic Society of Australia and New Zealand in Australia and New Zealand were sent regular emails between July 2009 and June 2014 requesting information on patients they had seen with any of 30 rare lung diseases. Prevalence rates were calculated using population statistics. Emails were sent to 649 Australian respiratory physicians and 65 in New Zealand. 231 (32.4%) physicians responded to emails a total of 1554 times (average 7.6 responses per physician). Prevalence rates of 30 rare lung diseases are reported. A multi-disease rare lung disease registry was implemented in the Australian and New Zealand health care settings that provided prevalence data on orphan lung diseases in this region but was limited by under reporting.

  8. Developing and testing a cost data collection instrument for noncommunicable disease registry planning.

    PubMed

    Subramanian, Sujha; Tangka, Florence; Edwards, Patrick; Hoover, Sonja; Cole-Beebe, Maggie

    2016-12-01

    This article reports on the methods and framework we have developed to guide economic evaluation of noncommunicable disease registries. We developed a cost data collection instrument, the Centers for Disease Control and Prevention's (CDC's) International Registry Costing Tool (IntRegCosting Tool), based on established economics methods We performed in-depth case studies, site visit interviews, and pilot testing in 11 registries from multiple countries including India, Kenya, Uganda, Colombia, and Barbados to assess the overall quality of the data collected from cancer and cardiovascular registries. Overall, the registries were able to use the IntRegCosting Tool to assign operating expenditures to specific activities. We verified that registries were able to provide accurate estimation of labor costs, which is the largest expenditure incurred by registries. We also identified several factors that can influence the cost of registry operations, including size of the geographic area served, data collection approach, local cost of living, presence of rural areas, volume of cases, extent of consolidation of records to cases, and continuity of funding. Internal and external registry factors reveal that a single estimate for the cost of registry operations is not feasible; costs will vary on the basis of factors that may be beyond the control of the registries. Some factors, such as data collection approach, can be modified to improve the efficiency of registry operations. These findings will inform both future economic data collection using a web-based tool and cost and cost-effectiveness analyses of registry operations in low- and middle-income countries (LMICs) and other locations with similar characteristics. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. [Huntington's Disease in Balearic Islands Population-Based Registry of Rare Diseases: Prevalence and Mortality during the Period 2010-2013. Spain].

    PubMed

    Cáffaro Rovira, Mercedes; Salom Castell, M Magdalena

    2017-02-16

    Huntington's disease is a hereditary disease with low prevalence. The low frequency of Huntington's disease leads to its inclusion as one of the pathologies in the Registry of Rare Diseases. The Balearic Islands Population-based Registry of Rare Diseases began in 2010. Previously, there had been no prevalence or mortality data for Huntington's disease in the Balearic Islands. The aim of this study was to determine the prevalence and mortality of Huntington's disease in the Balearic Islands between 2010 and 2013. The data sources were the Balearic Islands Population-based Registry of Rare Diseases, from which the diagnosed cases were obtained; the Balearic Islands Mortality Register, from which the deceased cases were obtained; the Balearic Islands Health Service, from which the number of Health Cards was obtained; and the National Institute for Statistics, from which population data were obtained. Prevalence and mortality rates were calculated. The Balearic Islands Population-based Registry of Rare Diseases registered 27 cases of Huntington's disease between 2010-2013. 63% of these were women. The period prevalence rate was 2.6 per 100,000 and the period mortality rate was 1.1 per 100,000. Menorca was the island with the highest rates, the prevalence rate was 5,9 per 100,000 and the mortality rate was 2,1 per 100,000. Prevalence and mortality of Huntington's disease in the Balearic Islands are low compared to similar areas.

  10. [Registries for rare diseases : OSSE - An open-source framework for technical implementation].

    PubMed

    Storf, Holger; Schaaf, Jannik; Kadioglu, Dennis; Göbel, Jens; Wagner, Thomas O F; Ückert, Frank

    2017-05-01

    Meager amounts of data stored locally, a small number of experts, and a broad spectrum of technological solutions incompatible with each other characterize the landscape of registries for rare diseases in Germany. Hence, the free software Open Source Registry for Rare Diseases (OSSE) was created to unify and streamline the process of establishing specific rare disease patient registries. The data to be collected is specified based on metadata descriptions within the registry framework's so-called metadata repository (MDR), which was developed according to the ISO/IEC 11179 standard. The use of a central MDR allows for sharing the same data elements across any number of registries, thus providing a technical prerequisite for making data comparable and mergeable between registries and promoting interoperability.With OSSE, the foundation is laid to operate linked patient registries while respecting strong data protection regulations. Using the federated search feature, data for clinical studies can be identified across registries. Data integrity, however, remains intact since no actual data leaves the premises without the owner's consent. Additionally, registry solutions other than OSSE can participate via the OSSE bridgehead, which acts as a translator between OSSE registry networks and non-OSSE registries. The pseudonymization service Mainzelliste adds further data protection.Currently, more than 10 installations are under construction in clinical environments (including university hospitals in Frankfurt, Hamburg, Freiburg and Münster). The feedback given by the users will influence further development of OSSE. As an example, the installation process of the registry for undiagnosed patients at University Hospital Frankfurt is described in more detail.

  11. Registry of Experimental Cancers of the National Cancer Institute. A database resource for cancer research.

    PubMed Central

    Berman, J. J.; Moore, G. W.; O'Neill, T. P.; Liebelt, A. G.; Saffiotti, U.

    1993-01-01

    The National Cancer Institute established the Registry of Experimental Cancers in March 1970. This registry consists of a permanent collection of pathological materials on spontaneous and induced lesions in laboratory animals that includes histological slides, paraffin blocks, autopsy findings, pathological diagnoses, photographs, and experimental records. The material presently is composed of approximately 60,000 consecutive records and is a valuable resource for researchers interested in tumors and other lesions arising spontaneously or from specific induction protocols in experimental animals. The entire registry database was transferred to an object-oriented database that permits registry staff to write programs for the different data field objects, thus customizing searches and other database functions. Twenty-seven animal species are represented and a total of 6,496 diagnostic entities and 1,106 treatment and control protocols are listed. Archival material may be retrieved for analysis of molecular markers. PMID:8434635

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

    PubMed Central

    Arner, Marianne

    2016-01-01

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

  13. Design and Development of a Web-Based Saudi National Diabetes Registry

    PubMed Central

    Subhani, Shazia; Khalid, Al-Rubeaan

    2010-01-01

    Background Given that diabetes is an extremely common disorder in Saudi Arabia, the National Diabetes Registry was designed by King Saud University Hospital Diabetes Center in collaboration with King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia, in the year 2001. The aim of the registry is to identify risk factors related to diabetes and to provide statistics to public health programs and health care professionals for use in planning and evaluation. The registry was designed to provide information on the extent and nature of specific types of diabetes, diabetes complications, and treatment of diabetes in the Kingdom. The registry has been available since 2001, with major collaborations from 26 hospitals as part of Phase I in which 100,000 patient data is to be collected on a regional level from Ar-Riyadh before extending the program to other regions of Saudi Arabia. Methods The web application was designed using relational database techniques along with on-line help topics to assist users to get acquainted with application functionalities. All Internet forms were designed with validation checks and appropriate messages to ensure quality of data. The security measures established within the application ensure that only authorized users can gain access to the functionalities of the registry at allowed times. Administrative features were designed to manage the registry-related operations easily. Results The diabetes registry has been in operation for almost 10 years, and around 67,000 patients have been registered to date. The Web-application offers an anytime-anywhere access to the registry’s data, removing geographical boundaries and allowing the national registry to provide real-time data entry, updates, reporting, and mapping functionalities more easily. Conclusion Merging related information in the form of databases can provide improved health care operations through instant access to data, ease of managing complex data structures, and

  14. Latin American Dialysis and Transplant Registry: Experience and contributions to end-stage renal disease epidemiology

    PubMed Central

    Cusumano, Ana Maria; Rosa-Diez, Guillermo Javier; Gonzalez-Bedat, Maria Carlota

    2016-01-01

    In 2015, 634387 million people (9% of the world’s population) resided in Latin America (LA), with half of those populating Brazil and Mexico. The LA Dialysis and Transplant Registry was initiated in 1991, with the aim of collecting data on renal replacement therapy (RRT) from the 20 LA-affiliated countries. Since then, the Registry has revealed a trend of increasing prevalence and incidence of end-stage kidney disease on RRT, which is ongoing and is correlated with gross national income, life expectancy at birth, and percentage of population that is older than 65 years. In addition, the rate of kidney transplantation has increased yearly, with > 70% being performed from deceased donors. According to the numbers reported for 2013, the rates of prevalence, incidence and transplantation were (in patients per million population) 669, 149 and 19.4, respectively. Hemodialysis was the treatment of choice (90%), and 43% of the patients undergoing this treatment was located in Brazil; in contrast, peritoneal dialysis prevailed in Costa Rica, El Salvador and Guatemala. To date, the Registry remains the only source of RRT data available to healthcare authorities in many LA countries. It not only serves to promote knowledge regarding epidemiology of end-stage renal disease and the related RRT but also for training of nephrologists and renal researchers, to improve understanding and clinical application of dialysis and transplantation services. In LA, accessibility to RRT is still limited and it remains necessary to develop effective programs that will reduce risk factors, promote early diagnosis and treatment of chronic kidney disease, and strengthen transplantation programs. PMID:27648403

  15. Latin American Dialysis and Transplant Registry: Experience and contributions to end-stage renal disease epidemiology.

    PubMed

    Cusumano, Ana Maria; Rosa-Diez, Guillermo Javier; Gonzalez-Bedat, Maria Carlota

    2016-09-06

    In 2015, 634387 million people (9% of the world's population) resided in Latin America (LA), with half of those populating Brazil and Mexico. The LA Dialysis and Transplant Registry was initiated in 1991, with the aim of collecting data on renal replacement therapy (RRT) from the 20 LA-affiliated countries. Since then, the Registry has revealed a trend of increasing prevalence and incidence of end-stage kidney disease on RRT, which is ongoing and is correlated with gross national income, life expectancy at birth, and percentage of population that is older than 65 years. In addition, the rate of kidney transplantation has increased yearly, with > 70% being performed from deceased donors. According to the numbers reported for 2013, the rates of prevalence, incidence and transplantation were (in patients per million population) 669, 149 and 19.4, respectively. Hemodialysis was the treatment of choice (90%), and 43% of the patients undergoing this treatment was located in Brazil; in contrast, peritoneal dialysis prevailed in Costa Rica, El Salvador and Guatemala. To date, the Registry remains the only source of RRT data available to healthcare authorities in many LA countries. It not only serves to promote knowledge regarding epidemiology of end-stage renal disease and the related RRT but also for training of nephrologists and renal researchers, to improve understanding and clinical application of dialysis and transplantation services. In LA, accessibility to RRT is still limited and it remains necessary to develop effective programs that will reduce risk factors, promote early diagnosis and treatment of chronic kidney disease, and strengthen transplantation programs.

  16. National kidney dialysis and transplant registries in Latin America: how to implement and improve them.

    PubMed

    González-Bedat, María Carlota; Rosa-Diez, Guillermo Javier; Fernández-Cean, Juan Manuel; Ordúñez, Pedro; Ferreiro, Alejandro; Douthat, Walter

    2015-09-01

    The Strategic Plan of the Pan American Health Organization, 2014-2019, Championing Health: Sustainable Development and Equityrecognizes that "Chronic kidney disease, caused mainly by complications of diabetes and hypertension, has increased in the Region." This Plan includes the first concrete goal on chronic kidney disease: to achieve a prevalence rate for renal replacement therapy of at least 700 patients per million population by 2019. National dialysis and transplant registries (DTR) are a useful tool for epidemiological research, health care planning, and quality improvement. Their success depends on the quality of their data and quality control procedures. This article describes the current situation of national DTRs in the Region and the content of their information and health indicators, and it offers recommendations for creating and maintaining them. It points to their heterogeneity or absence in some countries, in line with the inequities that patients face in access to renal replacement therapy. The complete lack of information in Caribbean countries prevents their inclusion in this communication, which requires immediate attention.

  17. 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.

  18. Is there a need for a national or a global apheresis registry?

    PubMed

    Stegmayr, Bernd; Korach, Jean-Michel; Norda, Rut; Rock, Gail; Fadel, Fouad

    2003-10-01

    Indications for apheresis may vary and more than 45 different diagnoses have been reported from various countries. New devices are being developed and, in the beginning their clinical implications and use are limited to detect rare but important side effects. However, to achieve more reliable information on the effects and side effects we need more extensive sampling of data. Collection of such data is considered a safety and quality issue in several countries. However, data is still limited and little is known about therapeutic apheresis practised around the world including the incidence and pattern of adverse events. The establishment of national registries and analyses of data on a global level therefore seems important. Thus the World Apheresis Association (WAA) has initiated a global apheresis registry for therapeutic procedures and collection of e.g., stem cells. The WAA registry is Internet based and the site is at www.iml.umu.se/medicin. A login code to test the registry is needed (AL61TMS). This report deals with the aim of a global registry as well as some comparative data regarding findings of the Canadian, French and Swedish registries.

  19. Establishment of a national on-line registry for apheresis in Korea.

    PubMed

    Song, Eun Young; Yoon, Jong Hyun; Lee, Jong Wook; Park, Chong Won; Kwon, Seog Woon; Kim, Dae Won; Lim, Young Ae; Kim, Hyun Ok; Han, Kyou Sup

    2008-04-01

    National apheresis registries can be used to evaluate changes in technology, clinical indications, and applications over the years. Since the establishment of the Korean Society of Apheresis (KSFA) in 1999, basic data on the status of apheresis have been collected using letters and e-mails on a biennial basis. In February 2006, a KSFA homepage and an on-line apheresis registry were constructed (http://www.apheresis.or.kr/). The registry consists of two sub-registries, one addressing overall aspects, e.g., the numbers and types of apheresis machines, total numbers of apheresis procedures, and the other addressing therapeutic plasmapheresis, e.g., diagnoses, modes of treatment, instrument used, replacement fluids, volumes processed, vascular access, anticoagulants, complications, and clinical responses. Data registered on-line is presumed to represent about 95% of total apheresis procedures performed in Korea. In this report, we introduce our on-line registry system and compared the data obtained by on-line registry with the previous ones.

  20. A registry of nationally appropriate mitigation actions: goals, outcomes, and institutional requisites.

    PubMed

    Linnér, Björn-Ola; Pahuja, Neha

    2012-01-01

    This article examines key issues in operationalizing a registry of nationally appropriate mitigation actions (NAMAs) undertaken by developing countries party to the United Nations framework convention on climate change. It analyzes goals, outcomes, and institutional prerequisites underlying various proposals to determine how a NAMA mechanism could work in international climate cooperation. The different proposals for how NAMA shall be designed relate to three basic effort-sharing arrangements in a future climate regime: binding commitments for all Parties, purely voluntary commitments for all, and legally binding commitments for Annex I countries but voluntary ones for others. We conclude that a NAMA registry could be designed so as initially to suit all three types of effort-sharing regimes. The article identifies three areas of potential common ground in a registry irrespective of effort-sharing type: the principle of common but differentiated responsibilities, the sustainable development objectives of the Convention, and the need for a systemic transition toward low-carbon energy technologies.

  1. Research Registries: A Tool to Advance Understanding of Rare Neuro-Ophthalmic Diseases

    PubMed Central

    Blankshain, Kimberly D; Moss, Heather E

    2016-01-01

    Background Medical research registries (MRR) are organized systems used to collect, store and analyze patient information. They are important tools for medical research with particular application to the study of rare diseases, including those seen in neuro-ophthalmic practice. Evidence Acquisition Evidence for this review was gathered from the writers’ experiences creating a comprehensive neuro-ophthalmology registry and review of the literature. Results MRR are typically observational and prospective databases of de-identified patient information. The structure is flexible and can accommodate a focus on specific diseases or treatments, surveillance of patient populations, physician quality improvement, or recruitment for future studies. They are particularly useful for the study of rare diseases. They can be integrated into the hierarchy of medical research at many levels provided their construction is well organized and they have several key characteristics including an easily manipulated database, comprehensive information on carefully selected patients and comply with human subjects regulations. MRR pertinent to neuro-ophthalmology include the UIC neuro-ophthalmology registry, Susac Syndrome Registry, Intracranial Hypertension Registry as well as larger scale patient outcome registries being developed by professional societies. Conclusion Medical research registries have a variety of forms and applications. With careful planning and clear goals, they are flexible and powerful research tools that can support multiple different study designs, and through this have the potential to advance understanding and care of neuro-ophthalmic diseases. PMID:27389624

  2. 77 FR 33264 - National Registry of Certified Medical Examiners Testing Providers Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... rule, the Agency decided to use the public/private partnership model. The Agency develops and provides... Providers Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), U.S. Department of Transportation (DOT). ACTION: Notice of Public Meeting. SUMMARY: The National Registry of Certified...

  3. 75 FR 72793 - National Saltwater Angler Registry Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA.... ADDRESSES: Gordon C. Colvin, Fishery Biologist, NMFS ST-12453, 1315 East-West Highway, Silver Spring, MD 20910. FOR FURTHER INFORMATION CONTACT: Gordon C. Colvin, Fishery Biologist; (301) 713-2367 x175; e-mail...

  4. Disease phenotype at diagnosis in pediatric Crohn's disease: 5-year analyses of the EUROKIDS Registry.

    PubMed

    de Bie, Charlotte I; Paerregaard, Anders; Kolacek, Sanja; Ruemmele, Frank M; Koletzko, Sibylle; Fell, John M E; Escher, Johanna C

    2013-02-01

    It has been speculated that pediatric Crohn's disease (CD) is a distinct disease entity, with probably different disease subtypes. We therefore aimed to accurately phenotype newly diagnosed pediatric CD by using the pediatric modification of the Montreal classification, the Paris classification. Information was collected from the EUROKIDS registry, a prospective, web-based registry of new-onset pediatric IBD patients in 17 European countries and Israel. When a complete diagnostic workup was performed (ileocolonoscopy, upper gastrointestinal [GI] endoscopy, small bowel imaging), CD patients were evaluated for ileocolonic disease extent, esophagogastroduodenal involvement, and jejunal/proximal ileal involvement. Disease behavior and the occurrence of granulomas were also analyzed. In all, 582 pediatric CD patients could be classified according to the Paris classification. Isolated terminal ileal disease (± limited cecal disease) was seen at presentation in 16%, isolated colonic disease in 27%, ileocolonic disease in 53%, and isolated upper GI disease in 4% of patients. In total, 30% had esophagogastroduodenal involvement and 24% jejunal/proximal ileal disease. Patients with L2 disease were less likely to have esophagogastroduodenal involvement or stricturing disease than patients with L1 or L3 disease. Terminal ileal disease and stricturing disease behavior were more common in children diagnosed after 10 years of age than in younger patients. Granulomas were identified in 43% of patients. Accurate phenotyping is essential in pediatric CD, as this affects the management of individual patients. Disease phenotypes differ according to age at disease onset. The Paris classification is a useful tool to capture the variety of phenotypic characteristics of pediatric CD.

  5. The National Anesthesia Clinical Outcomes Registry: A Sustainable Model for the Information Age?

    PubMed Central

    Dutton, Richard P.

    2014-01-01

    Anesthesiologists care for patients of all ages, with all conceivable comorbidities, in every kind of health care facility. This leads to a significant challenge in the collection of data to describe the specialty, and in the development of evidence-based performance measures for anesthesiologists. Whereas narrowly defined medical specialties have developed registries based on manual abstraction of clinical data from the medical record (e.g., cardiac surgery), this approach would be prohibitively expensive for anesthesiology, and is unlikely to generate statistically useful data when major adverse outcomes occur a handful of times in tens of thousands of cases. The American Society of Anesthesiologists (ASA) addressed this challenge in 2008 by funding a related organization, the Anesthesia Quality Institute (AQI), to develop the National Anesthesia Clinical Outcomes Registry (NACOR). The technical development of this registry and the approach taken to define the specialty of anesthesiology and the performance of anesthesiologists may serve as a model for other specialty society efforts. PMID:25848607

  6. Karachi Cancer Registry Data--implications for the National Cancer Control Program of Pakistan.

    PubMed

    Bhurgri, Yasmin

    2004-01-01

    Cancer registries play a major role in providing the data to justify establishment, implementation and monitoring of cancer control programs, therefore stability in cancer registration is of pivotal importance. An erroneous assessment of the cancer burden can have long-term negative implications for the limited health resources of a country. Thus, registries starting simultaneously with cancer control programs clearly cannot be adequate for the purpose. The Karachi Cancer Registry (KCR) is the first population-based registry of Pakistan, with 9 years proven data stability (1995-2003) for Karachi South (KS), a location with a population distribution similar to that for the country in general as regards age, gender, and religion. It also has the distinction of being the only district in the country with representation of all ethnic and socio-economic groups of the country. The primary recommended strategy for the 'National Cancer Control Program' (NCCP), Pakistan based on the assessment of eight common cancers in Karachi and the WHO estimates would be identical. A curb on the epidemic levels of tobacco and areca nut use would reduce malignancies in males by 43.7% and in females by 17.8%. WHO estimates put these figures at 45% and 18.5% for males and females respectively. Primary prevention in the form of diet control, checks on preservatives, dyes, and pesticides; protection from occupational hazards, control of biological agents and solar UV protection would help control of another half of the malignancies. Resource restrictions put high technology methods beyond the scope of Pakistan today. Early detection of cancers of accessible sites, though not an urgent requirement, would be warranted for oral, cervical and breast cancer, after sufficient capacity building, initially in the high-risk groups. In females, this could help target 47.6% (approximately half) of the malignancies and in men 13% of the total. Establishment of equitable pain control and a palliative

  7. Complications and treatment of patients with β-thalassemia in France: results of the National Registry

    PubMed Central

    Thuret, Isabelle; Pondarré, Corinne; Loundou, Anderson; Steschenko, Dominique; Girot, Robert; Bachir, Dora; Rose, Christian; Barlogis, Vincent; Donadieu, Jean; de Montalembert, Mariane; Hagege, Isabelle; Pegourie, Brigitte; Berger, Claire; Micheau, Marguerite; Bernaudin, Françoise; Leblanc, Thierry; Lutz, Laurence; Galactéros, Frédéric; Siméoni, Marie-Claude; Badens, Catherine

    2010-01-01

    Background β-thalassemia is a rare disease in France, encountered mainly in patients originating from Italy and North Africa. In the setting of the recent French plan for rare diseases, a National Registry for thalassemia has been developed since 2005. Epidemiological and clinical data have been collected on living patients with β-thalassemia major or intermedia, including those who underwent hematopoietic stem cell transplantation. Design and Methods A standardized questionnaire was sent to clinicians throughout the national professional networks involved in the management of thalassemic patients and data were updated every 18 months. A cross-sectional study was performed in February 2009. Results Data on 378 patients (267 with thalassemia major) with a median age of 20 were recorded. Hematopoietic stem cell transplantation was performed in 52 patients. Stature, rates of parenthood, splenectomy, and cholecystectomy were no different between non-transplanted thalassemia major and thalassemia intermedia patients, after adjustment for age. Among the 215 non-transplanted thalassemia major patients, the median serum ferritin level was 1240 ng/mL and the rates of iron-related complications were 10%, 6%, 10% and 48% for cardiac failure, diabetes, hypothyroidism, and hypogonadism, respectively. From 2005 to 2008, a dramatic switch in chelation treatment, from deferoxamine to deferasirox, was observed. Conclusions The rates of complications of iron overload in French thalassemia major patients appeared similar to those reported in other developed countries in which this condition is not endemic. There were no significant differences in height and parenthood rates between patients with the major and the intermedia forms of the disease, underlining the progress in clinical care. Future developments will focus on mortality and morbidity under oral chelation treatment. PMID:20007138

  8. Complications and treatment of patients with β-thalassemia in France: results of the National Registry.

    PubMed

    Thuret, Isabelle; Pondarré, Corinne; Loundou, Anderson; Steschenko, Dominique; Girot, Robert; Bachir, Dora; Rose, Christian; Barlogis, Vincent; Donadieu, Jean; de Montalembert, Mariane; Hagege, Isabelle; Pegourie, Brigitte; Berger, Claire; Micheau, Marguerite; Bernaudin, Françoise; Leblanc, Thierry; Lutz, Laurence; Galactéros, Frédéric; Siméoni, Marie-Claude; Badens, Catherine

    2010-05-01

    beta-thalassemia is a rare disease in France, encountered mainly in patients originating from Italy and North Africa. In the setting of the recent French plan for rare diseases, a National Registry for thalassemia has been developed since 2005. Epidemiological and clinical data have been collected on living patients with beta-thalassemia major or intermedia, including those who underwent hematopoietic stem cell transplantation. A standardized questionnaire was sent to clinicians throughout the national professional networks involved in the management of thalassemic patients and data were updated every 18 months. A cross-sectional study was performed in February 2009. Data on 378 patients (267 with thalassemia major) with a median age of 20 were recorded. Hematopoietic stem cell transplantation was performed in 52 patients. Stature, rates of parenthood, splenectomy, and cholecystectomy were no different between non-transplanted thalassemia major and thalassemia intermedia patients, after adjustment for age. Among the 215 non-transplanted thalassemia major patients, the median serum ferritin level was 1240 ng/mL and the rates of iron-related complications were 10%, 6%, 10% and 48% for cardiac failure, diabetes, hypothyroidism, and hypogonadism, respectively. From 2005 to 2008, a dramatic switch in chelation treatment, from deferoxamine to deferasirox, was observed. The rates of complications of iron overload in French thalassemia major patients appeared similar to those reported in other developed countries in which this condition is not endemic. There were no significant differences in height and parenthood rates between patients with the major and the intermedia forms of the disease, underlining the progress in clinical care. Future developments will focus on mortality and morbidity under oral chelation treatment.

  9. Developing a communitywide electronic health record disease registry in primary care practices: lessons learned from the Western new york beacon community.

    PubMed

    Heider, Arvela R; Maloney, Nancy A; Satchidanand, Nikhil; Allen, Geoffrey M; Mueller, Raymond; Gangloff, Steven; Singh, Ranjit

    2014-01-01

    Disease registries, as part of electronic health records (EHRs), have shown promise in improving care and outcomes. However, little is known about how best to implement them across communities, especially in communities that are not highly integrated. The Western New York (WNY) primary care community consists largely of independent practices using at least 20 different EHR products. This paper discusses the processes undertaken to develop a communitywide EHR disease registry in WNY, improvements it engendered, barriers overcome, and the lessons learned. HEALTHeLINK, under the Office of the National Coordinator for Health Information Technology Beacon Community Initiative, reached out to 98 primary care practices in the WNY region to establish EHR-based diabetes registries. Working with practices, community partners, and vendors, registry specifications were created. The registry was piloted with practices using one local vendor's EHR product and then rolled out to other practices, including five other EHR products. Using identified and de-identified registry datasets, quality benchmarking within and between practices and population health management were undertaken. From 2011 to 2013, the WNY Beacon Community assisted 98 practices (344 providers) serving over 50,000 adult diabetic patients. A major focus was on EHR registry development across diverse systems, and overcoming the challenges this presented. The Beacon diabetes registry was implemented at 85 of the 98 targeted practices. Of these registries, 65 met the criteria described in a later section for quality benchmarking and population health management purposes. Practices received quarterly benchmark reports summarizing their performance on key diabetes quality metrics and were compared to community practice averages. Practices used their registries for population health management by identifying and targeting patients in need of follow-up or specific diabetes-related care. The creation of the registry

  10. Developing a Communitywide Electronic Health Record Disease Registry in Primary Care Practices: Lessons Learned from the Western New York Beacon Community

    PubMed Central

    Heider, Arvela R.; Maloney, Nancy A.; Satchidanand, Nikhil; Allen, Geoffrey M.; Mueller, Raymond; Gangloff, Steven; Singh, Ranjit

    2014-01-01

    Background and Introduction: Disease registries, as part of electronic health records (EHRs), have shown promise in improving care and outcomes. However, little is known about how best to implement them across communities, especially in communities that are not highly integrated. The Western New York (WNY) primary care community consists largely of independent practices using at least 20 different EHR products. This paper discusses the processes undertaken to develop a communitywide EHR disease registry in WNY, improvements it engendered, barriers overcome, and the lessons learned. Methods: HEALTHeLINK, under the Office of the National Coordinator for Health Information Technology Beacon Community Initiative, reached out to 98 primary care practices in the WNY region to establish EHR-based diabetes registries. Working with practices, community partners, and vendors, registry specifications were created. The registry was piloted with practices using one local vendor’s EHR product and then rolled out to other practices, including five other EHR products. Using identified and de-identified registry datasets, quality benchmarking within and between practices and population health management were undertaken. Findings: From 2011 to 2013, the WNY Beacon Community assisted 98 practices (344 providers) serving over 50,000 adult diabetic patients. A major focus was on EHR registry development across diverse systems, and overcoming the challenges this presented. The Beacon diabetes registry was implemented at 85 of the 98 targeted practices. Of these registries, 65 met the criteria described in a later section for quality benchmarking and population health management purposes. Practices received quarterly benchmark reports summarizing their performance on key diabetes quality metrics and were compared to community practice averages. Practices used their registries for population health management by identifying and targeting patients in need of follow-up or specific

  11. [RD] PRISM Library: Patient Registry Item Specifications and Metadata for Rare Diseases.

    PubMed

    Richesson, Rachel; Shereff, Denise; Andrews, James

    2010-04-01

    Patient registries are important for understanding the causes and origins of rare diseases and estimating their impact; and they may prove critical developing new diagnostics and therapeutics. This paper introduces the [RD] PRISM resource , an NIH-funded project to develop a library of standardized question and answer sets to support rare disease research. The paper presents a project case-driven plan for creating a new registry using questions from an existing related registry, revising and expanding an existing registry, and showing interoperability of data collected from different registries and data sources. Each of the use cases involves the retrieval of indexed questions for re-use. Successful retrieval of questions can facilitate their re-use in registries, meaning new registries can be implemented more quickly, and the use of "standard" questions can be facilitated. The paper further discusses issues involved in encoding the sets with relevant data standards for interoperability and indexing encoded sets with metadata for optimal retrievability.

  12. Integration of site-specific health information: Agency for Toxic Substances and Disease Registry health assessments

    SciTech Connect

    Lesperance, A.M.; Siegel, M.R.

    1990-12-01

    The Agency for Toxic Substances and Disease Registry is required to conduct a health assessment of any site that is listed on or proposed for the US Environmental Protection Agency's National Priorities List. Sixteen US Department of Energy (DOE) sites currently fall into this category. Health assessments contain a qualitative description of impacts to public health and the environment from hazardous waste sites, as well as recommendations for actions to mitigate or eliminate risk. Because these recommendations may have major impacts on compliance activities at DOE facilities, the health assessments are an important source of information for the monitoring activities of DOE's Office of Environmental Compliance (OEC). This report provides an overview of the activities involved in preparing the health assessment, its role in environmental management, and its key elements.

  13. 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.

  14. Research Registries: A Tool to Advance Understanding of Rare Neuro-Ophthalmic Diseases.

    PubMed

    Blankshain, Kimberly D; Moss, Heather E

    2016-09-01

    Medical research registries (MRR) are organized systems used to collect, store, and analyze patient information. They are important tools for medical research with particular application to the study of rare diseases, including those seen in neuro-ophthalmic practice. Evidence for this review was gathered from the writers' experiences creating a comprehensive neuro-ophthalmology registry and review of the literature. MRR are typically observational and prospective databases of de-identified patient information. The structure is flexible and can accommodate a focus on specific diseases or treatments, surveillance of patient populations, physician quality improvement, or recruitment for future studies. They are particularly useful for the study of rare diseases. They can be integrated into the hierarchy of medical research at many levels provided their construction is well organized and they have several key characteristics including an easily manipulated database, comprehensive information on carefully selected patients, and comply with human subjects regulations. MRR pertinent to neuro-ophthalmology include the University of Illinois at Chicago neuro-ophthalmology registry, Susac Syndrome Registry, Intracranial Hypertension Registry, and larger-scale patient outcome registries being developed by professional societies. MRR have a variety of forms and applications. With careful planning and clear goals, they are flexible and powerful research tools that can support multiple different study designs, and this can provide the potential to advance understanding and care of neuro-ophthalmic diseases.

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

    PubMed

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

    2017-09-29

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

  16. [Leather dust and systematic research on occupational tumors: the national and regional registry TUNS].

    PubMed

    Mensi, Carolina; Sieno, Claudia; Consonni, Dario; Riboldi, Luciano

    2012-01-01

    The sinonasal cancer (SNC) are a rare tumors characterized by high occupational etiologic fraction. For this reason their incidence and etiology can be actively monitored by a dedicated cancer registry. The National Registry of these tumours is situated at the Italian Institute for Occupational Safety and Prevention (ISPESL) and is based on Regional Operating Centres (ROCs). In Lombardy Region the ROC has been established at the end of 2007 with the purpose to make a systematic surveillance and therefore to support in the most suitable way the scientific research and the prevention actions in the high risk working sectors. The aims of this surveillance are: to estimate the regional incidence of SNC, to define different sources of occupational and environmental exposure both known (wood, leather, nickel, chromium) and unknown. The registry collects all the new incident cases of epithelial SNC occurring in residents in Lombardy Region since 01.01.2008. The regional Registry is managed according to National Guidelines. Until January 2010 we received 596 cases of suspected SNC; only 91 (15%) of these were actually incident cases according to the inclusion criteria of the Registry, and they were preferentially adenocarcinoma and squamous carcinoma. In 2008 the regional age-standardized incidence rate of SNC for males and females, respectively, is 0.8 and 0.5 per 100,000. Occupational or environmental exposure to wood or leather dust is ascertained in over the 50% of cases. The occupational exposure to leather dust was duo to work in shoe factories. Our preliminary findings confirm that occupational exposure to wood and leather dusts are the more relevant risk factors for SNC. The study of occupational sectors and job activity in cases without such exposure could suggest new etiologic hypothesis.

  17. [National Registry of Home Parenteral Nutrition of the year 2001].

    PubMed

    Planas, M; Castellà, M; Moreno, J M; Pita, A M; Pedrón, C; Gómez Candela, C; Gómez Enterría, P; de la Cuerda, C; Pérez de la Cruz, A; Forga, M T; Martí, E; Garde, C; Carrera, J A; García Luna, P P; Ordóñez, J; Bonada, A; Pares, R M; Rodríguez, A

    2004-01-01

    We analyse the registered data of home parenteral nutrition (HPN) in our country during the year 2001. The data were collected through a previously designed questionnaire. Apart from epidemiological information, the form includes the disease to prescribe this treatment, the specific nutritional treatment used and its duration, access path, complications and readmission rate in hospital, follow-up of the treatment, and progress. All data were processed and analysed by the co-ordinating team. Seventeen hospitals participated, and 66 patients were enrolled. Middle age was 5.5 +/- 4.9 years for patients < 14 years old, and 49.2 +/- 15.8 years for those > or = 14 years old. The more prevalent diagnosis were: ischemic bowel (28.9%), neoplasm (22.7%), radiation enteritis (12.1%), motility disorders (4.5%) and Crohn's disease (4.5%). The mean time on HPN was 8.4 +/- 4.5 months. Tunnelled catheter was the preferential route (62.1%), followed by the implantated one (33.3%). The intermittent method (nocturnal) was preferential (81.8%). Patients receive the formula, mainly from hospital pharmacy (75.7%). The complications related to nutrition (1.3/patient) included the infections (0.46 sepsis/patient, and 0.19 catheter contamination/patients), mechanic (0.15/patient), metabolic (0.1/patient) and electrolytic disorders (0.07/patient). The readmission rate, for nutritional problems, was 1.34/patient. At the end of the year, 74.2% of the patients remained in the HPN program, and 25.8% abandoned the treatment (due to death: 52.9%, and to progress to oral feeding (25.3%). This review illustrates that the registration of HPN patients in our country is standing (1.65 patients/10(6) habitants), that vascular pathology is the more frequent diagnoses in HPN patients, and the rate of readmission and complications and the behaviour is similar to other series making this as a safe treatment in our place.

  18. [National registry of Home Enteral Nutrition in 2003].

    PubMed

    Planas, M; Lecha, M; García Luna, P P; Parés, R M; Chamorro, J; Martí, E; Bonada, A; Irles, J A; Boris, M A; Cardona, D; Zamarrón, I; Calañas, A J; Rodríguez, A; Camarero, E; Pérez de la Cruz, A; Mancha, A; De Luis Román, D; Cos, A; Luengo, L M; Jiménez, M; Bayo, P; Goenaga, M A

    2006-01-01

    To communicate the information available by the NADYA-SENPE Working Group from patients on Home Enteral Nutrition (HEN) in our country during the year 2003. The data were collected through a closed questionnaire included in the web site of the Working Group (www.nadya-senpe.com) available only by the authorized users. Variable included were: epidemiological information, the indication to prescribe this treatment, the access path, the specific nutritional formula used, the treatment duration, the complications and hospital readmission related to the nutritional treatment, the follow-up and the quality of life. We register 3,858 patients that belong to twenty-one hospitals. Mean age from those adults 66.2 +/- 18.9 years, and from those younger than 14, 6.0 +/- 4.3 years. Neurological and neoplasic diseases were the diagnostics more frequents (38.9% and 37.4%, respectively). Oral nutrition was the preferential rout used for the enteral nutrition (54.7%) followed by naso-enteral tube (26.6%), and only in 17.6% we used ostomy tubes. Polymeric was the enteral formula mainly utilized (80.1%). The mean time on HEN was 6.6 +/- 4.3 months; the 28.8% of patients stayed in the treatment for less than 3 months, 21.2 % between 3 and 6 months, and 50.0% more than 6 months. Patients were followed mainly by Nutritional Support Unit from the reference hospital (73.1%). While the reference hospital supplies the material (62.4%), reference hospital pharmacy (46.8%) and public pharmacies (32.0%) provides the enteral formula. Complications related to enteral nutrition included change of enteral tube (44.5%), gastrointestinal complications (30.5%), mechanical complications (21.7%), and the metabolic one (3.3%). These complications were followed by 0.02 hospitalizations/patient. At the end of the year, 54.7% of patients were in the HEN programme, and in 35.2 % HEN was finish due to accept oral conventional alimentation (49.2%) or by deceased of patients (40.9%). While 26.6% of the

  19. A population-based registry as a source of health indicators for rare diseases: the ten-year experience of the Veneto Region’s rare diseases registry

    PubMed Central

    2014-01-01

    Background Although rare diseases have become a major public health issue, there is a paucity of population-based data on rare diseases. The aim of this epidemiological study was to provide descriptive figures referring to a sizable group of unrelated rare diseases. Methods Data from the rare diseases registry established in the Veneto Region of north-east Italy (population 4,900,000), referring to the years from 2002 to 2012, were analyzed. The registry is based on a web-based system accessed by different users. Cases are enrolled by two different sources: clinicians working at Centers of expertise officially designated to diagnose and care patients with rare diseases and health professionals working in the local health districts. Deaths of patients are monitored by Death Registry. Results So far, 19,547 patients with rare diseases have been registered, and 23% of them are pediatric cases. The overall raw prevalence of the rare diseases monitored in the population under study is 33.09 per 10,000 inhabitants (95% CI 32.56-33.62), whilst the overall incidence is 3.85 per 10,000 inhabitants (95% CI 3.67-4.03). The most commonly-recorded diagnoses belong to the following nosological groups: congenital malformations (Prevalence: 5.45/10,000), hematological diseases (4.83/10,000), ocular disorders (4.47/10,000), diseases of the nervous system (3.51/10,000), and metabolic disorders (2,95/10,000). Most of the deaths in the study population occur among pediatric patients with congenital malformations, and among adult cases with neurological diseases. Rare diseases of the central nervous system carry the highest fatality rate (71.36/1,000). Rare diseases explain 4.2% of general population Years of Life Lost (YLLs), comparing to 1.2% attributable to infectious diseases and 2.6% to diabetes mellitus. Conclusions Our estimates of the burden of rare diseases at population level confirm that these conditions are a relevant public health issue. Our snapshot of their epidemiology

  20. A population-based registry as a source of health indicators for rare diseases: the ten-year experience of the Veneto Region's rare diseases registry.

    PubMed

    Mazzucato, Monica; Visonà Dalla Pozza, Laura; Manea, Silvia; Minichiello, Cinzia; Facchin, Paola

    2014-03-19

    Although rare diseases have become a major public health issue, there is a paucity of population-based data on rare diseases. The aim of this epidemiological study was to provide descriptive figures referring to a sizable group of unrelated rare diseases. Data from the rare diseases registry established in the Veneto Region of north-east Italy (population 4,900,000), referring to the years from 2002 to 2012, were analyzed. The registry is based on a web-based system accessed by different users. Cases are enrolled by two different sources: clinicians working at Centers of expertise officially designated to diagnose and care patients with rare diseases and health professionals working in the local health districts. Deaths of patients are monitored by Death Registry. So far, 19,547 patients with rare diseases have been registered, and 23% of them are pediatric cases. The overall raw prevalence of the rare diseases monitored in the population under study is 33.09 per 10,000 inhabitants (95% CI 32.56-33.62), whilst the overall incidence is 3.85 per 10,000 inhabitants (95% CI 3.67-4.03). The most commonly-recorded diagnoses belong to the following nosological groups: congenital malformations (Prevalence: 5.45/10,000), hematological diseases (4.83/10,000), ocular disorders (4.47/10,000), diseases of the nervous system (3.51/10,000), and metabolic disorders (2,95/10,000). Most of the deaths in the study population occur among pediatric patients with congenital malformations, and among adult cases with neurological diseases. Rare diseases of the central nervous system carry the highest fatality rate (71.36/1,000). Rare diseases explain 4.2% of general population Years of Life Lost (YLLs), comparing to 1.2% attributable to infectious diseases and 2.6% to diabetes mellitus. Our estimates of the burden of rare diseases at population level confirm that these conditions are a relevant public health issue. Our snapshot of their epidemiology is important for public health planning

  1. The UK National Flap Registry (UKNFR): A National Database for all pedicled and free flaps in the UK.

    PubMed

    Hazari, Anita; Walton, Peter

    2015-12-01

    The UK National Flap Registry (UKNFR) is a cross-speciality National Clinical Audit with participation by the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS), British Association of Head and Neck Oncologists (BAHNO), British Association of Oral and Maxillofacial Surgeons (BAOMS) and Association of Breast Surgery (ABS). The aim of UKNFR is to collect information about all major pedicled and free flap operations carried out in the UK and through that, assess the quality of care we provide for patients. This audit will allow appropriate comparison of clinical performance with national standards and provide useful data on changing trends. Participation in audit is integral to appraisal and revalidation in the UK.

  2. Total Ankle Replacement Survival Rates Based on Kaplan-Meier Survival Analysis of National Joint Registry Data.

    PubMed

    Bartel, Annette F P; Roukis, Thomas S

    2015-10-01

    National joint registry data provides unique information about primary total ankle replacement (TAR) survival. We sought to recreate survival curves among published national joint registry data sets using the Kaplan-Meier estimator. Overall, 5152 primary and 591 TAR revisions were included over a 2- to 13-year period with prosthesis survival for all national joint registries of 0.94 at 2-years, 0.87 at 5-years and 0.81 at 10-years. National joint registry datasets should strive for completion of data presentation including revision definitions, modes and time of failure, and patients lost to follow-up or death for complete accuracy of the Kaplan-Meier estimator.

  3. Internal disinhibition predicts 5‐year weight regain in the National Weight Control Registry (NWCR)

    PubMed Central

    Thomas, J. G.; Niemeier, H.; Wing, R. R.

    2016-01-01

    Summary Background Maintenance of weight loss remains elusive for most individuals. One potential innovative target is internal disinhibition (ID) or the tendency to eat in response to negative thoughts, feelings or physical sensations. Individuals high on ID do worse on average in standard behavioural treatment programmes, and recent studies suggest that disinhibition could play a significant role in weight regain. Purpose The purpose of the current study was to examine whether ID was associated with weight change over 5 years of follow‐up in the National Weight Control Registry, a registry of individuals who have successfully lost weight and maintained it. Methods From the National Weight Control Registry, 5,320 participants were examined across 5 years. Weight data were gathered annually. The disinhibition subscale of the Eating Inventory was used to calculate internal disinhibition and External Disinhibition (ED) and was collected at baseline, year 1, year 3 and year 5. Linear mixed models were used to estimate the weight loss maintained across follow‐up years 1 to 5 using ID and ED as baseline and prospective predictors. Results Internal disinhibition predicted weight regain in all analyses. ED interacted with ID, such that individuals who were high on ID showed greater weight regain if they were also higher on ED. Conclusions The ID scale could be a useful screening measure for risk of weight regain, given its brevity. Improved psychological coping could be a useful target for maintenance or booster interventions. PMID:27812382

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

    PubMed

    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

    2015-12-01

    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 and to investigate factors associated with ambulatory status. Cross-sectional analysis of data from a multisite patient registry. Descriptive analysis of mobility variables for 2604 individuals with spina bifida aged 5 and older are presented from 19 sites in the United States. Analysis of a subset of National Spina Bifida Patient Registry data from 380 individuals from 3 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. This study is the first to examine factors associated with ambulatory status in a large sample of individuals with myelomeningocele and nonmyelomeningocele subtypes of spina bifida. Results of this study delineate the breadth of strength and functional abilities within the different age groups and subtypes of spina bifida. The results may inform physicians of the characteristics of those with varying ambulatory abilities.

  5. National Registry of Acute Coronary Syndromes: results of the hospital phase in 2002.

    PubMed

    Ferreira, Jorge; Monteiro, Pedro; Mimoso, Jorge

    2004-10-01

    The National Registry of Acute Coronary Syndromes (ACS) was designed to assess the situation in Portugal regarding the clinical profile, diagnostic and therapeutic management and medium-term prognosis of the entire clinical spectrum of ACS, as well as to evaluate compliance with clinical guidelines and to monitor temporal trends and the impact of actions implemented for its improvement. The National Registry of ACS is a continuous, observational and prospective clinical registry started on January 1, 2002, that includes 44 Departments of Cardiology distributed all over the country. During 2002, 7348 episodes were recorded. The mean age was 66 +/- 13 years and 69% were male. Admission diagnosis was ST-segment elevation acute myocardial infarction (STE-AMI) in 45.4%, non-ST-segment elevation acute myocardial infarction (NSTE-AMI) in 38.9% and unstable angina (UA) in 15.7% of the patients. Reperfusion therapy was performed in 60.5% of the STE-AMI cohort, mainly with fibrinolytic therapy (75% of patients undergoing reperfusion therapy). The great majority of the patients (99%) received oral antiplatelets during hospitalization and low molecular weight heparins were the preferred antithrombin therapy. The use of other drugs with a positive impact on prognosis, during hospital stay and on discharge respectively, was 68% and 67% for beta-blockers, 69% and 66% for ACE inhibitors and 74% and 79% for statins. The majority of patients (52%) underwent coronary angiography and coronary angioplasty was performed in 36% of patients with STE-AMI, 24% with NSTE-AMI and 29% with UA. In-hospital mortality was 10.2% in patients with STE-AMI, 5.6% with NSTE-AMI and 0.8% with UA. There was great variability in the rate of use of the main treatments among the participating centers. The results of the National Registry of ACS reveal that the overall diagnostic and therapeutic management of ACS in Portugal is similar to that observed in contemporary national and international clinical

  6. Positive predictive value of cardiovascular diagnoses in the Danish National Patient Registry: a validation study

    PubMed Central

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

    2016-01-01

    Objective The majority of cardiovascular diagnoses in the Danish National Patient Registry (DNPR) remain to be validated despite extensive use in epidemiological research. We therefore examined the positive predictive value (PPV) of cardiovascular diagnoses in the DNPR. Design Population-based validation study. Setting 1 university hospital and 2 regional hospitals in the Central Denmark Region, 2010–2012. Participants For each cardiovascular diagnosis, up to 100 patients from participating hospitals were randomly sampled during the study period using the DNPR. Main outcome measure Using medical record review as the reference standard, we examined the PPV for cardiovascular diagnoses in the DNPR, coded according to the International Classification of Diseases, 10th Revision. Results A total of 2153 medical records (97% of the total sample) were available for review. The PPVs ranged from 64% to 100%, with a mean PPV of 88%. The PPVs were ≥90% for first-time myocardial infarction, stent thrombosis, stable angina pectoris, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, takotsubo cardiomyopathy, arterial hypertension, atrial fibrillation or flutter, cardiac arrest, mitral valve regurgitation or stenosis, aortic valve regurgitation or stenosis, pericarditis, hypercholesterolaemia, aortic dissection, aortic aneurysm/dilation and arterial claudication. The PPVs were between 80% and 90% for recurrent myocardial infarction, first-time unstable angina pectoris, pulmonary hypertension, bradycardia, ventricular tachycardia/fibrillation, endocarditis, cardiac tumours, first-time venous thromboembolism and between 70% and 80% for first-time and recurrent admission due to heart failure, first-time dilated cardiomyopathy, restrictive cardiomyopathy and recurrent venous thromboembolism. The PPV for first-time myocarditis was 64%. The PPVs were consistent within age, sex, calendar year and hospital categories. Conclusions The validity of

  7. Fractures in pituitary adenoma patients from the Dutch National Registry of Growth Hormone Treatment in Adults.

    PubMed

    van Varsseveld, N C; van Bunderen, C C; Franken, A A M; Koppeschaar, H P F; van der Lely, A J; Drent, M L

    2016-08-01

    The effects of growth hormone (GH) replacement therapy on fracture risk in adult GH deficient (GHD) patients with different etiologies of pituitary GHD are not well known, due to limited data. The aim of this study was to investigate characteristics and fracture occurrence at start of (baseline) and during long-term GH replacement therapy in GHD adults previously treated for Cushing's disease (CD) or acromegaly, compared to patients with previous nonfunctioning pituitary adenoma (NFPA). From the Dutch National Registry of Growth Hormone Treatment in Adults, a nationwide surveillance study in severe GHD adults, all patients using ≥30 days of GH replacement therapy with previous NFPA (n = 783), CD (n = 180) and acromegaly (n = 65) were selected. Patient characteristics, fractures and potential influencing factors were investigated. At baseline, patients with previous CD were younger, more often female and had more often a history of osteopenia or osteoporosis, whereas patients with previous acromegaly had more often received cranial radiotherapy and a longer duration between treatment of their pituitary tumor and start of adult GH replacement therapy. During follow-up, a fracture occurred in 3.8 % (n = 39) of all patients. Compared to patients with previous NFPA, only patients with previous acromegaly had an increased fracture risk after 6 years of GH replacement therapy. During GH replacement therapy, an increased fracture risk was observed in severe GHD adult patients previously treated for acromegaly, but not in those previously treated for CD, compared to severe GHD adult patients using GH replacement therapy because of previous NFPA. Further studies are needed to confirm these findings and to elucidate potential underlying mechanisms.

  8. Evaluation of participant recruitment methods to a rare disease online registry.

    PubMed

    Johnson, Kimberly J; Mueller, Nancy L; Williams, Katherine; Gutmann, David H

    2014-07-01

    Internet communication advances provide new opportunities to assemble individuals with rare diseases to online patient registries from wide geographic areas for research. However, there is little published information on the efficacy of different recruitment methods. Here we describe recruitment patterns and the characteristics of individuals with the self-identified autosomal dominant genetic disorder neurofibromatosis type 1 (NF1) who participated in an online patient registry during the 1-year period from 1/1/2012 to 12/31/2012. We employed four main mechanisms to alert potential participants to the registry: (1) Facebook and Google advertising, (2) government and academic websites, (3) patient advocacy groups, and (4) healthcare providers. Participants reported how they first heard about the registry through an online questionnaire. During the 1-year period, 880 individuals participated in the registry from all 50 U.S. States, the District of Columbia, Puerto Rico, and 39 countries. Facebook and Google were reported as referral sources by the highest number of participants (n=550, 72% Facebook), followed by healthcare providers (n=74), and government and academic websites (n=71). The mean participant age was 29±18 years and most participants reported White race (73%) and female sex (62%) irrespective of reported referral source. Internet advertising, especially through Facebook, resulted in efficient enrollment of large numbers of individuals with NF1. Our study demonstrates the potential utility of this approach to assemble individuals with a rare disease from across the world for research studies.

  9. An i2b2-based, generalizable, open source, self-scaling chronic disease registry.

    PubMed

    Natter, Marc D; Quan, Justin; Ortiz, David M; Bousvaros, Athos; Ilowite, Norman T; Inman, Christi J; Marsolo, Keith; McMurry, Andrew J; Sandborg, Christy I; Schanberg, Laura E; Wallace, Carol A; Warren, Robert W; Weber, Griffin M; Mandl, Kenneth D

    2013-01-01

    Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases.

  10. An i2b2-based, generalizable, open source, self-scaling chronic disease registry

    PubMed Central

    Quan, Justin; Ortiz, David M; Bousvaros, Athos; Ilowite, Norman T; Inman, Christi J; Marsolo, Keith; McMurry, Andrew J; Sandborg, Christy I; Schanberg, Laura E; Wallace, Carol A; Warren, Robert W; Weber, Griffin M; Mandl, Kenneth D

    2013-01-01

    Objective Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. Materials and methods Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. Results The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. Discussion We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. Conclusions The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases. PMID:22733975

  11. The Norwegian Labour Inspectorate's Registry for Work-Related Diseases: data from 2006.

    PubMed

    Samant, Yogindra; Parker, David; Wergeland, Ebba; Wannag, Axel

    2008-01-01

    The Norwegian Labour Inspectorates (NLI's) Registry for Work-Related Diseases was established in 1920. Based on the principle of sentinel health events (SHE), its central purpose is to provide information to the NLI to enable workplace interventions and the prevention of hazardous exposures. Although physicians are required to report work-related diseases to the NLI, only 3% did so in 2006. There were 3392 cases of work-related diseases reported to the NLI by 561 physicians in 2006. Diseases of the ear (noise-induced hearing loss) comprised 59% (n=1987) of the cases, while 12% (n=398) of the cases were attributed to the diseases of the respiratory system and 7% (n =239) were diseases of the skin and subcutaneous tissue. Despite limitations, the registry continues to inform NLI's prevention strategies, supplements data concerning work-environment surveillance, and provides impetus for epidemiological studies.

  12. 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.

  13. CERAD (Consortium to Establish a Registry for Alzheimer’s Disease) The first 20 years

    PubMed Central

    Fillenbaum, Gerda G.; van Belle, Gerald; Morris, John C.; Mohs, Richard C.; Mirra, Suzanne S.; Davis, Patricia C.; Tariot, Pierre N.; Silverman, Jeremy M.; Clark, Christopher M.; Welsh-Bohmer, Kathleen A.; Heyman, Albert

    2009-01-01

    The Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer’s disease (AD). The present report describes the measures that CERAD developed during its first decade, and their continued use in their original and translated forms. These measures include clinical, neuropsychological, neuropathological and behavioral assessments of AD, and also assessment of family history and parkinsonism in AD. An approach to evaluating neuroimages did not meet the standards desired. Further evaluations which could not be completed because of lack of funding (but where some materials are available), include evaluation of very severe AD, and of service use and need by patient and caregiver. The information that was developed in the U.S. and abroad permits standardized assessment of AD in clinical practice, facilitates epidemiological studies, and provides information valuable for individual and public health planning. CERAD materials and data remain available for those wishing to use them. PMID:18631955

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

    DTIC Science & Technology

    2013-03-01

    Parkinsonism , and another 12% reported multiple diagnoses of Parkinson’s disease and Parkinsonism . Table 2 below lists the cases by county. 15. Assessment...AD_________________ Award Number: W81XWH-07-1-0261 TITLE: California’s Parkinson’s Disease ...NUMBER California’s Parkinson’s Disease Registry Pilot Project – Coordination Center and Northern California Ascertainment 5b. GRANT NUMBER W81XWH

  15. 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.

  16. Agency for Toxic Substances and Disease Registry Brownfields/ land-reuse site tool.

    PubMed

    Perlman, Gary D; Berman, Laurel; Leann, Kathryn; Bing, Lemley

    2012-12-01

    As part of our continuing effort to highlight innovative approaches to improving the health and environment of communities, the Journal is pleased to bring back the bimonthly column from the U.S. Agency for Toxic Substances and Disease Registry (ATSDR). The ATSDR, based in Atlanta, Georgia, is a federal public health agency of the U.S. Department of Health and Human Services and shares a common office of the Director with the National Center for Environmental Health at the Centers for Disease Control and Prevention (CDC). ATSDR serves the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and diseases related to toxic substances. The purpose of this column is to inform readers of ATSDR's activities and initiatives to better understand the relationship between exposure to hazardous substances in the environment and their impact on human health and how to protect public health. We believe that the column will provide a valuable resource to our readership by helping to make known the considerable resources and expertise that ATSDR has available to assist communities, states, and others to assure good environmental health practice for all is served. The conclusions of this article are those of the author(s) and do not necessarily represent the views of ATSDR, CDC, or the U.S. Department of Health and Human Services. Gary D. Perlman is an environmental health scientist for ATSDR. He is a commissioned officer with the U.S. Public Health Service and has been deployed in support of numerous environmental disasters including hurricanes Katrina, Rita, Isabelle, and Irene, as well as the Deepwater Horizon oil spill. Laurel Berman is the national brownfields coordinator with ATSDR. She coordinates the ATSDR Brownfields/Land-Reuse Health Initiative. Kathryn Leann Lemley Bing is an environmental health scientist and an ATSDR regional representative in Atlanta. She has specialized

  17. Completeness and positive predictive value of registration of upper limb embolectomy in the Danish National Vascular Registry

    PubMed Central

    Andersen, Ljubica V; Mortensen, Leif S; Lindholt, Jes S; Faergeman, Ole; Henneberg, Eskild W; Frost, Lars

    2009-01-01

    Objective: To evaluate completeness and positive predictive value of the Danish National Vascular Registry regarding registration of the surgical procedures: embolectomy of brachial, ulnar, or radial artery. Study design and settings: The study was based on first-time embolectomies in the brachial, ulnar, or radial artery performed in Denmark from January 1, 1990 to December 31, 2002. The data were primarily retrieved from the Danish National Vascular Registry and secondarily from the Danish National Registry of Patients. Medical records were retrieved using a standardized form. Results: In total, 1433 incident cases of first-time embolectomy were found in both registries. The positive predictive value of the registration was 97.5% (95% confidence interval [CI]; 96.4–98.4). The degree of completeness was 86.5% (95% CI; 84.3–88.5). For the registration period from 1990 till 1996 the degree of completeness was 78.2% (95% CI; 74.4–81.7), and from 1997 till 2002 it was 93.8% (95% CI; 91.6–95.7). Conclusion: The completeness and positive predictive value of registration of embolectomy in the upper limb in the Danish National Vascular Registry was 86.5% and 97.5%, respectively. This registry can be a valuable tool for epidemiological research and quality-monitoring. PMID:20865084

  18. 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.

  19. The National Neurosurgery Quality and Outcomes Database Qualified Clinical Data Registry: 2015 measure specifications and rationale.

    PubMed

    Parker, Scott L; McGirt, Matthew J; Bekelis, Kimon; Holland, Christopher M; Davies, Jason; Devin, Clinton J; Atkins, Tyler; Knightly, Jack; Groman, Rachel; Zyung, Irene; Asher, Anthony L

    2015-12-01

    Meaningful quality measurement and public reporting have the potential to facilitate targeted outcome improvement, practice-based learning, shared decision making, and effective resource utilization. Recent developments in national quality reporting programs, such as the Centers for Medicare & Medicaid Services Qualified Clinical Data Registry (QCDR) reporting option, have enhanced the ability of specialty groups to develop relevant quality measures of the care they deliver. QCDRs will complete the collection and submission of Physician Quality Reporting System (PQRS) quality measures data on behalf of individual eligible professionals. The National Neurosurgery Quality and Outcomes Database (N(2)QOD) offers 21 non-PQRS measures, initially focused on spine procedures, which are the first specialty-specific measures for neurosurgery. Securing QCDR status for N(2)QOD is a tremendously important accomplishment for our specialty. This program will ensure that data collected through our registries and used for PQRS is meaningful for neurosurgeons, related spine care practitioners, their patients, and other stakeholders. The 2015 N(2)QOD QCDR is further evidence of neurosurgery's commitment to substantively advancing the health care quality paradigm. The following manuscript outlines the measures now approved for use in the 2015 N(2)QOD QCDR. Measure specifications (measure type and descriptions, related measures, if any, as well as relevant National Quality Strategy domain[s]) along with rationale are provided for each measure.

  20. United Kingdom Primary Sjogren's Syndrome Registry--a united effort to tackle an orphan rheumatic disease.

    PubMed

    Ng, Wan-Fai; Bowman, Simon J; Griffiths, Bridget

    2011-01-01

    Primary SS (pSS) is a multi-system autoimmune disease with a prevalence and health economic impact that are comparable with RA. However, pSS research has been relatively poorly supported. The creation of a large cohort of clinically well-characterized pSS patients will provide a catalyst and valuable resources to promote high-quality pSS research. In this review, we will describe the creation of such a cohort and the associated research biobank that is currently being established in the UK--entitled United Kingdom Primary Sjögren's Syndrome Registry (UKPSSR). We will discuss the strengths and weaknesses of the design of the registry and highlight the key challenges in the establishment of the registry and the strategies that we employ to overcome these barriers. Finally, we will consider the future development of the UKPSSR including utilization and maintenance of the cohort.

  1. A Reference Equation for Normal Standards for VO2 Max: Analysis from the Fitness Registry and the Importance of Exercise National Database (FRIEND Registry).

    PubMed

    Myers, Jonathan; Kaminsky, Leonard A; Lima, Ricardo; Christle, Jeffrey W; Ashley, Euan; Arena, Ross

    Existing normal standards for maximal oxygen uptake (VO2 max) are problematic because they tend to be population specific, lack normal distribution and portability, and are poorly represented by women. The objective of the current study was to apply the Fitness Registry and the Importance of Exercise: A National Data Base (FRIEND) Registry to improve upon previous regression formulas for normal standards for VO2 max using treadmill testing. Maximal treadmill tests were performed in 7783 healthy men and women (20-79years; maximal RER >1.0) from the FRIEND registry and a separate validation cohort of 1287 subjects. A regression equation for VO2 max was derived from the FRIEND registry and compared to the validation cohort and two commonly used equations (Wasserman and European). Age, gender, and body weight were the only significant predictors of VO2 max (multiple R=0.79, R(2)=0.62, p<0.001). The equation for predicting VO2 max was: [Formula: see text] Marked differences were observed in percentage predicted VO2 max achieved between commonly used reference equations, particularly among women, overweight and obese subjects. In the validation sample, the FRIEND equation closely paralleled measured VO2 max, with the validation group yielding a percent predicted VO2 max of 100.4% based on the FRIEND equation. An equation for age-predicted VO2 max derived from the FRIEND registry provided a lower average error between measured and predicted VO2 max than traditional equations, and thus may provide a more suitable normal standard relative to traditional equations. Published by Elsevier Inc.

  2. 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

  3. A National Emergency Airway Registry for children: landscape of tracheal intubation in 15 PICUs.

    PubMed

    Nishisaki, Akira; Turner, David A; Brown, Calvin A; Walls, Ron M; Nadkarni, Vinay M

    2013-03-01

    To characterize the landscape of process of care and safety outcomes for tracheal intubation across pediatric intensive care units Procedural process of care and safety outcomes of tracheal intubation across pediatric intensive care units has not been described. We hypothesize that the novel National Emergency Airway Registry for Children registry is a feasible tool to capture tracheal intubation process of care and outcomes. Prospective, descriptive. Fifteen academic PICUs in North America. Critically ill children requiring tracheal intubation in PICUs. Tracheal intubation quality improvement data were prospectively collected for all initial tracheal intubation in 15 PICUs from July 2010 to December 2011 using the National Emergency Airway Registry for Children tool with explicit site-specific compliance plans and operational definitions including adverse tracheal intubation associated events. One thousand seven hundred fifteen tracheal intubation encounters were reported (averaging 1/3.4 days, or 1/86 bed days). Ninety-eight percent of primary tracheal intubation were successful; 86% were successful with less than or equal to two attempts. First attempt was by pediatric residents in 23%, pediatric critical care fellows in 41%, and critical care attending physicians in 13%: first attempt success rate was 62%, first provider success rate was 79%. The first method was oral intubation in 1,659 (98%) and nasal in 55 (2%). Direct laryngoscopy was used in 96%. Ninety percent of tracheal intubation were with cuffed tracheal tubes. Adverse tracheal intubation associated events were reported in 20% of intubations (n = 372), with severe tracheal intubation associated events in 6% (n = 115). Esophageal intubation with immediate recognition was the most common tracheal intubation associated events (n = 167, 9%). History of difficult airway, diagnostic category, unstable hemodynamics, and resident provider as first airway provider were associated with occurrence of tracheal

  4. The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC): Results from Phase I and Scientific Opportunities in Phase II

    PubMed Central

    Kroner, Barbara L.; Tolunay, H. Eser; Basson, Craig T.; Pyeritz, Reed E.; Holmes, Kathryn; Maslen, Cheryl L.; Milewicz, Dianna M.; LeMaire, Scott A.; Hendershot, Tabitha; Desvigne-Nickens, Patrice; Devereux, Richard B.; Dietz, Harry C.; Song, Howard; Ringer, Danny; Mitchell, Megan; Weinsaft, Jonathan W.; Ravekes, William; Menashe, Victor; Eagle, Kim A.

    2011-01-01

    Background Genetically triggered thoracic aortic conditions (GenTAC) represent an important problem for patients and their families. Accordingly, the National Heart, Lung and Blood Institute (NHLBI) established the first phase of its national GenTAC Registry in 2006. Enrollment and Diagnoses Between 2007 and 2010, six enrolling centers established the GenTAC I Registry consisting of 2,046 patients [(Marfan syndrome 576 (28.2%); bicuspid aortic valve disease 504 (24.6%), aneurysm or dissection age <50 years 369 (18%), and others.] Biologic samples for DNA analyses (WBC’s or saliva) are available in 97% and stored plasma is available in 60% of enrollees. Results Initial scientific inquiry using the GenTAC Registry has included validation studies of genetic causes for aortic syndromes, potential usefulness of TGFB blood levels in Marfan subjects, and current surgical approaches to ascending aortic conditions. Future Opportunity GenTAC II will allow biannual follow-up of GenTAC I enrollees for up to nine years, enrollment of an additional 1,500 subjects, further integration of imaging findings with clinical and genetic data through utilization of an imaging core lab, important validation of phenotype-genotype correlations through a phenotyping core lab, and integration of a scientific advisory committee to help define the full range and depth of the Registry’s scientific capabilities. The registry resources are available to the external scientific community through an application process accessible at https://gentac.rti.org. PMID:21982653

  5. Immunization registries can be building blocks for national health information systems.

    PubMed

    Hinman, Alan R; Ross, David A

    2010-04-01

    Electronic health records and health information exchanges are necessary components of the information infrastructure to support a reformed health care system. However, they are not sufficient by themselves. Merely summing data from electronic health records together will not provide a comprehensive picture of the population, which is essential for tracking disease trends and treatment outcomes. Public health information systems such as immunization registries are an essential component of the information infrastructure and will allow assessment of the impact of changes in health care on the population as a whole.

  6. Strategies to achieve sustainability and quality in birth defects registries: the experience of the National Registry of Congenital Anomalies of Argentina.

    PubMed

    Groisman, Boris; Bidondo, Maria Paz; Gili, Juan Antonio; Barbero, Pablo; Liascovich, Rosa

    2013-01-01

    In many low-and middle-income countries, birth defects are not considered a public health priority and are perceived by the medical community as rare, unpreventable events. In this context, a registry of birth defects should address not only the collection, analysis, and dissemination of information but also contribute to local interventions like prevention, diagnosis, and treatment. We describe the National Registry of Congenital Anomalies of Argentina (RENAC) in terms of case definition, data collection, quality assurance, and data sending, coding, analysis, and information dissemination and we present the strategies used to ensure its sustainability. We emphasize strategies for motivating the people collecting data, such as training activities, participation in research projects, returning the processed data, making useful clinical information available, giving non-monetary rewards, and linking cases to genetic services.

  7. 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.

  8. 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.

  9. A renal registry for Africa: first steps

    PubMed Central

    Davids, M. Razeen; Eastwood, John B.; Selwood, Neville H.; Arogundade, Fatiu A.; Ashuntantang, Gloria; Benghanem Gharbi, Mohammed; Jarraya, Faiçal; MacPhee, Iain A.M.; McCulloch, Mignon; Plange-Rhule, Jacob; Swanepoel, Charles R.; Adu, Dwomoa

    2016-01-01

    There is a dearth of data on end-stage renal disease (ESRD) in Africa. Several national renal registries have been established but have not been sustainable because of resource limitations. The African Association of Nephrology (AFRAN) and the African Paediatric Nephrology Association (AFPNA) recognize the importance of good registry data and plan to establish an African Renal Registry. This article reviews the elements needed for a successful renal registry and gives an overview of renal registries in developed and developing countries, with the emphasis on Africa. It then discusses the proposed African Renal Registry and the first steps towards its implementation. A registry requires a clear purpose, and agreement on inclusion and exclusion criteria, the dataset and the data dictionary. Ethical issues, data ownership and access, the dissemination of findings and funding must all be considered. Well-documented processes should guide data collection and ensure data quality. The ERA-EDTA Registry is the world's oldest renal registry. In Africa, registry data have been published mainly by North African countries, starting with Egypt and Tunisia in 1975. However, in recent years no African country has regularly reported national registry data. A shared renal registry would provide participating countries with a reliable technology platform and a common data dictionary to facilitate joint analyses and comparisons. In March 2015, AFRAN organized a registry workshop for African nephrologists and then took the decision to establish, for the first time, an African Renal Registry. In conclusion, African nephrologists have decided to establish a continental renal registry. This initiative could make a substantial impact on the practice of nephrology and the provision of services for adults and children with ESRD in many African countries. PMID:26798479

  10. 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

  11. 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.

  12. Creating a global rare disease patient registry linked to a rare diseases biorepository database: Rare Disease-HUB (RD-HUB).

    PubMed

    Rubinstein, Yaffa R; Groft, Stephen C; Bartek, Ronald; Brown, Kyle; Christensen, Ronald A; Collier, Elaine; Farber, Amy; Farmer, Jennifer; Ferguson, John H; Forrest, Christopher B; Lockhart, Nicole C; McCurdy, Kate R; Moore, Helen; Pollen, Geraldine B; Richesson, Rachel; Miller, Vanessa Rangel; Hull, Sara; Vaught, Jim

    2010-09-01

    A movement to create a global patient registry for as many as 7,000 rare diseases was launched at a workshop, "Advancing Rare Disease Research: The Intersection of Patient Registries, Biospecimen Repositories, and Clinical Data." http://rarediseases.info.nih.gov/PATIENT_REGISTRIES_WORKSHOP/. The workshop was sponsored by the Office of Rare Diseases Research (ORDR). The focus was the building of an infrastructure for an internet-based global registry linking to biorepositories. Such a registry would serve the patients, investigators, and drug companies. To aid researchers the participants suggested the creation of a centralized database of biorepositories for rare biospecimens (RD-HUB)http://biospecimens.ordr.info.nih.gov/ that could be linked to the registry. Over two days of presentations and breakout sessions, several hundred attendees discussed government rules and regulations concerning privacy and patients' rights and the nature and scope of data to be entered into a central registry as well as concerns about how to validate patient and clinician-entered data to ensure data accuracy. Mechanisms for aggregating data from existing registries were also discussed. The attendees identified registry best practices, model coding systems, international systems for recruiting patients into clinical trials and novel ways of using the internet directly to invite participation in research. They also speculated about who would bear ultimate responsibility for the informatics in the registry and who would have access to the information. Hurdles associated with biospecimen collection and how to overcome them were detailed. The development of the recommendations was, in itself, an indication of the commitment of the rare disease community as never before. Published by Elsevier Inc.

  13. Quality control of a national bone marrow donor registry: results of a pilot study and proposal for a standardized approach.

    PubMed

    Tiercy, J-M; Stadelmann, S; Chapuis, B; Gratwohl, A; Schanz, U; Seger, R A; Faveri, G Nicoloso de; Kern, M; Morell, A; Schwabe, R; Schneider, P

    2003-09-01

    Unrelated hematopoietic stem cell transplantation (HSCT) is a recognized therapy for hematological diseases and over 8 million HLA-typed donors are ready to donate. Increased international exchanges and rapid requests through the Bone Marrow Donor Worldwide (BMDW) ask for standardized quality assurance. Since no such standards have been established to date, we tested a pilot program in order to evaluate donor availability and quality of HLA typing of the Swiss Registry. The 18500 donors of the registry have been analyzed by serology for HLA-AB and by molecular typing for HLA-DR. Through three successive annual quality control (QC) exercises, a total of 114 donor requests were sent to 13 blood transfusion centers responsible for donor recruitment asking for a blood sample. Donors were randomly selected according to recruitment periods (1988-1993; 1994-1997; 1998-2000), and to homozygosity for HLA-A and/or -B antigens. An additional 80 frozen blood samples from the repository corresponding to the three periods (n=26) and to the 2001 period (n=54) were also included in the HLA study. HLA-AB typings were done by polymerase chain reaction-sequence specific primers (PCR-SSP) and all discrepancies were retyped. The results showed that 79 samples provided by 69.3% of the requested donors were received within 14 days, and 19 samples (16.7%) were received in >14 days. Altogether, an 86% rate of donor availability was observed, independent of the recruitment period. Among the requested donors, 16 (14%) were not available: for medical reasons (two), for personal reasons (eight), for loss (one), and for an unknown reason (five). The HLA-A/B DNA typing results of 166 homozygous and 12 heterozygous blood samples showed that 437/439 (99.5%) of the assigned A/B antigens were correct. However in 36/178 donors (20.2%) an HLA-A or -B antigen had been missed (34 donors) or misassigned (two donors) by serology, with a decreasing discrepancy rate of 30% (1988-1993) to 18.5% in 2001

  14. Establishing national noncommunicable disease surveillance in a developing country: a model for small island nations.

    PubMed

    Rose, Angela M; Hambleton, Ian R; Jeyaseelan, Selvi M; Howitt, Christina; Harewood, Rhea; Campbell, Jacqueline; Martelly, Tanya N; Blackman, Tracey; George, Kenneth S; Hassell, Trevor A; Corbin, David O; Delice, Rudolph; Prussia, Patsy; Legetic, Branka; Hennis, Anselm J

    2016-02-01

    Objective To describe the surveillance model used to develop the first national, population-based, multiple noncommunicable disease (NCD) registry in the Caribbean (one of the first of its kind worldwide); registry implementation; lessons learned; and incidence and mortality rates from the first years of operation. Methods Driven by limited national resources, this initiative of the Barbados Ministry of Health (MoH), in collaboration with The University of the West Indies, was designed to collect prospective data on incident stroke and acute myocardial infarction (MI) (heart attack) cases from all health care facilities in this small island developing state (SIDS) in the Eastern Caribbean. Emphasis is on tertiary and emergency health care data sources. Incident cancer cases are obtained retrospectively, primarily from laboratories. Deaths are collected from the national death register. Results Phased introduction of the Barbados National Registry for Chronic NCDs ("the BNR") began with the stroke component ("BNR-Stroke," 2008), followed by the acute MI component ("BNR-Heart," 2009) and the cancer component ("BNR-Cancer," 2010). Expected case numbers projected from prior studies estimated an average of 378 first-ever stroke, 900 stroke, and 372 acute MI patients annually, and registry data showed an annual average of about 238, 593, and 349 patients respectively. There were 1 204 tumors registered in 2008, versus the expected 1 395. Registry data were used to identify public health training themes. Success required building support from local health care professionals and creating island-wide registry awareness. With spending of approximately US$ 148 per event for 2 200 events per year, the program costs the MoH about US$ 1 per capita annually. Conclusions Given the limited absolute health resources available to SIDS, combined surveillance should be considered for building a national NCD evidence base. With prevalence expected to increase further worldwide, Barbados

  15. Evaluation of ICD-10 algorithms to identify hypopituitary patients in the Danish National Patient Registry

    PubMed Central

    Berglund, Agnethe; Olsen, Morten; Andersen, Marianne; Nielsen, Eigil Husted; Feldt-Rasmussen, Ulla; Kistorp, Caroline; Gravholt, Claus Højbjerg; Stochhholm, Kirstine

    2017-01-01

    Objective Routinely collected health data may be valuable sources for conducting research. This study aimed to evaluate the validity of algorithms detecting hypopituitary patients in the Danish National Patient Registry (DNPR) using medical records as reference standard. Study design and setting Patients with International Classification of Diseases (10th edition [ICD-10]) diagnoses of hypopituitarism, or other diagnoses of pituitary disorders assumed to be associated with an increased risk of hypopituitarism, recorded in the DNPR during 2000–2012 were identified. Medical records were reviewed to confirm or disprove hypopituitarism. Results Hypopituitarism was confirmed in 911 patients. In a candidate population of 1,661, this yielded an overall positive predictive value (PPV) of 54.8% (95% confidence interval [CI]: 52.4–57.3). Using algorithms searching for patients recorded at least one, three or five times with a diagnosis of hypopituitarism (E23.0x) and/or at least once with a diagnosis of postprocedural hypopituitarism (E89.3x), PPVs gradually increased from 73.3% (95% CI: 70.6–75.8) to 83.3% (95% CI: 80.7–85.7). Completeness for the same algorithms, however, decreased from 90.8% (95% CI: 88.7–92.6) to 82.9% (95% CI: 80.3–85.3) respectively. Including data of hormone replacement in the same algorithms PPVs increased from 73.2% (95% CI: 70.6–75.7) to 82.6% (95% CI: 80.1–84.9) and completeness decreased from 94.3% (95% CI: 92.6–95.7) to 89.7% (95% CI: 87.5–91.6) with increasing records of E23.0x. Conclusion The DNPR is a valuable data source to identify hypopituitary patients using a search criteria of at least five records of E23.0x and/or at least one record of E89.3x. Completeness is increased when including hormone replacement data in the algorithm. The consequences of misclassification must, however, always be considered. PMID:28223847

  16. Clinical Research Participation among Aging Adults Enrolled in an Alzheimer’s Disease Center Research Registry

    PubMed Central

    Jefferson, Angela L.; Lambe, Susan; Chaisson, Christine; Palmisano, Joseph; Horvath, Kathy J.; Karlawish, Jason

    2011-01-01

    In light of our limited understanding of what motivates older adults to participate in clinical studies of Alzheimer’s disease (AD), the current study examines incentives and barriers to participating in AD clinical research among older adults. 235 participants enrolled in the Boston University Alzheimer’s Disease Center research registry (75 ± 8 years, range 58–99 years, 60% female), a longitudinal registry from which individuals are recruited into other clinical studies, completed a survey assessing registry participation satisfaction, religiousness, trust in healthcare institutions, and medical research attitudes. Most participants reported initially enrolling in the registry for societal benefit. Insufficient time was a commonly endorsed barrier to enrolling in other Center-approved studies, particularly among younger participants. Driving and a lack of transportation to the medical facility were also barriers, particularly for older participants. Transportation was the most popular incentive, followed by home-based visits (particularly for older participants and participants with less formal education) and compensation (particularly among respondents from racial/ethnic minority groups). Participation interest in other studies was associated with favorable medical research attitudes (r = 0.34, p = 0.00003) but not religiousness (r = −0.09 p = 0.21) or trust in healthcare institutions (r = 0.09, p = 0.17). Among older adults, societal benefit is a motivating factor for registry enrollment; however, participation in additional studies is hindered by insufficient time among younger participants and transportation barriers among older participants. Providing transportation, home-based visits, and modest compensation may improve participation rates. Furthermore, favorable attitudes toward medical research are strongly associated with interest in enrolling in additional studies and may serve as a beneficial outreach triage technique. PMID:21116048

  17. 77 FR 2126 - Pipeline Safety: Implementation of the National Registry of Pipeline and Liquefied Natural Gas...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ... Registry of Pipeline and Liquefied Natural Gas Operators AGENCY: Pipeline and Hazardous Materials Safety... registry of pipeline and liquefied natural gas operators. FOR FURTHER INFORMATION CONTACT: Jamerson Pender... 72878), titled: ``Pipeline Safety: Updates to Pipeline and Liquefied Natural Gas Reporting...

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

    PubMed

    Bose, Carl L; Bauserman, Melissa; Goldenberg, Robert L; Goudar, Shivaprasad S; McClure, Elizabeth M; Pasha, Omrana; Carlo, Waldemar A; Garces, Ana; Moore, Janet L; Miodovnik, Menachem; Koso-Thomas, Marion

    2015-01-01

    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. 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. 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. 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 systems and vital records, alternative

  19. Incidence of primary breast cancer in Iran: Ten-year national cancer registry data report.

    PubMed

    Jazayeri, Seyed Behzad; Saadat, Soheil; Ramezani, Rashid; Kaviani, Ahmad

    2015-08-01

    Breast cancer is the leading type of malignancy and the leading cause of cancer-related deaths in women worldwide. The screening programs and advances in the treatment of patients with breast cancer have led to an increase in overall survival. Cancer registry systems play an important role in providing basic data for research and the monitoring of the cancer status. In this study, the results of the 10-year national cancer registry (NCR) of Iran in breast cancer are reviewed. NCR database records were searched for primary breast cancer records according to ICD-O-3 coding and the cases were reviewed. A total of 52,068 cases were found with the coding of primary breast cancer. Females constituted 97.1% of the cases. Breast cancer was the leading type of cancer in Iranian females, accounting for 24.6% of all cancers. The mean age of the women with breast cancer was 49.6 years (95%CI 49.5-49.6). Most of the cases (95.7%) were registered as having invasive pathologies (behavior code 3). The most common morphology of primary breast cancer was invasive ductal carcinoma (ICD-O 8500/3) followed by invasive lobular carcinoma (ICD-O 8520/3) with relative frequencies of 77.8% and 5.2%, respectively. The average annual crude incidence of primary breast cancer in females was 22.6 (95%CI 22.1-23.1) per 100,000 females, with an age-standardized rate (ASR) of 27.4 (95%CI 22.5-35.9). There were no data on survival, staging or immunohistochemical marker(s) of the breast-cancer-registered cases. The incidence of breast cancer in Iran is lower than in low-middle-income neighboring countries. The NCR data registry of breast cancer is not accurate in monitoring the effect of screening programs or determining the current status of breast cancer in Iran. Screening programs of breast cancer in Iran have failed to enhance the detection of the patients with in situ lesion detection. A quality breast cancer registry and a screening program for breast cancer are both needed. Copyright © 2015

  20. Cancer Incidence in Egypt: Results of the National Population-Based Cancer Registry Program

    PubMed Central

    Ibrahim, Amal S.; Khaled, Hussein M.; Mikhail, Nabiel NH; Baraka, Hoda; Kamel, Hossam

    2014-01-01

    Background. This paper aims to present cancer incidence rates at national and regional level of Egypt, based upon results of National Cancer Registry Program (NCRP). Methods. NCRP stratified Egypt into 3 geographical strata: lower, middle, and upper. One governorate represented each region. Abstractors collected data from medical records of cancer centers, national tertiary care institutions, Health Insurance Organization, Government-Subsidized Treatment Program, and death records. Data entry was online. Incidence rates were calculated at a regional and a national level. Future projection up to 2050 was also calculated. Results. Age-standardized incidence rates per 100,000 were 166.6 (both sexes), 175.9 (males), and 157.0 (females). Commonest sites were liver (23.8%), breast (15.4%), and bladder (6.9%) (both sexes): liver (33.6%) and bladder (10.7%) among men, and breast (32.0%) and liver (13.5%) among women. By 2050, a 3-fold increase in incident cancer relative to 2013 was estimated. Conclusion. These data are the only available cancer rates at national and regional levels of Egypt. The pattern of cancer indicated the increased burden of liver cancer. Breast cancer occupied the second rank. Study of rates of individual sites of cancer might help in giving clues for preventive programs. PMID:25328522

  1. A new era of quality measurement in rheumatology: electronic clinical quality measures and national registries.

    PubMed

    Tonner, Chris; Schmajuk, Gabriela; Yazdany, Jinoos

    2017-03-01

    This article reviews the evolution of quality measurement in rheumatology, highlighting new health-information technology infrastructure and standards that are enabling unprecedented innovation in this field. Spurred by landmark legislation that ties physician payment to value, the widespread use of electronic health records, and standards such as the Quality Data Model, quality measurement in rheumatology is rapidly evolving. Rather than relying on retrospective assessments of care gathered through administrative claims or manual chart abstraction, new electronic clinical quality measures (eCQMs) allow automated data capture from electronic health records. At the same time, qualified clinical data registries, like the American College of Rheumatology's Rheumatology Informatics System for Effectiveness registry, are enabling large-scale implementation of eCQMs across national electronic health record networks with real-time performance feedback to clinicians. Although successful examples of eCQM development and implementation in rheumatology and other fields exist, there also remain challenges, such as lack of health system data interoperability and problems with measure accuracy. Quality measurement and improvement is increasingly an essential component of rheumatology practice. Advances in health information technology are likely to continue to make implementation of eCQMs easier and measurement more clinically meaningful and accurate in coming years.

  2. A New Era of Quality Measurement in Rheumatology: Electronic Clinical Quality Measures and National Registries

    PubMed Central

    Tonner, Chris; Schmajuk, Gabriela; Yazdany, Jinoos

    2017-01-01

    Purpose of Review We review the evolution of quality measurement in rheumatology, highlighting new health-information technology infrastructure and standards that are enabling unprecedented innovation in this field. Recent Findings Spurred by landmark legislation that ties physician payment to value, the widespread use of electronic health records (EHRs), and standards such as the Quality Data Model, quality measurement in rheumatology is rapidly evolving. Rather than relying on retrospective assessments of care gathered through administrative claims or manual chart abstraction, new electronic clinical quality measures (eCQMs) allow automated data capture from EHRs. At the same time, Qualified Clinical Data Registries, like the American College of Rheumatology’s RISE registry, are enabling large-scale implementation of eCQMs across national EHR networks with real-time performance feedback to clinicians. While successful examples of eCQM development and implementation in rheumatology and other fields exist, there also remain challenges, such as lack of health system data interoperability and problems with measure accuracy. Summary Quality measurement and improvement is increasingly an essential component of rheumatology practice. Advances in health information technology are likely to continue to make implementation of eCQMs easier and measurement more clinically meaningful and accurate in coming years. PMID:27941392

  3. 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

  4. Down syndrome: issues to consider in a national registry, research database and biobank.

    PubMed

    McCabe, Linda L; McCabe, Edward R B

    2011-01-01

    As the quality of life for individuals with Down syndrome continues to improve due to anticipatory healthcare, early intervention, mainstreaming in schools, and increased expectations, the lack of basic information regarding individuals with Down syndrome is being recognized, and the need to facilitate research through a national registry, research database and biobank is being discussed. We believe that there should not be ownership of the samples and information, but instead prefer stewardship of the samples and information to benefit the participants who provided them. We endorse a model with data and sample managers and a research review board to interface between the investigators and participants. Information and samples would be coded, and only a few data managers would know the relationship between the codes and identifying information. Research results once published should be included in an online newsletter. If appropriate, individual results should be shared with participants. A Down syndrome registry, research database and biobank should be accountable to participants, families, medical care providers, government, and funding sources.

  5. Hematologic malignancies in South Africa 2000-2006: analysis of data reported to the National Cancer Registry.

    PubMed

    Schonfeld, Sara J; Erdmann, Friederike; Wiggill, Tracey; Singh, Elvira; Kellett, Patricia; Babb, Chantal; Schüz, Joachim

    2016-04-01

    Little is known about the incidence patterns of hematologic malignancies in Sub-Saharan Africa, including South Africa. We estimated incidence rates of pathology-confirmed adult cases of leukemia, myeloma and related diseases (myeloma), Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) reported to the National Cancer Registry of South Africa (NCR) between 2000 and 2006, by age, gender, and population group (Black, White, Coloured, Asian/Indian). Gender-specific age-standardized rates were calculated overall and by population group and incidence rate ratios (IRRs) were estimated using Poisson regression models. Between 2000 and 2006, there were 14662 cases of leukemia, myeloma, HL, and NHL reported to the registry. Incidence rates of reported hematologic malignancies were generally 20-50% higher among males than females. Our analyses suggested marked differences in the rates of reported hematologic malignancies by population group which were most pronounced when comparing the White versus Black population groups (IRRs ranging from 1.6 for myeloma to 3.8 for HL for males and females combined). Challenges related to diagnosis and reporting of cancers may play a role in the patterns observed by population group while the set-up of the NCR (pathology-based) could lead to some degree of under-ascertainment in all groups. This is the first country-wide report of the incidence of hematologic malignancies in South Africa. Despite challenges, it is important to analyze and report available national cancer incidence data to raise awareness of the cancer burden and to characterize patterns by demographic characteristics so as ultimately to improve the provision of cancer-related health care. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  6. Proportion of patients in the Uganda rheumatic heart disease registry with advanced disease requiring urgent surgical interventions.

    PubMed

    Zhang, WanZhu; Okello, Emmy; Nyakoojo, Wilson; Lwabi, Peter; Mondo, Charles K

    2015-12-01

    Since the establishment of the Uganda Rheumatic Heart Registry, over 900 patients have been enrolled. We sought to stratify the patients in the registry according to disease severity and optimal management strategy. We reviewed data of 618 patients who had enrolled in the Registry between March 2010 and February 2013. The 67 patients who had died were excluded leaving 551 patients who were recruited. The optimum management strategy was determined according to the 2012 European Society of Cardiology guidelines on the management of valvular heart disease. Out of the 551 patient's records evaluated, 398 (72.3%) required invasive intervention, with 332(60.3%) patients requiring surgery and 66 (12.0%) requiring percutaneous mitral commissurotomy (PMC). This leaves only 27.7% of patients who required only medical management. Currently, majority of the patients (498, 90.4%) in the registry are on medical treatment. Of the 60.3% requiring surgical intervention, only 8.0% (44 patients) underwent valvular surgery and 5(1.0%) patients of the 66 (12.0%) underwent PMC successfully. There is a high proportion of patients with severe disease that require surgical treatment yet they cannot access this therapy due to absence of local expertise.

  7. Positive predictive values of ICD-10 codes to identify incident acute pancreatitis and incident primary malignancy in the Scandinavian national patient registries among women with postmenopausal osteoporosis.

    PubMed

    Munch, Troels; Christensen, Lotte B; Adelborg, Kasper; Tell, Grethe S; Apalset, Ellen M; Westerlund, Anna; Lagerros, Ylva T; Kahlert, Johnny; Xue, Fei; Ehrenstein, Vera

    2017-01-01

    Validation of definitions used to identify conditions of interest is imperative to epidemiologic studies based on routinely collected data. The objective of the study was thus to estimate positive predictive values (PPVs) of International Classification of Diseases, 10th Revision (ICD-10) codes to identify cases of incident acute pancreatitis leading to hospitalization and incident primary malignancy in the Scandinavian (Denmark, Norway, and Sweden) national patient registries in women with postmenopausal osteoporosis (PMO). This validation study included postmenopausal (defined as 55 years or older) women with osteoporosis, identified between 2005-2014. Potential cases were sampled based on ICD-10 codes from the three national patient registries. Cases were adjudicated by physicians, using medical record review as gold standard. PPVs with corresponding 95% CIs were computed. Medical records of 286 of 325 (retrieval rate 88%) women with PMO were available for adjudication. Acute pancreatitis leading to hospitalization had a PPV of 87.6% (95% CI: 80.8%-90.2%). Incident primary malignancy had a PPV of 88.1% (95% CI: 81.3%-92.7%). The PPVs did not vary substantially across the three countries. ICD-10 codes to identify acute pancreatitis leading to hospitalization, and incident primary malignancy in the Scandinavian national patient registries had high PPVs among women with PMO. This allows identification of cases of acute pancreatitis and incident primary malignancy with reasonable validity and to use these as outcomes in comparative analyses.

  8. Ethical issues involved in establishing a registry for familial Alzheimer's disease.

    PubMed

    Godard, B; Knoppers, B M; Glass, K; Grenon, M; Bouchard, R; Bouvier, M; Goulet, J; Gauvreau, D

    1994-01-01

    In January 1992, the IMAGE Project extended the establishment of its registry of familial Alzheimer cases to all areas of the province of Quebec, for collection of epidemiological and clinical data, as well as biological samples. The aim is to study genetic transmission patterns of Alzheimer's disease (AD) and to provide a sampling framework for further etiologic and risk factor studies. The IMAGE registry already includes data of a population-based study in the Saguenay-Lac-St-Jean area; the project to collect data on familial AD (FAD) cases across the province of Quebec is known as the ALGENE Initiative. The registry is thus a collection of "AD families" for both familial and sporadic cases. The establishment of the registry involves several steps in the field work: recruitment and selection of families; collection of information on family medical history; selection of informative families and genetic testing for AD/FAD by linkage analysis. As AD is not homogeneous in its etiology and since we do not know if, in the event that genetics is involved in AD whether or not penetrance of the gene(s) is high, we must be aware of the "genetic horizons" of AD in collecting and conserving data on families of cases, and in the genetic testing for AD/FAD by linkage analysis. Families who choose genetic testing must be aware of the implications of our undertaking, assured of the confidentiality of the test and, at the same time, they must understand its limitations. The experimental nature of our research project raises ethical dilemmas. This article examines these initial considerations of the field work involved in developing a registry pertaining to genetic testing for AD/FAD by linkage analysis and offers some preliminary observations on the experience of the first year of this project.

  9. Malaysian Cardiothoracic Surgery Registry--a patient registry to evaluate the health outcomes of patients undergoing surgery for cardiothoracic diseases in Malaysia.

    PubMed

    Anas, R; Rahman, I; Jahizah, H; Hassan, A; Ezani, T; Jong, Y H; Norzalina, E; Ziyadi, G; Balan, S; Ramadan, J; Lim, T O; Jamaiyah, H; Hidayah, H

    2008-09-01

    The formulation of the Cardiothoracic Registry. Cardiothoracic surgery is the field of medicine involved in surgical treatment of diseases affecting organs inside the thorax (the chest). It is a general treatment of conditions of the heart (heart disease) and lungs (lung disease). In Malaysia, due to lack of data collection we do not have estimates of number and outcome of such procedure in the country. Western figures are often used as our reference values and this may not accurately reflect our Malaysian population. The Malaysian Cardiothoracic Surgery Registry (MyCARE) by the Ministry of Health will be a valuable tool to provide timely and robust data of cardiology practice, its safety and cost effectiveness and most importantly the outcome of these patients in the Malaysian setting.

  10. 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

  11. The Management of Iron Chelation Therapy: Preliminary Data from a National Registry of Thalassaemic Patients

    PubMed Central

    Ceci, Adriana; Mangiarini, Laura; Felisi, Mariagrazia; Bartoloni, Franco; Ciancio, Angela; Capra, Marcello; D'Ascola, Domenico; Cianciulli, Paolo; Filosa, Aldo

    2011-01-01

    Thalassaemia and other haemoglobinopathies constitute an important health problem in Mediterranean countries, placing a tremendous emotional, psychological, and economic burden on their National Health systems. The development of new chelators in the most recent years had a major impact on the treatment of thalassaemia and on the quality of life of thalassaemic patients. A new initiative was promoted by the Italian Ministry of Health, establishing a Registry for thalassaemic patients to serve as a tool for the development of cost-effective diagnostic and therapeutic approaches and for the definition of guidelines supporting the most appropriate management of the iron-chelating therapy and a correct use of the available iron-chelating agents. This study represents the analysis of the preliminary data collected for the evaluation of current status of the iron chelation practice in the Italian thalassaemic population and describes how therapeutic interventions can widely differ in the different patients' age groups. PMID:21738864

  12. 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.

  13. The Danish Twin Registry: Linking Surveys, National Registers, and Biological Information

    PubMed Central

    Skytthe, Axel; Christiansen, Lene; Kyvik, Kirsten Ohm; Bødker, Frans L.; Hvidberg, Lars; Petersen, Inge; Nielsen, Morten M. F.; Bingley, Paul; Hjelmborg, Jacob; Tan, Qihua; Holm, Niels V.; Vaupel, James W.; McGue, Matt; Christensen, Kaare

    2013-01-01

    Over the last 60 years, the resources and the research in the Danish Twin Registry (DTR) have periodically been summarized. Here, we give a short overview of the DTR and a more comprehensive description of new developments in the twenty-first century. First, we outline our experience over the last decade of combining questionnaire and survey data with national demographic, social, and health registers in Statistics Denmark. Second, we describe our most recent data collection effort, which was conducted during the period 2008–2011 and included both in-person assessments of 14,000+ twins born 1931–1969 and sampling of biological material, hereby expanding and consolidating the DTR biobank. Third, two examples of intensively studied twin cohorts are given. The new developments in the DTR in the last decade have facilitated the ongoing research and laid the groundwork for new research directions. PMID:23084092

  14. Survival analysis of Down syndrome with congenital heart disease: a 5-years registry at QSNICH.

    PubMed

    Layangool, Thanarat; Sangtawesin, Chaisit; Kirawittaya, Tawatchai; Prompan, Worakan; Prachasilchai, Pimpak; Pechdamrongsakul, Amornrat

    2014-06-01

    Down syndrome (DS) is the most common chromosomal abnormality in children. Atrio-ventricular septal defect (AVSD) is the most common congenital heart disease (CHD) reported in DS. The mortality rate of DS with congenital heart disease (CHD) is 5-7 times higher than normal population. The survival rate in DS has improved with time and has reported up to 91% and 85% at one and ten years of age, respectively. To study the prevalence of CHD, clinical course, treatment, the overall survival in patients with DS compare with those who are associated with CHD. DS registry, multidisciplinary approach, single centre. All DS patients at QSNICH with parental signed consent were enrolled in the registry. The study was conducted for 5 years starting from May 2007 to April 2012. All patients were followed-up according to schedule modified from American Academic of Pediatrics (AAP) health supervision guideline. Standard treatment was given to all those children with diagnosis of CHD and/or other associated diseases. Four hundred and two cases of DS were enrolled. Two cases were excluded due to the parental inconvenience. The mode and mean age of the patients at registration were 1 and 7 months (1-62). Two hundred and seventy-one cases had an initial echocardiographic diagnosis of CHD, which included 91 of Patent ductus arteriosus (PDA), 49 of Ventricular septal defect (VSD), 34 of AVSD, 34 of secondum Atrial septal defect (ASD), 6 of Tetralogy of Fallot (TOF), 2 of Coractation of Aorta (CoA), 11 of other CHD and 44 of combined lesions. During the follow-up period, spontaneous closure of PDA, VSD and ASD occurred in 46, 12 and 15 cases, respectively. After the exclusion of those who had spontaneous closure, the prevalence rate of CHD in DS was 49.8%. VSD was the most common lesion, slightly more than PDA. Ninety-eight cases underwent cardiac surgery; including 39 of associated VSD, 24 of AVSD, 26 of PDA, 3 of TOF, 4 of CoA/AA repaired, one each of Cor triatriatum and primum ASD

  15. 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.

  16. [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

  17. A Squandered Opportunity?: A Review of SAMHSA's National Registry of Evidence-Based Programs and Practices for Offenders

    ERIC Educational Resources Information Center

    Wright, Benjamin J.; Zhang, Sheldon X.; Farabee, David

    2012-01-01

    In the past decade, the push for evidence-based programs has taken on unprecedented prominence in the fields of substance abuse and correctional treatment as a key determinant for intervention funding. The National Registry of Evidence-based Programs and Practices (NREPP), managed and funded by the Substance Abuse and Mental Health Services…

  18. 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…

  19. 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.

  20. Association Between Survival and Time of Day for Rapid Response Team Calls in a National Registry.

    PubMed

    Churpek, Matthew Michael; Edelson, Dana P; Lee, Ji Yeon; Carey, Kyle; Snyder, Ashley

    2017-10-01

    Decreased staffing at nighttime is associated with worse outcomes in hospitalized patients. Rapid response teams were developed to decrease preventable harm by providing additional critical care resources to patients with clinical deterioration. We sought to determine whether rapid response team call frequency suffers from decreased utilization at night and how this is associated with patient outcomes. Retrospective analysis of a prospectively collected registry database. National registry database of inpatient rapid response team calls. Index rapid response team calls occurring on the general wards in the American Heart Association Get With The Guidelines-Medical Emergency Team database between 2005 and 2015 were analyzed. None. The primary outcome was inhospital mortality. Patient and event characteristics between the hours with the highest and lowest mortality were compared, and multivariable models adjusting for patient characteristics were fit. A total of 282,710 rapid response team calls from 274 hospitals were included. The lowest frequency of calls occurred in the consecutive 1 AM to 6:59 AM period, with 266 of 274 (97%) hospitals having lower than expected call volumes during those hours. Mortality was highest during the 7 AM hour and lowest during the noon hour (18.8% vs 13.8%; adjusted odds ratio, 1.41 [1.31-1.52]; p < 0.001). Compared with calls at the noon hour, those during the 7 AM hour had more deranged vital signs, were more likely to have a respiratory trigger, and were more likely to have greater than two simultaneous triggers. Rapid response team activation is less frequent during the early morning and is followed by a spike in mortality in the 7 AM hour. These findings suggest that failure to rescue deteriorating patients is more common overnight. Strategies aimed at improving rapid response team utilization during these vulnerable hours may improve patient outcomes.

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

    PubMed

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

    2014-12-01

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

  2. Congenital malformations in Ecuadorian children: urgent need to create a National Registry of Birth Defects

    PubMed Central

    González-Andrade, Fabricio; López-Pulles, Ramiro

    2010-01-01

    Aim This study sets out (a) to estimate the prevalence of admissions by birth defects, using the official database of hospitals of Ecuador; and (b) to set the basis for a new National Register of Birth Defects in Ecuador that works as a program for the clinical and epidemiological investigation of risk factors in the etiology of congenital anomalies in Ecuadorian hospitals, using a case-control methodological approach. This is the first report in their class. Methods The data used in this study are derived from the National Register of Hospital Admission/Discharges of the Instituto Nacional de Estadísticas y Censos; data of the Ministry of Public Health were also used. Ecuador does not have an official Medical Birth Registry or a Congenital Malformations Registry. Results A total of 51,375 discharges by congenital malformations were registered in a 7-year period. Of these, 16,679 admissions were of children aged less than 1 year of age, with a birth prevalence rate (BPR) of 72.33/10,000 births. 77% of the congenital defects registered comprise the 50 most common birth defects observed in this age group. Cleft lip was the most prevalent birth defect in children less than 1 year of age and the second most common defect in children 1 to 5 years of age. Unilateral cleft lip shows a BPR of 4.57/10,000 births; cardiac birth defects as a group have a BPR of 4.2; hydrocephalus a BPR of 3.77; and Down’s syndrome a BPR of 3.70. Undescended testicle was the most prevalent birth defect in children between 1 to 5 years. 9384 children under 1 year of age were male (55.9%) and 7053 were female (42.1%). BPR in males was 40.45 and in females 30.40. Conclusion This report documents the prevalence estimates for birth defects reported in the hospital discharge data. These estimates are important to 1) plan for health-care and education needs of the Ecuadorian population, 2) identify increased occurrences of birth defects in specific geographic regions, 3) serve as a reference point

  3. ATSDR evaluation of health effects of chemicals. VI. Di(2-ethylhexyl)phthalate. Agency for Toxic Substances and Disease Registry.

    PubMed

    Fay, M; Donohue, J M; De Rosa, C

    1999-12-01

    Di(2-ethylhexyl)phthalate (also known as DEHP, bis(2-ethylhexyl)phthalate, or BEHP; CAS Registry Number 117-81-7) is a widely-used plasticizer. It is found in numerous plastic articles, such as paints, inks, floor tiles, upholstery, shower curtains, footwear, plastic bags, food-packaging materials, toys, and medical tubing. Not surprisingly, DEHP appears at many waste sites. As part of its mandate, the Agency for Toxic Substances and Disease Registry (ATSDR) prepares toxicological profiles on hazardous chemicals that are of greatest public health concern at Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) National Priority List (NPL) sites. These profiles comprehensively summarize toxicological and environmental information. This article constitutes the release of the bulk of ATSDR's profile for DEHP (ATSDR, 1993) into the mainstream scientific literature. An extensive listing of human and animal health effects, organized by route, duration, and endpoint, is presented. Toxicological information on toxicokinetics, biomarkers, interactions, sensitive subpopulations, reducing toxicity after exposure, and relevance to public health is also included. Environmental information encompasses physical properties, production and use, environmental fate, levels seen in the environment, analytical methods, and a listing of regulations. ATSDR, at the behest of Congress and therefore the citizenry, prepares these profiles to inform the public about site contaminants.

  4. Bicuspid and unicuspid aortic valves: Different phenotypes of the same disease? Insight from the GenTAC Registry.

    PubMed

    Krepp, Joseph M; Roman, Mary J; Devereux, Richard B; Bruce, Adrienne; Prakash, Siddharth K; Morris, Shaine A; Milewicz, Dianna M; Holmes, Kathryn W; Ravekes, William; Shohet, Ralph V; Pyeritz, Reed E; Maslen, Cheryl L; Kroner, Barbara L; Eagle, Kim A; Preiss, Liliana; Asch, Federico M

    2017-08-14

    Unicuspid aortic valve (UAV) is a rare disorder, often difficult to distinguish from bicuspid aortic valve (BAV). BAV and UAV share valve pathology such as the presence of a raphe, leaflet fusion, aortic stenosis, aortic regurgitation, and/or ascending aortic dilatation, but a comprehensive echocardiographic comparison of patients with UAV and BAV has not been previously performed. We investigated UAV and BAV patients at an early stage of disease included in GenTAC, a national registry of genetically related aortic aneurysms and associated cardiac conditions. Clinical and echocardiographic data from the GenTAC Registry were compared between 17 patients with UAV and 17 matched-controls with BAV. Baseline characteristics including demographics, clinical findings including family history of BAV and aortic aneurysm/coarctation, and echocardiographic variables were similar between BAV and UAV patients; aortic stenosis was more common and more severe in patients with UAV. This was evidenced by higher mean and peak gradient, smaller aortic valve area, and more advanced valvular degeneration (all P < .05). There were no significant differences in aortic dimensions, with a similar pattern of enlargement of the ascending aorta. The similar baseline characteristics with more accelerated aortic valve degeneration and stenosis suggest that UAV represents an extreme in the spectrum of BAV syndromes. Therefore, it is reasonable to consider application of recommendations for the management of patients with BAV to those with the rarer UAV. © 2017 Wiley Periodicals, Inc.

  5. Hospital for joint diseases participates in international spine registry Spine Tango after successful pilot study.

    PubMed

    Röder, Christoph; Errico, Thomas J; Spivak, Jeffrey M; Murray, M; Protopsaltis, T; Lis, A; Nordin, Margareta; Bendo, John

    2012-01-01

    Spine Tango is currently the only international spine registry in existence. It was developed under the auspices of Eurospine, the Spine Society of Europe, and is hosted at the University of Bern, Switzerland. The HJD Spine Center successfully tested Spine Tango during a 3-month pilot study and has since expanded documentation activities to more surgeons. Workflow integration and dedicated research staff are key factors for such an endeavor. Participation enables benchmarking against national and international peers and outcome research and quality assurance of surgical and non-surgical treatments.

  6. Inflammatory bowel disease in children: epidemiological analysis of the nationwide IBD registry in Japan.

    PubMed

    Ishige, Takashi; Tomomasa, Takeshi; Takebayashi, Tohru; Asakura, Keiko; Watanabe, Mamoru; Suzuki, Tomoko; Miyazawa, Reiko; Arakawa, Hirokazu

    2010-09-01

    We analyzed the database of the Japanese nationwide inflammatory bowel disease (IBD) registry, which was started in 1975, to characterize basic epidemiological and clinical features of childhood IBD, comparing them to those in adults. We analyzed the age of disease onset, disease severity and anatomical distribution in patients that were newly registered between 2003 and 2006 (n = 2,940 for CD and 14,857 for UC). We also analyzed the current age, gender and family history of IBD of all patients filed in 2005, which included patients who were newly registered in 2005 and those who had been registered before 2005 and for whom an annual report had been received in 2005 (total number of subjects: 10,934 for CD and 37,846 for UC). At the time of registration, 10.6% of CD and 5.9% of UC patients were ≤ 16 years old. In CD, the male to female ratio was 2.6 in adult- and 1.7 in childhood-onset patients (P < 0.001). In UC, the male to female ratio was close to 1 in both age groups. In comparison with adults, pediatric patients more commonly had a positive family history for CD and UC (P < 0.001), tended to have more severe disease at the time of registry (P < 0.001 for CD, P < 0.05 for UC) and more often had extensive colitis in UC (P < 0.001). The nationwide registry in Japan showed IBD in children has clinical features that are distinct from those in adults.

  7. 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.

  8. 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.

  9. Tuberculosis in Malaysia: predictors of treatment outcomes in a national registry.

    PubMed

    Liew, S M; Khoo, E M; Ho, B K; Lee, Y K; Mimi, O; Fazlina, M Y; Asmah, R; Lee, W K; Harmy, M Y; Chinna, K; Jiloris, F D

    2015-07-01

    To determine treatment outcomes and associated predictors of all patients registered in 2012 with the Malaysian National Tuberculosis (TB) Surveillance Registry. Sociodemographic and clinical data were analysed. Unfavourable outcomes included treatment failure, transferred out and lost to follow-up, treatment defaulters, those not evaluated and all-cause mortality. In total, 21 582 patients were registered. The mean age was 42.36 ± 17.77 years, and 14.2% were non-Malaysians. The majority were new cases (93.6%). One fifth (21.5%) had unfavourable outcomes; of these, 46% died, 49% transferred out or defaulted and 1% failed treatment. Predictors of unfavourable outcomes were older age, male sex, foreign citizenship, lower education, no bacille Calmette-Guérin (BCG) vaccination scar, treatment in tertiary settings, smoking, previous anti-tuberculosis treatment, human immunodeficiency virus infection, not receiving directly observed treatment, advanced chest radiography findings, multidrug-resistant TB (MDR-TB) and extra-pulmonary TB. For all-cause mortality, predictors were similar except for rural dwelling and nationality (higher mortality among locals). Absence of BCG scar, previous treatment for TB and MDR-TB were not found to be predictors of all-cause mortality. Indigenous populations in East Malaysia had lower rates of unfavourable treatment outcomes. One fifth of TB patients had unfavourable outcomes. Intervention strategies should target those at increased risk of unfavourable outcomes and all-cause mortality.

  10. The Prospective Non-Interventional DACCORD Study in the National COPD Registry in Germany: design and methods.

    PubMed

    Kardos, Peter; Vogelmeier, Claus; Buhl, Roland; Criée, Carl-Peter; Worth, Heinrich

    2015-01-12

    A variety of large randomized controlled trials (RCT's) evaluating pharmacotherapy in chronic obstructive pulmonary disease (COPD) patients does exist. One of the drugs that has been tested is the new long-acting anticholinergic glycopyrronium bromide. As the generalizability of results from RCT's is questionable we designed a longitudinal, prospective non-interventional study (DACCORD) of two years duration plus two years extension with at least 6000 participants in approximately 500 primary and secondary care practices in Germany (within the new established COPD National Prospective Registry), to assess patient reported outcomes (PRO's), lung function, adherence and drug safety. To circumvent the hurdle of inappropriate COPD diagnosis in a non-interventional trial, patients have to fulfill the inclusion criteria of the COPD disease management program (DMP) of the German statutory health insurances. Patient management should follow the German national COPD guidelines, which are based on Global Initiative for Chronic Obstructive Lung Disease 2007 (GOLD) report. Labels of prescribed drugs should also be taken into account. Patients received treatment as part of their standard care: at the discretion of the investigator patients were included in one of two arms. A: standard care with glycopyrronium containing regimen, and arm B: standard care without glycopyrronium. For 2016 we expect important results regarding longitudinal development of PRO's including exacerbations, lung function, adherence and side effects. We also investigate applicability of the new GOLD staging system in usual care. Data on diagnostic and treatment modalities in current German primary and secondary care, as well as pharmaco-economic data will be generated. 1. German Register for non-interventional studies: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb . 2. EMA EnCePP http://www.encepp.eu/ .

  11. 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.

  12. Fabry disease in Argentina: an evaluation of patients enrolled in the Fabry Registry.

    PubMed

    Politei, J M; Cabrera, G; Amartino, H; Valdez, R; Masllorens, F; Ripeau, D; Antongiovanni, N; Soliani, A; Luna, P; Cedrolla, M; Fernandez, S; Fainboim, A

    2013-01-01

    Fabry disease (FD) is an X-linked inborn error of metabolism caused by alpha-galactosidase A deficiency. The Fabry Registry is an ongoing, global observational database that compiles clinical data from patients with FD. Demographic and baseline clinical characteristics of Fabry Registry patients enrolled in Argentina were analysed and compared with patients enrolled in the rest of the world (ROW). Baseline clinical parameters included chronic kidney disease (CKD) stage, urine protein-to-creatinine ratio and left ventricular posterior wall thickness. Only data from untreated patients were included. As of 1 October 2010, 3752 patients were enrolled in the Registry, 70 patients from Argentina and 3682 from the ROW. Argentinean male subjects were younger than Fabry Registry male subjects enrolled in ROW: mean current age 32.5 years vs. 39.0 years for men (p = 0.0257 by t-test). The current age (mean ± standard deviation) of female subjects enrolled in Argentina was not significantly different from that of female subjects enrolled in the ROW: 40.1 ± 17.28 vs. 43.2 ±17.95 years respectively (p = 0.2967). Overall, a smaller percentage of patients from Argentina received ERT compared with patients in the ROW (54% vs. 58% respectively). When evaluated by gender, more men and fewer women in Argentina received ERT compared with ROW (85% vs. 79% for men and 27% vs. 38% for women). A larger proportion of patients in ROW had severe CKD (stage 4 or 5) compared with Argentina (9.8% vs. 0%), most likely because of the older age of the ROW population. The enrolment of Argentinean patients into the Fabry Registry has steadily increased, as has the inclusion of female and paediatric patients with FD. The medical community in Argentina should be aware of FD in these populations, as awareness will facilitate prompt diagnosis and initiation of treatment, thus leading to improved outcomes. © 2012 Blackwell Publishing Ltd.

  13. Development of an Inflammatory Bowel Disease Research Registry Derived from Observational Electronic Health Record Data for Comprehensive Clinical Phenotyping.

    PubMed

    Anderson, Alyce J M; Click, Benjamin; Ramos-Rivers, Claudia; Babichenko, Dmitriy; Koutroubakis, Ioannis E; Hartman, Douglas J; Hashash, Jana G; Schwartz, Marc; Swoger, Jason; Barrie, Arthur M; Dunn, Michael A; Regueiro, Miguel; Binion, David G

    2016-11-01

    Inflammatory bowel disease (IBD) is a heterogeneous collection of chronic inflammatory disorders of the digestive tract. Clinical, genetic, and pathological heterogeneity makes it increasingly difficult to translate efficacy studies into real-world practice. Our objective was to develop a comprehensive natural history registry derived from multi-year observational data to facilitate effectiveness and clinical phenotypic research in IBD. A longitudinal, consented registry with prospectively collected data was developed at UPMC. All adult IBD patients receiving care at the tertiary care center of UPMC are eligible for enrollment. Detailed data in the electronic health record are accessible for registry research purposes. Data are exported directly from the electronic health record and temporally organized for research. To date, there are over 2565 patients participating in the IBD research registry. All patients have demographic data, clinical disease characteristics, and disease course data including healthcare utilization, laboratory values, health-related questionnaires quantifying disease activity and quality of life, and analytical information on treatment, temporally organized for 6 years (2009-2015). The data have resulted in a detailed definition of clinical phenotypes suitable for association studies with parameters of disease outcomes and treatment response. We have established the infrastructure required to examine the effectiveness of treatment and disease course in the real-world setting of IBD. The IBD research registry offers a unique opportunity to investigate clinical research questions regarding the natural course of the disease, phenotype association studies, effectiveness of treatment, and quality of care research.

  14. 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.

  15. 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.

  16. Drug therapies and the risk of malignancy in Crohn's disease: results from the TREAT™ Registry.

    PubMed

    Lichtenstein, Gary R; Feagan, Brian G; Cohen, Russell D; Salzberg, Bruce A; Diamond, Robert H; Langholff, Wayne; Londhe, Anil; Sandborn, William J

    2014-02-01

    We assessed potential associations between malignancy and antitumor necrosis factor therapy in patients with Crohn's disease (CD), as this relationship is currently poorly defined. Utilizing data from the Crohn's Therapy, Resource, Evaluation, and Assessment Tool (TREAT™) Registry, a prospective cohort study examining long-term outcomes of CD treatments in community and academic settings, influences of baseline patient/disease characteristics and medications were assessed by survival analysis and multivariate models. Standardized incidence ratios and exact 95 % confidence intervals were determined as the ratio of events observed (TREAT) vs. expected (general population of USA). As of 23 February 2010, 6,273 CD patients (infliximab during registry=3,420 (during or within 1 year before registry=3,764); other-treatments-only: 2,509), were enrolled and, on average, had been followed for 5.2/7.6 years, respectively, for all/currently active patients. Crude cancer incidences were similar between infliximab- and other-treatments-only-exposed patients. Multivariate Cox regression analysis demonstrated that baseline age (hazard ratio (HR)=1.59/10 years; P<0.001), disease duration (HR=1.64/10 years; P=0.012), and smoking (HR=1.38; P=0.045) but neither immunosuppressive therapy alone (HR=1.43; P=0.11), infliximab therapy alone (HR=0.59; P=0.16), nor their combination (HR=1.22, P=0.34) were independently associated with the risk of malignancy. When compared with the general population, no significant increase in incidence was observed in any malignancy category. In an exposure-based analysis, use of immunosuppressants alone (odds ratio=4.19) or in combination with infliximab (3.33) seemed to be associated with a numerically, but not significantly, greater risk of malignancy than did treatment with infliximab alone (1.96) relative to treatment with neither. In the TREAT Registry, age, disease duration, and smoking were independently associated with increased risk of

  17. 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

  18. Danish Prostate Cancer Registry – methodology and early results from a novel national database

    PubMed Central

    Helgstrand, JT; Klemann, N; Røder, MA; Toft, BG; Brasso, K; Vainer, B; Iversen, P

    2016-01-01

    Background Systematized Nomenclature of Medicine (SNOMED) codes are computer-processable medical terms used to describe histopathological evaluations. SNOMED codes are not readily usable for analysis. We invented an algorithm that converts prostate SNOMED codes into an analyzable format. We present the methodology and early results from a new national Danish prostate database containing clinical data from all males who had evaluation of prostate tissue from 1995 to 2011. Materials and methods SNOMED codes were retrieved from the Danish Pathology Register. A total of 26,295 combinations of SNOMED codes were identified. A computer algorithm was developed to transcode SNOMED codes into an analyzable format including procedure (eg, biopsy, transurethral resection, etc), diagnosis, and date of diagnosis. For validation, ~55,000 pathological reports were manually reviewed. Prostate-specific antigen, vital status, causes of death, and tumor-node-metastasis classification were integrated from national registries. Results Of the 161,525 specimens from 113,801 males identified, 83,379 (51.6%) were sets of prostate biopsies, 56,118 (34.7%) were transurethral/transvesical resections of the prostate (TUR-Ps), and the remaining 22,028 (13.6%) specimens were derived from radical prostatectomies, bladder interventions, etc. A total of 48,078 (42.2%) males had histopathologically verified prostate cancer, and of these, 78.8% and 16.8% were diagnosed on prostate biopsies and TUR-Ps, respectively. Future perspectives A validated algorithm was successfully developed to convert complex prostate SNOMED codes into clinical useful data. A unique database, including males with both normal and cancerous histopathological data, was created to form the most comprehensive national prostate database to date. Potentially, our algorithm can be used for conversion of other SNOMED data and is available upon request. PMID:27729813

  19. Implantable cardioverter defibrillators and Chagas' disease: results of the ICD Registry Latin America.

    PubMed

    Muratore, Claudio A; Batista Sa, Luiz A; Chiale, Pablo A; Eloy, Ricardo; Tentori, Maria Cristina; Escudero, Jaime; Lima, Antonio Malan Cavalcanti; Medina, Luis E; Garillo, Raúl; Maloney, Jennifer

    2009-02-01

    Chagas' disease is an endemic parasitic affliction in Latin America. It is frequently associated with ventricular tachyarrhythmia and sudden death. The aim of this study is to assess the evolution of patients with Chagas' disease treated with an implantable cardioverter defibrillator (ICD). Eighty-nine chagasic patients with ICD were included for analysis from the Medtronic ICD Registry Latin America. At implant, mean age was 59 +/- 10 years, and 72% were male. Eighty-one patients (91%) had secondary prevention indications. Mean left ventricular ejection fraction was 40 +/- 11%, and mean follow-up was 12 +/- 7 months. During follow-up, six patients died (6.7%); three due to congestive heart failure, one due to sudden death, and two due to non-cardiac cause. Hospitalization occurred in seven patients. Thirty-eight patients (42%) received appropriate ICD therapies. A total of 737 episodes were detected by the ICD. The mean period between ICD implantation and the first appropriate therapy was 104 days. Electrical storms were observed in 14 of the 89 patients (15.7%). Inappropriate therapies were observed in seven patients. This registry confirms that ICD therapy provides protection by effectively terminating life-threatening arrhythmias in patients with Chagas' disease. This is especially so when patients receive the device for secondary prevention.

  20. Recent Progress of the ARegPKD Registry Study on Autosomal Recessive Polycystic Kidney Disease

    PubMed Central

    Ebner, Kathrin; Schaefer, Franz; Liebau, Max Christoph; Eid, L. A.

    2017-01-01

    Autosomal recessive polycystic kidney disease (ARPKD) is a rare monogenic disease with a severe phenotype often presenting prenatally or in early childhood. With its obligate renal and hepatic involvement, ARPKD is one of the most important indications for liver and/or kidney transplantation in childhood. Marked phenotypic variability is observed, the genetic basis of which is largely unknown. Treatment is symptomatic and largely empiric as evidence-based guidelines are lacking. Therapeutic initiatives for ARPKD face the problem of highly variable cohorts and lack of clinical or biochemical risk markers without clear-cut clinical end points. ARegPKD is an international, multicenter, retro- and prospective, observational study to deeply phenotype patients with the clinical diagnosis of ARPKD. Initiated in 2013 as a web-based registry (www.aregpkd.org), ARegPKD enrolls patients across large parts of Europe and neighboring countries. By January 2017, more than 400 patients from 17 mostly European countries have been registered in the ARPKD registry study with significant follow-up data. Due to comprehensive retro- and prospective data collection and associated biobanking, ARegPKD will generate a unique ARPKD cohort with detailed longitudinal clinical characterization providing a basis for future clinical trials as well as translational research. Hence, ARegPKD is hoped to contribute to the pathophysiological understanding of the disease and to the improvement of clinical management. PMID:28296980

  1. 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

  2. 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

  3. Country to country variation: what can be learnt from national cystic fibrosis registries.

    PubMed

    Goss, Christopher Hooper

    2015-11-01

    This review will address the evolving science involving international comparisons of populations of persons living with cystic fibrosis. Understanding the current clinical outcomes in cystic fibrosis is critical prior to assessing such comparisons. Countries that differ in clinical approaches provide natural experiments to assess those approaches. Recent studies have highlighted that the population of persons with cystic fibrosis is changing; estimates predict a continued growth of cystic fibrosis populations with substantial increases in persons with cystic fibrosis who are adults. Additional work highlighted differences in subpopulations (i.e. children); US cystic fibrosis children appear to have better lung function, but similar nutritional status, compared to UK cystic fibrosis children. These differences were associated with differences in intensity of care, with a higher proportion of US children receiving more cystic fibrosis-specific therapies. Additional research raises important questions regarding potential sampling bias in different patient registries and differing rates of unconfirmed cases of cystic fibrosis. These and other limitations are highlighted. Differences in both demographics and clinical outcomes in cystic fibrosis between nations can be informative, but, like many types of observational research, are at risk of unrecognized bias. Despite this limitation, these comparisons can lead to substantive improvements in care in cystic fibrosis.

  4. 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

  5. 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.

  6. New-onset diabetes after liver transplantation: a national report from China Liver Transplant Registry.

    PubMed

    Ling, Qi; Xu, Xiao; Xie, Haiyang; Wang, Kai; Xiang, Penghui; Zhuang, Runzhou; Shen, Tian; Wu, Jian; Wang, Weilin; Zheng, Shusen

    2016-05-01

    New-onset diabetes after transplantation (NODAT) is a serious complication of liver transplantation (LT). The present study aimed to investigate the risk factors of NODAT by a national survey using the China Liver Transplant Registry database. A total of 10 204 non-pre-existing diabetic patients undergone primary LT between January 2000 and December 2013 were included. Risk factors were identified by logistic regression analysis. NODAT occurred in 24.3% of liver recipients with a median follow-up time of 2.6 years, and was associated with a significantly lower patient survival. NODAT increased not only diabetes related complications (e.g., infection, kidney failure) but also biliary stricture and cholangitis. NODAT patients who received hypoglycaemic treatment had a worse prognosis and a higher hepatocellular carcinoma recurrence compared with those without treatment. New-onset hyperglycaemia (<30 days) was the major predictor of NODAT. Other risk factors included cold ischaemia time >9 h, recipient age >50 years, body mass index >25 kg/m(2) , other hepatitis (mainly hepatitis C), post-transplant intensive care unit stay >15 days, cytomegalovirus infection and corticosteroid at discharge. The incidence of NODAT in China is similar to that in Western countries. However, the NODAT-related complications are more common and severer in China compared with those in Western countries. The major risk factors are different. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. The completeness of chest X-ray procedure codes in the Danish National Patient Registry

    PubMed Central

    Hjertholm, Peter; Flarup, Kaare Rud; Guldbrandt, Louise Mahncke; Vedsted, Peter

    2017-01-01

    Objective The aim of this validation study was to assess the completeness of the registrations of chest X-rays (CXR) in two different versions of the Danish National Patient Registry (DNPR). Material and methods We included electronic record data on CXR performed on patients aged 40 to 99 years from nine radiology departments covering 20 Danish hospitals. From each department, we included data from three randomly selected weeks between 2004 and 2011 (reference standard). In two versions of the DNPR from the State Serum Institute (SSI) and Statistics Denmark, respectively, we investigated the proportion of registered CXR compared to the reference standard. Furthermore, we compared the completeness of the recorded data according to the responsible department (main department). Results We identified 11,235 patients and 12,513 CXR in the reference standard. The data from the SSI contained 12,265 (98%) CXR, whereas the data from Statistics Denmark comprised 9,151 (73.1%) CXR. The completeness of the SSI data was fairly constant across years, radiology departments, medical specialties, and age groups. The data from Statistics Denmark was almost complete in 2011 (95.8%). However, for the remaining study period, the data with radiology departments registered as the main department were lacking in the version from Statistics Denmark, and so the overall completeness was 73.1%. Conclusion The completeness of CXR registrations varied between 98% and 73% depending on the information source, and this should be considered when investigating radiology services in the basis of DNPR. PMID:28293121

  8. Trends in antihypertensive treatment--lessons from the National Acute Stroke Israeli (NASIS) registry.

    PubMed

    Koifman, Edward; Tanne, David; Molshatzki, Noa; Leibowitz, Avshalom; Grossman, Ehud

    2014-10-01

    Recent guidelines recommended different approaches to hypertension therapy. Our aim was to evaluate trends in blood pressure (BP) management among patients admitted with acute stroke over the past decade. The study population comprised 6279 consecutive patients, admitted with an acute stroke, and included in a national registry of three consecutive periods conducted during the years 2004-2010. We compared patients' characteristics and temporal trends of antihypertensive therapy utilization before hospital admission. Among 4727 hypertensive patients, 3940 (83%) patients have taken antihypertensive drug therapy - 1430 (30.2%) a single agent, 1500 (31.7%) two agents and 1010 (21.4%) three or more antihypertensive agents. The most common class used was renin-angiotensin system (RAS) blockers (n = 2575; 54%) followed by beta-blockers (n = 2033; 43%). The same pattern was observed in patients treated with monotherapy. The use of RAS blockers and beta-blockers has increased over the years (p < 0.001 for both), whereas the use of diuretics decreased and the use of calcium antagonists remained stable. Among those who were treated with a single agent, the use of diuretics and calcium antagonists decreased and the use of RAS blockers increased, whereas the use of beta-blockers remained unchanged. RAS blockers and beta-blockers are the most common antihypertensive agents used in Israel. Over time, the use of RAS blockers and beta-blockers has increased, whereas the use of diuretics decreased.

  9. The Japan Thrombosis Registry for Atrial Fibrillation, Coronary or Cerebrovascular Events (J-TRACE): a nation-wide, prospective large cohort study; the study design.

    PubMed

    Origasa, Hideki; Goto, Shinya; Uchiyama, Shinichiro; Shimada, Kazuyuki; Ikeda, Yasuo

    2008-06-01

    A previous history of myocardial infarction (MI), stroke, and the presence of atrial fibrillation (AF) are known risk factors for the onset of arterial thromboembolic events such as MI and ischemic stroke. To clarify the rate of incidence of such events for these high-risk patients in Japan, a nation-wide cohort study was conducted that was named the 'Japan Thrombosis Registry of Atrial Fibrillation, Coronary and Cerebrovascular Events' (ie, J-TRACE) [UMIN Registered ID C000000189]. In the J-TRACE registry, a total of 8,093 Japanese patients with either a history of stroke and/or MI or patients with non-valvular AF were registered. This registry was developed by specialists in cardiology and neurology, physicians working at general hospitals, as well as general practice physicians, from whole regions of Japan, possibly reflecting the real-world medical practice. Recruited patients will be followed up for 2-3 years. Medical history, accompanying risk factors, demographic characteristics, and information regarding the use of medications were collected for these patients at baseline. Cardiovascular ischemic events and serious adverse experiences, including cerebral bleedings, which occur during the follow-up period will be recorded over a maximum of 3 years. The J-TRACE offers an opportunity to provide fundamental information regarding the incidence of cardiovascular ischemic events by a stratum of the risk factor profile and current medical treatment for Japanese patients at high risk for thromboembolic diseases.

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

    PubMed Central

    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

    Background Tuberculosis (TB) remains a public health problem in Mexico while the incidence of diabetes mellitus type 2 (DM) has increased rapidly in recent years. Objective 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. Materials and Methods 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. Results 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. Conclusion 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. PMID:26075393

  11. Incidence of acute myocardial infarction in Islamic Republic of Iran: a study using national registry data in 2012.

    PubMed

    Ahmadi, A; Soori, H; Mehrabi, Y; Etemad, K; Samavat, T; Khaledifar, A

    2015-02-25

    Population-based data on myocardial infarction rates in the Islamic Republic of Iran have not been reported on a national or provincial scale. In a cross-sectional study, data were collected on 20 750 new cases of myocardial infarction (ICD10 codes I21-22) admitted to hospitals and registered by the Iranian Myocardial Infarction Registry in 2012. The crude and age-adjusted incidence for the 31 provinces and the whole country were directly calculated per 100 000 people using the WHO standard population. Overall, males comprised 72.4% of cases and had a significantly lower mean age at incidence than women [59.6 (SD 13.3) years versus 65.4 (SD 12.6) years]. The male:female incidence ratio was 2.63. The age-standardized myocardial infarction incidence rate was 73.3 per 100 000 in the whole country (95% CI: 72.3%-74.3%) and varied significantly from 24.5 to 152.5 per 100 000 across the 31 provinces. The study provides baseline data for monitoring and managing cardiovascular diseases in the country.

  12. 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.

  13. 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.

  14. Management and risk factor control of coronary artery disease in elderly versus nonelderly: a multicenter registry.

    PubMed

    Phrommintikul, Arintaya; Krittayaphong, Rungroj; Wongcharoen, Wanwarang; Boonyaratavej, Smonporn; Wongvipaporn, Chaiyasith; Tiyanon, Woraporn; Dinchuthai, Pakaphan; Kunjara-Na-Ayudhya, Rapeephon; Tatsanavivat, Pyatat; Sritara, Piyamitr

    2016-12-01

    Coronary artery disease (CAD) is a leading cause of death in elderly because aging is the important non-modifiable risk factors of atherosclerosis and also a predictor of poor outcomes. Underuse of guideline directed therapy may contribute to suboptimal risk factor control and worse outcomes in the elderly. We aimed to explore the management of CAD, risk factors control as well as goal attainment in elderly compared to nonelderly CAD patients. The CORE-Thailand is an ongoing multicenter, prospective, observational registry of patients with high atherosclerotic risk in Thailand. The data of 4120 CAD patients enrolled in this cohort was analyzed comparing between the elderly (age ≥ 65 years) vs. nonelderly (age < 65 years). There were 2172 elderly and 1948 nonelderly patients. The elderly CAD patients had higher prevalence of hypertension, dyslipidemia, atrial fibrillation and chronic kidney disease. The proportion of patients who received coronary revascularization was not different between the elderly and nonelderly CAD patients. Antiplatelets were prescribed less in the elderly while statin was prescribed in the similar proportion. Goal attainments of risk factor control of glycemic control, low density lipoprotein cholesterol, and smoking cessation except the blood pressure goal were higher in the elderly CAD patients. The CORE-Thailand registry showed the equity in the treatment of CAD between elderly and non-elderly. Elderly CAD patients had higher rate of goal attainment in risk factor control except blood pressure goal. The effects of goal attainment on cardiovascular outcomes will be demonstrated from ongoing cohort.

  15. Establishment of a Population-based Registry of Inflammatory Bowel Diseases in Fars Province, Iran.

    PubMed

    Taghavi, Seyed Alireza; Bagheri Lankarani, Kamran; Moini, Maryam; Hamidpour, Laleh; Ardebili, Maryam; Mansoorabadi, Zahra

    2012-04-01

    BACKGROUND Inflammatory bowel diseases (IBD) are debilitating diseases that lead to a variety of problems in a patient's daily life and are a huge burden for the health care system. Since this group of diseases are multifactorial and complex, long-term longitudinal studies are clearly needed to understand them better. A population-based registry (IBD-FaR) has been established in Fars, a southern Iranian province, with the intent to create a reliable data source. This registry will be of considerable help in future planning of health care resources necessary to deal with IBD and to enable investigators to test their theories on the origin and/or treatment of IBD. METHODS This registry is managed by both the Gastroenterohepatology Research Center and Health Policy Research Center at Shiraz University of Medical Sciences. A governing committee is responsible for decisions regarding budget allocations and use of data. The designed questionnaire includes a consent form, basic history data, risk factors, related procedures, medical therapy, and follow-up data. The establishment process has two parallel phases: in the first phase, data is collected from numerous sources, including annual hospital discharge data, referral from university affiliated physicians and private practices, pathologic reports, death certificates, self-referral, and insurance system data. In the interview, the questionnaire is completed and blood samples are taken. The gathered data are entered in a custom-designed, computerized data base. In the second phase, annual follow up interviews will be conducted. New IBD patients are also being registered. This phase will continue indefinitely, in order to include new incident cases. RESULTS Briefly, from May 2011 until December 2011, there were 188 patients [94 (50%) females and 94 (50%) males] diagnosed with IBD who were registered in IBD-FaR. Patients' age range was between 15 and 80 years. A total of 164 (87.2%) patients out of 188 were registered as

  16. National Transplants Registry in Poland: Early and Long-term Results of Organ Transplantations in the Years 1998 to 2014.

    PubMed

    Czerwiński, J; Antoszkiewicz, K; Grygiel, K; Karpeta, E; Górski, Ł; Dudkiewicz, M; Lewandowska, D

    2016-06-01

    In 2006, the National Transplants Registry, administered by the national transplant organization, was introduced in Poland for monitoring the results of organ transplantations. Statistical analysis is published yearly in Poltransplant Bulletin and publicly available on the website and reported to European institutions. The Transplants Registry cooperates with another registers functioning on-line, based on the web-net tool www.rejestry.net. We present the formal analysis of data collected for the years 1998 to 2014. Analysis covered the total number of organ transplantations in every transplant center; outcomes after 3 months and 1, 3, and 5 years; and if data were available after 10, 15, and 20 years from transplantation. Results presented are real, not extrapolated. Some examples are as follows. The total number of deceased kidney transplantations was 15,009; 1-year recipient survival was 95%, graft survival was 88% (data completeness of 81%), 5-year recipient survival was 87%, and graft survival was 74% (data completeness of 82%). The total number of deceased liver transplantations was 3143; 1-year recipient survival was 84%, graft survival was 81% (data completeness of 99%), 5-year recipient survival was 73%, and graft survival was 89% (data completeness of 99%). The National Transplant Registry is an important tool for quality and safety systems in the transplantation field on the national level. Nowadays, the Registry efficiently and effectively fulfills its tasks related to collecting records of all performed transplantations. Monitoring function for graft and recipient survival is also satisfied. Collected numbers are an important and unique source of information to be used by transplant institutions and referred to in the literature. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Multicenter Cohort Study of Acute Myocardial Infarction in Korea - Interim Analysis of the Korea Acute Myocardial Infarction Registry-National Institutes of Health Registry.

    PubMed

    Kim, Ju Han; Chae, Shung-Chull; Oh, Dong Joo; Kim, Hyo-Soo; Kim, Young Jo; Ahn, Youngkeun; Cho, Myeong Chan; Kim, Chong Jin; Yoon, Jung-Han; Park, Hyun-Young; Jeong, Myung Ho

    2016-05-25

    The Korea Acute Myocardial Infarction Registry (KAMIR)-National Institutes of Health (NIH) registry has the aim of evaluating the clinical characteristics, management, and long-term outcomes of patients with acute myocardial infarction (AMI) in Korea. Patients hospitalized for AMI in 20 tertiary university hospitals in Korea have been enrolled since November 2011. The study is expected to complete the scheduled enrollment of approximately 13,000 patients in October 2015, and follow-up duration is up to 5 years for each patient. As of October 2015, an interim analysis of 13,623 subjects was performed to understand the baseline clinical profiles of the study population. The mean age was 64.1 years; 73.5% were male; and 48.2% were diagnosed with ST-segment elevation AMI. Hypertension is a leading cause of AMI in Korea (51.2%), followed by smoking (38.5%) and diabetes mellitus (28.6%). Percutaneous coronary intervention was performed in 87.4% and its success rate was very high (99.4%). In-hospital, 1-year, and 2-year mortality rates were 3.9%, 4.3%, and 8.6%, respectively. The rates of major adverse cardiac events at 1 and 2 years were 9.6% and 18.8%, respectively. This analysis demonstrated the clinical characteristics of Korean AMI patients in comparison with those of other countries. It is necessary to develop guidelines for Asian populations to further improve their prognosis. (Circ J 2016; 80: 1427-1436).

  18. Autoimmune diseases induced by biological agents. A review of 12,731 cases (BIOGEAS Registry).

    PubMed

    Pérez-De-Lis, Marta; Retamozo, Soledad; Flores-Chávez, Alejandra; Kostov, Belchin; Perez-Alvarez, Roberto; Brito-Zerón, Pilar; Ramos-Casals, Manuel

    2017-09-07

    Biological drugs are therapies designed to target a specific molecule of the immune system that have been linked with the development of autoimmune diseases. Areas covered: The BIOGEAS Registry currently collects information about nearly 13,000 reported cases of autoimmune diseases developed in patients exposed to biologics, including more than 50 different systemic and organ-specific autoimmune disorders, of which psoriasis (n=6375), inflammatory bowel disease (n=845), demyelinating CNS disease (n=803), interstitial lung disease (n=519) and lupus (n=369) were the most frequently reported. The main biologics involved were anti-TNF agents in 9133 cases (adalimumab in 4154, infliximab in 3078 and etanercept in 1681), immune checkpoint inhibitors in 913 (ipilimumab in 524 and nivolumab in 225), B-cell targeted therapies in 741 (rituximab in 678), and growth factor inhibitors in 549 cases (bevacizumab in 544). Even though targeting a particular immune molecule may be associated with an excellent clinical response in most patients, an unexpected autoimmune disease may arise in around 8 out of 10,000 exposed patients. Expert opinion: Following the increased use of biologics, the number and diversity of induced autoimmune diseases is increasing exponentially. Management of these disorders will be an increasing clinical challenge in the daily practice in the next years.

  19. [Percutaneous cardiovascular intervention procedures in Brazil (1992-1993). Report of the National Registry-National Center for Cardiovascular Interventions].

    PubMed

    Sousa, A G

    1994-04-01

    To report the data on the first 2 years (1992-1993) of activity of the National Registry of Cardiovascular Interventions (CENIC) of the Hemodynamic and Angiography Department (DHA) of the Brazilian Society of Cardiology (SBC). The full members of the DHA of the SBC sent their data on seven types of interventions: balloon angioplasty (PTCA), mitral balloon valvoplasty (MBV), pulmonary balloon valvoplasty (PBV), aortic balloon valvoplasty (ABV), tricuspid balloon valvoplasty (TBV), aortic balloon dilation (AoB) and balloon dilation of pulmonary branches (PBB), to the CENIC. Ninety-seven interventional cardiologists and 71 hospitals in 14 states, participated in this data bank. During this time, 16,429 PTCA, 551 MBV, 347 PBV, 62 ABV, 61 AoB, 3 TBV and 3 PBB were registered. PTCA was therefore the most performed procedure (94%); primary success rate was 89.7%. As for the major complications, there were 2.5% acute myocardial infarction; 0.8% emergency bypass surgery and 1.8% death. As for the other interventions, the primary success rate was 92.9% for MBV, 88.5% for PBV, 80.3% for AoB, 72.6% for ABV, 66.7% for TBV with 0.54% deaths for MBV patients and 3.23% for ABV patients. The performance of the interventional cardiology in Brazil reflects the difusion of intervention methods in the main hospitals of the country. The results demonstrate a high efficacy and safety rate, characterizing an excellent performance.

  20. Patient perspectives on switching disease-modifying therapies in the NARCOMS registry

    PubMed Central

    Salter, Amber R; Marrie, Ruth Ann; Agashivala, Neetu; Belletti, Daniel A; Kim, Edward; Cutter, Gary R; Cofield, Stacey S; Tyry, Tuula

    2014-01-01

    Introduction The evolving landscape of disease-modifying therapies (DMTs) for multiple sclerosis raises important questions about why patients change DMTs. Physicians and patients could benefit from a better understanding of the reasons for switching therapy. Purpose To investigate the reasons patients switch DMTs and identify characteristics associated with the decision to switch. Method The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry conducted a supplemental survey among registry participants responding to the 2011 update survey. The supplemental survey investigated reasons for switching DMT, origin of the discussion of DMT change, and which factors influenced the decision. Chi-square tests, Fisher’s exact tests, and logistic regression were used for the analyses. Results Of the 691 eligible candidates, 308 responded and met the inclusion criteria (relapsing disease course, switched DMT after September 2010). The responders were 83.4% female, on average 52 years old, with a median (interquartile range) Patient-Determined Disease Steps score of 4 (2–5). The most recent prior therapy included first-line injectables (74.5%), infusions (18.1%), an oral DMT (3.4%), and other DMTs (4.0%). The discussion to switch DMT was initiated almost equally by physicians and participants. The primary reason for choosing the new DMT was based most frequently on physician’s recommendation (24.5%) and patient perception of efficacy (13.7%). Conclusion Participants frequently initiated the discussion regarding changing DMT, although physician recommendations regarding the specific therapy were still weighed highly. Long-term follow-up of these participants will provide valuable information on their disease trajectory, satisfaction with, and effectiveness of their new medication. PMID:25045254

  1. Translational research network and patient registry for auto-inflammatory diseases.

    PubMed

    Lainka, Elke; Bielak, Maria; Hilger, Volker; Basu, Oliver; Neudorf, Ulrich; Wittkowski, Helmut; Holzinger, Dirk; Roth, Johannes; Niehues, Tim; Foell, Dirk

    2011-01-01

    Auto-inflammatory diseases (AIDs) are characterized by recurrent self-limiting systemic inflammation. In a multicentre effort, we set out to register genetic, epidemiological and clinical features as well as prognostic factors of these diseases by prospective longitudinal and long-term documentation, in order to define novel AIDs and to better understand treatment responses and outcome. In 2009, a federally funded clinical and research consortium (AID-Net) was established, including an online registry for AIDs (http://www.aid-register.uk-essen.de). Inclusion criteria are disease-associated mutations for hereditary periodic fever syndromes [FMF, hyperimmunoglobulinaemia D and periodic fever syndrome (HIDS), TNF receptor 1-associated periodic syndrome (TRAPS) and cryopyrin-associated periodic syndrome (CAPS)], or, alternatively, clinically confirmed AID, systemic-onset JIA (SoJIA) and periodic fever, aphthous stomatitis, pharyngitis and adenopathy (PFAPA) syndrome with unknown genetic background. Patients were recruited to the registry and patient material was deposited in biomaterial banks (DNA/serum). In addition, basic research projects were initiated that focus on molecular mechanisms of AID. During the first 9 months, 117 patients (65 males, 52 females; age 1-21 years) have been recorded and classified as FMF (n=84), HIDS (n=1), TRAPS (n=3) and CAPS (n=1); clinically confirmed AID (n=5); SoJIA (n=22); and PFAPA (n=1). One hundred and fifty blood samples of 18 patients were included in biomaterial banks. Recruitment and follow-up of patients with AID will enable us to comprehensively address the correlation between clinical and epidemiological data, genetics and biomarkers. The translational approach may help to identify genetic or inflammatory markers relevant for the course and outcome of diseases.

  2. MR enterography in children with Crohn disease: results from the Belgian pediatric Crohn registry (Belcro).

    PubMed

    Alliet, P; Desimpelaere, J; Hauser, B; Janssens, E; Khamis, J; Lewin, M; De Greef, E; Smets, F; Paquot, I; Veereman, G; Souverijns, G

    2013-03-01

    Magnetic Resonance enterography (MRE) is an imaging modality avoiding ionizing radiation and the discomfort associated with enteroclysis. The results of MRE at diagnosis in the patients of the Belgian pediatric Crohn registry (Belcro) are compared to endoscopical and histological results. Results of MRE, endoscopy and histology were obtained from the medical charts and assigned to one of the following segments: jejunum, ileum, ascending colon, transverse colon, descending colon or rectosigmoid. MRE images were reviewed in a blinded way by 4 radiologists with specific interest in pediatric MRE. From the Belcro registry, twenty-two patients underwent a MRE during their work-up for Crohn disease. The results of endoscopy, histology and MRE were concordant (either all negative or positive) in the ileum in 16/18 patients and in the rectosigmoid, descending colon, transverse colon and ascending colon in resp 9, 8, 8 and 8/22 patients. In the non-concordant cases (MRE colon negative but endoscopy and/or histology positive), MRE could not reflect the subtle endoscopic or histologic lesions such as erosions that were described.In 4 cases where ileocaecal valve intubation was impossible ileal MRE findings were abnormal. MRE detected ileal stenosis, jejunal lesions and fistula in resp 4/22, 3/22 en 2/22 patients. The 100% and 75% interobserver agreement was resp 50-82% and 773-100% according to the different intestinal segments. MRE is a promising imaging modality avoiding radiation in Crohn disease. It should probably become the technique of first choice for the evaluation of extensive small bowel disease in children with Crohn disease.

  3. Effect of paramedic student internship on performance on the National Registry Written Exam.

    PubMed

    Salzman, Josh; Dillingham, Justin; Kobersteen, Jenny; Kaye, Koren; Page, David

    2008-01-01

    Paramedic students are exposed to numerous patient contacts during their required internship experience. There is no current research examining paramedic student internship experience in relation to performance on the written portion of the National Registry Exam (NRE-W). METHODS. A retrospective review from 2001 to 2006 of student records from FISDAP was completed. Three hundred ninety-six students met the inclusion criteria: 1) graduate of a paramedic program, 2) consent to access data, 3) internship data previously verified, and 4) NRE-W results available. Pearson correlation coefficients were used to determine if the number of advanced life support (ALS) runs (run with an i.v. and ECG, or one medication administered), hospital patient contacts (PCs), field PCs, total PCs (hospital PCs + field PCs), student team lead runs (TLs), in-hospital clinical hours, field internship hours, or total hours (in-hospital clinical hours + field internship hours) were associated with passing the NRE-W. Logistic regression was used to determine predictors of success on the NRE-W. The number of ALS runs and total PCs were the only variables associated with passing the NRE-W (p=0.003, 95% CI 0.05-0.24; p=0.047, 95% CI=0.00-0.20, respectively). These variables were also predictors for passing the NRE-W (OR = 1.015, 95% CI 1.005-1.025; OR=0.003, 95% CI 1.000-1.006, respectively). In this sample, the number of ALS runs students completed was the strongest clinical and field internship predictor of passing the NRE-W. The number of ALS runs and total PCs paramedic students complete need to be evaluated by paramedic programs.

  4. 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.

  5. Impact of screening versus symptomatic measurement of deep vein thrombosis in a national quality improvement registry.

    PubMed

    De Martino, Randall R; Beck, Adam W; Edwards, Matthew S; Corriere, Matthew A; Wallaert, Jessica B; Stone, David H; Cronenwett, Jack L; Goodney, Philip P

    2012-10-01

    Deep vein thrombosis (DVT) is a quality measure recorded by initiatives such as the National Surgical Quality Improvement Program (NSQIP). However, because surveillance-detected DVT rates may be higher than symptomatic DVT rates, we examined how differences in the method of DVT detection may affect the use of this quality measure. Using the NSQIP database (2007-2009), we compared DVT rates of vascular (amputation, open aortic procedures, and lower extremity bypass) and nonvascular (prostatectomy, gastric bypass [GBP], and hip arthroplasty) operations. Using a predefined literature search strategy, we compared the incidence of DVT in NSQIP to the incidence of DVT reported in published literature, diagnosed by symptomatic status or by surveillance studies. Within NSQIP, the overall incidence of postoperative DVT was 0.7%. This varied from 0.3% after GBP to 1.8% after open aortic surgery. Across all procedures except amputation, the incidence of DVT in NSQIP was similar to the incidence of DVT reported in our literature survey of "symptomatic" DVTs. The relative rate (RR) of literature-derived symptomatic DVTs to NSQIP ranged from 0.7 for aortic cases (95% confidence interval [CI], 0.3-1.7) to 1.4 (95% CI, .7-3.1) for GBP. Overall, surveillance studies had 11.6 higher RR of DVT compared to NSQIP (95% CI, 10.5-13), ranging from 2.6 for GBP (95% CI, 1.4-5) to 14 .5 for hip arthroplasty (95% CI, 10.5-20). The incidence of DVT reported in NSQIP is similar to the reported incidence of symptomatic DVT for many high-risk procedures but is much lower than rates of DVT reported in surveillance studies. Clear delineation of symptomatic vs surveillance detection of DVT would improve the usefulness of this measurement in quality improvement registries. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  6. Validity of the Prescriber Information in the Danish National Prescription Registry.

    PubMed

    Rasmussen, Lotte; Valentin, Julie; Gesser, Katarina Margareta; Hallas, Jesper; Pottegård, Anton

    2016-10-01

    The aim of this study was to measure the validity of the prescriber information recorded in the Danish National Prescription Registry (DNPR). The prescriber information recorded in the pharmacies' electronic dispensing system was considered to represent the prescriber information recorded in the DNPR. Further, the problem of validity of the prescriber information pertains only to non-electronic prescriptions, as these are manually entered into the dispensing system. The recorded prescriber information was thus validated against information from a total of 2000 non-electronic prescriptions at five Danish community pharmacies. The validity of the recorded prescriber information was measured at the level of the individual prescriber and the prescriber type, respectively. The proportion of non-electronic prescriptions with incorrect registrations was 22.4% (95% confidence interval (CI): 20.6-24.3) when considering individual prescriber identifiers and 17.8% (95% CI: 16.1-19.5) when considering prescriber type. When excluding prescriptions specifically registered as 'missing prescriber identifier', the proportions decreased to 9.5% (95% CI: 8.2-11.0) and 4.1% (95% CI: 3.2-5.1), respectively. The positive predictive values for the classification of prescriber types were in the range of 94.0-99.2%, while the sensitivity ranged between 64.6% and 91.8%. With a maximum of 14% non-electronic prescriptions of all prescriptions in the DNPR in 2015, this corresponds to correct classification of prescriber types in the DNPR of at least 97.5%. In conclusion, the prescriber information in the DNPR was found to be valid, especially in recent years. Researchers should be aware of the low sensitivity towards prescriptions from private practicing specialists.

  7. Heterogeneity in Trauma Registry Data Quality: Implications for Regional and National Performance Improvement in Trauma.

    PubMed

    Dente, Christopher J; Ashley, Dennis W; Dunne, James R; Henderson, Vernon; Ferdinand, Colville; Renz, Barry; Massoud, Romeo; Adamski, John; Hawke, Thomas; Gravlee, Mark; Cascone, John; Paynter, Steven; Medeiros, Regina; Atkins, Elizabeth; Nicholas, Jeffrey M

    2016-03-01

    Led by the American College of Surgeons Trauma Quality Improvement Program, performance improvement efforts have expanded to regional and national levels. The American College of Surgeons Trauma Quality Improvement Program recommends 5 audit filters to identify records with erroneous data, and the Georgia Committee on Trauma instituted standardized audit filter analysis in all Level I and II trauma centers in the state. Audit filter reports were performed from July 2013 to September 2014. Records were reviewed to determine whether there was erroneous data abstraction. Percent yield was defined as number of errors divided by number of charts captured. Twelve centers submitted complete datasets. During 15 months, 21,115 patient records were subjected to analysis. Audit filter captured 2,901 (14%) records and review yielded 549 (2.5%) records with erroneous data. Audit filter 1 had the highest number of records identified and audit filter 3 had the highest percent yield. Individual center error rates ranged from 0.4% to 5.2%. When comparing quarters 1 and 2 with quarters 4 and 5, there were 7 of 12 centers with substantial decreases in error rates. The most common missed complications were pneumonia, urinary tract infection, and acute renal failure. The most common missed comorbidities were hypertension, diabetes, and substance abuse. In Georgia, the prevalence of erroneous data in trauma registries varies among centers, leading to heterogeneity in data quality, and suggests that targeted educational opportunities exist at the institutional level. Standardized audit filter assessment improved data quality in the majority of participating centers. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  8. Socioeconomic Status and the Quality of Acute Stroke Care: The China National Stroke Registry.

    PubMed

    Pan, Yuesong; Chen, Ruoling; Li, Zixiao; Li, Hao; Zhao, Xingquan; Liu, Liping; Wang, Chunxue; Wang, Yilong; Wang, Yongjun

    2016-11-01

    The association of socioeconomic status (SES) with quality of stroke care is not well understood, and few studies have examined the association with different indicators of SES simultaneously. We assessed the impacts of low levels of education, occupation, and income on the quality of stroke care. We examined data from the China National Stroke Registry recording consecutive stroke patients between September 2007 and August 2008. Baseline low SES was measured using educational level <6 years, occupation as manual workers or no job, and average family income per capita at ≤¥1000 per month. Compliance with 11 performances was summarized in a composite score defined as the proportion of all needed care given. Poor quality of care was defined as having a composite score of 0.71 or less. Among 12 270 patients with ischemic stroke, 38.6% had <6 educational years, 37.6% had manual workers/no job, and 34.7% had income ≤¥1000 per month. There was an increased chance of receiving poor quality of care in patients with low education (adjusted odds ratio 1.15, 95% confidence interval 1.03-1.28), low occupation (adjusted odds ratio 1.16, 95% confidence interval 1.01-1.32), and low income (adjusted odds ratio 1.18, 95% confidence interval 1.06-1.30), respectively. People with low SES had poor performances on some aspects of care quality. Combined effects existed among these SES indicators; those with low SES from all 3 indicators had the poorest quality of care. There was a social gradient in the quality of stroke care. Continuous efforts of socioeconomic improvement will increase the quality of acute stroke care. © 2016 American Heart Association, Inc.

  9. [Risk stratified in the National Registry of Acute Coronary Syndromes at the IMSS].

    PubMed

    Borrayo-Sánchez, Gabriela; Madrid-Miller, Alejandra; Arriaga-Nava, Roberto; Ramos-Corrales, Marco Antonio; García-Aguilar, Jorge; Almeida-Gutiérrez, Eduardo

    2010-01-01

    to identify prognostic factors in the National Registry of Acute Coronary Syndromes. patients in medical care units with acute ischemic coronary syndrome (AICS) according to the criteria of the American Heart Association/American College of Cardiology/European Society of Cardiology, considering the GRACE score (GS) were studied. there were 2389 patients, 28.9 % women and 71.1 % men, mean age 63 ± 11.7 years; with AICS with ST-segment elevation (69.11 %) and 30.89 % with AICS without ST elevation. The average of GS was 168. A GS > 150 points in patients with AICS without ST elevation was associated with recurrent ischemia or angina (RR = 1.4, p = 0.05), left ventricular failure (RR = 3.1, p < 0.0001), stroke (RR = 2.9, p = 0.004) and arrhythmias (RR = 2.7, p < 0.0001). The patients with AICS with ST-segment elevation were associated with death (RR = 1.6, p = 0.01), reinfarction (RR = 1.7, p = 0.001), recurrent ischemia (RR = 1.2, p = 0.04), left ventricular failure (RR = 3.4, p < 0.001), stroke (RR = 3.9, p < 0.001) and arrhythmias (RR = 2.3, p < 0.001). Fibrinolytic therapy was used in 40.2 %. There was a negative correlation between GS and fibrinolytic therapy (r -0.04, p = 0.04). the AICS with ST-segment elevation is more frequent and have a high GS.

  10. EHR-based disease registries to support integrated care in a health neighbourhood: an ontology-based methodology.

    PubMed

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

    2014-01-01

    Disease registries derived from Electronic Health Records (EHRs) are widely used for chronic disease management. 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 accurately identify patients in an EHR or data repository, assess data quality and fitness for use by the multidisciplinary integrated care team. We report on this approach with routinely collected data in a practice based research network in Australia.

  11. Cost of care for cystic fibrosis: an investigation of cost determinants using national registry data.

    PubMed

    Gu, Yuanyuan; García-Pérez, Sonia; Massie, John; van Gool, Kees

    2015-09-01

    Cystic fibrosis (CF) is a progressive disease with treatments intensifying as patients get older and severity worsens. To inform policy makers about the cost burden in CF, it is crucial to understand what factors influence the costs and how they affect the costs. Based on 1,060 observations (from 731 patients) obtained from the Australian Data Registry, individual annual health care costs were calculated and a regression analysis was carried out to examine the impact of multiple variables on the costs. A method of retransformation and a hypothetical patient were used for cost analysis. We show that an additional one unit improvement of FEV1pp (i.e., forced expiratory volume in 1 s as a percentage of predicted volume) reduces the costs by 1.4%, or for a hypothetical patient whose FEV1pp is 73 the cost reduction is A$252. The presence of chronic infections increases the costs by 69.9-163.5% (A$12,852-A$30,047 for the hypothetical patient) depending on the type of infection. The type of CF genetic mutation and the patient's age both have significant effects on the costs. In particular, being homozygous for p.F508del increases the costs by 26.8% compared to all the other gene mutations. We conclude that bacterial infections have a very strong influence on the costs, so reducing both the infection rates and the severity of the condition may lead to substantial cost savings. We also suggest that the patient's genetic profile should be considered as an important cost determinant.

  12. National Vascular Registry Report on surgical outcomes and implications for vascular centres.

    PubMed

    Sidloff, D A; Gokani, V J; Stather, P W; Choke, E; Bown, M J; Sayers, R D

    2014-05-01

    The National Vascular Registry Report on Surgical Outcomes (NVSRO) coincided with the update of the National Health Service Standard Contract for Specialized Vascular Services in Adults (NHSSCSVS). The latter promises patients minimum standards for vascular centres. The present study aimed to determine whether current data support the standards proposed in the NHSSCSVS. Numbers of abdominal aortic aneurysm (AAA) repairs and carotid endarterectomies (CEAs) performed by hospital Trust and surgeon, and their outcomes were obtained from the NVRSO. These were assessed against NHSSCSVS recommendations that included: more than 60 AAA repairs per year per Trust, over 50 CEAs per year per Trust and at least six vascular surgeons per Trust. Based on NVRSO data, 107 hospital Trusts (92.2 per cent) would fail to meet the minimum standards required to achieve vascular centre status. Outcomes were poorer in these hospitals (overall mortality rate after AAA: 2.7 versus 1.3 per cent; P = 0.007). There were strong associations between number of AAA repairs or CEAs per Trust and better outcomes (AAA repair, P < 0.001; CEA, P = 0.004). These remained significant when analysed by individual surgeon (AAA repair, P < 0.001; CEA, P < 0.001). Trusts undertaking 60 or fewer elective AAA repairs per year had significantly higher elective AAA mortality rates (2.7 versus 1·7 per cent; P = 0.010). Trusts performing a minimum of 50 CEAs per year had significantly lower perioperative mortality/morbidity rates (1.9 versus 3.0 per cent; P = 0.032). Trusts with seven or more surgeons demonstrated lower AAA-related mortality rates (1.7 versus 2.7 per cent; P = 0.018). Data from the NVRSO suggest that the majority of hospital Trusts presently fail to meet the standards for vascular centre status. NVRSO data support a standard of more than 60 elective AAA repairs and 50 CEAs per Trust per year. A minimum of seven vascular surgeons per unit was associated with better outcomes

  13. Children with early-onset inflammatory bowel disease (IBD): analysis of a pediatric IBD consortium registry.

    PubMed

    Heyman, Melvin B; Kirschner, Barbara S; Gold, Benjamin D; Ferry, George; Baldassano, Robert; Cohen, Stanley A; Winter, Harland S; Fain, Patricia; King, Chris; Smith, Terry; El-Serag, Hashem B

    2005-01-01

    To determine the characteristics of inflammatory bowel disease (IBD) in young patients. Uniform data were collected from a cohort of patients with IBD who were enrolled from January 2000 to November 2002 at six pediatric centers (Pediatric IBD Consortium). Of 1370 children in the registry, the mean age at IBD diagnosis was 10.3 +/- 4.4 years; 54% were male, and 86% were white. Diagnosis was confirmed in 87 (6.1%) under 3 years of age, 211 (15.4%) before 6 years, 654 (47.7%) at 6 to 12 years, and 505 (36.9%) at 13 to 17 years. More than 63% of children younger than 8 years of age had isolated colonic disease, whether Crohn disease, ulcerative colitis (UC), or indeterminate colitis. Conversely, only 35% of those 8 years of age or older had isolated colonic disease ( P < .0001). Overall, 29% had one or more family members with IBD. The subgroup of children younger than 3 years of age with UC had the highest prevalence of first-degree relatives with IBD (44%). This demographically diverse pediatric IBD cohort revealed age-related variation in the distribution of IBD phenotype, with a high prevalence of isolated colonic disease in young children. Positive family history was especially common in young patients with UC.

  14. 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.

  15. A Registry Framework Enabling Patient-Centred Care.

    PubMed

    Bellgard, Matthew I; Napier, Kathryn; Render, Lee; Radochonski, Maciej; Lamont, Leanne; Graham, Caroline; Wilton, Steve D; Fletcher, Sue; Goldblatt, Jack; Hunter, Adam A; Weeramanthri, Tarun

    2015-01-01

    Clinical decisions rely on expert knowledge that draws on quality patient phenotypic and physiological data. In this regard, systems that can support patient-centric care are essential. Patient registries are a key component of patient-centre care and can come in many forms such as disease-specific, recruitment, clinical, contact, post market and surveillance. There are, however, a number of significant challenges to overcome in order to maximise the utility of these information management systems to facilitate improved patient-centred care. Registries need to be harmonised regionally, nationally and internationally. However, the majority are implemented as standalone systems without consideration for data standards or system interoperability. Hence the task of harmonisation can become daunting. Fortunately, there are strategies to address this. In this paper, a disease registry framework is outlined that enables efficient deployment of national and international registries that can be modified dynamically as registry requirements evolve. This framework provides a basis for the development and implementation of data standards and enables patients to seamlessly belong to multiple registries. Other significant advances include the ability for registry curators to create and manage registries themselves without the need to contract software developers, and the concept of a registry description language for ease of registry template sharing.

  16. The findings of the Agency for Toxic Substances and Disease Registry Medical Waste Tracking Act report.

    PubMed Central

    Lichtveld, M Y; Rodenbeck, S E; Lybarger, J A

    1992-01-01

    The Agency for Toxic Substances and Disease Registry (ATSDR) report "The Public Health Implications of Medical Waste: A Report to Congress" has been finalized and submitted to Congress. The report is a comprehensive review of all available data and information on the subject. Based on the data developed in the report, ATSDR concludes that the general public is not likely to be adversely affected by medical waste generated in the traditional health setting. However, the increase of in-home health care and other sources of nonregulated medical waste (e.g., intravenous drug users) provides opportunities for the general public to contact medical waste. In addition, ATSDR concludes that public health concerns exist for selected occupations involved with medical waste. These populations include janitorial and laundry workers, nurses, emergency medical personnel, and refuse workers. The ATSDR report also defines what material should be managed as medical waste and identifies research needs related to medical waste. PMID:1486856

  17. Management and risk factor control of coronary artery disease in elderly versus nonelderly: a multicenter registry

    PubMed Central

    Phrommintikul, Arintaya; Krittayaphong, Rungroj; Wongcharoen, Wanwarang; Boonyaratavej, Smonporn; Wongvipaporn, Chaiyasith; Tiyanon, Woraporn; Dinchuthai, Pakaphan; Kunjara-Na-Ayudhya, Rapeephon; Tatsanavivat, Pyatat; Sritara, Piyamitr

    2016-01-01

    Background Coronary artery disease (CAD) is a leading cause of death in elderly because aging is the important non-modifiable risk factors of atherosclerosis and also a predictor of poor outcomes. Underuse of guideline directed therapy may contribute to suboptimal risk factor control and worse outcomes in the elderly. We aimed to explore the management of CAD, risk factors control as well as goal attainment in elderly compared to nonelderly CAD patients. Methods The CORE-Thailand is an ongoing multicenter, prospective, observational registry of patients with high atherosclerotic risk in Thailand. The data of 4120 CAD patients enrolled in this cohort was analyzed comparing between the elderly (age ≥ 65 years) vs. nonelderly (age < 65 years). Results There were 2172 elderly and 1948 nonelderly patients. The elderly CAD patients had higher prevalence of hypertension, dyslipidemia, atrial fibrillation and chronic kidney disease. The proportion of patients who received coronary revascularization was not different between the elderly and nonelderly CAD patients. Antiplatelets were prescribed less in the elderly while statin was prescribed in the similar proportion. Goal attainments of risk factor control of glycemic control, low density lipoprotein cholesterol, and smoking cessation except the blood pressure goal were higher in the elderly CAD patients. Conclusions The CORE-Thailand registry showed the equity in the treatment of CAD between elderly and non-elderly. Elderly CAD patients had higher rate of goal attainment in risk factor control except blood pressure goal. The effects of goal attainment on cardiovascular outcomes will be demonstrated from ongoing cohort. PMID:28321237

  18. Females with Fabry disease frequently have major organ involvement: lessons from the Fabry Registry.

    PubMed

    Wilcox, William R; Oliveira, João Paulo; Hopkin, Robert J; Ortiz, Alberto; Banikazemi, Maryam; Feldt-Rasmussen, Ulla; Sims, Katherine; Waldek, Stephen; Pastores, Gregory M; Lee, Philip; Eng, Christine M; Marodi, Laszlo; Stanford, Kevin E; Breunig, Frank; Wanner, Christoph; Warnock, David G; Lemay, Roberta M; Germain, Dominique P

    2008-02-01

    Fabry disease (FD) is an X-linked lysosomal storage disease caused by alpha-galactosidase A deficiency. The Fabry Registry is a global clinical effort to collect longitudinal data on FD. In the past, most "carrier" females were usually thought to be clinically unaffected. A systematic effort has been made to enroll all FD females, regardless of symptomology. Of the 1077 enrolled females in the Registry, 69.4% had symptoms and signs of FD. The median age at symptom onset among females was 13 years, and even though 84.1% had a positive family history, the diagnosis was not made until a median age of 31 years. Twenty percent experienced major cerebrovascular, cardiac, or renal events, at a median age of 46 years. Among adult females with estimated glomerular filtration rate (eGFR) data (N=638), 62.5% had an eGFR <90 ml/min/1.73 m2 and 19.0% had eGFR <60 ml/min/1.73 m2. Proteinuria 300 mg/day was present in 39.0% of females, and 22.2% had >1 gram/day. Quality of life (QoL), as measured by the SF-36((R)) survey, was impaired at a later age than in males, but both genders experience significantly impaired QoL from the third decade of life onward. Thus, females with FD have a significant risk for major organ involvement and decreased QoL. Females should be regularly monitored for signs and symptoms of FD, and considered for enzyme replacement therapy.

  19. [Data protection for the national German Central Registry of Pediatric Hearing Disorders].

    PubMed

    Finckh-Krämer, U; Hess, M; Gross, M; Wienke, A

    1998-04-01

    The German Registry for Hearing Loss in Children (DZH) processes nationwide data from audiological centers. Coping with the accrued data and its subsequent management and analysis requires a high degree of security and control. To establish a nationwide registry it is necessary at an early stage to take into consideration the legal requirements of the participating states. Use of the DZH as an example demonstrates how a pragmatic solution can be reached. Special issues concerning data collection, transfer, storage and deletion, coding strategies to ensure anonymity, checking for duplicate entries, data separation, and automated data analysis and data protection are explained.

  20. Dengue in Malaysia: Factors Associated with Dengue Mortality from a National Registry.

    PubMed

    Liew, Su May; Khoo, Ee Ming; Ho, Bee Kiau; Lee, Yew Kong; Omar, Mimi; Ayadurai, Vickneswari; Mohamed Yusoff, Fazlina; Suli, Zailiza; Mudin, Rose Nani; Goh, Pik Pin; Chinna, Karuthan

    2016-01-01

    The increasing incidence and geographical distribution of dengue has had significant impact on global healthcare services and resources. This study aimed to determine the factors associated with dengue-related mortality in a cohort of Malaysian patients. This was a retrospective cohort study of patients in the Malaysian National Dengue Registry of 2013. The outcome measure was dengue-related mortality. Associations between sociodemographic and clinical variables with the outcome were analysed using multivariate analysis. There were 43 347 cases of which 13081 were serologically confirmed. The mean age was 30.0 years (SD 15.7); 60.2% were male. The incidence of dengue increased towards the later part of the calendar year. There were 92 probable dengue mortalities, of which 41 were serologically confirmed. Multivariate analysis in those with positive serology showed that increasing age (OR 1.03; CI:1.01-1.05), persistent vomiting (OR 13.34; CI: 1.92-92.95), bleeding (OR 5.84; CI 2.17-15.70) and severe plasma leakage (OR 66.68; CI: 9.13-487.23) were associated with mortality. Factors associated with probable dengue mortality were increasing age (OR 1.04; CI:1.03-1.06), female gender (OR 1.53; CI:1.01-2.33), nausea and/or vomiting (OR 1.80; CI:1.17-2.77), bleeding (OR 3.01; CI:1.29-7.04), lethargy and/or restlessness (OR 5.97; CI:2.26-15.78), severe plasma leakage (OR 14.72; CI:1.54-140.70), and shock (OR 1805.37; CI:125.44-25982.98), in the overall study population. Older persons and those with persistent vomiting, bleeding or severe plasma leakage, which were associated with mortality, at notification should be monitored closely and referred early if indicated. Doctors and primary care practitioners need to detect patients with dengue early before they develop these severe signs and symptoms.

  1. [Epidemiology of screening-targeted cancers according to new data of the Czech National Cancer Registry].

    PubMed

    Dušek, L; Mužík, J; Malúšková, D; Májek, O; Pavlík, T; Koptíková, J; Gregor, J; Brabec, P; Abrahámová, J

    2014-01-01

    The Czech Society for Oncology has developed an information system which combines the population-based Czech National Cancer Registry with clinical databases in order to cover the main areas of health care assessment - monitoring of the population burden, prediction of the number of cancer patients, diagnostic and treatment results. The presented data demonstrate a high cancer burden within the Czech population - each year there are approximately 8,000 new cases of colorectal cancer, 6,500 new cases of breast cancer, and 1,000 new cases of cervical cancer. And each year, about 4,000 people die from colorectal cancer, around 2,000 women die from breast cancer, and approximately 400 women die from cervical cancer in the Czech Republic. Population-based screening programmes focus on all of the above-mentioned groups of malignant tumours; therefore, it is essential to monitor epidemiological trends in order to assess the screening impact. Despite the high incidence rates of all three cancer types, the trend in mortality rates has been stable or has even decreased in the long term, which has inevitably led to a significant increase in the total prevalence of cancer patients. In 2011, the prevalence of colorectal cancer, breast cancer and cervical cancer amounted to 51,064 people, 67,261 women and 17,398 women, respectively. When compared with the year 2001, there was a 59%, 69% and 25% increase in the prevalence of colorectal cancer, breast cancer, and cervical cancer, respectively. Undoubtedly, taking care of high numbers of cancer patients will continue to require significant financial resources in the near future. As the epidemiological burden is still on the increase, preventive programmes need to be further promoted, including secondary prevention, which is provided through organised screening programmes. Although effective methods exist for timely diagnosis of all three of the above-mentioned cancer types, the epidemiological situation in the Czech Republic is

  2. National Alzheimer's disease program.

    PubMed

    Sotton, J; Boursaly, J; Rapin, J R; Xuong, N G; Starton, P; Rancurel, G; Bouillon, D; Leponcin, M

    1989-01-01

    The psycho-behavioral troubles of patients with an Alzheimer's Disease (AD) are such that it is very difficult to keep those patients within the normal family environment, and that it therefore proves necessary to have them placed in a specially adapted residence manned by a highly specialised medical and para-medical staff. Within the frame of such an approach, a new type of residence has been devised "Asclepios Gardens", a one-level ranch-type residence, including 44 individual apartments, each opening, on the one hand, on a little private garden opening itself on a large, strictly enclosed and protected, 5-acre park, and, on the other hand, on a collective living structure conceived for social activities under attentive medical care, to help the patients restore their social structures. In a such residences, besides the special training given to the staff (medical, para-medical), aimed at developing as much as possible the patients' autonomy and self-reliance in every aspect of everyday life, you find a psychometric computerized "activation" program, devised both on a collective basis with differentiated subprograms, for groups of patients that have been classified according to the degree of seriousness of their problem, and-whenever possible, with individual attention programs; the whole of this "activation" method has thus clearly a double target; first to develop what is left of the patients' autonomy, for instance by psychometric exercises, and moreover, to have them start new activities, which they had never practised before--this latter action with a view to developing their neuroplasticity resources. And finally, a new chemical therapy is proposed. This substance induced a significant improvement in 40% of cases and a slight improvement in 20%. These results were observed through a series of specific psychometric tests (Visuo Retention Test of Benton, Mnesic profile of Rey), a global scale (Mini Mental State), and a general evaluation of the patients

  3. Are all metal-on-metal hip revision operations contributing to the National Joint Registry implant survival curves?

    PubMed Central

    Sabah, S. A.; Henckel, J.; Koutsouris, S.; Rajani, R.; Hothi, H.; Skinner, J. A.; Hart, A. J.

    2016-01-01

    Aims 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. Methods 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. Results 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. Discussion 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. Take home message: Prospective Registry – retrieval linkage is a simple tool to evaluate and improve data quality on the NJR. Cite this article: Bone Joint J 2016;98-B:33–9. PMID:26733513

  4. Fatalities in farming and forestry: an examination of the registry information used in the Swedish national statistics, 1988-1997.

    PubMed

    Thelin, A

    2002-08-01

    In Sweden, work-related injuries are filed in the ISA, a national information system. The Occupational Safety and Health Administration is responsible for this registry, and local units of the ISA and the Labor Inspectorate provide the information. The risk of dying in a work-related accident is greatestfor those employed in farming and forestry. At the same time, small-scale industries such as farms and other entrepreneurial businesses have difficulties in reporting accidents. It is therefore possible that the registry is incomplete and/or has many errors with respect to this kind of occupational activity. Thus, it is of interest to study the ISA in this area. This study was carried out using information obtainedfrom the Labor Inspectorate (LI), the police, the occupational health service, and local persons. Errors were traced in 28 cases (17%), and at least one piece of necessary information was missing in 165 cases of a total of 167. Approximately 14% of the cases had such fundamental errors that the case should be withdrawn from the registry. Most of the errors concerned the victim's occupation/profession and the kind of work being done at the time of the accident. In order to be an adequate instrument for use in prevention work, the ISA files must be more complete. This is of special importance with respect to the characteristics of the events. At the same time, the number of errors should be reduced.

  5. 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

  6. Valvular heart disease associated with benfluorex therapy: results from the French multicentre registry.

    PubMed

    Le Ven, Florent; Tribouilloy, Christophe; Habib, Gilbert; Gueffet, Jean-Pierre; Maréchaux, Sylvestre; Eicher, Jean-Christophe; Blanchard-Lemoine, Bénédicte; Rousseau, Juliette; Hénon, Pierre; Jobic, Yannick; Etienne, Yves

    2011-04-01

    The aim of this paper is to report clinical characteristics, consequences, echocardiographic features, and pathological findings encountered in patients suffering from valvular disease associated with benfluorex exposure in a multicentre French registry. Forty patients suffering from unexplained restrictive valvular disease with a previous exposition to benfluorex, a fenfluramine derivative, were identified from eight French university hospitals. Patients were mostly women (87.5%) with a mean age of 57 ± 9 years and high body mass index of 30 ± 7 kg/m²; 37.5% of them presented with severe heart failure symptoms (NYHA class III and IV). Benfluorex mean daily dose was 415 ± 131 mg with total therapy duration of 72 ± 53 months. Resulting cumulative dose was 910 ± 675 g. Common echocardiographic findings were leaflets and sub-valvular apparatus thickening and retraction. Aortic and mitral valve regurgitations resulting from leaflets loss of coaptation were the most frequent findings (87.5 and 82.5%) and were severe in 29 patients (72.5%). Multiple valve involvements were present in 31 cases (77.5%). Pulmonary arterial hypertension was identified in 20 cases (50%). Histopathological examination demonstrated abundant extra cellular matrix encasing the leaflets without modification of valve architecture. Fifteen patients (37.5%) underwent valvular surgery. Benfluorex-related valvulopathy shares numerous characteristics with other drug-induced valvular disease. Clinical consequences may be serious with severe heart failure symptoms that may lead to surgical treatment.

  7. Addressing the gaps in diabetes care in first nations communities with the reorganizing the approach to diabetes through the application of registries (RADAR): the project protocol.

    PubMed

    Eurich, Dean T; Majumdar, Sumit R; Wozniak, Lisa A; Soprovich, Allison; Meneen, Kari; Johnson, Jeffrey A; Samanani, Salim

    2017-02-06

    Type-2 diabetes rates in First Nations communities are 3-5 times higher than the general Canadian population, resulting in a high burden of disease, complications and comorbidity. Limited community nursing capacity, isolated environments and a lack of electronic health records (EHR)/registries lead to a reactive, disorganized approach to diabetes care for many First Nations people. The Reorganizing the Approach to Diabetes through the Application of Registries (RADAR) project was developed in alignments with federal calls for innovative, culturally relevant, community-specific programs for people with type-2 diabetes developed and delivered in partnership with target communities. RADAR applies both an integrated diabetes EHR/registry system (CARE platform) and centralized care coordinator (CC) service that will support local healthcare. The CC will work with local healthcare workers to support patient and community health needs (using the CARE platform) and build capacity in best practices for type-2 diabetes management. A modified stepped wedge controlled trial design will be used to evaluate the model. During the baseline phase, the CC will work with local healthcare workers to identify patients with type-2 diabetes and register them into the CARE platform, but not make any management recommendations. During the intervention phase, the CC will work with local healthcare workers to proactively manage patients with type-2 diabetes, including monitoring and recall of patients, relaying clinical information and coordinating care, facilitated through the shared use of the CARE platform. The RE-AIM framework will provide a comprehensive assessment of the model. The primary outcome measure will be a 10% improvement in any one of A1c, BP, or cholesterol over the baseline values. Secondary endpoints will address other diabetes care indicators including: the proportion of clinical measures completed in accordance with guidelines (e.g., foot and eye examination, receipt of

  8. Using administrative medical claims data to supplement state disease registry systems for reporting zoonotic infections

    PubMed Central

    Coulter, Steven; Conner, William

    2013-01-01

    Objective To determine what, if any, opportunity exists in using administrative medical claims data for supplemental reporting to the state infectious disease registry system. Materials and methods Cases of five tick-borne (Lyme disease (LD), babesiosis, ehrlichiosis, Rocky Mountain spotted fever (RMSF), tularemia) and two mosquito-borne diseases (West Nile virus, La Crosse viral encephalitis) reported to the Tennessee Department of Health during 2000–2009 were selected for study. Similarly, medically diagnosed cases from a Tennessee-based managed care organization (MCO) claims data warehouse were extracted for the same time period. MCO and Tennessee Department of Health incidence rates were compared using a complete randomized block design within a general linear mixed model to measure potential supplemental reporting opportunity. Results MCO LD incidence was 7.7 times higher (p<0.001) than that reported to the state, possibly indicating significant under-reporting (∼196 unreported cases per year). MCO data also suggest about 33 cases of RMSF go unreported each year in Tennessee (p<0.001). Three cases of babesiosis were discovered using claims data, a significant finding as this disease was only recently confirmed in Tennessee. Discussion Data sharing between MCOs and health departments for vaccine information already exists (eg, the Vaccine Safety Datalink Rapid Cycle Analysis project). There may be a significant opportunity in Tennessee to supplement the current passive infectious disease reporting system with administrative claims data, particularly for LD and RMSF. Conclusions There are limitations with administrative claims data, but health plans may help bridge data gaps and support the federal administration's vision of combining public and private data into one source. PMID:22811492

  9. Palivizumab prophylaxis of respiratory syncytial virus disease in 2000-2001: results from The Palivizumab Outcomes Registry.

    PubMed

    Parnes, Curt; Guillermin, Judith; Habersang, Rolf; Nicholes, Peggy; Chawla, Vijay; Kelly, Tammy; Fishbein, Judith; McRae, Patty; Goessler, Mary; Gatti, Antoinette; Calcagno, John A; Eki, Cheryl; Harris, Kristen A; Joyave, Joseph; McFarland, Kathy; Protter, Paul; Sullivan, Mary; Stanford, Allan; Lovett, Nancy; Ortiz, Marisol; Rojas, Sharon; Cyrus, Scott; Cyrus, Janell; Cohen, Stuart; Buchin, Debbie; Riordan, Linda; Zuniga, Monica; Shah, Rupa; Minard, Carmen; Quintin, Arden; Douglas, Glenda; van Houten, John; Freutner, Sharyn; Chartrand, Stephen; Nowatzke, Patsy; Romero, Jose; Rhodes, Torunn; Benoit, Michelle; Walter, Emmanuel; Walker, Leslie; DeBonnett, Laurie; Cross, Mia; Free, Teresa; Martin, Sharman; Shank, Karen; Guedes, Ben; Atkinson, Lee Ann; Halpin, George J; Rouse, Kathy; Hand, Ivan; Geiss, Donna; Marshall, James R; Burleson, Lois; Boland, Jim; Seybold, Kelsey; Hunter, Vicki; Unfer, Susan; Schmucker, Jackie; Gley, Margaret; Marcus, Michael; Thompson, Patricia; Milla, Paulino; Young, Connie; Zanni, Robert; Zinno, Virginia; Fetter-Zarzeka, Alexandra; Busey, Amanda; Sokunbi, Modupe A; Airington, Sherrie; Richard, Nancy; Muraligopal, Vellore; Lewis, Stephanie; Weber, F Thomas; Giordano, Beverly P; Linehan, Denise; Roach, Jane; Davis, Randle; Rzepka, Andrew A; Booth, Teri; Smeltzer, David; Walsh, Jeanne; Arispe, Emilio; Rowley, Rhonda; Bolling, Christopher; Botts, Tanya; Haskett, Kateri; Raby, Deana; Batiz, Evelyn; Gelfand, Andrew; Farrell, Lynn; Butler, Stephen; Colby, Linda; Schochet, Peter; Bentler, Julie; Hirsch, David; Wilkinson, Lisa; Aaronson, Allen; Bennett, Eleanora; Wingate, Julie; Quinn, Dawn; Komendowski, Katherine; Deckard, Marcia; Frogel, Michael; Nerwen, Cliff; Copenhaver, Steven; Prater, Michele; Wolsztein, Jacob; Mackey, Kristine; Benbow, Marshall; Naranjo, Marisela; Hensley, Sandra; Hayes, Cindy; Sadeghi, Hossein; Lawson, Sally May; McCall, Mark; Combs, Karla; Ledbetter, Joel; Sarnosky, Karen; Swafford, Cathy; Speer, Michael; Barton, Wendy J; Mink, J W; Lemm, Dianne; Hudak, Mark; Case, Elizabeth; Rowen, Judith; Fuentes, Sandra; Pane, Carly; Richardson, Leslie; Chavarria, Cesar; Cassino, Deanne; Ghaffari, Kourosh; Carroll, Carol; Lee, Haesoon; Guclu, Lydia; Johnson, Christopher; Blum, Valerie; Boron, Marnie L; Sorrentino, Mark; Hirsch, Robert L; Van Veldhuisen, Paul C; Smith, Carol

    2003-06-01

    The objective of the Registry was to characterize the population of infants receiving prophylaxis for respiratory syncytial virus (RSV) disease by describing the patterns and scope of usage of palivizumab in a cross section of US infants. RSV hospitalization outcomes were also described. The Palivizumab (Synagis, MedImmune, Inc., 25 West Watkins Mill Road, Gaithersburg, MD 20878) Outcomes Registry was a prospective multicenter survey conducted at 63 sites. Demographics, injection history, and RSV hospitalization outcomes were collected on 2,116 infants receiving palivizumab. Infants were enrolled in the Registry between September 1, 2000-March 1, 2001, at the time of their first injection. Infants born at less than 32 weeks of gestation accounted for 47% of infants enrolled, and those between 32-35 weeks accounted for 45%; approximately 8% were greater than 35 weeks of gestation. Lower RSV hospitalization rates were observed in infants who had greater adherence to regularly scheduled injections. Nearly one-half of all hospitalizations occurred within the first and second injection intervals, suggesting the importance of early RSV protection. The confirmed RSV hospitalization rate of all infants in the Registry was 2.9%; the rate was 5.8% in infants with chronic lung disease of infancy, and 2.1% in premature infants without chronic lung disease. In conclusion, these data support the continued effectiveness of palivizumab prophylaxis for severe RSV lower respiratory tract disease in a large cohort of high-risk infants from geographically diverse pediatric offices and clinics. The Palivizumab Outcomes Registry provides an opportunity to assess palivizumab utilization and clinical effectiveness in the US.

  10. Complications Associated With Implantable Cardioverter Defibrillators in Adults With Congenital Heart Disease or Left Ventricular Noncompaction Cardiomyopathy (From the NCDR(®) Implantable Cardioverter-Defibrillator Registry).

    PubMed

    Gleva, Marye J; Wang, Yongfei; Curtis, Jeptha P; Berul, Charles I; Huddleston, Charles B; Poole, Jeanne E

    2017-08-08

    Patients with childhood heart disease are living longer and entering adulthood, and may undergo implantable cardioverter-defibrillator (ICD) implantation to reduce the risk of sudden death. We evaluated the characteristics of adult patients with congenital heart disease or left ventricular noncompaction cardiomyopathy (LVNC) in the National Cardiovascular Disease Registry ICD Registry and determined ICD-related in-hospital complications. Patients with LVNC or transposition of the great arteries, tetralogy of Fallot, Ebstein's anomaly, atrial septal defect, ventricular septal defect, or common ventricle were identified in the registry. In-hospital complications were compared among different diagnoses using the chi-square test for categorical variables and the F-test in analyses of variance for continuous variables. A total of 3,077 patients were identified. The mean age was 48.0 ± 16.0 years, and 39.9% were female. Single-chamber ICDs were implanted in 25.2%, dual chamber in 41.9%, and cardiac resynchronization in 30.8%. Intraprocedural or postprocedural complications occurred in 70 patients (2.3%); there were 6 in-hospital deaths (0.2%). The most frequent complications were acute lead dislodgments, pneumothorax, and hematomas. Patients with Ebstein's anomaly had the greatest complication rate (8.3%, p = 0.03). The complication rate was 1.55% in single-chamber devices, 1.86% in dual chamber, and 3.5% in cardiac resynchronization (p < 0.001). For initial implants, the complication rate was 2.55%, 1.62% in generator replacements, and 8.77% in lead revisions (p = 0.001). In conclusion, in this large contemporary adult cohort of congenital heart disease and LVNC patients who underwent ICD implant procedures, periprocedural complication rates were low. Lead-related risks predominated. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. 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.

  12. Clinical characteristics and in hospital outcomes of heart transplant recipients with allograft vasculopathy undergoing percutaneous coronary intervention: Insights from the National Cardiovascular Data Registry.

    PubMed

    Dasari, Tarun W; Saucedo, Jorge F; Krim, Selim; Alkhouli, Mohamad; Fonarow, Gregg C; Alvarez, Rene; Ibrahim, Homam; Dai, David; Wang, Tracy Y; Costa, Marco; Lindenfeld, JoAnn; Messenger, John C

    2015-12-01

    Cardiac allograft vasculopathy is a major cause of morbidity and mortality following heart transplantation. Large multicenter studies evaluating the clinical characteristics and inhospital outcomes of heart transplant recipients undergoing percutaneous coronary intervention (PCI) are lacking. To evaluate the clinical characteristics, treatment patterns and inhospital outcomes of heart transplant recipients undergoing PCI compared to general population. We analyzed 1,897,328 patients from the National Cardiovascular Data Registry CathPCI registry who underwent PCI of at least 1 native vessel between July 2009 and December 2013 from 1,477 centers, of which 542 patients (0.03%) were heart transplant recipients. Clinical characteristics were evaluated and, after 1:4 propensity matching, inhospital outcomes were compared between 538 heart transplant patients and 2,128 non-transplant patients. Transplant recipients undergoing PCI had a higher prevalence of diabetes, dyslipidemia and peripheral vascular disease; lower prevalence of angina, acute coronary syndrome, abnormal noninvasive functional study, and type C coronary lesions compared to the non-transplant PCI population. After propensity matching, all-cause inhospital mortality was similar between transplant and non-transplant groups (1.3% vs 1.0%; OR, 1.21; 95% CI, 0.54-2.67). This is the largest series to date outlining the characteristics of heart transplant recipients undergoing PCI. Similar inhospital outcomes were noted in heart transplant recipients compared to the general population. Further studies evaluating long-term outcomes are warranted. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Atypical disease phenotypes in pediatric ulcerative colitis: 5-year analyses of the EUROKIDS Registry.

    PubMed

    Levine, Arie; de Bie, Charlotte I; Turner, Dan; Cucchiara, Salvatore; Sladek, Malgorzata; Murphy, M Stephen; Escher, Johanna C

    2013-02-01

    Definitive diagnosis of pediatric ulcerative colitis (UC) may be particularly challenging since isolated colitis with overlapping features is common in pediatric Crohn's disease (CD), while atypical phenotypes of UC are not uncommon. The Paris classification allows more accurate phenotyping of atypical inflammatory bowel disease (IBD) patients. Our aim was to identify the prevalence of atypical disease patterns in new-onset pediatric UC using the Paris classification. Information was collected from the EUROKIDS Registry, an inception cohort of untreated pediatric IBD patients undergoing evaluation at diagnosis. Patients with IBD-unclassified were excluded. Patients with isolated Crohn's colitis served as a control group. Data from 898 pediatric patients (643 UC, 255 CD colitis) were included. Extensive or pancolitis was present in 77% of UC patients and macroscopic rectal sparing in 5%. Rectal sparing was inversely associated with age (mean age with rectal sparing 9.9 years vs. 11.8 without; P = 0.02). Upper gastrointestinal (UGI) involvement occurred in 4% of patients. Erosions in the stomach were present in 3.1% of children, but frank ulcerations in 0.4%; 0.8% of children had erosions or ulcerations limited to the esophagus or duodenum. The corresponding UGI involvement in Crohn's colitis was 22%. A cecal patch occurred in 2% of patients. Extensive disease and rectal sparing are age-dependent phenotypes in pediatric UC. Rectal sparing, cecal patch, backwash ileitis, and gastric erosions are not uncommon at diagnosis, while gastric ulcerations and erosions in the duodenum or esophagus are. Recognition of atypical phenotypes in pediatric-onset UC is crucial to prevent misclassification of IBD.

  14. 45-day mortality after 467,779 knee replacements for osteoarthritis from the National Joint Registry for England and Wales: an observational study.

    PubMed

    Hunt, Linda P; Ben-Shlomo, Yoav; Clark, Emma M; Dieppe, Paul; Judge, Andrew; MacGregor, Alex J; Tobias, Jon H; Vernon, Kelly; Blom, Ashley W

    2014-10-18

    Understanding the risk factors for early death after knee replacement could help to reduce the risk of mortality after this procedure. We assessed secular trends in death within 45 days of knee replacement for osteoarthritis in England and Wales, with the aim of investigating whether any change that we recorded could be explained by alterations in modifiable perioperative factors. We took data for knee replacements done for osteoarthritis in England and Wales between April 1, 2003, and Dec 31, 2011, from the National Joint Registry for England and Wales. Patient identifiers were used to link these data to the national mortality database and the Hospital Episode Statistics database to obtain details of death, sociodemographics, and comorbidity. We assessed mortality within 45 days by Kaplan-Meier analysis and assessed the role of patient and treatment factors by Cox proportional hazards models. 467,779 primary knee replacements were done to treat osteoarthritis during 9 years. 1183 patients died within 45 days of surgery, with a substantial secular decrease in mortality from 0·37% in 2003 to 0·20% in 2011, even after adjustment for age, sex, and comorbidity. The use of unicompartmental knee replacement was associated with substantially lower mortality than was total knee replacement (hazard ratio [HR] 0·32, 95% CI 0·19–0·54, p<0·0005). Several comorbidities were associated with increased mortality: myocardial infarction (HR 3·46, 95% CI 2·81–4·14, p<0·0005), cerebrovascular disease (3·35, 2·7–4·14, p<0·0005), moderate/severe liver disease (7·2, 3·93–13·21, p<0·0005), and renal disease (2·18, 1·76–2·69, p<0·0005). Modifiable perioperative risk factors, including surgical approach and thromboprophylaxis were not associated with mortality. Postoperative mortality after knee replacement has fallen substantially between 2003 and 2011. Efforts to further reduce mortality should concentrate more on older patients, those who are male and

  15. The Measurement to Understand Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) Study Community Registry and Biorepository

    PubMed Central

    Bhattacharya, Sayanti; Dunham, Ashley A; Cornish, Melissa A; Christian, Victoria A; Ginsburg, Geoffrey S; Tenenbaum, Jessica D; Nahm, Meredith L; Miranda, Marie Lynn; Califf, Robert M; Dolor, Rowena J; Newby, L Kristin

    2012-01-01

    Current understanding of chronic diseases is based on crude clinical characterization, imaging studies, and laboratory testing that has evolved over decades. The Measurement to Understand Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) Study is a multi-tiered, longitudinal study designed to enable classification of chronic diseases using clinically annotated biospecimen collections, -omic technologies, electronic health records, and standard epidemiological methods. We expect that detailed molecular classification will improve mechanistic understanding of chronic diseases, augmenting discovery and testing of new treatments, and allowing refined selection of prevention and treatment strategies. The MURDOCK Study Community Registry and Biorepository will serve as a bridge for validation of initial exploratory studies, a platform for future prospective studies in targeted populations, and a resource of both data (analytical and clinical) and samples for cross-registry meta-analyses and comparative population studies. Participation of local health care providers and the Cabarrus County/Kannapolis, NC, community will facilitate future medical research and provide the opportunity to educate and inform the public about genomic research, actively engaging them in shaping the future of medical discovery and treatment of chronic diseases. We present the rationale and study design for the MURDOCK Community Registry and Biorepository and baseline characteristics of the first 6000 participants. PMID:23145214

  16. Methodological challenges in monitoring new treatments for rare diseases: lessons from the cryopyrin-associated periodic syndrome registry

    PubMed Central

    2013-01-01

    Background The Cryopyrin-Associated Periodic Syndromes (CAPS) are a group of rare hereditary autoinflammatory diseases and encompass Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID). Canakinumab is a monoclonal antibody directed against IL-1 beta and approved for CAPS patients but requires post-approval monitoring due to low and short exposures during the licensing process. Creative approaches to observational methodology are needed, harnessing novel registry strategies to ensure Health Care Provider reporting and patient monitoring. Methods A web-based registry was set up to collect information on long-term safety and effectiveness of canakinumab for CAPS. Results Starting in November 2009, this registry enrolled 241 patients in 43 centers and 13 countries by December 31, 2012. One-third of the enrolled population was aged < 18; the overall population is evenly divided by gender. Enrolment is ongoing for children. Conclusions Innovative therapies in orphan diseases require post-approval structures to enable in depth understanding of safety and natural history of disease. The rarity and distribution of such diseases and unpredictability of treatment require innovative methods for enrolment and follow-up. Broad international practice-based recruitment and web-based data collection are practical. PMID:24016338

  17. Trends in percutaneous coronary intervention from 2004 to 2013 according to the Portuguese National Registry of Interventional Cardiology.

    PubMed

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

    2015-11-01

    The aim of the present paper is to report trends in Portuguese interventional cardiology from 2004 to 2013 and to compare them with other European countries. Based on the Portuguese National Registry of Interventional Cardiology and on official data from the Directorate-General of Health, we give an overview of developments in coronary interventions from 2004 to 2013. In 2013, 36 810 diagnostic catheterization procedures were performed, representing an increase of 34% compared to 2007 and a rate of 3529 coronary angiograms per million population. Coronary interventions increased by 65% in the decade from 2004 to 2013, with a total of 13 897 procedures and a rate of 1333 coronary interventions per million population in 2013. Primary percutaneous coronary intervention (PCI) increased by 265% from 2004 to 2013 (1328 vs. 3524), an adjusted rate of 338 primary PCIs per million, representing 25% of total angioplasties. Stents were the most frequently used devices, drug-eluting stents being used in 73% in 2013. Radial access increased from 4.1% in 2004 to 57.9% in 2013. Interventional cardiology in Portugal has been expanding since 2004. We would emphasize the fact that in 2013 all Portuguese interventional cardiology centers were participating in the National Registry of Interventional Cardiology, as well as the growth in primary PCI and increased use of radial access.

  18. The course of anaemia in children and adolescents with Crohn's disease included in a prospective registry.

    PubMed

    Van Biervliet, Stephanie; Smets, Françoise; Hofmann, Ilse; Degreef, Elisabeth; Hauser, Bruno; Bontems, Patrick; Vande Velde, Saskia; Arts, Wim; Paquot, Isabelle; Alliet, Philippe; Bossuyt, Peter; Louis, Edouard; Baert, Filip; Bauraind, Olivia; Rahier, Jean-François; Veereman, Gigi

    2015-01-01

    The aim of this study is to determine the prevalence and evolution of anaemia in prospectively followed children and adolescents diagnosed with Crohn's disease (CD). The BELCRO registry (inclusion May 2008-April 2010), describing current clinical treatment practice of children diagnosed with CD, provided data on age, height, body mass index (BMI), paediatric Crohn's disease activity index (PCDAI), therapy and haemoglobin (Hb) at diagnosis 12 and 24 months follow-up. Anaemia was defined as Hb < -2 sd, while severe anaemia was defined as Hb < -4 sd. Patients were classified as child ≤13 and adolescent >13 years of age. Ninety-six were included, 13 dropped out due to insufficient Hb data (37 females/46 males; median age 13.3 years, range 2.2-17.8 years). At diagnosis, the median Hb sd was -2.66 (-8.4; 1.07) and was correlated with the PCDAI (p = 0.013). At diagnosis, 51/83 (61%) were anaemic and all had active disease. Hb z-score significantly improved (p < 0.0001) but 26/68 (38%) remained anaemic at 12 months and 29/76 (38%) at 24 months of follow-up. The correlation to the PCDAI disappeared. At 24 months, children were more likely to be anaemic. There was no difference in iron dose nor duration of iron supplements between children and adolescents. Iron treatment was more readily given to patients presenting with anaemia. Hb did not differ between patients with (n = 28) or without iron supplements. Half of the patients with persisting anaemia were given iron supplements, of which, only three were given intravenously. Anaemia remains an important extra-intestinal manifestation of CD in children. Physicians, lacking optimal treatment strategies, undertreat their patients.

  19. Lessons from 30 years' data of Korean end-stage renal disease registry, 1985-2015.

    PubMed

    Jin, Dong-Chan; Yun, Sung Ro; Lee, Seoung Woo; Han, Sang Woong; Kim, Won; Park, Jongha; Kim, Yong Kyun

    2015-09-01

    The Korean Society of Nephrology (KSN) launched a nationwide official survey program about dialysis therapy in 1985. Nowadays, the accumulated data for 30 years by this "Insan Prof. Min Memorial end-stage renal disease (ESRD) Registry" program have been providing the essential information for dialysis clinical practice, academic nephrology research, and health management policy. We reviewed 30 years of data to identify important changes and implications for the future improvement of dialysis therapy in Korea. Hemodialysis patients, especially diabetics and elderly patients have increased in number very rapidly during recent years in Korea. The Korean prevalence rate of ESRD patients was about 70% of the United States and about 50% of Japan according to the international comparisons in the annual data report of United States Renal Data System. The blood pressure control, anemia control, and dialysis adequacy have continuously improved year by year. The importance of calcium and phosphorus control has also been increasing because of the increase in long-term dialysis patients. In addition, chronic dialysis complications should be closely monitored and dialysis modifications, such as hemodiafiltration therapy, might be considered. Because of the increase of private clinics and nursing hospitals in dialysis practice, the role of dialysis specialists and continuing education are thought to be essential. For strict cost-effective dialysis control of increasing elderly, diabetic, and long-term dialysis patients, the KSN ESRD patient registration should be run by the KSN and health ministry in cooperation, in which the dialysis fee reimbursement should be accompanied.

  20. 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

  1. The Danish Heart Registry

    PubMed Central

    Özcan, Cengiz; Juel, Knud; Flensted Lassen, Jens; von Kappelgaard, Lene Mia; Mortensen, Poul Erik; Gislason, Gunnar

    2016-01-01

    Aim The Danish Heart Registry (DHR) seeks to monitor nationwide activity and quality of invasive diagnostic and treatment strategies in patients with ischemic heart disease as well as valvular heart disease and to provide data for research. Study population All adult (≥15 years) patients undergoing coronary angiography (CAG), percutaneous coronary intervention (PCI), coronary artery bypass grafting, and heart valve surgery performed across all Danish hospitals were included. Main variables The DHR contains a subset of the data stored in the Eastern and Western Denmark Heart Registries (EDHR and WDHR). For each type of procedure, up to 70 variables are registered in the DHR. Since 2010, the data quality protocol encompasses fulfillment of web-based validation rules of daily-submitted records and yearly approval of the data by the EDHR and WDHR. Descriptive data The data collection on procedure has been complete for PCI and surgery since 2000, and for CAG as of 2006. From 2000 to 2014, the number of CAG, PCI, and surgical procedures changed by 231%, 193%, and 99%, respectively. Until the end of 2014, a total of 357,476 CAG, 131,309 PCI, and 60,831 surgical procedures had been performed, corresponding to 249,445, 100,609, and 55,539 first-time patients, respectively. The DHR generally has a high level of completeness (1–missing) of each procedure (>90%) when compared to the National Patient Registry. Variables important for assessing the quality of care have a high level of completeness for surgery since 2000, and for CAG and PCI since 2010. Conclusion The DHR contains valuable data on cardiac invasive procedures, which makes it an important national monitoring and quality system and at the same time serves as a platform for research projects in the cardiovascular field. PMID:27822091

  2. End stage renal disease in French Guiana (data from R.E.I.N registry): South American or French?

    PubMed

    Rochemont, Dévi Rita; Meddeb, Mohamed; Roura, Raoul; Couchoud, Cécile; Nacher, Mathieu; Basurko, Célia

    2017-06-30

    End-Stage renal disease (ESRD) causes considerable morbidity and mortality, and significantly alters patients' quality of life. There are very few published data on this problem in the French Overseas territories. The development of a registry on end stage renal disease in French Guiana in 2011 allowed to describe the magnitude of this problem in the region for the first time. Using data from the French Renal Epidemiology and Information Network registry (R.E.I.N). Descriptive statistics on quantitative and qualitative variables in the registry were performed on prevalent cases and incident cases in 2011, 2012 and 2013. French Guiana has one of the highest ESRD prevalence and incidence in France. The two main causes of ESRD were hypertensive and diabetic nephropathies. The French Guianese population had a different demographic profile (younger, more women, more migrants) than in mainland France. Most patients had at least one comorbidity, predominantly (95.3%) hypertension. In French Guiana dialysis was initiated in emergency for 71.3% of patients versus 33% in France (p < 0.001). These first results give important public health information: i) End stage renal disease has a very high prevalence relative to mainland France ii) Patients have a different demographic profile and enter care late in the course of their renal disease. These data are closer to what is observed in the Caribbean or in Latin America than in Mainland France.

  3. Major changes and improvements of dialysis therapy in Korea: review of end-stage renal disease registry.

    PubMed

    Jin, Dong Chan

    2015-01-01

    The Korean Society of Nephrology (KSN) launched a nationwide end-stage renal disease (ESRD) patient registry in 1985 called the Insan Prof. Byung-Suk Min Memorial ESRD Patient Registry. KSN members voluntarily participate in this registry, which has been collecting data through the Internet since 2000. The KSN ESRD patient registry data were reviewed to elucidate the major changes and improvements in dialysis therapy in Korea. The data review revealed: a rapid increase in the number of patients with ESRD; an increase in the number of patients with diabetic nephropathy; a decrease in the proportion of patients undergoing peritoneal dialysis; an increase in the role of private dialysis clinics; an increase in the number of elderly patients undergoing dialysis and the number of patients undergoing long-term dialysis; a decrease in mean blood pressure and an increase in pulse pressure; improvement in anemia treatment; improvement in dialysis adequacy; and improvement in the survival of patients undergoing dialysis. In conclusion, improvements have been made in blood pressure control, anemia treatment, and dialysis adequacy despite increases in the number of elderly patients, diabetic patients, and patients on long-term dialysis during the last two decades in Korea.

  4. Neuropathological assessment of Alzheimer's disease: the experience of the Consortium to Establish a Registry for Alzheimer's Disease.

    PubMed

    Mirra, S S

    1997-01-01

    The Consortium to Establish a Registry for Alzheimer's Disease (CERAD), a multicenter longitudinal study, has worked to establish standardized instruments for the evaluation of individuals clinically diagnosed as having Alzheimer's disease (AD). Since its formation in 1986, clinical neuropsychological, neuroimaging, and neuropathology assessment batteries have been developed. The neuropathology protocol not only establishes levels of certainty for the diagnosis of AD, but also facilitates correlations with clinical, genetic, and other data. We find a high rate of diagnostic accuracy: the clinical diagnosis of AD was confirmed in 176 of 201 (87.6%) CERAD dementia subjects. Coexistent vascular lesions, usually infarcts, were found in 32% of these confirmed AD cases, and 23% had coexisting Parkinson's disease (PD) changes (nigral degeneration and Lewy bodies at any site). In the remaining 25 cases (12.4%), neuropathologists attributed the primary cause of dementia to other conditions. In studies comparing neuropathology protocols for AD, several groups have found that the CERAD diagnosis most closely correlates with measures of dementia severity, such as the Mini-Mental State Examination (MMSE). Others have adopted the CERAD neuropathology protocol for multicenter brain banking, citing its relative simplicity and adaptability among laboratories, the experience of many AD centers with the protocol, and its application to other dementing conditions. The CERAD data set and batteries are increasingly used for a wide array of clinical, neuropathological, and genetic studies.

  5. Effects of Renal Denervation Documented in the Austrian National Multicentre Renal Denervation Registry

    PubMed Central

    Lambert, Thomas; Steinwender, Clemens; Weber, Thomas; Suppan, Markus; Brussee, Helmut; Koppelstätter, Christian; Kerschbaum, Julia; Watschinger, Bruno; Hohenstein-Scheibenecker, Katharina; Reindl-Schwaighofer, Roman; Sturmberger, Thomas; Kindslehner, Claudia; Weiss, Thomas Werner; Rohla, Miklos; Gruener, Peter; Maister, Petra; Auer, Johann; Dechant, Cornelia; Sykora, Josef; Krismer, Christoph; Glaser, Stefan; Zweiker, Robert

    2016-01-01

    Renal denervation (RDN) is a new procedure for treatment-resistant hypertensive patients. In order to monitor all procedures undergone in Austria, the Austrian Society of Hypertension established the investigator-initiated Austrian Transcatheter Renal Denervation (TREND) Registry. From April 2011 to September 2014, 407 procedures in 14 Austrian centres were recorded. At baseline, office and mean 24-h ambulatory blood pressure (ABP) were 171/94 and 151/89 mmHg, respectively, and patients were taking a median of 4 antihypertensive medications. Mean 24-h ABP changes after 2–6 weeks, 3, 6 and 12 months were -11/-6, -8/-4, -8/-5 and -10/-6 mmHg (p<0.05 at all measurements), respectively. The periprocedural complication rate was 2.5%. Incidence of long-term complications during follow-up (median 1 year) was 0.5%. Office BP and ABP responses showed only a weak correlation (Pearson coefficient 0.303). Based on the data from the TREND registry, ambulatory blood pressure monitoring in addition to office BP should be used for patient selection as well as for monitoring response to RDN. Furthermore, criteria for optimal patient selection are suggested. PMID:27529426

  6. The Barth Syndrome Registry: distinguishing disease characteristics and growth data from a longitudinal study.

    PubMed

    Roberts, Amy E; Nixon, Connie; Steward, Colin G; Gauvreau, Kimberly; Maisenbacher, Melissa; Fletcher, Matthew; Geva, Judith; Byrne, Barry J; Spencer, Carolyn T

    2012-11-01

    Barth syndrome (BTHS); MIM accession # 302060) is a rare X-linked recessive cardioskeletal mitochondrial myopathy with features of cardiomyopathy, neutropenia, and growth abnormalities. The objectives of this study were to further elucidate the natural history, clinical disease presentation, and course, and describe growth characteristics for males with BTHS. Patients with a confirmed genetic diagnosis of BTHS are referred to the BTHS Registry through the Barth Syndrome Foundation, self-referral, or physician referral. This study is based on data obtained from 73 subjects alive at the time of enrollment that provided self-reported and/or medical record abstracted data. The mean age at diagnosis of BTHS was 4.04 ± 5.45 years. While the vast majority of subjects reported a history of cardiac dysfunction, nearly 6% denied any history of cardiomyopathy. Although most subjects had only mildly abnormal cardiac function by echocardiography reports, 70% were recognized as having cardiomyopathy in the first year of life and 12% have required cardiac transplantation. Of the 73 enrolled subjects, there have been five deaths. Growth curves were generated demonstrating a shift down for weight, length, and height versus the normative population with late catch up in height for a significant percentage of cases. This data also confirms a significant number of patients with low birth weight, complications in the newborn period, failure to thrive, neutropenia, developmental delay of motor milestones, and mild learning difficulties. However, it is apparent that the disease manifestations are variable, both over time for an individual patient and across the BTHS population.

  7. Long-Term Clinical Outcomes According to Previous Manifestations of Atherosclerotic Disease (from the FAST-MI 2010 Registry).

    PubMed

    Puymirat, Etienne; Aissaoui, Nadia; Lemesle, Gilles; Cottin, Yves; Coste, Pierre; Schiele, François; Ferrières, Jean; Simon, Tabassome; Danchin, Nicolas

    2017-03-01

    The prognosis of patients with acute myocardial infarction (AMI) has notably improved in the past 20 years. Using the French Registry of ST-Elevation and Non-ST-elevation Myocardial Infarction (FAST-MI) 2010 registry, we investigated whether previous manifestations of atherosclerotic disease (i.e., previous MI, or a history of any form of atherosclerotic disease) are at truly increased risk compared with those in whom AMI is the first manifestation of the disease. FAST-MI 2010 is a nationwide French registry including 3,079 patients with AMI, among whom 1,062 patients had a history of cardiovascular atherosclerotic disease and 498 patients had a history of MI. Overall, patients with a history of atherosclerotic disease (or MI) were older compared with patients without known cardiovascular disease (71 ± 13 vs 63 ± 14 years) and had higher cardiovascular risk profiles and co-morbidities. Using fully adjusted Cox multivariate analysis, previous manifestations of atherosclerotic disease were associated with higher 3-year mortality (hazard ratio 1.80, 95% confidence interval 1.40 to 2.31; p <0.001) as history of previous MI alone (hazard ratio 1.32, 95% confidence interval 1.00 to 1.73; p = 0.048). Similar results were found in patients discharged alive. In conclusion, previous cardiovascular atherosclerotic disease represents 1/3 of patients with AMI and are strongly associated with worse long-term clinical outcomes. Intensive follow-up and therapy should be encouraged in this high-risk population.

  8. The predictive value of ICD-10 diagnostic coding used to assess Charlson comorbidity index conditions in the population-based Danish National Registry of Patients

    PubMed Central

    2011-01-01

    Background The Charlson comorbidity index is often used to control for confounding in research based on medical databases. There are few studies of the accuracy of the codes obtained from these databases. We examined the positive predictive value (PPV) of the ICD-10 diagnostic coding in the Danish National Registry of Patients (NRP) for the 19 Charlson conditions. Methods Among all hospitalizations in Northern Denmark between 1 January 1998 and 31 December 2007 with a first-listed diagnosis of a Charlson condition in the NRP, we selected 50 hospital contacts for each condition. We reviewed discharge summaries and medical records to verify the NRP diagnoses, and computed the PPV as the proportion of confirmed diagnoses. Results A total of 950 records were reviewed. The overall PPV for the 19 Charlson conditions was 98.0% (95% CI; 96.9, 98.8). The PPVs ranged from 82.0% (95% CI; 68.6%, 91.4%) for diabetes with diabetic complications to 100% (one-sided 97.5% CI; 92.9%, 100%) for congestive heart failure, peripheral vascular disease, chronic pulmonary disease, mild and severe liver disease, hemiplegia, renal disease, leukaemia, lymphoma, metastatic tumour, and AIDS. Conclusion The PPV of NRP coding of the Charlson conditions was consistently high. PMID:21619668

  9. Monitoring the practice of vascular surgery: findings from a national registry (1996-2011).

    PubMed

    Lozano, Francisco S; Marinello, Josep; Moreno, Rosa M; Aguilar, Maria D; López-Quintana, Alfonso; Gonzalez-Porras, Jose R; Alvarez, Javier; Giménez-Gaibar, Antonio; Alguacil, Rafael; Cairols, Marc A; Marco-Luque, Miguel A; Vaquero, Fernando; Callejas, José M

    2014-01-01

    The goal of this article is to present for the first time to the international community the detailed findings and outcomes of the Spanish Vascular Registry (SVR) after 16 years of experience. We examined the nationwide registry promoted by the Spanish Society of Angiology and Vascular Surgery (1996-2011). The changes in vascular surgical activity in Spain during the period of study were examined. We evaluated the number of services, medical specialists, consultations, admissions, and operations that occurred in Spain. We also assessed the trends in therapeutic activity and the medical and social impact of vascular pathology. A mean of 60 centers (range = 32-83) participated in the SVR (79.3 % of the total). In the last year of the study period, 94.3 % centers (100 % of teaching centers) participated. The mean number of activities per hospital per year was 5,298 consultations, 2,625 vascular explorations, 630 hospital admissions (61 % elective and 31 % emergency), and 742 surgical procedures. A total of 29,289 carotid stenosis procedures had been registered over 16 years. Both carotid endarterectomy (CEA) and carotid artery stenting (CAS) procedures have increased in frequency over time. In 2011, CAS constituted 19.3 % of all carotid procedures. A total of 31,703 abdominal aortic aneurysm (AAA) operations were registered during the study period. Surgery for ruptured AAA remained stable over time. Since its appearance in the year 2000, endovascular treatment (EVAR) increased steadily over time. Currently, EVAR represents about half of all AAA surgery (50.2 %). The total rate of in-hospital operative deaths was 1.1 %, but in-hospital mortality for open arterial surgery was 4 %. Mortality has decreased of late. The SVR has enabled us to understand the development and implementation of vascular surgery throughout Spain and to note the increased healthcare activity and the better overall results obtained as a consequence.

  10. Extracolonic Cancer in Inflammatory Bowel Disease: Data from the GETECCU Eneida Registry.

    PubMed

    Chaparro, María; Ramas, M; Benítez, J M; López-García, A; Juan, A; Guardiola, J; Mínguez, M; Calvet, X; Márquez, L; Fernández Salazar, L I; Bujanda, L; García, C; Zabana, Y; Lorente, R; Barrio, J; Hinojosa, E; Iborra, M; Cajal, M Domínguez; Van Domselaar, M; García-Sepulcre, M F; Gomollón, F; Piqueras, M; Alcaín, G; García-Sánchez, V; Panés, J; Domènech, E; García-Esquinas, E; Rodríguez-Artalejo, F; Gisbert, J P

    2017-07-01

    The objective of this study was (a) To know the prevalence and distribution of extracolonic cancer (EC) in patients with inflammatory bowel disease (IBD); (b) To estimate the incidence rate of EC; (c) To evaluate the association between EC and treatment with immunosuppressants and anti-tumor necrosis factor (TNF) agents. This was an observational cohort study. IBD and inclusion in the ENEIDA Project (a prospectively maintained registry) from GETECCU. Patients with EC before the diagnosis of IBD, lack of relevant data for this study, and previous treatment with immunosuppressants other than corticosteroids, thiopurines, methotrexate, or anti-TNF agents. The Kaplan-Meier method was used to evaluate the impact of several variables on the risk of EC, and any differences between survival curves were evaluated using the log-rank test. Stepwise multivariate Cox regression analysis was used to investigate factors potentially associated with the development of EC, including drugs for the treatment of IBD, during follow-up. A total of 11,011 patients met the inclusion criteria and were followed for a median of 98 months. Forty-eight percent of patients (5,303) had been exposed to immunosuppressants or anti-TNF drugs, 45.8% had been exposed to thiopurines, 4.7% to methotrexate, and 21.6% to anti-TNF drugs. The prevalence of EC was 3.6%. In the multivariate analysis, age (HR=1.05, 95% CI=1.04-1.06) and having smoked (hazards ratio (HR)=1.47, 95% confidence interval (CI)=1.10-1.80) were the only variables associated with a higher risk of EC. Neither immunosuppressants nor anti-TNF drugs seem to increase the risk of EC. Older age and smoking were associated with a higher prevalence of EC.

  11. Trimming exposure data, putting radiation workers at risk: improving disclosure and consent through a national radiation dose-registry.

    PubMed

    Shrader-Frechette, Kristin

    2007-10-01

    In the United States, regulatory standards allow workers to be exposed to ionizing radiation that can cause 1 additional cancer fatality per 400 workers per year. Because radiation-dose limits cover only single sources (e.g., a nuclear plant) or exposure classes (workplace, medical, or public) and are defined for average occupational exposure, workers typically do not know their precise cumulative, individual, and relative risks from radiation. Nevertheless, this information is necessary for informed consent, because most scientists say radiation effects are cumulative and linear with no risk threshold. To promote public health, informed consent, and better understanding of the effects of low-dose radiation, I argue for a multistage National Radiation-Dose Registry, beginning with cumulative, individual worker doses.

  12. The incidence of ulcerative colitis (1995-2011) and Crohn's disease (1995-2012) - based on nationwide Danish registry data.

    PubMed

    Nørgård, Bente Mertz; Nielsen, Jan; Fonager, Kirsten; Kjeldsen, Jens; Jacobsen, Bent Ascanius; Qvist, Niels

    2014-10-01

    The incidence of ulcerative colitis (UC) and Crohn's disease (CD) has increased during the 20th century in North America and Western Europe. However, there are conflicting reports whether the incidence has declined, stabilized or even continued to increase. No nationwide Danish data on the incidence of UC and CD exist after 1992, and therefore we studied the incidence of UC (1995 through 2011) and CD (1995 through 2012). Based on data from the Danish National Patient Registry we identified patients recorded with a first time diagnosis of UC or CD in the study periods. Among these - patients were only included in the study as incident cases if they had at least one more discharge diagnosis of UC/CD or at least three subsequent outpatient visits. We identified 17,500 patients with UC and 7863 patients with CD. The mean incidence rate for UC in 1995-1998 was 14.4 per 100,000 per year for women and 13.8 for men, increasing to 23.2 per 100,000 per year for women and 23.4 for men in the period of 2009-2011. The mean incidence rate for CD in 1995-1998 was 7.8 per 100,000 per year for women and 5.6 for men, increasing to 10.3 per 100,000 per year for women and 8.9 for men in the period of 2009-2012. Based on nationwide Danish data from the last two decades, the incidence rates of UC and CD have continued to increase. Copyright © 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

  13. Random sample (DOPPS) versus census-based (registry) approaches to kidney disease research.

    PubMed

    Port, Friedrich K; Wolfe, Robert A; Held, Philip J; Young, Eric W

    2003-01-01

    This review describes advantages and limitations of registries that base their analyses on the census of all patients. Registries may utilize the random sample approach to enrich their data for more detailed and informative research. The Dialysis Outcomes and Practice Pattern Study (DOPPS) and its random sample approach is discussed here in detail, with examples on the value of this method. The DOPPS is currently being expanded to allow for even more valuable studies. This methodology can also be applied to large countries that do not have an existing registry, as it is an effective way of collecting detailed information at a relatively low cost that is representative of the country or population as a whole.

  14. 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.

  15. Rationale, design and methods of CTCA-PRORECAD (Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease): a multicentre and multivendor registry.

    PubMed

    Maffei, E; Midiri, M; Russo, V; Rengo, M; Tedeschi, C; Spagnolo, P; Seitun, S; Francone, M; Guaricci, A I; Carrabba, N; Malagò, R; Cuocolo, A; Arcadi, T; Catalano, O A; Cademartiri, F

    2013-06-01

    This study was done to assess the prognostic value of computed tomography coronary angiography (CTCA) in a large multicentre population of patients with suspected coronary artery disease (CAD) and, in particular, its incremental value compared with traditional methods for risk stratification. This is a retrospective observational study that began in January 2003 conducted on patients with suspected CAD assessed with CTCA on the basis of symptoms (chest pain, dyspnoea) and/or abnormal or equivocal stress test and/or a high cardiovascular risk profile. The participating centres will provide data obtained with CTCA performed with 16-slice or higher equipment. Exclusion criteria are renal insufficiency, allergy to iodinated contrast material, pregnancy and previous myocardial infarction or revascularisation (percutaneous coronary intervention and/or coronary artery bypass graft). All patients are stratified by means of clinical assessment and/or data retrieved from a clinical database. Risk factors considered are hypertension, dyslipidaemia, diabetes mellitus, smoking, family history and obesity. Symptoms are classified as absent, typical chest pain, atypical chest pain and dyspnoea. Primary endpoints are death, major adverse cardiovascular events (cardiac death, unstable angina requiring hospitalisation, acute myocardial infarction) and shifting of cardiovascular risk category on the basis of coronary plaque burden. The secondary endpoint is coronary revascularisation. Telephone interviews and/or clinical databases are used for the follow-up. The study will be conducted on a population >1,000 patients. The information collected from the Prognostic Registry for Coronary Artery Disease (PRORECAD) will provide insight into the prognostic value of CTCA in addition to demographic and clinical features. The results will allow for better use and interpretation of CTCA for prognostic purposes.

  16. Challenges in Identifying Patients with Type 2 Diabetes for Quality-Improvement Interventions in Primary Care Settings and the Importance of Valid Disease Registries.

    PubMed

    Wozniak, Lisa; Soprovich, Allison; Rees, Sandra; Johnson, Steven T; Majumdar, Sumit R; Johnson, Jeffrey A

    2015-10-01

    Patient registries are considered an important foundation of chronic disease management, and diabetes patient registries are associated with better processes and outcomes of care. The purpose of this article is to describe the development and use of registries in the Alberta's Caring for Diabetes (ABCD) project to identify and reach target populations for quality-improvement interventions in the primary care setting. We applied the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) framework and expanded the definition of reach beyond the individual (i.e. patient) level to include the ability to identify target populations at an organizational level. To characterize reach and the implementation of registries, semistructured interviews were conducted with key informants, and a usual-care checklist was compiled for each participating Primary Care Network (PCN). Content analysis was used to analyze qualitative data. Using registries to identify and recruit participants for the ABCD interventions proved challenging. The quality of the registries depended on whether physicians granted PCN access to patient lists, the strategies used in development, the reliability of diagnostic information and the data elements collected. In addition, once a diabetes registry was developed, there was limited ability to update it. Proactive management of chronic diseases like diabetes requires the ability to reach targeted patients at the population level. We observed several challenges to the development and application of patient registries. Given the importance of valid registries, strong collaborations and novel strategies that involve policy-makers, PCNs and providers are needed to help find solutions to improve registry quality and resolve maintenance issues. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  17. Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

    ClinicalTrials.gov

    2016-09-01

    Rare Disorders; Undiagnosed Disorders; Disorders of Unknown Prevalence; Cornelia De Lange Syndrome; Prenatal Benign Hypophosphatasia; Perinatal Lethal Hypophosphatasia; Odontohypophosphatasia; Adult Hypophosphatasia; Childhood-onset Hypophosphatasia; Infantile Hypophosphatasia; Hypophosphatasia; Kabuki Syndrome; Bohring-Opitz Syndrome; Narcolepsy Without Cataplexy; Narcolepsy-cataplexy; Hypersomnolence Disorder; Idiopathic Hypersomnia Without Long Sleep Time; Idiopathic Hypersomnia With Long Sleep Time; Idiopathic Hypersomnia; Kleine-Levin Syndrome; Kawasaki Disease; Leiomyosarcoma; Leiomyosarcoma of the Corpus Uteri; Leiomyosarcoma of the Cervix Uteri; Leiomyosarcoma of Small Intestine; Acquired Myasthenia Gravis; Addison Disease; Hyperacusis (Hyperacousis); Juvenile Myasthenia Gravis; Transient Neonatal Myasthenia Gravis; Williams Syndrome; Lyme Disease; Myasthenia Gravis; Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome); Isolated Klippel-Feil Syndrome; Frasier Syndrome; Denys-Drash Syndrome; Beckwith-Wiedemann Syndrome; Emanuel Syndrome; Isolated Aniridia; Beckwith-Wiedemann Syndrome Due to Paternal Uniparental Disomy of Chromosome 11; Beckwith-Wiedemann Syndrome Due to Imprinting Defect of 11p15; Beckwith-Wiedemann Syndrome Due to 11p15 Translocation/Inversion; Beckwith-Wiedemann Syndrome Due to 11p15 Microduplication; Beckwith-Wiedemann Syndrome Due to 11p15 Microdeletion; Axenfeld-Rieger Syndrome; Aniridia-intellectual Disability Syndrome; Aniridia - Renal Agenesis - Psychomotor Retardation; Aniridia - Ptosis - Intellectual Disability - Familial Obesity; Aniridia - Cerebellar Ataxia - Intellectual Disability; Aniridia - Absent Patella; Aniridia; Peters Anomaly - Cataract; Peters Anomaly; Potocki-Shaffer Syndrome; Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11; Silver-Russell Syndrome Due to Imprinting Defect of 11p15; Silver-Russell Syndrome Due to 11p15 Microduplication; Syndromic Aniridia; WAGR Syndrome; Wolf

  18. Gender and Geographic Differences in the Prevalence of Intellectual Disability in Children: Analysis of Data from the National Disability Registry of Taiwan

    ERIC Educational Resources Information Center

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

    2012-01-01

    Intellectual disability (ID) is not uncommon in children, but data at the national level are limited, especially those on geographic differences. On the basis of the Disabled Welfare Law, Taiwan began to certify disabled residents and provide various services in 1980. All the cases are registered, and the registry provides a rare opportunity for…

  19. Update to agency for toxic substances and disease registry 2012 report on assessment of biota exposure to mercury originating from Savannah River Site.

    SciTech Connect

    Kuhne, W.

    2015-08-10

    The purpose of this report is to 1) update previous Savannah River National Laboratory (SRNL) assessment reports (Kvartek et al. 1994 and Halverson et al. 2008) on the fate of mercury in the Savannah River Site (SRS) environment and 2) address comments and recommendations from the review of SRS by the Agency for Toxic Substances and Disease Registry (ATSDR) concerning the evaluation of exposures to contaminants in biota originating from the SRS. The ATSDR reviewed and evaluated data from SRS, South Carolina Department of Health & Environmental Control (SCDHEC) and the Georgia Department of Natural Resources (GDNR) concerning the non-radioactive contaminant mercury. This report will provide a response and update to conclusions and recommendations made by the ATSDR.

  20. Renal replacement therapy for rare diseases affecting the kidney: an analysis of the ERA-EDTA Registry.

    PubMed

    Wühl, Elke; van Stralen, Karlijn J; Wanner, Christoph; Ariceta, Gema; Heaf, James Goya; Bjerre, Anna K; Palsson, Runolfur; Duneau, Gabrielle; Hoitsma, Andries J; Ravani, Pietro; Schaefer, Franz; Jager, Kitty J

    2014-09-01

    In recent years, increased efforts have been undertaken to address the needs of patients with rare diseases by international initiatives and consortia devoted to rare disease research and management. However, information on the overall prevalence of rare diseases within the end-stage renal disease (ESRD) population is limited. The aims of this study were (i) to identify those rare diseases within the ERA-EDTA Registry for which renal replacement therapy (RRT) is being provided and (ii) to determine the prevalence and incidence of RRT for ESRD due to rare diseases, both overall and separately for children and adults. The Orphanet classification of rare disease was searched for rare diseases potentially causing ESRD, and these diagnosis codes were mapped to the corresponding ERA-EDTA primary renal disease codes. Thirty-one diagnoses were defined as rare diseases causing ESRD. From 1 January 2007 to 31 December 2011, 7194 patients started RRT for a rare disease (10.6% children). While some diseases were exclusively found in adults (e.g. Fabry disease), primary oxalosis, cystinosis, congenital anomalies of the kidney and urinary tract (CAKUT) and medullary cystic kidney disease affected young patients in up to 46%. On 31 December 2011, 20 595 patients (12.4% of the total RRT population) were on RRT for ESRD caused by a rare disease. The point prevalence was 32.5 per million age-related population in children and 152.0 in adults. Only 5.8% of these patients were younger than 20 years; however, 57.7% of all children on RRT had a rare disease, compared with only 11.9% in adults. CAKUT and focal segmental glomerulosclerosis were the most prevalent rare disease entities among patients on RRT. More than half of all children and one of nine adults on RRT in the ERA-EDTA Registry suffer from kidney failure due to a rare disease, potentially with a large number of additional undiagnosed or miscoded cases. Comprehensive diagnostic assessment and the application of accurate

  1. Spatial analysis of myocardial infarction in Iran: National report from the Iranian myocardial infarction registry.

    PubMed

    Ahmadi, Ali; Soori, Hamid; Mehrabi, Yadollah; Etemad, Koorosh

    2015-05-01

    Myocardial infarction (MI) is a leading cause of mortality and morbidity in Iran. No spatial analysis of MI has been conducted to date. The present study was conducted to determine the pattern of MI incidence and to identify the associated factors in Iran by province. This study has two parts. One part is prospective and hospital-based, and the other part is an ecological study. In this study, the data of 20,750 new MI cases registered in Iranian Myocardial Infarction Registry in 2012 were used. For spatial analysis in global and local, spatial autocorrelation, Moran's I, Getis-Ord, and logistic regression models were used. Data were analyzed by Stata software and ArcGIS 9.3. Based on autocorrelation coefficient, a specific pattern was observed in the distribution of MI incidence in different provinces (Moran's I: 0.75, P < 0.001). Spatial pattern of incidence was approximately the same in men and women. MI incidence was clustering in six provinces (North Khorasan, Yazd, Kerman, Semnan, Golestan, and Mazandaran). Out of the associated factors with clustered MI in six provinces, temperature, humidity, hypertension, smoking, and body mass index (BMI) could be mentioned. Hypertension, smoking, and BMI contributed to clustering with, respectively, 2.36, 1.31, and 1.31 odds ratio. Addressing the place-based pattern of incidence and clarifying their epidemiologic dimension, including spatial analysis, has not yet been implemented in Iran. Report on MI incidence rate by place and formal borders is useful and is used in the planning and prioritization in different levels of health system.

  2. The epidemiology of geriatric burns in Iran: A national burn registry-based study.

    PubMed

    Emami, Seyed-Abolhassan; Motevalian, Seyed Abbas; Momeni, Mahnoush; Karimi, Hamid

    2016-08-01

    Defining the epidemiology and outcome of geriatric burn patients is critical for specialized burn centers, health-care workers, and governments. Better resource use and effective guidelines are some of the advantages of studies focusing on this aspect. The outcome of these patients serves as an objective criterion for quality control, research, and preventive programs. We used data from the burn registry program in our country. For 2 years, >28,700 burn patients were recorded, 1721 of whom were admitted. Among them, 187 patients were ≥55 years old. Sixty-nine percent of patients were male and 31% female, with a male to female ratio of 2.22:1. The mean±standard deviation (SD) of age was 63.4±8.1. The cause of burns was flame (58.2%) and scalds (20.3%). Most of the burns were sustained at home. The mean duration of hospital stay was 19.5 days (range 3-59 days). The mean (SD) of the total body surface area (TBSA) was 20.3% (8.4%). The median hospital stay (length of stay (LOS)) was 11 days (SD=14). The increase in TBSA was related to a longer LOS (p<0.02). Burn wound infection developed in 44.3% of patients. The presence of inhalation injury was significantly related to mortality (p<0.001). Among the patients, 9% recovered completely, 74.9% recovered partially (requiring further treatment), 1% underwent amputation, and 12.8% died. The lack of insurance coverage did not affect the survival of our geriatric burn patients. However, being alone or single, ignition of clothing, cause of burn, comorbid illnesses, complications following the burn, TBSA, age, and sepsis were positively correlated with mortality. The mean cost of treatment for each patient was about $7450. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  3. [Cardiac failure in Chilean hospitals: results of the National Registry of Heart Failure, ICARO].

    PubMed

    Castro, Pablo; Vukasovic, José Luis; Garcés, Eduardo; Sepúlveda, Luis; Ferrada, Marcela; Alvarado, Sergio

    2004-06-01

    Heart failure (HF) is a major public health problem. In Chile hospitalized patients due to HF have not been characterized. To evaluate clinical profile and outcome of patients hospitalized for heart failure in Chilean hospitals. Prospective registry of 14 centers. Patients hospitalized for HF in functional class III and IV were included. Epidemiological and clinical data, functional class, type of presentation, decompensation cause, electrocardiogram, echocardiogram, treatment and evolution were registered. Three hundred seventy two patients aged 69 +/- 13 years old, 59% men, were assessed. The main etiologies of HF were ischemic in 31.6%, hypertensive in 35.2%, valvular in 14.9% and idiopathic in 7.4%. There was a history of hypertension 69%, diabetes in 35%, myocardial infarction in 22%, atrial fibrillation (AF) in 28%. The presentation form of HF was chronic decompensated in 86%, acute in 12%, refractory in 2%. The causes of decompensation were non compliance with diet or medical prescriptions in 28%, infections in 22% and AF 17%. ECG showed AF in 36% and left bundle branch block in 16%. Echocardiography was performed in 52% of the patients, 69% had left ventricular ejection fraction <40%. On admission, 39% received angiotensin converting enzyme (ACE) inhibitors, 15% beta-blocker, 25% digoxin, 16% spironolactone and 53% furosemide. The mean hospital stay was 111 +/- 10 days and mortality was 4.5%. The elderly is the age group most commonly admitted to hospital due to HF. The main etiologies were ischemic and hypertensive. The main causes for decompensations were noncompliance with diet or medical prescriptions and infections. A significant proportion had a relatively well preserved ventricular systolic function.

  4. Safety and efficacy of endoscopic spray cryotherapy for Barrett's dysplasia: results of the National Cryospray Registry.

    PubMed

    Ghorbani, S; Tsai, F C; Greenwald, B D; Jang, S; Dumot, J A; McKinley, M J; Shaheen, N J; Habr, F; Coyle, W J

    2016-04-01

    Retrospective series have shown the efficacy of endoscopic spray cryotherapy in eradicating high-grade dysplasia (HGD) in Barrett's esophagus (BE); however, prospective data are lacking, and efficacy for low-grade dysplasia (LGD) is unclear. The aim of this study was to assess the efficacy and safety of spray cryotherapy in patients with LGD or HGD. A multicenter, prospective open-label registry enrolled patients with dysplastic BE. Spray cryotherapy was performed every 2-3 months until there was no endoscopic evidence of BE and no histological evidence of dysplasia, followed by surveillance endoscopies up to 2 years. Primary outcome measures were complete eradication of dysplasia (CE-D) and complete eradication of all intestinal metaplasia (CE-IM). Ninety-six subjects with Barrett's dysplasia (67% HGD; 65% long-segment BE; mean length 4.5 cm) underwent 321 treatments (mean 3.3 per subject). Mean age was 67 years, 83% were male. Eighty patients (83%) completed treatment with follow-up endoscopy (mean duration 21 months). In patients with LGD, rate of CE-D was 91% (21/23) and rate of CE-IM was 61% (14/23). In HGD, CE-D rate was 81% (46/57) and CE-IM was 65% (37/57). In patients with short-segment BE (SSBE) with any dysplasia, CE-D was achieved in 97% (30/31) and CE-IM in 77% (24/31). There were no esophageal perforations or related deaths. One subject developed a stricture, which did not require dilation. One patient was hospitalized for bleeding in the setting of non-steroidal anti-inflammatory drug use. In the largest prospective cohort to date, data suggest endoscopic spray cryotherapy is a safe and effective modality for eradication of BE with LGD or HGD, particularly with SSBE.

  5. Spatial analysis of myocardial infarction in Iran: National report from the Iranian myocardial infarction registry

    PubMed Central

    Ahmadi, Ali; Soori, Hamid; Mehrabi, Yadollah; Etemad, Koorosh

    2015-01-01

    Background: Myocardial infarction (MI) is a leading cause of mortality and morbidity in Iran. No spatial analysis of MI has been conducted to date. The present study was conducted to determine the pattern of MI incidence and to identify the associated factors in Iran by province. Materials and Methods: This study has two parts. One part is prospective and hospital-based, and the other part is an ecological study. In this study, the data of 20,750 new MI cases registered in Iranian Myocardial Infarction Registry in 2012 were used. For spatial analysis in global and local, spatial autocorrelation, Moran's I, Getis-Ord, and logistic regression models were used. Data were analyzed by Stata software and ArcGIS 9.3. Results: Based on autocorrelation coefficient, a specific pattern was observed in the distribution of MI incidence in different provinces (Moran's I: 0.75, P < 0.001). Spatial pattern of incidence was approximately the same in men and women. MI incidence was clustering in six provinces (North Khorasan, Yazd, Kerman, Semnan, Golestan, and Mazandaran). Out of the associated factors with clustered MI in six provinces, temperature, humidity, hypertension, smoking, and body mass index (BMI) could be mentioned. Hypertension, smoking, and BMI contributed to clustering with, respectively, 2.36, 1.31, and 1.31 odds ratio. Conclusion: Addressing the place-based pattern of incidence and clarifying their epidemiologic dimension, including spatial analysis, has not yet been implemented in Iran. Report on MI incidence rate by place and formal borders is useful and is used in the planning and prioritization in different levels of health system. PMID:26487871

  6. Comparison of cases captured in the national cancer data base with those in population-based central cancer registries.

    PubMed

    Lerro, Catherine C; Robbins, Anthony S; Phillips, Jerri Linn; Stewart, Andrew K

    2013-06-01

    The National Cancer Data Base (NCDB) is a large, geographically diverse hospital-based cancer registry that has been used to study factors related to cancer diagnosis, treatment, and survival. The primary purpose of this study was to compare the case counts and characteristics of patients in NCDB with population-based registries reported in the United States Cancer Statistics (USCS). Cancer case counts from NCDB were compared to case counts from USCS to measure NCDB's case coverage, or the percentage of cases captured. Case coverage was examined by a variety of characteristics, including state of residence, race/ethnicity, age, and primary cancer site. The overall NCDB case coverage was 67.4 %, ranging from a high of 88.7 % for Delaware to a low of 27.1 % for Arizona. Case coverage for white, black, and Asian/Pacific Islander cases was high (64.7 % to 67.4 %), but it was much lower for American Indians/Alaskan Natives (32.8 %) and those of Hispanic ethnicity (51.1 %). Among the elderly (aged 65 + years), case coverage is much lower compared to persons younger than 65 (63.0 % and 73.0 %, respectively). Case coverage also varied widely by site, with the highest being cervix (77.9 %) and the lowest being melanoma (50.6 %). This study highlights the geographic- and site-specific variation in NCDB case coverage, primarily as a result of NCDB facility presence and data collection and processing protocols. These findings illustrate the strengths and limitations of NCDB as a resource for nationwide data on cancer diagnosis, treatment, and survival.

  7. Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

    PubMed

    Cohen, Lee S; Viguera, Adele C; McInerney, Kathryn A; Freeman, Marlene P; Sosinsky, Alexandra Z; Moustafa, Danna; Marfurt, Samantha P; Kwiatkowski, Molly A; Murphy, Shannon K; Farrell, Adriann M; Chitayat, David; Hernández-Díaz, Sonia

    2016-03-01

    Second-generation antipsychotics are used to treat a spectrum of psychiatric illnesses in reproductive-age women. The National Pregnancy Registry for Atypical Antipsychotics was established to determine the risk of major malformations among infants exposed to second-generation antipsychotics during pregnancy relative to a comparison group of unexposed infants of mothers with histories of psychiatric morbidity. Women were prospectively followed during pregnancy and the postpartum period; obstetric, labor, delivery, and pediatric medical records were obtained. Eligible enrollees were pregnant women ages 18-45. The Registry is based at the Center for Women's Mental Health at Massachusetts General Hospital. Women were recruited through provider referral, self-referral, and the Center's web site. As of December 2014, 487 women were enrolled: 353 who used second-generation antipsychotics and 134 comparison women. Medical records were obtained for 82% of participants. A total of 303 women had completed the study and were eligible for inclusion in the analysis. Of 214 live births with first-trimester exposure to second-generation antipsychotics, three major malformations were confirmed. In the control group (N=89), one major malformation was confirmed. The absolute risk of major malformations was 1.4% for exposed infants and 1.1% for unexposed infants. The odds ratio for major malformations comparing exposed infants with unexposed infants was 1.25 (95% CI=0.13-12.19). The results suggest that it would be unlikely for second-generation antipsychotics to raise the risk of major malformations more than 10-fold beyond that observed in the general population or among control groups using other psychotropic medications. If the estimate stabilizes around the null with ongoing data collection, findings may be reassuring for both clinicians and women trying to make risk-benefit treatment decisions about using atypical antipsychotics during pregnancy. These findings are timely given

  8. Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: 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

    2016-05-24

    Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown. Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry - ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%-4.8%) within 1 year and 21.3% (95% CI, 20.7%-21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73-1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66-1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48-1.67), and greater hospice use among decedents in the patients' health referral region. More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus. © 2016 The Authors.

  9. Indications for percutaneous coronary interventions performed in U.S. Hospitals: a report from the National Cardiovascular Data Registry

    PubMed Central

    Cram, Peter; House, John A.; Messenger, John; Piana, Robert N.; Horwitz, Phillip A; Spertus, John A.

    2011-01-01

    Background There are many factors hypothesized as contributing to overuse of percutaneous coronary intervention (PCI) in the United States (U.S.), including financial ties between physicians and hospitals, but empirical data are lacking. We examined PCI indications in not-for-profit (NFP), major teaching, for-profit (FP) and physician-owned specialty hospitals. Methods A retrospective cohort study of 1,113,554 patients who underwent PCI in 694 hospitals (NFP=471, teaching=131, FP=79, specialty=13) participating in the National Cardiovascular Data Registry® (NCDR®) CathPCI Registry® between January 1, 2004 and December 31, 2007. PCI indications derived from American College of Cardiology (ACC) Guidelines were classified as: survival benefit (patients with primary reperfusion for STEMI); potential quality of life (QOL) benefit (patients with NSTEMI, ACS, positive stress test, or chest pain); or unclear indications (patients receiving PCI without an obvious potential survival or QOL benefit). Results The percentage of PCI performed for unclear indications was somewhat higher for specialty hospitals (5.1% of all procedures) as compared with other hospital categories (FP 4.7%, NFP 4.2%, teaching 4.5%; P<0.001). Overall, 17% of hospitals had 20% or more of their total PCI procedures performed for unclear indications but the proportion of FP, NFP, teaching, and specialty hospitals reaching this threshold was not statistically different (20%, 16%, 17% and 15% respectively; P=.84). Conclusions A small proportion of PCI procedures were performed in patients with unclear indications, but there was wide variation across hospitals. On average, specialty hospitals performed more PCIs for unclear indications. Efforts to reduce variability should be pursued. PMID:22305839

  10. [National Cancer Registry. Significance of a reliable database in the implementation of the required structural changes of cancer care in Hungary].

    PubMed

    Kásler, Miklós; Ottó, Szabolcs; Sólyom, Olimpia

    2014-09-07

    The authors summarize the basic objectives and scope of the Hungarian Cancer Registry. They review more than 100-year history of the national cancer database and its effects on current cancer data collection activities, which is outstanding in Europe. The compilation deals with the development of information technology, covers points of principle and practical issues such as parallel display and evaluation of mortality and morbidity statistics and their national and international importance concerning public health. The authors underline that reliable data collection and services of the National Cancer Registry are important for the society because they are public health issues with a critical importance for a better understanding of risk factors, prevention and patient care. Restructuring and European harmonization of the Hungarian cancer system are inevitable using a reliable information exchange and service, taking into account national specificities and international requirements.

  11. The efficacy of ranibizumab treatment in clinical practice in patients with the wet form of age-related macular degeneration. The results of the Czech National Registry.

    PubMed

    Chrapek, Oldrich; Jarkovsky, Jiri; Studnicka, Jan; Sin, Martin; Kolar, Petr; Jirkova, Barbora; Dusek, Ladislav; Pitrova, Sarka; Rehak, Jiri

    2015-09-01

    The aim of this communication was to evaluate ranibizumab in the treatment of wet age-related macular degeneration. Anonymised data on treatment efficacy and safety were consecutively entered into the Czech national database. From 01/09/2008 to 25/10/2011, 671 patients/685 eyes treated with ranibizumab monotherapy were entered in the registry. 454 ranibizumab treated eyes and 444 patients were monitored for 12-months. The dependent variable used to monitor disease progression and treatment results was change in visual acuity in the ETDRS (Early Treatment Diabetic Retinopathy Study) chart over time. After 12 months of treatment, a loss of < 15 letters in the ETDRS chart was found in 81.5% of eyes treated with ranibizumab. A gain of ≥ 15 letters was found in 9.7% of eyes on ranibizumab. The results for our patients treated in clinical practice with ranibizumab were poorer than those in the SUSTAIN (Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration) study. A rationale for this was sought in a sub-analysis. Sub-analysis demonstrated that treatment naive CNV (choroidal neovascularization), occult CNV and lower height of the macular oedema at the outset of the disease may be positive prognostic factors for final visual acuity in anti-VEGF (vascular endothelial growth factor) treated patients.

  12. National disease management plans for key chronic non-communicable diseases in Singapore.

    PubMed

    Tan, C C

    2002-07-01

    In Singapore, chronic, non-communicable diseases, namely coronary heart disease, stroke and cancer, account for more than 60% of all deaths and a high burden of disability and healthcare expenditure. The burden of these diseases is likely to rise with our rapidly ageing population and changing lifestyles, and will present profound challenges to our healthcare delivery and financing systems over the next 20 to 30 years. The containment and optimal management of these conditions require a strong emphasis on patient education and the development of integrated models of healthcare delivery in place of the present uncoordinated, compartmentalised way of delivering healthcare. To meet these challenges, the Ministry of Health's major thrusts are disease control measures which focus mainly on primary prevention; and disease management, which coordinates the national effort to reduce the incidence of these key diseases and their predisposing factors and to ameliorate their long-term impact by optimising control to reduce mortality, morbidity and complications, and improving functional status through rehabilitation. The key initiatives include restructuring of the public sector healthcare institutions into two clusters, each comprising a network of primary health care polyclinics, regional hospitals and tertiary institutions. The functional integration of these healthcare elements within each cluster under a common senior administrative and professional management, and the development of common clinical IT systems will greatly facilitate the implementation of disease management programmes. Secondly, the Ministry is establishing National Disease Registries in coronary heart disease, cancer, stroke, myopia and kidney failure, which will be valuable sources of clinical and outcomes data. Thirdly, in partnership with expert groups, national committees and professional agencies, the Ministry will produce clinical practice guidelines which will assist doctors and healthcare

  13. Burden of cancer in Malawi; common types, incidence and trends: national population-based cancer registry.

    PubMed

    Msyamboza, Kelias Phiri; Dzamalala, Charles; Mdokwe, Catherine; Kamiza, Steve; Lemerani, Marshal; Dzowela, Titha; Kathyola, Damson

    2012-03-16

    Cancer is a leading cause of morbidity and mortality worldwide with a majority of cases and deaths occurring in developing countries. While cancer of the lung, breast, colorectum, stomach and prostate are the most common types of cancer globally, in east and southern Africa these are less common and comprehensive data to inform policies are lacking. Nationwide cancer registry was conducted between September and October 2010 in Malawi. New cancer cases registered from 2007 to 2010 were identified from hospital and clinic registers of 81 out of 84 health facilities providing cancer diagnosis, treatment or palliative care services. Demographic and cancer data were extracted from registers and case notes using a standard form. A total of 18,946 new cases of cancer were registered in Malawi from 2007-2010. Of these 55.9% were females, 7.2% were children aged less than 15 years, 76.5% were adults aged 15-59 years and 16.4% were elderly aged 60 years or more. Only 17.9% of the cases had histologically verified diagnosis, 33.2% were diagnosed clinically and 49.6% based on clinical and some investigations. Amongst females, cancer of the cervix was the commonest accounting for 45.4% of all cases followed by Kaposi sarcoma (21.1%), cancer of the oesophagus (8.2%), breast (4.6%) and non-Hodgkin lymphoma (4.1%). In males, Kaposi sarcoma was the most frequent (50.7%) then cancer of oesophagus (16.9%), non-Hodgkin lymphoma (7.8), prostate (4.0%) and urinary bladder (3.7%). Age-standardised incidence rate per 100,000 population for all types of cancer in males increased from 31 in 1999-2002 to 56 in 2007-2010. In females it increased from 29 to 69. Kaposi sarcoma and cancer of the oesophagus, cervical cancer and Kaposi sarcoma were the main causes for the increased incidence in males and females respectively. It was estimated that, annually at least 8,151 new cases of cancer (all types) occur in Malawi. This study provided data on common types and trends of cancer that could be

  14. JBEI Registry

    SciTech Connect

    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.

  15. JBEI Registry

    SciTech Connect

    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.

  16. Improving quality of care using a diabetes registry and disease management services in an integrated delivery network.

    PubMed

    Campion, Francis X; Tully, George L; Barrett, Jo-Ann; Andre, Paulo; Sweeney, Ann

    2005-08-01

    Disease management for chronic conditions is a call for collaboration among all parties of the health care system. The Caritas Christi Health Care System established a unified American Diabetes Association (ADA) recognized outpatient diabetes self-management education program (DSME) in each of its six hospital communities and has established an Internet data portal with managed care organizations to improve preventive care for thousands of patients with diabetes. This article describes the stepwise process of building the successful Caritas Diabetes Care Program and the central role of the Caritas Diabetes Registry over a 5-year period.

  17. Incidence of Congenital Heart Disease: The 9-Year Experience of the Guangdong Registry of Congenital Heart Disease, China

    PubMed Central

    Zhuang, Jian; Chen, Guanchun; Mai, Jinzhuang; Guo, Xiaoling; Ou, Yanqiu; Chen, Jimei; Gong, Wei; Gao, Xiangmin; Wu, Yong; Nie, Zhiqiang

    2016-01-01

    There are 16.5 million newborns in China annually. However, the incidence of congenital heart disease (CHD) has not been evaluated. In 2004, we launched an active province-wide hospital-based CHD registry in the Guangdong Province of southern China. In this study, we examined the incidence of CHD and its subtypes from 2004 to 2012 and compared our findings to the literature. Our results indicate there is an increasing trend of CHD incidence. The increase in incidence occurred mainly for single lesion and the most common subtypes (e.g., ventricular or atrial septal defect, patent ductus arteriosus). There were no increases found for multiple lesions or more complex subtypes. The proportion of CHD cases that were detected early (e.g., 1 week) increased over time. The incidence of CHD stabilized in 2010–2012 with the average cumulative incidences of 9.7, 9.9, and 11.1 per 1,000 live births at 1 week, 1 month, and 1 year, respectively. The incidences of CHD subtypes were comparable with recent international results. The data did not support previous reports that Asian children have a higher incidence of pulmonary outflow obstructions and lower incidence of transposition of the great arteries. However, there was a lower incidence of left ventricular outflow tract obstructions observed in our series. The increase in CHD incidence observed over time was due to improved detection and diagnosis. The true incidence of CHD in China was approximately 11.1 per 1,000 live births, which is higher than previously reported. PMID:27409588

  18. A "pivot" Model to set up Large Scale Rare Diseases Information Systems: Application to the Fibromuscular Dysplasia Registry.

    PubMed

    Toubiana, Laurent; Ugon, Adrien; Giavarini, Alessandra; Riquier, Jérémie; Charlet, Jean; Jeunemaitre, Xavier; Plouin, Pierre-François; Jaulent, Marie-Christine

    2015-01-01

    The SIR-FMD project is a partnership between the Department of Genetics and Reference Centre for Rare Vascular Diseases at the Georges Pompidou European Hospital in Paris and the Medical Informatics and Knowledge Engineering Laboratory of Inserm. Its aim is to use an ontological approach to implement an information system for the French Fibromuscular Dysplasia Registry. The existing data was dispersed in numerous databases, which had been created independently. These databases have different structures and contain data of diverse quality. The project aims to provide generic solutions for the management of the communication of medical data. The secondary objective is to demonstrate the applicability of these generic solutions in the field of rare diseases (RD) in an operational context. The construction of the French FMD registry was a multistep process. A secure platform has been available since the beginning of November 2013. The medical records of 471 patients from the initial dataset provided by the HEGP-Paris, France have been included, and are accessible from a secure user account. Users are organized into a collaborative group, and can access patient groups. Each electronic patient record contains more than 2,200 items. The problem of semantic interoperability has become one of the major challenges for the development of applications requiring the sharing and reuse of data. The information system component of the SIR-FMD project has a direct impact on the standardisation of coding of rare diseases and thereby contributes to the development of e-Health.

  19. A contemporary view of diagnostic cardiac catheterization and percutaneous coronary intervention in the United States: a report from the CathPCI Registry of the National Cardiovascular Data Registry, 2010 through June 2011.

    PubMed

    Dehmer, Gregory J; Weaver, Douglas; Roe, Matthew T; Milford-Beland, Sarah; Fitzgerald, Susan; Hermann, Anthony; Messenger, John; Moussa, Issam; Garratt, Kirk; Rumsfeld, John; Brindis, Ralph G

    2012-11-13

    This study sought to provide a report to the public of data from the CathPCI Registry of the National Cardiovascular Data Registry. The CathPCI Registry collects data from approximately 85% of the cardiac catheterization laboratories in the United States. Data were summarized for 6 consecutive calendar quarters beginning January 1, 2010, and ending June 30, 2011. This report includes 1,110,150 patients undergoing only diagnostic cardiac catheterization and 941,248 undergoing percutaneous coronary intervention (PCI). Some notable findings include, for example, that on-site cardiac surgery was not available in 83% of facilities performing fewer than 200 PCIs annually, with these facilities representing 32.6% of the facilities reporting, but performing only 12.4% of the PCIs in this data sample. Patients 65 years of age or older represented 38.7% of those undergoing PCI, with 12.3% being 80 years of age or older. Almost 80% of PCI patients were overweight (body mass index ≥25 kg/m(2)), 80% had dyslipidemia, and 27.6% were current or recent smokers. Among patients undergoing elective PCI, 52% underwent a stress study before the procedure, with stress myocardial perfusion being used most frequently. Calcium scores and coronary computed tomography angiography were used very infrequently (<3%) before diagnostic or PCI procedures. Radial artery access was used in 8.3% of diagnostic and 6.9% of PCI procedures. Primary PCI was performed with a median door-to-balloon time of 64.5 min for nontransfer patients and 121 min for transfer patients. In-hospital risk-adjusted mortality in ST-segment elevation myocardial infarction patients was 5.2% in this sample. Data from the CathPCI Registry provide a contemporary view of the current practice of invasive cardiology in the United States. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. The UK transcatheter aortic valve implantation registry; one of the suite of registries hosted by the National Institute for Cardiovascular Outcomes Research (NICOR).

    PubMed

    Ludman, Peter F

    2012-12-01

    This registry was set up to create a comprehensive record of all TAVI procedures performed in the United Kingdom since the introduction of the technique in 2007, to help drive quality improvement and provide data for research. Funding is independent of industry. All hospitals in the UK provide data for every consecutive patient where TAVI was attempted. The dataset includes variables defining patient demographic features, indications, procedural details and outcomes up to the time of hospital discharge. There are variables for follow up at 1 and 3 years assessing symptoms and life status. An updated dataset will be collected from 2013. Mortality is tracked centrally. Data entry is performed by clinical staff and data clerks. No external validation. The data are available for research by application to the UK TAVI Steering Group using a data sharing agreement which can be obtained at NICOR (www.ucl.ac.uk/nicor/).

  1. Registries supporting new drug applications.

    PubMed

    Jonker, Carla J; van den Berg, H Marijke; Kwa, Marcel S G; Hoes, Arno W; Mol, Peter G M

    2017-10-06

    Knowledge of the benefits and risks of new drugs is incomplete at the time of marketing approval. Registries offer the possibility for additional, post-approval, data collection. For all new drugs, which were approved in the European Union between 2007 and 2010, we reviewed the frequency, the type, and the reason for requiring a registry. The European Public Assessment Reports, published on the website of the European Medicine Agency, were reviewed for drugs approved by the Committee for Medicinal Products for Human Use. We searched for key characteristics of these drugs, including therapeutic area (ATC1 level), level of innovation (the score is an algorithm based on availability of treatment and therapeutic effect), and procedural characteristics. In addition, we identified if these registries were defined by disease (disease registry) or exposure to a single drug (drug registry). Out of 116 new drugs approved in the predefined period, for 43 (37%), 1 to 6 registry studies were identified, with a total of 73 registries. Of these 46 were disease registries and 27 (single) drug registries. For 9 drugs, the registry was a specific obligation imposed by the regulators. The level of innovation and the orphan status of the drugs were determinants positively predicting post-approval registries (OR 10.3 [95% CI 1.0-103.9] and OR 2.8 [95% CI 1.0-7.5], respectively). The majority of registries required by regulators are existing disease registries. Registries are an important and frequently used tool for post-approval data collection for orphan and innovative drugs. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

  2. [Role of cancer registries].

    PubMed

    Schaffer, P

    1995-05-01

    The first Cancer Registries were created in 1975 in France. Their ulterior development and their scientific production have been furthered by the apparition from 1986 under the aegis of the Health Ministry and of the INSERM, of a National Population Registry Committee. Cancer Registries have seriously contributed to a better knowledge of the cancer problem in our country and to describe the french specificities, in particular the importance of the mouth and pharynx cancers. They insure both a monitoring and an alert role; they also contribute to the medical supervision of the Chernobyl accident effects. French registries play a very active role concerning clinical research. They participate to many European studies of health care evaluation. In other respects, many etiological studies have been realized about professional risks of cancer, risks linked with nutritional habits, and on the etiologic role of the Tamoxifen. Finally, certain registries have created DNA banks. If nowadays their role in health planning remains modest, they very actively contribute in evaluating screening actions of breast, cervix and large bowel cancers. They also attracted the attention of Health Authorities on the cervix cancer screening's incoherencies. They evaluate the pilot project of the breast cancer and the registry of the Côte d'Or country evaluates the efficacity of a randomized colo rectal mass screening study. The main difficulties met by the registries are linked with the development of laws protecting more and more the individual freedoms, making it harder and harder the registration exhaustive character.

  3. Worldwide variability in deceased organ donation registries

    PubMed Central

    Rosenblum, Amanda M; Li, Alvin Ho-Ting; Roels, Leo; Stewart, Bryan; Prakash, Versha; Beitel, Janice; Young, Kimberly; Shemie, Sam; Nickerson, Peter; Garg, Amit X

    2012-01-01

    The variability in deceased organ donation registries worldwide has received little attention. We considered all operating registries, where individual wishes about organ donation were recorded in a computerized database. We included registries which recorded an individual's decision to be a donor (donor registry), and registries which only recorded an individual's objection (non-donor registry). We collected information on 15 characteristics including history, design, use and number of registrants for 27 registries (68%). Most registries are nationally operated and government-owned. Registrations in five nations expire and require renewal. Some registries provide the option to make specific organ selections in the donation decision. Just over half of donor registries provide legally binding authorization to donation. In all national donor registries, except one, the proportion of adults (15+) registered is modest (<40%). These proportions can be even lower when only affirmative decisions are considered. One nation provides priority status on the transplant waiting list as an incentive to affirmative registration, while another nation makes registering a donation decision mandatory to obtain a driver's license. Registered objections in non-donor registries are rare (<0.5%). The variation in organ donor registries worldwide necessitates public discourse and quality improvement initiatives, to identify and support leading practices in registry use. PMID:22507140

  4. 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.

  5. 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

  6. Characteristics of Patients Diagnosed with Osteoporosis in South Korea: Results from the National Claim Registry

    PubMed Central

    Yoon, Hyun Koo

    2017-01-01

    Background Although osteoporosis is increasing medical issue in the elderly population, attempts to analyze the characteristics of patients diagnosed with osteoporosis are rare in South Korea. We investigated the characteristics of patients diagnosed with osteoporosis using Korea's National Health Insurance claims data, which includes almost Korean population. Methods We evaluated the patients who were diagnosed and treated with osteoporosis in medical institute in South Korea, using the national database by the Health Insurance Review & Assessment Service (HIRA). We evaluated the characteristic of patients and state of medical service utilization in 2010. Results The number of patients who were diagnosed with osteoporosis were 1,733,685, and almost of them (91.1%) were females. Fourteen point three percent of the patients had experienced osteoporosis-related fracture. The most commonly used type of institute and department was hospital and orthopedic surgery. Conclusions Considering increasing age population, basic information including characteristic of patients and current state of medical service utilization could be useful to perform appropriate management and treatment for osteoporosis patients in South Korea, using the National Health Insurance claims data. PMID:28326302

  7. Using national hip fracture registries and audit databases to develop an international perspective.

    PubMed

    Johansen, Antony; Golding, David; Brent, Louise; Close, Jacqueline; Gjertsen, Jan-Erik; Holt, Graeme; Hommel, Ami; Pedersen, Alma B; Röck, Niels Dieter; Thorngren, Karl-Göran

    2017-08-02

    Hip fracture is the commonest reason for older people to need emergency anaesthesia and surgery, and leads to prolonged dependence for many of those who survive. People with this injury are usually identified very early in their hospital care, so hip fracture is an ideal marker condition with which to audit the care offered to older people by health services around the world. We have reviewed the reports of eight national audit programmes, to examine the approach used in each, and highlight differences in case mix, management and outcomes in different countries. The national audits provide a consistent picture of typical patients - an average age of 80 years, with less than a third being men, and a third of all patients having cognitive impairment - but there was surprising variation in the type of fracture, of operation and of anaesthesia and hospital length of stay in different countries. These national audits provide a unique opportunity to compare how health care systems of different countries are responding to the same clinical challenge. This review will encourage the development and reporting of a standardised dataset to support international collaboration in healthcare audit. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. On the Creation, Utility and Sustaining of Rare Diseases Research Networks: Lessons learned from the Urea Cycle Disorders Consortium, the Japanese Urea Cycle Disorders Consortium and the European Registry and Network for Intoxication Type Metabolic Diseases

    PubMed Central

    Summar, Marshall L.; Endo, Fumio; Kölker, Stefan

    2016-01-01

    The past two decades has seen a rapid expansion in the scientific and public interest in rare diseases and their treatment. One consequence of this has been the formation of registries/longitudinal natural history studies for these disorders. Given the expense and effort needed to develop and maintain such programs, we describe our experience with three linked registries on the same disease group, urea cycle disorders. The Urea Cycle Disorders Consortium (UCDC) was formed in the U.S. in 2003 in response to a request for application from the National Institutes of Health (NIH); the European Registry and Network for Intoxication Type Metabolic Diseases (E-IMD) was formed in 2011 in response to a request for applications from the Directorate-General for Health and Consumers (DG SANCO) of the EU; and the Japanese Urea Cycle Disorders Consortium (JUCDC) was founded in 2012 as a sister organization to the UCDC and E-IMD. The functions of these groups are to collect natural history data, educate the professional and lay population, develop and test new treatments, and establish networks of excellence for the care for these disorders. The UCDC and JUCDC focus exclusively on urea cycle disorders while the E-IMD includes patients with urea cycle disorders and organic acidurias. More than 1400 patients have been enrolled in the three consortia, and numerous projects have been developed and joint meetings held including an international UCDC/E-IMD/JUCDC Urea Cycle meeting in Barcelona in 2013. This article summarizes some of the experiences from the three groups regarding formation, funding, and models for sustainability. PMID:25261246

  9. CREATION OF A MODEL TO PREDICT SURVIVAL IN PATIENTS WITH REFRACTORY COELIAC DISEASE USING A MULTINATIONAL REGISTRY

    PubMed Central

    Rubio-Tapia, Alberto; Malamut, Georgia; Verbeek, Wieke H.M.; van Wanrooij, Roy L.J.; Leffler, Daniel A.; Niveloni, Sonia I.; Arguelles-Grande, Carolina; Lahr, Brian D.; Zinsmeister, Alan R.; Murray, Joseph A.; Kelly, Ciaran P.; Bai, Julio C.; Green, Peter H.; Daum, Severin; Mulder, Chris J.J.; Cellier, Christophe

    2016-01-01

    Background Refractory coeliac disease is a severe complication of coeliac disease with heterogeneous outcome. Aim To create a prognostic model to estimate survival of patients with refractory coeliac disease. Methods We evaluated predictors of 5-year mortality using Cox proportional hazards regression on subjects from a multinational registry. Bootstrap re-sampling was used to internally validate the individual factors and overall model performance. The mean of the estimated regression coefficients from 400 bootstrap models was used to derive a risk score for 5-year mortality. Results The multinational cohort was composed of 232 patients diagnosed with refractory coeliac disease across 7 centers (range of 11–63 cases per center). The median age was 53 years and 150 (64%) were women. A total of 51 subjects died during 5-year follow-up (cumulative 5-year all-cause mortality = 30%). From a multiple variable Cox proportional hazards model, the following variables were significantly associated with 5-year mortality: age at refractory coeliac disease diagnosis (per 20 year increase, hazard ratio = 2.21; 95% confidence interval: 1.38, 3.55), abnormal intraepithelial lymphocytes (hazard ratio = 2.85; 95% confidence interval: 1.22, 6.62), and albumin (per 0.5 unit increase, hazard ratio = 0.72; 95% confidence interval: 0.61, 0.85). A simple weighted 3-factor risk score was created to estimate 5-year survival. Conclusions Using data from a multinational registry and previously-reported risk factors, we create a prognostic model to predict 5-year mortality among patients with refractory coeliac disease. This new model may help clinicians to guide treatment and follow-up. PMID:27485029

  10. Creation of a model to predict survival in patients with refractory coeliac disease using a multinational registry.

    PubMed

    Rubio-Tapia, A; Malamut, G; Verbeek, W H M; van Wanrooij, R L J; Leffler, D A; Niveloni, S I; Arguelles-Grande, C; Lahr, B D; Zinsmeister, A R; Murray, J A; Kelly, C P; Bai, J C; Green, P H; Daum, S; Mulder, C J J; Cellier, C

    2016-10-01

    Refractory coeliac disease is a severe complication of coeliac disease with heterogeneous outcome. To create a prognostic model to estimate survival of patients with refractory coeliac disease. We evaluated predictors of 5-year mortality using Cox proportional hazards regression on subjects from a multinational registry. Bootstrap resampling was used to internally validate the individual factors and overall model performance. The mean of the estimated regression coefficients from 400 bootstrap models was used to derive a risk score for 5-year mortality. The multinational cohort was composed of 232 patients diagnosed with refractory coeliac disease across seven centres (range of 11-63 cases per centre). The median age was 53 years and 150 (64%) were women. A total of 51 subjects died during a 5-year follow-up (cumulative 5-year all-cause mortality = 30%). From a multiple variable Cox proportional hazards model, the following variables were significantly associated with 5-year mortality: age at refractory coeliac disease diagnosis (per 20 year increase, hazard ratio = 2.21; 95% confidence interval, CI: 1.38-3.55), abnormal intraepithelial lymphocytes (hazard ratio = 2.85; 95% CI: 1.22-6.62), and albumin (per 0.5 unit increase, hazard ratio = 0.72; 95% CI: 0.61-0.85). A simple weighted three-factor risk score was created to estimate 5-year survival. Using data from a multinational registry and previously reported risk factors, we create a prognostic model to predict 5-year mortality among patients with refractory coeliac disease. This new model may help clinicians to guide treatment and follow-up. © 2016 John Wiley & Sons Ltd.

  11. Risk factors of suicide mortality among multiple attempters: A national registry study in Taiwan.

    PubMed

    Chen, I-Ming; Liao, Shih-Cheng; Lee, Ming-Been; Wu, Chia-Yi; Lin, Po-Hsien; Chen, Wei J

    2016-05-01

    Little is known about the risk factors of suicide mortality among multiple attempters. This study aims to investigate the predictors of suicidal mortality in a prospective cohort of attempters in Taiwan, focusing on the time interval and suicide method change between the last two nonfatal attempts. The representative data retrieved from the National Suicide Surveillance System (NSSS) was linked with National Mortality Database to identify the causes of death in multiple attempters during 2006-2008. Cox-proportional hazard models were applied to calculate the hazard ratios for the predictors of suicide. Among the 55,560 attempters, 6485 (11.7%) had survived attempts ranging from one to 11 times; 861 (1.5%) eventually died by suicide. Multiple attempters were characterized by female (OR = 1.56, p < 0.0001), nonrecipient of national aftercare service (OR = 1.62, p < 0.0001), and current contact with mental health services (OR = 3.17, p < 0.0001). Most multiple attempters who survived from hanging (68.1%) and gas poisoning (61.9%) chose the same method in the following fatal episode. Predictors of suicidal death were identified as male, older age (≥ 45 years), shorter interval and not maintaining methods of low lethality in the last two nonfatal attempts. Receipt of nationwide aftercare was associated with lower risk of suicide but the effect was insignificant. The time interval of the last two nonfatal attempts and alteration in the lethality of suicide method were significant factors for completed suicide. Risk assessment involving these two factors may be necessary for multiple attempters in different clinical settings. Effective strategies for suicide prevention emphasizing this high risk population should be developed in the future. Copyright © 2015. Published by Elsevier B.V.

  12. Modern utilization of penile prosthesis surgery: a national claim registry analysis.

    PubMed

    Segal, R L; Camper, S B; Burnett, A L

    2014-01-01

    The objective of this study was to evaluate the modern utilization of penile prosthesis surgery based on data derived from national claim databases and contrast to an analysis of patients similarly treated at an academic center during a contemporaneous period. A retrospective claim analysis utilizing a national database (MarketScan, Thomson Reuters) was performed for Commercial insurer and Medicare databases between January 2000 and March 2011. A retrospective analysis of contemporaneous penile prosthesis implantation at the Johns Hopkins Hospital (JHH) was done. Population demographics, comorbidities, previous (ED) therapies and time from ED diagnosis to surgery were assessed. Median ages for patients undergoing penile prosthesis implantation were 58, 70 and 63 years for the Commercial, Medicare and JHH cohorts, respectively. For the claim databases (Commercial, Medicare, respectively), hypertension (72%, 78%), dyslipidemia (71%, 56%) and diabetes mellitus (45%, 40%) were predominant comorbidities, whereas for the JHH database prostate cancer (51%) and its management by prostatectomy (45%) or radiation (12%) were predominant. Previous use of PDE5 inhibitors was similar across databases (60, 58 and 69% for Commercial, Medicare and JHH cohorts, respectively), although previous use of non-oral ED therapies was greater in the JHH database. Median time to surgery from initial ED diagnosis was 2, 2 and 4 years for the Commercial, Medicare and JHH patients, respectively. Demographic variables and ED risk factors associated with penile prosthesis surgery at a national population-based level over a contemporary period were defined. Some differences in utilization trends of penile prosthesis surgery exist at a single institutional level.

  13. Validation of primary metal-on-metal hip arthroplasties on the National Joint Registry for England, Wales and Northern Ireland using data from the London Implant Retrieval Centre

    PubMed Central

    Sabah, S. A.; Henckel, J.; Cook, E.; Whittaker, R.; Hothi, H.; Pappas, Y.; Blunn, G.; Skinner, J. A.; Hart, A. J.

    2015-01-01

    Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67 045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data. Cite this article: Bone Joint J 2015;97-B:10–18. PMID:25568407

  14. National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions

    ClinicalTrials.gov

    2016-12-19

    Marfan Syndrome; Turner Syndrome; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome; FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 Genetic Mutation; Bicuspid Aortic Valve Without Known Family History; Bicuspid Aortic Valve With Family History; Bicuspid Aortic Valve With Coarctation; Familial Thoracic Aortic Aneurysm and Dissections; Shprintzen-Goldberg Syndrome; Other Aneur/Diss of Thoracic Aorta Not Due to Trauma, <50yo; Other Congenital Heart Disease

  15. Prostate Cancer in South Africa: Pathology Based National Cancer Registry Data (1986–2006) and Mortality Rates (1997–2009)

    PubMed Central

    Babb, Chantal; Urban, Margaret; Kielkowski, Danuta; Kellett, Patricia

    2014-01-01

    Prostate cancer is one of the most common male cancers globally; however little is known about prostate cancer in Africa. Incidence data for prostate cancer in South Africa (SA) from the pathology based National Cancer Registry (1986–2006) and data on mortality (1997–2009) from Statistics SA were analysed. World standard population denominators were used to calculate age specific incidence and mortality rates (ASIR and ASMR) using the direct method. Prostate cancer was the most common male cancer in all SA population groups (excluding basal cell carcinoma). There are large disparities in the ASIR between black, white, coloured, and Asian/Indian populations: 19, 65, 46, and 19 per 100 000, respectively, and ASMR was 11, 7, 52, and 6 per 100 000, respectively. Prostate cancer was the second leading cause of cancer death, accounting for around 13% of male deaths from a cancer. The average age at diagnosis was 68 years and 74 years at death. For SA the ASIR increased from 16.8 in 1986 to 30.8 in 2006, while the ASMR increased from 12.3 in 1997 to 16.7 in 2009. There has been a steady increase of incidence and mortality from prostate cancer in SA. PMID:24955252

  16. Prostate cancer in South Africa: pathology based national cancer registry data (1986-2006) and mortality rates (1997-2009).

    PubMed

    Babb, Chantal; Urban, Margaret; Kielkowski, Danuta; Kellett, Patricia

    2014-01-01

    Prostate cancer is one of the most common male cancers globally; however little is known about prostate cancer in Africa. Incidence data for prostate cancer in South Africa (SA) from the pathology based National Cancer Registry (1986-2006) and data on mortality (1997-2009) from Statistics SA were analysed. World standard population denominators were used to calculate age specific incidence and mortality rates (ASIR and ASMR) using the direct method. Prostate cancer was the most common male cancer in all SA population groups (excluding basal cell carcinoma). There are large disparities in the ASIR between black, white, coloured, and Asian/Indian populations: 19, 65, 46, and 19 per 100 000, respectively, and ASMR was 11, 7, 52, and 6 per 100 000, respectively. Prostate cancer was the second leading cause of cancer death, accounting for around 13% of male deaths from a cancer. The average age at diagnosis was 68 years and 74 years at death. For SA the ASIR increased from 16.8 in 1986 to 30.8 in 2006, while the ASMR increased from 12.3 in 1997 to 16.7 in 2009. There has been a steady increase of incidence and mortality from prostate cancer in SA.

  17. Impact of smoking status on clinical outcomes after successful chronic total occlusion intervention: Korean national registry of CTO intervention.

    PubMed

    Lee, Min-Ho; Park, Jin Joo; Yoon, Chang-Hwan; Cha, Myung-Jin; Park, Sang-Don; Oh, Il-Young; Suh, Jung-Won; Cho, Young-Seok; Youn, Tae-Jin; Rha, Seung-Woon; Yu, Cheol Woong; Gwon, Hyeon-Cheol; Jang, Yangsoo; Kim, Hyo-Soo; Chae, In-Ho; Choi, Dong-Ju

    2016-05-01

    We sought to evaluate the effect of cigarette smoking on long-term outcomes after successful percutaneous coronary intervention for chronic total occlusion (CTO) lesions. Cigarette smoking promotes the progression of atherosclerosis but enhances the antiplatelet effect of clopidogrel. The Korea National Registry of CTO Intervention included 2,167 patients with CTO lesions from 26 centers who were successfully revascularized with drug-eluting stents from 2007 to 2009. Thrombotic events were defined as the composite of cardiac death, nonfatal myocardial infarction, and stent thrombosis. Current-smokers had more favorable baseline characteristics such as a younger age and lower prevalence of hypertension and diabetes mellitus. At 1 year, current-smokers had a significantly lower thrombotic event rate (1.1% vs. 2.7%, P = 0.034), but a significantly higher target vessel revascularization (TVR) rate (7.2% vs. 4.2%, P = 0.017) compared with never-smokers. After adjustment, current-smoking was independently associated with a 72% decreased risk for thrombotic events, and 73% increased risk for TVR. In patients with a revascularized CTO lesion, cigarette smoking is associated with fewer thrombotic events but with a higher incidence of TVR. Patients with CTO may benefit from smoking cessation to reduce TVR in conjunction with the use of new more potent antiplatelet agents whose effect is independent of cigarette smoking to improve thrombotic events. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  18. South African National Cancer Registry: Effect of withheld data from private health systems on cancer incidence estimates

    PubMed Central

    Singh, E; Underwood, J M; Nattey, C; Babb, C; Sengayi, M; Kellett, P

    2015-01-01

    Background The National Cancer Registry (NCR) was established as a pathology-based cancer reporting system. From 2005 to 2007, private health laboratories withheld cancer reports owing to concerns regarding voluntary sharing of patient data. Objectives To estimate the impact of under-reported cancer data from private health laboratories. Methods A linear regression analysis was conducted to project expected cancer cases for 2005 – 2007. Differences between actual and projected figures were calculated to estimate percentage under-reporting. Results The projected NCR case total varied from 53 407 (3.8% net increase from actual cases reported) in 2005 to 54 823 (3.7% net increase) in 2007. The projected number of reported cases from private laboratories in 2005 was 26 359 (19.7% net increase from actual cases reported), 27 012 (18.8% net increase) in 2006 and 27 666 (28.4% net increase) in 2007. Conclusion While private healthcare reporting decreased by 28% from 2005 to 2007, this represented a minimal impact on overall cancer reporting (net decrease of <4%). PMID:26242527

  19. The review of new evidence 5 years later: SAMHSA's National Registry of Evidence-based Programs and Practices (NREPP).

    PubMed

    Jobli, Edessa C; Gardner, Stephen E; Hodgson, Anna B; Essex, Alyson

    2015-02-01

    The Substance Abuse and Mental Health Services Administration (SAMHSA) decided that NREPP should offer a second review option for interventions that have already been reviewed and included in the registry for 5 years. Principals from 135 such interventions were invited to participate in a second review, and an exploratory study of the Principals' responses to this invitation was conducted. The study used a mixed-method approach, quantitatively describing characteristics of Principals and their interventions and qualitatively summarizing feedback from phone interviews with a convenience sample of Principals participating in a second review. Of the Principals invited, 21% accepted a second review, 24% were interested but unable or not ready to submit materials, and 56% did not accept or did not respond. Mental health treatment interventions were more likely to undergo a second review, and substance abuse treatment interventions were less likely. Similar percentages of interventions undergoing a second review had received funding from the National Institutes of Health (86%) and had been evaluated in a comparative effectiveness research study (79%). Overall ratings for interventions improved in each second review completed. The interviewed Principals perceived potentially lower ratings as the only risk in participating in a second review. Copyright © 2014 Elsevier Ltd. All rights reserved.

  20. Management of concomitant coronary artery disease in patients undergoing transcatheter aortic valve implantation: the United Kingdom TAVI Registry.

    PubMed

    Snow, Thomas M; Ludman, Peter; Banya, Winston; DeBelder, Mark; MacCarthy, Philip M; Davies, Simon W; Di Mario, Carlo; Moat, Neil E

    2015-11-15

    The management and impact of concomitant coronary artery disease in patients referred for TAVI remains contentious. We describe the prevalence, clinical impact and management of coronary artery disease (CAD) in patients in the United Kingdom TAVI Registry. All-inclusive study of patients undergoing TAVI in the United Kingdom (excluding Northern Ireland) from January 2007 to December 2011. Coronary artery disease at the time of TAVI was demonstrated on invasive angiography. 2588 consecutive patients were entered in the U.K. TAVI Registry. CAD was reported in 1171 pts with left main stem involvement in 12.4% of this cohort (n=145). Most patients were free of chest pain, but limited by dyspnoea (NYHA Class III & IV 81.9%). Angina was however more prevalent in those patients with CAD (p<0.0001). Hybrid PCI was uncommon, performed in only 14.7% of the CAD cohort (n=172). Survival at 30days, 1year, and 4years was 93.7%, 81.4% and 72.0% respectively. Adjusting for confounders in a multivariate model the presence and extent of CAD was not associated with early (30-days, p=0.36) or late (4years, p=0.10) survival. This contemporary study of coronary artery disease management in an "all-comers" patient population undergoing TAVI demonstrates that whilst often an indicator of significant underlying comorbidity coronary artery disease is not associated with decreased short or long-term survival. The majority of patients with aortic stenosis and concomitant CAD can be managed effectively by TAVI alone. However, the importance of the Heart Team in making decisions on individual patients must not be underestimated. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. Use of Anticoagulants and Antiplatelet Agents in Stable Outpatients with Coronary Artery Disease and Atrial Fibrillation. International CLARIFY Registry.

    PubMed

    Fauchier, Laurent; Greenlaw, Nicola; Ferrari, Roberto; Ford, Ian; Fox, Kim M; Tardif, Jean-Claude; Tendera, Michal; Steg, Ph Gabriel

    2015-01-01

    Few data are available regarding the use of antithrombotic strategies in coronary artery disease patients with atrial fibrillation (AF) in everyday practice. We sought to describe the prevalence of AF and its antithrombotic management in a contemporary population of patients with stable coronary artery disease. CLARIFY is an international, prospective, longitudinal registry of outpatients with stable coronary artery disease, defined as prior (≥12 months) myocardial infarction, revascularization procedure, coronary stenosis >50%, or chest pain associated with evidence of myocardial ischemia. Overall, 33,428 patients were screened, of whom 32,954 had data available for analysis at baseline; of these 2,229 (6.7%) had a history of AF. Median (interquartile range) CHA2DS2-VASc score was 4 (3, 5). Oral anticoagulation alone was used in 25.7%, antiplatelet therapy alone in 52.8% (single 41.8%, dual 11.0%), and both in 21.5%. OAC use was independently associated with permanent AF (p<0.001), CHA2DS2-VASc score (p=0.006), pacemaker (p<0.001), stroke (p=0.04), absence of angina (p=0.004), decreased left ventricular ejection fraction (p<0.001), increased waist circumference (p=0.005), and longer history of coronary artery disease (p=0.008). History of percutaneous coronary intervention (p=0.004) and no/partial reimbursement for cardiovascular medication (p=0.01, p<0.001, respectively) were associated with reduced oral anticoagulant use. In this contemporary cohort of patients with stable coronary artery disease and AF, most of whom are theoretical candidates for anticoagulation, oral anticoagulants were used in only 47.2%. Half of the patients received antiplatelet therapy alone and one-fifth received both antiplatelets and oral anticoagulants. Efforts are needed to improve adherence to guidelines in these patients. ISRCTN registry of clinical trials: ISRCTN43070564.

  2. Use of Anticoagulants and Antiplatelet Agents in Stable Outpatients with Coronary Artery Disease and Atrial Fibrillation. International CLARIFY Registry

    PubMed Central

    Fauchier, Laurent; Greenlaw, Nicola; Ferrari, Roberto; Ford, Ian; Fox, Kim M.; Tardif, Jean-Claude; Tendera, Michal; Steg, Ph. Gabriel

    2015-01-01

    Background Few data are available regarding the use of antithrombotic strategies in coronary artery disease patients with atrial fibrillation (AF) in everyday practice. We sought to describe the prevalence of AF and its antithrombotic management in a contemporary population of patients with stable coronary artery disease. Methods and Findings CLARIFY is an international, prospective, longitudinal registry of outpatients with stable coronary artery disease, defined as prior (≥12 months) myocardial infarction, revascularization procedure, coronary stenosis >50%, or chest pain associated with evidence of myocardial ischemia. Overall, 33,428 patients were screened, of whom 32,954 had data available for analysis at baseline; of these 2,229 (6.7%) had a history of AF. Median (interquartile range) CHA2DS2-VASc score was 4 (3, 5). Oral anticoagulation alone was used in 25.7%, antiplatelet therapy alone in 52.8% (single 41.8%, dual 11.0%), and both in 21.5%. OAC use was independently associated with permanent AF (p<0.001), CHA2DS2-VASc score (p=0.006), pacemaker (p<0.001), stroke (p=0.04), absence of angina (p=0.004), decreased left ventricular ejection fraction (p<0.001), increased waist circumference (p=0.005), and longer history of coronary artery disease (p=0.008). History of percutaneous coronary intervention (p=0.004) and no/partial reimbursement for cardiovascular medication (p=0.01, p<0.001, respectively) were associated with reduced oral anticoagulant use. Conclusions In this contemporary cohort of patients with stable coronary artery disease and AF, most of whom are theoretical candidates for anticoagulation, oral anticoagulants were used in only 47.2%. Half of the patients received antiplatelet therapy alone and one-fifth received both antiplatelets and oral anticoagulants. Efforts are needed to improve adherence to guidelines in these patients. Trial Registration ISRCTN registry of clinical trials: ISRCTN43070564. PMID:25915904

  3. In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI National Registry 2010-2011.

    PubMed

    Sabaté, Manel; Cánovas, Sergio; García, Eulogio; Hernández Antolín, Rosana; Maroto, Luis; Hernández, José María; Alonso Briales, Juan H; Muñoz García, Antonio J; Gutiérrez-Ibañes, Enrique; Rodríguez-Roda, Jorge

    2013-12-01

    The treatment of severe symptomatic aortic stenosis has been revolutionized by the technique of transcatheter valve replacement. The purpose of this study was to present the outcomes and predictors of mortality in patients enrolled between 2010 and 2011 in the Transcatheter Aortic Valve Replacement National Registry. We collected 131 preprocedural, 31 periprocedural, and 76 follow-up variables, and analyzed the immediate implant success rate, the 30-day safety endpoint, and all-cause 30-day and mid-term (mean follow-up, 244 days) mortality. From January 2010 to December 2011, a total of 1416 patients were included: 806 with Edwards valves and 610 with CoreValves. The implant success and 30-day mortality rates were 94% and 8%, respectively, without differences between types of valves and approaches. The 30-day safety endpoint and mid-term mortality rates were 14% and 16%, respectively, which were also similar between groups. The presence of comorbidities (renal failure, peripheral vascular disease, ejection fraction, and atrial fibrillation), the need for conversion to surgery, and at least moderate aortic regurgitation after transcatheter aortic valve implantation were identified as independent predictors of in-hospital and mid-term mortality. The prognosis of valve implant patients could be improved by including comorbidities in patient selection and by minimizing the degree of residual aortic regurgitation to optimize the results of the procedure. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  4. 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.

  5. National down syndrome patient database: Insights from the development of a multi-center registry study.

    PubMed

    Lavigne, Jenifer; Sharr, Christianne; Ozonoff, Al; Prock, Lisa Albers; Baumer, Nicole; Brasington, Campbell; Cannon, Sheila; Crissman, Blythe; Davidson, Emily; Florez, Jose C; Kishnani, Priya; Lombardo, Angela; Lyerly, Jordan; McCannon, Jessica B; McDonough, Mary Ellen; Schwartz, Alison; Berrier, Kathryn L; Sparks, Susan; Stock-Guild, Kara; Toler, Tomi L; Vellody, Kishore; Voelz, Lauren; Skotko, Brian G

    2015-11-01

    The Down Syndrome Study Group (DSSG) was founded in 2012 as a voluntary, collaborative effort with the goal of supporting evidenced-based health care guidelines for individuals with Down syndrome (DS). Since then, 5 DS specialty clinics have collected prospective, longitudinal data on medical conditions that co-occur with DS. Data were entered by clinical staff or trained designees into the National Down Syndrome Patient Database, which we created using REDCap software. In our pilot year, we enrolled 663 participants across the U.S., ages 36 days to 70 years, from multiple racial and ethnic backgrounds. Here we report: (i) the demographic distribution of participants enrolled, (ii) a detailed account of our database infrastructure, and (iii) lessons learned during our pilot year to assist future researchers with similar goals for other patient populations. © 2015 Wiley Periodicals, Inc.

  6. Trends in penetrating and anterior lamellar corneal grafting techniques for keratoconus: a national registry study.

    PubMed

    Godefrooij, Daniel A; Gans, Renze; Imhof, Saskia M; Wisse, Robert P L

    2016-08-01

    Keratoconus is a progressive disorder and one of the primary indications for corneal transplantation. Anterior lamellar keratoplasty offers several advantages over other techniques, including endothelial preservation and longer graft survival. In this study, we examined the recent trend of using lamellar techniques for keratoconus at a national level. Data were obtained from the Dutch national organ transplant database regarding corneal transplants for keratoconus performed in 2005 through 2014. Baseline characteristics for patients undergoing various techniques were obtained, and temporal trends were analysed. A total of 1041 operations were performed, including 736 penetrating keratoplasties (PKPs) and 297 anterior lamellar keratoplasties (ALKs). The mean age of the total surgical group was 37.4 ± 13.4 years, and 68% of patients were male (p = 0.0001). Preoperative patient characteristics were reported in all 1041 cases. The relative proportion of ALKs increased from 2005 (19% of cases) to 2010 (39% of cases) and remained approximately 30-40% thereafter. Descemet baring or deep anterior lamellar keratoplasty (DALK) was increasingly applied and was the predominant anterior lamellar technique performed from 2009 onwards. The number of corneal transplantations performed annually for keratoconus decreased during the past 10 years. Lamellar techniques were increasingly performed, accounting for approximately 35% of keratoplasties in 2010 and thereafter. Among ALK techniques, maximal depth DALK is the most prevalent keratoplasty performed for keratoconus in most recent years. Penetrating keratoplasty (PKP) is still common, with a stable frequency from 2010 onwards. © 2016 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  7. One-year outcomes and secondary prevention in patients after acute minor stroke: results from the China National Stroke Registry.

    PubMed

    Tan, Ying; Pan, Yuesong; Liu, Liping; Wang, Yilong; Zhao, Xingquan; Wang, Yongjun

    2017-06-01

    Limited data are available on secondary preventive therapy use and patient outcomes after acute minor ischemic stroke in China. This study investigated secondary prevention strategies and outcomes up to 1 year after minor ischemic stroke. Patients from the China National Stroke Registry experienced a minor ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score ≤5) and admitted to hospital within 24 hours of symptom onset were included. One-year rates of recurrent stroke, stroke-related disability, and all-cause death were evaluated. Risk factors associated with 1-year stroke recurrence were examined in a multivariate model. The secondary prevention strategies in the acute phase were evaluated as combination of secondary prevention medication classes and the medications used in 1 year follow-up were examined. The study included 1913 patients who had experienced acute minor ischemic stroke (mean age: 65.1 years; 67.3% men; mean NIHSS score: 2.5). Rates of recurrent stroke, disability, and death were 13.2, 17.0, and 6.3% at 1 year, respectively. History of hypertension, ischemic stroke, transient ischemic attack, and atrial fibrillation were independent predictors of one-year stroke recurrence. Rate of 1 year all-cause death in patients with triple combined therapy in acute phase was 4.1%, whereas in patients with none was 14.5%. At 1 year, only half patients continued the secondary prevention medications. Outcomes in individuals in China who had experienced acute minor stroke were unfavorable, underscoring the importance of early, sustained preventive therapy in this patient population. Combination of secondary prevention medication classes was associated with a lower risk of death.

  8. Characteristics and causes of penetrating eye injuries reported to the National Eye Trauma System Registry, 1985-91.

    PubMed Central

    Parver, L M; Dannenberg, A L; Blacklow, B; Fowler, C J; Brechner, R J; Tielsch, J M

    1993-01-01

    Ocular trauma is one of the most important preventable causes of visual impairment. The National Eye Trauma System was developed to provide optimal clinical care for severe ocular injuries, to foster research on eye injury, and to increase awareness of ocular trauma as a public health problem. From 1985 through 1991, the National Eye Trauma System Registry collected data on 2,939 cases of penetrating eye injury reported by ophthalmologists at 48 collaborating eye trauma centers in 28 States and Washington, DC. Eighty-three percent of the cases involved men; the median age of the patients was 27 years, ranging from 1 to 92 years of age. Seventy-seven percent of the injuries were unintentional, 22 percent were the result of assault, and 1 percent were self-inflicted. In 62 percent of the cases studied, the injured person's initial best corrected visual acuity in the injured eye was the ability to perceive hand motion, or worse. The settings in which the injuries occurred included the home (28 percent), the worksite (21 percent), at recreation (11 percent), and in transportation (8 percent). At the time of the injury, 1.5 percent of the injured persons were wearing safety glasses and 2.9 percent were wearing nonsafety glasses. There was evidence of definite or possible alcohol use by at least 24 percent of the injured persons and illicit drug use by 8 percent. The most frequent types of tissue damage included corneal or scleral laceration, traumatic cataract, intraocular foreign body, vitreous hemorrhage, and prolapse of intraocular tissue.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8210260

  9. The Value and Limitations of Guidelines, Expert Consensus, and Registries on the Management of Patients with Thoracic Aortic Disease

    PubMed Central

    Pacini, Davide; Murana, Giacomo; Leone, Alessandro; Di Marco, Luca; Pantaleo, Antonio

    2016-01-01

    Doctors are often faced with difficult decisions and uncertainty when patients need a certain treatment. They routinely rely on the scientific literature, in addition to their knowledge, experience, and patient preferences. Clinical practice guidelines are created with the intention of facilitating decision-making. They may offer concise instructions for the diagnosis, management (medical or surgical treatments), and prevention of specific diseases or conditions. All information included in the final version are the result of a systematic review of scientific articles and an assessment of the benefits and costs of alternative care options. The final document attempts to meet the needs of most patients in most circumstances and clinicians, aware of these recommendations, should always make individualized treatment decisions. In this review, we attempted to define the intent and applicability of clinical practice guidelines, expert consensus documents, and registry studies, focusing on the management of patients with thoracic aortic disease. PMID:27965917

  10. A registry of patients with end stage renal disease--the experience at hospital Sultanah Aminah, Johor Baru.

    PubMed

    Hooi, L S

    1993-06-01

    A registry of patients with end stage renal disease was started from 1st January 1990 at Hospital Sultanah Aminah, Johor Baru. There were 126 patients in 1990 and 129 in 1991. The peak age was 31 to 60 years old; males outnumbered females 1.5:1. Forty-three to fifty-six percent presented with small kidneys. Seventeen to twenty percent of patients had diabetes mellitus. In 1991, the racial distribution of patients was Malay: 50.4%, Chinese: 39.5%, Indian: 7.8% and others: 2.3%. The incidence of end stage renal disease in Johor Baru district was 79 per million per year in 1990 and 86 per million in 1991.

  11. The Value and Limitations of Guidelines, Expert Consensus, and Registries on the Management of Patients with Thoracic Aortic Disease.

    PubMed

    Pacini, Davide; Murana, Giacomo; Leone, Alessandro; Di Marco, Luca; Pantaleo, Antonio

    2016-12-01

    Doctors are often faced with difficult decisions and uncertainty when patients need a certain treatment. They routinely rely on the scientific literature, in addition to their knowledge, experience, and patient preferences. Clinical practice guidelines are created with the intention of facilitating decision-making. They may offer concise instructions for the diagnosis, management (medical or surgical treatments), and prevention of specific diseases or conditions. All information included in the final version are the result of a systematic review of scientific articles and an assessment of the benefits and costs of alternative care options. The final document attempts to meet the needs of most patients in most circumstances and clinicians, aware of these recommendations, should always make individualized treatment decisions. In this review, we attempted to define the intent and applicability of clinical practice guidelines, expert consensus documents, and registry studies, focusing on the management of patients with thoracic aortic disease.

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

    PubMed

    Pedrón-Giner, C; Navas-López, V M; Martínez-Zazo, A B; Martínez-Costa, C; Sánchez-Valverde, F; Blasco-Alonso, J; Moreno-Villares, J M; Redecillas-Ferreiro, S; Canals-Badía, M J; Rosell-Camps, A; Gil-Ortega, D; Gómez-López, L; García-Romero, R; Gutierrez-Junquera, C; Balmaseda-Serrano, E M; Bousoño-García, C; Marugán-Miguelsanz, J M; Peña-Quintana, L; González-Santana, D; López-Ruzafa, E; Chicano-Marín, F J; Cabrera-Rodriguez, R; Murray-Hurtado, M; Pérez-Moneo, B

    2013-04-01

    The home enteral nutrition (HEN) provides nutritional support to children with chronic diseases who are nutritionally compromised and allows them to be discharged more quickly from hospitals. In 2003, a web-based registry (Nutrición Enteral Pediátrica Ambulatoria y Domiciliaria, Pediatric Ambulatory and Home Enteral Nutrition -NEPAD-) was created with the objective of gathering information about pediatric HEN practices in Spain. The aim of this study was to report the implementation of the NEPAD (Nutrición Enteral Pediátrica Ambulatoria y Domiciliaria, Pediatric Ambulatory and Home Enteral Nutrition) registry of pediatric HEN in Spain and to analyze data evolution trends from 2003 to 2010. The data from the Spanish NEPAD registry were analyzed according to the following variables: demographic data, diagnosis, indication for HEN, nutritional support regime and administration route. Over the study period, 952 patients (1048 episodes) from 20 Spanish hospitals were included in the NEPAD registry. The most frequent indication for HEN was decreased oral intake (64%), and neurological disease was the most prevalent illness. HEN was delivered via a nasogastric tube in 573 episodes (54.7%), by gastrostomy in 375 episodes (35.8%), oral feeding in 77 episodes (7.3%) and by jejunal access in 23 episodes (2.2%). Significant differences in the mode of administration were observed based on the pathology of the child (χ(2), P<0.0001). The cyclic feeding was the most widely used technique for the administration of HEN. Most of the patients used a pump and a polymeric formula. Transition to oral feeding was the primary reason for discontinuation of this type of support. Since the NEPAD registry was established in Spain, the number of documented patients has increased more than 25-fold. Many children with chronic illness benefit from HEN, mainly those suffering from neurological diseases.

  13. Breast and Colon Cancer Family Registries

    Cancer.gov

    The Breast Cancer Family Registry and the Colon Cancer Family Registry were established by the National Cancer Institute as a resource for investigators to use in conducting studies on the genetics and molecular epidemiology of breast and colon cancer.

  14. Predicting short-term survival after liver transplantation on eight score systems: a national report from China Liver Transplant Registry.

    PubMed

    Ling, Qi; Dai, Haojiang; Zhuang, Runzhou; Shen, Tian; Wang, Weilin; Xu, Xiao; Zheng, Shusen

    2017-02-13

    To compare the performance of eight score systems (MELD, uMELD, MELD-Na. iMELD, UKELD, MELD-AS, CTP, and mCTP) in predicting the post-transplant mortality, we analyzed the data of 6,014 adult cirrhotic patients who underwent liver transplantation between January 2003 and December 2010 from the China Liver Transplant Registry database. In hepatitis B virus (HBV) group, MELD, uMELD and MELD-AS showed good predictive accuracies at 3-month mortality after liver transplantation; by comparison with other five models, MELD presented the best ability in predicting 3-month, 6-month and 1-year mortality, showing a significantly better predictive ability than UKELD and iMELD. In hepatitis C virus and Alcohol groups, the predictive ability did not differ significantly between MELD and other models. Patient survivals in different MELD categories were of statistically significant difference. Among patients with MELD score >35, a new prognostic model based on serum creatinine, need for hemodialysis and moderate ascites could identify the sickest one. In conclusion, MELD is superior to other score systems in predicting short-term post-transplant survival in patients with HBV-related liver disease. Among patients with MELD score >35, a new prognostic model can identify the sickest patients who should be excluded from waiting list to prevent wasteful transplantation.

  15. Predicting short-term survival after liver transplantation on eight score systems: a national report from China Liver Transplant Registry

    PubMed Central

    Ling, Qi; Dai, Haojiang; Zhuang, Runzhou; Shen, Tian; Wang, Weilin; Xu, Xiao; Zheng, Shusen

    2017-01-01

    To compare the performance of eight score systems (MELD, uMELD, MELD-Na. iMELD, UKELD, MELD-AS, CTP, and mCTP) in predicting the post-transplant mortality, we analyzed the data of 6,014 adult cirrhotic patients who underwent liver transplantation between January 2003 and December 2010 from the China Liver Transplant Registry database. In hepatitis B virus (HBV) group, MELD, uMELD and MELD-AS showed good predictive accuracies at 3-month mortality after liver transplantation; by comparison with other five models, MELD presented the best ability in predicting 3-month, 6-month and 1-year mortality, showing a significantly better predictive ability than UKELD and iMELD. In hepatitis C virus and Alcohol groups, the predictive ability did not differ significantly between MELD and other models. Patient survivals in different MELD categories were of statistically significant difference. Among patients with MELD score >35, a new prognostic model based on serum creatinine, need for hemodialysis and moderate ascites could identify the sickest one. In conclusion, MELD is superior to other score systems in predicting short-term post-transplant survival in patients with HBV-related liver disease. Among patients with MELD score >35, a new prognostic model can identify the sickest patients who should be excluded from waiting list to prevent wasteful transplantation. PMID:28198820

  16. Neural tube defects in Malaysia: data from the Malaysian National Neonatal Registry.

    PubMed

    Boo, Nem-Yun; Cheah, Irene G S; Thong, Meow-Keong

    2013-10-01

    This study aimed to determine the prevalence and early outcome of neural tube defects (NTDs) in Malaysia. This prospective study included all neonates with NTDs (spina bifida, anencephaly, encephalocoele) born in 2009 in 32 Malaysian hospitals in the Malaysian National Neonatal Network. The prevalence of NTDs was 0.42 per 1000 live births, being highest among the indigenous people of Sarawak (1.09 per 1000 live births) and lowest among Malaysians of Chinese descent (0.09 per 1000 live births). The most common type of NTDs was anencephaly (0.19 per 1000 live births), followed by spina bifida (0.11 per 1000 live births) and encephalocoele (0.07 per 1000 live births). Majority of the infants with anencephaly (94.5%, n = 51), 45.8% (n = 11) with encephalocoele and 9.5% (n = 4) with spina bifida died. The median duration of hospital stay was 4 (range: 0-161) days. NTDs were common in Malaysia. Mortality was high. Long-term monitoring of NTD prevalence following folic fortification of food is recommended.

  17. A descriptive study of intentional self-poisoning from New Zealand national registry data.

    PubMed

    Kumpula, Eeva-Katri; Nada-Raja, Shyamala; Norris, Pauline; Quigley, Paul

    2017-10-01

    Understanding which population groups intentionally poison themselves by overdose and which substances are used are key to developing prevention efforts for such injuries. This paper uses Ministry of Health (MOH) data to explore the demographic characteristics of those who intentionally self-poison and the substances used, identifies limitations of existing data collections and makes recommendations for the future. MOH mortality data from 2000 to 2012, and public hospital presentation data from 2000-2014 of cases of intentional self-poisoning (ISP), and poisoning of undetermined intent (UDP), were examined. Men were more at risk of fatal intentional poisonings, while young women and people from deprived areas were predominant in hospital presentations for ISP and UDP. While ICD-10 categories were available, there was limited information in the majority of MOH data about specific substances used in the poisonings. The current format of MOH data indicates that developing interventions to help young people and those living in deprived areas may be useful. Finding specific solutions is challenging when only limited nationwide substance-specific poisoning information is available. Implications for public health: Including specific substances in national data collections is important for addressing the public health challenge of intentional overdose morbidity and mortality. © 2017 The Authors.

  18. Physical Trauma and Amyotrophic Lateral Sclerosis: A Population-Based Study Using Danish National Registries

    PubMed Central

    Seals, Ryan M.; Hansen, Johnni; Gredal, Ole; Weisskopf, Marc G.

    2016-01-01

    Prior studies have suggested that physical trauma might be associated with the development of amyotrophic lateral sclerosis (ALS). We conducted a population-based, individually matched case-control study in Denmark to assess whether hospitalization for trauma is associated with a higher risk of developing ALS. There were 3,650 incident cases of ALS in the Danish National Patient Register from 1982 to 2009. We used risk-set sampling to match each case to 100 age- and sex-matched population controls alive on the date of the case's diagnosis. Odds ratios and 95% confidence intervals were calculated using a conditional logistic regression model. History of trauma diagnosis was also obtained from the Danish Patient Register. When traumas in the 5 years prior to the index date were excluded, there was a borderline association between any trauma and ALS (odds ratio (OR) = 1.09, 95% confidence interval (CI): 0.99, 1.19). A first trauma before age 55 years was associated with ALS (OR = 1.22, 95% CI: 1.08, 1.37), whereas first traumas at older ages were not (OR = 0.97, 95% CI: 0.85, 1.10). Our data suggest that physical trauma at earlier ages is associated with ALS risk. Age at first trauma could help explain discrepancies in results of past studies of trauma and ALS. PMID:26825926

  19. National Human Radiobiological Tissue Repository (NHRTR) at the United States Transuranium and Uranium Registries

    DOE Data Explorer

    The NHRTR, one component of the USTUR, contains frozen tissues, tissue solutions, microscope slides, and paraffin blocks that were collected by the USTUR at the autopsy of workers with documented intakes of plutonium, americium, uranium, and thorium. The samples are available to qualified scientists for further research. Thousands of frozen, ashed, dried, and plastic embedded bone samples from the radium studies carried out by Argonne National Laboratory, Argonne Cancer Research Hospital, the Massachusetts Institute of Technology, and the New Jersey Radium Research Project are available and linked by case number to de-identified, published case data. These data include the person's source of exposure (dial painter, therapeutic injection, etc.), estimated body burden, radiochemical results, and medical history. Other samples, including organs and whole body donations, have come from volunteer donors who were impacted by elements such as plutonium, throium, etc. See the USTUR website for information on how to apply for research samples or how to become a volunteer donor. [Information taken from http://www.ustur.wsu.edu/NHRTR/index.html#

  20. National Foundation for Infectious Diseases

    MedlinePlus

    ... Foodborne Disease Sexually Transmitted Diseases Vaccine Information Resources 2017 NFID Annual News Conference William Schaffner, MD, Patricia ... vaccines View NFID Public Service Announcements CONFERENCES & COURSES 2017 Fall Clinical Vaccinology Course November 3-4, 2017 ...

  1. The Epidemiology of Appendicitis and Appendectomy in South Korea: National Registry Data

    PubMed Central

    Lee, Jung Hun; Park, Young Sun; Choi, Joong Sub

    2010-01-01

    Background Appendicitis is one of the most frequent acute surgical conditions of the abdomen, and appendectomy is one of the most commonly performed operations in the world. However, epidemiological data on appendicitis have not been reported for South Korean or East Asian populations. Methods We analyzed the epidemiological features and lifetime risk of appendicitis and appendectomy in South Korea using data collected for the national health insurance database from 2005 through 2007. Results Appendectomy was performed in 59.70% of inpatients diagnosed with appendicitis. The overall incidences of appendicitis, total appendectomy, and perforated appendectomy were 22.71, 13.56, and 2.91 per 10 000 population per year, respectively. The incidence of appendicitis and appendectomy showed clear seasonality, with a peak in summer. The standardized lifetime risks of appendicitis and appendectomy were constant from 2005 through 2007. A life table model suggests that the lifetime risk of appendicitis is 16.33% for males and 16.34% for females, and that the lifetime risk of appendectomy is 9.89% for males and 9.61% for females. Conclusions As compared to results obtained in research on Western populations, appendicitis and appendectomy had a similar perforation rate and seasonality, but a higher overall incidence, in South Koreans. Between 2005 and 2007, the incidence of appendicitis and appendectomy was constant. Overall, an estimated 15 incidental appendectomies are performed to prevent 1 inpatient with suspected appendicitis, and 26 incidental appendectomies are performed to prevent 1 appendectomy. Incidental appendectomy may have greater preventive value in Koreans. PMID:20023368

  2. [Corneal transplantation in Hungary. Data of the National Keratoplasty Registry 1992-1996].

    PubMed

    Berta, A; Facskó, A; Kelenhegyi, C; Módis, L

    1997-06-29

    Upon the request of the National Transplantation Committee a nationwide keratoplasty register is functioning at the Department of Ophtalmology, University Medical School of Debrecen. Since then at the end of each year we collected data from the University Departments and Hospitals performing corneal transplantation concerning their keratoplasties and related activities. According to the acquired data the number of corneal transplantations performed in Hungary was 299 in 1992, 298 in 1993, 320 in 1994, 426 in 1995, and 479 in 1996. Keratoplasties in Hungary were performed in 6 University Departments and in 13 Hospitals, all together in 19 institutions in the past five years. The overwhelming majority of corneal transplantations (in 1995 95.8% and in 1996 96.4%) were penetrating keratoplasties. The ratios of lamellar keratoplasties in 1995 and in 1996 were 3.0% and 2.5%, respectively. The ratios of sclerokeratoplasties were slightly above 1% in both years. The distributions of implanted fresh and preserved (eye bank) corneas were around 50-50% in these two years so, that in 1995 a somewhat more and in 1996 somewhat less preserved corneas were used. This ratio for preserved corneas was less than 20% in the period between 1992 and 1994. The law regulating the procurement and the transplantation of corneas is based on presumed consent and explicit objection which is the better type of regulation for the performance of keratoplasties in large numbers. The number of corneal transplantations in Hungary in the past years was close to the figures of industrial countries (England, Germany) calculated for similar populations, inspite of the fact that financing was in many respects unacceptable.

  3. [The year 2002 national registry on home-based enteral nutrition].

    PubMed

    Planas, M; Lecha, M; García Luna, P P; Chamorro, J; Zamarrón, I; Parés, R M; Bonada, A; Cardona, D; Jiménez, M; Irles, J A; Boris, M A; Rodríguez, A; Calañas, A J; Camarero, E; Martí, E; Pérez de la Cruz, A; Mancha, A; Gómez Enterría, P; de Luis, D; Muñoz, A; Bayo, P; Luengo, L M

    2005-01-01

    To communicate the information available by the NADYA-SENPE Working Group from patients on Home Enteral Nutrition (HEN) in our country during the year 2002. The data were collected through a closed questionnaire included in the web site of the Working Group (www.nadya-senpe.com) available only by the authorized users. Variable included were: epidemiological information, the indication to prescribe this treatment, the access path, the specific nutritional formula used, the treatment duration, the complications and hospital readmission related to the nutritional treatment, the follow-up and the quality of life. We register 3967 patients that belong to twenty-one hospitals. Mean age from those adults 69.2 +/- 19.2 years, and from those younger than 14, 5.6 +/- 4.1 years. Neurological and neoplasic diseases were the diagnostics more frequents (39.2% and 34.6%, respectively). Oral nutrition was the preferential rout used for the enteral nutrition (53.6%) followed by naso-enteral tube (30.6%), and only in 15.8% we used ostomy tubes. Polymeric was the enteral formula mainly utilized (81.5%). The mean time on HEN was 5.8 +/- 4.4 months; the 35.7% of patients stayed in the treatment for less than 3 months, 22.4% between 3 and 6 months, and 41.6% more than 6 months. Patients were followed mainly by Nutritional Support Unit from the reference hospital (75.3%). While the reference hospital supplies the material (65.7%), reference hospital pharmacy (43%) and public pharmacies (37.3%) provides the enteral formula. Complications related to enteral nutrition included change of enteral tube (29.7%), mechanical complications (22.9%), gastrointestinal complications (22.9%), and the metabolic one (9.2%). These complications were followed by 0.02 hospitalizations/patient. At the end of the year, 49.3% of patients were in the HEN programme, and in 41.5% HEN was finish due to accept oral conventional alimentation (47.3%) or by deceased of patients. While 31.8% of the patients were

  4. 76 FR 27070 - National Institute of Allergy and Infectious Diseases;

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases... personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis... . Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel,...

  5. The Danish Stroke Registry

    PubMed Central

    Johnsen, Søren Paaske; Ingeman, Annette; Hundborg, Heidi Holmager; Schaarup, Susanne Zielke; Gyllenborg, Jesper

    2016-01-01

    Aim of database The aim of the Danish Stroke Registry is to monitor and improve the quality of care among all patients with acute stroke and transient ischemic attack (TIA) treated at Danish hospitals. Study population All patients with acute stroke (from 2003) or TIA (from 2013) treated at Danish hospitals. Reporting is mandatory by law for all hospital departments treating these patients. The registry included >130,000 events by the end of 2014, including 10,822 strokes and 4,227 TIAs registered in 2014. Main variables The registry holds prospectively collected data on key processes of care, mainly covering the early phase after stroke, including data on time of delivery of the processes and the eligibility of the individual patients for each process. The data are used for assessing 18 process indicators reflecting recommendations in the national clinical guidelines for patients with acute stroke and TIA. Patient outcomes are currently monitored using 30-day mortality, unplanned readmission, and for patients receiving revascularization therapy, also functional level at 3 months poststroke. Descriptive data Sociodemographic, clinical, and lifestyle factors with potential prognostic impact are registered. Conclusion The Danish Stroke Registry is a well-established clinical registry which plays a key role for monitoring and improving stroke and TIA care in Denmark. In addition, the registry is increasingly used for research. PMID:27843349

  6. Diagnostic yield of upper endoscopy in paediatric patients with Crohn's disease and ulcerative colitis. Subanalysis of the HUPIR registry.

    PubMed

    Kovacs, Marta; Muller, Katalin Eszter; Arato, Andras; Lakatos, Peter Laszlo; Kovacs, Judit B; Varkonyi, Agnes; Solyom, Eniko; Polgar, Marianne; Nemes, Eva; Guthy, Ildiko; Tokodi, Istvan; Toth, Gergely; Horvath, Agnes; Tarnok, Andras; Tomsits, Erika; Csoszánszky, Noemi; Balogh, Marta; Vass, Noemi; Bodi, Piroska; Dezsofi, Antal; Gardos, Laszlo; Micskey, Eva; Papp, Maria; Szucs, Daniel; Cseh, Aron; Molnar, Kriszta; Szabo, Doloresz; Veres, Gabor

    2012-02-01

    According to Porto Criteria upper gastrointestinal (UGI) endoscopy is recommended in patients with suspected inflammatory bowel disease (IBD). Nevertheless, previous studies revealed frequent involvement of UGI tract even in patients with ulcerative colitis (UC). The aim of the present study was to determine the diagnostic role of esophagogastroduodenoscopy (EGD) and assess the prevalence and different aspects of UGI involvement in children registered in the Hungarian Pediatric IBD Registry (HUPIR) from 1st of January 2007 to 31th of December 2009. Twenty seven institutes provided prospective follow-up data about newly diagnosed IBD patients to HUPIR. The registry was based on detailed questionnaire (76 parameters) involving anamnestic data, laboratory findings, activity indexes, diagnostic procedures, endoscopic examinations (EGD and ileocolonoscopy), and histological data. Localization and phenotype of disease were based on the Montreal classification criteria. During the 3-year period 420 children were diagnosed with IBD, 265 (63%) of them had Crohn's disease (CD), 130 (31%) UC, and 25 (6%) IBD-unclassified (IBD-U). The mean age at diagnosis was 13.2 years (range: 1.2-18 years). EGD was performed in 237 patients (56%), in most cases in patients suffering from CD. Macroscopic lesions on EGD were noted in 64% of patients with CD and 40% of children with UC. Characteristic lesions for CD (ulcer, erosion, aphthous lesion, and granuloma) were noted in 31% of CD patients, however, EGD helped to establish the final diagnosis in 9% of CD patients (diagnostic yield, 9%). There was a high frequency of UGI involvement in children with CD and UC. One third of CD patients showed significant lesions at upper endoscopy and one patient out of ten had real diagnostic help from EGD. Copyright © 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

  7. Effectiveness of selective risk based screening for Gestational Diabetes (GDM) in Malaysia: A retrospective cohort study based on the National Obstetric Registry (NOR) of Malaysia.

    PubMed

    Muniswaran, G; Soelar, S A; Karalasingam, S D; Bujang, M A; Jeganathan, R; Suharjono, H

    2017-02-01

    Gestational diabetes (GDM) has significant maternal and foetal implications. screening allows active interventions which significantly improves pregnancy outcomes. Despite World Health Organization (WHO), FIGO and National Institute of clinical Excellence (NIcE) recommendations for universal screening especially among high risk population; Malaysia currently adopts a selective risk based screening for GDM. the objective is to audit the effectiveness of the current practice of selective risk based screening in detection of GDM in Malaysia. this is a retrospective cohort study based on the National Obstetric Registry (NOR) which comprises of 14 major tertiary hospitals in Malaysia. the study period was from 1st January 2011 till 31st December 2012 and a total of 22,044 patients with GDM were analysed. Logistic regression analysis was used to calculate the crude odd ratio. the incidence of GDM in Malaysia is 8.4%. Maternal age of ≥25, booking bMI ≥27kg/m2, booking weight ≥80kg and previous hypertension are non-significant risk of developing GDM in Malaysia. Parity 5 and more was only associated with an odds-ratio of 1.02 (95% confidence Interval: 0.90-1.17) as compared to parity below 5. the association of women with previous stillbirth with GDM was not significant. current risk based screening for GDM based on maternal age, booking bMI, weight and hypertension is inappropriate. An ideal screening tool should precede disease complications, which is the novel objective of screening. Universal screening for GDM in Malaysia may be a more accurate measure, especially with regards to reducing maternal and foetal complications.

  8. Use of aldosterone antagonists at discharge after myocardial infarction: results from the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry-Get with the Guidelines (GWTG).

    PubMed

    Rao, Krishnasree K; Enriquez, Jonathan R; de Lemos, James A; Alexander, Karen P; Chen, Anita Y; McGuire, Darren K; Fonarow, Gregg C; Das, Sandeep R

    2013-10-01

    Aldosterone antagonists (AldA) improve survival after myocardial infarction (MI) in patients with left ventricular systolic dysfunction (ejection fraction [EF] <40%) concomitant with either clinical heart failure (HF) or diabetes mellitus (DM). Although current American College of Cardiology/American Heart Association guidelines provide a class I recommendation for AldA therapy in such patients, how US practice reflects these recommendations is unclear. Using data from the National Cardiovascular Data Registry ACTION Registry-GWTG, we describe contemporary discharge AldA prescription patterns among 202,213 patients discharged after acute MI from 526 US sites participating in ACTION Registry-GWTG between January 2007 and March 2011. Overall, 10.0% of patients were eligible for AldA without documented contraindication, with only 14.5% of eligible patients receiving AldA at discharge. Among the subset of AldA-eligible patients discharged on otherwise optimal medical therapy (68.9%), AldAs were prescribed to 16.1%. Aldosterone antagonist use was higher in patients with EF <40% and clinical HF with or without DM (17.7% and 16.6%, respectively), compared with patients with EF <40% and DM without clinical HF (7.8%, P < .001 for each). Fewer than 2% of participating centers used AldA in ≥50% of eligible patients. Despite clinical outcome evidence and class I guideline recommendations, AldAs are underused in the United States, with only 1 in 7 eligible patients prescribed AldA at discharge after MI. This contrasts with high use of other evidence-based post-MI medications and identifies a specific gap in translation of evidence into clinical practice. © 2013.

  9. The quality of severe mental disorder diagnoses in a national health registry as compared to research diagnoses based on structured interview.

    PubMed

    Nesvåg, Ragnar; Jönsson, Erik G; Bakken, Inger Johanne; Knudsen, Gun Peggy; Bjella, Thomas D; Reichborn-Kjennerud, Ted; Melle, Ingrid; Andreassen, Ole A

    2017-03-14

    Utilization of diagnostic information from national patient registries rests on the quality of the registered diagnoses. We aimed to investigate the agreement and consistency of diagnoses of psychotic and bipolar disorders in the Norwegian Patient Registry (NPR) compared to structured interview-based diagnoses given as part of a clinical research project. Diagnostic data from NPR were obtained for the period 01.01.2008-31.12.2013 for all patients who had been included in the Thematically Organized Psychosis (TOP) study between 18.10.2002 and 01.09.2014 with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia (n = 537), delusional disorder (n = 48), schizoaffective disorder (n = 118) or bipolar disorder (n = 408). Diagnostic agreement between the primary DSM-IV diagnosis in TOP and the International Classification of Diseases, 10th revision (ICD-10) diagnoses in NPR was evaluated using Cohen's unweighted nominal kappa (κ). Diagnostic consistency was calculated as the proportion of all registered severe mental disorder diagnoses in NPR that were equivalent to the primary diagnosis given in the TOP study. The proportion of patients registered with the equivalent ICD-10 diagnosis as the primary DSM-IV diagnosis given in TOP was 84.2% for the schizophrenia group, 68.8% for the delusional disorder group, 76.3% for the schizoaffective disorder group, and 78.4% for the bipolar disorder group. Diagnostic agreement was good for schizophrenia (κ = 0.74) and bipolar disorder (κ = 0.72), fair for schizoaffective disorder (κ = 0.63), and poor for delusional disorder (κ = 0.39). Among patients with DSM-IV schizophrenia, 4.7% were diagnosed with ICD-10 bipolar disorder, and among patients with DSM-IV bipolar disorder, 2.5% were diagnosed with ICD-10 schizophrenia. Diagnostic consistency was 84.9% for schizophrenia, 59.1% for delusional disorder, 65.9% for schizoaffective disorder, and 91

  10. Surgical Treatment of Patients Enrolled in the National Registry of Genetically Triggered Thoracic Aortic Conditions (GenTAC)

    PubMed Central

    Song, Howard K.; Bavaria, Joseph E.; Kindem, Mark W.; Holmes, Kathryn W.; Milewicz, Dianna M.; Maslen, Cheryl L.; Pyeritz, Reed E.; Basson, Craig T.; Eagle, Kim; Tolunay, H. Eser; Kroner, Barbara L.; Dietz, Hal; Menashe, Victor; Devereux, Richard B.; Desvigne-Nickens, Patrice; Ravekes, William; Weinsaft, Jonathan W.; Brambilla, Donald; Stylianou, Mario P.; Hendershot, Tabitha; Mitchell, Megan S.; LeMaire, Scott A.

    2011-01-01

    Background Genetic disorders are an important cause of thoracic aortic aneurysms (TAAs) in young patients. Despite advances in the treatment of genetically triggered TAAs, the optimal syndrome-specific treatment approach remains undefined. We used data from the NIH-funded, multicenter National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) to characterize the contemporary surgical treatment of patients with genetically triggered TAAs. Methods GenTAC’s aim is to collect longitudinal clinical data and banked biospecimens from 2800 patients with genetically triggered TAAs. We analyzed data from all patients enrolled in GenTAC to date whose clinical data were available (n=606; mean age, 37.5 years). Results The patients’ primary diagnoses included Marfan syndrome (35.8%), bicuspid aortic valve with aneurysm (29.2%), and familial TAAs and dissections (10.7%). More than half of patients (56.4%) had undergone at least 1 operation; the most common indications were aneurysm (85.7%), valve dysfunction (65.8%), and dissection (25.4%). Surgical procedures included replacement of the aortic root (50.6%), ascending aorta (64.8%), aortic arch (27.9%), and descending or thoracoabdominal aorta (12.4%). Syndrome-specific differences in age, indications for surgery, and procedure type were identified. Conclusions Patients with genetically transmitted TAAs evaluated in tertiary care centers frequently undergo surgery. Aneurysm repairs most commonly involve the aortic root and ascending aorta; distal repairs are less common. Like TAAs themselves, complications of TAAs, including dissection and aortic valve dysfunction, are important indications for surgery. Future studies will focus on syndrome- and gene-specific phenotypes, biomarkers, treatments, and outcomes to improve the treatment of patients with TAAs. PMID:19699898

  11. Nationwide Incidence of Ocular Melanoma in South Korea by Using the National Cancer Registry Database (1999-2011).

    PubMed

    Park, Sang Jun; Oh, Chang-Mo; Kim, Byung Woo; Woo, Se Joon; Cho, Hyunsoon; Park, Kyu Hyung

    2015-07-01

    The purpose of this study was to determine the age-standardized incidence rate of ocular melanoma and its subtypes in South Korea from 1999 to 2011. The national cancer registry in South Korea was reviewed to ascertain all ocular melanoma incidents between 1999 and 2011, which covered the entire South Korean population. Age-standardized incidence rates of ocular melanoma and its subtypes were calculated. Trends in incidence were analyzed by the use of Joinpoint regression. Analyses were stratified by tumor type, sex, age, and year of cancer diagnosis. A total of 464 ocular melanoma cases (227 men [48.9%]) were identified from 1999 to 2011. The age-standardized incidence rate for 1999 to 2011 was 0.60 (95% confidence interval [CI]: 0.55-0.66) per million people. Among ocular melanomas, uveal melanoma had the highest age-standardized incidence rate for 1999 to 2011 (0.42 [95% CI: 0.38-0.47] per million people), followed by conjunctival melanoma (0.12 [95% CI: 0.09-0.14] per million people). The age-standardized incidence rate was higher in 2006 to 2011 than in 1999 to 2005, and increasing incidence trends were observed throughout the study period. Incidence rate of ocular melanoma for 1999 to 2011 is relatively lower in South Korean population than in that reported in white population. Although ocular melanoma is still considered a rare cancer in South Korea, our findings suggest increasing incidence trends. This may warrant future in-depth study.

  12. The UK National Registry of ABO and HLA Antibody Incompatible Renal Transplantation: Pretransplant Factors Associated With Outcome in 879 Transplants

    PubMed Central

    Pankhurst, Laura; Hudson, Alex; Mumford, Lisa; Willicombe, Michelle; Galliford, Jack; Shaw, Olivia; Thuraisingham, Raj; Puliatti, Carmelo; Talbot, David; Griffin, Sian; Torpey, Nicholas; Ball, Simon; Clark, Brendan; Briggs, David; Fuggle, Susan V.; Higgins, Robert M.

    2017-01-01

    Background ABO and HLA antibody incompatible (HLAi) renal transplants (AIT) now comprise around 10% of living donor kidney transplants. However, the relationship between pretransplant factors and medium-term outcomes are not fully understood, especially in relation to factors that may vary between centers. Methods The comprehensive national registry of AIT in the United Kingdom was investigated to describe the donor, recipient and transplant characteristics of AIT. Kaplan-Meier analysis was used to compare survival of AIT to all other compatible kidney transplants performed in the United Kingdom. Cox proportional hazards regression modeling was used to determine which pretransplant factors were associated with transplant survival in HLAi and ABOi separately. The primary outcome was transplant survival, taking account of death and graft failure. Results For 522 HLAi and 357 ABO incompatible (ABOi) transplants, 5-year transplant survival rates were 71% (95% confidence interval [CI], 66-75%) for HLAi and 83% (95% CI, 78-87%) for ABOi, compared with 88% (95% CI, 87-89%) for 7290 standard living donor transplants, and 78% (95% CI, 77-79%) for 15 322 standard deceased donor transplants (P < 0.0001). Increased chance of transplant loss in HLAi was associated with increasing number of donor specific HLA antibodies, center performing the transplant, antibody level at the time of transplant, and an interaction between donor age and dialysis status. In ABOi, transplant loss was associated with no use of IVIg, cytomegalovirus seronegative recipient, 000 HLA donor-recipient mismatch; and increasing recipient age. Conclusions Results of AIT were acceptable, certainly in the context of a choice between living donor AIT and an antibody compatible deceased donor transplant. Several factors were associated with increased chance of transplant loss, and these can lead to testable hypotheses for further improving therapy. PMID:28706984

  13. Quantifying Selection Bias in National Institute of Health Stroke Scale Data Documented in an Acute Stroke Registry.

    PubMed

    Thompson, Michael P; Luo, Zhehui; Gardiner, Joseph; Burke, James F; Nickles, Adrienne; Reeves, Mathew J

    2016-05-01

    As a measure of stroke severity, the National Institutes of Health Stroke Scale (NIHSS) is an important predictor of patient- and hospital-level outcomes, yet is often undocumented. The purpose of this study is to quantify and correct for potential selection bias in observed NIHSS data. Data were obtained from the Michigan Stroke Registry and included 10 262 patients with ischemic stroke aged ≥65 years discharged from 23 hospitals from 2009 to 2012, of which 74.6% of patients had documented NIHSS. We estimated models predicting NIHSS documentation and NIHSS score and used the Heckman selection model to estimate a correlation coefficient (ρ) between the 2 model error terms, which quantifies the degree