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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. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    PubMed Central

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  3. Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study.

    PubMed

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-11-13

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.

  4. 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.

  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

    Zeeneldin, Ahmed A; Taha, Fatma M

    2016-01-01

    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.

  6. One of a kind--the Pan African Clinical Trials Registry, a regional registry for Africa.

    PubMed

    Abrams, Amber L

    2011-01-01

    The 2004 Ministerial Summit on Health Research called on the World Health Organization to to establish a registry network with the intention of providing a single access point to identify trials. In 2007 the International Committee of Medical Journal Editors amended their support of this initiative stating that only trials registered prospectively on a member registry of the WHO's Network of Primary Registers would be published. The Pan African Clinical Trials Registry (www.pactr.org), was established in early 2007 as the AIDS, TB and Malaria (ATM) Clinical Trials Registry with the aim of piloting the concept of a registry that would cater to the specific needs of African trialists. In 2009 the ATM Registry expanded its remit to include all diseases for all regions of Africa; The Pan African Clinical Trials Registry became the first and is presently the only African member of the World Health Organization's Network of Primary Registers.

  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. 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

  9. Clinical trial registries: more international, converging efforts are needed.

    PubMed

    Pansieri, Claudia; Pandolfini, Chiara; Bonati, Maurizio

    2017-02-27

    Clinical trial registries are being increasingly acknowledged worldwide. We searched for possibly trustworthy online registries that are not already included in the International Clinical Trials Registry Platform to evaluate whether other useful trial data sources exist and whether they could potentially be consulted, since the strategy search within this platform has recently been questioned. Fifty-nine registries were initially identified, and 11 of them fit the criteria applied and were analyzed for quality and usability. Four additional, potentially reliable registries were identified that researchers could exploit in order to obtain a more global view of the issue being investigated.

  10. Database and Registry Research in Orthopaedic Surgery: Part 2: Clinical Registry Data.

    PubMed

    Pugely, Andrew J; Martin, Christopher T; Harwood, Jared; Ong, Kevin L; Bozic, Kevin J; Callaghan, John J

    2015-11-04

    The use of large-scale national databases for observational research in orthopaedic surgery has grown substantially in the last decade, and the data sets can be categorized as either administrative claims or clinical registries. Clinical registries contain secondary data on patients with a specific diagnosis or procedure. The data are typically used for patient outcome surveillance to improve patient safety and health-care quality. Registries used in orthopaedic research exist at the regional, national, and international levels, and many were designed to specifically collect outcomes relevant to orthopaedics, such as short-term surgical complications, longer-term outcomes (implant survival or reoperations), and patient-reported outcomes. Although heterogeneous, clinical registries-in contrast to claims data-typically have a more robust list of variables, with relatively precise prospective data input, management infrastructure, and reporting systems. Some weaknesses of clinical registries include a smaller number of patients, inconstant follow-up duration, and use of sampling methods that may limit generalizability. Within the U.S., national joint registry adoption has lagged international joint registries. Given the changing health-care environment, it is likely that clinical registries will provide valuable information that has the potential to influence clinical practice improvement and health-care policy in the future.

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

    PubMed

    Anazawa, Takayuki; Miyata, Hiroaki; Gotoh, Mitsukazu

    2015-02-01

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

  12. The impact of a model-based clinical regional registry for attention-deficit hyperactivity disorder.

    PubMed

    Zanetti, Michele; Cartabia, Massimo; Didoni, Anna; Fortinguerra, Filomena; Reale, Laura; Mondini, Matteo; Bonati, Maurizio

    2016-03-17

    This article describes the development and clinical impact of the Italian Regional ADHD Registry, aimed at collecting and monitoring diagnostic and therapeutic pathways of care for attention-deficit hyperactivity disorder children and adolescents, launched by the Italian Lombardy Region in June 2011. In particular, the model-based software used to run the registry and manage clinical care data acquisition and monitoring, is described. This software was developed using the PROSAFE programme, which is already used for data collection in many Italian intensive care units, as a stand-alone interface case report form. The use of the attention-deficit hyperactivity disorder regional registry led to an increase in the appropriateness of the clinical management of all patients included in the registry, proving to be an important instrument in ensuring an appropriate healthcare strategy for children and adolescents with attention-deficit/hyperactivity disorder.

  13. 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

  14. Health technology assessment in Australia: a role for clinical registries?

    PubMed

    Scott, Anna Mae

    2016-03-31

    Objective Health technology assessment (HTA) is a process of assessing evidence to inform policy decisions about public subsidy of new drugs and medical procedures. Where evidence is uncertain but the technology itself is promising, funders may recommend funding on an interim basis. It is unknown whether evidence from clinical registries is used to resolve uncertainties identified in interim-funded decisions made by Australian HTA bodies. Therefore, the present study evaluated the role of evidence from clinical registries in resolving evidence uncertainties identified by the Medical Services Advisory Committee (MSAC).Methods All HTAs considered by MSAC between 1998 and 2015 were reviewed and assessments that recommended interim funding were identified. The MSAC website was searched to identify reassessments of these recommendations and sources of evidence used to resolve the uncertainties were identified.Results Of 173 HTA reports considered by MSAC, 17 (10%) contained an interim funding recommendation. Eight recommendations cited uncertainty around safety, 15 cited uncertainty around clinical effectiveness and 13 cited uncertainty around economics (cost-effectiveness and/or budget impact). Of the 17 interim funding recommendations, 11 (65%) have been reassessed. Only two reassessments relied on clinical registry evidence to resolve evidence gaps identified at the time of the interim funding recommendation.Conclusions Clinical registries are underused as a source of evidence for resolving uncertainties around promising new health technologies in Australia. An open dialogue between stakeholders on the role of registries in this context is needed.What is known about the topic? HTA is a process of assessing the evidence to inform policy decisions about public subsidy of new health technologies (e.g. pharmaceuticals, diagnostic tests, medical procedures). Where evidence is uncertain but the technology under evaluation is promising, funders may recommend the funding of

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

    PubMed Central

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

    2016-01-01

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

  16. 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

  17. [Quality management in oncology supported by clinical cancer registries].

    PubMed

    Klinkhammer-Schalke, Monika; Gerken, Michael; Barlag, Hagen; Tillack, Anett

    2015-01-01

    Efforts in nationwide quality management for oncology have so far failed to comprehensively document all levels of care. New organizational structures such as population-based clinical cancer registries or certified organ cancer centers were supposed to solve this problem more sufficiently, but they have to be accompanied by valid trans-sectoral documentation and evaluation of clinical data. To measure feasibility and qualitative effectiveness of guideline implementation we approached this problem with a nationwide investigation from 2000 to 2011. The rate of neoadjuvant radio/chemotherapy in stage UICC II/III rectum cancer, cut-off point 80% for separating good from insufficient quality, was used as a quality indicator. The nationwide analysis indicates an increase from 45% to 70%, but only with the implementation strategy of CME. The combination of new structures, evidence-based quality indicators, organ cancer center and clinical cancer registries has shown good feasibility and seems promising.

  18. 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

  19. 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

  20. Standardized Cardiovascular Data for Clinical Research, Registries, and Patient Care

    PubMed Central

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

    2013-01-01

    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. Nevertheless 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 two major technical standards organizations in healthcare, the Clinical Data Interchange Standards Consortium and Health Level 7 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. PMID

  1. A clinical registry of dementia based on the principle of epidemiological surveillance

    PubMed Central

    Garre-Olmo, Josep; Flaqué, Margarita; Gich, Jordi; Pulido, Teresa Osuna; Turbau, Josefina; Vallmajo, Natalia; Viñas, Marta; López-Pousa, Secundí

    2009-01-01

    Background Traditional epidemiological studies do not allow elucidating the reality of referral and diagnosis patterns of dementia in routine clinical practice within a defined territory. This information is useful and necessary in order to plan and allocate healthcare resources. This paper presents the results from a dementia case registry based on epidemiological surveillance fundamentals. Methods Standardised registry of dementia diagnoses made in 2007 by specialised care centres in the Health Region of Girona (RSG) (Spain), which encompasses an area of 5,517 sq. km and a reference population of 690,207 inhabitants. Results 577 cases of dementia were registered, of which 60.7% corresponded to cases of Alzheimer's disease. Presenile dementia accounted for 9.3% of the cases. Mean time between the onset of symptoms and clinical diagnosis was 2.4 years and the severity of the dementia was mild in 60.7% of the cases. High blood pressure, a family history of dementia, dislipidemia, and a past history of depression were the most common conditions prior to the onset of the disease (>20%). Conclusion The ReDeGi is a viable epidemiological surveillance device that provides information about the clinical and demographic characteristics of patients diagnosed with dementia in a defined geographical area. PMID:19175921

  2. Registries as Tools for Clinical Excellence and the Development of the Pelvic Floor Disorders Registry.

    PubMed

    Weber LeBrun, Emily E

    2016-03-01

    Surgical device innovation has been less regulated than drug development, allowing integration of unproven techniques and materials into standard practice. Successful device registries gather information on patient outcomes and can provide postmarket surveillance of new technologies and allow comparison with currently established treatments or devices. The Pelvic Floor Disorders Registry was developed in collaboration with the Food and Drug Administration, device manufacturers, and other stakeholders to serve as a platform for industry-sponsored postmarket device surveillance, investigator-initiated research, and quality and effectiveness benchmarking, all designed to improve the care of women with pelvic floor disorders.

  3. Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry

    PubMed Central

    Gaies, Michael; Donohue, Janet E.; Willis, Gina M.; Kennedy, Andrea T.; Butcher, John; Scheurer, Mark A.; Alten, Jeffrey A.; Gaynor, J. William; Schuette, Jennifer J.; Cooper, David S.; Jacobs, Jeffrey P.; Pasquali, Sara K.; Tabbutt, Sarah

    2015-01-01

    Background Clinical databases in congenital and paediatric cardiac care provide a foundation for quality improvement, research, policy evaluations and public reporting. Structured audits verifying data integrity allow database users to be confident in these endeavours. We report on the initial audit of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry. Materials and methods Participants reviewed the entire registry to determine key fields for audit, and defined major and minor discrepancies for the audited variables. In-person audits at the eight initial participating centres were conducted during a 12-month period. The data coordinating centre randomly selected intensive care encounters for review at each site. The audit consisted of source data verification and blinded chart abstraction, comparing findings by the auditors with those entered in the database. We also assessed completeness and timeliness of case submission. Quantitative evaluation of completeness, accuracy, and timeliness of case submission is reported. Results We audited 434 encounters and 29,476 data fields. The aggregate overall accuracy was 99.1%, and the major discrepancy rate was 0.62%. Across hospitals, the overall accuracy ranged from 96.3 to 99.5%, and the major discrepancy rate ranged from 0.3 to 0.9%; seven of the eight hospitals submitted >90% of cases within 1 month of hospital discharge. There was no evidence for selective case omission. Conclusions Based on a rigorous audit process, data submitted to the PC4 clinical registry appear complete, accurate, and timely. The collaborative will maintain ongoing efforts to verify the integrity of the data to promote science that advances quality improvement efforts. PMID:26358157

  4. Stroke Trials Registry

    MedlinePlus

    ... News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions Sponsors ... a clinical trial near you Welcome to the Stroke Trials Registry Our registry of clinical trials in ...

  5. Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

    PubMed Central

    Moja, Lorenzo P; Moschetti, Ivan; Nurbhai, Munira; Compagnoni, Anna; Liberati, Alessandro; Grimshaw, Jeremy M; Chan, An-Wen; Dickersin, Kay; Krleza-Jeric, Karmela; Moher, David; Sim, Ida; Volmink, Jimmy

    2009-01-01

    Background Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. Methods A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries. Results Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005–February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% – 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% – 33.5%) completed the key clinical and methodological data fields. Conclusion While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications. PMID:19624821

  6. Interoperability in clinical research: from metadata registries to semantically annotated CDISC ODM.

    PubMed

    Bruland, Philipp; Breil, Bernhard; Fritz, Fleur; Dugas, Martin

    2012-01-01

    Planning case report forms for data capture in clinical trials is a labor-insensitive and not formalized process. These CRFs are often neither standardized nor using defined data elements. Metadata registries as the NCI caDSR provide the capability to create forms based on common data elements. However, an exchange of these forms into clinical trial management systems through a standardized format like CDISC ODM is currently not offered. Thus, our objectives were to develop a mapping model between NCI forms and ODM. We analyzed 3012 NCI forms and included common data elements regarding their frequency and uniqueness. In this paper, we have created a mapping model between both formats and identified limitations in the conversion process: Semantic codes requested from the caDSR registry did not allow a proper mapping to ODM items and information like the number of module repetitions got lost. Summarized, it can be stated that our mapping model is feasible. However, mapping of semantic concepts in ODM needs to be specified more precisely.

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

    PubMed Central

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

    2016-01-01

    Objectives While national quality registries (NQRs) are suggested to provide opportunities for systematic follow-up and learning opportunities, and thus clinical improvements, features in registries and contexts triggering such processes are not fully known. This study focuses on one of the world's largest stroke registries, the Swedish NQR Riksstroke, investigating what aspects of the registry and healthcare organisations facilitate or hinder the use of registry data in clinical quality improvement. Methods Following particular qualitative studies, we performed a quantitative survey in an exploratory sequential design. The survey, including 50 items on context, processes and the registry, was sent to managers, physicians and nurses engaged in Riksstroke in all 72 Swedish stroke units. Altogether, 242 individuals were presented with the survey; 163 responded, representing all but two units. Data were analysed descriptively and through multiple linear regression. Results A majority (88%) considered Riksstroke data to facilitate detection of stroke care improvement needs and acknowledged that their data motivated quality improvements (78%). The use of Riksstroke for quality improvement initiatives was associated (R2=0.76) with ‘Colleagues’ call for local results’ (p=<0.001), ‘Management Request of Registry data’ (p=<0.001), and it was said to be ‘Simple to explain the results to colleagues’ (p=0.02). Using stepwise regression, ‘Colleagues’ call for local results’ was identified as the most influential factor. Yet, while 73% reported that managers request registry data, only 39% reported that their colleagues call for the unit's Riksstroke results. Conclusions While an NQR like Riksstroke demonstrates improvement needs and motivates stakeholders to make progress, local stroke care staff and managers need to engage to keep the momentum going in terms of applying registry data when planning, performing and evaluating quality initiatives. PMID

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

    PubMed Central

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

    2017-01-01

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

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. Veterans Health Administration multiple sclerosis surveillance registry: The problem of case-finding from administrative databases.

    PubMed

    Culpepper, William J; Ehrmantraut, Mary; Wallin, Mitchell T; Flannery, Kathleen; Bradham, Douglas D

    2006-01-01

    Establishment of a national multiple sclerosis (MS) surveillance registry (MSSR) is a primary goal of the Department of Veterans Affairs (VA) MS Center of Excellence. The initial query of Veterans Health Administration (VHA) databases identified 25,712 patients (labeled "VHA MS User Cohort") from fiscal years 1998 to 2002 based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code; service-connection for MS; and/or disease-modifying agent (DMA) use. Because of ICD-9-CM limitations, the initial query was overinclusive and resulted in many non-MS cases. Thus, we needed a more rigorous case-finding method. Our gold standard was chart review of the Computerized Patient Record System for the mid-Atlantic VA medical centers. After chart review, we classified patients as not having MS or having MS/possible MS. We also applied a statistical algorithm to classify cases based on service-connection for MS, DMA use, and/or at least one healthcare encounter a year with MS coded as the primary diagnosis. We completed two analyses with kappa coefficient and sensitivity analysis. The first analysis (efficacy) was limited to cases with a definitive classification based on chart review (n = 600). The kappa coefficient was 0.85, sensitivity was 0.93, and specificity was 0.92. The second analysis (effectiveness) included unknown cases that were classified as MS/possible MS (N = 682). The kappa coefficient was 0.82, sensitivity was 0.93, and specificity was 0.90. These findings suggest that the database algorithm reliably eliminated non-MS cases from the initial MSSR population and is a reasonable case-finding method at this intermediate stage of MSSR development.

  15. 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

  16. One year clinical outcomes of renal artery stenting: the results of ODORI Registry.

    PubMed

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

    2010-06-01

    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 micromol/l at baseline to 205 and 209 micromol/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.

  17. 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.

  18. 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

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

    PubMed

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

    2015-07-01

    The use of automatic registry systems for patient dose in digital mammography allows clinical audit and patient dose analysis of the whole sample of individual mammography exposures while fulfilling the requirements of the European Directives and other international recommendations. Further parameters associated with radiation exposure (tube voltage, X-ray tube output and HVL values for different kVp and target/filter combinations, breast compression, etc.) should be periodically verified and used to evaluate patient doses. This study presents an experience in routine clinical practice for mammography using automatic systems.

  20. Multi-Institutional Registry for Prostate Cancer Radiosurgery: A Prospective Observational Clinical Trial

    PubMed Central

    Freeman, Debra; Dickerson, Gregg; Perman, Mark

    2015-01-01

    Objective: To report on the design, methodology, and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery. Methods: The Registry for Prostate Cancer Radiosurgery (RPCR) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery (SBRT) for the treatment of clinically localized prostate cancer. Men with prostate cancer were asked to voluntarily participate in the registry. Demographic, baseline medical, and treatment-related data were collected and stored electronically in a Health Insurance Portability and Accountability Act-compliant database, maintained by Advertek, Inc. Enrolled men were asked to complete short, multiple choice questionnaires regarding their bowel, bladder, and sexual function. Patient-reported outcome forms were collected at baseline and at regular intervals (every 3–6 months) following treatment. Serial prostate-specific antigen measurements were obtained at each visit and included in the collected data. Results: From July 2010 to July 2013, nearly 2000 men from 45 participating sites were enrolled in the registry. The majority (86%) received radiosurgery as monotherapy. At 2 years follow-up, biochemical disease-free survival was 92%. No Grade 3 late urinary toxicity was reported. One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding). Erectile function was preserved in 80% of men <70 years old. Overall compliance with data entry was 64%. Conclusion: Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer. The RPCR represents the collective experience of multiple institutions, including community-based cancer centers, with outcome results in keeping with published, prospective trials of prostate SBRT. PMID:25657929

  1. Clinical Outcomes of Splenectomy in Children: Report of the Splenectomy in Congenital Hemolytic Anemia (SICHA) Registry

    PubMed Central

    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

    2014-01-01

    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 2005–2013 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 gm/dl, 52 week 12.8 ± 1.6 gm/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

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

    PubMed Central

    Ito, Tatsuya

    2016-01-01

    Background Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs). In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs. Aims The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries. Methods Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data. Results New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants. Conclusion There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan. PMID:26848574

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

    PubMed Central

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

    2009-01-01

    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 μmol/l at baseline to 205 and 209 μmol/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. PMID:19908091

  4. 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

  5. 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.

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

    PubMed

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

    2014-06-01

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

  7. 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.

  8. Endocardial Lead Extraction in the Polish Registryclinical practice versus current Heart Rhythm Society consensus

    PubMed Central

    Kutarski, Andrzej; Mitkowski, Przemysław; Przybylski, Andrzej; Lewek, Joanna; Małecka, Barbara; Smukowski, Tomasz; Maciąg, Aleksander; Śmigielski, Janusz

    2013-01-01

    Introduction Over the last 10 years, there has been an increasing number of patients with pacemaker (PM) and cardioverter-defibrillator (ICD). This study is a retrospective analysis of indications for endocardial pacemaker and ICD lead extractions between 2003 and 2009 based on the experience of three Polish Referral Lead Extraction Centers. Material and methods Since 2003, the authors have consecutively retrospectively collected all cases and entered the information in the database. All patients which had indication for lead extraction according to Heart Rhythm Society Guidelines were included to final analyze. Between 2003 and 2005, the data were analyzed together. Since 2006, data have been collected and analyzed annually. Results In each year, a significant increase in lead extraction was observed. The main indications for LE were infections in 52.4% of patients. Nonfunctioning lead extraction constituted the second group of indications for LE in 29.7% of patients. During the registry period, the percentage of class I indications decreased from 80% in 2006 to only 47% in 2009. On the other hand, increasingly more leads were removed because of class 2, especially class 2b. In 2009, 40% of leads were extracted due to class 2b. Conclusions Polish Registry of Endocardial Lead Extraction 2003-2009, shows an increasing frequency of lead extraction. The main indication for LE is infection: systemic and pocket. An increase in class 2, especially 2b, LE indication in every center during the study period was found. PMID:24904658

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

    PubMed

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

    2012-01-01

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

  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. Design, Development and Deployment of a Diabetes Research Registry to Facilitate Recruitment in Clinical Research

    PubMed Central

    Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

    2016-01-01

    Background and Aim A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). Method A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. Results After 5 years, the DRR has over 5,000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. Conclusion The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. PMID:26825022

  12. 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.

  13. Clinical and Epidemiological Characteristics of Pituitary Tumours using a Web-based Pituitary Tumour Registry in Oman

    PubMed Central

    Al-Futaisi, Abdullah; Saif, Al-Yaarubi; Al-Zakwani, Ibrahim; Al-Qassabi, Salim; Al-Riyami, Shaden; Wali, Yasser

    2007-01-01

    Objective: From a recently instituted web-based pituitary tumour registry at Sultan Qaboos University Hospital, Oman, this study explores the results of comprehensive clinical evaluation, hormonal levels, radiological evidence of pituitary mass lesion using magnetic resonance (MRI) and the different treatment modalities. Methods: All patients who were diagnosed with pituitary mass tumours in our tertiary care endocrinology clinic between January 1998 and February 2006 were registered in the Oman pituitary tumour registry. Two physicians performed hospital chart review and data entry. Results: A total of 160 entries were made into the pituitary tumour registry. The overall mean age of the cohort was 32 ±12 years (age range 8–73 years). The majority of registrations were female (n=114; 71%). There were 81 patients with non-functioning adenomas (50.6%), 59 with prolactinoma (36.9%) eight with acromegaly (5%), seven with craniopharyngioma (4.4%), four with Cushing’s disease (2.5%) and one with sarcoidosis (0.6%). Sub-group analyses were done only for the subjects with the 3 most prevalent pituitary tumours (non-functioning adenomas, prolactinomas, and acromegaly). The most prevalent symptoms are amenorrhea-galactorrhea (n=55; 37%), headache (n=31; 21%) and fatigue (n=23; 16%). The most common treatment modality was medical (n=58; 39%), followed by observation (n=56; 38%), surgery (n=31; 21%) and surgery plus medical (n=3; 2%). None of the patients in this registry are recorded to have died. Conclusion: To our knowledge, this is the first pituitary tumour registry in the Arabian Gulf countries using a web-based programme. This tumour registry will enable us to characterize clinical and the epidemiological features of pituitary tumours in the Sultanate of Oman. PMID:21654941

  14. 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

  15. 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

  16. A model for the design and implementation of a participant recruitment registry for clinical studies of older adults

    PubMed Central

    Dowling, N Maritza; Olson, Nevin; Mish, Thomas; Kaprakattu, Preethy; Gleason, Carey

    2012-01-01

    Background The identification and enlistment of suitable participants into clinical studies is often challenging, requiring a large commitment of time and staff resources. The recruitment and retention of populations typically underrepresented in research present additional challenges to enrollment of sufficient numbers of participants in clinical studies. Inadequate participation may undermine the pace and direction of new treatment discoveries. Purpose Registries of potential research participants are powerful tools to support research by providing a framework to streamline screening and recruitment and to maintain a communication history with potential research participants. The authors present a model for the development and implementation of a web-based database system to support recruitment, enrollment, and retention of potential study participants in close alignment with the goals of the Wisconsin Alzheimer’s Disease Research Center (ADRC). Methods The required data elements and major information domains for the registry were identified using a structured problem-solving and system design approach and the collaboration of a multidisciplinary team of stakeholders. The system performance, utility, and usability were assessed through multiple iterations with the users. Results The process-oriented approach culminated in a multifaceted tool that combined contact management and potential research participant registration to assist with the challenges of recruitment and retention in clinical research. A unique feature of the registry design model was its contact management capabilities for efficient tracking of all contacts with registrants. Limitations We have focused on the development and implementation of a system for the recruitment of older adults with specific cognitive and medical characteristics. However, our procedures for identifying data needs and database system utility and functionality can be transferred easily to other populations and settings

  17. 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…

  18. PS2-40: Using Automation to Add Electronic Clinical Data to a Research Patient Registry

    PubMed Central

    Fuller, Sharon; Carrell, David; Green, Beverly

    2013-01-01

    Background/Aims Clinical research trials often rely on automated data systems, such as the electronic medical record to create and maintain a patient registry, to determine a participant’s progress through the study, or for analytic purposes. Data might come from a variety of sources and include such elements as procedures, lab results, hospitalization, vital status, enrollment and participant responses from survey software. An automated process for adding outside data to a study tracking database can save significant time over abstraction or manual data import processes, and can allow determination of an individual’s study status in close to real time. Methods There are a number of ways of setting up an automated import process, depending on data needs and availability. Over the course of several clinical trials, we have developed a process with the following steps, all occurring automatically on a scheduled basis: 1. A SAS program performs Extract/Transform/Load (ETL) tasks: 1a. Extract and transform the desired data from each source. 1b. Load new data into a SAS dataset for historical purposes and into a staging table in the tracking database preparatory to actual use. 1c. Generate automated emails when specific milestones occur (e.g., study end date reached or first use of a given lab test code). 2. Another SAS program checks the ETL logs and sends email about any errors occurring in the ETL process. 3. A database job calls stored procedures to insert data from the staging tables into the main study events table and send email detailing how many records were processed. 3a. If manual intervention is needed before the final data is loaded, the user can call the stored procedure once data entry is complete. 3b. A master stored procedure can call individual procedures in order (e.g., importing a positive lab result may trigger randomization). Results The ETL process described above has proven itself to be robust and adaptable in a variety of study contexts

  19. 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.

  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. 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

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

    PubMed

    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.

  3. Role of preliminary registry data in development of a clinical trial for an innovative device: a small but integral piece of a health policy initiative

    PubMed Central

    Ricci, Donald R.; de Vries, Joost; Blanc, Raphael

    2017-01-01

    ABSTRACT Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained. Evaluation of procedural and follow-up efficacy and safety data in a preliminary series of cases, chosen to simulate published data, allows the design and conduct of clinical trials that are required to verify preliminary observations, closing the loop on one aspect of modifying health policy decisions. PMID:28321285

  4. 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.

  5. 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

  6. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    PubMed Central

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  7. 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.

  8. Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry.

    PubMed

    Sweeney, Joan; Brightling, Chris E; Menzies-Gow, Andrew; Niven, Robert; Patterson, Chris C; Heaney, Liam G

    2012-08-01

    Refractory asthma represents a significant unmet clinical need. Data from a national online registry audited clinical outcome in 349 adults with refractory asthma from four UK specialist centres in the British Thoracic Society Difficult Asthma Network. At follow-up, lung function improved, with a reduction in important healthcare outcomes, specifically hospital admission, unscheduled healthcare visits and rescue courses of oral steroids. The most frequent therapeutic intervention was maintenance oral corticosteroids and most steroid sparing agents (apart from omalizumab) demonstrated minimal steroid sparing benefit. A significant unmet clinical need remains in this group, specifically a requirement for therapies which reduce systemic steroid exposure.

  9. 75 FR 38683 - Federal Acquisition Regulation; FAR Case 2008-035, Registry of Disaster Response Contractors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... Response Contractors AGENCIES: Department of Defense (DoD), General Services Administration (GSA), and... of a registry of disaster response contractors. DATES: Effective Date: August 2, 2010. FOR FURTHER..., requires the establishment and maintenance of a registry of contractors willing to perform debris...

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

    PubMed Central

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

    2015-01-01

    Background Accurate information regarding race, ethnicity, and national origins is critical for identifying disparities in the cancer burden. Objectives To examine the use of a Spanish surname list to improve the quality of race-related information obtained from rapid case ascertainment (RCA) and to estimate the accuracy of race-related information obtained from cancer registry records collected by routine reporting. Subjects . Self-reported survey responses of 3,954 participants from California enrolled in the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS). Measures Sensitivity, specificity, positive predictive value (PPV), and percent agreement. We employed logistic regression to identify predictors of under-reporting and over-reporting of a race/ethnicity. Results Use of the Spanish surname list increased the sensitivity of RCA for Latino ethnicity from 37% to 83%. Sensitivity for cancer registry records collected by routine reporting was ≥95% for Whites, Blacks, and Asians, and specificity was high for all groups (86–100%). However, patterns of misclassification by race/ethnicity were found that could lead to biased cancer statistics for specific race/ethnicities. Discordance between self- and registry-reported race/ethnicity was more likely for women, Latinos, and Asians. Conclusion Methods to improve race and ethnicity data, such as using Spanish surnames in RCA and instituting data collection guidelines for hospitals, are needed to ensure minorities are accurately represented in clinical and epidemiological research. PMID:23938598

  11. 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

  12. Arthroplasty Registries, Patient Safety and Outlier Surgeons: the case for change.

    PubMed

    Cobb, Justin

    2015-12-01

    Joint registries were created to follow-up on the failure rate of different types of joint replacements. Since the only end-point is revision to another implant the registries are missing out today on essential data informing us about patients' outcome. Ideally, a modern and complete registry should capture 3 strata of data: 1) patient reported outcomes including both function and activity levels from before and after surgery, 2) morbidity including infection rates and mortality related to surgery, and 3) the cost of consecutive revision surgery. A modern knee specialist offering conservative solutions for defined problems enabling return to higher level activities may be reported as an outlier surgeon by registries today.

  13. Clinical Trial Registries Are of Minimal Use for Identifying Selective Outcome and Analysis Reporting

    ERIC Educational Resources Information Center

    Norris, Susan L.; Holmer, Haley K.; Fu, Rongwei; Ogden, Lauren A.; Viswanathan, Meera S.; Abou-Setta, Ahmed M.

    2014-01-01

    Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting: We selected one "index outcome" for each of three comparative effectiveness reviews…

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

    PubMed

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

    2015-11-01

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

  15. Chinese SLE Treatment and Research group (CSTAR) registry: I. Major clinical characteristics of Chinese patients with systemic lupus erythematosus.

    PubMed

    Li, M; Zhang, W; Leng, X; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Zhang, F; Zhao, Y; Zeng, X

    2013-10-01

    The Chinese systemic lupus erythematosus (SLE) treatment and research group (CSTAR) provides major clinical characteristics of SLE in China and establishes a platform to provide resources for future basic and clinical studies. CSTAR originated as a multicentre, consecutive, and prospective design. The data were collected online from 104 rheumatology centers, which covered 30 provinces in China. The registered patients were required to meet four or more of the American College of Rheumatology (ACR) criteria for the classification of SLE. All CSTAR centers use the same protocol-directed methods to provide uniform evaluations, which included demographic data, clinical features, laboratory examinations, and disease activity evaluations. The patient samples, including DNA samples and sera, were also collected for further quality controls and additional studies. Preliminary analysis from 2104 baseline evaluations was available for this analysis. Of 1914 female and 190 male patients (F:M=10.1), the mean age at onset was 29.2 y with confirmed diagnosis one year later at the age of 30.3 y. Eighty four (4.2%) of 2002 patients had a family history of rheumatic diseases, including 34 (1.7%) cases with SLE. In addition, one hundred and seven (5.2%) abnormal pregnancies were recorded among 2026 experiences. The characteristics of the CSTAR cohort were compared to similarly sized cohorts from other studies. We found that 56.1% of patients presented with concurrent hematological disorders compared to only 18.2% of European patients. Moreover, 47.4% of patients presented with nephropathy compared to 27.9% of European patients. Conversely, neurological manifestations were only seen in 4.8% of Chinese SLE patients compared to 19.4% of European patients, 12.1% of U.S. patients, 22.8% of Malaysian patients and 26.4% of Latin Americans. Pulmonary arterial hypertension and interstitial lung diseases were complications identified in 3.8% and 4.2% of Chinese lupus patients, respectively

  16. The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke

    PubMed Central

    Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

    2016-01-01

    Background The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. Materials and methods The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Results Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. Conclusion The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients. PMID:27942205

  17. Gorham's disease: clinical case.

    PubMed

    Sá, Pedro; Marques, Pedro; Oliveira, Carolina; Rodrigues, André Sá; Amorim, Nelson; Pinto, Rui

    2015-01-01

    Gorham's disease, also known as idiopathic massive osteolysis, is a rare pathological condition characterized by vascular proliferation that results in destruction and reabsorption of the bone matrix, of unknown etiology. It was first described by Jackson in 1838, but it was Gorham and Stout, in 1955, who defined this disease as a specific entity. It has variable clinical presentation and generally has progressive behavior. Controversy continues regarding the treatment and there is no standard treatment. This pathological condition generally presents a favorable prognosis. Here, a case of Gorham's disease with involvement of the left hip is presented, in a male patient without relevant antecedents.

  18. 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.

  19. [German resuscitation registry : science and resuscitation research].

    PubMed

    Gräsner, J-T; Seewald, S; Bohn, A; Fischer, M; Messelken, M; Jantzen, T; Wnent, J

    2014-06-01

    Sudden death due to cardiac arrest represents one of the greatest challenges facing modern medicine, not only because of the massive number of cases involved but also because of its tremendous social and economic impact. For many years, the magic figure of 1 per 1000 inhabitants per year was generally accepted as an estimate of the annual incidence of sudden death in the industrialized world, with a survival rate of 6 %. This estimate was based on large numbers of published reports of local, regional, national and multinational experience in the management of cardiac arrest. Measuring the global incidence of cardiac arrest is challenging as many different definitions of patient populations are used. Randomized controlled trials (RCT) provide insights into the value of specific treatments or treatment strategies in a well-defined section of a population. Registries do not compete with clinical studies, but represent a useful supplement to them. Surveys and registries provide insights into the ways in which scientific findings and guidelines are being implemented in clinical practice. However, as with clinical studies, comprehensive preparations are needed in order to establish a registry. This is all the more decisive because not all of the questions that may arise are known at the time when the registry is established. The German resuscitation registry started in May 2007 and currently more than 230 paramedic services and hospitals take part. More than 45,000 cases of out-of-hospital cardiac arrest and in-hospital cardiac arrest are included. With this background the German resuscitation registry is one of the largest databases in emergency medicine in Germany. After 5 years of running the preclinical care dataset was revised in 2012. Data variables that reflect current or new treatment were added to the registry. The postresuscitation basic care and telephone cardiopulmonary resuscitation (CPR) datasets were developed in 2012 and 2013 as well. The German

  20. [Role of cancer registries].

    PubMed

    Schaffer, P

    1995-05-01

    The first Cancer Registries were created in 1975 in France. Their ulterior development and their scientific production have been furthered by the apparition from 1986 under the aegis of the Health Ministry and of the INSERM, of a National Population Registry Committee. Cancer Registries have seriously contributed to a better knowledge of the cancer problem in our country and to describe the french specificities, in particular the importance of the mouth and pharynx cancers. They insure both a monitoring and an alert role; they also contribute to the medical supervision of the Chernobyl accident effects. French registries play a very active role concerning clinical research. They participate to many European studies of health care evaluation. In other respects, many etiological studies have been realized about professional risks of cancer, risks linked with nutritional habits, and on the etiologic role of the Tamoxifen. Finally, certain registries have created DNA banks. If nowadays their role in health planning remains modest, they very actively contribute in evaluating screening actions of breast, cervix and large bowel cancers. They also attracted the attention of Health Authorities on the cervix cancer screening's incoherencies. They evaluate the pilot project of the breast cancer and the registry of the Côte d'Or country evaluates the efficacity of a randomized colo rectal mass screening study. The main difficulties met by the registries are linked with the development of laws protecting more and more the individual freedoms, making it harder and harder the registration exhaustive character.

  1. The Danish Stroke Registry

    PubMed Central

    Johnsen, Søren Paaske; Ingeman, Annette; Hundborg, Heidi Holmager; Schaarup, Susanne Zielke; Gyllenborg, Jesper

    2016-01-01

    Aim of database The aim of the Danish Stroke Registry is to monitor and improve the quality of care among all patients with acute stroke and transient ischemic attack (TIA) treated at Danish hospitals. Study population All patients with acute stroke (from 2003) or TIA (from 2013) treated at Danish hospitals. Reporting is mandatory by law for all hospital departments treating these patients. The registry included >130,000 events by the end of 2014, including 10,822 strokes and 4,227 TIAs registered in 2014. Main variables The registry holds prospectively collected data on key processes of care, mainly covering the early phase after stroke, including data on time of delivery of the processes and the eligibility of the individual patients for each process. The data are used for assessing 18 process indicators reflecting recommendations in the national clinical guidelines for patients with acute stroke and TIA. Patient outcomes are currently monitored using 30-day mortality, unplanned readmission, and for patients receiving revascularization therapy, also functional level at 3 months poststroke. Descriptive data Sociodemographic, clinical, and lifestyle factors with potential prognostic impact are registered. Conclusion The Danish Stroke Registry is a well-established clinical registry which plays a key role for monitoring and improving stroke and TIA care in Denmark. In addition, the registry is increasingly used for research. PMID:27843349

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

    PubMed

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

    2017-03-01

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

  3. 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

  4. 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

  5. Genetic and Clinical Characteristics of Korean Patients with Isolated Hypoparathyroidism: From the Korean Hypopara Registry Study

    PubMed Central

    Park, So Young; Eom, Young Sil; Choi, Byoungho; Yi, Hyon-Seung; Yu, Seung-Hee; Lee, Kiyoung; Jin, Hyun-Seok; Chung, Yoon-Sok; Jung, Tae Sik

    2013-01-01

    Isolated hypoparathyroidism (IH) shows heterogeneous phenotypes and can be caused by defects in a variety of genes. The goal of our study was to determine the clinical features and to analyze gene mutations in a large cohort of Korean patients with sporadic or familial IH. We recruited 23 patients. They showed a broad range of onset age and various values of biochemical data. Whole exome sequencing was performed on two affected cases and one unaffected individual in a family. All coding exons and exon-intron borders of GCMB, CASR, and prepro-PTH were sequenced using PCR-amplified DNA. In one family who underwent the whole exome sequencing analysis, approximately 300 single nucleotide changes emerged as candidates for genetic alteration. Among them, we identified a functional mutation in exon 2 of GCMB (C106R) in two affected cases. Besides, heterozygous gain-of-function mutations in the CASR gene were found in other subjects; D410E and P221L. We also found one single nucleotide polymorphism (SNP) in the prepro-PTH gene, five SNPs in the CASR gene, and four SNPs in the GCMB gene. The current study represents a variety of biochemical phenotypes in IH patients with the molecular genetic diagnosis of IH. PMID:24133354

  6. [Hungarian Hypertension Registry].

    PubMed

    Kiss, István; Kékes, Ede

    2014-05-11

    Today, hypertension is considered endemic throughout the world. The number of individuals with high blood pressure and the increasing risk, morbidity and mortality caused by hypertension despite modern therapy do not decrease sufficiently. Hypertension has become a public health issue. Prevention and effective care require integrated datasets about many features, clinical presentation and therapy of patients with hypertension. The lack of this database in Hungary prompted the development of the registry which could help to provide population-based data for analysis. Data collection and processing was initiated by the Hungarian Society of Hypertension in 2002. Data recording into the Hungarian Hypertension Registry was performed four times (2002, 2005, 2007, 2011) and the registry currently contains data obtained from 108,473 patients. Analysis of these data indicates that 80% of the patients belong to the high or very high cardiovascular risk group. The registry provides data on cardiovascular risk of the hypertensive populations and the effectiveness of antihypertensive therapy in Hungary. Based on international experience and preliminary analysis of data from the Hungarian Hypertension Registry, establishment of hypertension registry may support the effectiveness of public health programs. A further step would be needed for proper data management control and the application of professional principles of evidence-based guidelines in the everyday practice.

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

    PubMed Central

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

    2017-01-01

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

  8. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry

    PubMed Central

    Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

    2016-01-01

    Objective Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. Methods A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. Results A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Conclusions Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. PMID:27881517

  9. Supplementary management of functional, hepatic damage with Liverubin (pharma-standard Silymarin). A 3-month registry.

    PubMed

    Pellegrini, L; Belcaro, G; Dugall, M; Hu, S; Gizzi, G; Corsi, M; Hosoi, M; Luzzi, R; Feragalli, B; Cotellese, R

    2015-10-08

    Mild, temporary hepatic failure (MTHF) is a common clinical problem; in case of repeated episodes MTHF may cause chronic liver impairment. This registry has evaluated MTHF in subjects using Liverubin (standardized Silymarin) for 8 weeks.

  10. Unravelling the myotonic dystrophy type 1 clinical spectrum: A systematic registry-based study with implications for disease classification.

    PubMed

    De Antonio, M; Dogan, C; Hamroun, D; Mati, M; Zerrouki, S; Eymard, B; Katsahian, S; Bassez, G

    2016-10-01

    The broad clinical spectrum of myotonic dystrophy type 1 (DM1) creates particular challenges for both medical care and design of clinical trials. Clinical onset spans a continuum from birth to late adulthood, with symptoms that are highly variable in both severity and nature of the affected organ systems. In the literature, this complex phenotype is divided into three grades (mild, classic, and severe) and four or five main clinical categories (congenital, infantile/juvenile, adult-onset and late-onset forms), according to symptom severity and age of onset, respectively. However, these classifications are still under discussion with no consensus thus far. While some specific clinical features have been primarily reported in some forms of the disease, there are no clear distinctions. As a consequence, no modifications in the management of healthcare or the design of clinical studies have been proposed based on the clinical form of DM1. The present study has used the DM-Scope registry to assess, in a large cohort of DM1 patients, the robustness of a classification divided into five clinical forms. Our main aim was to describe the disease spectrum and investigate features of each clinical form. The five subtypes were compared by distribution of CTG expansion size, and the occurrence and onset of the main symptoms of DM1. Analyses validated the relevance of a five-grade model for DM1 classification. Patients were classified as: congenital (n=93, 4.5%); infantile (n=303, 14.8%); juvenile (n=628, 30.7%); adult (n=694, 34.0%); and late-onset (n=326, 15.9%). Our data show that the assumption of a continuum from congenital to the late-onset form is valid, and also highlights disease features specific to individual clinical forms of DM1 in terms of symptom occurrence and chronology throughout the disease course. These results support the use of the five-grade model for disease classification, and the distinct clinical profiles suggest that age of onset and clinical form may

  11. West Virginia University Pediatric Stroke Registry: Clinical Description and Risk Factors Identification in Patients Living in a Rural Area

    PubMed Central

    Pergami, P.; Thayapararajah, S. W.; Seemaladinne, N.

    2015-01-01

    We develop an institutional pediatric stroke database at West Virginia University to support the classification and description of clinical and radiographic characteristics of children with stroke in West Virginia. Methods A custom-made database was developed using Microsoft Access to include specific query forms for data retrieval. Data were collected retrospectively from electronic medical record of pediatric patients with ischemic and hemorrhagic stroke, with emphasis on clinical presentation, risk factors and neuroimaging studies, between 2000 and 2012. Results In the children group cardiac disease was over-represented over vasculitis and hypercoagulable disorders. Neonates diagnosed with acute stroke were almost exclusively very sick or symptomatic patents. Conclusion Paediatric stroke in rural areas might be under-detected, particularly in neonates or in patients with mild or transient neurological signs. Patients with very high risk for stroke were over-represented in our registry; this support the need for increased awareness about paediatric stroke among practitioners and emergency room doctors in rural locations. PMID:25049311

  12. 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

  13. Lessons learned from the Pediatric Cardiomyopathy Registry (PCMR) Study Group.

    PubMed

    Wilkinson, James D; Westphal, Joslyn A; Bansal, Neha; Czachor, Jason D; Razoky, Hiedy; Lipshultz, Steven E

    2015-08-01

    Cardiomyopathy is a rare disorder of the heart muscle, affecting 1.13 cases per 100,000 children, from birth to 18 years of age. Cardiomyopathy is the leading cause of heart transplantation in children over the age of 1. The Pediatric Cardiomyopathy Registry funded in 1994 by the National Heart, Lung, and Blood Institute was established to examine the epidemiology of the disease in children below 18 years of age. More than 3500 children across the United States and Canada have been enrolled in the Pediatric Cardiomyopathy Registry, which has followed-up these patients until death, heart transplantation, or loss to follow-up. The Pediatric Cardiomyopathy Registry has provided the most in-depth illustration of this disease regarding its aetiology, clinical course, associated risk factors, and patient outcomes. Data from the registry have helped in guiding the clinical management of cardiomyopathy in children under 18 years of age; however, questions still remain regarding the most clinically effective diagnostic and treatment approaches for these patients. Future directions of the registry include the use of next-generation whole-exome sequencing and cardiac biomarkers to identify aetiology-specific treatments and improve diagnostic strategies. This article provides a brief synopsis of the work carried out by the Pediatric Cardiomyopathy Registry since its inception, including the current knowledge on the aetiologies, outcomes, and treatments of cardiomyopathy in children.

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

    PubMed Central

    Baser, M E

    1992-01-01

    OBJECTIVES. Since 1981, 15 states have established registries for surveillance of adult lead absorption, primarily based on reports of elevated blood lead levels from clinical laboratories. I review the status of the registries and recommend steps for further development. METHODS. Companies reported to the New York registry are compared with those cited by the Occupational Safety and Health Administration (OSHA). I present data on US workers and plants with potential lead exposures and blood tests, as well as review registries' reporting requirements. RESULTS. Registries identify many companies not cited by the Occupational Safety and Health Administration, but underreporting occurs because (1) reporting is usually not required from laboratories outside the state, (2) most registries use a blood lead reporting level of 1.21 mumol/L, which excludes many exposed workers, and (3) many companies with potential exposures do not have routine monitoring programs. CONCLUSIONS. Registries' reporting requirements and procedures should be standardized, including a blood lead reporting level of 0.72 mumol/L. Elevated blood lead levels should be a reportable condition nationwide, and a comprehensive national surveillance system should be established: clinical laboratories should be required to report cases to those states with lead registries or directly to the national adult lead registry. PMID:1636831

  15. Construction and management of ARDS/sepsis registry with REDCap

    PubMed Central

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

    2014-01-01

    Objective The study aimed to construct and manage an acute respiratory distress syndrome (ARDS)/sepsis registry that can be used for data warehousing and clinical research. Methods The workflow methodology and software solution of research electronic data capture (REDCap) was used to construct the ARDS/sepsis registry. Clinical data from ARDS and sepsis patients registered to the intensive care unit (ICU) of our hospital formed the registry. These data were converted to the electronic case report form (eCRF) format used in REDCap by trained medical staff. Data validation, quality control, and database management were conducted to ensure data integrity. Results The clinical data of 67 patients registered to the ICU between June 2013 and December 2013 were analyzed. Of the 67 patients, 45 (67.2%) were classified as sepsis, 14 (20.9%) as ARDS, and eight (11.9%) as sepsis-associated ARDS. The patients’ information, comprising demographic characteristics, medical history, clinical interventions, daily assessment, clinical outcome, and follow-up data, was properly managed and safely stored in the ARDS/sepsis registry. Data efficiency was guaranteed by performing data collection and data entry twice weekly and every two weeks, respectively. Conclusions The ARDS/sepsis database that we constructed and manage with REDCap in the ICU can provide a solid foundation for translational research on the clinical data of interest, and a model for development of other medical registries in the future. PMID:25276372

  16. 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.

  17. Detecting Dissonance in Clinical and Research Workflow for Translational Psychiatric Registries

    PubMed Central

    Cofiel, Luciana; Bassi, Débora U.; Ray, Ryan Kumar; Pietrobon, Ricardo; Brentani, Helena

    2013-01-01

    Background The interplay between the workflow for clinical tasks and research data collection is often overlooked, ultimately making it ineffective. Questions/purposes To the best of our knowledge, no previous studies have developed standards that allow for the comparison of workflow models derived from clinical and research tasks toward the improvement of data collection processes Methods In this study we used the term dissonance for the occurrences where there was a discord between clinical and research workflows. We developed workflow models for a translational research study in psychiatry and the clinic where its data collection was carried out. After identifying points of dissonance between clinical and research models we derived a corresponding classification system that ultimately enabled us to re-engineer the data collection workflow. We considered (1) the number of patients approached for enrollment and (2) the number of patients enrolled in the study as indicators of efficiency in research workflow. We also recorded the number of dissonances before and after the workflow modification. Results We identified 22 episodes of dissonance across 6 dissonance categories: actor, communication, information, artifact, time, and space. We were able to eliminate 18 episodes of dissonance and increase the number of patients approached and enrolled in research study trough workflow modification. Conclusion The classification developed in this study is useful for guiding the identification of dissonances and reveal modifications required to align the workflow of data collection and the clinical setting. The methodology described in this study can be used by researchers to standardize data collection process. PMID:24073246

  18. 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.

  19. [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.

  20. 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

  1. Clinical Characteristics of Patients with Newly Diagnosed Diabetic Macular Edema in Turkey: A Real-Life Registry Study—TURK-DEM

    PubMed Central

    Ozdek, Sengul; Ozmert, Emin; Ulay, Esat; Nomak, Gulsah

    2017-01-01

    Purpose. To evaluate the clinical and diagnostic characteristics of patients with newly diagnosed diabetic macular edema (DME) in Turkey in a real-life setting. Methods. A total of 945 consecutive patients (mean (SD) age: 61.3 (9.9) years, 55.2% male) with newly diagnosed DME were included. Data on patient demographics, comorbidities, ocular history, ophthalmic examination findings including type of DME, central macular thickness (CMT) via time domain (TD) and spectral domain (SD) optical coherence tomography (OCT), and planned treatments were recorded. Results. OCT (98.8%) and fundoscopy (92.9%) were the two most common diagnostic methods. Diffuse and focal DMEs were detected in 39.2% and 36.9% of cases, respectively. Laser photocoagulation (32.1%) and antivascular endothelial growth factors (anti-VEGF; 31.8%) were the most commonly planned treatments. The median CMT in the right eye was significantly greater in untreated than in treated patients [376.5 μm (range: 160–840) versus 342 μm (range: 146–999) (p = 0.002)] and in the left eye [370 μm (range: 201–780) versus 329 μm (range: 148–999) (p < 0.001)]. Conclusions. This study is the first large-scale real-life registry of DME patients in Turkey. SD-OCT and fundoscopy were the most common diagnostic methods. Laser photocoagulation and anti-VEGF therapy were the most common treatments. PMID:28316835

  2. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    PubMed

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  3. 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

  4. 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.

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

    PubMed Central

    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

    2015-01-01

    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

  6. Histopathological pattern of lymphomas and clinical presentation and outcomes of diffuse large B cell lymphoma: A multicenter registry based study from India

    PubMed Central

    Nimmagadda, Ramesh B. V.; Digumarti, Raghunadharao; Nair, Reena; Bhurani, Dinesh; Raina, Vinod; Aggarwal, Shyam; Patil, Shekhar; Gogoi, Pabitra K.; Sundaram, Subramanian; Goswami, Chanchal; Apte, Shashikant; Chakravarthy, Srinivas; Pathak, Anand

    2013-01-01

    Context: The distribution of various subtypes of lymphomas in India is different from other parts of the world. There is scarce multicentric data on the pattern and outcomes of lymphomas in India. Aims: The aim of this study is to evaluate the histopathological and the clinical pattern and treatment outcomes of lymphomas in India based on the retrospective data collected from a multicenter registry. Materials and Methods: Retrospective data was collected at 13 public and private hospitals in India for patients diagnosed with lymphoma between January 2005 and December 2009. The data collection was performed in the setting of a multicenter lymphoma registry Survival analyses were performed using the Kaplan-Meier method and compared using the log-rank test. Results: Non-Hodgkin's lymphoma (NHL) constituted 83.17% and Hodgkin's lymphoma (HL) for 16.83% of the 1733 registered and analyzed cases. Diffuse large B cell lymphoma (DLBCL) was the most common NHL (55%) followed by follicular lymphoma (11%). CHOP was the most common chemotherapy regimen administered (84%) while rituximab was used in 42.7% of those with DLBCL. Survival analysis of treatment naïve DLBCL patients (n = 791) was performed. Of these, 29% were lost to follow-up, 20% with active disease. The median follow-up in surviving patients is 31 (range: 1-88) months. Median progression-free survival (PFS) and overall survival (OS) in DLBCL patients has not reached. There was no significant difference in median PFS (69 months vs. 61 months, P = 0.1341), but OS was significant not reached (NR) vs. NR, P = 0.0012) within international prognostic index high or intermediate subgroups. Rituximab use was associated with significantly prolonged PFS (NR vs. 82 months, P = 0.0123), but not OS (NR vs. NR, P = 0.2214). Cox regression analysis in treatment naïve DLBCL patients showed a performatnce status, stage and receipt of six or more cycles of chemotherapy to be significantly associated with OS and all of the

  7. [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.

  8. The Swiss Orthopaedic Registry.

    PubMed

    Röder, Christoph; El-Kerdi, A; Frigg, A; Kolling, C; Staub, L P; Bach, B; Müller, U

    2005-01-01

    Following the tradition of the IDES European Hip Registry inaugurated by M. E. Müller in the 1960s, the Institute for Evaluative Research in Orthopaedic Surgery at the University of Bern started a new era of data collection using internet technology (www.memdoc.org). With support of the Swiss Orthopaedic Society, the pilot of the Swiss Orthopaedic Registry was conducted, and in cooperation with different academic and non-academic centers the practicability of integrating the various data collection instruments into the daily clinical workflow was evaluated. Three different sizes of hip and knee questionnaires were compiled, covering the individual demands of the participating hospitals whereby the smaller questionnaires always represent a subset of the next larger one. Different types of data collection instruments are available: the online interface, optical mark reader paper questionnaires, and barcode sheets. Precise implant tracking is implemented by scanning the implant barcodes directly in the operating theaters and linking them to the clinical data set via a central server. In addition, radiographic information can be linked with the clinical data set. The pilot clinics suggested enhancements to the user interface and additional features for data management. Also, recommendations were made to simplify content in some instances and diversify in others. With a new software release and adapted questionnaires the Swiss Orthopaedic Registry was officially launched in Summer 2005.

  9. Chinese multi-institutional registry (CMIR) for resected non-small cell lung cancer: survival analysis of 5,853 cases

    PubMed Central

    Liang, Wenhua; Shao, Wenlong; Jiang, Gening; Wang, Qun; Liu, Lunxu; Liu, Deruo; Wang, Zheng; Zhu, Zhihua

    2013-01-01

    Background Concerns on surgical treatment of non-small cell lung cancer (NSCLC) have been increasing recent years. However, the significance of previous studies based on single center or regional experience in China was impaired by small sample size. Here we described a Chinese Multi-institutional Registry (CMIR) to address this disadvantage and proposed a further collaboration project. Methods Information of patients diagnosed with stage I to III NSCLC who underwent radical resection between 2001 and 2008 in seven institutions from the People’s Republic of China was collected using a blinded standardized data form. Survival outcomes were calculated by Kaplan-Meier curves and Life-table method. Results A total of 5,853 patients who met the inclusion criteria were entered into the database. The average age was 58.9±10.7 years. Males (59.5%) and adenmocarcinoma (53.0%) represented the majority of all cases. Lobectomy (87.9%) was the major operation type in practice. The 5-year overall survival rates were 81.9% for stage IA, 71.6% for IB, 55.0% for IIA, 45.2% for IIB, 34.9% for IIIA and 23.3% for IIIB (P<0.001). Conclusions This is the first and the largest clinical database for resected NSCLC in China with optimal data quality. Future collaboration to expand and share this database nationwide is warranted. PMID:24409347

  10. 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

  11. Anatomical features and management of bioresorbable vascular scaffolds failure: A case series from the GHOST registry.

    PubMed

    Longo, Giovanni; Granata, Francesco; Capodanno, Davide; Ohno, Yohei; Tamburino, Claudia Ina; Capranzano, Piera; La Manna, Alessio; Francaviglia, Bruno; Gargiulo, Giuseppe; Tamburino, Corrado

    2015-06-01

    The Absorb bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California) promises to address some of the residual shortcomings of existing metallic stents, such as late events induced by permanent caging of the coronary vessel. Scaffold restenosis (ScR) of BVS has been poorly described so far and treatment strategies for this event remain to be codified. We report on a case series of 14 lesions in 12 patients presenting with ScR and discuss their anatomical features and management strategies. © 2015 Wiley Periodicals, Inc.

  12. 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

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

    PubMed

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

    2013-05-07

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

  14. Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.

    PubMed

    Baudard, Marie; Yavchitz, Amélie; Ravaud, Philippe; Perrodeau, Elodie; Boutron, Isabelle

    2017-02-17

    Objective To evaluate the impact of searching clinical trial registries in systematic reviews.Design Methodological systematic review and reanalyses of meta-analyses.Data sources Medline was searched to identify systematic reviews of randomised controlled trials (RCTs) assessing pharmaceutical treatments published between June 2014 and January 2015. For all systematic reviews that did not report a trial registry search but reported the information to perform it, the World Health Organization International Trials Registry Platform (WHO ICTRP search portal) was searched for completed or terminated RCTs not originally included in the systematic review.Data extraction For each systematic review, two researchers independently extracted the outcomes analysed, the number of patients included, and the treatment effect estimated. For each RCT identified, two researchers independently determined whether the results were available (ie, posted, published, or available on the sponsor website) and extracted the data. When additional data were retrieved, we reanalysed meta-analyses and calculated the weight of the additional RCTs and the change in summary statistics by comparison with the original meta-analysis.Results Among 223 selected systematic reviews, 116 (52%) did not report a search of trial registries; 21 of these did not report the information to perform the search (key words, search date). A search was performed for 95 systematic reviews; for 54 (57%), no additional RCTs were found and for 41 (43%) 122 additional RCTs were identified. The search allowed for increasing the number of patients by more than 10% in 19 systematic reviews, 20% in 10, 30% in seven, and 50% in four. Moreover, 63 RCTs had results available; the results for 45 could be included in a meta-analysis. 14 systematic reviews including 45 RCTs were reanalysed. The weight of the additional RCTs in the recalculated meta-analyses ranged from 0% to 58% and was greater than 10% in five of 14 systematic

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

    PubMed Central

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

    2017-01-01

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

  16. 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

  17. Attitudes toward Potential Participant Registries.

    PubMed

    Grill, Joshua D; Holbrook, Andrew; Pierce, Aimee; Hoang, Dan; Gillen, Daniel L

    2017-01-01

    Difficult participant recruitment is a consistent barrier to successful medical research. Potential participant registries represent an increasingly common intervention to overcome this barrier. A variety of models for registries exist, but few data are available to instruct their design and implementation. To provide such data, we surveyed 110 cognitively normal research participants enrolled in a longitudinal study of aging and dementia. Seventy-four (67%) individuals participated in the study. Most (78%, CI: 0.67, 0.87) participants were likely to enroll in a registry. Willingness to participate was reduced for registries that required enrollment through the Internet using a password (26%, CI: 0.16, 0.36) or through email (38%, CI: 0.27, 0.49). Respondents acknowledged their expectations that researchers share information about their health and risk for disease and their concerns that their data could be shared with for-profit companies. We found no difference in respondent preferences for registries that shared contact information with researchers, compared to honest broker models that take extra precautions to protect registrant confidentiality (28% versus 30%; p = 0.46). Compared to those preferring a shared information model, respondents who preferred the honest broker model or who lacked model preference voiced increased concerns about sharing registrant data, especially with for-profit organizations. These results suggest that the design of potential participant registries may impact the population enrolled, and hence the population that will eventually be enrolled in clinical studies. Investigators operating registries may need to offer particular assurances about data security to maximize registry enrollment but also must carefully manage participant expectations.

  18. Lingual thyroid: a clinical case.

    PubMed

    Quarracino, María; Aguas, Silvia

    2003-01-01

    Lingual thyroid is an abnormal formation appearing as the result of a deficient descent during embryological development of the thyroid gland through the thyroglossal duct to its normal pretracheal location. The lesion consists of a tumor mass of thyroid tissue located at the base of the tongue, in the region of the foramen caecum linguae. The size can vary from a few millimeters to several centimeters in diameter. More than 400 cases of lingual thyroid have been documented in the literature to date. Lingual thyroid has been identified in 10% of the tongues examined in some autopsy series. Its identification is of great significance, since it may constitute the only functional thyroid tissue in the body, and may inadvertently be destroyed as a result of histological biopsy procedures. The present study presents a clinical case of lingual thyroid in a 17-year-old female.

  19. 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.

  20. UK Renal Registry 11th Annual Report (December 2008): Chapter 15 The UK Renal Registry, UKRR database, validation and methodology.

    PubMed

    Ansell, David; Tomson, Charles R V

    2009-01-01

    The UK Renal Registry receives encrypted data extracts quarterly from each centre providing Renal Replacement Therapy (RRT) in England, Wales and Northern Ireland. Summary data is received from the Scottish Renal Registry to allow national statistics to be compiled. Data from patients receiving haemodialysis in satellite units or at home are reported through the main renal centre. Data from patients with functioning kidney transplants are reported through the centre providing routine clinical follow-up. The data are extracted from a variety of IT systems with varying functionality and no common messaging system, necessitating extensive data validation and cleaning prior to analysis. Growing confidence in the analyses since the inception of the Registry in 1995 has allowed de-anonymised centre-specific analyses of all outcomes, including survival, to be published, although incomplete data returns for primary renal diagnosis and comorbidity at start of RRT limit ability to adjust for case-mix.

  1. Frequency and clinical manifestations of patients with primary immunodeficiency disorders in Iran: update from the Iranian Primary Immunodeficiency Registry.

    PubMed

    Rezaei, Nima; Aghamohammadi, Asghar; Moin, Mostafa; Pourpak, Zahra; Movahedi, Masoud; Gharagozlou, Mohammad; Atarod, Lida; Ghazi, Bahram Mirsaeid; Isaeian, Anna; Mahmoudi, Maryam; Abolmaali, Kamran; Mansouri, Davoud; Arshi, Saba; Tarash, Naser Javaher; Sherkat, Roya; Akbari, Hedayat; Amin, Reza; Alborzi, Abdolvahab; Kashef, Sara; Farid, Reza; Mohammadzadeh, Iraj; Shabestari, Mehrnaz Sadeghi; Nabavi, Mohammad; Farhoudi, Abolhassan

    2006-11-01

    Primary immunodeficiency disorders (PID) are a heterogeneous group of diseases, characterized by an increased susceptibility to infections. A total of 930 patients (573 males and 357 females) are registered in Iranian PID Registry (IPIDR) during three decades. Predominantly antibody deficiencies were the most common (38.4%), followed by congenital defects of phagocyte number and/or function (28.3%), other well-defined immunodeficiency syndromes (17.7%), combined T- and B-cell immunodeficiencies (11.0%), complement deficiencies (2.4%), and diseases of immune dysregulation (2.3%). Common variable immunodeficiency was the most frequent disorder (20.8%), followed by chronic granulomatous disease, ataxia-telangiectasia, btk deficiency, selective IgA deficiency, and T-B-severe combined immunodeficiency. The frequency of other PID disorders was less than 50 in number (<5%). There is an increasing trend in recognition of more PID in the recent years. Construction of such registry is not only important for its epidemiological aspect but also for its role in increasing the physician's knowledge about such disorders.

  2. Sexual arousal and lubrication problems in women with clinically diagnosed hypoactive sexual desire disorder: preliminary findings from the hypoactive sexual desire disorder registry for women.

    PubMed

    Maserejian, Nancy N; Shifren, Jan; Parish, Sharon J; Segraves, R Taylor; Huang, Liyuan; Rosen, Raymond C

    2012-01-01

    Sexual desire and arousal difficulties are often correlated in women. However, no studies have examined characteristics of women with clinically diagnosed hypoactive sexual desire disorder (HSDD) that increase the likelihood of co-occurring arousal difficulties. The authors examined combined HSDD and arousal/ lubrication problems using baseline cross-sectional data from the HSDD Registry for Women. Their analyses were restricted to women who could be classified with certainty as having arousal or lubrication difficulties by the Female Sexual Function Index (requiring sexually activity in the past 4 weeks). Results showed that among 426 premenopausal women with HSDD, 50.2% had arousal problems, 42.5% lubrication problems, 39.0% combination, and 46.2% neither. Among 174 postmenopausal women, prevalence percentages were 58.0% arousal, 56.9% lubrication, 49.4% combined, and 34.5% neither. The strongest predictor of combined arousal/lubrication problems was self-reported severity of HSDD. Among premenopausal women, race/ethnicity, depression, and lower relationship happiness were also associated with combined arousal/lubrication problems. Among postmenopausal women, surgical menopause and use of selective serotonin reuptake inhibitors were positively associated with arousal problems. Arousal and lubrication problems were present in approximately half of this subsample of HSDD Registry participants, with distinctions in prevalence and predictors by menopausal status and type of arousal difficulty (arousal vs. lubrication).

  3. 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.

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

    PubMed

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

    2013-01-01

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

  5. 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.

  6. [Congenital retinal folds in different clinical cases].

    PubMed

    Munteanu, M

    2005-01-01

    We present 12 clinical cases of congenital retinal folds with different etiologies: posterior primitive vitreous persistency and hyperplasia (7 cases),retinocytoma (1 case). retinopathy of prematurity (1 case), astrocytoma of the retina (1 case), retinal vasculitis (1 case), Goldmann-Favre syndrome (1 case). Etiopathogenic and nosological aspects are discussed; the congenital retinal folds are interpreted as a symptom in a context of a congenital or acquired vitreo-retinal pathology.

  7. [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.

  8. Empowering patients and researchers through a common health information registry: a case example of adrenocortical carcinoma patients and researchers.

    PubMed

    Allwes, Deborah; Popovich, Michael L

    2007-01-01

    Adrenocortical Carcinoma is a rare malignant tumor that forms in the outer layer of tissue of the adrenal gland, which is a small gland situated on the anteriosuperior aspect of the kidneys. These glands produce steroid hormones, adrenaline, and noradrenaline that control heart rate, blood pressure, and other body functions. Because this cancer affects a limited number of patients, it is referred to as an Orphan disease, which is defined as a condition that affects fewer than 200,000 people nationwide. Internationally, there are 5,000-8,000 such diseases affecting an estimated 55 million people. There is often limited medical intervention for many of these conditions. With a small number of patients, and a correspondingly small number of providers and researches, this disease is a candidate for establishing a shareable information system that is used by the patient, provider, and researcher. This resource empowers the patient to support their care and treatment while allowing medical providers and researches to have valuable and broad access to patient activities and behaviors that may impact their treatment. Orphan disease registries are prime candidates for establishing health information resources that support communications between patients, providers, and researchers. As a resource, this information can be used to facilitate treatment protocols to include biomarker identification, testing and monitoring of new drugs. By empowering a common community of individuals that share a common disease, the potential to accelerate research and identify improved treatment options may also increase. This paper presents a strategic plan and design for implementing Orphan disease registries within an e-health environment that specifically links patients and providers with researchers. The Adrenocortical Carcinoma Registry will be used to demonstrate the implementation and potential of these systems.

  9. Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study

    PubMed Central

    Hansen, Niels Dalum; Valentiner-Branth, Palle

    2016-01-01

    Background Since 2013 the number of suspected adverse reactions to the quadrivalent human papillomavirus (HPV) vaccine reported to the Danish Medicines Agency (DMA) has increased. Due to the resulting public concerns about vaccine safety, the coverage of HPV vaccinations in the childhood vaccination programme has declined. The aim of the present study was to determine health care-seeking prior to the first HPV vaccination among females who suspected adverse reactions to HPV vaccine. Methods In this registry-based case-control study, we included as cases vaccinated females with reports to the DMA of suspected severe adverse reactions. We selected controls without reports of adverse reactions from the Danish vaccination registry and matched by year of vaccination, age of vaccination, and municipality, and obtained from the Danish National Patient Registry and The National Health Insurance Service Register the history of health care usage two years prior to the first vaccine. We analysed the data by logistic regression while adjusting for the matching variables. Results The study included 316 cases who received first HPV vaccine between 2006 and 2014. Age range of cases was 11 to 52 years, with a peak at 12 years, corresponding to the recommended age at vaccination, and another peak at 19 to 28 years, corresponding to a catch-up programme targeting young women. Compared with 163,910 controls, cases had increased care-seeking in the two years before receiving the first HPV vaccine. A multivariable model showed higher use of telephone/email consultations (OR 1.9; 95% CI 1.2–3.2), physiotherapy (OR 2.1; 95% CI 1.6–2.8) and psychologist/psychiatrist (OR 1.9; 95% CI 1.3–2.7). Cases were more likely to have a diagnosis in the ICD-10 chapters of diseases of the digestive system (OR 1.6; 95% CI 1.0–2.4), of the musculoskeletal system (OR 1.6; 95% CI 1.1–2.2), symptoms or signs not classified elsewhere (OR 1.8; 95% CI 1.3–2.5) as well as injuries (OR 1.5; 95% CI 1

  10. 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

  11. 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.

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

    PubMed

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

    2012-01-01

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

  13. 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.

  14. Clinical factors associated with statins prescription in acute ischemic stroke patients: findings from the Lombardia Stroke Registry

    PubMed Central

    2014-01-01

    Background Statins, due to their well-established pleiotropic effects, have noteworthy benefits in stroke prevention. Despite this, a significant proportion of high-risk patients still do not receive the recommended therapeutic regimens, and many others discontinue treatment after being started on them. The causes of non-adherence to current guidelines are multifactorial, and depend on both physicians and patients. The aim of this study is to identify the factors influencing statin prescription at Stroke Unit (SU) discharge. Methods This study included 12,750 patients enrolled on the web-based Lombardia Stroke Registry (LRS) from July 2009 to April 2012 and discharged alive, with a diagnosis of ischemic stroke or transient ischemic attack (TIA) and without contra-indication to statin therapy. By logistic regression analysis and classification trees, we evaluated the impact of demographic data, risk factors, tPA treatment, in-hospital procedures and complications on statin prescription rate at discharge. Results We observed a slight increase in statins prescription during the study period (from 39.1 to 43.9%). Lower age, lower stroke severity and prestroke disability, the presence of atherothrombotic/lacunar risk factors, a diagnosis of non-cardioembolic stroke, tPA treatment, the absence of in-hospital complications, with the sole exception of hypertensive fits and hyperglycemia, were the patient-related predictors of adherence to guidelines by physicians. Overall, dyslipidemia appears as the leading factor, while TOAST classification does not reach statistical significance. Conclusions In our region, Lombardia, adherence to guidelines in statin prescription at Stroke Unit discharge is very different from international goals. The presence of dyslipidemia remains the main factor influencing statin prescription, while the presence of well-defined atherosclerotic etiopathogenesis of stroke does not enhance statin prescription. Some uncertainties about the risk

  15. Effective Management of Bone Fractures with the Illuminoss® Photodynamic Bone Stabilization System: Initial Clinical Experience from the European Union Registry

    PubMed Central

    Gausepohl, Thomas; Pennig, Dietmar; Heck, Steffen; Gick, Sascha; Vegt, Paul A.; Block, Jon E.

    2017-01-01

    The IlluminOss® system (IS) uses a light-curable polymer contained within an inflatable balloon catheter, forming a patient customized intramedullary implant. A registry was established in Germany and The Netherlands to prospectively collect technical and clinical outcomes in patients treated with IS for fractures of the phalange, metacarpal, radius, ulna, distal radius, fibula, clavicle and/or olecranon. Humeral, femoral, tibial and pelvic fractures were included under compassionate use. Procedural success included successful placement of the device at the target fracture site and achievement of fracture stabilization. Clinical and radiographic assessments were made postoperatively through 12 months. One hundred thirty two patients (149 fractures) were enrolled with most fractures (85%) resulting from low-energy trauma. Simple fractures predominated (47%) followed by complex (23%) and wedge (16%) fractures. Procedural success was achieved in all patients and no implants required removal or revision. Normal range of motion was realized in 87% of fractures. Radiographically, there was substantial cortical bridging, total dissolution of the fracture line, and complete fracture healing. Across a variety of fracture types, the IS provides a safe and effective approach for rapid healing and functional recovery. PMID:28286623

  16. Effective Management of Bone Fractures with the Illuminoss® Photodynamic Bone Stabilization System: Initial Clinical Experience from the European Union Registry.

    PubMed

    Gausepohl, Thomas; Pennig, Dietmar; Heck, Steffen; Gick, Sascha; Vegt, Paul A; Block, Jon E

    2017-02-20

    The IlluminOss(®) system (IS) uses a light-curable polymer contained within an inflatable balloon catheter, forming a patient customized intramedullary implant. A registry was established in Germany and The Netherlands to prospectively collect technical and clinical outcomes in patients treated with IS for fractures of the phalange, metacarpal, radius, ulna, distal radius, fibula, clavicle and/or olecranon. Humeral, femoral, tibial and pelvic fractures were included under compassionate use. Procedural success included successful placement of the device at the target fracture site and achievement of fracture stabilization. Clinical and radiographic assessments were made postoperatively through 12 months. One hundred thirty two patients (149 fractures) were enrolled with most fractures (85%) resulting from low-energy trauma. Simple fractures predominated (47%) followed by complex (23%) and wedge (16%) fractures. Procedural success was achieved in all patients and no implants required removal or revision. Normal range of motion was realized in 87% of fractures. Radiographically, there was substantial cortical bridging, total dissolution of the fracture line, and complete fracture healing. Across a variety of fracture types, the IS provides a safe and effective approach for rapid healing and functional recovery.

  17. Clinical Effectiveness of Hydralazine-Isosorbide Dinitrate Therapy in Patients With Heart Failure and Reduced Ejection Fraction: Findings From the GWTG-HF Registry

    PubMed Central

    Khazanie, Prateeti; Liang, Li; Curtis, Lesley H.; Butler, Javed; Eapen, Zubin J.; Heidenreich, Paul A.; Bhatt, Deepak L.; Peterson, Eric D.; Yancy, Clyde W.; Fonarow, Gregg C.; Hernandez, Adrian F.

    2016-01-01

    Background In clinical trials, hydralazine-isosorbide dinitrate (H-ISDN) for heart failure with reduced ejection fraction reduced morbidity and mortality among black patients and patients with intolerance to angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). The effectiveness of H-ISDN in clinical practice is unknown. Methods and Results Using data from a clinical registry linked with Medicare claims, we examined the use and outcomes of H-ISDN between 2005 and 2011 among older patients hospitalized with heart failure and reduced ejection fraction. We adjusted for demographic and clinical characteristics using Cox proportional hazards models and inverse probability weighting. Among 4663 eligible patients, 22.7% of black patients and 18.2% of patients not on an ACE inhibitor or ARB were newly prescribed H-ISDN therapy at discharge. By 3 years, the cumulative incidence rates of mortality and readmission were similar between treated and untreated patients. After multivariable adjustment, 3-year outcomes remained similar for mortality (black patients: hazard ratio [HR], 0.92; 95% CI, 0.75–1.13; other patients: HR, 0.93; 95% CI, 0.79–1.09), all-cause readmission (black patients: HR, 0.98; 95% CI, 0.84–1.13; other patients: HR, 1.02; 95% CI, 0.90–1.17), and cardiovascular readmission (black patients: HR, 0.99; 95% CI, 0.82–1.19; other patients: HR, 0.94; 95% CI, 0.81–1.09). A post hoc analysis of Medicare Part D data revealed low postdischarge adherence to therapy. Conclusions Guideline-recommended initiation of H-ISDN therapy at hospital discharge was uncommon and adherence was low. For both black patients and patients of other races, there were no differences in outcomes between those treated and untreated at discharge. PMID:26867758

  18. [Pancoast tumor. A clinical case].

    PubMed

    Valdivies, Yusbiel José León; Sanchez de la Osa, Reinaldo Bárbaro; Barrera, Jany; Acosta, Carlos Enríquez

    2014-01-01

    We described a patient who was diagnosed with a Pancoast tumor in the Neumológico Benéfico Jurídico Hospital. This neoplastic non metastatic disease more frequently affects the brachial plexus. Therefore, a differential diagnosis of the painful shoulder was carried out and the patient was admitted in our center with the probable Pancoast tumor diagnosis. Subsequently, its study continued and the clinical suspicion was confirmed by a computerized tomography and a magnetic resonance, to be also confirmed later on with an anatomopathological study.

  19. Comparison of cancer diagnoses between the US solid organ transplant registry and linked central cancer registries.

    PubMed

    Yanik, Elizabeth L; Nogueira, Leticia M; Koch, Lori; Copeland, Glenn; Lynch, Charles F; Pawlish, Karen S; Finch, Jack L; Kahn, Amy R; Hernandez, Brenda Y; Segev, Dorry L; Pfeiffer, Ruth M; Snyder, Jon J; Kasiske, Bertram L; Engels, Eric A

    2016-04-07

    US transplant centers are required to report cancers in transplant recipients to the transplant network. The accuracy and completeness of these data, collected in the Scientific Registry of Transplant Recipients (SRTR), are unknown. We compared diagnoses in the SRTR and 15 linked cancer registries, for colorectal, liver, lung, breast, prostate, and kidney cancers, melanoma, and non-Hodgkin lymphoma (NHL). Among 187,384 transplants, 9323 cancers were documented in the SRTR or cancer registries. Only 36.8% of cancers were in both, with 47.5% and 15.7% of cases additionally documented solely in cancer registries or the SRTR, respectively. Agreement between the SRTR and cancer registries varied (kappa: 0.28 for liver cancer, 0.52-0.66 for lung, prostate, kidney, colorectum and breast cancers). Upon evaluation, some NHLs documented only in cancer registries were identified in the SRTR as another type of post-transplant lymphoproliferative disorder. Some SRTR-only cases were explained by miscoding (colorectal cancer instead of anal cancer, metastases as lung or liver cancers) or missed matches with cancer registries, partly due to out-migration from their catchment areas. Estimated sensitivity for identifying cancer was 52.5% for the SRTR and 84.3% for cancer registries. In conclusion, SRTR cancer data are substantially incomplete, limiting their usefulness for surveillance and research. This article is protected by copyright. All rights reserved.

  20. 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

  1. 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…

  2. 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…

  3. Changing roles of population-based cancer registries in Australia.

    PubMed

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

    2015-09-01

    Registries have key roles in cancer incidence, mortality and survival monitoring and in showing disparities across the population. Incidence monitoring began in New South Wales in 1972 and other jurisdictions soon followed. Registry data are used to evaluate outcomes of preventive, screening, treatment and support services. They have shown decreases in cancer incidence following interventions and have been used for workforce and other infrastructure planning. Crude markers of optimal radiotherapy and chemotherapy exist and registry data are used to show shortfalls against these markers. The data are also used to investigate cancer clusters and environmental concerns. Survival data are used to assess service performance and interval cancer data are used in screening accreditation. Registries enable determination of risk of multiple primary cancers. Clinical quality registries are used for clinical quality improvement. Population-based cancer registries and linked administrative data complement clinical registries by providing high-level system-wide data. The USA Commission on Cancer has long used registries for quality assurance and service accreditation. Increasingly population-based registry data in Australia are linked with administrative data on service delivery to assess system performance. Addition oftumour stage and otherprognostic indicators is important forthese analyses and is facilitated by the roll-out of structured pathology reporting. Data linkage with administrative data, following checks on the quality of these data, enables assessment of patterns of care and other performance indicators for health-system monitoring. Australian cancer registries have evolved and increasingly are contributing to broader information networks for health system management.

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

    PubMed

    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.

  5. 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

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

    PubMed

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

    2014-05-11

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

  7. Tutorial software for clinical chemistry incorporating interactive multimedia clinical cases.

    PubMed

    Hooper, J; O'Connor, J; Cheesmar, R; Price, C P

    1995-09-01

    We have developed computer-based clinical case histories incorporating multimedia elements to aid the learning of medicine in a problem-based manner. Topics have been developed in the specialty of Clinical Biochemistry but the approach used is suitable for any branch of clinical medicine. Each topic has material aimed at medical students and also postgraduate candidates for professional examinations. A browser program is also incorporated. Emphasis is made on interaction through the case and modeling of real-life decisions in diagnosis and treatment. Advantages of the program are self-paced learning, assessment of understanding, feedback, and emphasis on deep understanding of the basic physiological and biochemical processes underlying clinical problems.

  8. [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.

  9. [Herpetic encephalitis: a clinical case].

    PubMed

    Dryhant, L P; Sereda, V H; Kushpiĭ, O V; Tkachenko, V V; Kravchuk, N A; Inhula, N I; Sizina, A V; Sachko, Iu Iu; Andrusenko, A S; Tytenko, Iu I; Babirad, A M

    2012-01-01

    An example of diagnostics and treatment of patient is in-process made with herpetic encephalitis. It is well-proven in researches, that a herpetic encephalitis is 11.5% among sharp encephalitises. Morbidity is sporadic, some researchers specify on an increase its spring. An infection can be passed tiny and pin a way. Seasonal vibrations are not incident to the herpetic encephalitis. Two peaks of morbidity are on 5-30 years and age more senior 50 years. More than in 95% cases the virus of simple herpes of type serves as an exciter of herpetic encephalitis 1. A characteristic triad of herpetic encephalitis is the sharp feverish beginning, development of cramps of dzheksonovskogo type and violation of consciousness, developing usually after a brief respirator infection. Sometimes sudden development of cramps and loss of consciousness is preceded a fever. Example of such development of disease is made an in our work.

  10. Clinical cowpox cases in Norway.

    PubMed

    Tryland, M; Myrmel, H; Holtet, L; Haukenes, G; Traavik, T

    1998-01-01

    In 1994, a human and a feline case of cowpox virus infection appeared in the western part of Norway. Cowpox has not been diagnosed with certainty in Norway since the beginning of this century, when it was associated with the use of cowpox virus as a vaccine against smallpox. The human infection manifested as a spontaneously emerged, severe ulceration at the medial angle of the right eye in a 37-y-old woman, and developed into a relatively severe dermatitis. The ulcer healed slowly, leaving a scar. The feline infection was represented by a febrile, dehydrated and anorectic 6-months-old non-pedigree short-hair, with crater-like ulcers all over the body. After antibiotic and fluid therapy, revision of the skin lesions and amputation of a gangrenous toe, the cat recovered. Electron microscopy of the isolates and cultivation of virus on chorioallantoic membrane of chicken embryos confirmed the suspicion of cowpox virus infection.

  11. A Comparison of the Demographics, Clinical Features, and Survival of Patients with Adenoid Cystic Carcinoma of Major and Minor Salivary Glands Versus Less Common Sites within the SEER Registry

    PubMed Central

    Li, Nan; Xu, Li; Zhao, Hui; El-Naggar, Adel K.; Sturgis, Erich M.

    2012-01-01

    Objectives The scientific literature to date lacks population-based studies on the demographics, clinical features, and survival of patients with adenoid cystic carcinoma (ACC) of different anatomic sites. Methods We identified 5349 ACC cases in major salivary glands (N=1850), minor salivary glands (N=2077), breast (N=696), skin (N=291), lung and bronchus (N=203), female genital system (N=132), and eye and orbit (N=100) from the Surveillance, Epidemiology, and End Results (SEER) registry. Differences in demographics, clinical features, and survival of patients were assessed. Results ACC of the eye and orbit was associated with younger age at presentation (mean=49.9 years). ACC of the skin or breast tended to present with less aggressive prognostic features, while ACC of the lung and bronchus or eye and orbit tended to present with more aggressive prognostic features. In multivariate survival analysis of patients presenting with localized disease, patients with ACC of breast (HR=0.40) or skin (HR=0.40) had a significantly lower risk death than patients with ACC of major salivary glands, while patients with ACC of lung and bronchus (HR=3.72) or eye and orbit (HR=3.67) had a significantly higher risk. For patients presenting with regional disease, the only clear prognostic difference in multivariate analysis was that patients with ACC of skin did significantly better. Conclusions The demographics and clinical features of ACC differ by disease site. Site may be an important predictor of survival for patients presenting with localized disease but is less important for patients presenting with regional disease. PMID:22179977

  12. Coverage and predictors of vaccination against 2012/13 seasonal influenza in Madrid, Spain: analysis of population-based computerized immunization registries and clinical records.

    PubMed

    Jiménez-García, Rodrigo; Esteban-Vasallo, María D; Rodríguez-Rieiro, Cristina; Hernandez-Barrera, Valentín; Domínguez-Berjón, M A Felicitas; Carrasco Garrido, Pilar; Lopez de Andres, Ana; Cameno Heras, Moises; Iniesta Fornies, Domingo; Astray-Mochales, Jenaro

    2014-01-01

    We aim to determine 2012-13 seasonal influenza vaccination coverage. Data were analyzed by age group and by coexistence of concomitant chronic conditions. Factors associated with vaccine uptake were identified. We also analyze a possible trend in vaccine uptake in post pandemic seasons. We used computerized immunization registries and clinical records of the entire population of the Autonomous Community of Madrid, Spain (6,284,128 persons) as data source. A total of 871,631 individuals were vaccinated (13.87%). Coverage for people aged ≥ 65 years was 56.57%. Global coverage in people with a chronic condition was 15.7% in children and 18.69% in adults aged 15-59 years. The variables significantly associated with a higher likelihood of being vaccinated in the 2012-13 campaign for the age groups studied were higher age, being Spanish-born, higher number of doses of seasonal vaccine received in previous campaigns, uptake of pandemic vaccination, and having a chronic condition. We conclude that vaccination coverage in persons aged<60 years with chronic conditions is less than acceptable. The very low coverage among children with chronic conditions calls for urgent interventions. Among those aged ≥60 years, uptake is higher but still far from optimal and seems to be descending in post-pandemic campaigns. For those aged ≥65 years the mean percentage of decrease from the 2009/10 to the actual campaign has been 12%. Computerized clinical and immunization registers are useful tools for providing rapid and detailed information about influenza vaccination coverage in the population.

  13. Lymphocele: a clinical analysis of 19 cases

    PubMed Central

    Ge, Wei; Yu, De-Cai; Chen, Jun; Shi, Xian-Biao; Su, Lei; Ye, Qing; Ding, Yi-Tao

    2015-01-01

    Purpose: To summarize the clinical manifestations, diagnosis, and treatment of lymphocele. Materials and methods: 19 cases of lymphocele diagnosed by postoperative pathology from January 2003 to September 2012 were retrospectively analyzed, especially the general information, clinical manifestations, imaging, operations, and pathological findings. Results: In 19 cases, the common locations were in retroperitoneal, abdominal wall, and neck. There were no typical clinical manifestations with lymphocele. 6 cases visited hospital because of pain, while 13 cases were diagnosed incidentally with imaging or surgery. Fourteen cases undergoing CT were all displayed as cystic lesion. In 12 of 14 cases undergoing type-B ultrasonic, the masses were shown to be cystic lesion without special signs. 19 cases were all treated by surgical resection, and testified to be lymphocele with pathological analysis. The sensitivity of D2-40 was 89.5% (17/19) in our study. Conclusions: Lymphocele is very rare with no specific clinical manifestations. The preoperative diagnosis was based on imaging examinations, while definite diagnosis was based on the pathological, and (or) immunohistochemical examination with D2-40. The prognosis of lymphocele is good after it is removed completely. PMID:26221274

  14. A Registry Framework Enabling Patient-Centred Care.

    PubMed

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

    2015-01-01

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

  15. Association of Hospital-Level Volume of Extracorporeal Membrane Oxygenation Cases and Mortality. Analysis of the Extracorporeal Life Support Organization Registry

    PubMed Central

    Odetola, Folafoluwa O.; Kidwell, Kelley M.; Paden, Matthew L.; Bartlett, Robert H.; Davis, Matthew M.; Annich, Gail M.

    2015-01-01

    Rationale: Recent pediatric studies suggest a survival benefit exists for higher-volume extracorporeal membrane oxygenation (ECMO) centers. Objectives: To determine if higher annual ECMO patient volume is associated with lower case-mix–adjusted hospital mortality rate. Methods: We retrospectively analyzed an international registry of ECMO support from 1989 to 2013. Patients were separated into three age groups: neonatal (0–28 d), pediatric (29 d to <18 yr), and adult (≥18 yr). The measure of hospital ECMO volume was age group–specific and adjusted for patient-level case-mix and hospital-level variance using multivariable hierarchical logistic regression modeling. The primary outcome was death before hospital discharge. A subgroup analysis was conducted for 2008–2013. Measurements and Main Results: From 1989 to 2013, a total of 290 centers provided ECMO support to 56,222 patients (30,909 neonates, 14,725 children, and 10,588 adults). Annual ECMO mortality rates varied widely across ECMO centers: the interquartile range was 18–50% for neonates, 25–66% for pediatrics, and 33–92% for adults. For 1989–2013, higher age group–specific ECMO volume was associated with lower odds of ECMO mortality for neonates and adults but not for pediatric cases. In 2008–2013, the volume–outcome association remained statistically significant only among adults. Patients receiving ECMO at hospitals with more than 30 adult annual ECMO cases had significantly lower odds of mortality (adjusted odds ratio, 0.61; 95% confidence interval, 0.46–0.80) compared with adults receiving ECMO at hospitals with less than six annual cases. Conclusions: In this international, case-mix–adjusted analysis, higher annual hospital ECMO volume was associated with lower mortality in 1989–2013 for neonates and adults; the association among adults persisted in 2008–2013. PMID:25695688

  16. 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

  17. Prognostic value of the International Neuroblastoma Pathology Classification in Neuroblastoma (Schwannian stroma-poor) and comparison with other prognostic factors: a study of 182 cases from the Spanish Neuroblastoma Registry.

    PubMed

    Burgues, Octavio; Navarro, Samuel; Noguera, Rosa; Pellín, Antonio; Ruiz, Amparo; Castel, Victoria; Llombart-Bosch, Antonio

    2006-10-01

    In addition to clinical and biological factors, further valuable prognostic information in neuroblastoma (Schwannian stroma-poor) (NB) patients is provided by the histopathologic analysis and the application of the International Neuroblastoma Pathology Classification (INPC) system. The objective of this study was to assess the prognostic impact of the INPC classification in a series of NB (Schwannian stroma-poor) and its relation with other prognostic factors. One hundred eighty-two cases of NB were collected from the files of the Spanish Neuroblastoma Registry. Slides were reviewed, and NB cases were grouped into favorable and unfavorable categories according to INPC criteria, taking into account morphological features (mitosis-karyorrhexis index, histological subtype) and patient's age at diagnosis. Other pathological [presence of calcifications, tissular components, and number of mitotic cells per 10 high-power field (HPF)], immunohistochemical (P-glycoprotein and Ki-67 protein expression) and genetic (MYCN amplification and chromosome 1p deletion) features were also studied. Statistical analyses of overall survival with Kaplan-Meier curves and a multivariate study using Cox regression were performed (40.3% of NBs were considered favorable and 59.7% unfavorable). Unfavorable NB showed a mean survival time of 57 months compared with 89 months in favorable cases. Advanced stage, more than ten mitoses per 10 HPF, Ki-67 expression in more than 30% of tumor cells, MYCN oncogene amplification and chromosome 1p deletion were observed more frequently in unfavorable NB. The Cox regression analysis demonstrated that clinical stage (International Neuroblastoma Staging System stage 4) and histological subtype (undifferentiated NB) were the most important factors that influence the overall survival (p<0.001). INPC classification results are major prognostic indicators in NB and should be considered in the therapeutic stratification of NB patients.

  18. Integrated case learning: teaching clinical reasoning.

    PubMed

    Radomski, Natalie; Russell, John

    2010-05-01

    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 practices of clinical thinking that emerged in the ICL environment. We also explore how third year medical students perceived their ICL experiences in relation to the clinical situations encountered in the hospital setting. The context for the inquiry is a rural Clinical School in North West Victoria, Australia. We used a qualitative case study methodology following eight third-year medical students over an academic year. Individual and group interviews were conducted, together with observations and document/artefact analysis. Data was analysed using content and narrative methods. The ICL program was well received. Findings suggest that the group-based, simulated clinical reasoning process appears to help undergraduate medical students to rehearse, articulate and question their clinical decision-making pathways. We argue that the ICL process offers a professionally challenging, but supportive group learning 'space' for students to practise what it might mean to 'think', 'talk' and 'perform' like doctors in real settings. The ICL environment also appears to create a connective bridge between the 'classroom' and clinical practice.

  19. Methodology of clinical research in rare diseases: development of a research program in juvenile neuronal ceroid lipofuscinosis (JNCL) via creation of a patient registry and collaboration with patient advocates

    PubMed Central

    de Blieck, Elisabeth A.; Augustine, Erika F.; Marshall, Frederick J.; Adams, Heather; Cialone, Jennifer; Dure, Leon; Kwon, Jennifer M.; Newhouse, Nicole; Rose, Katherine; Rothberg, Paul G.; Vierhile, Amy; Mink, Jonathan W.

    2013-01-01

    Introduction Juvenile neuronal ceroid lipofuscinosis (JNCL; Batten disease) is a rare, inherited, fatal lysosomal storage childhood disorder. True for many rare diseases, there are no treatments that impact the course of JNCL. The University of Rochester Batten Center’s (URBC) mission is to find treatments to slow, halt, or prevent JNCL. Objectives Our initial objective was to develop clinical research infrastructure preparatory to clinical trials, establish a JNCL research cohort, construct a disease-specific clinical outcome measure, and validate a non-invasive diagnostic sampling method. The long-term objective is to design and implement JNCL clinical trials. Methods The Unified Batten Disease Rating Scale (UBDRS) was developed. The Batten Disease Support and Research Association (BDSRA) referred participants; annual BDSRA meetings provided a mobile research setting for registry enrollment and UBDRS piloting. Neuropsychological examinations were performed, enabling external validation of the UBDRS. Buccal epithelial cell collection for genotyping was introduced. Telemedicine for remote UBDRS assessment was piloted. Results The registry enrolled 198 families representing 237 children with NCL. The UBDRS was piloted, validated and has been used to collect natural history data from 120 subjects. Funding and regulatory approval were obtained for a recently launched phase II clinical trial. Several additional lines of inquiry were reported. Conclusion The registry and BDSRA collaboration have enabled development of a clinical rating scale, natural history and neuropsychological studies, and genetic studies for disease confirmation. This work highlights an approach for preparatory natural history research and infrastructure development needed to facilitate efficient implementation of clinical trials in rare diseases. PMID:23628560

  20. [Osteomyelitis after septic trochanteric bursitis - clinical case].

    PubMed

    Miguel, C; Gonçalves, I; Matos, Maria L; Coelho, Paulo Clemente

    2010-01-01

    We report the clinical case of a 76 years-old woman with a subacute trochanteric inflammatory pain with low-grade fever and laboratory markers of acute inflammation, associated with the ultrasonographic evidence of bursitis and radiologic evidence of femoral erosions, that resolved after intravenous antibiotherapy. Although rare, the infectious etiology should be considered in patients with clinical manifestations of bursitis and signs of systemic involvement.

  1. 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

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

    PubMed

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

    2006-05-01

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

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

    PubMed

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

    2013-04-01

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

  4. 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"…

  5. [Leiomyosarcoma of the gallbladder: a clinical case].

    PubMed

    Tocchi, A; Codacci-Pisanelli, M; Costa, G; Lepre, L; Agostini, N; Maggiolini, F

    1993-10-01

    A case of primary leiomyosarcoma of the gallbladder is reported together with a review of the literature. The nonspecific clinical picture of the disease and the consequent high frequency of misdiagnosis are stressed. Cholecystectomy combined with chemotherapy and radiotherapy is the treatment of choice suggested.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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…

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

    PubMed

    Kremer, Joel M

    2016-01-01

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

  12. 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

  13. University of Washington Twin Registry: Construction and characteristics of a community-based twin registry

    PubMed Central

    Afari, Niloofar; Noonan, Carolyn; Goldberg, Jack; Edwards, Karen; Gadepalli, Kiran; Osterman, Bethany; Evanoff, Cynthia; Buchwald, Dedra

    2010-01-01

    The University of Washington Twin Registry is a community-based registry of twins identified from the Washington State Department of Licensing. A fortuitous quirk in the Washington State drivers' license and identification number assignment, and collaborative Washington State laws, permitted us to build a statewide registry. Since obtaining approval from the Washington State Attorney General, the Washington State Department of Licensing has provided us with information on over 26,000 newly licensed twins, and we continue to receive computerized records on approximately 80 new twins per week. The University of Washington Twin Registry is assembled by mailing each twin a recruitment packet that includes an information sheet, brochure, brief survey, and nominal gift. Once both members of a twin pair have completed the packet, the pair is enrolled in the Registry. As of June 2006, 2,287 adult twin pairs have enrolled in the Registry; about one half of these are female-female pairs. Among all twins, the average age is 32 years. Based on self-report, 52% of twins are MZ, 42% are DZ, and zygosity on 6% cannot yet be determined. We also have established a clinical protocol for collecting additional data and DNA from all twins participating in research studies requiring an in-person visit. The Registry has established policies and procedures to protect the confidentiality of twin data and guidelines for the use of the Registry by investigators. Plans for the further growth of the University of Washington Twin Registry and its use are discussed. PMID:17254446

  14. [The registry for asbesto-related tumors].

    PubMed

    Melino, C

    2003-01-01

    The author stresses the importance of DPCM 10 December 2002 no.308, which determines the format and the rules to fill the registry for the cases of asbestos-related mesothelioma, according to art 36, comma 3, DLgs 277/91. The Author admits the usefulness of such a registry, but comments that its official approval came very late, because it actually was started in 1993 by ISPESL (The Higher Institute for Prevention and Safety of Labor), after the approval of DLgs 277/91. According to ISPESL initiative, all cases of mesothelioma and related circumstances were (and are) collected through a periferal information net operated by COR's.

  15. A pilot registry of unexplained fatiguing illnesses and chronic fatigue syndrome

    PubMed Central

    2013-01-01

    Background Chronic fatigue syndrome (CFS) has no diagnostic clinical signs or biomarkers, so diagnosis requires ruling out conditions with similar signs and symptoms. We conducted a pilot registry of unexplained fatiguing illnesses and CFS to determine the feasibility of establishing and operating a registry and implementing an education outreach initiative. The pilot registry was conducted in Bibb County, Georgia. Patient referrals were obtained from healthcare providers who were identified by using various education outreach initiatives. These referrals were later supplemented with self-referrals by members of a local CFS support group. All patients meeting referral criteria were invited to participate in a screening interview to determine eligibility. If patients met registry criteria, they were invited to a one-day clinic for physical and laboratory evaluations. We classified patients based on the 1994 case definition. Results We registered 827 healthcare providers. Forty-two providers referred 88 patients, and 58 patients (66%) completed clinical evaluation. Of the 188 CFS support group members, 53 were self-referred and 46 (87%) completed the clinical evaluation. Of the 104 participants completing evaluation, 36% (n = 37) met the criteria for CFS, 17% (n = 18) had insufficient fatigue or symptoms (ISF), and 47% (n = 49) were found to have exclusionary medical or psychiatric illnesses. Classification varied significantly by type of referral but not by previous history of CFS diagnosis. Healthcare providers referred more patients who were classified as CFS as compared to support group referrals in which more exclusionary conditions were identified. Family practice and internal medicine specialties made the most referrals and had the highest number of CFS cases. We conducted three CME events, held three “Meet and Greet” sessions, visited four large clinical health practices and health departments, mailed five registry newsletters, and conducted

  16. 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

  17. Recent trends in population-based cancer registries in Japan: the Act on Promotion of Cancer Registries and drastic changes in the historical registry.

    PubMed

    Matsuda, Tomohiro; Sobue, Tomotaka

    2015-02-01

    Cancer registration in Japan has a long history spanning over 60 years; the first population-based cancer registry was established in Miyagi prefecture in 1951. The progress made in the regional population-based cancer registries in terms of standardization and quality improvement during the 10 years of the third comprehensive strategy for cancer control was highlighted in the history of cancer registration in Japan. However, there were still weak points regarding local government-oriented cancer registries that remained, e.g., the reporting of cancer cases to the population-based cancer registries was not a mandatory task for medical institutions. After the Cancer Control Act in 2006, the Act on Promotion of Cancer Registries was finally enacted in Japan on December 6, 2013. According to that Act, hospital managers must report information on any primary cancer that was first diagnosed in their institutions from January 1, 2016 to the prefectural governors. Given the increasing number of cases and amount of information recorded, it would have been almost impossible to maintain our cancer registries using the same system, and changes were required to obtain reliable cancer statistics. This was particularly important in Japan, because the country is facing a hyper-aging society, with two to three million cancer patients requiring entry of detailed information. We appreciate the long history of the Japanese cancer registry, but it is necessary to make dramatic changes to bring the registry up to date and to be able to track the increasing amount of information.

  18. 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.

  19. Hip fracture registries: utility, description, and comparison.

    PubMed

    Sáez-López, P; Brañas, F; Sánchez-Hernández, N; Alonso-García, N; González-Montalvo, J I

    2017-04-01

    Hip fractures (HF) are prevalent and involve high morbidity and mortality so improving their management is important. HF registries are a good way to improve knowledge about this condition and its quality of care, while at the same time reducing clinical variability, optimizing efficiency, improving outcomes, and reducing costs.

  20. 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

  1. International Breast Implant Registry: a user report.

    PubMed

    Renner, C; Neuhann-Lorenz, C

    2006-01-01

    The International Breast Implant Registry (IBIR) was founded in 2002 under the auspices of the International Plastic, Reconstructive, and Aesthetic Surgery Foundation (IPRAF), the International Confederation for Plastic, Reconstructive, and Aesthetic Surgery (IPRAS), and the European and International Committee for Quality Assurance, Medical Technologies, and Devices in Plastic (EQUAM) on the basis of continuous discussion about the safety and compatibility of different breast implants. The IBIR aims to integrate and replace the already existing national breast implant registries. It also is assumed that the European Parliament, the Food and Drug Administration, and international organizations of plastic and aesthetic surgeons will postulate obligatory international breast implant registration. Currently, IBIR is in a pilot phase with the goal of understanding data collection issues and concerns in various countries whereby the data entered to date will be completely available in the final version. A well-established global registry represents an important tool of quality assurance. By publishing their experiences in applying the registry, the authors aim to encourage more plastic and aesthetic surgeons to submit their cases to the registry and thus enhance its value as a successful and powerful device.

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

    PubMed

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

    2013-01-01

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

  3. Tonsillolith: a report of three clinical cases.

    PubMed

    de Moura, Mariela Dura Gontijo; Madureira, Davidson Fróis; Noman-Ferreira, Luiz Cláudio; Abdo, Evandro Neves; de Aguiar, Evandro Guimarães; Freire, Addah Regina da Silva

    2007-03-01

    Tonsillolith is a rare dystrophic calcification as a result of chronic inflammation of the tonsils. Three asymptomatic cases of tonsillolith are reported, incidentally discovered through panoramic radiographs, which showed different sizes of radiopaque images, varying from 2 to 5 mm; cases I and III images did not overlap the mandible ramus, which led to a probable diagnosis of soft tissue calcification. Case II had radiopaque unilateral images, with osseous tissue density, overlapping the mandibular ramus, leading to a benign intra-osseous lesion, which was considered as differential diagnosis. No symptoms were reported in any case. Only case I had clinical characteristics, showing highly consistent white plaques partially visible through the mucosa. Computed tomography of the maxillofacial region/head and neck were requested to find out the exact location of these images, since most of the overlapping radiopaque images in the mandibular ramus were very similar to intra-osseous abnormalities. The computed tomography showed hyperdense images in the palatine tonsils, confirming the diagnosis of tonsillolith. The patients are currently under follow-up. No treatment is required if there is no symptom. In conclusion, tonsillolith might show images on panoramic radiographs similar to intra osseous abnormalities. The diagnosis is relatively easy when computed tomography is requested, although the images are not pathognomonic. Therefore, clinicians should consider other pathologies as differential diagnosis.

  4. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2011-06-01

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

  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…

  6. Sinonasal Cancer and Occupational Exposure in a Population-Based Registry

    PubMed Central

    Mensi, Carolina; Sieno, Claudia; Riboldi, Luciano; Bertazzi, Pier Alberto

    2013-01-01

    We examined occupational exposures among subjects with sinonasal cancer (SNC) recorded in a population-based registry in the Lombardy Region, the most populated and industrialized Italian region. The registry collects complete clinical information and exposure to carcinogens regarding all SNC cases occurring in the population of the region. In the period 2008–2011, we recorded 210 SNC cases (137 men, 73 women). The most frequent occupational exposures were to wood (44 cases, 21.0%) and leather dust (29 cases, 13.8%), especially among men: 39 cases (28.5%) to wood and 23 cases (16.8%) to leather dust. Exposure to other agents was infrequent (<2%). Among 62 subjects with adenocarcinoma, 50% had been exposed to wood dust and 30.7% to leather dust. The proportions were around 10% in subjects with squamous cell carcinoma and about 20% for tumors with another histology. The age-standardized rates (×100,000 person-years) were 0.7 in men and 0.3 in women. Complete collection of cases and their occupational history through a specialized cancer registry is fundamental to accurately monitor SNC occurrence in a population and to uncover exposure to carcinogens in different industrial sectors, even those not considered as posing a high risk of SNC, and also in extraoccupational settings. PMID:24082884

  7. [Cirsoid aneurysm: apropos of a clinical case].

    PubMed

    Valesi, M G; De Giovanni, M; Coppolino, S; Tentarelli, M N

    1983-12-01

    The authors, after mentioning the anatomopathologic, physiopathologic and clinical features of cyrsoid aneurysms, presently classed in the chapter of the congenital artero-venous fistulas, show a case, angiographically discovered, of cyrsoid aneurysm with palmar location, elsewhere already subjected twice to unsuccessful operation, and successfully operated at the Institute of Surgical Pathology of the Pavia University. The Authors think the morphologic and topographic features of such lesion, its relative local malignancy and trend to relapsing, justify why the old denomination of cyrsoid aneurysm was kept, even in the frame of the more general chapter of artero-venous fistulas.

  8. 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.

  9. 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

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

    PubMed

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

    1994-01-01

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

  11. Validation of prostate‐specific antigen laboratory values recorded in Surveillance, Epidemiology, and End Results registries

    PubMed Central

    Adamo, Margaret (Peggy); Boten, Jessica A.; Coyle, Linda M.; Lam, Clara J. K.; Negoita, Serban; Penberthy, Lynne; Stevens, Jennifer L.; Ward, Kevin C.

    2016-01-01

    BACKGROUND Researchers have used prostate‐specific antigen (PSA) values collected by central cancer registries to evaluate tumors for potential aggressive clinical disease. An independent study collecting PSA values suggested a high error rate (18%) related to implied decimal points. To evaluate the error rate in the Surveillance, Epidemiology, and End Results (SEER) program, a comprehensive review of PSA values recorded across all SEER registries was performed. METHODS Consolidated PSA values for eligible prostate cancer cases in SEER registries were reviewed and compared with text documentation from abstracted records. Four types of classification errors were identified: implied decimal point errors, abstraction or coding implementation errors, nonsignificant errors, and changes related to “unknown” values. RESULTS A total of 50,277 prostate cancer cases diagnosed in 2012 were reviewed. Approximately 94.15% of cases did not have meaningful changes (85.85% correct, 5.58% with a nonsignificant change of <1 ng/mL, and 2.80% with no clinical change). Approximately 5.70% of cases had meaningful changes (1.93% due to implied decimal point errors, 1.54% due to abstract or coding errors, and 2.23% due to errors related to unknown categories). Only 419 of the original 50,277 cases (0.83%) resulted in a change in disease stage due to a corrected PSA value. CONCLUSIONS The implied decimal error rate was only 1.93% of all cases in the current validation study, with a meaningful error rate of 5.81%. The reasons for the lower error rate in SEER are likely due to ongoing and rigorous quality control and visual editing processes by the central registries. The SEER program currently is reviewing and correcting PSA values back to 2004 and will re‐release these data in the public use research file. Cancer 2017;123:697–703. © 2016 American Cancer Society. PMID:27783399

  12. Establishing an institutional therapeutic apheresis registry.

    PubMed

    Mann, Steven A; McCleskey, Brandi; Marques, Marisa B; Adamski, Jill

    2016-12-01

    Apheresis was first performed as a therapeutic procedure in the 1950s. The first national therapeutic apheresis (TA) registry was established in Canada in 1981 and other national registries followed, including two attempts at establishing an international TA registry. There is no national registry in the United States. Our large, academic, tertiary hospital has a very active TA service. We created a TA database to track all procedures performed by the apheresis service by transferring data from paper appointment logs and the electronic medical records into a Microsoft Access database. Retrospective data from each TA procedure performed at UAB from January 1, 2003 through December 31, 2012 were entered, including the type of procedure, indication, date, and patient demographics. Microsoft Excel was used for data analysis. During the 10-year period, our TA service treated 1,060 patients and performed 11,718 procedures. Of these patients, 70% received therapeutic plasma exchange (TPE), 21% received extracorporeal photopheresis (ECP), 4.5% received red cell exchange (RCE), 4.2% received leukocytapheresis, and 0.6% underwent platelet depletion. Among the procedures, 54% were TPEs, 44% were ECPs, 1.3% were RCEs, 0.5% were leukocytaphereses, and 0.1% were platelet depletions. According to the current literature, national and international TA use is underreported. We believe that the UAB TA registry provides useful information about TA practices in our region and can serve as a model for other institutions. Furthermore, data from multiple institutional registries can be used for clinical research to increase the available evidence for the role of TA in various conditions. J. Clin. Apheresis 31:516-522, 2016. © 2015 Wiley Periodicals, Inc.

  13. 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.

  14. Malaysian Psoriasis Registry--preliminary report of a pilot study using a newly revised registry form.

    PubMed

    Chang, C C; Gangaram, H B; Hussein, S H

    2008-09-01

    The Malaysian Psoriasis Registry, established in 1998, is the first skin disease clinical registry in Malaysia. It aims to provide useful data on various aspects of psoriasis. Following an extensive revision of the registry form in 2007, a total of 509 psoriasis patients from 10 government dermatologic centres were reviewed in a three month pilot study. The onset of psoriasis was during the second to fourth decade of life in the majority of patients. There was no sexual and ethnic predilection. A positive family history was present in 21.2%, and more common in patients with younger disease onset. The main aggravating factors of psoriasis were stress, sunlight and infection. Plaque psoriasis was the commonest clinical type (80.9%). Joint disease was present in 17.3% of patients, among which mono-/oligoarticular type being the commonest. Nail changes occurred in 68%. More psoriasis patients were overweight and obese compared to the normal population. The mean Dermatologic Life Quality Index (DLQI) score was 8.08 +/- 6.29, and changes during subsequent follow-up may reflect therapeutic effectiveness. This study enabled evaluation of the revised registry form and helped in identifying shortcomings in the implementation of the registry.

  15. Economic assessment of central cancer registry operations, Part III: Results from 5 programs.

    PubMed

    Tangka, Florence; Subramanian, Sujha; Beebe, Maggie Cole; Trebino, Diana; Michaud, Frances

    2010-01-01

    In this article, we report results from the cost analysis of 5 central cancer registries funded by the National Program of Cancer Registries (NPCR). To estimate the true economic costs of operating a cancer registry, we used a cost-assessment tool (CAT) to collect data on all registry activities, not just those funded by the NPCR. Data were collected on actual, rather than budgeted, expenditures, including personnel, consultants, information technology (IT) support, and other factors influencing costs. Factors that can affect registry costs include the amount of consolidation from abstract to incident cases, the method of data reporting, the number of edits that must be performed manually versus electronically, and the amount of interstate data exchange required of a registry. Expenditures were allocated to specific surveillance and data enhancement and analysis activities. Our study confirmed that cost per case varies across registry activities. The cost of surveillance activities per case ranges from $24.79 to $95.78 while the cost of data enhancement and analysis registry activities per reported cancer case ranges from $2.91 to $9.32. Total cost per reported cancer case also varies, ranging from $30 to slightly more than $100, with a median of $45.84. Further research using data from all NPCR-funded registries is required to assess reasons for this variation. Information gained from such an assessment will improve efficiency in registry operations and provide data to better quantify the funding requirements for expanding registry activities.

  16. The Brazilian Twin Registry.

    PubMed

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

    2016-12-01

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

  17. 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

  18. 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.

  19. Understanding cutaneous tuberculosis: two clinical cases

    PubMed Central

    De Maio, Flavio; Trecarichi, Enrico Maria; Visconti, Elena; Sanguinetti, Maurizio; Sali, Michela

    2016-01-01

    Tuberculosis (TB) is an ancient human disease and remains today one of the most important public health problems and the second most frequent cause of death from an infectious disease worldwide. While pulmonary TB is the most common form, extra-pulmonary TB is on the rise due to the increase in immunosuppressed subjects. Cutaneous TB manifestations are rare forms of extra-pulmonary TB due to systemic dissemination of bacilli or direct inoculation, involving skin or skin-associated tissue, more common in immunocompromised subjects. Some risk factors and the features of the lesion may prompt the suspicion of cutaneous TB, but only microbiological assays can confirm the diagnosis. Our work summarizes cutaneous TB manifestations and differences from other skin mycobacterial infections, also describes two characteristic clinical cases. PMID:28348793

  20. Clinical ICT systems: augmenting case management.

    PubMed

    Baldwin, Lynne P; Clarke, Malcolm; Jones, Russell

    2002-01-01

    In order to improve the diagnosis and subsequent care given to patients, health-care workers involved in the management of their care, as well as the treatment itself, are increasingly looking at the role that information and communication technologies (ICTs) can play in supporting the complex interactions between patient, doctor or nurse, consultant and medical equipment. Effective communication both amongst health-care workers and between health-care workers and their patients in both primary and secondary care is vital; ICTs can play an important role in this. In this paper possible interpretations given to the term "telemedicine" are discussed, and then attention is turned to the challenges involved in human interaction and the role of ICTs. An example of a clinical ICT system (AIDMAN) is used to illustrate how face-to-face interaction has usefully been supported by way of a "virtual" consultation, which facilitates remote medical diagnosis and can provide improved case management.

  1. [Wegener's granulomatosis. Three cases with different clinical courses].

    PubMed

    Wawrzyńska, L; Sawionek, I; Filipecki, S

    1996-01-01

    Three cases of Wegener's granulomatosis are presented. In every case the different clinical picture was observed. In the first case dominated the pulmonary changes and fingers necrosis. In that case the excellent therapeutic effect of etoposide was observed. In the second case the most important clinical sings illustrated severe renal insufficiency. The third case demonstrated pericardial and skin changes. The significance of early diagnosis and early institution of proper therapy was discussed.

  2. Obturator prostheses following palatal resection: clinical cases.

    PubMed

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

    2010-02-01

    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 materials

  3. 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

  4. Predicting outcome in traumatic brain injury: Sharing experience of pilot traumatic brain injury registry

    PubMed Central

    Pal, Ranabir; Munivenkatappa, Ashok; Agrawal, Amit; Menon, Geetha R.; Galwankar, Sagar; Mohan, P. Rama; Kumar, S. Satish; Subrahmanyam, B. V.

    2016-01-01

    Background: A reliable prediction of outcome for the victims of traumatic brain injury (TBI) on admission is possible from concurrent data analysis from any systematic real-time registry. Objective: To determine the clinical relevance of the findings from our TBI registry to develop prognostic futuristic models with readily available traditional and novel predictors. Materials and Methods: Prospectively collected data using predesigned pro forma were analyzed from the first phase of a trauma registry from a South Indian Trauma Centre, compatible with computerized management system at electronic data entry and web data entry interface on demographics, clinical, management, and discharge status. Statistical Analysis: On univariate analysis, the variables with P < 0.15 were chosen for binary logistic model. On regression model, variables were selected with test of coefficient 0.001 and with Nagelkerke R2 with alpha error of 5%. Results: From 337 cases, predominantly males from rural areas in their productive age, road traffic injuries accounted for two-thirds cases, one-fourths occurred during postmonsoon while two-wheeler was the most common prerequisite. Fifty percent of patients had moderate to severe brain injury; the most common finding was unconsciousness followed by vomiting, ear bleed, seizures, and traumatic amnesia. Fifteen percent required intracranial surgery. Patients with severe Glasgow coma scale score were 4.5 times likely to have the fatal outcome (P = 0.003). Other important clinical variables accountable for fatal outcomes were oral bleeds and cervical spine injury while imperative socio-demographic risk correlates were age and seasons. Conclusion: TBI registry helped us finding predictors of clinical relevance for the outcomes in victims of TBI in search of prognostic futuristic models in TBI victims. PMID:27722114

  5. 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.

  6. 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…

  7. The Danish Heart Registry

    PubMed Central

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

    2016-01-01

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

  8. 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

  9. 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.

  10. The New ADL Registry. ADL Registry Web Portal Changes

    DTIC Science & Technology

    2009-08-19

    Approaches 18 19 Primary ADL Registry Contributors Contributor Records Entry Date Navy eLearning (US Navy) 2,086 08/05/2008 Joint Knowledge Development...ADL Registry  http://adlregistry.adlnet.gov/  Navy eLearning Content Team  https://www.netc.navy.mil/ile  Joint Knowledge Online  http

  11. Three-Year Clinical Outcomes of a Polymer-Free Paclitaxel-Eluting Microporous Stent in Real-World Practice: Final Results of the Safety and Efficacy Registry of the Yinyi Stent (SERY-I)

    PubMed Central

    Zhu, Jinzhou; Zhang, Qi; Chen, Lianglong; Zhang, Chenyun; Zhou, Xuchen; Yuan, Yong; Zhang, Ruiyan

    2017-01-01

    Background The safety and efficacy of a China-made polymer-free paclitaxel-eluting microporous stent (Yinyi) at 1-year has been previously reported. However, limited evidence exists regarding the long-term performance of this novel drug-eluting stent (DES). This study investigated the 3-year efficacy and safety of the Yinyi stent in the setting of safety and efficacy registry of the Yinyi stent (SERY-I) clinical trial. Methods Between June 2008 and August 2009, a total of 1045 patients undergoing percutaneous coronary intervention (PCI) were implanted with ≥ 1 Yinyi stents at 27 medical centers in mainland China. Thereafter, clinical follow-up was performed for a period of 3 years after enrollment. The primary endpoint was the cumulative rate of composite major adverse cardiac events (MACE) including target lesion revascularization (TLR), the combined incidence of cardiac death, and non-fatal myocardial infarction; the second endpoint was the incidence of stent thrombosis. Results Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 (98.7%) patients received dual antiplatelet therapy for at least 12 months. At 3 years, a total of 13 (1.33%) patients had suffered cardiac death. The incidence of non-fatal myocardial infarction and TLR was 9 (0.92%) and 58 (5.92%) among the patients. Stent thrombosis occurred in 13 (1.33%) patients, and the rate of Academic Research Consortium (ARC) definite or probable stent thrombosis was 0.82%. Conclusions Given the limitations that SERY-I was a single arm, nonrandomized study and only telephone follow-up was performed without angiographic analysis, the safety and efficacy of Yinyi stent observed in this extended follow-up Registry needs further verification. PMID:28115804

  12. 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

  13. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2010-11-01

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

  14. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2009-11-01

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

  15. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2012-07-01

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

  16. Alaska Native Parkinson’s Disease Registry

    DTIC Science & Technology

    2007-11-01

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

  17. Survival differences between patients with Hodgkin lymphoma treated inside and outside clinical trials. A study based on the EORTC-Netherlands Cancer Registry linked data with 20 years of follow-up.

    PubMed

    Liu, Lifang; Giusti, Francesco; Schaapveld, Michael; Aleman, Berthe; Lugtenburg, Pieternella; Meijnders, Paul; Hutchings, Martin; Lemmens, Valery; Bogaerts, Jan; Visser, Otto

    2017-01-01

    The survival of patients diagnosed with Hodgkin lymphoma (HL) has improved from 70% to 90% in clinical trials. However, population-based data has shown lower survival. In this study, clinical trial data were linked with cancer registry to identify trial and non-trial participants and differences in overall survival and associated factors were assessed. In 1986-2004, 27% of HL patients aged 15-70 years participated in clinical trials. Compared to non-trial participants, trial participants were younger (median age, 31 vs. 34 years), had staging registered more accurately and had an 8% higher 20-year survival rate (73% vs. 65%). After adjusting for baseline differences, no differences in survival (hazard ratio = 0·96, 95% confidence interval 0·82-1·12), or in subgroup analysis according to stage, remained. Over time, increased administration of chemotherapy in combination with radiotherapy, together with the decreased use of radiotherapy alone was observed among the trial population. This trend was later followed in non-trial participants, coinciding with a similar 'take-up' in survival. The observed superior survival among patients with HL treated in clinical trials can be largely explained by the differences in baseline characteristics, particularly younger age. High trial participation rate and centralized expertise facilitates the implementation of trial findings to real-world practice.

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

    PubMed

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

    2014-03-01

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

  19. An electronic registry for physiotherapists in Belgium.

    PubMed

    Buyl, Ronald; Nyssen, Marc

    2008-01-01

    This paper describes the results of the KINELECTRICS project. Since more and more clinical documents are stored and transmitted in an electronic way, the aim of this project was to design an electronic version of the registry that contains all acts of physiotherapists. The solution we present here, not only meets all legal constraints, but also enables to verify the traceability and inalterability of the generated documents, by means of SHA-256 codes. The proposed structure, using XML technology can also form a basis for the development of tools that can be used by the controlling authorities. By means of a certification procedure for software systems, we succeeded in developing a user friendly system that enables end-users that use a quality labeled software package, to automatically produce all the legally necessary documents concerning the registry. Moreover, we hope that this development will be an incentive for non-users to start working in an electronic way.

  20. Trauma registries: history, logistics, limitations, and contributions to emergency medicine research.

    PubMed

    Zehtabchi, Shahriar; Nishijima, Daniel K; McKay, Mary Pat; Mann, N Clay

    2011-06-01

    Trauma registries have been designed to serve a number of purposes, including quality improvement, injury prevention, clinical research, and policy development. Since their inception over 30 years ago, there are increasingly more institutions with trauma registries, many of which submit data to a national trauma registry. The goal of this review is to describe the history, logistics, and characteristics of trauma registries and their contribution to emergency medicine and trauma research. Discussed in this review are the limitations of trauma registries, such as variability in quality and type of the collected data, absence of data pertaining to long-term and functional outcomes, prehospital information, and complications as well as other methodologic obstacles limiting the utility of registry data in clinical and epidemiologic research.

  1. 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

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

    PubMed

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

    2016-04-01

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

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

    PubMed

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

    2014-09-01

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

  4. Heartworm disease in dogs: unusual clinical cases.

    PubMed

    Venco, L; Kramer, L; Genchi, Claudio

    2005-10-24

    Two unusual cases of heartworm infection are described, including one of spontaneous rupture of cardiac chambers, most likely due to the progressive increase in pressure within the right ventricle caused by Dirofilaria immitis infection. Another case report describes persistent left cranial vena cava, which interfered with the surgical removal of heartworm via the left jugular vein.

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

    PubMed

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

    2008-12-01

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

  6. [A registry of registries and cohorts: recommendations for metadata and policies].

    PubMed

    Stausberg, J; Semler, S; Neugebauer, E A M

    2014-12-01

    Registries and cohort studies play a central role in patient-oriented medical research, in particular in health services research. In order to increase the transparency about ongoing registries and cohort studies in Germany, and to promote communication and cooperation between the drivers in the field a so-called register portal should be established. Metadata are characteristics that are used to describe registries and cohort studies in the register portal. A limited set of characteristics, the core set, should correctly describe the projects on the one hand while reducing workload for data capture and data administration on the other hand. The core set consists of 26 data elements that had been defined in a Delphi-consensus process involving experts from the working group registries of the German Network for Health Services Research (DNVF) and the working group IT infrastructure and quality management of the Technology, Methods, and Infrastructure for Networked Medical Research (TMF). Transparent policies are required to guarantee traceability and reliability of the portal's services. Six so-called top-level-tasks and 37 use cases were defined in an interim report so far. The metadata have been agreed upon by most of the member associations of the DNVF. Metadata and rules of procedures are the starting point for the practical implementation of the register portal in the next future.

  7. The moral case for the clinical placebo.

    PubMed

    Gold, Azgad; Lichtenberg, Pesach

    2014-04-01

    Placebos are arguably the most commonly prescribed drug, across cultures and throughout history. Nevertheless, today many would consider their use in the clinic unethical, since placebo treatment involves deception and the violation of patients' autonomy. We examine the placebo's definition and its clinical efficacy from a biopsychosocial perspective, and argue that the intentional use of the placebo and placebo effect, in certain circumstances and under several conditions, may be morally acceptable. We highlight the role of a virtue-based ethical orientation and its implications for the beneficent use of the placebo. In addition, the definitions of lying and deception are discussed, clarified and applied to the clinical placebo dilemma. Lastly, we suggest that concerns about patient autonomy, when invoked as a further argument against administering placebos, are extended beyond their reasonable and coherent application.

  8. The Kaiser Permanente Shoulder Arthroplasty Registry

    PubMed Central

    Ake, Christopher F; Burke, Mary F; Singh, Anshuman; Yian, Edward H; Paxton, Elizabeth W; Navarro, Ronald A

    2015-01-01

    Background and purpose Shoulder arthroplasty is being performed in the United States with increasing frequency. We describe the medium-term findings from a large integrated healthcare system shoulder arthroplasty registry. Patients and methods Shoulder arthroplasty cases registered between January 2005 and June 2013 were included for analysis. The registry included patient characteristics, surgical information, implant data, attrition, and patient outcomes such as surgical site infections, venous thromboembolism, and revision procedures. Results During the study period, 6,336 primary cases were registered. Median follow-up time for all primaries was 3.3 years; 461 cases were lost to follow-up by ending of health plan membership. Primary cases were predominantly female (56%) and white (81%), with an average age of 70 years. The most common reason for surgery was osteoarthritis in 60% of cases, followed by acute fracture (17%) and rotator cuff tear arthropathy (15%). In elective shoulder arthroplasty procedures, 200 all-cause revisions (4%) were reported, with glenoid wear being the most common reason. Interpretation Most arthroplasties were elective procedures: over half performed for osteoarthritis. Glenoid wear was the most common reason for revision of primary shoulder arthroplasty in elective cases. PMID:25727949

  9. [Proliferative diabetic retinopathy -- therapeutic approach (clinical case)].

    PubMed

    Burcea, M; Muşat, Ovidiu; Mahdi, Labib; Gheorghe, Andreea; Spulbar, F; Gobej, I

    2014-01-01

    We present the case of a 54 year old pacient diagnosed with neglected insulin dependent diabetes and proliferative diabetic retinopathy. Surgery was recommended and we practiced posterior vitrectomy, endolaser and heavy silicone oil endotamponade. Post-operative evolution was favorable.

  10. Sources of bias in clinical ethics case deliberation.

    PubMed

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2014-10-01

    A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance and risk factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved.

  11. 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

  12. 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.

  13. Osteonecrosis caused by Bisphosphonates: a clinical case

    PubMed Central

    SPINELLI, D.; DE VICO, G.; BONINO, M.; BARLATTANI, A.; BOLLERO, P.; BARLATTANI, A.

    2010-01-01

    SUMMARY The osteonecrosis of the maxillares caused by bisphosphonates (OMB) either wrongly known or not reconised in earlier times became nowadays very important among the dentists and maxillo-facials surgeons because of the potential serious consequences that might bring in the oral cave of the patients, who are suffering already for their base condition. The goal of our work was to verify if a deep treatment and an attentive observation with a close follow-up can bring to the resolution of serious cases of ostenecrosis of the maxillares by bisphosphonantes. Although without a statistic value our case report put the basis for a chance to execute wider casistic studies. PMID:23285372

  14. [Clinical cases of acquired coagulation inhibitors].

    PubMed

    Yamane, T; Hino, M; Ota, K; Akahori, M; Hirai, M; Inoue, T; Mugitani, A; Tatsumi, N

    2000-12-01

    The acquired coagulation factor inhibitors are classified into alloantibodies, which appear in association with supplementary treatment for congenital coagulation factor deficiency, and autoantibodies, which are spontaneously produced. We report here 2 cases of acquired factor VIII inhibitor and 1 case of factor V inhibitor. Case 1: A 52-year-old woman noted swelling of the right parotid region in March 1988. Though contrast examination was scheduled, she was admitted for detailed examination due to a markedly prolonged coagulation time. An APTT correction test suggested that decreased factor VIII activity was due to the presence of an inhibitor. Since antinuclear antibody and SS-A antibody were positive and infiltration by lymphocytes in the salivary gland acini in a lip biopsy specimen was detected, Sjögren's syndrome was diagnosed. Case 2: A 33-year-old woman had normal delivery of her second child in February 1998. In June 1998, she suffered slight contusion in the left lower limb. The affected site became swollen and painful, making walking difficult. Since both upper limbs became markedly swollen after 1 week, she visited our hospital. Prolonged APTT and a marked decrease in factor VIII activity were observed. Factor VIII inhibitor titer was high at 19 Bethesda units. Case 3: A 64-year-old man had had asymptomatic macroscopic hematuria since the beginning of August 1998 but was placed under observation since no abnormal findings were observed on various imaging tests. However, he was admitted to Osaka City General Medical Center because of vesicular tamponade. Factor V activity was markedly decreased to 1.0%. PT correction test suggested that decreased factor V activity was due to the presence of an inhibitor. The underlying disease could not be determined in this case. In patients with acquired coagulation inhibitors, bleeding symptoms are reported to be mild in many cases, and severe bleeding is rare. However, cases of death without severe bleeding or

  15. Congenital dislocation of the patella - clinical case.

    PubMed

    Miguel Sá, Pedro; Raposo, Filipa; Santos Carvalho, Manuel; Alegrete, Nuno; Coutinho, Jorge; Costa, Gilberto

    2016-01-01

    Congenital patellar dislocation is a rare condition in which the patella is permanently dislocated and cannot be reduced manually. The patella develops normally as a sesamoid bone of the femur. This congenital dislocation results from failure of the internal rotation of the myotome that forms the femur, quadriceps muscle and extensor apparatus. It usually manifests immediately after birth, although in some rare cases, the diagnosis may be delayed until adolescence or adulthood. Early diagnosis is important, thereby allowing surgical correction and avoiding late sequelae, including early degenerative changes in the knee. A case of permanent dislocation of the patella is presented here, in a female child aged seven years.

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

    PubMed

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

    2017-01-27

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

  17. Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

    PubMed Central

    Choi, Chang Won

    2015-01-01

    The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers. PMID:26566353

  18. [Myomatous tumor of the stomach. 3 clinical cases].

    PubMed

    Boschi, L; Lecce, F

    1993-10-15

    Three cases of smooth muscle tumors of the stomach are reported: a leiomyoma, a leiomyosarcoma and a leiomyoblastoma observed over a period of five years. Clinical presentation, diagnostic procedure and surgical treatment are discussed and the literature is reviewed.

  19. [Atypical presentation of a clinical case of giant cell arteritis].

    PubMed

    Rosselló Aubach, L L; Torres Cortada, G; Cabau Rúbies, J; Aragón Sanz, M A; Oncins Torres, R

    2006-06-01

    We present a very unusual clinical case of giant cell arteritis with uterus involvement, in a women of 66 years old, that began clinical features of pain and functional limitation of shoulders and hip 3 mouth before been operated of uterus prolapse with hysterectomy. Biopsy of uterus found affected arterial vesels with wall sclerosis and granulomatous inflamation with giant cells, without necrosis, involving media and perivascular portions suggesting giant cell arteritis. In a previous reports review, we only found ten similar clinical cases. In that cases, clinical features were no suggestif of the disease. Although the well known tendency of arteritis to involve some specific vascular areas, the case we present is an example of the systemic course of the disease and his difficulty to diagnose.

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

    PubMed

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

    2017-03-13

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

  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.

  2. Knee osteoarthrosis secondary to ochronosis - clinical case.

    PubMed

    da Silva Martins Ferreira, Andreia Maria; Lima Santos, Filipe; Castro Costa, André Miguel; Pereira Barbosa, Bruno Miguel; Reis Rocha, Rui Miguel; Fontes Lebre, Joaquim Fernando

    2014-01-01

    Alkaptonuria is a rare metabolic disease in which a deficiency of the enzyme homogentisate dioxygenase causes an accumulation of homogentisic acid. Ochronosis consists of excessive deposition of homogentisic acid in the connective tissue and presents as a chestnut brown or black pigmentation. With aging, the accumulation of pigments from homogentisic acid in the joints causes osteoarthrosis. There is no specific treatment for the disease and the approach is symptomatic. Arthroplasty is the solution for severe cases of osteoarthrosis caused by this pathological condition and presents results comparable to those from patients with primary osteoarthrosis. Here, the case of a 67-year-old patient who underwent several arthroplasty procedures because of osteoarthrosis caused by this rare pathological condition is presented. The last surgical intervention consisted of total right knee arthroplasty.

  3. Chorangiocarcinoma: a case report and clinical review

    PubMed Central

    Huang, Bin; Zhang, Yan-Ping; Yuan, Dan-Fang; Yang, Rui; Wang, Chun; Wu, Rui-Fang

    2015-01-01

    Objective: We describe a case of chorangiocarcinoma, a chorangioma covered by an abnormal trophoblastic proliferation, presenting in a term placenta and in an asymptomatic pregnancy. Evidence of metastasis was found on follow-up of the mother. Materials and methods: The lesion Was diagnosed by pathologic examination after cesarian section at term for fetal macrosomia, performed because of the abnormal gross findings in the placenta. After uncomplicated delivery, a thealthy child was born and the placent was expelled completely. There was follow-up in the mother and the child, up to 19 months after delivery. Results: Gross examination of the placenta showed a well-demarcated and grayish yellow-white mass, bulging paracentrally from the fetal surface. Histology revealed a trophoblastic proliferation inside a chorangioma, consisting of extensive central necrosis and high mitotic activity. Immunohistochemical staining showed strong intensity for hCG, PLAP, CK, CD31 (+) and CD34 (+); Ki67 showed a high proliferation index. Follow-up revealed metastasis in the mother and chemotherapy were performed at 3 months postpartum. Conclusion: This is only the sixth reported case of chorangiocarcinoma of the placenta in the literature. However, no metastasis were discovered in the reported case, which was not identical to ours. Follow-up revealed metastasis at lung in the mother. Chorangiocarcinoma should be carefully examined and followed-up. PMID:26629223

  4. 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…

  5. Teaching clinical reasoning: case-based and coached.

    PubMed

    Kassirer, Jerome P

    2010-07-01

    Optimal medical care is critically dependent on clinicians' skills to make the right diagnosis and to recommend the most appropriate therapy, and acquiring such reasoning skills is a key requirement at every level of medical education. Teaching clinical reasoning is grounded in several fundamental principles of educational theory. Adult learning theory posits that learning is best accomplished by repeated, deliberate exposure to real cases, that case examples should be selected for their reflection of multiple aspects of clinical reasoning, and that the participation of a coach augments the value of an educational experience. The theory proposes that memory of clinical medicine and clinical reasoning strategies is enhanced when errors in information, judgment, and reasoning are immediately pointed out and discussed. Rather than using cases artificially constructed from memory, real cases are greatly preferred because they often reflect the false leads, the polymorphisms of actual clinical material, and the misleading test results encountered in everyday practice. These concepts foster the teaching and learning of the diagnostic process, the complex trade-offs between the benefits and risks of diagnostic tests and treatments, and cognitive errors in clinical reasoning. The teaching of clinical reasoning need not and should not be delayed until students gain a full understanding of anatomy and pathophysiology. Concepts such as hypothesis generation, pattern recognition, context formulation, diagnostic test interpretation, differential diagnosis, and diagnostic verification provide both the language and the methods of clinical problem solving. Expertise is attainable even though the precise mechanisms of achieving it are not known.

  6. [Disseminated sporotrichosis - clinical case and discussion].

    PubMed

    Barroso Pereira, João Cláudio; Grijó, Amorita; Ribeiro Machado Pereira, Rosângela; Noel S Oliveira, Andreza; de Andrade, Ana Cláudia; Ferreira, Ana Cláudia M; Corrêa Brant Machado, Christiane; Veiga Coutinho, Débora; Vale Rios, Danilo; Pereira Pires, Bárbara

    2008-01-01

    The authors report a case of a patient with a prior history of alcohol abuse who developed nodules and ulcerated skin lesions on his trunk and lower extremities along the line of the lymphatic draining area. The patient's X-ray showed reticular nodular intersticial infiltrates at the lung bases. There was a positive culture of supraclavicular lymph node for Sporothrix schenckii. After specific treatment using mainly potassium iodide, there was regression of cutaneous lesions and lung infiltrates. The authors present a discussion on the deseases' forms of presentation, highlighting the lung involvement ans further discuss the diagnosis and treatment of sporotrichosis.

  7. [Whipple's disease: A clinical case report].

    PubMed

    Krums, L M; Bodunova, N A; Sabel'nikova, E A; Khomeriki, S G; Mirzoev, K M; Sokolova, M S; Parfenov, A I

    2017-01-01

    The paper describes a 56-year-old female patient who in December 2015 lost her appetite and 20 kg of weight, had diarrhea, rapidly increasing weakness, dizziness, joint pains, fever, swelling of the feet, and convulsions. Blood tests revealed anemia, elevated erythrocyte sedimentation rate, and hypoproteinemia. Computed tomography showed enlarged mesenteric and retroperitoneal lymph nodes. The doctor suspected lymphoma and referred her to the Moscow Clinical Research Center. The diagnosis of Whipple's disease was established by carrying out a small intestinal (duodenal) mucosal biopsy with the PAS reaction. A fat-free diet and antibiotic therapy with co-trimoxazole 2.0 g/day and ciprolen 0.3 g/day were prescribed for the patient. Fever and diarrhea disappeared, appetite appeared, weight gained, and blood counts normalized over 1 month of treatment. The patient was discharged with a recommendation to continue antibiotic treatment until the histopathological signs of the disease ceased.

  8. MRI for clinically suspected pediatric appendicitis: case interpretation.

    PubMed

    Moore, Michael M; Brian, James M; Methratta, Sosamma T; Hulse, Michael A; Choudhary, Arabinda K; Eggli, Kathleen D; Boal, Danielle K B

    2014-05-01

    As utilization of MRI for clinically suspected pediatric appendicitis becomes more common, there will be increased focus on case interpretation. The purpose of this pictorial essay is to share our institution's case interpretation experience. MRI findings of appendicitis include appendicoliths, tip appendicitis, intraluminal fluid-debris level, pitfalls of size measurements, and complications including abscesses. The normal appendix and inguinal appendix are also discussed.

  9. [Zosteriform lichen aureus. Pediatric clinical case].

    PubMed

    Rivera-Rodríguez, Álvaro; Hernández Ostiz, Sergio; Morales-Moya, Ana L; Prieto-Torres, Lucía; Álvarez-Salafranca, Marcial; Ara Martín, Mariano

    2017-04-01

    Lichen aureus is a rare pigmented purpuric dermatosis. We present an unusual case because of the pediatric age and the great number of lesions with zosteriform distribution. He is a 10-yearold boy, with a brownish, smaller than 1 cm, sharp edges, lichenified surface, asymptomatic macule, over the inner aspect of the left leg with a zosteriform distribution. The histology showed a band-like inflammatory infiltrate in the superficial dermis, composed of lymphocytes, histiocytes, erythrocytes and haemosiderin. He was diagnosed with zosteriform lichen aureus and was treated with topical mometasone furoate during 3 weeks resulting in partial lightening of the macules. Lesions have remained 2 years later, and new ones have appeared in the ipsilateral ankle. We must consider differential diagnosis with other pigmented purpuric dermatitis and pigmented purpuric mycosis fungoides. There are many therapeutic options and it tends to disappear spontaneously, so new studies are necessary.

  10. 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.

  11. French registry of acute leukemia and myelodysplastic syndromes. Age distribution and hemogram analysis of the 4496 cases recorded during 1982-1983 and classified according to FAB criteria. Groupe Francais de Morphologie Hematologique

    SciTech Connect

    Not Available

    1987-09-15

    During 1982 and 1983, 4496 new cases were recorded in the French Registry of acute leukemia and myelodysplastic syndromes by the French Group of Hematologic Morphology. This cooperative group associated members of 37 university centers spread throughout France; these centers handle the overwhelming majority of acute leukemias diagnoses. The cases were all classified according to FAB guidelines. Two thousand four hundred ninety-nine cases of acute myeloid leukemia were recorded, with similar total recruitment and distribution by cytologic subclass for both years. Hemogram data analysis revealed significant differences between different classes for certain parameters, particularly leukocytosis. A greater proportion of the acute myelogenous leukemias (AMLs) secondary to chemotherapy and/or radiotherapy (n = 145) were unclassifiable according to the French-American-British (FAB) system than the de novo AMLs (n = 1954). Eight hundred twenty cases of myelodysplastic syndromes were analyzed. Their frequency was underestimated due to optional reporting during the first year and the less favorable position of the university centers for recruiting these syndromes. The characteristics of the hemograms were established for acquired idiopathic sideroblastic anemia (n = 107), refractory anemia with excess blasts (RAEB) (n = 329), chronic myelomonocytic leukemia (n = 129) and RAEB in transformation (n = 65). Analysis of the 1177 acute lymphoblastic leukemias (ALLs) recorded showed good stability from one year to the next in terms of numbers of cases and distribution in the subclasses L1, L2, and L3. The distribution among these three subclasses by age also was determined. For L1 and L2 the hemogram data were examined separately for adults and children. The study of 74 cases of type L3 ALL enabled us to detail the hematologic presentation of this rare form of leukemia.

  12. 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

  13. Current status of acute stroke management in Korea: a report on a multicenter, comprehensive acute stroke registry.

    PubMed

    Kim, Beom Joon; Han, Moon-Ku; Park, Tai Hwan; Park, Sang-Soon; Lee, Kyung Bok; Lee, Byung-Chul; Yu, Kyung-Ho; Cha, Jae Kwan; Kim, Dae-Hyun; Lee, Jun; Lee, Soo Joo; Ko, Youngchai; Park, Jong-Moo; Kang, Kyusik; Cho, Yong-Jin; Hong, Keun-Sik; Cho, Ki-Hyun; Kim, Joon-Tae; Kim, Dong-Eog; Lee, Juneyoung; Lee, Ji Sung; Jang, Myung Suk; Broderick, Joseph P; Yoon, Byung-Woo; Bae, Hee-Joon

    2014-06-01

    There are limited data on the utilization of diagnostics and the variation of treatments at the national level in acute stroke care. Clinical Research Center for Stroke--5th division stroke registry aimed to describe stroke statistics and quality of care in Korea and to implement quality indicators. Clinical Research Center for Stroke--5th division registry was established in April 2008 and covers pretreatment demographics, medical and stroke severity measures, diagnostic evaluation, hyperacute revascularization, in-hospital management, discharge disposition, quality indicators, and long-term functional outcomes. Consecutive stroke cases from 12 participating centers are registered to a web-based database. Meticulous data management and auditing policy were applied. A total of 14,792 ischemic stroke cases were enrolled from April 2008 to January 2012. The median National Institutes of Health Stroke Scale score was 4 at admission, with median delay of onset to arrival of 14 h. Rate of risk factor management before stroke exceeds more than 80% for hypertension and diabetes. Revascularization procedures were performed in 1736 subjects (12%), and 34% were endovascular (n = 598). Substantial variability was noted in the preferred modality of hyperacute revascularization (range of endovascular recanalization = 6-60%), use of computed tomography (30-93%), and perfusion imaging (2-96%). The Clinical Research Center for Stroke--5th division registry documented that the current practice of acute stroke care in South Korea largely met the standard of guidelines, but variability of practice still remains. The registry would provide an opportunity to evaluate the quality of stroke care across South Korea and compare it with that of other countries.

  14. [A clinical analysis of 10 cases with cardiac lymphoma].

    PubMed

    Li, Y H; Shi, C Y; Duan, F Q; Pang, Y; Li, H B; Zhang, L Q; Liu, Z H; Ouyang, L; Yue, C Y; Xie, M C; Jiang, Z J; Xiao, Y

    2017-02-14

    Objective: To analyze the morbidity, clinical characteristics, therapeutic outcomes and prognosis of cardiac lymphoma. Methods: Individual patient data were obtained from pathology defined 10 cases of cardiac lymphoma from Jan 2000 to Jun 2016. The patient's general information, clinical manifestation, pathological diagnosis, laboratory examination, cardiac involvement feature, cardiac complications, treatment, therapeutic effect and prognosis were analyzed. Results: Of 3 918 cases of lymphoma patients, 10 cases of cardiac involvement were identified, including primary cardiac lymphoma (PCL) in 1 case, secondary cardiac lymphoma (SCL) in 9 cases. Of the 10 patients in our analysis, the male-to-female ratio was 3∶2, with a median age of 55 (19-88) years old. The most presenting complaints were dyspnea in 7 cases, followed by chest pain in 5 cases, fatigue in 2 patients and edema in 2 cases. Pathological types included diffuse large B cell lymphoma (DLBCL) in 7 cases, T cell lymphoma (T-LBL) in 1 case, Hodgkin's lymphoma (HL) in 1 case, and Burkitt lymphoma (BL) in 1 case. The sites of the heart affected by lymphoma in the PCL patient were right and left atriums with multiple nodules; and for SCL, the sites were mainly pericardium associated with a pericardial effusion in 5 cases, a pericardial mass in 2 cases. Congestive heart failure affects 7 patients and cardiac arrhythmias were identified in 4 cases mainly sinus tachycardia, atrial fibrillation and atrioventricular block. Except one untreated because of old age and poor performance, the rest of 9 patients were treated by either chemotherapy in 4 cases or chemotherapy combined radiotherapy (including the extracardiac sites) in 5 patients. With the median follow-up of 9 months, the one PCL patient achieved partial response (PR) , progress free survival (PFS) for 6 months and the overall survival (OS) for 21 months; in the cohort of 6 SCL patients cardiac involved at diagnosis, complete response (CR) was achieved

  15. 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

  16. Haematuria on the Spanish Registry of Glomerulonephritis.

    PubMed

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

    2016-01-28

    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.

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

    PubMed

    Uva, Miguel Sousa; Mota, João Carlos

    2003-10-01

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

  18. 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

    2016-06-17

    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.

  19. Nurse-managed wound clinic. A case study in success.

    PubMed

    Crumbley, D R; Ice, R C; Cassidy, R

    1999-01-01

    The wound Care Clinic at Naval Hospital Charleston is a nurse-managed ambulatory clinic that has demonstrated the successful application of nursing case management in caring for patients with chronic and complex wounds. Nursing case management is an outcomes-based system of assessment, planning, provision of nursing services, coordination of interdisciplinary efforts, education, and referral. Nursing case management has been shown, in the literature and at Naval Hospital Charleston, to be an extension of role of professional nursing practice and results in decreased costs, improved quality of care, faster wound healing times, decreased complications, and greater coordination of care between specialty disciplines. These positive results are illustrated in several case studies. Nursing case management has many implications for the successful implementation of any healthcare delivery system where decreased costs and improved quality of care are valued, and it has special benefit in the complex management of chronically ill patients.

  20. Breast and Colon Cancer Family Registries

    Cancer.gov

    The Breast Cancer Family Registry and the Colon Cancer Family Registry were established by the National Cancer Institute as a resource for investigators to use in conducting studies on the genetics and molecular epidemiology of breast and colon cancer.

  1. Nephrology registry gives specialty control of quality data.

    PubMed

    Weinstein, Adam; Beckrich, Amy; Singer, Dale

    2015-11-01

    It is important for providers and practices to begin working with registry level data. Submitting data to a qualified clinical data registry currently satisfies Meaningful Use Stage II menu set items. In the future, with the rollout of MIPS and the increasing focus on sharing risk, registry data will be used as a benchmark for both publicly-reported performance (the physician compare program will be linked to provider-level QCDR data) and modifications to reimbursement. It is important to remember that PQRS data is the basis for the value based modifier now and MIPS- related quality data after 2018. The RPA has launched and is evolving a unique and versatile nephrology-specific data collection and analytics tool. In collaboration with the American Society of Diagnostic and Interventional Nephrology, vascular access measures will be added to the registry for 2016. The registry and the analytics platform is a tier of software operating above your practice management system and EHR and, if data can be obtained, it can span all the locations in which nephrologists provide care.

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

    PubMed

    Parker, Samantha

    2014-09-01

    This review aims to provide guidance on emerging concepts and policy related to European reference networks (ERNs) for rare diseases (RDs) and the development and management of RD patient registries. A major problem facing many RDs including rare renal disorders is that patients do not have a specialist centre that they can attend where clinicians, working as a multidisciplinary team, are experts in the particular disease. Furthermore, for most RDs, no single centre, and in many cases no single country, has sufficient numbers of patients and resources to fully understand the natural history or to conduct clinical and translational research. Therefore, the pooling of manpower and resources through the establishment of ERN and RD patient registries is a common and necessary area of collaboration. The concept of European networks for RDs dates back to the early 2000s and the Commission launch of a call for European pilot reference networks for RDs. These networks of expert centres have been brought together through the desire for further knowledge and innovation in RD areas. Networks demand a holistic approach and long-term vision with close collaboration between clinicians, diagnostic laboratories, scientists, patients and their families. The development of legal measures for ERNs is in progress at the Commission and these networks will be a shared responsibility of the Commission and member states. In the context of ERNs, an essential activity is the patient registries. Patient registries are organized databases where patient information, including demographic, medical and family history, are collected, stored and available for retrieval via standardized and secure methods. Patient registries are increasingly recognized as crucial tools for RD research for which international collaboration is absolutely essential to understand the pathogenesis of rare genotypes, achieve a unified collection of phenotypic data, foster natural history studies providing the foundation

  3. A PROLOG registry of experts

    SciTech Connect

    Ferrada, J.J.; Mashburn, S.A.; Rodgers, B.R.

    1988-01-01

    This paper discusses the use of Prolog in the construction of a user-friendly registry of consultants. This data base provides access by name, expertise, organization, or state. Also discussed are the features of this language which make it adaptable for this purpose. 3 refs., 11 figs. (LSP)

  4. In-Hospital and One-Year Clinical Outcome of Percutaneous Coronary Intervention in a Tertiary Hospital in Oman: Oman PCI Registry

    PubMed Central

    Panduranga, Prashanth; Al-Rashidi, Majdah; Al-Hajri, Fatma

    2017-01-01

    Objectives The aim of the study was to investigate the in-hospital and one-year clinical outcome of patients treated with percutaneous coronary intervention (PCI) in a tertiary hospital in Oman. Methods We conducted a retrospective, single-center, observational study looking at patients > 18 years old who underwent a PCI from 1 January to 31 December 2013. The primary end point was the occurrence of a major adverse cardiovascular event (MACE), defined as death, any myocardial infarction (MI), cerebrovascular accident (CVA), and target vessel revascularization (TVR) with either repeat PCI or coronary artery bypass surgery (CABG). Secondary end-points included procedural success rate, angina status, stent thrombosis, and the rate of redo-PCI/CABG for in-stent restenosis. Results A total of 1 045 consecutive patients were analyzed. The mean age of the cohort was 58.2±11.2 years. Hyperlipidemia (66.8%), hypertension (55.1%), and diabetes mellitus (45.9%) were the predominant risk factors. Stable angina, ST-elevation MI, non-ST-elevation MI, and post-acute coronary syndrome (ACS) were common indications (approximately 20.0% each). The angiographic and procedural success rate was 95.0%. Forty-six percent of patients had single-vessel disease, 34.4% had double vessel disease, and triple vessel disease was seen in 19.1% of patients. Ninety-eight percent had balloon angioplasty with stenting, and only 1.9% of patients had balloon angioplasty without stenting. The majority of patients had single-vessel stenting (81.3%). A drug-eluting stent was used in 88.4% of patients, and a bare-metal stent in 11.6%. In-hospital MACE was 3.6%. There were 19 in-hospital deaths (1.8%), and four patients (0.4%) had CVA/MI. Out of 1 026 patients discharged, 100 patients were lost to follow-up. Among the 926 patients followed-up, 673 patients (72.7%) were asymptomatic. One-year MACE was 17.0%, including 5.0% death and 6.0% MI. Repeat revascularization was performed in 53 patients (5

  5. 27 CFR 24.115 - Registry number.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Registry number. 24.115... OF THE TREASURY LIQUORS WINE Establishment and Operations Application § 24.115 Registry number. Upon approval of the application, the appropriate TTB officer will assign a registry number to the bonded...

  6. 42 CFR 493.1850 - Laboratory registry.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratory registry. 493.1850 Section 493.1850... registry. (a) Once a year CMS makes available to physicians and to the general public specific information...) The laboratory registry is compiled for the calendar year preceding the date the information is...

  7. 27 CFR 24.115 - Registry number.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  8. 27 CFR 24.115 - Registry number.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Registry number. 24.115... OF THE TREASURY LIQUORS WINE Establishment and Operations Application § 24.115 Registry number. Upon approval of the application, the appropriate TTB officer will assign a registry number to the bonded...

  9. 42 CFR 493.1850 - Laboratory registry.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratory registry. 493.1850 Section 493.1850... registry. (a) Once a year CMS makes available to physicians and to the general public specific information...) The laboratory registry is compiled for the calendar year preceding the date the information is...

  10. 14 CFR 47.19 - Registry.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Registry. 47.19 Section 47.19 Aeronautics... General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA under this Part must be mailed to the Registry, Department of Transportation, Post Office Box...

  11. 27 CFR 24.115 - Registry number.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  12. 42 CFR 493.1850 - Laboratory registry.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Laboratory registry. 493.1850 Section 493.1850... registry. (a) Once a year CMS makes available to physicians and to the general public specific information...) The laboratory registry is compiled for the calendar year preceding the date the information is...

  13. 14 CFR 47.19 - Registry.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Registry. 47.19 Section 47.19 Aeronautics... General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA under this part must be mailed to the Registry, Department of Transportation, Post Office Box...

  14. 27 CFR 24.115 - Registry number.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  15. 14 CFR 47.19 - Registry.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Registry. 47.19 Section 47.19 Aeronautics... General § 47.19 Registry. Each application, request, notification, or other communication sent to the FAA under this part must be mailed to the Registry, Department of Transportation, Post Office Box...

  16. 42 CFR 493.1850 - Laboratory registry.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Laboratory registry. 493.1850 Section 493.1850... registry. (a) Once a year CMS makes available to physicians and to the general public specific information...) The laboratory registry is compiled for the calendar year preceding the date the information is...

  17. 42 CFR 493.1850 - Laboratory registry.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratory registry. 493.1850 Section 493.1850... registry. (a) Once a year CMS makes available to physicians and to the general public specific information...) The laboratory registry is compiled for the calendar year preceding the date the information is...

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

    PubMed Central

    Mitchell, Ian; Lanctôt, Krista L.

    2013-01-01

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

  19. Respiratory-related hospitalizations following prophylaxis in the Canadian registry for palivizumab (2005-2012) compared to other international registries.

    PubMed

    Paes, Bosco; Mitchell, Ian; Li, Abby; Harimoto, Tetsuhiro; Lanctôt, Krista L

    2013-01-01

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

  20. German Cranial Reconstruction Registry (GCRR): protocol for a prospective, multicentre, open registry

    PubMed Central

    Giese, Henrik; Sauvigny, Thomas; Sakowitz, Oliver W; Bierschneider, Michael; Güresir, Erdem; Henker, Christian; Höhne, Julius; Lindner, Dirk; Mielke, Dorothee; Pannewitz, Robert; Rohde, Veit; Scholz, Martin; Schuss, Patrick; Regelsberger, Jan

    2015-01-01

    Introduction Owing to increasing numbers of decompressive craniectomies in patients with malignant middle cerebral artery infarction, cranioplastic surgery becomes more relevant. However, the current literature mainly consists of retrospective single-centre (evidence class III) studies. This leads to a wide variability of technical approaches and clinical outcomes. To improve our knowledge about the key elements of cranioplasty, which may help optimising clinical treatment and long-term outcome, a prospective multicentre registry across Germany, Austria and Switzerland will be established. Methods All patients undergoing cranioplastic surgery in participating centres will be invited to join the registry. Technical methods, materials, medical history, adverse events and clinical outcome measures, including modified Rankin scale and EQ-5D, will be assessed at several time points. Patients will be accessible to inclusion either at initial decompressive surgery or when cranioplasty is planned. Scheduled monitoring will be carried out at time of inclusion and subsequently at time of discharge, if any readmission is necessary, and at follow-up presentation. Cosmetic results and patient satisfaction will also be assessed. Collected data will be managed and statistically analysed by an independent biometric institute. The primary endpoint will be mortality, need for operative revision and neurological status at 3 months following cranioplasty. Ethics and dissemination Ethics approval was obtained at all participating centres. The registry will provide reliable prospective evidence on surgical techniques, used materials, adverse events and functional outcome, to optimise patient treatment. We expect this study to give new insights in the treatment of skull defects and to provide a basis for future evidence-based therapy regarding cranioplastic surgery. Trial registration number This trial is indexed in the German Clinical Trials Register (DRKS-ID: DRKS00007931). The

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

    PubMed

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

    2012-10-01

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

  2. 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

  3. REAC/TS Radiation Accident Registry: An Overview

    SciTech Connect

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

    2012-12-12

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

  4. Does a case completion curriculum influence dental students' clinical productivity?

    PubMed

    Park, Sang E; Susarla, Harlyn K; Nalliah, Romesh; Timothé, Peggy; Howell, T Howard; Karimbux, Nadeem Y

    2012-05-01

    The purpose of this study was to evaluate the effects of a new clinical curriculum on dental student productivity as measured by number of procedures performed in the student teaching practice. Harvard School of Dental Medicine adopted a new clinical education model for the predoctoral program in summer 2009 based upon a Case Completion Curriculum (CCC) rather than a discipline-based numeric threshold system. The two study groups (threshold group and case completion group) consisted of students who graduated in 2009 and 2010. Clinical performance was assessed by clinical productivity across five major discipline areas: periodontics, operative dentistry, removable prosthodontics, fixed prosthodontics, and endodontics. The relationships between the two study groups with regard to number of procedures performed by category revealed that the case completion group performed a significantly higher number of operative and removable prosthodontic procedures, but fewer periodontal and endodontic procedures (p≤0.03). No statistically significant difference in number of procedures was observed with fixed prosthodontic procedures between the two groups. Clinical productivity as a result of redesigning the clinical component of the curriculum varied in selected disciplines. The CCC, in which the comprehensive management of the patient was the priority, contributed to achieving a patient-based comprehensive care practice.

  5. [Cases of clinical and subclinical mastitis due to "D" streptococci].

    PubMed

    Aleksieva, V; Todorov, D

    1981-01-01

    Cytologic and bacteriologic investigations were carried out with a total of 364 samples of cow milk and secretion from 11 farms taken from individual quarters of the udder that have reacted positively and strongly positively with the rapid mastitis test Bernburg. It was found that in 330 of the cases there were data of clinical and subclinical mastitis of varying etiology. In 43 of the cases the causative agent (as isolated in pure cultures) proved to be "D" streptococci, giving positive reaction as judged by Schermann's criteria--from 9 cases of clinical and 34 cases of subclinical mastitis. The cell count varied from 360 000 to more than 5 million per cub. cm. Detailed studies were carried out on the cultural and biochemical properties of 31 strains of "D" streptococci, 17 strains belonging to Str. faecalis var. zymogenes, 9 strains--to Str. faecalis var. faecalis, and 5 strains--to Str. faecalis var. liquefaciens.

  6. Contemporary registries on P2Y12 inhibitors in patients with acute coronary syndromes in Europe: overview and methodological considerations.

    PubMed

    Jukema, J Wouter; Lettino, Maddalena; Widimský, Petr; Danchin, Nicolas; Bardaji, Alfredo; Barrabes, Jose A; Cequier, Angel; Claeys, Marc J; De Luca, Leonardo; Dörler, Jakob; Erlinge, David; Erne, Paul; Goldstein, Patrick; Koul, Sasha M; Lemesle, Gilles; Lüscher, Thomas F; Matter, Christian M; Montalescot, Gilles; Radovanovic, Dragana; Lopez-Sendón, Jose; Tousek, Petr; Weidinger, Franz; Weston, Clive F M; Zaman, Azfar; Zeymer, Uwe

    2015-10-01

    Patient registries that document real-world clinical experience play an important role in cardiology as they complement the data from randomized controlled trials, provide valuable information on drug use and clinical outcomes, and evaluate to what extent guidelines are followed in practice. The Platelet Inhibition Registry in ACS EvalUation Study (PIRAEUS) project is an initiative of registry holders who are managing national or international registries observing patients with acute coronary syndromes (ACS). The aim of PIRAEUS is to systematically compare and combine available information/insights from various European ACS registries with a focus on P2Y12 inhibitors. The present publication introduces the 17 participating registries in a narrative and tabular form, and describes which ACS groups and which dual antiplatelet therapies were investigated. It sets the basis for upcoming publications that will focus on effectiveness and safety of the antiplatelets used.

  7. A renal registry for Africa: first steps

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    2013-01-01

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

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

    PubMed Central

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

    2017-01-01

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

  10. Orofacial pain of cardiac origin: Review literature and clinical cases

    PubMed Central

    Garcia-Vicente, Laia; Jané-Salas, Enric; Estrugo-Devesa, Albert; Chimenos-Küstner, Eduardo; Roca-Elias, Josep

    2012-01-01

    The most common types of orofacial pain originate at the dental or periodontal level or in the musculoskeletal structures. However, the patient may present pain in this region even though the source is located elsewhere in the body. One possible source of heterotopic pain is of cardiac origin. Objectives: Report two cases of orofacial pain of cardiac origin and review the clinical cases described in the literature. Study Design: Description of clinical cases and review of clinical cases. Results and conclusions: Nine cases of atypical pain of cardiac origin are recorded, which include 5 females and 4 males. In craniofacial structures, pain of cardiac origin is usually bilateral. At the craniofacial level, the most frequent location described is in the throat and jaw. Pain of cardiac origin is considered atypical due to its location, although roughly 10% of the cases of cardiac ischemia manifest primarily in craniofacial structures. Finally, the differential diagnosis of pain of odontogenic origin must be taken into account with pain of non-odontogenic origin (muscle, psychogenic, neuronal, cardiac, sinus and neurovascular pain) in order to avoid diagnostic errors in the dental practice as well as unnecessary treatments. Key words:Orofacial pain, ischemic heart disease, heterotopic pain, odontalgia. PMID:22322488

  11. Thyroid Cancer and Tumor Collaborative Registry (TCCR)

    PubMed Central

    Shats, Oleg; Goldner, Whitney; Feng, Jianmin; Sherman, Alexander; Smith, Russell B.; Sherman, Simon

    2016-01-01

    A multicenter, web-based Thyroid Cancer and Tumor Collaborative Registry (TCCR, http://tccr.unmc.edu) allows for the collection and management of various data on thyroid cancer (TC) and thyroid nodule (TN) patients. The TCCR is coupled with OpenSpecimen, an open-source biobank management system, to annotate biospecimens obtained from the TCCR subjects. The demographic, lifestyle, physical activity, dietary habits, family history, medical history, and quality of life data are provided and may be entered into the registry by subjects. Information on diagnosis, treatment, and outcome is entered by the clinical personnel. The TCCR uses advanced technical and organizational practices, such as (i) metadata-driven software architecture (design); (ii) modern standards and best practices for data sharing and interoperability (standardization); (iii) Agile methodology (project management); (iv) Software as a Service (SaaS) as a software distribution model (operation); and (v) the confederation principle as a business model (governance). This allowed us to create a secure, reliable, user-friendly, and self-sustainable system for TC and TN data collection and management that is compatible with various end-user devices and easily adaptable to a rapidly changing environment. Currently, the TCCR contains data on 2,261 subjects and data on more than 28,000 biospecimens. Data and biological samples collected by the TCCR are used in developing diagnostic, prevention, treatment, and survivorship strategies against TC. PMID:27168721

  12. Thyroid Cancer and Tumor Collaborative Registry (TCCR).

    PubMed

    Shats, Oleg; Goldner, Whitney; Feng, Jianmin; Sherman, Alexander; Smith, Russell B; Sherman, Simon

    2016-01-01

    A multicenter, web-based Thyroid Cancer and Tumor Collaborative Registry (TCCR, http://tccr.unmc.edu) allows for the collection and management of various data on thyroid cancer (TC) and thyroid nodule (TN) patients. The TCCR is coupled with OpenSpecimen, an open-source biobank management system, to annotate biospecimens obtained from the TCCR subjects. The demographic, lifestyle, physical activity, dietary habits, family history, medical history, and quality of life data are provided and may be entered into the registry by subjects. Information on diagnosis, treatment, and outcome is entered by the clinical personnel. The TCCR uses advanced technical and organizational practices, such as (i) metadata-driven software architecture (design); (ii) modern standards and best practices for data sharing and interoperability (standardization); (iii) Agile methodology (project management); (iv) Software as a Service (SaaS) as a software distribution model (operation); and (v) the confederation principle as a business model (governance). This allowed us to create a secure, reliable, user-friendly, and self-sustainable system for TC and TN data collection and management that is compatible with various end-user devices and easily adaptable to a rapidly changing environment. Currently, the TCCR contains data on 2,261 subjects and data on more than 28,000 biospecimens. Data and biological samples collected by the TCCR are used in developing diagnostic, prevention, treatment, and survivorship strategies against TC.

  13. Hereditary cancer registries improve the care of patients with a genetic predisposition to cancer: contributions from the Dutch Lynch syndrome registry.

    PubMed

    Vasen, Hans F A; Velthuizen, Mary E; Kleibeuker, Jan H; Menko, Fred H; Nagengast, Fokke M; Cats, Annemieke; van der Meulen-de Jong, Andrea E; Breuning, Martijn H; Roukema, Anne J; van Leeuwen-Cornelisse, Inge; de Vos Tot Nederveen Cappel, Wouter H; Wijnen, Juul T

    2016-07-01

    The Dutch Hereditary Cancer Registry was established in 1985 with the support of the Ministry of Health (VWS). The aims of the registry are: (1) to promote the identification of families with hereditary cancer, (2) to encourage the participation in surveillance programs of individuals at high risk, (3) to ensure the continuity of lifelong surveillance examinations, and (4) to promote research, in particular the improvement of surveillance protocols. During its early days the registry provided assistance with family investigations and the collection of medical data, and recommended surveillance when a family fulfilled specific diagnostic criteria. Since 2000 the registry has focused on family follow-up, and ensuring the quality of surveillance programs and appropriate clinical management. Since its founding, the registry has identified over 10,000 high-risk individuals with a diverse array of hereditary cancer syndromes. All were encouraged to participate in prevention programmes. The registry has published a number of studies that evaluated the outcome of surveillance protocols for colorectal cancer (CRC) in Lynch syndrome, as well as in familial colorectal cancer. In 2006, evaluation of the effect of registration and colonoscopic surveillance on the mortality rate associated with colorectal cancer (CRC) showed that the policy led to a substantial decrease in the mortality rate associated with CRC. Following discovery of MMR gene defects, the first predictive model that could select families for genetic testing was published by the Leiden group. In addition, over the years the registry has produced many cancer risk studies that have helped to develop appropriate surveillance protocols. Hereditary cancer registries in general, and the Lynch syndrome registry in particular, play an important role in improving the clinical management of affected families.

  14. A Computerized Case Study Exercise for Clinical Pharmacy Students.

    ERIC Educational Resources Information Center

    Guy, Wendell A.; Piltz, George W.

    1982-01-01

    A computer-assisted exercise consisting of a case history of an asthmatic patient and a series of multiple-choice questions that forced the student to reanswer until reaching the correct response enable students to practice using clinical information, follow treatment steps, and have feedback on their treatment choices. (Author/MSE)

  15. Client interfaces to the Virtual Observatory Registry

    NASA Astrophysics Data System (ADS)

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

    2015-04-01

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

  16. [Clinical case of the month. Constrictive pericarditis with a macroscopically normal pericardium: apropos of a case].

    PubMed

    Hoffer, E; Materne, P; Limet, R; Boland, J

    2007-04-01

    The diagnosis of constrictive pericarditis is not easy to make. This rare condition can be suggested by clinical, echocardiograohic, hemodynamic, and radiological signs. It must be distinguished from restrictive cardiomyopathy as therapeutic options are radically different. We present an ambiguous case of constrictive pericarditis with macroscopically normal pericardium recognized 10 years after open-chest cardiac surgery: a large pericardiectomy rapidly induced clinical improvement.

  17. Varied clinical presentation of os odontoideum: a case report

    PubMed Central

    Chrobak, Karen; Larson, Ryan; Stern, Paula J.

    2014-01-01

    Objective: To present a case of an os odontoideum and to provide insight into the varied clinical presentations. Clinical Features: A 54 year old man presented with chronic neck pain without headache. A clinical examination was performed and the chiropractor viewed his AP and lateral radiographs. Previous flexion/ extension radiographs and MRI imaging from 2009 were requested for review. The patient was diagnosed with grade II mechanical neck pain. Treatment was rendered that day which included spinal manipulation/ mobilization. Several days later the requested imaging reports were received and described the presence of an os odontoideum. Conclusion: In the presence of os odontoideum, familiarity with the signs and symptoms of potential cervical instability is imperative. Health care providers must remain diligent in their patient histories, physical exams, and imaging. This case highlights the importance of following up on imaging studies to rule out diagnoses that would involve treatment contraindications thus ensuring safe and effective treatment. PMID:25202154

  18. Clinical outcomes of 3-year experience of targeted temperature management in patients with out-of-hospital cardiac arrest at Songklanagarind Hospital in Southern Thailand: an analysis of the MICU-TTM registry

    PubMed Central

    Vattanavanit, Veerapong; Bhurayanontachai, Rungsun

    2016-01-01

    Background Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of intensive care unit admission, which results in high hospital mortality. Targeted temperature management (TTM) was introduced several years ago and is considered to improve neurological and mortality outcomes. This management process was implemented in our hospital in 2012, which was expected to improve the standard of care in OHCA patients. Purpose We aimed to report the clinical and mortality outcomes after TTM was introduced to our hospital in 2012. Patients and methods An analysis of data from the Medical Intensive Care Unit-TTM registry between 2012 and 2015 was performed. After successful cardiopulmonary resuscitation, TTM was applied to all OHCA patients regardless of causes if there was no contraindication. The Cerebral Performance Category scale score and other clinical outcomes were recorded and analyzed. Results Out of 23 patients, 87% were male and the mean age was 54.5±18.1 years. The causes of OHCA from cardiac etiology comprised 52.2%. The most common initial cardiac rhythm was ventricular fibrillation (47.8%). The survival rate to hospital discharge was 47.8% (11/23), but neurological outcomes were in a persistent vegetative state (8/11, 72.7%). The group with poor neurological outcomes had a significantly higher Acute Physiologic Assessment and Chronic Health Evaluation II score than the group with good neurological outcomes (22.9±4.2 vs 16.0±3.6, P=0.01). In the multivariate analysis, initial shockable rhythm was associated with survival at hospital discharge (odds ratio 10.1, 95% confidence interval 1.1–94.3, P=0.04). Conclusion TTM in OHCA patients gave better mortality benefits compared to our previous records, despite poor neurological outcomes. Ventilator-associated pneumonia was the major complication of TTM. Therefore, TTM should be considered in OHCA patients, especially in shockable rhythms, after return of spontaneous circulation. PMID:27660500

  19. EPA Facility Registry Service (FRS): RBLC

    EPA Pesticide Factsheets

    This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link to the RACT/BACT/LAER Clearinghouse (RBLC). The RBLC database contains case-specific information on the air pollution technologies that have been required to reduce the emission of air pollutions from stationary sources. RACT, or Reasonably Available Control Technology, is required on existing sources in areas that are not meeting national ambient air quality standards. BACT, or Best Available Control Technology, is required on major new or modified sources in clean areas. LAER, or Lowest Achievable Emission Rate, is required on major new or modified sources in non-attainment areas. FRS identifies and geospatially locates facilities, sites or places subject to environmental regulations or of environmental interest. Using vigorous verification and data management procedures, FRS integrates facility data from EPA's national program systems, other federal agencies, and State and tribal master facility records and provides EPA with a centrally managed, single source of comprehensive and authoritative information on facilities. This data set contains the subset of FRS integrated facilities that link to RBLC facilities once the RBLC data has been integrated into the FRS database. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs.

  20. Update on the NAS-NRC Twin Registry.

    PubMed

    Page, William F

    2006-12-01

    The National Academy of Sciences-National Research Council (NAS-NRC) Twin Registry is one of the oldest, national population-based twin registries in the United States. It consists of 15,924 white male twin pairs born in the years 1917 to 1927 (inclusive), both of whom served in the armed forces, mostly during World War II. This article updates activity in this registry since the earlier 2002 article in Twin Research. The results of clinically based studies on dementia, Parkinson's disease, age-related macular degeneration, and primary osteoarthritis were published, as well as articles based on previously collected questionnaire data on chronic fatigue syndrome, functional limitations, and healthy aging. In addition, risk factor studies are being planned to merge clinical data with earlier collected risk factor data from questionnaires. Examination data from the subset of National Heart, Lung, and Blood Institute (NHLBI) twins resulted in a number of articles, including the relationship of endogenous sex hormones to coronary heart disease and morphological changes in aging brain structures. The NEO Five-Factor Personality Inventory (a paper-and-pencil self-administered questionnaire) has been fielded for the first time. A push to consolidate the various data holdings of the registry is being made.

  1. The Danish National Multiple Myeloma Registry

    PubMed Central

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

    2016-01-01

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

  2. Trichomycosis (Trichobacteriosis): Clinical and Microbiological Experience with 56 Cases

    PubMed Central

    Bonifaz, Alexandro; Váquez-González, Denisse; Fierro, Leonel; Araiza, Javier; Ponce, Rosa María

    2013-01-01

    Background: Trichomycosis is asymptomatic bacterial infection of the axillary hairs caused by Corynebacterium sp. Objective: to bring a series of cases of trichomycosis, its clinical and microbiological experience. Materials and Methods: This report consists in a linear and observational retrospective study of 15 years of cases of trichomycosis confirmed clinically and microbiologically. Results: Fifty six confirmed cases of trichomycosis were included in this report. The majority were men 53/56 (94.6%), mean age was 32.5 years. The most commonly affected area was the axilla (92%), trichomycosis flava was the principal variant 55/56 (98.2%) and signs and symptoms associated were hyperhidrosis (87.5%), hairs’ texture change (57.1%) and odor (35.7%). Bacterial concretions were observed in all cases, and the predominant causative agent in 89.3% of all cases was Corynebacterium sp. Thirty patients were included in therapeutic portion of the study, and 28 (93.3%) of them experienced a clinical and microbiological cure. Conclusion: Trichomycosis is asymptomatic, superficial infection, which primarily affects axillary hairs. PMID:23960390

  3. Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment

    PubMed Central

    Willemsen, Jochem; Della Rosa, Elena; Kegerreis, Sue

    2017-01-01

    This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases. PMID:28210235

  4. Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment.

    PubMed

    Willemsen, Jochem; Della Rosa, Elena; Kegerreis, Sue

    2017-01-01

    This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases.

  5. Clinical features of paroxysmal kinesigenic dyskinesia: report of 24 cases.

    PubMed

    Sun, Wei; Li, Jianing; Zhu, Yulan; Yan, Xiaobo; Wang, Weizhi

    2012-12-01

    Paroxysmal kinesigenic dyskinesia (PKD) is the most common type of paroxysmal dyskinesia and is characterized by involuntary, intermittent movements induced by sudden movements. Here, we describe 24 patients with PKD, whose clinical data were analyzed. The attacks of involuntary movements were all short lasting, and could involve extremities, trunk, neck, or face without alteration of consciousness. The motor function was normal between attacks, and in some cases, attacks could be evoked during examination. Most patients had normal electroencephalogram (EEG) and neuroimaging results, but 2 cases had abnormal EEGs, and another 2 cases had bilateral calcification of basal ganglion on brain computed tomography (CT) scans. Previous history of misdiagnosis was a predominant feature, while treatments based on misdiagnosis sometimes did lead to improvement. Here, we discuss the clinical characteristics, especially the abnormalities of investigations and misdiagnosis, and recent insights into the pathophysiology of PKD.

  6. CIRSE Vascular Closure Device Registry

    SciTech Connect

    Reekers, Jim A.; Mueller-Huelsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zelenak, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

    2011-02-15

    Purpose: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.

  7. [The contribution of the Italian association of cancer registries (AIRTUM)].

    PubMed

    Crocetti, Emanuele; Buzzoni, Carlotta

    2016-01-01

    The study of cluster requires the ability to identify, with accuracy and completeness, the health events of interest and their geographical location and time of occurrence. For rare and complex diseases, such as childhood cancers, it is possible to observe a significant health migration from the place of residence, which makes the detection even more complex. The best tool to identify these rare diseases is represented by cancer registries (CRs). In fact, CRs collect, through many sources, information related to tumours that arise in the population resident in their areas of activity. The number of the sources of information has increased thanks to the computerization of health services. The availability of multiple sources of information increases the completeness of data collection overcoming the limits of a single source, and makes it possible to describe the diagnostic-therapeutic course and the outcome of the cases. Among all data sources, for childhood cancers the model 1.01, which summarize the clinical information of the cases treated in one of the Italian Association of paediatric haematology and oncology (AIEOP) centres, is relevant. Moreover, CRs produce reliable and comparable data due to the use of international rules and classifications for the definition of the topography and morphology of cancer, for the date of diagnosis, and for quality checks. In Italy, the Italian association of cancer registries (AIRTUM) coordinates the activities of 45 population CRs, both general and specialized (by age or tumour type). AIRTUM involves a population of over 6.7 million citizens under the age of 20 years, approximately 60% of the total resident population. AIRTUM plays a role of coordination, support, and harmonization for Italian CRs through training, accreditation, and a shared database, it promotes and participates in national and international collaboration involving scientific societies (AIEOP, Italian Association of medical oncology - AIOM, Italian

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-02-15

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

  10. A registry-based case-control study of risk factors for the development of multiple non-fatal injuries on the job.

    PubMed

    Li, C Y; Du, C L; Chen, C J; Sung, F C

    1999-07-01

    Using compensation records of Taiwan, we conducted a case-control study nested within a cohort of 77,846 active workers who experienced at least one incidence of non-fatal work-related injury between 1994 and 1996 in order to explore factors associated with risk of sustaining multiple non-fatal injuries in the workplace. Cases (n = 2,616) were workers with more than three incidences of non-fatal injury during the study period and controls (n = 3,974) were randomly sampled from workers who experienced only one incidence of non-fatal injury during the same period. Compared with construction workers, workers employed in mining and quarrying (OR = 2.7), manufacturing (OR = 1.2), commerce (OR = 1.6), transport, storage and communication (OR = 1.3) and social, personal and community service (OR = 1.4) were all at significantly elevated risk of multiple non-fatal injuries. Both age and wage showed a significant dose-response effect on the risk of developing multiple non-fatal injuries. The preliminary analysis suggests that workers in certain industries are at significantly elevated risks of multiple work-related non-fatal injuries, in particular those in the mining and quarry industries. Additionally, further preventive measures should be aimed at protecting older workers from such injuries and further studies would help provide more specific interpretations on the positive association between higher wage earning and risk of multiple non-fatal injuries.

  11. Differences in Baseline Characteristics and Outcomes at One-and Two-Year Follow-up of Cancer Survivors Accrued via Self-Referral versus Cancer Registry in the FRESH START Diet and Exercise Trial

    PubMed Central

    Snyder, Denise Clutter; Sloane, Richard; Lobach, David; Lipkus, Isaac M.; Peterson, Bercedis; Kraus, William; Demark-Wahnefried, Wendy

    2013-01-01

    Participant accrual to research studies is a challenge, and oftentimes advertisements are used to supplement cases ascertained through clinic caseloads and cancer registries. It is unknown however, if cases ascertained through these two sources differ. In this study, we compare self-referred (n=209) versus cancer registry-ascertained participants (n=334) enrolled in FRESH START, a randomized controlled trial promoting a healthy diet and increased exercise among breast and prostate cancer survivors. The two groups were compared on baseline characteristics, adherence, attrition, and outcomes by study arm. Compared to participants enrolled from registries, self-referrals were significantly younger (54.1±10.4 vs. 58.7±10.7 years), more likely to have later-staged disease and to have received chemotherapy (40% vs. 19%), and more likely to report “fighting spirit” coping styles (50% vs. 30%), lower quality-of-life (88.2+15.1 vs. 92.0+12.9), fewer co-morbid conditions (1.87±1.60 vs. 2.24±1.78), and lower consumption of 5 or more daily servings of fruits and vegetables (35% vs. 45%)(p-values <.05). While no differences in behavior change were observed between self-referred and registry-ascertained cases assigned to the tailored intervention arm, this was not the case within the attention control arm. Among those who received the attention control intervention of standardized materials in the public domain, self-referred versus registry-ascertained participants demonstrated significantly greater increases in exercise at 1-year follow-up, and significantly greater increases in fruit and vegetable consumption at both 1- and 2-year follow-up (p-values <.05). Several differences exist between self-referred versus registry-ascertained participants, including motivation to respond to standardized educational materials which appears significantly greater in self-referred populations. PMID:18483353

  12. Quality of trauma care and trauma registries.

    PubMed

    Pino Sánchez, F I; Ballesteros Sanz, M A; Cordero Lorenzana, L; Guerrero López, F

    2015-03-01

    Traumatic disease is a major public health concern. Monitoring the quality of services provided is essential for the maintenance and improvement thereof. Assessing and monitoring the quality of care in trauma patient through quality indicators would allow identifying opportunities for improvement whose implementation would improve outcomes in hospital mortality, functional outcomes and quality of life of survivors. Many quality indicators have been used in this condition, although very few ones have a solid level of scientific evidence to recommend their routine use. The information contained in the trauma registries, spread around the world in recent decades, is essential to know the current health care reality, identify opportunities for improvement and contribute to the clinical and epidemiological research.

  13. [Clinically isolated discharges from the nipples. Apropos of 74 cases].

    PubMed

    Granger, M; Fetissof, F; Jallais, L; Sam Giao, M; Lansac, J

    1985-01-01

    74 cases with discharge from the breasts were treated surgically by pyramidectomy and histology. The histology was studied. The causes were: 1) ectasia (55%), 2) papilloma (30%) and 3), much more rare, cancer (8%). A blood-stained discharge (31 cases, 42%) could be due to these three causes, but the 4 cancers and the 2 borderline lesions belonged to the group of blood-stained discharges. A serious discharge (17 cases, 23%) could be due to ectasia or a papilloma. A thick discharge (16 cases, 21.5%) is always due to ectasia. The lactiferous duct is treated clinically and using X-rays to outline it. X-ray diagnostic methods and cytology are used in making the diagnosis. Clusters of papillae show that there is intra-canular proliferation. The literature is reviewed and a scheme of treatment is outlined.

  14. Complications of Zygomatic Implants: Our Clinical Experience with 4 Cases

    PubMed Central

    Tzerbos, Fotios; Theologie-Lygidakis, Nadia; Fakitsas, Dimitrios; Fakitsas, Ioannis

    2016-01-01

    Zygomatic implants have been used for rehabilitation of the edentulous atrophic maxilla as an alternative to bone grafting for almost two decades resulting in satisfactory clinical outcomes. However, the patients with edentulous atrophic maxilla treated using this technique may present serious complications that could put the prosthetic restoration at risk. Four cases are reported in this paper, one case with a cutaneous fistula in the left zygomatic-orbital area caused by aseptic necrosis at the apical part of the implant, which was treated with the surgical removal of this part, a second case with loss of the right zygomatic implant due to failure of osseointegration and two cases of periimplantitis that resulted in partial and complete removal of the implant, respectively. All patients who had complications were treated without compromising the restoration which remained functional after appropriately modified treatment. PMID:27847399

  15. I RBH - First Brazilian Hypertension Registry

    PubMed Central

    Jardim, Paulo César Brandão Veiga; de Souza, Weimar Kunz Sebba Barroso; Lopes, Renato Delascio; Brandão, Andréa Araújo; Malachias, Marcus V. Bolívar; Gomes, Marco Mota; Moreno Júnior, Heitor; Barbosa, Eduardo Costa Duarte; Póvoa, Rui Manoel dos Santos

    2016-01-01

    Background: A registry assessing the care of hypertensive patients in daily clinical practice in public and private centers in various Brazilian regions has not been conducted to date. Such analysis is important to elucidate the effectiveness of this care. Objective: To document the current clinical practice for the treatment of hypertension with identification of the profile of requested tests, type of administered treatment, level of blood pressure (BP) control, and adherence to treatment. Methods: National, observational, prospective, and multicenter study that will include patients older than 18 years with hypertension for at least 4 weeks, following up in public and private centers and after signing a consent form. The study will exclude patients undergoing dialysis, hospitalized in the previous 30 days, with class III or IV heart failure, pregnant or nursing, with severe liver disease, stroke or acute myocardial infarction in the past 30 days, or with diseases with a survival prognosis < 1 year. Evaluations will be performed at baseline and after 1 year of follow-up. The parameters that will be evaluated include anthropometric data, lifestyle habits, BP levels, lipid profile, metabolic syndrome, and adherence to treatment. The primary outcomes will be hospitalization due to hypertensive crisis, cardiocirculatory events, and cardiovascular death, while secondary outcomes will be hospitalization for heart failure and requirement of dialysis. A subgroup analysis of 15% of the sample will include noninvasive central pressure evaluation at baseline and study end. The estimated sample size is 3,000 individuals for a prevalence of 5%, sample error of 2%, and 95% confidence interval. Results: The results will be presented after the final evaluation, which will occur at the end of a 1-year follow-up. Conclusion: The analysis of this registry will improve the knowledge and optimize the treatment of hypertension in Brazil, as a way of modifying the prognosis of

  16. Patient reported outcomes in hip arthroplasty registries.

    PubMed

    Paulsen, Aksel

    2014-05-01

    PROs are used increasingly in orthopedics and in joint registries, but still many aspects of use in this area have not been examined in depth. To be able to introduce PROs in the DHR in a scientific fashion, my studies were warranted; the feasibility of four often used PROs (OHS, HOOS, EQ-5D and SF-12) was examined in a registry context. Having the PROs in the target language is an absolute necessity, so I translated, cross-culturally adapted and validated a Danish language version of an often used PRO (OHS), since this PRO had no properly developed Danish language version. To minimize data loss and to maximize the data quality I validated our data capture procedure, an up to date AFP system, by comparing scannable, paper-based PROs, with manual single-key- and double-key entered data. To help further registry-PRO studies, I calculated the number of patients needed to discriminate between subgroups of age, sex, diagnosis, and prosthesis type for each of four often used PROs (OHS, HOOS, EQ-5D and SF-12), and to simplify the clinical interpretation of PRO scores and PRO change scores in PRO studies, I estimated MCII and PASS for two often used PROs (EQ-5D and HOOS). The feasibility study included 5,747 THA patients registered in the DHR, and I found only minor differences between the disease-specific and the generic PROs regarding ceiling and floor effects as well as discarded items. The HOOS, the OHS, the SF-12, and the EQ-5D are all appropriate PROs for administration in a hip registry. I found that group sizes from 51 to 1,566 were needed for subgroup analysis, depending on descriptive factors and choice of PRO. The AFP study included 200 THA patients (398 PROs, 4,875 items and 21,887 data fields), and gave excellent results provided use of highly structured questionnaires. OMR performed equally as well as manual double-key entering, and better than single-key entering. The PRO translation and validation study included 2,278 patients (and 212 patients for the test

  17. Central odontogenic fibroma: Retrospective study of 8 clinical cases

    PubMed Central

    Hrichi, Radia; Gargallo-Albiol, Jordi; Berini-Aytés, Leonardo

    2012-01-01

    Introduction and Objectives: The central odontogenic fibroma (COF) is a benign odontogenic tumour derived from the dental mesenchymal tissues. It is a rare tumour and only 70 cases of it have been published. Bearing in mind the rareness of the tumour, 8 new cases of central odontogenic fibroma have been found by analyzing the clinical, radiological and histopathological characteristics of COF. Patients and Method: A retrospective study was carried out on 3011 biopsies in the Service of Oral and Maxillofacial Surgery of the Dental Clinic of Barcelona University between January 1995 and March 2008. 85 odontogenic tumours were diagnosed of which 8 were central odontogenic fibroma. The radiological study was based on orthopantomographs, periapical and occlusal radiographies and computerised tomographics. The variables collected were: sex, age, clinical characteristics of the lesion, treatment received and possible reappearances of the tumour. Results: The central odontogenic fibroma represents 9.4% of all odontogenic tumours. Of the 8 cases, 5 were diagnosed in men and 3 in women. The average age was 19.9 years with an age range of 11 to 38 years. The most common location of the tumour was in the mandible. All cases were associated with unerupted teeth. Of the 8 tumours, 3 provoked rhizolysis of the adjacent teeth and 4 cases caused cortical bone expansion. 50% of the patients complained of pain associated to the lesion. No case of recurrence was recorded up to 2 years after the treatment. Conclusions: Central odontogenic fibromas usually evolve asymptomatically although they can manifest very aggressively provoking dental displacement and rhizolysis. Radiologically, COF manifest as a uni or multilocular radiotransparent image although they can be indistinguishable from other radiotransparent lesions making diagnosis more difficult. COF treatment involves conservative surgery as well as follow-up patient checks. Key words: Odontogenic tumour, central odontogenic

  18. Age distribution, polyps and rectal cancer in the Egyptian population-based cancer registry

    PubMed Central

    Veruttipong, Darlene; Soliman, Amr S; Gilbert, Samuel F; Blachley, Taylor S; Hablas, Ahmed; Ramadan, Mohamed; Rozek, Laura S; Seifeldin, Ibrahim A

    2012-01-01

    AIM: To describe the clinical and epidemiologic profiles of the disease and to compare the findings with those generated from the previous hospital-based studies. METHODS: The Gharbiah cancer registry is the only population-based cancer registry in Egypt since 1998. We analyzed the data of all colorectal cancer patients included in the registry for the period of 1999-2007. All medical records of the 1364 patients diagnosed in Gharbiah during the study period were retrieved and the following information abstracted: age, residence, diagnosis date, grade, stage, topology, clinical characteristics, and histology variables. Egyptian census data for 1996 and 2006 were used to provide the general population’s statistics on age, sex, residence and other related demographic factors. In addition to age- and sex-specific incidence rate analyses, we analyze the data to explore the incidence distribution by rural-urban differences among the 8 districts of the province. We also compared the incidence rates of Gharbiah to the rates of the Surveillance Epidemiology and End Results (SEER) data of the United States. RESULTS: Over the 9 year-period, 1364 colorectal cancer cases were included. The disease incidence under age 40 years was relatively high (1.3/105) while the incidence in the age groups 40 and over was very low (12.0/105, 19.4/105 and 21.2/105 in the age groups 40-59 years, 60-69 years and > 70 years, respectively). The vast majority of tumors (97.2%) had no polyps and 37.2% of the patients presented with primary lesions in the rectum. Colorectal cancer was more common in patients from urban (55%) than rural (45%) areas. Regional differences in colon and rectal cancer incidence in the 8 districts of the study province may reflect different etiologic patterns in this population. The registry data of Egypt shows a slightly higher incidence of colorectal cancer than the United States in subjects under age 40 years. The results also shows significantly lower incidence of

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

    PubMed

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

    2016-01-01

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

  20. Congenital abnormalities associated with limb deficiency defects: a population study based on cases from the Hungarian Congenital Malformation Registry (1975-1984).

    PubMed

    Evans, J A; Vitez, M; Czeizel, A

    1994-01-01

    Limb deficiency defects (LD) occurring among 1,575,904 births in Hungary during 1975-1984 were reviewed. The overall birth prevalence of LD was 1 in 1,816. This paper discusses the nature and distribution of the limb and other defects in the 275 (32%) children who had structural malformations in other systems. Two main forms of classification were used: morphologic and causal. Additional malformations were most commonly seen in infants with amelia, rudimentary limb (RL), radial/tibial (RT), intercalary or central axis (CA) LD and rarely in those with terminal transverse (TT) or ulnar/fibular (UF) defects. Upper limbs (81%) were involved significantly more often than lower limbs (42%) and there were more right-sided defects (83% vs. 71%) due to an excess of right arm involvement especially with radial ray and split hand anomalies. Single limb involvement was relatively common with amelia (88%), UF (82%), RT (50%), and TT (50%) defects. With other LD, multimelic involvement was more characteristic. This was usually symmetric with intercalary and RL defects but asymmetric with CA anomalies and digital deficiencies (DD). From a causal perspective, 17% of cases had genetic disorders, 52% had recognized associations, anomalies, sequences, environmental causes or patterns of unknown origin, and 31% had unknown patterns of malformations. The commonest entities were amnion disruption sequence (16% of cases) and VACTERL association (8%). Both of these disorders showed unusual temporal distribution. As anticipated, patterns of malformations differed with the type of LD. Amelia and digital amputations were often seen with body wall defects, atypical anencephaly or encephalocele, and cleft lip reflecting amnion disruption. Rudimentary limb was seen with anencephaly, omphalocele, renal agenesis, aberrant genitalia, and imperforate anus, reflecting defects of blastogenesis including the cloacal exstrophy and caudal regression sequences and Schisis association. Radial

  1. Cervical Paraganglioma Mimicking Thyroid Nodule: A Rare Clinical Case

    PubMed Central

    Aydoğan, Berna İmge; Dizbay Sak, Serpil; Güllü, Sevim

    2016-01-01

    Objective. Paraganglioma is a rare neuroendocrine tumor. When it is located in the neck, it is commonly misdiagnosed as other thyroid neoplasms. Case Report. We report a case of cervical paraganglioma in a 55-year-old female. Patient was admitted to our clinic with goiter and neck pain. Thyroid ultrasonography revealed a 20 mm solitary, heterogeneous nodule located in the upper pole of left thyroid lobe. Fine needle aspiration cytology was nondiagnostic. She underwent left lobectomy and histopathology showed paraganglioma. Discussion. Cervical paragangliomas should be considered in the differential diagnosis of thyroid nodules. PMID:27066280

  2. [Clinical single case study (n-of-1 trial)].

    PubMed

    Speich, R

    1998-09-01

    We conducted a single case (N-of-1) randomized trial in two patients. In the first case with bronchiolitis obliterans after lung transplantation a beneficial effect of inhaled steroids could be documented. The second patient suffered from symptoms compatible with HIV-associated M. Addison improving after cortisone, but the adrenocortical function was normal. Because the patient required the cortison treatment to be continued, we performed a n-of-1 trial which demonstrated the inefficacy of cortisone. This experience underscores the feasibility and usefulness of N-of-1 randomized clinical trials in medical practice.

  3. Lyell's Syndrome and Antimalarials: A Case Report and Clinical Review

    PubMed Central

    Nunes, Joana Miranda; Santareno, Sofia; Guerreiro, Lina; Margalho, Ana Filipa

    2017-01-01

    Toxic epidermal necrolysis (TEN) or Lyell's syndrome is a rare, however, life-threatening mucocutaneous disorder with an epidermal detachment of a total body surface area (TBSA) of >30%. It is triggered by an idiosyncratic immune-allergic reaction to a drug, with many possible drugs implicated. Treatment success relies on early diagnosis and withdrawal of suspected/causative drug(s) and supportive care. Clinical evidence for specific therapies is still sparse. It is described a case of Lyell syndrome by sulfonamides for chemoprophylaxis of malaria. The patient presented with an extensive, rapidly evolving skin detachment, which progressed, despite supportive therapy, involving about 80% of TBSA. This led us to initiate a course of immunoglobulin with good clinical response. The aim of this work is to provide a discussion of the case and simultaneously make a practical literature review of TEN. PMID:28250622

  4. [Juvenile vascular pathology due to homocystinuria. A clinical case report].

    PubMed

    Stio, F; Battisti, G; Felici, A; Marigliani, M; De Vita, M; Finizio, R; Fabrizio, G; Porcelli, C; Granai, A V

    1993-01-01

    The authors report a case of juvenile vasculopathy in a homocystinuria patient. They point out that thromboembolism may be the only symptomatic expression of this genetically determined metabolic disease. Diagnostic approach and surgical therapy of the vascular lesions as well as medical therapy to prevent further complications are analysed. The opportunity to perform clinical tests for the diagnosis of homocystinuria in all those young patients presenting vascular lesions without other risk factors is finally stressed.

  5. [Differential diagnosis from hyperglycemic ketoacidosis: pesticide poisoning. Clinical case].

    PubMed

    Vélez, Paola; Paredes, Patricio; Fuenmayor, Frances

    2016-04-01

    Diabetic ketoacidosis in children causes serious morbidity and mortality, especially if it is not recognized on time in the initial diagnosis. However, there are other diseases that can appear to be a metabolic disorder of this kind and be ignored if it is not suspected. We present a clinical case with hyperglycemic ketoacidosis due to the contact with organophosphate; we had to use a continuous infusion of insulin to control the metabolic disorder without repercussions after the girl came home.

  6. Early onset marfan syndrome: Atypical clinical presentation of two cases

    PubMed Central

    Ozyurt, A; Baykan, A; Argun, M; Pamukcu, O; Halis, H; Korkut, S; Yuksel, Z; Gunes, T; Narin, N

    2015-01-01

    Early onset Marfan Syndrome (eoMFS) is a rare, severe form of Marfan Syndrome (MFS). The disease has a poor prognosis and most patients present with resistance to heart failure treatment during the newborn period. This report presents two cases of eoMFS with similar clinical features diagnosed in the newborn period and who died at an early age due to the complications related to the involvement of the cardiovascular system. PMID:26929908

  7. Inception of an Australian spine trauma registry: the minimum dataset.

    PubMed

    Tee, J W; Chan, C H P; Gruen, R L; Fitzgerald, M C B; Liew, S M; Cameron, P A; Rosenfeld, J V

    2012-06-01

    Background The establishment of a spine trauma registry collecting both spine column and spinal cord data should improve the evidential basis for clinical decisions. This is a report on the pilot of a spine trauma registry including development of a minimum dataset. Methods A minimum dataset consisting of 56 data items was created using the modified Delphi technique. A pilot study was performed on 104 consecutive spine trauma patients recruited by the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR). Data analysis and collection methodology were reviewed to determine its feasibility. Results Minimum dataset collection aided by a dataset dictionary was uncomplicated (average of 5 minutes per patient). Data analysis revealed three significant findings: (1) a peak in the 40 to 60 years age group; (2) premorbid functional independence in the majority of patients; and (3) significant proportion being on antiplatelet or anticoagulation medications. Of the 141 traumatic spine fractures, the thoracolumbar segment was the most frequent site of injury. Most were neurologically intact (89%). Our study group had satisfactory 6-month patient-reported outcomes. Conclusion The minimum dataset had high completion rates, was practical and feasible to collect. This pilot study is the basis for the development of a spine trauma registry at the Level 1 trauma center.

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

    PubMed

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

    2015-09-01

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

  9. [Mastocytosis. Review of the literature and description of clinical cases].

    PubMed

    Melikian, A L; Subortseva, I N; Goriacheva, S R; Kolosheinova, T I; Vakhrusheva, M V; Kovrigina, A M; Sudarikov, A B; Dvirnyk, V N; Obukhova, T N

    2014-01-01

    The term mastocytosis (MC) encompasses a group of rare diseases characterized by the tumorous proliferation of clonal mast cells and the infiltration of one or several organs. The clinical picture of MC is extremely diverse from skin lesions that can spontaneously regress to the aggressive disease forms associated with organ dysfunction and short survival. Nowadays, the 2008 WHO classification identifies 7 MC subtypes. The disease is diagnosed on the basis of its clinical manifestations and detection of tumorous mast cell infiltrations via morphological, immunohistochemical, immunophenotypic, genetic, and molecular examinations. Abnormal mast cells are characterized by the atypical morphology and pathological expression of CD25 and CD2 antigens. Enhanced serum tryptase activity is a common sign in all MC subtypes. More than 90% of the patients have D816V KIT mutations in the mast cells. This paper reviews the literature. Three cases are described as a clinical example in patients with different MC subtypes.

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

    PubMed

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

    2012-03-01

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

  11. eXtended MetaData Registry

    SciTech Connect

    2006-10-25

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

  12. Pittsburgh Registry of Infant Multiplets (PRIM).

    PubMed

    Strassberg, Melissa; Peters, Katherine; Marazita, Mary; Ganger, Jennifer; Watt-Morse, Margaret; Murrelle, Lenn; Tarter, Ralph; Vanyukov, Michael

    2002-10-01

    This paper describes the Pittsburgh Registry of Infant Multiplets (PRIM; Pittsburgh, Pennsylvania), the results of pilot research conducted in this registry, and the plans for future studies. The main focus of the registry is on psychological development and the risk for behavioral disorders. Particularly, characteristics associated with antisociality and the risk for substance use disorders (e.g., aggressivity, hyperactivity/impulsivity), as well as language development and other traits (e.g., dental health) are among the research targets.

  13. UNUSUAL CLINICAL CASES THAT MIMIC ACUTE DISSEMINATED ENCEPHALOMYELITIS.

    PubMed

    Duman, Özgür; Yürekli, Vedat Ali; Gencpinar, Pinar; Karaali, Kamil; Gümüş, Hakan; Okuyaz, Çetin; Hazar, Volkan; Haspolat, Şenay

    2015-09-01

    Acute disseminated encephalomyelitis (ADEM) is an immune-mediated monophasic inflammatory demyelinating disorder of the central nervous system which poses a diagnostic challenge. We report on six cases of different etiologies that mimicked the clinical and radiologic findings of ADEM. The cases were collected from four different reference hospitals in Turkey. The same radiologist from the Akdeniz University Faculty of Medicine examined the magnetic resonance images of all patients. Three (50%) patients had antecedent infections. Initial symptoms of the patients were as follows: fever in 50%, altered consciousness in 33.3% and convulsions in 16.7% of patients. Neurologic examination showed long tract signs in 83.3%, ataxia in 50% and altered consciousness in 50% of patients. Cerebrospinal fluid examination revealed lymphocytic pleocytosis only in case 6. Four patients received steroid pulse therapy and one of these initially underwent intravenous immunoglobulin therapy. The patients' definitive diagnoses were as follows: paraspinal neuroblastoma-associated paraneoplastic syndrome; histiocytic sarcoma; mitochondrial myopathy, encephalopathy, lactic acidosis and stroke-like episodes; and cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy in one patient each, while two patients had hemophagocytic syndrome. The present case series demonstrated difficulties in diagnosing ADEM while revealing extremely rare disorders that mimic ADEM radiologically and clinically.

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

    PubMed

    Richesson, Rachel; Shereff, Denise; Andrews, James

    2010-04-01

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

  15. Cancer registries in Africa 2014: A survey of operational features and uses in cancer control planning.

    PubMed

    Gakunga, Robai; Parkin, D Maxwell

    2015-11-01

    A questionnaire survey of all active population based cancer registries in sub-Saharan Africa obtained information on their characteristics (size, staffing, funding), methods of working, the nature of any links between registries and their respective Health Authorities (national and/or local), and the use of their data in research or cancer control planning. 23/25 registries (92%) responded. Sources of direct funding and estimated amounts from each source were established, and suggest that it is approximately US$8-9 per case registered. Almost half of the funding is used for routine data collection, processing and analysis. Staffing levels vary, partly as a function of the registry size (approximately one FTE per 300 cases registered). Most data collection is active, using multiple sources (median 10 per registry), and is largely paper-based (abstraction onto paper forms), although all use the computer system CanReg© for data entry, storage and analysis. Most reporting by the registries is remarkably timely, and in general, their results are widely used by health authorities and other stakeholders in planning and evaluating services, while research output is much more variable. These registries are the source of almost all the existing information on cancer incidence and mortality in sub-Saharan Africa, as published in IARC's "Globocan".

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

    PubMed

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

    2015-06-01

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

  17. [A clinical case of demyelinating disease with basilar impression].

    PubMed

    Gasparini, A; Sterlicchio, M; Castiglioni, E; Raimondi, E

    1994-11-01

    The authors report a clinical case of a 48-year-old female patient admitted to the Neurological Division following acute symptoms characterised by generalised asthenia, motory disorders (incoordination, equilibrium or gait deficit) accompanied by diplopia. Instrumental (medullary and encephalic NMR) and laboratory tests revealed a malformation of the atlo-occpital hinge with basilar impression and areas of corticosubcortical demyelinisation signifying multiple sclerosis. The liquor test was also positive for the presence of oligoclonal bands of IgG with a Link index of 0.97 (lower v.n. at 0.7). The association between these two pathologies is rare, whereas the need for a differential diagnosis between them often arises. Therefore, two pathologies which are mutually exclusive in many cases were present in an associated form in this case.

  18. INDICATIONS FOR DISTAL RADIOULNAR ARTHROPLASTY: REPORT ON THREE CLINICAL CASES

    PubMed Central

    Santos, Cláudia; Pereira, Alexandre; Sousa, Marco; Trigeuiros, Miguel; Silva, César

    2015-01-01

    Distal radioulnar arthroplasty is an attractive solution for treating various pathological conditions of the distal radioulnar joint because it allows restoration of stability, load transmission and function. The main indications are: radioulnar impingement after partial or complete resection of the distal ulna; and degenerative, inflammatory or post-traumatic arthritis of the distal radioulnar joint. The authors present three clinical cases of distal radioulnar pathological conditions: two patients with post-traumatic sequelae and one case of distal radioulnar impingement after a Sauvé-Kapandji operation. The three cases were treated surgically with a metallic prosthesis to replace the distal ulna (First Choice - Ascension®). The first two were treated with a resurfacing prosthesis and the last one with a modular prosthesis. All of the patients had achieved pain relief and increased movement of the distal radioulnar joint after one year of postoperative follow-up. PMID:27047827

  19. ACTH adenomas transforming their clinical expression: report of 5 cases.

    PubMed

    Zoli, Matteo; Faustini-Fustini, Marco; Mazzatenta, Diego; Marucci, Gianluca; De Carlo, Eugenio; Bacci, Antonella; Pasquini, Ernesto; Lanzino, Giuseppe; Frank, Giorgio

    2015-02-01

    OBJECT Adrenocorticotropic hormone (ACTH) adenomas have been recognized as a more aggressive and invasive subtype of pituitary adenomas. An additional and clinically relevant peculiarity of these tumors is their ability to modify their clinical expression from a silent form to Cushing disease or vice versa. The aim of this study was to review a series of patients with pituitary adenomas and analyze the clinical implications of the transformation of clinical expression in 5 cases that showed this phenomenon. METHODS The authors retrospectively reviewed a series of patients with pituitary adenoma and collected clinical, biohumoral, and neuroradiological data of those who presented with a transformation from silent ACTH adenomas to functioning tumors or vice versa. In all the cases, preoperative assessment consisted of brain MRI, ophthalmological examination, and complete baseline endocrinological investigation. In patients with clinical and/or biochemical findings suspicious for Cushing syndrome, a low-dose dexamethasone suppression test was performed to rule in or out this diagnosis. Endocrinological evaluations were repeated 1 month after surgery, 3 months after surgery, and every 6 months or annually thereafter. Ophthalmological evaluations and brain MRIs were repeated after 3 months and then every 6 or 12 months thereafter. RESULTS Five patients (2 men and 3 women) included in this series had corticotropic tumors that showed transformation from an endocrinologically silent form to manifest Cushing disease and vice versa. The mean age at presentation was 40 years (range 18-51 years). In 3 of these patients, a transformation from silent to functioning ACTH adenoma with manifest Cushing disease occurred. In 1 patient, the authors observed the transition from a functioning to a silent adenoma with spontaneous resolution of hypercortisolism. Another patient's silent adenoma "shifted" to a functioning adenoma and then regressed back to a silent form with spontaneous

  20. [The user´s reporting from the national registry of catheter aortic valve implantations (Czech TAVI Registry): the possibilities of the analytical reports based on the database system TrialDB2].

    PubMed

    Bláha, Milan; Kala, Petr; Klimeš, Daniel; Bernat, Ivo; Branny, Marian; Cervinka, Pavel; Horák, Jan; Kočka, Viktor; Mates, Martin; Němec, Petr; Pešl, Ladislav; Stípal, Roman; Sťásek, Josef; Zelízko, Michael

    2014-10-01

    Assessment of the treatment procedures and their results is increasingly important in current medicine. The emphasis is put on an effective use of the health technologies (HTA). Unlike randomised studies, which involve strictly selected groups of patients who meet inclusion and exclusion criterias, the multicentre clinical registries provide a real-life picture of the treatment safety and effectiveness. Well prepared registries involve both research database and a friendly user interface enabling collection of parametric and easily analyzable data. Although there are some technological aspects aiming to ensure a maximum quality of entered data, cooperation with the users and data managers is essential. Such a registry, otherwise meaningful, must provide answers to previously defined medical hypotheses. Regular feedback to users (so called benchmarking or reporting) is considered to be of key importance. The Czech TAVI Registry (CTR) is a good example of reaching all of the above defined criterias. This registry contains data of approximately 95 % of all transcatheter aortic valve implantations (TAVI) performed in the Czech Republic. It is based on a general system aimed at the design of clinical trials, namely the TrialDB2 (a database system for clinical registries developed by the Institute of Biostatistics and Analyses at the Masaryk University (IBA MU). CTR has been run as an English-language version under the auspices of the Czech Society of Cardiology and represents one of the top-quality registries maintained by IBA MU. This paper presents the currently available database systems and some reports from this particular registry.

  1. The GEOSS Component and Service Registry

    NASA Astrophysics Data System (ADS)

    Di, L.; Bai, Y.; Shen, D.; Shao, Y.; Shrestha, R.; Wang, H.; Nebert, D. D.

    2011-12-01

    Petabytes of Earth science data have been accumulated through space- and air-borne Earth observation programs during the last several decades. The data are valuable both scientifically and socioeconomically. The value of these data could be further increased significantly if the data from these programs can be easily discovered, accessed, integrated, and analyzed. The Global Earth Observation System of Systems (GEOSS) is addressing this need. Coordinated by the Group on Earth Observations (or GEO), a voluntary partnership of 86 governments, the European Commission, and 61 intergovernmental, international, and regional organizations has been working on implementing GEOSS for a number of years. After four years of international collaboration, the GEOSS Common Infrastructure (GCI) has been established. GCI consists of the Standards and Interoperability Registry (SIR), the Component and Service Registry (CSR), the GEO clearinghouse, and the GEO Portal. The SIR maintains the list of the public standards recognized by the GEO. CSR provides a centralized registry for available Earth Observation resources. The GEO clearinghouse works as a single search facility for GEOSS-wide resources and the GEO Portal provides an integrated Web-based interfaces for users. Since January 2007, researchers at CSISS, GMU have collaborated with officials from the Federal Geographic Data Committee (FGDC) on designing, implementing, maintaining, and upgrading CSR. Currently CSR provides the following capabilities for data providers: user registration, resource registration, and service interface registration. The CSR clients can discover the resources registered in CSR through OGC Catalog for Web (CSW), UUDI, and other standard interfaces. During the resource registration process, providers may define detailed descriptive information for their resources, in particular, the targeted societal benefit area and sub-areas of focus, and the targeted critical Earth Observations. The service

  2. Creation of an international registry to support discovery in schwannomatosis.

    PubMed

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

    2017-02-01

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

  3. Result Publication of Chinese Trials in World Health Organization Primary Registries

    PubMed Central

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

    2010-01-01

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

  4. Fasa Registry on Acute Myocardial Infarction (FaRMI): Feasibility Study and Pilot Phase Results

    PubMed Central

    Askari, Alireza; Zakeri, Habib; Farjam, Mojtaba; Dehghan, Azizallah; Zendehdel, Kazem

    2016-01-01

    Background Myocardial infarction (MI) is the leading cause of death in Iran. Every attempt to improve treatment patterns and patient outcomes needs a surveillance system to both consider the efficacy and safety measures. Fasa Registry on Myocardial Infarction (FaRMI) is the first population-based registry for acute MI in Iran targeted to provide meticulous description of patients’ characteristics, to explore the management patterns of these patients, to discover the degree of adherence to the practice guidelines, and to investigate the determinants of poor in-hospital and later outcomes. Methods A diagnosis of acute MI (type I, II and III) was made upon the accepted criteria by the attending cardiologists and types IV and V MI were excluded. Two registrar nurses gathered data on demographics, place of residence and ethnicity, past medical history, risk factors, and the clinical course. Management patterns in the pre-hospital setting, during the hospital stay and at the discharge time were recorded. Routine laboratory results and cardiac biomarkers on three consecutive days were registered. Results pilot phase included the first 95 patients, 63.5% of whom were men and 31.5% were women. With a mean age of 62.89±13.75 years among participants, the rate of premature MI was 31.8%. ST segment elevation MI accounted for 68.2% cases and inferior wall was the most prevalent region involved followed by anterior and posterior walls. Discussion Obtained data on the characteristics of patients suffering an MI event revealed the major determinants of delay in initiation of therapies and contributors of poor outcome. Completeness of data was guaranteed upon involvement of multiple checkpoints and data quality was secured by means of automatic validation processes in addition to weekly physicians’ roundups. Conclusion Execution of FaRMI in the form presented is feasible and it will build up a comprehensive population-based registry for MI in the region. PMID:27907128

  5. Lichenoid sarcoidosis: a case with clinical and histopathological lichenoid features.

    PubMed

    Garrido-Ruiz, Maria C; Enguita-Valls, Ana B; de Arriba, Marta González; Vanaclocha, Francisco; Peralto, Jose Luis Rodriguez

    2008-06-01

    Sarcoidosis is a chronic multisystemic granulomatous disease of unknown etiology, characterized by the formation of noncaseating granulomas in the involved organs. Cutaneous involvement is about 25% with different clinical expressions, the lichenoid pattern being one of the rarest types of cutaneous sarcoidosis. Lichenoid sarcoidosis clinically manifests with multiple scale papules involving extensive skin areas, especially the trunk, limbs, and face mimicking a lichen planus. Although diverse histologic patterns have been previously related, a lichenoid granulomatous infiltrate involving the dermo-epidermal junction has never been reported in lichenoid sarcoidosis. We report a case of a 43-year-old woman presenting with skin-colored pruritic papules, slightly scaling in trunk, extremities, and ears. These symptoms condition continued to expand and worsen for several years. The patient was otherwise in good health with no lymphadenopathies. Histopathologic examination of a skin biopsy showed an upper dermal granulomatous infiltrate of epithelioid cells, without necrosis, distributed in a lichenoid pattern with many cytoid bodies. We consider this may be the first case presenting a characteristic microscopic granulomatous lichen-like pattern in the setting of a clinically lichenoid type of sarcoidosis.

  6. Coping with the isotretinoin registry.

    PubMed

    Baldwin, Hilary E

    2006-01-01

    The isotretinoin registry has arrived. It has a lofty goal of preventing all isotretinoin pregnancies. How we got to this point and what the registry means to prescribers and patients have many dermatologists confused and concerned. Will it be burdensome, will it preclude the use in most offices of this most important drug? Will it breed a new group of "isotretinologists" who are willing to take on the challenge? This article endeavors to answer these questions and to put most concerns at rest. The new system seems ultimately to have few changes compared to the risk management program we are already (technically) following. The difference is that compliance with all the rules will be monitored and mandatory. The system seems user friendly, is accessible to the computer-savvy as well as those of us still addicted to telephone, and may well turn out to be much fuss made over minimal hassle. What is clear is that this is likely our last chance to save this wonderful drug from oblivion. It is time for dermatologists to step to the plate and do what is in the best interest of their patients.

  7. Histopathological and clinical traps in lichen sclerosus: a case report.

    PubMed

    Brănişteanu, Daciana Elena; Brănişteanu, Daniel Constantin; Stoleriu, Gabriela; Ferariu, Dan; Voicu, Cătălina Maria; Stoica, Loredana Elena; Căruntu, Constantin; Boda, Daniel; Filip-Ciubotaru, Florina Mihaela; Dimitriu, Andreea; Radu, Cezar Doru

    2016-01-01

    Lichen sclerosus et atrophicus and limited systemic scleroderma (acrosclerosis) are inflammatory skin diseases that ultimately evolve into two distinct modes of atrophic scar formation, but which can easily be confused clinically. They are very rarely associated. The literature has reported cases in which lichen sclerosus was associated with various forms of scleroderma, but often with localized morphea. The characteristic histopathological picture of lichen sclerosus includes a thin epidermis, with orthohyperkeratosis and vascular degeneration in the basal layer, loss of elastic fibers, and band-like inflammatory infiltrate in the papillary dermis, while systemic sclerosis is characterized by excessive deposition of collagen in the dermis, accompanied by reduction in adnexal structures and their entrapment in collagen, and the presence of perivascular lymphocytic inflammatory infiltrate. We present the case of a 40-year-old female patient clinically diagnosed with systemic scleroderma and lichen sclerosus involving the genital mucosa. Physical examination in conjunction with laboratory findings (elevated antinuclear, anti-Scl-70, anti-SSA antibodies and immunogram) induced the supposition of the coexistence of lichen sclerosus and systemic scleroderma, fact confirmed by pathological examination. Systemic therapy with corticosteroids, immunosuppressive and phlebotropic drugs, peripheral vasodilators and other tropic adjuvants and topically potent topical corticosteroids was initiated. The course was favorable under therapy, the hardened skin slightly regaining elasticity, relief of itching and disappearance of lichen sclerosus lesions. Our case reaffirms the uncommon association of these two disorders. The importance of history, physical and laboratory examinations in making a diagnosis of certainty in emphasized.

  8. Examining an ethical dilemma: a case study in clinical practice.

    PubMed

    Narrigan, Deborah

    2004-01-01

    When clients and health care providers differ in their understanding of what is right or wrong, an ethical dilemma may arise. Such dilemmas occur in everyday clinical practice. Health care providers have the professional responsibility to analyze these dilemmas. A clinical case study of an ethical dilemma that occurred in a cross-cultural context is examined. The language of the client and provider differed, and no interpreter service was available. Given these conditions, the provider's ethical dilemma was whether, and if so how, to give safe, satisfying care that respected the needs of a client with limited English proficiency. Measuring the morality of the provider's decisions and actions using Rawls' ethical theory of social justice finds deficits. A 10-step Bioethical Decision-Making Model by Thompson is used to demonstrate one method for analyzing the moral dimension of a clinical scenario focusing on the decisions and actions taken by a midwife. Scrutinizing ethically challenging clinical encounters will result in better understanding of the moral dimensions of practice.

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

    PubMed

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

    2006-04-01

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

  10. Clinical Management of Two Root Resorption Cases in Endodontic Practice

    PubMed Central

    2016-01-01

    Root resorption is a pathological process involving loss of hard dental tissues. It may occur as a consequence of dental trauma, orthodontic treatment, and bleaching, and occasionally it accompanies periodontal disease. Although the mechanism of resorption process is examined in detail, its etiology is not fully understood. Wide open apical foramen is more difficult to manage and the root canal may often overfill. In this report we present two cases of root resorption and describe means for its clinical management. We conclude that useful measure of a success or failure in managing root resorption is the persistence of the resorption process. It is a clear sign of an active ongoing inflammatory process and shows the clinical need for retreatment. PMID:27648314

  11. Bilateral external ear canal osteomas - discussion on a clinical case.

    PubMed

    Gheorghe, D C; Stanciu, A E; Ulici, A; Zamfir-Chiru-Anton, A

    2016-01-01

    Osteomas of the external ear are uncommon benign tumors that need to be differentiated from the external ear canal exostoses, bony proliferations that are linked mainly to cold-water exposure. Clinical manifestations vary from no symptoms to recurrent local infections and external ear cholesteatoma. Objective: presenting a rare case that we did not find described in the published literature. A patient with multiple long-term asymptomatic osteomas of both external ear canals presented to our department. Material: Data recorded from the patient's medical record was reviewed and analyzed. Surgery was performed and histology confirmed the presumptive diagnosis. Results: There was a discrepancy between the local severity of the disease, with a complete obstruction of his ear canals, and the long-term disease-free status of the patient. Conclusion: We hypothesized about the etiology of these multiple bilateral osteomas of the EAC, in light of the clinical and surgical findings.

  12. [Assessment of individual clinical outcomes: regarding an electroconvulsive therapy case].

    PubMed

    Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo

    2015-01-01

    Evaluation of therapeutic results and of the efficacy and effectiveness of treatments is an area of interest both for clinicians and researchers. In general, randomized controlled trial designs have been used as the methodology of choice in which intergroup comparisons are made having a minimum of participants in each arm of treatment. However, these procedures are seldom used in daily clinical practice. Despite this fact, the evaluation of treatment results for a specific patient is important for the clinician in order to address if therapeutic goals have been accomplished both in terms of statistical significance and clinical meaningfulness. The methodology based on the reliable change index (Jacobson y Truax)1 provides an estimate of these two criteria. The goal of this article is to propose a procedure to apply the methodology with a single case study of a woman diagnosed with major depression and treated with electroconvulsive therapy.

  13. Validation of a Perfusion Registry: Methodological Approach and Initial Findings

    PubMed Central

    Paugh, Theron A.; Dickinson, Timothy A.; Theurer, Patricia F.; Bell, Gail F.; Shann, Kenneth G.; Baker, Robert A.; Mellas, Nicholas B.; Prager, Richard L.; Likosky, Donald S.

    2012-01-01

    Abstract: Although regional and national registries exist to measure and report performance of cardiac surgical programs, few registries exist dedicated to the practice of cardiopulmonary bypass (CPB). We developed and implemented a cardiovascular perfusion registry (Perfusion Measures and outcomes [PERForm] Registry) within the structure of the Michigan Society of Thoracic and Cardiovascular Surgeons (MSTCVS) to improve our understanding of the practice of CPB. The PERForm Registry comprises data elements describing the practice of CPB. Fourteen medical centers within MSTCVS have voluntarily reported these data on procedures in which CPB is used. We validated the case count among procedures performed between January 1, 2011 to December 31, 2011, and validated the values among 20 fields at three medical centers. We queried database managers at all 14 medical centers to identify the infrastructure that contributed to best overall data collection performance. We found that 98% of all records submitted to the PERForm and 95% of those submitted to the Society of Thoracic Surgeons (STS) matched. We found quite favorable agreement in our audit of select fields (95.8%). Those centers with the most favorable performance in this validation study were more likely to use electronic data capture, have a perfusionist as the STS database manager, and have involvement of the STS database manager in the PERForm or STS databases. We successfully and accurately collected data concerning cardiovascular perfusion among 14 institutions in conjunction with the MSTCVS. Future efforts will focus on expanding data collection to all MSTCVS participating institutions as well as more broadly outside of Michigan. PMID:23198390

  14. 14 CFR 47.19 - Registry.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  15. 50 CFR 600.1410 - Registry process.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 50 Wildlife and Fisheries 12 2014-10-01 2014-10-01 false Registry process. 600.1410 Section 600.1410 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC AND ATMOSPHERIC... United States § 600.1410 Registry process. (a) A person may register through the NMFS web site at...

  16. 50 CFR 600.1410 - Registry process.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 50 Wildlife and Fisheries 10 2011-10-01 2011-10-01 false Registry process. 600.1410 Section 600.1410 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC AND ATMOSPHERIC... United States § 600.1410 Registry process. (a) A person may register through the NMFS web site at...

  17. 50 CFR 600.1410 - Registry process.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 50 Wildlife and Fisheries 12 2013-10-01 2013-10-01 false Registry process. 600.1410 Section 600.1410 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC AND ATMOSPHERIC... United States § 600.1410 Registry process. (a) A person may register through the NMFS web site at...

  18. Esthetic management of anterior dental anomalies: A clinical case.

    PubMed

    Chafaie, Amir

    2016-09-01

    Many types of dental abnormality can be observed in the anterior sectors, where they can cause genuine esthetic problems for our patients. While conventional prosthetic treatments offer the best solutions in terms of esthetic result and durability, they involve the sacrifice of significant quantities of mineralized dental material and cannot be undertaken before the periodontal tissues are mature. Other less invasive alternatives should be envisaged as transitional, or sometimes even permanent, solutions for the management of these anomalies in children and adolescents. This article discusses these options and presents a clinical case where composite resin veneers and microabrasion of the enamel were used to treat dental agenesis and enamel dysplasia.

  19. Laser laparoscopic partial nephrectomy in clinical cases (N=17)

    NASA Astrophysics Data System (ADS)

    Teodorovich, Oleg; Zabrodina, Natalia; Galljamov, Eduard; Yankovskaya, Inna; Kochiev, David; Lukashev, Alexei

    2011-03-01

    A pulsed Nd:YAG laser approved for clinical use in Russian Federation was used for laparoscopic partial nephrectomy(LPN). Patients with T1N0M0 (N=17) cancer underwent laser LPN during 2006-2009 for removal tumor sized from 2.0 to 3.9 cm. Successful laser LPN was performed without ischemia in all cases. Bleeding during laser LPN was substantially reduced due to laser coagulation of tissue. Currently all patients are under medical supervision with no recurrence of tumor. A pulsed Nd:YAG laser showed safety and efficacy of LPN in humans.

  20. [Hypothalamyc hamartomas: different ways of clinical debut. Cases report].

    PubMed

    Cemeli-Cano, Mercedes; López Úbeda, Marta; Muñoz, Antonio de Arriba; Ferrer Lozano, Marta; Labarta Aizpún, José I

    2015-12-01

    Hypothalamic hamartomas are benign tumors of gray substance composed by hyperplasic neurons. They are usually asymptomatic small masses with extensions into the third ventricular cavity. In some instances they can cause cognitive behavioral alterations, seizures and/or central precocious puberty depending on the location. Here we present two cases of central precocious puberty due to hypothalamic hamartomas at 2(8/12) and 7 years of age. The younger patient also presents gelastic seizures, typically associated with hypothalamic hamartomas. After the clinical and radiological findings, they started treatment with GnRH analogues and a regression of the puberty signs without progression in the hamartomas size was observed.

  1. Case reports and clinical guidelines for managing radix entomolaris

    PubMed Central

    Thomas, Bejoy J.; Nishad, A.; Paulaian, Benin; Sam, Jonathan Emil

    2016-01-01

    Knowledge about the external and internal anatomy of the tooth is essential for successful dental practice. Anomalies in the tooth are often encountered which poses difficulties in dental treatments. As like any other tooth, mandibular first molars are also prone for anatomic malformations. One such anatomic variation is the presence of extra root distolingually. This distolingual root is called radix entomolaris (RE). The presence of an additional root can lead to difficulties during endodontic therapy. This article is a report of two cases describing the management of the first mandibular molars with an RE and clinical guidelines for its management. PMID:27829770

  2. [Cerebral hydatid cyst: Clinical case and review of the literature].

    PubMed

    Acha-Sánchez, José Luis; Yaya-Loo, Héctor José; Chipana-Sotomayor, Marco Enrique

    2016-12-13

    Hydatid disease is an accidental parasitosis, with brain location being rare. The case is reported of a 33year-old male, with no history of note, who was admitted to hospital with intracranial hypertension syndrome and right hemiparesis. Computed tomography showed a cystic lesion in the left frontal-parietal lobule. Surgery was performed by complete excision of the lesion, with a good outcome. Hydatid disease is a rare condition in the brain. Clinical suspicion is important for an early diagnosis. A review is presented on the pathogenesis, diagnosis and treatment of cerebral hydatid disease.

  3. The NeuroAiD Safe Treatment (NeST) Registry: a protocol

    PubMed Central

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

    2015-01-01

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

  4. Improving Patient Outcomes in Gynecology: The Role of Large Data Registries and Big Data Analytics.

    PubMed

    Erekson, Elisabeth A; Iglesia, Cheryl B

    2015-01-01

    Value-based care is quality health care delivered effectively and efficiently. Data registries were created to collect accurate information on patients with enough clinical information to allow for adequate risk adjustment of postoperative outcomes. Because most gynecologic procedures are elective and preference-sensitive, offering nonsurgical alternatives is an important quality measure. The Center for Medicare and Medicaid Services (CMS), in conjunction with mandates from the Affordable Care Act, passed by Congress in 2010, has developed several initiatives centered on the concept of paying for quality care, and 1 of the first CMS initiatives began with instituting payment penalties for hospital-acquired conditions, such as catheter-associated urinary tract infections, central line-associated bloodstream infections, and surgical site infections. Registries specific to gynecology include the Society for Assisted Reproductive Technology registry established in 1996; the FIBROID registry established in 1999; the Pelvic Floor Disorders Registry established by the American Urogynecologic Society in conjunction with other societies (2014); and the Society of Gynecologic Oncologists Clinical Outcomes Registry. Data from these registries can be used to critically analyze practice patterns, find best practices, and enact meaningful changes in systems and workflow. The ultimate goal of data registries and clinical support tools derived from big data is to access accurate and meaningful data from electronic records without repetitive chart review or the need for direct data entry. The most efficient operating systems will include open-access computer codes that abstract data, in compliance with privacy regulations, in real-time to provide information about our patients, their outcomes, and the quality of care that we deliver.

  5. Methodology of integration of a clinical data warehouse with a clinical information system: the HEGP case.

    PubMed

    Zapletal, Eric; Rodon, Nicolas; Grabar, Natalia; Degoulet, Patrice

    2010-01-01

    Clinical Data Warehouses (CDW) can complement current Clinical Information Systems (CIS) with functions that are not easily implemented by traditional operational database systems. Here, we describe the design and deployment strategy used at the Pompidou University Hospital in southwest Paris. Four realms are described: technological realm, data realm, restitution realm, and administration realm. The corresponding UML use cases and the mapping rules from the shared integrated electronic health records to the five axes of the i2b2 CDW star model are presented. Priority is given to the anonymization and security principles used for the 1.2 million patient records currently stored in the CDW. Exploitation of a CDW by clinicians and investigators can facilitate clinical research, quality evaluations and outcome studies. These indirect benefits are among the reasons for the continuous use of an integrated CIS.

  6. Paper 3: EUROCAT data quality indicators for population-based registries of congenital anomalies.

    PubMed

    Loane, Maria; Dolk, Helen; Garne, Ester; Greenlees, Ruth

    2011-03-01

    The European Surveillance of Congenital Anomalies (EUROCAT) network of population-based congenital anomaly registries is an important source of epidemiologic information on congenital anomalies in Europe covering live births, fetal deaths from 20 weeks gestation, and terminations of pregnancy for fetal anomaly. EUROCAT's policy is to strive for high-quality data, while ensuring consistency and transparency across all member registries. A set of 30 data quality indicators (DQIs) was developed to assess five key elements of data quality: completeness of case ascertainment, accuracy of diagnosis, completeness of information on EUROCAT variables, timeliness of data transmission, and availability of population denominator information. This article describes each of the individual DQIs and presents the output for each registry as well as the EUROCAT (unweighted) average, for 29 full member registries for 2004-2008. This information is also available on the EUROCAT website for previous years. The EUROCAT DQIs allow registries to evaluate their performance in relation to other registries and allows appropriate interpretations to be made of the data collected. The DQIs provide direction for improving data collection and ascertainment, and they allow annual assessment for monitoring continuous improvement. The DQI are constantly reviewed and refined to best document registry procedures and processes regarding data collection, to ensure appropriateness of DQI, and to ensure transparency so that the data collected can make a substantial and useful contribution to epidemiologic research on congenital anomalies.

  7. Vallecular cysts in clinical practice: report of two cases

    PubMed Central

    Zamfir-Chiru-Anton, A; Gheorghe, DC

    2016-01-01

    The objective of the two case reports was to discuss the pathogenesis, origin, and therapeutic options for vallecular cysts. Method of Study. 2 children diagnosed in our department were treated by transoral endoscopic surgery, using cold instruments, suspension laryngoscopy and the operating microscope. Results. Both cases presented breathing and deglutition problems at diagnosis. The surgery aimed the complete excision, with cold instruments, via transoral access. No complications occurred and the postoperative healing was uneventful. No recurrences were observed on the long-term follow-up. Conclusion. Clinical, imagistic, and surgical data support the thyroglossal duct origin of vallecular cysts (base of tongue variant) and the complete excision is required to obtain long lasting cure. PMID:27974936

  8. [Experience in thyroglossal duct pathology: clinical case series].

    PubMed

    Cieri, Patricio; Udaquiola, Julia E; Calello, Santiago E; Libero, Daniel H

    2016-10-01

    The thyroglossal duct cyst pathology represents the second cause of bening cervical anomalies in childhood. Diagnosis is mainly clinical. Sistrunk (1920) proposed a surgical technique that is still considered the gold standard for definitive treatment of this condition. A retrospective study was made including patients who underwent surgery for thyroglossal duct cyst pathology in our department between June 2008 and August 2015. In this period, we performed 54 procedures in 45 patients (39 primary cases). Median age was 4.7 years; 14/39 patients (31.1%) had pre-operative infection. All patients were studied with neck ultrasound. A Sistrunk's procedure was performed in all cases. The global recurrence rate was 17.8% (8/45).

  9. [Chondrosarcoma of the upper jaw. Apropos of a clinical case].

    PubMed

    Smatt, V

    1977-01-01

    Initially it has been a tendency to place chondrosarcoma in the general category of osteogenic sarcoma. Jaffe et Lichtenstein claimed that the concept of chondrosarcoma as a separate entity has a firm clinical and histological basis. Chondrosarcomas may arise in peripheral long and flat bones. The maxillary location is very rare, it represents about 0,7% of the whole body. 40 well documented instances are yet counted in the literature. Reporting a personnal case, the author proceeds to a comparative study between the three varieties of maxillary sarcomas, evokes the special histogenesis in this location, he reminds the interest of bone electrocoagulation as curative treatment, and discusses the difficulty in making a prognosis 3 years after surgery without local recurrence or metastasis in this case.

  10. Vallecular cysts in clinical practice: report of two cases.

    PubMed

    A, Zamfir-Chiru-Anton; Dc, Gheorghe

    2016-01-01

    The objective of the two case reports was to discuss the pathogenesis, origin, and therapeutic options for vallecular cysts. Method of Study. 2 children diagnosed in our department were treated by transoral endoscopic surgery, using cold instruments, suspension laryngoscopy and the operating microscope. Results. Both cases presented breathing and deglutition problems at diagnosis. The surgery aimed the complete excision, with cold instruments, via transoral access. No complications occurred and the postoperative healing was uneventful. No recurrences were observed on the long-term follow-up. Conclusion. Clinical, imagistic, and surgical data support the thyroglossal duct origin of vallecular cysts (base of tongue variant) and the complete excision is required to obtain long lasting cure.

  11. Odontogenic calcificant cystic tumor: a report of two clinical cases.

    PubMed

    Reyes, Daniel; Villanueva, Julio; Espinosa, Sebastián; Cornejo, Marco

    2007-03-01

    Odontogenic Calcificant Cystic Tumor (OCCT) is an infrequent injury. It arises from odontogenic epithelial rests present in the maxilla, jaw or gum. Gorlin and col. described the OCCT for first time as an own pathological entity in 1962. Clinically, the OCCT represents 1% of the odontogenic injuries. It is possible to be found from the first decade to the eighth decade. It affects in same proportion the maxilla and the jaw, being the most common in the dented zones, with greater incidence in the first molar area. Two case reports of OCCT in two different ages, both in female individuals, one at 5 years old and the other at 35 years old are presented. Enucleation of the tumor was the treatment chosen. The purpose of this article is to present a review of the literature related to these two cases of OCCT and its treatment, putting an emphasis on its aetiology, biological behaviour and treatment.

  12. [Analysis of six cases concerning clinical features of rhinolith].

    PubMed

    Ran, Xiangqun; Zhao, Xingyu; Tong, Hongxia

    2014-11-01

    To analyze six cases concerning clinical features, the treatment process and curative effect of Rhinolith. The six patients had unilateral nasal obstruction, three of them were accompanied with purulent nasal discharge, two had blood with them, one patient had repeated hemorrhage of nasal cavity and two patients had developed headache. By using endoscopic, four irregular stones which are yellow, gray and brown were found in the middle and back end. Because of the severe nasal septum deviation and inferior turbinate polypoid, the stone could not be seen clearly but could be touched by aspirator. In sinus CT examination of 6 cases, it showed incomplete irregular shapes and had high density unilateral nasal cavity in the posterior segment. 4 patients had nasal deviation, 3 patients had ipsilateral sinusitis. 4 patients removed their stone by using endoscopy, 2 patients took the stone away after correction of nasal septum. Pathologic diagnosis: rhinolith. Two patients also had exogenous foreign matters which were considered as pseudo nasal stones.

  13. Considerations Before Establishing an Environmental Health Registry

    PubMed Central

    Antao, Vinicius C.; Muravov, Oleg I.; Sapp, James; Larson, Theodore C.; Pallos, L. Laszlo; Sanchez, Marchelle E.; Williamson, G. David; Horton, D. Kevin

    2016-01-01

    Public health registries can provide valuable information when health consequences of environmental exposures are uncertain or will likely take long to develop. They can also aid research on diseases that may have environmental causes that are not completely well defined. We discuss factors to consider when deciding whether to create an environmental health registry. Those factors include public health significance, purpose and outcomes, duration and scope of data collection and availability of alternative data sources, timeliness, availability of funding and administrative capabilities, and whether the establishment of a registry can adequately address specific health concerns. We also discuss difficulties, limitations, and benefits of exposure and disease registries, based on the experience of the Agency for Toxic Substances and Disease Registry. PMID:26066912

  14. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies.

    PubMed

    O'Donnell, Lauren A; Perry, Michael W; Doup, Dane't R

    2015-12-01

    For many students in the health sciences, including doctor of pharmacy (PharmD) students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions), and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course.

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

    PubMed

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

    2016-06-01

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

  16. Orthokeratinized Odontogenic Cyst: A Report of Three Clinical Cases

    PubMed Central

    González Galván, María del Carmen; García-García, Abel; Anitua-Aldecoa, Eduardo; Martinez-Conde Llamosas, Rafael; Aguirre-Urizar, José Manuel

    2013-01-01

    The orthokeratinized odontogenic cyst (OOC) is a rare developmental odontogenic cyst that has been considered as a variant of the keratocystic odontogenic tumour (KCOT) until Wright (1981) defined it as a different entity. Surgery is the usual treatment, and recurrence or association with Gorlin-Goltz syndrome has rarely been described. In this report, we presented three cases of this pathology, and we review the principal clinical, histological, radiological, and therapeutic aspects. Case 1. A 73-year-old female presents with a slight swelling on the right mandible, associated with an unilocular well-defined radiolucent lesion. Case 2. A 27-year-old female presents with a painful mandibular swelling associated with an unilocular radiolucent lesion posterior to the 4.8. Case 3. A 61-year-old male was casually detected presents with an unilocular radiolucent lesion distal to the 4.8. Conclusion. The OOC is a specific odontogenic clinicopathological entity that should be differentiated from the KCOT as it presents a completely different biological behaviour. PMID:24191203

  17. The clinical case report: a tool for hypothesis generation.

    PubMed

    Sniderman, A D

    1996-10-01

    The clinical case report is generally limited to a description of unusual examples of the complications of disease or responses to therapy. However, it can also be used to present novel hypotheses which have been derived from individual cases. Two examples of this latter genre are presented and updated. These are Syndrome X and the stiff left atrial syndrome. In both instances, general and novel formulations were derived from single cases. With respect to Syndrome X, a hypothesis was generated that the chest pain and ST abnormalities in these patients represent excess activation of adenosine A1 receptors in the absence of myocardial ischemia. With respect to the stiff left atrial syndrome, recognition of the first case led to the recognition of the problem in many others. Now, a variant of the syndrome has been recognized in which mitral regurgitation is also present. In addition, the possibility that tricuspid annuloplasty may rescue patients dying of cardiac cachexia due to right heart failure caused by combined pressure and volume overload of the right ventricle is outlined.

  18. [Creating a European registry of patient registries--a service oriented approach].

    PubMed

    Pajić, Vanja; Pristas, Ivan; Meglic, Matic

    2013-06-01

    Healthcare registries in European countries are producing a large amount of data that are difficult to share and which, for the lack of interoperability, do not meet the real needs of data users, i.e. various groups of researchers, professionals and patients. Also, data gathered from healthcare registries are usually considered as isolated islands of information, which makes the task of approaching these data an arduous one. The suggested solution to these problems lies in the service approach to health registries and the data contained within them. Applying the service approach to registries, the healthcare data can escape the narrow confines of health registries in which they reside by transforming them into packages of predefined services in accordance with the end-user needs, which introduces the concept of metadata registries as service catalogues. Such a model of a service-oriented metadata registry as a catalog of services is discussed here as a real possibility and a dire need. The purpose of such a metadata registry is the collection of relevant data from the service provider and delivery of a predefined and reusable set of services to the service consumer. Interoperability thus achieved transcends the traditional problems of data exchange because it comes to grips with the services intended for and defined by the end-user, and not relying solely on data as a final deliverable. At the European Union level, such a metadata registry is currently under development, with the working title PARENT (Patient Registry Initiative) 'Registry of registries'. The mission of this metadata registry is to combine all the relevant European patient registries into such a service-oriented model.

  19. The Danish Neuro-Oncology Registry

    PubMed Central

    Hansen, Steinbjørn

    2016-01-01

    Aim of database The Danish Neuro-Oncology Registry (DNOR) was established by the Danish Neuro-Oncology Group as a national clinical database. It was established for the purpose of supporting research and development in adult patients with primary brain tumors in Denmark. Study population DNOR has registered clinical data on diagnostics and treatment of all adult patients diagnosed with glioma since January 1, 2009, which numbers approximately 400 patients each year. Main variables The database contains information about symptoms, presurgical magnetic resonance imaging (MRI) characteristics, performance status, surgical procedures, residual tumor on postsurgical MRI, postsurgical complications, diagnostic and histology codes, radiotherapy, and chemotherapy. Descriptive data DNOR publishes annual reports on descriptive data. During the period of registration, postoperative MRI is performed in a higher proportion of the patients (Indicator II), and a higher proportion of patients have no residual tumor after surgical resection of the primary tumor (Indicator IV). Further data are available in the annual reports. The indicators reflect only minor elements of handling brain tumor patients. Another advantage of reporting indicators is the related multidisciplinary discussions giving a better understanding of what actually is going on, thereby facilitating the work on adjusting the national guidelines in the Danish Neuro-Oncology Group. Conclusion The establishment of DNOR has optimized the quality in handling primary brain tumor patients in Denmark by reporting indicators and facilitating a better multidisciplinary collaboration at a national level. DNOR provides a valuable resource for research. PMID:27822109

  20. The Case Anatomical Knowledge Index (CAKI): A Novel Method Used to Assess Anatomy Content in Clinical Cases

    ERIC Educational Resources Information Center

    Banda, Sekelani S.

    2009-01-01

    There are concerns in the literature that the use of case-based teaching of anatomy could be compromising the depth and scope of anatomy learned by students in a problem-based learning curriculum. Poor selection of clinical cases that are used as vehicles for teaching/learning anatomy may be the root problem because some clinical cases do not…

  1. The importance of rheumatology biologic registries in Latin America.

    PubMed

    de la Vega, Maria; da Silveira de Carvalho, Hellen M; Ventura Ríos, Lucio; Goycochea Robles, Maria V; Casado, Gustavo C

    2013-04-01

    Rheumatoid arthritis is a systemic inflammatory disorder characterized by joint articular pain and disability. Although there is scarcity of data available on the incidence and prevalence of RA in Latin America, there is a growing recognition of this disease where chronic diseases are on the rise and infectious disease on the decline. RA is a substantial burden to patients, society, and the healthcare system. The heterogeneity identified within RA presents an opportunity for personalized medicine, especially in regions with such demographic diversity as that of Latin America. To understand the long-term effects of treatment for RA especially on safety, registries have been established, a number of which have been created in Latin America. Despite their weaknesses (e.g., lack of controls and randomization), registries have provided additional and complementary information on the use of biologics in clinical practice in Latin America and other regions. Although certain challenges remain in the implementation and maintenance of registries, they continue to provide real-life data to clinical practice contributing to improved patient care.

  2. Tourette syndrome: clinical and psychological aspects of 250 cases.

    PubMed

    Comings, D E; Comings, B G

    1985-05-01

    Tourette syndrome is a common hereditary neuropsychiatric disorder consisting of multiple tics and vocal noises. We summarize here clinical aspects of 250 consecutive cases seen over a period of 3 years. The sex ratio was four males to one female, and the mean age of onset was 6.9 years. Only 10% were Jewish, indicating that it is not more prevalent in Ashkenazi Jews. Only 33% had compulsive swearing (coprolalia), indicating that this is not necessary for the diagnosis. The most frequent initial symptoms were rapid eye-blinking, facial grimacing, and throat-clearing. In this series, it was clear that Tourette syndrome is a psychiatric as well as a neurological disorder. Significant discipline problems and/or problems with anger and violence occurred in 61%, and 54% had attention-deficit disorder with hyperactivity. Some degree of exhibitionism was present in 15.9% of males and 6.1% of females. Obsessive-compulsive behavior was seen in 32%. Other than tics and vocal noises, the most common parental complaints were of short temper and everything being a confrontation. There were no significant clinical differences between familial and sporadic cases. Whenever a child presents with a learning disorder, attention-deficit disorder, or significant discipline or emotional problems, the parents should be questioned about the presence of tics or vocal noises in the patient and other family members.

  3. Tourette syndrome: clinical and psychological aspects of 250 cases.

    PubMed Central

    Comings, D E; Comings, B G

    1985-01-01

    Tourette syndrome is a common hereditary neuropsychiatric disorder consisting of multiple tics and vocal noises. We summarize here clinical aspects of 250 consecutive cases seen over a period of 3 years. The sex ratio was four males to one female, and the mean age of onset was 6.9 years. Only 10% were Jewish, indicating that it is not more prevalent in Ashkenazi Jews. Only 33% had compulsive swearing (coprolalia), indicating that this is not necessary for the diagnosis. The most frequent initial symptoms were rapid eye-blinking, facial grimacing, and throat-clearing. In this series, it was clear that Tourette syndrome is a psychiatric as well as a neurological disorder. Significant discipline problems and/or problems with anger and violence occurred in 61%, and 54% had attention-deficit disorder with hyperactivity. Some degree of exhibitionism was present in 15.9% of males and 6.1% of females. Obsessive-compulsive behavior was seen in 32%. Other than tics and vocal noises, the most common parental complaints were of short temper and everything being a confrontation. There were no significant clinical differences between familial and sporadic cases. Whenever a child presents with a learning disorder, attention-deficit disorder, or significant discipline or emotional problems, the parents should be questioned about the presence of tics or vocal noises in the patient and other family members. PMID:3859204

  4. The use of databases and registries to enhance colonoscopy quality.

    PubMed

    Logan, Judith R; Lieberman, David A

    2010-10-01

    Administrative databases, registries, and clinical databases are designed for different purposes and therefore have different advantages and disadvantages in providing data for enhancing quality. Administrative databases provide the advantages of size, availability, and generalizability, but are subject to constraints inherent in the coding systems used and from data collection methods optimized for billing. Registries are designed for research and quality reporting but require significant investment from participants for secondary data collection and quality control. Electronic health records contain all of the data needed for quality research and measurement, but that data is too often locked in narrative text and unavailable for analysis. National mandates for electronic health record implementation and functionality will likely change this landscape in the near future.

  5. Polyarticular lipoma arborescens--a clinical and aesthetical case.

    PubMed

    Silva, Lígia; Terroso, Georgina; Sampaio, Luzia; Monteiro, Eurico; Pimenta, Sofia; Pinto, Fernanda; Pinto, José A; Ventura, Francisco S

    2013-06-01

    Lipoma arborescens is a benign tumor, but it may be a reactive process to other disorders, and its clinical, analytical, radiological and ultrasound presentation may be redundant to any synovial tumor. Despite the characteristic feature on magnetic resonance imaging (MRI), the correct differential diagnosis in atypical presentation, and the need for timely removal of the lesion to prevent joint damage, forces, ultimately, to invasive procedures. The clinical case reported here, fourth described in English language publications on the polyarticular form, also presented other specificities related to one of the swellings, in the knee. Because of its atypical location in the popliteal fossa, recurrent episodes of joint effusion, personal history of knee trauma, pulmonary tuberculosis, and family history of rheumatoid arthritis required particular attention. This process was hampered by the refusal of knee (and ankle) surgery by the patient. He accepted surgical removal of the swellings of the wrists, for aesthetical reasons, with pathologic confirmation of the diagnosis, and clinical success in that location. MRI of the knee showed the typical image of lipoma arborescens, but also other changes that compromise the prognosis.

  6. Clinical and histopathological review of 229 cases of ranula.

    PubMed

    Jia, Yulin; Zhao, Yifang; Chen, Xinming

    2011-10-01

    The purpose of this paper was to evaluate the relationship between the thrombosis and secretory duct dilation, lesion size, clinical types, nature (primary or recurrent) and duration of illness in the development of ranula. A total of 229 cases of sublingual gland cysts were treated with surgical resection from Jan. 1990 to Feb. 2010. The patients' data were investigated on histopathological findings, size of ranula, the clinical types, nature of ranula (primary or recurrent) and duration of illness. Sections from the paraffin-embedded blocks were HE-stained. CK expression was immunohistochemically detected. Among 229 cases the incidence of venous thrombosis was 58.52%. The incidence of venous thrombosis with or without duct dilation was 73.25% and 26.39% respectively, with a significant difference between the two groups (P<0.005). The incidence of venous thrombosis of ranulas with diameter larger or less than 3 cm was 72.22% and 46.28% (P<0.005). The incidence of venous thrombosis of oral ranula, plunging ranula and mixed ranula was 49.37%, 77.19% and 85.71% respectively, with a significant difference found between oral and plunging or mixed ranula (P<0.01). The incidence of venous thrombosis in ranula patients with duration of illness longer or less than 3 months was 69.77% and 51.75% (P<0.01). The incidence of venous thrombosis with recurrent and primary ranulas was 51.85% and 64.85%, without a significant difference noted between them (P>0.05). It is concluded that the formation of venous thrombosis was related to the dilation of secretory duct, lesion size, clinical types, duration of lesion but formation of venous thrombosis was not related to the nature (primary or recurrent) of ranulas.

  7. Right Homonymous Hemianopia: A Clinical Case Report of Schizencephaly

    PubMed Central

    Neves, Arminda; Carvalheira, Fausto; Campos, Joana; Alfaiate, Pedro; Campos, António; Paulo, João; Sousa, Castro

    2016-01-01

    Purpose To report a case of a 56-year-old male with right homonymous hemianopia. Methods Retrospective descriptive study of a case report based on information from clinical records, patient observation and analysis of complementary diagnostic tests. Results An asymptomatic 56-year-old male presented to our hospital for a routine ophthalmic examination. The best-corrected visual acuity was 20/20 in the right eye (RE) and in the left eye (LE). Pupillary function, intraocular pressure, external segment examinations and slit-lamp biomicroscopy were normal, bilaterally. Fundoscopy showed a cup-to-disc (C/D) ratio in the RE of 0.3 and of 0.4 in the LE. Retinal nerve fiber layer (RNFL) thickness measured by spectral domain optical coherence tomography revealed thinning of the superior, temporal and nasal RNFL in the RE and thinning of the superior, inferior and temporal RNFL in the LE. Automated static perimetry showed right homonymous hemianopia. Brain computed tomography (CT) showed an open-lip schizencephaly with a significant reduction of the left brain parenchyma. Conclusions Despite the large visual defect, the patient was unaware of it and had an active professional life. This is an interesting case because despite the extensive morphological abnormalities seen on brain CT there is a relatively small functional repercussion. PMID:26889154

  8. Evidence and practice in spine registries

    PubMed Central

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

    2015-01-01

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

  9. Outcome of acute idiosyncratic drug-induced liver injury: Long-term follow-up in a hepatotoxicity registry.

    PubMed

    Andrade, Raúl J; Lucena, M Isabel; Kaplowitz, Neil; García-Muņoz, Beatriz; Borraz, Yolanda; Pachkoria, Ketevan; García-Cortés, Miren; Fernández, M Carmen; Pelaez, Gloria; Rodrigo, Luis; Durán, José A; Costa, Joan; Planas, Ramón; Barriocanal, Anabel; Guarner, Carlos; Romero-Gomez, Manuel; Muņoz-Yagüe, Teresa; Salmerón, Javier; Hidalgo, Ramón

    2006-12-01

    A chronic adverse reaction may occur in some instances of drug-induced liver injury (DILI), even despite drug cessation. In our study, we obtained records from a Spanish registry and evaluated cases of DILI with biochemical evidence of long-term damage. Chronic outcome was defined as a persistent biochemical abnormality of hepatocellular pattern of damage more than 3 months after drug withdrawal or more than 6 months after cholestatic/mixed damage. Data on 28 patients with a chronic clinical evolution (mean follow-up 20 months) between November 1995 and October 2005 were retrieved (18 female; overall mean age 55 yr) and accounted for 5.7% of total idiosyncratic DILI cases (n = 493) submitted to the registry. The main drug classes were cardiovascular and central nervous system (28.5% and 25%, respectively), which, in contrast, represented only 9.8% and 13%, respectively, of all DILI cases. The most frequent causative drugs were amoxicillin-clavulanate (4 of 69 cases), bentazepam (3 of 7 cases), atorvastatin (2 of 7 cases), and captopril (2 of 5 cases). Patients with cholestatic/mixed injury (18 of 194 cases [9%]) were more prone to chronicity than patients with hepatocellular injury (10 of 240 cases; P < .031). In the case of chronic hepatocellular injury, 3 patients progressed to cirrhosis and 2 to chronic hepatitis. In the cholestatic/mixed group, liver biopsy indicated cirrhosis in 1 patient and ductal lesions in 3 patients. In conclusion, cholestatic/mixed type of damage is more prone to become chronic while, in the hepatocellular pattern, the severity is greater. Cardiovascular and central nervous system drugs are the main groups leading to chronic liver damage.

  10. TSOC-HFrEF Registry: A Registry of Hospitalized Patients with Decompensated Systolic Heart Failure: Description of Population and Management

    PubMed Central

    Wang, Chun-Chieh; Chang, Hung-Yu; Yin, Wei-Hsian; Wu, Yen-Wen; Chu, Pao-Hsien; Wu, Chih-Cheng; Hsu, Chih-Hsin; Wen, Ming-Shien; Voon, Wen-Chol; Lin, Wei-Shiang; Huang, Jin-Long; Chen, Shyh-Ming; Yang, Ning-I; Chang, Heng-Chia; Chang, Kuan-Cheng; Sung, Shih-Hsien; Shyu, Kou-Gi; Lin, Jiunn-Lee; Mar, Guang-Yuan; Chan, Kuei-Chuan; Kuo, Jen-Yuan; Wang, Ji-Hung; Chen, Zhih-Cherng; Tseng, Wei-Kung; Cherng, Wen-Jin

    2016-01-01

    Introduction Heart failure (HF) is a medical condition with a rapidly increasing incidence both in Taiwan and worldwide. The objective of the TSOC-HFrEF registry was to assess epidemiology, etiology, clinical management, and outcomes in a large sample of hospitalized patients presenting with acute decompensated systolic HF. Methods The TSOC-HFrEF registry was a prospective, multicenter, observational survey of patients presenting to 21 medical centers or teaching hospitals in Taiwan. Hospitalized patients with either acute new-onset HF or acute decompensation of chronic HFrEF were enrolled. Data including demographic characteristics, medical history, primary etiology of HF, precipitating factors for HF hospitalization, presenting symptoms and signs, diagnostic and treatment procedures, in-hospital mortality, length of stay, and discharge medications, were collected and analyzed. Results A total of 1509 patients were enrolled into the registry by the end of October 2014, with a mean age of 64 years (72% were male). Ischemic cardiomyopathy and dilated cardiomyopathy were diagnosed in 44% and 33% of patients, respectively. Coronary artery disease, hypertension, diabetes, and chronic renal insufficiency were the common comorbid conditions. Acute coronary syndrome, non-compliant to treatment, and concurrent infection were the major precipitating factors for acute decompensation. The median length of hospital stay was 8 days, and the in-hospital mortality rate was 2.4%. At discharge, 62% of patients were prescribed either angiotensin-converting enzyme-inhibitors or angiotensin receptor blockers, 60% were prescribed beta-blockers, and 49% were prescribed mineralocorticoid receptor antagonists. Conclusions The TSOC-HFrEF registry provided important insights into the current clinical characteristics and management of hospitalized decompensated systolic HF patients in Taiwan. One important observation was that adherence to guideline-directed medical therapy was suboptimal

  11. Palmoplantar Dermatoses- A Clinical Study of 300 Cases

    PubMed Central

    Rajashekhar, Nadiga; Gejje, Somashekar

    2016-01-01

    Introduction Dermatoses affecting palms and soles are among the most difficult of all dermatological therapeutic problems. Many previous studies have focused on the specific diseases of palmoplantar dermatoses. However, none of them have included a comprehensive study of palmoplantar dermatoses. Aims: To study the epidemiological aspects like age distribution, sex distribution, the dermatoses affecting the palms & soles and the frequency of involvement of palms, soles or both palms & soles, in patient with palmoplantar dermatoses. Materials and Methods This cross sectional study was conducted in the Department of Dermatology between October 2011 to September 2013. First 300 cases attending the department of dermatology primarily with complaints pertaining to palms and soles were enrolled in the study. After taking consent a detailed history and clinical examination pertaining to the aim of the study was recorded and analysed, which included inspection of morphology and distribution of lesions and palpation of any swelling. Direct microscopic examination of scrapings, wet mounted with 10% potassium hydroxide was done for cases with scaly lesions. Those who had a pustule, gram staining was done. Patch testing using Indian Standard Battery Series was done for those cases of eczema. A sample for biopsy was taken when diagnosis could not be arrived clinically, and subjected to histopathological examination. Results In our study of 300 patients with palmoplantar dermatoses, 164 were females and 136 were males, the ratio observed being 1.2:1. The peak incidence was found in the age group 21-30 years, with 41 females (25%) and 35 males (25.7%). Most frequently affected individuals in this study were housewives (30%). The most common five diseases of palmoplantar dermatoses were palmoplantar psoriasis (20.7%), moniliasis (19%), palmoplantar hyperhidrosis (7%), keratolysis exfoliativa (6%) and pitted keratolysis (6%). Majority of patients had involvement of both palms and

  12. Clinical Applications of Mineral Trioxide Aggregate: Report of Four Cases

    PubMed Central

    Battepati, Prashant M

    2010-01-01

    The greatest threats to developing teeth are dental caries and traumatic injuries. The primary goal of all restorative treatment is to maintain pulp vitality so that normal root development or apexogenesis can occur. If pulpal exposure occurs, then a pulpotomy procedure aims to preserve pulp vitality to allow for normal root development. Historically, calcium hydroxide has been the material of choice for pulpotomy procedures. Recently, an alternative material called mineral trioxide aggregate (MTA) has demonstrated the ability to induce hard-tissue formation in pulpal tissue. This article describes the clinical and radiographic outcome of a series of cases involving the use of MTA in pulpotomy, apexogenesis and apexification procedures and root perforations repair. PMID:27625556

  13. [Basilar ectasia and stroke: clinical aspects of 21 cases].

    PubMed

    de Oliveira, R de M; Cardeal, J O; Lima, J G

    1997-09-01

    Ectasia of the basilar artery (EB) occurs when its diameter is greater than normal along all or part of its course, and/or when it is abnormally tortuous. EB may cause cranial nerve dysfunction, ischemic stroke or subarachnoid hemorrhage, pseudotumor or hydrocephalus. We tried to describe cases of stroke associated with EB, analyze its frequency, clinical aspects, and the mechanisms involved in different forms of its presentation. We found 21 patients with stroke and EB. The association between EB and stroke was more prevalent in males over the age of fifty. Main symptoms were hemiparesia, cranial nerves dysfunction, and cerebellar ataxia. Cerebral infarcts associated with EB were due to different mechanisms: arterial thrombosis, artery-to-artery embolism, mass effect with angulation and obstruction of the vertebral and basilar branches.

  14. [TREATMENT OF EXTREMELY PREMATURE NEWBORN INFANT WITH INO. CLINICAL CASE].

    PubMed

    Radulova, P; Slancheva, B; Marinov, R

    2015-01-01

    Prolonged inhaled nitric oxide (iNO) from birth in preterm neonates with BPD improves endogenous surfactant function as well as lung growth, angiogenesis, and alveologenesis. As a result there is a reduction in the frequency of the "new" form of BPD in neonates under 28 weeks of gestation and birth weight under 1000 gr. Delivery of inhaled nitric oxide is a new method of prevention of chronic lung disease. According to a large number of randomized trials iNO in premature neonates reduces pulmonary morbidity and leads to a reduction of the mortality in this population of patients. This new therapy does not have serious side effects. We represent a clinical case of extremely premature newborn infant with BPD treated with iNO.

  15. [Cough and hypoxemia as clinical manifestation of pulmonary alveolar proteinosis. Clinical case report].

    PubMed

    Nieto, Mary; Dicembrino, Manuela; Ferraz, Rubén; Romagnoli, Fernando; Giugno, Hilda; Ernst, Glenda; Siminovich, Monica; Botto, Hugo

    2016-06-01

    Alveolar proteinosis is a rare chronic lung disease, especially in children, characterized by abnormal accumulation of lipoproteins and derived surfactant in the intra-alveolar space that generates a severe reduction of gas exchange. Idiopathic presentation form constitutes over 90% of cases, a phenomenon associated with production of autoimmune antibodies directed at the receptor for granulocyte-macrophage colony-stimulating factor. A case of a girl of 5 years of age treated because of atypical pneumonia with unfavorable evolution due to persistent hypoxemia is presented. The diagnosis is obtained through pathologic examination of lung biopsy by thoracotomy, as treatment is carried out by 17bronchopulmonary bronchoscopy lavages and the patient evidences marked clinical improvement.

  16. A Review of Clinical Cases of Infection with Photorhabdus Asymbiotica.

    PubMed

    Gerrard, John G; Stevens, Robert P

    2017-03-17

    The three recognised Photorhabdus species are bioluminescent Gram-negative bacilli of the family Enterobacteriaceae. They are all pathogenic to insects and form a symbiotic relationship with nematodes of the genus Heterorhabditis. P. luminescens and P. temperata are both harmless to humans whilst P. asymbiotica, on the other hand, is a human pathogen that is a symbiont of the newly described nematode vector, Heterorhabditis gerrardi. In this chapter, we review the epidemiological and clinical features of eighteen human cases of P. asymbiotica infection including fifteen from the published literature and three previously unreported cases. Human infection has been reported in the USA and Australia and probably occurs in other parts of Asia where it remains undocumented. Infection occurs most commonly in warmer months particularly after rainfall. Patients may have a history of recent exposure to sand or sandy soil. P. asymbiotica causes both locally invasive soft tissue infection and disseminated disease with bacteraemia. Soft tissue infection may be multifocal with involvement of more than one limb and the trunk. The organism is sensitive to a number of antibiotics in vitro, but treatment failures have been associated with the use of beta-lactams and aminoglycosides. We suggest treatment with a four-week course of an oral fluoroquinolone such as ciprofloxacin. The organism grows readily on standard media from specimens such as wound swabs, pus, blood and even sputum and can be identified in a clinical microbiology laboratory but the diagnosis needs to be considered. The correct diagnosis is most likely to be made where there is close cooperation between clinician and microbiologist.

  17. Using the journal BMJ Case Reports to promote the publication of clinical case reports

    PubMed Central

    Montano, Blanca San José

    2016-01-01

    Objective The study updates and enhances clinicians' knowledge about clinical case reports (CCRs) and encourages publication of such articles. Methods The author developed and offered a session about BMJ Case Reports to medical and surgical departments in the University Hospital of Móstoles. The session reviewed the contents and add-on services of the journal, conventional and alternative indicators of journal quality, use of CCRs to share valuable clinical lessons, and manuscript preparation and submission. Results The main result of these sessions was submission of eight CCRs to BMJ Case Reports, of which four were accepted. One submitting author was invited to serve as peer reviewer for the journal. Other clinicians are preparing five new CCRs for submission to BMJ Case Reports or other journals. Conclusions The learning sessions were successful in promoting writing and publication of CCRs. Young staff and postgraduate residents seemed especially encouraged to publish CCRs that had already been presented in their departmental sessions. As a librarian, I gained experience in CCR publication and reinforced my position as an essential supporter of the hospital's teaching and publishing activity. PMID:27822158

  18. Erythroderma: A clinical-etiological study of 82 cases.

    PubMed

    Yuan, Xiao-Ying; Guo, Jian-You; Dang, Yu-Ping; Qiao, Li; Liu, Wei

    2010-01-01

    Erythroderma is an uncommon skin disorder characterized by generalized reddening and scaling of over 90% of the skin. It represents a maximal stage of skin irritation induced by several skin diseases such as psoriasis, contact dermatitis, drug reactions, and mycosis fungoides. Data including the clinical symptoms, laboratory examinations and skin biopsies were collected from 82 erythroderma patients admitted to our hospital in the period between Jan.1st, 2003 and Dec.31st, 2008. According to clinical findings, laboratory findings and biopsy results, the most common causative factors were pre-existing dermatoses (72.0%), followed by drug reactions (17.0%), idiopathic causes (6.1%) and malignancies (4.9%). Among the pre-existing dermatoses, psoriasis is the most common etiology (30.5%). We also found hypereosinophilic syndrome, sarcoidosis and dermatomyositis could be causes of erythroderma. In the drug-induced group, Chinese traditional herbal medicines were probably the most frequently implicated drugs in our series, with 9 of the 14 cases (64.3%). Follow-up information was obtained for 65 patients, and most of our patients had improved symptoms after treatment. In our series we found a high percentage of erythroderma secondary to pre-existing dermatoses and a low percentage of erythroderma secondary to malignancy. Among drugs as an etiological group, Chinese traditional herbal medicines were the most frequent drugs. From our follow-up study, the prognosis of most patients with erythroderma is relatively good.

  19. 20 CFR 655.144 - Electronic job registry.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 20 CFR 655.144 - Electronic job registry.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  1. 20 CFR 655.144 - Electronic job registry.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  2. 20 CFR 655.144 - Electronic job registry.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 20 CFR 655.144 - Electronic job registry.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  4. 20 CFR 655.34 - Electronic job registry.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  5. 48 CFR 26.205 - Disaster Response Registry.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Disaster Response Registry... Response Registry. (a) Contracting officers shall consult the Disaster Response Registry at www.ccr.gov to... prospective vendors voluntarily participating in the Disaster Response Registry can be retrieved using the...

  6. 29 CFR 500.170 - Establishment of registry.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 3 2011-07-01 2011-07-01 false Establishment of registry. 500.170 Section 500.170 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement Central Public Registry § 500.170 Establishment of registry. The Administrator shall establish a central public registry of all persons issued a...

  7. 48 CFR 26.205 - Disaster Response Registry.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Disaster Response Registry... Response Registry. (a) Contracting officers shall consult the Disaster Response Registry via https://www...) A list of prospective vendors voluntarily participating in the Disaster Response Registry can...

  8. 29 CFR 500.170 - Establishment of registry.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Establishment of registry. 500.170 Section 500.170 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement Central Public Registry § 500.170 Establishment of registry. The Administrator shall establish a central public registry of all persons issued a...

  9. 48 CFR 26.205 - Disaster Response Registry.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Disaster Response Registry... Response Registry. (a) Contracting officers shall consult the Disaster Response Registry via https://www...) A list of prospective vendors voluntarily participating in the Disaster Response Registry can...

  10. 29 CFR 500.170 - Establishment of registry.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 3 2012-07-01 2012-07-01 false Establishment of registry. 500.170 Section 500.170 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement Central Public Registry § 500.170 Establishment of registry. The Administrator shall establish a central public registry of all persons issued a...

  11. 22 CFR 96.70 - Operation of the Complaint Registry.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Operation of the Complaint Registry. 96.70... Complaints § 96.70 Operation of the Complaint Registry. (a) The Secretary will establish a Complaint Registry.... The Secretary may provide for the Complaint Registry to be funded in whole or in part from...

  12. 48 CFR 26.205 - Disaster Response Registry.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Disaster Response Registry... Response Registry. (a) Contracting officers shall consult the Disaster Response Registry via https://www...) A list of prospective vendors voluntarily participating in the Disaster Response Registry can...

  13. 48 CFR 26.205 - Disaster Response Registry.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Disaster Response Registry... Response Registry. (a) Contracting officers shall consult the Disaster Response Registry at www.ccr.gov to... prospective vendors voluntarily participating in the Disaster Response Registry can be retrieved using the...

  14. 29 CFR 500.170 - Establishment of registry.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 3 2013-07-01 2013-07-01 false Establishment of registry. 500.170 Section 500.170 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement Central Public Registry § 500.170 Establishment of registry. The Administrator shall establish a central public registry of all persons issued a...

  15. 78 FR 28124 - Registry for Attorneys and Representatives

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... Executive Office for Immigration Review 8 CFR Part 1292 RIN 1125-AA39 Registry for Attorneys and... established a mandatory electronic registry for attorneys and accredited representatives who practice before... mandatory electronic registry (eRegistry) for attorneys \\1\\ and accredited representatives \\2\\ who...

  16. 22 CFR 96.70 - Operation of the Complaint Registry.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Operation of the Complaint Registry. 96.70... Complaints § 96.70 Operation of the Complaint Registry. (a) The Secretary will establish a Complaint Registry.... The Secretary may provide for the Complaint Registry to be funded in whole or in part from...

  17. 29 CFR 500.170 - Establishment of registry.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 3 2014-07-01 2014-07-01 false Establishment of registry. 500.170 Section 500.170 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement Central Public Registry § 500.170 Establishment of registry. The Administrator shall establish a central public registry of all persons issued a...

  18. 22 CFR 96.70 - Operation of the Complaint Registry.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Operation of the Complaint Registry. 96.70... Complaints § 96.70 Operation of the Complaint Registry. (a) The Secretary will establish a Complaint Registry.... The Secretary may provide for the Complaint Registry to be funded in whole or in part from...

  19. 22 CFR 96.70 - Operation of the Complaint Registry.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Operation of the Complaint Registry. 96.70... Complaints § 96.70 Operation of the Complaint Registry. (a) The Secretary will establish a Complaint Registry.... The Secretary may provide for the Complaint Registry to be funded in whole or in part from...

  20. Italian Registry of Congenital Bleeding Disorders

    PubMed Central

    Giampaolo, Adele; Abbonizio, Francesca; Arcieri, Romano; Hassan, Hamisa Jane

    2017-01-01

    In Italy, the surveillance of people with bleeding disorders is based on the National Registry of Congenital Coagulopathies (NRCC) managed by the Italian National Institute of Health (Istituto Superiore di Sanità). The NRCC collects epidemiological and therapeutic data from the 54 Hemophilia Treatment Centers, members of the Italian Association of Hemophilia Centres (AICE). The number of people identified with bleeding disorders has increased over the years, with the number rising from approx. 7000 in 2000 to over 11,000 in 2015. The NRCC includes 4020 patients with hemophilia A and 859 patients with hemophilia B. The prevalence of the rare type 3 vWD is 0.20/100,000 inhabitants. Less common congenital bleeding disorders include the following deficiencies: Factor I (fibrinogen), Factor II (prothrombin), Factor V, Factor VII, Factor X, Factor XI and Factor XIII, which affect 1953 patients. Hepatitis C Virus (HCV) infection affects 1561 patients, more than 200 of whom have two infections (HCV + HIV). Estimated hemophilia-related drug consumption in 2015 was approx. 550 million IU of FVIII for hemophilia A patients and approx. 70 million IU of FIX for hemophilia B patients. The NRCC, with its bleeding disorder data set, is a tool that can provide answers to fundamental questions in public health, monitoring care provision and drug treatment, as well as facilitating clinical and epidemiological research. PMID:28335488

  1. New registry and tracking system for renal transplantation in Japan.

    PubMed

    Yuzawa, K; Takahara, S; Kanmochi, T; Takahashi, K; Teraoka, S

    2010-12-01

    Following The Declaration of Istanbul 2008, a registration committees of The Japan Society for Transplantation and The Japanese Society for Clinical Renal Transplantation planned to establish a new registry and tracking system for renal transplant recipients and donors supported by a Health Labor Sciences Research Grant by The Ministry of Health Labour and Welfare. In place of the previous paper-based system, we established the new registry and tracking system, JARTRE (Japan Renal Transplantation Registry), using USB memory in 2009. Recipient and donor data were inputted into the USB memory at the transplantation centers. The memory was reviewed a yearly by committees. The recipient and donor registration included details from both. The tracking is performed centrally 3 months, 1 year, and every year after the operation. The advantages of this system are the ease of input, adequacy of the data, and rapid statistical processing. In 2009, we registered 97.9% of new renal transplantation recipients and donors; in 2008 it was more than 81.9% of all past renal transplantation recipients in Japan.

  2. Adenoid Cystic Carcinoma of the Breast: A Clinical Case Report

    PubMed Central

    Kocaay, Akin Firat; Celik, Suleyman Utku; Hesimov, Ilkin; Eker, Tevfik; Percinel, Sibel; Demirer, Seher

    2016-01-01

    Introduction: Adenoid cystic carcinoma (ACC) is an uncommon tumor of the breast, accounting for approximately 0.1% to 1% of all breast cancers. It is characterized by rare lymph node involvement and distant metastasis, and associated with a favorable prognosis with excellent survival, despite its triple-negative status. In the current state of knowledge, results of breast-conserving treatment with postoperative radiotherapy seem to be equivalent to mastectomy alone, with respect to survival for ACC of the breast. Due to its rarity, there is no consensus on optimal treatment for patients with ACC. Otherwise, the role of chemotherapy and hormonal therapy remains controversial. Further clinical studies are required to compare treatment options for ACC. But, a long-term follow-up is very important and mandatory for affected patients, due to the late onset of local relapse and occurrence of distant metastasis. Case report: Here, we report the case of a patient who presented with a palpable breast mass in the left breast that turned out to be an ACC of the breast. PMID:27994304

  3. Eruption cysts: A series of 66 cases with clinical features

    PubMed Central

    Şen-Tunç, Emine; Şaroğlu-Sönmez, Işıl; Bayrak, Şule; Tüloğlu, Nuray

    2017-01-01

    Background An eruption cyst (EC) is a benign, developmental cyst associated with a primary or permanent tooth. This paper presents 66 ECs in 53 patients who reported to 3 different centers in Turkey between 2014-2015. Material and Methods 53 patients (31 male, 22 female) with 66 ECs were diagnosed and treated over a 1-year period. The mean age of patients was 5.4 years (minimum 5 months, maximum 11 years). Clinical examination and periapical radiographs were used to establish diagnosis. Age, gender, site, history of trauma and type of treatment were recorded. Results Of the 66 ECs diagnosed in 53 patients, more than half (56.6%) were located in the maxilla, with the maxillary first primary molars the teeth most commonly associated with ECs (30.3%). Multiple ECs were diagnosed in 13 of the 53 patients. ECs had previously diagnosed in the primary dentition of 2 patients, 3 patients reported a history of trauma to primary teeth. In the majority of patients (46 cases, 86.8%), no treatment was provided, whereas surgical treatment was provided in the remaining 7 cases (13.2%). Conclusions Eruption cysts are usually asymptomatic and do not require treatment;. however, if the cyst is symptomatic, it should be treated with simple surgical excision. Key words:Odontogenic cyst, children, eruption cyst, oral pathology. PMID:28160586

  4. [General anesthesia in Cohen syndrome. Report of a clinical case].

    PubMed

    Cavaliere, F; Cormaci, S; Cormaci, M; Alberti, A

    1995-04-01

    The case of a 23 years old woman, affected by the Cohen syndrome, who underwent general anesthesia for extensive dental surgery, is reported. The Cohen syndrome is an autosomal recessive syndrome that causes mental retardation, obesity, short stature as well as oral, ocular, and limb anomalies. The problems the anesthesiologist could deal with include the capacity of the patient to cooperate; difficult intubation because of maxillary hypoplasia, micrognathia, narrow and high-arched palate, and prominent maxillary central incisors; generalized muscular hypotonia; moderate leukopenia, that could theoretically increase the risk of infection: and, finally, possible associated mitral valve prolapse or hiatus hernia. In the case reported the presence of mitral valve prolapse or hiatus hernia was ruled out echographically. The patient was premedicated with diazepam and atropine i.m.; general anesthesia was carried out by propofol-fentanyl association and myorelaxation was obtained with atracurium. Nasotracheal intubation was performed easily in spite of oral anomalies so that the usefulness of thyromental distance, which was 7 cm long, as a clinical test to evaluate a potentially difficult intubation was confirmed. Noteworthy, the thyromental distance was the only test which was suitable for the uncooperative patient. At the end of surgery muscular tone recovered promptly and the endotracheal tube could be regularly removed. No complication was registered postoperatively.

  5. [Functional aniseikonia: clinical study of 110 cases (author's transl)].

    PubMed

    Reboud, F N; Vola, J L; Berard, P V

    1981-01-01

    A clinical study was conducted in 110 cases of subjective aniseikonia, a syndrome that is often neglected. After in practice summarizing the different distortions composing the phenomenon of aniseikonia, a description of the prototype apparatus used for the experiments is given: it is eikonometric stereo-projector the originality of which lies in the measuring system, constituted by the projected stereograms. Three parameters were studied: depth-perception, peerception threshold of anseiikonic disparity, and value of the found aniseikonia. The results are presented in relation to 3 groups of subjects: 14 emmetropic, 32 isometropic, and 64 anisometropic, 32 isometropic, and 64 anisometropic patients, including 24 monocular aphakic. The author shows the advantage of contact lens correction in the last cases: with an average of 3.5 p. cent, the found aniseikonia was always inferior to 6 p. cent and to the theorectical levels currently accepted. Finally, the phenomenon of "cortical malleability" arises in the adaptation of the patient to his optical correction and could regularly and progressively be increased.

  6. EPA Facility Registry Service (FRS): Power Plants

    EPA Pesticide Factsheets

    This GIS dataset contains data on power plants, based on the Energy Information Administration's EIA-860 dataset and supplemented with data from EPA's Facility Registry Service (FRS) compiled from various EPA programs.

  7. Airborne Hazards and Open Burn Pit Registry

    MedlinePlus

    ... browser, or you may try from a different computer. You may also see this problem if you are in a high security environment where this is disabled by a network policy. The Registry will work in JavaScript-enabled ...

  8. Using Registries to Identify Adverse Events in Rheumatic Diseases

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2013-11-01

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

  10. Urachal carcinoma: a pathologic and clinical study of 46 cases

    PubMed Central

    Dhillon, Jasreman; Liang, Yu; Kamat, Ashish M.; Siefker-Radtke, Arlene; Dinney, Colin P.; Czerniak, Bogdan; Guo, Charles C.

    2015-01-01

    Summary Urachal carcinoma is a rare tumor that has not been well studied. To determine the pathologic and clinical features of this disease, we retrospectively evaluated 46 cases from our surgical pathology files. The patients included 16 women and 30 men, with a mean age of 53.4 years (range, 28–82 years). Forty patients had undergone cystectomy, and the remaining 6 had undergone transurethral bladder biopsy. Most tumors were located at the dome (n=44); only 2 were located at both the dome and anterior wall. All tumors consisted of adenocarcinoma, including mucinous (n=36), enteric (n=7), not otherwise specified (n=2), and signet ring cell (n=1) types. Focal areas of signet ring cell features were present in 23 cases, but urothelial carcinoma in situ was not identified in any cases. The tumors invaded the muscularis propria (n=8), perivesical adipose tissue (n=27), and abdominal wall (n=3). Twenty-five patients had died of cancer at a mean of 32 months (range, 12–74 months), and 21 patients were alive at a mean of 65 months (range, 7–230 months). The median cancer-specific survival time of urachal adenocarcinoma patients was 45 months, which was significantly longer than that of bladder urothelial carcinoma patients with similar-stage disease (p=0.047). Patients’ cancer-specific survival was associated with tumor stage according to the Sheldon, Mayo, and TNM staging systems. In conclusion, urachal carcinomas are predominantly composed of invasive adenocarcinomas, which commonly demonstrate mucinous features. Most tumors present at advanced stages but are still associated with a better survival rate than bladder urothelial carcinomas. PMID:26364859

  11. Urachal carcinoma: a pathologic and clinical study of 46 cases.

    PubMed

    Dhillon, Jasreman; Liang, Yu; Kamat, Ashish M; Siefker-Radtke, Arlene; Dinney, Colin P; Czerniak, Bogdan; Guo, Charles C

    2015-12-01

    Urachal carcinoma is a rare tumor that has not been well studied. To determine the pathologic and clinical features of this disease, we retrospectively evaluated 46 cases from our surgical pathology files. The patients included 16 women and 30 men, with a mean age of 53.4 years (range, 28-82 years). Forty patients had undergone cystectomy, and the remaining 6 had undergone transurethral bladder biopsy. Most tumors were located at the dome (n = 44); only 2 were located at both the dome and anterior wall. All tumors consisted of adenocarcinoma, including mucinous (n = 36), enteric (n = 7), not otherwise specified (n = 2), and signet ring cell (n = 1) types. Focal areas of signet ring cell features were present in 23 cases, but urothelial carcinoma in situ was not identified in any cases. The tumors invaded the muscularis propria (n = 8), perivesical adipose tissue (n = 27), and abdominal wall (n = 3). Twenty-five patients had died of cancer at a mean of 32 months (range, 12-74 months), and 21 patients were alive at a mean of 65 months (range, 7-230 months). The median cancer-specific survival time of urachal adenocarcinoma patients was 45 months, which was significantly longer than that of bladder urothelial carcinoma patients with similar-stage disease (P = .047). Patients' cancer-specific survival was associated with tumor stage according to the Sheldon, Mayo, and TNM staging systems. In conclusion, urachal carcinomas are predominantly composed of invasive adenocarcinomas, which commonly demonstrate mucinous features. Most tumors present at advanced stages but are still associated with a better survival rate than bladder urothelial carcinomas.

  12. Compartment syndrome after total knee arthroplasty: regarding a clinical case.

    PubMed

    Pinheiro, Ana Alexandra da Costa; Marques, Pedro Miguel Dantas Costa; Sá, Pedro Miguel Gomes; Oliveira, Carolina Fernandes; da Silva, Bruno Pombo Ferreira; de Sousa, Cristina Maria Varino

    2015-01-01

    Although compartment syndrome is a rare complication of total knee arthroplasty, it is one of the most devastating complications. It is defined as a situation of increased pressure within a closed osteofascial space that impairs the circulation and the functioning of the tissues inside this space, thereby leading to ischemia and tissue dysfunction. Here, a clinical case of a patient who was followed up in orthopedic outpatient consultations due to right gonarthrosis is presented. The patient had a history of arthroscopic meniscectomy and presented knee flexion of 10° before the operation, which consisted of total arthroplasty of the right knee. The operation seemed to be free from intercurrences, but the patient evolved with compartment syndrome of the ipsilateral leg after the operation. Since compartment syndrome is a true surgical emergency, early recognition and treatment of this condition through fasciotomy is crucial in order to avoid amputation, limb dysfunction, kidney failure and death. However, it may be difficult to make the diagnosis and cases may not be recognized if the cause of compartment syndrome is unusual or if the patient is under epidural analgesia and/or peripheral nerve block, which thus camouflages the main warning sign, i.e. disproportional pain. In addition, edema of the limb that underwent the intervention is common after total knee arthroplasty operations. This study presents a review of the literature and signals that the possible rarity of cases is probably due to failure to recognize this condition in a timely manner and to placing these patients in other diagnostic groups that are less likely, such as neuropraxia caused by using a tourniquet or peripheral nerve injury.

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

    PubMed

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

    2008-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Buyl, Ronald; Nyssen, Marc

    2008-01-01

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

  16. [A perspective for the role of drug registries in the post-marketing surveillance].

    PubMed

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    Drug registries are implemented after the authorization of new products and represent a tool for systematic collection of data aimed at obtaining additional knowledge on appropriateness, effectiveness and safety. The design of registries needs to be coherent with the main objective and a study protocol is required before the implementation. A registry aimed at the appropriateness of drug use should be primarily considered for high cost drugs when there is a risk, either for the patients' safety or for public expenditure, in using the drug outside the approved indications. Since the registry is a condition for the access to drugs, and all users are included, an extremely simplified data collection is required. However, the data should be available at regional level to allow record linkage procedures with other databases for conducting outcome studies. When registries are aimed at acquiring new information on the risk profile, the duration and the regional extension of data collection should be coherent with the expected incidence of events of interest. A great attention should be devoted in preventing that patients are lost to follow-up, since the reasons for being lost are frequently associated with harmful outcomes, such as adverse drug reactions. In a registry focused on effectiveness, the main aim consists in ascertaining the reasons (the prognostic factors), for possible discrepancies between premarketing studies and clinical practice. Taking into account the greater incidence of the expected events, there are fewer reasons for extending data collection to all users, whereas the main attention should focus on quality controls and the ascertainment of confounding factors. Given the relevance of the validity issues, in the set out of a registry it is important to think about ad hoc resources and the adequacy of infrastructures. As for any epidemiological study, an adequate qualification of the researcher/clinician in charge of conducting a registry should be

  17. A prospective registry of emergency department patients admitted with infection

    PubMed Central

    2011-01-01

    Background Patients with infections account for a significant proportion of Emergency Department (ED) workload, with many hospital patients admitted with severe sepsis initially investigated and resuscitated in the ED. The aim of this registry is to systematically collect quality observational clinical and microbiological data regarding emergency patients admitted with infection, in order to explore in detail the microbiological profile of these patients, and to provide the foundation for a significant programme of prospective observational studies and further clinical research. Methods/design ED patients admitted with infection will be identified through daily review of the computerised database of ED admissions, and clinical information such as site of infection, physiological status in the ED, and components of management abstracted from patients' charts. This information will be supplemented by further data regarding results of investigations, microbiological isolates, and length of stay (LOS) from hospital electronic databases. Outcome measures will be hospital and intensive care unit (ICU) LOS, and mortality endpoints derived from a national death registry. Discussion This database will provide substantial insights into the characteristics, microbiological profile, and outcomes of emergency patients admitted with infections. It will become the nidus for a programme of research into compliance with evidence-based guidelines, optimisation of empiric antimicrobial regimens, validation of clinical decision rules and identification of outcome determinants. The detailed observational data obtained will provide a solid baseline to inform the design of further controlled trials planned to optimise treatment and outcomes for emergency patients admitted with infections. PMID:21269438

  18. [RDPLF and Rein, 2 complementary registries: a comparison of the collected data].

    PubMed

    Couchoud, Cécile; Duman, Mirela; Frimat, Luc; Ryckelynck, Jean-Philippe; Verger, Christian

    2007-03-01

    The 2 registries RDPLF and Rein are information systems concerning the treatment of end-stage renal disease. The aim of the study was to evaluate the representativeness and exhaustivity of the recorded cases as well as the accuracy of the informations in the 2 registries. Were included 375 adults, who started a first ESRD treatment between 1 January 2003 and 31 December 2003 in 7 French regions and were treated by peritoneal dialysis (PD) on the first day of the 4th month of ESRD treatment. 264 patients were identified found in both registries. Age, body mass index and albuminemia didn't differ significantly. The mean haemoglobin level was higher in RDPLF. There was a good concordance on sex, diabetes status but less so on primary renal disease and PD modalities. There were significant discrepancies between the two registries on the date of the first treatment. The analysis of outcomes (transplantation or death) showed 8 discrepancies related to the lack of recording of the event in one of the 2 registries. The good global agreement observed between Rein and RDPLF for the common data emphasizes the fiability and representativeness of the 2 structures and the synergy of their activities for a best evaluation of the quality of peritoneal dialysis. This study shows the necessity of a common patient identification that will allow us to maintain a good complementarity between the 2 registries and will favour common studies.

  19. Atypical teratoid rhabdoid tumor in the first year of life: the Canadian ATRT registry experience and review of the literature.

    PubMed

    Fossey, Mary; Li, Haocheng; Afzal, Samina; Carret, Anne-Sophie; Eisenstat, David D; Fleming, Adam; Hukin, Juliette; Hawkins, Cynthia; Jabado, Nada; Johnston, Donna; Brown, Tania; Larouche, Valerie; Scheinemann, Katrin; Strother, Douglas; Wilson, Beverly; Zelcer, Shayna; Huang, Annie; Bouffet, Eric; Lafay-Cousin, Lucie

    2017-01-19

    While 2/3 of patients with ATRT are less than 3 years at diagnosis, the literature suggests younger children present with more aggressive disease and poorer outcome. However, little data exist on characteristics and outcome of patients diagnosed with ATRT in the first year of life. In particular, it is unclear whether they access similar treatments as do older children. We compared the cohort of patients ≤12 months from the Canadian ATRT registry to all cases extracted from the literature reported between 1996 and 2014 to describe their clinical and treatment characteristics, and potential prognostic factors. Twenty-six (33.7%) patients from the Canadian registry were ≤12 months at diagnosis as were 120 cases identified in the literature. Post-operatively, 46% of the registry's patients underwent palliation as opposed to 10.8% in the literature cohort. Palliative patients were significantly younger than those who received active therapy (3.3 vs. 6.6 months). While the use of high-dose chemotherapy (HDC) was relatively similar in both cohorts (42.9 and 35.5% respectively), radiotherapy (RT) use was significantly lower in the Canadian cohort (14.3 vs 44.9%). Children ≤6 months, who received active therapy, had a worst outcome than older ones. Gross total resection, HDC and adjuvant RT were associated with better outcomes. Eighty percent of the tested patients had evidence of germline mutation of INI1. While 1/3 of ATRT occurs within the first year of life, a large proportion only received palliative therapy. Even when actively treated, children ≤6 months fare worse. Some selected patients benefit from HDC.

  20. Ophthalmic manifestations in IgG4-related disease: Clinical presentation and response to treatment in a French case-series.

    PubMed

    Ebbo, Mikael; Patient, Matthieu; Grados, Aurelie; Groh, Matthieu; Desblaches, Julien; Hachulla, Eric; Saadoun, David; Audia, Sylvain; Rigolet, Aude; Terrier, Benjamin; Perlat, Antoinette; Guillaud, Constance; Renou, Frederic; Bernit, Emmanuelle; Costedoat-Chalumeau, Nathalie; Harlé, Jean-Robert; Schleinitz, Nicolas

    2017-03-01

    IgG4-related disease (IgG4-RD) is characterized by variable tissue or organ involvements sharing common pathological findings. Orbital or orbital adnexa involvement of the disease has been reported in a few case series. The aim of our study was to characterize and analyze ophthalmic manifestations from a nationwide French case-series.Patients with IgG4-RD and orbital or orbital adnexa involvement included in the French multicentric IgG4-RD case-registry were identified. Only patients fulfilling "modified" comprehensive diagnostic criteria with pathological documentation were retained for the study. Clinical, biological, pathological, radiological findings and data regarding the response to treatment were retrospectively analyzed.According to our data registry, the frequency of IgG4-related ophthalmic disease (IgG4-ROD) was 17%. Mean age at diagnosis was 55.1 ± 7.1 years with a male/female ratio of 2.2. The 19 cases of IgG4-ROD consisted of lacrimal gland (68.4%), soft tissue (57.9%), extra-ocular muscles (36.8%), palpebral (21.1%), optical nerve (10.5%), orbital bone (10.5%), and mononeuritis (V1 and/or V2, 10.5%) involvements. IgG4-ROD was bilateral in 57.9% of cases. Extra-ophthalmic manifestations were reported in 78.9% of cases. All patients responded to prednisone but two-thirds of patients relapsed within a mean (SD) of 9.8 (3.5) months and 72.2% required long-term glucocorticoids and/or immunosuppressive agents. Eight patients were treated by rituximab with a favorable response in 87.5% of cases.Lacrimal involvement is the most frequent ophthalmic manifestation of IgG4-RD and is frequently associated with extra-orbital manifestations. Despite initial favorable response to steroids, the long-term management of relapsing patients needs to be improved.

  1. [The EUCORE registry: objectives and general results].

    PubMed

    Cercenado, Emilia; Pachón, Jerónimo

    2012-02-01

    The European Cubicin Outcomes Registry and Experience (EUCORE) is an ongoing, retrospective, European, post-marketing, non-comparative database of daptomycin use in patients that have received at least one daptomycin dose. The primary objective is to evaluate the clinical outcomes of patients treated with this drug. This article presents the analysis of patients included in Spanish institutions from January 2006 to March 2010. A total of 726 patients were included: 66% males, 48.6% aged more than 65 years old, and 70% with comorbidities. Daptomycin was administered in the outpatient setting in 20.3% of the patients. More than 50% of the patients received a dose of 6 mg/kg/day and in 80% daptomycin was administered as a rescue therapy. The median treatment duration was 14 days. The infections treated were bacteremia (32.51%), skin and soft tissue infections (31.4%), infectious endocarditis (14.33%), infections associated with prosthetic materials (10.9%), osteoarticular infections (6.1%), and others. Infections were caused by Staphylococcus aureus (40.5%; 14.4% methicilllin-resistant), coagulase-negative staphylococci (34.5%), enterococci (11.7%) and group viridans streptococci (2.9%). The overall rate of clinical success was 78.4% (81.5% when administered as first-line therapy and 77.6% when administered as rescue therapy). In patients with renal failure, the efficacy of daptomycin was lower. At the end of therapy, 8.7% of patients showed a decrease in creatinine clearance, and in 25 patients creatine kinase values were more than 10 times higher than normal values. Daptomycin is a safe and effective antimicrobial agent for the treatment of severe infections caused by Gram-positive bacteria.

  2. Use of registry employees can pose legal problems.

    PubMed

    Hoffman, S F

    1994-07-01

    In view of the potential legal liability to which a recipient entity can be exposed when using registry employees, some care must be taken in drafting registry contract services and in modulating the recipient entity's behavior towards the registry personnel. The following steps should generally be taken by health care establishments purchasing registry services to minimize such exposure: (1) Ensure that the registry treats its personnel as employees and complies with all applicable employment law obligations, including state and federal employment tax requirements, workers' compensation laws, and any state law wage and hour requirements in the recipient's state. (2) If using an out-of-state registry, make sure that the registry also has workers' compensation insurance in the recipient's state and complies with that state workers' compensation laws. (3) Make sure that termination decisions regarding registry employees are not made for reasons that violate any federal anti-discrimination laws. (4) Provide in the registry agreement for full indemnification by the registry to the recipient. (5) Ensure that the registry is solvent and has adequate insurance to honor its indemnification obligation. (6) Obtain a warranty from the registry that it carefully screens all of its employees before hiring them. (7) Expressly state in the registry agreement that the registry has the right to discipline and supervise the personnel it refers. (8) Do not reject registry personnel for reasons that would be improper with respect to the facility's own employees, e.g., race, sex, age, religion, disability, etc.

  3. Early observational research and registries during the 2009–2010 influenza A pandemic

    PubMed Central

    Fowler, Robert A.; Webb, Steven A. R.; Rowan, Kathy M.; Sprung, Charles L.; Thompson, B. Taylor; Randolph, Adrienne G.; Jouvet, Philippe; Lapinsky, Stephen; Rubinson, Lewis; Rello, Jordi; Cobb, J. Perren; Rice, Todd W.; Uyeki, Tim; Marshall, John C.

    2013-01-01

    As a critical care community, we have an obligation to provide not only clinical care but also the research that guides initial and subsequent clinical responses during a pandemic. There are many challenges to conducting such research. The first is speed of response. However, given the near inevitability of certain events, for example, viral respiratory illness such as the 2009 pandemic, geographically circumscribed natural disasters, or acts of terror, many study and trial designs should be preplanned and modified quickly when specific events occur. Template case report forms should be available for modification and web entry; centralized research ethics boards and funders should have the opportunity to preview and advise on such research beforehand; and national and international research groups should be prepared to work together on common studies and trials for common challenges. We describe the early international critical care research response to the influenza A 2009 (H1N1) pandemic, including specifics of observational study case report form, registry, and clinical trial design, cooperation of international critical care research organizations, and the early results of these collaborations. PMID:20101176

  4. Unusual clinical presentation in two cases of multiple sulfatase deficiency.

    PubMed

    Blanco-Aguirre, M E; Kofman-Alfaro, S H; Rivera-Vega, M R; Medina, C; Valdes-Flores, M; Rizzo, W B; Cuevas-Covarrubias, S A

    2001-01-01

    Multiple sulfatase deficiency (MSD) is an inborn error of metabolism that combines the clinical features of late infantile metachromatic leukodystrophy and mucopolysaccharidosis. The characteristic biochemical abnormality is a reduction in the activities of several sulfatases, with consequent tissue accumulation of sulfatides, sulfated glycosaminoglycans, sphingolipids, and steroid sulfates. In this study we present two unusual cases of MSD with variable enzymatic deficiency of arylsulfatases A, B, and C. Both patients had ichthyosis, broad thumbs and index fingers, an unusually slow progression of the neurologic symptoms, and lacked the hepatosplenomegaly that is typical of MSD. Olivopontocerebellar atrophy was present and one patient had a large retrocerebellar cyst. Mucopolysaccharides were not detected in the urine from either subject. Leukocyte arylsulfatase A activity in patient 1 was 0.46 nmol/mg protein/hr and in patient 2 was 0.0 nmol/mg protein/hr (normal 0.7-5.0 nmol/mg protein/hr). Leukocyte arylsulfatase B activity in patient 1 was 24 nmol/mg protein/hr and in patient 2 was 22 nmol/mg protein/hr (normal 115-226 nmol/mg protein/hr). Leukocyte arylsulfatase C in patient 1 was 0.30 pmol/mg protein/hr and in patient 2 was 0.28 pmol/mg protein/hr (normal 0.84 pmol/mg protein/hr). In conclusion, these two patients with MSD had mild clinical presentations not previously reported and variable enzymatic deficiency of arylsulfatases A, B, and C.

  5. Insights from the early experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

    PubMed

    Rumsfeld, John S; Holmes, David R; Stough, Wendy Gattis; Edwards, Fred H; Jacques, Louis B; Mack, Michael J

    2015-03-01

    The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges.

  6. The Italian Dystonia Registry: rationale, design and preliminary findings.

    PubMed

    Defazio, Giovanni; Esposito, M; Abbruzzese, G; Scaglione, C L; Fabbrini, G; Ferrazzano, G; Peluso, S; Pellicciari, R; Gigante, A F; Cossu, G; Arca, R; Avanzino, L; Bono, F; Mazza, M R; Bertolasi, L; Bacchin, R; Eleopra, R; Lettieri, C; Morgante, F; Altavista, M C; Polidori, L; Liguori, R; Misceo, S; Squintani, G; Tinazzi, M; Ceravolo, R; Unti, E; Magistrelli, L; Coletti Moja, M; Modugno, N; Petracca, M; Tambasco, N; Cotelli, M S; Aguggia, M; Pisani, A; Romano, M; Zibetti, M; Bentivoglio, A R; Albanese, A; Girlanda, P; Berardelli, A

    2017-02-18

    The Italian Dystonia Registry is a multicenter data collection system that will prospectively assess the phenomenology and natural history of adult-onset dystonia and will serve as a basis for future etiological, pathophysiological and therapeutic studies. In the first 6 months of activity, 20 movement disorders Italian centres have adhered to the registry and 664 patients have been recruited. Baseline historical information from this cohort provides the first general overview of adult-onset dystonia in Italy. The cohort was characterized by a lower education level than the Italian population, and most patients were employed as artisans, builders, farmers, or unskilled workers. The clinical features of our sample confirmed the peculiar characteristics of adult-onset dystonia, i.e. gender preference, peak age at onset in the sixth decade, predominance of cervical dystonia and blepharospasm over the other focal dystonias, and a tendency to spread to adjacent body parts, The sample also confirmed the association between eye symptoms and blepharospasm, whereas no clear association emerged between extracranial injury and dystonia in a body site. Adult-onset dystonia patients and the Italian population shared similar burden of arterial hypertension, type 2 diabetes, coronary heart disease, dyslipidemia, and hypothyroidism, while hyperthyroidism was more frequent in the dystonia population. Geographic stratification of the study population yielded no major difference in the most clinical and phenomenological features of dystonia. Analysis of baseline information from recruited patients indicates that the Italian Dystonia Registry may be a useful tool to capture the real world clinical practice of physicians that visit dystonia patients.

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

    PubMed

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

    2015-01-01

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

  8. [Data from the IN-HF Outcome registry].

    PubMed

    Misuraca, Gianfranco; Di Tano, Giuseppe; Camerini, Alberto; Cloro, Cosima; Gorini, Marco

    2012-05-01

    The IN-HF Outcome registry enrolled 1855 patients admitted for acute heart failure and 3755 outpatients with chronic heart failure seen at 64 cardiology units of the Italian Network-Heart Failure. We assessed gender-related differences in clinical characteristics, management, and short- and long-term mortality and morbidity outcomes. Women were older, more often hypertensive and with a higher prevalence of heart failure with preserved systolic function. Aggressive management was less frequent in women who underwent less often diagnostic and therapeutic procedures. We found no gender-related differences in either acute or long-term mortality nor in hospital readmissions.

  9. Placental sulfatase deficiency: clinical and biochemical study of 16 cases.

    PubMed

    Bedin, M; Alsat, E; Tanguy, G; Cedard, L

    1980-01-01

    Clinical and biochemical data of 16 typical cases of placental sulfatase deficiency have been observed. In vivo loading tests with DHA-S allowed us to make a prenatal diagnosis. In vitro experiments gave confirmation, showing zero or virtually zero placental sulfatase activity towards delta 5P or DHA sulfates Aromatase activities, when tested, were normal or more often less than standard values, the latter showing themselves rather large individual variations. All pregnancies were associated with the delivery of male neonates in good health but 3. The 15 living babies have been developing normally since then. These results, together with those reported in the literature, suggest that placental sulfatase deficiency is under control of an X-linked recessive character, this being supported by the recent observation of such a disorder in two sisters simultaneously pregnant. As to the high frequency problem of cesarian section, pointed out by several authors, we cannot conclude, from our own observations, that the defect has an obvious influence on the good outcome of labor, as 10 out of the 16 women delivered vaginally near term.

  10. Clinical case of cerebral amebiasis caused by E. histolytica.

    PubMed

    Maldonado-Barrera, Cinthya A; Campos-Esparza, Maria Del Rosario; Muñoz-Fernández, Luis; Victoria-Hernández, Joaquin A; Campos-Rodríguez, Rafael; Talamás-Rohana, Patricia; Ventura-Juárez, Javier

    2012-03-01

    Although amebic brain abscess is a rare form of invasive amebiasis, when present, it is frequently lethal. This disorder always begins with the infection of the colon by Entamoeba histolytica trophozoites, which then travel to extra-intestinal tissues through the bloodstream. Amebic brain abscesses are produced when trophozoites invade the central nervous system. Computerized axial tomography scans can be used to diagnose the presence or absence of a brain abscess with a certainty of 100%. However, this diagnostic tool does not reveal the etiological agent of disease. By analyzing the clinical case of a patient that died due to untimely treatment of this malady, the present study aims to identify a diagnostic tool that can give a precise determination of the etiological agent and therefore permit adequate and opportune treatment. Currently, diagnosis of amebic brain abscess is often done by identification of the ameba in a biopsy or autopsy. By immunohistochemistry and immunofluorescence with specific antibodies, we identified the existence of E. histolytica, which presents proteins similar to Naegleria fowleri in its membrane.

  11. Sheehan syndrome: clinical and laboratory evaluation of 20 cases.

    PubMed

    Ozkan, Yusuf; Colak, Ramis

    2005-06-01

    Sheehan syndrome (SS) or post-partum pituitary necrosis is a pituitary insufficiency secondary to excessive post-partum blood losses. SS is a very significant cause of maternal morbidity and mortality in developing countries although it is a rarity in developed countries in which obstetrical care has been improved. In this study, we reviewed 20 cases retrospectively who were diagnosed as SS in our clinic. The patients aged 40 to 65 years with a mean age of 51.12 +/- 9.44 years (mean +/- SD). Time to make a definitive diagnosis of the disease ranged between 5 and 25 years with a mean of 16.35 +/- 4.74 years. Three of our patient (15%) had a previous diagnosis of SS. Three patients (15%) were referred to emergency service for hypoglycemia, three patients (15%) for hypothyroidism and one patient (5%) for hyponatremia. Dynamic examination of the pituitary revealed GH, Prolactin, FSH, TSH and ACTH insufficiency in all of the patients. One of our patients had a sufficient LH response to LHRH challenge. All of the patients were imaged with pituitary MRI. Eleven patients had empty sella and 9 patients had partial empty sella. SS is still a common problem in our country, especially in rural areas. Considering the duration of disease, important delays occur in diagnosis and treatment of the disease.

  12. [Treatment of postmenopausal osteoporosis in the general medical practice (clinical case)].

    PubMed

    Zhdan, V M; Kitura, O Ie; Kitura, Ie M; Babanina, M Iu; Tkachenko, M V

    2013-03-01

    In this article demonstrated a clinical case of patients with postmenopausal osteoporosis with compression fractures of (Th(IV)). Indicates the basic risk factors for postmenopausal osteoporosis, clinic, diagnosis, principles of therapy.

  13. Fifty-year anniversary of the Vietnam Vascular Registry and a historic look at vascular registries.

    PubMed

    Hata, Kai W; Propper, Brandon; Rich, Norman

    2017-01-01

    The management of arterial injuries has evolved from simple cauterization of the time of Ambrose Paré to the more complex repairs of today. Through history there has been much learned from combat regarding the management of vascular injuries. Starting in World War I, vascular registries have been established to further study and refine the management of these injuries. One of the most pivotal registries was the Vietnam Vascular Registry established by Dr Norman Rich. The lessons learned from these registries have been carried on to the current conflicts with the establishment of the Global War on Terror Vascular Initiative. We compare 100 lower extremity vascular injuries from the Vietnam Vascular Registry to 100 injuries in the Global War on Terror Vascular Initiative database as we continue to improve the future with lessons from our past.

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

    PubMed Central

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

    2011-01-01

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

  15. A Patient Registry to Improve Patient Safety: Recording General Neurosurgery Complications

    PubMed Central

    Sarnthein, Johannes; Stieglitz, Lennart; Clavien, Pierre-Alain; Regli, Luca

    2016-01-01

    Background To improve the transparency of the local health care system, treatment cost was recently referenced to disease related groups. Treatment quality must be legally documented in a patient registry, in particular for the highly specialized treatments provided by neurosurgery departments. Methods In 2013 we have installed a patient registry focused on cranial neurosurgery. Surgeries are characterized by indication, treatment, location and other specific neurosurgical parameters. Preoperative state and postoperative outcome are recorded prospectively using neurological and sociological scales. Complications are graded by their severity in a therapy-oriented complication score system (Clavien-Dindo-Grading system, CDG). Results are presented at the monthly clinical staff meeting. Results Data acquisition compatible with the clinic workflow permitted to include all eligible patients into the registry. Until December 2015, we have registered 2880 patients that were treated in 3959 surgeries and 8528 consultations. Since the registry is fully operational (August 2014), we have registered 325 complications on 1341 patient discharge forms (24%). In 64% of these complications, no or only pharmacological treatment was required. At discharge, there was a clear correlation of the severity of the complication and the Karnofsky Performance Status (KPS, ρ = -0.3, slope -6 KPS percentage points per increment of CDG) and the length of stay (ρ = 0.4, slope 1.5 days per increment of CDG). Conclusions While the therapy-oriented complication scores correlate reasonably well with outcome and length of stay, they do not account for new deficits that cannot be treated. Outcome grading and complication severity grading thus serve a complimentary purpose. Overall, the registry serves to streamline and to complete information flow in the clinic, to identify complication rates and trends early for the internal quality monitoring and communication with patients. Conversely, the

  16. Contributions of the Transplant Registry: The 2006 Annual Report of the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS).

    PubMed

    Smith, Jodi M; Stablein, Donald M; Munoz, Ricardo; Hebert, Diane; McDonald, Ruth A

    2007-06-01

    This summary of the NAPRTCS 2006 Annual Report of the Transplant Registry highlights the significant impact the registry has had in advancing knowledge in pediatric renal transplantation worldwide. This cooperative group has collected clinical information on children undergoing a renal transplantation since 1987 and now includes over 150 participating medical centers in the USA, Canada, Mexico, and Costa Rica. Currently, the NAPRTCS transplant registry includes information on 9837 renal transplants in 8990 patients (NAPRTCS 2006 Annual Report). Since the first data analysis in 1989, NAPRTCS reports have documented marked improvements in outcome after renal transplantation in addition to identifying factors associated with both favorable and poor outcomes. The registry has served to document and influence practice patterns, clinical outcomes, and changing trends in renal transplantation.

  17. ISMAC: An Intelligent System for Customized Clinical Case Management and Analysis

    PubMed Central

    You, Mingyu; Chen, Chong; Li, Guo-Zheng; Yan, Shi-Xing; Sun, Sheng; Zeng, Xue-Qiang; Zhao, Qing-Ce; Xu, Liao-Yu; Huang, Su-Ying

    2015-01-01

    Clinical cases are primary and vital evidence for Traditional Chinese Medicine (TCM) clinical research. A great deal of medical knowledge is hidden in the clinical cases of the highly experienced TCM practitioner. With a deep Chinese culture background and years of clinical experience, an experienced TCM specialist usually has his or her unique clinical pattern and diagnosis idea. Preserving huge clinical cases of experienced TCM practitioners as well as exploring the inherent knowledge is then an important but arduous task. The novel system ISMAC (Intelligent System for Management and Analysis of Clinical Cases in TCM) is designed and implemented for customized management and intelligent analysis of TCM clinical data. Customized templates with standard and expert-standard symptoms, diseases, syndromes, and Chinese Medince Formula (CMF) are constructed in ISMAC, according to the clinical diagnosis and treatment characteristic of each TCM specialist. With these templates, clinical cases are archived in order to maintain their original characteristics. Varying data analysis and mining methods, grouped as Basic Analysis, Association Rule, Feature Reduction, Cluster, Pattern Classification, and Pattern Prediction, are implemented in the system. With a flexible dataset retrieval mechanism, ISMAC is a powerful and convenient system for clinical case analysis and clinical knowledge discovery. PMID:26495425

  18. [The posturological department as clinical support for occupational medicine: clinical cases and results of a hospital unit].

    PubMed

    Centemeri, R; D'Orso, M I; Latocca, R; Pagani, W; Cesana, G C

    2007-01-01

    The posturologic visit is a not widely known medical method for the evaluation and the therapy of low back pain. We describe the clinical and instrumental method followed in our posturological clinical unit organized jointly by hospital and university and the clinical cases evaluated in two years. An individual diagnostic evaluation and a personal therapy allowed an almost generalized complete remission of the symptoms and a very low number of reactivation of low back pain after a follow up of one years.

  19. Digital Device in Postextraction Implantology: A Clinical Case Presentation

    PubMed Central

    Borgonovo, A. E.; Rigaldo, F.; Battaglia, D.; Giannì, A. B.

    2014-01-01

    Aim. The aim of this work is to describe a case of immediate implant placement after extraction of the upper right first premolar, with the use of CAD/CAM technology, which allows an early digital impression of the implant site with an intraoral scanner (MHT 3D Progress, Verona, Italy). Case Report. A 46-year-old female was referred with a disorder caused by continuous debonding of the prosthetic crown on the upper right first premolar. Clinically, there were no signs, and the evaluation of the periapical radiograph showed a fracture of the root, with a mesial well-defined lesion of the hard tissue of the upper right first premolar, as the radiolucent area affected the root surface of the tooth. It was decided, in accordance with the patient, that the tooth would be extracted and the implant (Primer, Edierre implant system, Genoa, Italy) with diameter of 4.2 mm and length of 13 mm would be inserted. After the insertion of the implant, it was screwed to the scan abutment, and a scan was taken using an intraoral scanner (MHT 3D Progress, Verona, Italy). The scanned images were processed with CAD/CAM software (Exocad DentalCAD, Darmstadt, Germany) and the temporary crown was digitally drawn (Dental Knowledge, Milan, Italy) and then sent to the milling machine for production with a composite monoblock. After 4 months, when the implant was osteointegrated, it was not necessary to take another dental impression, and the definitive crown could be screwed in. Conclusion. The CAD/CAM technology is especially helpful in postextraction implant for aesthetic rehabilitation, as it is possible to immediately fix a provisional crown with an anatomic shape that allows an optimal healing process of the tissues. Moreover, the removal of healing abutments, and the use of impression copings, impression materials, and dental stone became unnecessary, enabling the reduction of the chair time, component cost, and patient's discomfort. However, it is still necessary for scientific

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

    PubMed Central

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

    2016-01-01

    The aims of this study were to provide a comprehensive summary of the body of research disseminated by Cerebral Palsy (CP) registries and surveillance programs from January 2009 through May 2014 in order to describe the influence their results have on our overall understanding of CP. Secondly, registries/surveillance programs and the work they produced were evaluated and grouped using standardized definitions and classification systems. Method A systematic review search in PubMed, CINAH and Embase for original articles published from 1 January 2009 to 20 May 2014 originating from or supported by population based CP registries and surveillance programs or population based national registries including CP were included. Articles were grouped by 2009 World CP Registry Congress aim, registry/surveillance program classification, geographical region, and the International Classification of Function, Disability and Health (ICF) domain. Registry variables were assessed using the ICF-CY classification. Results Literature searches returned 177 articles meeting inclusion criteria. The majority (69%) of registry/surveillance program productivity was related to contributions as a Resource for CP Research. Prevention (23%) and Surveillance (22%) articles were other areas of achievement, but fewer articles were published in the areas of Planning (17%) and Raising the Profile of CP (2%). There was a range of registry/surveillance program classifications contributing to this productivity, and representation from multiple areas of the globe, although most of the articles originated in Europe, Australia, and Canada. The domains of the ICF that were primarily covered included body structures and function at the early stages of life. Encouragingly, a variety of CP registry/surveillance program initiatives included additional ICF domains of participation and environmental and personal factors. Interpretation CP registries and surveillance programs, including novel non-traditional ones

  1. Registry of hemophilia and other bleeding disorders in Syria.

    PubMed

    Ali, T; Schved, J F

    2012-11-01

    Creating a national registry for bleeding disorders is a major step in establishing a National Hemophilia Care Program in all countries. Creating such a registry which would contain accurate and regularly updated data, including laboratory analysis confirmed by a reference laboratory established at the Syrian Hemophilia Society. Blood samples were drawn and analysed in the Society reference laboratory for the following screening tests: prothrombin time (PT), APTT and coagulation factor assays. Inhibitor detection and VWF RiCof were performed depending on the result of the screening tests. HBs Ag, anti-HCV, anti-HIV 1+2 and syphilis tests were also performed to detect transfusion transmitted agents (TTA). Diagnosis of the bleeding disorder type was confirmed for 760 of these cases. Among the 760 confirmed patients, 82.5% had haemophilia. Among these, 89.6%were haemophilia A; 10.4% were haemophilia B; 8.3% had VWD; 9.2% had other rare bleeding disorders as follows: 1.2% FVII deficiency, 0.7% FV deficiency, 1.8% F1 deficiency, 0.4% FX deficiency, 1.4% platelets dysfunctions (mainly Glanzmann Thrombasthenia) and 3.7% had combined FVIII and FV deficiency. Eighty (21.3%) cases of 375 screened for transfusion transmitted agents were positive for at least one infection: 0.5% were HBsAg positive, 19.7% were anti-HCV positive, 0.8% had combined HBsAg and anti-HCV positivity and 0.3% was anti-Syphilis positive. All patients were negative for HIV1 and HIV2. The preliminary data presented here follow known data on haemophilia A, haemophilia B and VWD disease. This registry will certainly help in improving haemophilia care in Syria.

  2. Posttraumatic Stress Disorder and Late-Onset Smoking in the Vietnam Era Twin Registry

    ERIC Educational Resources Information Center

    Koenen, Karestan C.; Hitsman, Brian; Lyons, Michael J.; Stroud, Laura; Niaura, Raymond; McCaffery, Jeanne; Goldberg, Jack; Eisen, Seth A.; True, William; Tsuang, Ming

    2006-01-01

    Epidemiological and clinical studies have consistently reported associations between smoking and posttraumatic stress disorder (PTSD). This study analyzed diagnostic interview data on 6,744 members of the Vietnam Era Twin Registry to clarify the PTSD-smoking relation and to examine whether genetic liability for smoking moderated this relation.…

  3. First annual report of the Austrian CML registry.

    PubMed

    Schmidt, Stefan; Wolf, Dominik; Thaler, Josef; Burgstaller, Sonja; Linkesch, Wolfgang; Petzer, Andreas; Fridrik, Michael; Lang, Alois; Agis, Hermine; Valent, Peter; Krieger, Otto; Walder, Alois; Korger, Markus; Schlögl, Ernst; Sliwa, Tamer; Wöll, Ernst; Mitterer, Manfred; Eisterer, Wolfgang; Pober, Michael; Gastl, Günther

    2010-10-01

    The Austrian chronic myeloid leukemia (CML) registry monitors individual disease courses, treatments applied, clinical outcome, and side effects of CML patients on a nationwide basis to provide data on the "real-life" situation and to complement the information and interpretation gained from the selected patient population observed in clinical trials. This report summarizes the Austrian CML registry data as of March 2009. A total of 179 patients have been registered with a median number of 1012 follow-up visits and median observation duration of 20 months. At diagnosis most patients (n = 163) were in chronic phase (early, late, and secondary), whereas only 4 were in advanced phase. A total of 137 patients were treated with tyrosine kinase inhibitors (TKIs), of which 14 received first and second generation TKIs sequentially. Other treatment modalities included chemotherapy or interferon and stem cell transplantation (SCT). Cumulative incidence rates for complete hematological responses (CHR) were 91.6% and 94.4% at 12 and 24 months, respectively, compared to cumulative incidence rates of complete cytogenetical response rates of 64% and 80% at these timepoints. A total of 5 patients progressed from chronic phase to accelerated (n = 3) and blastic phase (n = 2) while receiving imatinib standard dose. Estimated overall survival (OS) rate at 60 months was 90% and progression free survival (PFS) according to European Leukemia Net (ELN) failure definition was 58%.

  4. Rituximab use in the catastrophic antiphospholipid syndrome: descriptive analysis of the CAPS registry patients receiving rituximab.

    PubMed

    Berman, Horacio; Rodríguez-Pintó, Ignasi; Cervera, Ricard; Morel, Nathalie; Costedoat-Chalumeau, Nathalie; Erkan, Doruk; Shoenfeld, Yehuda; Espinosa, Gerard

    2013-09-01

    The catastrophic variant of the antiphospholipid syndrome (APS) is characterized by thrombosis in multiple organs developing over a short period of time. First-line treatment for the catastrophic APS is the combination of anticoagulation plus corticosteroids plus plasma exchange and/or intravenous immunoglobulin. Despite this regimen, the mortality remains high and new treatment options are needed. By a systematic review of the Catastrophic APS Registry (CAPS Registry), we identified 20 patients treated with rituximab. The purpose of this study is to describe the clinical manifestations, laboratory features, and outcomes of rituximab-treated CAPS patients. In addition, the rationale for using rituximab in catastrophic APS is discussed.

  5. Case Complexity and Quality Attestation for Clinical Ethics Consultants.

    PubMed

    Spielman, Bethany; Craig, Jana; Gorka, Christine; Miller, Keith

    2015-01-01

    A proposal by the American Society for Bioethics and Humanities (ASBH) to identify individuals who are qualified to perform ethics consultations neglects case complexity in candidates' portfolios. To protect patients and healthcare organizations, and to be fair to candidates, a minimum case complexity level must be clearly and publicly articulated. This proof-of-concept study supports the feasibility of assessing case complexity. Using text analytics, we developed a complexity scoring system, and retrospectively analyzed more than 500 ethics summaries of consults performed at an academic medical center during 2013. We demonstrate its use with seven case summaries that range in complexity from uncomplicated to very complicated. We encourage the ASBH to require a minimum level of case complexity, and recommend that attestation portfolios include several cases of moderate complexity and at least one very complex case.

  6. Reflection-in-Action: Case Study of a Clinical Supervisor.

    ERIC Educational Resources Information Center

    Turner-Muecke, Lee A.

    1986-01-01

    Applies Donald Schon's concept of the "reflective practitioner" to Robert Goldhammer's clinical supervision cycle (pre-observation conference, observation, analysis and strategy, supervision conference, and postconference analysis), stressing personal growth purposes for teacher and supervisor alike. Explores a clinical supervisor's…

  7. Rational-emotive therapy and depression: a clinical case study.

    PubMed

    Horton, A M; Johnson, C H

    1980-12-01

    Rational-emotive group and bibliotherapy were used to treat a depressed patient in a clinical setting. Psychological test data document a dramatic improvement. It is suggested that rational-emotive therapy may prove efficacious for the treatment of some depressed patients in clinical settings.

  8. National Marrow Donor Program and Be The Match Registry

    MedlinePlus

    ... National Marrow Donor Program and Be The Match Registry Past Issues / Summer 2011 Table of Contents Creating ... Donor Program (NMDP) and its Be The Match Registry are nonprofit organizations dedicated to creating an opportunity ...

  9. 76 FR 38619 - Proposed Information Collection; Comment Request; National Saltwater Angler Registry and State...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

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

  10. [From clinical trials to clinical practice. Experience with rivaroxaban in the anticoagulant treatment of patients with non-valvular atrial fibrillation].

    PubMed

    Barrios, V; Escobar, C

    2016-03-04

    Despite the information provided by clinical trials is important, there are relevant clinical differences between those patients included in clinical trials and data of daily outpatient clinics. As a result, in some cases, the results of randomized clinical trials could not be directly applied to clinical practice. In this context, to perform «real-life» registries is mandatory. In the ROCKET-AF study, rivaroxaban, a once-daily direct oral anticoagulant, was at least as effective as warfarin for preventing stroke or systemic embolism, with similar rates of major bleeding, but with a lesser risk of intracranial, critical and fatal bleedings. In the last years, different large registries have confirmed that rivaroxaban is effective and even safer in real-life patients than in ROCKET-AF. The aim of this review is to update the current evidence about the efficacy, effectiveness and safety of rivaroxaban in real-life patients.

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

    PubMed

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

    2011-01-01

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

  12. The Joys of Clinical Trials: A Case Study of a Multicenter Pharmaceutical Trial.

    ERIC Educational Resources Information Center

    Soronson, Bryan M.; Shaw, Diana V.

    1994-01-01

    A discussion of clinical trials in the pharmaceutical industry describes typical processes and administrative issues, then presents a case in which a foreign pharmaceutical company negotiated with a university for sponsorship of a multicenter clinical trial of a new drug therapy. Problems and important considerations in clinical trials are…

  13. The Role of Biomedical Knowledge in Diagnosis of Difficult Clinical Cases

    ERIC Educational Resources Information Center

    Woods, Nicole N.; Brooks, Lee R.; Norman, Geoffrey R.

    2007-01-01

    Although biomedical knowledge is believed to be of little value in diagnosis of routine clinical cases, studies of clinical reasoning have found that physicians revert to use of basic biomedical knowledge when faced with challenging clinical problems. The current paper presents two experiments that empirically examine the role of biomedical…

  14. Physician-administered clinical score of vulvar lichen sclerosus: A study of 36 cases

    PubMed Central

    Naswa, Smriti; Marfatia, Yogesh S.

    2015-01-01

    Introduction: Vulvar lichen sclerosus (VLS) often remains undetected for years due to lack of awareness, as well as private nature of the disease. Advanced disease severely affects the quality of life and is associated with increased risk of vulvar squamous cell carcinoma (SCC). The aim of this study was to assess the usefulness of a physician-administered clinical scoring system for the clinical diagnosis and evaluation of VLS. To the best of our knowledge, this is the first study using the clinical score developed by Günthert et al on the VLS patients. Materials and Methods: The study conducted was an observational cross-sectional study of 36 cases attending Dermatology OPD of Government Medical College with clinically proven and previously untreated VLS enrolled over a 1 year period. Cases were retrospectively subjected to evaluation by physician-administered clinical score based on 6 clinical features, viz. erosions, agglutination, hyperkeratosis, stenosis, fissures, and atrophy. Results: The average age of 36 clinically diagnosed VLS cases was 56.4 years. Most common clinical features were hyperkeratosis and atrophy found in 86.11% cases followed by erosions (75%) with one-third cases having grade 2 (severe) changes. One case had well-differentiated SCC clitoris at presentation. The mean physician-administered clinical score was 5.583, and 80.56% cases had clinical score ≥4 validating the clinical diagnosis. Discussion: Early diagnosis and prompt treatment is the key to prevent sequelae and complications of VLS. The physician-administered clinical score can be a useful tool to diagnose and later evaluate the response of treatment and prognosis of VLS cases. PMID:26692611

  15. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

    PubMed Central

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin

    2015-01-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

  16. Oral clefts with associated anomalies: findings in the Hungarian Congenital Abnormality Registry

    PubMed Central

    Sárközi, Andrea; Wyszynski, Diego F; Czeizel, Andrew E

    2005-01-01

    Background Over the years, great efforts have been made to record the frequency of orofacial clefts in different populations. However, very few studies were able to account for the etiological and phenotypic heterogeneity of these conditions. Thus, data of cases with syndromic orofacial clefts from large population-based studies are infrequent. Methods Clinically recognized and notified syndromes and associations including cleft lip with or without cleft palate and other congenital anomalies were selected from the Hungarian Congenital Abnormality Registry (HCAR) between 1973 and 1982 and prevalence rates were calculated. Results Of 3,110 cases reported as having orofacial clefts, 653 had multiple congenital abnormalities. Of these, 60 (9.2%) had a known etiology (monogenic: 25 or 3.8%, chromosomal: 31 or 4.7%, teratogenic: 4 or 0.6%). Seventy-three subjects (11.2%) had schisis in addition to the oral cleft. Skeletal anomalies were the most common malformations among cases with cleft lip with/without cleft palate (CL/P) and cleft palate (CP). Disorders of the central nervous system and cardiovascular malformations were also frequently associated. Conclusion Surveillance systems, such as the HCAR, provide useful information about prevalence rates of congenital anomalies in a population. However, in a field where new syndromes are being discovered and classifications regularly updated, these rates should only be accepted as provisional. PMID:15985166

  17. 50 CFR 600.1410 - Registry process.

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  18. 46 CFR 67.17 - Registry endorsement.

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