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

    PubMed

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

    2013-01-01

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

  3. 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

  4. 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.

  5. The registry case finding engine: an automated tool to identify cancer cases from unstructured, free-text pathology reports and clinical notes.

    PubMed

    Hanauer, David A; Miela, Gretchen; Chinnaiyan, Arul M; Chang, Alfred E; Blayney, Douglas W

    2007-11-01

    The American College of Surgeons mandates the maintenance of a cancer registry for hospitals seeking accreditation. At the University of Michigan Health System, more than 90% of all registry patients are identified by manual review, a method common to many institutions. We hypothesized that an automated computer system could accurately perform this time- and labor-intensive task. We created a tool to automatically scan free-text medical documents for terms relevant to cancer. We developed custom-made lists containing approximately 2,500 terms and phrases and 800 SNOMED codes. Text is processed by the Case Finding Engine (CaFE), and relevant terms are highlighted for review by a registrar and used to populate the registry database. We tested our system by comparing results from the CaFE to those by trained registrars who read through 2,200 pathology reports and marked relevant cases for the registry. The clinical documentation (eg, electronic chart notes) of an additional 476 patients was also reviewed by registrars and compared with the automated process by the CaFE. For pathology reports, the sensitivity for automated case identification was 100%, but specificity was 85.0%. For clinical documentation, sensitivity was 100% and specificity was 73.7%. Types of errors made by the CaFE were categorized to direct additional improvements. Use of the CaFE has resulted in a considerable increase in the number of cases added to the registry each month. The system has been well accepted by our registrars. CaFE can improve the accuracy and efficiency of tumor registry personnel and helps ensure that cancer cases are not overlooked.

  6. Differential case ascertainment in clinical registry versus administrative data and impact on outcomes assessment for pediatric cardiac operations.

    PubMed

    Pasquali, Sara K; Peterson, Eric D; Jacobs, Jeffrey P; He, Xia; Li, Jennifer S; Jacobs, Marshall L; Gaynor, J William; Hirsch, Jennifer C; Shah, Samir S; Mayer, John E

    2013-01-01

    Administrative datasets are often used to assess outcomes and quality of pediatric cardiac programs; however their accuracy regarding case ascertainment is unclear. We linked patient data (2004-2010) from the Society of Thoracic Surgeons Congenital Heart Surgery (STS-CHS) Database (clinical registry) and the Pediatric Health Information Systems (PHIS) database (administrative database) from hospitals participating in both to evaluate differential coding/classification of operations between datasets and subsequent impact on outcomes assessment. Eight individual benchmark operations and the Risk Adjustment in Congenital Heart Surgery, version 1 (RACHS-1) categories were evaluated. The primary outcome was in-hospital mortality. The cohort included 59,820 patients from 33 centers. There was a greater than 10% difference in the number of cases identified between data sources for half of the benchmark operations. The negative predictive value (NPV) of the administrative (versus clinical) data was high (98.8%-99.9%); the positive predictive value (PPV) was lower (56.7%-88.0%). Overall agreement between data sources in RACHS-1 category assignment was 68.4%. These differences translated into significant differences in outcomes assessment, ranging from an underestimation of mortality associated with truncus arteriosus repair by 25.7% in the administrative versus clinical data (7.01% versus 9.43%; p = 0.001) to an overestimation of mortality associated with ventricular septal defect (VSD) repair by 31.0% (0.78% versus 0.60%; p = 0.1). For the RACHS-1 categories, these ranged from an underestimation of category 5 mortality by 40.5% to an overestimation of category 2 mortality by 12.1%; these differences were not statistically significant. This study demonstrates differences in case ascertainment between administrative and clinical registry data for children undergoing cardiac operations, which translated into important differences in outcomes assessment. Copyright © 2013 The

  7. Differential Case Ascertainment in Clinical Registry vs. Administrative Data and Impact on Outcomes Assessment in Pediatric Heart Surgery

    PubMed Central

    Pasquali, Sara K.; Peterson, Eric D.; Jacobs, Jeffrey P.; He, Xia; Li, Jennifer S.; Jacobs, Marshall L.; Gaynor, J. William; Hirsch, Jennifer C.; Shah, Samir S.; Mayer, John E.

    2013-01-01

    Background Administrative datasets are often used to assess outcomes and quality in pediatric heart surgery; however their accuracy regarding case ascertainment is unclear. We linked patient data (2004–2010) from the STS Congenital Heart Surgery Database (clinical registry), and Pediatric Health Information Systems Database (administrative database) from hospitals participating in both to evaluate differential coding/classification of operations between datasets, and subsequent impact on outcomes assessment. Methods Eight individual benchmark operations and the RACHS-1 categories were evaluated. The primary outcome was in-hospital mortality. Results The cohort included 59,820 patients (33 centers). There was a >10% difference in the number of patients identified between datasources for half of the benchmark operations. Negative predictive value of the administrative (vs. clinical) data was high (98.8–99.9%); positive predictive value was lower (56.7–88.0%). Overall agreement between datasources in RACHS-1 category assignment was 68.4%. These differences translated into significant differences in outcomes assessment, ranging from an underestimation of mortality associated with truncus arteriosus repair by 25.7% in the administrative vs. clinical data (7.01% vs. 9.43%, p=0.001), to an overestimation of mortality associated with VSD repair by 31.0% (0.78% vs. 0.60%, p=0.1). For the RACHS-1 categories, these ranged from an underestimation of Category 5 mortality by 40.5%, to an overestimation of Category 2 mortality by 12.1%; these differences were not statistically significant. Conclusions This study demonstrates differences in case ascertainment between administrative and clinical registry data for children undergoing heart surgery, which translated into important differences in outcomes assessment. PMID:23141907

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

    PubMed

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

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

  9. [Implementation of electronic registry in orthodontic clinic].

    PubMed

    Persin, L S; Merzhvinskaya, E I

    2017-01-01

    The paper describes technical and methodological features of electronic registry in orthodontic clinic. The authors elaborated custom made software according to Russian Ministry of Health requirements for medical local nets and databases. The registry allows processing of medical statistics and forming of reports, as well as analyzing medical staff effectiveness and seasonal dynamics of clinical work.

  10. 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.

  11. 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.

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

    PubMed Central

    Zeeneldin, Ahmed A.; Taha, Fatma M.

    2015-01-01

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

  13. 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

  14. 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

  15. The T1D Exchange clinic registry.

    PubMed

    Beck, Roy W; Tamborlane, William V; Bergenstal, Richard M; Miller, Kellee M; DuBose, Stephanie N; Hall, Callyn A

    2012-12-01

    The T1D Exchange includes a clinic-based registry, a patient-centric web site called Glu, and a biobank. The aim of the study was to describe the T1D Exchange clinic registry and provide an overview of participant characteristics. Data obtained through participant completion of a questionnaire and chart extraction include diabetes history, management, and monitoring; general health; lifestyle; family history; socioeconomic factors; medications; acute and chronic diabetic complications; other medical conditions; and laboratory results. Data were collected from 67 endocrinology centers throughout the United States. We studied 25,833 adults and children with presumed autoimmune type 1 diabetes (T1D). Participants ranged in age from less than 1 to 93 yr, 50% were female, 82% were Caucasian, 50% used an insulin pump, 6% used continuous glucose monitoring, and 16% had a first-degree family member with T1D. Glycosylated hemoglobin at enrollment averaged 8.3% and was highest in 13 to 25 yr olds. The prevalence of renal disease was ≤4% until T1D was present for at least 10 yr, and retinopathy treatment was ≤2% until T1D was present for at least 20 yr. A severe hypoglycemic event (seizure or coma) in the prior 12 months was reported by 7% of participants and diabetic ketoacidosis in the prior 12 months by 8%. The T1D Exchange clinic registry provides a database of important information on individuals with T1D in the United States. The rich dataset of the registry provides an opportunity to address numerous issues of relevance to clinicians and patients, including assessments of associations between patient characteristics and diabetes management factors with outcomes.

  16. Open-access clinical trial registries: the Italian scenario.

    PubMed

    Mosconi, Paola; Roberto, Anna

    2012-10-18

    Citizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey were to assess the availability of clinical trial registries for Italian citizens and to examine the transparency of the data items reported. The availability of open-access clinical trial registries was surveyed on a sample of 182 websites, including research institutes and centers of excellence (IRCCS-teaching hospitals), hospitals and associations. For each registry we downloaded a sample of two trials to assess the correspondence of the data items reported. Results from the Italian and international registries were compared. Fifteen percent of the sample had an open-access registry of clinical trials. Comparison of the data items available, in terms of completeness and transparency, from institutional and international registries indicated wide variability. Italian citizens, patients and their associations have scant access to local registries of clinical trials, and international registries are generally more informative. On the European level, advocacy and lobby actions are needed among citizens and patients to boost the diffusion of open-access clinical trial registries without language barriers, thereby facilitating participation, access to information, and the coordination of clinical research.

  17. 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.

  18. 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.

  19. Can rheumatoid arthritis (RA) registries provide contextual safety data for modern RA clinical trials? The case for mortality and cardiovascular disease.

    PubMed

    Michaud, Kaleb; Berglind, Niklas; Franzén, Stefan; Frisell, Thomas; Garwood, Christopher; Greenberg, Jeffrey D; Ho, Meilien; Holmqvist, Marie; Horne, Laura; Inoue, Eisuke; Nyberg, Fredrik; Pappas, Dimitrios A; Reed, George; Symmons, Deborah; Tanaka, Eiichi; Tran, Trung N; Verstappen, Suzanne M M; Wesby-van Swaay, Eveline; Yamanaka, Hisashi; Askling, Johan

    2016-10-01

    We implemented a novel method for providing contextual adverse event rates for a randomised controlled trial (RCT) programme through coordinated analyses of five RA registries, focusing here on cardiovascular disease (CVD) and mortality. Each participating registry (Consortium of Rheumatology Researchers of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (SRR) (Sweden), Norfolk Arthritis Register (NOAR) (UK), CORRONA International (East Europe, Latin America, India) and Institute of Rheumatology, Rheumatoid Arthritis (IORRA) (Japan)) defined a main cohort from January 2000 onwards. To address comparability and potential bias, we harmonised event definitions and defined several subcohorts for sensitivity analyses based on disease activity, treatment, calendar time, duration of follow-up and RCT exclusions. Rates were standardised for age, sex and, in one sensitivity analysis, also HAQ. The combined registry cohorts included 57 251 patients with RA (234 089 person-years)-24.5% men, mean (SD) baseline age 58.2 (13.8) and RA duration 8.2 (11.7) years. Standardised registry mortality rates (per 100 person-years) varied from 0.42 (CORRONA) to 0.80 (NOAR), with 0.60 for RCT patients. Myocardial infarction and major adverse cardiovascular events (MACE) rates ranged from 0.09 and 0.31 (IORRA) to 0.39 and 0.77 (SRR), with RCT rates intermediate (0.18 and 0.42), respectively. Additional subcohort analyses showed small and mostly consistent changes across registries, retaining reasonable consistency in rates across the Western registries. Additional standardisation for HAQ returned higher mortality and MACE registry rates. This coordinated approach to contextualising RA RCT safety data demonstrated reasonable differences and consistency in rates for mortality and CVD across registries, and comparable RCT rates, and may serve as a model method to supplement clinical trial analyses for drug development programmes. Published by the BMJ Publishing

  20. 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.

  1. [Taxonomy and definition of clinical registries].

    PubMed

    Costa, Giuseppe

    2015-09-01

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

  2. 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

  3. 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.

  4. The Surgical Intensive Care-infection Registry: a research registry with daily clinical support capabilities.

    PubMed

    Fadlalla, Adam M A; Golob, Joseph F; Claridge, Jeffrey A

    2009-01-01

    Infections in the surgical and trauma intensive care unit (STICU) are responsible for significant patient morbidity and mortality. Research into these infectious complications often uses administrative databases or clinical information systems designed for documenting and billing daily patient care. Neither of these sources is intended for research, and many investigators have questioned their accuracy. The Surgical Intensive Care-Infection Registry (SIC-IR) was developed as a research data repository to use to monitor STICU infections. SIC-IR is a relational database application designed to collect quality data and to integrate with daily patient care. SIC-IR prospectively collects and archives more than 100 clinical variables daily on each STICU patient to ensure completeness and correctness of the registry. Furthermore, SIC-IR aids in clinical activities by providing patient summaries and medical record documentation. SIC-IR provides accurate data for STICU infection research and enables the users to easily undertake quality-of-care improvement initiatives.

  5. Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers.

    PubMed

    Dear, Rachel; Barratt, Alexandra; Askie, Lisa; McGeechan, Kevin; Arora, Sheena; Crossing, Sally; Currow, David; Tattersall, Martin

    2011-02-01

    Clinical trials registries are now operating in the USA, Europe, Australia, China, and India and more are planned. Trial registries could be an excellent source of information about clinical trials for patients and others affected by cancer as well as health care professionals, but may be difficult for patients to navigate and use. An opportunity arose in Australia to develop a consumer friendly cancer clinical trials website (Australian Cancer Trials Online (ACTO), www.australiancancertrials.gov.au) using an automated data feed from two large clinical trial registries. In this article, we describe aspects of this new website, and explore ways in which such a website may add value to clinical trial data which are already collected and held by trial registries. The development of ACTO was completed by a Web company working in close association with staff at the Australian New Zealand Clinical Trials Registry (ANZCTR), and with consumer representatives. Data for the website were sourced directly and only from clinical trial registries, thus avoiding the creation of an additional trials database. It receives an automated, daily data feed of newly registered cancer clinical trials from both the ANZCTR and Clinical Trials.gov. The development of ACTO exemplifies the advantage of a local clinical trial registry working with consumers to provide accessible information about cancer clinical trials to meet consumers' information needs. We found that the inclusion of a lay summary added substantial value for consumers, and recommend that consideration be given to adding a lay summary to the mandatory data items collected by all trial registries. Furthermore, improved navigation, decision support tools, and consistency in data collection between clinical trial registries will also enable consumer websites to provide additional value for users. Clinical trial registration is not compulsory in Australia. If the additional cancer items (including a lay summary) are not provided

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

    PubMed

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

    2015-03-01

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

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

    PubMed Central

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

    2015-01-01

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

  8. 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

  9. Cancer registries in four provinces in Turkey: a case study

    PubMed Central

    2012-01-01

    Background The burden of cancer affects all countries; while high-income countries have the capacity and resources to establish comprehensive cancer control programs, low and middle-income countries have limited resources to develop such programs. This paper examines factors associated with the development of cancer registries in four provinces in Turkey. It looks at the progress made by these registries, the challenges they faced, and the lessons learned. Other countries with similar resources can benefit from the lessons identified in this case study. Methods A mix of qualitative case study methods including key informant interviews, document review and questionnaires was used. Results This case study showed that surveillance systems that accurately report current cancer-related data are essential components of a country’s comprehensive cancer control program. At the initial stages, Turkey established one cancer registry with international support, which was used as a model for other registries. The Ministry of Health recognized the value of the registry data and its contribution to the country’s cancer control program and is supporting sustainability of these registries as a result. Conclusions This study demonstrates how Turkey was able to use resources from multiple sources to enhance its population based cancer registry system in four provinces. With renewed international interest in non-communicable diseases and cancer following the 2011 UN high-level meeting on NCDs, low- and middle- income countries can benefit from Turkey’s experience. Other countries can utilize lessons learned from Turkey as they address cancer burden and establish their own registries. PMID:23110989

  10. Methodological Challenges When Comparing Demographic and Clinical Characteristics of International Observational Registries.

    PubMed

    Verstappen, Suzanne M M; Askling, Johan; Berglind, Niklas; Franzen, Stefan; Frisell, Thomas; Garwood, Christopher; Greenberg, Jeffrey D; Holmqvist, Marie; Horne, Laura; Lampl, Kathy; Michaud, Kaleb; Nyberg, Fredrik; Pappas, Dimitrios A; Reed, George; Symmons, Deborah P M; Tanaka, Eiichi; Tran, Trung N; Yamanaka, Hisashi; Ho, Meilien

    2015-12-01

    Comparisons of data from different registries can be helpful in understanding variations in many aspects of rheumatoid arthritis (RA). The study aim was to assess and improve the comparability of demographic, clinical, and comorbidity data from 5 international RA registries. Using predefined definitions, 2 subsets of patients (main cohort and subcohort) from 5 international observational registries (Consortium of Rheumatology Researchers of North America Registry [CORRONA], the Swedish Rheumatology Quality of Care Register [SRR], the Norfolk Arthritis Register [NOAR], the Institute of Rheumatology Rheumatoid Arthritis cohort [IORRA], and CORRONA International) were evaluated and compared. Patients ages >18 years with RA, and present in or recruited to the registry from January 1, 2000, were included in the main cohort. Patients from the main cohort with positive rheumatoid factor and/or erosive RA who had received ≥1 synthetic disease-modifying antirheumatic drug (DMARD), and switched to or added another DMARD, were included in the subcohort at time of treatment switch. Age and sex distributions were fairly similar across the registries. The percentage of patients with a high Disease Activity Score in 28 joints score varied between main cohorts (17.5% IORRA, 18.9% CORRONA, 24.7% NOAR, 27.7% CORRONA International, and 36.8% SRR), with IORRA, CORRONA, and CORRONA International including more prevalent cases of RA; the differences were smaller for the subcohort. Prevalence of comorbidities varied across registries (e.g., coronary artery disease ranged from 1.5% in IORRA to 7.9% in SRR), partly due to the way comorbidity data were captured and general cultural differences; the pattern was similar for the subcohorts. Despite different inclusion criteria for the individual RA registries, it is possible to improve the comparability and interpretability of differences across RA registries by applying well-defined cohort definitions. © 2015, American College of

  11. 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

  12. 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

  13. [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.

  14. 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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

    Ogino, Daisuke; Takahashi, Kunihiko; Sato, Hajime

    2014-11-05

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

  17. [Clinical and demographic characteristics of the cases of dementia diagnosed in the Health District of Girona throughout the period 2007-2010: data from the Girona Dementia Registry (ReDeGi)].

    PubMed

    Calvo-Perxas, L; Osuna, M T; Gich, J; Eligio-Hernandez, E; Linares, M; Vinas, M; Casas, I; Turro-Garriga, O; Lopez-Pousa, S; Garre-Olmo, J

    2012-04-01

    The Girona Dementia Registry (ReDeGi, from Spanish: Registro de Demencias de Girona) is a population-based epidemiological surveillance mechanism that registers the cases of dementia diagnosed by the reference centres in the Girona Health District. To report on the frequency of the diagnoses and their clinical and sociodemographic characteristics, as well as to compare differences depending on the different subtypes of dementia. The method used consisted in a consecutive standardised register of the diagnoses involving dementia in specialised procedures in the Girona Health District between 2007 and 2010. A total of 2814 cases were registered, which represents a clinical incidence of 6.6 cases per 1000 persons/year. Of this total number, 69.2% were primary degenerative dementias, 18.9% were dementias secondary to a vascular pathology, 5.4% were other secondary dementias and 6.5% were non-specific dementias. The mean age was 79.2 ± 7.6 years (range: 33-99 years) and 59.3% were females. The mean time elapsed since the onset of symptoms and clinical diagnosis was 2.5 ± 1.7 years. The mean score on the Blessed dementia scale was 7.7 ± 4.5 points and in the minimental test it was 17.6 ± 5.4 points. A family history of dementia was present in 26.6% of cases and 69.6% presented one or more cardiovascular risk factors. In 60.6% of cases they were cases of mild dementia, 28.5% were moderate and 10.9% were severe cases. The epidemiological surveillance activity carried out by the ReDeGi throughout the period 2007-2010 has made it possible to record information that is extremely valuable for the planning and management of health care resources.

  18. The Sudden Death in the Young Case Registry: Collaborating to Understand and Reduce Mortality.

    PubMed

    Burns, Kristin M; Bienemann, Lauren; Camperlengo, Lena; Cottengim, Carri; Covington, Theresa M; Dykstra, Heather; Faulkner, Meghan; Kobau, Rosemarie; Erck Lambert, Alexa B; MacLeod, Heather; Parks, Sharyn E; Rosenberg, Ellen; Russell, Mark W; Shapiro-Mendoza, Carrie K; Shaw, Esther; Tian, Niu; Whittemore, Vicky; Kaltman, Jonathan R

    2017-03-01

    Knowledge gaps persist about the incidence of and risk factors for sudden death in the young (SDY). The SDY Case Registry is a collaborative effort between the National Institutes of Health, the Centers for Disease Control and Prevention, and the Michigan Public Health Institute. Its goals are to: (1) describe the incidence of SDY in the United States by using population-based surveillance; (2) compile data from SDY cases to create a resource of information and DNA samples for research; (3) encourage standardized approaches to investigation, autopsy, and categorization of SDY cases; (4) develop partnerships between local, state, and federal stakeholders toward a common goal of understanding and preventing SDY; and (5) support families who have lost loved ones to SDY by providing resources on bereavement and medical evaluation of surviving family members. Built on existing Child Death Review programs and as an expansion of the Sudden Unexpected Infant Death Case Registry, the SDY Case Registry achieves its goals by identifying SDY cases, providing guidance to medical examiners/coroners in conducting comprehensive autopsies, evaluating cases through child death review and an advanced review by clinical specialists, and classifying cases according to a standardized algorithm. The SDY Case Registry also includes a process to obtain informed consent from next-of-kin to save DNA for research, banking, and, in some cases, diagnostic genetic testing. The SDY Case Registry will provide valuable incidence data and will enhance understanding of the characteristics of SDY cases to inform the development of targeted prevention efforts. Copyright © 2017 by the American Academy of Pediatrics.

  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. Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

    PubMed

    Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

    2017-10-06

    Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Musculoskeletal CPD revision: cases from the New Zealand bone and soft tissue tumour registry.

    PubMed

    Weerakkody, Yuranga Dilan; Dray, Michael; Pinto, Clinton; Rosenfeldt, Michael; Flint, Michael

    2012-02-01

    The following case report was selected from the New Zealand Bone and Soft Tissue Tumour Registry to highlight some key concepts and findings in musculoskeletal imaging with radiological-pathological correlation. The presentation follows a question and answer format followed by clinical information, selected images, diagnosis, discussion and teaching points. © 2012 The Authors. Journal of Medical Imaging and Radiation Oncology © 2012 The Royal Australian and New Zealand College of Radiologists.

  3. 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

  4. The Mexican Acromegaly Registry: Clinical and Biochemical Characteristics at Diagnosis and Therapeutic Outcomes.

    PubMed

    Portocarrero-Ortiz, Lesly A; Vergara-Lopez, Alma; Vidrio-Velazquez, Maricela; Uribe-Diaz, Ana María; García-Dominguez, Avril; Reza-Albarrán, Alfredo Adolfo; Cuevas-Ramos, Daniel; Melgar, Virgilio; Talavera, Juan; Rivera-Hernandez, Aleida de Jesus; Valencia-Méndez, Carla Valentina; Mercado, Moisés

    2016-11-01

    Acromegaly is a systemic disorder caused by a GH-secreting pituitary adenoma. As with other rare diseases, acromegaly registries developed in various European countries have provided us with important information. The objective of the study was to analyze the epidemiological, clinical, biochemical, and therapeutic data from the Mexican Acromegaly Registry (MAR). The setting of the study was a nationwide patient registry. The MAR was created in 2009. It gathers data from 24 participating centers belonging to three different institutions using a specifically designed on-line platform. Only patients diagnosed after 1990 were included in the program. A total of 2057 patients (51% female, mean age at diagnosis 41.1 ± 24.5 y) have been registered for an estimated prevalence of 18 cases per 1 million inhabitants. Hypertension, glucose intolerance, diabetes, and dyslipidemia were present in 27%, 18.4%, 30%, and 24% of the patients, respectively. The IGF-1 level at diagnosis and the concomitant presence of hypertension were significantly associated with the development of diabetes. Transsphenoidal surgery was the primary treatment in 72% of the patients. Pharmacological treatment, mostly with somatostatin analogs, was administered primarily and adjunctively in 26% and 54% of the patients, respectively. Treatment choice varied among the three participating institutions, with the predominance of pharmacological therapy in two of them and of radiation therapy in the third. Therapeutic outcomes were similar to those reported in the European registries. The MAR is the largest and first non-European registry of the disease. Our findings highlight important within-country differences in treatment choice due to variations in the availability of resources.

  5. Systemic autoimmune diseases co-existing with chronic hepatitis C virus infection (the HISPAMEC Registry): patterns of clinical and immunological expression in 180 cases.

    PubMed

    Ramos-Casals, M; Jara, L-J; Medina, F; Rosas, J; Calvo-Alen, J; Mañá, J; Anaya, J-M; Font, J

    2005-06-01

    To describe the clinical and immunologic characteristics of a large series of patients with systemic autoimmune diseases (SAD) associated with chronic hepatitis C virus (HCV) infection. We analysed 180 patients diagnosed with SAD and chronic HCV infection seen consecutively at our centres during the last 10 years. The clinical and immunological patterns of disease expression were compared with 180 SAD-matched patients without chronic HCV infection. A total of 180 HCV patients fulfilled the classification criteria for the following SAD: Sjogren's syndrome (n = 77), systemic lupus erythematosus (n = 43), rheumatoid arthritis (n = 14), antiphospholipid syndrome (n = 14), polyarteritis nodosa (n = 8) and other SAD (n = 24). One hundred and thirty (72%) patients were female and 50 (28%) male, with a mean age at SAD diagnosis of 50 years. The main immunologic features were antinuclear antibodies in 69% of patients, cryoglobulinaemia in 62%, hypocomplementaemia in 56% and rheumatoid factor (RF) in 56%. Compared with the SAD-matched HCV-negative group, SAD-HCV patients presented a lower prevalence of females (P = 0.016), an older age at SAD diagnosis (P = 0.039) and a higher prevalence of vasculitis (P < 0.001) and neoplasia (P < 0.001). Immunologically, SAD-HCV patients presented a lower prevalence of antinuclear (P = 0.036), anti-extractable nuclear antigen (P = 0.038) and anti-DNA (P = 0.005) antibodies, and a higher frequency of RF (P = 0.003), hypocomplementaemia (P < 0.001) and cryoglobulins (P < 0.001). In comparison with an SAD-matched HCV-negative population, SAD-HCV patients were older and more likely to be male, with a higher frequency of vasculitis, cryoglobulinaemia and neoplasia. This complex pattern of disease expression is generated by a chronic viral infection that induces both liver and autoimmune disease.

  6. 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.

  7. Minimum Data Set for Cystic Fibrosis Registry: a Case Study in Iran

    PubMed Central

    Kalankesh, Leila R; Dastgiri, Saeed; Rafeey, Mandana; Rasouli, Narmin; Vahedi, Leila

    2015-01-01

    Background: over the last 25 years several national registries of CF have been set up. Such systems can be very useful in providing an integrated resource for improving patient care and conducting research on the disease. Minimum Data Set is a common set of data items that should be used to collect and report data in the registry. The principal aim of this research was to determine minimum data set for the CF registry in north-west of Iran. Methods: data items collected by several selected registries of cystic fibrosis were studied and an initial set of data was selected by the researchers. A group of experts including epidemiologists, pediatricians, and CF specialists were asked to review the proposed data elements and score them based on their importance by using a nine-point Likert scale. The items scored as important or highly important by more than 50 % of the experts, were included in final list of minimum data set. Availability of data was evaluated through reviewing medical records of 144 patients hospitalized in Children Hospital located in Tabriz. Results: overall six classes of data (46 items) were identified in the selected registry systems for cystic fibrosis: patient demographics, administrative data, survival status, diagnostic procedures, genetic and clinical manifestations, and therapeutics. Thirty two data elements from all six categories of data were approved by the experts as the minimum data set for cystic fibrosis registry system. Availability of data in administrative category and survival class was 100 percent. Collecting data on medications was feasible in 100% of the cases as well. In class of demographic data, accessibility of patient name, age, gender, place of birth, and date of birth was 100 percent. In group of diagnostic procedures, partial availability of data was found for sweat test and genetic test. No data was found on the antenatal screening, exercise tolerance test, and glucose tolerance test. Conclusion: this work can be

  8. Minimum data set for cystic fibrosis registry: a case study in iran.

    PubMed

    Kalankesh, Leila R; Dastgiri, Saeed; Rafeey, Mandana; Rasouli, Narmin; Vahedi, Leila

    2015-02-01

    over the last 25 years several national registries of CF have been set up. Such systems can be very useful in providing an integrated resource for improving patient care and conducting research on the disease. Minimum Data Set is a common set of data items that should be used to collect and report data in the registry. The principal aim of this research was to determine minimum data set for the CF registry in north-west of Iran. data items collected by several selected registries of cystic fibrosis were studied and an initial set of data was selected by the researchers. A group of experts including epidemiologists, pediatricians, and CF specialists were asked to review the proposed data elements and score them based on their importance by using a nine-point Likert scale. The items scored as important or highly important by more than 50 % of the experts, were included in final list of minimum data set. Availability of data was evaluated through reviewing medical records of 144 patients hospitalized in Children Hospital located in Tabriz. overall six classes of data (46 items) were identified in the selected registry systems for cystic fibrosis: patient demographics, administrative data, survival status, diagnostic procedures, genetic and clinical manifestations, and therapeutics. Thirty two data elements from all six categories of data were approved by the experts as the minimum data set for cystic fibrosis registry system. Availability of data in administrative category and survival class was 100 percent. Collecting data on medications was feasible in 100% of the cases as well. In class of demographic data, accessibility of patient name, age, gender, place of birth, and date of birth was 100 percent. In group of diagnostic procedures, partial availability of data was found for sweat test and genetic test. No data was found on the antenatal screening, exercise tolerance test, and glucose tolerance test. this work can be considered as a first step toward establishing

  9. 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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Löpprich, Martin; Knaup, Petra

    2016-01-01

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

  12. A statewide case registry for surveillance of occupational heavy metals absorption

    SciTech Connect

    Baser, M.E.; Marion, D. )

    1990-02-01

    The New York State Heavy Metals Registry is a legislatively mandated program through which clinical laboratories, physicians, and health facilities report state residents 18 years of age and older with elevated levels of lead, mercury, arsenic, or cadmium in blood or urine. From 1982-86, the current employer was determined for 95.9 percent of 3,309 cases. Occupational exposures in 328 companies accounted for 82.8 percent of cases. The majority of companies were reported for lead (247 companies, 75.3 percent of total) or mercury (47 companies, 14.3 percent of total). Of the 247 companies reported to the Registry for lead, the Occupational Safety and Health Administration (OSHA) inspected 18 of 98 companies (18.4 percent) in the manufacturing sector, but only one of 149 companies (0.6 percent) outside the manufacturing sector. We conclude that the Registry effectively detects companies with heavy metals exposures, and is an especially useful adjunct to OSHA inspections outside the manufacturing sector.

  13. A statewide case registry for surveillance of occupational heavy metals absorption.

    PubMed Central

    Baser, M E; Marion, D

    1990-01-01

    The New York State Heavy Metals Registry is a legislatively mandated program through which clinical laboratories, physicians, and health facilities report state residents 18 years of age and older with elevated levels of lead, mercury, arsenic, or cadmium in blood or urine. From 1982-86, the current employer was determined for 95.9 percent of 3,309 cases. Occupational exposures in 328 companies accounted for 82.8 percent of cases. The majority of companies were reported for lead (247 companies, 75.3 percent of total) or mercury (47 companies, 14.3 percent of total). Of the 247 companies reported to the Registry for lead, the Occupational Safety and Health Administration (OSHA) inspected 18 of 98 companies (18.4 percent) in the manufacturing sector, but only one of 149 companies (0.6 percent) outside the manufacturing sector. We conclude that the Registry effectively detects companies with heavy metals exposures, and is an especially useful adjunct to OSHA inspections outside the manufacturing sector. PMID:2297058

  14. Systematic review protocol assessing the processes for linking clinical trial registries and their published results

    PubMed Central

    Bashir, Rabia; Dunn, Adam G

    2016-01-01

    Introduction Clinical trial registries are an important source of information for tracking clinical trials from their inception through to their reporting, and have been used to measure publication bias and outcome reporting bias. Our aim is to survey and quantify the processes that have been used to identify links between clinical trial registries and published trial reports in studies that rely on these links to evaluate the completeness and accuracy of trial reporting. Methods and analysis We will identify studies that describe a process for identifying the links between a trial registry included in the WHO International Clinical Trial Registry Platform and published trial results, and use those links to evaluate the completeness and accuracy of trial reporting. Information extracted from the studies will include the purpose and application domain of the study, registries used or searched, processes by which the links were identified, the study period and proportions for which links were found. We will summarise what is known about the number and availability of links between clinical trial registries and published results, and examine how automatic linking, inference and inquiry processes have been used to identify links since the introduction of trial registries. Ethics and dissemination The systematic review is focused on the analysis of secondary data and does not require ethics approval. The results of the systematic review will be used to inform standard processes used to identify links to and from clinical trial registries in studies that evaluate the completeness and accuracy of clinical trial reports, as well as systematic reviews. Our findings will be disseminated by publishing the systematic review in a peer-reviewed journal, and by engaging with stakeholders from clinical trial registries and bibliographic databases. PMID:27697881

  15. Impact of clinical registries on quality of patient care and clinical outcomes: A systematic review.

    PubMed

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

    2017-01-01

    Clinical quality registries (CQRs) are playing an increasingly important role in improving health outcomes and reducing health care costs. CQRs are established with the purpose of monitoring quality of care, providing feedback, benchmarking performance, describing pattern of treatment, reducing variation and as a tool for conducting research. To synthesise the impact of clinical quality registries (CQRs) as an 'intervention' on (I) mortality/survival; (II) measures of outcome that reflect a process or outcome of health care; (III) health care utilisation; and (IV) healthcare-related costs. The following electronic databases were searched: MEDLINE, EMBASE, CENTRAL, CINAHL and Google Scholar. In addition, a review of the grey literature and a reference check of citations and reference lists within articles was undertaken to identify relevant studies in English covering the period January 1980 to December 2016. The PRISMA-P methodology, checklist and standard search strategy using pre-defined inclusion and exclusion criteria and structured data extraction tools were used. Data on study design and methods, participant characteristics attributes of included registries and impact of the registry on outcome measures and/or processes of care were extracted. We identified 30102 abstracts from which 75 full text articles were assessed and finally 17 articles were selected for synthesis. Out of 17 studies, six focused on diabetes care, two on cardiac diseases, two on lung diseases and others on organ transplantations, rheumatoid arthritis, ulcer healing, surgical complications and kidney disease. The majority of studies were "before after" design (#11) followed by cohort design (#2), randomised controlled trial (#2), experimental non randomised study and one cross sectional comparison. The measures of impact of registries were multifarious and included change in processes of care, quality of care, treatment outcomes, adherence to guidelines and survival. Sixteen of 17 studies

  16. 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 ...

  17. Clinical and molecular characteristics of homozygous familial hypercholesterolemia patients: Insights from SAFEHEART registry.

    PubMed

    Alonso, Rodrigo; Díaz-Díaz, Jose Luis; Arrieta, Francisco; Fuentes-Jiménez, Francisco; de Andrés, Raimundo; Saenz, Pedro; Ariceta, Gema; Vidal-Pardo, José I; Almagro, Fatima; Argueso, Rosa; Prieto-Matos, Pablo; Miramontes, José P; Pintó, Xavier; Rodriguez-Urrego, Johana; Perez de Isla, Leopoldo; Mata, Pedro

    2016-01-01

    Homozygous familial hypercholesterolemia (HoFH) is a rare genetic disorder associated with very high levels of cholesterol, accelerated atherosclerosis and very premature death, often secondary to occlusion of the coronary ostia by supravalvular atheroma in untreated individuals. To describe molecular and clinical characteristics of HoFH enrolled at SAFEHEART registry and to evaluate the role of the type of mutation in clinical expression. SAFEHEART is a registry of molecularly defined familial hypercholesterolemia patients. A standardized phone call is made every year for the follow-up. Patients with confirmed HoFH were selected. Molecular and clinical characteristics were analyzed. Thirty-four HoFH patients (27 true HoFH, 4 compound heterozygous familial hypercholesterolemia, and 3 autosomal recessive hypercholesterolemia) have been enrolled in the period 2004-2015. Twenty different mutations in LDLR gene have been detected. Sixteen patients carry defective mutations (DMs), and 15 carry null mutations (NMs). Only patients with NMs met low-density lipoprotein cholesterol (LDL-C) criteria for clinical diagnosis. Patients with NMs had higher untreated LDL-C levels (P < .0001), more aortic valve stenosis (P < .05), and lower age at first cardiovascular event (P < .05) compared to patients with DMs. In the follow-up, 1 liver transplant patient died and 3 cases underwent revascularization procedures. Eight cases started LDL apheresis and 1 case had a liver transplant. HoFH phenotypic expression is highly variable. These patients have high atherosclerotic coronary artery disease risk including aortic valve stenosis and do not achieve the LDL-C treatment goals with standard therapy. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  18. Development of clinical-quality registries in Australia: the way forward.

    PubMed

    Evans, Sue M; Scott, Ian A; Johnson, Niall P; Cameron, Peter A; McNeil, John J

    2011-04-04

    Australia is developing a national performance framework aimed at measuring health outcomes across the health system. Clinical registries provide a clinically credible means of monitoring health care processes and outcomes, yet only five Australian registries currently have national coverage. At a national level, clinical registry development should be prioritised to target conditions or procedures that are suspected of being associated with large variations in processes or outcomes of care and that impact significantly on health care costs and patient morbidity. Registries should also aim to capture information across care interfaces and to monitor the medium and long-term safety and effectiveness of specific devices, procedures and drugs. ©The Medical Journal of Australia 2011

  19. 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.

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

    PubMed

    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

    2009-07-22

    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. 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. 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. 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.

  1. 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

  2. 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

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

    PubMed

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

    2016-04-26

    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. 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. 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. CRD42015017319. Published by the BMJ Publishing Group Limited. For permission to use (where not

  4. Clinical Data Element Ontology for Unified Indexing and Retrieval of Data Elements across Multiple Metadata Registries.

    PubMed

    Jeong, Senator; Kim, Hye Hyeon; Park, Yu Rang; Kim, Ju Han

    2014-10-01

    Classification of data elements (DEs), which is used in clinical documents is challenging, even in across ISO/IEC 11179 compliant clinical metadata registries (MDRs) due to no existence of reliable standard for identifying DEs. We suggest the Clinical Data Element Ontology (CDEO) for unified indexing and retrieval of DEs across MDRs. The CDEO was developed through harmonization of existing clinical document models and empirical analysis of MDRs. For specific classification as using data element concept (DEC), The Simple Knowledge Organization System was chosen to represent and organize the DECs. Six basic requirements also were set that the CDEO must meet, including indexing target to be a DEC, organizing DECs using their semantic relationships. For evaluation of the CDEO, three indexers mapped 400 DECs to more than 1 CDEO term in order to determine whether the CDEO produces a consistent index to a given DEC. The level of agreement among the indexers was determined by calculating the intraclass correlation coefficient (ICC). We developed CDEO with 578 concepts. Through two application use-case scenarios, usability of the CDEO is evaluated and it fully met all of the considered requirements. The ICC among the three indexers was estimated to be 0.59 (95% confidence interval, 0.52-0.66). The CDEO organizes DECs originating from different MDRs into a single unified conceptual structure. It enables highly selective search and retrieval of relevant DEs from multiple MDRs for clinical documentation and clinical research data aggregation.

  5. Utilization of Clinical Trials Registries in Obstetrics and Gynecology Systematic Reviews.

    PubMed

    Bibens, Michael E; Chong, A Benjamin; Vassar, Matt

    2016-02-01

    To evaluate the use of clinical trials registries in published obstetrics and gynecologic systematic reviews and meta-analyses. We performed a metaepidemiologic study of systematic reviews between January 1, 2007, and December 31, 2015, from six obstetric and gynecologic journals (Obstetrics & Gynecology, Obstetrical & Gynecological Survey, Human Reproduction Update, Gynecologic Oncology, British Journal of Obstetrics and Gynaecology, and American Journal of Obstetrics & Gynecology). All systematic reviews included after exclusions were independently reviewed to determine whether clinical trials registries had been included as part of the search process. Studies that reported using a trials registry were further examined to determine whether trial data were included in the analysis of these systematic reviews. Our initial search resulted in 292 articles, which was narrowed to 256 after exclusions. Of the 256 systematic reviews meeting our selection criteria, 47 (18.4%) used a clinical trials registry. Eleven of the 47 (23.4%) systematic reviews found unpublished data and two included unpublished data in their results. A majority of systematic reviews in clinical obstetrics and gynecology journals do not conduct searches of clinical trials registries or do not make use of data obtained from these searches. Failure to make use of such data may lead to an inaccurate summary of available evidence and may contribute to an overrepresentation of published, statistically significant outcomes.

  6. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications.

    PubMed

    Wieseler, Beate; Kerekes, Michaela F; Vervoelgyi, Volker; McGauran, Natalie; Kaiser, Thomas

    2012-01-03

    To investigate to what extent three types of documents for reporting clinical trials provide sufficient information for trial evaluation. Retrospective analysis Primary studies and corresponding documents (registry reports, clinical study reports, journal publications) from 16 health technology assessments of drugs conducted by the German Institute for Quality and Efficiency in Health Care between 2006 and February 2011. Data analysis We assessed reporting quality for each study and each available document for six items on methods and six on outcomes, and dichotomised them as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of studies with complete reporting for methods and outcomes, per item and overall, and compared the findings. We identified 268 studies. Publications, study reports and registry reports were available for 192 (72%), 101 (38%), and 78 (29%) studies, respectively. Reporting quality was highest in study reports, which overall provided complete information for 90% of items (1086/1212). Registry reports provided more complete information on outcomes than on methods (overall 330/468 (71%) v 147/468 (31%)); the same applied to publications (594/1152 (52%) v 458/1152 (40%)). In the matched pairs analysis, reporting quality was poorer in registry reports than in study reports for overall methods and outcomes (P<0.001 in each case). Compared with publications, reporting quality was poorer in registry reports for overall methods (P<0.001), but better for outcomes (P=0.005). Registry reports and publications insufficiently report clinical trials but may supplement each other. Measures to improve reporting include the mandatory worldwide implementation of adequate standards for results registration.

  7. Operating principles for running a clinical quality registry: are they feasible?

    PubMed

    Ogilvy, Michelle; Kollias, James

    2012-11-01

    The National Breast Cancer Audit (NBCA) was one of six national registries selected by open tender to test and validate the draft Operating Principles and Technical Standards for Australian Clinical Quality Registries. The standardization proposed by the Australian Commission on Safety and Quality in Health Care through this initiative sought to improve the overall efficiency and function of registries, as well as compatibility between registries. The NBCA's role involved testing, and implementing where possible, the proposed principles and standards in the NBCA environment so as to validate them in an operating registry. The forty-two draft operating principles were evaluated by the NBCA based on four factors: relevance to the audit, feasibility of implementation by the audit, extent of difficulty in implementation and extent of improvement. An evaluation of the technical standards was also conducted. At the completion of the project, the audit met 27 of the 42 draft principles with only three principles marked as entirely unfeasible or not relevant to the NBCA. The remaining principles were either in the process of being implemented, implemented in part or awaiting discussion through governance channels. A revised principles and standards document has been produced. This will have a significant impact on quality of care in Australia as more audits and registries use it as a guide. Changes implemented at the NBCA have enhanced the audit as a tool for improving the quality of care received by early breast cancer patients. © 2012 The Authors. ANZ Journal of Surgery © 2012 Royal Australasian College of Surgeons.

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

    PubMed

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

    2017-09-07

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

  14. Hyperthermia-related clinical trials on cancer treatment within the ClinicalTrials.gov registry.

    PubMed

    Cihoric, Nikola; Tsikkinis, Alexandros; van Rhoon, Gerard; Crezee, Hans; Aebersold, Daniel M; Bodis, Stephan; Beck, Marcus; Nadobny, Jacek; Budach, Volker; Wust, Peter; Ghadjar, Pirus

    2015-01-01

    Hyperthermia has been shown to improve the effectiveness of chemotherapy and radiotherapy in the treatment of cancer. This paper summarises all recent clinical trials registered in the ClinicalTrials.gov registry. The records of 175,538 clinical trials registered at ClinicalTrials.gov were downloaded on 29 September 2014 and a database was established. We searched this database for hyperthermia or equivalent words. A total of 109 trials were identified in which hyperthermia was part of the treatment regimen. Of these, 49 trials (45%) had hyperthermic intraperitoneal chemotherapy after cytoreductive surgery (HIPEC) as the primary intervention, and 14 other trials (13%) were also testing some form of intraperitoneal hyperthermic chemoperfusion. Seven trials (6%) were testing perfusion attempts to other locations (thoracic/pleural n = 4, limb n = 2, hepatic n = 1). Sixteen trials (15%) were testing regional hyperthermia, 13 trials (12%) whole body hyperthermia, seven trials (6%) superficial hyperthermia and two trials (2%) interstitial hyperthermia. One remaining trial tested laser hyperthermia. In contrast to the general opinion, this analysis shows continuous interest and ongoing clinical research in the field of hyperthermia. Interestingly, the majority of trials focused on some form of intraperitoneal hyperthermic chemoperfusion. Despite the high number of active clinical studies, HIPEC is a topic with limited attention at the annual meetings of the European Society for Hyperthermic Oncology and the Society of Thermal Medicine. The registration of on-going clinical trials is of paramount importance for the achievement of a comprehensive overview of available clinical research activities involving hyperthermia.

  15. Using an international clinical registry of regional anesthesia to identify targets for quality improvement.

    PubMed

    Sites, Brian D; Barrington, Michael J; Davis, Matthew

    2014-01-01

    Despite the widespread use of regional anesthesia, limited information on clinical performance exists. Institutions, therefore, have little knowledge of how they are performing in regard to both safety and effectiveness. In this study, we demonstrate how a medical institution (or physician/physician group) may use data from a multicenter clinical registry of regional anesthesia to inform quality improvement strategies. We analyzed data from the International Registry of Regional Anesthesia that includes prospective data on peripheral regional anesthesia procedures from 19 centers located around the world. Using data from the clinical registry, we present summary statistics of the overall safety and effectiveness of regional anesthesia. Furthermore, we demonstrate, using a variety of performance measures, how these data can be used by hospitals to identify areas for quality improvement. To do so, we compare the performance of 1 member institution (a US medical center in New Hampshire) to that of the other 18 member institutions of the clinical registry. The clinical registry contained information on 23,271 blocks that were performed between June 1, 2011, and May 1, 2014, on 16,725 patients. The overall success rate was 96.7%, immediate complication rate was 2.2%, and the all-cause 60-day rate of neurological sequelae was 8.3 (95% confidence interval, 7.2- 9.7) per 10,000. Registry-wide major hospital events included 7 wrong-site blocks, 3 seizures, 1 complete heart block, 1 retroperitoneal hematoma, and 3 pneumothoraces. For our reference medical center, we identified areas meriting quality improvement. Specifically, after accounting for differences in the age, sex, and health status of patient populations, the reference medical center appeared to rely more heavily on opioids for postprocedure management, had higher patient pain scores, and experienced delayed discharge when compared with other member institutions. To our knowledge, this is the first large

  16. Using an International Clinical Registry of Regional Anesthesia to Identify Targets for Quality Improvement

    PubMed Central

    Sites, Brian D.; Barrington, Michael J.; Davis, Matthew

    2014-01-01

    Background Despite the widespread use of regional anesthesia, limited information on clinical performance exists. Institutions, therefore, have little knowledge of how they are performing in regards to both safety and effectiveness. In this study, we demonstrate how a medical institution (or physician/physician group) may use data from a multi-center clinical registry of regional anesthesia to inform quality improvement strategies. Methods We analyzed data from the International Registry of Regional Anesthesia that includes prospective data on peripheral regional anesthesia procedures from 19 centers located around the world. Using data from the clinical registry, we present summary statistics of the overall safety and effectiveness of regional anesthesia. Furthermore, we demonstrate, using a variety of performance measures, how these data can be used by hospitals to identify areas for quality improvement. To do so, we compare the performance of one member institution (a United States medical center in New Hampshire) to that of the other 18 member institutions of the clinical registry. Results The clinical registry contained information on 23,271 blocks that were performed between June 1, 2011, and May 1, 2014, on 16,725 patients. The overall success rate was 96.7%, immediate complication rate was 2.2%, and the all-cause 60-day rate of neurological sequelae was 8.3 (95% CI, 7.2–9.7) per 10,000. Registry wide major hospital events included 7 wrong site blocks, 3 seizures, 1 complete heart block, 1 retroperitoneal hematoma, and 3 pneumothoraces. For our reference medical center, we identified areas meriting quality improvement. Specifically, after accounting for differences in the age, sex, and health status of patient populations, the reference medical center appeared to rely more heavily on opioids for post procedure management, had higher patient pain scores, and experienced delayed discharge when compared with other member institutions. Conclusions To our

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

    PubMed Central

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

    2011-01-01

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

  18. 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.

  19. Development of the Andalusian Registry of Patients Receiving Community Case Management, for the follow-up of people with complex chronic diseases.

    PubMed

    Morales-Asencio, Jose M; Kaknani-Uttumchandani, Shakira; Cuevas-Fernández-Gallego, Magdalena; Palacios-Gómez, Leopoldo; Gutiérrez-Sequera, José L; Silvano-Arranz, Agustina; Batres-Sicilia, Juan Pedro; Delgado-Romero, Ascensión; Cejudo-Lopez, Ángela; Trabado-Herrera, Manuel; García-Lara, Esteban L; Martin-Santos, Francisco J; Morilla-Herrera, Juan C

    2015-10-01

    Complex chronic diseases are a challenge for the current configuration of health services. Case management is a service frequently provided for people with chronic conditions, and despite its effectiveness in many outcomes, such as mortality or readmissions, uncertainty remains about the most effective form of team organization, structures and the nature of the interventions. Many processes and outcomes of case management for people with complex chronic conditions cannot be addressed with the information provided by electronic clinical records. Registries are frequently used to deal with this weakness. The aim of this study was to generate a registry-based information system of patients receiving case management to identify their clinical characteristics, their context of care, events identified during their follow-up, interventions developed by case managers and services used. The study was divided into three phases, covering the detection of information needs, the design and its implementation in the health care system, using literature review and expert consensus methods to select variables that would be included in the registry. A total of 102 variables representing structure, processes and outcomes of case management were selected for their inclusion in the registry after the consensus phase. A web-based registry with modular and layered architecture was designed. The framework follows a pattern based on the model-view-controller approach. In its first 6 months after the implementation, 102 case managers have introduced an average number of 6.49 patients each one. The registry permits a complete and in-depth analysis of the characteristics of the patients who receive case management, the interventions delivered and some major outcomes as mortality, readmissions or adverse events. © 2015 John Wiley & Sons, Ltd.

  20. How TAVI registries report clinical outcomes-A systematic review of endpoints based on VARC-2 definitions.

    PubMed

    Zhang, Shixuan; Kolominsky-Rabas, Peter L

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed. A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients' characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry's publications. This review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation. Since the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase

  1. 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. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. The Oklahoma Thrombotic Thrombocytopenic Purpura-haemolytic Uraemic Syndrome Registry. A model for clinical research, education and patient care.

    PubMed

    George, J N; Vesely, S K; Terrell, D R; Deford, C C; Reese, J A; Al-Nouri, Z L; Stewart, L M; Lu, K H; Muthurajah, D S

    2013-05-29

    The Oklahoma Thrombotic Thrombocytopenic Purpura-Haemolytic Uraemic Syndrome (TTP-HUS) Registry has a 24 year record of success for collaborative clinical research, education, and patient care. This article tells the story of how the Registry began and it describes the Registry's structure and function. The Registry provides a model for using a cohort of consecutive patients to investigate a rare disorder. Collaboration between Oklahoma, United States and Bern, Switzerland has been the basis for successful interpretation of Registry data. Registry data have provided new insights into the evaluation and management of TTP. Because recovery from acute episodes of TTP has been assumed to be complete, the increased prevalence of hypertension, diabetes, depression, and death documented by long-term follow-up was unexpected. Registry data have provided opportunities for projects for students and trainees, education of physicians and nurses, and also for patients themselves. During our follow-up, patients have also educated Registry investigators about problems that persist after recovery from an acute episode of TTP. Most important, Registry data have resulted in important improvements for patient care.

  3. Systematic Reviews Published in Emergency Medicine Journals Do Not Routinely Search Clinical Trials Registries: A Cross-Sectional Analysis.

    PubMed

    Keil, Lukas G; Platts-Mills, Timothy F; Jones, Christopher W

    2015-10-01

    Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  4. 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.

  5. 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

  6. 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.

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

    PubMed

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

    2016-05-01

    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. This was a prospective, noninterventional study (registry) in neurological centres (hospitals and offices) throughout Germany. 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). 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.

  8. [Freiburg keratoconus registry : Example of application of smart data for clinical research and inititial results].

    PubMed

    Lang, S J; Böhringer, D; Reinhard, T

    2016-06-01

    Keratoconus is a progressive corneal disease with thinning and scarring of the cornea. Diagnostic and treatment options are usually evaluated in large prospective or retrospective trials. Big data and smart data provide the possibility to analyze routine data for clinical research. In this article we report the generation of a monocentric keratoconus registry by means of computerized data analysis of routine data. This demonstrates the potential of clinical research by means of routine data. A "clinical data warehouse" was created from all available routine electronic data. At the time of first presentation, each eye was classified into one out of four categories: suspected, early disease, late disease and status postkeratoplasty. Through integration of multiple data sources the clinical course for each patient was documented in the registry. A total of 3681 eyes from 1841 patients were included. The median follow-up time was 0.54 years. Patient age was higher in the groups with more severe stages of keratoconus, the proportion of female patients was higher in the group of suspected keratoconus and patient age and male to female ratios showed statistically significant differences between the groups (p < 0.001). We were able to create a "clinical data warehouse" by linking multiple data sources and normalizing the data. With this tool we established a novel, monocentric keratoconus registry. Only the grading of disease severity and the exclusion of false positive results were carried out manually. In our opinion establishing a structured clinical data warehouse has a huge potential for clinical and retrospective studies and proves the value of the Smart Data concept.

  9. Support for immunization registries among parents of vaccinated and unvaccinated school-aged children: a case control study.

    PubMed

    Linkins, Robert W; Salmon, Daniel A; Omer, Saad B; Pan, William Ky; Stokley, Shannon; Halsey, Neal A

    2006-09-22

    Immunizations have reduced childhood vaccine preventable disease incidence by 98-100%. Continued vaccine preventable disease control depends on high immunization coverage. Immunization registries help ensure high coverage by recording childhood immunizations administered, generating reminders when immunizations are due, calculating immunization coverage and identifying pockets needing immunization services, and improving vaccine safety by reducing over-immunization and providing data for post-licensure vaccine safety studies. Despite substantial resources directed towards registry development in the U.S., only 48% of children were enrolled in a registry in 2004. Parental attitudes likely impact child participation. Consequently, the purpose of this study was to assess the attitudes of parents of vaccinated and unvaccinated school-aged children regarding: support for immunization registries; laws authorizing registries and mandating provider reporting; opt-in versus opt-out registry participation; and financial worth and responsibility of registry development and implementation. A case control study of parents of 815 children exempt from school vaccination requirements and 1630 fully vaccinated children was conducted. Children were recruited from 112 elementary schools in Colorado, Massachusetts, Missouri, and Washington. Surveys administered to the parents, asked about views on registries and perceived utility and safety of vaccines. Parental views were summarized and logistic regression models compared differences between parents of exempt and vaccinated children. Surveys were completed by 56.1% of respondents. Fewer than 10% of parents were aware of immunization registries in their communities. Among parents aware of registries, exempt children were more likely to be enrolled (65.0%) than vaccinated children (26.5%) (p value = 0.01). A substantial proportion of parents of exempt children support immunization registries, particularly if registries offer choice for

  10. 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

  11. 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.

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

    PubMed Central

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

    2010-01-01

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

  13. Safety and clinical outcomes among older adults receiving daptomycin therapy: Insights from a patient registry.

    PubMed

    DePestel, Daryl D; Hershberger, Ellie; Lamp, Kenneth C; Malani, Preeti N

    2010-12-01

    Serious gram-positive bacterial infections are an important cause of morbidity and mortality among older adults and can present significant challenges to clinicians. Data evaluating the safety and effectiveness of newer agents in this population are limited. Daptomycin is a lipopeptide with activity against resistant gram-positive organisms. To better understand the overall safety and effectiveness of daptomycin in older adults (≥66 years of age), the authors reviewed the data that were collected as part of an ongoing registry maintained by Cubist Pharmaceuticals, Inc. (Lexington, Massachusetts), the manufacturer of daptomycin. The Cubicin Outcomes Registry and Experience (CORE) is a multicenter, retrospective registry designed to collect postmarketing clinical data on patients who received daptomycin. The CORE data collected from 58 institutions across the United States between January 1, 2005, and December 31, 2007, were analyzed to better understand the overall safety profile of daptomycin and the clinical outcomes of older adults who were treated with this agent. Patients were considered to be nonevaluable if the medical record did not contain sufficient information to determine response at the end of therapy. Nonevaluable patients were excluded from the clinical outcome analysis but included in the safety analysis. The registry contained 1073 patients aged ≥66 years who received daptomycin; 23.8% (255/1073) were ≥81 years of age. Overall, 18.1% (194/1073) of patients experienced 324 adverse events, and 6.2% (67/1073) of patients experienced 97 adverse events that were considered possibly related to treatment with daptomycin. The most frequently reported adverse events that were considered possibly treatment related included creatine phosphokinase (CPK) elevations, gastrointestinal disorders, and skin rashes. Among the 67 patients who experienced ≥1 adverse event that was possibly related to daptomycin, 30 discontinued therapy due to the adverse event

  14. 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

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

    PubMed

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

    2017-06-01

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

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

    PubMed

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

    2014-12-01

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

  17. Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: results from the Euro-ASA registry.

    PubMed

    Veselka, Josef; Jensen, Morten Kvistholm; Liebregts, Max; Januska, Jaroslav; Krejci, Jan; Bartel, Thomas; Dabrowski, Maciej; Hansen, Peter Riis; Almaas, Vibeke Marie; Seggewiss, Hubert; Horstkotte, Dieter; Tomasov, Pavol; Adlova, Radka; Bundgaard, Henning; Steggerda, Robbert; Ten Berg, Jurriën; Faber, Lothar

    2016-05-14

    The first cases of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) were published two decades ago. Although the outcomes of single-centre and national ASA registries have been published, the long-term survival and clinical outcome of the procedure are still debated. We report long-term outcomes from the as yet largest multinational ASA registry (the Euro-ASA registry). A total of 1275 (58 ± 14 years, median follow-up 5.7 years) highly symptomatic patients treated with ASA were included. The 30-day post-ASA mortality was 1%. Overall, 171 (13%) patients died during follow-up, corresponding to a post-ASA all-cause mortality rate of 2.42 deaths per 100 patient-years. Survival rates at 1, 5, and 10 years after ASA were 98% (95% CI 96-98%), 89% (95% CI 87-91%), and 77% (95% CI 73-80%), respectively. In multivariable analysis, independent predictors of all-cause mortality were age at ASA (P < 0.01), septum thickness before ASA (P < 0.01), NYHA class before ASA (P = 0.047), and the left ventricular (LV) outflow tract gradient at the last clinical check-up (P = 0.048). Alcohol septal ablation reduced the LV outflow tract gradient from 67 ± 36 to 16 ± 21 mmHg (P < 0.01) and NYHA class from 2.9 ± 0.5 to 1.6 ± 0.7 (P < 0.01). At the last check-up, 89% of patients reported dyspnoea of NYHA class ≤2, which was independently associated with LV outflow tract gradient (P < 0.01). The Euro-ASA registry demonstrated low peri-procedural and long-term mortality after ASA. This intervention provided durable relief of symptoms and a reduction of LV outflow tract obstruction in selected and highly symptomatic patients with obstructive HCM. As the post-procedural obstruction seems to be associated with both worse functional status and prognosis, optimal therapy should be focused on the elimination of LV outflow tract gradient. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please

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

    PubMed

    Tonner, Chris; Schmajuk, Gabriela; Yazdany, Jinoos

    2017-03-01

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

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

    PubMed Central

    Tonner, Chris; Schmajuk, Gabriela; Yazdany, Jinoos

    2017-01-01

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

  20. 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

  1. Clinical characteristics of patients with multiple sclerosis enrolled in a new registry in Egypt.

    PubMed

    Zakaria, Magd; Zamzam, Dina A; Abdel Hafeez, Mohamed A; Swelam, Mahmoud S; Khater, Shaimaa S; Fahmy, Mai F; Abdel Hady, Ayman; Fouad, Mohamed M; Abdel Nasser, Azza; Aref, Hany; Gadallah, Mohsen

    2016-11-01

    Epidemiological studies of multiple sclerosis (MS) are lacking in Egypt. To study the characteristics of Egyptian patients with multiple sclerosis in a new registry in a major tertiary referral centre in Cairo, Egypt. Patients were from the project MS database of the Multiple Sclerosis Unit at Ain Shams University Hospitals (N=950). We conducted a detailed medical history and examination including the Expanded Disability Status Scale (EDSS). Females represented 72% of subjects (female: male ratio 2.57:1). The mean age of disease onset was 26.1±7.6 years. Relapsing-remitting MS (RRMS) was the most common presentation (74.6%). Visual or sensory symptoms were the most common at presentation with RRMS, while motor symptoms were the most common presentation in other types of MS. Time to diagnosis was delayed up to 2 years in 27.8% of patients. The mean EDSS score was 3.6±2.1; 55% had EDSS≤3. About half (49%) received a disease-modifying drug. Progressive MS and motor presentation were associated with higher disability. This is the first documented MS registry from Egypt. The clinical characteristics of MS in Egypt was similar to other Arab countries and western countries. MS is more common among females in Egypt, with RRMS being the most common presentation. Visual symptoms and motor symptoms were the most common presentations in RRMS and progressive MS, respectively. Our findings also highlight the value of establishing registries in Egypt in order to be able to study, prospectively, the clinical course of the disease, the response to various DMD's and the epidemiology of MS in Egypt. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. 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

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

    PubMed

    Ito, Tatsuya

    2016-01-01

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

  4. 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

  5. Clinical features and outcomes of carotid artery stenting by clinical expert consensus criteria: a report from the CARE registry.

    PubMed

    Anderson, H Vernon; Rosenfield, Kenneth A; White, Christopher J; Ho, Kalon K L; Spertus, John A; Jones, Philip G; Tang, Fengming; Cates, Christopher U; Jaff, Michael R; Koroshetz, Walter J; Katzan, Irene L; Hopkins, L Nelson; Rumsfeld, John S; Brindis, Ralph G

    2010-03-01

    In 2007, a multispecialty society task force published a clinical expert consensus document (CECD) on carotid stenting (CAS), containing recommendations for appropriate patient selection and quality of care. The CECD also inspired creation of a large, national registry of carotid revascularization, the Carotid Artery Revascularization and Endarterectomy (CARE) registry. Our goal here was to investigate whether initial CAS procedures submitted to CARE conformed to CECD recommendations, and examine their clinical outcomes. We analyzed CAS procedures for the period January 1, 2005 through December 31, 2008. These were grouped into those that conformed to CECD recommendations [CECD(+), n = 4,636, 79.8%] and those that did not [CECD(-), n = 1,168, 20.2%]. The CECD(+) patients were older than CECD(-) patients (71.5 +/- 10.3 vs. 67.6 +/- 10.3 years, P = 0.001, respectively), and more frequently had chronic kidney disease (46.9% vs. 17.8%, P = 0.001), chronic lung disease (33.0% vs. 12.4%, P = 0.001), ejection fraction Clinical outcomes at 30 days were similar, including death (1.24% vs. 0.76%, P = 0.184), stroke (5.32% vs. 5.34%, P = 0.954), and death, stroke, or MI (7.04% vs. 6.95%, P = 0.944). Most CAS procedures submitted to CARE conformed to CECD recommendations for patient selection. For reported data, clinical outcomes at 30 days were similar for procedures meeting and those not meeting recommendations, and were similar to outcomes reported by other large registries. These findings suggest that acceptable patient selection criteria for CAS are employed as it expands beyond investigators into more widespread clinical practice.

  6. 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

  7. 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.

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

    PubMed

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

    2016-11-01

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

  9. Use of Health Plan Combined with Registry Data to Predict Clinical Trial Recruitment

    PubMed Central

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

    2014-01-01

    Background Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients age ≥ 50 receiving anti- tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4,000 patients needed for the trial and to facilitate site selection. Methods Using national United States data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients’ treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Results Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1,980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 40-45 largest rheumatology practices. Conclusion Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources. PMID:24346611

  10. 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.

  11. 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

  12. 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.

  13. 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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2013-04-01

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

  16. 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

  17. Electronic data capture for registries and clinical trials in orthopaedic surgery: open source versus commercial systems.

    PubMed

    Shah, Jatin; Rajgor, Dimple; Pradhan, Shreyasee; McCready, Mariana; Zaveri, Amrapali; Pietrobon, Ricardo

    2010-10-01

    Collection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal. Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system. WHERE ARE WE NOW?: Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems. WHERE DO WE NEED TO GO?: To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process. HOW DO WE GET THERE?: Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.

  18. 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.

  19. 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. Copyright © 2014 John Wiley & Sons

  20. Uses of cancer registries for public health and clinical research in Europe: Results of the European Network of Cancer Registries survey among 161 population-based cancer registries during 2010-2012.

    PubMed

    Siesling, S; Louwman, W J; Kwast, A; van den Hurk, C; O'Callaghan, M; Rosso, S; Zanetti, R; Storm, H; Comber, H; Steliarova-Foucher, E; Coebergh, J W

    2015-06-01

    To provide insight into cancer registration coverage, data access and use in Europe. This contributes to data and infrastructure harmonisation and will foster a more prominent role of cancer registries (CRs) within public health, clinical policy and cancer research, whether within or outside the European Research Area. During 2010-12 an extensive survey of cancer registration practices and data use was conducted among 161 population-based CRs across Europe. Responding registries (66%) operated in 33 countries, including 23 with national coverage. Population-based oncological surveillance started during the 1940-50s in the northwest of Europe and from the 1970s to 1990s in other regions. The European Union (EU) protection regulations affected data access, especially in Germany and France, but less in the Netherlands or Belgium. Regular reports were produced by CRs on incidence rates (95%), survival (60%) and stage for selected tumours (80%). Evaluation of cancer control and quality of care remained modest except in a few dedicated CRs. Variables evaluated were support of clinical audits, monitoring adherence to clinical guidelines, improvement of cancer care and evaluation of mass cancer screening. Evaluation of diagnostic imaging tools was only occasional. Most population-based CRs are well equipped for strengthening cancer surveillance across Europe. Data quality and intensity of use depend on the role the cancer registry plays in the politico, oncomedical and public health setting within the country. Standard registration methodology could therefore not be translated to equivalent advances in cancer prevention and mass screening, quality of care, translational research of prognosis and survivorship across Europe. Further European collaboration remains essential to ensure access to data and comparability of the results. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Evaluating Early Case Capture of Pediatric Cancers in Seven Central Cancer Registries in the United States, 2013

    PubMed Central

    Neri, Antonio; Rohan, Elizabeth; Clerkin, Castine; Underwood, J. Michael; Ryerson, A. Blythe; Stewart, Sherri L.

    2016-01-01

    Objective Cancer is the second-leading cause of death in children, but incidence data are not available until two years after diagnosis, thereby delaying data dissemination and research. An early case capture (ECC) surveillance program was piloted in seven state cancer registries to register pediatric cancer cases within 30 days of diagnosis. We sought to determine the quality of ECC data and understand pilot implementation. Methods We used quantitative and qualitative methods to evaluate ECC. We assessed data quality by comparing demographic and clinical characteristics from the initial ECC submission to a resubmission of ECC pilot data and to the most recent year of routinely collected cancer data for each state individually and in aggregate. We conducted telephone focus groups with registry staff to determine ECC practices and difficulties in August and September 2013. Interviews were recorded, transcribed, and coded to identify themes. Results Comparing ECC initial submissions with submissions for all states, ECC data were nationally representative for age (9.7 vs. 9.9 years) and sex (673 of 1,324 [50.9%] vs. 42,609 of 80,547 [52.9%] male cases), but not for primary site (472 of 1,324 [35.7%] vs. 27,547 of 80,547 [34.2%] leukemia/lymphoma cases), behavior (1,219 of 1,324 [92.1%] vs. 71,525 of 80,547 [88.8%] malignant cases), race/ethnicity (781 of 1,324 [59.0%] vs. 64,518 of 80,547 [80.1%] white cases), or diagnostic confirmation (1,233 of 1,324 [93.2%] vs. 73,217 of 80,547 [90.9%] microscopically confirmed cases). When comparing initial ECC data with resubmission data, differences were seen in race/ethnicity (808 of 1,324 [61.1%] vs. 1,425 of 1,921 [74.2%] white cases), primary site (475 of 1,324 [35.9%] vs. 670 of 1,921 [34.9%] leukemia/lymphoma cases), and behavior (1,215 of 1,324 [91.8%] vs. 1,717 of 1,921 [89.4%] malignant cases). Common themes from focus group analysis included implementation challenges and facilitators, benefits of ECC, and utility of

  2. Evaluating Early Case Capture of Pediatric Cancers in Seven Central Cancer Registries in the United States, 2013.

    PubMed

    Puckett, Mary; Neri, Antonio; Rohan, Elizabeth; Clerkin, Castine; Underwood, J Michael; Ryerson, A Blythe; Stewart, Sherri L

    2016-01-01

    Cancer is the second-leading cause of death in children, but incidence data are not available until two years after diagnosis, thereby delaying data dissemination and research. An early case capture (ECC) surveillance program was piloted in seven state cancer registries to register pediatric cancer cases within 30 days of diagnosis. We sought to determine the quality of ECC data and understand pilot implementation. We used quantitative and qualitative methods to evaluate ECC. We assessed data quality by comparing demographic and clinical characteristics from the initial ECC submission to a resubmission of ECC pilot data and to the most recent year of routinely collected cancer data for each state individually and in aggregate. We conducted telephone focus groups with registry staff to determine ECC practices and difficulties in August and September 2013. Interviews were recorded, transcribed, and coded to identify themes. Comparing ECC initial submissions with submissions for all states, ECC data were nationally representative for age (9.7 vs. 9.9 years) and sex (673 of 1,324 [50.9%] vs. 42,609 of 80,547 [52.9%] male cases), but not for primary site (472 of 1,324 [35.7%] vs. 27,547 of 80,547 [34.2%] leukemia/lymphoma cases), behavior (1,219 of 1,324 [92.1%] vs. 71,525 of 80,547 [88.8%] malignant cases), race/ethnicity (781 of 1,324 [59.0%] vs. 64,518 of 80,547 [80.1%] white cases), or diagnostic confirmation (1,233 of 1,324 [93.2%] vs. 73,217 of 80,547 [90.9%] microscopically confirmed cases). When comparing initial ECC data with resubmission data, differences were seen in race/ethnicity (808 of 1,324 [61.1%] vs. 1,425 of 1,921 [74.2%] white cases), primary site (475 of 1,324 [35.9%] vs. 670 of 1,921 [34.9%] leukemia/lymphoma cases), and behavior (1,215 of 1,324 [91.8%] vs. 1,717 of 1,921 [89.4%] malignant cases). Common themes from focus group analysis included implementation challenges and facilitators, benefits of ECC, and utility of ECC data. ECC provided data

  3. From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research.

    PubMed

    de la Torre Hernández, José M; Edelman, Elazer R

    2017-08-21

    The most important challenge faced by human beings is health. The only way to provide better solutions for health care is innovation, true innovation. The only source of true innovation is research, good research indeed. The pathway from a basic science study to a randomized clinical trial is long and not free of bumps and even landmines. These are all the obstacles and barriers that limit the availability of resources, entangle administrative-regulatory processes, and restrain investigators' initiatives. There is increasing demand for evidence to guide clinical practice but, paradoxically, biomedical research has become increasingly complex, expensive, and difficult to integrate into clinical care with increased barriers to performing the practical aspects of investigation. We face the challenge of increasing the volume of biomedical research and simultaneously improving the efficiency and output of this research. In this article, we review the main stages and methods of biomedical research, from nonclinical studies with animal and computational models to randomized trials and clinical registries, focusing on their limitations and challenges, but also providing alternative solutions to overcome them. Fortunately, challenges are always opportunities in disguise. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  4. 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

  5. Comparison of racial differences in childhood cancer risk in case-control studies and population-based cancer registries.

    PubMed

    Slusky, Danna A; Mezei, Gabor; Metayer, Catherine; Selvin, Steve; Von Behren, Julie; Buffler, Patricia A

    2012-02-01

    Although selection bias in case-control studies has been studied extensively, little is known about selection of cases and controls among various ethnic groups. This study compares racial differences in childhood cancer rates as estimated by case-control studies with various design features. It also compares estimates of racial distribution among cases as reported by case-control studies to those observed for an ideal case series with complete ascertainment of cases for these studies or in population-based cancer registries in corresponding geographic regions and calendar periods. Peer-reviewed publications on childhood leukemia and brain tumors from North America, published between 1980 and 2007, were reviewed. Incidence data by race/ethnicity were compiled from research publications, federal cancer statistics, and cancer registries. Meta-analysis was conducted to assess racial/ethnic differences by study characteristics. Racial distributions of cases from published case-control studies were compared to those of a presumably noncensored case distribution (i.e. include both participating and non-participating cases in a case-control study) or cases recorded by cancer registries. In interview-based case-control studies of childhood cancer, the proportion of Whites compared to non-Whites tended to be higher among controls than among cases; however, the opposite was true for record-based case-control studies. Additionally, the proportion of Whites tended to be higher among the participating cases in the published case-control studies compared to the proportion of Whites among the non-participating cases or in cancer registries. Investigators need to consider differential participation by racial group as a potential source of bias in the interpretation of case-control study results. Copyright © 2011 Elsevier Ltd. All rights reserved.

  6. Occupational Snake Bites: a Prospective Case Series of Patients Reported to the ToxIC North American Snakebite Registry.

    PubMed

    Spyres, Meghan B; Ruha, Anne-Michelle; Seifert, Steven; Onisko, Nancy; Padilla-Jones, Angela; Smith, Eric Anthony

    2016-12-01

    In the developing world, occupation has been identified as a risk factor for snake bite. Such an association has not been described in the USA. The objective of this study was to describe the epidemiology and clinical manifestations of occupational snake bite in patients reported to the ToxIC North American Snakebite Registry (NASBR). This was a prospective case series of patients reported to the ToxIC NASBR between January 1, 2014 and November 5, 2015. Variables collected included snake species, patient demographics, date and location of exposure, occupation, bite location, clinical manifestations, and management. Of 180 adult snake bites reported, 25 (13.9 %; 95 % CI 9.2-19.8 %) were occupational in nature. Rattlesnake envenomations were common (80 %). Most snake bites (96 %) occurred in men. Occupations most associated with snake bite were landscaping (28 %) and working directly with snakes (24 %). Fifty-six percent of bites occurred in an outdoor work environment. Seventy-six percent of envenomations were to the upper extremities. Intentional interaction occurred in 40 % of cases, all of which sustained finger envenomations. No cases presented with apparent acute ethanol intoxication. The majority of occupational snake bites occurred in men working outdoors and were unintentional injuries. Bites involving the upper extremity tended to result from intentional interactions. Acute ethanol intoxication did not appear to be involved with occupational envenomations.

  7. 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

  8. 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.

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

    PubMed

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

    2015-07-01

    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. 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. 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. 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%. 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.

  10. 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

  11. The Regional Immunization Registry as a Public Health Tool for Improving Clinical Practice and Guiding Immunization Delivery Policy

    PubMed Central

    Kempe, Allison; Beaty, Brenda L.; Steiner, John F.; Pearson, Kellyn A.; Lowery, N. Elaine; Daley, Matthew F.; Crane, Lori A.; Berman, Stephen

    2004-01-01

    Objectives. We assessed the distribution of immunization records among 3 health care delivery sectors and the impact of a regional immunization registry on “up to date” rates. Methods. Immunization registry records in 2 regions were categorized as having originated in private practices, community health centers, or public health clinics. “Up to date” rates were calculated after we sequentially added immunization records from the 3 sectors. Results. The percentage of children with immunizations documented in multiple sectors increased with age from 7 to 24 months, and children who were seen in multiple sectors were more likely to be up to date. There were relative increases in “up to date” rates of 50% for children aged 24 months. Conclusions. The regional immunization registry is a powerful public health tool for increasing documented “up to date” rates and providing insights into patterns of immunization delivery. PMID:15249300

  12. Potential use cases for the development of an electronic health facility registry in Nigeria: Key informant’s perspectives

    PubMed Central

    Makinde, Olusesan Ayodeji; Azeez, Aderemi; Adebayo, Wura

    2016-01-01

    Background: Master facility lists (MFL) maintain an important standard (unique identifier) in country health information systems that will aid integration and interoperability of multiple health facility based data sources. However, this standard is not readily available in several low and middle income countries where reliable data is most needed for efficient planning. The World Health Organization in 2012 drew up guidelines for the creation of MFLs in countries but this guideline still requires domestication and process modeling for each country adopting it. Nigeria in 2013 published a paper-based MFL directory which it hopes to migrate to an electronic MFL registry for use across the country. Objective: To identify the use cases of importance in the development of an electronic health facility registry to manage the MFL compiled in Nigeria. Methods: Potential use cases for the health facility registry were identified through consultations with key informants at the Federal Ministry of Health. These will serve as input into an electronic MFL registry development effort. Results: The use cases identified include: new health facility is created, update of status of health facility, close-out, relocation, new information available, delete and management of multi-branch health facility. Conclusion: Development of an application for the management of MFLs requires proper architectural analysis of the manifestations that can befall a health facility through its lifecycle. A MFL electronic registry will be invaluable to manage health facility data and will aid the integration and interoperability of health facility information systems. PMID:28149447

  13. 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…

  14. 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…

  15. 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

  16. Clinical and genetic features of Australian families with long QT syndrome: A registry-based study.

    PubMed

    Burns, Charlotte; Ingles, Jodie; Davis, Andrew M; Connell, Vanessa; Gray, Belinda; Hunt, Lauren; McGaughran, Julie; Semsarian, Christopher

    2016-12-01

    Familial long QT syndrome (LQTS) is a primary arrhythmogenic disorder caused by mutations in ion channel genes. The phenotype ranges from asymptomatic individuals to sudden cardiac arrest and death. LQTS is a rare but significant health problem for which global data should exist. This study sought to provide the first clinical and genetic description of Australian families with LQTS. We performed a cross-sectional study to evaluate clinical and genetic features of families with LQTS. We recruited individuals from the Australian Genetic Heart Disease Registry and Genetic Heart Disease Clinic, in Sydney, Australia, and included those with a diagnosis of LQTS according to the most recent consensus statement. Among 108 families with LQTS, 173 individuals were affected. Twenty-five (32%) probands had a sudden cardiac death (SCD) event (including appropriate implantable cardioverter defibrillator [ICD] therapy, or resuscitated cardiac arrest). There were 64 (82%) probands who underwent genetic testing, and 34 (53%) had a pathogenic or likely pathogenic mutation in. Having a family history of LQTS was significantly associated with identification of a pathogenic result (79% versus 14%, p<0.0001). There were 16 (9%) participants who experienced delay to diagnosis of at least 12 months. This is the first clinical and genetic study in a large cohort of Australian families with LQTS. Findings from this study suggest that the clinical and genetic features in this population are not dissimilar to those described in North American, European, and Asian cohorts. Global-scale information about families with LQTS is an important initiative to ensure diagnostic and management approaches are applicable to different populations and ethnicities.

  17. 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.

  18. 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

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

    PubMed

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

    2012-04-01

    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. 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). 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. 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. 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. As with any multipurpose registry database system

  20. 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

  1. 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

  2. Anomalies associated with gastroschisis and omphalocele: analysis of 2825 cases from the Texas Birth Defects Registry.

    PubMed

    Benjamin, Bonna; Wilson, Golder N

    2014-04-01

    The increasing prevalence of abdominal wall defects prompted analysis of anomalies associated with gastroschisis and omphalocele in the Texas Birth Defects Registry (TDBR). Cases of gastroschisis (ICD9 code 756.71), omphalocele (756.70), and/or unspecified anomalies of the abdominal wall (756.79) were obtained from the TDBR after IRB approval and analyzed using Microsoft Access© and Excel© databases. Analysis began with 2825 cases including 1831 of gastroschisis, 814 of omphalocele, and 180 of unspecified abdominal wall defects plus 9680 associated anomalies that were classified according to system. The overall prevalence of abdominal wall defects among 3,806,299 Texas births from 1999 to 2008 was 7.4 per 10,000 with 4.8 per 10,000 for gastroschisis and 2.1 for omphalocele. After excluding ambiguous cases (8.5% possibly misclassified), anomaly spectra were similar for the two AWD with musculoskeletal (limb contractures or defects), cardiovascular, gastrointestinal, urogenital, and central nervous system defects being most common. Of 1831 cases with gastroschisis, 594 (32%) had associated anomalies compared to 654 (80%) of 814 omphalocele cases. Gastroschisis as well as omphalocele has significant associated anomalies that are important to appreciate during pre- and postnatal management. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Systemic lupus erythematosus in an African Caribbean population: incidence, clinical manifestations, and survival in the Barbados National Lupus Registry.

    PubMed

    Flower, Cindy; Hennis, Anselm J M; Hambleton, Ian R; Nicholson, George D; Liang, Matthew H

    2012-08-01

    To assess the epidemiology, clinical features, and outcomes of systemic lupus erythematosus (SLE) in the predominantly African Caribbean population of Barbados. A national registry of all patients diagnosed with SLE was established in 2007. Complete case ascertainment was facilitated by collaboration with the island's sole rheumatology service, medical practitioners, and the lupus advocacy group. Informed consent was required for inclusion. Between January 1, 2000 and December 31, 2009, there were 183 new cases of SLE (98% African Caribbean) affecting 172 women and 11 men for unadjusted annual incidence rates of 12.21 (95% confidence interval [95% CI] 10.46-14.18) and 0.84 (95% CI 0.42-1.51) per 100,000 person-years, respectively. Excluding pediatric cases (ages <18 years), the unadjusted incidence rate among women was 15.14 per 100,000 person-years. The principal presenting manifestations were arthritis (84%), nephritis (47%), pleuritis (41.5%), malar rash (36.4%), and discoid lesions (33.1%). Antinuclear antibody positivity was 95%. The overall 5-year survival rate was 79.9% (95% CI 69.6-87.1), decreasing to 68% in patients with nephritis. A total of 226 persons with SLE were alive at the end of the study for point prevalences of 152.6 (95% CI 132.8-174.5) and 10.1 (95% CI 5.4-17.2) per 100,000 among women and men, respectively. Rates of SLE in Barbadian women are among the highest reported to date, with clinical manifestations similar to African American women and high mortality. Further study of this population and similar populations of West African descent might assist our understanding of environmental, genetic, and health care issues underpinning disparities in SLE. Copyright © 2012 by the American College of Rheumatology.

  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. Clinical presentation of intraocular retinoblastoma; 5-year hospital-based registry in Egypt.

    PubMed

    El Zomor, Hossam; Nour, Radwa; Alieldin, Adel; Taha, Hala; Montasr, Mohamed M; Moussa, Emad; El Nadi, Enas; Ezzat, Sameera; Alfaar, Ahmad S

    2015-12-01

    To study the presenting signs of Retinoblastoma in Egypt at Egypt's main pediatric oncology referral center. This is a prospective descriptive study (hospital-based registry) conducted at Children's Cancer Hospital Egypt between July 2007 and December 2012. Out of 262 patients diagnosed with retinoblastoma, 244 were suffering from intra-ocular disease at presentation. One hundred thirty-nine (57%) patients presented with unilateral disease, while 105 (43%) suffered bilateral disease. The mean age at presentation was 20.6 ± 17 months, averaging 18.87 ± 11.76 months for bilateral and 25.72 ± 18.78 months for unilateral disease. The most common clinical presentation was leukocoria in 180 (73.8%) patients, strabismus in 32 (13.1%) patients and decreased visual acuity in 12 (4.9%) patients. Group D and E disease represented 62% of all affected eyes. Patients with advanced disease (Group C-E) had longer duration of symptoms. In Egypt, retinoblastoma patients present more frequently with advanced disease. There is an ever-increasing need to develop a national team dedicated to studying disease significance and formulating a national awareness program. Copyright © 2015 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

  7. 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

  8. Patient registries of acute coronary syndrome: assessing or biasing the clinical real world data?

    PubMed

    Ferreira-González, Ignacio; Marsal, Josep R; Mitjavila, Francesca; Parada, Antoni; Ribera, Aida; Cascant, Purificación; Soriano, Núria; Sánchez, Pedro L; Arós, Fernando; Heras, Magda; Bueno, Héctor; Marrugat, Jaume; Cuñat, José; Civeira, Emilia; Permanyer-Miralda, Gaietà

    2009-11-01

    The risk of selection bias in registries and its consequences are relatively unexplored. We sought to assess selection bias in a recent registry about acute coronary syndrome and to explore the way of conducting and reporting patient registries of acute coronary syndrome. We analyzed data from patients of a national acute coronary syndrome registry undergoing an audit about the comprehensiveness of the recruitment/inclusion. Patients initially included by hospital investigators (n=3265) were compared to eligible nonincluded (missed) patients (n=1439). We assessed, for 25 exposure variables, the deviation of the in-hospital mortality relative risks calculated in the initial sample from the actual relative risks. Missed patients were of higher risk and received less recommended therapies than the included patients. In-hospital mortality was almost 3 times higher in the missed population (9.34% [95% CI, 7.84 to 10.85] versus 3.9% [95% CI, 2.89 to 4.92]). Initial relative risks diverged from the actual relative risks more than expected by chance (P<0.05) in 21 variables, being higher than 10% in 17 variables. This deviation persisted on a smaller degree on multivariable analysis. Additionally, we reviewed a sample of 129 patient registries focused on acute coronary syndrome published in thirteen journals, collecting information on good registry performance items. Only in 38 (29.4%) and 48 (37.2%) registries was any audit of recruitment/inclusion and data abstraction, respectively, mentioned. Only 4 (3.1%) authors acknowledged potential selection bias because of incomplete recruitment. Irregular inclusion can introduce substantial systematic bias in registries. This problem has not been explicitly addressed in a substantial number of them.

  9. 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.

  10. Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis: data from the DUO Registry.

    PubMed

    Denton, Christopher P; Krieg, Thomas; Guillevin, Loic; Schwierin, Barbara; Rosenberg, Daniel; Silkey, Mariabeth; Zultak, Maurice; Matucci-Cerinic, Marco

    2012-05-01

    The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). The DUO Registry is a European, prospective, multicentre, observational, registry of SSc patients with ongoing digital ulcer disease, irrespective of treatment regimen. Data collected included demographics, SSc duration, SSc subset, internal organ manifestations, autoantibodies, previous and ongoing interventions and complications related to digital ulcers. Up to 19 November 2010 a total of 2439 patients had enrolled into the registry. Most were classified as either limited cutaneous SSc (lcSSc; 52.2%) or diffuse cutaneous SSc (dcSSc; 36.9%). Digital ulcers developed earlier in patients with dcSSc compared with lcSSc. Almost all patients (95.7%) tested positive for antinuclear antibodies, 45.2% for anti-scleroderma-70 and 43.6% for anticentromere antibodies (ACA). The first digital ulcer in the anti-scleroderma-70-positive patient cohort occurred approximately 5 years earlier than the ACA-positive patient group. This study provides data from a large cohort of SSc patients with a history of digital ulcers. The early occurrence and high frequency of digital ulcer complications are especially seen in patients with dcSSc and/or anti-scleroderma-70 antibodies.

  11. 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

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

    PubMed

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

    2017-01-01

    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. 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. 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. 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.

  13. Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

    PubMed

    Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

    2014-11-01

    The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014

  14. Polymyxin B hemoperfusion in clinical practice: the picture from an unbound collaborative registry.

    PubMed

    2014-01-01

    After the publication of the EUPHAS trial, the clinical use of polymyxin B hemoperfusion (Toraymyxin®) increased significantly in Italy. Nevertheless, no structured data collections have been carried out to underline the characteristics of treated patients. Therefore, a collaborative registry of clinical data was promoted among users in order to better define the structure of the prospective data collection named the EUPHAS2 project. Neither inclusion criteria nor therapeutic constraints were imposed, highlighting adherence to clinical evidence provided by previous randomized controlled trials, and also unusual or borderline practice in the selection of patients for polymyxin B-based cartridges (PMX-DHP). This first retrospective phase of data collection included patients with severe sepsis and septic shock treated with Toraymyxin over the last 3 years, up to July 2013. Thirty-one hospitals participated in the EUPHAS2 study, collecting data on 306 patients. Enrolled patients were grouped according to the main source of sepsis: abdominal (41.8%) and nonabdominal (58.2%). The abdominal patients had characteristics well matching those selected for the EUPHAS randomized controlled trial in terms of time-to-enrolment, severity of the illness, 28-day mortality and in-hospital mortality. Their 28-day mortality rate was 35% with a significant reduction of the Sequential Organ Failure Assessment Score (SOFA) score after 72 h of treatment (p < 0.001). Patients with nonabdominal sepsis were heterogeneous and only a few of them had their endotoxin activity tested in a manner not allowing a reliable evaluation of the real efficacy of the treatment and organ dysfunction control. Their 28-day mortality rate was 49% and the SOFA score did not significantly change before and after treatment. In conclusion, clinical experience confirms the results of the original EUPHAS randomized trial in terms of outcome for patients with abdominal severe sepsis. Specific studies focused on a

  15. Statin use and risk of endometrial cancer: a nationwide registry-based case-control study.

    PubMed

    Sperling, Cecilie D; Verdoodt, Freija; Friis, Søren; Dehlendorff, Christian; Kjaer, Susanne K

    2017-02-01

    Laboratory and epidemiological evidence have suggested that statin use may protect against the development of certain cancers, including endometrial cancer. In a nationwide registry-based case-control study, we examined the association between statin use and risk of endometrial cancer. Cases were female residents of Denmark with a primary diagnosis of endometrial cancer during 2000-2009. For each case, we selected 15 female population controls matched on date of birth (±one month) using risk-set sampling. Ever use of statin was defined as two or more prescriptions on separate dates. Conditional logistic regressions were used to estimate age-matched (by design) and multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (CI) for endometrial cancer associated with statin use. The multivariable-adjusted models included parity, hormone replacement therapy (HRT), obesity, diabetes, chronic obstructive pulmonary disease and education. We evaluated whether the association between statin use and endometrial cancer varied with duration and intensity of statin use, type of endometrial cancer or patient characteristics. The study population comprised 5382 endometrial cancer cases and 72 127 population controls. We observed no association between ever use of statins and endometrial cancer risk (OR 1.03, 95% CI 0.94-1.14). In addition, endometrial cancer risk did not vary substantially with duration or intensity of statin use. Stratification by type of endometrial cancer also yielded neutral ORs. In our nationwide case-control study, we found no association between statin use and risk of endometrial cancer. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

  16. 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.

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

    PubMed

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

    2016-01-01

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

  18. 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

  19. Clinical and Demographic Features of Vertigo: Findings from the REVERT Registry

    PubMed Central

    Agus, Sam; Benecke, Heike; Thum, Cornelia; Strupp, Michael

    2013-01-01

    Introduction: Despite being a common disease, data on vertigo management in a real-world setting are scarce. Aims: To provide information on the vertigo and its management in a real-world setting. Methods: Data were collected from 4,294 patients with vertigo in 13 countries over 28 months via a multi-national, non-interventional observational study (the so-called REVERT registry). Data included medical history and details of anti-vertigo therapy. “Clinical global impression” (CGI) of severity (CGI-S) was assessed at baseline (V1) and then at 6 months follow-up (V2) along with CGI change (CGI-C). All variables were analyzed descriptively. Results: The majority of patients were female, >40 years of age, and almost half had co-morbid cardio-vascular disease. Diagnoses were split into four categories: 37.2% “other vertigo of peripheral vestibular origin,” 26.9% benign paroxysmal positional vertigo (BPPV), 20.5% “peripheral vestibular vertigo of unknown origin,” and 15.4% Ménière’s disease (MD). Betahistine was the most commonly prescribed therapy prior to and after enrollment, and was followed by piracetam, ginkgo biloba, and diuretics. MD had the highest proportion of betahistine treated patients. Almost half of patients were “moderately ill” at V1 based on CGI-S. At V2, patient distribution moved toward “less severe illness” (91.0% improved). The greatest improvements were in the more severely ill, and those with BPPV or “other vertigo of peripheral origin.” Conclusion: There was a reduction in illness severity over the course of the study, some of which is likely to be due to pharmacological intervention. Further studies are needed to confirm these results. PMID:23675366

  20. Real-time continuous glucose monitoring among participants in the T1D Exchange clinic registry.

    PubMed

    Wong, Jenise C; Foster, Nicole C; Maahs, David M; Raghinaru, Dan; Bergenstal, Richard M; Ahmann, Andrew J; Peters, Anne L; Bode, Bruce W; Aleppo, Grazia; Hirsch, Irl B; Kleis, Lora; Chase, H Peter; DuBose, Stephanie N; Miller, Kellee M; Beck, Roy W; Adi, Saleh

    2014-10-01

    To assess the frequency of continuous glucose monitoring (CGM) device use, factors associated with its use, and the relationship of CGM with diabetes outcomes (HbA1c, severe hypoglycemia [SH], and diabetic ketoacidosis [DKA]). Survey questions related to CGM device use 1 year after enrollment in the T1D Exchange clinic registry were completed by 17,317 participants. Participants were defined as CGM users if they indicated using real-time CGM during the prior 30 days. Nine percent of participants used CGM (6% of children <13 years old, 4% of adolescents 13 to <18 years, 6% of young adults 18 to <26 years, and 21% of adults ≥26 years). CGM use was more likely with higher education, higher household income, private health insurance, longer duration of diabetes, and use of insulin pump (P < 0.01 all factors). CGM use was associated with lower HbA1c in children (8.3% vs. 8.6%, P < 0.001) and adults (7.7% vs. 7.9%, P < 0.001). In adults, more frequent use of CGM (≥6 days/week) was associated with lower mean HbA1c. Only 27% of users downloaded data from their device at least once per month, and ≤15% of users reported downloading their device at least weekly. Among participants who used CGM at baseline, 41% had discontinued within 1 year. CGM use is uncommon but associated with lower HbA1c in some age-groups, especially when used more frequently. Factors associated with discontinuation and infrequent use of retrospective analysis of CGM data should be considered in developing next-generation devices and education on CGM use. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  1. Asymptomatic atrial fibrillation: clinical correlates, management, and outcomes in the EORP-AF Pilot General Registry.

    PubMed

    Boriani, Giuseppe; Laroche, Cecile; Diemberger, Igor; Fantecchi, Elisa; Popescu, Mircea Ioachim; Rasmussen, Lars Hvilsted; Sinagra, Gianfranco; Petrescu, Lucian; Tavazzi, Luigi; Maggioni, Aldo P; Lip, Gregory Y H

    2015-05-01

    Atrial fibrillation is often asymptomatic, but outcomes require further characterization. The study objective was to investigate the clinical presentation, management, and outcomes in asymptomatic and symptomatic patients with atrial fibrillation who were prospectively enrolled in the EurObservational Research Programme - Atrial Fibrillation (EORP-AF) Pilot General Registry. A total of 3119 patients were enrolled, and 1237 (39.7%) were asymptomatic (European Heart Rhythm Association [EHRA] score I). Among symptomatic patients, 963 (51.2%) had mild symptoms (EHRA score II) and 919 (48.8%) had severe or disabling symptoms (EHRA III-IV). Permanent atrial fibrillation was 3-fold more common in asymptomatic patients than in symptomatic patients. On multivariate analysis, male gender (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.384-1.921), older age (OR, 1.019; 95% CI, 1.012-1.026), previous myocardial infarction (OR, 1.681; 95% CI, 1.350-2.093), and limited physical activity (OR, 1.757; 95% CI, 1.495-2.064) were associated significantly with asymptomatic (EHRA I) atrial fibrillation. Fully asymptomatic atrial fibrillation (absence of current and previous symptoms) was present in 520 patients (16.7%) and was associated independently with male gender, age, and previous myocardial infarction. Appropriate guideline-based prescription of oral anticoagulants was lower in these patients, and aspirin was prescribed more frequently. Mortality at 1 year was more than 2-fold higher in asymptomatic patients compared with symptomatic patients (9.4% vs 4.2%, P < .0001) and was associated independently with older age and comorbidities, including chronic kidney disease and chronic heart failure. Asymptomatic atrial fibrillation is common in daily cardiology practice and is associated with elderly age, more comorbidities, and high thromboembolic risks. A higher 1-year mortality was found in asymptomatic patients compared with symptomatic patients. Copyright © 2015 Elsevier

  2. Poor glycemic control in younger women attending Malaysian public primary care clinics: findings from adults diabetes control and management registry.

    PubMed

    Cheong, Ai Theng; Lee, Ping Yein; Sazlina, Shariff-Ghazali; Mohamad Adam, Bujang; Chew, Boon How; Mastura, Ismail; Jamaiyah, Haniff; Syed Alwi, Syed-Abdul-Rahman; Sri Wahyu, Taher; Nafiza, Mat-Nasir

    2013-12-10

    Women of reproductive age are a group of particular concern as diabetes may affect their pregnancy outcome as well as long-term morbidity and mortality. This study aimed to compare the clinical profiles and glycemic control of reproductive and non-reproductive age women with type 2 diabetes (T2D) in primary care settings, and to determine the associated factors of poor glycemic control in the reproductive age group women. This was a cross-sectional study using cases reported by public primary care clinics to the Adult Diabetes Control and Management registry from 1st January to 31st December 2009. All Malaysian women aged 18 years old and above and diagnosed with T2D for at least 1 year were included in the analysis. The target for glycemic control (HbA1c < 6.5%) is in accordance to the recommended national guidelines. Both univariate and multivariate approaches of logistic regression were applied to determine whether reproductive age women have an association with poor glycemic control. Data from a total of 30,427 women were analyzed and 21.8% (6,622) were of reproductive age. There were 12.5% of reproductive age women and 18.0% of non-reproductive age women that achieved glycemic control. Reproductive age group women were associated with poorer glycemic control (OR = 1.5, 95% CI = 1.2-1.8). The risk factors associated with poor glycemic control in the reproductive age women were being of Malay and Indian race, longer duration of diabetes, patients on anti-diabetic agents, and those who had not achieved the target total cholesterol and triglycerides. Women with T2D have poor glycemic control, but being of reproductive age was associated with even poorer control. Health care providers need to pay more attention to this group of patients especially for those with risk factors. More aggressive therapeutic strategies to improve their cardiometabolic control and pregnancy outcome are warranted.

  3. Registries in orthopaedics.

    PubMed

    Delaunay, C

    2015-02-01

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

  4. 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.

  5. [Malignant melanoma of the skin as evidenced by epidemiological cancer registries in Germany -- incidence, clinical parameters, variations in recording].

    PubMed

    Lehnert, M; Eberle, A; Hentschel, S; Katalinic, A; Kieschke, J; Schmidtmann, I; Schubert-Fritschle, G; Stegmaier, C; Hense, H-W

    2005-10-01

    To exclude bias of registration evidenced by relevant differences among German cancer registries in the incidence of malignant melanoma (melanocarcinoma). Cancer registries in the Federal German states of Hamburg, Schleswig-Holstein, Bremen, Rhineland-Palatinate, Saarland, the Munich District and the County of Münster featured registration data of malignant melanoma diagnosed in 2000 A. D. Figures and incidence rates, distribution of T-stage of the primary tumour were analysed as well as the distribution of sources reporting melanoma to the registries. Details of outpatient treatment of cutaneous melanoma by dermatologists in private practice were investigated. Data of 2,471 malignant melanoma cases were analysed. The highest age standardised incidence rates were 15.7 per 100,000 women and 19 per 100,000 men while the lowest rates were reported as 7.8 and 6.6 per 100,000, respectively (European standard). The proportion of stage T1 tumours varied between 21.5 and 59.2 %. We observed remarkable variations in the structure of reporting sources among the registries. The proportion of reports from dermatologists in private practice varied between 2.2 and 62 %, with higher proportions associated with more T1-T2 tumours but also lower completeness of stage reports. No clear association was identified between incidence of melanoma and reporting sources. Malignant melanomas of smaller size (T1-T2) are reported more frequently in an outpatient setting but very often without data. Hospital departments of dermatology contribute high-quality data with better completeness especially for later stage melanomas. Desirable inclusion of notifications from nationwide operating dermatopathology laboratories is complicated by the Federal German structure of cancer registration. Especially in case of malignant melanoma of the skin notification reports from all sectors of the health care system are imperative for valid epidemiological results.

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

    PubMed Central

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

    2016-01-01

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

  7. 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…

  8. 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…

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

    PubMed

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

    2015-02-01

    Historically, African Americans have been underrepresented in clinical trials (CTs) compared to whites. A growing number of research institutions have created CT registries to match volunteers with appropriate studies. In a sample of 745 African Americans from 16 churches, we tested the impact of a culturally tailored intervention aimed at increasing enrollment in a university-based CT registry. Half of the churches received a culturally tailored CT education program (intervention) and half of the churches received a program about healthy eating (comparison). The main outcomes were the odds of post-test self-reported enrollment and verified enrollment. Using linear regression, post-test willingness to participate in a CT was also assessed. Odds of verified enrollment were higher in the intervention than comparison group (OR=2.95, 95% CI: 1.33-6.5, p=0.01). Post-test self-reported enrollment in the registry was also higher among the intervention group than comparison group members (OR=1.94, 95% CI: 1.08-3.47, p=0.03). Willingness to participate in a future CT was higher in the intervention group (β=0.74, p=0.02). A culturally tailored education program about CTs can increase enrollment of African Americans in a university-based clinical trials registry. Community engagement and health education workshops may improve minority CT enrollment over time. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  10. 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

  11. Contemporary clinical characteristics, treatment, and outcomes of angiographically confirmed coronary stent thrombosis: results from a multicenter California registry.

    PubMed

    Yeo, Khung Keong; Mahmud, Ehtisham; Armstrong, Ehrin J; Bennett, William E; Shunk, Kendrick A; MacGregor, John S; Li, Zhongmin; Low, Reginald I; Rogers, Jason H

    2012-03-01

    To describe the contemporary treatment and outcomes for patients with angiographically confirmed (definite) stent thrombosis (ST). Limited data are available on contemporary treatment patterns and outcomes of patients with ST in the United States. In this multicenter California registry, consecutive cases of definite ST over 5 years were identified. Clinical characteristics, in-hospital outcomes, and long-term survival are reported. One hundred and sixty five consecutive episodes of ST were identified in 153 patients from January 2005 to February 2010. The distribution of acute (≤24 hr), subacute (24 hr to 30 days), late (30 days to 1 year), and very late (≥1 year) ST was 3.9%, 21.8%, 17.6%, and 50.3%, respectively. Only 41.2% of patients were on dual antiplatelet therapy at the time of presentation, while 22.4% of patients were on none. Of the 61.4% of patients treated with restenting, 71.1% of them received a drug-eluting stent. Procedural success was 88.1%, and in-hospital death, stroke, and CABG occurred in 5.5%, 0.6%, and 6.1% of subjects, respectively. All-cause mortality at 1 year was 14.3%. Although female gender, diabetes mellitus (DM), bifurcation disease, ejection fraction <40%, and cardiogenic shock at the time of presentation were associated with an increased risk of in-hospital mortality, only DM (P = 0.047) and bifurcation disease (P = 0.027) remained independent predictors of in-hospital death. In-hospital mortality from definite ST is lower than previously reported, but long-term mortality remains high. DM and bifurcation disease, but not type of percutaneous therapy, are independently associated with in-hospital mortality. Copyright © 2011 Wiley Periodicals, Inc.

  12. Influence of age on clinical and revascularization outcomes in the North American Solitaire Stent-Retriever Acute Stroke Registry.

    PubMed

    Castonguay, Alicia C; Zaidat, Osama O; Novakovic, Roberta; Nguyen, Thanh N; Taqi, M Asif; Gupta, Rishi; Sun, Chung-Huan J; Martin, Coleman; Holloway, William E; Mueller-Kronast, Nils; E English, Joey; Linfante, Italo; Dabus, Guilherme; Malisch, Tim W; Marden, Franklin A; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Michael T; Badruddin, Aamir; Abraham, Michael G; Janardhan, Vallabh; Shaltoni, Hashem; Yoo, Albert J; Abou-Chebl, Alex; Chen, Peng R; Britz, Gavin W; Kaushal, Ritesh; Nanda, Ashish; A Issa, Mohammad; Nogueira, Raul G

    2014-12-01

    The Solitaire With the Intention for Thrombectomy (SWIFT) and thrombectomy revascularization of large vessel occlusions in acute ischemic stroke (TREVO 2) trial results demonstrated improved recanalization rates with mechanical thrombectomy; however, outcomes in the elderly population remain poorly understood. Here, we report the effect of age on clinical and angiographic outcome within the North American Solitaire-FR Stent-Retriever Acute Stroke (NASA) Registry. The NASA Registry recruited sites to submit data on consecutive patients treated with Solitaire-FR. Influence of age on clinical and angiographic outcomes was assessed by dichotomizing the cohort into ≤80 and >80 years of age. Three hundred fifty-four patients underwent treatment in 24 centers; 276 patients were ≤80 years and 78 were >80 years of age. Mean age in the ≤80 and >80 cohorts was 62.2±13.2 and 85.2±3.8 years, respectively. Of patients >80 years, 27.3% had a 90-day modified Rankin Score ≤2 versus 45.4% ≤80 years (P=0.02). Mortality was 43.9% and 27.3% in the >80 and ≤80 years cohorts, respectively (P=0.01). There was no significant difference in time to revascularization, revascularization success, or symptomatic intracranial hemorrhage between the groups. Multivariate analysis showed age >80 years as an independent predictor of poor clinical outcome and mortality. Within the >80 cohort, National Institutes of Health Stroke Scale (NIHSS), revascularization rate, rescue therapy use, and symptomatic intracranial hemorrhage were independent predictors of mortality. Greater than 80 years of age is predictive of poor clinical outcome and increased mortality compared with younger patients in the NASA registry. However, intravenous tissue-type plasminogen activator use, lower NIHSS, and shorter revascularization time are associated with better outcomes. Further studies are needed to understand the endovascular therapy role in this cohort compared with medical therapy. © 2014 American

  13. 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

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

    PubMed

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

    2016-01-01

    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. 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. 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. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

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

    PubMed

    Lubowitz, James H; Smith, Patrick A

    2012-03-01

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

  16. Demographic and clinical data in acquired hemophilia A: results from the European Acquired Haemophilia Registry (EACH2).

    PubMed

    Knoebl, P; Marco, P; Baudo, F; Collins, P; Huth-Kühne, A; Nemes, L; Pellegrini, F; Tengborn, L; Lévesque, H

    2012-04-01

    Acquired hemophilia A (AHA) is a rare autoimmune disease caused by autoantibodies against coagulation factor VIII and characterized by spontaneous hemorrhage in patients with no previous family or personal history of bleeding. Although data on several AHA cohorts have been collected, limited information is available on the optimal management of AHA. The European Acquired Hemophilia Registry (EACH2) was established to generate a prospective, large-scale, pan-European database on demographics, diagnosis, underlying disorders, bleeding characteristics, treatment and outcome of AHA patients. Five hundred and one (266 male, 235 female) patients from 117 centers and 13 European countries were included in the registry between 2003 and 2008. In 467 cases, hemostasis investigations and AHA diagnosis were triggered by a bleeding event. At diagnosis, patients were a median of 73.9 years. AHA was idiopathic in 51.9%; malignancy or autoimmune diseases were associated with 11.8% and 11.6% of cases. Fifty-seven per cent of the non-pregnancy-related cases were male. Four hundred and seventy-four bleeding episodes were reported at presentation, and hemostatic therapy initiated in 70.5% of patients. Delayed diagnosis significantly impacted treatment initiation in 33.5%. Four hundred and seventy-seven patients underwent immunosuppression, and 72.6% achieved complete remission. Representing the largest collection of consecutive AHA cases to date, EACH2 facilitates the analysis of a variety of open questions in AHA. © 2012 International Society on Thrombosis and Haemostasis.

  17. [Multiple sclerosis epidemiological situation update: pertinence and set-up of a population based registry of new cases in Catalonia].

    PubMed

    Otero, S; Batlle, J; Bonaventura, I; Brieva, Ll; Bufill, E; Cano, A; Carmona, O; Escartín, A; Marco, M; Moral, E; Munteis, E; Nos, C; Pericot, I; Perkal, H; Ramió-Torrentà, Ll; Ramo-Tello, C; Saiz, A; Sastre-Garriga, J; Tintoré, M; Vaqué, J; Montalban, X

    2010-05-16

    The first epidemiological studies on multiple sclerosis (MS) around the world pictured a north to south latitudinal gradient that led to the first genetic and environmental pathogenic hypothesis. MS incidence seems to be increasing during the past 20 years based on recent data from prospective studies performed in Europe, America and Asia. This phenomenon could be explained by a better case ascertainment as well as a change in causal factors. The few prospective studies in our area together with the increase in the disease in other regions, justifies an epidemiological MS project in order to describe the incidence and temporal trends of MS. A prospective multicenter MS registry has been established according to the actual requirements of an epidemiological surveillance system. Case definition is based on the fulfillment of the McDonald diagnostic criteria. The registry setting is the geographical area of Cataluna (northeastern Spain), using a wide network of hospitals specialized in MS management. Recent epidemiological studies have described an increase in MS incidence. In order to contrast this finding in our area, we consider appropriate to set up a population based registry.

  18. Clinical Outcomes of Single- versus Dual-Chamber Implantable Cardioverter Defibrillators: Lessons from the Israeli ICD Registry.

    PubMed

    Konstantino, Yuval; Haim, Moti; Boxer, Jeremy; Goldenberg, Ilan; Feldman, Alexander; Michowitz, Yoav; Glikson, Michael; Suleiman, Mahmoud

    2016-06-01

    To compare the clinical outcomes of a single- versus dual-chamber ICD for primary prevention of sudden cardiac death in a large, national ICD registry. Data were collected from the prospective Israeli ICD Registry. Baseline characteristics and clinical outcomes including mortality, admissions for heart failure (HF), and ICD therapy were compared between the two groups. A total of 1,125 subjects, 37% with a single-chamber and 63% with a dual-chamber ICD, constructed the baseline cohort. Approximately 80% had ischemic heart disease (IHD). Mean follow-up was 22 months, mean ejection fraction was 30%, and mean QRS width was 103 milliseconds in both groups. During follow-up, there were no significant differences in the rate of mortality, admissions for HF, appropriate or inappropriate therapy, or in time to any of the clinical outcomes. Using multivariate analysis, single-chamber ICD was not associated with increased risk of death or admission for HF. In a subgroup of patients with IHD, single-chamber ICD was associated with a higher rate of inappropriate therapy. In this large retrospective population-based cohort, dual-chamber ICD showed no benefit in reducing the incidence of death or HF admissions, whereas in a subgroup of patients with IHD, single-chamber ICD was associated with increased inappropriate therapy. Further prospective studies are necessary to assess the benefit of dual-chamber ICD in reducing the rate of inappropriate therapy. © 2016 Wiley Periodicals, Inc.

  19. 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

  20. Canine dysautonomia: two clinical cases.

    PubMed

    Jamieson, P M; Scudamore, C L; Ruppert, C E; Mauchline, S; Simpson, J W

    2002-01-01

    Two clinical cases of canine dysautonomia are described. Two young female neutered dogs were presented with clinical signs including vomiting, diarrhoea, faecal tenesmus, dysphagia and urinary retention. Decreased tear production, dry mucous membranes, bilateral Horner's syndrome, decreased anal sphincter tone and gastrointestinal hypomotility were also observed. Presumptive diagnoses of dysautonomia were made based on the clinical presentation and investigations. Postmortem histopathological examination in one of the cases demonstrated marked depletion of neuronal cell bodies in the intestinal myenteric plexuses and parasympathetic ganglia, confirming the diagnosis in this case. Criteria for aiding the antemortem diagnosis of this rare condition based on clinical observations and diagnostic testing are proposed.

  1. 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

    ... GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Parts 2, 4, 7, 10, 13... National Aeronautics and Space Administration (NASA). ACTION: Final rule. SUMMARY: The Civilian Agency..., requires the establishment and maintenance of a registry of contractors willing to perform debris removal...

  2. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications.

    PubMed

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Jørgensen, Karsten Juhl; Lundh, Andreas; Schroll, Jeppe; Gøtzsche, Peter C

    2014-06-04

    To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms. Data on primary efficacy analysis and major harms extracted from each data source and compared. Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder. Clinical study reports, including protocols as appendices (total 13,729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer's online clinical trial registry were searched for trial results. Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor inconsistencies in the population in the primary efficacy analysis between the protocol and clinical study report and within the clinical study report for one trial. Furthermore, we found contradictory information within the reports for seven serious adverse events and eight adverse events that led to discontinuation but with no apparent bias. In each trial, a median of 406 (range 177-645) and 166 (100-241) treatment emergent adverse events (adverse events that emerged or worsened after study drug was started) in the randomised phase were not reported in journal articles and Lilly trial registry reports, respectively. We also found publication bias in relation to beneficial effects. Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There

  3. 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.

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

    PubMed

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

    2013-06-01

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

  5. 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.

  6. 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.

  7. Clinical Pregenetic Screening for Stroke Monogenic Diseases: Results From Lombardia GENS Registry.

    PubMed

    Bersano, Anna; Markus, Hugh Stephen; Quaglini, Silvana; Arbustini, Eloisa; Lanfranconi, Silvia; Micieli, Giuseppe; Boncoraglio, Giorgio B; Taroni, Franco; Gellera, Cinzia; Baratta, Silvia; Penco, Silvana; Mosca, Lorena; Grasso, Maurizia; Carrera, Paola; Ferrari, Maurizio; Cereda, Cristina; Grieco, Gaetano; Corti, Stefania; Ronchi, Dario; Bassi, Maria Teresa; Obici, Laura; Parati, Eugenio A; Pezzini, Alessando; De Lodovici, Maria Luisa; Verrengia, Elena P; Bono, Giorgio; Mazucchelli, Francesca; Zarcone, Davide; Calloni, Maria Vittoria; Perrone, Patrizia; Bordo, Bianca Maria; Colombo, Antonio; Padovani, Alessandro; Cavallini, Anna; Beretta, Simone; Ferrarese, Carlo; Motto, Cristina; Agostoni, Elio; Molini, Graziella; Sasanelli, Francesco; Corato, Manuel; Marcheselli, Simona; Sessa, Maria; Comi, Giancarlo; Checcarelli, Nicoletta; Guidotti, Mario; Uccellini, Davide; Capitani, Erminio; Tancredi, Lucia; Arnaboldi, Marco; Incorvaia, Barbara; Tadeo, Carlo Sebastiano; Fusi, Laura; Grampa, Giampiero; Merlini, Giampaolo; Trobia, Nadia; Comi, Giacomo Pietro; Braga, Massimiliano; Vitali, Paolo; Baron, Pierluigi; Grond-Ginsbach, Caspar; Candelise, Livia

    2016-07-01

    Lombardia GENS is a multicentre prospective study aimed at diagnosing 5 single-gene disorders associated with stroke (cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy, Fabry disease, MELAS [mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes], hereditary cerebral amyloid angiopathy, and Marfan syndrome) by applying diagnostic algorithms specific for each clinically suspected disease We enrolled a consecutive series of patients with ischemic or hemorrhagic stroke or transient ischemic attack admitted in stroke units in the Lombardia region participating in the project. Patients were defined as probable when presenting with stroke or transient ischemic attack of unknown etiopathogenic causes, or in the presence of <3 conventional vascular risk factors or young age at onset, or positive familial history or of specific clinical features. Patients fulfilling diagnostic algorithms specific for each monogenic disease (suspected) were referred for genetic analysis. In 209 patients (57.4±14.7 years), the application of the disease-specific algorithm identified 227 patients with possible monogenic disease. Genetic testing identified pathogenic mutations in 7% of these cases. Familial history of stroke was the only significant specific feature that distinguished mutated patients from nonmutated ones. The presence of cerebrovascular risk factors did not exclude a genetic disease. In patients prescreened using a clinical algorithm for monogenic disorders, we identified monogenic causes of events in 7% of patients in comparison to the 1% to 5% prevalence reported in previous series. © 2016 American Heart Association, Inc.

  8. Registries in Clinical Epidemiology: the European Surveillance System on Contact Allergies (ESSCA).

    PubMed

    Uter, W; Schnuch, A; Wilkinson, M; Dugonik, A; Dugonik, B; Ganslandt, T

    2016-01-01

    Disease registries rely on consistent electronic data capturing (EDC) pertinent to their objectives; either by using existing electronic data as far as available, or by implementing specific software solutions. To describe the current practice of an international disease registry (European Surveillance System on Contact Allergies, ESSCA, www.essca-dc.org) against different state of the art approaches for EDC. Since 2002, ESSCA is collecting data, currently from 53 departments in 12 countries. Departmental EDC software ranges from spreadsheets to comprehensive "patch test software" based on a relational database. In the Erlangen data centre, such diverse data is imported, converted to a common format, quality checked and pooled for scientific analyses. Feed-back to participating departments for quality control is provided by standardised reports. Varying author teams publish scientific analyses addressing the objective of contact allergy surveillance. Although ESSCA represents a historically grown, heterogeneous network and not one unified approach to EDC, some of its features have contributed to its viability in the last 12 years and may be useful to consider for similar investigator-initiated networks.

  9. 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.

  10. Predicting cardiovascular intensive care unit readmission after cardiac surgery: derivation and validation of the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) cardiovascular intensive care unit clinical prediction model from a registry cohort of 10,799 surgical cases.

    PubMed

    van Diepen, Sean; Graham, Michelle M; Nagendran, Jayan; Norris, Colleen M

    2014-11-19

    In medical and surgical intensive care units, clinical risk prediction models for readmission have been developed; however, studies reporting the risks for cardiovascular intensive care unit (CVICU) readmission have been methodologically limited by small numbers of outcomes, unreported measures of calibration or discrimination, or a lack of information spanning the entire perioperative period. The purpose of this study was to derive and validate a clinical prediction model for CVICU readmission in cardiac surgical patients. A total of 10,799 patients more than or equal to 18 years in the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) registry who underwent cardiac surgery (coronary artery bypass or valvular surgery) between 2004 and 2012 and were discharged alive from the first CVICU admission were included. The full cohort was used to derive the clinical prediction model and the model was internally validated with bootstrapping. Discrimination and calibration were assessed using the AUC c index and the Hosmer-Lemeshow tests, respectively. A total of 479 (4.4%) patients required CVICU readmission. The mean CVICU length of stay (19.9 versus 3.3 days, P <0.001) and in-hospital mortality (14.4% versus 2.2%, P <0.001) were higher among patients readmitted to the CVICU. In the derivation cohort, a total of three preoperative (age ≥ 70, ejection fraction, chronic lung disease), two intraoperative (single valve repair or replacement plus non-CABG surgery, multivalve repair or replacement), and seven postoperative variables (cardiac arrest, pneumonia, pleural effusion, deep sternal wound infection, leg graft harvest site infection, gastrointestinal bleed, neurologic complications) were independently associated with CVICU readmission. The clinical prediction model had robust discrimination and calibration in the derivation cohort (AUC c index = 0.799; Hosmer-Lemeshow P = 0.192). The validation point estimates and confidence

  11. [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

  12. Differences in the Clinical Profile and Outcomes of Typical and Atypical Takotsubo Syndrome: Data From the International Takotsubo Registry.

    PubMed

    Ghadri, Jelena R; Cammann, Victoria L; Napp, L Christian; Jurisic, Stjepan; Diekmann, Johanna; Bataiosu, Dana Roxana; Seifert, Burkhardt; Jaguszewski, Milosz; Sarcon, Annahita; Neumann, Catharina A; Geyer, Verena; Prasad, Abhiram; Bax, Jeroen J; Ruschitzka, Frank; Lüscher, Thomas F; Templin, Christian

    2016-06-01

    Apical ballooning is broadly recognized as the classic form of takotsubo syndrome (TTS). Atypical subtypes of TTS also exist, which constitute about 20% of all cases. To date, clinical profile and course of atypical TTS types have rarely been studied. To characterize the clinical profile and outcomes of typical vs atypical types of TTS in a large patient cohort. Records of 1750 patients from the International Takotsubo Registry, comprising 26 participating cardiovascular centers in 9 different countries, were reviewed and data on clinical profile and outcomes collected from January 1, 2011, to December 31, 2014. Clinical characteristics and in-hospital as well as long-term outcomes were assessed. Of 1750 patients diagnosed with TTS between 1998 and 2014, a total of 1430 (81.7%) presented with apical TTS (defined as typical TTS) and 320 (18.3%) with midventricular, basal, or focal TTS (all defined as atypical TTS). Patients with atypical TTS were younger than those with typical TTS (mean [SD], 62.5 [13.3] vs 67.3 [12.9] years; P < .001). Brain natriuretic peptide levels on admission were lower (median factor increase of the upper limit of normal, 4.18 vs 6.59; P = .02) and left ventricular ejection fraction was higher (mean [SD], 43.4% [10.7%] vs 40.6% [12.0%]; P < .001) in patients with atypical than those with typical forms of TTS. ST-segment depression was more prevalent in patients with atypical TTS (31 of 286 [10.8%] vs 90 of 1292 [7.0%]; P = .03), while ST-segment elevation was found more frequently in patients with typical TTS (593 of 1292 [45.9%] vs 97 of 286 [33.9%]; P < .001). Patients with atypical TTS more often had neurologic disorders than those with typical TTS (81 of 274 [29.6%] vs 286 of 1251 [22.9%]; P = .02). While in-hospital mortality was comparable between patients with atypical and typical TTS (10 of 320 [3.1%] vs 62 of 1430 [4.3%]; P = .32), the atypical forms showed a favorable outcome at 1 year (P = .01

  13. 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

  14. Clinical features of CKD-MBD in Japan: cohort studies and registry.

    PubMed

    Hamano, Takayuki; Sakaguchi, Yusuke; Fujii, Naohiko; Isaka, Yoshitaka

    2017-03-01

    Randomized controlled trials (RCTs) are essential for evidence-based medicine; however, cohort studies and registries provide an important information about risk factors and, hence, shed light on the target of laboratory parameters. The uniqueness of the current Japanese CKD-MBD guidelines lies in the lower target range of intact parathyroid hormone levels than those used in other countries, which is based on analyses of the nationwide Japan Renal Data Registry. Cohort studies were also useful in exploring risk factors of renal outcome in predialysis patients. It was revealed that low vitamin D status (very prevalent in Japan) and high fibroblast growth factor 23 (FGF23) levels predict poor renal outcome. The reported association of FGF23 levels with left ventricular hypertrophy (LVH) and heart failure observed in cohort studies may support the idea of adding the 4th component of CKD-MBD, namely, "LVH" to the three original components. When it is not feasible to conduct RCTs regarding intervention, we have no choice but to rely on observational studies with sophisticated analysis methods, such as facility-level analysis and marginal structural model minimizing indication bias. Observational studies conducted in Japan revealed that the side effects of medications for CKD-MBD, resultant compliance, and effective doses in terms of hard outcome in Japanese patients were found to be different from those in other countries. For example, the MBD-5D study confirmed the benefit of cinacalcet in terms of mortality despite its median dose of only 25 mg/day. These data are very helpful for future guidelines specific to Japanese patients with CKD.

  15. [Neuroretinitis. Clinical cases].

    PubMed

    Valverde-Gubianas, M; Ramos-López, J F; López-Torres, J A; Toribio-García, M; Milla-Peñalver, C; Gálvez Torres-Puchol, J; Medialdea-Marcos, S

    2009-08-01

    Evaluate the etiology and the most frequent funduscopic alterations of the neuroretinitis. We present the case of a woman 24 years old with a bilateral decrease of visual sharpness (AV), painless and progressive, the funduscopic examination of which reveals a bilateral optical disc edema, with no hemorrhages or exudates, retina edema of the posterior pole and phlebitic areas. The systematic study was normal except for the hemogram (18,000/mm(3) leucocytes with 79% neutrophils) and the positive serology next to a Chlamydia. We also present the case of a 64 years old woman with a decrease of AV at the right eye of one week duration. At the back of the eye a macular star can be seen, and papilla edema. A systematic study gave normal results and positive serology at Bartonella henselae. The illness produced by a cat scratch is the most common cause of neuroretinitis. The customary findings are a loss of AV, discromatopsia, afferent papillary defects and abnormality on the visual field. Other frequent findings at the back of the eye are hemorrhagic nerve fibers, cotton-like exudates, papilla edema, macular star and glassy inflammation. The roll of antibiotic therapy is questionable. Oral ciprofloxacine seems to give good results.

  16. Use of a registry-generated audit, feedback, and patient reminder intervention in an internal medicine resident clinic--a randomized trial.

    PubMed

    Thomas, Kris G; Thomas, Matthew R; Stroebel, Robert J; McDonald, Furman S; Hanson, Gregory J; Naessens, James M; Huschka, Todd R; Kolars, Joseph C

    2007-12-01

    Disease registries, audit and feedback, and clinical reminders have been reported to improve care processes. To assess the effects of a registry-generated audit, feedback, and patient reminder intervention on diabetes care. Randomized controlled trial conducted in a resident continuity clinic during the 2003-2004 academic year. Seventy-eight categorical Internal Medicine residents caring for 483 diabetic patients participated. Residents randomized to the intervention (n = 39) received instruction on diabetes registry use; quarterly performance audit, feedback, and written reports identifying patients needing care; and had letters sent quarterly to patients needing hemoglobin A1c or cholesterol testing. Residents randomized to the control group (n = 39) received usual clinic education. Hemoglobin A1c and lipid monitoring, and the achievement of intermediate clinical outcomes (hemoglobin A1c <7.0%, LDL cholesterol <100 mg/dL, and blood pressure <130/85 mmHg) were assessed. Patients cared for by residents in the intervention group had higher adherence to guideline recommendations for hemoglobin A1c testing (61.5% vs 48.1%, p = .01) and LDL testing (75.8% vs 64.1%, p = .02). Intermediate clinical outcomes were not different between groups. Use of a registry-generated audit, feedback, and patient reminder intervention in a resident continuity clinic modestly improved diabetes care processes, but did not influence intermediate clinical outcomes.

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

    PubMed Central

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

    2014-01-01

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

  18. Varied spectrum of clinical presentation and mortality in a prospective registry of visceral leishmaniasis in a low endemicity area of Northern Italy

    PubMed Central

    2013-01-01

    Background Visceral Leishmaniasis (VL) is endemic in 88 countries, in areas of relatively low incidence with a relevant proportion of immune suppressed patients clinical presentation, diagnosis and management may present difficulties and pitfalls. Methods Demographic data, clinical, laboratory features and therapeutic findings were recorded in patients identified by a regional VL disease registry from January 2007 to December 2010. Results A total of 55 patients (36 adults mean age 48.7 years, 19 children median age 37.5 months) were observed presenting with 65 episodes. All childen were immunocompetent, whereas adults affected by VL included both immunocompetent (n°17) and immunesuppressed (n°19) patients. The clinical presentation was homogeneous in children with predominance of fever and hepato-splenomegaly. A wider spectrum of clinical presentations was observed in immunocompromised adults. Bone marrow detection of intracellular parasites (Giemsa staining) and serology (IFAT) were the most frequently used diagnostic tools. In addition, detection of urinary antigen was used in adult patients with good specificity (90%). Liposomal amphotericin B was the most frequently prescribed first line drug (98.2% of cases) with 100% clinical cure. VL relapses (n°10) represented a crucial finding: they occurred only in adult patients, mainly in immunocompromised patients (40% of HIV, 22% of non-HIV immunocompromised patients, 5,9% of immunocompetent patients). Furthermore, three deaths with VL were reported, all occurring in relapsing immunocompromised patients accounting for a still high overall mortality in this group (15.8%). Conclusions The wide spectrum of clinical presentation in immunesuppresed patients and high recurrence rates still represent a clinical challenge accounting for high mortality. Early clinical identification and satisfactory treatment performance with liposomal amphotericin B are confirmed in areas with low-level endemicity and good clinical

  19. 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

  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. MERGING VETERANS AFFAIRS RHEUMATOID ARTHRITIS REGISTRY AND PHARMACY DATA TO ASSESS METHOTREXATE ADHERENCE AND DISEASE ACTIVITY IN CLINICAL PRACTICE

    PubMed Central

    Cannon, Grant W; Sauer, Brian C; Hayden, Candace L; Ying, Jian; Curtis, Jeffrey R; Reimold, Andreas M; Caplan, Liron; Kerr, Gail S; Richards, J Steuart; Johnson, Dannette S; Mikuls, Ted R

    2017-01-01

    Objective The Veterans Affairs Rheumatoid Arthritis (VARA) registry and the VA Pharmacy Benefits Management (PBM) database were linked to determine the association of methotrexate (MTX) adherence with RA disease activity. Methods For each patient, the medication possession ratio (MPR) was calculated for the first episode of MTX exposure of ≥12 weeks duration for both new and established MTX users. High MTX adherence was defined as an MPR ≥0.80 and low MTX adherence <0.80. For each patient, the mean DAS28, ESR, and CRP observed during registry follow-up were compared in high versus low adherence groups. Results In 455 RA patients, the prescribed doses of MTX (16±4mg versus 16±4mg, p=0.6) were similar in high adherence patients (n=370) in comparison to low adherence patients (n=85). However, the actual observed MTX doses taken by patients were significantly higher in the high adherence group (16±5mg versus 11±3mg, p<0.001). DAS28 (3.6±1.2 versus 3.9±1.5, p<0.02), ESR (24±18 versus 29±24, p= 0.05) and CRP (1.2±1.3 versus 1.6±1.5, p<0.03) were lower in the high adherence group compared to those with low MTX adherence. These variances were not explained by differences in baseline demographic features, concurrent treatments, or whether MTX was initiated before or after VARA enrollment. Conclusion High MTX adherence was associated with improved clinical outcomes in RA patients treated with MTX. Adjustment for potential confounders did not alter the estimated effect of adherence. These results demonstrate the advantages of being able to merge clinical observations with pharmacy databases to evaluate anti-rheumatic drugs in clinical practice. PMID:21905260

  2. 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

  3. Case-control study of lung function in World Trade Center Health Registry area residents and workers.

    PubMed

    Friedman, Stephen M; Maslow, Carey B; Reibman, Joan; Pillai, Parul S; Goldring, Roberta M; Farfel, Mark R; Stellman, Steven D; Berger, Kenneth I

    2011-09-01

    Residents and area workers who inhaled dust and fumes from the World Trade Center disaster reported lower respiratory symptoms in two World Trade Center Health Registry surveys (2003-2004 and 2006-2007), but lung function data were lacking. To examine the relationship between persistent respiratory symptoms and pulmonary function in a nested case-control study of exposed adult residents and area workers 7-8 years after September 11, 2001. Registrants reporting post September 11th onset of a lower respiratory symptom in the first survey and the same symptom in the second survey were solicited as potential cases. Registrants without lower respiratory symptoms in either Registry survey were solicited as potential control subjects. Final case-control status was determined by lower respiratory symptoms at a third interview (the study), when spirometry and impulse oscillometry were also performed. We identified 180 cases and 473 control subjects. Cases were more likely than control subjects to have abnormal spirometry (19% vs. 11%; P < 0.05), and impulse oscillometry measurements of elevated airway resistance (R5; 68% vs. 27%; P < 0.0001) and frequency dependence of resistance (R₅₋₂₀; 36% vs. 7%; P < 0.0001). When spirometry was normal, cases were more likely than control subjects to have elevated R₅ and R₅₋₂₀ (62% vs. 25% and 27% vs. 6%, respectively; both P < 0.0001). Associations between symptoms and oscillometry held when factors significant in bivariate comparisons (body mass index, spirometry, and exposures) were analyzed using logistic regression. This study links persistent respiratory symptoms and oscillometric abnormalities in World Trade Center-exposed residents and area workers. Elevated R₅ and R₅₋₂₀ in cases despite normal spirometry suggested distal airway dysfunction as a mechanism for symptoms.

  4. Definition, epidemiology and registries of pulmonary hypertension.

    PubMed

    Awdish, R; Cajigas, H

    2016-05-01

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

  5. 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

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

    PubMed

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

    2016-11-23

    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. 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. 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. 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  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. [The European Registry of Cataract Surgery Outcomes: Clinic of Ophthalmology, Kaunas University of Medicine].

    PubMed

    Jasinskas, Vytautas; Zemaitiene, Reda; Kusleika, Saulius; Miniauskiene, Goda; Acas, Saulius

    2002-01-01

    Evaluate the outcome of cataract surgery in Clinic of Ophthalmology, Kaunas University of Medicine (COKUM) and to compare it with the outcome of the European Cataract Outcome Study Group (ECOSG) data. The study was started on the 1st of October, 2000 and ended on the 30th April, 2001 on the basis of the protocol of the European Cataract Outcome Study Group. Every patient at each participating unit having surgery during the first study month was evaluated. The study was closed 6 months after surgery. The study enroled 3944 patients, out of them 361 was from COKUM. The mean induced astigmatism was 0.86+/-0.21 D in COKUM and 0.63+/-0.23 D in ECOSG. The visual acuity of the operated eye was 0.3 or lower in 28.1 percent of patients, 0.4-0.7 in 31.7 percent and 0.8 or higher in 40.2 percent of COKUM patients in the whole study group percentages were 11.8, 27.6 and 60.6, respectively. 44.3 percent of COKUM patients; underwent phacoemulsiphication, while among ECOSG this procedure was the most common (91.8 percent). The number of complications during surgery was 5.5 percent of all cases in COKUM while in European countries it was 3.7 percent. Cataract surgery data collected from 39 units in 18 European countries allowed participants to compare their performance with that of colleagues in an anonymous manner. This study is also an indicator of cataract surgery development in COKUM and in Lithuania.

  9. Clinical epidemiology in Italian Registry of Infective Endocarditis (RIEI): Focus on age, intravascular devices and enterococci.

    PubMed

    Cecchi, Enrico; Chirillo, Fabio; Castiglione, Anna; Faggiano, Pompilio; Cecconi, Moreno; Moreo, Antonella; Cialfi, Alessandro; Rinaldi, Mauro; Del Ponte, Stefano; Squeri, Angelo; Corcione, Silvia; Canta, Francesca; Gaddi, Oscar; Enia, Francesco; Forno, Davide; Costanzo, Piera; Zuppiroli, Alfredo; Ronzani, Giuliana; Bologna, Flavio; Patrignani, Anna; Belli, Riccardo; Ciccone, Giovannino; De Rosa, Francesco Giuseppe

    2015-01-01

    The epidemiology of infective endocarditis (IE) is changing due to a number of factors, including aging and health related comorbidities and medical procedures. The aim of this study is to describe the main clinical, epidemiologic and etiologic changes of IE from a large database in Italy. We prospectively collected episodes of IE in 17 Italian centers from July 2007 to December 2010. We enrolled 677 patients with definite IE, of which 24% health-care associated. Patients were male (73%) with a median age of 62 years (IQR: 49-74) and 61% had several comorbidities. One hundred and twenty-eight (19%) patients had prosthetic left side IE, 391 (58%) native left side IE, 94 (14%) device-related IE and 54 (8%) right side IE. A predisposing cardiopathy was present in 50%, while odontoiatric and non odontoiatric procedures were reported in 5% and 21% of patients respectively. Symptoms were usually atypical and precocious. The prevalent etiology was represented by Staphylococcus aureus (27%) followed by coagulase-negative staphylococci (CNS, 21%), Streptococcus viridans (15%) and enterococci (14%). CNS and enterococci were relatively more frequent in patients with intravascular devices and prosthesis and S. viridans in left native valve. Diagnosis was made by transthoracic and transesophageal echocardiography in 62% and 94% of cases, respectively. The in-hospital mortality was 14% and 1-year mortality was 21%. The epidemiology is changing in Italy, where IE more often affects older patients with comorbidities and intravascular devices, with an acute onset and including a high frequency of enterococci. There were few preceding odontoiatric procedures. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Comparison of hospital variation in acute myocardial infarction care and outcome between Sweden and United Kingdom: population based cohort study using nationwide clinical registries.

    PubMed

    Chung, Sheng-Chia; Sundström, Johan; Gale, Chris P; James, Stefan; Deanfield, John; Wallentin, Lars; Timmis, Adam; Jernberg, Tomas; Hemingway, Harry

    2015-08-07

    To assess the between hospital variation in use of guideline recommended treatments and clinical outcomes for acute myocardial infarction in Sweden and the United Kingdom. Population based longitudinal cohort study using nationwide clinical registries. Nationwide registry data comprising all hospitals providing acute myocardial infarction care in Sweden (SWEDEHEART/RIKS-HIA, n=87; 119,786 patients) and the UK (NICOR/MINAP, n=242; 391,077 patients), 2004-10. Between hospital variation in 30 day mortality of patients admitted with acute myocardial infarction. Case mix standardised 30 day mortality from acute myocardial infarction was lower in Swedish hospitals (8.4%) than in UK hospitals (9.7%), with less variation between hospitals (interquartile range 2.6% v 3.5%). In both countries, hospital level variation and 30 day mortality were inversely associated with provision of guideline recommended care. Compared with the highest quarter, hospitals in the lowest quarter for use of primary percutaneous coronary intervention had higher volume weighted 30 day mortality for ST elevation myocardial infarction (10.7% v 6.6% in Sweden; 12.7% v 5.8% in the UK). The adjusted odds ratio comparing the highest with the lowest quarters for hospitals' use of primary percutaneous coronary intervention was 0.70 (95% confidence interval 0.62 to 0.79) in Sweden and 0.68 (0.60 to 0.76) in the UK. Differences in risk between hospital quarters of treatment for non-ST elevation myocardial infarction and secondary prevention drugs for all discharged acute myocardial infarction patients were smaller than for reperfusion treatment in both countries. Between hospital variation in 30 day mortality for acute myocardial infarction was greater in the UK than in Sweden. This was associated with, and may be partly accounted for by, the higher practice variation in acute myocardial infarction guideline recommended treatment in the UK hospitals. High quality healthcare across all hospitals, especially

  11. [MICROSCOPIC COLITIS: THE CLINICAL CASE].

    PubMed

    Kulygina, Y A; Skalinskaya, M I; Ageeva, T A

    2015-01-01

    During past years incidence and prevalence of microscopic colitis (MC) have increased, that is possible caused to the improvement of knowledge of doctors about the disease. This article contain modern views on epidemiology, diagnostic and variant of microscopic colitis treatment. A typical clinical picture of MC in the form of recurrent a watery diarrhea, with the absence of pathologic changes at roentgenologic and endoscopic investigations is described with the example of a clinical case.

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

    PubMed

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

    2016-10-01

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

  13. Clinical characteristics and outcome of inpatients versus outpatients with venous thromboembolism: findings from the RIETE Registry.

    PubMed

    Maestre, Ana; Sánchez, Rosario; Rosa, Vladimir; Aujesky, Drahomir; Lorenzo, Alicia; Barillari, Giovanni; Monreal, Manuel

    2010-10-01

    Patients with venous thromboembolism (VTE) treated with anticoagulants are at risk of death from pulmonary embolism (PE) and/or bleeding. However, whether patients who develop VTE in hospital have a higher complication rate than those who develop VTE in an outpatient setting is unclear. RIETE is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic VTE. We compared the 3-month incidence of fatal PE and fatal bleeding in patients in whom the VTE had developed while in hospital for another medical condition (inpatients) with those who presented to the emergency ward because of VTE (outpatients). Up to April 2008, 22,133 patients with acute VTE were enrolled: 10,461 (47%) presented with PE, 11,672 with deep vein thrombosis. Overall, 6445 (29%) were inpatients. During the study period, those who developed VTE as inpatients had a significantly higher incidence of fatal PE (2.1% vs. 1.5%; odds ratio: 1.4; 95% CI: 1.1-1.7), overall death (7.0% vs. 5.4%; odds ratio: 1.3; 95% CI: 1.2-1.5), and major bleeding (2.9% vs. 2.1%; odds ratio: 1.4; 95% CI: 1.1-1.6) than outpatients. The incidence of fatal bleeding was not significantly increased (0.7% vs. 0.5%; odds ratio: 1.2; 95% CI: 0.9-1.8). In multivariable analysis, inpatient status was significantly associated with a higher risk for fatal PE (odds ratio: 1.3; 95% CI: 1.1-1.7). VTE occurring in hospitalized patients carries a significantly higher risk for death of PE than in outpatients, underscoring the importance of VTE prevention strategies in the hospital setting. Copyright (c) 2010 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  14. 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

  15. [Pericardial hydatidosis. A clinical case].

    PubMed

    Răutu, F; Manolache, C; Nistor, S

    1993-01-01

    We present a case of intrapericardial hydatidosis in a 56 year old man. The clinical and paraclinical investigations revealed a tumoral structure which is localised in the right costo-phrenic sinus without stating precisely the etiology and localisation of the tumoral structure. The thoracotomy points out the multilocularis intrapericardial hydatidosis, that was surgically solved. The case is very important by the rare occurrence, the diagnosis difficulties and surgical treatment.

  16. Clinical characteristics, management, and outcomes of acute heart failure patients: observations from the Gulf acute heart failure registry (Gulf CARE).

    PubMed

    Sulaiman, Kadhim; Panduranga, Prashanth; Al-Zakwani, Ibrahim; Alsheikh-Ali, Alawi A; AlHabib, Khalid F; Al-Suwaidi, Jassim; Al-Mahmeed, Wael; AlFaleh, Hussam; Elasfar, Abdelfatah; Al-Motarreb, Ahmed; Ridha, Mustafa; Bulbanat, Bassam; Al-Jarallah, Mohammed; Bazargani, Nooshin; Asaad, Nidal; Amin, Haitham

    2015-04-01

    The purpose of this study was to describe the clinical characteristics, management, and outcomes of acute heart failure (HF) patients from the Gulf acute heart failure registry (Gulf CARE). Data from 5005 HF patients admitted to 47 hospitals in seven Gulf countries during February to November 2012 were analysed. Fifty-five per cent of patients presented with acute decompensated chronic HF, while 45% had new-onset HF. Mean age was 59 ± 15 years, 63% were males, and 83% were Gulf citizens. Co-morbid conditions were hypertension (61%), diabetes mellitus (50%), CAD (47%), and atrial fibrillation or flutter (14%). The median LVEF was 35% (25-45%) with 69% presenting as HF with reduced EF (HFrEF). CAD was the most prevalent aetiology (53%) followed by idiopathic cardiomyopathy (18%), hypertensive heart disease (16%), and valvular heart disease (9%). At discharge, 71% and 78% of patients received beta-blockers and ACE inhibitors/ARBs, respectively. Use of coronary intervention and device therapy was <10%. In-hospital mortality was 6.3%. Re-hospitalization and cumulative mortality at 3 and 12 months were 18%/13% and 40%/20%, respectively. Gulf CARE results show that patients from this region are a decade younger than their Western counterparts, with a high prevalence of diabetes and HFrEF, and a lower prevalence of AF. Use of coronary intervention and device therapy was low, with high re-hospitalization rates. Short- and long-term mortality rates were similar to those of Western registries, but should be interpreted in the light of the younger age of Gulf CARE patients. © 2015 The Authors. European Journal of Heart Failure © 2015 European Society of Cardiology.

  17. [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.

  18. Exclusion of older patients from ongoing clinical trials for hematological malignancies: an evaluation of the National Institutes of Health Clinical Trial Registry.

    PubMed

    Hamaker, Marije E; Stauder, Reinhard; van Munster, Barbara C

    2014-10-01

    Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function restrictions was noted in 51%. One-third of the studies that excluded older patients based on age allowed inclusion of younger patients with poor performance status; 8% did not place any restrictions on organ function. Over time, there was a shift from exclusion based on age (p value for trend <.001) toward exclusion based on organ function (p = .2). Industry-sponsored studies were least likely to exclude older patients (p < .001). Notably, 27% of currently recruiting clinical trials for hematological malignancies use age-based exclusion criteria. Although physiological reserves diminish with age, the heterogeneity of the elderly population does not legitimize exclusion based on chronological age alone. Investigators should critically review whether sufficient justification exists for every exclusion criterion before incorporating it in trial protocols. ©AlphaMed Press.

  19. Clinical profile of 266 Filipino patients with rheumatoid arthritis included in the rheumatoid arthritis database and registry (RADAR) of the Philippine General Hospital.

    PubMed

    Penserga, Ester G; Natividad, Therese Aileen L; Salido, Evelyn S

    2015-05-01

    To describe Filipino patients with rheumatoid arthritis (RA) entered in the Rheumatoid arthritis database and registry (RADAR) of the Philippine General Hospital. Cases entered to RADAR from 2010-2012 were included. All fulfilled the 1987 American College of Rheumatology criteria for classification of RA. Included cases gave written infomed consent. Data extracted were demographics, clinical presentation, laboratory tests, treatment and disease course. Means and proportions were used for population characteristics. Two hundred and sixty-six cases were included. Mean age was 44 years, with 9 : 1 female preponderance and mean diagnosis time of 5 years. There was symmetrical polyarthritis with high tender and swollen joint count and mean Disease Activity Score of 28 joints, erythrocyte sedimentation rate of 5.27 (3.39, 8.13). Rheumatoid factor was positive in 2/3 of cases. Hypertension, tuberculosis and diabetes were important co-morbidities. Treatment included prednisone, non-steroidal anti-inflammatory drugs and methotrexate. At 12 months of treatment, evaluable cases (< 20%) showed improvement from high to moderate disease activity. Methotrexate average dose was 8.6 mg/week. Nine cases received biologic agents. Factors affecting treatment included access to rheumatology centers, low socioeconomic status, presence of co-morbid diseases and treatment adverse events. This study reports a cohort of Filipino RA patients seen in a government arthritis unit whose disease characteristics are similar to what is reported worldwide. This cohort differs from most studies in having a high female to male ratio, a long delay in diagnosis, and high attrition rate. Mean methotrexate dose was low and there was less access to biologic disease-modifying anti-rheumatic drugs. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

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

    PubMed

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

    2013-01-01

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

  1. 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.

  2. Detecting dissonance in clinical and research workflow for translational psychiatric registries.

    PubMed

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

    2013-01-01

    The interplay between the workflow for clinical tasks and research data collection is often overlooked, ultimately making it ineffective. 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. 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. 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. 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.

  3. 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

  4. Temporal Trends in Clinical Outcome After Percutaneous Coronary Intervention 1984-2010 - Report From the Juntendo PCI Registry.

    PubMed

    Naito, Ryo; Miyauchi, Katsumi; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Dohi, Tomotaka; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Isoda, Kikuo; Daida, Hiroyuki

    2016-01-01

    Since the introduction of PCI in 1977, it has evolved along with advances in the technology, improvement in operator technique and establishment of medical therapy. However, little is known of the improvement in clinical outcome following PCI. Data from the Juntendo PCI Registry during 1984-2010 were analyzed. The patients were divided into 3 groups according to date of index PCI: POBA era, January 1984-December 1997; BMS era, January 1998-July 2004; and DES era, August 2004-February 2010. The primary endpoint was a composite of MACE including all-cause mortality, non-fatal MI, non-fatal stroke and revascularization. A total of 3,831 patients were examined (POBA era, n=1,147; BMS era, n=1,180; DES era, n=1,504). Mean age was highest in the DES era. The prevalence of diabetes and hypertension was higher in the DES and BMS eras than in the POBA era. Unadjusted cumulative event-free survival rate for 2-year MACE was significantly different across the 3 eras. Adjusted relative risk reduction for 2-year MACE was 56% in the DES era and 34% in the BMS era, both compared with the POBA era. Age, ACS, and LVEF were associated with the incidence of MACE. Clinical outcome of PCI improved across the 26-year study period, despite the higher patient risk profile in the recent era.

  5. First Sociodemographic, Pretreatment and Clinical Data from a German Web-Based Registry for Child and Adolescent Anorexia Nervosa.

    PubMed

    Bühren, Katharina; Herpertz-Dahlmann, Beate; Dempfle, Astrid; Becker, Katja; Egberts, Karin M; Ehrlich, Stefan; Fleischhaker, Christian; von Gontard, Alexander; Hahn, Freia; Jaite, Charlotte; Kaess, Michael; Legenbauer, Tanja; Renner, Tobias J; Schrötter, Ellen; Schulze, Ulrike; Sinzig, Judith; Antony, Gisela; Hebebrand, Johannes; Föcker, Manuel

    2017-09-01

    The first web-based registry for childhood and adolescent anorexia nervosa (AN) in Germany was established to systematically collect demographic and clinical data. These data as well as information on how young individuals with AN can find access to healthcare services are presented. Patients´ data from child and adolescent psychiatry departments of 12 university hospitals and two major nonuniversity hospitals in Germany were collected between January 2015 and December 2016. All patients met the ICD-10 diagnostic criteria for (atypical) AN. Sociodemographic data, type and amount of healthcare utilization before admission, and clinical data at admission and discharge were compiled. 258 patients with a mean age of 14.7 years and a mean BMI at admission of 15.3 kg/m(2) were included. The parents and patients had a higher educational level than the general German population. More than 80 % of the patients reported having utilized healthcare before hospitalization. The mean duration of outpatient treatment before hospitalization was 7 months. There seem to be major barriers to specialist treatment for young patients with AN in Germany, which should be analyzed in future studies.

  6. Relation between chelation and clinical outcomes in lower-risk patients with myelodysplastic syndromes: Registry analysis at 5 years.

    PubMed

    Lyons, Roger M; Marek, Billie J; Paley, Carole; Esposito, Jason; McNamara, Katie; Richards, Paul D; DiBella, Nicholas; Garcia-Manero, Guillermo

    2017-05-01

    Prospective data are needed to ascertain the impact of iron chelation therapy in patients with myelodysplastic syndromes. The present 5-year prospective registry analysis was conducted to compare clinical outcomes between chelated and nonchelated patients with lower-risk myelodysplastic syndromes and transfusional iron overload. In an interim analysis at 24 months, we previously reported that chelation therapy was associated with longer median overall survival and a tendency toward longer leukemia-free survival and fewer cardiac events. In the present report, we detail findings from the final analysis at 5 years. We confirm, at the conclusion of this 5-year, prospective, non-interventional study, that overall survival was significantly longer in patients who received iron chelation therapy vs those who did not. Causes of death in the overall population were predominantly myelodysplastic syndromes/acute myeloid leukemia followed by cardiac disease. Time to progression to acute myeloid leukemia was also significantly longer in patients receiving chelation therapy, and significantly fewer patients progressed to leukemia vs those not receiving chelation therapy. Limitations of the study include a potential for clinical bias, as patients with longer predicted survival may have been chosen for chelation therapy, the differences present in concomitant conditions at baseline, and the possibility that some high-risk patients were not identified due to limited cytogenetic classification. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. 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

  8. Midterm clinical outcome following Edwards SAPIEN or Medtronic Corevalve transcatheter aortic valve implantation (TAVI): Results of the Belgian TAVI registry.

    PubMed

    Collas, Valérie M; Dubois, Christophe; Legrand, Victor; Kefer, Joëlle; De Bruyne, Bernard; Dens, Jo; Rodrigus, Inez E; Herijgers, Paul; Bosmans, Johan M

    2015-09-01

    To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV). Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid- and long term clinical outcome data, coming from large "real world" national registries, remains contributive. Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n = 460), while 12 exclusively used CoreValve THV (n = 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk). Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P = 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P = 0.45; intermediate risk: 62% vs. 59%, P = 0.94; high risk: 48% vs. 53%, P = 0.65). Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve. © 2015 Wiley Periodicals, Inc.

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

    PubMed Central

    2013-01-01

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

  10. 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.

  11. 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

  12. [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.

  13. 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.

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

    PubMed

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

    2014-07-01

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

  15. Analysis of stage and clinical/prognostic factors for colon and rectal cancer from SEER registries: AJCC and collaborative stage data collection system.

    PubMed

    Chen, Vivien W; Hsieh, Mei-Chin; Charlton, Mary E; Ruiz, Bernardo A; Karlitz, Jordan; Altekruse, Sean F; Ries, Lynn A G; Jessup, J Milburn

    2014-12-01

    The Collaborative Stage (CS) Data Collection System enables multiple cancer registration programs to document anatomic and molecular pathology features that contribute to the Tumor (T), Node (N), Metastasis (M) - TNM - system of the American Joint Committee on Cancer (AJCC). This article highlights changes in CS for colon and rectal carcinomas as TNM moved from the AJCC 6th to the 7th editions. Data from 18 Surveillance, Epidemiology, and End Results (SEER) population-based registries were analyzed for the years 2004-2010, which included 191,361colon and 73,341 rectal carcinomas. Overall, the incidence of colon and rectal cancers declined, with the greatest decrease in stage 0. The AJCC's 7th edition introduction of changes in the subcategorization of T4, N1, and N2 caused shifting within stage groups in 25,577 colon and 10,150 rectal cancers diagnosed in 2010. Several site-specific factors (SSFs) introduced in the 7th edition had interesting findings: 1) approximately 10% of colon and rectal cancers had tumor deposits - about 30%-40% occurred without lymph node metastases, which resulted in 2.5% of colon and 3.3% of rectal cases becoming N1c (stage III A/B) in the AJCC 7th edition; 2) 10% of colon and 12% of rectal cases had circumferential radial margins <1 mm; 3) about 46% of colorectal cases did not have a carcinoembryonic antigen (CEA) testing or documented CEA information; and 4) about 10% of colorectal cases had perineural invasion. Adoption of the AJCC 7th edition by the SEER program provides an assessment tool for staging and SSFs on clinical outcomes. This evidence can be used for education and improved treatment for colorectal carcinomas. © 2014 American Cancer Society.

  16. Analysis of Stage and Clinical/Prognostic Factors for Colon and Rectal Cancer from SEER Registries: AJCC and Collaborative Stage Data Collection System

    PubMed Central

    Chen, Vivien W.; Hsieh, Mei-Chin; Charlton, Mary E.; Ruiz, Bernardo A.; Karlitz, Jordan; Altekruse, Sean; Ries, Lynn A.; Jessup, J. Milburn

    2014-01-01

    Background The Collaborative Stage (CS) Data Collection System enables multiple cancer registration programs to document anatomic and molecular pathology features that contribute to the Tumor (T), Node (N), Metastasis (M) (TNM) system of the American Joint Committee on Cancer (AJCC). This chapter highlights changes in CS for colon and rectal carcinomas as TNM moved from the AJCC 6th to the 7th edition. Methods Data from 18 Surveillance, Epidemiology, and End Results (SEER) population-based registries were analyzed for the years 2004-2010, which included 191 361colon and 73 341 rectal carcinomas. Results Overall, the incidence of colon and rectal cancer declined, with the greatest decrease in stage 0. The AJCC's 7th edition introduction of changes in the subcategorization of T4, N1, and N2 caused shifting within stage groups in 25 577 colon and 10 150 rectal cancers diagnosed in 2010. Several site-specific factors (SSFs) introduced in the 7th edition had interesting findings: 1) approximately 10% of colon and rectal cancers had tumor deposits - about 30-40% occurred without lymph node metastases which resulted in 2.5% of colon and 3.3% of rectal cases becoming N1c (stage III A/B) in AJCC 7th edition ; 2) 10% of colon and 12% of rectal cases had circumferential radial margins <1 mm; 3) about 46% of colorectal cases did not have a CEA testing or documented CEA information; and 4) about 10% of colorectal cases had perineural invasion. Conclusion Adoption of AJCC 7th edition by the SEER Program provides an assessment tool for staging and SSFs on clinical outcomes. This evidence can be used for education and improved treatment for colorectal carcinomas. PMID:25412391

  17. 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

  18. Is There Evidence for Systematic Upcoding of ASA Physical Status Coincident with Payer Incentives? A Regression Discontinuity Analysis of the National Anesthesia Clinical Outcomes Registry.

    PubMed

    Schonberger, Robert B; Dutton, Richard P; Dai, Feng

    2016-01-01

    demonstrated the ability to detect deliberate upcoding occurring at rates exceeding 2% of eligible cases of patients younger than 65 years. We found no evidence for a significant discontinuity in the pattern of ASA physical status scores coincident with Medicare eligibility at age 65 years for the nondeferrable conditions of hip, femur, or lower leg fracture repair. Our data do not support the presence of fraudulent ASA physical status scoring among National Anesthesia Clinical Outcomes Registry contributors. If deliberate upcoding of ASA physical status scores is present in our data, the behavior is either too rare or too insensitive to the removal of payer incentives at age 65 years to be evident in the present analysis.

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

    PubMed

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

    2014-12-01

    To evaluate the genetic findings, demographic features and clinical presentation of tumour necrosis factor receptor-associated autoinflammatory syndrome (TRAPS) in patients from the Eurofever/EUROTRAPS international registry. A web-based registry collected retrospective data on patients with TNFRSF1A sequence variants and inflammatory symptoms. Participating hospitals included paediatric rheumatology centres and adult centres with a specific interest in autoinflammatory diseases. Cases were independently validated by experts in the disease. Complete information on 158 validated patients was available. The most common TNFRSF1A variant was R92Q (34% of cases), followed by T50M (10%). Cysteine residues were disrupted in 27% of cases, accounting for 39% of sequence variants. A family history was present in 19% of patients with R92Q and 64% of those with other variants. The median age at which symptoms began was 4.3 years but 9.1% of patients presented after 30 years of age. Attacks were recurrent in 88% and the commonest features associated with the pathogenic variants were fever (88%), limb pain (85%), abdominal pain (74%), rash (63%) and eye manifestations (45%). Disease associated with R92Q presented slightly later at a median of 5.7 years with significantly less rash or eye signs and more headaches. Children were more likely than adults to present with lymphadenopathy, periorbital oedema and abdominal pains. AA amyloidosis has developed in 16 (10%) patients at a median age of 43 years. In this, the largest reported case series to date, the genetic heterogeneity of TRAPS is accompanied by a variable phenotype at presentation. Patients had a median 70 symptomatic days a year, with fever, limb and abdominal pain and rash the commonest symptoms. Overall, there is little evidence of a significant effect of age or genotype on disease features at presentation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  20. 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.

  1. Prostate cancer clinical presentation, incidence, mortality and survival in Guadeloupe over the period 2008-2013 from a population-based cancer registry.

    PubMed

    Deloumeaux, J; Bhakkan, B; Eyraud, R; Braud, F; Manip M'Ebobisse, N; Blanchet, P; Brureau, L

    2017-09-18

    The Caribbean population of Guadeloupe has one of the highest incidence rates of prostate cancer worldwide. In 2008, a population-based cancer registry was set up for the monitoring of cancer incidence in the aftermath of the environmental pollution with chlordecone, a persistent organochlorine insecticide formerly used in banana plantations. We describe the clinical presentation, incidence, mortality and survival of prostate cancer for the period 2008-2013. The Guadeloupe cancer registry has been routinely collecting all incident cases of cancer since 2008. We compared age-specific incidence rates between different populations, and calculated incidence and mortality rates standardized to the world population. Kaplan-Meier observed survival and estimated age-standardized net survival were calculated by category for age, PSA level, and Gleason score using the Pohar-Perme method. Overall, 3,295 cases of prostate cancer were recorded. World-standardized incidence and mortality were respectively 184.1 [177.8-190.4] and 23.9 [21.9-25.7] per 100,000 person-years. At diagnosis, the mean age of patients was 68 ± 9.6 years old and 22% were aged over 75. Median PSA level was 8.9 [IQR: 6.0-16.0] and 13.6% of the patients had a Gleason ≥ 8. Five-year observed and net survivals were, respectively, 79.6% [77.9-81.2] and 90.7% [88.6-92.8]. The incidence of prostate cancer in Guadeloupe is among the highest in the world, along with those of the neighboring Caribbean countries and US African-Americans. We observed no decrease in incidence rates, and a decreasing but non-significant trend in mortality rates, which nonetheless remain higher than in high-income countries. Many Genome-Wide Association Studies are conducted to identify genetic markers involved in prostate cancer risk. In the Caribbean, complementary studies on both lifestyle and behavioral factors should highlight potential common risks among populations who share both genetic and environmental

  2. 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

  3. 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

  4. Severe Hypoglycemia and Diabetic Ketoacidosis among Youth with Type 1 Diabetes in the T1D Exchange Clinic Registry

    PubMed Central

    Cengiz, Eda; Xing, Dongyuan; Wong, Jenise C.; Wolfsdorf, Joseph I.; Haymond, Morey W.; Rewers, Arleta; Shanmugham, Satya; Tamborlane, William V.; Willi, Steven M.; Seiple, Diane L.; Miller, Kellee M.; DuBose, Stephanie N.; Beck, Roy W.

    2014-01-01

    Objective Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) are common serious acute complications of type 1 diabetes (T1D). The aim of this study was to determine the frequency of SH and DKA and identify factors related to their occurrence in the T1D Exchange pediatric and young adult cohort. Research Design and Methods The analysis included 13,487 participants in the T1D Exchange clinic registry aged 2-<26 years with T1D ≥2 years. Separate logistic regression models were used to evaluate the association of baseline demographic and clinical factors with the occurrence of SH or DKA in the prior 12 months. Results Non-White race, no private health insurance and lower household income were associated with higher frequencies of both SH and DKA (p<0.001). SH frequency was highest in children <6 years old (p=0.005), but across the age range, SH was not associated with HbA1c levels after controlling for other factors (p=0.72). DKA frequency was highest in adolescents (p<0.001) and associated with higher HbA1c (p<0.001). Conclusions Our data show that poor glycemic control increases the risk of DKA but does not protect against severe hypoglycemia in youth and young adults with type 1 diabetes. The high frequencies of SH and DKA observed in disadvantaged minorities with T1D highlight the need for targeted interventions and new treatment paradigms for patients in these high risk groups. PMID:23469984

  5. 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

  6. Correlates of overweight and obesity in 5529 adolescents with type 1 diabetes: The T1D Exchange Clinic Registry.

    PubMed

    Minges, Karl E; Whittemore, Robin; Weinzimer, Stuart A; Irwin, Melinda L; Redeker, Nancy S; Grey, Margaret

    2017-04-01

    To describe the prevalence of overweight and obesity in adolescents with type 1 diabetes (T1D) and to examine the associations among socio-demographic, clinical, and self-management factors by weight status. We analyzed baseline data obtained from 5529 adolescents with T1D (mean age=15.4±1.4years, 51.8% male, 77.9% white, mean HbA1c=8.7±1.8%; 72mmol/mol) from the T1D Exchange Clinic Registry. We examined correlates of weight status using multinomial logistic regression analyses. Overweight (22.9%) and obesity (13.1%) were prevalent in the overall sample and was highest among girls (40.8%) and adolescents of Hispanic/Latino race/ethnicity (46.1%). Female gender, older age, annual household income <$35,000 (vs. ≥$200,000), high school parental educational attainment (vs. ≥graduate degree), lower HbA1c, longer duration of T1D, higher amount of insulin, and a recent visit with an allied healthcare provider were independently and significantly associated with higher odds of overweight or obesity. Adolescents who self-rated their health as fair/poor (vs. excellent) had the highest odds of obesity (OR 3.92, 95% CI 2.53-6.06). Overweight/obesity is prevalent among adolescents with T1D, especially among girls and those of diverse race/ethnicity. Some of these factors may be amenable to remediation and point to subgroups that can benefit from obesity prevention and management efforts. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. 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.

  8. 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.

  9. [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.

  10. 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

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

    PubMed

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

    2014-09-01

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

  12. 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.

  13. Establishing a Canadian registry of patients with amyotrophic lateral sclerosis.

    PubMed

    Korngut, L; Genge, A; Johnston, M; Benstead, T; Bourque, P; Briemberg, H; Casey, A; D'Amour, M; Dupré, N; Figlewicz, D; Hader, W; Johnston, W; Kalra, S; Melanson, M; O'Connell, C; Rouleau, G; Shoesmith, C; Wee, J; Zinman, L

    2013-01-01

    Amyotrophic lateral sclerosis (ALS) is a devastating cause of progressive weakness, respiratory failure and death. To date there is no effective therapy to meaningfully extend survival but continuously emerging targets and putative treatments are studied in clinical trials. Canadian epidemiological data on ALS is scarce and the socioeconomic impact of ALS on Canadian society is unclear. The Canadian Neuromuscular Disease Registry (CNDR) is a national clinic-based registry of patients with neuromuscular diseases with the goal of facilitating the design and execution of clinical research. We conducted a national stakeholder survey to assess interest for a Canadian ALS registry and an assessment of expected case ascertainment. A dataset derivation meeting was held to establish the registry medical dataset. We report the results of the national stakeholder survey, case ascertainment assessment, and the derived dataset that have resulted in the current implementation of a Canadian registry of patients with ALS. The development of this long sought-after resource is a significant step forward for the Canadian ALS patient and research communities that will result in more efficient clinical trial recruitment and advancements in our understanding of ALS in Canada.

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

    PubMed

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

    2015-05-01

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

  15. 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

  16. Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry.

    PubMed

    Pasquali, Sara K; Lam, Wendy K; Chiswell, Karen; Kemper, Alex R; Li, Jennifer S

    2012-11-01

    Clinical trials are the gold standard for generating evidence-based knowledge in medicine. Recent legislation requiring trials to be registered at ClinicalTrials.gov has enabled evaluation of the clinical trial enterprise as a whole, which was previously not possible. The purpose of this study was to create a snapshot of the pediatric clinical trial portfolio. All interventional trials registered at ClinicalTrials.gov from July 2005 to September 2010 were included. Pediatric (ie, enrolling patients aged 0-18 years) trial characteristics, therapeutic area, location, and funding were described. Secondary objectives included describing pediatric trials over time and comparison with nonpediatric trials. During this time, 5035 pediatric trials were registered compared with >10 times as many nonpediatric trials. Neonates/infants were eligible for enrollment in 46.6% of trials versus children (77.9%) and adolescents (45.2%). Nearly one-half of pediatric trials enrolled <100 subjects, and more pediatric trials versus nonpediatric trials evaluated preventive therapies. The proportion of pediatric trials evaluating a drug intervention declined over time, and there were fewer Phase 0 to II versus Phase III to IV trials. Infectious disease/vaccine studies (23%) were the most common, followed by psychiatric/mental health (13%) studies. Many trials enrolled patients outside the United States, and <15% of trials were sponsored by the National Institutes of Health or other US federal agencies. Analysis of the ClinicalTrials.gov data set allows description of the current scope of pediatric trials. These data may be useful to stakeholders in informing decisions regarding the conduct of trials in children and provide insight into mechanisms to advance pediatric trial infrastructure and methodology toward improving child health.

  17. 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

  18. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience.

    PubMed

    Campbell, Meredith S; Schatz, Desmond A; Chen, Vincent; Wong, Jenise C; Steck, Andrea; Tamborlane, William V; Smith, Jennifer; Beck, Roy W; Cengiz, Eda; Laffel, Lori M; Miller, Kellee M; Haller, Michael J

    2014-03-01

    Optimizing glycemic control in pediatric type 1 diabetes (T1D) is essential to minimizing long-term risk of complications. We used the T1D Exchange database from 58 US diabetes clinics to identify differences in diabetes management characteristics among children categorized as having excellent vs. poor glycemic control. Among registry participants 6-17 yr old with diabetes duration ≥ 2 yr, those with excellent control [(A1c <7%)(53 mmol/mol) (N = 588)] were compared with those with poor control [(A1c ≥ 9% )(75 mmol/mol) (N = 2684)] using logistic regression. The excellent and poor control groups differed substantially in diabetes management (p < 0.001 for all) with more of the excellent control group using insulin pumps, performing blood glucose monitoring ≥ 5 ×/d, missing fewer boluses, bolusing before meals rather than at the time of or after a meal, using meal-specific insulin:carbohydrate ratios, checking their blood glucose prior to giving meal time insulin, giving insulin for daytime snacks, giving more bolus insulin, and using a lower mean total daily insulin dose than those in poor control. After adjusting for demographic and socioeconomic factors, diabetes management characteristics were still strongly associated with good vs. poor control. Notably, frequency of severe hypoglycemia was similar between the groups while DKA was more common in the poorly controlled group. Children with excellent glycemic control tend to exhibit markedly different diabetes self-management techniques than those with poor control. This knowledge may further inform diabetes care providers and patients about specific characteristics and behaviors that can be augmented to potentially improve glycemic control. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Risk-adjusted hospital mortality rates for stroke: evidence from the Australian Stroke Clinical Registry (AuSCR).

    PubMed

    Cadilhac, Dominique A; Kilkenny, Monique F; Levi, Christopher R; Lannin, Natasha A; Thrift, Amanda G; Kim, Joosup; Grabsch, Brenda; Churilov, Leonid; Dewey, Helen M; Hill, Kelvin; Faux, Steven G; Grimley, Rohan; Castley, Helen; Hand, Peter J; Wong, Andrew; Herkes, Geoffrey K; Gill, Melissa; Crompton, Douglas; Middleton, Sandy; Donnan, Geoffrey A; Anderson, Craig S

    2017-05-01

    Hospital data used to assess regional variability in disease management and outcomes, including mortality, lack information on disease severity. We describe variance between hospitals in 30-day risk-adjusted mortality rates (RAMRs) for stroke, comparing models that include or exclude stroke severity as a covariate. Cohort design linking Australian Stroke Clinical Registry data with national death registrations. Multivariable models using recommended statistical methods for calculating 30-day RAMRs for hospitals, adjusted for demographic factors, ability to walk on admission, stroke type, and stroke recurrence. Australian hospitals providing at least 200 episodes of acute stroke care, 2009-2014. Hospital RAMRs estimated by different models. Changes in hospital rank order and funnel plots were used to explore variation in hospital-specific 30-day RAMRs; that is, RAMRs more than three standard deviations from the mean. In the 28 hospitals reporting at least 200 episodes of care, there were 16 218 episodes (15 951 patients; median age, 77 years; women, 46%; ischaemic strokes, 79%). RAMRs from models not including stroke severity as a variable ranged between 8% and 20%; RAMRs from models with the best fit, which included ability to walk and stroke recurrence as variables, ranged between 9% and 21%. The rank order of hospitals changed according to the covariates included in the models, particularly for those hospitals with the highest RAMRs. Funnel plots identified significant deviation from the mean overall RAMR for two hospitals, including one with borderline excess mortality. Hospital stroke mortality rates and hospital performance ranking may vary widely according to the covariates included in the statistical analysis.

  20. Gender related differences in clinical profile and outcome of patients with heart failure. Results of the RICA Registry.

    PubMed

    Conde-Martel, A; Arkuch, M E; Formiga, F; Manzano-Espinosa, L; Aramburu-Bodas, O; González-Franco, Á; Dávila-Ramos, M F; Suárez-Pedreira, I; Herrero-Domingo, A; Montero-Pérez-Barquero, M

    2015-10-01

    To analyze the differential clinical characteristics according to gender of patients with heart failure in terms of etiology, comorbidity, triggers, treatment, hospital stay and overall mortality at one year. We employed data from the RICA registry, a multicenter prospective cohort of patients hospitalized in internal medicine departments for heart failure, with a follow-up of one year. We analyzed the differences between the gender in terms of the etiology of the heart disease, comorbidity, triggers, left ventricle ejection fraction, functional state, mental condition, treatment, length of stay and mortality at 1 year. A total of 1772 patients (47.2% men) were included. The women were older than the men (p<.001) and had a higher prevalence of hypertension, obesity, chronic kidney disease, atrial fibrillation and preserved left ventricle ejection fraction (p<.001). The men's medical history had a predominance of myocardial infarction, chronic obstructive pulmonary disease, peripheral arteriopathy (p<.001) and anemia (p=.02). In the women, a hypertensive etiology was predominant, followed by valvular. The main triggers were hypertension and atrial fibrillation. Treatment with beta-blockers, ACEIs and/or ARBs did not differ by sex. The women had poorer functional capacity (p<.001), according to the Barthel index. After adjusting for age and other prognostic factors, the mortality at one year was lower among the women (RR: 0.69; 95% CI 0.53-0.89; p=.004). HF in women occurs at a later age and with different comorbidities. The hypertensive and valvular etiology is predominant, with preserved left ventricle ejection fraction, and the age-adjusted mortality is lower than in men. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  1. Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry).

    PubMed

    Godino, Cosmo; Furuichi, Shinichi; Latib, Azeem; Morici, Nuccia; Chieffo, Alaide; Romagnoli, Enrico; Tamburino, Corrado; Barbagallo, Rossella; Cera, Michela; Antoniucci, David; Goktekin, Omer; Di Mario, Carlo; Reimers, Bernard; Grube, Eberhard; Airoldi, Flavio; Sangiorgi, Giuseppe M; Colombo, Antonio

    2008-10-15

    Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.

  2. Quality of Acute Care and Long-Term Quality of Life and Survival: The Australian Stroke Clinical Registry.

    PubMed

    Cadilhac, Dominique A; Andrew, Nadine E; Lannin, Natasha A; Middleton, Sandy; Levi, Christopher R; Dewey, Helen M; Grabsch, Brenda; Faux, Steve; Hill, Kelvin; Grimley, Rohan; Wong, Andrew; Sabet, Arman; Butler, Ernest; Bladin, Christopher F; Bates, Timothy R; Groot, Patrick; Castley, Helen; Donnan, Geoffrey A; Anderson, Craig S

    2017-04-01

    Uncertainty exists over whether quality improvement strategies translate into better health-related quality of life (HRQoL) and survival after acute stroke. We aimed to determine the association of best practice recommended interventions and outcomes after stroke. Data are from the Australian Stroke Clinical Registry during 2010 to 2014. Multivariable regression was used to determine associations between 3 interventions: received acute stroke unit (ASU) care and in various combinations with prescribed antihypertensive medication at discharge, provision of a discharge care plan, and outcomes of survival and HRQoL (EuroQoL 5-dimensional questionnaire visual analogue scale) at 180 days, by stroke type. An assessment was also made of outcomes related to the number of processes patients received. There were 17 585 stroke admissions (median age 77 years, 47% female; 81% managed in ASUs; 80% ischemic stroke) from 42 hospitals (77% metropolitan) assessed. Cumulative benefits on outcomes related to the number of care processes received by patients. ASU care was associated with a reduced likelihood of death (hazard ratio, 0.49; 95% confidence interval, 0.43-0.56) and better HRQoL (coefficient, 21.34; 95% confidence interval, 15.50-27.18) within 180 days. For those discharged from hospital, receiving ASU+antihypertensive medication provided greater 180-day survival (hazard ratio, 0.45; 95% confidence interval, 0.38-0.52) compared with ASU care alone (hazard ratio, 0.64; 95% confidence interval, 0.54-0.76). HRQoL gains were greatest for patients with intracerebral hemorrhage who received care bundles involving discharge processes (range of increase, 11%-19%). Patients with stroke who receive best practice recommended hospital care have improved long-term survival and HRQoL. © 2017 American Heart Association, Inc.

  3. A comprehensive assessment of the association between anemia, clinical covariates and outcomes in a population-wide heart failure registry.

    PubMed

    Jonsson, Asa; Hallberg, Ann-Charlotte; Edner, Magnus; Lund, Lars H; Dahlstrom, Ulf

    2016-05-15

    The aim was to investigate the prevalence of, predictors of, and association with mortality and morbidity of anemia in a large unselected cohort of patients with heart failure (HF) and reduced ejection fraction (HFrEF) and to explore if there were specific subgroups of high risk. In patients with HFrEF in the Swedish Heart Failure Registry, we assessed hemoglobin levels and associations between baseline characteristics and anemia with logistic regression. Using propensity scores for anemia, we assessed the association between anemia and outcomes with Cox regression, and performed interaction and sub-group analyses. There were 24,511 patients with HFrEF (8303 with anemia). Most important independent predictors of anemia were higher age, male gender and renal dysfunction. One-year survival was 75% with anemia vs. 81% without (p < 0.001). In the matched cohort after propensity score the hazard ratio associated with anemia was for all-cause death 1.34 (1.28-1.40; p < 0.0001), CV mortality 1.28 (1.20-1.36; p < 0.0001), and combined CV mortality or HF hospitalization 1.24 (1.18-1.30; p < 0.0001). In interaction analyses, anemia was associated with greater risk with lower age, male gender, EF 30-39%, and NYHA-class I-II. In HFrEF, anemia is associated with higher age, male gender and renal dysfunction and increased risk of mortality and morbidity. The influence of anemia on mortality was significantly greater in younger patients, in men, and in those with more stable HF. The clinical implication of these findings might be in the future to perform targeted treatment studies. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

    PubMed

    Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

    2017-08-02

    The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

  5. Measuring safety and quality to improve clinical outcomes--current activities and future directions for the Australian Cardiac Procedures Registry.

    PubMed

    Reid, Christopher M; Brennan, Angela L; Dinh, Diem T; Billah, Baki; Costolloe, Carl B; Shardey, Gilbert C; Ajani, Andrew E

    2010-10-18

    Routine monitoring of performance in the provision of cardiac services aids quality assurance and enables comparisons of performance to national and international standards. The Australasian Society of Cardiac and Thoracic Surgeons conducts a surgical registry that has grown from six hospitals participating in 2001 to 21 contributing in 2010. Variation in performance is monitored on a quarterly basis through the use of control chart methodology, and a peer-review mechanism and governance process for reporting have been established. Proposed future developments of the registry include its expansion to include interventional cardiology procedures, such as implantation of stents and cardiac devices, and a modular format, with the patient rather than the procedure being the key element of the system. An Australian Cardiac Procedures Registry will provide information to stakeholders, including consumers, clinicians, health funders and policymakers, on performance standards and quality of care of medical services affecting an ever-increasing number of Australians.

  6. 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

  7. Rationale and design of a global registry to evaluate real-world clinical outcomes in patients with atrial fibrillation and high risk of stroke treated with left atrial appendage occlusion using the AMPLATZER amulet device-Perspective of available/ongoing registries of catheter-based LAA occlusion.

    PubMed

    Hildick-Smith, David; Diener, Hans-Christoph; Schmidt, Boris; Paul, Vincent; Settergren, Magnus; Teiger, Emmanuel; Camm, John; Tondo, Claudio; Landmesser, Ulf

    2017-09-01

    To describe the rationale and design of a global prospective registry on catheter-based left atrial appendage (LAA) occlusion using the second generation AMPLATZER Amulet LAA occlusion device and to provide a comprehensive perspective on available/ongoing registries for catheter-based LAA occlusion. Given the increasing clinical application of catheter-based LAA occlusion, there is an important need for prospective real-world clinical data regarding this cardiac intervention. The Global Amplatzer Amulet LAA registry aims to provide prospective real-world data from an all-comer population of atrial fibrillation (AF) patients undergoing catheter-based LAA occlusion for stroke prevention. This observational, prospective, multicenter registry will provide peri-procedural and long-term clinical outcome data for catheter-based LAA occlusion using a second generation LAA occlusion device. The global registry will enroll 1,000 patients at up to 75 institutions. Patients will be followed for 2 years after implantation. Primary endpoints will report procedural and long-term data on ischemic stroke, systemic embolism, cardiovascular death and major bleeding. The study will involve independent event adjudication and echocardiographic core laboratory evaluation. Long-term follow-up data are expected in 2018. The Global Amplatzer Amulet LAA registry will collect safety and efficacy information on catheter-based LAA occlusion. Characteristics of available and ongoing catheter-based LAA occlusion registries are described. There is an important need for prospective real-world clinical data of catheter-based LAA occlusion given the increasing application of this intervention. The present global real-world registry will expand our knowledge on peri-procedural and long-term outcome of catheter-based LAA occlusion using a second generation occlusion device. © 2017 Wiley Periodicals, Inc.

  8. One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients: Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTre rEgistry).

    PubMed

    Colombo, Antonio; Godino, Cosmo; Donahue, Michael; Testa, Luca; Chiarito, Mauro; Pavon, Anna Giulia; Colantonio, Riccardo; Cappelletti, Alberto; Monello, Alberto; Magni, Valeria; Milazzo, Diego; Parisi, Rosario; Nicolino, Annamaria; Moshiri, Shahram; Fattori, Rossella; Aprigliano, Gianfranco; Palloshi, Altin; Caramanno, Giuseppe; Montorfano, Matteo; Bedogni, Francesco; Margonato, Alberto; Briguori, Carlo

    2016-07-01

    Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. Impact of anaemia on clinical outcome in patients with atrial fibrillation undergoing percutaneous coronary intervention: insights from the AFCAS registry.

    PubMed

    Puurunen, Marja; Kiviniemi, Tuomas; Nammas, Wail; Schlitt, Axel; Rubboli, Andrea; Nyman, Kai; Karjalainen, Pasi; Kirchhof, Paulus; Lip, Gregory Y H; Airaksinen, Juhani K E

    2014-05-13

    Anaemia has an adverse impact on the outcome in the general patient population undergoing percutaneous coronary intervention (PCI). The aim of this study was to analyse the impact of anaemia on the 12-month clinical outcome of patients with atrial fibrillation (AF) undergoing PCI and therefore requiring intense antithrombotic treatment. We hypothesised that anaemia might be associated with a worse outcome and more bleeding in these anticoagulated patients. Data were collected from 17 secondary care centres in Europe. Consecutive patients with AF undergoing PCI were enrolled in the prospective, multicenter AFCAS (Atrial Fibrillation undergoing Coronary Artery Stenting) registry. Altogether, 929 patients participated in the study. Preprocedural haemoglobin concentration was available for 861 (92.7%; 30% women). The only exclusion criteria were inability or unwillingness to give informed consent. Anaemia was defined as a haemoglobin concentration of <12 g/dL for women and <13 g/dL for men. The primary endpoint was occurrence of major adverse cardiac and cerebrovascular events (MACCE) or bleeding events. 258/861 (30%) patients had anaemia. Anaemic patients were older, more often had diabetes, higher CHA2DS2-VASc scores, prior history of heart failure, chronic renal impairment and acute coronary syndrome. Anaemic patients had more MACCE than non-anaemic (29.1% vs 19.4%, respectively, p=0.002), and minor bleeding events (7.0% vs 3.3%, respectively, p=0.028), with a trend towards more total bleeding events (25.2% vs 21.7%, respectively, p=0.059). No difference was observed in antithrombotic regimens at discharge. In multivariate analysis, anaemia was an independent predictor of all-cause mortality at 12-month follow-up (hazard ratio 1.62, 95% CI 1.05 to 2.51, p=0.029). Anaemia was a frequent finding in patients with AF referred for PCI. Anaemic patients had a higher all-cause mortality, more thrombotic events and minor bleeding events. Anaemia seems to be an

  10. 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.

  11. 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.

  12. Acute heart failure with and without acute coronary syndrome: clinical correlates and prognostic impact (From the HEARTS registry).

    PubMed

    AlFaleh, Hussam; Elasfar, Abdelfatah A; Ullah, Anhar; AlHabib, Khalid F; Hersi, Ahmad; Mimish, Layth; Almasood, Ali; Al Ghamdi, Saleh; Ghabashi, Abdullah; Malik, Asif; Hussein, Gamal A; Al-Murayeh, Mushabab; Abuosa, Ahmed; Al Habeeb, Waleed; Kashour, Tarek S

    2016-05-20

    Little is know about the outcomes of acute heart failure (AHF) with acute coronary syndrome (ACS-AHF), compared to those without ACS (NACS-AHF). We conducted a prospective registry of AHF patients involving 18 hospitals in Saudi Arabia between October 2009 and December 2010. In this sub-study, we compared the clinical correlates, management and hospital course, as well as short, and long-term outcomes between AHF patients with and without ACS. Of the 2609 AHF patients enrolled, 27.8 % presented with ACS. Compared to NACS-AHF patients, ACS-AHF patients were more likely to be old males (Mean age = 62.7 vs. 60.8 years, p = 0.003, and 73.8 % vs. 62.7 %, p < 0.001, respectively), and to present with De-novo heart failure (56.6 % vs. 28.1 %, p < 0.001). Additionally they were more likely to have history of ischemic heart disease, diabetes, dyslipidemia, and less likely to have chronic kidney disease (p < 0.001 for all comparisons). The prevalence of severe LV systolic dysfunction (EF < 30 %) was higher in ACS-AHF patients. During hospital stay, ACS-AHF patients were more likely to develop shock (p < 0.001), recurrent heart failure (p = 0.02) and needed more mechanical ventilation (p < 0.001). β blockers and Angiotensin Converting Enzyme inhibitors were used more often in ACS-AHF patients (p = 0.001 and, p = 0.004 respectively). ACS- AHF patients underwent more coronary angiography and had higher prevalence of multi-vessel coronary artery disease (p < 0.001 for all comparisons). The unadjusted hospital and one-month mortality were higher in ACS-AHF patients (OR = 1.6 (1.2-2.2), p = 0.003 and 1.4 (1.0-1.9), p = 0.026 respectively). A significant interaction existed between the level of left ventricular ejection fraction and ACS-AHF status. After adjustment, ACS-AHF status was only significantly associated with hospital mortality (OR = 1.6 (1.1-2.4), p = 0.019). The three-years survival following hospital discharge was not different between the two groups. AHF patients

  13. Renal dysfunction and clinical outcomes of patients undergoing ICD and CRTD implantation: data from the Israeli ICD registry.

    PubMed

    Eisen, Alon; Suleiman, Mahmoud; Strasberg, Boris; Sela, Ron; Rosenheck, Shimon; Freedberg, Nahum A; Geist, Michael; Ben-Zvi, Shlomit; Goldenberg, Ilan; Glikson, Michael; Haim, Moti

    2014-09-01

    Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) reduce mortality in patients with heart failure (HF) and left ventricular dysfunction. However, their efficacy in patients with chronic kidney disease (CKD) is controversial. We examined the association between renal dysfunction and clinical outcomes in patients undergoing ICD and CRT defibrillator (CRTD) implantation. Data were collected from the Israeli ICD registry. Estimated glomerular filtration rate (eGFR) at implantation was assessed using the modification of diet in renal disease formula. Primary outcome was all-cause mortality. Secondary outcomes included the composite endpoints of death or HF and death or ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation [VT/VF]); any hospitalizations; first appropriate and inappropriate ICD therapy. During the study period (July 2010-November 2012), 2,811 patients were implanted with ICD or CRTD. One-year follow-up data were available for 730 ICD patients and 453 CRTD patients. Patients with eGFR < 30 mL/minute/1.73 m(2) (n = 54, 4.6%) were older, had a higher prevalence of diabetes, hypertension, or ischemic heart disease. eGFR <30 mL/minute/1.73 m(2) was associated with increased mortality risk in ICD (HR 5.4; 95% CI 1.5-19.2), but not in CRTD patients (HR 0.9; 95% CI 0.1-7.5). Renal dysfunction was associated with the composite endpoints of death or HF and death or VT/VF in ICD, but not in CRTD patients. Mean eGFR during follow-up decreased by 8.0 ± 4.3 mL/minute/1.73 m(2) in ICD patients (P = 0.06) and by 1.8 ± 1.3 mL/minute/1.73 m(2) in patients with CRTD (P = 0.2). Based on this retrospective analysis, CKD is associated with adverse prognosis after ICD implantation, but not after CRTD implantation. GFR decreased in patients with ICD, but not in CRTD patients. © 2014 Wiley Periodicals, Inc.

  14. Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials.

    PubMed

    Raftery, James; Fairbank, Eleanor; Douet, Lisa; Dent, Louise; Price, Alison; Milne, Ruairidh; Walley, Tom

    2012-08-20

    A 2003 survey suggested the number of noncommercial trials in the UK was declining. Formation of the NIHR in 2006 and increased research spending by the Department of Health may have increased the number of noncommercial trials but no data are available. Available data on UK noncommercial trials (were obtained from the two relevant registries: ISRCTN register for the UK, and US ClinicalTrials.gov. Data on each trial were sorted by start year, and compared with the: 2003 survey, and UKCRN portfolio database from 2007. The number of UK noncommercial trials registered rose from 25 in 1990 to 188 in 1999, peaked at 533 in 2003, and fell back to 334 in 2009. Total trials registered was similar to but slightly above those in the 2003 survey up to 1998, then rose sharply to 2002 before falling to 2007. From 2007 to 2009 the number registered to start each year was similar to but slightly above the UKCRN database. Less than 10% of UK noncommercial trials registered with ClinGov for most years before 2005, but this rose to 35% by 2009. For the periods of overlap, trial registration data provide fairly similar totals to other sources on the number of noncommercial trials starting each year. The rise and fall in the number of trials registered between 1999 and 2007 was due to those registered in the ISRCTN database as funded by NHS Trusts. After 2007, the number of trials registered as funded by NHS Trusts has fallen in the ISRCTN register but these trials may have migrated to the US ClinGov register. The total number of noncommercial trial starts, excluding those funded by NHS Trusts, has been upward since around 2002. By 2009 the two main funders were NIHR and charities. Feasibility of using registration data to monitor the number of noncommercial trials has been demonstrated but is complicated by the use of two registers and difficulties in accessing the data. We recommend an annual report on the number of noncommercial trials registering each year.

  15. EUROCOURSE lessons learned from and for population-based cancer registries in Europe and their programme owners: Improving performance by research programming for public health and clinical evaluation.

    PubMed

    Coebergh, Jan Willem; van den Hurk, Corina; Rosso, Stefano; Comber, Harry; Storm, Hans; Zanetti, Roberto; Sacchetto, Lidia; Janssen-Heijnen, Maryska; Thong, Melissa; Siesling, Sabine; van den Eijnden-van Raaij, Janny

    2015-06-01

    Population-based cancer registries (CRs) in Europe have played a supportive, sometimes guiding, role in describing geographic variation of cancer epidemics and comparisons of oncological practice and preventive interventions since the 1950s for all types of cancer, separate and simultaneously. This paper deals with historical and longitudinal developments of the roughly 160 CRs and their programme owners (POs) that emerged since 1927 and accelerating since the late 70s especially in southern and continental Europe. About 40 million newly diagnosed patients were recorded since the 1950s out of a total of 100 million of whom almost 20 million are still alive and about 10% annually dying from cancer. The perception of unity in diversity and suboptimal comparability in performance and governance of CRs was confirmed in the EUROCOURSE (EUROpe against cancer: Optimisation of the Use of Registries for Scientific Excellence in research) European Research Area (ERA)-net coordination FP7 project of the European Commission (EU) which explored best practices, bottlenecks and future challenges of CRs. Regional oncologic and public health changes but also academic embedding of CRs varied considerably, although Anno 2012 optimal cancer surveillance indeed demanded intensive collaboration with professional and institutional stakeholders in two major areas (public health and clinical research) and five minor overlapping cancer research domains: aetiologic research, mass screening evaluation, quality of care, translational prognostics and survivorship. Each of these domains address specific study questions, mixes of disciplines, methodologies, additional data-sources and funding mechanisms. POs tended to become more and more public health institutes, Health ministries, but also comprehensive cancer centres and cancer societies through more and more funding at project or programme basis. POs were not easy to pin down because of their multiple, sometimes competitive (funding

  16. Incidence and Clinical Features of Drug-induced Lung Injury in Patients with Advanced Colorectal Cancer Receiving Cetuximab: Results of a Prospective Multicenter Registry

    PubMed Central

    Satoh, Taroh; Gemma, Akihiko; Kudoh, Shoji; Sakai, Fumikazu; Yamaguchi, Kensei; Watanabe, Toshiaki; Ishiguro, Megumi; Inoshiri, Shogo; Izawa, Makiko; Sugihara, Kenichi; Sakata, Yuh

    2014-01-01

    Objective We investigated the incidence and clinical features of drug-induced lung injury during cetuximab therapy in Japanese patients with colorectal cancer in a prospective multicenter registry based on a central registration system. Methods We investigated and followed up patients with or suspected of having drug-induced lung injury among 2006 patients with cetuximab-treated colorectal cancer. A subcommittee of medical oncologists, pulmonologists and a radiologist evaluated and discussed each case of drug-induced lung injury that occurred during cetuximab therapy. Results Sixty-six patients were identified and further examinations of drug-induced lung injury were conducted during the registration period. We analyzed time to onset, patient characteristics and factors associated with mortality. Cetuximab-related drug-induced lung injury occurred in 24 (1.2%) patients, and was rated as Grade 3 or worse in 15 (0.7%) patients. Fourteen patients received steroid pulse therapy. Ten patients with drug-induced lung injury died, of whom eight received steroid pulse therapy. The incidence of drug-induced lung injury was significantly higher in elderly patients, and in patients with prior interstitial lung disease. There was no particular trend in the time to onset. Patients with early onset of drug-induced lung injury (within 90 days) after starting cetuximab therapy had higher mortality than patients with later onset (over 90 days). Conclusions The incidence of drug-induced lung injury in cetuximab-treated patients was 1.2%. Because drug-induced lung injury is potentially serious, it is important to promptly initiate appropriate treatments. Considering that early onset drug-induced lung injury during cetuximab therapy is associated with a poor prognosis, close monitoring is mandatory for these patients. PMID:25210144

  17. Effectiveness of biologic DMARDs in monotherapy versus in combination with synthetic DMARDs in rheumatoid arthritis: data from the Swiss Clinical Quality Management Registry.

    PubMed

    Gabay, Cem; Riek, Myriam; Scherer, Almut; Finckh, Axel

    2015-09-01

    To determine the frequency of use of biologic DMARDs (bDMARDs) in monotherapy, to describe the baseline characteristics of patients treated with bDMARDs in monotherapy and to compare the effectiveness of bDMARDs in monotherapy with that of bDMARDs in combination with synthetic DMARDs (sDMARDs). Using data from the Swiss RA (SCQM-RA) registry, bDMARD treatment courses (TCs) were classified either as monotherapy or as combination therapy, depending on the presence of concomitant sDMARDs. Prescription of bDMARD monotherapy was analysed using logistic regression. bDMARD retention was analysed using Kaplan-Meier and Cox models with the addition of time-varying covariate effects. Evolution of the DAS28 over time was analysed with mixed-effects models for longitudinal data. A total of 4218 TCs on bDMARDs from 3111 patients were included, of which 1136 TCs (27%) were initiated as monotherapy. bDMARD monotherapy was preferentially prescribed to older, co-morbid patients with longer disease duration, lower BMI, more active disease and more previous bDMARDs. After adjusting for potential confounding factors, drug retention was significantly lower in monotherapy [hazard ratio 1.15 (95% CI: 1.03, 1.30)]. Other factors such as type of bDMARD and calendar year of prescription were associated with a stronger effect on drug retention. Response to treatment in terms of DAS28 evolution was also slightly but significantly less favourable in monotherapy (P = 0.04). Our data suggest that bDMARD monotherapy is prescribed to more complex cases and is significantly less effective than bDMARD therapy in combination with sDMARDs, but to an extent that is clinically only marginally relevant. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  18. 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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. [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.

  2. Prognostic impact of human epidermal growth factor-like receptor 2 and hormone receptor status in inflammatory breast cancer (IBC): analysis of 2,014 IBC patient cases from the California Cancer Registry.

    PubMed

    Zell, Jason A; Tsang, Walter Y; Taylor, Thomas H; Mehta, Rita S; Anton-Culver, Hoda

    2009-01-01

    Inflammatory breast cancer (IBC) is an aggressive form of breast cancer associated with overexpression of Her2/Neu (human epidermal growth factor-like receptor 2 (HER2)) and poor survival. We investigated survival differences for IBC patient cases based on hormone receptor status and HER2 receptor status using data from the California Cancer Registry, as contrasted with locally advanced breast cancer (LABC), metastatic breast cancer (MBC) and non-T4 breast cancer. A case-only analysis of 80,099 incident female breast cancer patient cases in the California Cancer Registry during 1999 to 2003 was performed, with follow-up through March 2007. Overall survival (OS) and breast cancer-specific survival (BC-SS) were analyzed using Kaplan-Meier methods and Cox proportional hazards ratios. A total of 2,014 IBC, 1,268 LABC, 3,059 MBC, and 73,758 non-T4 breast cancer patient cases were identified. HER2+ was associated with advanced tumor stage (P < 0.0001). IBC patient cases were more likely to be HER2+ (40%) and less likely to be hormone receptor-positive (HmR+) (59%) compared with LABC (35% and 69%, respectively), MBC (35% and 74%), and non-T4 patient cases (22% and 82%). HmR+ status was associated with improved OS and BC-SS for each breast cancer subtype after adjustment for clinically relevant factors. In multivariate analysis, HER2+ (versus HER2-) status was associated with poor BC-SS for non-T4 patient cases (hazards ratio = 1.16, 95% confidence interval 1.05 to 1.28) and had a borderline significant association with improved BC-SS for IBC (hazards ratio = 0.82, 95% confidence interval = 0.68 to 0.99). Despite an association with advanced tumor stage, HER2+ status is not an independent adverse prognostic factor for survival among IBC patient cases.

  3. The health disparities cancer collaborative: a case study of practice registry measurement in a quality improvement collaborative

    PubMed Central

    2010-01-01

    Background Practice registry measurement provides a foundation for quality improvement, but experiences in practice are not widely reported. One setting where practice registry measurement has been implemented is the Health Resources and Services Administration's Health Disparities Cancer Collaborative (HDCC). Methods Using practice registry data from 16 community health centers participating in the HDCC, we determined the completeness of data for screening, follow-up, and treatment measures. We determined the size of the change in cancer care processes that an aggregation of practices has adequate power to detect. We modeled different ways of presenting before/after changes in cancer screening, including count and proportion data at both the individual health center and aggregate collaborative level. Results All participating health centers reported data for cancer screening, but less than a third reported data regarding timely follow-up. For individual cancers, the aggregate HDCC had adequate power to detect a 2 to 3% change in cancer screening, but only had the power to detect a change of 40% or more in the initiation of treatment. Almost every health center (98%) improved cancer screening based upon count data, while fewer (77%) improved cancer screening based upon proportion data. The aggregate collaborative appeared to increase breast, cervical, and colorectal cancer screening rates by 12%, 15%, and 4%, respectively (p < 0.001 for all before/after comparisons). In subgroup analyses, significant changes were detectable among individual health centers less than one-half of the time because of small numbers of events. Conclusions The aggregate HDCC registries had both adequate reporting rates and power to detect significant changes in cancer screening, but not follow-up care. Different measures provided different answers about improvements in cancer screening; more definitive evaluation would require validation of the registries. Limits to the implementation and

  4. Clinical status, psychosocial impairments, medical treatment and health care costs for patients with inflammatory bowel disease (IBD) in Germany: an online IBD registry.

    PubMed

    Bokemeyer, B; Hardt, J; Hüppe, D; Prenzler, A; Conrad, S; Düffelmeyer, M; Hartmann, P; Hoffstadt, M; Klugmann, T; Schmidt, C; Weismüller, J; Mittendorf, T; Raspe, H

    2013-06-01

    The aim of this cross-sectional study was to establish an online inflammatory bowel disease (IBD) registry for a first picture of the situation of IBD outpatients' treatment in Germany. Between March 2006 and July 2007 IBD outpatients from 24 gastroenterological specialist practices and two hospitals in Germany were enrolled in an Internet-based registry to evaluate the outpatients' clinical status, psychological impairments, provided health care, as well as medical treatment and medication costs. 1032 IBD patients (ulcerative colitis/UC: 519; Crohn's disease/CD: 511; indeterminate colitis: 2) were enrolled in the study (age: 43 ± 14 years/M ± SD). Disease duration of all patients averaged 10 ± 8.5 years. In 519 UC-patients (49% male; 33% pancolitis), 66% were in remission as were 55% of CD patients (37 % male; 41 % active smokers). Associated with higher rates of disease activity (CDAI ≥ 150; CAI>4) were corticosteroids (CD, UC), topical medication (UC), relevant reported depressive symptoms (15%; 6-31%) and impairments in sexuality (21%; 9-42%). Relevant medication groups prescribed were oral aminosalicylates (UC: 70%; CD: 47%); immunosuppressive therapy - mostly azathioprine/6 MP (CD: 47%; UC: 26%), and Infliximab (CD: 8%; UC: 3%). Strongly associated with their clinical disease activity in UC as well as CD patients, 15% (6-31%) reported relevant depressive symptoms and 21% (9-42%) relevant impairments in sexuality. The registry constitutes a large complemental database for the patient population in Germany. About one third of the IBD patients were not in clinical remission (CDAI ≥150/CAI >4) (CD: 45%; UC: 27%), although high rates of immunosuppressive drugs (CD: 47%; UC 26%) were administered. This study shows a large burden of active disease associated with an unexpectedly high (co)morbidity and high psychosocial impairments, indicating a reduced health state in IBD patients. Copyright © 2012 European Crohn's and Colitis Organisation. Published by

  5. [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.

  6. 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.

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

    PubMed

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

    2015-12-01

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

  8. 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

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

    PubMed

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

    2017-01-01

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

  10. 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

  11. 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.

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

    PubMed Central

    Hughes, Shannon; Cohen, David; Jaggi, Rachel

    2014-01-01

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

  13. Descriptive epidemiological study of vaginal cancer using data from the Osaka Japan population-based cancer registry: Long-term analysis from a clinical viewpoint.

    PubMed

    Yagi, Asami; Ueda, Yutaka; Kakuda, Mamoru; Tanaka, Yusuke; Egawa-Takata, Tomomi; Morimoto, Akiko; Iwamiya, Tadashi; Matsuzaki, Shinya; Kobayashi, Eiji; Yoshino, Kiyoshi; Fukui, Keisuke; Ito, Yuri; Nakayama, Tomio; Kimura, Tadashi

    2017-08-01

    Vaginal cancer is such a rare tumor that epidemiological and clinical information for it is based mainly on studies of small numbers of cases. The aim of the present study was to perform a descriptive epidemiological analysis of vaginal cancer using a significantly larger population-based dataset from the Japanese Osaka Cancer Registry.The age-standardized incidence of vaginal cancer per 1,000,000 persons, from 1976 to 2010, was calculated and examined for trends. Relative-survival analysis was applied to estimate a more up-to-date 10-year period calculation, using data from recently followed-up patients. The conditional 5-year survival of patients who survived for 0 to 5 years after diagnosis was calculated.A total of 481 cases of vaginal cancer were registered in Osaka during the 35-year period from 1976 to 2010. The age-adjusted incidence rate has significantly and consistently decreased over this time [annual percent change (APC) = -1.29, 95% confidence interval (95% CI): -0.3 ∼ -2.2]; however, due to significant population aging, the raw incidence of vaginal cancer appeared to have been increasing. The 10-year relative survival of patients with surgery-based treatments was comparable to that of radiation-based treatments, implying that surgery and radiotherapy provide similar therapeutic benefits (P = .98). The 10-year relative survival was not significantly different during the period of 1976 to 2000 compared with the period of 2001 to 2008, although there has been, in the latter period, a tendency for improvement of long-term survival, especially for survival longer than 5 years. The longer the time after diagnosis, the higher the conditional 5-year relative-survival at 0 to 4 years after diagnosis.The age-adjusted incidence of vaginal cancer has decreased since 1976. Regrettably, the 10-year survival rate did not similarly improve, and it remained stable during the period from 2001 to 2008, compared with the period from 1976 to 2000, indicating

  14. Variation in recruitment across sites in a consent-based clinical data registry: lessons from the Canadian Stroke Network

    PubMed Central

    Willison, Donald J; Kapral, Moira K; Peladeau, Pierrot; Richards, Janice A; Fang, Jiming; Silver, Frank L

    2006-01-01

    Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that

  15. Short- and long-term clinical outcome after various stent implantation: overview of the results of uni- and multicenter stent registries.

    PubMed

    Gyöngyösi, Mariann; Khorsand, Aliashgar; Sperker, Wolfgang; Strehblow, Christoph; Wexberg, Paul; Probst, Peter; Siostrzonek, Peter; Lang, Irene; Sochor, Heinz; Glogar, Dietmar

    2004-07-01

    The present study reports the results of the short- and long-term outcomes of prospective uni- and multicenter stent registries: Palmaz-Schatz (n = 140 patients), Ave-Micro and GFX (n = 280), Multilink Duet (n = 340), Multilink Tetra (n = 192), and Carbo (n = 140) Stent Registries, as well as the predictors and angiographic cutoff points predicting major adverse cardiac events (MACE) after different stent implantations. Significant decrease in subacute stent thrombosis (from 2.9% to 0) and MACE (from 35% to 8.3%) occurred as the improved stents, optimized stent implantation technique, and new postintervention drug therapy were introduced. The changes of angiographic cutoff values (postintervention minimal lumen diameter and preintervention reference diameter: from 2.9 and 3.1 mm for Palmaz-Schatz to 2.5 and 2.8 mm for Multilink Duet, Multilink Tetra, and Carbo stents) and clinical and angiographic factors predicting MACE indicated the change of traditional restenosis paradigm and that progress in clinical practice might be able to counterbalance unfavorable lesion and intervention-related characteristics. Copyright 2004 Wiley-Liss, Inc.

  16. Clinical outcomes of temporary mechanical circulatory support as a direct bridge to heart transplantation: a nationwide Spanish registry.

    PubMed

    Barge-Caballero, Eduardo; Almenar-Bonet, Luis; Gonzalez-Vilchez, Francisco; Lambert-Rodríguez, José L; González-Costello, José; Segovia-Cubero, Javier; Castel-Lavilla, María A; Delgado-Jiménez, Juan; Garrido-Bravo, Iris P; Rangel-Sousa, Diego; Martínez-Sellés, Manuel; De la Fuente-Galan, Luis; Rábago-Juan-Aracil, Gregorio; Sanz-Julve, Marisa; Hervás-Sotomayor, Daniela; Mirabet-Pérez, Sonia; Muñiz, Javier; Crespo-Leiro, María G

    2017-09-26

    In Spain, listing for high-urgent heart transplantation is allowed for critically ill candidates not weanable from temporary mechanical circulatory support (T-MCS). We sought to analyse the clinical outcomes of this strategy. We conducted a case-by-case, retrospective review of clinical records of 291 adult patients listed for high-urgent heart transplantation under temporary devices from 2010 to 2015 in 16 Spanish institutions. Survival after listing and adverse clinical events were studied. At the time of listing, 169 (58%) patients were supported on veno-arterial extracorporeal membrane oxygenation (VA-ECMO), 70 (24%) on temporary left ventricular assist devices (T-LVAD) and 52 (18%) on temporary biventricular assist devices (T-BiVAD). Seven patients transitioned from VA-ECMO to temporary ventricular assist devices while on the waiting list. Mean time on T-MCS was 13.1 ± 12.6 days. Mean time from listing to transplantation was 7.6 ± 8.5 days. Overall, 230 (79%) patients were transplanted and 54 (18.6%) died during MCS. In-hospital postoperative mortality after transplantation was 33.3%, 11.9% and 26.2% for patients bridged on VA-ECMO, T-LVAD and T-BiVAD, respectively (P = 0.008). Overall survival from listing to hospital discharge was 54.4%, 78.6% and 55.8%, respectively (P = 0.002). T-LVAD support was independently associated with a lower risk of death over the first year after listing (hazard ratio 0.52, 95% confidence interval 0.30-0.92). Patients treated with VA-ECMO showed the highest incidence rate of adverse clinical events associated with T-MCS. Temporary devices may be used to bridge critically ill candidates directly to heart transplantation in a setting of short waiting list times, as is the case of Spain. In our series, bridging with T-LVAD was associated with more favourable outcomes than bridging with T-BiVAD or VA-ECMO. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  17. Primary Healthcare-based Diabetes Registry in Puducherry: Design and Methods.

    PubMed

    Lakshminarayanan, Subitha; Kar, Sitanshu Sekhar; Gupta, Rajeev; Xavier, Denis; Bhaskar Reddy, S Vijaya

    2017-01-01

    Diabetes registries monitor the population prevalence and incidence of diabetes, monitor diabetes control program, provide information of quality of care to health service providers, and provide a sampling frame for interventional studies. This study documents the process of establishing a prospective diabetes registry in a primary health-care setting in Puducherry. This is a facility-based prospective registry conducted in six randomly selected urban health centers in Puducherry, with enrollment of all known patients with diabetes attending chronic disease clinics. Administrative approvals were obtained from Government Health Services. Manuals for training of medical officers, health-care workers, and case report forms were developed. Diabetes registry was prepared using Epi Info software. In the first phase, demographic characteristics, risk factors, complications, coexisting chronic conditions, lifestyle and medical management, and clinical outcomes were recorded. Around 2177 patients with diabetes have been registered in six Primary Health Centres out of a total of 2948 participants seeking care from chronic disease clinic. Registration coverage ranges from 61% to 105% in these centers. This study has documented methodological details, and learning experiences gained while developing a diabetes registry at the primary health care level and the scope for upscaling to a Management Information System for Diabetes and a State-wide Registry. Improvement in patient care through needs assessment and quality assurance in service delivery is an important theme envisioned by this registry.

  18. Primary Healthcare-based Diabetes Registry in Puducherry: Design and Methods

    PubMed Central

    Lakshminarayanan, Subitha; Kar, Sitanshu Sekhar; Gupta, Rajeev; Xavier, Denis; Bhaskar Reddy, S. Vijaya

    2017-01-01

    Background: Diabetes registries monitor the population prevalence and incidence of diabetes, monitor diabetes control program, provide information of quality of care to health service providers, and provide a sampling frame for interventional studies. This study documents the process of establishing a prospective diabetes registry in a primary health-care setting in Puducherry. Methods: This is a facility-based prospective registry conducted in six randomly selected urban health centers in Puducherry, with enrollment of all known patients with diabetes attending chronic disease clinics. Administrative approvals were obtained from Government Health Services. Manuals for training of medical officers, health-care workers, and case report forms were developed. Diabetes registry was prepared using Epi Info software. Results: In the first phase, demographic characteristics, risk factors, complications, coexisting chronic conditions, lifestyle and medical management, and clinical outcomes were recorded. Around 2177 patients with diabetes have been registered in six Primary Health Centres out of a total of 2948 participants seeking care from chronic disease clinic. Registration coverage ranges from 61% to 105% in these centers. Conclusion: This study has documented methodological details, and learning experiences gained while developing a diabetes registry at the primary health care level and the scope for upscaling to a Management Information System for Diabetes and a State-wide Registry. Improvement in patient care through needs assessment and quality assurance in service delivery is an important theme envisioned by this registry. PMID:28553589

  19. Acute case-fatality rates of stroke and acute myocardial infarction in a Japanese population: Takashima stroke and AMI registry, 1989-2005.

    PubMed

    Rumana, Nahid; Kita, Yoshikuni; Turin, Tanvir Chowdhury; Nakamura, Yasuyuki; Takashima, Naoyuki; Ichikawa, Masaharu; Sugihara, Hideki; Morita, Yutaka; Hirose, Kunihiko; Kawakami, Kenzou; Okayama, Akira; Miura, Katsuyuki; Ueshima, Hirotsugu

    2014-10-01

    Few comprehensive stroke and acute myocardial infarction registries of long duration exist in Japan to illustrate trends in acute case-fatality of stroke and acute myocardial infarction with greater precision. We examined 17-year case-fatality rates of stroke and acute myocardial infarction using an entire community-monitoring registration system to investigate trends in these rates over time in a Japanese population. Data were obtained from the Takashima Stroke and AMI Registry covering a stable population of approximately 55 000 residents of Takashima County in central Japan. We divided the total observation period of 17 years into four periods, 1989-1992, 1993-1996, 1997-2000, and 2001-2005. We calculated gender, age-specific and age-adjusted acute case-fatality rates (%) of stroke and acute myocardial infarction across these four periods. During the study period of 1989-2005, there were 341 fatal cases within 28 days of onset among 2239 first-ever stroke events and 163 fatal cases among 433 first-ever acute myocardial infarction events. The age-adjusted acute case-fatality rate of stroke was 14·9% in men and 15·7% in women. The age-adjusted acute case-fatality rate of acute myocardial infarction was 34·3% in men and 43·3% in women. The age-adjusted acute case-fatality rates of stroke and acute myocardial infarction showed insignificant differences across the four time periods. The average annual change in the acute case-fatality rate of stroke (-0·2%; 95% CI: -2·4-2·1) and acute myocardial infarction (2·7%; 95% CI: -0·7-6·1) did not change significantly across the study years. The acute case-fatality rates of stroke and acute myocardial infarction have remained stable from 1989 to 2005 in a rural and semi-urban Japanese population. © 2014 World Stroke Organization.

  20. 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.

  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. Validation of Retention in HIV Care Status Using the New York City HIV Surveillance Registry and Clinical Care Data From a Large HIV Care Center.

    PubMed

    Pati, Rituparna; Robbins, Rebekkah S; Braunstein, Sarah L

    2017-01-11

    Improving retention in care is a key element of the National HIV/AIDS Strategy (NHAS). However, definitions for measuring retention in care are not standardized. To compare measures of retention based on both clinic visit data and HIV laboratory surveillance data. Retrospective cohort study. New York City (NYC), New York. We matched adult patients with HIV infection seen at the Spencer Cox Center for Health (SCC) in 2010 or 2011 with the NYC HIV Surveillance Registry. Retention in care was measured on the basis of SCC electronic medical record (EMR) data (≥1 medical visits in 2012) and Surveillance Registry data (≥2 CD4/viral load [VL] tests ≥90 days apart in 2012). There were 5746 adult HIV-infected patients seen at SCC between 2010 and 2011 who matched with the Surveillance Registry. Seventy-eight percent (n = 4469) had 1 or more medical visits at SCC in 2012 and were considered retained on the basis of the EMR definition, among which 3831 (86%) met the surveillance definition for retention in care. Patients who did not have a medical visit at SCC in 2012 (n = 1277) were lost to care in NYC (n = 485; 36%), engaged in care at an alternate provider (n = 622; 49%), or died after their last SCC visit (n = 197; 15%). This study is an important comparison of laboratory surveillance versus clinic visit-based measures of retention in care in an urban setting with the largest HIV epidemic in the country. Collaborative projects between local health departments and clinical care providers can help validate the care status of patients and inform the allocation of resources to reengage patients who are lost to care. The combined use of laboratory and clinic visit-based data to measure retention in care provides a more accurate representation of the care status of HIV-infected patients than use of a single data source alone. Routine sharing of data by public health institutions and clinical care providers would help target resources toward reengaging patients who are

  3. Clinical outcomes with Biolimus (A9)™ eluting stent, 'BioMatrix' in diabetic patients--interim results from multicenter post market surveillance registry in India.

    PubMed

    Seth, Ashok; Hiremath, Shirish; Dani, Sameer; Kapoor, Sunil; Jain, R K; Abhaichand, Rajpal; Trivedi, Shailendra; Kaul, Upendra; Patil, Aruna; Khemnar, Bhushan; Rangnekar, Hrishikesh

    2013-01-01

    The objective of this registry is to establish safety and efficacy of BioMatrix, BioMatrix™-Biolimus A9™ eluting stent in diabetic population in India. Diabetes mellitus is a major predisposing factor for coronary artery disease. Prognosis for diabetic population patients presenting with coronary artery disease who undergo coronary revascularization is inferior to non diabetics and remains an independent risk factor of restenosis, need for revascularization, and overall mortality. Stent thrombosis is a potential complication of first generation, permanent polymer drug-eluting stents. Biodegradable polymer is a good relief in this era and its utility in diabetic patients will be a major advantage for them. 334 patients with diabetes mellitus and requiring angioplasty, implanted with BioMatrix stent were followed at 1, 6, 12 and 24 months who entered in a multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, 12 and 24 months. The mean age was 58.71 ± 9.2 years, 81% were males, comorbidity index was 1.6 ± 1.02, and 59.1% presented with acute coronary syndrome. The incidence of adverse event rates was: MACE 1.27%. There were no incidences of myocardial infarction (MI) and target vessel revascularization (TVR). Definite stent thrombosis occurred only in 2 patients. In this registry of diabetic population treated with BioMatrixTM-Biolimus A9TM eluting stent (BioMatrix), the reported incidence of MACE and ST were much lower than previously published results. The 1- and 2-year follow-up result supports favorable clinical outcomes of using BioMatrix stents as a suitable alternative to contemporary DES available during PCI in diabetic patients. Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  4. Clinical practices, complications, and mortality in neurological patients with acute severe hypertension: the Studying the Treatment of Acute hyperTension registry.

    PubMed

    Mayer, Stephan A; Kurtz, Pedro; Wyman, Allison; Sung, Gene Y; Multz, Alan S; Varon, Joseph; Granger, Christopher B; Kleinschmidt, Kurt; Lapointe, Marc; Peacock, W Frank; Katz, Jason N; Gore, Joel M; O'Neil, Brian; Anderson, Frederick A

    2011-10-01

    To determine the demographic and clinical features, hospital complications, and predictors of 90-day mortality in neurologic patients with acute severe hypertension. Studying the Treatment of Acute hyperTension (STAT) was a multicenter (n=25) observational registry of adult critical care patients with severe hypertension treated with intravenous therapy. Emergency department or intensive care unit. A qualifying blood pressure measurement>180 mm Hg systolic or >110 mm Hg diastolic (>140/90 mm Hg for subarachnoid hemorrhage) was required for inclusion in the STAT registry. Patients with a primary neurologic admission diagnosis were included in the present analysis. All patients were treated with at least one parenteral (bolus or continuous infusion) antihypertensive agent. Of 1,566 patients included in the STAT registry, 432 (28%) had a primary neurologic diagnosis. The most common diagnoses were subarachnoid hemorrhage (38%), intracerebral hemorrhage (31%), and acute ischemic stroke (18%). The most common initial drug was labetalol (48%), followed by nicardipine (15%), hydralazine (15%), and sodium nitroprusside (13%). Mortality at 90 days was substantially higher in neurologic than in non-neurologic patients (24% vs. 6%, p<.0001). Median initial blood pressure was 183/95 mm Hg and did not differ between survivors and nonsurvivors. In a multivariable analysis, neurologic patients who died experienced lower minimal blood pressure values (median 103/45 vs. 118/55 mm Hg, p<.0001) and were less likely to experience recurrent hypertension requiring intravenous treatment (29% vs. 51%, p=.0001) than those who survived. Mortality was also associated with an increased frequency of neurologic deterioration (32% vs. 10%, p<.0001). Neurologic emergencies account for approximately 30% of hospitalized patients with severe acute hypertension, and the majority of those who die. Mortality in hypertensive neurologic patients is associated with lower minimum blood pressure values

  5. 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.

  6. 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

  7. Is There Evidence for Systematic Upcoding of American Society of Anesthesiologists Physical Status Coincident with Payer Incentives? A Regression Discontinuity Analysis of the National Anesthesia Clinical Outcomes Registry

    PubMed Central

    Schonberger, Robert B.; Dutton, Richard P.; Dai, Feng

    2015-01-01

    Background Modifications in physician billing patterns have been shown to occur in response to payer incentives, but the phenomenon remains largely unexplored in billing for anesthesia services. Within the field of anesthesiology, Medicare’s policy not to provide additional reimbursement for higher American Society of Anesthesiologists (ASA) Physical Status scores contrasts with the practices of most private payers, and this pattern of reimbursement introduces a change in billing incentives once patients attain Medicare eligibility. We hypothesized that, coincident with the onset of widespread Medicare eligibility at age 65, a discontinuity in reported ASA Physical Status scores would be observed after controlling for the underlying trend of increasing ASA Physical Status scores with age. This phenomenon would manifest as a pattern of upcoding of ASA Physical Status Scores for patients below the age of 65 that would become less common in patients age 65 and older. Methods Using data on age, gender, ASA Physical Status scores, and type of surgery from the National Anesthesia Clinical Outcomes Registry (NACOR), we used a quasi-experimental regression discontinuity design to analyze whether there was evidence for a discontinuity in reported ASA Physical Status scores occurring at age 65 for the non-deferrable anesthesia services accompanying hip, femur, or lower leg fracture repair. Results A total of 49,850 records were analyzed. In models designed to detect regression discontinuity at age 65, neither the binary variable “age ≥ 65” nor the interaction term of age*age ≥ 65 was a statistically significant predictor of the outcome of ASA Physical Status score. The statistical inference was unchanged when ASA Physical Status scores were reclassified as a binary outcome (1–2 vs. 3–5) and when different bandwidths around age 65 were used. To test the validity of our study design for detecting regression discontinuity, simulations of the occurrence of

  8. 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.

  9. Using Disguised Clinical Case Material

    ERIC Educational Resources Information Center

    Kantrowitz, Judy L.

    2010-01-01

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

  10. 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).

  11. Combined Registry for the Clinical Use of Mechanical Ventricular Assist Pumps and the Total Artificial Heart in conjunction with heart transplantation: sixth official report--1994.

    PubMed

    Mehta, S M; Aufiero, T X; Pae, W E; Miller, C A; Pierce, W S

    1995-01-01

    The Combined Registry has existed since 1985 with a design toward the voluntary submission of data from centers undertaking mechanical circulatory assistance. The compiled results of the Combined Registry for the Clinical Use of Mechanical Ventricular Assist Pumps and the Total Artificial Heart was reviewed and subjected to strict statistical evaluation. More than 2000 implanted devices have been reported through January 1994, and 584 of these have been placed with the intention of bridge to heart transplantation. Nearly 70% of these patients have subsequently undergone heart transplantation, and 69% of those patients have survived to discharge from the hospital. Outcome statistics continue to favor isolated left ventricular support, although only discharge rates are significantly improved over right (p = 0.01) or biventricular assistance (p < 0.001) and the total artificial heart (p < 0.001). Within the group of left ventricular devices no individual mode of support proved advantageous over the others for transplantation or discharge rates. The 30-day mortality for all devices is approximately 36%, which remains much higher than that for orthotopic heart transplants. Isolated left ventricular support, however, had a 30-day mortality of only 9% with similar improvement in 12- and 24-month survival. These data show the continued success with these devices for bridging critically ill patients to transplantation. Additionally, it supports the ongoing development of devices implanted for long-term use, which might replace orthotopic transplantation for those patients currently deemed marginal candidates.

  12. 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.

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

    PubMed Central

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

    2014-01-01

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

  14. Statistical Cluster Analysis of the British Thoracic Society Severe Refractory Asthma Registry: Clinical Outcomes and Phenotype Stability

    PubMed Central

    Newby, Chris; Heaney, Liam G.; Menzies-Gow, Andrew; Niven, Rob M.; Mansur, Adel; Bucknall, Christine; Chaudhuri, Rekha; Thompson, John; Burton, Paul; Brightling, Chris

    2014-01-01

    Background Severe refractory asthma is a heterogeneous disease. We sought to determine statistical clusters from the British Thoracic Society Severe refractory Asthma Registry and to examine cluster-specific outcomes and stability. Methods Factor analysis and statistical cluster modelling was undertaken to determine the number of clusters and their membership (N = 349). Cluster-specific outcomes were assessed after a median follow-up of 3 years. A classifier was programmed to determine cluster stability and was validated in an independent cohort of new patients recruited to the registry (n = 245). Findings Five clusters were identified. Cluster 1 (34%) were atopic with early onset disease, cluster 2 (21%) were obese with late onset disease, cluster 3 (15%) had the least severe disease, cluster 4 (15%) were the eosinophilic with late onset disease and cluster 5 (15%) had significant fixed airflow obstruction. At follow-up, the proportion of subjects treated with oral corticosteroids increased in all groups with an increase in body mass index. Exacerbation frequency decreased significantly in clusters 1, 2 and 4 and was associated with a significant fall in the peripheral blood eosinophil count in clusters 2 and 4. Stability of cluster membership at follow-up was 52% for the whole group with stability being best in cluster 2 (71%) and worst in cluster 4 (25%). In an independent validation cohort, the classifier identified the same 5 clusters with similar patient distribution and characteristics. Interpretation Statistical cluster analysis can identify distinct phenotypes with specific outcomes. Cluster membership can be determined using a classifier, but when treatment is optimised, cluster stability is poor. PMID:25058007

  15. Statistical cluster analysis of the British Thoracic Society Severe refractory Asthma Registry: clinical outcomes and phenotype stability.

    PubMed

    Newby, Chris; Heaney, Liam G; Menzies-Gow, Andrew; Niven, Rob M; Mansur, Adel; Bucknall, Christine; Chaudhuri, Rekha; Thompson, John; Burton, Paul; Brightling, Chris

    2014-01-01

    Severe refractory asthma is a heterogeneous disease. We sought to determine statistical clusters from the British Thoracic Society Severe refractory Asthma Registry and to examine cluster-specific outcomes and stability. Factor analysis and statistical cluster modelling was undertaken to determine the number of clusters and their membership (N = 349). Cluster-specific outcomes were assessed after a median follow-up of 3 years. A classifier was programmed to determine cluster stability and was validated in an independent cohort of new patients recruited to the registry (n = 245). Five clusters were identified. Cluster 1 (34%) were atopic with early onset disease, cluster 2 (21%) were obese with late onset disease, cluster 3 (15%) had the least severe disease, cluster 4 (15%) were the eosinophilic with late onset disease and cluster 5 (15%) had significant fixed airflow obstruction. At follow-up, the proportion of subjects treated with oral corticosteroids increased in all groups with an increase in body mass index. Exacerbation frequency decreased significantly in clusters 1, 2 and 4 and was associated with a significant fall in the peripheral blood eosinophil count in clusters 2 and 4. Stability of cluster membership at follow-up was 52% for the whole group with stability being best in cluster 2 (71%) and worst in cluster 4 (25%). In an independent validation cohort, the classifier identified the same 5 clusters with similar patient distribution and characteristics. Statistical cluster analysis can identify distinct phenotypes with specific outcomes. Cluster membership can be determined using a classifier, but when treatment is optimised, cluster stability is poor.

  16. [Astrocytoma and epilepsy. Clinical case].

    PubMed

    Moreno-Jiménez, Sergio; Miranda-Fernández, Karen Alejandra; García Gutiérrez, Mónica; Vázquez-Estrada, Norma; Müller-Grohmann, Stephanie; Flores-Vázquez, Fabiola

    2016-07-11

    Pilocytic astrocytoma is a rare tumour, usually occurring in paediatric ages, and mainly located in the posterior fossa. It can cause hydrocephalus and intracranial hypertension and, less frequently, seizures, or a focal neurological deficit. The main imaging study by magnetic resonance imaging, which shows a tumour with solid and cystic components without peri-lesional swelling. The election treatment is surgical, and the patient is considered cured if a total resection is accomplished. The case is presented of 22-year-old female patient with a supratentorial pilocytic astrocytoma and epilepsy. Histopathology reported a low grade glial proliferation, with an extensive fibrillar matrix, small cells without atypia, extensive calcifications and piloid areas consisting of bipolar fusiform cells, and some Rosenthal fibres. There were also spongiotic areas consisting of multipolar cells and associated microcysts. The final report was a pilocytic astrocytoma. Pilocytic astrocytoma is more frequent in paediatric patients and in the posterior fossa. The case presented is of a young female adult with supratentorial location, making it a special case. The surgery achieved a total resection. The long-term prognosis is good, but it is necessary to perform a follow-up, particularly in adult patients because of a higher risk of recurrence. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

  17. The Management of Schizophrenia in Clinical Practice (MOSAIC) Registry: a focus on patients, caregivers, illness severity, functional status, disease burden and healthcare utilization.

    PubMed

    Nasrallah, Henry A; Harvey, Philip D; Casey, Daniel; Csoboth, Csilla T; Hudson, James I; Julian, Laura; Lentz, Ellen; Nuechterlein, Keith H; Perkins, Diana O; Kotowsky, Nirali; Skale, Tracey G; Snowden, Lonnie R; Tandon, Rajiv; Tek, Cenk; Velligan, Dawn; Vinogradov, Sophia; O'Gorman, Cedric

    2015-08-01

    The Management of Schizophrenia in Clinical Practice (MOSAIC), a disease-based registry of schizophrenia, was initiated in December 2012 to address important gaps in our understanding of the impact and burden of schizophrenia and to provide insight into the current status of schizophrenia care in the US. Recruitment began in December 2012 with ongoing assessment continuing through May 2014. Participants were recruited from a network of 15 centralized Patient Assessment Centers supporting proximal care sites. Broad entry criteria included patients diagnosed with schizophrenia, schizophreniform or schizoaffective disorder, presenting within the normal course of care, in usual treatment settings, aged ≥18years and able to read and speak English. By May 2014, 550 participants (65.8% male, 59.8% White, 64.4% single, mean age 42.9years), were enrolled. The majority had a diagnosis of schizophrenia (62.0%). Mean illness duration at entry was 15.0years. Common comorbidities at entry were high lipid levels (26.9%), hypertension (23.1%) and type II diabetes (13%). Participants were categorized by baseline overall Clinical Global Impression-Schizophrenia Severity Score as minimally (9.1%), mildly (25.3%), moderately (39.9%), markedly (22.3%) and severely (3.4%) ill. Most commonly used second generation antipsychotics at entry were risperidone (17.8%), clozapine (16.5%), olanzapine (14.0%), aripiprazole (13.6%) and quetiapine (5.6%). No large-scale patient registry has been conducted in the US to longitudinally follow patients with schizophrenia and describe symptom attributes, support network, care access and disease burden. These data provide important epidemiological, clinical and outcome insights into the burden of schizophrenia in the US. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Registering Randomized Clinical Trials and the Case for CONSORT

    PubMed Central

    Elliott, Timothy R.

    2008-01-01

    Recent controversies in medical research and the increasing reliance on randomized clinical trials to inform evidence-based practice have prompted coordinated attempts to standardize reporting and register information about trials for consistency and transparency. The Consolidated Standards of Reporting Trials guidelines (D. G. Altman et al., 2001) and trial registry are described in this article, and the implications for clinical and experimental research in psychopharmacology are discussed. PMID:18179303

  19. [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.

  20. 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.

  1. Clinical and Genotypic Spectrum of Chronic Granulomatous Disease in 71 Latin American Patients: First Report from the LASID Registry.

    PubMed

    de Oliveira-Junior, Edgar Borges; Zurro, Nuria Bengala; Prando, Carolina; Cabral-Marques, Otavio; Pereira, Paulo Vitor Soeiro; Schimke, Lena-Friederick; Klaver, Stefanie; Buzolin, Marcia; Blancas-Galicia, Lizbeth; Santos-Argumedo, Leopoldo; Pietropaolo-Cienfuegos, Dino Roberto; Espinosa-Rosales, Francisco; King, Alejandra; Sorensen, Ricardo; Porras, Oscar; Roxo-Junior, Persio; Forte, Wilma Carvalho Neves; Orellana, Julio Cesar; Lozano, Alejandro; Galicchio, Miguel; Regairaz, Lorena; Grumach, Anete Sevciovic; Costa-Carvalho, Beatriz Tavares; Bustamante, Jacinta; Bezrodnik, Liliana; Oleastro, Matias; Danielian, Silvia; Condino-Neto, Antonio

    2015-12-01

    We analyzed data from 71 patients with chronic granulomatous disease (CGD) with a confirmed genetic diagnosis, registered in the online Latin American Society of Primary Immunodeficiencies (LASID) database. Latin American CGD patients presented with recurrent and severe infections caused by several organisms. The mean age at disease onset was 23.9 months, and the mean age at CGD diagnosis was 52.7 months. Recurrent pneumonia was the most frequent clinical condition (76.8%), followed by lymphadenopathy (59.4%), granulomata (49.3%), skin infections (42%), chronic diarrhea (41.9%), otitis (29%), sepsis (23.2%), abscesses (21.7%), recurrent urinary tract infection (20.3%), and osteomyelitis (15.9%). Adverse reactions to bacillus Calmette-Guérin (BCG) vaccination were identified in 30% of the studied Latin American CGD cases. The genetic diagnoses of the 71 patients revealed 53 patients from 47 families with heterogeneous mutations in the CYBB gene (five novel mutations: p.W361G, p.C282X, p.W483R, p.R226X, and p.Q93X), 16 patients with the common deletion c.75_76 del.GT in exon 2 of NCF1 gene, and two patients with mutations in the CYBA gene. The majority of Latin American CGD patients carry a hemizygous mutation in the CYBB gene. They also presented a wide range of clinical manifestations most frequently bacterial and fungal infections of the respiratory tract, skin, and lymph nodes. Thirty percent of the Latin American CGD patients presented adverse reactions to BCG, indicating that this vaccine should be avoided in these patients. © 2015 Wiley Periodicals, Inc.

  2. Contemporary profile of acute heart failure in Southern Nigeria: data from the Abeokuta Heart Failure Clinical Registry.

    PubMed

    Ogah, Okechukwu S; Stewart, Simon; Falase, Ayodele O; Akinyemi, Joshua O; Adegbite, Gail D; Alabi, Albert A; Ajani, Akinlolu A; Adesina, Julius O; Durodola, Amina; Sliwa, Karen

    2014-06-01

    The aim of this study was to determine the contemporary profile, clinical characteristics, and intrahospital outcomes of acute heart failure (AHF) in an African urban community. There are limited data on the current burden and characteristics of AHF in Nigerian Africans. Comprehensive and detailed clinical and sociodemographic data were prospectively collected from 452 consecutive patients presenting with AHF to the only tertiary hospital in Abeokuta, Nigeria (population about 1 million) over a 2-year period. The mean age was 56.6 ± 15.3 years (57.3 ± 13.4 years for men, 55.7 ± 17.1 years for women), and 204 patients (45.1%) were women. Overall, 415 subjects (91.8%) presented with de novo AHF. The most common risk factor for heart failure was hypertension (pre-existing in 64.3% of patients). Type 2 diabetes mellitus was present in 41 patients (10.0%). Hypertensive heart failure was the most common etiological cause of heart failure, responsible for 78.5% of cases. Dilated cardiomyopathy (7.5%), cor pulmonale (4.4%), pericardial disease (3.3%), rheumatic heart disease (2.4%), and ischemic heart disease were less common (0.4%) causes. The majority of subjects (71.2%) presented with left ventricular dysfunction (mean left ventricular ejection fraction 43.9 ± 9.0%), with valvular dysfunction and abnormal left ventricular geometry frequently documented. The mean duration of hospital stay was 11.4 ± 9.1 days, and intrahospital mortality was 3.8%. Compared with those in high-income countries, patients presenting with AHF in Abeokuta, Nigeria, are relatively younger and still of working age. It is also more common in men and associated with severe symptoms because of late presentation. Intrahospital mortality is similar to that in other parts of the world. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. 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

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

    PubMed

    Mølbak, Kåre; Hansen, Niels Dalum; Valentiner-Branth, Palle

    2016-01-01

    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. 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. 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 1.2-1.9). Before receiving the first HPV

  5. Five-year Prognosis after Mild to Moderate Ischemic Stroke by Stroke Subtype: A Multi-Clinic Registry Study

    PubMed Central

    Lv, Yumei; Fang, Xianghua; Asmaro, Karam; Liu, Hongjun; Zhang, Xinqing; Zhang, Hongmei; Qin, Xiaoming; Ji, Xunming

    2013-01-01

    Background and Purpose Mild to moderate ischemic stroke is a common presentation in the outpatient setting. Among the various subtypes of stroke, lacunar infarction (LI) is generally very common. Currently, little is known about the long-term prognosis and factors associated with the prognosis between LI and non-LI. This study aims to compare the risk of death and acute cardiovascular events between patients with LI and non-LI, and identify potential risk factors associated with these outcomes. Methods A total of 710 first-ever ischemic stroke patients (LI: 474, non-LI: 263) from 18 clinics were recruited consecutively from 2003 to 2004. They were prospectively followed-up until the end of 2008. Hazard ratios and 95% confidence intervals were calculated using multivariable Cox proportional hazards regression. Results After a 5-year follow up, 54 deaths and 96 acute cardiovascular events occurred. Recurrent stroke was the most common cause of death (19 cases, 35.18%) and new acute cardiovascular events (75 cases, 78.13%). There were no significant differences between patients with LI and non-LI in their risks of death, new cardiovascular events, and recurrent stroke after adjusting for age, sex, hypertension, diabetes, cardiac diseases, body mass index, dyslipidemia, smoking, alcohol consumption, ADL dependence, and depressive symptoms. Among the modifiable risk factors, diabetes, hypertension, ADL dependency, and symptoms of depression were independent predictors of poor outcomes in patients with LI. In non-LI patients, however, no modifiable risk factors were detected for poor outcomes. Conclusion Long-term outcomes did not differ significantly between LI and non-LI patients. Detecting and managing vascular risk factors and depression as well as functional rehabilitation may improve the prognoses of LI patients. PMID:24223696

  6. Pleuropulmonary Blastoma: A Report on 350 Central Pathology–Confirmed Pleuropulmonary Blastoma Cases by the International Pleuropulmonary Blastoma Registry

    PubMed Central

    Messinger, Yoav H.; Stewart, Douglas R.; Priest, John R.; Williams, Gretchen M.; Harris, Anne K.; Schultz, Kris Ann P.; Yang, Jiandong; Doros, Leslie; Rosenberg, Philip S.; Hill, D. Ashley; Dehner, Louis P.

    2014-01-01

    Background Pleuropulmonary blastoma (PPB) has 3 subtypes on a tumor progression pathway ranging from type I (cystic) to type II (cystic/solid) and type III (completely solid). A germline mutation in DICER1 is the genetic cause in the majority of PPB cases. Methods Patients confirmed to have PPB by central pathology review were included, and their clinical characteristics and outcomes were reported. Germline DICER1 mutations were sought with Sanger sequencing. Results There were 435 cases, and a central review confirmed 350 cases to be PPB; 85 cases (20%) were another entity. Thirty-three percent of the 350 PPB cases were type I or type I regressed (type Ir), 35% were type II, and 32% were type III or type II/III. The median ages at diagnosis for type I, type II, and type III patients were 8, 35, and 41 months, respectively. The 5-year overall survival (OS) rate for type I/Ir patients was 91%; all deaths in this group were due to progression to type II or III. OS was significantly better for type II versus type III (P=.0061); the 5-year OS rates were 71% and 53%, respectively. Disease-free survival (DFS) was also significantly better for type II versus type III (P=.0002); the 5-year DFS rates were 59% and 37%, respectively. The PPB type was the strongest predictor of outcome. Metastatic disease at the diagnosis of types II and III was also an independent unfavorable prognostic factor. Sixty-six percent of the 97 patients tested had a heterozygous germline DICER1 mutation. In this subset, the DICER1 germline mutation status was not related to the outcome. Conclusion Cystic type I/Ir PPB has a better prognosis than type II, and type II has a better outcome than type III. Surveillance of DICER1 carriers may allow the earlier detection of cystic PPB before its progression to type II or III PPB and thereby improve outcomes. PMID:25209242

  7. 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…

  8. 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…

  9. 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…

  10. [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.

  11. 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.

  12. Digital ulcers and cutaneous subsets of systemic sclerosis: Clinical, immunological, nailfold capillaroscopy, and survival differences in the Spanish RESCLE Registry.

    PubMed

    Tolosa-Vilella, Carles; Morera-Morales, Maria Lluisa; Simeón-Aznar, Carmen Pilar; Marí-Alfonso, Begoña; Colunga-Arguelles, Dolores; Callejas Rubio, José Luis; Rubio-Rivas, Manuel; Freire-Dapena, Maika; Guillén-Del Castillo, Alfredo; Iniesta-Arandia, Nerea; Castillo-Palma, Maria Jesús; Egurbide-Arberas, Marivi; Trapiellla-Martínez, Luis; Vargas-Hitos, José A; Todolí-Parra, José Antonio; Rodriguez-Carballeira, Mónica; Marin-Ballvé, Adela; Pla-Salas, Xavier; Rios-Blanco, Juan José; Fonollosa-Pla, Vicent

    2016-10-01

    Digital ulcers (DU) are the most common vascular complication of systemic sclerosis (SSc). We compared the characteristics between patients with prior or current DU with those never affected and evaluated whether a history of DU may be a predictor of vascular, organ involvement, and/or death in patients with SSc. Data from SSc patients with or without prior or current DU were collected by 19 referral centers in an ongoing registry of Spanish SSc patients, named Registro de ESCLErodermia (RESCLE). Demographics, organ involvement, autoimmunity features, nailfold capillary pattern, survival time, and causes of death were analyzed to identify DU related characteristics and survival of the entire series and according to the following cutaneous subsets-diffuse cutaneous SSc (dcSSc), limited cutaneous SSc (lcSSc), and SSc sine scleroderma (ssSSc). Out of 1326, 552 patients enrolled in the RESCLE registry had prior or current DU, 88% were women, the mean age was 50 ± 16 years, and the mean disease duration from first SSc symptom was 7.6 ± 9.6 years. Many significant differences were observed in the univariate analysis between patients with and without prior/current DU. Multivariate analysis identified that history of prior/current DU in patients with SSc was independently associated to younger age at SSc diagnosis, diffuse cutaneous SSc, peripheral vascular manifestations such Raynaud's phenomenon, telangiectasia, and acro-osteolysis but no other vascular features such as pulmonary arterial hypertension or scleroderma renal crisis. DU was also associated to calcinosis cutis, interstitial lung disease, as well as worse survival. Multivariate analysis performed in the cutaneous subsets showed that prior/current DU were independently associated: (1) in dcSSc, to younger age at SSc diagnosis, presence of telangiectasia and calcinosis and rarely a non-SSc pattern on nailfold capillaroscopy; (2) in lcSSc, to younger age at SSc diagnosis, presence of Raynaud's phenomenon as

  13. Evaluation of the measles clinical case definition.

    PubMed

    Hutchins, Sonja S; Papania, Mark J; Amler, Robert; Maes, Edward F; Grabowsky, Mark; Bromberg, Kenneth; Glasglow, Victoria; Speed, Tamika; Bellini, William J; Orenstein, Walter A

    2004-05-01

    An accurate system of identifying and classifying suspected measles cases is critical for the measles surveillance system in the United States. To examine the performance of the clinical case definition in predicting laboratory confirmation of suspected cases of measles, we reviewed 4 studies conducted between 1981 and 1994. A clinical case definition was examined that included a generalized maculopapular rash, fever (>or=38.3 degrees C, if measured), and either a cough, coryza, or conjunctivitis. Serological confirmation of measles was done either by hemagglutination inhibition assay, complement fixation assay, or enzyme immunoassays. The positive predictive value of the clinical case definition decreased from 74% to 1% as incidence decreased from 171 cases/100000 population to 1.3 cases/100000 population. Sensitivity was high, and for the larger studies with the most precise estimates, sensitivity was 76%-88%. The low positive predictive value of the clinical case definition in settings of low incidence demonstrates that serological confirmation is essential to ensure an accurate diagnosis of measles when measles is rare.

  14. A novel clinical score (InterTAK Diagnostic Score) to differentiate takotsubo syndrome from acute coronary syndrome: results from the International Takotsubo Registry.

    PubMed

    Ghadri, Jelena R; Cammann, Victoria L; Jurisic, Stjepan; Seifert, Burkhardt; Napp, L Christian; Diekmann, Johanna; Bataiosu, Dana Roxana; D'Ascenzo, Fabrizio; Ding, Katharina J; Sarcon, Annahita; Kazemian, Elycia; Birri, Tanja; Ruschitzka, Frank; Lüscher, Thomas F; Templin, Christian

    2017-08-01

    Clinical presentation of takotsubo syndrome (TTS) mimics acute coronary syndrome (ACS) and does not allow differentiation. We aimed to develop a clinical score to estimate the probability of TTS and to distinguish TTS from ACS in the acute stage. Patients with TTS were recruited from the International Takotsubo Registry ( www.takotsubo-registry.com) and ACS patients from the leading hospital in Zurich. A multiple logistic regression for the presence of TTS was performed in a derivation cohort (TTS, n = 218; ACS, n = 436). The best model was selected and formed a score (InterTAK Diagnostic Score) with seven variables, and each was assigned a score value: female sex 25, emotional trigger 24, physical trigger 13, absence of ST-segment depression (except in lead aVR) 12, psychiatric disorders 11, neurologic disorders 9, and QTc prolongation 6 points. The area under the curve (AUC) for the resulting score was 0.971 [95% confidence interval (CI) 0.96-0.98] and using a cut-off value of 40 score points, sensitivity was 89% and specificity 91%. When patients with a score of ≥50 were diagnosed as TTS, nearly 95% of TTS patients were correctly diagnosed. When patients with a score ≤31 were diagnosed as ACS, ∼95% of ACS patients were diagnosed correctly. The score was subsequently validated in an independent validation cohort (TTS, n = 173; ACS, n = 226), resulting in a score AUC of 0.901 (95% CI 0.87-0.93). The InterTAK Diagnostic Score estimates the probability of the presence of TTS and is able to distinguish TTS from ACS with a high sensitivity and specificity. NCT0194762. © 2016 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

  15. Clinical outcome of successful percutaneous coronary intervention for chronic total occlusion: results from the multicenter Korean Chronic Total Occlusion (K-CTO) registry.

    PubMed

    Kim, Byeong-Keuk; Shin, Sanghoon; Shin, Dong-Ho; Hong, Myeong-Ki; Gwon, Hyeon-Cheol; Kim, Hyo-Soo; Yu, Cheol Woong; Park, Hun Sik; Chae, In-Ho; Rha, Seung-Woon; Lee, Seung-Hwan; Kim, Moo-Hyun; Hur, Seung-Ho; Jang, Yangsoo

    2014-06-01

    To investigate the impact of the success or failure of chronic total occlusion (CTO) interventions on the clinical outcomes in the current drug-eluting stent (DES) era. The impact of the successful CTO intervention on long-term clinical outcomes still remains unclear. Between 2007 and 2009, a total of 2568 patients with CTO were followed in a multicenter Korean CTO registry. Of these, successful recanalization with DESs occurred in 2045 patients (successful CTO group), whereas failure occurred in 523 patients (failed CTO group). The occurrence of the composite of cardiac death and myocardial infarction (MI) was compared between the successful CTO and failed CTO groups. During follow-up (median duration, 729 days), the occurrence of cardiac death or MI was significantly lower in the successful CTO group than in the failed CTO group (1.7% vs 3.3%; hazard ratio, 0.50; 95% confidence interval, 0.28-0.91; P=.02) and the cumulative occurrence in the successful CTO group was also significantly lower than in the failed CTO group (1.7% vs 3.0%; P=.03) by the Kaplan-Meier method. The successful CTO group had a significantly lower need for bypass surgery than the failed CTO group (0.2% vs 2.5%; P<.001). In multivariate analysis, procedural success of CTO (odds ratio, 0.51; 95% CI, 0.29-0.92) was significantly predictive of the occurrence of cardiac death or MI, together with age and left ventricular ejection fraction <40%. This registry study demonstrated that successful CTO intervention with DESs compared to failed CTO intervention was associated with lower event rates during follow-up.

  16. Impact of smoking status on clinical outcomes after successful chronic total occlusion intervention: Korean national registry of CTO intervention.

    PubMed

    Lee, Min-Ho; Park, Jin Joo; Yoon, Chang-Hwan; Cha, Myung-Jin; Park, Sang-Don; Oh, Il-Young; Suh, Jung-Won; Cho, Young-Seok; Youn, Tae-Jin; Rha, Seung-Woon; Yu, Cheol Woong; Gwon, Hyeon-Cheol; Jang, Yangsoo; Kim, Hyo-Soo; Chae, In-Ho; Choi, Dong-Ju

    2016-05-01

    We sought to evaluate the effect of cigarette smoking on long-term outcomes after successful percutaneous coronary intervention for chronic total occlusion (CTO) lesions. Cigarette smoking promotes the progression of atherosclerosis but enhances the antiplatelet effect of clopidogrel. The Korea National Registry of CTO Intervention included 2,167 patients with CTO lesions from 26 centers who were successfully revascularized with drug-eluting stents from 2007 to 2009. Thrombotic events were defined as the composite of cardiac death, nonfatal myocardial infarction, and stent thrombosis. Current-smokers had more favorable baseline characteristics such as a younger age and lower prevalence of hypertension and diabetes mellitus. At 1 year, current-smokers had a significantly lower thrombotic event rate (1.1% vs. 2.7%, P = 0.034), but a significantly higher target vessel revascularization (TVR) rate (7.2% vs. 4.2%, P = 0.017) compared with never-smokers. After adjustment, current-smoking was independently associated with a 72% decreased risk for thrombotic events, and 73% increased risk for TVR. In patients with a revascularized CTO lesion, cigarette smoking is associated with fewer thrombotic events but with a higher incidence of TVR. Patients with CTO may benefit from smoking cessation to reduce TVR in conjunction with the use of new more potent antiplatelet agents whose effect is independent of cigarette smoking to improve thrombotic events. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  17. Clinical predictors for fatal pulmonary embolism in 15,520 patients with venous thromboembolism: findings from the Registro Informatizado de la Enfermedad TromboEmbolica venosa (RIETE) Registry.

    PubMed

    Laporte, Silvy; Mismetti, Patrick; Décousus, Hervé; Uresandi, Fernando; Otero, Remedios; Lobo, Jose Luis; Monreal, Manuel

    2008-04-01

    Clinical predictors for fatal pulmonary embolism (PE) in patients with venous thromboembolism have never been studied. Using data from the international prospective Registro Informatizado de la Enfermedad TromboEmbolica venosa (RIETE) registry about patients with objectively confirmed symptomatic acute venous thromboembolism, we determined independent predictive factors for fatal PE. Between March 2001 and July 2006, 15 520 consecutive patients (mean age+/-SD, 66.3+/-16.9 years; 49.7% men) with acute venous thromboembolism were included. Symptomatic deep-vein thrombosis without symptomatic PE was observed in 58.0% (n=9008) of patients, symptomatic nonmassive PE in 40.4% (n=6264), and symptomatic massive PE in 1.6% (n=248). At 3 months, the cumulative rates of overall mortality and fatal PE were 8.65% and 1.68%, respectively. On multivariable analysis, patients with symptomatic nonmassive PE at presentation exhibited a 5.42-fold higher risk of fatal PE compared with patients with deep-vein thrombosis without symptomatic PE (P<0.001). The risk of fatal PE was multiplied by 17.5 in patients presenting with a symptomatic massive PE. Other clinical factors independently associated with an increased risk of fatal PE were immobilization for neurological disease, age >75 years, and cancer. PE remains a potentially fatal disease. The clinical predictors identified in the present study should be included in any clinical risk stratification scheme to optimally adapt the treatment of PE to the risk of the fatal outcome.

  18. 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.

  19. Catastrophic antiphospholipid syndrome (CAPS): update from the 'CAPS Registry'.

    PubMed

    Cervera, R

    2010-04-01

    Although less than 1% of patients with the antiphospholipid syndrome (APS) develop the catastrophic variant, its potentially lethal outcome emphasizes its importance in clinical medicine today. However, the rarity of this variant makes it extraordinarily difficult to study in any systematic way. In order to put together all of the published case reports as well as the new diagnosed cases from all over the world, an international registry of patients with catastrophic APS (CAPS Registry) was created in 2000 by the European Forum on Antiphospholipid Antibodies (see http://www.med.ub.es/MIMMUN/FORUM/CAPS.HTM). Currently, it documents the entire clinical, laboratory and therapeutic data of more than 300 patients whose data has been fully registered.

  20. 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

  1. International importance of robust breast device registries.

    PubMed

    Cooter, Rodney D; Barker, Shane; Carroll, Sean M; Evans, Gregory R D; von Fritschen, Uwe; Hoflehner, Helmut; Le Louarn, Claude; Lumenta, David B; Mathijssen, Irene M J; McNeil, John; Mulgrew, Stephen; Mureau, Marc A M; Perks, Graeme; Rakhorst, Hinne; Randquist, Charles; Topaz, Moris; Verheyden, Charles; de Waal, John

    2015-02-01

    Breast implants are high-risk devices that have been at the epicenter of much debate and controversy. In light of the Poly Implant Prothèse crisis, data registries among 11 national societies around the world are cooperatively calling for the urgent need to establish robust national clinical quality registries based on international best practice within a framework of international collaboration. A survey was conducted on the historic and current status of national breast device registries. Eleven countries participated in the study, illustrating different data collection systems and registries around the world. Data collection was designed to illustrate the capabilities of current national registries, with particular focus on capture rate and outcome reporting mechanisms. A study of national breast implant registries revealed that less than half of the participating countries had operational registries and that none of these had adequately high data capture to enable reliable outcome analysis. The study revealed that the two most common problems that discouraged participation are the complexity of data sets and the opt-in consent model. Recent implant crises have highlighted the need for robust registries. This article argues the importance of securing at least 90 percent data capture, which is achievable through the opt-out consent model. Since adopting this model, the Australian Breast Device Registry has increased data capture from 4 percent to over 97 percent. Simultaneously, it is important to foster international collaboration from the outset to avoid duplication of efforts and enable the development of effective international early warning systems.

  2. Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics.

    PubMed

    Burn, Julie; Sims, Andrew J; Keltie, Kim; Patrick, Hannah; Welham, Sally A; Heaney, Liam G; Niven, Robert M

    2016-12-01

    Bronchial thermoplasty (BT) is a novel treatment for severe asthma. Its mode of action and ideal target patient group remain poorly defined, though clinical trials provided some evidence on efficacy and safety. This study presents procedural and short-term safety evidence from routine UK clinical practice. Patient characteristics and safety outcomes (procedural complications, 30-day readmission and accident and emergency (A&E) attendance, length of stay) were assessed using two independent data sources, the British Thoracic Society UK Difficult Asthma Registry (DAR) and Hospital Episodes Statistics (HES) database. A matched cohort (with records in both) was used to estimate safety outcome event rates and compare them with clinical trials. Between June 2011 and January 2015, 215 procedure records (83 patients; 68 treated in England) were available from DAR and 203 (85 patients) from HES. 152 procedures matched (59 patients; 6 centres), and of these, 11.2% reported a procedural complication, 11.8% resulted in emergency respiratory readmission, 0.7% in respiratory A&E attendance within 30 days (20.4% had at least one event) and 46.1% involved a post-procedure stay. Compared with published clinical trials which found lower hospitalisation rates, BT patients in routine clinical practice were, on average, older, had worse baseline lung function and asthma quality of life. A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.

  3. 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.

  4. Inclusion of 'minor' trauma cases provides a better estimate of the total burden of injury: Queensland Trauma Registry provides a unique perspective.

    PubMed

    Lang, Jacelle; Dallow, Natalie; Lang, Austin; Tetsworth, Kevin; Harvey, Kathy; Pollard, Cliff; Bellamy, Nicholas

    2014-08-01

    Injury is recognised as a frequent cause of preventable mortality and morbidity; however, incidence estimates focusing only on the extent of mortality and major trauma may seriously underestimate the magnitude of the total injury burden. There currently exists a paucity of information regarding minor trauma, and the aim of this study was to increase awareness of the contribution of minor trauma cases to the total burden of injury. The demographics, injury details, acute care factors and outcomes of both minor trauma cases and major trauma cases were evaluated using data from the state-wide trauma registry in Queensland, Australia, from 2005 to 2010. The impact of changes in Abbreviated Injury Scale (AIS) versions on the classification of minor and major injury cases was also assessed. Over the 6-year period, minor cases [Injury Severity Score (ISS) ≤ 12] accounted for almost 90% of all trauma included on the Queensland Trauma Registry (QTR). These cases utilised more than half a million acute care bed days, underwent more than 66,500 operations, and accounted for more than 48,000 patient transport episodes via road ambulance, fixed wing aircraft, or helicopter. Furthermore, more than 5800 minor trauma cases utilised in-hospital rehabilitation services; almost 3000 were admitted to an ICU; and more than 20,000 were admitted to hospital for greater than one week. When using the contemporary criteria for classifying trauma (AIS 08), the proportion of cases classified as minor trauma (87.7%) and major trauma (12.3%) were similar to the proportion using the traditional criteria for AIS90 (87.9% and 12.1%, respectively). This evaluation of minor trauma cases admitted to public hospitals in Queensland detected high levels of demand placed on trauma system resources in terms of acute care bed days, operations, ICU admissions, in-hospital rehabilitation services and patient transportation, and which are all associated with high cost. These data convincingly demonstrate

  5. Pleuropulmonary blastoma: a report on 350 central pathology-confirmed pleuropulmonary blastoma cases by the International Pleuropulmonary Blastoma Registry.

    PubMed

    Messinger, Yoav H; Stewart, Douglas R; Priest, John R; Williams, Gretchen M; Harris, Anne K; Schultz, Kris Ann P; Yang, Jiandong; Doros, Leslie; Rosenberg, Philip S; Hill, D Ashley; Dehner, Louis P

    2015-01-15

    Pleuropulmonary blastoma (PPB) has 3 subtypes on a tumor progression pathway ranging from type I (cystic) to type II (cystic/solid) and type III (completely solid). A germline mutation in DICER1 is the genetic cause in the majority of PPB cases. Patients confirmed to have PPB by central pathology review were included, and their clinical characteristics and outcomes were reported. Germline DICER1 mutations were sought with Sanger sequencing. There were 435 cases, and a central review confirmed 350 cases to be PPB; 85 cases (20%) were another entity. Thirty-three percent of the 350 PPB cases were type I or type I regressed (type Ir), 35% were type II, and 32% were type III or type II/III. The median ages at diagnosis for type I, type II, and type III patients were 8, 35, and 41 months, respectively. The 5-year overall survival (OS) rate for type I/Ir patients was 91%; all deaths in this group were due to progression to type II or III. OS was significantly better for type II versus type III (P = .0061); the 5-year OS rates were 71% and 53%, respectively. Disease-free survival (DFS) was also significantly better for type II versus type III (P = .0002); the 5-year DFS rates were 59% and 37%, respectively. The PPB type was the strongest predictor of outcome. Metastatic disease at the diagnosis of types II and III was also an independent unfavorable prognostic factor. Sixty-six percent of the 97 patients tested had a heterozygous germline DICER1 mutation. In this subset, the DICER1 germline mutation status was not related to the outcome. Cystic type I/Ir PPB has a better prognosis than type II, and type II has a better outcome than type III. Surveillance of DICER1 carriers may allow the earlier detection of cystic PPB before its progression to type II or III PPB and thereby improve outcomes. © 2014 American Cancer Society.

  6. 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.

  7. Next-Generation Registries: Fusion of Data for Care, and Research

    PubMed Central

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

    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. PMID:24303257

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

    PubMed

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

    2016-05-01

    Registries are useful to address questions that are difficult to answer in clinical trials. The objective of this study was to describe and compare two heart failure (HF) cohorts from two Spanish HF registries. We compared the RICA and EAHFE registries, both of which are prospective multicentre cohort studies including patients with decompensated HF consecutively admitted to internal medicine wards (RICA) or attending the emergency department (EAHFE). From the latter registry we only included patients who were admitted to internal medicine wards. A total of 5137 patients admitted to internal medicine wards were analysed (RICA: 3287 patients; EAHFE: 1850 patients). Both registries included elderly patients (RICA: mean (SD) age 79 (9) years; EAHFE: mean (SD) age 81 (9) years), with a slight predominance of female gender (52% and 58%, respectively, in the RICA and EAHFE registries) and with a high proportion of patients with preserved ejection fraction (58% and 62%, respectively). Some differences in comorbidities were noted, with diabetes mellitus, dyslipidaemia, chronic renal failure and atrial fibrillation being more frequent in the RICA registry while cognitive and functional impairment predominated in the EAHFE registry. The 30-day mortality after discharge was 3.4% in the RICA registry and 4.8% in the EAHFE registry (p<0.05) and the 30-day readmission rate was 7.5% in the RICA registry (readmission to hospital) and 24.0% in the EAHFE registry (readmission to emergency department) (p<0.001). We found differences in the clinical characteristics of patients admitted to Spanish internal medicine wards for decompensated HF depending on inclusion in either the RICA or EAHFE registry. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. Long-Term Clinical Outcomes of Final Kissing Ballooning in Coronary Bifurcation Lesions Treated With the 1-Stent Technique: Results From the COBIS II Registry (Korean Coronary Bifurcation Stenting Registry).

    PubMed

    Yu, Cheol Woong; Yang, Jeong Hoon; Song, Young Bin; Hahn, Joo-Yong; Choi, Seung-Hyuk; Choi, Jin-Ho; Lee, Hyun Jong; Oh, Ju Hyeon; Koo, Bon-Kwon; Rha, Seung Woon; Jeong, Jin-Ok; Jeong, Myung-Ho; Yoon, Jung Han; Jang, Yangsoo; Tahk, Seung-Jea; Kim, Hyo-Soo; Gwon, Hyeon-Cheol

    2015-08-24

    This study investigated the impact of final kissing ballooning (FKB) after main vessel (MV) stenting on outcomes in patients with coronary bifurcation lesions after application of the 1-stent technique. Although FKB has been established as the standard method for bifurcation lesions treated with a 2-stent strategy, its efficacy in a 1-stent approach is highly controversial. This study enrolled 1,901 patients with a bifurcation lesion with a side branch diameter ≥2.3 mm, treated solely with the 1-stent technique using a drug-eluting stent from 18 centers in Korea between January 1, 2003 and December 31, 2009. The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction, or target lesion revascularization. Propensity score-matching analysis was also performed. FKB was performed in 620 patients and the post minimal lumen diameter of the MV and side branch was larger in the FKB group than in the non-FKB group. During follow-up (median 36 months), the incidence of MACE (adjusted hazard ratio [HR]: 0.68, 95% confidence interval [CI]: 0.46 to 0.99; p = 0.048) was lower in the FKB group than the non-FKB group. After propensity score matching (545 pairs), the FKB group had a lower incidence of MACE (adjusted HR: 0.50, 95% CI: 0.30 to 0.85; p = 0.01), and target lesion revascularization in the MV (adjusted HR: 0.51, 95% CI: 0.28 to 0.93; p = 0.03) and both vessels (adjusted HR: 0.47, 95% CI: 0.25 to 0.90; p = 0.02) than in the non-FKB group. In coronary bifurcation lesions, we demonstrated that the 1-stent technique with FKB was associated with a favorable long-term clinical outcome, mainly driven by the reduction of target lesion revascularization in the MV or both vessels as a result of an increase in minimal lumen diameter. (Korean Coronary Bifurcation Stenting Registry II [COBIS II]: NCT01642992). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. Five-year analysis of a multi-institutional prospective clinical trial of delayed intervention and surveillance for small renal masses: the DISSRM registry.

    PubMed

    Pierorazio, Phillip M; Johnson, Michael H; Ball, Mark W; Gorin, Michael A; Trock, Bruce J; Chang, Peter; Wagner, Andrew A; McKiernan, James M; Allaf, Mohamad E

    2015-09-01

    A growing body of retrospective literature is emerging regarding active surveillance (AS) for patients with small renal masses (SRMs). There are limited prospective data evaluating the effectiveness of AS compared to primary intervention (PI). To determine the characteristics and clinical outcomes of patients who chose AS for management of their SRM. From 2009 to 2014, the multi-institutional Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) registry prospectively enrolled 497 patients with solid renal masses ≤4.0cm who chose PI or AS. AS versus PI. The registry was designed and powered as a noninferiority study based on historic recurrence rates for PI. Analyses were performed in an intention-to-treat manner. Primary outcomes were overall survival (OS) and cancer-specific survival (CSS). Of the 497 patients enrolled, 274 (55%) chose PI and 223 (45%) chose AS, of whom 21 (9%) crossed over to delayed intervention. AS patients were older, had worse Eastern Cooperative Oncology Group scores, total comorbidities, and cardiovascular comorbidities, had smaller tumors, and more often had multiple and bilateral lesions. OS for PI and AS was 98% and 96% at 2 yr, and 92% and 75% at 5 yr, respectively (log rank, p=0.06). At 5 yr, CSS was 99% and 100% for PI and AS, respectively (p=0.3). AS was not predictive of OS or CSS in regression modeling with relatively short follow-up. In a well-selected cohort with up to 5 yr of prospective follow-up, AS was not inferior to PI. The current report is among the first prospective analyses of patients electing for active surveillance of a small renal mass. Discussion of active surveillance should become part of the standard discussion for management of small renal masses. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  11. [Effects of statin use on intracranial hemorrhage and clinical outcome after intravenous rt-PA for acute ischemic stroke: SAMURAI rt-PA registry].

    PubMed

    Makihara, Noriko; Okada, Yasushi; Koga, Masatoshi; Shiokawa, Yoshiaki; Nakagawara, Jyoji; Furui, Eisuke; Kimura, Kazumi; Yamagami, Hiroshi; Hasegawa, Yasuhiro; Kario, Kazuomi; Okuda, Satoshi; Naganuma, Masaki; Toyoda, Kazunori

    2010-04-01

    We evaluated whether pre- and post-stroke statin use was associated with intracranial hemorrhage (ICH) and clinical outcome at 3 months after intravenous recombinant tissue plasminogen activator (IV rt-PA) for acute ischemic stroke. This study enrolled 600 consecutive patients (72 +/- 12 years, woman 37.2%) who received IV rt-PA at ten stroke centers that participated in the SAMURAI rt-PA Registry from October 2005 to July 2008. Statins were used prior to stroke in 112% and within 72 h after IV rt-PA in 10.0% of patients. One hundred nineteen patients (19.8%) developed ICH. Pre-stroke statin use was not an independent factor associated with ICH (OR 1.46; 95% CI 0.76-2.81, p = 0.225). Of 535 patients with a premorbid mRS < or = 1, 199 (37.2%) had a favorable clinical outcome at 3 months (mRS < or = 1). Pre-stroke statin use (OR 1.05; 95% CI 0.55-2.01, p = 0.879), as well as post-stroke statin use (OR 1.31; 95% CI 0.66-2.59, p = 0.440), was not an independent predictor of outcome. In patients who received IV rt-PA for acute ischemic stroke, statin use did not increase ICH after thrombolysis, nor was it associated with clinical outcome.

  12. Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry.

    PubMed

    Gonzalez-Ruiz, Armando; Gargalianos-Kakolyris, Panayiotis; Timerman, Artur; Sarma, Jayanta; José González Ramallo, Víctor; Bouylout, Kamel; Trostmann, Uwe; Pathan, Rashidkhan; Hamed, Kamal

    2015-06-01

    The aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections. Patients were enrolled in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)), a non-interventional, multicenter, observational registry. The real-world data were collected across 18 countries (Europe, Latin America, and Asia) for patients who had received at least one dose of daptomycin between January 2006 and April 2012. Two-year follow-up data were collected until 2014 for patients with endocarditis, intracardiac/intravascular device infection, osteomyelitis, or orthopedic device infection. A total of 6075 patients were enrolled. The most common primary infections were complicated skin and soft tissue infection (31.7%) and bacteremia (20.7%). Staphylococcus aureus was the most frequently reported pathogen (42.9%; methicillin-resistant S. aureus [MRSA], 23.2%), followed by Staphylococcus epidermidis and other coagulase-negative staphylococci (CoNS, 28.5%). The most commonly prescribed dose of daptomycin was 6 mg/kg/day (43.6%), and the median duration of therapy was 11 (range 1-300) days. Overall clinical success rate was 80.5%, and was similar whether daptomycin was used as first-line (82.9%) or second-line (79.2%) therapy. Clinical success rates were high in patients with S. aureus (83.9%; MRSA 83.0%) and CoNS (including S. epidermidis, 82.5%) infections. The majority of patients with endocarditis or intracardiac/intravascular device infection (86.7%) or osteomyelitis/orthopedic device infection (85.9%) had a sustained response during the 2-year follow-up period. There were no new or unexpected safety findings. Results from real-world clinical experience showed that daptomycin is a valuable therapeutic option in the management of various difficult-to-treat Gram-positive infections. This study was funded by Novartis Pharma AG.

  13. Are Cancer Registries Unconstitutional?

    PubMed Central

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

    2010-01-01

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

  14. 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.

  15. [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.

  16. 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

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

    PubMed Central

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

    2013-01-01

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

  18. Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system.

    PubMed

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

    2013-10-25

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

  19. Spanish Registry of Patients With Alpha-1 Antitrypsin Deficiency: Database Evaluation and Population Analysis.

    PubMed

    Lara, Beatriz; Blanco, Ignacio; Martínez, María Teresa; Rodríguez, Esther; Bustamante, Ana; Casas, Francisco; Cadenas, Sergio; Hernández, José M; Lázaro, Lourdes; Torres, María; Curi, Sergio; Esquinas, Cristina; Dasí, Francisco; Escribano, Amparo; Herrero, Inés; Martínez-Delgado, Beatriz; Michel, Francisco Javier; Rodríguez-Frías, Francisco; Miravitlles, Marc

    2017-01-01

    REDAAT, the Spanish Registry of Patients with Alpha-1 Antitrypsin Deficiency, was set up in order to improve knowledge of this disease. This study is an evaluation of the registry and an analysis of its patient population. The registry has a database hosted on the website www.redaat.es. It collects clinical and functional data on patients with PiSZ, ZZ phenotypes and other rare variants. Thanks to the collaboration of 124 physicians, the registry currently contains information on 511 individuals from 103 healthcare centers. Of these 511, 348 (74.2%) are Pi*ZZ homozygotes, and 100 (19.5%) are Pi*SZ heterozygotes. More cases are seen in tertiary level hospitals. A total of 81% of the cases have respiratory disease, and a lower proportion of AATD cases were detected by family screening or liver disease. Follow-up data are available for 45% of the cases, and 35% received alpha-1 antitripsin replacement therapy. The REDAAT registry is a useful tool for obtaining quality information about this minority disease in routine clinical practice conditions, although it is difficult to obtain follow-up data, and the representativeness of the sample included cannot be determined. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

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

    PubMed Central

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

    2015-01-01

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

  1. [Report of an amyopathic dermatomyositis clinical case].

    PubMed

    Monteiro, Paulo; Duarte, Cátia; Salvador, Maria João; Malcata, Armando

    2009-01-01

    The authors report a clinical case of a 41-years-old man with astenia and myalgias maintained for many years without an accurate diagnosis. Amyopathic dermatomyositis was diagnosed based on the presence of typical cutaneous lesions and the absence of myositis. Subsequent evidence of subclinical myositis allowed the diagnosis of hypomyophatic dermatomyositis. Finally, the diagnosis of classical dermatomyositis could be made when the patient presented elevated levels of muscle enzimes. There was a good clinical response to imunossupressor therapy and the patient remains asymptomatic. Differences in the clinical management of amyopathic, hypomyopathic and classic dermatomyositis are discussed.

  2. 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

  3. [Geographical differences in clinical characteristics and management of stable outpatients with coronary artery disease: comparison between the Italian and international population included in the Worldwide CLARIFY registry].

    PubMed

    Pozzoli, Massimo; Tavazzi, Luigi

    2014-04-01

    Limited data are available regarding specific differences among countries in demographic and clinical characteristics and treatment of patients with stable coronary artery disease. CLARIFY is an international, prospective and longitudinal registry including more than 33 000 patients with stable coronary artery disease enrolled in 45 countries worldwide. Data were used to compare the characteristics of patients enrolled in Italy with those enrolled in Europe and in the rest of the world. Baseline data were available for 33 283 patients, 2112 of whom from Italy and 12 614 from the remaining western European countries. Italian patients were found to be older, more frequently smoker, hypertensive and with sedentary habits. In addition, they presented more frequently a history of myocardial infarction, carotid arterial disease and chronic obstructive pulmonary disease. In addition, when compared with patients of both European and international cohorts, more Italian patients had undergone coronary angiography and angioplasty. As far as treatment was concerned, a greater number of Italian patients were taking ivabradine, angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers, nitrates, thienopyridines, while those taking beta-blockers, calcium antagonists and other antianginal medications were fewer. Among ambulatory patients with stable coronary artery disease, there are important geographic differences in terms of risk factors, clinical characteristics, surgical and pharmacological treatment.

  4. 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.

  5. 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

  6. [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.

  7. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

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

  8. 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

  9. Marketing and clinical trials: a case study

    PubMed Central

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

    2007-01-01

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

  10. Marketing and clinical trials: a case study.

    PubMed

    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

    2007-11-20

    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. 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. 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. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  11. 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.

  12. The use of a registry database in clinical trial design: assessing the influence of entry criteria on statistical power and number of eligible patients.

    PubMed

    Peelen, Linda; Peek, Niels; de Jonge, Evert; Scheffer, Gert Jan; de Keizer, Nicolette F

    2007-01-01

    Randomized clinical trials (RCTs) are prospective empirical studies used to investigate the effect of a particular medical intervention. The design of a clinical trial is a delicate decision process, as each of the decisions that are taken in this process influences the eventual result of the clinical trial. Despite the efforts that are put into trial design, many trials fail to show an effect of the intervention. In some of these situations the intervention may be truly ineffective, however, more often this is caused by problems with the inclusion of patients and a resulting lack of statistical power to show the effect. To avoid this problem, in the design of a trial, the statistical power that can be achieved with the current design choices is calculated and balanced with economic considerations. In the choice of the entry criteria however, an important step in the design process, the influence of the chosen criteria on statistical power and number of eligible patients is not quantified. As these criteria influence the characteristics of the study population and the number of patients that will be eligible for the trial, and thereby the chances of finding an effect of the intervention, we believe that also in the choice of entry criteria explicit estimates of the number of eligible patients should be made. This paper presents a method to arrive at precise, objective estimates of statistical power and the number of eligible patients, using a registry database. Furthermore, we describe how this method is incorporated in the process of choosing entry criteria for a clinical trial. We illustrate the method with an example in the area of severe sepsis.

  13. 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

  14. The efficacy of lumbar discectomy and single-level fusion for spondylolisthesis: results from the NeuroPoint-SD registry: clinical article.

    PubMed

    Ghogawala, Zoher; Shaffrey, Christopher I; Asher, Anthony L; Heary, Robert F; Logvinenko, Tanya; Malhotra, Neil R; Dante, Stephen J; Hurlbert, R John; Douglas, Andrea F; Magge, Subu N; Mummaneni, Praveen V; Cheng, Joseph S; Smith, Justin S; Kaiser, Michael G; Abbed, Khalid M; Sciubba, Daniel M; Resnick, Daniel K

    2013-11-01

    There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures. An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform. Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work. It is feasible to build a national spine registry for the

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

    PubMed

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

    2014-01-01

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

  16. 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.

  17. Low testosterone and clinical outcomes in Chinese men with type 2 diabetes mellitus - Hong Kong Diabetes Registry.

    PubMed

    Cheung, Kitty Kit-Ting; Lau, Eric Siu-Him; So, Wing-Yee; Ma, Ronald Ching-Wan; Ozaki, Risa; Kong, Alice Pik-Shan; Chow, Francis Chun-Chung; Chan, Juliana Chung-Ngor; Luk, Andrea On-Yan

    2017-01-01

    To assess the implications of low testosterone on cardiovascular risk factors, metabolic syndrome (MES) and clinical outcomes in Chinese men with Type 2 Diabetes (T2D). A prospective cohort study carried out in a university hospital involving a consecutive cohort of 1239 Chinese men with T2D and a median disease duration of 9years followed up for 4.8years. Clinical characteristics, frequency of MES, serum total testosterone and clinical events were analyzed. Multivariate logistic regression was performed to examine the independent association of low testosterone with MES after adjustment for confounding covariates. Cox proportional hazards regression analysis was used to derive hazard ratio for clinical outcomes. More men with low testosterone had cardiovascular-renal disease and MES than those with normal testosterone. The adjusted odds ratio (OR) of low testosterone for MES was 2.63 (95% Confidence Interval [CI] 1.56-4.61). After a median follow-up of 4.8years, the hazard ratio (HR) of low testosterone was 2.22 (95% CI 1.23-4.01) for incident non-prostate cancer. In a multivariate Cox-regression model, the HRs were attenuated but remained significant with adjustment for MES and renal parameters. Chinese men with low testosterone had high prevalence of cardiovascular disease and MES with high incidence non-prostate cancer. Copyright © 2016 The Author(s). Published by Elsevier B.V. All rights reserved.

  18. Cost-effectiveness of clinical remission by treat to target strategy in established rheumatoid arthritis: results of the CREATE registry.

    PubMed

    Cárdenas, M; de la Fuente, S; Castro-Villegas, M C; Romero-Gómez, M; Ruiz-Vílchez, D; Calvo-Gutiérrez, J; Escudero-Contreras, A; Del Prado, J R; Collantes-Estévez, E; Font, P

    2016-12-01

    To analyse the cost-effectiveness, in daily clinical practice, of the strategy of treating to the target of clinical remission (CR) in patients with established rheumatoid arthritis (RA), after 2 years of treatment with biological therapy. Adult patients with established RA were treated with biological therapy and followed up for 2 years by a multidisciplinary team responsible for their clinical management. Treatment effectiveness was evaluated by the DAS28 score. The direct costs incurred during this period were quantified from the perspective of the healthcare system. We calculated the cost-effectiveness of obtaining a DAS28 < 2.6, considered as CR. The study included 144 RA patients treated with biological therapies. After 2 years of treatment, 32.6% of patients achieved CR. The mean cost of achieving CR at 2 years was 79,681 ± 38,880 euros. The strategy of treatment to the target of CR is considered the most effective, but in actual clinical practice in patients with established RA, it has a high cost.

  19. Pulmonary arterial hypertension: epidemiology and registries.

    PubMed

    McGoon, Michael D; Benza, Raymond L; Escribano-Subias, Pilar; Jiang, Xin; Miller, Dave P; Peacock, Andrew J; Pepke-Zaba, Joanna; Pulido, Tomas; Rich, Stuart; Rosenkranz, Stephan; Suissa, Samy; Humbert, Marc

    2013-12-24

    Registries of patients with pulmonary arterial hypertension (PAH) have been instrumental in characterizing the presentation and natural history of the disease and provide a basis for prognostication. Since the initial accumulation of data conducted in the 1980s, subsequent registry databases have yielded information about the demographic factors, treatment, and survival of patients and have permitted comparisons between populations in different eras and environments. Inclusion of patients with all subtypes of PAH has also allowed comparisons of these subpopulations. We describe herein the basic methodology by which PAH registries have been conducted, review key insights provided by registries, summarize issues related to interpretation and comparison of the results, and discuss the utility of data to predict survival outcomes. Potential sources of bias, particularly related to the inclusion of incident and/or prevalent patients and missing data, are addressed. A fundamental observation of current registries is that survival in the modern treatment era has improved compared with that observed previously and that outcomes among PAH subpopulations vary substantially. Continuing systematic clinical surveillance of PAH will be important as treatment evolves and as understanding of mechanisms advance. Considerations for future directions of registry studies include enrollment of a broader population of patients with pulmonary hypertension of all clinical types and severity and continued globalization and collaboration of registry databases. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. 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

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

    2013-07-01

    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. 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. Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.

  1. 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

  2. Chinese SLE Treatment and Research group (CSTAR) registry VII: prevalence and clinical significance of serositis in Chinese patients with systemic lupus erythematosus.

    PubMed

    Zhao, J; Bai, W; Zhu, P; Zhang, X; Liu, S; Wu, L; Ma, L; Bi, L; Zuo, X; Sun, L; Huang, C; Tian, X; Li, M; Zhao, Y; Zeng, X

    2016-05-01

    To investigate both the prevalence and clinical characteristics of serositis in Chinese patients with systemic lupus erythematosus (SLE) in a large cohort in the Chinese SLE Treatment and Research group (CSTAR) database. A prospective cross-sectional study of patients with SLE was conducted based on the data from the CSTAR registry. Serositis was defined according to the 1999 revised American College of Rheumatology (ACR) criteria for SLE - that is, pleuritis/pleural effusion and/or pericarditis/pericardial effusion detected by echocardiography, chest X-ray or chest computerized tomography (CT) scan. Peritonitis/peritoneal effusion were confirmed by abdominal ultrasonography. We analysed the prevalence and clinical associations of serositis with demographic data, organ involvements, laboratory findings and SLE disease activity. Of 2104 patients with SLE, 345 were diagnosed with serositis. The prevalence of lupus nephritis (LN), interstitial lung disease and pulmonary arterial hypertension, as well as the presence of leukocytopenia, thrombocytopenia, hypocomplementemia and anti-dsDNA antibodies was significantly higher in patients with serositis (P < 0.05). Significantly higher SLE disease activity scores were found in patients with serositis compared to those patients without serositis (P < 0.05). Lupus-related peritonitis had similar clinical manifestations and laboratory profiles as serositis caused by SLE. There is a significant association of nephropathy, interstitial lung disease, pulmonary arterial hypertension, hypocomplementemia, leukocytopenia, thrombocytopenia and elevated anti-dsDNA antibodies with serositis. The results suggest that higher SLE disease activity contributes to serositis development, and should be treated aggressively. © The Author(s) 2016.

  3. Prognostic impact of renal dysfunction does not differ according to the clinical profiles of patients: insight from the acute decompensated heart failure syndromes (ATTEND) registry.

    PubMed

    Inohara, Taku; Kohsaka, Shun; Sato, Naoki; Kajimoto, Katsuya; Keida, Takehiko; Mizuno, Masayuki; Takano, Teruo

    2014-01-01

    Renal dysfunction associated with acute decompensated heart failure (ADHF) is associated with impaired outcomes. Its mechanism is attributed to renal arterial hypoperfusion or venous congestion, but its prognostic impact based on each of these clinical profiles requires elucidation. ADHF syndromes registry subjects were evaluated (N = 4,321). Logistic regression modeling calculated adjusted odds ratios (OR) for in-hospital mortality for patients with and without renal dysfunction. Renal dysfunction risk was calculated for subgroups with hypoperfusion-dominant (eg. cold extremities, a low mean blood pressure or a low proportional pulse pressure) or congestion-dominant clinical profiles (eg. peripheral edema, jugular venous distension, or elevated brain natriuretic peptide) to evaluate renal dysfunction's prognostic impact in the context of the two underlying mechanisms. On admission, 2,150 (49.8%) patients aged 73.3 ± 13.6 years had renal dysfunction. Compared with patients without renal dysfunction, those with renal dysfunction were older and had dominant ischemic etiology jugular venous distension, more frequent cold extremities, and higher brain natriuretic peptide levels. Renal dysfunction was associated with in-hospital mortality (OR 2.36; 95% confidence interval 1.75-3.18, p<0.001), and the prognostic impact of renal dysfunction was similar in subgroup of patients with hypoperfusion- or congestion-dominant clinical profiles (p-value for the interaction ranged from 0.104-0.924, and was always >0.05). Baseline renal dysfunction was significantly associated with in-hospital mortality in ADHF patients. The prognostic impact of renal dysfunction was the same, regardless of its underlying etiologic mechanism.

  4. Association between discordance of LDL-C and non-HDL-C and clinical outcomes in patients with stent implantation: from the FU-Registry.

    PubMed

    Shiiba, Michiyo; Zhang, Bo; Miura, Shin-Ichiro; Ike, Amane; Nose, Daisuke; Kuwano, Takashi; Imaizumi, Satoshi; Sugihara, Makoto; Iwata, Atushi; Nishikawa, Hiroaki; Kawamura, Akira; Shirai, Kazuyuki; Yasunaga, Shin'ichiro; Saku, Keijiro

    2017-08-16

    It is not yet clear whether the discordance of low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) predicts the follow-up clinical outcome (major adverse cardiovascular events: MACEs) in patients with coronary stent implantation. Among 2015 patients with coronary stent implantation (Fukuoka University [FU]-Registry), excluding those with acute coronary syndrome or hemodialysis, we selected 801 patients who had undergone successful stent implantation with a follow-up until 18 months, and classified them into 3 groups according to baseline LDL-C and non-HDL-C levels [percentile(P)non-HDL-C more than (P)LDL-C, (P)non-HDL-C equal to (P)LDL-C, and (P)non-HDL-C less than (P) LDL-C]. We found that the discordance of (P)LDL-C and (P)non-HDL-C was not a significant predictor of MACEs. Higher LDL-C level was consistently and independently associated with higher incidences of MACEs after controlling for conventional risk factors and the type of stent used by multivariate Cox regression analyses. In conclusion, LDL-C levels are more important than non-HDL-C levels and the discordance of LDL-C and non-HDL-C levels as predictors of MACEs in patients with stable angina after stent implantation.

  5. Boosting Quality Registries with Clinical Decision Support Functionality*. User Acceptance of a Prototype Applied to HIV/TB Drug Therapy.

    PubMed

    Wannheden, Carolina; Hvitfeldt-Forsberg, Helena; Eftimovska, Elena; Westling, Katarina; Ellenius, Johan

    2017-08-11

    The care of HIV-related tuberculosis (HIV/TB) is complex and challenging. Clinical decision support (CDS) systems can contribute to improve quality of care, but more knowledge is needed on factors determining user acceptance of CDS. To analyze physicians' and nurses' acceptance of a CDS prototype for evidence-based drug therapy recommendations for HIV/TB treatment. Physicians and nurses were involved in designing a CDS prototype intended for future integration with the Swedish national HIV quality registry. Focus group evaluation was performed with ten nurses and four physicians, respectively. The Unified Theory of Acceptance and Use of Technology (UTAUT) was used to analyze acceptance. We identified several potential benefits with the CDS prototype as well as some concerns that could be addressed by redesign. There was also concern about dependence on physician attitudes, as well as technical, organizational, and legal issues. Acceptance evaluation at a prototype stage provided rich data to improve the future design of a CDS prototype. Apart from design and development efforts, substantial organizational efforts are needed to enable the implementation and maintenance of a future CDS system.

  6. 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.

  7. 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

  8. The efficacy of ranibizumab treatment in clinical practice in patients with the wet form of age-related macular degeneration. The results of the Czech National Registry.

    PubMed

    Chrapek, Oldrich; Jarkovsky, Jiri; Studnicka, Jan; Sin, Martin; Kolar, Petr; Jirkova, Barbora; Dusek, Ladislav; Pitrova, Sarka; Rehak, Jiri

    2015-09-01

    The aim of this communication was to evaluate ranibizumab in the treatment of wet age-related macular degeneration. Anonymised data on treatment efficacy and safety were consecutively entered into the Czech national database. From 01/09/2008 to 25/10/2011, 671 patients/685 eyes treated with ranibizumab monotherapy were entered in the registry. 454 ranibizumab treated eyes and 444 patients were monitored for 12-months. The dependent variable used to monitor disease progression and treatment results was change in visual acuity in the ETDRS (Early Treatment Diabetic Retinopathy Study) chart over time. After 12 months of treatment, a loss of < 15 letters in the ETDRS chart was found in 81.5% of eyes treated with ranibizumab. A gain of ≥ 15 letters was found in 9.7% of eyes on ranibizumab. The results for our patients treated in clinical practice with ranibizumab were poorer than those in the SUSTAIN (Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration) study. A rationale for this was sought in a sub-analysis. Sub-analysis demonstrated that treatment naive CNV (choroidal neovascularization), occult CNV and lower height of the macular oedema at the outset of the disease may be positive prognostic factors for final visual acuity in anti-VEGF (vascular endothelial growth factor) treated patients.

  9. Efficacy of the Essential Amino Acids and Keto-Analogues on the CKD progression rate in real practice in Russia - city nephrology registry data for outpatient clinic.

    PubMed

    Zemchenkov, Alexander; Konakova, Irina N

    2016-07-07

    Renal replacement therapy (RRT) is growing by 10 % per year in Russia, but pre-dialysis care which can retard CKD progression and delay the start of RRT remains limited. We evaluate the effect of Essential Amino Acids and Keto-analogues (EAA/KA) on CKD progression. The effect of low protein diet (LPD), supplemented by EAA/KA, on GFR slope changes between first and second treatment period (five sequential visits per period) in 96 patients withs CKD Stage 3B-5 was compared to GFR slope changes in the control group of 96 patients, randomly selected from matched (by gender, age, diagnosis and CKD Stage) cohort of 320 patients from the city Registry. The mean baseline eGFR was 23 ± 9 ml/min/1.73 m2; 29 % had CKD3B, 45 % - CKD4, 26 % - CKD5. The rate of eGFR decline changed from -2.71 ± 2.38 to -2.01 ± 2.26 ml/min/1.73 m2 per year in the treatment group and from -2.18 ± 2.01 to -2.04 ± 2.18 ml/min/1.73 m2 per year in the control group. Only in the treatment group the difference was significant (p = 0.04 and p = 0.6). Standardized effect size for intervention was significant in treatment group: -0.3 (of pooled SD), 95 % CI -0.58 ÷  -0.02 and non-significant in control group: -0.07 (-0.35 ÷ +0.22). The univariate and multivariate analysis of EAA/KA therapy effect demonstrated that it was probably more effective in patients of older age, with higher time-averaged proteinuria (PU), lower phosphate level, in patients with glomerular v. interstitial diseases, and in females. Only the latter factor was significant at pre-specified level (<0.05). LPD combined with EAA/KA supplementation lead to the decrease of the CKD progression both in well-designed clinical study and in real nephrology practice in wide variety diseases and settings. Registry data can be helpful to reveal patients with optimal chances for beneficial effect of LPD supplemented by EAA/KA. ISRCTN28190556 06/05/2016.

  10. Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis.

    PubMed

    Noble, Stephane; Stortecky, Stefan; Heg, Dik; Tueller, David; Jeger, Raban; Toggweiler, Stefan; Ferrari, Enrico; Nietlispach, Fabian; Taramasso, Maurizio; Maisano, Francesco; Grünenfelder, Jürg; Jüni, Peter; Huber, Christoph; Carrel, Thierry; Windecker, Stephan; Wenaweser, Peter; Roffi, Marco

    2017-04-07

    Data on procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI) with the new-generation self-expanding Medtronic Evolut R prosthesis in comparison with its predecessor, the Medtronic CoreValve, are scarce. The aim of this study was to assess the safety and efficacy of the Evolut R device compared with the former-generation CoreValve. In a nationwide, prospective, multicentre cohort study, outcomes of consecutive transfemoral TAVI patients treated with the new-generation Medtronic Evolut R (September 2014 - February 2016) and the Medtronic CoreValve (February 2011 - February 2016) were investigated. Events were reported according to VARC-2 and adjudicated by a clinical events committee. During the study period, 317 and 678 consecutive patients underwent TAVI with the Evolut R and the CoreValve bioprosthesis, respectively. Baseline clinical characteristics between the groups were comparable, although Evolut R patients were lower risk according to the STS score (4.8±3.4% vs. 6.9±5.0%, p<0.001) and logistic EuroSCORE (17.3±13% vs. 20.1±13%, p=0.009). Implantation of the Evolut R was associated with a lower use of predilatation (48.1% vs. 72.4%, p<0.001), a shorter procedure time (67.9±36 min vs. 76.7±42 min, p=0.002), and less contrast dye use during the procedure (155.2±98 ml vs. 208.0±117 ml, p<0.001). Post-procedural mean gradient was comparable (7.4±4.7 mmHg vs. 7.5±5.0 mmHg), as were the 30-day rates of moderate to severe aortic regurgitation (8.5% vs. 10.5%), major vascular (9.8% vs. 10.3%) and life-threatening bleeding complications (5.4% vs. 5.3%), disabling stroke (1.9% vs. 1.6%), all-cause mortality (3.2% vs. 3.4%) as well as permanent pacemaker implantation (22.1% vs. 23.4%). Thirty-day clinical outcomes were favourable and comparable between the Evolut R and the CoreValve bioprosthesis.

  11. 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

  12. Current trends and outcomes of breast reconstruction following nipple-sparing mastectomy: results from a national multicentric registry with 1006 cases over a 6-year period.

    PubMed

    Casella, Donato; Calabrese, Claudio; Orzalesi, Lorenzo; Gaggelli, Ilaria; Cecconi, Lorenzo; Santi, Caterina; Murgo, Roberto; Rinaldi, Stefano; Regolo, Lea; Amanti, Claudio; Roncella, Manuela; Serra, Margherita; Meneghini, Graziano; Bortolini, Massimiliano; Altomare, Vittorio; Cabula, Carlo; Catalano, Francesca; Cirilli, Alfredo; Caruso, Francesco; Lazzaretti, Maria Grazia; Meattini, Icro; Livi, Lorenzo; Cataliotti, Luigi; Bernini, Marco

    2017-05-01

    Reconstruction options following nipple-sparing mastectomy (NSM) are diverse and not yet investigated with level IA evidence. The analysis of surgical and oncological outcomes of NSM from the Italian National Registry shows its safety and wide acceptance both for prophylactic and therapeutic cases. A further in-depth analysis of the reconstructive approaches with their trend over time and their failures is the aim of this study. Data extraction from the National Database was performed restricting cases to the 2009-2014 period. Different reconstruction procedures were analyzed in terms of their distribution over time and with respect to specific indications. A 1-year minimum follow-up was conducted to assess reconstructive unsuccessful events. Univariate and multivariate analyses were performed to investigate the causes of both prosthetic and autologous failures. 913 patients, for a total of 1006 procedures, are included in the analysis. A prosthetic only reconstruction is accomplished in 92.2 % of cases, while pure autologous tissues are employed in 4.2 % and a hybrid (prosthetic plus autologous) in 3.6 %. Direct-to-implant (DTI) reaches 48.7 % of all reconstructions in the year 2014. Prophylactic NSMs have a DTI reconstruction in 35.6 % of cases and an autologous tissue flap in 12.9 % of cases. Failures are 2.7 % overall: 0 % in pure autologous flaps and 9.1 % in hybrid cases. Significant risk factors for failures are diabetes and the previous radiation therapy on the operated breast. Reconstruction following NSM is mostly prosthetic in Italy, with DTI gaining large acceptance over time. Failures are low and occurring in diabetic and irradiated patients at the multivariate analysis.

  13. Mayo Registry for Telemetry Efficacy in Arrest Study: An Assessment of the Utility of Telemetry in Predicting Clinical Decompensation.

    PubMed

    Snipelisky, David; Ray, Jordan; Matcha, Gautam; Roy, Archana; Harris, Dana; Bosworth, Veronica; Dumitrascu, Adrian; Clark, Brooke; Vadeboncoeur, Tyler; Kusumoto, Fred; Bowman, Cammi; Burton, M Caroline

    2016-02-17

    Our study assesses the utility of telemetry in identifying decompensation in patients with documented cardiopulmonary arrest. A retrospective review of inpatients who experienced a cardiopulmonary arrest from May 1, 2008, until June 30, 2014, was performed. Telemetry records 24 hours prior to and immediately preceding cardiopulmonary arrest were reviewed. Patient subanalyses based on clinical demographics were made as well as analyses of survival comparing patients with identifiable rhythm changes in telemetry to those without. Of 242 patients included in the study, 75 (31.0%) and 110 (45.5%) experienced telemetry changes at the 24-hour and immediately preceding time periods, respectively. Of the telemetry changes, the majority were classified as nonmalignant (n = 50, 66.7% and n = 66, 55.5% at 24 hours prior and immediately preceding, respectively). There was no difference in telemetry changes between intensive care unit (ICU) and non-ICU patients and among patients stratified according to the American Heart Association telemetry indications. There was no difference in survival when comparing patients with telemetry changes immediately preceding and at 24 hours prior to an event (n = 30, 27.3% and n = 15, 20.0%) to those without telemetry changes during the same periods (n = 27, 20.5% and n = 42, 25.2%; P = .22 and .39). Telemetry has limited utility in predicting clinical decompensation in the inpatient setting. © The Author(s) 2016.

  14. West Virginia University pediatric stroke registry: clinical description and risk factors identification in patients from a rural area.

    PubMed

    Pergami, Paola; Thayapararajah, Sathees Waran; Seemaladinne, Nirupama

    2015-01-01

    To develop an institutional pediatric stroke database at West Virginia University to support the classification and description of clinical and radiographic characteristics of pediatric stroke in children living in rural areas. 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. In the children group, vasculitis and hypercoagulable disorders were identified less frequently than reported. In the neonate group, only extremely sick, symptomatic patents were acutely diagnosed with stroke. Patients with the most common risk factors for stroke (cardiac disease) were overrepresented. This suggests that in children receiving medical attention in rural areas less common risk factors for stroke might not be identified, increasing the risk recurrence. Increased index of suspicion is needed about pediatric stroke in rural areas, and early transfer to a tertiary care center for identification of risk factors is mandatory. © The Author(s) 2014.

  15. Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: two-year insights from the APPOSITION III (A Post-Market registry to assess the STENTYS self-exPanding COronary Stent In AcuTe MyocardIal InfarctiON) registry.

    PubMed

    Lu, Huangling; Grundeken, Maik J; Vos, Nicola S; IJsselmuiden, Alexander J J; van Geuns, Robert-Jan; Wessely, Rainer; Dengler, Thomas; La Manna, Alessio; Silvain, Johanne; Montalescot, Gilles; Spaargaren, René; Tijssen, Jan G P; Amoroso, Giovanni; de Winter, Robbert J; Koch, Karel T

    2017-08-04

    The APPOSITION III registry evaluated the feasibility and performance of the STENTYS self-apposing stent in an ST-segment elevation myocardial infarction (STEMI) population. This novel self-apposing stent device lowers stent strut malapposition rates and therefore carries the potential to prevent stent undersizing during primary percutaneous coronary intervention (PCI) in STEMI patients. To date, no long-term data are available using this device in the setting of STEMI. We aimed to evaluate the long-term clinical outcomes of the APPOSITION III registry. This was an international, prospective, multicentre post-marketing registry. The study population consisted of 965 STEMI patients. The primary endpoint, major adverse cardiac events (MACE), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR). At two years, MACE occurred in 11.2%, cardiac death occurred in 2.3%, TV-MI occurred in 2.3% and CD-TLR in 9.2% of patients. The two-year definite stent thrombosis (ST) rate was 3.3%. Incremental event rates between one- and two-year follow-up were 1.0% for TV-MI, 1.8% for CD-TLR, and 0.5% for definite ST. Post-dilation resulted in significantly reduced CD-TLR and ST rates at 30-day landmark analyses. Results were equivalent between the BMS and PES STENTYS subgroups. This registry revealed low rates of adverse events at two-year follow-up, with an incremental ST rate as low as 0.5% in the second year, demonstrating that the self-apposing technique is feasible in STEMI patients on long-term follow-up while using post-dilatation.

  16. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines.

    PubMed

    Wood, Jamie R; Miller, Kellee M; Maahs, David M; Beck, Roy W; DiMeglio, Linda A; Libman, Ingrid M; Quinn, Maryanne; Tamborlane, William V; Woerner, Stephanie E

    2013-07-01

    To assess the proportion of youth with type 1 diabetes under the care of pediatric endocrinologists in the United States meeting targets for HbA1c, blood pressure (BP), BMI, and lipids. Data were evaluated for 13,316 participants in the T1D Exchange clinic registry younger than 20 years old with type 1 diabetes for ≥1 year. American Diabetes Association HbA1c targets of <8.5% for those younger than 6 years, <8.0% for those 6 to younger than 13 years old, and <7.5% for those 13 to younger than 20 years old were met by 64, 43, and 21% of participants, respectively. The majority met targets for BP and lipids, and two-thirds met the BMI goal of <85th percentile. Most children with type 1 diabetes have HbA1c values above target levels. Achieving American Diabetes Association goals remains a significant challenge for the majority of youth in the T1D Exchange registry.

  17. Demographic, Hematologic, and Clinical Features of Myelodysplastic Syndrome Patients: Results from the First Polish Myelodysplastic Syndrome Registry.

    PubMed

    Mądry, Krzysztof; Machowicz, Rafał; Waszczuk-Gajda, Anna; Drozd-Sokołowska, Joanna; Hołowiecka, Beata Stella; Wiater, Elżbieta; Mital, Andrzej; Obara, Agata; Szmigielska-Kapłon, Anna; Kołkowska-Leśniak, Agnieszka; Sikorska, Anna; Subocz, Edyta; Mendrek, Włodzimierz; Szczepańska, Magdalena; Biedroń, Monika; Jachalska, Anna; Wasilewska, Ewa; Wojciechowska, Małgorzata; Guzicka-Kazimierczak, Renata; Kopacz, Agnieszka; Katinas, Katarzyna; Kruger, Witold; Dawidowska, Anna; Salamańczuk, Zoriana; Zawirska, Daria; Świderska, Alina; Jędrzejczak, Wiesław Wiktor; Dwilewicz-Trojaczek, Jadwiga

    2015-01-01

    Epidemiological studies on myelodysplastic syndromes (MDS) in Middle-Eastern Europe are scarce. No data about the demographic, clinical, and laboratory features of Polish MDS patients have been published. The aim of this study was to assess the epidemiological data and toxic exposure of Polish MDS patients and their association with hematological parameters and clinical outcomes. For 15 months, 966 living MDS patients were enrolled at 24 centers (12 university and 12 community hospitals). Follow-up was conducted for the next 55 months. The percentage of patients older than 80 years (16%) was between the values for Eastern and Western countries. In patients younger than 55 years, a female predominance was observed (male/female ratio 0.70:1 vs. 1.29:1; p < 0.001). Female patients had higher platelet counts (160 × 10⁹/l vs. 111 × 10⁹/l; p < 0.001). Patients exposed to chemicals were younger than patients without such exposure; their median age at MDS diagnosis was 66 vs. 70 years (p = 0.037). Smokers had significantly lower hemoglobin concentrations (8.6 vs. 9.1 g/dl; p = 0.032) and lower platelet counts (99 × 10⁹/l vs. 137 × 10⁹/l; p < 0.001) than nonsmokers. We provide the first description of the characteristics of Polish MDS patients. Females predominated in the group aged <60 years and they had higher platelet counts. The course of the disease is affected by toxic exposure and smoking. © 2015 S. Karger AG, Basel.

  18. Statistical methods to monitor risk factors in a clinical database: example of a national cardiac surgery registry.

    PubMed

    Siregar, Sabrina; Roes, Kit C B; van Straten, Albert H M; Bots, Michiel L; van der Graaf, Yolanda; van Herwerden, Lex A; Groenwold, Rolf H H

    2013-01-01

    Comparison of outcomes requires adequate risk adjustment for differences in patient risk and the type of intervention performed. Both unintentional and intentional misclassification (also called gaming) of risk factors might lead to incorrect benchmark results. Therefore, misclassification of risk factors should be detected. We investigated the use of statistical process control techniques to monitor the frequency of risk factors in a clinical database. A national population-based study was performed using simulation and statistical process control. All patients who underwent cardiac surgery between January 1, 2007, and December 31, 2009, in all 16 cardiothoracic surgery centers in the Netherlands were included. Data on 46 883 consecutive cardiac surgery interventions were extracted. The expected risk factor frequencies were based on 2007 and 2008 data. Monthly frequency rates of 18 risk factors in 2009 were monitored using a Shewhart control chart, exponentially weighted moving average chart, and cumulative sum chart. Upcoding (ie, gaming) in random patients was simulated and detected in 100% of the simulations. Subtle forms of gaming, involving specifically high-risk patients, were more difficult to identify (detection rate of 44%). However, the accompanying rise in mean logistic European system for cardiac operative risk evaluation (EuroSCORE) was detected in all simulations. Statistical process control in the form of a Shewhart control chart, exponentially weighted moving average, and cumulative sum charts provide a means to monitor changes in risk factor frequencies in a clinical database. Surveillance of the overall expected risk in addition to the separate risk factors ensures a high sensitivity to detect gaming. The use of statistical process control for risk factor surveillance is recommended.

  19. 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.

  20. Clinical characteristics of patients with factor V Leiden or prothrombin G20210A and a first episode of venous thromboembolism. Findings from the RIETE Registry.

    PubMed

    Gadelha, Telma; Roldán, Vanessa; Lecumberri, Ramón; Trujillo-Santos, Javier; del Campo, Raquel; Poggio, Renzo; Monreal, Manuel

    2010-10-01

    The clinical characteristics of patients with factor V Leiden or prothrombin G20210A presenting with a first episode of venous thromboembolism (VTE) have not been thoroughly studied. RIETE is an ongoing registry of consecutive patients with acute VTE. We compared the clinical characteristics of patients with factor V Leiden, prothrombin G20210A, or no thrombophilia, at presentation with a first episode of VTE. As of May 2009, 22428 patients had been enrolled with a first episode of VTE. Of these, 345 had factor V Leiden, 261 had prothrombin G20210A, and 2399 tested negative. Sixty-two percent of the VTE episodes in women with factor V Leiden or prothrombin G20210A (40% in men) were associated with an acquired risk factor. Among women, pregnancy or contraceptive use accounted for 63% and 67% of such risk factors. Patients with factor V Leiden presented with pulmonary embolism (PE) less likely than those with prothrombin G20210A (31% vs. 51%; p<0.001) or with negative testing (31% vs. 45%, p<0.001). In addition, PE patients with Factor V Leiden presented with hypoxaemia (Sat O(2) levels<90%) less likely than those with prothrombin G20210A (4.5% vs. 17%; p<0.001) or with no thrombophilia (4.5% vs. 20%; p<0.001). Most VTE episodes in women (not men) with factor V Leiden or prothrombin G20210A were associated with an acquired risk factor (mostly pregnancy or contraceptive use). Only 4.5% of patients with factor V Leiden presenting with acute PE had hypoxaemia. Copyright © 2010 Elsevier Ltd. All rights reserved.

  1. Clinical management and hospital outcomes of acute coronary syndrome patients in Mexico: The Third National Registry of Acute Coronary Syndromes (RENASICA III).

    PubMed

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

    2016-01-01

    To describe current management and clinical outcomes in patients hospitalized with an acute coronary syndrome (ACS) in Mexico. RENASICA III was a prospective multicenter registry of consecutive patients hospitalized with an ACS. Patients had objective evidence of ischemic heart disease; those with type II infarction or secondary ischemic were excluded. Study design conformed to current quality recommendations. A total of 123 investigators at 29 tertiary and 44 community hospitals enrolled 8296 patients with an ACS (4038 with non-ST-elevation myocardial infarction/unstable angina [NSTEMI/UA], 4258 with ST-elevation myocardial infarction [STEMI]). The majority were younger (62±12years) and 76.0% were male. On admission 80.5% had ischemic chest pain lasting >20min and clinical stability. Left ventricular dysfunction was more frequent in NSTEMI/UA than in those with STEMI (30.0% vs. 10.7%, p<0.0001). In STEMI 37.6% received thrombolysis and 15.0% primary PCI. PCI was performed in 39.6% of NSTEMI/UA (early strategy in 10.8%, urgent strategy in 3.0%). Overal