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Sample records for clinical case registries

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

    PubMed Central

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

    2013-01-01

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

  2. Clinical disease registries in acute myocardial infarction

    PubMed Central

    Ashrafi, Reza; Hussain, Hussain; Brisk, Robert; Boardman, Leanne; Weston, Clive

    2014-01-01

    Disease registries, containing systematic records of cases, have for nearly 100 years been valuable in exploring and understanding various aspects of cardiology. This is particularly true for myocardial infarction, where such registries have provided both epidemiological and clinical information that was not readily available from randomised controlled trials in highly-selected populations. Registries, whether mandated or voluntary, prospective or retrospective in their analysis, have at their core a common study population and common data definitions. In this review we highlight how registries have diversified to offer information on epidemiology, risk modelling, quality assurance/improvement and original research-through data mining, transnational comparisons and the facilitation of enrolment in, and follow-up during registry-based randomised clinical trials. PMID:24976913

  3. 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. PMID:26579661

  4. The Toxicology Investigators Consortium Case Registry--the 2014 Experience.

    PubMed

    Rhyee, Sean H; Farrugia, Lynn; Campleman, Sharan L; Wax, Paul M; Brent, Jeffrey

    2015-12-01

    The Toxicology Investigators Consortium (ToxIC) Case Registry was established in 2010 by the American College of Medical Toxicology. The Registry includes all medical toxicology consultations performed at participating sites. The Registry was queried for all cases entered between January 1 and December 31, 2014. Specific data reviewed for analysis included demographics (age, gender, ethnicity), source of consultation, reasons for consultation, agents involved in toxicological exposures, signs, symptoms, clinical findings, fatalities, and treatment. In 2014, 9172 cases were entered in the Registry across 47 active member sites. Females accounted for 51.1 % of cases. The majority (65.1 %) of cases were adults between the ages of 19 and 65. Caucasians made up the largest identified ethnic group (48.9 %). Most Registry cases originated from the inpatient setting (93.5 %), with a large majority of these consultations coming from the emergency department or inpatient admission services. Intentional and unintentional pharmaceutical exposures continued to be the most frequent reasons for consultation, accounting for 61.7 % of cases. Among cases of intentional pharmaceutical exposure, 62.4 % were associated with a self-harm attempt. Non-pharmaceutical exposures accounted for 14.1 % of Registry cases. Similar to the past years, non-opioid analgesics, sedative-hypnotics, and opioids were the most commonly encountered agents. Clinical signs or symptoms were noted in 81.9 % of cases. There were 89 recorded fatalities (0.97 %). Medical treatment (e.g., antidotes, antivenom, chelators, supportive care) was rendered in 62.3 % of cases. Patient demographics and exposure characteristics in 2014 Registry cases remain similar to prior years. The majority of consultations arose in the acute care setting (emergency department or inpatient) and involved exposures to pharmaceutical products. Among exposures, non-opioid analgesics, sedative/hypnotics, and opioids were the most frequently

  5. The Egyptian clinical trials’ registry profile: Analysis of three trial registries (International Clinical Trials Registry Platform, Pan-African Clinical Trials Registry and clinicaltrials.gov)

    PubMed Central

    Zeeneldin, Ahmed A.; Taha, Fatma M.

    2015-01-01

    Registering clinical trials (CTs) in public domains enhances transparency, increases trust in research, improves participation and safeguards against publication bias. This work was done to study the profile of clinical research in Egypt in three CT registries with different scopes: the WHO International CT Registry Platform (ICTRP), the continental Pan-African CT Registry (PACTR) and the US clinicaltrials.gov (CTGR). In March 2014, ICTRP, PACTR and CTGR were searched for clinical studies conducted in Egypt. It was found that the number of studies conducted in Egypt (percentage) was 686 (0.30%) in ICTRP, 56 (11.3%) in PACTR and 548 (0.34%) in CTGR. Most studies were performed in universities and sponsored by university/organization, industry or individual researchers. Inclusion of adults from both genders predominated. The median number of participants per study in the three registries ranged between 63 and 155. The conditions researched differed among the three registries and study purpose was mostly treatment followed by prevention. Endpoints were mostly efficacy followed by safety. Observational:Interventional studies (i.e. clinical trials) represented 15.5%:84.5% in ICTRP, 0%:100% in PACTR and 16.4%:83.6% in CTGR. Most interventions were drugs or procedures. Observational studies were mostly prospective and cohort studies. Most CTs were phase 3 and tested drugs or procedures. Parallel group assignment and random allocation predominated. Blinding was implemented in many of trials and was mostly double-blind. We conclude that CTs from Egypt in trial registries are apparently low and do not accurately reflect clinical research conducted in Egypt or its potential. Development of an Egyptian CT registry is eagerly needed. Registering all Egyptian CTs in public domains is highly recommended. PMID:26843968

  6. Creating an effective clinical registry for rare diseases.

    PubMed

    D'Agnolo, Hedwig Ma; Kievit, Wietske; Andrade, Raul J; Karlsen, Tom Hemming; Wedemeyer, Heiner; Drenth, Joost Ph

    2016-06-01

    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

  7. 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

  8. US Beryllium Case Registry through 1977

    SciTech Connect

    Sprince, N.L.; Kazemi, H.

    1980-02-01

    A synopsis of the cases reported to the Beryllium Case Registry between 1973 and 1977 is presented. As of 1973, there were 832 cases of beryllium disease entered into the Registry. In the five years since that report, 55 additional cases have been added, 40 men and 15 women. Exposures occured in the electronics and nuclear industries in the production and use of beryllium containing alloys and beryllium oxide ceramis. Pathological changes in the lung tissue are described. Cases continue to be reported in which the diagnosis was sarcoidosis until the history of beryllium exposure led to the finding of beryllium in the lung tissue or mediastinal lymph node biopsy. Data from the Registry support the fact that chronic beryllium disease is a continued occupational hazard.

  9. Clinical Cancer Registries - Are They Up for Health Services Research?

    PubMed

    Pobiruchin, Monika; Bochum, Sylvia; Martens, Uwe M; Schramm, Wendelin

    2016-01-01

    Clinical cancer registries are a valuable data source for health services research (HSR). HSR is in need of high quality routine care data for its evaluations. However, the secondary use of routine data - such as documented cancer cases in a disease registry - poses new challenges in terms of data quality, IT-management, documentation processes and data privacy. In the clinical cancer registry Heilbronn-Franken, real-world data from the Giessen Tumor Documentation System (GTDS) was utilized for analyses of patients' disease processes and guideline adherence in follow-up care. A process was developed to map disease state definitions to fields of the GTDS database and extract patients' disease progress information. Thus, the disease process of sub-cohorts could be compared to each other, e.g., comparison of disease free survival of HER2 (human epidermal growth factor receptor 2)-positive and -negative women who were treated with Trastuzumab, a targeted therapy applied in breast cancer. In principle, such comparisons are feasible and of great value for HSR as they depict a routine care setting of a diverse patient cohort. Yet, local documentation practice, missing flow of information from external health care providers or small sub-cohorts impede the analyses of clinical cancer registries data bases and usage for HSR. PMID:27577380

  10. The Toxicology Investigators Consortium Case Registry-the 2015 Experience.

    PubMed

    Farrugia, Lynn A; Rhyee, Sean H; Campleman, Sharan L; Ruha, Anne-Michelle; Weigand, Timothy; Wax, Paul M; Brent, Jeffrey

    2016-09-01

    The American College of Medical Toxicology established the Toxicology Investigators Consortium (ToxIC) Case Registry in 2010. The Registry contains all medical toxicology consultations performed at participating sites. The Registry has continued to grow since its inception, and as of December 31, 2015, contains 43,099 cases. This is the sixth annual report of the ToxIC Registry, summarizing the additional 8115 cases entered in 2015. Cases were identified by a query of the Registry for all cases entered between January 1 and December 31, 2015. Specific data reviewed for analysis included demographics (age, race, gender), source of consultation, reason for consultation, agents and agent classes involved in exposures, signs, symptoms, clinical findings, fatalities, and treatment. By the end of 2015, there were 50 active sites, consisting of 101 separate health-care facilities; 51.2 % of cases involved females. Adults between the ages of 19 and 65 made up the majority (64.2 %) of Registry cases. Caucasian race was the most commonly reported (55.6 %); 9.6 % of cases were identified as Hispanic ethnicity. Inpatient and emergency department referrals were by far the most common referral sources (92.9 %). Intentional pharmaceutical exposures remained the most frequent reason for consultation, making up 52.3 % of cases. Of these intentional pharmaceutical exposures, 69 % represented an attempt at self-harm, and 85.6 % of these were a suicide attempt. Nonopioid analgesics, sedative-hypnotics, and antidepressant agents were the most commonly reported agent classes in 2015. Almost one-third of Registry cases involved a diagnosed toxidrome (32.8 %), with a sedative-hypnotic toxidrome being the most frequently described. Significant vital sign abnormalities were recorded in 25.3 % of cases. There were 98 fatalities reported in the Registry (1.2 %). Adverse drug reactions were reported in 4.3 % of cases. Toxicological treatment was given in 65.3 % of cases, with 33.0

  11. Ankylosing spondylitis clinical registries: principles, practices and possibilities.

    PubMed

    Caplan, Liron; Clegg, Daniel O; Inman, Robert D

    2013-06-01

    The need for a rigorously developed longitudinal registry of patients with spondyloarthritis (SpA) is clear and urgent. Like randomized controlled trials, registries rely on a prospective, systematic protocol-driven approach to data acquisition to assess outcomes for a prescribed cohort of patients. Registries seek to capture large numbers of patients across large geographic zones and can serve as a valuable resource for patient advocacy, patient education and support, incidence and prevalence, and broad demographic profiles. Building on 3 existing registries--the Prospective Study of Outcomes in Ankylosing Spondylitis, the Program to Understand the Longterm Outcomes of Spondyloarthritis (PULSAR) and the University Health Network Spondyloarthritis Program--these registries and the Spondylitis Association of America propose to form a combined registry of North American SpA patients. The combined registry would, ideally, complement ongoing clinical goals and improve patient care. PMID:23841118

  12. [Taxonomy and definition of clinical registries].

    PubMed

    Costa, Giuseppe

    2015-09-01

    In order to assess the needs of knowledge about surveillance and registries in Italy and to prepare a proposal for the advancement of monitoring and recording capacity, a working group led by the Italian Association of Epidemiology and composed by the University of Turin, the Institute of Health and Agenas, carried out a survey of definitions and approaches used in public health and consulted the main Italian experts in surveillance and registries. Some of the reflections developed in this project are presented, to assess to which extent they are adaptable to the prospects the program PRIER aims to. Different aspects of the issue are analyzed: from the frame work necessary to identify information needs and how to improve the ability to measure and types of definitions and taxonomies of the registers, to the implications of the choices about what to include in registries on regulation of the instruments and investment priorities for new registries and surveillance. PMID:26418503

  13. The toxicology investigators consortium case registry-the 2013 experience.

    PubMed

    Rhyee, Sean H; Farrugia, Lynn; Wiegand, Timothy; Smith, Eric A; Wax, Paul M; Brent, Jeffrey

    2014-12-01

    The Toxicology Investigators Consortium (ToxIC) Case Registry was established in 2010 by the American College of Medical Toxicology. The Registry includes all medical toxicology consultations performed at participating sites. This report summarizes the Registry data for 2013. A query of the ToxIC Registry was carried out for the dates of January 1 through December 31, 2013. Specific data reviewed for analysis included demographics (age, gender), source of consultation, reasons for consultation, agents involved in toxicological exposures, signs, symptoms and clinical findings, and treatment. A total of 8,598 cases were entered into the Registry in 2013. Females accounted for 49.2 % of cases, males for 47.7 %, and gender was not reported in 3.1 %. The majority of patients (63.4 %) were adults between the ages of 19 and 65 years. There were 93 fatalities (1.1 %). Most referrals for medical toxicology consultation originated from the emergency department (59.7 %) or inpatient services (16.7 %). Exposures to pharmaceutical products (intentional and unintentional) made up 50.0 % of cases. Illicit drug abuse (8.0 %) and adverse drug reactions (ADRs) (4.8 %) were the next most frequent reasons for consultation. Similar to past years, nonopioid analgesics, sedative-hypnotics, and opioids were the most commonly encountered agents. Symptoms or clinical findings were documented in 71.1 % of patients. Of all cases, 54.6 % required some form of medical treatment (antidotes, antivenom, chelation, specific types of supportive care). This report serves as a comprehensive survey of medical toxicology practice within participating institutions. Prior trends continued to apply this year and indicate analgesic (opioid and nonopioid), sedative-hypnotic/muscle relaxant agents, illicit drug use, and ADRs continue to be major toxicological problems. Cases requiring medical toxicology consultation in 2013 predominantly involved pharmaceuticals and illicit drugs. Reasons for these drug

  14. Using Registries to Recruit Subjects for Clinical Trials

    PubMed Central

    Tan, Meng H; Thomas, Matthew; MacEachern, Mark P

    2015-01-01

    Aim We studied the use of patient/disease registries to recruit potential subjects for prospective clinical trials - describing the number, types and major benefits of using this approach. Methods In December 2013, we conducted a focused database search in PubMed, EMBASE, and Web of Science for studies (English language only) that used registries to recruit subjects for clinical trials published in 2004-2013. Of the 233 unique citations identified, 21 used registries to recruit subjects - 10 papers and 11 abstracts. Pearling and search for subsequent full papers of the abstracts identified 4 more papers. Results Our analysis, based on these 25 citations, showed 14 are related to cancer, 3 to diabetes mellitus, 1 each to stroke, asthma, and celiac disease and 5 are disease neutral. Many types of registries (population-based cancer, quality improvement, disease-specific, web-based disease-neutral registries, local general practice registers, and national health database) are used to recruit subjects for clinical trials and uncover new knowledge. Overall, 16 registries are in the US, 4 in UK, 1 each in Canada, Spain, Australia and I in many countries. Registries can identify very large number of subjects for screening for eligibility for clinical trials, especially in very large trials, rare disease trials, and trials involving minority patients. Conclusions Registries can retrospectively identify very large numbers of potential subjects for screening for eligibility and enrollment in prospective clinical trials. This matching can lead to more timely recruitment and help solve a major problem in conducting clinical trials. PMID:25545027

  15. Metadata registry and management system based on ISO 11179 for cancer clinical trials information system

    PubMed Central

    Park, Yu Rang; Kim*, Ju Han

    2006-01-01

    Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers. PMID:17238675

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

    PubMed

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

    2012-12-01

    In 2010, the American College of Medical Toxicology established its Case Registry, the Toxicology Investigators Consortium (ToxIC). ToxIC is a prospective registry, which exclusively compiles suspected and confirmed toxic exposure cases cared for at the bedside by medical toxicologists at its participating sites. The Registry aims to fulfill two important gaps in the field: a real-time toxicosurveillance system to identify current poisoning trends and a powerful research tool in toxicology. ToxIC allows extraction of information from medical records making it the most robust multicenter database on chemical toxicities in existence. All cases seen by medical toxicologists at participating institutions were entered in a database. Information characterizing patients entered in 2011 was tabulated. 2010 data was also included so that cumulative total numbers could be described as well. The current report is a summary of the data collected in 2011 in comparison to 2010 entries and also includes cumulative data through December 31st, 2011. During 2011, 28 sites with 49 specific institutions contributed a total of 6,456 cases to the Registry. The total number of cases entered into the registry at the end of 2011 was 10,392. Emergency departments remained the most common source of consultations in 2011, accounting for 53 % of cases. The most common reason for consultation was for pharmaceutical overdoses, which occurred in 48 % of patients, including intentional (37 %) and unintentional (11 %) exposures. The most common classes of agents were sedative-hypnotics (1,492 entries in 23 % of cases), non-opioid analgesics (1,368 cases in 21 % of cases), opioids (17 %), antidepressants (16 %), stimulants/sympathomimetics (12 %), and ethanol (8 %). N-acetylcysteine was the most commonly administered antidote during 2011, similar to 2010, followed by the opioid antagonist naloxone, sodium bicarbonate, physostigmine and flumazenil. Anti-crotalid Fab fragments (CroFab) were

  17. 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

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

    PubMed

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

    2015-01-01

    In clinical research, many potentially useful variables are available via the routine activity of cancer center-based clinical registries (CCCR). We present the experience of the breast cancer clinical registry at Fondazione IRCCS "Istituto Nazionale dei Tumori" to give an example of how a CCCR can be planned, implemented, and used. Five criteria were taken into consideration while planning our CCCR: (a) available clinical and administrative databases ought to be exploited to the maximum extent; (b) open source software should be used; (c) a Web-based interface must be designed; (d) CCCR data must be compatible with population-based cancer registry data; (e) CCCR must be an open system, able to be connected with other data repositories. The amount of work needed for the implementation of a CCCR is inversely linked with the amount of available coded data: the fewer data are available in the input databases as coded variables, the more work will be necessary, for information technology staff, text mining analysis, and registrars (for collecting data from clinical records). A cancer registry in a comprehensive cancer center can be used for several research aspects, such as estimate of the number of cases needed for clinical studies, assessment of biobank specimens with specific characteristics, evaluation of clinical practice and adhesion to clinical guidelines, comparative studies between clinical and population sets of patients, studies on cancer prognosis, and studies on cancer survivorship. PMID:25953447

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

    PubMed

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

    2013-12-01

    In 2010, the American College of Medical Toxicology (ACMT) established its Case Registry, the Toxicology Investigators Consortium (ToxIC). All cases are entered prospectively and include only suspected and confirmed toxic exposures cared for at the bedside by board-certified or board-eligible medical toxicologists at its participating sites. The primary aims of establishing this Registry include the development of a realtime toxico-surveillance system in order to identify and describe current or evolving trends in poisoning and to develop a research tool in toxicology. ToxIC allows for extraction of data from medical records from multiple sites across a national and international network. All cases seen by medical toxicologists at participating institutions were entered into the database. Information characterizing patients entered in 2012 was tabulated and data from the previous years including 2010 and 2011 were included so that cumulative numbers and trends could be described as well. The current report includes data through December 31st, 2012. During 2012, 38 sites with 68 specific institutions contributed a total of 7,269 cases to the Registry. The total number of cases entered into the Registry at the end of 2012 was 17,681. Emergency departments remained the most common source of consultation in 2012, accounting for 61 % of cases. The most common reason for consultation was for pharmaceutical overdose, which occurred in 52 % of patients including intentional (41 %) and unintentional (11 %) exposures. The most common classes of agents were sedative-hypnotics (1,422 entries in 13 % of cases) non-opioid analgesics (1,295 entries in 12 % of cases), opioids (1,086 entries in 10 % of cases) and antidepressants (1,039 entries in 10 % of cases). N-acetylcysteine (NAC) was the most common antidote administered in 2012, as it was in previous years, followed by the opioid antagonist naloxone, sodium bicarbonate, physostigmine and flumazenil. Anti-crotalid Fab

  20. SpineData – a Danish clinical registry of people with chronic back pain

    PubMed Central

    Kent, Peter; Kongsted, Alice; Jensen, Tue Secher; Albert, Hanne B; Schiøttz-Christensen, Berit; Manniche, Claus

    2015-01-01

    Background Large-scale clinical registries are increasingly recognized as important resources for quality assurance and research to inform clinical decision-making and health policy. We established a clinical registry (SpineData) in a conservative care setting where more than 10,000 new cases of spinal pain are assessed each year. This paper describes the SpineData registry, summarizes the characteristics of its clinical population and data, and signals the availability of these data as a resource for collaborative research projects. Methods The SpineData registry is an Internet-based system that captures patient data electronically at the point of clinical contact. The setting is the government-funded Medical Department of the Spine Centre of Southern Denmark, Hospital Lillebaelt, where patients receive a multidisciplinary assessment of their chronic spinal pain. Results Started in 2011, the database by early 2015 contained information on more than 36,300 baseline episodes of patient care, plus the available 6-month and 12-month follow-up data for these episodes. The baseline questionnaire completion rate has been 93%; 79% of people were presenting with low back pain as their main complaint, 6% with mid-back pain, and 15% with neck pain. Collectively, across the body regions and measurement time points, there are approximately 1,980 patient-related variables in the database across a broad range of biopsychosocial factors. To date, 36 research projects have used data from the SpineData registry, including collaborations with researchers from Denmark, Australia, the United Kingdom, and Brazil. Conclusion We described the aims, development, structure, and content of the SpineData registry, and what is known about any attrition bias and cluster effects in the data. For epidemiology research, these data can be linked, at an individual patient level, to the Danish population-based registries and the national spinal surgery registry. SpineData also has potential for the

  1. Understanding Orthopaedic Registry Studies: A Comparison with Clinical Studies.

    PubMed

    Inacio, Maria C S; Paxton, Elizabeth W; Dillon, Mark T

    2016-01-01

    Orthopaedic registries are valuable for monitoring patient outcomes in real-world settings. Registries are useful for identifying procedure incidence and device utilization, evaluating outcomes, determining patients at risk for complications and reoperations, identifying devices in recall situations, assessing comparative effectiveness of procedures and devices, and providing data for research studies. In the present report, we describe how orthopaedic registries can be used to conduct research and how they compare with randomized controlled trials (RCTs) in regard to methodology. Using an example, a comparison of the performance of mobile and fixed bearings in total knee arthroplasty, we evaluate the differences between, and the similarities of, RCTs and registry cohort studies with regard to how they are conducted and how their findings are reported. Orthopaedic registry studies differ from RCTs in many ways and offer certain advantages. The strengths and limitations of registry cohort studies and RCTs must be understood to properly evaluate the literature. PMID:26738910

  2. Analysis of Existing Guidelines for the Systematic Planning Process of Clinical Registries.

    PubMed

    Löpprich, Martin; Knaup, Petra

    2016-01-01

    Clinical registries are a powerful method to observe the clinical practice and natural disease history. In contrast to clinical trials, where guidelines and standardized methods exist and are mandatory, only a few initiatives have published methodological guidelines for clinical registries. The objective of this paper was to review these guidelines and systematically assess their completeness, usability and feasibility according to a SWOT analysis. The results show that each guideline has its own strengths and weaknesses. While one supports the systematic planning process, the other discusses clinical registries in great detail. However, the feasibility was mostly limited and the special requirements of clinical registries, their flexible, expandable and adaptable technological structure was not addressed consistently. PMID:27577423

  3. Manganese Superoxide Dismutase and Breast Cancer Recurrence: A Danish Clinical Registry-Based Case-Control Study, and a Meta-Analysis

    PubMed Central

    Cronin-Fenton, Deirdre P.; Christensen, Mariann; Lash, Timothy L.; Ahern, Thomas P.; Pedersen, Lars; Garne, Jens Peter; Ewertz, Marianne; Autrup, Herman; Sørensen, Henrik T.; Hamilton-Dutoit, Stephen

    2014-01-01

    Background Manganese superoxide dismutase (MnSOD) inhibits oxidative damage and cancer therapy effectiveness. A polymorphism in its encoding gene (SOD2: Val16Ala rs4880) may confer poorer breast cancer survival, but data are inconsistent. We examined the association of SOD2 genotype and breast cancer recurrence (BCR) among patients treated with cyclophosphamide-based chemotherapy (Cyclo). We compared our findings with published studies using meta-analyses. Methods We conducted a population-based case-control study of BCR among women in Jutland, Denmark. Subjects were diagnosed with non-metastatic breast cancer from 1990–2001, received adjuvant Cyclo, and were registered in the Danish Breast Cancer Cooperative Group. We identified 118 patients with BCR and 213 matched breast cancer controls. We genotyped SOD2 and used conditional logistic regression to compute the odds ratio (OR) and associated 95% confidence intervals (95% CI) of BCR. We used random-effects meta-analytic models to evaluate the association of SOD2 polymorphisms and BCR. Results The frequency of the SOD2-Ala allele was 70% in cases versus 71% in controls; 40% versus 44% were heterozygotes, and 30% versus 25% were homozygotes, respectively. Heterozygote and homozygote carriers of the Ala allele had no increased rate of BCR (OR = 1.1, 95%CI = 0.65, 2.0, and OR = 0.87, 95%CI = 0.47, 1.6, respectively). Five studies informed the meta-analytic models; summary estimates associating BCR for homozygote, or any inheritance of the variant Ala allele were 1.18 (95%CI = 0.74, 1.88), and 1.18, (95%CI = 0.91, 1.54), respectively. Conclusion Our findings do not suggest that MnSOD enzymatic activity, as measured by SOD2 genotype, affects rates of BCR among patients treated with Cyclo. PMID:24498107

  4. THE RARE DISEASES CLINICAL RESEARCH NETWORK CONTACT REGISTRY UPDATE: FEATURES AND FUNCTIONALITY

    PubMed Central

    Richesson, Rachel; Sutphen, Rebecca; Shereff, Denise; Krischer, Jeff

    2013-01-01

    The Rare Diseases Clinical Research Network (RDCRN) Contact Registry has grown in size and scope since it was first reported in this journal in 2007. In this paper, we reflect on our seven years’ experience developing and expanding the RDCRN Contact Registry to include many more rare diseases. We present the functional and data requirements that motivated this registry, and the new features and policies that have been developed since. Given the high costs and long-term commitment required to build patient registries, the RDCRN Contact Registry experience represents a reasonable approach for identifying and cultivating potential research populations, with minimal resources and patient burden. The basic model of a patient-reported registry has not changed since our 2007 report, but the number of diseases has grown from 42 to 201, and the types of information that are exchanged with participants has expanded. A patient-directed information-sharing feature has been added to reduce barriers to communication between investigators and patients affected by rare and genetic diseases. As specific data and research needs arise, the Contact Registry can be leveraged to access needed data or to solicit patients for particular research opportunities. This multiple-disease registry is scalable, expandable, and standards-driven, and has become a model for clinical and translational research across rare and many other diseases. PMID:22405970

  5. Development, Implementation, and Use of a Local and Global Clinical Registry for Neurosurgery.

    PubMed

    Kondziolka, Douglas; Cooper, Benjamin T; Lunsford, L Dade; Silverman, Joshua

    2015-06-01

    Physicians are being challenged to obtain data for outcomes research and measures of quality practice in medicine. We developed a prospective data collection system (registry) that provides data points across all elements of a neurosurgical stereotactic radiosurgery practice. The registry architecture is scalable and suitable for any aspect of neurosurgical practice. Our purpose was to outline the challenges in creating systems for high quality data acquisition and describe experiences in initial testing and use. Over a two year period, a multicenter team working with software engineers developed a comprehensive radiosurgery registry based on a MS-Sequel® server platform. Three neurosurgeons at one center were responsible for final editing. Alpha testing began in September 2012 and server-based beta testing began in February 2013. The major elements included demographics, disease-based items (47 categories for different brain tumors, vascular malformations, and functional disorders) with relevant clinical grading systems, treatment-based items (imaging, physics, clinical), and follow-up data (clinical, imaging, subsequent therapeutics). Nine hundred patients were entered into the registry at one test center, with new entries and follow-up data entered daily at the point of contact. With experience, the mean time for one new entry was 6 minutes. Mean time for one follow-up entry was 45 seconds. The system was made secure for individual use and amenable for both data entry and research. Analytics used different filters to create customized outcomes charts as selected by the user (e.g., survival, neurologic function, complications). A local or multicenter prospective data collection registry was created for use across 47 clinical indications for stereotactic cranial radiosurgery. Further refinement of fields and logic is ongoing. The system is reliable, robust, and allows use of rapid analytical tools. Large medical registries will become widely used for collection

  6. Leveraging effective clinical registries to advance medical care quality and transparency.

    PubMed

    Klaiman, Tamar; Pracilio, Valerie; Kimberly, Laura; Cecil, Kate; Legnini, Mark

    2014-04-01

    Policy makers, payers, and the general public are increasingly focused on health care quality improvement. Measuring quality requires robust data systems that collect data over time, can be integrated with other systems, and can be analyzed easily for trends. The goal of this project was to study effective tools and strategies in the design and use of clinical registries with the potential to facilitate quality improvement, value-based purchasing, and public reporting on the quality of care. The research team worked with an expert panel to define characteristics of effectiveness, and studied examples of effective registries in cancer, cardiovascular care, maternity, and joint replacement. The research team found that effective registries were successful in 1 or more of 6 key areas: data standardization, transparency, accuracy/completeness of data, participation by providers, financial sustainability, and/or providing feedback to providers. The findings from this work can assist registry designers, sponsors, and researchers in implementing strategies to increase the use of clinical registries to improve patient care and outcomes. PMID:24152057

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

    PubMed

    Michels, D K; Zamieroski, M

    1990-12-01

    In summary, having data from other service areas available in a relational clinical database could resolve many of the problems existing in today's registry systems. Uniting sophisticated information systems into a centralized database system could definitely be a corporate asset in managing the bottom line. PMID:10108501

  8. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry--The EXCITING-ILD Registry.

    PubMed

    Kreuter, Michael; Herth, Felix J F; Wacker, Margarethe; Leidl, Reiner; Hellmann, Andreas; Pfeifer, Michael; Behr, Jürgen; Witt, Sabine; Kauschka, Dagmar; Mall, Marcus; Günther, Andreas; Markart, Philipp

    2015-01-01

    Despite a number of prospective registries conducted in past years, the current epidemiology of interstitial lung diseases (ILD) is still not well defined, particularly regarding the prevalence and incidence, their management, healthcare utilisation needs, and healthcare-associated costs. To address these issues in Germany, a new prospective ILD registry, "Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases" (EXCITING-ILD), is being conducted by the German Centre for Lung Research in association with ambulatory, inpatient, scientific pulmonology organisations and patient support groups. This multicentre, noninterventional, prospective, and observational ILD registry aims to collect comprehensive and validated data from all healthcare institutions on the incidence, prevalence, characteristics, management, and outcomes regarding all ILD presentations in the real-world setting. Specifically, this registry will collect demographic data, disease-related data such as ILD subtype, treatments, diagnostic procedures (e.g., HRCT, surgical lung biopsy), risk factors (e.g., familial ILD), significant comorbidities, ILD managements, and disease outcomes as well as healthcare resource consumption. The EXCITING-ILD registry will include in-patient and out-patient ILD healthcare facilities in more than 100 sites. In summary, this registry will document comprehensive and current epidemiological data as well as important health economic data for ILDs in Germany. PMID:26640781

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

    PubMed Central

    2013-01-01

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

  10. A federated semantic metadata registry framework for enabling interoperability across clinical research and care domains.

    PubMed

    Sinaci, A Anil; Laleci Erturkmen, Gokce B

    2013-10-01

    In order to enable secondary use of Electronic Health Records (EHRs) by bridging the interoperability gap between clinical care and research domains, in this paper, a unified methodology and the supporting framework is introduced which brings together the power of metadata registries (MDR) and semantic web technologies. We introduce a federated semantic metadata registry framework by extending the ISO/IEC 11179 standard, and enable integration of data element registries through Linked Open Data (LOD) principles where each Common Data Element (CDE) can be uniquely referenced, queried and processed to enable the syntactic and semantic interoperability. Each CDE and their components are maintained as LOD resources enabling semantic links with other CDEs, terminology systems and with implementation dependent content models; hence facilitating semantic search, much effective reuse and semantic interoperability across different application domains. There are several important efforts addressing the semantic interoperability in healthcare domain such as IHE DEX profile proposal, CDISC SHARE and CDISC2RDF. Our architecture complements these by providing a framework to interlink existing data element registries and repositories for multiplying their potential for semantic interoperability to a greater extent. Open source implementation of the federated semantic MDR framework presented in this paper is the core of the semantic interoperability layer of the SALUS project which enables the execution of the post marketing safety analysis studies on top of existing EHR systems. PMID:23751263

  11. Treatment of patients with multifocal motor neuropathy with immunoglobulins in clinical practice: the SIGNS registry

    PubMed Central

    Stangel, Martin; Gold, Ralf; Pittrow, David; Baumann, Ulrich; Borte, Michael; Fasshauer, Maria; Hensel, Manfred; Huscher, Dörte; Reiser, Marcel; Sommer, Claudia

    2016-01-01

    Objectives: The management of patients with multifocal motor neuropathy (MMN) under everyday clinical conditions has been insufficiently studied. We therefore collected comprehensive observational data on patients with MMN who received intravenous (IV) or subcutaneous (SC) immunoglobulins (IGs) as maintenance therapy. Methods: This was a prospective, noninterventional study (registry) in neurological centres (hospitals and offices) throughout Germany. Results: As of 1 December 2015, 80 patients with MMN were included (mean age 55.4 ± 9.8 years, 67% males, mean disease duration 10.7 ± 10.2 years). The affected limb regions were predominantly distal muscle groups of the upper extremities. On the inflammatory neuropathy cause and treatment (INCAT) scale, 94% of the patients had some disability in the arms and 61% in the legs. At inclusion, 98.8% received IVIG and 1.3% SCIG. Substantial variation was observed between IVIG treatment intervals (every 0.7 to 17.3 weeks) and dosage (0.2–2.1 g/kg body weight received during a single administration; mean monthly dosage, 0.9 g/kg body weight). However, the mean monthly dosage was steady over time. At 1-year follow up, improvement was seen in muscle strength, INCAT and quality of life (QoL) scores (SF-36 questionnaire). Conclusions: The management of patients with MMN in everyday clinical practice demonstrates a wide range of absolute dosages and treatment intervals of IG, supporting the recommended practice of determining treatment dose on an individual patient basis. The improvements in muscle strength and reduction in disability, accompanied by increased QoL, strengthen the case for use of IG as a maintenance treatment for MMN. PMID:27134672

  12. One Year Clinical Outcomes of Renal Artery Stenting: The Results of ODORI Registry

    SciTech Connect

    Sapoval, M.; Tamari, I.; Goffette, P.; Downes, M.; Senechal, Q.; Fanelli, F.; Reimer, P.; Negaiwi, Z.; Cassin, P. De; Heye, S.; Korobov, V.; Tsetis, D.; Abada, H.

    2010-06-15

    The safety, efficacy and long term clinical benefits of renal artery revascularization by stenting are still a matter of debate. The aim of our study was to define the safety and efficacy of renal artery stenting with the Tsunami peripheral stent (Terumo Corporation, Tokyo, Japan). The ODORI was a prospective, multicentre registry which enrolled 251 consecutive patients, (276 renal arteries) in 36 centres across Europe. The primary endpoint was acute procedural success defined as <30% residual stenosis after stent placement. Secondary endpoints included major adverse events, blood pressure control, serum creatinine level, and target lesion revascularization (TLR) at 6 and 12 months. Patients were 70 {+-} 10 years old, 59% were male, 33% had diabetes, and 96% hypertension. The main indications for renal stent implantation were hypertension in 83% and renal salvage in 39%. Direct stent implantation was performed in 76% of the cases. Acute success rate was 100% with residual stenosis of 2.5 {+-} 5.4%. Systolic/diastolic blood pressure decreased from a mean of 171/89 at baseline to 142/78 mmHg at 6 months (p < 0.0001 vs. baseline), and 141/80 mmHg at 12 months (p < 0.0001 vs. baseline). Mean serum creatinine concentration did not change significantly in the total population. However, there was significant improvement in the highest tercile (from 283 {mu}mol/l at baseline to 205 and 209 {mu}mol/l at 6 and 12 months respectively). At 12-months, rates of restenosis and TLR were 6.6 and 0.8% respectively. The 12 month cumulative rate of all major clinical adverse events was 6.4% while the rate of device or procedure related events was 2.4%. In hypertensive patients with atherosclerotic renal artery stenosis Tsunami peripheral balloon-expandable stent provides a safe revascularization strategy, with a potential beneficial impact on hypertension control and renal function in the highest risk patients.

  13. I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes

    PubMed Central

    de Albuquerque, Denilson Campos; de Souza, João David; Bacal, Fernando; Rohde, Luiz Eduardo Paim; Bernardez-Pereira, Sabrina; Berwanger, Otavio; Almeida, Dirceu Rodrigues

    2015-01-01

    Background Heart failure (HF) is one of the leading causes of hospitalization in adults in Brazil. However, most of the available data is limited to unicenter registries. The BREATHE registry is the first to include a large sample of hospitalized patients with decompensated HF from different regions in Brazil. Objective Describe the clinical characteristics, treatment and prognosis of hospitalized patients admitted with acute HF. Methods Observational registry study with longitudinal follow-up. The eligibility criteria included patients older than 18 years with a definitive diagnosis of HF, admitted to public or private hospitals. Assessed outcomes included the causes of decompensation, use of medications, care quality indicators, hemodynamic profile and intrahospital events. Results A total of 1,263 patients (64±16 years, 60% women) were included from 51 centers from different regions in Brazil. The most common comorbidities were hypertension (70.8%), dyslipidemia (36.7%) and diabetes (34%). Around 40% of the patients had normal left ventricular systolic function and most were admitted with a wet-warm clinical-hemodynamic profile. Vasodilators and intravenous inotropes were used in less than 15% of the studied cohort. Care quality indicators based on hospital discharge recommendations were reached in less than 65% of the patients. Intrahospital mortality affected 12.6% of all patients included. Conclusion The BREATHE study demonstrated the high intrahospital mortality of patients admitted with acute HF in Brazil, in addition to the low rate of prescription of drugs based on evidence. PMID:26131698

  14. Clinical Characteristics of Children With Juvenile Dermatomyositis: The Childhood Arthritis and Rheumatology Research Alliance Registry

    PubMed Central

    Robinson, Angela Byun; Hoeltzel, Mark F.; Wahezi, Dawn M.; Becker, Mara L.; Kessler, Elizabeth A.; Schmeling, Heinrike; Carrasco, Ruy; Huber, Adam M.; Feldman, Brian M.; Reed, Ann M.

    2014-01-01

    Objective To investigate aspects of juvenile dermatomyositis (DM), including disease characteristics and treatment, through a national multicenter registry. Methods Subjects meeting the modified Bohan and Peter criteria for definite juvenile DM were analyzed from the cross-sectional Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry between 2010 and 2012 from 55 US pediatric rheumatology centers. Demographics, disease characteristics, diagnostic assessments, and medication exposure data were collected at enrollment. Results A total of 384 subjects met the criteria for analysis. At enrollment, the median Childhood Myositis Assessment Scale score was 51 (interquartile range [IQR] 46–52), the median Childhood Health Assessment Questionnaire score was 0 (IQR 0–0.5), and the median physician and subject global assessment scores were 1 (IQR 0–2) and 1 (IQR 0–3), respectively, out of a maximum of 10. Of the diagnostic assessments, magnetic resonance imaging was more likely than electromyography or muscle biopsy to show abnormalities. A total of 329 subjects had ≥2 diagnostic studies performed, and >34% of these subjects reported ≥1 negative study. Ninety-five percent had been treated with corticosteroids and 92% with methotrexate, suggesting that these medications were almost universally prescribed for juvenile DM in the US. Conclusion In 2 years, the ongoing CARRA Registry has collected clinical data on 384 children with juvenile DM and has the potential to become one of the largest juvenile DM cohorts in the world. More research is needed about prognostic factors in juvenile DM, and differences in therapy based on manifestations of disease need to be explored by practitioners. This registry provides the infrastructure needed to advance clinical and translational research and represents a major step toward improving outcomes of children with juvenile DM. PMID:23983017

  15. WWW accessible system for national/regional registries of clinical results of cord blood transplants: a tool to facilitate cooperative clinical research.

    PubMed

    Fernández, M N; Pascual, M; Bañas, M H; Bravo, G; Salvador, C H

    1998-12-01

    A system, accessible via internet, has been developed to support the Spanish Registry of Cord Blood Transplants (RETSCU). The system includes a database of clinical results directly accessible by transplant centers (TCs) and cord blood banks (CBBs) (restricted to own cases regarding primary data and unrestricted regarding statistics derived from validated data) and gives open access to Web pages containing results approved for publication. It also includes internal mail for two-way and broadcast messages. Patients' data are essentially those included in Eurocord forms. Additional features of the system are: confidentiality; inalterability of validated primary data; identifiability of data sources. The Unix central computer is accessible via the WWW. For security, data transmission is encrypted and passwords are required for access. Copies are regularly updated. Data can be loaded from CBBs and TCs. The procedure for creating and updating records is user-friendly, with the possibility of errors being minimized by extensive automated checks. Validation of patients' records by a manager is required before making data available for general statistical analysis. TCs and CBBs may retrieve data on their own cases, regardless of validation, as individual records or in tables directly transferable to common statistical programs. Statistical analysis may be done on validated data from all the patients in the Registry or from groups selected according to HLA compatibility and disease, type of transplant (related/unrelated), or protocol. Several similarly designed and managed national/regional Registries might be networked and their data integrated into a multinational Registry. Our system would require some additional developments to be used in this way. PMID:9949627

  16. Diagnostic Clinical and Laboratory Findings in Response to Predetermining Bacterial Pathogen: Data from the Meningitis Registry

    PubMed Central

    Karanika, Maria; Vasilopoulou, Vasiliki A.; Katsioulis, Antonios T.; Papastergiou, Panagiotis; Theodoridou, Maria N.; Hadjichristodoulou, Christos S.

    2009-01-01

    Background Childhood Meningitis continues to be an important cause of mortality in many countries. The search for rapid diagnosis of acute bacterial meningitis has lead to the further exploration of prognostic factors. This study was scheduled in an attempt to analyze various clinical symptoms as well as rapid laboratory results and provide an algorithm for the prediction of specific bacterial aetiology of childhood bacterial meningitis. Methodology and Principal Findings During the 32 year period, 2477 cases of probable bacterial meningitis (BM) were collected from the Meningitis Registry (MR). Analysis was performed on a total of 1331 confirmed bacterial meningitis cases of patients aged 1 month to 14 years. Data was analysed using EPI INFO (version 3.4.3-CDC-Atlanta) and SPSS (version 15.0 - Chicago) software. Statistically significant (p<0.05) variables were included in a conditional backward logistic regression model. A total of 838 (63.0%) attributed to Neisseria meningitidis, 252 (18.9%) to Haemophilus influenzae, 186 (14.0%) to Streptococcus pneumoniae and 55 (4.1%) due to other bacteria. For the diagnosis of Meningococcal Meningitis, the most significant group of diagnostic criteria identified included haemorrhagic rash (OR 22.36), absence of seizures (OR 2.51), headache (OR 1.83) and negative gram stain result (OR 1.55) with a Positive Predictive Value (PPV) of 96.4% (95%CI 87.7–99.6). For the diagnosis of Streptococcus pneumoniae, the most significant group of diagnostic criteria identified included absence of haemorrhagic rash (OR 13.62), positive gram stain (OR 2.10), coma (OR 3.11), seizures (OR 3.81) and peripheral WBC≥15000/µL (OR 2.19) with a PPV of 77.8% (95%CI 40.0–97.2). For the diagnosis of Haemophilus influenzae, the most significant group of diagnostic criteria included, absence of haemorrhagic rash (OR 13.61), age≥1year (OR 2.04), absence of headache (OR 3.01), CSF Glu<40 mg/dL (OR 3.62) and peripheral WBC<15000/µL (OR 1.74) with a

  17. The sudden unexpected infant death case registry: a method to improve surveillance.

    PubMed

    Shapiro-Mendoza, Carrie K; Camperlengo, Lena T; Kim, Shin Y; Covington, Theresa

    2012-02-01

    This article describes a multistate population-based surveillance system for monitoring sudden unexpected infant deaths (SUIDs) known as the SUID Case Registry pilot program. The pilot program represents collaboration between the Centers for Disease Control and Prevention and the National Center for Child Death Review (NCCDR), which is funded by the Health Resources and Services Administration. The SUID Case Registry builds on existing child death review system activities and protocols. The objectives of the SUID Case Registry are to collect accurate and consistent population-based data about the circumstances and events associated with SUID cases, to improve the completeness and quality of SUID case investigations, and to use a decision-making algorithm with standardized definitions to categorize SUID cases. States who participate in the pilot program commit to review all SUID cases in their state by using their multidisciplinary state and local child death review teams. These teams request and review data from death scene investigators, medical examiners and coroners, law enforcement, social services, pediatric and obstetric providers, and public health per usual, but as part of the pilot program, supplement their SUID case reviews by discussing additional medical, environmental, and behavioral factors, and entering this data using the NCCDR Web-based Case Reporting System. This new surveillance system aims to improve knowledge of factors surrounding SUID events and improve investigation practices. The surveillance system will allow researchers and program planners to create prevention strategies and interventions, ultimately reducing SUIDs and injury-related infant deaths. PMID:22232303

  18. Comparison of Eligibility Criteria Between Protocols, Registries, and Publications of Cancer Clinical Trials.

    PubMed

    Zhang, Sheng; Liang, Fei; Li, Wenfeng; Tannock, Ian

    2016-11-01

    Trial registration and public accessibility of appended or published protocols of phase III randomized clinical trials (RCTs) allow comparison of reported research with essential aspects of trial design. We determined how eligibility criteria of participants specified in protocols were described in trial registries and articles of 255 cancer RCTs published in leading journals. The mean proportion of matching eligibility criteria between protocols and publications per trial (the primary endpoint) was 44.0% (95% confidence interval [CI] = 40.8% to 47.3%). Almost all discrepancies in eligibility criteria (96.7%, 95% CI = 96.1% to 97.3%) suggested to readers of articles that a broader study population was included. The mean proportion of matching eligibility criteria between protocols and registries was 72.9% (95% CI = 68.2% to 77.7%, the secondary endpoint). We conclude that there are substantial differences in eligibility criteria between trial protocols, registries and articles. Inaccurate reporting of eligibility criteria may prevent appropriate assessment of the applicability of trial results. PMID:27226519

  19. Clinical outcomes of splenectomy in children: report of the splenectomy in congenital hemolytic anemia registry.

    PubMed

    Rice, Henry E; Englum, Brian R; Rothman, Jennifer; Leonard, Sarah; Reiter, Audra; Thornburg, Courtney; Brindle, Mary; Wright, Nicola; Heeney, Matthew M; Smithers, Charles; Brown, Rebeccah L; Kalfa, Theodosia; Langer, Jacob C; Cada, Michaela; Oldham, Keith T; Scott, J Paul; St Peter, Shawn; Sharma, Mukta; Davidoff, Andrew M; Nottage, Kerri; Bernabe, Kathryn; Wilson, David B; Dutta, Sanjeev; Glader, Bertil; Crary, Shelley E; Dassinger, Melvin S; Dunbar, Levette; Islam, Saleem; Kumar, Manjusha; Rescorla, Fred; Bruch, Steve; Campbell, Andrew; Austin, Mary; Sidonio, Robert; Blakely, Martin L

    2015-03-01

    The outcomes of children with congenital hemolytic anemia (CHA) undergoing total splenectomy (TS) or partial splenectomy (PS) remain unclear. In this study, we collected data from 100 children with CHA who underwent TS or PS from 2005 to 2013 at 16 sites in the Splenectomy in Congenital Hemolytic Anemia (SICHA) consortium using a patient registry. We analyzed demographics and baseline clinical status, operative details, and outcomes at 4, 24, and 52 weeks after surgery. Results were summarized as hematologic outcomes, short-term adverse events (AEs) (≤30 days after surgery), and long-term AEs (31-365 days after surgery). For children with hereditary spherocytosis, after surgery there was an increase in hemoglobin (baseline 10.1 ± 1.8 g/dl, 52 week 12.8 ± 1.6 g/dl; mean ± SD), decrease in reticulocyte and bilirubin as well as control of symptoms. Children with sickle cell disease had control of clinical symptoms after surgery, but had no change in hematologic parameters. There was an 11% rate of short-term AEs and 11% rate of long-term AEs. As we accumulate more subjects and longer follow-up, use of a patient registry should enhance our capacity for clinical trials and engage all stakeholders in the decision-making process. PMID:25382665

  20. The Swedish MS registryclinical support tool and scientific resource

    PubMed Central

    Hillert, J; Stawiarz, L

    2015-01-01

    The Swedish MS registry (SMSreg) is designed to assure quality health care for patients with multiple sclerosis (MS). It has been active since 2001 and web-based since 2004. It runs on government funding only and is used in all Swedish neurology departments. The SMSreg currently includes data on 14,500 of Sweden's estimated 17,500 prevalent patients with MS. One important function of SMSreg, to which participation is voluntary, is to serve as a tool for decision support and to provide an easy overview of the patient information needed at clinical visits. This is its core feature and explains why the majority of Swedish MS specialists contribute data. Another success factor for SMSreg is that entered data can be readily accessed, either through a query function into Excel format or through a set of predesigned tables and diagrams in which parameters can be selected. Recent development includes a portal allowing patients to view a summary of their registered data and to report a set of patient-reported outcomes. SMSreg data have been used in close to 100 published scientific reports. Current projects include an incidence cohort (EIMS), post-marketing cohorts of patients on novel disease-modifying drugs (IMSE), and a prevalence cohort (GEMS). As these studies combine physical sampling and questionnaire data with clinical documentation and possible linkage to other public registries, together they provide an excellent platform for integrated MS research. PMID:26046553

  1. The Swedish MS registryclinical support tool and scientific resource.

    PubMed

    Hillert, J; Stawiarz, L

    2015-01-01

    The Swedish MS registry (SMSreg) is designed to assure quality health care for patients with multiple sclerosis (MS). It has been active since 2001 and web-based since 2004. It runs on government funding only and is used in all Swedish neurology departments. The SMSreg currently includes data on 14,500 of Sweden's estimated 17,500 prevalent patients with MS. One important function of SMSreg, to which participation is voluntary, is to serve as a tool for decision support and to provide an easy overview of the patient information needed at clinical visits. This is its core feature and explains why the majority of Swedish MS specialists contribute data. Another success factor for SMSreg is that entered data can be readily accessed, either through a query function into Excel format or through a set of predesigned tables and diagrams in which parameters can be selected. Recent development includes a portal allowing patients to view a summary of their registered data and to report a set of patient-reported outcomes. SMSreg data have been used in close to 100 published scientific reports. Current projects include an incidence cohort (EIMS), post-marketing cohorts of patients on novel disease-modifying drugs (IMSE), and a prevalence cohort (GEMS). As these studies combine physical sampling and questionnaire data with clinical documentation and possible linkage to other public registries, together they provide an excellent platform for integrated MS research. PMID:26046553

  2. Ambulatory blood pressure monitoring in daily clinical practice - the Spanish ABPM Registry experience.

    PubMed

    Gorostidi, Manuel; Banegas, José R; de la Sierra, Alejandro; Vinyoles, Ernest; Segura, Julián; Ruilope, Luis M

    2016-01-01

    Many patients are hypertensive at the medical settings but show normal blood pressure out of the doctor's office, and are classified as white-coat hypertensives. On the other hand, many patients with controlled hypertension at the clinic show ambulatory blood pressure levels above the thresholds considered for an adequate blood pressure control, known as having masked hypertension. Using data from the Spanish Ambulatory Blood Pressure Monitoring Registry (Spanish ABPM Registry), a national program developed to promote the use of the ambulatory technique for hypertension management in daily practice, we have reviewed the main strengths of this approach, that is the ability to detect discrepancies of blood pressure status with respect to office blood pressure measurement, and to better assess accurate rates of hypertension control. White-coat hypertension within patients with elevated office blood pressure, and masked hypertension within office-controlled patients affected one of three patients in each office status. On the other hand, rates of ambulatory blood pressure control (50%) doubled those of office blood pressure control (25%), still remaining half the patients uncontrolled. We think that a systematic use of ambulatory blood pressure monitoring, and strategies to improve blood pressure control constitute key priorities in hypertension management. PMID:26541761

  3. 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. PMID:26621418

  4. CNS Sites Cooperate to Detect Duplicate Subjects with a Clinical Trial Subject Registry

    PubMed Central

    Wilcox, Charles S.; Gevorgyan, Lilit; Shawkat, Adnan

    2013-01-01

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

  5. The French Gaucher’s disease registry: clinical characteristics, complications and treatment of 562 patients

    PubMed Central

    2012-01-01

    Background Clinical features, complications and treatments of Gaucher’s disease (GD), a rare autosomal–recessive disorder due to a confirmed lysosomal enzyme (glucocerebrosidase) deficiency, are described. Methods All patients with known GD, living in France, with ≥1 consultations (1980–2010), were included in the French GD registry, yielding the following 4 groups: the entire cohort, with clinical description; and its subgroups: patients with ≥1 follow-up visits, to investigate complications; recently followed (2009–2010) patients; and patients treated during 2009–2010, to examine complications before and during treatment. Data are expressed as medians (range) for continuous variables and numbers (%) for categorical variables. Results Among the 562 registry patients, 265 (49.6%) were females; 454 (85.0%) had type 1, 22 (4.1%) type 2, 37 (6.9%) perinatal–lethal type and 21 (3.9%) type 3. Median ages at first GD symptoms and diagnosis, respectively, were 15 (0–77) and 22 (0–84) years for all types. The first symptom diagnosing GD was splenomegaly and/or thrombocytopenia (37.6% and 26.3%, respectively). Bone-marrow aspiration and/or biopsy yielded the diagnosis for 54.7% of the patients, with enzyme deficiency confirming GD for all patients. Birth incidence rate was estimated at 1/50,000 and prevalence at 1/136,000. For the 378 followed patients, median follow-up was 16.2 (0.1–67.6) years. Major clinical complications were bone events (BE; avascular necrosis, bone infarct or pathological fracture) for 109 patients, splenectomy for 104, and Parkinson’s disease for 14; 38 patients died (neurological complications for 15 type-2 and 3 type-3 patients, GD complications for 11 type-1 and another disease for 9 type-1 patients). Forty-six had monoclonal gammopathy. Among 283 recently followed patients, 36 were untreated and 247 had been treated during 2009–2010; 216 patients received treatment in December 2010 (126 with imiglucerase, 45

  6. Clinical and genetic features of rhabdoid tumors of the heart registered with the European Rhabdoid Registry (EU-RHAB).

    PubMed

    Bartelheim, Kerstin; Sumerauer, David; Behrends, Uta; Kodetova, Daniela; Kucera, Filip; Leuschner, Ivo; Neumayer, Petra; Oyen, Florian; Rübe, Christian; Siebert, Reiner; Schneppenheim, Reinhard; Seeringer, Angela; Vasovcak, Peter; Frühwald, Michael C

    2014-09-01

    Rhabdoid tumors are rare but highly aggressive malignancies of infancy and early childhood with a generally unfavorable prognosis. Despite a wide variety of anatomic locations rhabdoid tumors share mutational inactivation of the SWI/SNF (SWItch/Sucrose NonFermentable) core component gene SMARCB1 (also known as INI1, hSNF5 or BAF47) in chromosome 22. As this inactivation usually results in loss of SMARCB1 expression, detectable by an antibody against the SMARCB1 protein, the accurate diagnosis of a rhabdoid tumor may be more distinctly and frequently made. Several reports on rhabdoid tumors presenting in various anatomic sites outside the kidneys and CNS are on record. We report two cases of rhabdoid tumors originating in the heart (cardiac tissue), which were entered into the European Rhabdoid Registry (EU-RHAB). The first case presented with intracardial and -cranial lesions as well as malignant ascites, while the second patient demonstrated an isolated cardiac tumor. This induced a different therapeutic approach and subsequently different clinical course (death 7 weeks after diagnosis in patient 1). Patient 2 presented with a bifocal intracardial tumor without metastases and remains in complete remission for 46 months since diagnosis following multimodal therapy. The second case demonstrates that even in a potentially futile clinical situation early and accurate diagnosis followed by prompt and intensive multimodal therapy may offer prolonged survival, potential cure and improved quality of life. PMID:24972932

  7. Analysis of safety outcomes for radial versus femoral access for percutaneous coronary intervention from a large clinical registry

    PubMed Central

    Dobies, David R; Barber, Kimberly R; Cohoon, Amanda L

    2016-01-01

    Objective Using a multisite, contemporary registry of 58 862 percutaneous coronary intervention (PCI) procedures in a national healthcare system, the present study compared radial access with femoral access on safety and efficacy outcomes. Methods This is a real-world, large-scale, retrospective study using clinical data from a 137-hopsital System and reported to a multisite clinical registry. All patients undergoing a cardiac catheterisation procedure were included in this database. The primary end points were major bleeding and radiation exposure. Multivariate logistic regression modelling was used to compare access groups. Results Femoral access (n=55 729) accounted for 94.7% and radial access (n=3137) for 5.3%. There were fewer bleeding events in the radial group (n=28, 0.9%) than those in the femoral group (n=1234, 2.2%) in the unadjusted analysis. For patients receiving bivalirudin, bleeding occurred in 337 patients (1.6%), and there was no difference in rates between radial access (n=13, 1.1%) and femoral access (n=327, 1.7%) (OR=0.65, CI 0.40 to 1.22, p=0.19). The radial technique resulted in higher radiation exposure in each case, but particularly for procedures involving prior coronary artery bypass graft history and non-ST-elevated myocardial infarction patients. The mean fluoroscopy time among femoral access procedures was 15.68 min (SD=11.7) versus 19.86 min (SD=13.8) for radial access procedures (p<0.0001). Conclusions Radial access for PCI is associated with higher fluoroscopy times but not with less major bleeding when bivalirudin is used. Our analysis, combined with other study findings, suggest that the safest route for PCI may be the use of femoral access with bivalirudin. PMID:27547427

  8. Coupled variable selection for regression modeling of complex treatment patterns in a clinical cancer registry.

    PubMed

    Schmidtmann, I; Elsäßer, A; Weinmann, A; Binder, H

    2014-12-30

    For determining a manageable set of covariates potentially influential with respect to a time-to-event endpoint, Cox proportional hazards models can be combined with variable selection techniques, such as stepwise forward selection or backward elimination based on p-values, or regularized regression techniques such as component-wise boosting. Cox regression models have also been adapted for dealing with more complex event patterns, for example, for competing risks settings with separate, cause-specific hazard models for each event type, or for determining the prognostic effect pattern of a variable over different landmark times, with one conditional survival model for each landmark. Motivated by a clinical cancer registry application, where complex event patterns have to be dealt with and variable selection is needed at the same time, we propose a general approach for linking variable selection between several Cox models. Specifically, we combine score statistics for each covariate across models by Fisher's method as a basis for variable selection. This principle is implemented for a stepwise forward selection approach as well as for a regularized regression technique. In an application to data from hepatocellular carcinoma patients, the coupled stepwise approach is seen to facilitate joint interpretation of the different cause-specific Cox models. In conditional survival models at landmark times, which address updates of prediction as time progresses and both treatment and other potential explanatory variables may change, the coupled regularized regression approach identifies potentially important, stably selected covariates together with their effect time pattern, despite having only a small number of events. These results highlight the promise of the proposed approach for coupling variable selection between Cox models, which is particularly relevant for modeling for clinical cancer registries with their complex event patterns. PMID:25345575

  9. Clinical Differences between Subtypes of Atrial Fibrillation and Flutter: Cross-Sectional Registry of 407 Patients

    PubMed Central

    Almeida, Eduardo Dytz; Guimarães, Raphael Boesche; Stephan, Laura Siga; Medeiros, Alexandre Kreling; Foltz, Katia; Santanna, Roberto Tofani; Pires, Leonardo Martins; Kruse, Marcelo Lapa; de Lima, Gustavo Glotz; Leiria, Tiago Luiz Luz

    2015-01-01

    Introduction Atrial fibrillation and atrial flutter account for one third of hospitalizations due to arrhythmias, determining great social and economic impacts. In Brazil, data on hospital care of these patients is scarce. Objective To investigate the arrhythmia subtype of atrial fibrillation and flutter patients in the emergency setting and compare the clinical profile, thromboembolic risk and anticoagulants use. Methods Cross-sectional retrospective study, with data collection from medical records of every patient treated for atrial fibrillation and flutter in the emergency department of Instituto de Cardiologia do Rio Grande do Sul during the first trimester of 2012. Results We included 407 patients (356 had atrial fibrillation and 51 had flutter). Patients with paroxysmal atrial fibrillation were in average 5 years younger than those with persistent atrial fibrillation. Compared to paroxysmal atrial fibrillation patients, those with persistent atrial fibrillation and flutter had larger atrial diameter (48.6 ± 7.2 vs. 47.2 ± 6.2 vs. 42.3 ± 6.4; p < 0.01) and lower left ventricular ejection fraction (66.8 ± 11 vs. 53.9 ± 17 vs. 57.4 ± 16; p < 0.01). The prevalence of stroke and heart failure was higher in persistent atrial fibrillation and flutter patients. Those with paroxysmal atrial fibrillation and flutter had higher prevalence of CHADS2 score of zero when compared to those with persistent atrial fibrillation (27.8% vs. 18% vs. 4.9%; p < 0.01). The prevalence of anticoagulation in patients with CHA2DS2-Vasc ≤ 2 was 40%. Conclusions The population in our registry was similar in its comorbidities and demographic profile to those of North American and European registries. Despite the high thromboembolic risk, the use of anticoagulants was low, revealing difficulties for incorporating guideline recommendations. Public health strategies should be adopted in order to improve these rates. PMID:26016782

  10. United States Transuranium and Uranium Registries (USTUR): De-identified Case Data

    DOE Data Explorer

    The United States Transuranium and Uranium Registries (USTUR) is a research program studying actinide elements deposited within the human body û in persons with measurable, documented exposures to those elements. The Registries are operated by the Washington State University (WSU) College of Pharmacy, with administrative offices and laboratory facilities in Richland, Washington. The Registries are funded by a grant from the United States Department of Energy (DOE) Office of Health Studies. The mission of the USTUR is to study the uptake, translocation and retention (biokinetics) and tissue dosimetry of uranium, plutonium, americium, and other actinides in occupationally exposed humans (workers), over their whole lifetime (from exposure through full lifespan), and to serve as a national and international resource for testing and improving the application of excreta monitoring and other contemporary bioassay data to predict tissue dose rates measured at autopsy. These studies are fundamental to evaluating and improving the reliability of, and confidence in, both prospective and retrospective assessments of tissue doses and risks from intakes of actinide materials through inhalation, ingestion, or contaminated wounds. Narrative, de-identified case summaries can be viewed by case number for whole body donations, partial body donations, and special studies. Possible intakes, health physics data, autopsy and pathology findings, and tissue analysis data are described. Radiochemistry data such as wet weight, ashed weight, and measured activity are reported, along with health physics data such as urine and fecal analysis results. USTUR autopsy cases are coded using the International Classisfication of Diseases (ICD) versions 9 and 10. Pathology data can be searched by these codes and viewed by relation to death and severity. [Taken from http://www.ustur.wsu.edu/AboutUs/overview.html and from http://www.ustur.wsu.edu/Mission/index.html and from http://www.ustur.wsu.edu/DeidentifiedData/database.html

  11. Electronic Patient Registries Improve Diabetes Care and Clinical Outcomes in Rural Community Health Centers

    ERIC Educational Resources Information Center

    Pollard, Cecil; Bailey, Kelly A.; Petitte, Trisha; Baus, Adam; Swim, Mary; Hendryx, Michael

    2009-01-01

    Context: Diabetes care is challenging in rural areas. Research has shown that the utilization of electronic patient registries improves care; however, improvements generally have been described in combination with other ongoing interventions. The level of basic registry utilization sufficient for positive change is unknown. Purpose: The goal of…

  12. Impact of clinical registries on quality of patient care and health outcomes: protocol for a systematic review

    PubMed Central

    Hoque, Dewan Md Emdadul; Kumari, Varuni; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M

    2016-01-01

    Introduction Many developed countries have regional and national clinical registries aimed at improving health outcomes of patients diagnosed with particular diseases or cared for in particular healthcare settings. Clinical quality registries (CQRs) are clinical registries established with the purpose of monitoring quality of care and providing feedback to improve health outcomes. The aim of this systematic review is to understand the impact of CQRs on (1) mortality/survival; (2) measures of outcome that reflect a process or outcome of healthcare; (3) healthcare utilisation and (4) costs. Methods and analysis The PRISMA-P methodology, checklist and standard strategy using predefined inclusion and exclusion criteria and structured data abstraction tools will be followed. A search of the electronic databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL will be undertaken, in addition to Google Scholar and grey literature, to identify studies in English covering the period January 1980 to December 2014. Case–control, cohort, randomised controlled trials and controlled clinical trials which describe the registry as an intervention will be eligible for inclusion. Narrative synthesis of study findings will be conducted, guided by a conceptual framework developed to analyse the outcome measure of the registry using defined criteria. If sufficient studies are identified with a similar outcome of interest and measure using the same comparator and time of interval, results will be pooled for random-effects meta-analysis. Test for heterogeneity and sensitivity analysis will be conducted. To identify reporting bias, forest plots and funnel plots will be created and, if required, Egger's test will be conducted. Ethics and dissemination Ethical approval is not required as primary data will not be collected. Review results will be published as a part of thesis, peer-reviewed journal and conferences. Trial registration number CRD

  13. Using software agents to maintain autonomous patient registries for clinical research.

    PubMed Central

    Murphy, S. N.; Rabbani, U. H.; Barnett, G. O.

    1997-01-01

    A software agent is an application that can function in an autonomous and intelligent fashion. We have used mobile software agents to maintain clinicians' patient research databases (patient registries). Agents were used to acquire data from the clinician and place it into the registries, copy data from hospital databases into the registries, and report data from the registries. The agents were programmed with the intelligence to navigate through complex network security, interact with legacy systems, and protect themselves from various forms of failure at multiple levels. To maximize the separation between our system and the hospital information infrastructure we often used Java, a platform-independent language, to program and distribute our software agents. By using mobile agents, we were able to distribute the computing time required by these applications to underutilized host machines upon which the registries could be maintained. PMID:9357591

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

    PubMed

    Lim, G C C; Azura, D

    2008-09-01

    Cancer burden in Malaysia is increasing. Although there have been improvements in cancer treatment, these new therapies may potentially cause an exponential increase in the cost of cancer treatment. Therefore, justification for the use of these treatments is mandated. Availability of local data will enable us to evaluate and compare the outcome of our patients. This will help to support our clinical decision making and local policy, improve access to treatment and improve the provision and delivery of oncology services in Malaysia. The National Cancer Patient Registry was proposed as a database for cancer patients who seek treatment in Malaysia. It will be a valuable tool to provide timely and robust data on the actual setting in oncology practice, safety and cost effectiveness of treatment and most importantly the outcome of these patients. PMID:19230247

  15. Establishing a clinic-based pancreatic cancer and periampullary tumour research registry in Quebec

    PubMed Central

    Smith, A.L.; Bascuñana, C.; Hall, A.; Salman, A.; Andrei, A.Z.; Volenik, A.; Rothenmund, H.; Ferland, D.; Lamoussenery, D.; Kamath, A.S.; Amre, R.; Caglar, D.; Gao, Z.H.; Haegert, D.G.; Kanber, Y.; Michel, R.P.; Omeroglu–Altinel, G.; Asselah, J.; Bouganim, N.; Kavan, P.; Arena, G.; Barkun, J.; Chaudhury, P.; Gallinger, S.; Foulkes, W.D.; Omeroglu, A.; Metrakos, P.; Zogopoulos, G.

    2015-01-01

    Background Enrolling patients in studies of pancreatic ductal adenocarcinoma (pdac) is challenging because of the high fatality of the disease. We hypothesized that a prospective clinic-based study with rapid ascertainment would result in high participation rates. Using that strategy, we established the Quebec Pancreas Cancer Study (qpcs) to investigate the genetics and causes of pdac and other periampullary tumours (pats) that are also rare and underrepresented in research studies. Methods Patients diagnosed with pdac or pat were introduced to the study at their initial clinical encounter, with a strategy to enrol participants within 2 weeks of diagnosis. Patient self-referrals and referrals of unaffected individuals with an increased risk of pdac were also accepted. Family histories, epidemiologic and clinical data, and biospecimens were collected. Additional relatives were enrolled in families at increased genetic risk. Results The first 346 completed referrals led to 306 probands being enrolled, including 190 probands affected with pdac, who represent the population focus of the qpcs. Participation rates were 88.4% for all referrals and 89.2% for pdac referrals. Family history, epidemiologic and clinical data, and biospecimens were ascertained from 91.9%, 54.6%, and 97.5% respectively of patients with pdac. Although demographics and trends in risk factors in our patients were consistent with published statistics for patients with pdac, the qpcs is enriched for families with French-Canadian ancestry (37.4%), a population with recurrent germ-line mutations in hereditary diseases. Conclusions Using rapid ascertainment, a pdac and pat research registry with high participation rates can be established. The qpcs is a valuable research resource and its enrichment with patients of French-Canadian ancestry provides a unique opportunity for studies of heredity in these diseases. PMID:25908910

  16. Clinical Stages in Patients with Primary and Subsequent Cancers Based on the Czech Cancer Registry 1976–2005

    PubMed Central

    Štampach, Radim; Dítě, Petr; Kozel, Jiří; Horváth, Teodor; Kubíček, Petr

    2013-01-01

    Of 1,486,984 new cancers registered in the Czech Cancer Registry in 1976-2005, 290,312 (19.5%) were multiple malignant neoplasms (MMNs), of which there were 65,292 primary and 89,796 subsequent cases in men and 59,970 primary and 75,254 subsequent cases in women. The duplicities were higher in women, and the triplicities and others (3–6 MMNs) were higher in men. The most frequent diagnoses were the primary cancers of skin, gastrointestinal and urinary tract, male genital organs, respiratory tract in men, and cancers of skin, breast, female genital organs, and gastrointestinal tract in women. The analysis of the early and advanced clinical stages shows that the number of subsequent advanced stages increased after primary advanced stages. Their time-age-space distributions visualized maps of MMNs in 14 Czech regions. These results support the improvement of algorithms of dispensary care for the early detection of the subsequent neoplasms. PMID:23936674

  17. The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European Countries.

    PubMed

    Hoffmann, V S; Baccarani, M; Hasford, J; Lindoerfer, D; Burgstaller, S; Sertic, D; Costeas, P; Mayer, J; Indrak, K; Everaus, H; Koskenvesa, P; Guilhot, J; Schubert-Fritschle, G; Castagnetti, F; Di Raimondo, F; Lejniece, S; Griskevicius, L; Thielen, N; Sacha, T; Hellmann, A; Turkina, A G; Zaritskey, A; Bogdanovic, A; Sninska, Z; Zupan, I; Steegmann, J-L; Simonsson, B; Clark, R E; Covelli, A; Guidi, G; Hehlmann, R

    2015-06-01

    This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months. 94.3% of the 2904 CML patients were diagnosed in chronic phase (CP). Median age was 56 years. 55.5% of patients had comorbidities, mainly cardiovascular (41.9%). High-risk patients were 24.7% by Sokal, 10.8% by EURO, and 11.8% by EUTOS risk scores. The raw incidence increased with age from 0.39/100,000/year in people 20-29 years old to 1.52 in those >70 years old, and showed a maximum of 1.39 in Italy and a minimum of 0.69 in Poland (all countries together: 0.99). The proportion of Sokal and Euro score high-risk patients seen in many countries indicates that trial patients were not a positive selection. Thus from a clinical point of view the results of most trials can be generalized to most countries. The incidences observed among European countries did not differ substantially. The estimated number of new CML cases per year in Europe is about 6370. PMID:25783795

  18. Mutation screening of PALB2 in clinically ascertained families from the Breast Cancer Family Registry.

    PubMed

    Nguyen-Dumont, Tú; Hammet, Fleur; Mahmoodi, Maryam; Tsimiklis, Helen; Teo, Zhi L; Li, Roger; Pope, Bernard J; Terry, Mary Beth; Buys, Saundra S; Daly, Mary; Hopper, John L; Winship, Ingrid; Goldgar, David E; Park, Daniel J; Southey, Melissa C

    2015-01-01

    Loss-of-function mutations in PALB2 are associated with an increased risk of breast cancer, with recent data showing that female breast cancer risks for PALB2 mutation carriers are comparable in magnitude to those for BRCA2 mutation carriers. This study applied targeted massively parallel sequencing to characterize the mutation spectrum of PALB2 in probands attending breast cancer genetics clinics in the USA. The coding regions and proximal intron-exon junctions of PALB2 were screened in probands not known to carry a mutation in BRCA1 or BCRA2 from 1,250 families enrolled through familial cancer clinics by the Breast Cancer Family Registry. Mutation screening was performed using Hi-Plex, an amplicon-based targeted massively parallel sequencing platform. Screening of PALB2 was successful in 1,240/1,250 probands and identified nine women with protein-truncating mutations (three nonsense mutations and five frameshift mutations). Four of the 33 missense variants were predicted to be deleterious to protein function by in silico analysis using two different programs. Analysis of tumors from carriers of truncating mutations revealed that the majority were high histological grade, invasive ductal carcinomas. Young onset was apparent in most families, with 19 breast cancers under 50 years of age, including eight under the age of 40 years. Our data demonstrate the utility of Hi-Plex in the context of high-throughput testing for rare genetic mutations and provide additional timely information about the nature and prevalence of PALB2 mutations, to enhance risk assessment and risk management of women at high risk of cancer attending clinical genetic services. PMID:25575445

  19. Mutation screening of PALB2 in clinically ascertained families from the Breast Cancer Family Registry

    PubMed Central

    Nguyen-Dumont, Tú; Hammet, Fleur; Mahmoodi, Maryam; Tsimiklis, Helen; Teo, Zhi L.; Li, Roger; Pope, Bernard J.; Terry, Mary Beth; Buys, Saundra S.; Daly, Mary; Hopper, John L.; Winship, Ingrid; Goldgar, David E.; Park, Daniel J.; Southey, Melissa C.

    2015-01-01

    Loss-of-function mutations in PALB2 are associated with an increased risk of breast cancer, with recent data showing that female breast cancer risks for PALB2 mutation carriers are comparable in magnitude to those for BRCA2 mutation carriers. This study applied targeted massively parallel sequencing to characterize the mutation spectrum of PALB2 in probands attending breast cancer genetics clinics in the USA. The coding regions and proximal intron–exon junctions of PALB2 were screened in probands not known to carry a mutation in BRCA1 or BCRA2 from 1,250 families enrolled through familial cancer clinics by the Breast Cancer Family Registry. Mutation screening was performed using Hi-Plex, an amplicon-based targeted massively parallel sequencing platform. Screening of PALB2 was successful in 1,240/1,250 probands and identified nine women with protein-truncating mutations (three nonsense mutations and five frameshift mutations). Four of the 33 missense variants were predicted to be deleterious to protein function by in silico analysis using two different programs. Analysis of tumors from carriers of truncating mutations revealed that the majority were high histological grade, invasive ductal carcinomas. Young onset was apparent in most families, with 19 breast cancers under 50 years of age, including eight under the age of 40 years. Our data demonstrate the utility of Hi-Plex in the context of high-throughput testing for rare genetic mutations and provide additional timely information about the nature and prevalence of PALB2 mutations, to enhance risk assessment and risk management of women at high risk of cancer attending clinical genetic services. PMID:25575445

  20. 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

  1. 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. PMID:25526544

  2. Registry of the clinical characteristics of spondyloarthritis in a cohort of Egyptian population.

    PubMed

    Tayel, M Y; Soliman, E; El Baz, W F; El Labaan, A; Hamaad, Y; Ahmed, M H

    2012-09-01

    AS showed a higher incapacity for work, felt more pain and presented more axial affection than others. The most utilized treatments were the conventional drugs including non-steroidal anti-inflammatory drugs, followed by sulfasalazine (50%), methotrexate (14%), and steroids (6%). Tumor necrosis factor-alpha inhibitors were received by 7 patients (14%), mostly in the form of Infliximab (85.7%) and were used by only 38.7% of patients with BASDAI of 4 or more. This registry provides the first clinical and demographic data of SpA patients in Egypt upon which a large-scale database registration can be initiated. The most frequently diagnosed SpA in Egyptian patients was AS, with mainly combined axial and peripheral involvement. The clinical spectrum of SpAs seen among Egyptians is similar to most other registries; however, Egyptian AS patients showed some differences in the clinical manifestations. The low frequency of HLA-B27 and the clinical variations in AS may be due to different genetic and/or environmental factors in Egypt. PMID:21879376

  3. Registries in orthopaedics.

    PubMed

    Delaunay, C

    2015-02-01

    The first nationwide orthopaedic registry was created in Sweden in 1975 to collect data on total knee arthroplasty (TKA). Since then, several countries have established registries, with varying degrees of success. Managing a registry requires time and money. Factors that contribute to successful registry management include the use of a single identifier for each patient to ensure full traceability of all procedures related to a given implant; a long-term funding source; a contemporary, rapid, Internet-based data collection method; and the collection of exhaustive data, at least for innovative implants. The effects of registries on practice patterns should be evaluated. The high cost of registries raises issues of independence and content ownership. Scandinavian countries have been maintaining orthopaedic registries for nearly four decades (since 1975). The first English-language orthopaedic registry was not created until 1998 (in New Zealand), and both the US and many European countries are still struggling to establish orthopaedic registries. To date, there are 11 registered nationwide registries on total knee and total hip replacement. The data they contain are often consistent, although contradictions occur in some cases due to major variations in cultural and market factors. The future of registries will depend on the willingness of health authorities and healthcare professionals to support the creation and maintenance of these tools. Surgeons feel that registries should serve merely to compare implants. Health authorities, in contrast, have a strong interest in practice patterns and healthcare institution performances. Striking a balance between these objectives should allow advances in registry development in the near future. PMID:25553603

  4. Outcomes from the Body & Soul Clinical Trials Project: A university-church partnership to improve African American enrollment in a clinical trial registry

    PubMed Central

    Langford, Aisha T.; Resnicow, Ken; Beasley, Derrick D.

    2014-01-01

    Objectives Historically, African Americans have been underrepresented in clinical trials (CTs) compared to whites. A growing number of research institutions have created CT registries to match volunteers with appropriate studies. In a sample of 745 African Americans from 16 churches, we tested the impact of a culturally tailored intervention aimed at increasing enrollment in a university-based CT registry. Methods Half of the churches received a culturally tailored CT education program (intervention) and half of the churches received a program about healthy eating (comparison). The main outcomes were the odds of posttest self-reported enrollment and verified enrollment. Using linear regression, posttest willingness to participate in a CT was also assessed. Results Odds of verified enrollment were higher in the intervention than comparison group (OR= 2.95, 95% CI: 1.33–6.5, p=0.01). Posttest self-reported enrollment in the registry was also higher among the intervention group than comparison group members (OR=1.94, 95% CI: 1.08–3.47, p=0.03). Willingness to participate in a future CT was higher in the intervention group (β=0.74, p=0.02). Conclusions A culturally tailored education program about CTs can increase enrollment of African Americans in a university-based clinical trials registry. Practice implications Community engagement and health education workshops may improve minority CT enrollment over time. PMID:25468392

  5. Fetal intracranial haemorrhages caused by fetal and neonatal alloimmune thrombocytopenia: an observational cohort study of 43 cases from an international multicentre registry

    PubMed Central

    Tiller, Heidi; Kamphuis, Marije M; Flodmark, Olof; Papadogiannakis, Nikos; David, Anna L; Sainio, Susanna; Koskinen, Sinikka; Javela, Kaija; Wikman, Agneta Taune; Kekomaki, Riitta; Kanhai, Humphrey H H; Oepkes, Dick; Husebekk, Anne; Westgren, Magnus

    2013-01-01

    Objective To characterise pregnancies where the fetus or neonate was diagnosed with fetal and neonatal alloimmune thrombocytopenia (FNAIT) and suffered from intracranial haemorrhage (ICH), with special focus on time of bleeding onset. Design Observational cohort study of all recorded cases of ICH caused by FNAIT from the international No IntraCranial Haemorrhage (NOICH) registry during the period 2001–2010. Setting 13 tertiary referral centres from nine countries across the world. Participants 37 mothers and 43 children of FNAIT pregnancies complicated by fetal or neonatal ICH identified from the NOICH registry was included if FNAIT diagnosis and ICH was confirmed. Primary and secondary outcome measures Gestational age at onset of ICH, type of ICH and clinical outcome of ICH were the primary outcome measures. General maternal and neonatal characteristics of pregnancies complicated by fetal/neonatal ICH were secondary outcome measures. Results From a total of 592 FNAIT cases in the registry, 43 confirmed cases of ICH due to FNAIT were included in the study. The majority of bleedings (23/43, 54%) occurred before 28 gestational weeks and often affected the first born child (27/43, 63%). One-third (35%) of the children died within 4 days after delivery. 23 (53%) children survived with severe neurological disabilities and only 5 (12%) were alive and well at time of discharge. Antenatal treatment was not given in most (91%) cases of fetal/neonatal ICH. Conclusions ICH caused by FNAIT often occurs during second trimester and the clinical outcome is poor. In order to prevent ICH caused by FNAIT, at-risk pregnancies must be identified and prevention and/or interventions should start early in the second trimester. PMID:23524102

  6. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

    PubMed Central

    Lemos, Pedro A; Chandwani, Prakash; Saxena, Sudheer; Ramachandran, Padma Kumar; Abhyankar, Atul; Campos, Carlos M; Marchini, Julio Flavio; Galon, Micheli Zanotti; Verma, Puneet; Sandhu, Manjinder Singh; Parikh, Nikhil; Bhupali, Ashok; Jain, Sharad; Prajapati, Jayesh

    2016-01-01

    Objectives To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up. Interventions Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures The primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months. Results At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm. Conclusions The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up. PMID:26888727

  7. Regional administrative health registries as a resource in clinical epidemiologyA study of options, strengths, limitations and data quality provided with examples of use.

    PubMed

    Sørensen, H T

    1997-01-01

    The present thesis, which is based on a review and 12 published articles, concerns clinical epidemiological methods [176-187].The Nordic countries have for many years established numerous registries. The establishment in Denmark of the National Population Registry in 1924 and the personal registration number (the CPR number) in 1968 allowed person-identification of remarkable quality, and made it possible to gather information on the same person in several registries. This situation is unique to the Nordic countries.The administrative registries were not primarily established for research purposes but have often proved a valuable tool in research. Despite the extensive use of registries in research, the methodological literature on this subject is limited. The purpose of the present thesis was: 1) to analyse strengths and limitations in using regional administrative registries in research, 2) to develop a framework for evaluation of existing registries for use in clinical epidemiological research, 3) to develop methods for evaluation of the data quality in regional registries, and 4) to evaluate four regional Danish administrative health registries for use in clinical epidemiological research.The analyses of strengths, limitations and data quality were based on studies of data from the regional hospital information systems, health service registries, and public health officers' surveillance system for strong analgesics and notifiable diseases.Against the background of the studies, the many advantages of using registries in research are discussed. The most important advantage is that data already exist and time consumption is thus considerably reduced, compared with studies based on collection of primary data. Costs are also considerably reduced. Other advantages included the generally large sample sizes, which provide great precision in estimates and which allow the study of rare exposures, diseases and other effects. Typically, the registries are complete as far

  8. Stroke Trials Registry

    MedlinePlus

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

  9. Neurosurgery clinical registry data collection utilizing Informatics for Integrating Biology and the Bedside and electronic health records at the University of Rochester.

    PubMed

    Pittman, Christine A; Miranpuri, Amrendra S

    2015-12-01

    In a population health-driven health care system, data collection through the use of clinical registries is becoming imperative to continue to drive effective and efficient patient care. Clinical registries rely on a department's ability to collect high-quality and accurate data. Currently, however, data are collected manually with a high risk for error. The University of Rochester's Department of Neurosurgery in conjunction with the university's Clinical and Translational Science Institute has implemented the integrated use of the Informatics for Integrating Biology and the Bedside (i2b2) informatics framework with the Research Electronic Data Capture (REDCap) databases. PMID:26621414

  10. Trauma registry reengineered.

    PubMed

    Wargo, Christina; Bolig, Nicole; Hixson, Heather; McWilliams, Nate; Rummerfield, Heather; Stratton, Elaine; Woodruff, Tracy

    2014-01-01

    A successful trauma registry balances accuracy of abstraction and timeliness of case submissions to achieve quality performance. Staffing to achieve quality performance is a challenge at times based on competitive institutional need. The aim of this performance improvement timing study was to identify trauma registry job responsibilities and redesign the responsibilities to create increased abstraction time and maintain accuracy of data abstraction. The outcome is measured by case submission rates with existing staffing and interrater reliability outcomes. PMID:25397337

  11. 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.

  12. RD-Connect: an integrated platform connecting databases, registries, biobanks and clinical bioinformatics for rare disease research.

    PubMed

    Thompson, Rachel; Johnston, Louise; Taruscio, Domenica; Monaco, Lucia; Béroud, Christophe; Gut, Ivo G; Hansson, Mats G; 't Hoen, Peter-Bram A; Patrinos, George P; Dawkins, Hugh; Ensini, Monica; Zatloukal, Kurt; Koubi, David; Heslop, Emma; Paschall, Justin E; Posada, Manuel; Robinson, Peter N; Bushby, Kate; Lochmüller, Hanns

    2014-08-01

    Research into rare diseases is typically fragmented by data type and disease. Individual efforts often have poor interoperability and do not systematically connect data across clinical phenotype, genomic data, biomaterial availability, and research/trial data sets. Such data must be linked at both an individual-patient and whole-cohort level to enable researchers to gain a complete view of their disease and patient population of interest. Data access and authorization procedures are required to allow researchers in multiple institutions to securely compare results and gain new insights. Funded by the European Union's Seventh Framework Programme under the International Rare Diseases Research Consortium (IRDiRC), RD-Connect is a global infrastructure project initiated in November 2012 that links genomic data with registries, biobanks, and clinical bioinformatics tools to produce a central research resource for rare diseases. PMID:25029978

  13. Usefulness of ambulatory blood pressure monitoring (ABPM) in daily clinical practice: Data from the Spanish ABPM registry.

    PubMed

    Segura, Julian; Banegas, Jose R; Ruilope, Luis M

    2014-01-01

    1. Hypertension is one of the most important challenges for public health systems because of its high prevalence and its association with the risk of cardiovascular and renal diseases. 2. Adequate control of hypertension is low in population and medical settings, with physicians frequently misclassifying patients' blood pressure status based on readings taken in the clinic rather than ambulatory blood pressure measurements (ABPM). 3. Data from the Spanish Society of Hypertension ABPM registry support ABPM as a feasible option in the primary care setting, providing valuable information for the diagnosis and management of hypertension. By using ABPM rather than office BP monitoring, BP control can be doubled. This is an encouraging message to clinicians, although there is still a relatively large degree of undetected controlled and uncontrolled hypertension. 4. This short review describes the design, development and main results of the Spanish Society of Hypertension ABPM registry, a project based on a large-scale network of Spanish physicians trained in ABPM. PMID:23710883

  14. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry—The EXCITING-ILD Registry

    PubMed Central

    Kreuter, Michael; Herth, Felix J. F.; Wacker, Margarethe; Leidl, Reiner; Hellmann, Andreas; Pfeifer, Michael; Behr, Jürgen; Witt, Sabine; Kauschka, Dagmar; Mall, Marcus; Günther, Andreas; Markart, Philipp

    2015-01-01

    Despite a number of prospective registries conducted in past years, the current epidemiology of interstitial lung diseases (ILD) is still not well defined, particularly regarding the prevalence and incidence, their management, healthcare utilisation needs, and healthcare-associated costs. To address these issues in Germany, a new prospective ILD registry, “Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases” (EXCITING-ILD), is being conducted by the German Centre for Lung Research in association with ambulatory, inpatient, scientific pulmonology organisations and patient support groups. This multicentre, noninterventional, prospective, and observational ILD registry aims to collect comprehensive and validated data from all healthcare institutions on the incidence, prevalence, characteristics, management, and outcomes regarding all ILD presentations in the real-world setting. Specifically, this registry will collect demographic data, disease-related data such as ILD subtype, treatments, diagnostic procedures (e.g., HRCT, surgical lung biopsy), risk factors (e.g., familial ILD), significant comorbidities, ILD managements, and disease outcomes as well as healthcare resource consumption. The EXCITING-ILD registry will include in-patient and out-patient ILD healthcare facilities in more than 100 sites. In summary, this registry will document comprehensive and current epidemiological data as well as important health economic data for ILDs in Germany. PMID:26640781

  15. Treatment patterns and clinical outcomes in patients with renal cell carcinoma in the UK: insights from the RECCORD registry

    PubMed Central

    Wagstaff, J.; Jones, R.; Hawkins, R.; Porfiri, E.; Pickering, L.; Bahl, A.; Brown, J.; Buchan, S.

    2016-01-01

    Background The aim of the RECCORD registry was to gather real-world UK data on the use of targeted therapies in renal cell carcinoma (RCC) and assess clinical outcomes. Here, demographic and outcome data are presented with the treatment patterns and demographic profile of patients on the registry. Patients and methods Patients were retrospectively identified at seven UK hospitals with large cancer centres in England (5), Scotland (1) and Wales (1). Anonymised data were collected through an online registry covering demographics, treatments and outcomes. Five hundred and fourteen UK adult patients with metastatic RCC were included in the study for analysis. Patients were included if they were treated for metastatic RCC at one of the seven centres, and started systemic anti-cancer treatment from March 2009 to November 2012 inclusive. In addition to demographic factors, the principal outcome measures were overall survival (OS), time to disease progression and toxicity. Results The majority of first-line treatment was with sunitinib; first-line use of pazopanib increased as the study progressed. 15.8% of patients received second-line treatment, half of whom were prescribed everolimus. Median OS (from initiation of first-line treatment) was 23.9 months (95% confidence interval [CI] 18.6–29.1 months), similar to that reported for clinical trials of targeted RCC therapies [Ljungberg B, Campbell SC, Choi HY et al. The epidemiology of renal cell carcinoma. Eur Urol 2011; 60: 615–621; Abe H, Kamai T. Recent advances in the treatment of metastatic renal cell carcinoma. Int J Urol 2013; 20: 944–955; Motzer RJ, Hutson TE, Tomczak P et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 3584–3590]. OS was significantly longer for those who received second-line treatment after disease progression (33.0 months; 95% CI 30.8–35.2 months) than those who did not (20

  16. US Transuranium and Uranium Registries case study on accidental exposure to uranium hexafluoride.

    PubMed

    Avtandilashvili, Maia; Puncher, Matthew; McComish, Stacey L; Tolmachev, Sergei Y

    2015-03-01

    The United States Transuranium and Uranium Registries' (USTUR) whole-body donor (Case 1031) was exposed to an acute inhalation of uranium hexafluoride (UF6) produced from an explosion at a uranium processing plant 65 years prior to his death. The USTUR measurements of tissue samples collected at the autopsy indicated long-term retention of inhaled slightly enriched uranium material (0.85% (235)U) in the deep lungs and thoracic lymph nodes. In the present study, the authors combined the tissue measurement results with historical bioassay data, and analysed them with International Commission on Radiological Protection (ICRP) respiratory tract models and the ICRP Publication 69 systemic model for uranium using maximum likelihood and Bayesian statistical methods. The purpose of the analysis was to estimate intakes and model parameter values that best describe the data, and evaluate their effect on dose assessment. The maximum likelihood analysis, which used the ICRP Publication 66 human respiratory tract model, resulted in a point estimate of 79 mg of uranium for the occupational intake composed of 86% soluble, type F material and 14% insoluble, type S material. For the Bayesian approach, the authors applied the Markov Chain Monte Carlo method, but this time used the revised human respiratory tract model, which is currently being used by ICRP to calculate new dose coefficients for workers. The Bayesian analysis estimated that the mean uranium intake was 160 mg, and calculated the case-specific lung dissolution parameters with their associated uncertainties. The parameters were consistent with the inhaled uranium material being predominantly soluble with a small but significant insoluble component. The 95% posterior range of the rapid dissolution fraction (the fraction of deposited material that is absorbed to blood rapidly) was 0.12 to 0.91 with a median of 0.37. The remaining fraction was absorbed slowly, with a 95% range of 0.000 22 d(-1) to 0.000 36

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

    PubMed Central

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

    2015-01-01

    Objectives Our study aimed to investigate the effect of cigarette smoking on the clinical phenotype of patients registered in the Chinese Systemic Lupus Erythematosus (SLE) Treatment and Research (CSTAR) group registry database, the first online registry of Chinese patients with SLE. Methods A prospective cross-sectional study of Chinese SLE patients was conducted using the CSTAR. Our case-control analysis was performed on age- and gender-matched subjects to explore the potential effect of cigarette smoking on the clinical manifestation of SLE. Results Smokers comprised 8.9% (65/730) of patients, and the ratio of females/males was 19/46. Thirty-nine patients were current smokers, and 26 were ex-smokers. Data showed significant differences between smokers and nonsmokers in the following areas: nephropathy (58.5% vs. 39.2%; p = 0.003), microscopic hematuria (30.8% vs. 19.1%; p = 0.025), proteinuria (53.8% vs. 34.4%; p = 0.002), and SLE Disease Activity Index(DAI) scores (12.38±8.95 vs. 9.83±6.81; p = 0.028). After adjusting for age and gender, significant differences between smokers and nonsmokers were found with photosensitivity (35.9% vs. 18%; p = 0.006), nephropathy (59.4% vs. 39.8%; p = 0.011), and proteinuria (54.7% vs. 35.2%). Although smokers tended to have greater disease severity compared with nonsmokers (SLEDAI scores: 12.58±8.89 vs.10.5±7.09), the difference was not significant (p = 0.081). Conclusions Cigarette smoking triggers the development and exacerbation of SLE, especially with respect to renal involvement. Chinese smokers with SLE should be advised to discontinue cigarette use. PMID:26280671

  18. Definition, epidemiology and registries of pulmonary hypertension.

    PubMed

    Awdish, R; Cajigas, H

    2016-05-01

    Pulmonary arterial hypertension (PAH) is a subcategory of pulmonary hypertension (PH) that comprises a group of disorders with similar pulmonary vascular pathology. Though PH is common, the estimated incidence of IPAH is 1-3 cases per million, making it a rare disease. The hemodynamic definition of PAH is a mean pulmonary artery pressure at rest >OR = 25 mm Hg in the presence of a pulmonary capillary wedge pressure clinical overlap with a common syndrome necessitated the creation of registries. These registries have been indispensable in the characterization and mapping of the natural history of the disease. Equations and risk calculators derived from registries have given clinicians a basis for risk stratification and prognostication. The sequential accumulation of data since the registries began in the 1980s allows for comparisons to be made. Patients who are differentiated by treatment eras and environments can be contrasted. Variability among inclusion criteria similarly allows for comparisons of these subpopulations. This article provides an overview of available registries, highlights insights provided by each and discusses key issues around the interpretation and extrapolation of data from PAH registries. Registries have allowed us to appreciate the improvement in survival afforded by modern therapy and enhanced detection of this disease. Moving forward, a more global approach to registries is needed, as is enhanced collaboration and centralization. PMID:26438630

  19. Accuracy of administrative and clinical registry data in reporting postoperative complications after surgery for oral cavity squamous cell carcinoma

    PubMed Central

    Awad, Mahmoud I.; Shuman, Andrew G.; Montero, Pablo H.; Palmer, Frank L.; Shah, Jatin P.; Patel, Snehal G.

    2016-01-01

    Background The purpose of this study was to describe and compare how postoperative complications after oral cavity squamous cell carcinoma (SCC) surgery are reported in medical records, institutional billing claims, and national clinical registries. Methods The medical records of 355 previously untreated patients who underwent surgery for oral cavity SCC at our institution were retrospectively reviewed for postoperative complications. Information was compared with claims and National Surgical Quality Improvement Program (NSQIP) data. Results We identified 219 patients (62%) experiencing 544 complications (10% major). Billing claims identified 29% of these patients, 36% of overall complications, and 98% of major complications. Of overlapping patients, NSQIP identified 27% of patients, 33% of overall complications, and 100% of major complications noted on chart abstraction. Conclusion The incidence of minor postoperative complications after oral cavity SCC surgery is relatively high. Both claims data and NSQIP accurately recorded major complications, but were suboptimal compared to chart abstraction in capturing minor complications. PMID:24623622

  20. Surgery and Risk of Sporadic Creutzfeldt-Jakob Disease in Denmark and Sweden: Registry-Based Case-Control Studies

    PubMed Central

    Mahillo-Fernandez, Ignacio; de Pedro-Cuesta, Jesús; Bleda, Maria José; Cruz, Mabel; Mølbak, Kåre; Laursen, Henning; Falkenhorst, Gerhard; Martínez-Martín, Pablo; Siden, Åke

    2008-01-01

    Background Epidemiologic evidence of surgical transmission of sporadic Creutzfeldt-Jakob disease (sCJD) remains controversial. Methods From Danish and Swedish registries we selected 167 definite and probable sCJD cases (with onset between 1987 and 2003) and 3,059 controls (835 age-, sex-, and residence-matched, and 2,224 unmatched). Independent of case/control status, surgical histories were obtained from National Hospital Discharge Registries. Surgical procedures were categorized by body system group and lag time to onset of sCJD. Exposure frequencies were compared using logistic regression. Results A history of any major surgery, conducted ≥20 years before sCJD onset, was more common in cases than both matched (OR = 2.44, 95% CI = 1.46–4.07) and unmatched controls (OR = 2.25, 95% CI = 1.48–3.44). This observation was corroborated by a linear increase in risk per surgical discharge (OR = 1.57, 95% CI = 1.13–2.18; OR = 1.50, 95% CI = 1.18–1.91). Surgery of various body systems, including peripheral vessels, digestive system and spleen, and female genital organs, was significantly associated with increased sCJD risk. Conclusions A variety of major surgical procedures constitute a risk factor for sCJD following an incubation period of many years. A considerable number of sCJD cases may originate from health care-related accidental transmission. PMID:18843192

  1. The phenotype of TNF receptor-associated autoinflammatory syndrome (TRAPS) at presentation: a series of 158 cases from the Eurofever/EUROTRAPS international registry

    PubMed Central

    Lachmann, H J; Papa, R; Gerhold, K; Obici, L; Touitou, I; Cantarini, L; Frenkel, J; Anton, J; Kone-Paut, I; Cattalini, M; Bader-Meunier, B; Insalaco, A; Hentgen, V; Merino, R; Modesto, C; Toplak, N; Berendes, R; Ozen, S; Cimaz, R; Jansson, A; Brogan, P A; Hawkins, P N; Ruperto, N; Martini, A; Woo, P; Gattorno, M

    2014-01-01

    Objective To evaluate the genetic findings, demographic features and clinical presentation of tumour necrosis factor receptor-associated autoinflammatory syndrome (TRAPS) in patients from the Eurofever/EUROTRAPS international registry. Methods A web-based registry collected retrospective data on patients with TNFRSF1A sequence variants and inflammatory symptoms. Participating hospitals included paediatric rheumatology centres and adult centres with a specific interest in autoinflammatory diseases. Cases were independently validated by experts in the disease. Results Complete information on 158 validated patients was available. The most common TNFRSF1A variant was R92Q (34% of cases), followed by T50M (10%). Cysteine residues were disrupted in 27% of cases, accounting for 39% of sequence variants. A family history was present in 19% of patients with R92Q and 64% of those with other variants. The median age at which symptoms began was 4.3 years but 9.1% of patients presented after 30 years of age. Attacks were recurrent in 88% and the commonest features associated with the pathogenic variants were fever (88%), limb pain (85%), abdominal pain (74%), rash (63%) and eye manifestations (45%). Disease associated with R92Q presented slightly later at a median of 5.7 years with significantly less rash or eye signs and more headaches. Children were more likely than adults to present with lymphadenopathy, periorbital oedema and abdominal pains. AA amyloidosis has developed in 16 (10%) patients at a median age of 43 years. Conclusions In this, the largest reported case series to date, the genetic heterogeneity of TRAPS is accompanied by a variable phenotype at presentation. Patients had a median 70 symptomatic days a year, with fever, limb and abdominal pain and rash the commonest symptoms. Overall, there is little evidence of a significant effect of age or genotype on disease features at presentation. PMID:23965844

  2. Clinical Presentation and Outcomes by Sex in Arrhythmogenic Right Ventricular Cardiomyopathy: Findings from the North American ARVC Registry

    PubMed Central

    Choudhary, Naila; Tompkins, Christine; Polonsky, Bronislava; Mcnitt, Scott; Calkins, Hugh; Estes, N. A. Mark; Krahn, Andrew D.; Link, Mark S.; Marcus, Frank I.; Towbin, Jeffrey A.; Zareba, Wojciech

    2016-01-01

    Clinical Presentation and Outcomes Background Sex differences in clinical presentation and outcomes of hereditary arrhythmias are commonly reported. We aimed to compare clinical presentation and outcomes in men and women with arrhythmogenic right ventricular cardiomyopathy (ARVC) enrolled in the North American ARVC Registry. Methods A total of 125 ARVC probands (55 females, mean age 38 ± 12; 70 males, mean age 41 ± 15) diagnosed, as either “affected” or “borderline” were included. Baseline clinical characteristics and time-dependent outcomes including syncope, ventricular tachycardia (VT), fast VT (>240 bpm), ventricular fibrillation (VF), and death were compared between males and females. Results The percentage of ARVC subjects diagnosed as “affected” (84% vs. 89%; P = 0.424) or “borderline” (16% vs. 11%; P = 0.424) was similar between females and males. Among the baseline characteristics, inverted T-waves in V2 trended to be more common in women (P = 0.09), whereas abnormal signal-averaged ECGs (SAECGs; P < 0.001) and inducible VT/VF (P = 0.026) were more frequent in men. During a mean follow-up of 37 ± 20 months, the probability of ICD-recorded VT/VF or death was not significantly different between men and women (P = 0.456). However, there was a trend toward lower risk of fast VT/VF or death in women compared to men (hazard ratio 0.41, 95% CI 0.151–1.113, P = 0.066). Abnormal SAECG and evidence of intramyocardial fat by cardiac MRI was associated with adverse outcomes in men (P = 0.006 and 0.02 respectively). Conclusion In the North American ARVC Registry, we found similar frequency of “affected” and “borderline” subjects between men and women. Sex-related differences were observed in baseline ECG, SAECG, Holter-recorded ventricular arrhythmias, and VT inducibility. Men showed a trend toward greater risk of fast VT than women. PMID:26840461

  3. Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID)

    PubMed Central

    2011-01-01

    Introduction Evidence from a number of open-label, uncontrolled studies has suggested that rituximab may benefit patients with autoimmune diseases who are refractory to standard-of-care. The objective of this study was to evaluate the safety and clinical outcomes of rituximab in several standard-of-care-refractory autoimmune diseases (within rheumatology, nephrology, dermatology and neurology) other than rheumatoid arthritis or non-Hodgkin's lymphoma in a real-life clinical setting. Methods Patients who received rituximab having shown an inadequate response to standard-of-care had their safety and clinical outcomes data retrospectively analysed as part of the German Registry of Autoimmune Diseases. The main outcome measures were safety and clinical response, as judged at the discretion of the investigators. Results A total of 370 patients (299 patient-years) with various autoimmune diseases (23.0% with systemic lupus erythematosus, 15.7% antineutrophil cytoplasmic antibody-associated granulomatous vasculitides, 15.1% multiple sclerosis and 10.0% pemphigus) from 42 centres received a mean dose of 2,440 mg of rituximab over a median (range) of 194 (180 to 1,407) days. The overall rate of serious infections was 5.3 per 100 patient-years during rituximab therapy. Opportunistic infections were infrequent across the whole study population, and mostly occurred in patients with systemic lupus erythematosus. There were 11 deaths (3.0% of patients) after rituximab treatment (mean 11.6 months after first infusion, range 0.8 to 31.3 months), with most of the deaths caused by infections. Overall (n = 293), 13.3% of patients showed no response, 45.1% showed a partial response and 41.6% showed a complete response. Responses were also reflected by reduced use of glucocorticoids and various immunosuppressives during rituximab therapy and follow-up compared with before rituximab. Rituximab generally had a positive effect on patient well-being (physician's visual analogue scale; mean

  4. Occupational risk factors for testicular cancer: a registry-based case-control study in Rhineland Palatinate – Germany

    PubMed Central

    Yousif, Lamyaa; Hammer, Gaël P.; Emrich, Katharina; Blettner, Maria; Zeeb, Hajo

    2013-01-01

    Objectives: Testicular cancer affects mainly men below the age of 50. An association with occupation and social status has been suggested but risk factors are not well understood. A registry-based case-control study focusing on occupation was performed in Germany. Methods: All 348 testicular cancer cases with available gainful occupational information registered between 2000 and 2005; as well as 564 suitable controls (from a pool of other cancers) were drawn from the Cancer Registry of Rhineland-Palatinate. Unconditional logistic regression was used to compute odds ratios (OR) and associated 95% confidence intervals (CI). Results: Slightly elevated OR were observed for technicians and related professionals (OR 1.62, 95% CI 1.00–2.63) and for clerical support workers (OR 1.71, 95% CI 1.14–2.56). This increase was highest in the age group 20–50 for technicians (OR 2.02, 95% CI 1.23–3.33) and clerks (OR 2.00, 95% CI 1.30–3.09), respectively. An association with testicular cancer was observed for no other occupation. Conclusion: An increased risk of testicular cancer was observed for technicians and related professionals and clerical support workers. This could be related to socioeconomic status or sedentary life style, two factors that were identified in previous studies. While the feasibility of a purely registry-based study was shown, missing occupational data and the choice of cancer controls represent challenges to the validity of this approach. PMID:24265602

  5. Validation of administrative hospital data for identifying incident pancreatic and periampullary cancer cases: a population-based study using linked cancer registry and administrative hospital data in New South Wales, Australia

    PubMed Central

    Creighton, Nicola; Walton, Richard; Roder, David; Aranda, Sanchia; Currow, David

    2016-01-01

    Objectives Informing cancer service delivery with timely and accurate data is essential to cancer control activities and health system monitoring. This study aimed to assess the validity of ascertaining incident cases and resection use for pancreatic and periampullary cancers from linked administrative hospital data, compared with data from a cancer registry (the ‘gold standard’). Design, setting and participants Analysis of linked statutory population-based cancer registry data and administrative hospital data for adults (aged ≥18 years) with a pancreatic or periampullary cancer case diagnosed during 2005–2009 or a hospital admission for these cancers between 2005 and 2013 in New South Wales, Australia. Methods The sensitivity and positive predictive value (PPV) of pancreatic and periampullary cancer case ascertainment from hospital admission data were calculated for the 2005–2009 period through comparison with registry data. We examined the effect of the look-back period to distinguish incident cancer cases from prevalent cancer cases from hospital admission data using 2009 and 2013 as index years. Results Sensitivity of case ascertainment from the hospital data was 87.5% (4322/4939), with higher sensitivity when the cancer was resected (97.9%, 715/730) and for pancreatic cancers (88.6%, 3733/4211). Sensitivity was lower in regional (83.3%) and remote (85.7%) areas, particularly in areas with interstate outflow of patients for treatment, and for cases notified to the registry by death certificate only (9.6%). The PPV for the identification of incident cases was 82.0% (4322/5272). A 2-year look-back period distinguished the majority (98%) of incident cases from prevalent cases in linked hospital data. Conclusions Pancreatic and periampullary cancer cases and resection use can be ascertained from linked hospital admission data with sufficient validity for informing aspects of health service delivery and system-level monitoring. Limited tumour clinical

  6. Registries Help Moms Measure Medication Risks

    MedlinePlus

    ... in the case of the North American Antiepileptic Drug Pregnancy Registry, which studies the effects of drugs for ... is taking. For example, the North American Antiepileptic Drug Pregnancy Registry website lists more than 30 medications being ...

  7. Clinical trials for vaccine development in registry of Korea Food and Drug Administration.

    PubMed

    Kang, Seog-Youn

    2013-01-01

    Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop vaccines in the context of self reliance and to protect public health. Along with the recognized infrastructures for clinical trials, clinical trials for vaccines have also gradually been conducted at multinational sites as well as at local sites. KFDA will support to expand six to eleven kinds of vaccines by 2017. In accordance with integrated regulatory system, KFDA has promoted clinical trials, established national lot release procedure, and strengthened good manufacturing practices inspection and post marketing surveillance. Against this backdrop, KFDA will support the vaccine development and promote excellent public health protection. PMID:23596594

  8. Long-term performance of the second-generation cobalt-chromium sirolimus-eluting stents in real-world clinical practice: 3-year clinical outcomes from the prospective multicenter FOCUS registry

    PubMed Central

    Zhang, Feng; Yang, Ji’e; Qian, Juying; Ge, Lei; Zhou, Jun

    2016-01-01

    Background The short- and mid-term outcomes of the second-generation cobalt-chromium sirolimus-eluting stent (CoCr-SES) in real-world patients had been reported previously, but the long-term performance remained unclear. The objective of this analysis was to evaluate the long-term safety and efficacy of the second-generation CoCr-SES from the FOCUS registry. Methods The FOCUS registry (ClinicalTrials.gov Identifier: NCT00868829) enrolled all-comers eligible to receive Firebird-2 CoCr-SES. Follow-up was continued to 3 years to evaluate long-term safety and effectiveness of the second-generation CoCr-SES in real-world practice. Results of the extended-use group and standard-use group are compared to explore performance of CoCr-SES in more severe patients with more complex lesions. Results The rate of 3-year MACE was 7.37%, consisting of 84 cases (1.78%) of cardiac death, 166 cases (3.52%) of MI and 98 cases (2.08%) of TVR. ARC definite/probable stent thrombosis happened in 34 (0.72%) patients, only 3 new cases (<0.1%) of very late stent thrombosis was reported in the third year. Meanwhile, the difference of MACE (7.77% vs. 6.06%; P=0.058), TLF (4.71% vs. 3.49%; P=0.085) and ARC definite/probable stent thrombosis (0.83% vs. 0.37%; P=0.116) between extended-use group and standard-use group showed no significance. Conclusions The second-generation CoCr-SES was associated with continued low rates of 3-year MACE, TLF and stent thrombosis in a broad spectrum of patients. PMID:27499948

  9. [Perinatal Information System. Incorporation latency and impact on perinatal clinical registry].

    PubMed

    Simini, F; Fernández, A; Sosa, C; Díaz Rossello, J L

    2001-10-01

    The Perinatal Information System (SIP) is a clinical record, local management and quality assurance software standard in Latin America and the Caribbean. The time to implement SIP in a Maternity Hospital is evaluated as well as the effect of statistics on perinatal health indicators in subsequent years. In the sample of 20 Maternity Hospitals (5 Countries, 40% Private and 60% Public) 85% had a reliable information system by the third year of use of SIP. 15% of hospitals still had problems at that time that were already clear during the second year, a time corrective measures can still be taken. The evaluation of the impact of yearly reports shows that 58% of recommendations were fulfilled, specially those regarding the complete filling-in of clinical records (62%) and to a lesser extent variables that reflect clinical practices and organization of services (52%). The conclusion is that Maternity Hospitals in Latin America and the Caribbean have the capacity to adopt a complex tool of computerized clinical records for quality assurance of perinatal care and monitoring of health indicators. PMID:11816526

  10. JBEI Registry

    Energy Science and Technology Software Center (ESTSC)

    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 Registriesmore » for data sharing and exchange.« less

  11. Mortality patterns from lung cancer and nonneoplastic respiratory disease among white males in the Beryllium Case Registry

    SciTech Connect

    Infante, P.F.; Wagoner, J.K.; Sprince, N.L.

    1980-02-01

    Study was undertaken of mortality patterns among white males entered into the Beryllium Case Registry (BCR) while alive with a diagnosis of beryllium-related nonneoplastic respiratory symptoms or disease. Analyses demonstrate an excessive risk of lung cancer among those subjects in the BCR who had been previously diagnosed with acute chemical pneumonitis or bronchitis secondary to short-term beryllium exposure. In the evaluation of the excessive lung cancer risk in this population, consideration should be given to the competing effects from the high case fatality rate of nonneoplastic respiratory disease. This excessive risk of lung cancer could not be explained on the basis of cigarette smoking per se. The findings of the present study utilizing subjects in the BCR are consistent with results of animal studies that over 30 years ago first demonstrated beryllium to be a carcinogen and with numerous epidemiologic studies demonstrating an increased risk of lung cancer among workers occupationally exposed to beryllium and its compounds.

  12. Daptomycin for the treatment of osteomyelitis and orthopaedic device infections: real-world clinical experience from a European registry.

    PubMed

    Malizos, K; Sarma, J; Seaton, R A; Militz, M; Menichetti, F; Riccio, G; Gaudias, J; Trostmann, U; Pathan, R; Hamed, K

    2016-01-01

    Osteomyelitis is a serious infection predominantly caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Orthopaedic device-related infections are complex and require a careful combination of surgical intervention and antimicrobial therapy. Daptomycin, a cyclic lipopeptide, effectively penetrates soft tissue and bone and demonstrates rapid concentration-dependent bactericidal activity against Gram-positive pathogens. This retrospective, non-interventional study evaluated clinical outcomes in patients with osteomyelitis or orthopaedic device infections treated with daptomycin from the European Cubicin® Outcomes Registry and Experience (EU-CORE(SM)) study. Patients were treated between January 2006 and April 2012, with follow-up to 2014. Clinical outcomes were assessed as success (cured or improved), failure or non-evaluable. Of 6,075 patients enrolled, 638 (median age, 63.5 years) had primary infections of osteomyelitis or orthopaedic device infections, 224 had non-prosthetic osteomyelitis, 208 had osteomyelitis related to a permanent or temporary prosthetic device, and 206 had orthopaedic device infections. The most commonly isolated pathogen was S. aureus (214 [49.1 %]; 24.8 % were MRSA). Overall, 455 (71.3 %) patients had received previous antibiotic therapy. Patients underwent surgical interventions, including tissue (225 [35.3 %]) and bone (196 [30.7 %]) debridement, as part of their treatment. Clinical success rates were 82.7 % and 81.7 % in S. aureus and coagulase-negative staphylococcal infections. Adverse events (AEs) and serious AEs assessed as possibly related to daptomycin were observed in 6.7 % and 1.9 % of patients, respectively. Daptomycin was discontinued by 5.5 % of patients due to AEs and 10 (1.6 %) deaths were reported. In conclusion, daptomycin was effective and safe in patients with osteomyelitis or orthopaedic device infections. PMID:26563898

  13. Demographics, Clinical Characteristics, Management, and Outcomes of Acute Heart Failure Patients: Observations from the Oman Acute Heart Failure Registry

    PubMed Central

    Panduranga, Prashanth; Sulaiman, Kadhim; Al-Zakwani, Ibrahim; Alazzawi, Aouf AbdlRahman; Abraham, Abraham; Singh, Prit Pal; Narayan, Narayan Anantha; Rajarao, Mamatha Punjee; Khdir, Mohammed Ahmed; Abdlraheem, Mohamad; Siddiqui, Aftab Ahmed; Soliman, Hisham; Elkadi, Osama Abdellatif; Bichu, Ruchir Kumar; Al Lawati, Kumayl Hasan

    2016-01-01

    Objectives We sought to describe the demographics, clinical characteristics, management and outcomes of patients in Oman with acute heart failure (AHF) as part of the Gulf aCute heArt failuRe rEgistry (CARE) project. Methods Data were analyzed from 988 consecutive patients admitted with AHF to 12 hospitals in Oman between 14 February and 14 November 2012. Results The mean age of our patients was 63±12 years. Over half (57%) were male and 95% were Omani citizens. Fifty-seven percent of patients presented with acute decompensated chronic heart failure (ADCHF) while 43% had new-onset AHF. The primary comorbid conditions were hypertension (72%), coronary artery disease (55%), and diabetes mellitus (53%). Ischemic heart disease (IHD), hypertensive heart disease, and idiopathic cardiomyopathy were the most common etiologies of AHF in Oman. The median left ventricular ejection fraction of the cohort was 36% (27–45%) with 56% of the patients having heart failure with reduced ejection fraction (< 40%). Atrial fibrillation was seen in 15% of patients. Acute coronary syndrome (ACS) and non-compliance with medications were the most common precipitating factors. At discharge, angiotensin converting enzyme inhibitors and beta-blockers were prescribed adequately, but aldosterone antagonists were under prescribed. Within 12-months follow-up, one in two patients were rehospitalized for AHF. In-hospital mortality was 7.1%, which doubled to 15.7% at three months and reached 26.4% at one-year post discharge. Conclusions Oman CARE was the first prospective multicenter registry of AHF in Oman and showed that heart failure (HF) patients present at a younger age with recurrent ADCHF and HF with reduced ejection fraction. IHD was the most common etiology of HF with a low prevalence of AHF, but a high prevalence of acute coronary syndrome and non-compliance with medications precipitating HF. A quarter of patients died at one-year follow-up even though at discharge medical therapy was

  14. The National Spina Bifida Patient Registry: Profile of a Large Cohort of Participants from the First 10 Clinics

    PubMed Central

    Sawin, Kathleen J.; Liu, Tiebin; Ward, Elisabeth; Thibadeau, Judy; Schechter, Michael S.; Soe, Minn M.; Walker, William

    2015-01-01

    Objective To use data from the US National Spina Bifida Patient Registry (NSBPR) to describe variations in Contexts of Care, Processes of Care, and Health Outcomes among individuals with spina bifida (SB) receiving care in 10 clinics. Study design Reported here are baseline cross-sectional data representing the first visit of 2172 participants from 10 specialized, multidisciplinary SB clinics participating in the NSBPR. We used descriptive statistics, the Fisher exact test, χ2 test, and Wilcoxon rank-sum test to examine the data. Results The mean age was 10.1 (SD 8.1) years with slightly more female subjects (52.5%). The majority was white (63.4%) and relied upon public insurance (53.5%). One-third had sacral lesions, 44.8% had mid-low lumbar lesions, and 24.9% had high lumbar and thoracic lesions. The most common surgery was ventricular shunt placement (65.7%). The most common bladder-management technique among those with bladder impairment was intermittent catheterization (69.0%). Almost 14% experienced a pressure ulcer in the last year. Of those ages 5 years or older with bowel or bladder impairments, almost 30% were continent of stool; a similar percentage was continent of urine. Most variables were associated with type of SB diagnosis. Conclusion The NSBPR provides a cross section of a predominantly pediatric population of patients followed in specialized SB programs. There were wide variations in the variables studied and major differences in Context of Care, Processes of Care, and Health Outcomes by type of SB. Such wide variation and the differences by type of SB should be considered in future analyses of outcomes. PMID:25444012

  15. Management of patients with idiopathic pulmonary fibrosis in clinical practice: the INSIGHTS-IPF registry.

    PubMed

    Behr, Jürgen; Kreuter, Michael; Hoeper, Marius M; Wirtz, Hubert; Klotsche, Jens; Koschel, Dirk; Andreas, Stefan; Claussen, Martin; Grohé, Christian; Wilkens, Henrike; Randerath, Winfried; Skowasch, Dirk; Meyer, F Joachim; Kirschner, Joachim; Gläser, Sven; Herth, Felix J F; Welte, Tobias; Huber, Rudolf Maria; Neurohr, Claus; Schwaiblmair, Martin; Kohlhäufl, Martin; Höffken, Gert; Held, Matthias; Koch, Andrea; Bahmer, Thomas; Pittrow, David

    2015-07-01

    After introduction of the new international guidelines on idiopathic pulmonary fibrosis (IPF) in 2011, we investigated clinical management practices for patients with IPF according to physicians' diagnoses. A prospective, multicenter, noninterventional study with comprehensive quality measures including on-site source data verification was performed in Germany. 502 consecutive patients (171 newly diagnosed, 331 prevalent; mean±SD age 68.7±9.4 years, 77.9% males) with a mean disease duration of 2.3±3.5 years were enrolled. IPF diagnosis was based on clinical assessments and high-resolution computed tomography (HRCT) in 90.2%, and on surgical lung biopsy combined with histology in 34.1% (lavage in 61.8%). The median 6-min walk distance was 320 m (mean 268±200 m). The mean forced vital capacity was 72±20% pred and diffusing capacity of the lung for carbon monoxide was 35±15% pred. No drugs were administered in 17.9%, oral steroids in 23.7%, N-acetylcysteine in 33.7%, pirfenidone in 44.2% and other drugs in 4.6% of patients. Only 2.8% of the cohort was listed for lung transplantation. IPF patients were diagnosed in line with the new guidelines. They had more severe disease than those enrolled in recent randomised controlled trials. In addition to HRCT, the frequency of lung biopsies was surprisingly high. Treatment patterns varied substantially. PMID:25837040

  16. Pulmonary embolism: Epidemiology and registries.

    PubMed

    Monreal, Manuel; Mahé, Isabelle; Bura-Riviere, Alessandra; Prandoni, Paolo; Verhamme, Peter; Brenner, Benjamin; Wells, Phil S; Di Micco, Pierpaolo; Bertoletti, Laurent

    2015-12-01

    Real-life data is important in understanding the needs of patients in routine clinical practice, particularly owing to the fact that almost a quarter of patients with venous thromoboembolism (VTE) have at least one exclusion criterion preventing their recruitment into randomized clinical trials. The Registro Informatizado de Enfermedad Trombo Embólica (RIETE) registry is an ongoing, international, multicentre, prospective registry of consecutive patients presenting with acute VTE. In this chapter, we summarized some of the most relevant data concerning the epidemiology of VTE in the RIETE registry. PMID:26547675

  17. [Clinical characteristics of patients with persistent atrial fibrillation referred for cardioversion: Spanish Cardioversion Registry (REVERSE)].

    PubMed

    Alegret, Josep M; Viñolas, Xavier; Sagristá, Jaume; Hernández-Madrid, Antonio; Berruezo, Antonio; Moya, Angel; Martínez Sande, José L; Pastor, Agustín

    2008-06-01

    The objectives were to investigate the treatment and clinical characteristics of patients referred for cardioversion in Spain and to compare them with those reported in the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) and RACE (RAte Control versus Electrical cardioversion) studies. The prospective study involved 1515 consecutive patients with persistent atrial fibrillation who were referred for cardioversion at 96 Spanish hospitals. Half of the patients were being treated with Vaughan-Williams group-I or -III antiarrhythmic drugs. The most frequently used approach to anticoagulation was to administer dicoumarins 34 weeks before and after cardioversion. Our patients were younger than those in the AFFIRM and RACE studies. Compared with AFFIRM patients, our patients had a lower prevalence of previous embolism, ischemic heart disease, hypertension, diabetes, and systolic dysfunction. Compared with RACE patients, our patients had a lower prevalence of ischemic heart disease and previous embolism, but a slightly higher prevalence of hypertension and diabetes. We conclude that patients referred for cardioversion in Spain clearly had a lower cardiovascular risk profile than those in the AFFIRM study, and appeared to have a lower risk profile than those in the RACE study. PMID:18570785

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

    PubMed Central

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

    2014-01-01

    Background: Since 2005, International Committee of Medical Journal Editors (ICMJE) member journals have required that clinical trials be registered in publicly available trials registers before they are considered for publication. Objectives: The research explores whether it is adequate, when searching to inform systematic reviews, to search for relevant clinical trials using only public trials registers and to identify the optimal search approaches in trials registers. Methods: A search was conducted in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) for research studies that had been included in eight systematic reviews. Four search approaches (highly sensitive, sensitive, precise, and highly precise) were performed using the basic and advanced interfaces in both resources. Results: On average, 84% of studies were not listed in either resource. The largest number of included studies was retrieved in ClinicalTrials.gov and ICTRP when a sensitive search approach was used in the basic interface. The use of the advanced interface maintained or improved sensitivity in 16 of 19 strategies for Clinicaltrials.gov and 8 of 18 for ICTRP. No single search approach was sensitive enough to identify all studies included in the 6 reviews. Conclusions: Trials registers cannot yet be relied upon as the sole means to locate trials for systematic reviews. Trials registers lag behind the major bibliographic databases in terms of their search interfaces. Implications: For systematic reviews, trials registers and major bibliographic databases should be searched. Trials registers should be searched using sensitive approaches, and both the registers consulted in this study should be searched. PMID:25031558

  19. Evaluation and implementation of public health registries.

    PubMed

    Solomon, D J; Henry, R C; Hogan, J G; Van Amburg, G H; Taylor, J

    1991-01-01

    A rapid proliferation of registries has occurred during the last 20 years. Given the long-term commitment of resources associated with registries and limited public health funding, proposals for new registries should be carefully considered before being funded. A registry is defined as a data base of identifiable persons containing a clearly defined set of health and demographic data collected for a specific public health purpose. Criteria for evaluating whether a registry is needed, feasible, or the most effective and efficient means of collecting a specific set of health data are presented. They include an evaluation of the stated purpose; a review of the function, duration, and scope of the registry; consideration of existing alternative data sources; an assessment of the practical feasibility of the registry; the likelihood of sufficient start-up and long-term funding; and an evaluation of the cost effectiveness of the registry. Creating a public health registry is a complex process. A range of technical and organizational skills is required for a registry to be successfully implemented. Eight requirements are identified as crucial for the successful development of a new registry. They include an implementation plan, adequate documentation, quality control procedures, case definition and case-finding (ascertainment) procedures, determination of data elements, data collection and processing procedures, data access policy, and a framework for dissemination of registry data and findings. PMID:1902306

  20. Comprehensive Description of Clinical Characteristics of a Large Systemic Lupus Erythematosus Cohort from the Spanish Rheumatology Society Lupus Registry (RELESSER) With Emphasis on Complete Versus Incomplete Lupus Differences

    PubMed Central

    Rúa-Figueroa, Íñigo; Richi, Patricia; López-Longo, Francisco Javier; Galindo, María; Calvo-Alén, Jaime; Olivé-Marqués, Alejandro; Loza-Santamaría, Estíbaliz; Vicente, Sabina Pérez; Erausquin, Celia; Tomero, Eva; Horcada, Loreto; Uriarte, Esther; Sánchez-Atrio, Ana; Rosas, José; Montilla, Carlos; Fernández-Nebro, Antonio; Rodríguez-Gómez, Manuel; Vela, Paloma; Blanco, Ricardo; Freire, Mercedes; Silva, Lucía; Díez-Álvarez, Elvira; Ibáñez-Barceló, Mónica; Zea, Antonio; Narváez, Javier; Martínez-Taboada, Víctor; Marenco, José Luis; de Castro, Mónica Fernández; Fernández-Berrizbeitia, Olaia; Hernández-Beriain, José Ángel; Gantes, Marian; Hernández-Cruz, Blanca; Pérez-Venegas, José J.; Pecondón, Ángela; Marras, Carlos; Carreira, Patricia; Bonilla, Gema; Torrente, Vicente; Castellví, Iván; Alegre, Juan; Moreno, Mireia; Raya, Enrique; de la Peña, Paloma García; Vázquez, Tomás; Aguirre, Ángeles; Quevedo, Víctor; Pego-Reigosa, José M.

    2015-01-01

    Abstract Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multiple organ involvement and pronounced racial and ethnic heterogeneity. The aims of the present work were (1) to describe the cumulative clinical characteristics of those patients included in the Spanish Rheumatology Society SLE Registry (RELESSER), focusing on the differences between patients who fulfilled the 1997 ACR-SLE criteria versus those with less than 4 criteria (hereafter designated as incomplete SLE (iSLE)) and (2) to compare SLE patient characteristics with those documented in other multicentric SLE registries. RELESSER is a multicenter hospital-based registry, with a collection of data from a large, representative sample of adult patients with SLE (1997 ACR criteria) seen at Spanish rheumatology departments. The registry includes demographic data, comprehensive descriptions of clinical manifestations, as well as information about disease activity and severity, cumulative damage, comorbidities, treatments and mortality, using variables with highly standardized definitions. A total of 4.024 SLE patients (91% with ≥4 ACR criteria) were included. Ninety percent were women with a mean age at diagnosis of 35.4 years and a median duration of disease of 11.0 years. As expected, most SLE manifestations were more frequent in SLE patients than in iSLE ones and every one of the ACR criteria was also associated with SLE condition; this was particularly true of malar rash, oral ulcers and renal disorder. The analysis—adjusted by gender, age at diagnosis, and disease duration—revealed that higher disease activity, damage and SLE severity index are associated with SLE [OR: 1.14; 95% CI: 1.08–1.20 (P < 0.001); 1.29; 95% CI: 1.15–1.44 (P < 0.001); and 2.10; 95% CI: 1.83–2.42 (P < 0.001), respectively]. These results support the hypothesis that iSLE behaves as a relative stable and mild disease. SLE patients from the RELESSER register do not appear to differ

  1. Comprehensive description of clinical characteristics of a large systemic lupus erythematosus cohort from the Spanish Rheumatology Society Lupus Registry (RELESSER) with emphasis on complete versus incomplete lupus differences.

    PubMed

    Rúa-Figueroa, Íñigo; Richi, Patricia; López-Longo, Francisco Javier; Galindo, María; Calvo-Alén, Jaime; Olivé-Marqués, Alejandro; Loza-Santamaría, Estíbaliz; Vicente, Sabina Pérez; Erausquin, Celia; Tomero, Eva; Horcada, Loreto; Uriarte, Esther; Sánchez-Atrio, Ana; Rosas, José; Montilla, Carlos; Fernández-Nebro, Antonio; Rodríguez-Gómez, Manuel; Vela, Paloma; Blanco, Ricardo; Freire, Mercedes; Silva, Lucía; Díez-Álvarez, Elvira; Ibáñez-Barceló, Mónica; Zea, Antonio; Narváez, Javier; Martínez-Taboada, Víctor; Marenco, José Luis; de Castro, Mónica Fernández; Fernández-Berrizbeitia, Olaia; Hernández-Beriain, José Ángel; Gantes, Marian; Hernández-Cruz, Blanca; Pérez-Venegas, José J; Pecondón, Ángela; Marras, Carlos; Carreira, Patricia; Bonilla, Gema; Torrente, Vicente; Castellví, Iván; Alegre, Juan; Moreno, Mireia; Raya, Enrique; de la Peña, Paloma García; Vázquez, Tomás; Aguirre, Ángeles; Quevedo, Víctor; Pego-Reigosa, José M

    2015-01-01

    Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multiple organ involvement and pronounced racial and ethnic heterogeneity. The aims of the present work were (1) to describe the cumulative clinical characteristics of those patients included in the Spanish Rheumatology Society SLE Registry (RELESSER), focusing on the differences between patients who fulfilled the 1997 ACR-SLE criteria versus those with less than 4 criteria (hereafter designated as incomplete SLE (iSLE)) and (2) to compare SLE patient characteristics with those documented in other multicentric SLE registries.RELESSER is a multicenter hospital-based registry, with a collection of data from a large, representative sample of adult patients with SLE (1997 ACR criteria) seen at Spanish rheumatology departments. The registry includes demographic data, comprehensive descriptions of clinical manifestations, as well as information about disease activity and severity, cumulative damage, comorbidities, treatments and mortality, using variables with highly standardized definitions.A total of 4.024 SLE patients (91% with ≥4 ACR criteria) were included. Ninety percent were women with a mean age at diagnosis of 35.4 years and a median duration of disease of 11.0 years. As expected, most SLE manifestations were more frequent in SLE patients than in iSLE ones and every one of the ACR criteria was also associated with SLE condition; this was particularly true of malar rash, oral ulcers and renal disorder. The analysis-adjusted by gender, age at diagnosis, and disease duration-revealed that higher disease activity, damage and SLE severity index are associated with SLE [OR: 1.14; 95% CI: 1.08-1.20 (P < 0.001); 1.29; 95% CI: 1.15-1.44 (P < 0.001); and 2.10; 95% CI: 1.83-2.42 (P < 0.001), respectively]. These results support the hypothesis that iSLE behaves as a relative stable and mild disease. SLE patients from the RELESSER register do not appear to differ substantially from

  2. Data Standards in Diabetes Patient Registries

    PubMed Central

    Richesson, Rachel L

    2011-01-01

    Widespread adoption of electronic health records (EHRs) and expansion of patient registries present opportunities to improve patient care and population health and advance translational research. However, optimal integration of patient registries with EHR functions and aggregation of regional registries to support national or global analyses will require the use of standards. Currently, there are no standards for patient registries and no content standards for health care data collection or clinical research, including diabetes research. Data standards can facilitate new registry development by supporting reuse of well-defined data elements and data collection systems, and they can enable data aggregation for future research and discovery. This article introduces standardization topics relevant to diabetes patient registries, addresses issues related to the quality and use of registries and their integration with primary EHR data collection systems, and proposes strategies for implementation of data standards in diabetes research and management. PMID:21722563

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

    PubMed

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

    2013-05-01

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

  4. Utilization of Observation Units for the Care of Poisoned Patients: Trends from the Toxicology Investigators Consortium Case Registry.

    PubMed

    Judge, Bryan S; Ouellette, Lindsey M; VandenBerg, Melissa; Riley, Brad D; Wax, Paul M

    2016-03-01

    Many poisoned patients may only require a period of observation after their exposure. There are limited data describing the use of observation units for managing poisoned adult and pediatric patients. We performed a retrospective review of all patients reported to the ToxIC Case Registry between January 1, 2012 and December 31, 2013. Eligible patients included those who received a bedside consultation by a medical toxicologist and whose care was provided in an observation unit, or those who were admitted under the care of a medical toxicologist in an observation unit. A total of 15,562 poisonings were reported to the registry during the study period, of which 340 (2.2 %) involved patients who were cared for in an observation unit. Of these patients, 22.1 % were 18 years of age or younger, and the remaining 77.9 % were greater than 18 years of age. The most common reason for exposure was the intentional ingestion of a pharmaceutical agent in both adult (30.2 %) and pediatric patients (36.0 %). Alcohols (ethanol) (24.9 %), opioids (20.0 %), and sedative-hypnotics (17.7 %) were the most common agent classes involved in adult patient exposures. The most common agent classes involved in pediatric exposures were antidepressants (12.0 %), anticonvulsants (10.7 %), and envenomations (10.7 %). In adult patients, the most common signs and symptoms involved the nervous system (52.0 %), a toxidrome (17.0 %), or a major vital sign abnormality (14.7 %). In pediatric patients, the most common signs and symptoms involved the nervous system (53.3 %), a toxidrome (21.3 %), or a major vital sign abnormality (17.3 %). The results of this study demonstrate that a wide variety of poisoned patients have been cared for in an observation unit in consultation with a board-certified medical toxicologist. Patterns for the reasons for exposure, agents responsible for the exposure, and toxicological treatments will continue to evolve. Further study is needed to identify

  5. Transition probabilities of HER2-positive and HER2-negative breast cancer patients treated with Trastuzumab obtained from a clinical cancer registry dataset

    PubMed Central

    Pobiruchin, Monika; Bochum, Sylvia; Martens, Uwe M.; Kieser, Meinhard; Schramm, Wendelin

    2016-01-01

    Records of female breast cancer patients were selected from a clinical cancer registry and separated into three cohorts according to HER2-status (human epidermal growth factor receptor 2) and treatment with or without Trastuzumab (a humanized monoclonal antibody). Propensity score matching was used to balance the cohorts. Afterwards, documented information about disease events (recurrence of cancer, metastases, remission of local/regional recurrences, remission of metastases and death) found in the dataset was leveraged to calculate the annual transition probabilities for every cohort. PMID:27054173

  6. Transition probabilities of HER2-positive and HER2-negative breast cancer patients treated with Trastuzumab obtained from a clinical cancer registry dataset.

    PubMed

    Pobiruchin, Monika; Bochum, Sylvia; Martens, Uwe M; Kieser, Meinhard; Schramm, Wendelin

    2016-06-01

    Records of female breast cancer patients were selected from a clinical cancer registry and separated into three cohorts according to HER2-status (human epidermal growth factor receptor 2) and treatment with or without Trastuzumab (a humanized monoclonal antibody). Propensity score matching was used to balance the cohorts. Afterwards, documented information about disease events (recurrence of cancer, metastases, remission of local/regional recurrences, remission of metastases and death) found in the dataset was leveraged to calculate the annual transition probabilities for every cohort. PMID:27054173

  7. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study

    PubMed Central

    Hughes, Shannon; Cohen, David; Jaggi, Rachel

    2014-01-01

    Objective To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies. Design Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles. Setting Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health. Main outcome measure 3 coders extracted data on the numbers and types of SAEs. Results 244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles’ (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; p<0.001) times more likely to be published with no discrepancy in their associated journal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov. Conclusions Substantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to

  8. The German national registry for primary immunodeficiencies (PID)

    PubMed Central

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

    2013-01-01

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

  9. 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

  10. Towards a Real Estate Registry 3d Model in Portugal: Some Illustrative Case Studies

    NASA Astrophysics Data System (ADS)

    de Almeida, J.-P.; Ellul, C.; Rodrigues-de-Carvalho, M. M.

    2013-09-01

    The 3D concept emerged as a key concept within geoinformation science. 3D geoinformation has been proved to be feasible and its added value over 2D geoinformation is widely acknowledged by researchers from various fields. Even so, 3D concept merits still need to be exploited further and more specific applications and associate products are needed - such as within real estate cadastre, our ultimate field of interest. The growing densification of urban land use is consequently increasing situations of vertical stratification of ownership rights. Traditional 2D cadastral models are not able to fully handle spatial information on those rights in the third dimension. Thus, 3D cadastre has been attracting researchers to better register and spatially represent real world overlapping situations. A centralised distributed cadastral management system, implementing a 2D cadastral model, has been conceived by the national cadastral agency in Portugal: the so-called SiNErGIC. The authors seek to show with this paper that there is room though for further investigation on the suitability of a 3D modelling approach instead, which should not be confined only to topologicalgeometric representations but should also be extended in order to be able to incorporate the legal/administrative component. This paper intends to be the first step towards the design of a prototype of a 3D cadastral model capable of handling the overall multipurpose cadastral reality in Portugal; it focuses primarily on the clear identification of some case studies that may illustrate the pertinence of such an approach in the context of this country.

  11. Infection as cause of immobility and occurrence of venous thromboembolism: analysis of 1635 medical cases from the RIETE registry.

    PubMed

    Frasson, Stefania; Gussoni, Gualberto; Di Micco, Pierpaolo; Barba, Raquel; Bertoletti, Laurent; Nuñez, Manuel J; Valero, Beatriz; Samperiz, Angel Luis; Rivas, Agustina; Monreal, Manuel

    2016-04-01

    Several risk assessment models include infection and immobility among the items to be considered for venous thromboembolism (VTE) prevention. However, information on patients with infection leading to immobility and developing VTE are limited, as well as on the role of specific types of infection. Data were collected from the worldwide RIETE registry, including patients with symptomatic objectively confirmed VTE, and followed-up for at least 3 months. The overall population of RIETE at June 2013 (n = 47,390) was considered. Acute infection leading to immobility was reported in 3.9 % of non-surgical patients. Compared with patients immobilized due to dementia, patients with infection had a shorter duration of immobilization prior to VTE (less than 4 weeks in 94.2 vs. 25.9 % of cases; p < 0.001). During the 3-month follow-up, VTE patients with infection versus those with dementia had a lower rate of fatal bleeding (0.5 vs. 1.1 %; p < 0.05) or fatal PE (1.7 vs. 3.5 %; p < 0.01). Patients with respiratory tract infections had more likely PE as initial VTE presentation than other types of infection (62.3 vs. 37.7 %; p < 0.001). Significantly more patients with pneumonia than those with other respiratory infections had received VTE prophylaxis (50.2 vs. 30.6 %; p < 0.001). Following VTE, patients with sepsis showed a significantly higher risk of fatal bleeding. Based on our real-world data, infection seems to contribute to the pathogenesis of VTE by accelerating the effects of immobility. Its role as VTE risk factor probably deserves further attention and specific assessment in order to optimize VTE prophylaxis and treatment. PMID:26121973

  12. Creation of a Hyponatremia Registry Supported by an Industry-Derived Quality Control Methodology

    PubMed Central

    D., Giunta; N., Fuentes; V., Pazo; M. L., Posadas-Martínez; H., Michellangelo; G., Waisman; F., González Bernaldo De Quirós

    2010-01-01

    Background A clinical registry encompasses a selective set of rigorously collected and stored clinical data focused on a specific condition. Hyponatremia has multiple, complex underlying causes and is one of the most frequent laboratory abnormalities. No systematic registries of hyponatremic patients have been reported in the medical literature. The purpose of this project was to create a registry for hyponatremia in order to obtain epidemiological data that will help to better understand this condition. Objective This paper describes the creation of a registry for hyponatremia within a single institution that employs industry-based approaches for quality management to optimize data accuracy and completeness. Methods A prospective registry of incident hyponatremia cases was created for this study. A formalized statistically based quality control methodology was developed and implemented to analyze and monitor all the process indicators that were developed to ensure data quality. Results Between December 2006 and April 2009, 2443 episodes of hyponatremia were included. Six process indicators that reflect the integrity of the system were evaluated monthly, looking for variation that would suggest systematic problems. The graphical representation of the process measures through control charts allowed us to identify and subsequently address problems with maintaining the registry. Conclusion In this project we have created a novel hyponatremia registry. To ensure the quality of the data in this registry we have implemented a quality control methodology based on industrial principles that allows us to monitor the performance of the registry over time through process indicators in order to detect systematic problems. We postulate that this approach could be reproduced for other registries. PMID:23616856

  13. The Value and Relevance of the T Cell Lymphoma Registries and International Collaborations: the Case of COMPLETE and the T-Cell Project.

    PubMed

    Bellei, Monica; Nabhan, Chadi; Pesce, Emanuela Anna; Conte, Luana; Vose, Julie M; Foss, Francine; Federico, Massimo

    2015-12-01

    Peripheral T cell lymphomas (PTCLs) are a heterogeneous group of lymphoid malignancies that portend a poor prognosis and have an undefined optimal therapeutic strategy. Data on best practices stem from prior studies that have generally included B cell lymphomas. However, the enhanced ability to diagnose PTCLs, the development of newer agents specific for PTCLs, and its increased incidence have called the scientific community to develop better strategies to combat these neoplasms. To that end, T cell lymphoma registries were developed in an attempt to answer relevant questions on the prognosis and management of PTCLs. The largest registries currently enrolling patients are the Comprehesive Oncology Measures for PeripheraL T-cEll Lymphoma TrEatment (COMPLETE) and the T-Cell Project. Despite the inherent limitations of these studies, valuable information are being collected to refine our management approaches and to aid in designing future clinical trials. This review illustrates the value of these registries and describes the critical questions that need to be answered. PMID:26449717

  14. Body mass index and survival after diagnosis of invasive breast cancer: a study based on the Japanese National Clinical Database-Breast Cancer Registry.

    PubMed

    Kawai, Masaaki; Tomotaki, Ai; Miyata, Hiroaki; Iwamoto, Takayuki; Niikura, Naoki; Anan, Keisei; Hayashi, Naoki; Aogi, Kenjiro; Ishida, Takanori; Masuoka, Hideji; Iijima, Kotaro; Masuda, Shinobu; Tsugawa, Koichiro; Kinoshita, Takayuki; Nakamura, Seigo; Tokuda, Yutaka

    2016-06-01

    Few studies have reported the association between body mass index (BMI) and outcome among Asian breast cancer patients. We analyzed data for 20,090 female invasive breast cancer patients who had been followed-up for a median period of 6.7 years entered in the National Clinical Database-Breast Cancer Registry between 2004 and 2006. We used mainly the WHO criteria for BMI (kg/m(2) ) categories; <18.5 (underweight), ≥18.5-<21.8 (reference), ≥21.8-<25, ≥25-<30 (overweight), and ≥30 (obese). We divided normal weight patients into two subgroups because this category includes many patients compared to others. The timing of BMI measurement was not specified. The Cox proportional hazards model and cubic spline regression were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Smoking, alcohol, and physical activity were not controlled. A total of 1418 all-cause, 937 breast cancer-specific deaths, and 2433 recurrences were observed. Obesity was associated with an increased risk of all-cause (HR: 1.46; 95% CI: 1.16-1.83) and breast cancer-specific death (HR: 1.47; 95% CI: 1.11-1.93) for all patients, and with all-cause (HR: 1.47; 95% CI: 1.13-1.92) and breast cancer-specific death (HR: 1.58; 95% CI: 1.13-2.20) for postmenopausal patients. Being underweight was associated with an increased risk of all-cause death for all (HR: 1.41; 95% CI: 1.16-1.71) and for postmenopausal patients (HR: 1.45; 95% CI: 1.15-1.84). With regard to subtype and menopausal status, obesity was associated with an increased risk of breast cancer-specific death for all cases of luminal B tumor (HR: 2.59; 95% CI: 1.51-4.43; Pheterogeneity of Luminal B vs. Triple negative = 0.016) and for postmenopausal patients with luminal B tumor (HR: 3.24; 95% CI: 1.71-6.17). Being obese or underweight is associated with a higher risk of death among female breast cancer patients in Japan. PMID:26923549

  15. [Gastric melanoma--clinical case].

    PubMed

    Doran, H; Pătraşcu, Tr; Catrina, E; Mihalache, O; Degeratu, D; Predescu, G

    2009-01-01

    Malignant melanomas of the gastrointestinal tract and particulary of the stomach are very rare intra-operative findings. The majority of such melanomas are metastatic from a cutaneous primary. We present the clinical case of a 69-years-old woman with malignant melanoma of the left pectoral region resected in 1988, presented with epigastric pain, weight loss and anaemia. Endoscopy and CT-scan suggested the diagnosis of malignant tumor of the large curvature of the stomach. Explorative laparotomy revealed a large ulcerated tumor of the fornix, with spleno-pancreatic invasion. We also found several pigmented satellite nodules. The surgical solution consisted in a total gastrectomy and distal spleno-pancreatectomy. Histology revealed the tumor and the satellite nodules to be composed of nests of epithelioid cells with melanin pigment. After 3 months, the evolution was favorable. There are some articles in medical literature which present cases of primary gastric melanomas. According to these scientific criterias from the literature, we discussed the nature of this melanoma - a primary or a metastatic one. PMID:19943569

  16. Prevalence, prenatal diagnosis and clinical features of oculo-auriculo-vertebral spectrum: a registry-based study in Europe

    PubMed Central

    Barisic, Ingeborg; Odak, Ljubica; Loane, Maria; Garne, Ester; Wellesley, Diana; Calzolari, Elisa; Dolk, Helen; Addor, Marie-Claude; Arriola, Larraitz; Bergman, Jorieke; Bianca, Sebastiano; Doray, Berenice; Khoshnood, Babak; Klungsoyr, Kari; McDonnell, Bob; Pierini, Anna; Rankin, Judith; Rissmann, Anke; Rounding, Catherine; Queisser-Luft, Annette; Scarano, Gioacchino; Tucker, David

    2014-01-01

    Oculo-auriculo-vertebral spectrum is a complex developmental disorder characterised mainly by anomalies of the ear, hemifacial microsomia, epibulbar dermoids and vertebral anomalies. The aetiology is largely unknown, and the epidemiological data are limited and inconsistent. We present the largest population-based epidemiological study to date, using data provided by the large network of congenital anomalies registries in Europe. The study population included infants diagnosed with oculo-auriculo-vertebral spectrum during the 1990–2009 period from 34 registries active in 16 European countries. Of the 355 infants diagnosed with oculo-auriculo-vertebral spectrum, there were 95.8% (340/355) live born, 0.8% (3/355) fetal deaths, 3.4% (12/355) terminations of pregnancy for fetal anomaly and 1.5% (5/340) neonatal deaths. In 18.9%, there was prenatal detection of anomaly/anomalies associated with oculo-auriculo-vertebral spectrum, 69.7% were diagnosed at birth, 3.9% in the first week of life and 6.1% within 1 year of life. Microtia (88.8%), hemifacial microsomia (49.0%) and ear tags (44.4%) were the most frequent anomalies, followed by atresia/stenosis of external auditory canal (25.1%), diverse vertebral (24.3%) and eye (24.3%) anomalies. There was a high rate (69.5%) of associated anomalies of other organs/systems. The most common were congenital heart defects present in 27.8% of patients. The prevalence of oculo-auriculo-vertebral spectrum, defined as microtia/ear anomalies and at least one major characteristic anomaly, was 3.8 per 100 000 births. Twinning, assisted reproductive techniques and maternal pre-pregnancy diabetes were confirmed as risk factors. The high rate of different associated anomalies points to the need of performing an early ultrasound screening in all infants born with this disorder. PMID:24398798

  17. The California Clinical Data Project: a case study in the adoption of clinical data standards for quality improvement.

    PubMed

    Sujansky, Walter; Chang, Sophia

    2006-01-01

    The California Clinical Data Project is a statewide initiative to remove barriers to the widespread and effective use of information technology to improve chronic disease care. The project is a case study in the development and widespread adoption of clinical data standards by varied and often competing stakeholders. As an initial step, the project defined precise data standards for the batch reporting of pharmacy claims data and laboratory results data. These uniform standards facilitate the flow of existing electronic clinical information into disease registries and electronic health record systems. Pharmacy and lab results data now are being exchanged electronically with this standard among the largest health plans, medical groups, and clinical laboratories participating in California's pay-for-performance programs. Lessons from this project may apply to the development and adoption of data standards for other states and locales and for the emerging national health information infrastructure. PMID:16903664

  18. [Vertical fractures: apropos of 2 clinical cases].

    PubMed

    Félix Mañes Ferrer, J; Micò Muñoz, P; Sánchez Cortés, J L; Paricio Martín, J J; Miñana Laliga, R

    1991-01-01

    The aim of the study is to present a clinical review of the vertical root fractures. Two clinical cases are presented to demonstrates the criteria for obtaining a correct diagnosis of vertical root fractures. PMID:1659859

  19. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry.

    PubMed

    Miller, Kellee M; Foster, Nicole C; Beck, Roy W; Bergenstal, Richard M; DuBose, Stephanie N; DiMeglio, Linda A; Maahs, David M; Tamborlane, William V

    2015-06-01

    To examine the overall state of metabolic control and current use of advanced diabetes technologies in the U.S., we report recent data collected on individuals with type 1 diabetes participating in the T1D Exchange clinic registry. Data from 16,061 participants updated between 1 September 2013 and 1 December 2014 were compared with registry enrollment data collected from 1 September 2010 to 1 August 2012. Mean hemoglobin A1c (HbA1c) was assessed by year of age from <4 to >75 years. The overall average HbA1c was 8.2% (66 mmol/mol) at enrollment and 8.4% (68 mmol/mol) at the most recent update. During childhood, mean HbA1c decreased from 8.3% (67 mmol/mol) in 2-4-year-olds to 8.1% (65 mmol/mol) at 7 years of age, followed by an increase to 9.2% (77 mmol/mol) in 19-year-olds. Subsequently, mean HbA1c values decline gradually until ∼30 years of age, plateauing at 7.5-7.8% (58-62 mmol/mol) beyond age 30 until a modest drop in HbA1c below 7.5% (58 mmol/mol) in those 65 years of age. Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) remain all too common complications of treatment, especially in older (SH) and younger patients (DKA). Insulin pump use increased slightly from enrollment (58-62%), and use of continuous glucose monitoring (CGM) did not change (7%). Although the T1D Exchange registry findings are not population based and could be biased, it is clear that there remains considerable room for improving outcomes of treatment of type 1 diabetes across all age-groups. Barriers to more effective use of current treatments need to be addressed and new therapies are needed to achieve optimal metabolic control in people with type 1 diabetes. PMID:25998289

  20. The importance of registries in cancer control.

    PubMed

    Leal, Yelda A; Fernández-Garrote, Leticia M; Mohar-Betancourt, Alejandro; Meneses-García, Abelardo

    2016-04-01

    Cancer is one of the major causes of morbidity and mortality in the world, with 14.1 million new cases and 8.2 million deaths annually. A marked disparity exists between developed countries and developing countries, with 57% of new cases and 65% of deaths in 2012 occurring in developing countries. This global picture can only be obtained because of data obtained from population-based cancer registries, which allow cancer estimations for different geographic areas. Our objective is to perform a review of different types of registries and their role in the control of cancer. These types of registries are lacking in developing countries. In Central and South America, only 6% of the population is included in cancer registries versus 83% in North America. It is necessary to increase the coverage of cancer registries to obtain more reliable data that will more appropriately guide control programs. PMID:27557391

  1. Frequency of Attainment of Low-Density Lipoprotein Cholesterol and Non-High-Density Lipoprotein Cholesterol Goals in Cardiovascular Clinical Practice (from the National Cardiovascular Data Registry PINNACLE Registry).

    PubMed

    Spinler, Sarah A; Cziraky, Mark J; Willey, Vincent J; Tang, Fengming; Maddox, Thomas M; Thomas, Tyan; Dueñas, Gladys G; Virani, Salim S

    2015-08-15

    Studies have found that non-high-density lipoprotein cholesterol (non-HDL-C) is a superior marker for coronary heart disease compared to low-density lipoprotein cholesterol (LDL-C). Little is known about achievement of non-HDL-C goals outside clinical trials. Within a population of 146,064 patients with dyslipidemia in the PINNACLE Registry and a subgroup of 36,188 patients with diabetes mellitus (DM), we examined the proportion of patients and patient characteristics associated with having LDL-C, non-HDL-C, and both LDL-C and non-HDL-C levels at National Cholesterol Education Program goals. LDL-C, non-HDL-C, and both LDL-C and non-HDL-C goals in the overall cohort were achieved by 73%, 73.4%, and 68.9% patients, respectively. Significant predictors of meeting all 3 goals were age, male gender, statin, nonstatin, and combined statin plus nonstatin use. Patients with co-morbidities of hypertension, previous stroke or transient ischemic attack, peripheral arterial disease, myocardial infarction, and smoking were less likely to have LDL-C, non-HDL-C, and both LDL-C and non-HDL-C levels at National Cholesterol Education Program goal. In the overall cohort, patients with DM were less likely to meet non-HDL-C and both LDL-C and non-HDL-C goals. In the subgroup of patients with DM, predictors of meeting lipid goals were similar to the overall cohort. In conclusion, these data suggest contemporary treatment patterns by cardiologists successfully achieve lipid goals in most patients. Younger, female patients and those with atherosclerotic cardiovascular disease and risk factors, such as hypertension and DM, are less likely to achieve goals and may require more careful follow-up after statin initiation. Both LDL-C and non-HDL-C goals are achieved in <70% of patients, suggesting room for improvement if a goal-targeted individualized strategy is adopted. PMID:26089010

  2. The case for decoupling assembly and submission standards to maintain a more flexible registry of biological parts.

    PubMed

    Alnahhas, Razan N; Slater, Ben; Huang, Yunle; Mortensen, Catherine; Monk, Jordan W; Okasheh, Yousef; Howard, Marco D; Gottel, Neil R; Hammerling, Michael J; Barrick, Jeffrey E

    2014-01-01

    The Registry of Standard Biological Parts only accepts genetic parts compatible with the RFC 10 BioBrick format. This combined assembly and submission standard requires that four unique restriction enzyme sites must not occur in the DNA sequence encoding a part. We present evidence that this requirement places a nontrivial burden on iGEM teams developing large and novel parts. We further argue that the emergence of inexpensive DNA synthesis and versatile assembly methods reduces the utility of coupling submission and assembly standards and propose a submission standard that is compatible with current quality control strategies while nearly eliminating sequence constraints on submitted parts. PMID:25525459

  3. Integrating Patient Reported Outcomes With Clinical Cancer Registry Data: A Feasibility Study of the Electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) System

    PubMed Central

    Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

    2013-01-01

    Background Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. Objective This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Methods Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. Results ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both P<.001). Most non-consenters (71.1%, 234/329) cited information technology reasons (ie, difficulty using a computer). Questionnaires were fully or partially completed by 85.1% (541/636) of invited participants at T1 (80 questions total), 70.0% (442/631) at T2 (102-108 questions), and 66.3% (414/624) at T3 (148-154 questions), and fully completed at all three time-points by 57.6% (344/597) of participants. Reminders (mainly via email) effectively prompted responses. The PROs were successfully linked with cancer registry data for 100% of patients (N=636). Participant feedback

  4. 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

  5. Central registry in psychiatry: A structured review

    PubMed Central

    Prakash, Jyoti; Ramakrishnan, TS; Das, R. C.; Srivastava, K.; Mehta, Suresh; Shashikumar, R.

    2014-01-01

    Background: Central registry in psychiatry is being practiced in few countries and has been found useful in research and clinical management. Role of central registry has also expanded over the years. Materials and Methods: All accessible internet database Medline, Scopus, Embase were accessed from 1990 till date. Available data were systematically reviewed in structured manner and analyzed. Results: Central registry was found useful in epidemiological analysis, association studies, outcome studies, comorbidity studies, forensic issue, effective of medication, qualitative analysis etc., Conclusion: Central registry proves to be effective tool in quantitative and qualitative understanding of psychiatry practice. Findings of studies from central registry can be useful in modifying best practice and evidence based treatment in psychiatry. PMID:25535438

  6. The Italian National Rare Diseases Registry

    PubMed Central

    Taruscio, Domenica; Kodra, Yllka; Ferrari, Gianluca; Vittozzi, Luciano

    2014-01-01

    Introduction Rare disease registries are a priority at European level and specific actions are being implemented by the European Commission to support their development. In Italy, a National Registry of rare diseases has been established in 2001 as a network of regional registries. The latter have gradually been established and the full coverage of the Italian territory was attained during 2011. Methods Here we describe the basic features of the National Registry of rare diseases; the activities carried out to promote consistent operations in the regional registries; and the overall quality and composition of the records collected. Results After a validation process, including removal of duplicate records, 110,841 records of patients with rare diseases, single and with group denominations, are stored in the National Registry of rare diseases. They correspond to the overall diagnoses communicated to national registry by regional registries up to 30 June 2012. The quality of the data collected by the the National Registry of rare diseases has been assessed with respect to completeness and consistency of procedures. Variables characterising case and diagnosis showed a very limited number of missing values. Records reported at least one case of 485 rare conditions. Discussion To date, the National Registry of rare diseases is a surveillance system with the main objective of producing epidemiologic evidence on rare diseases in Italy, and of supporting policy making and health services planning. Data quality still represents a limitation for any sound epidemiological estimate of rare diseases in Italy. However, improvements of the quality of collected data and the completeness of case notifications should be strengthened. PMID:24922301

  7. Chinese SLE treatment and research group registry: III. association of autoantibodies with clinical manifestations in Chinese patients with systemic lupus erythematosus.

    PubMed

    Li, Jing; Leng, Xiaomei; Li, Zhijun; Ye, Zhizhong; Li, Caifeng; Li, Xiaofeng; Zhu, Ping; Wang, Zhengang; Zheng, Yi; Li, Xiangpei; Zhang, Miaojia; Tian, Xin-Ping; Li, Mengtao; Zhao, Jiuliang; Zhang, Feng-Chun; Zhao, Yan; Zeng, Xiaofeng

    2014-01-01

    We investigated the characteristics of Chinese SLE patients by analyzing the association between specific autoantibodies and clinical manifestations of 2104 SLE patients from registry data of CSTAR cohort. Significant (P<0.05) associations were found between anti-Sm antibody, anti-rRNP antibody, and malar rash; between anti-RNP antibody, anti-SSA antibody, and pulmonary arterial hypertension (PAH); between anti-SSB antibody and hematologic involvement; and between anti-dsDNA antibody and nephropathy. APL antibody was associated with hematologic involvement, interstitial lung disease, and a lower prevalence of oral ulcerations (P<0.05). Associations were also found between anti-dsDNA antibody and a lower prevalence of photosensitivity, and between anti-SSA antibody and a lower prevalence of nephropathy (P<0.05). Most of these findings were consistent with other studies in the literature but this study is the first report on the association between anti-SSA and a lower prevalence of nephropathy. The correlations of specific autoantibodies and clinical manifestations could provide clues for physicians to predict organ damages in SLE patients. We suggest that a thorough screening of autoantibodies should be carried out when the diagnosis of SLE is established, and repeated echocardiography annually in SLE patients with anti-RNP or anti-SSA antibody should be performed. PMID:24864270

  8. The PLDD registry.

    PubMed

    Chambers, R A; Botsford, J A; Fanelli, E

    1995-06-01

    The rapid acceptance of minimally invasive surgery in the United States has largely occurred without statistical proof of its superiority over traditional methods. All players in the healthcare field now see the need for valid outcome studies supporting the efficacy of new treatment techniques. Percutaneous laser disc decompression (PLDD) will gain wide acceptance only if it is statistically shown to be a safe and effective alternative treatment of a lumbar disc herniation. To that end, a central PLDD registry has been developed and implemented into clinical practice at several centers. This article reviews healthcare trends that motivated the creation of this data repository and discusses the history of its development. The currently used PLDD evaluation form is outlined and its utility is discussed. Most importantly, preliminary PLDD results and complications based on the data received are presented and analyzed. PMID:10150649

  9. Using Disguised Clinical Case Material

    ERIC Educational Resources Information Center

    Kantrowitz, Judy L.

    2010-01-01

    When, why, and how clinicians decide to write about clients are ethical concerns. There are risks and potential clinical ramifications as well as responsibilities for how these decisions are made. On the basis of 141 interviews with psychoanalysts who have published in 3 major national and international psychoanalytic journals, the author explores…

  10. Clinical and Prognostic Factors for Renal Parenchymal, Pelvis, and Ureter Cancers in SEER Registries: Collaborative Stage Data Collection System, Version 2

    PubMed Central

    Altekruse, Sean F.; Dickie, Lois; Wu, Xiao-Cheng; Hsieh, Mei-Chin; Wu, Manxia; Lee, Richard; Delacroix, Scott

    2015-01-01

    BACKGROUND The American Joint Committee on Cancer’s (AJCC) 7th edition cancer staging manual reflects recent changes in cancer care practices. This report assesses changes from the AJCC 6th to the AJCC 7th edition stage distributions and the quality of site-specific factors (SSFs). METHODS Incidence data for renal parenchyma and pelvis and ureter cancers from 18 Surveillance, Epidemiology, and End Results (SEER) registries were examined, including staging trends during 2004–2010, stage distribution changes between the AJCC 6th and 7th editions, and SSF completeness for cases diagnosed in 2010. RESULTS From 2004 to 2010, the percentage of stage I renal parenchyma cancers increased from 50% to 58%, whereas stage IV and unknown stage cases decreased (18% to 15%, and 10% to 6%, respectively). During this period, the percentage of stage 0a renal pelvis and ureter cancers increased from 21% to 25%, and stage IV and unknown stage tumors decreased (20% to 18%, and 7% to 5%, respectively). Stage distributions under the AJCC 6th and 7th editions were about the same. For renal parenchymal cancers, 71%–90% of cases had known values for 6 required SSFs. For renal pelvis and ureter cancers, 74% of cases were coded as known for SSF1 (WHO/ISUP grade) and 47% as known for SSF2 (depth of renal parenchymal invasion). SSF values were known for larger proportions of cases with reported resections. CONCLUSIONS Stage distributions between the AJCC 6th and 7th editions were similar. SSFs were known for more than two-thirds of cases, providing more detail in the SEER database relevant to prognosis. PMID:25412394

  11. United States Transuranium and Uranium Registries

    SciTech Connect

    Kathren, R.

    1993-02-28

    The United States Transuranium and Uranium Registries are unique human tissue research programs studying the distribution, dose, and possible biological effects of the actinide elements in man, with the primary goal of assuring the adequacy of radiation protection standards for these radionuclides. The Registries research is based on radiochemical analysis of tissues collected at autopsy from voluntary donors who have documented occupational exposure to the actinides. To date, tissues, or in some cases radioanalytical results only, have been obtained from approximately 300 individuals; another 464 living individuals have volunteered to participate in the Registries research programs and have signed premortem informed consent and autopsy permissions. The Registries originated at the National Plutonium Registry which was started in 1968 as a then Atomic Energy Commission project under the aegis of a prime contractor at the Hanford site. In 1970, the name was changed to the United States Transuranium Registry to reflect a broader involvement with the higher actinides. In 1978, an administratively separate parallel registry, the United States Uranium Registry, was formed to carry out similar studies among uranium fuel cycle workers.

  12. The virtual observatory registry

    NASA Astrophysics Data System (ADS)

    Demleitner, M.; Greene, G.; Le Sidaner, P.; Plante, R. L.

    2014-11-01

    In the Virtual Observatory (VO), the Registry provides the mechanism with which users and applications discover and select resources-typically, data and services-that are relevant for a particular scientific problem. Even though the VO adopted technologies in particular from the bibliographic community where available, building the Registry system involved a major standardisation effort, involving about a dozen interdependent standard texts. This paper discusses the server-side aspects of the standards and their application, as regards the functional components (registries), the resource records in both format and content, the exchange of resource records between registries (harvesting), as well as the creation and management of the identifiers used in the system based on the notion of authorities. Registry record authors, registry operators or even advanced users thus receive a big picture serving as a guideline through the body of relevant standard texts. To complete this picture, we also mention common usage patterns and open issues as appropriate.

  13. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry

    PubMed Central

    Ricci, Renato Pietro; Morichelli, Loredana; D'Onofrio, Antonio; Calò, Leonardo; Vaccari, Diego; Zanotto, Gabriele; Curnis, Antonio; Buja, Gianfranco; Rovai, Nicola; Gargaro, Alessio

    2013-01-01

    Aims The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. Methods and results The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients. Conclusion Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption. PMID:23362021

  14. Factors Associated With Microalbuminuria in 7,549 Children and Adolescents With Type 1 Diabetes in the T1D Exchange Clinic Registry

    PubMed Central

    Daniels, Mark; DuBose, Stephanie N.; Maahs, David M.; Beck, Roy W.; Fox, Larry A.; Gubitosi-Klug, Rose; Laffel, Lori M.; Miller, Kellee M.; Speer, Heather; Tamborlane, William V.; Tansey, Michael J.

    2013-01-01

    OBJECTIVE To examine factors associated with clinical microalbuminuria (MA) diagnosis in children and adolescents in the T1D Exchange clinic registry. RESEARCH DESIGN AND METHODS T1D Exchange participants <20 years of age with type 1 diabetes ≥1 year and urinary albumin-to-creatinine ratio (ACR) measured within the prior 2 years were included in the analysis. MA diagnosis required all of the following: 1) a clinical diagnosis of sustained MA or macroalbuminuria, 2) confirmation of MA diagnosis by either the most recent ACR being ≥30 mg/g or current treatment with an ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB), and 3) no known cause for nephropathy other than diabetes. Logistic regression was used to assess factors associated with MA. RESULTS MA was present in 329 of 7,549 (4.4%) participants, with a higher frequency associated with longer diabetes duration, higher mean glycosylated hemoglobin (HbA1c) level, older age, female sex, higher diastolic blood pressure (BP), and lower BMI (P ≤ 0.01 for each in multivariate analysis). Older age was most strongly associated with MA among participants with HbA1c ≥9.5% (≥80 mmol/mol). MA was uncommon (<2%) among participants with HbA1c <7.5% (<58 mmol/mol). Of those with MA, only 36% were receiving ACEI/ARB treatment. CONCLUSIONS Our results emphasize the importance of good glycemic and BP control, particularly as diabetes duration increases, in order to reduce the risk of nephropathy. Since age and diabetes duration are important nonmodifiable factors associated with MA, the importance of routine screening is underscored to ensure early diagnosis and timely treatment of MA. PMID:23610082

  15. Using Clinical Cases to Teach General Chemistry

    ERIC Educational Resources Information Center

    Dewprashad, Brahmadeo; Kosky, Charles; Vaz, Geraldine S.; Martin, Charlotte L.

    2004-01-01

    A clinical study was designed and used to show the relationship of health and medicine, in a typical clinical scenario, where many chemical principles are involved and that an integrated knowledge of chemistry and biology is essential to the understanding, diagnosing and treating of illnesses. A case study would be a positive learning experience…

  16. Integrated Case Learning: Teaching Clinical Reasoning

    ERIC Educational Resources Information Center

    Radomski, Natalie; Russell, John

    2010-01-01

    Learning how to "think like doctors" can be difficult for undergraduate medical students in their early clinical years. Our model of collaborative Integrated Case Learning (ICL) and simulated clinical reasoning aims to address these issues. Taking a socio-cultural perspective, this study investigates the reflective learning interactions and…

  17. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    PubMed Central

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3°; p < 0.001), remained at 12 months (−4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery. PMID:26844224

  18. New registry: National Cancer Patient Registry--Colorectal Cancer.

    PubMed

    Wendy, L; Radzi, M

    2008-09-01

    Colorectal cancer is emerging as one of the commonest cancers in Malaysia. Data on colorectal cancer from the National Cancer Registry is very limited. Comprehensive information on all aspects of colorectal cancer, including demographic details, pathology and treatment outcome are needed as the management of colorectal cancer has evolved rapidly over the years involving several disciplines including gastroenterology, surgery, radiology, pathology and oncology. This registry will be an important source of information that can help the development of guidelines to improve colorectal cancer care relevant to this country. The database will initially recruit all colorectal cancer cases from eight hospitals. The data will be stored on a customized web-based case report form. The database has begun collecting data from 1 October 2007 and will report on its first year findings at the end of 2008. PMID:19230248

  19. Second generation registry framework

    PubMed Central

    2014-01-01

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

  20. Clinical cases in acute intoxication.

    PubMed

    Smith, Sean B; Maguire, Jennifer; Mauck, Karen F

    2009-12-01

    Over 2.5 million accidental and intentional drug-related poisonings are reported annually in the United States. Early diagnosis and management of patients who present with acute intoxication can significantly reduce both morbidity and mortality. The initial evaluation of patients with suspected or proven intoxications should focus on hemodynamic stability, mental status, and respiratory function. However, early recognition of toxic ingestion is paramount to implementing life-saving treatments. Important historical clues are often found in a social history that considers intravenous drug use, alcohol use, and any access or exposure to illicit substances. A patient's medication list should also be scrutinized for psychoactive or sedative medications, such as tricyclic antidepressants or opioids. In this article we present case-based discussions of the specific diagnosis and management of 5 commonly occurring acute intoxication syndromes. PMID:20877175

  1. Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry

    PubMed Central

    Sharma, Sanjeev; Shumway, Richard; Perry, David; Bydder, Sean; Simpson, C. Kelley; D'Ambrosio, David

    2015-01-01

    Objectives: To report on initial patient characteristics, treatment practices, toxicity, and early biochemical disease-free survival (bDFS) of localized prostate cancer treated with stereotactic body radiotherapy (SBRT) and enrolled in the RSSearch® Patient Registry. Methods: A retrospective analysis was conducted on patients with clinically localized prostate cancer enrolled in RSSearch® from June 2006 - January 2015. Patients were classified as low-risk (PSA ≤ 10 ng/ml, T1c-T2a, Gleason score ≤ 6), intermediate-risk (PSA 10.1 - 20 ng/ml, T2b-T2c, or Gleason 7), or high-risk (PSA > 20 ng/ml, T3 or Gleason ≥ 8). Toxicity was reported using Common Toxicity Criteria for Adverse Events, version 3. Biochemical failure was assessed using the Phoenix definition (nadir + 2 ng/ml). The Kaplan-Meier analysis was used to calculate bDFS and association of patient and tumor characteristics with the use of SBRT. Results: Four hundred thirty-seven patients (189 low, 215 intermediate, and 33 high-risk) at a median of 69 years (range: 48-88) received SBRT at 17 centers. Seventy-eight percent of patients received 36.25 Gy/5 fractions, 13% received 37 Gy/5 fractions, 6% received 35 Gy/5 fractions, 3% received 38 Gy/4 fractions, and 5% received a boost dose of 19.5-29 Gy following external beam radiation therapy. Median follow-up was 20 months (range: 1–64 months). Genitourinary (GU) and gastrointestinal (GI) toxicities were minimal, with no acute or late Grade 3+ GU or GI toxicity. Late Grade 1 and 2 urinary frequency was 25% and 8%. Late Grade 1 and 2 proctitis was 3% and 2%. Median PSA decreased from 5.8 ng/ml (range: 0.3-43) to 0.88, 0.4, and 0.3 ng/ml at one, two, and three years. Two-year bDFS for all patients was 96.1%. Two-year bDFS was 99.0%, 94.5%, and 89.8% for low, intermediate, and high-risk patients (p < 0.0001). Two-year bDFS was 99.2%, 93.2%, and 90.4% for Gleason ≤ 6, Gleason 7, and Gleason ≥ 8 (p < 0.0001). Two-year bDFS was 96.4%, 97

  2. Clinical Presentation, Management and Outcome of Acute Coronary Syndrome in Yemen: Data from GULF RACE - 2 Registry

    PubMed Central

    Ahmed, Al-Motarreb; Abdulwahab, Al-Matry; Hesham, Al-Fakih; Nawar, Wather

    2013-01-01

    Background: Acute Coronary Syndrome (ACS) is increasing in Yemen in recent years and there are no data available on its short and long-term outcome. We evaluated the clinical pictures, management, in-hospital, and long-term outcomes of the ACS patients in Yemen. Design and Setting: A 9-month prospective, multi-center study conducted in 26 hospitals from 9 governorates. The study included 30-day and 1-year mortality follow-up. Patients and Methods: One thousand seven hundred and sixty one patients with ACS were collected prospectively during the 9-month period. Patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTEACS), including non-ST-elevation myocardial infarction and unstable angina were included. Conclusions: ACS patients in Yemen present at a relatively young age with high prevalence of Smoking, khat chewing and hypertension. STEMI patients present late, and their acute management is poor. In-hospital evidence-based medication rates are high, but coronary revascularization procedures were very low. In-hospital mortality was high and long-term mortality rates increased two folds compared with the in-hospital mortality. PMID:24695681

  3. Innovative Interventional and Imaging Registries: Precision Medicine in Cerebrovascular Disorders

    PubMed Central

    Liebeskind, David S.

    2015-01-01

    Background Precision medicine in cerebrovascular disorders may be greatly advanced by the use of innovative interventional and imaging-intensive registries. Registries have remained subsidiary to randomized controlled trials, yet vast opportunities exist to leverage big data in stroke. Summary This overview builds upon the rationale for innovative, imaging-intensive interventional registries as a pivotal step in realizing precision medicine for several cerebrovascular disorders. Such enhanced registries may serve as a model for expansion of our translational research pipeline to fully leverage the role of phase IV investigations. The scope and role of registries in precision medicine are considered, followed by a review on the history of stroke and interventional registries, data considerations, critiques or barriers to such initiatives, and the potential modernization of registry methods into efficient, searchable, imaging-intensive resources that simultaneously offer clinical, research and educational added value. Key Messages Recent advances in technology, informatics and endovascular stroke therapies converge to provide an exceptional opportunity for registries to catapult further progress. There is now a tremendous opportunity to deploy registries in acute stroke, intracranial atherosclerotic disease and carotid disease where other clinical trials leave questions unanswered. Unlike prior registries, imaging-intensive and modernized methods may leverage current technological capabilities around the world to efficiently address key objectives and provide added clinical, research and educational value. PMID:26600792

  4. Clinical Utility of the J-CTO Score in Coronary Chronic Total Occlusion Interventions: Results from a Multicenter Registry

    PubMed Central

    Christopoulos, Georgios; Wyman, R. Michael; Alaswad, Khaldoon; Karmpaliotis, Dimitri; Lombardi, William; Grantham, J. Aaron; Yeh, Robert W.; Jaffer, Farouc A.; Cipher, Daisha J.; Rangan, Bavana V.; Christakopoulos, Georgios E.; Kypreos, Megan A.; Lembo, Nicholas; Kandzari, David; Garcia, Santiago; Thompson, Craig A.; Banerjee, Subhash; Brilakis, Emmanouil S.

    2015-01-01

    Background The performance of the J-CTO score in predicting success and efficiency of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. Methods and Results We examined the records of 650 consecutive patients who underwent CTO PCI between 2011 and 2014 at six experienced centers in the United States. Six hundred and fifty-seven lesions were classified as easy (J-CTO=0), intermediate (J-CTO=1), difficult (J-CTO=2), and very difficult (J-CTO≥3). The impact of the J-CTO score on technical success and procedure time was evaluated with univariable logistic and linear regression, respectively. The performance of the logistic regression model was assessed with the Hosmer-Lemeshow statistic and receiver operator characteristic curves. Antegrade wiring techniques were used more frequently in easy lesions (97%) than very difficult lesions (58%), whereas the retrograde approach became less frequent with increased lesion difficulty (41% for very difficult lesions vs. 13% for easy lesions). The logistic regression model for technical success demonstrated satisfactory calibration and discrimination (p for Hosmer-Lemeshow=0.743 and area under curve=0.705). The J-CTO score was associated with a two-fold increase in the odds of technical failure (odds ratio 2.04, 95% confidence interval [95% CI] 1.52-2.80, p<0.001). Procedure time increased by approximately 20 minutes for every one-point increase of the J-CTO score (regression coefficient 22.33, 95% CI 17.45-27.22, p<0.001). Conclusions J-CTO score was strongly associated with final success and efficiency in this study, supporting its expanded use in CTO interventions. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02061436. PMID:26162857

  5. Gender Differences in In-Hospital Clinical Outcomes after Percutaneous Coronary Interventions: An Insight from a Japanese Multicenter Registry

    PubMed Central

    Numasawa, Yohei; Kohsaka, Shun; Miyata, Hiroaki; Noma, Shigetaka; Suzuki, Masahiro; Ishikawa, Shiro; Nakamura, Iwao; Nishi, Yutaro; Ohki, Takahiro; Negishi, Koji; Takahashi, Toshiyuki; Fukuda, Keiichi

    2015-01-01

    Background Gender differences in clinical outcomes after percutaneous coronary intervention (PCI) among different age groups are controversial in the era of drug-eluting stents, especially among the Asian population who are at higher risk for bleeding complications. Methods and Results We analyzed data from 10,220 patients who underwent PCI procedures performed at 14 Japanese hospitals from September 2008 to April 2013. A total of 2,106 (20.6%) patients were women. Women were older (72.7±9.7 vs 66.6±10.8 years, p<0.001), and had a lower body mass index (23.4±4.0 vs 24.3±3.5, p<0.001), with a higher prevalence of hypertension (p<0.001), hyperlipidemia (p<0.001), insulin-dependent diabetes (p<0.001), renal failure (p<0.001), and heart failure (p<0.001) compared with men. Men tended to have more bifurcation lesions (p = 0.003) and chronic totally occluded lesions (p<0.001) than women. Crude overall complications (14.8% vs 9.5%, p<0.001) and the rate of bleeding complications (5.3% vs 2.8%, p<0.001) were significantly higher in women than in men. On multivariate analysis in the total cohort, female sex was an independent predictor of overall complications (OR, 1.47; 95% CI, 1.26–1.71; p<0.001) and bleeding complications (OR, 1.74; 95% CI, 1.36–2.24; p<0.001) after adjustment for confounding variables. A similar trend was observed across the middle-aged group (≥55 and <75 years) and old age group (≥75 years). Conclusions Women are at higher risk than men for post-procedural complications after PCI, regardless of age. PMID:25635905

  6. [What can and cannot be achieved by registries : Perspective of the registry working group of the German Network of Health Services Research].

    PubMed

    Neugebauer, E A M; Stausberg, J

    2016-06-01

    In addition to clinical trials, registries and cohort studies are the fundamental basis of patient-orientated research. The importance of registries is increasing because more questions involving patient care under routine conditions (real world data) need to be answered. This article supplies answers to the questions: what can be achieved with registries and what are the limitations? Starting with a consensus definition of a registry from the German Network of Health Services Research (DNVF), the question of existing registries was examined and it was concluded that there was a lack of transparency. Consequently, a registry of registries similar to clinical trials registries is urgently needed as well as an evaluation of the quality of existing registries. Criteria are deduced that allow an assessment of the quality of a registry and which comprehensive possibilities registries can provide are discussed in eight different areas of interest to clinicians. The limitations of registries compared to randomized clinical trials and cohort studies are emphasized and discussed in this article. In the future, the use of registry-based randomized clinical trials (RRCT) will allow data related to efficacy as well as to effectiveness to be collated. PMID:27169850

  7. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

    The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance" ("R"[superscript 2],…

  8. Case Studies: Windows onto Clinical Supervision.

    ERIC Educational Resources Information Center

    Nolan, Jim; And Others

    1993-01-01

    By examining the structures and activities common to six case studies of clinical teacher supervision, this article identifies five conditions that facilitate changes in teacher thinking and behavior: development of a supportive, collegial relationship; teacher control over supervision products; continuity over time; focused, descriptive records…

  9. Marketing and clinical trials: a case study

    PubMed Central

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-01-01

    Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

  10. Chapter 43: Registry Clients

    NASA Astrophysics Data System (ADS)

    Greene, G.; Plante, R.

    The registry is a central component for the development of astronomical tools and applications requiring search and discovery. It contains standard descriptions for a variety of astronomical resources and services, including methods for remote invocation. Using web service technology, programmatic interfaces to the registry offer a powerful and robust mechanism for extracting specific sets of services and also a framework for combining a variety of astronomical resources into complex applications, for example, Datascope, Open SkyQuery, and WESIX. While the legacy of the NVO does not extend far back into history, we present here the current state of interfaces that client applications and tools have been built on, yet also extend the concepts to the new standard Registry Interface which will provide a uniform client interface protocol throughout the IVOA registry network. We explore this technology and discuss several implementations that exist in the current VO framework using JAVA, C#, Python, and IDL.

  11. EXCEL Clinical Trial (Universal Registry)

    ClinicalTrials.gov

    2012-11-30

    Chronic Coronary Occlusion; Left Main Coronary Artery Disease; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

  12. BILATERAL ANTERIOR GLENOHUMERAL DISLOCATION: CLINICAL CASE

    PubMed Central

    Silva, Luís Pires; Sousa, Cristina Varino; Rodrigues, Elisa; Alpoim, Bruno; Leal, Miguel

    2015-01-01

    Bilateral anterior glenohumeral dislocation is a rare occurrence. We present a case of bilateral anterior glenohumeral dislocation caused by a fall. The interest in publishing this case is that this is a clinical rarity with few cases reported in the literature. An 89-year-old female patient was brought to the emergency department after a fall, complaining of intense pain in both shoulders and inability to move them. Objective examination showed clinical signs giving the suspicion of bilateral anterior glenohumeral dislocation, which was confirmed by x-ray imaging. Both dislocations were successfully reduced in the emergency department using the modified Milch technique. When a synchronous and symmetrical force has acted on both shoulders and these are painful with significant functional limitation, the suspicion of bilateral glenohumeral dislocation is a differential diagnosis to be considered, even though it is rare. PMID:27047826

  13. Advance modern medicine with clinical case reports

    PubMed Central

    2014-01-01

    Randomized clinical trial (RCT) can fail to demonstrate the richness of individual patient characteristics. Given the unpredictable nature of medicine, a patient may present in an unusual way, have a strange new pathology, or react to a medical intervention in a manner not seen before. The publication of these novelties as case reports is a fundamental way of conveying medical knowledge. Throughout history there have been famous case studies that shaped the way we view health and disease. Case reports can have the following functions: (I) descriptions of new diseases; (II) study of mechanisms; (III) discovery new therapies; (IV) recognition of side effects; and (V) education. Before submitting a case report, it is worthwhile to refer to the Case Report Check Sheet described by Green and Johnson [2006]. PMID:25525572

  14. Characteristics of incident female breast cancer in Lebanon, 1990-2013: Descriptive study of 612 cases from a hospital tumor registry.

    PubMed

    Chahine, Georges; El Rassy, Elie; Khazzaka, Aline; Saleh, Khalil; Rassy, Nathalie; Khalife, Nadine; Atallah, David

    2015-06-01

    Despite the fact that breast cancer is a major health issue, very few studies describe its characteristics in the Arab world or the Middle East, particularly in Lebanon. We report in this article a retrospective pilot study of the characteristics of breast cancer in Lebanon. The pathological characteristics of 624 patients diagnosed between 1990 and 2013 randomly chosen from the archives of an oncology clinic affiliated to Hotel Dieu de France Hospital are analyzed. The mean age at diagnosis is 54.6±13.4 years with 43% diagnosed before the age of 50 years. The infiltrative ductal carcinoma represents the major pathological subtype. One third of the tumors had a size of more than 2 cm at diagnosis. Estrogen-receptors are positive in more than 50% of our patients and Her2-neu is overexpresssed in 30%. Luminal A represents 45.5% and the triple negative subgroup constitutes only 8.3%. Breast cancer in Lebanon is evolving to a more indolent disease. Therefore, public awareness and institution of screening programs are required. These programs should be based on national epidemiological data and necessitate the activation of the national cancer registry. PMID:25828075

  15. Dentine in a capsule: clinical case reports.

    PubMed

    Kenchappa, Mallikarjuna; Gupta, Shilpi; Gupta, Puneet; Sharma, Priyamvada

    2015-01-01

    Biodentine TM , a calcium silicate based material has been popular now and can be used as an alternative to mineral trioxide aggregate (MTA) due to superior physical and biologic properties. It has been known by several terms as Biodentine, dentin substitute, and RD 94. It has varied clinical applications such as apexification, apexogenesis, pulpotomy, internal resorption, root perforation repair, retrograde filling, pulp capping procedure, and dentin replacement. This article describes the clinical case reports using Biodentine in apexification, apexogenesis, pulpotomy, and root perforation repair. PMID:26156282

  16. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry

    PubMed Central

    Puls, Miriam; Lubos, Edith; Boekstegers, Peter; von Bardeleben, Ralph Stephan; Ouarrak, Taoufik; Butter, Christian; Zuern, Christine S.; Bekeredjian, Raffi; Sievert, Horst; Nickenig, Georg; Eggebrecht, Holger; Senges, Jochen; Schillinger, Wolfgang

    2016-01-01

    Aims The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort—which is the largest published to date. Methods and results Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). Conclusions Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort

  17. A registry of ankylosing spondylitis registries and prospects for global interfacing

    PubMed Central

    Reveille, John D.

    2013-01-01

    Purpose of review To review the optimal criteria and conditions for establishing a clinical registry, as well as detailing their application in a number of ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA) Registries already in existence. Recent findings Recent genetic studies and studies of long-term treatment efficacy and side-effects have underscored the need for large numbers of patients, much larger than would be possible from a single center or consortium. An optimal Registry should have its aims established upfront, with appropriate governance and oversight, and inclusion and exclusion criteria for participating collaborators and subject defined. Collaborators contributing subjects to a Registry should use validated instruments for which they have been previously trained. The numerous cross-sectional and longitudinal Registries on AS and axSpA have been recently established that differ widely depending on the referral and selection issues. Summary The challenge of large-scale examinations of genetics, comorbidities, medication usage, and side-effects in spondyloarthritis underscores the need for combining data from well characterized registries of AS patients which require careful planning. There are currently many such registries available internationally, offering promise for collaborations and data pooling that can answer some of the pressing questions facing rheumatology clinicians and researchers. PMID:23656716

  18. Patient-reported outcome measures in arthroplasty registries

    PubMed Central

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

    2016-01-01

    Abstract — The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or

  19. [Clinical cases of occupational chronic manganese intoxication].

    PubMed

    Konstantinova, T N; Lakhman, O L; Katamanova, E V; Kartapol'tseva, N V; Meshcheriagin, V A; Rusanova, D V; Andreeva, O K

    2009-01-01

    Classic symptoms of manganese intoxication are very rarely seen nowadays. Clinic in Angarsk Research Institute for Occupational medicine and Human ecology registered two cases of stage I and II chronic manganese intoxication over 10 years among electric welders. The cases were diagnosed with consideration of long length of exposure to manganese with the ambient air level exceeding the MAC 1.5 times, the disease manifestation at middle age, high manganese level in serum and urine, characteristic neurologic symptoms in association with organic psychopathologic defects and polyneuropathy of limbs. PMID:19278189

  20. Incidence rate of ovarian cancer cases in Saudi Arabia: an observational descriptive epidemiological analysis of data from Saudi Cancer Registry 2001–2008

    PubMed Central

    Alghamdi, Ibrahim G; Hussain, Issam I; Alghamdi, Mohamed S; Alghamdi, Mansour M; Dohal, Ahlam A; El-Sheemy, Mohammed A

    2014-01-01

    Purpose This study provides descriptive epidemiological data, such as the percentage of cases diagnosed, crude incidence rate (CIR), and age-standardized incidence rate (ASIR) of ovarian cancer in Saudi Arabia from 2001–2008. Patients and methods A retrospective descriptive epidemiological analysis of all ovarian cancer cases recorded in the Saudi Cancer Registry (SCR) from January 2001–December 2008 was performed. The data were analyzed using descriptive statistics, analysis of variance tests, Poisson regression, and simple linear modeling. Results A total of 991 ovarian cancer cases were recorded in the SCR from January 2001–December 2008. The region of Riyadh had the highest overall ASIR at 3.3 cases per 100,000 women, followed by the Jouf and Asir regions at 3.13 and 2.96 cases per 100,000 women. However, Hail and Jazan had the lowest rates at 1.4 and 0.6 cases per 100,000 women, respectively. Compared to Jazan, the incidence rate ratio for the number of ovarian cancer cases was significantly higher (P<0.001) in the Makkah region at 6.4 (95% confidence interval [CI]: 4.13–9.83), followed by Riyadh at 6.3 (95% CI: 4.10–9.82), and the eastern region of Saudi Arabia at 4.52 (95% CI: 2.93–6.98). The predicted annual CIR and ASIR for ovarian cancer in Saudi Arabia could be defined by the equations 0.9 + (0.07× years) and 1.71 + (0.09× years), respectively. Conclusion We observed a slight increase in the CIRs and ASIRs for ovarian cancer in Saudi Arabia from 2001–2008. Riyadh, Jouf, and Asir had the highest overall ASIR, while Jazan and Hail had the lowest rates. Makkah, Riyadh, and the eastern region of Saudi Arabia had the highest incidence rate ratio for the number of ovarian cancer cases. Further analytical studies are required to determine the potential risk factors of ovarian cancer among Saudi women. PMID:25028565

  1. Floating Vitreous Cyst: Two Clinical Cases

    PubMed Central

    Lavric, Alenka; Urbancic, Mojca

    2013-01-01

    Purpose To report two cases of solitary unilateral vitreous cyst. Methods A complete ocular examination, fundus photography, B-scan ultrasound and spectral-domain optical coherence tomography were performed in both patients. Results The first patient (a 39-year-old man) presented with transient blurred vision in the right eye. The second patient (a 78-year-old man) reported transient blurred vision in the right eye when changing head position. He was referred to the Eye Hospital because of vitreomacular traction in the other eye. After examination, a diagnosis of vitreous cyst was made in both cases. Conclusions Vitreous cysts are rare clinical findings. They can occur in normal eyes or in eyes with certain ocular pathologies. When a cyst floats into the visual axis area, it can disturb visual function; therefore, patients usually report transient blurring of vision. A prompt clinical examination is necessary for differentiating this rare condition. PMID:24348410

  2. Clinical case seminar in pediatric thyroid disease.

    PubMed

    Szinnai, G; Léger, J; Bauer, A J; Pearce, E N; Ramos, H E; Canalli, M H; Onigata, K; Elisei, R; Radetti, G; Polak, M; Van Vliet, G; Deladoëy, J

    2014-01-01

    Pediatric thyroid diseases cover a large spectrum of congenital and acquired forms, ranging from congenital primary or central hypothyroidism, autoimmune thyroid disease, iodine deficiency, rare genetic defects of thyroid hormone action, metabolism and cell membrane transport to benign nodules and malignant tumors. The previous 15 papers of the textbook Paediatric Thyroidology gave a systematic overview of the current knowledge and guidelines on all these diseases. In this final paper, the authors collected a series of patient histories from their clinics illustrating frequently encountered clinical problems and providing key learning points and references to each case. Although not fully comprehensive, it aims at providing relevant clinical knowledge on thyroid diseases of the neonate, the child, and the adolescent. PMID:25231455

  3. NATIONAL CONGENITAL RUBELLA SYNDROME REGISTRY (NCRSR)

    EPA Science Inventory

    The system compiles information on all U.S. congenital rubella syndrome cases. The registry includes cases reported to CDC since 1969. Information collected includes demographic data, laboratory results, and disease symptoms. These data are used to calculate incidence rates and o...

  4. Trends in Prevalence and Characteristics of Post-Neonatal Cerebral Palsy Cases: A European Registry-Based Study

    ERIC Educational Resources Information Center

    Germany, Laurence; Ehlinger, Virginie; Klapouszczak, Dana; Delobel, Malika; Hollody, Katalin; Sellier, Elodie; De La Cruz, Javier; Alberge, Corine; Genolini, Christophe; Arnaud, Catherine

    2013-01-01

    The present paper aims to analyze trends over time in prevalence of cerebral palsy of post-neonatal origin, to investigate whether changes are similar according to severity and to describe the disability profile by etiology. Post-neonatal cases, birth years 1976 to 1998, were identified from the Surveillance of Cerebral Palsy in Europe…

  5. Cancer incidence in Ghana, 2012: evidence from a population-based cancer registry

    PubMed Central

    2014-01-01

    Background Data on cancers is a challenge in most developing countries. Population-based cancer registries are also not common in developing countries despite the usefulness of such registries in informing cancer prevention and control programmes. The availability of population-based data on cancers in Africa varies across different countries. In Ghana, data and research on cancer have focussed on specific cancers and have been hospital-based with no reference population. The Kumasi Cancer Registry was established as the first population-based cancer registry in Ghana in 2012 to provide information on cancer cases seen in the city of Kumasi. Methods This paper reviews data from the Kumasi Cancer Registry for the year 2012. The reference geographic area for the registry is the city of Kumasi as designated by the 2010 Ghana Population and Housing Census. Data was from all clinical departments of the Komfo Anokye Teaching Hospital, Pathology Laboratory Results, Death Certificates and the Kumasi South Regional Hospital. Data was abstracted and entered into Canreg 5 database. Analysis was conducted using Canreg 5, Microsoft Excel and Epi Info Version 7.1.2.0. Results The majority of cancers were recorded among females accounting for 69.6% of all cases. The mean age at diagnosis for all cases was 51.6 years. Among males, the mean age at diagnosis was 48.4 compared with 53.0 years for females. The commonest cancers among males were cancers of the Liver (21.1%), Prostate (13.2%), Lung (5.3%) and Stomach (5.3%). Among females, the commonest cancers were cancers of the Breast (33.9%), Cervix (29.4%), Ovary (11.3%) and Endometrium (4.5%). Histology of the primary tumour was the basis of diagnosis in 74% of cases with clinical and other investigations accounting for 17% and 9% respectively. The estimated cancer incidence Age Adjusted Standardised Rate for males was 10.9/100,000 and 22.4/100, 000 for females. Conclusion This first attempt at population-based cancer

  6. [Considerations on limits and profits of registries].

    PubMed

    Addis, Antonio; Costa, Enrico; De Palma, Rossana; Magrini, Nicola; Marata, Anna Maria; Martelli, Luisa; Papini, Donato; Traversa, Giuseppe

    2015-09-01

    The article collects the summary of the discussion occurred in the setting of PRIER II, in the session dedicated to the taxonomy of registries. Shown below, some specific contributions by health professionals working at the regional departments, which deal with registries, as well as the contribution on the same subject by specialists working at some pharmaceutical companies. In particular, after the presentation summarized in the article by prof. Giuseppe Costa1, the contributions, respectively by a representative of the Emilia-Romagna Region, of a health and hospital service and by the PRIER II workgroup, are following. Finally, a collective work with all participants to the working group took place to focus on all the issues considered to be crucial in defining clinical registries. At the same discussion table, institutional representatives of the regulatory national and regional branch were also invited to take into consideration the points of view of all public and private registry users, in particular in their benefits, limits and purposes. Going through the discussion on a specific check list and deepening a number of statements identified by the working group, a list of key points, essential to characterize each clinical registry, was produced. PMID:26418504

  7. Comprehensive capture of cutaneous melanoma by the Ontario Cancer Registry: validation study using community pathology reports.

    PubMed

    Tran, Jennifer M; Schwartz, Rodrigo; Fung, Kinwah; Rochon, Paula; Chan, An-Wen

    2016-01-01

    Melanoma is often managed outside hospital settings, creating the potential for underreporting to cancer registries. To our knowledge, completeness of melanoma capture in cancer registries has not been assessed using external data sources since the 1980s. We evaluated the melanoma capture rate from 1993 to 2009 in a provincial cancer registry. We identified all melanoma diagnoses in pathology reports from a major community laboratory in Ontario, Canada. Pathologically confirmed diagnoses were linked to Ontario Cancer Registry (OCR) records using health insurance numbers. We calculated capture rates as the proportion of patients with melanoma confirmed by a pathology report, with a corresponding melanoma diagnosis in OCR. OCR captured 3,798 of 4,275 (88.8, 95 % confidence interval: 87.9, 89.8 %) invasive melanoma diagnoses over the 17-year period. Annual capture rates of 94 % or higher were found for over half the study period. Among all 29,133 melanoma diagnoses in OCR, 27.6 % were registered based on a pathology report alone, compared with 3.4 % for non-cutaneous malignancies. This suggests that comprehensive capture of melanoma cases by a provincial cancer registry is achievable using source data from community laboratories. There is a need for ongoing validation to ensure data remain accurate and complete to reliably inform clinical care, research, and policy. PMID:26537120

  8. Clinical expression of facioscapulohumeral muscular dystrophy in carriers of 1–3 D4Z4 reduced alleles: experience of the FSHD Italian National Registry

    PubMed Central

    Nikolic, Ana; Ricci, Giulia; Sera, Francesco; Bucci, Elisabetta; Govi, Monica; Mele, Fabiano; Rossi, Marta; Ruggiero, Lucia; Vercelli, Liliana; Ravaglia, Sabrina; Brisca, Giacomo; Fiorillo, Chiara; Villa, Luisa; Maggi, Lorenzo; Cao, Michelangelo; D'Amico, Maria Chiara; Siciliano, Gabriele; Antonini, Giovanni; Santoro, Lucio; Mongini, Tiziana; Moggio, Maurizio; Morandi, Lucia; Pegoraro, Elena; Angelini, Corrado; Di Muzio, Antonio; Rodolico, Carmelo; Tomelleri, Giuliano; Grazia D'Angelo, Maria; Bruno, Claudio; Berardinelli, Angela; Tupler, Rossella

    2016-01-01

    Objectives Facioscapulohumeral muscular dystrophy type 1 (FSHD1) has been genetically linked to reduced numbers (≤8) of D4Z4 repeats at 4q35. Particularly severe FSHD cases, characterised by an infantile onset and presence of additional extra-muscular features, have been associated with the shortest D4Z4 reduced alleles with 1–3 repeats (1–3 DRA). We searched for signs of perinatal onset and evaluated disease outcome through the systematic collection of clinical and anamnestic records of de novo and familial index cases and their relatives, carrying 1–3 DRA. Setting Italy. Participants 66 index cases and 33 relatives carrying 1–3 DRA. Outcomes The clinical examination was performed using the standardised FSHD evaluation form with validated inter-rater reliability. To investigate the earliest signs of disease, we designed the Infantile Anamnestic Questionnaire (IAQ). Comparison of age at onset was performed using the non-parametric Wilcoxon rank-sum or Kruskal-Wallis test. Comparison of the FSHD score was performed using a general linear model and Wald test. Kaplan-Meier survival analysis was used to estimate the age-specific cumulative motor impairment risk. Results No patients had perinatal onset. Among index cases, 36 (54.5%) showed the first signs by 10 years of age. The large majority of patients with early disease onset (26 out of 36, 72.2%) were de novo; whereas the majority of patients with disease onset after 10 years of age were familial (16, 53.3%). Comparison of the disease severity outcome between index cases with age at onset before and over 10 years of age, failed to detect statistical significance (Wald test p value=0.064). Of 61 index cases, only 17 (27.9%) presented extra-muscular conditions. Relatives carrying 1–3 DRA showed a large clinical variability ranging from healthy subjects, to patients with severe motor impairment. Conclusions The size of the D4Z4 allele is not always predictive of severe clinical outcome. The high

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

    NASA Astrophysics Data System (ADS)

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

    1997-05-01

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

  10. [Romanian national registry for interstitial lung diseases and sarcoidosis (REGIS): rationale and methods].

    PubMed

    Strâmbu, Irina; Ioniţă, Diana; Belaconi, Ionela; Stoia, Irina; Tudorache, Voicu

    2012-01-01

    Interstitial lung diseases (ILD) are a group of extremely heterogeneous conditions (over 200), with low prevalence, but in most cases with severe impact on the quality of life and survival of the patients. The ILD group comprises: idiopathic pulmonary fibrosis, sarcoidosis, hypersensitivity pneumonitis, colagen diseases, vasculitis, eosinophilic pneumonia etc. The prevalence of these diseases is unknown in Romania; the accurate diagnosis needs access to special investigations and expertise with this group of diseases. The authors propose the initiation of a National Registry for Interstitial Lung Diseases and Sarcoidosis (REGIS), based on the lessons learned from other national ILD) registries, which should allow building-up an extended clinical expertise in ILD, evaluating epidemiological data, creating an educational platform for young physicians, better understanding of the outcome and prognosis of these diseases, shaping Romanian Guidelines for the diagnosis and management of ILD, using the data base for clinical research. The registry is started as a pilot in two Romanian centres: "Marius Nasta" Institute of Pneumology in Bucharest and Pneumology Clinic, "Victor Babey" Infectious Diseases Hospital Timişoara. After refining the inclusion criteria for the data base, editing guidelines for ILD diagnosis and launching the registry website, other Romanian centres with interest in ILD will also be able to feed information. PMID:22545484

  11. A Registry for Evaluation of Efficiency and Safety of Surgical Treatment of Cartilage Defects: The German Cartilage Registry (KnorpelRegister DGOU)

    PubMed Central

    2016-01-01

    Background The need for documentation in cartilage defects is as obvious as in other medical specialties. Cartilage defects can cause significant pain, and lead to reduced quality of life and loss of function of the affected joint. The risk of developing osteoarthritis is high. Therefore, the socioeconomic burden of cartilage defects should not be underestimated. Objective The objective of our study was to implement and maintain a registry of all patients undergoing surgical treatment of cartilage defects. Methods We designed this multicenter registry for adults whose cartilage defects of a knee, ankle, or hip joint are treated surgically. The registry consists of two parts: one for the physician and one for the patient. Data for both parts will be gathered at baseline and at 6-, 12-, 24-, 36-, 60-, and 120-month follow-ups. Results To date, a wide range of German, Swiss, and Austrian trial sites are taking part in the German Cartilage Registry, soon to be followed by further sites. More than 2124 (as of January 31, 2016) cases are already documented and the first publications have been released. Conclusions The German Cartilage Registry addresses fundamental issues regarding the current medical care situation of patients with cartilage defects of knee, ankle, and hip joints. In addition, the registry will help to identify various procedure-specific complications, along with putative advantages and disadvantages of different chondrocyte products. It provides an expanding large-scale, unselected, standardized database for cost and care research for further retrospective studies. Trial Registration German Clinical Trials Register: DRKS00005617; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005617 (Archived by WebCite at http://www.webcitation.org/6hbFqSws0) PMID:27357998

  12. [The Italian ArthroPlasty Registry: a model to export?].

    PubMed

    Torre, Marina; Romanini, Emilio

    2016-05-01

    Medical devices (MD) registries are essentials to evaluate outcomes. They represent a key tool to support market surveillance and vigilance, being critical to identify and characterize the implants, assess their performance and trace patients in case of recall. Therefore, the recent "Proposal for a Regulation of the European Parliament and of the Council on medical devices" asked both the Commission and the Member States to take all appropriate measures to encourage the establishment of registers for specific types of devices, setting common principles to collect comparable information. In Italy more than 170.000 joint replacements were performed in 2013 in over 750 hospitals. Experiences at international level and in some Italian regions show that data from registries are crucial to define the best approach to joint replacement surgery. Results from registries can lead to changes in clinical practice, adopting the best available evidence and avoiding choices associated with poorer outcomes. The Italian Arthroplasty Registry project (RIAP) started in 2006 funded by the DG of Medical Devices and Pharmaceutical Service of the Ministry of Health. Data collection uses Hospital Discharge Records integrated by additional information essential to describe the procedure and identify the implants. As soon as the new European Regulation is approved, a Unique Device Identifier will be assigned to every device. Lacking this information, device identification is currently possible by browsing the RIAP MD Library that includes about 55,000 records and is constantly updated by 60 Manufacturers. The model designed within the RIAP project is simple and might be applied for every implanted device when the additional minimum dataset is defined. PMID:27311121

  13. [The IRIS® Registry : Purpose and perspectives. German Version].

    PubMed

    Parke Ii, D W; Lum, F; Rich, W L

    2016-06-01

    The American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) launched about 2 years ago and has already become the largest national clinical specialty data registry with nearly 50 million patient visits and over 14 million unique patients. The purpose of the registry is to support and promote continued improvement in the delivery of eye care. The perspectives that "big data" encompass are the key issues facing ophthalmology and eye care, including public health and public policy concerning disease incidence and prevalence, utilization of eye care services, natural history of disease, disease surveillance, comparative effectiveness, safety and adverse event monitoring, compliance with "best practices" and clinical guidelines, etc. The valuable real-world and current-day insights provided by the IRIS Registry and other registries like it will accelerate scientific learning and improvements in care delivery, particularly in a cost-constrained environment. PMID:27277752

  14. [Caudal regression sequence: clinical-radiological case].

    PubMed

    Zepeda T, Juan; García M, Mirna; Morales S, Jorge; Pantoja H, Miguel A; Espinoza G, Aníbal

    2015-01-01

    Caudal regression syndrome is an uncommon congenital malformation that includes a wide spectrum of clinical presentations. Characterised by caudal musculoskeletal compromise, it can be associated to neurological, gastrointestinal, renal and genitourinary defects. Although the specific aetiology has not been clarified, it has been associated with the presence of maternal diabetes and mutations in homeobox gene HBLX9. Its diagnosis is based on a good prenatal ultrasound detection, detailed physical examination, and post-natal imaging study using radiography and magnetic resonance. Caudal regression syndrome requires multidisciplinary management, and it seems that good metabolic control of gestational diabetes constitutes the best preventive measure available. We present the clinical case and images of a male term newborn, born to a pregestational diabetic mother with poor metabolic control and a prenatal ultrasound diagnosis of lumbar spine, iliac bones and lower limbs malformation. Born in good conditions, the diagnosis was confirmed using X-rays and magnetic resonance. PMID:26455704

  15. The clinical case for proton beam therapy

    PubMed Central

    2012-01-01

    Abstract Over the past 20 years, several proton beam treatment programs have been implemented throughout the United States. Increasingly, the number of new programs under development is growing. Proton beam therapy has the potential for improving tumor control and survival through dose escalation. It also has potential for reducing harm to normal organs through dose reduction. However, proton beam therapy is more costly than conventional x-ray therapy. This increased cost may be offset by improved function, improved quality of life, and reduced costs related to treating the late effects of therapy. Clinical research opportunities are abundant to determine which patients will gain the most benefit from proton beam therapy. We review the clinical case for proton beam therapy. Summary sentence Proton beam therapy is a technically advanced and promising form of radiation therapy. PMID:23083010

  16. Clinical presentation of pili torti - Case report*

    PubMed Central

    Yang, Jeane Jeong Hoon; Cade, Karine Valentim; Rezende, Flavia Cury; Pereira, José Marcos; Pegas, José Roberto Pereira

    2015-01-01

    Pili torti also known as ‘twisted hairs’ (Latin: pili=hair; torti=twisted) is a rare, congenital or acquired clinical presentation, in which the hair shaft is flattened at irregular intervals and twisted 180º along its axis. It is clinically characterized by fragile, brittle, coarse and lusterless hairs, due to uneven light reflection on the twisted hair surface. Pili torti may be associated with neurological abnormalities and ectodermal dysplasias. There is no specifi c treatment for this condition, but it may improve spontaneously after puberty. We report a case of pili torti in a child who presented fragile, brittle, diffi cult to comb hair. The patient had no comorbidities. PMID:26312667

  17. The National Mental Health Registry (NMHR).

    PubMed

    Aziz, A A; Salina, A A; Abdul Kadir, A B; Badiah, Y; Cheah, Y C; Nor Hayati, A; Ruzanna, Z Z; Sharifah Suziah, S M; Chee, K Y

    2008-09-01

    The National Mental Health Registry (NMHR) collects information about patients with mental disorder in Malaysia. This information allows us to estimate the incidence of selected mental disorders, and to evaluate risk factors and treatment in the country. The National Mental Health Registry (NMHR) presented its first report in 2004, a year after its establishment. The report focused on schizophrenia as a pioneer project for the National Mental Health Registry. The development of the registry has progressed with data collected from government-based facilities, the academia and the private sector. The 2003-2005 report was recently published and distributed. Since then the registry has progressed to include suicides and other mental illnesses such as depression. The NMHR Report 2003-2005 provides detailed information about the profile of persons with Schizophrenia who presented for the first time to various psychiatry and mental health providers throughout Malaysia. More detailed description regarding pharmacotherapy is reported and few cross tabulations done in an effort to provide better understanding and more clinically meaningful reports. PMID:19227671

  18. Hysterical personality and family: a clinical case.

    PubMed

    Valerio, C; Santilli, V B; Valitutti, C; Bianchi di Castelbianco, A; Cesario, L

    1992-01-01

    Within the framework of family typology, the therapist can organize and orient his own observations, by confronting the characteristics of a particular family system, with the models of a "shared reality". Structural and organizational analysis of the family system, according to a general typology, can also be useful when the therapist has to deal with a defined and a not specific symptom or disease, and when a differential diagnosis is necessary for its pragmatic effects. This is often the case of hysteria, which according to many authors can show today various, confused shapes, as depression, general existential discomfort, anorexia and bulimia, and forms of exhibited addition. The authors present a clinical case, trying to point out how a "typology-oriented" observation of the family system, allowed the therapists to clarify an individual condition, otherwise difficult to understand. PMID:1476362

  19. Consensus, clinical decision making, and unsettled cases.

    PubMed

    Adams, David M; Winslade, William J

    2011-01-01

    The model of clinical ethics consultation (CEC) defended in the ASBH Core Competencies report has gained significant traction among scholars and healthcare providers. On this model, the aim of CEC is to facilitate deliberative reflection and thereby resolve conflicts and clarify value uncertainty by invoking and pursuing a process of consensus building. It is central to the model that the facilitated consensus falls within a range of allowable options, defined by societal values: prevailing legal requirements, widely endorsed organizational policies, and professional standards of practice and codes of conduct. Moreover, the model stipulates that ethics consultants must refrain from giving substantive recommendations regarding how parties to a moral disagreement in the clinic should evaluate their options. We argue that this model of CEC is incomplete, because it wrongly assumes that what counts as the proper set of allowable options among which the parties are to deliberate will itself always be clearly discernible. We illustrate this problem with a recent case on which one of us consulted-a neonate born with trisomy 18 (T18). We try to show that law, policy, and standards of practice reveal no clear answer to the question posed by the case: namely, whether forgoing gastrostomy tube feedings for a baby with T18 is allowable. We suggest there may be other kinds of cases in which it may simply be unsettled whether a given choice falls within the set of allowable options within which consensus is to be facilitated. What should an ethicist do when confronting such unsettled cases? We agree with the facilitation model that an ethicist should remain neutral among the allowable options, when it is clear what the allowable options are. But, in unsettled cases, the role of a consultant should be expanded to include a process of moral inquiry into what the allowable options should be. We end by raising the issue of whether this means an ethicist should share his or her own

  20. Clinical applications of CO2 lasers: clinical cases

    NASA Astrophysics Data System (ADS)

    Sinibaldi, Kenneth R.

    1994-09-01

    The most common surgery performed in our clinic with the CO2 laser is the cutting and vaporization of neoplasms associated with the head and neck, in particular, the squamous cell carcinoma in the cat. A majority of the tumors are malignant and 50% are metastatic at the time of presentation for surgery. Experience has taught us that early detection and removal with the CO2 laser affords the best prognosis. To date, roughly 100 cases have been treated with the CO2 laser. The success rate in the dog is not as rewarding as in the cat. Most cases were done with 5 - 10 watts of power continuous or pulsed wave, using a 125 mm or 50 mm handpiece. The laser beam was focused or defocused to adjust for cutting, vaporization, and coagulation. No post-op care of the wounds was recommended. Other small neoplasms in and around the ears, head, and neck can also be removed easily with the CO2 laser.

  1. Multicenter breast cancer collaborative registry.

    PubMed

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

    2011-01-01

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

  2. Multicenter Breast Cancer Collaborative Registry

    PubMed Central

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

    2011-01-01

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

  3. Real-world Experience of Carotid Artery Stenting in Japan: Analysis of 7,134 Cases from JR-NET1 and 2 Nationwide Retrospective Multi-center Registries

    PubMed Central

    EGASHIRA, Yusuke; YOSHIMURA, Shinichi; SAKAI, Nobuyuki; ENOMOTO, Yukiko

    2014-01-01

    The present study aimed to demonstrate the “real-world” experiences of carotid artery stenting (CAS) in Japan using Japanese Registry of Neuroendovascular Therapy (JR-NET) 1 and 2, retrospective nationwide multi-center surveillances. JR-NET1 and 2 registries are retrospective surveillances conducted between January 2005 and December 2007 and January 2008 and December 2009, respectively, in Japan regarding neuroendovascular therapy. A total of 7,134 procedures (1,943 for JR-NET1 and 5,191 for JR-NET2) were included in this study and retrieved data were analyzed retrospectively. Treatment results of two surveillance periods were similar. In JR-NET2 registry, total of 5,191 lesions were treated by CAS and 5,008 of 5,191 procedures (96.5%) were performed by the board-certified surgeons of Japanese Society of Neuroendovascular Therapy. The rate of technical success was extremely high (99.99%), and the rate of clinically significant complication was low (3.2%). These results were comparable to a previous large study in Japan. Multivariate logistic analysis revealed that age [odds ratio (OR), 1.04 per year; 95% confidence interval (CI), 1.02–1.07; p = 0.0004), symptomatic lesion (OR, 1.87; 95% CI; p = 0.0004), and the use of closed-cell type stent (OR, 0.58; 95% CT, 0.32–1.00; p = 0.05) were independently associated with clinically significant complications. It was revealed that good clinical results were achieved in patients who underwent CAS in Japan. It is expected that the evolution of devices and increasing experiences of surgeons would lead to further improvement of the clinical results, and further investigation would be required to clarify the optimal treatment strategy and therapeutic efficacy of CAS, especially in symptomatic lesions. PMID:24305031

  4. SveDem, the Swedish Dementia Registry – A Tool for Improving the Quality of Diagnostics, Treatment and Care of Dementia Patients in Clinical Practice

    PubMed Central

    Religa, Dorota; Fereshtehnejad, Seyed-Mohammad; Cermakova, Pavla; Edlund, Ann-Katrin; Garcia-Ptacek, Sara; Granqvist, Nicklas; Hallbäck, Anne; Kåwe, Kerstin; Farahmand, Bahman; Kilander, Lena; Mattsson, Ulla-Britt; Nägga, Katarina; Nordström, Peter; Wijk, Helle; Wimo, Anders; Winblad, Bengt; Eriksdotter, Maria

    2015-01-01

    Background The Swedish Dementia Registry (SveDem) was developed with the aim to improve the quality of diagnostic work-up, treatment and care of patients with dementia disorders in Sweden. Methods SveDem is an internet based quality registry where several indicators can be followed over time. It includes information about the diagnostic work-up, medical treatment and community support (www.svedem.se). The patients are diagnosed and followed-up yearly in specialist units, primary care centres or in nursing homes. Results The database was initiated in May 2007 and covers almost all of Sweden. There were 28 722 patients registered with a mean age of 79.3 years during 2007–2012. Each participating unit obtains continuous online statistics from its own registrations and they can be compared with regional and national data. A report from SveDem is published yearly to inform medical and care professionals as well as political and administrative decision-makers about the current quality of diagnostics, treatment and care of patients with dementia disorders in Sweden. Conclusion SveDem provides knowledge about current dementia care in Sweden and serves as a framework for ensuring the quality of diagnostics, treatment and care across the country. It also reflects changes in quality dementia care over time. Data from SveDem can be used to further develop the national guidelines for dementia and to generate new research hypotheses. PMID:25695768

  5. Screening Cases within a Statewide Autism Registry: A Comparison of Parental Reports Using "DSM-IV-TR" Criteria versus the "SCQ"

    ERIC Educational Resources Information Center

    Goin-Kochel, Robin P.; Cohen, Robert

    2008-01-01

    Parents and caregivers of 70 children enrolled in a university-based, statewide autism registry (M age = 9.5 years) completed two questionnaires, one generated from criteria outlined in the "Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision" (DSM-IV-TR) and the other the "Social Communication Questionnaire"…

  6. A Classic Clinical Case: Neutrophilic Eccrine Hidradenitis

    PubMed Central

    Copaescu, Ana-Maria; Castilloux, Jean-François; Chababi-Atallah, Myrna; Sinave, Christian; Bertrand, Janie

    2013-01-01

    Background Neutrophilic eccrine hidradenitis (NEH) is a rare condition described mostly in adult patients receiving chemotherapy for acute myelogenous leukemia. When it affects the facial region, it can mimic cellulitis and delay the diagnostic, thus proper recognition is essential. Objective This article describes a classic case of NEH. We will review the diagnostic, the differential diagnostic (mostly cellulitis) and the management of this condition. Methods After a literature review, the patient's file was properly studied in order to portray a clear picture of this condition. Medical photographs and appropriate physical examination upon presentation are also included. Results The diagnostic for NEH was suggested by the clinical presentation and confirmed histopathologically (skin biopsy). Conclusion The diagnostic of NEH is essential in order to prevent multiple unnecessary antibiotics. PMID:24474918

  7. Obturator prostheses following palatal resection: clinical cases

    PubMed Central

    Tirelli, G; Rizzo, R; Biasotto, M; Di Lenarda, R; Argenti, B; Gatto, A; Bullo, F

    2010-01-01

    Summary Malignant tumours of the upper gum and hard palate account for 1-5% of malignant neoplasms of the oral cavity; two thirds of the lesions which involve these areas are squamous cell carcinomas. Most of these carcinomas are diagnosed late, when they invade the underlying bone. The procedures of choice for removal are: alveolectomy, palatectomy, maxillectomy, which may be total or partial. Surgical reconstruction of the defect may be carried out using a wide range of microvascularized flaps: osteomuscolocutaneous of the internal iliac crest, an osteocutaneous flap of the fibula or scapula, fascia, or osteocutaneous radial flap, or a pedicled flap of temporal muscle. These flaps are supported by single or multiple obturator prostheses. Rehabilitation via palatal obturators is preferred in patients with a poor prognosis or in weak condition. Rehabilitation aims to: restore the separation between the oral and nasal cavities, enable the patient to swallow, maintain or provide mastication, sufficient occlusion and mandibular support, support the soft facial tissues, re-establish speech and restore an aesthetically pleasing smile. Hence, it is crucial to work in close cooperation with the staff who makes the prosthesis and who evaluates the case when the surgery is planned and obtains the necessary gnatological, anatomical and functional information. Thereafter, during the surgical stage, for the immediate obturators, or in the successive days, for the temporary obturators, work is devoted to making the prostheses. In this regard, the Odonto-prostheses Service of the Stomatological Clinic does not follow a rigid protocol but materials and techniques are selected on a personal basis, according to the features of each individual clinical case. Mobile rehabilitative systems are the systems of choice, both of which related to the traditional concepts of retention and stability and systems of self-stabilizing prostheses according to J. Dichamp, albeit modified in

  8. [Dizziness and syncope : clinical case examples].

    PubMed

    Athanasiadis, A; Sechtem, U

    2014-06-01

    Syncope is defined as a transient, self-limiting loss of consciousness and postural tone due to transient global cerebral hypoperfusion. After syncope the following questions have to be answered: was it a syncopal episode, has the etiological diagnosis been determined, are there data suggestive of a high risk of cardiovascular events or death and what are the therapeutic options? Therefore, a standardized diagnostic work-up is necessary. This diagnostic work-up with differential diagnostic considerations is given for three clinical cases: a 52-year-old man experienced syncope while driving a car and on the morning of the same day syncope had previously occurred while in a standing position. The initial cardiological and neurological evaluation revealed no pathological findings but after implantation of a loop recorder a further syncope with a sinus arrest of 17 s occurred 1 year later. The patient received a single chamber pacemaker. The second case is a 79-year-old female with Parkinson's disease for many years and a primary autonomic dysfunction leading to dizziness and syncope due to pronounced blood pressure fluctuations with hypertensive and hypotensive phases. The last patient is a 22-year-old female with postural orthostatic tachycardia syndrome and recurrent syncope. The diagnostic evaluation and treatment proved to be difficult. PMID:24898287

  9. [GRANULOMATOSIS WITH POLYANGIITIS (WEGENER'S): CLINICAL CASE].

    PubMed

    Zimba, E; Olkhova, O

    2016-05-01

    Granulomatosis with polyangiitis (Wegener's disease) - systemic vasculitis, initial manifestations, the clinical picture may be present in a wide variety. This leads to difficulties in establishing a timely diagnosis. The prognosis in untreated generalized granulomatosis with polyangiitis is extremely poor. The present case report illustrates a late diagnosis of granulomatosis with polyangiitis. A 53-year-old woman was diagnosed with granulomatosis with polyangiitis only after ten months of onset of disease. Wrong diagnosis of tuberculosis of ear leads to a lot of delay in the treatment this type of vasculitis. At the time of diagnosis she had generalized form of disease presented with involvement of the eyes, upper and lower respiratory tracts, kidneys, and nervous system. Remission was achieved with methylprednisolone and cyclophosphamide but suffered a relapse shortly afterwards. Further treatment with rituximab achieved a second remission, but the patient continued to suffer from dry conjunctivitis. Symptomatic therapy in this case was ineffective. An effective pathogenic therapy for this condition was instillation of cyclosporine eye drops. PMID:27348166

  10. Breadth versus volume: Neurology outpatient clinic cases in medical education.

    PubMed

    Albert, Dara V; Blood, Angela D; Park, Yoon Soo; Brorson, James R; Lukas, Rimas V

    2016-06-01

    This study examined how volume in certain patient case types and breadth across patient case types in the outpatient clinic setting are related to Neurology Clerkship student performance. Case logs from the outpatient clinic experience of 486 students from The University of Chicago Pritzker School of Medicine, USA, participating in the 4week Neurology Clerkship from July 2008 to June 2013 were reviewed. A total of 12,381 patient encounters were logged and then classified into 13 diagnostic categories. How volume of cases within categories and the breadth of cases across categories relate to the National Board of Medical Examiners Clinical Subject Examination for Neurology and a Neurology Clerkship Objective Structured Clinical Examination was analyzed. Volume of cases was significantly correlated with the National Board of Medical Examiners Clinical Subject Examination for Neurology (r=.290, p<.001), the Objective Structured Clinical Examination physical examination (r=.236, p=.011), and the Objective Structured Clinical Examination patient note (r=.238, p=.010). Breadth of cases was significantly correlated with the National Board of Medical Examiners Clinical Subject Examination for Neurology (r=.231, p=.017), however was not significantly correlated with any component of the Objective Structured Clinical Examination. Volume of cases correlated with higher performance on measures of specialty knowledge and clinical skill. Fewer relationships emerged correlating breadth of cases and performance on the same measures. This study provides guidance to educators who must decide how much emphasis to place on volume versus breadth of cases in outpatient clinic learning experiences. PMID:26896906

  11. Uses and limitations of registry and academic databases.

    PubMed

    Williams, William G

    2010-01-01

    A database is simply a structured collection of information. A clinical database may be a Registry (a limited amount of data for every patient undergoing heart surgery) or Academic (an organized and extensive dataset of an inception cohort of carefully selected subset of patients). A registry and an academic database have different purposes and cost. The data to be collected for a database is defined by its purpose and the output reports required for achieving that purpose. A Registry's purpose is to ensure quality care, an Academic Database, to discover new knowledge through research. A database is only as good as the data it contains. Database personnel must be exceptionally committed and supported by clinical faculty. A system to routinely validate and verify data integrity is essential to ensure database utility. Frequent use of the database improves its accuracy. For congenital heart surgeons, routine use of a Registry Database is an essential component of clinical practice. PMID:20307864

  12. [The Austrian Stroke-Unit-Registry].

    PubMed

    Hofer, Christine; Kiechl, Stefan; Lang, Wilfried

    2008-01-01

    Since 2003 the Austrian Stroke-Unit-Registry has been administered by the Gesundheit Osterreich GmbH. A total of 26 out of the 32 existing Stroke Units in Austria take part in the project, financed by the Federal Ministry of Health and accompanied by a steering group. This paper provides a description of the objectives, organisation, methodology and the data set of the registry. The main objective of the registry is quality assurance and quality improvement of stroke-treatment in stroke units. Therefore, the participating stroke units document their cases using a web-based database. The data are discussed in the steering group and the stroke units get feedback in terms of benchmarking-graphs. The data set follows a modular approach and contains information about stroke, transport, admission to the hospital, stroke unit discharge and the 3-month follow-up. Between 2003 and 2007 about 27,000 cases (containing about 20,000 strokes) were documented in the registry. PMID:18766309

  13. Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

    ERIC Educational Resources Information Center

    Chester, Victoria

    2011-01-01

    Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

  14. United States Transuranium and Uranium Registries. Annual report

    SciTech Connect

    Kathren, R.

    1993-02-28

    The United States Transuranium and Uranium Registries are unique human tissue research programs studying the distribution, dose, and possible biological effects of the actinide elements in man, with the primary goal of assuring the adequacy of radiation protection standards for these radionuclides. The Registries research is based on radiochemical analysis of tissues collected at autopsy from voluntary donors who have documented occupational exposure to the actinides. To date, tissues, or in some cases radioanalytical results only, have been obtained from approximately 300 individuals; another 464 living individuals have volunteered to participate in the Registries research programs and have signed premortem informed consent and autopsy permissions. The Registries originated at the National Plutonium Registry which was started in 1968 as a then Atomic Energy Commission project under the aegis of a prime contractor at the Hanford site. In 1970, the name was changed to the United States Transuranium Registry to reflect a broader involvement with the higher actinides. In 1978, an administratively separate parallel registry, the United States Uranium Registry, was formed to carry out similar studies among uranium fuel cycle workers.

  15. Clinical course of fetal hydrocephalus: 40 cases.

    PubMed

    Pretorius, D H; Davis, K; Manco-Johnson, M L; Manchester, D; Meier, P R; Clewell, W H

    1985-04-01

    The clinical course and outcome of hydrocephalus diagnosed in utero is not well understood. To approach this problem 40 cases were reviewed of intrauterine fetal hydrocephalus diagnosed with sonography, and follow-up information was obtained regarding them. Sonograms were evaluated for cerebral dimensions, biparietal diameter, brain mantle size, ventricular ratio, amount of amniotic fluid, and associated abnormalities. Neonatal brain sonograms and computed tomographic (CT) scans were reviewed also. Clinical charts were reviewed for maternal age and parity, referral source, family history, fetal age at diagnosis and delivery, mode of delivery, physical examination and/or autopsy findings, karyotype, amniotic alpha 1 fetoprotein level, cause of death, shunt placement after birth, and status of live infants. The observations indicate that the prognosis for fetal hydrocephalus is poor. Only six infants (15%) were alive after an average follow-up of 13 months. Three children were normal and the other three had neurologic abnormalities ranging from severe (paralysis and incontinence) to minimal (2-3 months delayed motor development). Thirty-four fetuses or neonates died. Nine families elected to terminate pregnancy. Ten opted for decompression at delivery for progressive hydrocephalus. Neural tube defects were present in 12 of 23 infants at delivery. Fourteen other infants had additional significant congenital abnormalities. Other abnormal sonographic findings included polyhydramnios (13 of 38), oligohydramnios or decreased fluid (nine of 38), neural tube defect (nine of 40), and other congenital abnormalities (nine of 40). These findings indicate that hydrocephalus diagnosed in utero by sonography is caused by a heterogeneous group of disorders. In general, the prognosis for normal development is poor. Individual prognoses, however, depend on the specific malformations and the interventions used. PMID:3883714

  16. Erythroderma: A clinical study of 97 cases

    PubMed Central

    Akhyani, Maryam; Ghodsi, Zahra S; Toosi, Siavash; Dabbaghian, Hossein

    2005-01-01

    Background Erythroderma is a rare skin disorder that may be caused by a variety of underlying dermatoses, infections, systemic diseases and drugs. Methods We reviewed the clinical, laboratory and biopsy material of 97 patients diagnosed with erythroderma who were treated in our department over a 6-year period (1996 through 2002). Results The male-female ratio was 1.85:1. The mean age at diagnosis was 46.2 years. The most common causative factors were dermatoses (59.7%), followed by drug reactions (21.6%), malignancies (11.3%) and idiopathic causes (7.2%). Carbamazepine was the most common drug (57.1%). The best clinicopathologic correlation was found in cutaneous T-cell lymphoma and pityriasis rubra pilaris related erythroderma. Apart from scaling and erythema that were present in all patients, pruritus was the most common finding (97.5%), followed by fever (33.6%), lymphadenopathy (21.3%), edema (14.4%) and hyperkeratosis (7.2%). Conclusion This study outlines that underlying etiologic factors of erythroderma may show geographic variations. Our series had a high percentage of erythroderma secondary to preexisting dermatoses and a low percentage of idiopathic cases. There was no HIV-infected patient among our series based on multiple serum antibody tests. The clinical features of erythroderma were identical, irrespective of the etiology. The onset of the disease was usually insidious except in drug-induced erythroderma, where it was acute. The group associated with the best prognosis was that related to drugs. PMID:15882451

  17. Clinical response to eliglustat in treatment-naïve patients with Gaucher disease type 1: Post-hoc comparison to imiglucerase-treated patients enrolled in the International Collaborative Gaucher Group Gaucher Registry.

    PubMed

    Ibrahim, Jennifer; Underhill, Lisa H; Taylor, John S; Angell, Jennifer; Peterschmitt, M Judith

    2016-09-01

    Eliglustat is a recently approved oral therapy in the United States and Europe for adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers (> 90% of patients) that has been shown to decrease spleen and liver volume and increase hemoglobin concentrations and platelet counts in untreated adults with Gaucher disease type 1 and maintain these parameters in patients previously stabilized on enzyme replacement therapy. In a post-hoc analysis, we compared the results of eliglustat treatment in treatment-naïve patients in two clinical studies with the results of imiglucerase treatment among a cohort of treatment-naïve patients with comparable baseline hematologic and visceral parameters in the International Collaborative Gaucher Group Gaucher Registry. Organ volumes and hematologic parameters improved from baseline in both treatment groups, with a time course and degree of improvement in eliglustat-treated patients similar to imiglucerase-treated patients. PMID:27408819

  18. Danish Hip Arthroscopy Registry: an epidemiologic and perioperative description of the first 2000 procedures

    PubMed Central

    Mygind-Klavsen, Bjarne; Grønbech Nielsen, Torsten; Maagaard, Niels; Kraemer, Otto; Hölmich, Per; Winge, Søren; Lund, Bent; Lind, Martin

    2016-01-01

    Danish Hip Arthroscopy Registry (DHAR) was initiated in 2012 as a web-based prospective registry. The purpose of this study was to evaluate and report the epidemiologic and perioperative data of the first 2000 procedures in a Danish hip arthroscopy population and to describe the development of DHAR. We describe the use of various Patient Related Outcome Measures related to non-arthritic hip patients. The 2000 procedures consisted of 56% females and 44% males. Mean age 37.5 years, mean surgical time was 86.5 min and mean traction time 50.5 min. The most frequently performed procedure was CAM and Pincer resection in 93.5% of the cases. Labral refixation or repair was done in 70.3% of the cases. The most common type of acetabular chondral damage was grade II lesions (36.6%). Grade III and IV changes were seen in 36.1% of the cases. The preoperative iHOT12 was 45 (mean) based on all 12 items. EQ-5D was 0.65 and HAGOS sub-scores were 51 (pain), 49 (symptoms), 53 (ADL), 35 (sport), 20 (physical activity) and 29, respectively. We conclude that patients undergoing hip arthroscopy report considerable pain, loss of function, reduced level of activity and reduced quality-of-life prior to surgery. The problems with development and maintaining a large clinical registry are described and further studies are needed to validate data completeness. We consider the development of a national clinical registry for hip arthroscopy as a successful way of developing and maintaining a valuable clinical and scientific tool. PMID:27583150

  19. Danish Hip Arthroscopy Registry: an epidemiologic and perioperative description of the first 2000 procedures.

    PubMed

    Mygind-Klavsen, Bjarne; Grønbech Nielsen, Torsten; Maagaard, Niels; Kraemer, Otto; Hölmich, Per; Winge, Søren; Lund, Bent; Lind, Martin

    2016-07-01

    Danish Hip Arthroscopy Registry (DHAR) was initiated in 2012 as a web-based prospective registry. The purpose of this study was to evaluate and report the epidemiologic and perioperative data of the first 2000 procedures in a Danish hip arthroscopy population and to describe the development of DHAR. We describe the use of various Patient Related Outcome Measures related to non-arthritic hip patients. The 2000 procedures consisted of 56% females and 44% males. Mean age 37.5 years, mean surgical time was 86.5 min and mean traction time 50.5 min. The most frequently performed procedure was CAM and Pincer resection in 93.5% of the cases. Labral refixation or repair was done in 70.3% of the cases. The most common type of acetabular chondral damage was grade II lesions (36.6%). Grade III and IV changes were seen in 36.1% of the cases. The preoperative iHOT12 was 45 (mean) based on all 12 items. EQ-5D was 0.65 and HAGOS sub-scores were 51 (pain), 49 (symptoms), 53 (ADL), 35 (sport), 20 (physical activity) and 29, respectively. We conclude that patients undergoing hip arthroscopy report considerable pain, loss of function, reduced level of activity and reduced quality-of-life prior to surgery. The problems with development and maintaining a large clinical registry are described and further studies are needed to validate data completeness. We consider the development of a national clinical registry for hip arthroscopy as a successful way of developing and maintaining a valuable clinical and scientific tool. PMID:27583150

  20. An international registry for neurodegeneration with brain iron accumulation

    PubMed Central

    2012-01-01

    We report the development of an international registry for Neurodegeneration with Brain Iron Accumulation (NBIA), in the context of TIRCON (Treat Iron-Related Childhood-Onset Neurodegeneration), an EU-FP7 – funded project. This registry aims to combine scattered resources, integrate clinical and scientific knowledge, and generate a rich source for future research studies. This paper describes the content, architecture and future utility of the registry with the intent to capture as many NBIA patients as possible and to offer comprehensive information to the international scientific community. PMID:22985983

  1. [Neonatal Dengue. Presentation of clinical cases].

    PubMed

    Romero-Santacruz, Edith; Lira-Canul, Janeth Jaqueline; Pacheco-Tugores, Fredy; Palma-Chan, Adolfo Gonzalo

    2015-05-01

    Dengue is an infectious disease caused by a flavivirus, with four serotypes, transmitted by the mosquito Aedes aegypti. In Mexico it is a public health problem, especially in the region of central and southeast of the country. The disease can be asymptomatic or present serious forms and even death. It is confirmed by detection of the NS1 Antigen; IgM antibodies, polymerase chain reaction and virus isolation. The vertical transmission to de newborn has been little studied. 7 cases in neonates from November to December 2011 are reported. All patients were male, obtained by caesarean section between 34 and 40 weeks of gestation, whose mothers were enrolled with fever and symptoms associated with dengue disease and serology positive for dengue. Six with positive AgNS1 and one positive IgM; one mother died. All the newborns had positive serology for dengue, 4 with positive AgNS1 and 3 positive IgM. The clinical features of the newborn ranged from asymptomatic to one serious dengue fever, shock and hemorrhage. The symptomatic 6 attended with thrombocytopenia, changes in temperature and unspecific disturbance. The severity of mothers conditioned disrepair product at birth, but not with subsequent gravity of the new born. Vertical trasmission of dengue should be suspected in risk areas, to maintain vigilance and to give early treatment. Also is neccesary promote the realization of specific diagnostic and therapeutic guidelines to the neonatal period. PMID:26233977

  2. Case studies in clinical practice development.

    PubMed

    Chopra, Romi; Lipman, John; Murphy, Timothy P

    2005-03-01

    By asking identical questions of several successful practitioners of clinical interventional radiology, a snapshot of the current and future status of interventional radiology as a clinical discipline is presented. PMID:21326672

  3. Southern Saskatchewan Ticagrelor Registry experience

    PubMed Central

    Dehghani, Payam; Chopra, Varun; Bell, Ali; Kelly, Sheila; Zulyniak, Lori; Booker, Jeff; Zimmermann, Rodney; Semchuk, William; Cheema, Asim N; Lavoie, Andrea J

    2014-01-01

    Background As ticagrelor enters into clinical use for acute coronary syndrome, it is important to understand patient/physician behavior in terms of appropriate use, adherence, and event rates. Methods The Southern Saskatchewan Ticagrelor Registry is a prospective, observational, multicenter cohort study that identifies consecutive patients started on ticagrelor. We aimed to evaluate both on- and off-label use, identify characteristics of patients who prematurely stop ticagrelor, and describe patient/physician behavior contributing to inappropriate stoppage of this medication. Results From April 2012 to September 2013, 227 patients were initiated on ticagrelor, with a mean age of 62.2±12.1 years. The participants were 66% men and had a mean follow up of 157.4±111.7 days. Seventy-four patients (32.4%) had off-label indications. Forty-seven patients (20.7%) prematurely stopped ticagrelor and were more likely to be older, women, nonwhite, present with shock, and complain of dyspnea. Twenty-six of the 47 patients stopped ticagrelor inappropriately because of patient nonadherence (18 patients) and physician advice (eight patients). A composite outcome event of death from vascular causes, myocardial infarction, or stroke occurred in 8.8% of the entire cohort and was more likely to occur in those older then 65 years, those presenting with cardiogenic shock, and those who prematurely stopped ticagrelor. Conclusion In this real-world registry of patients started on ticagrelor, a third have off-label indications and a fifth prematurely stop the medication. Premature discontinuation was an independent predictor of major life-threatening bleeding and increased composite event rate of death from vascular causes, myocardial infarction, or stroke. PMID:25342889

  4. An international registry for primary ciliary dyskinesia.

    PubMed

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

    2016-03-01

    Primary ciliary dyskinesia (PCD) is a rare autosomal recessive disorder leading to chronic upper and lower airway disease. Fundamental data on epidemiology, clinical presentation, course and treatment strategies are lacking in PCD. We have established an international PCD registry to realise an unmet need for an international platform to systematically collect data on incidence, clinical presentation, treatment and disease course.The registry was launched in January 2014. We used internet technology to ensure easy online access using a web browser under www.pcdregistry.eu. Data from 201 patients have been collected so far. The database is comprised of a basic data form including demographic and diagnostic information, and visit forms designed to monitor the disease course.To establish a definite PCD diagnosis, we used strict diagnostic criteria, which required two to three diagnostic methods in addition to classical clinical symptoms. Preliminary analysis of lung function data demonstrated a mean annual decline of percentage predicted forced expiratory volume in 1 s of 0.59% (95% CI 0.98-0.22).Here, we present the development of an international PCD registry as a new promising tool to advance the understanding of this rare disorder, to recruit candidates for research studies and ultimately to improve PCD care. PMID:26659107

  5. The growing number of hemophilia registries: Quantity vs. quality.

    PubMed

    Keipert, C; Hesse, J; Haschberger, B; Heiden, M; Seitz, R; van den Berg, H M; Hilger, A

    2015-05-01

    Registries for rare diseases provide a tool for obtaining an overview of the clinical situation and can be used to discover points of improvement and to monitor long-term safety. Registries could also become a powerful tool to provide supporting information for marketing authorization. There is an urgent need for a pan-European or global strategy that supports consistent data. Therefore, transparency in data collection, harmonization of the database structures, and the convergence of scientific approaches are required. PMID:25669198

  6. The Registry of Canadian Stroke Network : an evolving methodology.

    PubMed

    Fang, Jiming; Kapral, Moira K; Richards, Janice; Robertson, Annette; Stamplecoski, Melissa; Silver, Frank L

    2011-06-01

    Stroke registries can provide information on evidence-based practices and interventions, which are critical for us to understand how stroke care is delivered and how outcomes are achieved. The Registry of Canadian Stroke Network (RCSN) was initiated in 2001 and has evolved over the past decade. In the first two years, we found it extremely difficult to obtain informed consent from the patient or surrogate which led to selection biases in the registry. Subsequently (2003 onwards), under the new health privacy legislation in Ontario, Canada, the RCSN was granted special status as a "prescribed registry" which allowed us to collect data on all consecutive patients at the regional stroke centres without consent. The stroke data was encrypted and all personal contact information had been removed, therefore we could no longer conduct follow- up interviews. To obtain patient outcomes after discharge, we linked the non-consent-based registry database to population-based administrative databases to obtain information on patient mortality, readmissions, socioeconomic status, medication use and other clinical information of interest. In addition, the registry methodology was modified to include a periodic population-based audit on a sample of all stroke patients from over 150 acute hospitals across the province, in addition to continuous data collection at the 12 registry hospitals in the province. The changes in the data collection methodology developed by the RCSN can be applied to other provinces and countries. PMID:21739386

  7. A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear™ P-IROS)

    PubMed Central

    2014-01-01

    Background Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described. Methods/Design The Cochlear™ Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia. Discussion The use of a registry such as

  8. Assessment and Reporting of Driving Fitness in Patients with Dementia in Clinical Practice: Data from SveDem, the Swedish Dementia Registry

    PubMed Central

    Lovas, Joel; Fereshtehnejad, Seyed-Mohammad; Cermakova, Pavla; Lundberg, Catarina; Johansson, Björn; Johansson, Kurt; Winblad, Bengt; Eriksdotter, Maria; Religa, Dorota

    2016-01-01

    Background: Driving constitutes a very important aspect of daily life and is dependent on cognitive functions such as attention, visuo-spatial skills and memory, which are often compromised in dementia. Therefore, the driving fitness of patients with dementia needs to be addressed by physicians and those that are deemed unfit should not be allowed to continue driving. Objective: We aimed at investigating to what extent physicians assess driving fitness in dementia patients and determinant factors for revoking of their licenses. Methods: This study includes 15113 patients with newly diagnosed dementia and driver’s license registered in the Swedish Dementia Registry (SveDem). The main outcomes were reporting to the licensing authority and making an agreement about driving eligibility with the patients. Results: Physicians had not taken any action in 16% of dementia patients, whereas 9% were reported to the authority to have their licenses revoked. Males (OR = 3.04), those with an MMSE score between 20–24 (OR = 1.35) and 10–19 (OR = 1.50), patients with frontotemporal (OR = 3.09) and vascular dementia (OR = 1.26) were more likely to be reported to the authority. Conclusion: For the majority of patients with dementia, driving fitness was assessed. Nevertheless, physicians did not address the issue in a sizeable proportion of dementia patients. Type of dementia, cognitive status, age, sex and burden of comorbidities are independent factors associated with the assessment of driving fitness in patients with dementia. Increased knowledge on how these factors relate to road safety may pave the way for more specific guidelines addressing the issue of driving in patients with dementia. PMID:27163829

  9. Evaluation of gemtuzumab ozogamycin associated sinusoidal obstructive syndrome: Findings from an academic pharmacovigilance program review and a pharmaceutical sponsored registry

    PubMed Central

    Magwood-Golston, Jametta S.; Kessler, Samuel; Bennett, Charles L.

    2016-01-01

    Background In 2000, the Food and Drug Administration (FDA) approved gemtuzumab ozogamycin for monotherapy for older patients with relapsed AML. A 0.9% rate of hepatic sinusoidal obstructive syndrome (SOS) was noted in licensing trials. In 2001, FDA received reports of 14 GO-associated SOS cases from MD Anderson Cancer Center. A State of South Carolina/National Cancer Institute funded pharmacovigilance program and a manufacturer sponsored registry independently evaluated this concern. Methods The manufacturer’s registry and the academic program focused on risk factors and incidence of GO-associated SOS in routine clinical practice and clinical trial settings, respectively. Comparisons were made of findings and dissemination efforts from the two studies. Results Retrospective analysis of clinical trials by the academic initiative identified 99 cases of SOS among 221 GO-treated stem cell patients and 649 patients who did not undergo HSCTs. SOS rates were 3% when GO was administered at doses ≤6 mg/m2 as monotherapy or with non-hepatotoxic agents; 28% when administered with 6-thioguanine, a hepatotoxic agent; 15% when administered as monotherapy at doses at a dose of 9 mg/m2, and between 15% and 40% if a stem cell transplant (SCT) was performed within 3 months of GO administration. Death from SOS occurred in 33% of the cases. The manufacturer’s registry prospectively evaluated 482 GO-treated patients who received a mean dose of 7.8 mg/m2. Overall, 41% received concomitant chemotherapy, 18% had undergone prior SCT, 9.1% developed SOS, and death from SOS occurred in 60% of the SOS cases. Findings from each initiative were disseminated at national conferences and in peer-reviewed manuscripts beginning in 2003. Conclusion Retrospective review of clinical trials, case series, and FDA reports and prospective registries can provide important information on safety signals initially identified in licensing trials. PMID:27030962

  10. Bowenoid papulosis: clinical and histological study of eight cases.

    PubMed Central

    Gimeno, E; Vilata, J J; Sanchez, J L; Lloret, A; Fortea, J M

    1987-01-01

    Eight cases of bowenoid papulosis are reported. The clinical diagnoses were confirmed by histology. In one case an immunoperoxidase method showed the presence of papillomavirus antigen in the nucleus of the most superficial epidermal cells. We consider bowenoid papulosis to be a condition with specific features that distinguish it clinically and histologically from carcinoma in situ and condylomata acuminata. Images PMID:3034760

  11. The Pediatric Cardiomyopathy Registry: 1995–2007

    PubMed Central

    Wilkinson, James D.; Sleeper, Lynn A.; Alvarez, Jorge A.; Bublik, Natalya; Lipshultz, Steven E.

    2008-01-01

    Cardiomyopathy is a serious disorder of the heart muscle and, although rare, it is potentially devastating in children. Funded by the National Heart Lung and Blood Institute since 1994, the Pediatric Cardiomyopathy Registry (PCMR) was designed to describe the epidemiology and clinical course of selected CMs in patients 18 years old or younger and to promote the development of etiology-specific prevention and treatment strategies. Currently, data from more than 3,000 children with cardiomyopathy have been entered in the PCMR database with annual follow-up continuing until death, heart transplant, or loss-to-follow up. Using PCMR data, the incidence of cardiomyopathy in two large regions of the United States is estimated to be 1.13 cases per 100,000 children. Only 1/3 of children had a known etiology at the time of cardiomyopathy diagnosis. Diagnosis was associated with certain patient characteristics, family history, echocardiographic findings, laboratory testing, and biopsy. Greater incidence was found in boys and infants (<1 yr) for both dilated and hypertrophic cardiomyopathy (DCM, HCM) and black race for only DCM. In DCM, prognosis is worse in older children (>1yr), heart failure (HF) at diagnosis or idiopathic etiology. For HCM, worse prognosis is associated with inborn errors of metabolism or combination of HCM and another cardiomyopathy functional type. The best outcomes were observed in children presenting at age >1 yr with idiopathic HCM. PCMR data have enabled analysis of patients with cardiomyopathy and muscular dystrophy, as well as Noonan Syndrome. Currently, collaborations with the Pediatric Heart Transplant Study group and a newly established Pediatric Cardiomyopathy Biologic Specimen Repository at Texas Children’s Hospital will continue to yield important results. The PCMR is the largest and most complete multi-center prospective data resource regarding the etiology, clinical course and outcomes for children with cardiomyopathy. PMID:19343086

  12. Feasibility of creating a National ALS Registry using administrative data in the United States

    PubMed Central

    KAYE, WENDY E.; SANCHEZ, MARCHELLE; WU, JENNIFER

    2015-01-01

    Uncertainty about the incidence and prevalence of amyotrophic lateral sclerosis (ALS), as well as the role of the environment in the etiology of ALS, supports the need for a surveillance system/registry for this disease. Our aim was to evaluate the feasibility of using existing administrative data to identify cases of ALS. The Agency for Toxic Substances and Disease Registry (ATSDR) funded four pilot projects at tertiary care facilities for ALS, HMOs, and state based organizations. Data from Medicare, Medicaid, the Veterans Health Administration, and Veterans Benefits Administration were matched to data available from site-specific administrative and clinical databases for a five-year time-period (1 January 2001–31 December 2005). Review of information in the medical records by a neurologist was considered the gold standard for determining an ALS case. We developed an algorithm using variables from the administrative data that identified true cases of ALS (verified by a neurologist). Individuals could be categorized into ALS, possible ALS, and not ALS. The best algorithm had sensitivity of 87% and specificity of 85%. We concluded that administrative data can be used to develop a surveillance system/ registry for ALS. These methods can be explored for creating surveillance systems for other neurodegenerative diseases. PMID:24597459

  13. Clinical case of rabies in Bulgaria.

    PubMed

    Nenova, M; Gantcheva, T

    2001-01-01

    The history of a six-year-old girl, hospitalised in the Clinic of Infectious Diseases of the Medical University of Varna with diagnosed meningoencephalitis, obs. rabies, and epidemiological data of dog bite without adequate prophylaxis is presented. The clinical course was unusual: the symptoms of aero- and hydrophobia were not clearly demonstrated, choreic hyperkynesias, torsion seizures and high initial pleocytosis in cerebrospinal fluid were present. The pathological picture is described. Ethiological diagnosis was proven by immunofluorescence test of brain tissue. PMID:12078128

  14. 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

  15. [Penile cutaneous horn. A clinical case].

    PubMed

    Conde Sánchez, J M; Rico López, J; Blasco Hernández, P; Espinosa Olmedo, J; Domínguez Domínguez, M; García Pérez, M

    2000-02-01

    Contribution of a case report of cutaneous horn of penis surgically treated with extensive resection of the implantation base. A well differentiated, microinvasive epidermoid carcinoma was histopathologically demonstrated on a hyperkeratosis squamous papilloma. Although underlying lesions to cutaneous horn are usually benign, malignant changes have been reported in up to one third of cases; surgical treatment should therefore include extensive resection of the implantation base. PMID:10829451

  16. The Lupus Family Registry and Repository

    PubMed Central

    Rasmussen, Astrid; Sevier, Sydney; Kelly, Jennifer A.; Glenn, Stuart B.; Aberle, Teresa; Cooney, Carisa M.; Grether, Anya; James, Ellen; Ning, Jared; Tesiram, Joanne; Morrisey, Jean; Powe, Tiny; Drexel, Mark; Daniel, Wes; Namjou, Bahram; Ojwang, Joshua O.; Nguyen, Kim L.; Cavett, Joshua W.; Te, Jeannie L.; James, Judith A.; Scofield, R. Hal; Moser, Kathy; Gilkeson, Gary S.; Kamen, Diane L.; Carson, Craig W.; Quintero-del-Rio, Ana I.; Ballesteros, Maria del Carmen; Punaro, Marilynn G.; Karp, David R.; Wallace, Daniel J.; Weisman, Michael; Merrill, Joan T.; Rivera, Roberto; Petri, Michelle A.; Albert, Daniel A.; Espinoza, Luis R.; Utset, Tammy O.; Shaver, Timothy S.; Arthur, Eugene; Anaya, Juan-Manuel; Bruner, Gail R.

    2011-01-01

    The Lupus Family Registry and Repository (LFRR) was established with the goal of assembling and distributing materials and data from families with one or more living members diagnosed with SLE, in order to address SLE genetics. In the present article, we describe the problems and solutions of the registry design and biometric data gathering; the protocols implemented to guarantee data quality and protection of participant privacy and consent; and the establishment of a local and international network of collaborators. At the same time, we illustrate how the LFRR has enabled progress in lupus genetics research, answering old scientific questions while laying out new challenges in the elucidation of the biologic mechanisms that underlie disease pathogenesis. Trained staff ascertain SLE cases, unaffected family members and population-based controls, proceeding in compliance with the relevant laws and standards; participant consent and privacy are central to the LFRR’s effort. Data, DNA, serum, plasma, peripheral blood and transformed B-cell lines are collected and stored, and subject to strict quality control and safety measures. Coded data and materials derived from the registry are available for approved scientific users. The LFRR has contributed to the discovery of most of the 37 genetic associations now known to contribute to lupus through 104 publications. The LFRR contains 2618 lupus cases from 1954 pedigrees that are being studied by 76 approved users and their collaborators. The registry includes difficult to obtain populations, such as multiplex pedigrees, minority patients and affected males, and constitutes the largest collection of lupus pedigrees in the world. The LFRR is a useful resource for the discovery and characterization of genetic associations in SLE. PMID:20864496

  17. American Society of Clinical Oncology

    MedlinePlus

    ... Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial aiming to describe the performance of ... Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial aiming to describe the performance of ...

  18. Incidence of Type 1 Diabetes among Children and Adolescents in Italy between 2009 and 2013: The Role of a Regional Childhood Diabetes Registry

    PubMed Central

    Fortunato, F.; Cappelli, M. G.; Vece, M. M.; Caputi, G.; Delvecchio, M.; Prato, R.; Martinelli, D.; Workgroup, Apulian Childhood-Onset Diabetes Registry

    2016-01-01

    Background. Surveillance represents a key strategy to control type 1 diabetes mellitus (T1DM). In Italy, national data are missing. This study aimed at evaluating the incidence of T1DM in subjects <18 year olds in Apulia (a large southeastern region, about 4,000,000 inhabitants) and assessing the sensitivity of the regional Registry of Childhood-Onset Diabetes (RCOD) in the 2009–2013 period. Methods. We performed a retrospective study matching records from regional Hospital Discharge Registry (HDR), User Fee Exempt Registry (UFER), and Drugs Prescription Registry (DPR) and calculated T1DM incidence; completeness of each data source was also estimated. In order to assess the RCOD sensitivity we compared cases from the registry to those extracted from HDR-UFER-DPR matching. Results. During 2009–2013, a total of 917 cases (about 184/year) in at least one of the three sources and an annual incidence of 25.2 per 100,000 were recorded, lower in infant, increasing with age and peaked in 5- to 9-year-olds. The completeness of DPR was 78.7%, higher than that of UFER (64.3%) and of HDR (59.6%). The RCOD's sensitivity was 39.05% (360/922; 95% CI: 34.01%–44.09%). Conclusions. Apulia appeared as a high-incidence region. A full, active involvement of physicians working in paediatric diabetes clinics would be desirable to improve the RCOD performance. PMID:27092312

  19. [Castleman's disease: considerations on a clinical case].

    PubMed

    Spaghi, A; Costa, D; Gangarossa, I; Albergati, M G; Castoldi, O; Nastasi, G

    1989-01-01

    A case of a patient with angiofollicular lymph-node hyperplasia (Castleman's disease), of the plasma cell type, is described. The course of the disease evolved from an unilateral inguinal adenopathy to a generalised intraabdominal adenopathy which took the patient to death. Diagnostic and therapeutic aspects are discussed. PMID:2739529

  20. [Multisystemic sarcoidosis. A clinical case report].

    PubMed

    Cerri, D; Carabelli, A; Vanotti, P; Candiani, F; Bertani, E; Peroni, G; Gelmetti, C

    1990-12-01

    Sarcoidosis is a granulomatous disorder of unknown etiology with a multi-disciplinary interest. However, a multiple organ involvement is not always clearly presented. A case of a 62-year-old woman with cutaneous, pulmonary, ocular, cardiac, bone and articular involvement is described. PMID:2075284

  1. Impact of Frailty and Other Geriatric Syndromes on Clinical Management and Outcomes in Elderly Patients With Non-ST-Segment Elevation Acute Coronary Syndromes: Rationale and Design of the LONGEVO-SCA Registry.

    PubMed

    Alegre, Oriol; Ariza-Solé, Albert; Vidán, María T; Formiga, Francesc; Martínez-Sellés, Manuel; Bueno, Héctor; Sanchís, Juan; López-Palop, Ramón; Abu-Assi, Emad; Cequier, Àngel

    2016-07-01

    The incidence of acute coronary syndromes (ACS) is high in the elderly. Despite a high prevalence of frailty and other aging-related variables, little information exists about the optimal clinical management in patients with coexisting geriatric syndromes. The aim of the LONGEVO-SCA registry (Impacto de la Fragilidad y Otros Síndromes Geriátricos en el Manejo y Pronóstico Vital del Anciano con Síndrome Coronario Agudo sin Elevación de Segmento ST) is to assess the impact of aging-related variables on clinical management, prognosis, and functional status in elderly patients with ACS. A series of 500 consecutive octogenarian patients with non-ST-segment elevation ACS from 57 centers in Spain will be included. A comprehensive geriatric assessment will be performed during the admission, assessing functional status (Barthel Index, Lawton-Brody Index), frailty (FRAIL scale, Short Physical Performance Battery), comorbidity (Charlson Index), nutritional status (Mini Nutritional Assessment-Short Form), and quality of life (Seattle Angina Questionnaire). Patients will be managed according to current recommendations. The primary outcome will be the description of mortality and its causes at 6 months. Secondary outcomes will be changes in functional status and quality of life. Results from this study might significantly improve the knowledge about the impact of aging-related variables on management and outcomes of elderly patients with ACS. Clinical management of these patients has become a major health care problem due to the growing incidence of ACS in the elderly and its particularities. PMID:27362592

  2. Facilitating case studies in massage therapy clinical education.

    PubMed

    Baskwill, Amanda

    2013-01-01

    The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

  3. Sports Neurology in Clinical Practice: Case Studies.

    PubMed

    Seifert, Tad

    2016-08-01

    With regard to persistent posttraumatic headache, there is legitimate concern that duration of symptoms may have an impact on the efficacy of future treatment attempts. Without neuropathologic confirmation, a clinical diagnosis of chronic traumatic encephalopathy cannot be made with a high degree of confidence. Sport-related headaches are challenging in a return-to-play context, because it is often unclear whether an athlete has an exacerbation of a primary headache disorder, has new-onset headache unrelated to trauma, or is in the recovery phase after concussion. Regular physical exercise may prove beneficial to multiple neurologic disease states. PMID:27445251

  4. Twelve months clinical outcome after bioresorbable vascular scaffold implantation in patients with stable angina and acute coronary syndrome. Data from the Polish National Registry

    PubMed Central

    Rzeszutko, Łukasz; Siudak, Zbigniew; Tokarek, Tomasz; Plens, Krzysztof; Włodarczak, Adrian; Lekston, Andrzej; Ochała, Andrzej; Gil, Robert J.; Balak, Wojciech

    2016-01-01

    Introduction There are limited data describing bioresorbable vascular scaffold (BVS) implantation in complex lesions. Only short-term clinical outcomes are available for patients with acute coronary syndrome (ACS). Aim To evaluate 12-month clinical outcome, safety and effectiveness of BVS implantation in complex lesions and in stable angina (SA) or ACS. Material and methods Five hundred ninety-one patients with SA/ACS were enrolled between October 2012 and November 2013 in 30 invasive cardiology centres in Poland. At least one BVS implantation during percutaneous coronary intervention (PCI) was the only inclusion criteria. The clinical endpoint was the occurrence of a major adverse cardiovascular event (MACE) (all-cause death, myocardial infarction (MI), clinically driven target lesion revascularisation (TLR) with urgent PCI or target vessel revascularisation (TVR) with urgent coronary artery bypass grafting (CABG)) and device-oriented composite endpoint (DOCE) (cardiac death, urgent target vessel revascularisation with PCI/CABG, target vessel MI) during 12-month follow-up. Results After 12 months TLR with urgent PCI was significantly more often reported in patients with diagnosed UA (4.59%; p < 0.02) in comparison with other PCI indications. No significant differences were found in terms of composite MACE endpoint, cumulative MACE (p = 0.09), stent thrombosis (p = 0.2) or restenosis (p = 0.2). There were no significant differences in cumulative MACE and composite MACE endpoint between patients with no/mild versus moderate/severe tortuosity and no/mild versus moderate/severe calcification of the target vessel. No significant difference was found between groups of patients with or without bifurcation of the target vessel. Device-oriented composite endpoint was significantly more often reported in the ACS group (3.2% vs. 0.47%; p < 0.03), most frequently in patients with diagnosed UA (5.5%). Conclusions Bioresorbable vascular scaffold can be successfully and safely

  5. Ten years after the first inspection of a candidate European centre, an EBMT registry analysis suggests that clinical outcome is improved when hematopoietic SCT is performed in a JACIE accredited program.

    PubMed

    Chabannon, C; Pamphilon, D; Vermylen, C; Gratwohl, A; Niederwieser, D; McGrath, E; Lamers, C; Lanza, F; Slaper-Cortenbach, I; Madrigal, A; Apperley, J

    2012-01-01

    In 2010, JACIE, the Joint Accreditation Committee of ISCT (International Society for Cell Therapy) Europe and EBMT (European group for Blood and Marrow Transplantation) celebrated the tenth anniversary of the first inspection of a European hematopoietic SCT program. JACIE standards establish the criteria for a comprehensive quality management program that covers all three major domains of activity that are necessary for the delivery of HSCT: clinical, collection and processing, as well as their interactions with ancillary and supportive activities. Although more than 200 European programs have applied for JACIE accreditation, and more than 100 have been granted accreditation, a recent retrospective analysis of the large-size EBMT registry of autologous and allogenic hematopoietic HSCT demonstrates that one of the factors affecting the overall survival of recipients of allogenic transplantation is the status of the transplant program regarding JACIE accreditation. This provides one of the first demonstrations that introduction of a quality management system contributes to the overall survival of patients treated with a highly specific medical procedure, and represents a milestone in the implementation of JACIE. PMID:21383685

  6. Critical path case management: the headache clinic.

    PubMed

    Sobkowski, D A; Maquera, V

    1996-01-01

    A practical application of a neurology case management healthcare delivery mode results in increased access to specialty providers, shorter follow-up periods, and improved continuity of medical care. The program described in the following sections was developed at a naval hospital for the ongoing evaluation of therapeutic schemes to optimize headache therapy and, 1 year after implementation, shows improvement in patient outcomes and resource use. PMID:9192570

  7. Clinical Competence: General Ability or Case-Specific?

    ERIC Educational Resources Information Center

    Wimmers, Paul F.; Splinter, Ted A. W.; Hancock, Gregory R.; Schmidt, Henk G.

    2007-01-01

    Background: Before the 1970s, research into the development of clinical competence was mainly focused on general problem-solving abilities. The scope of research changed when Elstein and colleagues discovered that individual ability to solve clinical problems varies considerably across cases. It was concluded that problem solving abilities are…

  8. Rationale, Design, Methodology and Hospital Characteristics of the First Gulf Acute Heart Failure Registry (Gulf CARE)

    PubMed Central

    Sulaiman, Kadhim J.; Panduranga, Prashanth; Al-Zakwani, Ibrahim; Alsheikh-Ali, Alawi; Al-Habib, Khalid; Al-Suwaidi, Jassim; Al-Mahmeed, Wael; Al-Faleh, Husam; El-Asfar, Abdelfatah; Al-Motarreb, Ahmed; Ridha, Mustafa; Bulbanat, Bassam; Al-Jarallah, Mohammed; Bazargani, Nooshin; Asaad, Nidal; Amin, Haitham

    2014-01-01

    Background: There is paucity of data on heart failure (HF) in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE). Materials and Methods: Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF). The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. Results: A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain) participated in the project. The majority of hospitals were community hospitals (46%; 22/47) followed by non-University teaching (32%; 15/47 and University hospitals (17%). Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47) with 59% (28/47) having catheterization laboratory facilities. However, only 29% (14/47) had a dedicated HF clinic facility. Most patients (71%) were cared for by a cardiologist. Conclusions: Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden of HF in

  9. Using Case Study Analysis and Case Writing to Structure Clinical Experiences in a Teacher Education Program

    ERIC Educational Resources Information Center

    Floyd, Deborah M.; Bodur, Yasar

    2005-01-01

    This study reports on the design and results of a two-semester study on the use of case study analysis and case writing in clinical experiences in an undergraduate teacher education program. Findings indicated that structured experiences with case studies and case writing increase preservice teachers' informed decision making on educational…

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

    PubMed

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

    2015-12-01

    The purpose of this study was to describe and quantify procedures and methods that maximized the efficiency of the Gharbiah Cancer Registry (GPCR), the only population-based cancer registry in Egypt. The procedures and measures included a locally-developed software program to translate names from Arabic to English, a new national ID number for demographic and occupational information, and linkage of cancer cases to new electronic mortality records of the Ministry of Health. Data was compiled from the 34,058 cases from the registry for the years 1999-2007. Cases and registry variables about demographic and clinical information were reviewed by year to assess trends associated with each new method or procedure during the study period. The introduction of the name translation software in conjunction with other demographic variables increased the identification of detected duplicates from 23.4% to 78.1%. Use of the national ID increased the proportion of cases with occupation information from 27% to 89%. Records with complete mortality information increased from 18% to 43%. Proportion of cases that came from death certificate only, decreased from 9.8% to 4.7%. Overall, the study revealed that introducing and utilizing local and culture-specific methodological changes, software, and electronic non-cancer databases had a significant impact on data quality and completeness. This study may have translational implications for improving the quality of cancer registries in LMICs considering the emerging advances in electronic databases and utilization of health software and computerization of data. PMID:26590335

  11. A case-based assistant for clinical psychiatry expertise.

    PubMed Central

    Bichindaritz, I.

    1994-01-01

    Case-based reasoning is an artificial intelligence methodology for the processing of empirical knowledge. Recent case-based reasoning systems also use theoretic knowledge about the domain to constrain the case-based reasoning. The organization of the memory is the key issue in case-based reasoning. The case-based assistant presented here has two structures in memory: cases and concepts. These memory structures permit it to be as skilled in problem-solving tasks, such as diagnosis and treatment planning, as in interpretive tasks, such as clinical research. A prototype applied to clinical work about eating disorders in psychiatry, reasoning from the alimentary questionnaires of these patients, is presented as an example of the system abilities. PMID:7950011

  12. Arterioureteral fistula: an unusual clinical case.

    PubMed

    Coelho, Hugo; Freire, Maria José; Azinhais, Paulo; Temido, Paulo

    2016-01-01

    Arterioureteral fistulas (AUFs) are abnormal communications between a major artery and the mid to distal ureter. It is a rare but potentially life-threatening condition that is seldom recognised. We present a case of a 66-year-old man who was admitted to the surgical ward owing to infection of an aortic bifemoral bypass graft. During admission, the patient developed persistent haematuria with considerable loss of haemoglobin. He was submitted to urgent surgical exploration of the graft. An ascending pyelography performed at the beginning of the surgery clearly shows a communication between the left ureter and the vascular graft. Open surgical exploration was undertaken, the fistulised section of the ureter resected and an end-to-end ureteroplasty was performed. The vascular graft was removed and the patient later submitted to left supracondylar amputation. Urinary drainage remained intact. PMID:26969358

  13. Methylbromide intoxication: a clinical case study.

    PubMed

    Breeman, Wim

    2009-01-01

    The port of Rotterdam, The Netherlands, is the world's largest container port. In 2006, one of these containers caused a chemical incident. Methylbromide is used in some countries as a pesticide for the fumigation of maritime containers. Because of an insufficiently performed detoxification, this insecticide intoxicated several employees and some of the ambulance crew and Mobile Medical Team (MMT). The victims displayed symptoms of sore throat, irritated eyes, and hypersalivation. One of the victims suffered from multiple epileptic seizures. Two victims were admitted to the intensive care unit for respiratory support. Three other employees showed milder symptoms and received supportive care but were not admitted to the hospital. This complicated case shows that the safety of the ambulance crew and MMT must be guaranteed. It also demonstrates that healthcare providers cannot always oversee the accident scene and that there are some pitfalls that are almost impossible to prevent. PMID:20118865

  14. Two-year clinical outcomes after coronary drug-eluting stent placement in Chinese men and women: a multicenter, prospective registry study

    PubMed Central

    Shrestha, Rajiv; Gami, Sandeep; Xu, Jing; Xie, Du-Jiang; Liu, Zhi-Zhong; Xu, Tian; Ye, Fei; Din, Shi-Qing; Qian, Xue-Song; Yang, Song; Liu, Yue-Qiang; Li, Feng; Zhang, Ai-Ping; Chen, Shao-Liang

    2013-01-01

    Background Previous studies have reported a discrepancy in baseline characteristics and outcomes after percutaneous coronary intervention between men and women. However, this finding has never been verified in the Chinese population. The present study analyzed two-year clinical outcomes after placement of coronary drug-eluting stents in Chinese men and women. Methods From January 2005 to December 2010, a total of 3804 Chinese patients (2776 men, 1028 women) who underwent drug-eluting stent implantation were studied prospectively. The primary endpoint was the composite major adverse cardiac event (MACE) rate, including myocardial infarction, cardiac death, and target vessel revascularization at two years. Stent thrombosis served as the safety endpoint. Propensity score matching was used to compare the adjusted MACE rate between the two groups. Results At two-year follow-up, unadjusted rates of myocardial infarction, non-ST segment elevation myocardial infarction, target vessel revascularization, and MACE were significantly different between men (6.84%, 4.6%, 13.1%, and 21.7%, respectively) and women (3.8% [P = 0.001], 2.0% [P < 0.001] 10.3% [P = 0.025], and 16.3% [P < 0.001], respectively). After propensity score matching, there were no significant differences in composite MACE and individual endpoints at two years between the genders. Conclusion Despite all the unfavorable risk factor clustering in women and complex coronary disease in men, the two-year clinical outcomes after coronary stent placement were comparable between Chinese women and men. PMID:23874087

  15. PCCR: Pancreatic Cancer Collaborative Registry.

    PubMed

    Sherman, Simon; Shats, Oleg; Ketcham, Marsha A; Anderson, Michelle A; Whitcomb, David C; Lynch, Henry T; Ghiorzo, Paola; Rubinstein, Wendy S; Sasson, Aaron R; Grizzle, William E; Haynatzki, Gleb; Feng, Jianmin; Sherman, Alexander; Kinarsky, Leo; Brand, Randall E

    2011-01-01

    The Pancreatic Cancer Collaborative Registry (PCCR) is a multi-institutional web-based system aimed to collect a variety of data on pancreatic cancer patients and high-risk subjects in a standard and efficient way. The PCCR was initiated by a group of experts in medical oncology, gastroenterology, genetics, pathology, epidemiology, nutrition, and computer science with the goal of facilitating rapid and uniform collection of critical information and biological samples to be used in developing diagnostic, prevention and treatment strategies against pancreatic cancer. The PCCR is a multi-tier web application that utilizes Java/JSP technology and has Oracle 10 g database as a back-end. The PCCR uses a "confederation model" that encourages participation of any interested center, irrespective of its size or location. The PCCR utilizes a standardized approach to data collection and reporting, and uses extensive validation procedures to prevent entering erroneous data. The PCCR controlled vocabulary is harmonized with the NCI Thesaurus (NCIt) or Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT). The PCCR questionnaire has accommodated standards accepted in cancer research and healthcare. Currently, seven cancer centers in the USA, as well as one center in Italy are participating in the PCCR. At present, the PCCR database contains data on more than 2,700 subjects (PC patients and individuals at high risk of getting this disease). The PCCR has been certified by the NCI Center for Biomedical Informatics and Information Technology as a cancer Biomedical Informatics Grid (caBIG(®)) Bronze Compatible product. The PCCR provides a foundation for collaborative PC research. It has all the necessary prerequisites for subsequent evolution of the developed infrastructure from simply gathering PC-related data into a biomedical computing platform vital for successful PC studies, care and treatment. Studies utilizing data collected in the PCCR may engender new approaches

  16. 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

  17. Worldwide variability in deceased organ donation registries.

    PubMed

    Rosenblum, Amanda M; Li, Alvin Ho-Ting; Roels, Leo; Stewart, Bryan; Prakash, Versha; Beitel, Janice; Young, Kimberly; Shemie, Sam; Nickerson, Peter; Garg, Amit X

    2012-08-01

    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

  18. A comprehensive stroke center patient registry: advantages, limitations, and lessons learned

    PubMed Central

    Siegler, James E.; Boehme, Amelia K.; Dorsey, Adrianne M.; Monlezun, Dominique J.; George, Alex J.; Shaban, Amir; Bockholt, H. Jeremy; Albright, Karen C.; Martin-Schild, Sheryl

    2015-01-01

    Introduction The use of a medical data registry allows institutions to effectively manage information for many different investigations related to the registry, as well as evaluate patient's trends over time, with the ultimate goal of recognizing trends that may improve outcomes in a particular patient population. Methods The purpose of this article is to illustrate our experience with a stroke patient registry at a comprehensive stroke center and highlight advantages, disadvantages, and lessons learned in the process of designing, implementing, and maintaining a stroke registry. We detail the process of stroke registry methodology, common data element (CDE) definitions, the generation of manuscripts from a registry, and the limitations. Advantages The largest advantage of a registry is the ability to prospectively add patients, while allowing investigators to go back and collect information retrospectively if needed. The continuous addition of new patients increases the sample size of studies from year to year, and it also allows reflection on clinical practices from previous years and the ability to investigate trends in patient management over time. Limitations The greatest limitation in this registry pertains to our single-entry technique where multiple sites of data entry and transfer may generate errors within the registry. Lessons Learned To reduce the potential for errors and maximize the accuracy and efficiency of the registry, we invest significant time in training competent registry users and project leaders. With effective training and transition of leadership positions, which are continuous and evolving processes, we have attempted to optimize our clinical research registry for knowledge gain and quality improvement at our center. PMID:26913217

  19. Advances in myelofibrosis: a clinical case approach.

    PubMed

    Mascarenhas, John O; Orazi, Attilio; Bhalla, Kapil N; Champlin, Richard E; Harrison, Claire; Hoffman, Ronald

    2013-10-01

    Primary myelofibrosis is a member of the myeloproliferative neoplasms, a diverse group of bone marrow malignancies. Symptoms of myelofibrosis, particularly those associated with splenomegaly (abdominal distention and pain, early satiety, dyspnea, and diarrhea) and constitutional symptoms, represent a substantial burden to patients. Most patients eventually die from the disease, with a median survival ranging from approximately 5-7 years. Mutations in Janus kinase 2 (JAK2), a kinase that is essential for the normal development of erythrocytes, granulocytes, and platelets, notably the V617F mutation, have been identified in approximately 50% of patients with myelofibrosis. The approval of a JAK2 inhibitor in 2011 has improved the outlook of many patients with myelofibrosis and has changed the treatment landscape. This article focuses on some of the important issues in current myelofibrosis treatment management, including differentiation of myelofibrosis from essential thrombocythemia and polycythemia vera, up-dated data on the results of JAK2 inhibitor therapy, the role of epigenetic mechanisms in myelofibrosis pathogenesis, investigational therapies for myelofibrosis, and advances in hematopoietic stem cell transplant. Three myelofibrosis cases are included to underscore the issues in diagnosing and treating this complex disease. PMID:24091929

  20. Clinical analysis of cases of neonatal Streptococcus agalactiae sepsis.

    PubMed

    Zeng, S J; Tang, X S; Zhao, W L; Qiu, H X; Wang, H; Feng, Z C

    2016-01-01

    With the advent of antibiotic resistance, pathogenic bacteria have become a major threat in cases of neonatal sepsis; however, guidelines for treatment have not yet been standardized. In this study, 15 cases of neonatal Streptococcus agalactiae sepsis from our hospital were retrospectively analyzed. Of these, nine cases showed early-onset and six cases showed late-onset sepsis. Pathogens were characterized by genotyping and antibiotic sensitivity tests on blood cultures. Results demonstrated that in cases with early-onset sepsis, clinical manifestations affected mainly the respiratory tract, while late-onset sepsis was accompanied by intracranial infection. Therefore, we suggest including a cerebrospinal fluid examination when diagnosing neonatal sepsis. Bacterial genotyping indicated the bacteria were mainly type Ib, Ia, and III S. agalactiae. We recommend treatment with penicillin or ampicillin, since bacteria were resistant to clindamycin and tetracycline. In conclusion, our results provide valuable information for the clinical treatment of S. agalactiae sepsis in neonatal infants. PMID:27323190

  1. Pulmonary sequestration in children: a clinical analysis of 48 cases

    PubMed Central

    Ou, Jiangfeng; Lei, Xiaoying; Fu, Zhou; Huang, Ying; Liu, Enmei; Luo, Zhengxiu; Peng, Donghong

    2014-01-01

    Background: This study aimed to explore clinical features, diagnosis, treatment, and outcomes of children’s pulmonary sequestration (PS) to reduce misdiagnosis. Methods: Clinical records of 48 children with PS in Children’s Hospital of Chongqing Medical University between April 1994 and April 2013 were retrieved, and the literature was reviewed. Results: 48 cases were collected, 30 cases confirmed (Group A) and 18 suspicious cases (Group B). In Group A, 16 cases were confirmed before operation by 64-row enhanced CT (4 cases), enhanced CT combined with three-dimensional reconstruction (9 cases), and digital subtraction angiography (3 cases). Misdiagnosis rate was 36.7%, while missed diagnosis rate 10%. 26 cases received surgery and were confirmed finally. Aberrant arterial supply mainly originated from thoracic aorta (22 cases) and abdominal aorta (5 cases). Hypoplasia and chronic inflammation were shown by postoperative histopathological examinations in all children with surgery. There was no operative mortality. Encapsulated pleural effusion occurred in one patient as only post-operation complication. All were discharged after successful treatment. Conclusion: Chest X-ray and color Doppler ultrasound can be used for routine screening for PS. Technique of choice for confirmation is three-dimensional chest CT. Identifying anomalous systemic artery is key for confirmed diagnosis. Surgery is recommended as early as possible. X-ray plus ultrasound as routine screening combined with three-dimensional CT for definitive diagnosis and video-assisted thoracoscopic surgery might be best choice for PS in future. PMID:24995095

  2. Complete ascertainment of Parkinson disease in the Swedish Twin Registry

    PubMed Central

    Wirdefeldt, Karin; Gatz, Margaret; Bakaysa, Stephanie L.; Fiske, Amy; Flensburg, Måns; Petzinger, Giselle M.; Widner, Håkan; Lew, Mark F.; Welsh, Mickie; Pedersen, Nancy L.

    2008-01-01

    This report describes the ascertainment of Parkinson disease (PD) in all individuals aged 50 years or older (49,814 individuals) from the Swedish Twin Registry. In phase one of the study, all twins were screened for PD using telephone interviews, with a response rate of 72.7%. In phase two, twins with suspected PD were re-contacted to exclude anyone from follow-up who reported parkinsonian symptoms due to diseases other than PD. In the third phase, in-person clinical evaluations were completed for twins who were still considered PD suspects after phase two and for a sample of co-twins. During the clinical evaluations, we also collected blood samples and information about a variety of environmental exposures. Overall prevalence rate for PD was 496 per 100,000 individuals. Among the 132 PD cases identified, there were only three concordant twin pairs. In total 7.2% of PD cases reported a first degree relative with PD. PMID:17532098

  3. Haematuria on the Spanish Registry of Glomerulonephritis

    PubMed Central

    Yuste, Claudia; Rivera, Francisco; Moreno, Juan Antonio; López-Gómez, Juan Manuel

    2016-01-01

    Recent studies suggest a pathogenic role for glomerular haematuria among renal function. However, there is no data on the prevalence of haematuria from a large renal biopsy registry. We analysed the prevalence of gross (GH) and microscopic (mH) haematuria in 19,895 patients that underwent native renal biopsies from the Spanish Registry of Glomerulonephritis. Haematuria’s overall incidence was 63% (GH 8.6% and mH 55.1%), being more frequent in males (64.7% vs. 62.4%). GH was more prevalent in patients <18 years (21.3% vs. 7.7%). The commonest clinical presentation associated with GH was acute kidney injury (31.5%) and IgA Nephropathy (IgAN) (33.6%) was the most frequent histological finding. GH patients showed a significantly (p < 0.05) lower eGFR and proteinuria levels as compared with patients with mH and without haematuria. Moreover, mH was more prevalent in adults (56.3%). Nephrotic syndrome was the commonest clinical presentation in mH patients (32.2%) and IgAN (18.5%) the most frequent histological finding. In conclusion, haematuria, is a frequent urinalysis finding in patients underwent native renal biopsy. The most frequent histological finding in both GH and mH is IgAN. Whereas, GH is more frequent in young males with acute kidney injury, mH is commoner among adults with nephrotic syndrome. PMID:26818712

  4. Medical Specialty Society Sponsored Data Registries – Opportunities in Plastic Surgery

    PubMed Central

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

    2014-01-01

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

  5. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries

    PubMed Central

    Codreanu, Catalin; Damjanov, Nemanja

    2015-01-01

    Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA). Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs) and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols) often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs) and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]). The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA. PMID:25670881

  6. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries.

    PubMed

    Codreanu, Catalin; Damjanov, Nemanja

    2015-01-01

    Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA). Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs) and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols) often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs) and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]). The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA. PMID:25670881

  7. Retinoblastoma Registry report--Hospital Kuala Lumpur experience.

    PubMed

    Jamalia, R; Sunder, R; Alagaratnam, J; Goh, P P

    2010-06-01

    Retinoblastoma is a childhood ocular cancer. The aim of this paper is to describe the clinical and epidemiological characteristics of patients with retinoblastoma in a major paediatric ophthalmology center in the country. Retrospective information was collected through the retinoblastoma registry. Late presentation with advanced staging is a major problem. PMID:21488473

  8. Clinical and radiological findings of a bilateral coronoid hyperplasia case

    PubMed Central

    Torenek, Kubra; Duman, Suayip Burak; Bayrakdar, Ibrahim Sevki; Miloglu, Ozkan

    2015-01-01

    Coronoid hyperplasia (CH) is an infrequent condition that can be defined as an abnormal bony elongation of histologically normal bone. Progressive and painless difficulty in opening the mouth is the main clinical finding of CH. In this case report, the clinical and radiological findings for a 23-year-old male patient with bilateral CH are presented. When plain radiographies are not sufficient for diagnosis and evaluation of the CH, cone-beam computed tomography can be used. PMID:25713499

  9. The clinical features and prognosis of rhabdomyosarcoma: follow-up studies on pediatric tumors from the Japanese Pediatric Tumor Registry 1971-1980. Part II. Committee of Malignant Tumors, Japanese Society of Pediatric Surgeons.

    PubMed

    Nakada, K

    1990-09-01

    A retrospective study was conducted on 126 patients with rhabdomyosarcoma enrolled in the Japanese Pediatric Tumor Registry between 1971 and 1980. The age of the patients ranged from less than 1 year to 15 years, and the male to female ratio was 1.3:1.0. Primary sites included the pelvis (37.3 per cent), abdomen (23.8 per cent), head and neck (21.4 per cent), thorax (9.5 per cent), extremities (6.4 per cent) and unknown (1.6 per cent). According to the staging system of the Japanese Society of Pediatric Surgeons, the extent of disease was classified into stages Ia (26.2 per cent of the total); Ib (14.6 per cent); II (12.6 per cent), III (29.1 per cent) and IV (17.5 per cent). The clinical stage was significantly correlated with survival outcome in this series (p less than 0.05). Age, sex, histology and primary site per se had no independent prognostic influence on tumor-free survival. With regard to treatment modalities, surgery was performed in 94.0 per cent of the patients, and radiotherapy at a mean dose of 37 Gy, and/or multi-agent chemotherapy in 41.7 per cent and 80.0 per cent, respectively. The patients who underwent total excision had a better survival outcome than those who did not (p less than 0.05). Combination chemotherapy such as VAC was more commonly administered in the latter study period. The overall 2-year tumor-free survival rate (2YTFSR) significantly improved from 24.0 per cent in the former period between 1971 and 1975 to 48.7 per cent in the latter period between 1976 and 1980 (p less than 0.05). PMID:2243442

  10. Real-World Use of 3rd Line Therapy for Multiple Myeloma in Austria: An Austrian Myeloma Registry (AMR) Analysis of the Therapeutic Landscape and Clinical Outcomes prior to the Use of Next Generation Myeloma Therapeutics

    PubMed Central

    Willenbacher, Ella; Weger, Roman; Rochau, Ursula; Siebert, Uwe; Willenbacher, Wolfgang

    2016-01-01

    Objective Clinical trials demonstrate improving survival in patients with multiple myeloma (MM) after treatment. However, it is unclear whether increased survival translates to a similar benefit in a real world setting. Methods We analyzed the overall survival of 347 multiple myeloma patients in Austria by means of a national registry (AMR), focused on results from 3rd and later lines of therapy. This benchmark was chosen to define a baseline prior to the broad application of upcoming 2nd generation drugs (carfilzomib, pomalidomide). Results Projected 10 years survival for patients with MM in Austria is estimated to be 56% in patients diagnosed in between the years 2011–2014, 21% in patients with a diagnosis made between 2000–2005, and 39% in those with a diagnosis made between 2006–2010). For the same intervals a significant increase in the use of both bortezomib, lenalidomide and thalidomide—so called IMiDs (from 2005 onwards) and their simultaneous use in combination therapies (from 2010 onwards) could be shown. The use of autologous transplantation (ASCT) remained more or less constant at ~ 35% of patients in the 1st line setting over the whole period, comparing well to international practice patterns, while the use of 2nd line ASCT increased from 5.5% to 18.7% of patients. Patients in 3rd or later line treatment (n = 105), showed that even in relapsed and refractory disease median survival was 27 months with a considerable proportion of long-term survivors (~20%). Conclusion & Perspective With the expected emergence of additional active anti-myeloma compounds, we aim to assess survival in patients with relapsed and refractory MM. PMID:26937956