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

PubMed

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

2016-06-01

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

Are all metal-on-metal hip revision operations contributing to the National Joint Registry implant survival curves? : a study comparing the London Implant Retrieval Centre and National Joint Registry datasets.

PubMed

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

2016-01-01

The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records. We analysed metal-on-metal hip revision procedures performed between 2003 and 2013. A total of 69 929 revision procedures from the NJR and 929 revised pairs of components from the LIRC were included. We were able to link 716 (77.1%) revision procedures on the NJR to the LIRC. This meant that 213 (22.9%) revision procedures at the LIRC could not be identified on the NJR. We found that 349 (37.6%) explants at the LIRC completed the full linkage process to both NJR primary and revision databases. Data completion was excellent (> 99.9%) for revision procedures reported to the NJR. This study has shown that only approximately one third of retrieved components at the LIRC, contributed to survival curves on the NJR. We recommend prospective registry-retrieval linkage as a tool to feedback missing and erroneous data to the NJR and improve data quality. Prospective Registry - retrieval linkage is a simple tool to evaluate and improve data quality on the NJR. ©2016 Sabah et al.

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

PubMed

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

2016-12-01

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

Prospective assessment of the occurrence of anemia in patients with heart failure: results from the Study of Anemia in a Heart Failure Population (STAMINA-HFP) Registry.

PubMed

Adams, Kirkwood F; Patterson, James H; Patterson, John H; Oren, Ron M; Mehra, Mandeep R; O'Connor, Christopher M; Piña, Ileana L; Miller, Alan B; Chiong, Jun R; Dunlap, Stephanie H; Cotts, William G; Felker, Gary M; Schocken, Douglas D; Schwartz, Todd A; Ghali, Jalal K

2009-05-01

Although a potentially important pathophysiologic factor in heart failure, the prevalence and predictors of anemia have not been well studied in unselected patients with heart failure. The Study of Anemia in a Heart Failure Population (STAMINA-HFP) Registry prospectively studied the prevalence of anemia and the relationship of hemoglobin to health-related quality of life and outcomes among patients with heart failure. A random selection algorithm was used to reduce bias during enrollment of patients seen in specialty clinics or clinics of community cardiologists with experience in heart failure. In this initial report, data on prevalence and correlates of anemia were analyzed in 1,076 of the 1,082 registry patients who had clinical characteristics and hemoglobin determined by finger-stick at baseline. Overall (n = 1,082), the registry patients were 41% female and 73% white with a mean age (+/-SD) of 64 +/- 14 years (68 +/- 13 years in community and 57 +/- 14 years in specialty sites, P < .001). Among the 1,076 patients in the prevalence analysis, mean hemoglobin was 13.3 +/- 2.1 g/dL (median 13.2 g/dL); and anemia (defined by World Health Organization criteria) was present in 34%. Age identified patients at risk for anemia, with 40% of patients >70 years affected. Initial results from the STAMINA-HFP Registry suggest that anemia is a common comorbidity in unselected outpatients with heart failure. Given the strong association of anemia with adverse outcomes in heart failure, this study supports further investigation concerning the importance of anemia as a therapeutic target in this condition.

Upper Airway Stimulation for Obstructive Sleep Apnea: Results from the ADHERE Registry.

PubMed

Boon, Maurits; Huntley, Colin; Steffen, Armin; Maurer, Joachim T; Sommer, J Ulrich; Schwab, Richard; Thaler, Erica; Soose, Ryan; Chou, Courtney; Strollo, Patrick; Kezirian, Eric J; Chia, Stanley; Withrow, Kirk; Weidenbecher, Mark; Strohl, Kingman; Doghramji, Karl; Hofauer, Benedikt; Heiser, Clemens

2018-03-01

Objective Upper airway stimulation (UAS) is an alternative treatment option for patients unable to tolerate continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA). Studies support the safety and efficacy of this therapy. The aim of this registry is to collect retrospective and prospective objective and subjective outcome measures across multiple institutions in the United States and Germany. To date, it represents the largest cohort of patients studied with this therapy. Study Design Retrospective and prospective registry study. Setting Ten tertiary care hospitals in the United States and Germany. Subjects and Methods Patients were included who had moderate to severe OSA, were intolerant to CPAP, and were undergoing UAS implantation. Baseline demographic and sleep study data were collected. Objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction were reviewed. Results The registry enrolled 301 patients between October 2016 and September 2017. Mean ± SD AHI decreased from 35.6 ± 15.3 to 10.2 ± 12.9 events per hour ( P < .0001), and Epworth Sleepiness Scale scores decreased from 11.9 ± 5.5 to 7.5 ± 4.7 ( P < .0001) from baseline to the posttitration visit. Patients utilized therapy for 6.5 hours per night. There were low rates of procedure- and device-related complications. Clinical global impression scores demonstrated that the majority of physicians (94%) saw improvement in their patients' symptoms with therapy. The majority of patients (90%) were more satisfied with UAS than CPAP. Conclusions Across a multi-institutional registry, UAS therapy demonstrates significant improvement in subjective and objective OSA outcomes, good therapy adherence, and high patient satisfaction.

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey.

PubMed

Hunter, Kylie Elizabeth; Seidler, Anna Lene; Askie, Lisa M

2018-03-01

To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100-500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Despite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed Central

Blankshain, Kimberly D; Moss, Heather E

2016-01-01

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

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

THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.

PubMed

Fernández, Óscar

2016-01-01

From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects. A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported. The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THC:CBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 sprays/day. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THC:CBD oromucosal spray. The findings aligned closely with the UK/German/Swiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 sprays/day) and safety profile, including no evidence of addiction, abuse or misuse. The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice. © 2016 S. Karger AG, Basel.

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

PubMed

Scott, Amelia; Rucklidge, Julia J; Mulder, Roger T

2015-01-01

To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding. Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.

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/

Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry)

PubMed Central

Onorati, Francesco; Gherli, Riccardo; Mariscalco, Giovanni; Girdauskas, Evaldas; Quintana, Eduardo; Santini, Francesco; De Feo, Marisa; Sponga, Sandro; Tozzi, Piergiorgio; Bashir, Mohamad; Perrotti, Andrea; Pappalardo, Aniello; Ruggieri, Vito Giovanni; Santarpino, Giuseppe; Rinaldi, Mauro; Ronaldo, Silva; Nicolini, Francesco

2018-01-01

Introduction Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the ‘real clinical world’. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both ‘sutured’ and ‘sutureless’ valves) will provide a ‘real-world’ picture of available results of current surgical options and will help to clarify the ‘grey zones’ of current guidelines. Methods and analysis European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing ‘early’ 30-day all-cause and cardiovascular mortality, as well as major morbidity, and ‘late’ cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results. Ethics and dissemination The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship. Trial registration number NCT03143361; Pre-results. PMID:29440154

Maternal mortality in Denmark, 1985-1994.

PubMed

Andersen, Betina Ristorp; Westergaard, Hanne Brix; Bødker, Birgit; Weber, Tom; Møller, Margrete; Sørensen, Jette Led

2009-02-01

In Denmark, maternal mortality has been reported over the last century, both locally through hospital reports and in national registries. The purpose of this study was to analyze data from national medical registries of pregnancy-related deaths in Denmark 1985-1994 and to classify them according to the UK Confidential Enquiry into Maternal Deaths (CEMD). All deaths of women with a registered pregnancy within 12 months prior to the death were identified by comparing the Danish medical registries, death certificates, and relevant codes according to International Classification of Diseases (ICD-10). All cases were classified using the UK CEMD classification. Cases of maternal death were further evaluated by an audit group. 311 cases were classified. 92 deaths (29.6%) occurred 42 days), 1 woman died from a direct obstetric cause, 46 from indirect causes, and 172 from fortuitous causes. Hypertensive disorders of pregnancy were the major cause of direct maternal deaths. The rate of maternal deaths constituted 9.8/100,000 maternities (i.e. the number of women delivering registrable live births at any gestation or stillbirths at 24 weeks of gestation or later). This is the first systematic report on deaths in Denmark based on data from national registries. The maternal mortality rate in Denmark is comparable to the rates in other developed countries. Fortunately, statistics are low, but each case represents potential learning. Obstetric care has changed and classification methods differ between countries. Prospective registration and registry linkage seem to be a way to ensure completion. This retrospective study has provided the background for a prospective study on registration and evaluation of maternal mortality in Denmark.

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

PubMed

Blankshain, Kimberly D; Moss, Heather E

2016-09-01

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

Development of an International Canine Spinal Cord Injury observational registry: a collaborative data-sharing network to optimize translational studies of SCI.

PubMed

Moore, Sarah A; Zidan, Natalia; Spitzbarth, Ingo; Nout-Lomas, Yvette S; Granger, Nicolas; da Costa, Ronaldo C; Levine, Jonathan M; Jeffery, Nick D; Stein, Veronika M; Tipold, Andrea; Olby, Natasha J

2018-05-23

Prospective cross-sectional cohort study. The canine spontaneous model of spinal cord injury (SCI) is as an important pre-clinical platform as it recapitulates key facets of human injury in a naturally occurring context. The establishment of an observational canine SCI registry constitutes a key step in performing epidemiologic studies and assessing the impact of therapeutic strategies to enhance translational research. Further, accumulating information on dogs with SCI may contribute to current "big data" approaches to enhance understanding of the disease using heterogeneous multi-institutional, multi-species datasets from both pre-clinical and human studies. Multiple veterinary academic institutions across the United States and Europe. Common data elements recommended for experimental and human SCI studies were reviewed and adapted for use in a web-based registry, to which all dogs presenting to member veterinary tertiary care facilities were prospectively entered over ~1 year. Analysis of data accumulated during the first year of the registry suggests that 16% of dogs with SCI present with severe, sensorimotor-complete injury and that 15% of cases are seen by a tertiary care facility within 8 h of injury. Similar to the human SCI population, 34% were either overweight or obese. Severity of injury and timing of presentation suggests that neuroprotective studies using the canine clinical model could be conducted efficiently using a multi-institutional approach. Additionally, pet dogs with SCI experience similar comorbidities to people with SCI, in particular obesity, and could serve as an important model to evaluate the effects of this condition.

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

PubMed

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

2017-09-01

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

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

PubMed

Sanderson, Georgina; Ariyaratne, Thathya V; Wyss, Josephine; Looi, Valerie

2014-01-01

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

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

PubMed Central

2014-01-01

Background Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described. Methods/Design The Cochlear™ Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia. Discussion The use of a registry such as the Cochlear P-IROS will generate valuable data to support research interests of academics and clinicians around the globe. The data generated will be relevant for a wide range of stakeholders including regulators, payers, providers, policy makers, patients and their families, each with a different perspective for the acceptance and adoption of implantable hearing devices for the treatment of hearing loss. PMID:25317075

Design characteristics of the Corrona Japan rheumatoid arthritis registry.

PubMed

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

2018-01-01

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

[Orange Platform].

PubMed

Toba, Kenji

2017-07-01

The Organized Registration for the Assessment of dementia on Nationwide General consortium toward Effective treatment in Japan (ORANGE platform) is a recently established nationwide clinical registry for dementia. This platform consists of multiple registries of patients with dementia stratified by the following clinical stages: preclinical, mild cognitive impairment, early-stage, and advanced-stage dementia. Patients will be examined in a super-longitudinal fashion, and their lifestyle, social background, genetic risk factors, and required care process will be assessed. This project is also notable because the care registry includes information on the successful, comprehensive management of patients with dementia. Therefore, this multicenter prospective cohort study will contribute participants to all clinical trials for Alzheimer's disease as well as improve the understanding of individuals with dementia.

Assessment of follow-up, and the completeness and accuracy of cancer case ascertainment in three areas of India

PubMed Central

Mathew, Aleyamma; Daniel, Carrie R.; Ferrucci, Leah M.; Seth, Tulika; Devesa, Susan S.; George, Preethi S.; Shetty, Hemali; Devasenapathy, Niveditha; Yurgalevitch, Susan; Rastogi, Tanuja; Prabhakaran, Dorairaj; Gupta, Prakash C.; Chatterjee, Nilanjan; Sinha, Rashmi

2012-01-01

Background A prospective study of diet and cancer has not been conducted in India; consequently, little is known regarding follow-up rates or the completeness and accuracy of cancer case ascertainment. Methods We assessed follow-up in the India Health Study (IHS; 4,671 participants aged 35–69 residing in New Delhi, Mumbai, or Trivandrum). We evaluated the impact of medical care access and relocation, re-contacted the IHS participants to estimate follow-up rates, and conducted separate studies of cancer cases to evaluate registry coverage (604 cases in Trivandrum) and the accuracy of self- and proxy-reporting (1600 cases in New Delhi and Trivandrum). Results Over 97% of people reported seeing a doctor and 85% had lived in their current residence for over six years. The 2-year follow-up rate was 91% for Trivandrum and 53% for New Delhi. No cancer cases were missed among public institutions participating in the surveillance program in Trivandrum during 2003–04; but there are likely to be unmatched cases (ranging from 5 to13% of total cases) from private hospitals in the Trivandrum registry, as there are no mandatory reporting requirements. Vital status was obtained for 36% of cancer cases in New Delhi as compared to 78% in Trivandrum after a period of 4 years. Conclusions A prospective cohort study of cancer may be feasible in some centers in India with active follow-up to supplement registry data. Inclusion of cancers diagnosed at private institutions, unique identifiers for individuals, and computerized medical information would likely improve cancer registries. PMID:21621499

Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE)

PubMed Central

2011-01-01

Background A registry of patients with cervical dystonia (Cervical Dystonia Patient Registry for Observation of onaBotulinumtoxinA Efficacy [CD PROBE]) was initiated to capture data regarding physician practices and patient outcomes with onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA, USA). Methods and baseline demographics from an interim analysis are provided. Methods/Design This is a prospective, multicenter, clinical registry in the United States enrolling subjects with cervical dystonia (CD) who are toxin naïve and/or new to the physicians' practices, or who had been in a clinical trial but received their last injection ≥ 16 weeks prior to enrollment. Subjects are followed over 3 injection cycles of onabotulinumtoxinA, with assessments at time of injection and 4-6 weeks later. Information on physician's practice, patient demographics, CD disease history, duration of treatment intervals and neurotoxin dose, dilution, use of electromyography, and muscles injected are collected. Outcomes are assessed by physicians and subjects using various questionnaires. Discussion This ongoing registry includes 609 subjects with the following baseline data: 75.9% female, 93.6% Caucasian, mean age 57.6 ± 14.3, age at symptom onset 48.3 ± 16.2, and time to diagnosis 5.4 ± 8.6 years, with an additional 1.0 ± 3.5 years before treatment. Of those employed at the time of diagnosis, 36.6% stopped working as a result of CD. CD PROBE, the largest clinical registry of CD treatment, will provide useful data on current treatment practices with onabotulinumtoxinA, potentially leading to refinements for optimization of outcomes. Trial registration NCT00836017 PMID:22054223

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.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme.

PubMed

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-09-01

Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%). Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

PubMed Central

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-01-01

Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need. PMID:23850682

Safety of vaccinations in patients with cryopyrin-associated periodic syndromes: a prospective registry based study.

PubMed

Jaeger, Veronika K; Hoffman, Hal M; van der Poll, Tom; Tilson, Hugh; Seibert, Julia; Speziale, Antonio; Junge, Guido; Franke, Kristina; Vritzali, Eleni; Hawkins, Philip N; Kuemmerle-Deschner, Jasmin; Walker, Ulrich A

2017-09-01

Pneumococcal, tetanus and influenza vaccinations are recommended for patients with cryopyrin-associated periodic syndromes (CAPS) when treated with immunosuppressive medication. The aim of this publication is to report the safety of pneumococcal and other vaccinations in CAPS patients. All CAPS patients followed in the β-CONFIDENT (Clinical Outcomes and Safety Registry study of Ilaris patients) registry were analysed if they had received a vaccination. The β-CONFIDENT registry is a global, long-term, prospective, observational registry, capturing and monitoring patients treated with canakinumab. Sixty-eight CAPS patients had received a total of 159 vaccine injections, 107 injections against influenza, 19 pneumococcal vaccinations, 12 against tetanus/diphtheria antigens and 21 other vaccinations. Fourteen per cent of injections had elicited at least one vaccine reaction. All five vaccine-related serious adverse events were associated with pneumococcal vaccination. Vaccine reactions were observed in 70% of pneumococcal vaccinations, compared with 7% in influenza and 17% in tetanus/diphtheria vaccinations. The odds ratios to react to the pneumococcal vaccines compared with influenza and tetanus/diphtheria vaccines were 31.0 (95% CI: 8, 119) and 10.8 (95% CI: 2, 74). Vaccine reactions after pneumococcal vaccinations were more severe and lasted significantly longer (up to 3 weeks) compared with other vaccinations. In two patients, pneumococcal vaccination also elicited symptoms consistent with systemic inflammation due to CAPS reactivation. Pneumococcal vaccines, unlike other vaccines, frequently trigger severe local and systemic inflammation in CAPS patients. Clinicians must balance potential benefits of pneumococcal immunization against safety concerns. The 13-valent pneumococcal conjugate vaccine might be favourable over the polysaccharide vaccine in CAPS patients. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

The need for a disease-specific prospective pregnancy registry for multiple sclerosis (MS).

PubMed

Alwan, Sura; Chambers, Christina D; Armenti, Vincent T; Sadovnick, A Dessa

2015-01-01

Multiple sclerosis (MS) is the most commonly acquired neurological disorder affecting young adults of reproductive age with an approximately 3:1 female to male ratio. Although pregnancy is not contraindicated in MS, data are limited regarding pregnancy outcome among MS patients, and the safety or risk to the fetus associated with most maternal MS treatments, such as disease modifying therapies (DMTs), during pregnancy is unknown. We review available epidemiological and registry data on MS and pregnancy and discuss the need to initiate a North American Multiple Sclerosis Pregnancy Registry that will prospectively identify pregnancies in women with MS, obtain information on the disease, and its treatment during gestation and lactation and follow the children to determine their health status. Copyright © 2014 Elsevier B.V. All rights reserved.

Reducing selection bias in case-control studies from rare disease registries.

PubMed

Cole, J Alexander; Taylor, John S; Hangartner, Thomas N; Weinreb, Neal J; Mistry, Pramod K; Khan, Aneal

2011-09-12

In clinical research of rare diseases, where small patient numbers and disease heterogeneity limit study design options, registries are a valuable resource for demographic and outcome information. However, in contrast to prospective, randomized clinical trials, the observational design of registries is prone to introduce selection bias and negatively impact the validity of data analyses. The objective of the study was to demonstrate the utility of case-control matching and the risk-set method in order to control bias in data from a rare disease registry. Data from the International Collaborative Gaucher Group (ICGG) Gaucher Registry were used as an example. A case-control matching analysis using the risk-set method was conducted to identify two groups of patients with type 1 Gaucher disease in the ICGG Gaucher Registry: patients with avascular osteonecrosis (AVN) and those without AVN. The frequency distributions of gender, decade of birth, treatment status, and splenectomy status were presented for cases and controls before and after matching. Odds ratios (and 95% confidence intervals) were calculated for each variable before and after matching. The application of case-control matching methodology results in cohorts of cases (i.e., patients with AVN) and controls (i.e., patients without AVN) who have comparable distributions for four common parameters used in subject selection: gender, year of birth (age), treatment status, and splenectomy status. Matching resulted in odds ratios of approximately 1.00, indicating no bias. We demonstrated bias in case-control selection in subjects from a prototype rare disease registry and used case-control matching to minimize this bias. Therefore, this approach appears useful to study cohorts of heterogeneous patients in rare disease registries.

The CRAC cohort model: A computerized low cost registry of interventional cardiology with daily update and long-term follow-up.

PubMed

Rangé, G; Chassaing, S; Marcollet, P; Saint-Étienne, C; Dequenne, P; Goralski, M; Bardiére, P; Beverilli, F; Godillon, L; Sabine, B; Laure, C; Gautier, S; Hakim, R; Albert, F; Angoulvant, D; Grammatico-Guillon, L

2018-05-01

To assess the reliability and low cost of a computerized interventional cardiology (IC) registry to prospectively and systematically collect high-quality data for all consecutive coronary patients referred for coronary angiogram or/and coronary angioplasty. Rigorous clinical practice assessment is a key factor to improve prognosis in IC. A prospective and permanent registry could achieve this goal but, presumably, at high cost and low level of data quality. One multicentric IC registry (CRAC registry), fully integrated to usual coronary activity report software, started in the centre Val-de-Loire (CVL) French region in 2014. Quality assessment of CRAC registry was conducted on five IC CathLab of the CVL region, from January 1st to December 31st 2014. Quality of collected data was evaluated by measuring procedure exhaustivity (comparing with data from hospital information system), data completeness (quality controls) and data consistency (by checking complete medical charts as gold standard). Cost per procedure (global registry operating cost/number of collected procedures) was also estimated. CRAC model provided a high-quality level with 98.2% procedure completeness, 99.6% data completeness and 89% data consistency. The operating cost per procedure was €14.70 ($16.51) for data collection and quality control, including ST-segment elevation myocardial infarction (STEMI) preadmission information and one-year follow-up after angioplasty. This integrated computerized IC registry led to the construction of an exhaustive, reliable and costless database, including all coronary patients entering in participating IC centers in the CVL region. This solution will be developed in other French regions, setting up a national IC database for coronary patients in 2020: France PCI. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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

PubMed

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

2013-03-01

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

Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study.

PubMed

Frantz, Robert P; Schilz, Robert J; Chakinala, Murali M; Badesch, David B; Frost, Adaani E; McLaughlin, Vallerie V; Barst, Robyn J; Rosenberg, Daniel M; Miller, Dave P; Hartline, Brian K; Benton, Wade W; Farber, Harrison W

2015-02-01

Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.

Pattern of care and effectiveness of treatment for glioblastoma patients in the real world: Results from a prospective population-based registry. Could survival differ in a high-volume center?

PubMed Central

Brandes, Alba A.; Franceschi, Enrico; Ermani, Mario; Tosoni, Alicia; Albani, Fiorenzo; Depenni, Roberta; Faedi, Marina; Pisanello, Anna; Crisi, Girolamo; Urbini, Benedetta; Dazzi, Claudio; Cavanna, Luigi; Mucciarini, Claudia; Pasini, Giuseppe; Bartolini, Stefania; Marucci, Gianluca; Morandi, Luca; Zunarelli, Elena; Cerasoli, Serenella; Gardini, Giorgio; Lanza, Giovanni; Silini, Enrico Maria; Cavuto, Silvio; Baruzzi, Agostino

2014-01-01

Background As yet, no population-based prospective studies have been conducted to investigate the incidence and clinical outcome of glioblastoma (GBM) or the diffusion and impact of the current standard therapeutic approach in newly diagnosed patients younger than aged 70 years. Methods Data on all new cases of primary brain tumors observed from January 1, 2009, to December 31, 2010, in adults residing within the Emilia-Romagna region were recorded in a prospective registry in the Project of Emilia Romagna on Neuro-Oncology (PERNO). Based on the data from this registry, a prospective evaluation was made of the treatment efficacy and outcome in GBM patients. Results Two hundred sixty-seven GBM patients (median age, 64 y; range, 29–84 y) were enrolled. The median overall survival (OS) was 10.7 months (95% CI, 9.2–12.4). The 139 patients ≤aged 70 years who were given standard temozolomide treatment concomitant with and adjuvant to radiotherapy had a median OS of 16.4 months (95% CI, 14.0–18.5). With multivariate analysis, OS correlated significantly with KPS (HR = 0.458; 95% CI, 0.248–0.847; P = .0127), MGMT methylation status (HR = 0.612; 95% CI, 0.388–0.966; P = .0350), and treatment received in a high versus low-volume center (HR = 0.56; 95% CI, 0.328–0.986; P = .0446). Conclusions The median OS following standard temozolomide treatment concurrent with and adjuvant to radiotherapy given to (72.8% of) patients aged ≤70 years is consistent with findings reported from randomized phase III trials. The volume and expertise of the treatment center should be further investigated as a prognostic factor. PMID:26034628

Health Care Cost Analysis in a Population-based Inception Cohort of Inflammatory Bowel Disease Patients in the First Year of Diagnosis.

PubMed

Niewiadomski, Olga; Studd, Corrie; Hair, Christopher; Wilson, Jarrad; McNeill, John; Knight, Ross; Prewett, Emily; Dabkowski, Paul; Dowling, Damian; Alexander, Sina; Allen, Benjamin; Tacey, Mark; Connell, William; Desmond, Paul; Bell, Sally

2015-11-01

There are limited prospective population-based data on the health care cost of IBD in the post-biologicals era. A prospective registry that included all incident cases of inflammatory bowel disease [IBD] was established to study disease progress and health cost. To prospectively assess health care costs in the first year of diagnosis among a well-characterised cohort of newly diagnosed IBD patients. Incident cases of IBD were prospectively identified in 2007-2008 and 2010-2013 from multiple health care providers, and enrolled into the population-based registry. Health care resource utilisation for each patient was collected through active surveillance of case notes and investigations including specialist visits, diagnostic tests, medications, medical hospitalisation, and surgery. Off 276 incident cases of IBD, 252 [91%] were recruited to the registry, and health care cost was calculated for 242 (146 Crohn's disease [CD] and 96 ulcerative colitis [UC] patients). The median cost in CD was higher at A$5905 per patient (interquartile range [IQR]: A$1571-$91,324) than in UC at A$4752 [IQR: A$1488-A$58,072]. In CD, outpatient resources made up 55% of all cost, with medications accounting for 32% of total cost [15% aminosalicylates, 15% biological therapy], followed by surgery [31%], and diagnostic testing [21%]. In UC, medications accounted for 39% of total cost [of which 37% was due to 5-aminosalicylates, and diagnostics 29%; outpatient cost contributed 71% to total cost. In the first year of diagnosis, outpatient resources account for the majority of cost in both CD and UC. Medications are the main cost driver in IBD. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program.

PubMed

Shields, Kristine E; Wiholm, Bengt-Erik; Hostelley, Linda S; Striano, Linda F; Arena, Sam R; Sharrar, Robert G

2004-01-01

Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. However, there are limited data available to inform decision-making. The Merck Pregnancy Registry Program is a company-run pregnancy registry whose objective is to acquire and analyse information on drug exposures and pregnancy outcomes to better describe the safety profile of Merck products used during pregnancy. Information is collected from women and healthcare providers who call to report drug exposure during pregnancy. Prospective pregnancies are followed up to outcome and data are collected via questionnaires, telephone calls and a review of medical records. Reports are classified as prospective (information received prior to knowledge of pregnancy outcome) or retrospective (received after the outcome is known). Congenital anomaly reports are assessed for timing of exposure, maternal age and medical history, biological plausibility and concomitant medication exposures. Rates of pregnancy outcomes and birth defects in the prospective cohort are computed and confidence intervals are calculated to reflect the strength of the finding based on the sample size. Rates of pregnancy outcomes in the Pregnancy Registry are compared with the rates of pregnancy outcomes in the general US population and, if available, in subpopulations with the relevant disease states. The limitations of post-marketing surveillance are well known as voluntary reporting of individuals and healthcare professionals is known to be subject to various types of bias. Small sample size is another major limitation. However, the strength of the registry lies in its ability to gather pregnancy outcome reports early in the life of a product and to recognise and analyse unusual birth defects. Our data suggest that pregnancy registries can be used to review human exposure data in a systematic fashion so that useful information can be shared with women and their healthcare providers. The use of the pregnancy registry design has allowed for the collection and analysis of data on the effects of drug exposures on human pregnancies that have otherwise been difficult to obtain.

The utility of international shoulder joint replacement registries and databases: a comparative analytic review of two hundred and sixty one thousand, four hundred and eighty four cases.

PubMed

Bayona, Carlos Eduardo Afanador; Somerson, Jeremy S; Matsen, Frederick A

2018-02-01

National registries are valuable tools for understanding the results of shoulder arthroplasty across populations. These databases provide an unselected view of shoulder joint replacement within geographical areas that cannot be obtained from case series or prospective studies. They can be particularly helpful in determining which diagnoses, patients, procedures, and prostheses have higher than expected rates of revision. In an attempt to determine the generalizability of registry data, we asked, 'how similar are the patients and procedures among the different national registries?' We analyzed national shoulder arthroplasty registries and databases accessed via Internet portals and through a PubMed literature search. Seven national/regional registries and five publications regarding national shoulder arthroplasty data were identified; these sources contained a combined total of 261,484 shoulder arthroplasty cases. The percentages of hemiarthroplasty, anatomic (aTSA) and reverse total shoulders (rTSA), the diagnoses leading to arthroplasty, the mean patient age, and the distribution of patient gender varied significantly among these different databases. This study indicates that the indications for and application of shoulder arthroplasty have important geographical variations and that these variations must be considered when comparing outcomes of shoulder arthroplasty from different locations. Without controlling for age, gender, diagnosis and procedure type, the results from one national registry may not be applicable to patients from a different location. In that national data provide the opportunity to reduce costs by identifying implants and procedures with higher failure rates, the funding of registries needs to be free of conflicts of interest.

Prospective data collection of a new procedure by a specialty society: the FIBROID registry.

PubMed

Myers, Evan R; Goodwin, Scott; Landow, Wendy; Mauro, Matthew; Peterson, Eric; Pron, Gaylene; Spies, James B; Worthington-Kirsch, Robert

2005-07-01

To describe registry methods and baseline patient demographics from a national sample of women undergoing uterine artery embolization for uterine leiomyomata. Interventional radiology practices were recruited to submit data by a secure Web site on women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline data included patient demographics, prior medical, surgical, and obstetrical history, uterine anatomy, and quality-of-life measures. Subsequent data collected included details of the uterine artery embolization procedure and hospital stay and outcomes at 30 days; patients were also offered the opportunity to participate in longer-term follow-up. Characteristics of white and African-American women were compared using t tests, chi(2), or Wilcoxon rank-sum tests as appropriate. As of December 31, 2002, 3,319 uterine artery embolization cases had been entered into the registry by 72 sites; number of patients entered by individual sites ranged from 1 to 514. Of these patients, 95.4% consented to participation in the short-term outcomes registry. Forty-eight percent of patients were African American, and 44.4% were white and non-Hispanic. Heavy menstrual bleeding was the single most bothersome symptom in 64.3% of patients. Compared with white non-Hispanic women, African-American women were significantly younger, more likely to be obese, had larger uteri and more numerous leiomyomata, more severe symptoms, and poorer quality-of-life scores before treatment. It is feasible to collect prospective data on new technologies. The FIBROID Registry prospectively collected data on more than 3,000 women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline patient characteristics of this patient population seem to be similar to those of women undergoing other procedures for leiomyomata. III.

Setting up of the Indian HIPEC Registry: A Registry for Indian Patients with Peritoneal Surface Malignancies.

PubMed

Bhatt, Aditi; Mehta, Sanket; Ramakrishnan As; Pande, Pankaj; Rajan, Firoz; Rangole, Ashvin; Saklani, Avanish; Sethna, Kayomarz; Singh, Shivendra; Zaveri, Shabber; Gopinath, K S

2017-12-01

There are various registries for patients with peritoneal metastases (PM) that aid pooling of data and generate evidence that dictates current clinical practice. This manuscript describes the setting up of the Indian HIPEC registry that was set up with a similar goal by a group of Indian surgeons. This is a registry for patients with PM treated with CRS and HIPEC in India. It also acts as a database for storing treatment-related information. Patients with PM from colorectal ovarian, gastric, appendiceal tumors, and other rare peritoneal tumors/metastases from rare tumors are enrolled in the registry. A coordinator updates the disease status of patients on a yearly basis. A private organization maintains the database. A non-disclosure agreement is signed between the company and each surgeon contributing to the registry to maintain confidentiality. For enrolling patients, securing institutional permission depends on the requirement of each institute; patient consent is mandatory. Data entry can be prospective or retrospective. To propose and conduct a study, the approval of a scientific committee linked to the registry is required. The Indian HIPEC registry is a practical database for Indian surgeons. There is no regulatory body that mandates collection and publication of scientific data in India. The onus is on each surgeon to capture valuable information pertaining to these common and rare diseases that could contribute to the existing scientific knowledge and guide the treatment of these patients in the future. The next challenge will be to enter data into the registry.

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

PubMed

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

2017-01-10

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

Outcomes of Middle Eastern Patients Undergoing Percutaneous Coronary Intervention: The Primary Analysis of the First Jordanian PCI Registry.

PubMed

Alhaddad, Imad A; Tabbalat, Ramzi; Khader, Yousef; Al-Mousa, Eyas; Izraiq, Mahmoud; Nammas, Assem; Jarrah, Mohammad; Saleh, Akram; Hammoudeh, Ayman

2017-01-01

This is a prospective multicenter registry designed to evaluate the incidence of adverse cardiovascular events in Middle Eastern patients undergoing percutaneous coronary interventions (PCI). The registry was also designed to determine the predictors of poor outcomes in such patients. We enrolled 2426 consecutive patients who underwent PCI at 12 tertiary care centers in Jordan between January 2013 and February 2014. A case report form was used to record data prospectively at hospital admission, discharge, and 12 months of follow-up. Mean age was 56 ± 11 years, females comprised 21% of the study patients, 62% had hypertension, 53% were diabetics, and 57% were cigarette smokers. Most patients (77%) underwent PCI for acute coronary syndrome. In-hospital and 1-year mortality rates were 0.78% and 1.94%, respectively. Definite or probable stent thrombosis occurred in 9 patients (0.37%) during hospitalization and in 47 (1.94%) at 1 year. Rates of target vessel repeat PCI and coronary artery bypass graft surgery at 1 year were 3.4% and 0.6%, respectively. The multivariate analysis revealed that cardiogenic shock, congestive heart failure, ST-segment deviation, diabetes, and major bleeding were significantly associated with higher risk of 1-year mortality. In this first large Jordanian registry of Middle Eastern patients undergoing PCI, patients treated were relatively young age population with low in-hospital and 1-year adverse cardiovascular events. Certain clinical features were associated with worse outcomes and may warrant aggressive therapeutic strategies.

Establishing the characteristics for patients with chronic Complex Regional Pain Syndrome: the value of the CRPS-UK Registry.

PubMed

Shenker, Nicholas; Goebel, Andreas; Rockett, Mark; Batchelor, James; Jones, Gareth T; Parker, Richard; de C Williams, Amanda C; McCabe, Candida

2015-05-01

The long-term prognosis of patients with Complex Regional Pain Syndrome (CRPS) is unknown with no reported prospective studies from the United Kingdom longer than 18 months. The CRPS-UK Network aims to study this by use of a Registry. The aims of this article are, to outline the CRPS-UK Registry, assess the validity of the data and to describe the characteristics of a sample of the UK CRPS population. A web-based CRPS-UK Registry was developed and made accessible to centres experienced in diagnosing and managing patients with CRPS. Pragmatic annual follow-up questions were agreed. Up until July 2013, the Registry has recruited 240 patients. A blinded, validation study of 20 consecutive patients from two centres (10 each) demonstrated 95.6% completion and 99.4% accuracy of a random sample of the recorded data. These patients had chronic disease (median duration: 29 months); 72.5% were female (2.6:1), with a mean age at symptoms onset of 43 years, and were left-handed more than expected (21.8% versus 10% in the general population). Patients reported a delayed diagnosis, with the median time between symptom onset and diagnosis of 6 months. In all, 30 patients (12.5%) had multiple limb involvement and (83.3%) had a contiguous spread of CRPS. CRPS-UK Registry is a validated method for actively recruiting well-characterised patients with CRPS to provide further information on the long-term outcome.

Establishing the characteristics for patients with chronic Complex Regional Pain Syndrome: the value of the CRPS-UK Registry

PubMed Central

Goebel, Andreas; Rockett, Mark; Batchelor, James; Jones, Gareth T; Parker, Richard; de C Williams, Amanda C; McCabe, Candida

2015-01-01

Objective: The long-term prognosis of patients with Complex Regional Pain Syndrome (CRPS) is unknown with no reported prospective studies from the United Kingdom longer than 18 months. The CRPS-UK Network aims to study this by use of a Registry. The aims of this article are, to outline the CRPS-UK Registry, assess the validity of the data and to describe the characteristics of a sample of the UK CRPS population. Methods: A web-based CRPS-UK Registry was developed and made accessible to centres experienced in diagnosing and managing patients with CRPS. Pragmatic annual follow-up questions were agreed. Results: Up until July 2013, the Registry has recruited 240 patients. A blinded, validation study of 20 consecutive patients from two centres (10 each) demonstrated 95.6% completion and 99.4% accuracy of a random sample of the recorded data. These patients had chronic disease (median duration: 29 months); 72.5% were female (2.6:1), with a mean age at symptoms onset of 43 years, and were left-handed more than expected (21.8% versus 10% in the general population). Patients reported a delayed diagnosis, with the median time between symptom onset and diagnosis of 6 months. In all, 30 patients (12.5%) had multiple limb involvement and (83.3%) had a contiguous spread of CRPS. Conclusion: CRPS-UK Registry is a validated method for actively recruiting well-characterised patients with CRPS to provide further information on the long-term outcome. PMID:26516567

Mexican registry of pulmonary hypertension: REMEHIP.

PubMed

Sandoval Zarate, Julio; Jerjes-Sanchez, Carlos; Ramirez-Rivera, Alicia; Zamudio, Tomas Pulido; Gutierrez-Fajardo, Pedro; Elizalde Gonzalez, Jose; Leon, Mario Seoane Garcia De; Gamez, Miguel Beltran; Abril, Francisco Moreno Hoyos; Michel, Rodolfo Parra; Aguilar, Humberto Garcia

REMEHIP is a prospective, multicentre registry on pulmonary hypertension. The main objective will be to identify the clinical profile, medical care, therapeutic trends and outcomes in adult and pediatric Mexican patients with well-characterized pulmonary hypertension. REMEHIP a multicenter registry began in 2015 with a planned recruitment time of 12 months and a 4-year follow-up. The study population will comprise a longitudinal cohort study, collecting data on patients with prevalent and incident pulmonary hypertension. Will be included patients of age >2 years and diagnosis of pulmonary hypertension by right heart catheterization within Group 1 and Group 4 of the World Health Organization classification. The structure, data collection and data analysis will be based on quality current recommendations for registries. The protocol has been approved by institutional ethics committees in all participant centers. All patients will sign an informed consent form. Currently in Mexico, there is a need of observational registries that include patients with treatment in the everyday clinical practice so the data could be validated and additional information could be obtained versus the one from the clinical trials. In this way, REMEHIP emerges as a link among randomized clinical trials developed by experts and previous Mexican experience. Copyright © 2016 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

The FReedom from Ischemic Events-New Dimensions for Survival (FRIENDS) registry: design of a prospective cohort study of patients with advanced peripheral artery disease.

PubMed

Keo, Hong H; Duval, Sue; Baumgartner, Iris; Oldenburg, Niki C; Jaff, Michael R; Goldman, JoAnne; Peacock, James M; Tretinyak, Alexander S; Henry, Timothy D; Luepker, Russell V; Hirsch, Alan T

2013-12-19

Advanced lower extremity peripheral artery disease (PAD), whether presenting as acute limb ischemia (ALI) or chronic critical limb ischemia (CLI), is associated with high rates of cardiovascular ischemic events, amputation, and death. Past research has focused on strategies of revascularization, but few data are available that prospectively evaluate the impact of key process of care factors (spanning pre-admission, acute hospitalization, and post-discharge) that might contribute to improving short and long-term health outcomes. The FRIENDS registry is designed to prospectively evaluate a range of patient and health system care delivery factors that might serve as future targets for efforts to improve limb and systemic outcomes for patients with ALI or CLI. This hypothesis-driven registry was designed to evaluate the contributions of: (i) pre-hospital limb ischemia symptom duration, (ii) use of leg revascularization strategies, and (iii) use of risk-reduction pharmacotherapies, as pre-specified factors that may affect amputation-free survival. Sequential patients would be included at an index "vascular specialist-defined" ALI or CLI episode, and patients excluded only for non-vascular etiologies of limb threat. Data including baseline demographics, functional status, co-morbidities, pre-hospital time segments, and use of medical therapies; hospital-based use of revascularization strategies, time segments, and pharmacotherapies; and rates of systemic ischemic events (e.g., myocardial infarction, stroke, hospitalization, and death) and limb ischemic events (e.g., hospitalization for revascularization or amputation) will be recorded during a minimum of one year follow-up. The FRIENDS registry is designed to evaluate the potential impact of key factors that may contribute to adverse outcomes for patients with ALI or CLI. Definition of new "health system-based" therapeutic targets could then become the focus of future interventional clinical trials for individuals with advanced PAD.

National Dyslipidemia Registry of the Spanish Arteriosclerosis Society: Current status.

PubMed

Pérez-Calahorra, Sofía; Sánchez-Hernández, Rosa M; Plana, Núria; Valdivielso, Pedro; Civeira, Fernando

Clinical registries are a very effective tool to verify the usual clinical practice, to compare clinical strategies and to improve the knowledge of diagnostic and therapeutic new procedures. The National Registry of Dyslipemias of the Spanish Society of Arteriosclerosis (SEA) is an on-line, retrospective and prospective database where the different Spanish lipid units accredited by the SEA introduce data from patients with disorders of lipid metabolism. The registry was created in 2013, and since then clinical, analytical, genetic and evolutionary data of 4,449 patients have been introduced until June 2017. In the last year the registry has given rise to a considerable number of international publications and there are several more in progress. An ambitious incentive plan for inclusion of patients has been initiated to get the SEA registry as a global reference that helps to improve the knowledge and clinical management of these patients. From the coordinating group of the registry we encourage all SEA partners to collaborate in the multiple forms that the registry allows, and to make it an international scientific reference. Copyright © 2017. Publicado por Elsevier España, S.L.U.

Feasibility of comparing core data from existing trauma registries in scandinavia. Reaching for a Scandinavian major trauma outcome study (MTOS).

PubMed

Ringdal, K G; Lossius, H M

2007-01-01

The organisation of trauma care in Scandinavia has several similarities, including trauma registries, but so far there are limited amount of research on efficiency and outcome. Data and results from trauma outcome studies like the US MTOS are not fully applicable to the Scandinavian trauma population. To reveal the feasibility of using data from existing trauma registries of major hospitals in Scandinavia, for a minimal common dataset, in a joint, prospective Scandinavian MTOS. We collected data points, data point definitions, and inclusion/exclusion criteria, from the major trauma registries of the Swedish trauma registry standard, three university hospitals in Denmark, one university hospital in Finland, and the Norwegian National Trauma Registry. The collected material was compared to reveal common data points, inclusion criteria, and the compatibility of data point definitions. The median number of data points was 147 (range 71-257; interquartile range = 90-205). Most registries lacked precise data definition catalogues. Only 16 data points could be considered as common, of which just a few were core trauma data. Four data points had the same data category options but were not considered having the same data point definitions. The inclusion criteria were not uniform. Trauma registries in Scandinavia have few common core data and data point definitions. There were data points for calculating the Trauma and Injury Severity Score (TRISS) but the inclusion criteria varied too much to ensure a valid comparison. A consensus process for a joint trauma core data set will be initiated by the Scandinavian Networking Group for Trauma and Emergency Management (SCANTEM) to increase research on trauma efficiency and outcome.

Infection rates in patients from five rheumatoid arthritis (RA) registries: contextualising an RA clinical trial programme

PubMed Central

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

2017-01-01

Objective Patients with rheumatoid arthritis (RA) have an increased risk of serious infections. Comparing infection rates across RA populations is complicated by differences in background infection risk, population composition and study methodology. We measured infection rates from five RA registries globally, with the aim to contextualise infection rates from an RA clinical trials population. Methods We used data from Consortium of Rheumatology Research of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (Sweden), Norfolk Arthritis Register (UK), CORRONA International (multiple countries) and Institute of Rheumatology Rheumatoid Arthritis (Japan) and an RA clinical trial programme (fostamatinib). Within each registry, we analysed a main cohort of all patients with RA from January 2000 to last available data. Infection definitions were harmonised across registries. Sensitivity analyses to address potential confounding explored subcohorts defined by disease activity, treatment change and/or prior comorbidities and restriction by calendar time or follow-up. Rates of infections were estimated and standardised to the trial population for age/sex and, in one sensitivity analysis also, for Health Assessment Questionnaire (HAQ) score. Results Overall, age/sex-standardised rates of hospitalised infection were quite consistent across registries (range 1.14–1.62 per 100 patient-years). Higher and more consistent rates across registries and with the trial programme overall were seen when adding standardisation for HAQ score (registry range 1.86–2.18, trials rate 2.92) or restricting to a treatment initiation subcohort followed for 18 months (registry range 0.99–2.84, trials rate 2.74). Conclusion This prospective, coordinated analysis of RA registries provided incidence rate estimates for infection events to contextualise infection rates from an RA clinical trial programme and demonstrated relative comparability of hospitalised infection rates across registries. PMID:29081988

Vision for a Global Registry of Anticipated Public Health Studies

PubMed Central

Choi, Bernard C.K.; Frank, John; Mindell, Jennifer S.; Orlova, Anna; Lin, Vivian; Vaillancourt, Alain D.M.G.; Puska, Pekka; Pang, Tikki; Skinner, Harvey A.; Marsh, Marsha; Mokdad, Ali H.; Yu, Shun-Zhang; Lindner, M. Cristina; Sherman, Gregory; Barreto, Sandhi M.; Green, Lawrence W.; Svenson, Lawrence W.; Sainsbury, Peter; Yan, Yongping; Zhang, Zuo-Feng; Zevallos, Juan C.; Ho, Suzanne C.; de Salazar, Ligia M.

2007-01-01

In public health, the generation, management, and transfer of knowledge all need major improvement. Problems in generating knowledge include an imbalance in research funding, publication bias, unnecessary studies, adherence to fashion, and undue interest in novel and immediate issues. Impaired generation of knowledge, combined with a dated and inadequate process for managing knowledge and an inefficient system for transferring knowledge, mean a distorted body of evidence available for decisionmaking in public health. This article hopes to stimulate discussion by proposing a Global Registry of Anticipated Public Health Studies. This prospective, comprehensive system for tracking research in public health could help enhance collaboration and improve efficiency. Practical problems must be discussed before such a vision can be further developed. PMID:17413073

Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study.

PubMed

Schaefer, Franz; Hoppe, Bernd; Jungraithmayr, Therese; Klaus, Günter; Pape, Lars; Farouk, Mourad; Addison, Janet; Manamley, Nick; Vondrak, Karel

2016-03-01

Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD). In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded. A total of 319 patients were included in the analysis (mean age, 9.1 years), 158 (49.5%) of whom were on dialysis at study entry. Of 434 serious AEs reported in 162 children, the most common were peritonitis (10.0%), gastroenteritis (6.0%), and hypertension (4.1%). Six patients (1.9%) died (unrelated to DA). Four patients (1.3%) experienced six serious adverse drug reactions. The geometric mean DA dose range was 1.4-2.0 μg/kg/month. Mean baseline Hb concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively. Overall, 48 patients (15.0%) received ≥1 transfusion. No new safety signals for DA were identified in children receiving DA for CKD anemia for ≤2 years. Based on Hb concentrations and transfusion requirements, DA was effective at managing anemia in these patients.

The African Lupus Genetics Network (ALUGEN) registry: standardized, prospective follow-up studies in African patients with systemic lupus erythematosus.

PubMed

Hodkinson, B; Mapiye, D; Jayne, D; Kalla, A; Tiffin, N; Okpechi, I

2016-03-01

The prevalence and severity of systemic lupus erythematosus (SLE) differs between ethnic groups and geographical regions. Although initially reported as rare, there is growing evidence that SLE is prevalent and runs a severe course in Africa. There is a paucity of prospective studies on African SLE patients. The African Lupus Genetics Network (ALUGEN) is a multicentred framework seeking to prospectively assess outcomes in SLE patients in Africa. Outcomes measured will be death, hospital admission, disease activity flares, and SLE-related damage. We will explore predictors for these outcomes including clinical, serological, socio-demographic, therapeutic and genetic factors. Further, we will investigate comorbidities and health-related quality of life amongst these patients. Data of patients recently (≤ 5 yrs) diagnosed with SLE will be collected at baseline and annual follow-up visits, and captured electronically. The ALUGEN project will facilitate standardized data capture for SLE cases in Africa, allowing participating centres to develop their own SLE registries, and enabling collaboration to enrich our understanding of inter-ethnic and regional variations in disease expression. Comprehensive, high-quality multi-ethnic data on African SLE patients will expand knowledge of the disease and inform clinical practice, in addition to augmenting research capacity and networking links and providing a platform for future biomarker and interventional studies. © The Author(s) 2015.

Predictive value of 3-month lumbar discectomy outcomes in the NeuroPoint-SD Registry.

PubMed

Whitmore, Robert G; Curran, Jill N; Ali, Zarina S; Mummaneni, Praveen V; Shaffrey, Christopher I; Heary, Robert F; Kaiser, Michael G; Asher, Anthony L; Malhotra, Neil R; Cheng, Joseph S; Hurlbert, John; Smith, Justin S; Magge, Subu N; Steinmetz, Michael P; Resnick, Daniel K; Ghogawala, Zoher

2015-10-01

The authors have established a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures using prospectively collected outcomes. Collection of these data requires an extensive commitment of resources from each site. The aim of this study was to determine whether outcomes data from shorter-interval follow-up could be used to accurately estimate long-term outcome following lumbar discectomy. An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level lumbar discectomy for treatment of disc herniation were included. SF-36 and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Quality-adjusted life year (QALY) data were calculated using SF-6D utility scores. Correlations among outcomes at each follow-up time point were tested using the Spearman rank correlation test. One hundred forty-eight patients were enrolled over 1 year. Their mean age was 46 years (49% female). Eleven patients (7.4%) required a reoperation by 1 year postoperatively. The overall 1-year follow-up rate was 80.4%. Lumbar discectomy was associated with significant improvements in ODI and SF-36 scores (p < 0.0001) and with a gain of 0.246 QALYs over the 1-year study period. The greatest gain occurred between baseline and 3-month follow-up and was significantly greater than improvements obtained between 3 and 6 months or 6 months and 1 year(p < 0.001). Correlations between 3-month, 6-month, and 1-year outcomes were similar, suggesting that 3-month data may be used to accurately estimate 1-year outcomes for patients who do not require a reoperation. Patients who underwent reoperation had worse outcomes scores and nonsignificant correlations at all time points. This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. Three-month outcome data may be used to accurately estimate outcome at future time points and may lower costs associated with registry data collection. This registry effort provides a practical foundation for the acquisition of outcome data following lumbar discectomy.

Acute adverse events associated with the administration of Crotalidae polyvalent immune Fab antivenom within the North American Snakebite Registry.

PubMed

Kleinschmidt, Kurt; Ruha, Anne-Michelle; Campleman, Sharan; Brent, Jeffrey; Wax, Paul

2018-04-24

Crotalidae Polyvalent Immune Fab (Fab Antivenom) is the primary Viperid antivenom used in the United States since 2000. Adverse event data associated with its use are limited. The purpose of this study is to describe the prevalence of acute adverse events associated with the use of Fab antivenom. The American College of Medical Toxicology's Toxicology Investigators Consortium maintains a prospective case registry of poisoned and envenomated patients managed by medical toxicologists at the bedside. This registry includes the North American Snakebite sub-registry. We performed a review of 438 cases entered into the Snakebite sub-registry. A total of 373 (85.2%) received at least one vial of Fab Antivenom. Forty percent were children. Adverse events occurred in 10 patients (2.7%) of whom six were adults. Rash was the most common adverse event. More severe adverse events (hypotension, bronchospasm, and/or angioedema) occurred in four (1.1%) patients. Prophylaxis was administered prior to Fab antivenom in 4.0%. Eight patients received various treatments for their adverse events. Neither the initial number of Fab antivenom vials, atopic history, nor prior envenomation correlated with the prevalence of adverse events. This prevalence of adverse events was lower than in previous studies and in a meta-analysis of 11 studies. The types of adverse events and treatments used are consistent with those in previous reports. There were no prior reports of prophylaxis use with which to compare. The prevalence of Fab antivenom adverse events in the North American Snakebite Registry was 2.7%.

The EMBARC European Bronchiectasis Registry: protocol for an international observational study

PubMed Central

Aliberti, Stefano; Polverino, Eva; Vendrell, Montserrat; Crichton, Megan; Loebinger, Michael; Dimakou, Katerina; Clifton, Ian; van der Eerden, Menno; Rohde, Gernot; Murris-Espin, Marlene; Masefield, Sarah; Gerada, Eleanor; Shteinberg, Michal; Ringshausen, Felix; Haworth, Charles; Boersma, Wim; Rademacher, Jessica; Hill, Adam T.; Aksamit, Timothy; O'Donnell, Anne; Morgan, Lucy; Milenkovic, Branislava; Tramma, Leandro; Neves, Joao; Menendez, Rosario; Paggiaro, Perluigi; Botnaru, Victor; Skrgat, Sabina; Wilson, Robert; Goeminne, Pieter; De Soyza, Anthony; Welte, Tobias; Torres, Antoni; Elborn, J. Stuart; Blasi, Francesco

2016-01-01

Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1) a clinical history consistent with bronchiectasis; and 2) computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1) bronchiectasis due to known cystic fibrosis; 2) age <18 years; and 3) patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials. PMID:27730179

Comparison of ISS, NISS, and RTS score as predictor of mortality in pediatric fall.

PubMed

Soni, Kapil Dev; Mahindrakar, Santosh; Gupta, Amit; Kumar, Subodh; Sagar, Sushma; Jhakal, Ashish

2017-01-01

Studies to identify an ideal trauma score tool representing prediction of outcomes of the pediatric fall patient remains elusive. Our study was undertaken to identify better predictor of mortality in the pediatric fall patients. Data was retrieved from prospectively maintained trauma registry project at level 1 trauma center developed as part of Multicentric Project-Towards Improving Trauma Care Outcomes (TITCO) in India. Single center data retrieved from a prospectively maintained trauma registry at a level 1 trauma center, New Delhi, for a period ranging from 1 October 2013 to 17 February 2015 was evaluated. Standard anatomic scores Injury Severity Score (ISS) and New Injury Severity Score (NISS) were compared with physiologic score Revised Trauma Score (RTS) using receiver operating curve (ROC). Heart rate and RTS had a statistical difference among the survivors to nonsurvivors. ISS, NISS, and RTS were having 50, 50, and 86% of area under the curve on ROCs, and RTS was statistically significant among them. Physiologically based trauma score systems (RTS) are much better predictors of inhospital mortality in comparison to anatomical based scoring systems (ISS and NISS) for unintentional pediatric falls.

Description of Patients Undergoing Mohs Surgery in Spain: Initial Report on Data From the Spanish Registry of Mohs Surgery (REGESMOHS).

PubMed

Ruiz-Salas, V; Garcés, J R; Miñano Medrano, R; Alonso-Alonso, T; Rodríguez-Prieto, M Á; López-Estebaranz, J L; Sanmartín-Jiménez, O; Guillén Barona, C; Delgado Jiménez, Y; Toll-Abelló, A; Vargas Diez, E; Ciudad Blanco, C; Alfaro Rubio, A; Allende Markixana, I; de Eusebio Murillo, E; Manubens-Mercadé, E; Vázquez-Veiga, H; Barchino Ortiz, L; García-Doval, I; Redondo Bellón, P

2015-09-01

The Spanish registry of Mohs micrographic surgery started collecting data in July 2013. The aim of the registry is to report on the use of this technique in Spain and the outcomes achieved. In the present article, we describe the characteristics of patients and the tumors treated. This is a prospective cohort study of patients treated with Mohs micrographic surgery. The participating centers are hospitals where at least one intervention of this type is performed each week. All patients considered for Mohs micrographic surgery in participating centers are included in the registry except those who have been declared legally incompetent. Between July 2013 and October 2014, data from 655 patients were included in the registry. The most common tumor involved was basal cell carcinoma, and the most common histological subtype was infiltrative basal cell carcinoma. Most of the tumors treated were located on the face or scalp, and the most common site was the nose. Almost 40% of the tumors treated were recurrent or persistent, and preoperative tumor size was similar to that reported in other European studies and in Australia. In total, 45.5% of patients had received previous surgical treatment. The findings are similar to those reported in other studies, and the data collected are useful for assessing whether the results of studies carried out elsewhere are applicable in Spain. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

The Cerebral Palsy Research Registry: Development and Progress Toward National Collaboration in the United States

PubMed Central

Hurley, Donna S.; Sukal-Moulton, Theresa; Msall, Michael E.; Gaebler-Spira, Deborah; Krosschell, Kristin J.; Dewald, Julius P.

2011-01-01

Cerebral palsy is the most common neurodevelopmental motor disability in children. The condition requires medical, educational, social, and rehabilitative resources throughout the life span. Several countries have developed population-based registries that serve the purpose of prospective longitudinal collection of etiologic, demographic, and functional severity. The United States has not created a comprehensive program to develop such a registry. Barriers have been large population size, poor interinstitution collaboration, and decentralized medical and social systems. The Cerebral Palsy Research Registry was created to fill the gap between population and clinical-based cerebral palsy registries and promote research in the field. This is accomplished by connecting persons with cerebral palsy, as well as their families, to a network of regional researchers. This article describes the development of an expandable cerebral palsy research registry, its current status, and the potential it has to affect families and persons with cerebral palsy in the United States and abroad. PMID:21677201

Hospitalization and Survival in Patients Using Epoprostenol for Injection in the PROSPECT Observational Study

PubMed Central

Frantz, Robert P.; Schilz, Robert J.; Chakinala, Murali M.; Badesch, David B.; Frost, Adaani E.; McLaughlin, Vallerie V.; Barst, Robyn J.; Rosenberg, Daniel M.; Miller, Dave P.; Hartline, Brian K.; Benton, Wade W.

2015-01-01

BACKGROUND: Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. METHODS: PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). RESULTS: A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. CONCLUSIONS: Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management. PMID:25320967

Probability of Finding Marrow Unrelated Donor (MUD) for an Indian patient in a Multi-national Human Leukocyte Antigen (HLA) Registry.

PubMed

Tiwari, Aseem K; Bhati-Kushwaha, Himakshi; Kukreja, Pooja; Mishra, Vikash C; Tyagi, Neetu; Sharma, Ashish; Raina, Vimarsh

2015-06-01

With an increase in the number of transplants happening globally, hematopoietic stem cells (HSC) transplantation from matched unrelated donor (MUD) has begun. The increasing trend of MUD transplants across countries has been largely facilitated with the conspicuous growth of volunteer HSC donor noted in the last decade i.e. 8 million HSC donors in 2002 to more than 22 million in 2013 registered in 71 member registries of the Bone Marrow Donor Worldwide (BMDW). Some populations of the world are still very poorly represented in these registries. Since, the chances of successful engraftment and disease free survival are directly proportional to the HLA compatibility between the recipient and the prospective donor, the diversity of the HLA system at the antigenic and allelic level and the heterogeneity of HLA data of the registered donors has a bearing on the probability of finding a volunteer unrelated HSC donor for patients from such populations. In the present study 126 patients were identified suffering from hematological diseases requiring MUD transplant. Their HLA typing was performed and search was done using BMDW database. The search results for these Indian patients in the multinational registry as well as in the Indian Registries were analyzed using mean, range, standard deviation and finally evaluated in terms of probability for finding matched donor (MUD). Total Asian population is only 11 % in the BMDW making it difficult to find a MUD for an Asian patient. The current study supports this, experimentally; revealing that the probability of finding an allele match for an Indian patient in the multinational Human Leukocyte Antigen (HLA) registries is 16 % and a dismal 0.008 % in the Indian registries (donors in Indian registries is just 33,678 as compared to 22.5 million in BMDW). This greatly, emphasizes on enhancing the number of Indian donors in Indian and multi-national registries.

[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.

Statistical Process Control: A Quality Tool for a Venous Thromboembolic Disease Registry.

PubMed

Posadas-Martinez, Maria Lourdes; Rojas, Liliana Paloma; Vazquez, Fernando Javier; De Quiros, Fernan Bernaldo; Waisman, Gabriel Dario; Giunta, Diego Hernan

2016-01-01

We aim to describe Statistical Control Process as a quality tool for the Institutional Registry of Venous Thromboembolic Disease (IRTD), a registry developed in a community-care tertiary hospital in Buenos Aires, Argentina. The IRTD is a prospective cohort. The process of data acquisition began with the creation of a computerized alert generated whenever physicians requested imaging or laboratory study to diagnose venous thromboembolism, which defined eligible patients. The process then followed a structured methodology for patient's inclusion, evaluation, and posterior data entry. To control this process, process performance indicators were designed to be measured monthly. These included the number of eligible patients, the number of included patients, median time to patient's evaluation, and percentage of patients lost to evaluation. Control charts were graphed for each indicator. The registry was evaluated in 93 months, where 25,757 patients were reported and 6,798 patients met inclusion criteria. The median time to evaluation was 20 hours (SD, 12) and 7.7% of the total was lost to evaluation. Each indicator presented trends over time, caused by structural changes and improvement cycles, and therefore the central limit suffered inflexions. Statistical process control through process performance indicators allowed us to control the performance of the registry over time to detect systematic problems. We postulate that this approach could be reproduced for other clinical registries.

Predicting surgical site infection after spine surgery: a validated model using a prospective surgical registry.

PubMed

Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

2014-09-01

The impact of surgical site infection (SSI) is substantial. Although previous study has determined relative risk and odds ratio (OR) values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of SSI, rather than relative risk or OR values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of SSI after spine surgery. This study performs a multivariate analysis of SSI after spine surgery using a large prospective surgical registry. Using the results of this analysis, this study will then create and validate a predictive model for SSI after spine surgery. The patient sample is from a high-quality surgical registry from our two institutions with prospectively collected, detailed demographic, comorbidity, and complication data. An SSI that required return to the operating room for surgical debridement. Using a prospectively collected surgical registry of more than 1,532 patients with extensive demographic, comorbidity, surgical, and complication details recorded for 2 years after the surgery, we identified several risk factors for SSI after multivariate analysis. Using the beta coefficients from those regression analyses, we created a model to predict the occurrence of SSI after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created a predictive model based on our beta coefficients from our multivariate analysis. The final predictive model for SSI had a receiver-operator curve characteristic of 0.72, considered to be a fair measure. The final model has been uploaded for use on SpineSage.com. We present a validated model for predicting SSI after spine surgery. The value in this model is that it gives the user an absolute percent likelihood of SSI after spine surgery based on the patient's comorbidity profile and invasiveness of surgery. Patients are far more likely to understand an absolute percentage, rather than relative risk and confidence interval values. A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery. In addition, a tool such as this can be of great use particularly as health care trends toward pay for performance, quality metrics (such as SSI), and risk adjustment. To facilitate the use of this model, we have created a Web site (SpineSage.com) where users can enter patient data to determine likelihood for SSI. Copyright © 2014 Elsevier Inc. All rights reserved.

Strategies for successful trauma registry implementation in low- and middle-income countries-protocol for a systematic review.

PubMed

Paradis, Tiffany; St-Louis, Etienne; Landry, Tara; Poenaru, Dan

2018-02-21

The benefits of trauma registries have been well described. The crucial data they provide may guide injury prevention strategies, inform resource allocation, and support advocacy and policy. This has been shown to reduce trauma-related mortality in various settings. Trauma remains a leading cause of mortality in low- and middle-income countries (LMICs). However, the implementation of trauma registries in LMICs can be challenging due to lack of funding, specialized personnel, and infrastructure. This study explores strategies for successful trauma registry implementation in LMICs. The protocol was registered a priori (CRD42017058586). A peer-reviewed search strategy of multiple databases will be developed with a senior librarian. As per PRISMA guidelines, first screen of references based on abstract and title and subsequent full-text review will be conducted by two independent reviewers. Disagreements that cannot be resolved by discussion between reviewers shall be arbitrated by the principal investigator. Data extraction will be performed using a pre-defined data extraction sheet. Finally, bibliographies of included articles will be hand-searched. Studies of any design will be included if they describe or review development and implementation of a trauma registry in LMICs. No language or period restrictions will be applied. Summary statistics and qualitative meta-narrative analyses will be performed. The significant burden of trauma in LMIC environments presents unique challenges and limitations. Adapted strategies for deployment and maintenance of sustainable trauma registries are needed. Our methodology will systematically identify recommendations and strategies for successful trauma registry implementation in LMICs and describe threats and barriers to this endeavor. The protocol was registered on the PROSPERO international prospective register of systematic reviews ( CRD42017058586 ).

Clinical characteristics during diagnosis of a prospective cohort of patients with systemic lupus erythematosus treated in Spanish Departments of Internal Medicine: The RELES study.

PubMed

Canora, J; García, M; Mitjavila, F; Espinosa, G; Suárez, S; González-León, R; Sopeña, B; Boldova, R; Castro, A; Ruiz-Irastorza, G

Patient registries are useful tools for assessing rare diseases. Our objective is to present the Spanish registry of patients with systemic lupus erythematosus (Registro español de pacientes con lupus eritematoso sistémico, RELES). RELES was started in 2008 as an observational, prospective, multicentre cohort registry that included patients from the time they were diagnosed. The registry's objective is to analyse the incidence and noninflammatory complications of systemic lupus erythematosus (SLE). The departments of internal medicine of 38 Spanish hospitals participate in this registry. A total of 298 patients with a mean age of 40.8±15.7 years were included, 88.9% of whom were women and 85.6% of whom were white. In the first visit, there was a predominance of joint manifestations (74.5%). One hundred and seventy-seven patients (59.4%) were positive for anti-native DNA. In these patients, there was a higher rate of lupus nephritis (26.7% vs. 14%, p=.009; relative risk [RR], 1.33), haemolytic anaemia (13.6% vs. 4.1%, p=.07; RR, 1.46) and lymphopenia (55.4% vs. 43.8%, p=.05; RR, 1.21). The median Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) score was 9.64 points (interquartile range, 4-13). The patients treated with antimalarial drugs before the diagnosis of SLE had a median SLEDAI score in the first visit of 5, compared with 8 for those who were not treated with these drugs (p=.02). RELES constitutes the first Spanish patient cohort with SLE recorded from the time of the diagnosis. The presence of anti-DNA has been related to severe manifestations such as nephritis and haemolytic anaemia. Treatment with antimalarial drugs before the diagnosis was associated with less active disease at the initial presentation. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

PubMed

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be laid down on the quality of trials being conducted in order to provide justice in the name of EBP. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry.

PubMed

Russo, Robert J

2013-03-01

Until recently, the presence of a permanent pacemaker or an implantable cardioverter-defibrillator has been a relative contraindication for the performance of magnetic resonance imaging (MRI). A number of small studies have shown that MRI can be performed with minimal risk when patients are properly monitored and device programming is modified appropriately for the procedure. However, the risk of performing MRI for patients with implanted cardiac devices has not been sufficiently evaluated to advocate routine clinical use. The aim of the present protocol is to prospectively determine the rate of adverse clinical events and device parameter changes in patients with implanted non-MRI-conditional cardiac devices undergoing clinically indicated nonthoracic MRI at 1.5 T. The MagnaSafe Registry is a multicenter, prospective cohort study of up to 1500 MRI examinations in patients with pacemakers or implantable cardioverter-defibrillators implanted after 2001 who undergo clinically indicated nonthoracic MRI following a specific protocol to ensure that preventable potential adverse events are mitigated. Adverse events and changes in device parameter measurements that may be associated with the imaging procedure will be documented. Through August 2012, 701 MRI studies have been performed, representing 47% of the total target enrollment. The results of this registry will provide additional documentation of the risk of MRI and will further validate a clinical protocol for screening and the performance of clinically indicated MRI for patients with implanted cardiac devices. Copyright © 2013 Mosby, Inc. All rights reserved.

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.

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support).

PubMed

Jorde, Ulrich P; Kushwaha, Sudhir S; Tatooles, Antone J; Naka, Yoshifumi; Bhat, Geetha; Long, James W; Horstmanshof, Douglas A; Kormos, Robert L; Teuteberg, Jeffrey J; Slaughter, Mark S; Birks, Emma J; Farrar, David J; Park, Soon J

2014-05-06

A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. New device technology developed in the clinical research setting requires validation in a real-world setting. The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator.

PubMed

van Barreveld, M; Dijkgraaf, M G W; Hulleman, M; Boersma, L V A; Delnoy, P P H M; Meine, M; Tuinenburg, A E; Theuns, D A M J; van der Voort, P H; Kimman, G P; Buskens, E; Tijssen, J P G; Bruinsma, N; Verstraelen, T E; Zwinderman, A H; van Dessel, P H F M; Wilde, A A M

2017-10-01

Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy. The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women. The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

Incidence and Outcomes of Cardiopulmonary Resuscitation in Pediatric Intensive Care Units

PubMed Central

Berg, Robert A.; Nadkarni, Vinay M.; Clark, Amy E.; Moler, Frank; Meert, Kathleen; Harrison, Rick E.; Newth, Christopher J. L.; Sutton, Robert M.; Wessel, David L.; Berger, John T.; Carcillo, Joseph; Dalton, Heidi; Heidemann, Sabrina; Shanley, Thomas P.; Zuppa, Athena F.; Doctor, Allan; Tamburro, Robert F.; Jenkins, Tammara L.; Dean, J. Michael; Holubkov, Richard; Pollack, Murray M.

2015-01-01

Objective To determine the incidence of cardiopulmonary resuscitation (CPR) in pediatric intensive care units (PICU) and subsequent outcomes. Design, Setting, and Patients Multi-center prospective observational study of children 30 minutes, p30 minutes of CPR. Conclusions These data establish that contemporary PICU CPR, including long durations of CPR, results in high rates of survival to hospital discharge (45%) and favorable neurologic outcomes among survivors (89%). Rates of survival with favorable neurologic outcomes were similar among cardiac and non-cardiac patients. The rigorous prospective, observational study design avoided the limitations of missing data and potential selection biases inherent in registry and administrative data. PMID:26646466

JenaValve.

PubMed

Treede, Hendrik; Rastan, Ardawan; Ferrari, Markus; Ensminger, Stephan; Figulla, Hans-Reiner; Mohr, Friedrich-Wilhelm

2012-09-01

The JenaValve is a next-generation TAVI device which consists of a well-proven porcine root valve mounted on a low-profile nitinol stent. Feeler guided positioning and clip fixation on the diseased leaflets allow for anatomically correct implantation of the device without rapid pacing. Safety and efficacy of transapical aortic valve implantation using the JenaValve were evaluated in a multicentre prospective study that showed good short and midterm results. The valve was CE-mark released in Europe in September 2011. A post-market registry ensures on-going and prospective data collection in "real-world" patients. The transfemoral JenaValve delivery system will be evaluated in a first-in-man study in the near future.

Clinical Trials Network / Building Infrastructure to Accelerate Transfer of Basic Research in Spinal Cord Injury (SCI) to Clinical Practice

DTIC Science & Technology

2015-05-01

Glasgow Coma Scale (GCS) and of associated injuries with the Abbreviated Injury Scale . The American Spinal Injury Association impairment scale (AIS) is...registry protocol includes: the AIS Impairment Scale , and where appropriate, the Functional Independence Measure FIM™, the Spinal Cord Independence...have been achieved with the registry. Enrollment of 762 participants has demonstrated that is feasible to acquire prospective standardized research

The Danish Neuro-Oncology Registry: establishment, completeness and validity.

PubMed

Hansen, Steinbjørn; Nielsen, Jan; Laursen, René J; Rasmussen, Birthe Krogh; Nørgård, Bente Mertz; Gradel, Kim Oren; Guldberg, Rikke

2016-08-30

The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database completeness of patient registration and validity of data. The completeness of the number of patients registered in the database was evaluated in the study period from January 2009 through December 2014 by comparing cases reported to the DNOR with the Danish National Patient Registry and the Danish Pathology Registry. The data validity of important clinical variables was evaluated by a random sample of 100 patients from the DNOR using the medical records as reference. A total of 2241 patients were registered in the DNOR by December 2014 with an overall patient completeness of 92 %, which increased during the study period (from 78 % in 2009 to 96 % in 2014). Medical records were available for all patients in the validity analyses. Most variables showed a high agreement proportion (56-100 %), with a fair to good chance-corrected agreement (k = 0.43-1.0). The completeness of patient registration was very high (92 %) and the validity of the most important patient data was good. The DNOR is a newly established national database, which is a reliable source for future scientific studies and clinical quality assessments among patients with gliomas.

Patients With Newly Diagnosed Hypertension Treated With the Renin Angiotensin Receptor Blocker Azilsartan Medoxomil vs Angiotensin-Converting Enzyme Inhibitors: The Prospective EARLY Registry.

PubMed

Schmieder, Roland E; Potthoff, Sebastian A; Bramlage, Peter; Baumgart, Peter; Mahfoud, Felix; Buhck, Hartmut; Ouarrak, Taoufik; Ehmen, Martina; Senges, Jochen; Gitt, Anselm K

2015-12-01

For patients with newly diagnosed hypertension, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) are usually the first-line therapies. There is, however, no real-life data regarding the relative clinical effectiveness and tolerability of either drug class. The prospective registry, Treatment With Azilsartan Compared to ACE Inhibitors in Antihypertensive Therapy (EARLY), was conducted to evaluate the effectiveness of the ARB azilsartan medoxomil (AZL-M) vs ACE inhibitors in real-world patients. Of the 1153 patients with newly diagnosed hypertension who were included in the registry, 789 were prescribed AZL-M and 364 were prescribed an ACE inhibitor. After multivariate adjustment, AZL-M was found to provide superior blood pressure reduction and better target blood pressure (<140/90 mm Hg) achievement. The proportion of patients with adverse events was not statistically different between groups. The authors conclude that in newly diagnosed hypertensive patients, AZL-M provides superior blood pressure control with a similar safety profile compared with ACE inhibitors. © 2015 Wiley Periodicals, Inc.

Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test.

PubMed

Hsueh, Eddy C; DeBloom, James R; Lee, Jonathan; Sussman, Jeffrey J; Covington, Kyle R; Middlebrook, Brooke; Johnson, Clare; Cook, Robert W; Slingluff, Craig L; McMasters, Kelly M

2017-08-29

A 31-gene expression profile (GEP) test that provides risk classification of cutaneous melanoma (CM) patients has been validated in several retrospective studies. The objective of the reported study was a prospective evaluation of the GEP performance in patients enrolled in two clinical registries. Three-hundred twenty two CM patients enrolled in the EXPAND (NCT02355587) and INTEGRATE (NCT02355574) registries met the criteria of age ≥ 16 years, successful GEP result and ≥1 follow-up visit for inclusion in this interim analysis. Primary endpoints were recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS). Median follow-up was 1.5 years for event-free patients. Median age for subjects was 58 years (range 18-87) and median Breslow thickness was 1.2 mm (range 0.2-12.0). Eighty-eight percent (282/322) of cases had stage I/II disease and 74% (237/322) had a SLN biopsy. Seventy-seven percent (248/322) had class 1 molecular profiles. 1.5-year RFS, DMFS, and OS rates were 97 vs. 77%, 99 vs. 89%, and 99 vs. 92% for class 1 vs. class 2, respectively (p < 0.0001 for each). Multivariate Cox regression showed Breslow thickness, mitotic rate, and GEP class to significantly predict recurrence (p < 0.01), while tumor thickness was the only significant predictor of distant metastasis and overall survival in this interim analysis. Interim analysis of patient outcomes from a combined prospective cohort supports the 31-gene GEP's ability to stratify early-stage CM patients into two groups with significantly different metastatic risk. RFS outcomes in this real-world cohort are consistent with previously published analyses with retrospective specimens. GEP testing complements current clinicopathologic features and increases identification of high-risk patients. ClinicalTrials.gov, NCT02355574  and NCT02355587.

A Prospective Survey of Atrial Fibrillation Management for Real-world Guideline Adherence: COmparison study of Drugs for symptom control and complication prEvention of Atrial Fibrillation (CODE-AF) Registry.

PubMed

Kim, Hyeongsoo; Kim, Tae Hoon; Cha, Myung Jin; Lee, Jung Myung; Park, Junbeom; Park, Jin Kyu; Kang, Ki Woon; Shim, Jaemin; Uhm, Jae Sun; Kim, Jun; Park, Hyung Wook; Choi, Eue Keun; Kim, Jin Bae; Kim, Changsoo; Lee, Young Soo; Joung, Boyoung

2017-11-01

The aging population is rapidly increasing, and atrial fibrillation (AF) is becoming a significant public health burden in Asia, including Korea. This study evaluated current treatment patterns and guideline adherence of AF treatment. In a prospective observational registry (COmparison study of Drugs for symptom control and complication prEvention of Atrial Fibrillation [CODE-AF] registry), 6,275 patients with nonvalvular AF were consecutively enrolled between June 2016 and April 2017 from 10 tertiary hospitals in Korea. The AF type was paroxysmal, persistent, and permanent in 65.3%, 30.0%, and 2.9% of patients, respectively. Underlying structural heart disease was present in 11.9%. Mean CHA₂DS₂-VASc was 2.7±1.7. Oral anticoagulation (OAC), rate control, and rhythm control were used in 70.1%, 53.9%, and 54.4% of patients, respectively. OAC was performed in 82.7% of patients with a high stroke risk. However, antithrombotic therapy was inadequately used in 53.4% of patients with a low stroke risk. For rate control in 192 patients with low ejection fraction (<40%), β-blocker (65.6%), digoxin (5.2%), or both (19.3%) were adequately used in 90.1% of patients; however, a calcium channel blocker was inadequately used in 9.9%. A rhythm control strategy was chosen in 54.4% of patients. The prescribing rate of class Ic antiarrythmics, dronedarone, and sotalol was 16.9% of patients with low ejection fraction. This study shows how successfully guidelines can be applied in the real world. The nonadherence rate was 17.2%, 9.9%, and 22.4% for stroke prevention, rate control, and rhythm control, respectively. Copyright © 2017. The Korean Society of Cardiology

Has clinical activity in paediatric neurology changed in the past 11 years?

PubMed

Martínez Menéndez, B; Escolar Escamilla, E; Pinel González, A; Cerezo García, M; Martínez Sarries, F J; Morlán Gracia, L

We believe that the demand for paediatric neurology (PN) care has increased over the past decade, and that reasons for requesting consultations have also changed. The objective of this study is to complete a registry study to profile the demand for PN care in 2013 and compare results to those from a study performed in 2002. A prospective registry of PN healthcare activities was completed at Hospital Universitario de Getafe in 2013. Results were compared with those from a prospective registry study conducted in 2002. The number of visits increased from 1,300 in 2002 to 1,982 in 2013 (a 52.46% increase), and from 32.6 visits per 1,000 children to 57.48 (a 76.32% increase). Outpatient consultations accounted for 92.2% of all PN consultations in 2013. Currently, attention deficit-hyperactivity disorder (ADHD) is the most frequent diagnosis (27.6% in 2013 vs. 8.1% in 2002). Although the percentage of headache consultations has decreased (19% in 2013 vs. 22% in 2002), headache was still the most common reason for an initial visit in 2013 (32.1%), followed by ADHD (19.1%). Epilepsy remains the most frequent diagnosis in hospitalised patients (30.3% in 2013 vs. 36.7% in 2002). PN is fundamentally an outpatient activity that has increased considerably in recent years. This increase is mainly due to neurodevelopmental disorders, especially ADHD. We might state that the role of ADHD in PN is comparable to that of dementia in general neurology. Copyright © 2014 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Study design and baseline characteristics of the national observational study of diagnostic and interventional cardiac catheterization by the French Society of Cardiology.

PubMed

Puymirat, Etienne; Blanchard, Didier; Perier, Marie-Cécile; PiaDonataccio, Maria; Gilard, Martine; Lefèvre, Thierry; Mulak, Geneviève; le Breton, Hervé; Danchin, Nicolas; Spaulding, Christian; Jouven, Xavier

2013-08-01

The national observational study of diagnostic and interventional cardiac catheterization (ONACI) is a prospective multicenter registry of the French Society of Cardiology including all interventional cardiology procedures performed from 2004. We aimed to evaluate "real-world" management of patients with coronary artery disease in France from this registry. The present study was focused on data collected from 2004 to 2008. Patient demographics and co-morbidities, invasive parameters, treatment options, and procedural techniques were prospectively collected. Patients were recruited from 99 hospitals (55% of patients were hospitalized in private clinics and 45% in public institutions). During a 5-year period, a total of 298,105 patients underwent coronary angiography and 176,166 patients underwent percutaneous coronary intervention. Diagnosis was acute coronary syndrome in 22%, stable angina or silent ischemia in 23%, and atypical chest pain in 9% of cases. Normal coronary arteries or nonsignificant coronary narrowing were found in 26% of patients. Radial access was increasingly used over the years regardless of the indication. The average number of percutaneous coronary interventions per procedure was 1.5 ± 0.7 (range, 1.3 ± 0.7 to 1.5 ± 0.7) and that of stents per procedure was 1.5 ± 0.8 (range, 1.5 ± 0.8 to 1.6 ± 0.8). Drug-eluting stents were used in 45% (range, 34% to 62%), increasing from 2004 to 2006, and then decreasing after the 2006 controversy. In conclusion, ONACI is one of the largest catheterization registries during this period, providing a detailed and comprehensive global description of the spectrum and management of patients with suspected coronary artery disease undergoing cardiac catheterization. Copyright © 2013 Elsevier Inc. All rights reserved.

The Mataró Stroke Registry: a 10-year registry in a community hospital.

PubMed

Palomeras Soler, E; Fossas Felip, P; Casado Ruiz, V; Cano Orgaz, A; Sanz Cartagena, P; Muriana Batiste, D

2015-06-01

A prospective stroke registry leads to improved knowledge of the disease. We present data on the Mataró Hospital Registry. In February-2002 a prospective stroke registry was initiated in our hospital. It includes sociodemographic data, previous diseases, clinical, topographic, etiological and prognostic data. We have analyzed the results of the first 10 years. A total of 2,165 patients have been included, 54.1% male, mean age 73 years. The most frequent vascular risk factor was hypertension (65.4%). Median NIHSS on admission: 3 (interquartile range, 1-8). Stroke subtype: 79.7% ischemic strokes, 10.9% hemorrhagic, and 9.4% TIA. Among ischemic strokes, the etiology was cardioembolic in 26.5%, large-vessel disease in 23.7%, and small-vessel in 22.9%. The most frequent topography of hemorrhages was lobar (47.4%), and 54.8% were attributed to hypertension. The median hospital stay was 8 days. At discharge, 60.7% of patients were able to return directly to their own home, and 52.7% were independent for their daily life activities. After 3 months these percentages were 76.9% and 62.9%, respectively. Hospital mortality was 6.5%, and after 3 months 10.9%. Our patient's profile is similar to those of other series, although the severity of strokes was slightly lower. Length of hospital stay, short-term and medium term disability, and mortality rates are good, if we compare them with other series. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

The Italian Registry of Antiphospholipid Antibodies.

PubMed

Finazzi, G

1997-01-01

The clinical importance of antiphospholipid antibodies (APA) derives from their association with a syndrome of venous and arterial thrombosis, recurrent fetal loss and thrombocytopenia known as the antiphospholipid syndrome (APS). The Italian Registry of Antiphospholipid Antibodies was set up in 1989 for the purpose of collecting a large number of patients with lupus anticoagulant (LA) or anticardiolipin antibodies (ACA) for clinical studies in order to obtain more information on the clinical features of APS. The Italian Registry has completed two clinical studies and proposed an international trial on the treatment of APS patients. These activities of the Registry are reviewed herein. Additional information has been obtained from pertinent articles and abstracts published in journals covered by the Science Citation Index and Medline. The first study of the Registry was a retrospective analysis of enrolled patients which showed that: a) the prevalence of thrombosis and thrombocytopenia was similar in cases with idiopathic APA or APA secondary to systemic lupus erythematosus, and b) the rate of thrombosis was significantly reduced in patients with severe thrombocytopenia but not in those with only a mild reduction of the platelet count. The second study was a prospective survey of the natural history of the disease, showing that a) previous thrombosis and ACA titer > 40 units were independent predictors of subsequent vascular complications; b) a history of miscarriage or thrombosis is significantly associated with adverse pregnancy outcome; c) hematological malignancies can develop during follow-up and patients with APA should be considered at increased risk of developing NHL. Thus the possibility of a hematologic neoplastic disease should be borne in mind in the initial evaluation and during the follow-up of these patients. The latest initiative of the Registry was the proposal of an international, randomized clinical trial (WAPS study) aimed at assessing the efficacy and safety of high-dose warfarin in preventing recurrent thrombosis in patients with APA and vascular disease. The study is scheduled to start in March 1997.

International geographic correlation study of the prevalence of disorders of male reproductive health.

PubMed

Serrano, T; Chevrier, C; Multigner, L; Cordier, S; Jégou, B

2013-07-01

Is there evidence at the population level of associations between different male genital disorders, outside Scandinavian countries? At an international scale, there is evidence for a number of correlations between rates of four male reproductive disorders (hypospadias, cryptorchidism, testicular cancer and low sperm concentration). Some associations between these outcomes have been shown in studies focusing on individuals and mainly in Nordic European countries. These associations, together with histological evidence of a dysgenesis pattern in testicular tissue specimens, have generated the concept of the existence of a 'testicular dysgenesis syndrome' originating in utero. This is a geographical correlation study using cancer, malformations rates and sperm quality data collected between the years 1998 and 2005. Incidence rates of testicular cancer were extracted from International Agency for Research on Cancer registries and Globocan, while cryptorchidism and hypospadias prevalence rates were obtained from EUROCAT and International Clearinghouse for Birth Defects Surveillance and Research registries. Sperm concentration data were extracted from recent studies using standardized methodology. A total of 39 registries and 9 sperm studies were selected. Non-parametric Spearman correlation tests were used to test the association between these four disorders. Correlations were computed for all registries together, for registries with high-quality matching coverage only and by continents. Sensitivity analyses were also conducted using data from prospective clinical studies to take into account potential bias related mainly to ascertainment of malformation rates. We found positive correlations between testicular cancer and hypospadias (r = 0.32, P = 0.05) and between hypospadias and cryptorchidism (r = 0.70, P = 0.008). Stronger correlations were observed when using registries with high-quality matching coverage. Among these registries, differences between Europe and the rest of the world appeared (the positive correlation between testicular cancer and cryptorchidism was stronger outside Europe, r = 0.83, P = 0.01 compared with 0.40, P = 0.60 for European registries). A negative correlation between testicular cancer and sperm concentration was observed (r = -0.88, P = 0.002). These correlations support our initial hypothesis but remain only suggestive due to the intrinsic limitations in the study design (i.e. geographical correlation study) and do not allow causal inference. Differences in the ascertainment of malformations rates (definition, length of follow-up) make the international comparison difficult. The small number of registries for some conditions (cryptorchidism) or of studies (for sperm quality) and the absence of information about major risk factors such as ethnicity and socioeconomic status in the registries are also limitations. Our findings are in agreement with results of studies focusing on individuals and suggest that shared risk factors are present in the populations studied.

The Kola Birth Registry and perinatal mortality in Moncegorsk, Russia.

PubMed

Vaktskjold, Arild; Talykova, Ljudmila; Chashchin, Valerij; Nieboer, Evert; Odland, Jon Øyvind

2004-01-01

A population-based birth registry has been set up for the Arctic town of Moncegorsk in north-western Russia. In this investigation, the quality and the content of the registry are assessed and the perinatal mortality (PM) rates in the period 1973-97 estimated. Enrollment in the Kola Birth Registry (KBR) involved the retrospective inclusion of all births with at least 28 weeks of gestation in Moncegorsk in the period 1973-97. The data in the registry were assessed for data entry errors, completeness of data and population coverage. The annual PM rates were estimated for live- and stillborns with at least 28 weeks of gestation. The KBR contains detailed information about the newborn, delivery, pregnancy and mother for 21 214 births by women from Moncegorsk, covering at least 96% of all the births by the population in the period studied. No records were missing data for gender and birth date of the newborn, and more than 99.9% of the records contained data about gestational age and birthweight. Data concerning the mothers' employment were missing in 0.4% of the records. The annual PM rate fell from more than 20 to less than 10 deaths per 1000 births during this period. The KBR provides an extensive data source useful for case-control and register-based prospective studies, and constitutes the first such compilation in Russia. The homogeneity of the population in Moncegorsk makes it advantageous for epidemiological investigations. The PM rate in Moncegorsk was lower than the overall rate in Russia.

Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial.

PubMed

Fröbert, Ole; Götberg, Matthias; Angerås, Oskar; Jonasson, Lena; Erlinge, David; Engstrøm, Thomas; Persson, Jonas; Jensen, Svend E; Omerovic, Elmir; James, Stefan K; Lagerqvist, Bo; Nilsson, Johan; Kåregren, Amra; Moer, Rasmus; Yang, Cao; Agus, David B; Erglis, Andrejs; Jensen, Lisette O; Jakobsen, Lars; Christiansen, Evald H; Pernow, John

2017-07-01

Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year. The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Night work and prostate cancer in men: a Swedish prospective cohort study

PubMed Central

Åkerstedt, Torbjrn; Narusyte, Jurgita; Svedberg, Pia; Kecklund, Göran; Alexanderson, Kristina

2017-01-01

Objectives Prostate cancer is the most common cancer and the second leading cause of cancer-related deaths among men, but the contributing factors are unclear. One such may be night work because of the day/night alternation of work and the resulting disturbance of the circadian system. The purpose of the present study was to investigate the prospective relation between number of years with night work and prostate cancer in men. Design Cohort study comparing night and day working twins with respect to incident prostate cancer in 12 322 men. Setting Individuals in the Swedish Twin Registry. Participants 12 322 male twins. Outcome measures Prostate cancer diagnoses obtained from the Swedish Cancer Registry with a follow-up time of 12 years, with a total number of cases=454. Results Multiple Cox proportional hazard regression analysis, adjusted for a number of covariates, showed no association between ever night work and prostate cancer, nor for duration of night work and prostate cancer. Analysis of twin pairs discordant for prostate cancer (n=332) showed no significant association between night work and prostate cancer. Conclusions The results, together with previous studies, suggest that night work does not seem to constitute a risk factor for prostate cancer. PMID:28600375

Long-term outcome for immune suppression and immune related lymphoproliferative disorder: prospective data from the United Kingdom Children's Leukaemia and Cancer Group registry 1994-2004.

PubMed

Taj, Mary M; Hadzic, Nedim; Height, Susan E; Wotherspoon, Andrew; Burke, Margaret; Hobson, Rachel; Viskaduraki, Maria; Pinkerton, C Ross

2012-05-01

Prospective national registry data on 98 patients were studied to determine the long-term outcome of immune related lymphoproliferative disease (LPD) and define prognostic factors. Seventy-three developed LPD following organ transplant (26 liver, 21 heart, 15 kidney, nine bone marrow [BM], two bowel). Twenty-five had non-transplant related immunosuppression. Age was 1.1-17 years (median 8.6). Fifty-eight patients had lymphomatous, 21 systemic and 17 lymphadenopathic disease. Sixty (73%) were disseminated and 22 (27%) localized. Thirty-three (54%) were monoclonal. Seventy-three (83%) were Epstein-Barr virus (EBV) positive. Median follow-up was 7.6 years. LPD developed earlier after liver and BM as compared to heart or kidney transplant. Five-year overall survival (OS) was 58%. Prognosis was best after liver and kidney transplant (OS >77%). Mortality was higher following heart (2.5 times) and BM transplant (5 times). Adverse prognostic factors were disseminated or lymphomatous disease and lack of reduction of immunosuppression. With appropriate reduction of immunosuppression, rituximab and low-dose chemotherapy, long-term survival is high.

Transarterial Onyx Embolization of Intracranial Dural Fistulas: A Prospective Cohort, Systematic Review, and Meta-Analysis.

PubMed

Sadeh-Gonike, Udi; Magand, Nicolas; Armoiry, Xavier; Riva, Roberto; Labeyrie, Paul Emile; Lamy, Bernadette; Lukaszewicz, Anne-Claire; Lehot, Jean-Jacques; Turjman, Francis; Gory, Benjamin

2018-06-01

Onyx is important embolic material in the endovascular treatment of intracranial dural arteriovenous fistula (DAVF). However, its impact on DAVF occlusion rates, morbidity, mortality, and complication rates is not fully examined. To improve understanding of safety and effectiveness profiles associated with transarterial endovascular treatment using Onyx for intracranial DAVF. We analyzed data from our prospective clinical registry and conducted a systematic review of all previous transarterial embolization studies using Onyx published between January 2005 and December 2015 in MEDLINE and EMBASE. In the prospective study, 41 transarterial procedures were performed in 33 consecutive patients harboring 36 DAVFs. Complete initial exclusion was obtained in 32 of 36 (88.9%) fistulas; 31 fistulas were followed up showing 4 (12.9%) recurrences. Procedure-related morbidity and mortality were 3% and 0%, respectively. The literature review identified 19 studies involving a total of 425 patients with 463 DAVFs. Meta-analysis, including our registry data, showed an initial complete occlusion rate of 82% (95% confidence interval [CI]: 74%, 88%; I2, 70.6%), and recurrence rate at midterm of 2% (95% CI: 0%, 5%; I2, 21.5%). Pooled postoperative neurological deficit, procedure-related morbidity, and mortality rates were 4% (95% CI: 2%, 6%; I2, 0%), 3% (95% CI: 1%, 5%; I2, 0%), and 0%, respectively. This meta-analysis suggests that transarterial embolization with Onyx is a safe treatment modality for DAVFs. Although Onyx showed a low recurrence rate at midterm, the long-term risk is poorly addressed in our study and should warrant a longer follow-up.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Influences on participant reporting in the World Health Organisation drugs exposure pregnancy registry; a qualitative study.

PubMed

Allen, Elizabeth N; Gomes, Melba; Yevoo, Lucy; Egesah, Omar; Clerk, Christine; Byamugisha, Josaphat; Mbonye, Anthony; Were, Edwin; Mehta, Ushma; Atuyambe, Lynn M

2014-10-31

The World Health Organisation has designed a pregnancy registry to investigate the effect of maternal drug use on pregnancy outcomes in resource-limited settings. In this sentinel surveillance system, detailed health and drug use data are prospectively collected from the first antenatal clinic visit until delivery. Over and above other clinical records, the registry relies on accurate participant reports about the drugs they use. Qualitative methods were incorporated into a pilot registry study during 2010 and 2011 to examine barriers to women reporting these drugs and other exposures at antenatal clinics, and how they might be overcome. Twenty-seven focus group discussions were conducted in Ghana, Kenya and Uganda with a total of 208 women either enrolled in the registry or from its source communities. A question guide was designed to uncover the types of exposure data under- or inaccurately reported at antenatal clinics, the underlying reasons, and how women prefer to be asked questions. Transcripts were analysed thematically. Women said it was important for them to report everything they had used during pregnancy. However, they expressed reservations about revealing their consumption of traditional, over-the-counter medicines and alcohol to antenatal staff because of anticipated negative reactions. Some enrolled participants' improved relationship with registry staff facilitated information sharing and the registry tools helped overcome problems with recall and naming of medicines. Decisions about where women sought care, which influenced medicines used and antenatal clinic attendance, were influenced by pressure within and outside of the formal healthcare system to conform to conflicting behaviours. Conversations also reflected women's responsibilities for producing a healthy baby. Women in this study commonly take traditional medicines in pregnancy, and to a lesser extent over-the-counter medicines and alcohol. The World Health Organisation pregnancy registry shows potential to enhance their reporting of these substances at the antenatal clinic. However, more work is needed to find optimal techniques for eliciting accurate reports, especially where the detail of constituents may never be known. It will also be important to find ways of sustaining such drug exposure surveillance systems in busy antenatal clinics.

Sports participation with arachnoid cysts.

PubMed

Strahle, Jennifer; Selzer, Béla J; Geh, Ndi; Srinivasan, Dushyanth; Strahle, MaryKathryn; Martinez-Sosa, Meleine; Muraszko, Karin M; Garton, Hugh J L; Maher, Cormac O

2016-04-01

OBJECT There is currently no consensus on the safety of sports participation for patients with an intracranial arachnoid cyst (AC). The authors' goal was to define the risk of sports participation for children with this imaging finding. METHODS A survey was prospectively administered to 185 patients with ACs during a 46-month period at a single institution. Cyst size and location, treatment, sports participation, and any injuries were recorded. Eighty patients completed at least 1 subsequent survey following their initial entry into the registry, and these patients were included in a prospective registry with a mean prospective follow-up interval of 15.9 ± 8.8 months. RESULTS A total 112 patients with ACs participated in 261 sports for a cumulative duration of 4410 months or 1470 seasons. Of these, 94 patients participated in 190 contact sports for a cumulative duration of 2818 months or 939 seasons. There were no serious or catastrophic neurological injuries. Two patients presented with symptomatic subdural hygromas following minor sports injuries. In the prospective cohort, there were no neurological injuries CONCLUSIONS Permanent or catastrophic neurological injuries are very unusual in AC patients who participate in athletic activities. In most cases, sports participation by these patients is safe.

Registration status and outcome reporting of trials published in core headache medicine journals.

PubMed

Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

2015-11-17

To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

Moving toward the reduction of publication/reporting biases in clinical trials using a new international standard.

PubMed

Doi, Yuriko

2016-01-01

Evidence-based medicine (EBM) is fundamental to ensuring high-quality medical care. It requires systematic reviews and meta-analyses to synthesize diverse information available from individual clinical studies. However, the literature reviewed may represent an incomplete and selective set of research findings, which could lead to publication/reporting biases and distort the true picture of research as a whole. Prospective registry of all clinical trials in the world is mandatory to reduce the biases, which have been disclosed on the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO) since 2007. The Japan Primary Registries Network (JPRN) is included in the ICTRP. ClinicalTrials.gov, the U.S. clinical trial registry, reports the standardized data of registered trials and offers access to submitted outcomes online. However, the JPRN does not systematically include the outcomes. On April 14, 2015, the WHO published a new statement online on the public disclosure of clinical trial results, which requires researchers to define the timeframes of reporting main findings and key outcomes, to call for results-reporting older, but still unpublished trials, and to outline steps to improve linkages between clinical trial registry entries and their published results. The WHO's new position will facilitate global efforts to reduce publication/reporting biases in clinical trials. Japan will have to actively participate in these efforts as well.

[Characteristics and clinical course of patients with acute heart failure and the therapeutic measures applied in Spanish emergency departments: based on the EAHFE registry (Epidemiology of Acute Heart Failure in Emergency Departments)].

PubMed

Llorens, Pere; Escoda, Rosa; Miró, Òscar; Herrero-Puente, Pablo; Martín-Sánchez, Francisco Javier; Jacob, Javier; Garrido, José Manuel; Pérez-Durá, María José; Gil, Cristina; Fuentes, Marta; Alonso, Héctor; Muller, Christian; Mebazaa, Alexander

2015-02-01

To analyze data recorded in the EAHFE registry (Epidemiology of Acute Heart Failure in Emergency Departments), which collects information on the clinical characteristics and laboratory findings of patients with acute heart failure (AHF) treated in 29 Spanish hospital emergency departments (EDs) as well as therapies used and clinical course. We analyzed changes in management observed over time and compared the results with data recorded in other AHF registries. Prospective multicenter cohort study of consecutive patients treated in 3 different years: 2007, 2009, and 2011. We collected demographic, clinical, and laboratory data; medications taken prior to the emergency and in the ED; and outcome variables (in-hospital and 30-day and 1-year mortality rates, readmissions within 30 days). Changes in therapy and course in the 3 years were analyzed. The literature was reviewed to find other national and international AHF registries. A total of 5845 patients were included (2007, 948; 2009, 1483; 2011, 3414). The mean age was 79 years and 56% were women. The AHF episode registered was the first experienced by 34.6% of the patients. Comorbidity was high: 82% had hypertension, 42.3% had diabetes mellitus, and 47.7% had atrial fibrillation. Severe or total functional dependence was observed in 21.9%, and 57.3% had systolic dysfunction (left ventricular ejection fraction, 38.3%). The main treatments administered consisted in diuretics (96.8%), endovenous nitroglycerine (20.7%), noninvasive ventilation (6.4%), and inotropic agents or vasopressors (3.6%). The glomerular filtration rate was low in 57%. Troponin and natriuretic peptide levels were measured in the EDs in 49.1% and 42.4% of the cases, respectively. Patients presented as normotensive in 66.4% of the cases, hypertensive in 23.5%, and hypotensive in 4.6% (0.7% in shock); 76.1% were admitted (1.9% to the ICU). The median hospital stay was 7 days and 23.9% were discharged from the ED. In-hospital mortality was 7.6%; 30-day mortality was 9.4% and 1-year mortality 29.5%. Orders for troponin and natriuretic peptide determinations increased over the 3 study periods, and the intravenous infusion of diuretics and inotropic agents and vasoconstrictors decreased (P < 0.001, all comparisons). Revisits within 30 days also decreased (P = 0.004). No changes were observed in in-hospital or 30-day mortality rates between 2007 and 2011. We reviewed 14 previously published registry reports (8 compiled prospectively); only 2 of the registries included ED patients. The EAHFE registry describes the characteristics of AHF in a cohort that resembles the universe of our patients with AHF. Significant changes were observed over time in some aspects of AHF management. Revisits decreased, but mortality rates remained unchanged. Only 2 other previously analyzed registries included patients with AHF treated in hospital EDs.

Lesion length impacts long term outcomes of drug-eluting stents and bare metal stents differently.

PubMed

Chang, Shang-Hung; Chen, Chun-Chi; Hsieh, Ming-Jer; Wang, Chao-Yung; Lee, Cheng-Hung; Hsieh, I-Chang

2013-01-01

Long lesions have been associated with adverse outcomes in percutaneous coronary interventions with bare metal stents (BMS). However, the exact impact of lesion length on the short- and long-term outcomes of drug-eluting stent (DES) implantations is not as clear. This study compared the impact of lesion length on angiographic and clinical outcomes of BMS and DES in a single-center prospective registry. Lesion length was divided into tertiles. The primary endpoints were angiographically defined binary in-stent restenosis (ISR) rate and major adverse cardiac event (MACE). Of the 4,312 de novo lesions in 3,447 consecutive patients in the CAPTAIN registry, 2,791 lesions (of 2,246 patients) received BMS, and the remaining 1,521 lesions (of 1,201 patients) received DES. The mean follow-up duration was 4.5 years. The longer the lesion, the higher the ISR rate (14%, 18%, and 29%, p<0.001) and the lower the MACE-free survivals (p = 0.007) in the BMS group. However, lesion length showed no such correlation with ISR rates (4.7%, 3.3%, and 7.8%, p = 0.67) or MACE-free survivals (p = 0.19) in the DES group. In our single-center prospective registry, lesion length defined in tertiles has no impact on the short-term (ISR) or long-term (MACE) outcomes of patients implanted with DES. In contrast, longer lesion correlates with higher ISR and MACE rates in BMS group.

Open and endovascular aneurysm repair in the Society for Vascular Surgery Vascular Quality Initiative.

PubMed

Spangler, Emily L; Beck, Adam W

2017-12-01

The Society for Vascular Surgery Vascular Quality Initiative is a patient safety organization and a collection of procedure-based registries that can be utilized for quality improvement initiatives and clinical outcomes research. The Vascular Quality Initiative consists of voluntary participation by centers to collect data prospectively on all consecutive cases within specific registries which physicians and centers elect to participate. The data capture extends from preoperative demographics and risk factors (including indications for operation), through the perioperative period, to outcomes data at up to 1-year of follow-up. Additionally, longer-term follow-up can be achieved by matching with Medicare claims data, providing long-term longitudinal follow-up for a majority of patients within the Vascular Quality Initiative registries. We present the unique characteristics of the Vascular Quality Initiative registries and highlight important insights gained specific to open and endovascular abdominal aortic aneurysm repair. Copyright © 2017 Elsevier Inc. All rights reserved.

Participation in research improves overall patient management: insights from the Global Rheumatic Heart Disease registry (REMEDY).

PubMed

Prendergast, E A; Perkins, S; Engel, M E; Cupido, B; Francis, V; Joachim, A; Al Kebsi, M; Bode-Thomas, F; Damasceno, A; Abul Fadl, A; El Sayed, A; Gitura, B; Kennedy, N; Ibrahim, A; Mucumbitsi, J; Adeoye, A M; Musuku, J; Okello, E; Olunuga, T; Sheta, S; Mayosi, B M; Zühlke, L J

Rheumatic heart disease (RHD) is a major public health problem in low- and middle-income countries (LIMCs), with a paucity of high-quality trial data to improve patient outcomes. Investigators felt that involvement in a recent large, observational RHD study impacted positively on their practice, but this was poorly defined. The purpose of this study was to document the experience of investigators and research team members from LMICs who participated in a prospective, multi-centre study, the global Rheumatic Heart Disease Registry (REMEDY), conducted in 25 centres in 14 countries from 2010 to 2012. We conducted an online survey of site personnel to identify and quantify their experiences. Telephone interviews were conducted with a subset of respondents to gather additional qualitative data. We asked about their experiences, positive and negative, and about any changes in RHD management practices resulting from their participation in REMEDY as a registry site. The majority of respondents in both the survey and telephone interviews indicated that participation as a registry site improved their management of RHD patients. Administrative changes included increased attention to follow-up appointments and details in patient records. Clinical changes included increased use of penicillin prophylaxis, and more frequent INR monitoring and contraceptive counselling. Our study demonstrates that participation in clinical research on RHD can have a positive impact on patient management. Furthermore, REMEDY has led to increased patient awareness and improved healthcare workers' knowledge and efficiency in caring for RHD patients.

The French prospective multisite registry on sudden unexpected infant death (OMIN): rationale and study protocol

PubMed Central

Levieux, Karine; Patural, Hugues; Harrewijn, Inge; Briand Huchet, Elisabeth; de Visme, Sophie; Gallot, Géraldine; Chalumeau, Martin; Gras Le Guen, Christèle; Hanf, Matthieu; Garcia-Meric, Patricia

2018-01-01

Introduction Even after ‘back-to-sleep’ campaigns, sudden unexpected infant death (SUID) continues to be the leading cause of death for infants 1 month to 1 year old in developed countries, with devastating social, psychological and legal implications for families. To sustainably tackle this problem and decrease the number of SUIDs, a French SUID registry was initiated in 2015 to (1) inform prevention with standardised data, (2) understand the mechanisms leading to SUID and the contribution of the already known or newly suggested risk factors and (3) gather a multidisciplinary group of experts to coordinate and develop innovative and urgent research in the SUID area. Methods and analysis This observational multisite prospective observatory includes all cases of sudden unexpected deaths in children younger than 2 years occurring in the French territory covered by the 35 participating French referral centres. From these cases, various data concerning sociodemographic conditions, death scene, personal and family medical history, parental behaviours, sleep environment, clinical examinations, biological and imagery investigations and autopsy are systematically collected. These data will be complemented as of 2018 with a biobank of diverse biological samples (blood, hair, urine, faeces and cerebrospinal fluid), with other administrative health-related data (health claim reimbursements and hospital admissions) and socioenvironmental data. Insights from exploratory descriptive statistics and thematic analysis will be combined for the design of targeted strategies to effectively reduce preventable infant deaths. Ethics and dissemination The French sudden unexpected infant death registry (Observatoire National des Morts Inattendues du Nourrisson registry;OMIN) was approved in 2015 by the French Data Protection Authority in clinical research (Commission Nationale de l’Informatique et des Libertés: number 915273) and by an independent ethics committee (Groupe Nantais d’Ethique dans le Domaine de la Santé: number 2015-01-27). Results will be discussed with associations of families affected by SUID, caregivers, funders of the registry, medical societies and researchers and will be submitted to international peer-reviewed journals and presented at international conferences. PMID:29666137

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

PubMed

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

2017-07-01

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

Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME).

PubMed

Maggi, Mario; Wu, Frederick C W; Jones, Thomas H; Jackson, Graham; Behre, Hermann M; Hackett, Geoffrey; Martin-Morales, Antonio; Balercia, Giancarlo; Dobs, Adrian S; Arver, Stefan T E; Maggio, Marcello; Cunningham, Glenn R; Isidori, Andrea M; Quinton, Richard; Wheaton, Olivia A; Siami, Flora S; Rosen, Raymond C

2016-10-01

The aim of this study was to assess cardiovascular (CV) safety of testosterone replacement therapy (TRT) in a large, diverse cohort of European men with hypogonadism (HG). The Registry of Hypogonadism in Men (RHYME) was designed as a multi-national, longitudinal disease registry of men diagnosed with hypogonadism (HG) at 25 clinical sites in six European countries. Data collection included a complete medical history, physical examination, blood sampling and patient questionnaires at multiple study visits over 2-3 years. Independent adjudication was performed on all mortalities and CV outcomes. Of 999 patients enrolled with clinically diagnosed HG, 750 (75%) initiated some form of TRT. Registry participants, including both treated and untreated patients, contributed 23 900 person-months (99.6% of the targeted) follow-up time. A total of 55 reported CV events occurred in 41 patients. Overall, five patients died of CV-related causes (3 on TRT, 2 untreated) and none of the deaths were adjudicated as treatment-related. The overall CV incidence rate was 1522 per 100 000 person-years. CV event rates for men receiving TRT were not statistically different from untreated men (P=.70). Regardless of treatment assignment, CV event rates were higher in older men and in those with increased CV risk factors or a prior history of CV events. Age and prior CV history, not TRT use, were predictors of new-onset CV events in this multi-national, prospective hypogonadism registry. © 2016 John Wiley & Sons Ltd.

The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes.

PubMed

Köckerling, Ferdinand; Simon, Thomas; Hukauf, Martin; Hellinger, Achim; Fortelny, Rene; Reinpold, Wolfgang; Bittner, Reinhard

2017-06-07

To assess the role of registries in the postmarketing surveillance of surgical meshes. To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry. The present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834). Patients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P < 0.001). In the multivariable analysis, the recurrence rate was highly significantly influenced by the mesh type used (P < 0.001). If Physiomesh was used, that led to a highly significant increase in the recurrence rate on 1-year follow-up (odds ratio 2.570, 95% CI 2.057, 3.210). The mesh type used also had a significant influence on chronic pain rates. The importance of real-world data for postmarketing surveillance of surgical meshes has been demonstrated in this registry-based study. Randomized controlled trials are needed for premarket approval of new devices. The role of sponsorship of device studies by the manufacturing company must be taken into account.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.

Short rest between shift intervals increases the risk of sick leave: a prospective registry study.

PubMed

Vedaa, Øystein; Pallesen, Ståle; Waage, Siri; Bjorvatn, Bjørn; Sivertsen, Børge; Erevik, Eilin; Svensen, Erling; Harris, Anette

2017-07-01

The purpose of this study was to use objective registry data to prospectively investigate the effects of quick returns (QR, <11 hours of rest between shifts) and night shifts on sick leave. A total of 1538 nurses (response rate =41.5%) answered questionnaires on demographics and personality and provided consent to link this information to registry data on shift work and sick leave from employers' records. A multilevel negative binomial model was used to investigate the predictive effect of exposure to night shifts and QR every month for 1 year, on sick leave the following month. Exposure to QR the previous month increased the risk for sick leave days (incidence rate ratio (IRR)=1.066, 95% CI 1.022 to 1.108, p<0.01) and sick leave spells (IRR=1.059, 95% CI 1.025 to 1.097, p<0.001) the following month, whereas night shifts did not. 83% per cent of the nurses experienced QR within a year, and on average they were exposed to 3.0 QR per month (SD=1.6). Personality characteristics associated with shift work tolerance (low on morningness, low on languidity and high on flexibility) were not associated with sick leave, and did not moderate the relationship between QR and sick leave. We found a positive linear relationship between QR and sick leave. Avoiding QR may help reduce workers' sick leave. The restricted recovery opportunity associated with QR may give little room for beneficial effects of individual characteristics usually associated with shift work tolerance. 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/.

Management of outpatients in France with stable coronary artery disease. Findings from the prospeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease (CLARIFY) registry.

PubMed

Danchin, Nicolas; Ferrieres, Jean; Guenoun, Maxime; Cattan, Simon; Rushton-Smith, Sophie K; Greenlaw, Nicola; Ferrari, Roberto; Steg, Philippe Gabriel

2014-01-01

Improvements in the treatment of coronary artery disease mean that an increasing number of patients survive acute cardiovascular events and live as outpatients with or without anginal symptoms. To determine the characteristics and management of contemporary outpatients with stable coronary artery disease in Western Europe, and to compare France with the other Western European countries. CLARIFY (prospeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease) is an international, prospective, observational, longitudinal study. Between November 2009 and July 2010, 32,954 adult outpatients with stable coronary artery disease (defined as a history of documented myocardial infarction [of >3 months], prior coronary revascularization, chest pain with myocardial ischaemia, or coronary stenosis of>50% proven by angiography) were enrolled in 45 countries. The demographics and management of CLARIFY patients enrolled in France were compared with those enrolled in other Western European countries (Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland and the UK). Of the 14,726 patients enrolled in Western Europe (mean age 66.2 [10.2] years; 79.6% male), 2432 (16.5%) were from France. The use of aspirin was lower in France than in other Western European countries (74.5% vs. 86.9%, respectively), whereas use of thienopyridines (48.5% vs. 21.7%), oral anticoagulants (12.3% vs. 9.0%) and lipid-lowering drugs (95.8% vs. 92.5%) was higher. Beta-blockers were used in 73% of both groups. Angina was less prevalent in France (6.3% vs. 15.5%) and French patients showed higher levels of physical activity than their counterparts in Western Europe. The management of patients with stable CAD in France appears favourable, with good adherence to guideline-based therapies, but there remains room for improvement in terms of symptom and risk factor control. Copyright © 2014. Published by Elsevier Masson SAS.

Night work and prostate cancer in men: a Swedish prospective cohort study.

PubMed

Åkerstedt, Torbjrn; Narusyte, Jurgita; Svedberg, Pia; Kecklund, Göran; Alexanderson, Kristina

2017-06-08

Prostate cancer is the most common cancer and the second leading cause of cancer-related deaths among men, but the contributing factors are unclear. One such may be night work because of the day/night alternation of work and the resulting disturbance of the circadian system. The purpose of the present study was to investigate the prospective relation between number of years with night work and prostate cancer in men. Cohort study comparing night and day working twins with respect to incident prostate cancer in 12 322 men. Individuals in the Swedish Twin Registry. 12 322 male twins. Prostate cancer diagnoses obtained from the Swedish Cancer Registry with a follow-up time of 12 years, with a total number of cases=454. Multiple Cox proportional hazard regression analysis, adjusted for a number of covariates, showed no association between ever night work and prostate cancer, nor for duration of night work and prostate cancer. Analysis of twin pairs discordant for prostate cancer (n=332) showed no significant association between night work and prostate cancer. The results, together with previous studies, suggest that night work does not seem to constitute a risk factor for prostate cancer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Significance of prior percutaneous revascularisation in patients with acute coronary syndromes: insights from the prospective PROSPECT registry.

PubMed

Iñiguez, Andrés; Brener, Sorin J; Jiménez, Victor A; Maehara, Akiko; Mintz, Gary S; Xu, Ke; Weisz, Giora; Lansky, Alexandra J; De Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W

2016-04-20

Prior percutaneous coronary intervention (PCI) is increasingly encountered in acute coronary syndrome (ACS) patients, with uncertain significance. We sought to evaluate the impact of prior PCI in ACS patients. Patients with ACS enrolled in the prospective PROSPECT registry underwent three-vessel intravascular ultrasound and virtual histology evaluation after successful PCI of the culprit lesion(s). We identified patients with prior PCI (>6 months before index ACS) and compared their outcomes to those without prior PCI. Time-to-event for major adverse cardiac events (MACE) was estimated up to three years, and the independent association between prior PCI and MACE was evaluated in a multivariable model. Among 696 patients enrolled, 77 (11.1%) had prior PCI. They were older and more likely to have prior myocardial infarction, chronic kidney disease, and congestive heart failure. At three years, patients with prior PCI had significantly higher rates of cardiac death, rehospitalisation for worsening angina, and MACE (adjusted HR=1.73 [95% CI: 1.09, 2.75], p=0.02), independent of other comorbidities and intravascular ultrasound findings. Prior PCI was noted in over 10% of patients with ACS and was associated with higher mortality and morbidity, independent of other comorbidities. Prior PCI should be considered a high-risk feature when evaluating ACS patients.

A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

PubMed

Mustapha, Jihad A; Lansky, Alexandra; Shishehbor, Mehdi; Miles McClure, John; Johnson, Sarah; Davis, Thomas; Makam, Prakash; Crowder, William; Konstantino, Eitan; Attaran, Robert R

2018-05-01

The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use. © 2018 Wiley Periodicals, Inc.

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).

PubMed

Haddara, Sami; Jacques, Jeremie; Lecleire, Stéphane; Branche, Julien; Leblanc, Sarah; Le Baleur, Yann; Privat, Jocelyn; Heyries, Laurent; Bichard, Philippe; Granval, Philippe; Chaput, Ulriikka; Koch, Stephane; Levy, Jonathan; Godart, Bruno; Charachon, Antoine; Bourgaux, Jean-François; Metivier-Cesbron, Elodie; Chabrun, Edouard; Quentin, Vincent; Perrot, Bastien; Vanbiervliet, Geoffroy; Coron, Emmanuel

2016-12-01

Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed. ClinicalTrials.gov (NCT02595853). © Georg Thieme Verlag KG Stuttgart · New York.

Registry on acute cardiovascular events during endurance running races: the prospective RACE Paris registry.

PubMed

Gerardin, Benoît; Collet, Jean-Philippe; Mustafic, Hazrije; Bellemain-Appaix, Anne; Benamer, Hakim; Monsegu, Jacques; Teiger, Emmanuel; Livarek, Bernard; Jaffry, Murielle; Lamhaut, Lionel; Fleischel, Catherine; Aubry, Pierre

2016-08-21

Long distance running races are associated with a low risk of life-threatening events much often attributed to hypertrophic cardiomyopathy. However, retrospective analyses of aetiology lack consistency. Incidence and aetiology of life-threatening/fatal events were assessed in long distance races in the prospective Registre des Accidents Cardiaques lors des courses d'Endurance (RACE Paris Registry) from October 2006 to September 2012. Characteristics of life-threatening/fatal events were analysed by interviewing survivors and reviewing medical records including post-mortem data of each case. Seventeen life-threatening events were identified of 511 880 runners of which two were fatal. The vast majority were cardiovascular events (13/17) occurring in experienced male runners [mean (±SD) age 43 ± 10 years], with infrequent cardiovascular risk factors, atypical warning symptoms prior to the race or negative treadmill test when performed. Acute myocardial ischaemia was the predominant aetiology (8 of 13) and led to immediate myocardial revascularization. All cases with initial shockable rhythm survived. There was no difference in event rate according to marathons vs. half-marathons and events were clustered at the end of the race. A meta-analysis of all available studies including the RACE Paris registry (n = 6) demonstrated a low prevalence of life-threatening events (0.75/100 000) and that presentation with non-shockable rhythm [OR = 29.9; 95% CI (4.0-222.5), P = 0.001] or non-ischaemic aetiology [OR = 6.4; 95% CI (1.4-28.8), P = 0.015] were associated with case-fatality. Life-threatening/fatal events during long distance races are rare, most often unpredictable and mainly due to acute myocardial ischaemia. Presentation with non-shockable rhythm and non-ischaemic aetiology are the major determinant of case fatality. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

The use of a medico economic database as a part of French apheresis registry.

PubMed

Kanouni, T; Aubas, P; Heshmati, F

2017-02-01

An apheresis registry is a part of each learned apheresis society. The interest in this is obvious, in terms of knowledge of the practice of apheresis, adverse events, and technical issues. However, because of the weight of data entry it could never be exhaustive and some data will be missing. While continuing our registry efforts and our efforts to match with other existing registries, we decided to extend the data collection to a medico-economic database that is available in France, the Programme de Médicalisation du Système d'Information (PMSI) that has covered reimbursement information for each public or private hospital since 2007. It contains almost all apheresis procedures in all apheresis fields, demographic patient data, and primary and related diagnoses, among other data. Although this data does not include technical apheresis issues or other complications of the procedures, its interest is great and it is complementary to the registry. From 2003-2014, we have recorded 250,585 apheresis procedures, for 48,428 patients. We showed that the data are reliable and exhaustive. The information shows a perfect real life practice in apheresis, regarding indications, the rhythm and the duration of apheresis treatment. This prospective data collection is sustainable and allows us to assess the impact of healthcare guidelines. Our objective is to extend the data collection and match it to other existing databases; this will allow us to conduct, for example, a cohort study specifically for ECP. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development and evaluation of a centralised computerised registry for ureteric stents: completing the audit cycle.

PubMed

Davis, N F; Murray, G; O'Connor, T; Browne, C; MacCraith, E; Galvin, D; Mulvin, D; Quinlan, D; Lennon, G

2017-11-01

A forgotten ureteric stent may result in severe renal impairment leading to nephrectomy. To compare the effectiveness of a centralised computerised registry for monitoring ureteric stent activity with a previously established theatre stent logbook system. This prospective audit was performed in two 9-monthly intervals. During the first interval, insertion/removal of a ureteric stent was documented in a specific theatre stent logbook. In the second interval, an electronic centralised computerised registry was developed to document insertion/removal of a ureteric stent onto an accessible hospital server. A computerised traffic-light system was also developed to identify patients with an indwelling stent for >3 months. The primary outcome variable was the number of prolonged indwelling ureteric stents in both groups. During the first time interval, 188 ureteric stents were inserted and 182 (96%) were removed or changed. Six (4%) patients underwent insertion of a ureteric stent for a prolonged period of time (>6 months). This subgroup required complex endourological intervention for stent removal due to encrustation. During the second time interval, 157 ureteric stents were inserted and all patients had their stent removed or changed within 6 months. No patients in this group were lost to follow-up. This study demonstrates that a centralised computerised ureteric stent registry is superior to a conventional logbook for monitoring ureteric stent activity. We propose the introduction a centralised nationalised ureteric stent registry for eliminating the potential for prolonged or forgotten ureteric stents.

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

PubMed Central

Mitchell, Ian; Lanctôt, Krista L.

2013-01-01

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

Outcome of Heart Failure with Preserved Ejection Fraction: A Multicentre Spanish Registry

PubMed Central

Castillo, Juan C; Anguita1, Manuel P; Jiménez, Manuel

2009-01-01

Background: Studies on clinical features, treatment and prognosis of patients with congestive heart failure (CHF) and preserved left ventricular ejection fraction (LVEF) are few and their results frequently conflicting. Aims: To investigate the characteristics and long term prognosis of patients with CHF and preserved (≥ 45%) LVEF. Methods and Results: We conducted a prospective multicentre study with 4720 patients attended in 62 heart failure clinics from 1999 to 2003 in Spain (BADAPIC registry). LVEF was preserved in 30% patients. Age, female gender, prevalence of atrial fibrillation, hypertension and non-ischaemic cardiopathy were all significantly greater in patients with preserved LVEF. Mean follow-up was 40±12 months. Mortality and other cardiovascular complication rates during follow up were similar in both groups. On multivariate analysis ejection fraction was not an independent predictor for mortality. Survival at one and five years was similar in both groups (79% and 59% for patients with preserved LVEF and 78% and 57% for those with reduced LVEF, respectively). Conclusions: In the BADAPIC registry, a high percentage of heart failure patients had preserved LVEF. Although clinical differences were seen between groups, morbidity and mortality were similar in both groups. PMID:21037850

Workplace Bullying as a Predictor of Disability Retirement: A Prospective Registry Study of Norwegian Employees.

PubMed

Nielsen, Morten Birkeland; Emberland, Jan Shahid; Knardahl, Stein

2017-07-01

The aim of this study was to determine 1) whether bullying is related to all-cause disability retirement, 2) whether bullying contributes to the variance in disability retirement above high job demands and lack of job control, and 3) to establish gender differences in the relationship. Survey data from 14,501 Norwegian employees on exposure factors linked to registry data on all-cause disability retirement. Bullying significantly predicted risk of disability retirement (hazard ratio = 1.55; 95% confidence interval = 1.13 to 2.12). This relationship remained statistically significant after adjusting for job demands and lack of job control. Women had the highest risk of disability, but both bullied men and women had a higher risk of disability than nonbullied employees of the same gender. Bullying is a risk factor for disability retirement. Measures taken to prevent bullying may be beneficial for reducing both health problems and disability retirement.

Interest of a simple on-line screening registry for measuring ICU burden related to an influenza pandemic.

PubMed

Richard, Jean-Christophe Marie; Pham, Tài; Brun-Buisson, Christian; Reignier, Jean; Mercat, Alain; Beduneau, Gaëtan; Régnier, Bernard; Mourvillier, Bruno; Guitton, Christophe; Castanier, Matthias; Combes, Alain; Le Tulzo, Yves; Brochard, Laurent

2012-07-09

The specific burden imposed on Intensive Care Units (ICUs) during the A/H1N1 influenza 2009 pandemic has been poorly explored. An on-line screening registry allowed a daily report of ICU beds occupancy rate by flu infected patients (Flu-OR) admitted in French ICUs. We conducted a prospective inception cohort study with results of an on-line screening registry designed for daily assessment of ICU burden. Among the 108 centers participating to the French H1N1 research network on mechanical ventilation (REVA) - French Society of Intensive Care (SRLF) registry, 69 ICUs belonging to seven large geographical areas voluntarily participated in a website screening-registry. The aim was to daily assess the ICU beds occupancy rate by influenza-infected and non-infected patients for at least three weeks. Three hundred ninety-one critically ill infected patients were enrolled in the cohort, representing a subset of 35% of the whole French 2009 pandemic cohort; 73% were mechanically ventilated, 13% required extra corporal membrane oxygenation (ECMO) and 22% died. The global Flu-OR in these ICUs was only 7.6%, but it exceeded a predefined 15% critical threshold in 32 ICUs for a total of 103 weeks. Flu-ORs were significantly higher in University than in non-University hospitals. The peak ICU burden was poorly predicted by observations obtained at the level of large geographical areas. The peak Flu-OR during the pandemic significantly exceeded a 15% critical threshold in almost half of the ICUs, with an uneven distribution with time, geographical areas and between University and non-University hospitals. An on-line assessment of Flu-OR via a simple dedicated registry may contribute to better match resources and needs.

Atrial fibrillation in Middle Eastern Arab and South Asian patients hospitalized with acute myocardial infarction: experience from a 20-year registry in qatar (1991-2010).

PubMed

Salam, Amar M; Al, Binali Hajar A; Singh, Rajvir; Gehani, Abdurrazzak; Asaad, Nidal; Al-Qahtani, Awad; Suwaidi, Jassim Al

2013-04-01

Recent evidence suggests that there are ethnic variations in atrial fibrillation (AF) susceptibility and incidence following acute myocardial infarction (AMI). The aim of this study was to evaluate the incidence and predictors of AF in the setting of AMI in Middle Eastern Arab and South Asian patients and its impact on in-hospital morbidity and mortality. A retrospective analysis of a prospective registry of all patients hospitalized with AMI in the state of Qatar from 1991 through 2010 was made. Clinical characteristics and outcomes of AMI patients with and without AF were compared. Sub-analysis according to ethnicity was also performed. During the 20-year period; a total of 12,881 patients were hospitalized with AMI. Of these 5028 were Arabs and 5985 were South Asians. A total of 227 had AF during hospitalization with an overall incidence of 1.8% (156 Arabs; incidence 3.1% and 48 South Asians; incidence 0.8%). The mean age of AF patients was 65 years (Arabs 69, South Asians 54). Patients with AF were significantly older and had more cardiovascular co-morbidities than patients without AF, and were more likely to have non-ST elevation AMI on presentation. Patients with AF had significantly higher in-hospital mortality rate (20.3% versus 7.1%; P=0.001) and stroke rates (1.8% versus 0.3%; P=0.001) when compared to patients without AF. Age was the only independent predictor of AF development in patients with AMI in our study. Our study reports variability in the prevalence of AF among AMI patients according to ethnicity using a 20-year registry from a Middle Eastern country. Advancing age was the major independent predictor of AF in our AMI patients. Further prospective studies are required evaluating optimal therapeutic approaches for these high-risk patients in order to reduce the high mortality observed.

Antibiotics in Pregnancy Increase Children's Risk of Otitis Media and Ventilation Tubes.

PubMed

Pedersen, Tine Marie; Stokholm, Jakob; Thorsen, Jonathan; Mora-Jensen, Anna-Rosa Cecilie; Bisgaard, Hans

2017-04-01

To study the association between antibiotic intake in pregnancy and the development of otitis media and placement of ventilation tubes (VTs) in the offspring under the hypothesis that antibiotics in pregnancy may alter the offspring's propensity for disease. Data from the 700 children in the Copenhagen Prospective Studies on Asthma in Childhood 2010 unselected birth cohort study were used. Information on maternal antibiotic use and other exposures during pregnancy was collected prospectively from interviews and validated in national registries. Otitis media episodes were registered in a prospective diary for 3 years. Information regarding children's VTs was obtained from national registries. There were 514 children who had diary information and were included in the analysis regarding otitis media episodes. For VTs analysis, 699 children were included. Thirty-seven percent of the mothers received antibiotics during pregnancy, and this was associated with increased risk of otitis media (adjusted hazard ratio 1.30; 95% CI 1.04-1.63; P = .02). The risk of receiving VTs was especially associated with third trimester antibiotics (adjusted hazard ratio 1.60; 95% CI 1.08-2.36, P = .02). The risk of otitis media increased with increasing number of treatments (per-level adjusted hazard ratio 1.20; 95% CI 1.04-1.40; P = .02), but for VTs this association was not significant after adjustment. Maternal use of antibiotics during pregnancy is associated with an increased risk of otitis media and VT insertions in the offspring. Antibiotics late in pregnancy mainly contributed to these effects, pointing toward potential transmission of an unfavorable microbiome from mother to child. Copyright © 2016 Elsevier Inc. All rights reserved.

Cohort profile: cerebral palsy in the Norwegian and Danish birth cohorts (MOBAND-CP)

PubMed Central

Tollånes, Mette C; Strandberg-Larsen, Katrine; Forthun, Ingeborg; Petersen, Tanja Gram; Moster, Dag; Andersen, Anne-Marie Nybo; Stoltenberg, Camilla; Olsen, Jørn; Wilcox, Allen J

2016-01-01

Purpose The purpose of MOthers and BAbies in Norway and Denmark cerebral palsy (MOBAND-CP) was to study CP aetiology in a prospective design. Participants MOBAND-CP is a cohort of more than 210 000 children, created as a collaboration between the world's two largest pregnancy cohorts—the Norwegian Mother and Child Cohort study (MoBa) and the Danish National Birth Cohort. MOBAND-CP includes maternal interview/questionnaire data collected during pregnancy and follow-up, plus linked information from national health registries. Findings to date Initial harmonisation of data from the 2 cohorts has created 140 variables for children and their mothers. In the MOBAND-CP cohort, 438 children with CP have been identified through record linkage with validated national registries, providing by far the largest such sample with prospectively collected detailed pregnancy data. Several studies investigating various hypotheses regarding CP aetiology are currently on-going. Future plans Additional data can be harmonised as necessary to meet requirements of new projects. Biological specimens collected during pregnancy and at delivery are potentially available for assay, as are results from assays conducted on these specimens for other projects. The study size allows consideration of CP subtypes, which is rare in aetiological studies of CP. In addition, MOBAND-CP provides a platform within the context of a merged birth cohort of exceptional size that could, after appropriate permissions have been sought, be used for cohort and case-cohort studies of other relatively rare health conditions of infants and children. PMID:27591025

Giving blood and enrolling on the stem cell donor registry: ranking of obstacles and motives in Switzerland.

PubMed

Bart, Thomas; Volken, Thomas; Fischer, Yvonne; Taleghani, Behrouz Mansouri

2014-07-01

To obtain a better understanding of factors affecting blood and blood stem cell donation behavior in Switzerland, a series of studies has been performed. In the recent study of this series, which is described here, motivators and barriers in the field of blood and blood stem cell donation were identified. Web-based survey data from a non-random sample of the Swiss population 2012/2013 (n = 3,153) were used to describe and compare the ranking of motives and obstacles to donate blood and to enroll on the Swiss blood stem cell registry. Wilcoxon rank-sum test and Spearman's rank correlations were used to assess differences and associations between ranks and groups. The prospect of saving lives and solidarity were the top two motives to donate blood or to enroll on the blood stem cell registry. The top two obstacles to enroll on the blood stem cell registry were lack of general information on blood stem cell donation and on its risks, whereas the top two obstacles to donate blood were the lack of information where and when to donate and deferral of or exclusion from blood donation. Classical altruistic motives are top drivers for giving blood as well as registering for blood stem cell donation. Recruitment campaigns should focus on these motivators. Similarities in motivational factors as well as in obstacles regarding blood and blood stem cell donation can be found.

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

PubMed

Choi, Chang Won; Park, Moon Sung

2015-10-01

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

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

PubMed

Wetzel, F Todd; McNally, Thomas A; Phillips, Frank M

2002-11-15

Retrospective literature review. To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.

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

PubMed

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

2014-01-01

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

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

PubMed Central

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

2014-01-01

Background: There is paucity of data on heart failure (HF) in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE). Materials and Methods: Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF). The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. Results: A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain) participated in the project. The majority of hospitals were community hospitals (46%; 22/47) followed by non-University teaching (32%; 15/47 and University hospitals (17%). Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47) with 59% (28/47) having catheterization laboratory facilities. However, only 29% (14/47) had a dedicated HF clinic facility. Most patients (71%) were cared for by a cardiologist. Conclusions: Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden of HF in this region. PMID:24949181

Analysis of the time and workers needed to conduct systematic reviews of medical interventions using data from the PROSPERO registry

PubMed Central

Borah, Rohit; Brown, Andrew W; Capers, Patrice L; Kaiser, Kathryn A

2017-01-01

Objectives To summarise logistical aspects of recently completed systematic reviews that were registered in the International Prospective Register of Systematic Reviews (PROSPERO) registry to quantify the time and resources required to complete such projects. Design Meta-analysis. Data sources and study selection All of the 195 registered and completed reviews (status from the PROSPERO registry) with associated publications at the time of our search (1 July 2014). Data extraction All authors extracted data using registry entries and publication information related to the data sources used, the number of initially retrieved citations, the final number of included studies, the time between registration date to publication date and number of authors involved for completion of each publication. Information related to funding and geographical location was also recorded when reported. Results The mean estimated time to complete the project and publish the review was 67.3 weeks (IQR=42). The number of studies found in the literature searches ranged from 27 to 92 020; the mean yield rate of included studies was 2.94% (IQR=2.5); and the mean number of authors per review was 5, SD=3. Funded reviews took significantly longer to complete and publish (mean=42 vs 26 weeks) and involved more authors and team members (mean=6.8 vs 4.8 people) than those that did not report funding (both p<0.001). Conclusions Systematic reviews presently take much time and require large amounts of human resources. In the light of the ever-increasing volume of published studies, application of existing computing and informatics technology should be applied to decrease this time and resource burden. We discuss recently published guidelines that provide a framework to make finding and accessing relevant literature less burdensome. PMID:28242767

Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score.

PubMed

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

2016-01-11

This study sought to develop a novel parsimonious score for predicting technical success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) performed using the hybrid approach. Predicting technical success of CTO PCI can facilitate clinical decision making and procedural planning. We analyzed clinical and angiographic parameters from 781 CTO PCIs included in PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) using a derivation and validation cohort (2:1 sampling ratio). Variables with strong association with technical success in multivariable analysis were assigned 1 point, and a 4-point score was developed from summing all points. The PROGRESS CTO score was subsequently compared with the J-CTO (Multicenter Chronic Total Occlusion Registry in Japan) score in the validation cohort. Technical success was 92.9%. On multivariable analysis, factors associated with technical success included proximal cap ambiguity (beta coefficient [b] = 0.88), moderate/severe tortuosity (b = 1.18), circumflex artery CTO (b = 0.99), and absence of "interventional" collaterals (b = 0.88). The resulting score demonstrated good calibration and discriminatory capacity in the derivation (Hosmer-Lemeshow chi-square = 2.633; p = 0.268, and receiver-operator characteristic [ROC] area = 0.778) and validation (Hosmer-Lemeshow chi-square = 5.333; p = 0.070, and ROC area = 0.720) subset. In the validation cohort, the PROGRESS CTO and J-CTO scores performed similarly in predicting technical success (ROC area 0.720 vs. 0.746, area under the curve difference = 0.026, 95% confidence interval = -0.093 to 0.144). The PROGRESS CTO score is a novel useful tool for estimating technical success in CTO PCI performed using the hybrid approach. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-10-15

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

Psychiatric and neurological symptoms in patients with Niemann-Pick disease type C (NP-C): Findings from the International NPC Registry.

PubMed

Bonnot, Olivier; Gama, Clarissa S; Mengel, Eugen; Pineda, Mercè; Vanier, Marie T; Watson, Louise; Watissée, Marie; Schwierin, Barbara; Patterson, Marc C

2017-10-09

Niemann-Pick disease type C (NP-C) is a rare inherited neurovisceral disease that should be recognised by psychiatrists as a possible underlying cause of psychiatric abnormalities. This study describes NP-C patients who had psychiatric manifestations at enrolment in the international NPC Registry, a unique multicentre, prospective, observational disease registry. Treating physicians' data entries describing psychiatric manifestations in NPC patients were coded and grouped by expert psychiatrists. Out of 386 NP-C patients included in the registry as of October 2015, psychiatric abnormalities were reported to be present in 34% (94/280) of those with available data. Forty-four patients were confirmed to have identifiable psychiatric manifestations, with text describing these psychiatric manifestations. In these 44 patients, the median (range) age at onset of psychiatric manifestations was 17.9 years (2.5-67.9; n = 15), while the median (range) age at NP-C diagnosis was 23.7 years (0.2-69.8; n = 34). Almost all patients (43/44; 98%) had an occurrence of ≥1 neurological manifestation at enrolment. These data show that substantial delays in diagnosis of NP-C are long among patients with psychiatric symptoms and, moreover, patients presenting with psychiatric features and at least one of cognitive impairment, neurological manifestations, and/or visceral symptoms should be screened for NP-C.

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 knowledge, this is the first large-scale effort to use a clinical registry to provide comparative outcome rates representing the safety and effectiveness of regional anesthesia. These results can be used to help inform quality improvement strategies. PMID:25275578

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

PubMed

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

2017-03-15

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

Externalized conductors and insulation failure in Biotronik defibrillator leads: History repeating or a false alarm?

PubMed

De Maria, Elia; Borghi, Ambra; Bonetti, Lorenzo; Fontana, Pier Luigi; Cappelli, Stefano

2017-02-16

Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads. Conductor externalization is a "unique" failure mechanism: Cables externalize through the insulation ("inside-out" abrasion) and appear outside the lead body. Recently, single reports described a similar failure also for Biotronik leads. Moreover, some studies reported a high rate of electrical dysfunction (not only insulation failure) with Biotronik Linox leads and a reduced survival rate in comparison with the competitors. In this paper we describe the case of a patient with a Biotronik Kentrox ICD lead presenting with signs of insulation failure and conductor externalization at fluoroscopy. Due to the high risk of extraction we decided to implant a new lead, abandoning the damaged one; lead reimplant was uneventful. Subsequently, we review currently available literature about Biotronik Kentrox and Linox ICD lead failure and in particular externalized conductors. Some single-center studies and a non-prospective registry reported a survival rate between 88% and 91% at 5 years for Linox leads, significantly worse than that of other manufacturers. However, the preliminary results of two ongoing multicenter, prospective registries (GALAXY and CELESTIAL) showed 96% survival rate at 5 years after implant, well within industry standards. Ongoing data collection is needed to confirm longer-term performance of this family of ICD leads.

Externalized conductors and insulation failure in Biotronik defibrillator leads: History repeating or a false alarm?

PubMed Central

De Maria, Elia; Borghi, Ambra; Bonetti, Lorenzo; Fontana, Pier Luigi; Cappelli, Stefano

2017-01-01

Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads. Conductor externalization is a “unique” failure mechanism: Cables externalize through the insulation (“inside-out” abrasion) and appear outside the lead body. Recently, single reports described a similar failure also for Biotronik leads. Moreover, some studies reported a high rate of electrical dysfunction (not only insulation failure) with Biotronik Linox leads and a reduced survival rate in comparison with the competitors. In this paper we describe the case of a patient with a Biotronik Kentrox ICD lead presenting with signs of insulation failure and conductor externalization at fluoroscopy. Due to the high risk of extraction we decided to implant a new lead, abandoning the damaged one; lead reimplant was uneventful. Subsequently, we review currently available literature about Biotronik Kentrox and Linox ICD lead failure and in particular externalized conductors. Some single-center studies and a non-prospective registry reported a survival rate between 88% and 91% at 5 years for Linox leads, significantly worse than that of other manufacturers. However, the preliminary results of two ongoing multicenter, prospective registries (GALAXY and CELESTIAL) showed 96% survival rate at 5 years after implant, well within industry standards. Ongoing data collection is needed to confirm longer-term performance of this family of ICD leads. PMID:28255544

Immediate and long-term clinical outcome after spinal cord stimulation for refractory stable angina pectoris.

PubMed

Di Pede, Francesco; Lanza, Gaetano Antonio; Zuin, Guerrino; Alfieri, Ottavio; Rapati, Massimo; Romanò, Massimo; Circo, Antonio; Cardano, Paola; Bellocci, Fulvio; Santini, Massimo; Maseri, Attilio

2003-04-15

The treatment of patients with angina pectoris refractory to medical therapy and unsuitable for revascularization procedures has yet not been well standardized. Previous retrospective studies and small prospective studies have suggested beneficial effects of spinal cord stimulation (SCS) in these patients. We created a Prospective Italian Registry of SCS to evaluate the short- and long-term clinical outcome of patients who underwent SCS device implantation because of severe refractory angina pectoris. Overall, 104 patients were enrolled in the registry (70 men, aged 68 +/- 17 years), most of whom (83%) had severe coronary artery disease. Average follow-up was 13.2 +/- 8 months. Overall, 17 patients (16%) died, 8 (8%) due to cardiac death. Among clinical variables, only age was found to be significantly associated both with total mortality (p = 0.04) and cardiac mortality (p = 0.02) on Cox regression analysis. A significant improvement of anginal symptoms (> or =50% reduction of weekly anginal episodes, compared with baseline) occurred in 73% of patients, and Canadian Cardiovascular Society angina class improved by > or =1 class in 80% and by > or =2 classes in 42% of patients, with a relevant reduction in the rate of hospital admission and days spent in the hospital because of angina (p <0.0001 for both). No life-threatening or clinically serious complications were observed. The most frequent side effect consisted of superficial infections, either at the site of puncture of electrode insertion or of the abdominal pocket, which occurred in 6 patients. In conclusion, our prospective data point out that SCS can be performed safely and is associated with a sustained improvement of anginal symptoms in a relevant number of patients with refractory stable angina pectoris.

Two-year comprehensive medical management of degenerative lumbar spine disease (lumbar spondylolisthesis, stenosis, or disc herniation): a value analysis of cost, pain, disability, and quality of life: clinical article.

PubMed

Parker, Scott L; Godil, Saniya S; Mendenhall, Stephen K; Zuckerman, Scott L; Shau, David N; McGirt, Matthew J

2014-08-01

Current health care reform calls for a reduction of procedures and treatments that are less effective, more costly, and of little value (high cost/low quality). The authors assessed the 2-year cost and effectiveness of comprehensive medical management for lumbar spondylolisthesis, stenosis, and herniation by utilizing a prospective single-center multidisciplinary spine center registry in a real-world practice setting. Analysis was performed on a prospective longitudinal quality of life spine registry. Patients with lumbar spondylolisthesis (n = 50), stenosis (n = 50), and disc herniation (n = 50) who had symptoms persisting after 6 weeks of medical management and who were eligible for surgical treatment were entered into a prospective registry after deciding on nonsurgical treatment. In all cases, comprehensive medical management included spinal steroid injections, physical therapy, muscle relaxants, antiinflammatory medication, and narcotic oral agents. Two-year patient-reported outcomes, back-related medical resource utilization, and occupational work-day losses were prospectively collected and used to calculate Medicare fee-based direct and indirect costs from the payer and societal perspectives. The maximum health gain associated with medical management was defined as the improvement in pain, disability, and quality of life experienced after 2 years of medical treatment or at the time a patient decided to cross over to surgery. The maximum health gain in back pain, leg pain, disability, quality of life, depression, and general health state did not achieve statistical significance by 2 years of medical management, except for pain and disability in patients with disc herniation and back pain in patients with lumbar stenosis. Eighteen patients (36%) with spondylolisthesis, 11 (22%) with stenosis, and 17 (34%) with disc herniation eventually required surgical management due to lack of improvement. The 2-year improvement did not achieve a minimum clinically important difference in any outcome measure. The mean 2-year total cost (direct plus indirect) of medical management was $6606 for spondylolisthesis, $7747 for stenosis, and $7097 for herniation. In an institution-wide, prospective, longitudinal quality of life registry that measures cost and effectiveness of all spine care provided, comprehensive medical management did not result in sustained improvement in pain, disability, or quality of life for patients with surgically eligible degenerative lumbar spondylolisthesis, stenosis, or disc herniation. From both the societal and payer perspective, continued medical management of patients with these lumbar pathologies in whom 6 weeks of conservative therapy failed was of minimal value given its lack of health utility and effectiveness and its health care costs. The findings from this real-world practice setting may more accurately reflect the true value and effectiveness of nonoperative care in surgically eligible patient populations.

Comparison of Clinical Characteristics among Subtypes of Visual Symptoms in Patients with Transient Ischemic Attack: Analysis of the PROspective Multicenter registry to Identify Subsequent cardiovascular Events after TIA (PROMISE-TIA) Registry.

PubMed

Tanaka, Koji; Uehara, Toshiyuki; Kimura, Kazumi; Okada, Yasushi; Hasegawa, Yasuhiro; Tanahashi, Norio; Suzuki, Akifumi; Nakagawara, Jyoji; Arii, Kazumasa; Nagahiro, Shinji; Ogasawara, Kuniaki; Uchiyama, Shinichiro; Matsumoto, Masayasu; Iihara, Koji; Toyoda, Kazunori; Minematsu, Kazuo

2018-06-01

A transient visual symptom (TVS) is a clinical manifestation of transient ischemic attack (TIA). The aim of this study was to investigate differences in clinical characteristics among subtypes of TVS using multicenter TIA registry data. Patients with TIA visiting within 7 days of onset were prospectively enrolled from 57 hospitals between June 2011 and December 2013. Clinical characteristics were compared between patients with 3 major subtypes of TVS (transient monocular blindness [TMB], homonymous lateral hemianopia [HLH], and diplopia). Of 1365 patients, 106 (7.8%) had TVS, including 40 TMB (38%), 34 HLH (32%), 17 diplopia (16%), and 15 others/unknown (14%). Ninety-one patients with 1 of the 3 major subtypes of TVS were included. Symptoms persisted on arrival in 12 (13%) patients. Isolated TVS was significantly more common in TMB than in HLH and diplopia (88%, 62%, and 0%, respectively; P < .001). Duration of symptoms was shorter in patients with TMB than those with HLH (P = .004). The ABCD 2 score was significantly lower in patients with TMB compared with those with HLH and diplopia (median 2 [interquartile range 2-3] versus 3 [2-4] and 4 [2-5], respectively; P = .005). Symptomatic extracranial internal carotid artery stenosis or occlusion was seen in 14 (16%) patients, and was more frequent in TMB than in HLH and diplopia (28%, 9%, and 0%, respectively; P = .015). TVS was an uncommon symptom in our TIA multicenter cohort. Some differences in clinical characteristics were found among subtypes of TVS. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Disease Evolution and Response to Rapamycin in Activated Phosphoinositide 3-Kinase δ Syndrome: The European Society for Immunodeficiencies-Activated Phosphoinositide 3-Kinase δ Syndrome Registry

PubMed Central

Maccari, Maria Elena; Abolhassani, Hassan; Aghamohammadi, Asghar; Aiuti, Alessandro; Aleinikova, Olga; Bangs, Catherine; Baris, Safa; Barzaghi, Federica; Baxendale, Helen; Buckland, Matthew; Burns, Siobhan O.; Cancrini, Caterina; Cant, Andrew; Cathébras, Pascal; Cavazzana, Marina; Chandra, Anita; Conti, Francesca; Coulter, Tanya; Devlin, Lisa A.; Edgar, J. David M.; Faust, Saul; Fischer, Alain; Garcia-Prat, Marina; Hammarström, Lennart; Heeg, Maximilian; Jolles, Stephen; Karakoc-Aydiner, Elif; Kindle, Gerhard; Kiykim, Ayca; Kumararatne, Dinakantha; Grimbacher, Bodo; Longhurst, Hilary; Mahlaoui, Nizar; Milota, Tomas; Moreira, Fernando; Moshous, Despina; Mukhina, Anna; Neth, Olaf; Neven, Benedicte; Nieters, Alexandra; Olbrich, Peter; Ozen, Ahmet; Schmid, Jana Pachlopnik; Picard, Capucine; Prader, Seraina; Rae, William; Reichenbach, Janine; Rusch, Stephan; Savic, Sinisa; Scarselli, Alessia; Scheible, Raphael; Sediva, Anna; Sharapova, Svetlana O.; Shcherbina, Anna; Slatter, Mary; Soler-Palacin, Pere; Stanislas, Aurelie; Suarez, Felipe; Tucci, Francesca; Uhlmann, Annette; van Montfrans, Joris; Warnatz, Klaus; Williams, Anthony Peter; Wood, Phil; Kracker, Sven; Condliffe, Alison Mary; Ehl, Stephan

2018-01-01

Activated phosphoinositide 3-kinase (PI3K) δ Syndrome (APDS), caused by autosomal dominant mutations in PIK3CD (APDS1) or PIK3R1 (APDS2), is a heterogeneous primary immunodeficiency. While initial cohort-descriptions summarized the spectrum of clinical and immunological manifestations, questions about long-term disease evolution and response to therapy remain. The prospective European Society for Immunodeficiencies (ESID)-APDS registry aims to characterize the disease course, identify outcome predictors, and evaluate treatment responses. So far, 77 patients have been recruited (51 APDS1, 26 APDS2). Analysis of disease evolution in the first 68 patients pinpoints the early occurrence of recurrent respiratory infections followed by chronic lymphoproliferation, gastrointestinal manifestations, and cytopenias. Although most manifestations occur by age 15, adult-onset and asymptomatic courses were documented. Bronchiectasis was observed in 24/40 APDS1 patients who received a CT-scan compared with 4/15 APDS2 patients. By age 20, half of the patients had received at least one immunosuppressant, but 2–3 lines of immunosuppressive therapy were not unusual before age 10. Response to rapamycin was rated by physician visual analog scale as good in 10, moderate in 9, and poor in 7. Lymphoproliferation showed the best response (8 complete, 11 partial, 6 no remission), while bowel inflammation (3 complete, 3 partial, 9 no remission) and cytopenia (3 complete, 2 partial, 9 no remission) responded less well. Hence, non-lymphoproliferative manifestations should be a key target for novel therapies. This report from the ESID-APDS registry provides comprehensive baseline documentation for a growing cohort that will be followed prospectively to establish prognostic factors and identify patients for treatment studies. PMID:29599784

Disease Evolution and Response to Rapamycin in Activated Phosphoinositide 3-Kinase δ Syndrome: The European Society for Immunodeficiencies-Activated Phosphoinositide 3-Kinase δ Syndrome Registry.

PubMed

Maccari, Maria Elena; Abolhassani, Hassan; Aghamohammadi, Asghar; Aiuti, Alessandro; Aleinikova, Olga; Bangs, Catherine; Baris, Safa; Barzaghi, Federica; Baxendale, Helen; Buckland, Matthew; Burns, Siobhan O; Cancrini, Caterina; Cant, Andrew; Cathébras, Pascal; Cavazzana, Marina; Chandra, Anita; Conti, Francesca; Coulter, Tanya; Devlin, Lisa A; Edgar, J David M; Faust, Saul; Fischer, Alain; Garcia-Prat, Marina; Hammarström, Lennart; Heeg, Maximilian; Jolles, Stephen; Karakoc-Aydiner, Elif; Kindle, Gerhard; Kiykim, Ayca; Kumararatne, Dinakantha; Grimbacher, Bodo; Longhurst, Hilary; Mahlaoui, Nizar; Milota, Tomas; Moreira, Fernando; Moshous, Despina; Mukhina, Anna; Neth, Olaf; Neven, Benedicte; Nieters, Alexandra; Olbrich, Peter; Ozen, Ahmet; Schmid, Jana Pachlopnik; Picard, Capucine; Prader, Seraina; Rae, William; Reichenbach, Janine; Rusch, Stephan; Savic, Sinisa; Scarselli, Alessia; Scheible, Raphael; Sediva, Anna; Sharapova, Svetlana O; Shcherbina, Anna; Slatter, Mary; Soler-Palacin, Pere; Stanislas, Aurelie; Suarez, Felipe; Tucci, Francesca; Uhlmann, Annette; van Montfrans, Joris; Warnatz, Klaus; Williams, Anthony Peter; Wood, Phil; Kracker, Sven; Condliffe, Alison Mary; Ehl, Stephan

2018-01-01

Activated phosphoinositide 3-kinase (PI3K) δ Syndrome (APDS), caused by autosomal dominant mutations in PIK3CD (APDS1) or PIK3R1 (APDS2), is a heterogeneous primary immunodeficiency. While initial cohort-descriptions summarized the spectrum of clinical and immunological manifestations, questions about long-term disease evolution and response to therapy remain. The prospective European Society for Immunodeficiencies (ESID)-APDS registry aims to characterize the disease course, identify outcome predictors, and evaluate treatment responses. So far, 77 patients have been recruited (51 APDS1, 26 APDS2). Analysis of disease evolution in the first 68 patients pinpoints the early occurrence of recurrent respiratory infections followed by chronic lymphoproliferation, gastrointestinal manifestations, and cytopenias. Although most manifestations occur by age 15, adult-onset and asymptomatic courses were documented. Bronchiectasis was observed in 24/40 APDS1 patients who received a CT-scan compared with 4/15 APDS2 patients. By age 20, half of the patients had received at least one immunosuppressant, but 2-3 lines of immunosuppressive therapy were not unusual before age 10. Response to rapamycin was rated by physician visual analog scale as good in 10, moderate in 9, and poor in 7. Lymphoproliferation showed the best response (8 complete, 11 partial, 6 no remission), while bowel inflammation (3 complete, 3 partial, 9 no remission) and cytopenia (3 complete, 2 partial, 9 no remission) responded less well. Hence, non-lymphoproliferative manifestations should be a key target for novel therapies. This report from the ESID-APDS registry provides comprehensive baseline documentation for a growing cohort that will be followed prospectively to establish prognostic factors and identify patients for treatment studies.

APPLES TO APPLES OR APPLES TO ORANGES? INTERNATIONAL VARIATION IN REPORTING OF PROCESS AND OUTCOME OF CARE FOR OUT-OF-HOSPITAL CARDIAC ARREST

PubMed Central

Nishiyama, Chika; Brown, Siobhan P; May, Susanne J; Iwami, Taku; Koster, Rudolph W.; Beesems, Stefanie G.; Kuisma, Markku; Salo, Ari; Jacobs, Ian; Finn, Judith; Sterz, Fritz; Nürnberger, Alexander; Smith, Karen; Morrison, Laurie; Olasveengen, Theresa M.; Callaway, Clifton W.; Shin, Sang Do; Gräsner, Jan-Thorsten; Daya, Mohamud; Ma, Matthew Huei-Ming; Herlitz, Johan; Strömsöe, Anneli; Aufderheide, Tom P.; Masterson, Siobhán; Wang, Henry; Christenson, Jim; Stiell, Ian; Davis, Dan; Huszti, Ella; Nichol, Graham

2014-01-01

Objectives Survival after out-of-hospital cardiac arrest (OHCA) varies between communities, due in part to variation in the methods of measurement. The Utstein template was disseminated to standardize comparisons of risk factors, quality of care and outcomes in patients with OHCA. We sought to assess whether OHCA registries are able to collate common data using the Utstein template. A subsequent study will assess whether the Utstein factors explain differences in survival between emergency medical services (EMS) systems. Study design Retrospective study. Setting This retrospective analysis of prospective cohorts included adults treated for OHCA, regardless of the etiology of arrest. Data describing the baseline characteristics of patients, and the process and outcome of their care were grouped by EMS system, de-identified then collated. Included were core Utstein variables and timed event data from each participating registry. This study was classified as exempt from human subjects’ research by a research ethics committee. Measurements and Main Results Twelve registries with 265 first-responding EMS agencies in 14 countries contributed data describing 125,840 cases of OHCA. Variation in inclusion criteria, definition, coding, and process of care variables were observed. Contributing registries collected 61.9% of recommended core variables and 42.9% of timed event variables. Among core variables, the proportion of missingness was mean 1.9 ± 2.2%. The proportion of unknown was mean 4.8 ± 6.4%. Among time variables, missingness was mean 9.0 ± 6.3%. Conclusions International differences in measurement of care after OHCA persist. Greater consistency would facilitate improved resuscitation care and comparison within and between communities. PMID:25010784

Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers.

PubMed

Wieschowski, Susanne; Silva, Diego S; Strech, Daniel

2016-11-01

Publication bias in animal research, its extent, its predictors, and its potential countermeasures are increasingly discussed. Recent reports and conferences highlight the potential strengths of animal study registries (ASRs) in this regard. Others have warned that prospective registration of animal studies could diminish creativity, add administrative burdens, and complicate intellectual property issues in translational research. A literature review and 21 international key-informant interviews were conducted and thematically analyzed to develop a comprehensive matrix of main- and subcategories for potential ASR-related strengths, weaknesses, facilitators, and barriers (SWFBs). We identified 130 potential SWFBs. All stakeholder groups agreed that ASRs could in various ways improve the quality and refinement of animal studies while allowing their number to be reduced, as well as supporting meta-research on animal studies. However, all stakeholder groups also highlighted the potential for theft of ideas, higher administrative burdens, and reduced creativity and serendipity in animal studies. Much more detailed reasoning was captured in the interviews than is currently found in the literature, providing a comprehensive account of the issues and arguments around ASRs. All stakeholder groups highlighted compelling potential strengths of ASRs. Although substantial weaknesses and implementation barriers were highlighted as well, different governance measures might help to minimize or even eliminate their impact. Such measures might include confidentiality time frames for accessing prospectively registered protocols, harmonized reporting requirements across ASRs, ethics reviews, lab notebooks, and journal submissions. The comprehensive information gathered in this study could help to guide a more evidence-based debate and to design pilot tests for ASRs.

Impact of chronic kidney disease on use of evidence-based therapy in stable coronary artery disease: a prospective analysis of 22,272 patients.

PubMed

Kalra, Paul R; García-Moll, Xavier; Zamorano, José; Kalra, Philip A; Fox, Kim M; Ford, Ian; Ferrari, Roberto; Tardif, Jean-Claude; Tendera, Michal; Greenlaw, Nicola; Steg, Ph Gabriel

2014-01-01

To assess the frequency of chronic kidney disease (CKD), define the associated demographics, and evaluate its association with use of evidence-based drug therapy in a contemporary global study of patients with stable coronary artery disease. 22,272 patients from the ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease (CLARIFY) were included. Baseline estimated glomerular filtration rate (eGFR) was calculated (CKD-Epidemiology Collaboration formula) and patients categorised according to CKD stage: >89, 60-89, 45-59 and <45 mL/min/1.73 m2. Mean (SD) age was 63.9±10.4 years, 77.3% were male, 61.8% had a history of myocardial infarction, 71.9% hypertension, 30.4% diabetes and 75.4% dyslipidaemia. Chronic kidney disease (eGFR<60 mL/min/1.73 m2) was seen in 22.1% of the cohort (6.9% with eGFR<45 mL/min/1.73 m2); lower eGFR was associated with increasing age, female sex, cardiovascular risk factors, overt vascular disease, other comorbidities and higher systolic but lower diastolic blood pressure. High use of secondary prevention was seen across all CKD stages (overall 93.4% lipid-lowering drugs, 95.3% antiplatelets, 75.9% beta-blockers). The proportion of patients taking statins was lower in patients with CKD. Antiplatelet use was significantly lower in patients with CKD whereas oral anticoagulant use was higher. Angiotensin-converting enzyme inhibitor use was lower (52.0% overall) and inversely related to declining eGFR, whereas angiotensin-receptor blockers were more frequently prescribed in patients with reduced eGFR. Chronic kidney disease is common in patients with stable coronary artery disease and is associated with comorbidities. Whilst use of individual evidence-based medications for secondary prevention was high across all CKD categories, there remains an opportunity to improve the proportion who take all three classes of preventive therapies. Angiotensin-converting enzyme inhibitors were used less frequently in lower eGRF categories. Surprisingly the reverse was seen for angiotensin-receptor blockers. Further evaluation is required to fully understand these associations. The CLARIFY (ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease) Registry is registered in the ISRCTN registry of clinical trials with the number ISRCTN43070564. http://www.controlled-trials.com/ISRCTN43070564.

Effect of edaravone on favorable outcome in patients with acute cerebral large vessel occlusion: subanalysis of RESCUE-Japan Registry.

PubMed

Miyaji, Yuki; Yoshimura, Shinichi; Sakai, Nobuyuki; Yamagami, Hiroshi; Egashira, Yusuke; Shirakawa, Manabu; Uchida, Kazutaka; Kageyama, Hirohito; Tomogane, Yusuke

2015-01-01

The data of the nationwide prospective registry of acute cerebral large vessel occlusion (LVO; RESCUE-Japan Registry) were analyzed to know the effect of edaravone, a free radical scavenger, on clinical outcome at 90 days after onset. In this registry, patients with acute cerebral LVO admitted within 24 h after onset were prospectively registered. The effect of various factors including endovascular treatment (EVT), intravenous recombinant tissue plasminogen activator (IV rt-PA), and other medication including edaravone on favorable outcome (modified Rankin scale 0-1) was analyzed. Of the 1,454 registered patients, 1,442 patients (99.2%) had the information of edaravone were analyzed. In total, edaravone group had more patients with favorable outcome compared to non-edaravone group (22.9% vs. 13.8%, p = 0.0006). Edaravone increased favorable outcome in patients treated with IV rt-PA (29.4% vs. 11.1%, p = 0.0107), but not with EVT (21.2% vs. 13.9%, p = 0.309). Logistic regression analysis revealed that higher National Institutes of Health Stroke Scale (NIHSS) score on admission [odds ratio (OR) 0.875, 95% confidence interval (CI) 0.858-0.894] and advanced age (OR 0.963, 95%CI 0.952-0.975) were significantly related to unfavorable outcome. In contrast, IV rt-PA (OR 2.489, 95%CI 1.867-3.319), EVT (OR 1.375, 95%CI 1.013-1.865), and edaravone (OR 1.483, 95%CI 1.027-2.143) were significantly associated with favorable outcome. This analysis indicated that IV rt-PA, EVT, and edaravone were effective to obtain favorable outcome in patients with acute LVO. Combination IV rt-PA with edaravone was more effective.

Effect of Edaravone on Favorable Outcome in Patients with Acute Cerebral Large Vessel Occlusion: Subanalysis of RESCUE-Japan Registry

PubMed Central

MIYAJI, Yuki; YOSHIMURA, Shinichi; SAKAI, Nobuyuki; YAMAGAMI, Hiroshi; EGASHIRA, Yusuke; SHIRAKAWA, Manabu; UCHIDA, Kazutaka; KAGEYAMA, Hirohito; TOMOGANE, Yusuke

2015-01-01

The data of the nationwide prospective registry of acute cerebral large vessel occlusion (LVO; RESCUE-Japan Registry) were analyzed to know the effect of edaravone, a free radical scavenger, on clinical outcome at 90 days after onset. In this registry, patients with acute cerebral LVO admitted within 24 h after onset were prospectively registered. The effect of various factors including endovascular treatment (EVT), intravenous recombinant tissue plasminogen activator (IV rt-PA), and other medication including edaravone on favorable outcome (modified Rankin scale 0–1) was analyzed. Of the 1,454 registered patients, 1,442 patients (99.2%) had the information of edaravone were analyzed. In total, edaravone group had more patients with favorable outcome compared to non-edaravone group (22.9% vs. 13.8%, p = 0.0006). Edaravone increased favorable outcome in patients treated with IV rt-PA (29.4% vs. 11.1%, p = 0.0107), but not with EVT (21.2% vs. 13.9%, p = 0.309). Logistic regression analysis revealed that higher National Institutes of Health Stroke Scale (NIHSS) score on admission [odds ratio (OR) 0.875, 95% confidence interval (CI) 0.858–0.894] and advanced age (OR 0.963, 95%CI 0.952–0.975) were significantly related to unfavorable outcome. In contrast, IV rt-PA (OR 2.489, 95%CI 1.867–3.319), EVT (OR 1.375, 95%CI 1.013–1.865), and edaravone (OR 1.483, 95%CI 1.027–2.143) were significantly associated with favorable outcome. This analysis indicated that IV rt-PA, EVT, and edaravone were effective to obtain favorable outcome in patients with acute LVO. Combination IV rt-PA with edaravone was more effective. PMID:25739433

Data from a nationwide registry on sports-related sudden cardiac deaths in Germany

PubMed Central

Scharhag, Jürgen; Meyer, Tim

2015-01-01

Background Prospective national registries examining the incidence and aetiology of sports-related sudden cardiac death (SrSCD) not only in competitive athletes but also in recreational sports participants are uncommon. In May 2012, a prospective registry on SrSCD was installed to examine the incidence and particularly the aetiology of such events in the general population in Germany. Methods The registry consists of a web-based platform to record SrSCD cases. Media-monitoring and cooperation with 15 institutes of forensic medicine complemented the search. SrSCD was defined as death occurring during sports activity or up to 1 hour after its cessation, regardless of successful resuscitation. We included subjects at all levels of competition as well as recreational athletes. Results After 30 months of observation, 144 SrSCDs were recorded (mean age 46.8 ± 16.2 years). The overall incidence was 1.2–1.5/million/year, with 97% being male. Most of the cases occurred in the context of non-elite competitive or recreational sports. Football and running were the most common disciplines. In subjects ≤35 years, myocarditis prevailed, whereas in athletes ≥35 years, CAD predominated by far. Few cardiomyopathies were observed. Conclusions In Germany, the largest proportion of SrSCDs occurs in middle-aged men during recreational sports or non-elite competitive sports. The distribution of cardiac diseases responsible for SrSCD seems to vary among European countries. Our findings may indicate the need for a larger focus on myocarditis prevention in the young as well as widening the screening scope to younger athletes below the ‘elite’ level and to senior athletes. PMID:26130495

Data from a nationwide registry on sports-related sudden cardiac deaths in Germany.

PubMed

Bohm, Philipp; Scharhag, Jürgen; Meyer, Tim

2016-04-01

Prospective national registries examining the incidence and aetiology of sports-related sudden cardiac death (SrSCD) not only in competitive athletes but also in recreational sports participants are uncommon. In May 2012, a prospective registry on SrSCD was installed to examine the incidence and particularly the aetiology of such events in the general population in Germany. The registry consists of a web-based platform to record SrSCD cases. Media-monitoring and cooperation with 15 institutes of forensic medicine complemented the search. SrSCD was defined as death occurring during sports activity or up to 1 hour after its cessation, regardless of successful resuscitation. We included subjects at all levels of competition as well as recreational athletes. After 30 months of observation, 144 SrSCDs were recorded (mean age 46.8 ± 16.2 years). The overall incidence was 1.2-1.5/million/year, with 97% being male. Most of the cases occurred in the context of non-elite competitive or recreational sports. Football and running were the most common disciplines. In subjects ≤35 years, myocarditis prevailed, whereas in athletes ≥35 years, CAD predominated by far. Few cardiomyopathies were observed. In Germany, the largest proportion of SrSCDs occurs in middle-aged men during recreational sports or non-elite competitive sports. The distribution of cardiac diseases responsible for SrSCD seems to vary among European countries. Our findings may indicate the need for a larger focus on myocarditis prevention in the young as well as widening the screening scope to younger athletes below the 'elite' level and to senior athletes. © The European Society of Cardiology 2015.

Obesity in Youth with Type 1 Diabetes in Germany, Austria, and the United States.

PubMed

DuBose, Stephanie N; Hermann, Julia M; Tamborlane, William V; Beck, Roy W; Dost, Axel; DiMeglio, Linda A; Schwab, Karl Otfried; Holl, Reinhard W; Hofer, Sabine E; Maahs, David M

2015-09-01

To examine the current extent of the obesity problem in 2 large pediatric clinical registries in the US and Europe and to examine the hypotheses that increased body mass index (BMI) z-scores (BMIz) are associated with greater hemoglobin A1c (HbA1c) and increased frequency of severe hypoglycemia in youth with type 1 diabetes (T1D). International (World Health Organization) and national (Centers for Disease Control and Prevention/German Health Interview and Examination Survey for Children and Adolescents) BMI references were used to calculate BMIz in participants (age 2-<18 years and ≥ 1 year duration of T1D) enrolled in the T1D Exchange (n = 11,435) and the Diabetes Prospective Follow-up (n = 21,501). Associations between BMIz and HbA1c and severe hypoglycemia were assessed. Participants in both registries had median BMI values that were greater than international and their respective national reference values. BMIz was significantly greater in the T1D Exchange vs the Diabetes Prospective Follow-up (P < .001). After stratification by age-group, no differences in BMI between registries existed for children 2-5 years, but differences were confirmed for 6- to 9-, 10- to 13-, and 14- to 17-year age groups (all P < .001). Greater BMIz were significantly related to greater HbA1c levels and more frequent occurrence of severe hypoglycemia across the registries, although these associations may not be clinically relevant. Excessive weight is a common problem in children with T1D in Germany and Austria and, especially, in the US. Our data suggest that obesity contributes to the challenges in achieving optimal glycemic control in children and adolescents with T1D. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2018-02-01

Data about Hodgkin lymphoma (HL) in developing countries are scarce and suggest the existence of substantial disparities in healthcare and outcomes in large areas of the world. In 2009, a prospective registry of HL was implemented in Brazil. Web-based data were contributed by 20 institutions across the country participating in the Brazilian Prospective Hodgkin's Lymphoma Registry. The aim of this study was to present the clinical features and outcomes of newly diagnosed patients with HL aged 13 to 90 years. Multivariate Cox regression models were used to estimate progression-free (PFS) and overall survival (OS) by clinical factors. A total of 674 patients with classical HL were analysed, with a median follow-up of 37 months. Median age was 30 years (13-90). The median time from the onset of symptoms to diagnosis was 6 months (0-60). Only 6% of patients had early favourable disease, while 65% had advanced disease. Stage IVB was present in 26% and a high-risk International Prognostic Score in 38%. Doxorubicin, bleomycin, vinblastine, and dacarbazine was used in 93%. The median dose of radiotherapy was 36 Gy for localized disease and 32 Gy for advanced disease. The 3 year PFS in early favourable, early unfavourable, and advanced disease were 95%, 88%, and 66%, respectively. High-risk International Prognostic Score, advanced disease, and age greater than or equal to 60 were independently associated with poorer PFS and OS; performance status greater than or equal to 2 was also associated with a poorer OS. Poor-risk patients predominated. Radiation doses for localized disease appear higher than current recommendations. Outcomes appear inferior in developing countries than in developed countries. Delayed diagnosis is probably a major factor underlying these findings. Scattered reports from developing nations suggest that many aspects of standard care in developed countries remain unmet needs for populations living in developing countries. The present report contributes to this body of data, with a proper description of what is currently achieved in urban areas in Brazil. Copyright © 2017 John Wiley & Sons, Ltd.

Real-world use of the second-generation cobalt-chromium sirolimus-eluting stents: 12-month results from the prospective multicentre FOCUS registry.

PubMed

Zhang, Feng; Ge, Junbo; Qian, Juying; Ge, Lei; Zhou, Jun

2012-12-20

The FOCUS registry is a prospective, multicentre, web-based programme designed to collect clinical outcome data from real-world patients receiving the second-generation cobalt-chromium sirolimus-eluting stent (CoCr-SES). From March 2009 to February 2010, a total of 5,084 patients from 83 centres who were eligible to receive CoCr-SES were enrolled in the FOCUS registry. The primary endpoint was 12-month major adverse cardiac events (MACE, defined as the composite of cardiac death, myocardial infarction [MI], and target vessel revascularisation [TVR]). One-year data were available for 5,013 (98.6%) of the 5,084 patients enrolled. The primary endpoint occurred in 174 (3.47%) of 5,013 patients, consisting of 43 (0.86%) cardiac deaths, 132 (2.63%) MI, and 46 (0.92%) TVR. According to the Academic Research Consortium definition, definite and probable stent thrombosis (ST) occurred in 0.52% (26/5,013) of patients, including 19 cases of early ST and 7 of late ST. The 12-month MACE rates were 3.73% and 2.60% for extended-use and standard-use patients, respectively (p=0.065). The second-generation CoCr-SES was associated with low rates of 12-month MACE and ST in a broad spectrum of patients, thereby confirming the clinical safety and efficacy of this stent in a real-world setting.

Accuracy of a state immunization registry in the pediatric emergency department.

PubMed

Stecher, Dawn S; Adelman, Raymond; Brinkman, Traci; Bulloch, Blake

2008-02-01

The purpose of this study was to ascertain whether either parental recall or a state immunization registry was as accurate as the medical record in determining immunization status in the emergency department (ED). A convenience sample of children younger than 5 years who presented to the ED between July 2004 and May 2005 were enrolled prospectively. After obtaining informed consent, parents were asked about their child's immunization status. All children then had their immunization data accessed in the Arizona State Immunization Information System. The information obtained from the state registry, as well as the information from the parental interview, was then compared with the information on the medical record obtained from the primary care physician (PCP). Data were analyzed using simple descriptive statistics. A total of 332 children were enrolled in the study. A total of 302 (91%) children enrolled were found in the state database, and 222 (74%) of these had a medical record available for comparison. The database agreed with the PCP record in 130 (59%) cases; parental report agreed with the PCP record in 149 (62%) cases. Although most children can be found in the state immunization registry, it seems to be similar in accuracy to parental recall of immunization status when each is compared with the medical record. This may have been due to either underreporting of immunizations from the community or a delay in updating the state database. At this time, neither parental recall nor the database would accurately determine a child's immunization status during an ED visit.

Background and design of the ACCA-EAPCI registry on ST-segment elevation myocardial infarction of the European Society of Cardiology.

PubMed

Zeymer, Uwe; Ludman, Peter; Danchin, Nicolas; Kala, Petr; Maggioni, Aldo P; Weidinger, Franz

2018-02-01

Treatment of patients with acute ST-segment elevation myocardial infarction has improved over past decades, with reperfusion therapy being the cornerstone in the acute phase. Based on the results of large randomised trials the current ST-segment elevation myocardial infarction guidelines of the European Society of Cardiology (ESC) recommend acute treatments and secondary prevention therapies. However, there are large variations between ESC countries in the treatment of patients presenting with ST-segment elevation myocardial infarction. Therefore the ESC has initiated a prospective registry to evaluate the current treatments and outcomes of these patients with a special focus on adherence to the ESC guidelines and on differences between countries and regions. This paper describes the methodology and design of the ST-segment elevation myocardial infarction registry conducted in collaboration of the Acute Cardiac Care Association and the European Association of Percutaneous Coronary Intervention.

Secular trends, treatments, and outcomes of Middle Eastern Arab and South Asian patients hospitalized with atrial fibrillation: insights from a 20-year registry in Qatar (1991-2010).

PubMed

Salam, Amar M; AlBinali, Hajar A; Al-Mulla, Abdul Wahid; Singh, Rajvir; Al Suwaidi, Jassim

2013-10-01

A prospective registry was made of all patients hospitalized with atrial fibrillation (AF) in the State of Qatar from 1991 to 2010. Clinical characteristics, management, and outcomes were compared according to ethnicity (Middle Eastern Arab vs South Asian). During this 20-year period, 2857 Arabs and 548 Asians were hospitalized for AF. Arabs were 9 years older and more likely to have hypertension, diabetes mellitus (DM), chronic renal impairment, and dyslipidemia than the Asians. Valvular heart disease and acute coronary syndromes were more common among Asians, while congestive heart failure was more common in Arabs. The overall inhospital mortality was lower in Asians than that of Arabs, while stroke rates were comparable. There was an increase in the prevalence of DM and hypertension in both the groups in the latter years of the study period, but there was no change in mortality trends. Our findings underscore the need to study AF according to ethnicity.

Peutz-Jeghers syndrome: data from the Singapore Polyposis Registry and a shifting paradigm in management.

PubMed

Tan, Veronique Km; Koh, Poh Koon; Loi, Carol Tt; Eu, Kong Weng; Tang, Choong Leong

2010-01-01

Peutz-Jeghers Syndrome (PJS) is an uncommon autosomal dominant hamartomatous polyposis syndrome. Morbidity arises from polyp-related complications and increased risks of malignancy. We report on PJS patients registered in the Singapore Polyposis Registry, identified principal causes of morbidity and appraised current management strategies. A followup protocol based on recent literature has been proposed. A search of a prospectively collected database in the Singapore Polyposis Registry was made. Only patients who fulfilled the diagnostic criteria of PJS were included. The clinical records were retrieved for review. Information on affected family members was obtained from the Registry's pedigree records. Seven unrelated patients fulfilled the criteria of having PJS. Principal causes of morbidity include recurrent bouts of abdominal colic, episodes of intestinal obstruction, gastrointestinal bleeding and the need for repeated laparotomies. Six out of 7 patients had initial presentation with acute intestinal obstruction requiring emergency laparotomy. Management was mostly problem-oriented and marked inter-surgeon variation with regard to cancer screening and genetic counselling was observed. Patients with PJS suffer gastrointestinal complications from polyposis and are at increased risks for developing cancers. A move towards surveillance and planned comprehensive care may reduce the morbidity of the condition. A protocol driven approach conducted in the setting of a Polyposis Registry is ideally suited to facilitate such care.

Preeclampsia Associates with Asthma, Allergy, and Eczema in Childhood.

PubMed

Stokholm, Jakob; Sevelsted, Astrid; Anderson, Ulrik D; Bisgaard, Hans

2017-03-01

Preeclampsia reflects an unusual increase in systemic inflammation during pregnancy. We studied associations between preeclampsia and asthma, allergy, and eczema in Copenhagen Prospective Studies on Asthma in Childhood 2000 (COPSAC 2000 ) and in national registries. COPSAC 2000 is a high-risk birth cohort of 411 Danish children. Asthma, allergy, and eczema were diagnosed prospectively, and lung function measured at age 1 month and 7 years. Sensitization was evaluated at age 6 months, 18 months, 4 years, and 6 years by skin prick tests and IgE measurements. The register-based cohort included 1.7 million children from Danish national registries in the 35-year period 1977-2012. Children born to mothers with preeclampsia were analyzed regarding risk of asthma, allergy, and eczema. In the COPSAC 2000 cohort, 5.6% (n = 23) were diagnosed with preeclampsia. Preeclampsia was associated with increased risk of treatment with inhaled corticosteroids at age 7 years (adjusted odds ratio, 4.01 [95% confidence interval (CI), 1.11-14.43]; P = 0.0337), increased bronchial responsiveness to methacholine (adjusted β-coefficient log-μmol, -0.80 [95% CI, -1.55 to -0.06]; P = 0.0348), and allergic rhinitis (adjusted odds ratio, 4.83 [95% CI, 1.58-14.78]; P = 0.0057) in the 7-year-old children. Furthermore, the children had an increased risk of sensitization to both aeroallergens and food allergens, and increased amount of total IgE during childhood. In the registry-based cohort, 3.7% (n = 62,728) were born to mothers with preeclampsia. Preeclampsia was associated with increased risk of asthma, eczema, and aeroallergen and food allergy, especially pronounced after a duration of preeclampsia of 14 days or more. Maternal asthma increased the risk of preeclampsia. Preeclampsia is a shared prenatal risk factor for asthma, eczema, and allergy in childhood pointing toward in utero immune programming of the child.

A Comparison of Functional Outcome in Patients Sustaining Major Trauma: A Multicentre, Prospective, International Study

PubMed Central

Rainer, Timothy H.; Yeung, Hiu Hung; Gabbe, Belinda J.; Yuen, Kai Y.; Ho, Hiu F.; Kam, Chak W.; Chang, Annice; Poon, Wai S.; Cameron, Peter A.; Graham, Colin A.

2014-01-01

Objectives To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. Summary Background Data Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR). Methods Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE) functional outcome and risk-adjusted Short-Form 12 (SF-12) health status at 6 and 12 months after injury. Results 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17), and at 12 months was 0.83 (95% CI: 0.60, 1.12). Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: −1.2, 3.6) and 12-months (adjusted mean difference: −0.4, 95% CI: −3.2, 2.4) compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: −2.1, 2.8) or 12-months (adjusted mean difference: 1.8, 95% CI: −0.8, 4.5). Conclusion The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions. PMID:25157522

The Parkinson’s Registry Investigation of Diagnosis and Etiology (PRIDE) Study

DTIC Science & Technology

2015-04-01

to investigate endotoxin exposure as a risk factor for Parkinson’s disease and parkinsonism , by investigating a prospective cohort of women textile...the author( s ) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other...NUMBER W81XWH-13-1-0054 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR( S ) 5d. PROJECT NUMBER Dr. Caroline M. Tanner 5e. TASK NUMBER E

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.

A digitally facilitated citizen-science driven approach accelerates participant recruitment and increases study population diversity.

PubMed

Puhan, Milo A; Steinemann, Nina; Kamm, Christian P; Müller, Stephanie; Kuhle, Jens; Kurmann, Roland; Calabrese, Pasquale; Kesselring, Jürg; von Wyl, Viktor; Swiss Multiple Sclerosis Registry Smsr

2018-05-16

Our aim was to assess whether a novel approach of digitally facilitated, citizen-science research, as followed by the Swiss Multiple Sclerosis Registry (Swiss MS Registry), leads to accelerated participant recruitment and more diverse study populations compared with traditional research studies where participants are mostly recruited in study centres without the use of digital technology. The Swiss MS Registry is a prospective, longitudinal, observational study covering all Switzerland. Participants actively contribute to the Swiss MS Registry, from defining research questions to providing data (online or on a paper form) and co-authoring papers. We compared the recruitment dynamics over the first 18 months with the a priori defined recruitment goals and assessed whether a priori defined groups were enrolled who are likely to be missed by traditional research studies. The goal to recruit 400 participants in the first year was reached after only 20 days, and by the end of 18 months 1700 participants had enrolled in the Swiss MS Registry, vastly exceeding expectations. Of the a priori defined groups with potential underrepresentation in other studies, 645 participants (46.5%) received care at a private neurology practice, 167 participants (12%) did not report any use of healthcare services in the past 12 months, 32 (2.3%) participants lived in rural mountainous areas, and 20 (2.0% of the 1041 for whom this information was available) lived in a long-term care facility. Having both online and paper options increased diversity of the study population in terms of geographic origin and type and severity of disease, as well as use of health care services. In particular, paper enrolees tended to be older, more frequently affected by progressive MS types and more likely to have accessed healthcare services in the past 12 months. Academic and industry-driven medical research faces substantial challenges in terms of patient involvement, recruitment, relevance and generalisability. Digital studies and stakeholder engagement may have enormous potential for medical research. But many digital studies are based on limited participant information and/or informed consent and unclear data ownership, and are subject to selection bias, confounding and information bias. The Swiss MS Registry serves as an example of a digitally enhanced, citizen-science study that leverages the advantages of both traditional medical research, with its established research methods, and novel societal and technological developments, while mitigating their ethical and legal disadvantages and risks.

The NeuroAiD Safe Treatment (NeST) Registry: a protocol

PubMed Central

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

2015-01-01

Introduction NeuroAiD (MLC601, MLC901), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries. The NeuroAiD Safe Treatment (NeST) Registry aims to assess its use and safety in the real-world setting. Methods and analysis The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional and cognitive state, compliance, concomitant medications, and side effects, if any, among patients on NeuroAiD. Patients who are taking or have been prescribed NeuroAiD may be included. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialisation of NeuroAiD) and during subsequent visits. The primary outcome assessed is safety (ie, non-serious and serious adverse event), while compliance and neurological status over time are secondary outcomes. The in-person follow-up assessments are timed with clinical appointments. Anonymised data will be extracted and collectively analysed. Initial target sample size for the registry is 2000. Analysis will be performed after every 500 participants entered with completed follow-up information. Ethics and dissemination Doctors who prescribe NeuroAiD will be introduced to the registry by local partners. The central coordinator of the registry will discuss the protocol and requirements for implementation with doctors who show interest. Currently, the registry has been approved by the Ethics Committees of Universiti Kebangsaan Malaysia (Malaysia) and National Brain Center (Indonesia). In addition, for other countries, Ethics Committee approval will be obtained in accordance with local requirements. Trial registration number NCT02536079. PMID:26567259

Patterns in Vulvodynia Treatments and 6-Month Outcomes for Women Enrolled in the National Vulvodynia Registry-An Exploratory Prospective Study.

PubMed

Lamvu, Georgine; Alappattu, Meryl; Witzeman, Kathryn; Bishop, Mark; Robinson, Michael; Rapkin, Andrea

2018-05-01

Vulvodynia is a poorly characterized condition with multiple treatment options that have been described as largely ineffective in research settings. To describe treatment patterns in women enrolled in the National Vulvodynia Registry and determine if there is an association between selected treatments and patient-reported outcomes such as pain, sexual function, and psychological distress after 6 months of treatment. Participants completed questionnaires on general medical history and patient-reported outcomes using the short-form McGill Pain Questionnaire, the Female Sexual Function Index, the Short Form-12 quality-of-life questionnaire, the Coping Strategies Questionnaire, and the State-Trait Anxiety Inventory. The evaluation also included pain sensitivity assessment of the vaginal mucosa using a cotton-tipped applicator and the vaginal muscles using a single-digit. In this prospective cohort study, all measurements were collected at baseline and again at 6 months after treatment. Type of treatment, number of treatments, self-reported pain intensity, dyspareunia, and pain-related psychological distress measures are reported at baseline and 6 months. Of 344 women enrolled, 282 received treatment; 78 different treatments were identified and categorized by type (eg, topical, oral, physical therapy) and number. The most commonly used treatments were topical (85%, n = 241), physical therapy (52%, n = 147), and oral medications (45%, n = 128). Notably, 73% of participants received ≥2 treatments. There was no association between type or number of treatments and patient characteristics. At 6 months, women reported improvements in general pain (P = .001), pain during intercourse (P = .001), catastrophizing (P = .000), and anxiety (P = .000). The Short Form-12 quality-of-life questionnaire showed improvements in physical limitations (P = .024), emotional limitations (P = .003), well-being (P = .025), and social function (P = .010). However, all domains of the Female Sexual Function Index indicated worsening in sexual function (P = .000) except for pain. Multi-modal treatments were most commonly used in clinical practice and improvements in patient-reported outcomes such as quality of life, distress, and pain were noted; however, participants who returned at 6 months continued to report poor sexual function. Strengths include a prospective and long-term study design that evaluated women in clinical settings. Limitations include a high rate of loss to follow-up for certain measures and inability to evaluate efficacy of individual treatments. In a setting where women were receiving highly specialized care, we found wide variation in the type and number of treatments used to treat vulvodynia. Despite this heterogeneity in treatment selection, women reported significant improvements in all study measures except sexual function. Lamvu G, Alappattu M, Witzeman K, et al. Patterns in Vulvodynia Treatments and 6-Month Outcomes for Women Enrolled in the National Vulvodynia Registry-An Exploratory Prospective Study. J Sex Med 2018;15:705-715. Published by Elsevier Inc.

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.

Lacking evidence for performance of implants used for proximal femoral fractures - A systematic review.

PubMed

Nyholm, Anne Marie; Palm, Henrik; Malchau, Henrik; Troelsen, Anders; Gromov, Kirill

2016-03-01

Evaluation of the long-term performance of implants used in trauma surgery relies on post-marked clinical studies since no registry based implant assessment exists. The purpose of this study was to evaluate the evidence of performance of implants currently used for treating proximal femoral fractures (PFF) in Denmark. PubMed was searched for clinical studies on primary PFF with follow-up ≥12 months, reporting implant-related failure and evaluating one of following: DHS, CHS, HipLoc, Gamma3, IMHS, InterTan, PFN, PFNA or PTN. English language and publication date after 1st of January 1990. All studies were evidence level II or III. 30 publications for SHS were found: 13 of CHS, 15 of DHS and 2 of HipLoc. In total CHS was evaluated in 1110 patients (900 prospectively), DHS in 2486 (567 prospectively) and HipLoc in 251 (all prospectively). Fifty-four publications for nails were found: 13 of Gamma3, 7 of IMHS, 5 of InterTan, 10 of PFN, 24 of PFNA and 0 of PTN. In total Gamma3 was evaluated in 1088 patients (829 prospectively), IMHS in 1543 (210 prospectively), InterTan in 595 (585 prospectively), PFN in 716 (557 prospectively), PFNA in 1762 (1018 prospectively) and PTN in 0. The clinical evidence behind the current implants used for proximal femoral fractures is weak considering the number of implants used worldwide. Sporadic evaluation is not sufficient to identify long term problems. A systematic post market surveillance of implants used for fracture treatment, preferable by a national register, is necessary in the future. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Acute myocardial infarction in Morocco: FES-AMI registry data].

PubMed

Akoudad, H; El Khorb, N; Sekkali, N; Mechrafi, A; Zakari, N; Ouaha, L; Lahlou, I

2015-12-01

Acute myocardial infarction is the most dangerous complication of coronary atherothrombosis. There are several disparities in regard to its management around the world. The aim of this study is to analyze the specificities of management of acute myocardial infarction in Morocco. FES-AMI (Fès Acute Myocardial Infarction) is a prospective monocentric registry conducted in cardiology department of Hassan II university hospital in Fès. In this registry, we enrolled patients with acute myocardial infarction who presented within 5 days after symptom onset. From January 2005 to August 2015, we enrolled 1835 patients. Seventy-five percent of patients were males and mean age was 60 years old. Fifty-one percent of patients were smokers, 27% were hypertensives and 14% were diabetics. Sixty-six percent of patients had more than 2 risk factors. Time from symptom onset to hospital admission was less than six hours for 40% of the patients. Thirty-six percent of patients were admitted more than twelve hours after the onset of chest pain. Only 37% of patients received reperfusion therapy, 31% with in-hospital thrombolysis and 6% with primary angioplasty. In-hospital mortality was 7.6%. The patients enrolled in our registry have late presentation of acute myocardial infarction and less rate of reperfusion therapy. Furthermore, the majority of our patients have multiple risk factors and this result underlines the failure of preventive interventions. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusion Performed by Highly Experienced Japanese Specialists: The First Report From the Japanese CTO-PCI Expert Registry.

PubMed

Suzuki, Yoriyasu; Tsuchikane, Etsuo; Katoh, Osamu; Muramatsu, Toshiya; Muto, Makoto; Kishi, Koichi; Hamazaki, Yuji; Oikawa, Yuji; Kawasaki, Tomohiro; Okamura, Atsunori

2017-11-13

This report describes the registry and presents an initial analysis of outcomes for the different PCI approaches taken by the specialists. Strategies for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) are complex. The Japanese Board of CTO Interventional Specialists has developed a prospective, nonrandomized registry of patients undergoing CTO-PCIs performed by 41 highly experienced Japanese specialists. Over the study period of January 2014 to December 2015, the registry included 2,846 consecutive CTO-PCI cases undertaken in Japan. The authors compared clinical outcomes between the different PCI approaches, following the intention-to-treat principle. The overall technical success rate of the procedures was 89.9%. The specialists frequently chose a retrograde approach as the primary CTO-PCI strategy (in 27.8% of cases). The technical success rate of the primary antegrade approach was significantly better than that of the primary retrograde approach (91.0% vs. 87.3%; p < 0.0001). The technical success rate decreased to 78.0% with the rescue retrograde approach. Parallel guidewire crossing and intravascular ultrasound-guided wire crossing were performed after guidewire escalation during antegrade CTO-PCI with a high technical success rate (75.0% to 88.9%). Severe lesion calcification was a strong predictor of failed CTO-PCI. CTO-PCI performed by highly experienced specialists achieved a high technical success rate. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2013-09-01

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

Prediagnostic alcohol consumption and colorectal cancer survival: The Colon Cancer Family Registry.

PubMed

Phipps, Amanda I; Robinson, Jamaica R; Campbell, Peter T; Win, Aung Ko; Figueiredo, Jane C; Lindor, Noralane M; Newcomb, Polly A

2017-05-15

Although previous studies have noted an increased risk of colorectal cancer (CRC) among moderate to heavy alcohol consumers in comparison with nondrinkers, the relation between alcohol consumption and CRC survival remains unclear. Cases of incident invasive CRC diagnosed between 1997 and 2007 were identified via population-based cancer registries at 4 study sites in the Colon Cancer Family Registry. Study participants completed a risk-factor questionnaire on prediagnostic behaviors, including wine, beer, and liquor consumption, at the baseline. Prospective follow-up for survival was conducted for 4966 CRC cases. Cox regression was used to compare nondrinkers with individuals who consumed, on average, 1 or more servings of alcohol per day in the years preceding their CRC diagnosis with respect to overall and disease-specific survival. Separate analyses by beverage type, stratified by patient and tumor attributes, were also performed. All models were adjusted for the age at diagnosis, sex, study site, year of diagnosis, smoking history, body mass index, and education. Prediagnostic beer and liquor consumption was not associated with CRC survival; however, higher levels of wine consumption were modestly associated with a better prognosis overall (CRC-specific hazard ratio [HR], 0.70, 95% confidence interval [CI], 0.48-1.03; overall HR, 0.70; 95% CI, 0.53-0.94). Similar patterns were noted in stratified analyses. These findings suggest that prediagnostic wine consumption is modestly associated with more favorable survival after CRC. Cancer 2017;123:1035-43. © 2016 American Cancer Society. © 2016 American Cancer Society.

Comparing the responsiveness of functional outcome assessment measures for trauma registries.

PubMed

Williamson, Owen D; Gabbe, Belinda J; Sutherland, Ann M; Wolfe, Rory; Forbes, Andrew B; Cameron, Peter A

2011-07-01

Measuring long-term disability and functional outcomes after major trauma is not standardized across trauma registries. An ideal measure would be responsive to change but not have significant ceiling effects. The aim of this study was to compare the responsiveness of the Glasgow Outcome Scale (GOS), GOS-Extended (GOSE), Functional Independence Measure (FIM), and modified FIM in major trauma patients, with and without significant head injuries. Patients admitted to two adult Level I trauma centers in Victoria, Australia, who survived to discharge from hospital, were aged 15 years to 80 years with a blunt mechanism of injury, and had an estimated Injury Severity Score >15 on admission, were recruited for this prospective study. The instruments were administered at baseline (hospital discharge) and by telephone interview 6 months after injury. Measures of responsiveness, including effect sizes, were calculated. Bootstrapping techniques, and floor and ceiling effects, were used to compare the measures. Two hundred forty-three patients participated, of which 234 patients (96%) completed the study. The GOSE and GOS were the most responsive instruments in this major trauma population with effect sizes of 5.3 and 4.4, respectively. The GOSE had the lowest ceiling effect (17%). The GOSE was the instrument with greatest responsiveness and the lowest ceiling effect in a major trauma population with and without significant head injuries and is recommended for use by trauma registries for monitoring functional outcomes and benchmarking care. The results of this study do not support the use of the modified FIM for this purpose.

Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR).

PubMed

Olivares, J M; Rodriguez-Morales, A; Diels, J; Povey, M; Jacobs, A; Zhao, Z; Lam, A; Villalobos Vega, J C; Cuéllar, J Alonso; de Castro, F J Alberca; Quintero, C Morillo-Velarde; Martíin, J F Román; Domínguez, P Tabares; Ojeda, J L Prados; Cortés, S Sanz; Cala, F I Mata; Marín, C Gutiérrez; Castro, L Moyano; Duaso, M A Haza; Albarracín, J Requena; Vergara, G Narbona; Benítez, A Fernández; Cleries, F Mayoral; Pérez-Brian, J M García-Herrera; Aragón, A Bordallo; Navarro, J C Rodríguez; Biedma, J A Algarra; de Pedro, R Bravo; González, J F Delgado; López, M E Jaén; Moreno, H Díaz; López, J A Soto; Rodríguez, E Ojeda; de Hoyos, C Martínez; Sacristán, M Pardilla; Martín, M D Molina; Ballesteros, E Martín; Rodríguez, P A Sopelana; Menéndez, L Fernández; Rivas, R Santos; del Pino Cuadrado, P; Lauffer, J Correas; Solano, J J Rodríguez; Martínez, J M Fernández; Solano, F García; Rodríguez, P García-Lamberde; Rodríguez, J A Romero; Cano, T Rodríguez; Fortacin, M Ducaju; Lobeiras, J M Blanco; Sampedro, J M Piñeiro; Bravo, A Pérez; Pellicer, A Fernández; López, M D Alonso; Liste, J Fraga; Fernández, M Riobo; Losada, A Casas; Mendez, R Vazquez-Noguerol; Romero, S Agra; Blanco, J J Blanco; Bonaselt, I Tortajada; Mahia, M C García; del Valle, E Ferrer Gómez; Yañez, P Quiroga; Camarasa, M Gelabert; Alonso, J A Barbado; Mendez, G Florez; Feliz, F Doce; Lamela, M A López; Piñero, M Vega; Alvarado, P Fuentes; Gómez, I López; Martín, P Fadon; Gómez, J L Santos; López, A García; Jiménez, A Rodríguez; Nafs, A Escudero; Barquero, N Casas; Ortiz, R Fernández-Villamor; Noguera, J L Velez; Carrasco, P Ruiz; Muñoz, J Martín; Palma, M Masegoza; Hortelano, C Marín; Bonome, L Sánchez; Sevilla, J Sánchez; Juan, J M Mongil San; Ramos, J M García; Muñoz, J L Vallejo; Guisasola, J Elorza; Vazquez, L Santamaria; Guerras, F Campo; Nebot, F J Arrufat; Fernández, F J Baron; Nicolau, A L Palomo; Subirats, R Catala; Kidias, M Messays; Navarro, V Fabregat; García, B Frades; del Rosal, F Mejias; de Vicente Muñoz, T; Ballester, J Año; Lieb, P Malabia; Martel, A Delgado; Bea, E Roca; Joaquim, I Grau; Enjuanes, F Boatas; Piñol, M Bañuelos; Carbonell, E Fontova I; Muñoz, R Martín; Giribets, C Argila; Sans, L Albages; Blanco, A Serrano; Felipe, M Arcega; Muñoz, P González; Villanueva, A Pons; Arroyo, M Bernardo; Borri, R Coronas; Fallada, S Miret; Merola, M Celma; Rodon, E Parellada; Palmes, J R Pigem; Martínez, E Pérez; Catala, J Matarredona; Coca, A Sandoval; Ferrandiz, F Pascual; Paya, E Ferrandiz; Caballero, G Iturri; Bonet, A Franco; Figueras, J Fluvia; Pagador, P Moreno; Garibo, M Medina; Camo, V Pérez; Carrillo, C Sanz; Valero, C Pelegrin; Rebollo, F J Caro; García Campayo, J; Sala Ayma, J M Sala; Roig, M Martínez; de Uña Mateos, M A; Bertolin, R García; García, A Martín; Mazo, F Jiménez; Velasco, J L Galvez; Pérez, L Santa Maria; Casado, C Jiménez; Barba, J J Mancheño; Diaz, M Conde; Rubio, J P Alcon; Mandoli, A Soler; Herrero, A Uson; Martínez, A Rodríguez; Serrano, P Salgado; Rodríguez, E Nieto; Montesinos, J Segui; Macia, J Ferragud; Mateos Marcos, A Mateos; Soto, J V Pérez-Fuster; Dumont, M Verdaguer; Pagan, J Parra; Martínez, V Balanza; Santiuste de Pablos, M; Delgado, C Espinosa; Quiles, M D Martínez; López, F J Manzanera; Navarro, P Pozo; Torres, A Micol; Ingles, F J Martínez; Arias-Camison, J M Salmeron; Manzano, J C López; Peña, R Villanueva; Guitarte, G Petersen; Fontecilla, H Blasco; Romero, J Barjau; Gil, R Sanz; Lozano, J Marín; Adanez, L Donaire; Zarranz Herrera-Oria, I; Jiménez, J Pérez; Vaz, F Carrato; García, O Sanz; Anton, C Contreras; Casula, R Reixach; Hernandez, M C Natividad; Escabias, F Teba; Torresano, J Rodríguez; Pérez-Villamil, A Huidobro; Estevez, L; Figuero, M Aragües; Muñoz de Morales, A; Calvin, J L Rodríguez; Criado, M Delgado; Rodríguez, V Molina; Ambrosolio, E Balbo; Madera, P M Holgado; Alfaro, G Ponce; Vidal, M M Rojas; Valtuille, A García; Ruiz, O; Cabornero, G Lucas; Echevarria Martínez de Bujo, M; Mallen, M J Maicas; Puigros, J Santandreu; Martorell, A Liñana; Forteza, A Clar; Arrebola, E Rodríguez; Rodríguez de la Torre, M; Saiz, C G Anton; Bardolet I Casas, C; Linde, E Rodríguez; De Arce Cordon, R; Molina, E M Padial; Carazo, F J Ruiz; Romero, J J Muro; Cano, D Vico; Dorado, M Soria; Velazquez, S Campos; Sánchez, A J Rodríguez; Leon, S Ocio; Sánchez, K Pachas; Benitez, M Henry; Zugarramurai, A Intxausti; Contreras, M A; De la Varga González, M; Marín, P Barreiro; Robina, F Gómez; García, M Sánchez; Pérez, F J Otero; Bros, P Cubero; Gómez, A Carrillo; de Dios Molina Martín, J; Perera, J L Carrasco; Averbach, M C; Perera, J L Carrasco; Palancares, E Goenaga; Gallego de Dios, M T; Rojo, C Fernández; Iglesias, S Sánchez; Merino, M I Rubio; Mestre, N Prieto; Urdaniz, A Pérez; Sánchez, J M Martínez; Seco, R Gordo; Muñoz, J Franco; Agut, M Mateos; Lozano, M L Blanco; Herguedas, F Martín; Pena, A Torcal; García, J Vicente; Martínez, A Varona; Sanz Granado, O Sanz; Fernández, M A Medina; Canseco, J M Moran; López, P A Megia; Martín, M A Franco; Barrio, J A Espina; Ubago, J Giner; Bennassar, M Roca; Díez, J M Olivares; Fleta, J L Hernandez; Fortes, F Porras; López, C Arango; Medina, O; Alvarez, D Figuera; Roca, J M Peña; Valladolid, G Rubio; Tavera, J A Furquet; García-Castrillon Sales, J A; Llordes, I Batalla; Melgarejo, C Anchuistegui; Cañas de la Paz, F; Callol, V Vallés; García, M Bousoño; García, J Bobes; Leal, F J Vaz; Corrales, E Cáceres; Iglesias, E Sánchez; Gómez, M A Carreiras; Serrano, G García; Chillarón, E G Román; Aguado, F J Samino; Castillo, J J Molina; González, A González; Vázquez, J Gallardo; Peralvarez, M Bolivar; Diaz, M Rios; Mesa, M Ybarzabal; Artiles, F J Acosta; Chao, M Ajoy; Mesa, M Ybarzabal; del Rosario Santana, P; Escudero, M A García; Berenguer, M Molla; Llacer, J M Bonete; Berna, J A Juan; Ortiz, J Barragán; Pardell, L Tost; Hernández-Alvarez de Sotomayor, C; Méndez, M R Cejas; Garate, R Cabrera; Múgica, B Díaz; González, M Caballero; Domingo, J Pujol; Navarro, C Sáez; Vera, G Selva; Cuquerella, M A; Monzo, J Lonjedo; Boada, P Cervera; Pérez, M F Martín; Parrado, E Carrasco; Sánchez, J J Yañez; Fernández, J Calvo

2009-06-01

The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is a prospective, observational study of patients with schizophrenia designed to evaluate long-term treatment outcomes in routine clinical practice. Parameters were assessed at baseline and at 3 month intervals for 2 years in patients initiated on risperidone long-acting injection (RLAI) (n=1345) or a new oral antipsychotic (AP) (n=277; 35.7% and 36.5% on risperidone and olanzapine, respectively) in Spain. Hospitalization prior to therapy was assessed by a retrospective chart review. At 24 months, treatment retention (81.8% for RLAI versus 63.4% for oral APs, p<0.0001) and reduction in Clinical Global Impression Severity scores (-1.14 for RLAI versus -0.94 for APs, p=0.0165) were significantly higher with RLAI. Compared to the pre-switch period, RLAI patients had greater reductions in the number (reduction of 0.37 stays per patient versus 0.2, p<0.05) and days (18.74 versus 13.02, p<0.01) of hospitalizations at 24 months than oral AP patients. This 2 year, prospective, observational study showed that, compared to oral antipsychotics, RLAI was associated with better treatment retention, greater improvement in clinical symptoms and functioning, and greater reduction in hospital stays and days in hospital in patients with schizophrenia. Improved treatment adherence, increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia.

Overview of Coronary Heart Disease Risk Initiatives in South Asia.

PubMed

Kalra, Ankur; Bhatt, Deepak L; Rajagopalan, Sanjay; Suri, Kunal; Mishra, Sundeep; Iqbal, Romaina; Virani, Salim S

2017-06-01

Cardiovascular disease (CVD) is now the leading cause of morbidity and mortality worldwide. Industrialization and economic growth have led to an unprecedented increment in the burden of CVD and their risk factors in less industrialized regions of the world. While there are abundant data on CVD and their risk factors from longitudinal cohort studies done in the West, good-quality data from South Asia are lacking. Several multi-institutional, observational, prospective registries, and epidemiologic cohorts in South Asia have been established to systematically evaluate the burden of CVD and their risk factors. The PINNACLE (Practice Innovation and Clinical Excellence) India Quality Improvement Program (PIQIP), the Kerala Acute Coronary Syndrome (ACS), and Trivandrum Heart Failure registries have focused on secondary prevention of CVD and performance measurement in both outpatient and inpatient settings, respectively. The Prospective Urban and Rural Epidemiology (PURE), Centre for Cardiometabolic Risk Reduction in South Asia (CARRS), and other epidemiologic and genetic studies have focused on primary prevention of CVD and evaluated variables such as environment, smoking, physical activity, health systems, food and nutrition policy, dietary consumption patterns, socioeconomic factors, and healthy neighborhoods. The international cardiovascular community has been responsive to a burgeoning cardiovascular disease burden in South Asia. Several collaborations have formed between the West (North America in particular) and South Asia to catalyze evidence-based and data-driven changes in the federal health policy in this part of the world to promote cardiovascular health and mitigate cardiovascular risk.

Self-selection and bias in a large prospective pregnancy cohort in Norway.

PubMed

Nilsen, Roy M; Vollset, Stein Emil; Gjessing, Håkon K; Skjaerven, Rolv; Melve, Kari K; Schreuder, Patricia; Alsaker, Elin R; Haug, Kjell; Daltveit, Anne Kjersti; Magnus, Per

2009-11-01

Self-selection in epidemiological studies may introduce selection bias and influence the validity of study results. To evaluate potential bias due to self-selection in a large prospective pregnancy cohort in Norway, the authors studied differences in prevalence estimates and association measures between study participants and all women giving birth in Norway. Women who agreed to participate in the Norwegian Mother and Child Cohort Study (43.5% of invited; n = 73 579) were compared with all women giving birth in Norway (n = 398 849) using data from the population-based Medical Birth Registry of Norway in 2000-2006. Bias in the prevalence of 23 exposure and outcome variables was measured as the ratio of relative frequencies, whereas bias in exposure-outcome associations of eight relationships was measured as the ratio of odds ratios. Statistically significant relative differences in prevalence estimates between the cohort participants and the total population were found for all variables, except for maternal epilepsy, chronic hypertension and pre-eclampsia. There was a strong under-representation of the youngest women (<25 years), those living alone, mothers with more than two previous births and with previous stillbirths (relative deviation 30-45%). In addition, smokers, women with stillbirths and neonatal death were markedly under-represented in the cohort (relative deviation 22-43%), while multivitamin and folic acid supplement users were over-represented (relative deviation 31-43%). Despite this, no statistically relative differences in association measures were found between participants and the total population regarding the eight exposure-outcome associations. Using data from the Medical Birth Registry of Norway, this study suggests that prevalence estimates of exposures and outcomes, but not estimates of exposure-outcome associations are biased due to self-selection in the Norwegian Mother and Child Cohort Study.

Trauma airway management in emergency departments: a multicentre, prospective, observational study in Japan.

PubMed

Nakao, Shunichiro; Kimura, Akio; Hagiwara, Yusuke; Hasegawa, Kohei

2015-02-04

Although successful airway management is essential for emergency trauma care, comprehensive studies are limited. We sought to characterise current trauma care practice of airway management in the emergency departments (EDs) in Japan. Analysis of data from a prospective, observational, multicentre registry-the Japanese Emergency Airway Network (JEAN) registry. 13 academic and community EDs from different geographic regions across Japan. 723 trauma patients who underwent emergency intubation from March 2010 through August 2012. ED characteristics, patient and operator demographics, methods of airway management, intubation success or failure at each attempt and adverse events. A total of 723 trauma patients who underwent emergency intubation were eligible for the analysis. Traumatic cardiac arrest comprised 32.6% (95% CI 29.3% to 36.1%) of patients. Rapid sequence intubation (RSI) was the initial method chosen in 23.9% (95% CI 21.0% to 27.2%) of all trauma patients and in 35.5% (95% CI 31.4% to 39.9%) of patients without cardiac arrest. Overall, intubation was successful in ≤3 attempts in 96% of patients (95% CI 94.3% to 97.2%). There was a wide variation in the initial methods of intubation; RSI as the initial method was performed in 0-50.9% of all trauma patients among 12 EDs. Similarly, there was a wide variation in success rates and adverse event rates across the EDs. Success rates varied between 35.5% and 90.5% at the first attempt, and 85.1% and 100% within three attempts across the 12 EDs. In this multicentre prospective study in Japan, we observed a high overall success rate in airway management during trauma care. However, the methods of intubation and success rates were highly variable among hospitals. 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.

Study protocol: The back pain outcomes using longitudinal data (BOLD) registry

PubMed Central

2012-01-01

Background Back pain is one of the most important causes of functional limitation, disability, and utilization of health care resources for adults of all ages, but especially among older adults. Despite the high prevalence of back pain in this population, important questions remain unanswered regarding the comparative effectiveness of commonly used diagnostic tests and treatments in the elderly. The overall goal of the Back pain Outcomes using Longitudinal Data (BOLD) project is to establish a rich, sustainable registry to describe the natural history and evaluate prospectively the effectiveness, safety, and cost-effectiveness of interventions for patients 65 and older with back pain. Methods/design BOLD is enrolling 5,000 patients ≥ 65 years old who present to a primary care physician with a new episode of back pain. We are recruiting study participants from three integrated health systems (Kaiser-Permanente Northern California, Henry Ford Health System in Detroit and Harvard Vanguard Medical Associates/ Harvard Pilgrim Health Care in Boston). Registry patients complete validated, standardized measures of pain, back pain-related disability, and health-related quality of life at enrollment and 3, 6 and 12 months later. We also have available for analysis the clinical and administrative data in the participating health systems’ electronic medical records. Using registry data, we will conduct an observational cohort study of early imaging compared to no early imaging among patients with new episodes of back pain. The aims are to: 1) identify predictors of early imaging and; 2) compare pain, functional outcomes, diagnostic testing and treatment utilization of patients who receive early imaging versus patients who do not receive early imaging. In terms of predictors, we will examine patient factors as well as physician factors. Discussion By establishing the BOLD registry, we are creating a resource that contains patient-reported outcome measures as well as electronic medical record data for elderly patients with back pain. The richness of our data will allow better matching for comparative effectiveness studies than is currently possible with existing datasets. BOLD will enrich the existing knowledge base regarding back pain in the elderly to help clinicians and patients make informed, evidence-based decisions regarding their care. PMID:22554166

Pathological, Oncologic and Functional Outcomes of a Prospective Registry of Salvage High Intensity Focused Ultrasound Ablation for Radiorecurrent Prostate Cancer.

PubMed

Siddiqui, Khurram M; Billia, Michele; Arifin, Andrew; Li, Fan; Violette, Philippe; Chin, Joseph L

2017-01-01

In this prospective registry we prospectively assessed the oncologic, functional and safety outcomes of salvage high intensity focused ultrasound for radiorecurrent prostate cancer. A total of 81 men were prospectively recruited and evaluated at regular scheduled study visits to 6 months after high intensity focused ultrasound and thereafter as per standard of care. Transrectal ultrasound guided biopsy was performed at 6 months. The primary end point was absence or histological persistence of disease at 6-month biopsy. Secondary end points included quality of life, biochemical recurrence-free survival, overall survival, cancer specific survival and progression to androgen deprivation therapy. Survival analysis was performed according to the Kaplan-Meier method and multivariate analysis was performed using the log rank (Mantel-Cox) test. Mean ± SD prostate specific antigen before high intensity focused ultrasound was 4.06 ± 2.88 ng/ml. At 6 months 63 men underwent biopsy, of whom 22 (35%) had residual disease. At a mean followup of 53.5 ± 31.6 months median biochemical recurrence-free survival was 63 months. The 5-year overall and cancer specific survival rates were 88% and 94.4%, respectively. Nadir prostate specific antigen less than 0.5 ng/ml was a significant predictor of biochemical recurrence-free survival (p=0.014, 95% CI 1.22-5.87). I-PSS significantly increased (p <0.001) while IIEF-5 scores decreased and the SF-36 score did not change significantly. The rate of rectal fistulization and severe incontinence was 3.7% each. A total of 223 complications were recorded in the 180 days after high intensity focused ultrasound (Clavien-Dindo grade 1-195, grade II-20, grade III-7, grade IVa-1). Salvage high intensity focused ultrasound appears to be a viable treatment option for radiorecurrent prostate cancer, with acceptable morbidity. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

The impact of spine stability on cervical spinal cord injury with respect to demographics, management, and outcome: a prospective cohort from a national spinal cord injury registry.

PubMed

Paquet, Jérôme; Rivers, Carly S; Kurban, Dilnur; Finkelstein, Joel; Tee, Jin W; Noonan, Vanessa K; Kwon, Brian K; Hurlbert, R John; Christie, Sean; Tsai, Eve C; Ahn, Henry; Drew, Brian; Bailey, Christopher S; Fourney, Daryl R; Attabib, Najmedden; Johnson, Michael G; Fehlings, Michael G; Parent, Stefan; Dvorak, Marcel F

2018-01-01

Emergent surgery for patients with a traumatic spinal cord injury (SCI) is seen as the gold standard in acute management. However, optimal treatment for those with the clinical diagnosis of central cord syndrome (CCS) is less clear, and classic definitions of CCS do not identify a unique population of patients. The study aimed to test the authors' hypothesis that spine stability can identify a unique group of patients with regard to demographics, management, and outcomes, which classic CCS definitions do not. This is a prospective observational study. The sample included participants with cervical SCI included in a prospective Canadian registry. The outcome measures were initial hospitalization length of stay, change in total motor score from admission to discharge, and in-hospital mortality. Patients with cervical SCI from a prospective Canadian SCI registry were grouped into stable and unstable spine cohorts. Bivariate analyses were used to identify differences in demographic, injury, management, and outcomes. Multivariate analysis was used to better understand the impact of spine stability on motor score improvement. No conflicts of interest were identified. Compared with those with an unstable spine, patients with cervical SCI and a stable spine were older (58.8 vs. 44.1 years, p<.0001), more likely male (86.4% vs. 76.1%, p=.0059), and have more medical comorbidities. Patients with stable spine cervical SCI were more likely to have sustained their injury by a fall (67.4% vs. 34.9%, p<.0001), and have high cervical (C1-C4; 58.5% vs. 43.3%, p=.0009) and less severe neurologic injuries (ASIA Impairment Scale C or D; 81.3% vs. 47.5%, p<.0001). Those with stable spine injuries were less likely to have surgery (67.6% vs. 92.6%, p<.0001), had shorter in-hospital lengths of stay (median 84.0 vs. 100.5 days, p=.0062), and higher total motor score change (20.7 vs. 19.4 points, p=.0014). Multivariate modeling revealed that neurologic severity of injury and spine stability were significantly related to motor score improvement; patients with stable spine injuries had more motor score improvement. We propose that classification of stable cervical SCI is more clinically relevant than classic CCS classification as this group was found to be unique with regard to demographics, neurologic injury, management, and outcome, whereas classic CCS classifications do not . This classification can be used to assess optimal management in patients where it is less clear if and when surgery should be performed. Copyright © 2017 Elsevier Inc. All rights reserved.

Assessing the health effects associated with occupational radiation exposure in Korean radiation workers: protocol for a prospective cohort study.

PubMed

Seo, Songwon; Lim, Wan Young; Lee, Dal Nim; Kim, Jung Un; Cha, Eun Shil; Bang, Ye Jin; Lee, Won Jin; Park, Sunhoo; Jin, Young Woo

2018-03-30

The cancer risk of radiation exposure in the moderate-to-high dose range has been well established. However, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. Several epidemiological studies of Korean radiation workers have been conducted, but the data were analysed retrospectively in most cases. Moreover, groups with relatively high exposure, such as industrial radiographers, have been neglected. Therefore, we have launched a prospective cohort study of all Korean radiation workers to assess the health effects associated with occupational radiation exposure. Approximately 42 000 Korean radiation workers registered with the Nuclear Safety and Security Commission from 2016 to 2017 are the initial target population of this study. Cohort participants are to be enrolled through a nationwide self-administered questionnaire survey between 24 May 2016 and 30 June 2017. As of 31 March 2017, 22 982 workers are enrolled in the study corresponding to a response rate of 75%. This enrolment will be continued at 5-year intervals to update information on existing study participants and recruit newly hired workers. Survey data will be linked with the national dose registry, the national cancer registry, the national vital statistics registry and national health insurance data via personal identification numbers. Age-specific and sex-specific standardised incidence and mortality ratios will be calculated for overall comparisons of cancer risk. For dose-response assessment, excess relative risk (per Gy) and excess absolute risk (per Gy) will be estimated with adjustments for birth year and potential confounders, such as lifestyle factors and socioeconomic status. This study has received ethical approval from the institutional review board of the Korea Institute of Radiological and Medical Sciences (IRB No. K-1603-002-034). All participants provided written informed consent prior to enrolment. The findings of the study will be disseminated through scientific peer-reviewed journals and be provided to the public, including radiation workers, via the study website (http://www.rhs.kr/) and onsite radiation safety education. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cohort profile: cerebral palsy in the Norwegian and Danish birth cohorts (MOBAND-CP).

PubMed

Tollånes, Mette C; Strandberg-Larsen, Katrine; Forthun, Ingeborg; Petersen, Tanja Gram; Moster, Dag; Andersen, Anne-Marie Nybo; Stoltenberg, Camilla; Olsen, Jørn; Wilcox, Allen J

2016-09-02

The purpose of MOthers and BAbies in Norway and Denmark cerebral palsy (MOBAND-CP) was to study CP aetiology in a prospective design. MOBAND-CP is a cohort of more than 210 000 children, created as a collaboration between the world's two largest pregnancy cohorts-the Norwegian Mother and Child Cohort study (MoBa) and the Danish National Birth Cohort. MOBAND-CP includes maternal interview/questionnaire data collected during pregnancy and follow-up, plus linked information from national health registries. Initial harmonisation of data from the 2 cohorts has created 140 variables for children and their mothers. In the MOBAND-CP cohort, 438 children with CP have been identified through record linkage with validated national registries, providing by far the largest such sample with prospectively collected detailed pregnancy data. Several studies investigating various hypotheses regarding CP aetiology are currently on-going. Additional data can be harmonised as necessary to meet requirements of new projects. Biological specimens collected during pregnancy and at delivery are potentially available for assay, as are results from assays conducted on these specimens for other projects. The study size allows consideration of CP subtypes, which is rare in aetiological studies of CP. In addition, MOBAND-CP provides a platform within the context of a merged birth cohort of exceptional size that could, after appropriate permissions have been sought, be used for cohort and case-cohort studies of other relatively rare health conditions of infants and children. 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/

Toward evidence-based diagnosis of myocarditis in children and adolescents: Rationale, design, and first baseline data of MYKKE, a multicenter registry and study platform.

PubMed

Messroghli, Daniel R; Pickardt, Thomas; Fischer, Marcus; Opgen-Rhein, Bernd; Papakostas, Konstantin; Böcker, Dorothée; Jakob, André; Khalil, Markus; Mueller, Goetz C; Schmidt, Florian; Kaestner, Michael; Udink Ten Cate, Floris E A; Wagner, Robert; Ruf, Bettina; Kiski, Daniela; Wiegand, Gesa; Degener, Franziska; Bauer, Ulrike M M; Friede, Tim; Schubert, Stephan

2017-05-01

The aim of this registry is to provide data on age-related clinical features of suspected myocarditis and to create a study platform allowing for deriving diagnostic criteria and, at a later stage, testing therapeutic interventions in patients with myocarditis. After an initial 6-month pilot phase, MYKKE was opened in June 2014 as a prospective multicenter registry for patients from pediatric heart centers, university hospitals, and community hospitals with pediatric cardiology wards in Germany. Inclusion criteria consisted of age<18 years and hospitalization for suspected myocarditis as leading diagnosis at the discretion of the treating physician. By December 31, 2015, fifteen centers across Germany were actively participating and had enrolled 149 patients. Baseline data reveal 2 age peaks (<2 years, >12 years), show higher proportions of males, and document a high prevalence of severe disease courses in pediatric patients with suspected myocarditis. Severe clinical courses and early adverse events were more prevalent in younger patients and were related to severely impaired leftventricular ejection fraction at initial presentation. MYKKE represents a multicenter registry and research platform for children and adolescents with suspected myocarditis that achieve steady recruitment and generate a wide range of real-world data on clinical course, diagnostic workup, and treatment of this group of patients. The baseline data reveal the presence of 2 age peaks and provide important insights into the severity of disease in children with suspected myocarditis. In the future, MYKKE might facilitate interventional substudies by providing an established collaborating network using common diagnostic approaches. Copyright © 2017 Elsevier Inc. All rights reserved.

Contemporary rates of appropriate shock therapy in patients who receive implantable device therapy in a real-world setting: From the Israeli ICD Registry.

PubMed

Sabbag, Avi; Suleiman, Mahmoud; Laish-Farkash, Avishag; Samania, Nimer; Kazatsker, Mark; Goldenberg, Ilan; Glikson, Michael; Beinart, Roy

2015-12-01

Implantable cardioverter-defibrillators (ICDs) have become the mainstay of preventive measures for sudden cardiac death (SCD). However, there are limited data on rates of appropriate life-saving ICD shock therapies in contemporary real-life settings. The purpose of the study was to evaluate the rate of appropriate life-saving ICD shock therapies in a contemporary registry. The Israeli ICD Registry includes all implants and other ICD operative procedures nationwide. The present study comprises 2349 consecutive cases who were enrolled in the Registry and prospectively followed up for information regarding survival, hospitalizations, and ICD therapies since 2010. Kaplan-Meier survival analysis showed that the rate of appropriate ICD shock therapy at 30-month follow-up was 2.6% among patients who received an ICD for primary prevention compared with 7.4% among those who received a device for secondary prevention (log-rank P < .001). Rates of appropriate ICD shocks among primary prevention patients were 1.1% at 1-year of follow-up and 2.6% at 30 months, whereas the corresponding rates in the secondary prevention group were 3.8% at 1 year and 7.4% at 30 months (log-rank P < .001). A total of 253 patients (4.8%) died during follow-up, 65% of noncardiac causes. Rates of life-saving appropriate ICD shock therapies among patients implanted with a defibrillator for the primary prevention of SCD in a contemporary real-world setting are lower than reported previously. These findings suggest a need for improved risk stratification and patient selection in this population. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2010-06-01

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

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.

Long term outcomes data for the Burns Registry of Australia and New Zealand: Is it feasible?

PubMed

Gabbe, Belinda J; Cleland, Heather; Watterson, Dina M; Schrale, Rebecca; McRae, Sally; Parker, Christine; Taggart, Susan; Edgar, Dale W

2015-12-01

Incorporating routine and standardised collection of long term outcomes following burn into burn registries would improve the capacity to quantify burn burden and evaluate care. To evaluate methods for collecting the long term functional and quality of life outcomes of burns patients and establish the feasibility of implementing these outcomes into a multi-centre burns registry. Five Burns Registry of Australia and New Zealand (BRANZ) centres participated in this prospective, longitudinal study. Patients admitted to the centres between November 2009 and November 2010 were followed-up at 1, 6, 12 and 24-months after injury using measures of burn specific health, health status, fatigue, itch and return to work. Participants in the study were compared to BRANZ registered patients at the centres over the study timeframe to identify participation bias, predictors of successful follow-up were established using a Generalised Estimating Equation model, and the completion rates by mode of administration were assessed. 463 patients participated in the study, representing 24% of all BRANZ admissions in the same timeframe. Compared to all BRANZ patients in the same timeframe, the median %TBSA and hospital length of stay was greater in the study participants. The follow-up rates were 63% at 1-month, 47% at 6-months; 40% at 12-months, and 21% at 24-months after injury, and there was marked variation in follow-up rates between the centres. Increasing age, greater %TBSA and opt-in centres were associated with greater follow-up. Centres which predominantly used one mode of administration experienced better follow-up rates. The low participation rates, high loss to follow-up and responder bias observed indicate that greater consideration needs to be given to alternative models for follow-up, including tailoring the follow-up protocol to burn severity or type. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

An international prospective cohort study of mobile phone users and health (Cosmos): design considerations and enrolment.

PubMed

Schüz, Joachim; Elliott, Paul; Auvinen, Anssi; Kromhout, Hans; Poulsen, Aslak Harbo; Johansen, Christoffer; Olsen, Jørgen H; Hillert, Lena; Feychting, Maria; Fremling, Karin; Toledano, Mireille; Heinävaara, Sirpa; Slottje, Pauline; Vermeulen, Roel; Ahlbom, Anders

2011-02-01

There is continuing public and scientific interest in the possibility that exposure to radiofrequency (RF) electromagnetic fields (EMF) from mobile telephones or other wireless devices and applications might increase the risk of certain cancers or other diseases. The interest is amplified by the rapid world-wide penetration of such technologies. The evidence from epidemiological studies published to date have not been consistent and, in particular, further studies are required to identify whether longer term (well beyond 10 years) RF exposure might pose some health risk. The "Cosmos" study described here is a large prospective cohort study of mobile telephone users (ongoing recruitment of 250,000 men and women aged 18+ years in five European countries - Denmark, Finland, Sweden, The Netherlands, UK) who will be followed up for 25+ years. Information on mobile telephone use is collected prospectively through questionnaires and objective traffic data from network operators. Associations with disease risks will be studied by linking cohort members to existing disease registries, while changes in symptoms such as headache and sleep quality and of general well-being are assessed by baseline and follow-up questionnaires. A prospective cohort study conducted with appropriate diligence and a sufficient sample size, overcomes many of the shortcomings of previous studies. Its major advantages are exposure assessment prior to the diagnosis of disease, the prospective collection of objective exposure information, long-term follow-up of multiple health outcomes, and the flexibility to investigate future changes in technologies or new research questions. Copyright © 2010 Elsevier Ltd. All rights reserved.

THC:CBD spray and MS spasticity symptoms: data from latest studies.

PubMed

Rekand, Tiina

2014-01-01

New clinical experience with 9-delta-tetrahydocannabinol (THC) and cannabidiol (CBD) oromucosal spray (Sativex®) involving more than an additional 1,000 patients with MS spasticity (approximately 150 in clinical studies and 900 in post-marketing surveillance studies) have become available in 2013 and are reviewed. A randomized, placebo controlled long-term follow-up clinical trial with THC:CBD spray versus placebo demonstrated that it was not associated with cognitive decline, depression or significant mood changes after 12 months of treatment. Furthermore, in a prospective observational pilot study involving 33 patients (60% female) aged 33-68 years and a mean disease duration of 6.6 years, THC:CBD oromucosal spray did not adversely influence standard driving ability in patients with moderate to severe MS spasticity. Other new long term observational data about the use of THC:CBD oromucosal spray in clinical practice are available from patient registries in the UK, Germany and Spain. Findings to date reinforce the efficacy and safety observed in Phase III clinical trials. It is of interest that in practice average dosages used by patients tended to be lower than those reported in clinical studies (5-6.4 vs. >8 sprays/day), and effectiveness was maintained in the majority of patients. Importantly, no additional safety concerns were identified in the registry studies which included findings from patients who have been treated for prolonged periods (in the German/UK registry 45% of patients had >2 years exposure). Thus, these new data support a positive benefit-risk relationship for THC:CBD oromucosal spray during longer-term use. © 2014 S. Karger AG, Basel.

The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.

PubMed

Beckmann, A; Hamm, C; Figulla, H R; Cremer, J; Kuck, K H; Lange, R; Zahn, R; Sack, S; Schuler, G C; Walther, T; Beyersdorf, F; Böhm, M; Heusch, G; Funkat, A K; Meinertz, T; Neumann, T; Papoutsis, K; Schneider, S; Welz, A; Mohr, F W

2012-07-01

Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing aortic valve procedures in Germany joined the registry. By now, 91 sites which perform TAVI in Germany participate and more than 15,000 datasets are already in the registry.Conclusion The implementation of new or innovative medical therapies needs supervision under the conditions of a well-structured scientific project. Up to now relevant data for implementation of TAVI and long-term results are missing. In contrast to randomized controlled trials, GARY is a prospective, controlled, 5-year observational multicenter registry, and a real world investigation with only one exclusion criterion, the absence of patients' written consent. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

An overview and online registry of microvillus inclusion disease patients and their MYO5B mutations.

PubMed

van der Velde, K Joeri; Dhekne, Herschel S; Swertz, Morris A; Sirigu, Serena; Ropars, Virginie; Vinke, Petra C; Rengaw, Trebor; van den Akker, Peter C; Rings, Edmond H H M; Houdusse, Anne; van Ijzendoorn, Sven C D

2013-12-01

Microvillus inclusion disease (MVID) is one of the most severe congenital intestinal disorders and is characterized by neonatal secretory diarrhea and the inability to absorb nutrients from the intestinal lumen. MVID is associated with patient-, family-, and ancestry-unique mutations in the MYO5B gene, encoding the actin-based motor protein myosin Vb. Here, we review the MYO5B gene and all currently known MYO5B mutations and for the first time methodologically categorize these with regard to functional protein domains and recurrence in MYO7A associated with Usher syndrome and other myosins. We also review animal models for MVID and the latest data on functional studies related to the myosin Vb protein. To congregate existing and future information on MVID geno-/phenotypes and facilitate its quick and easy sharing among clinicians and researchers, we have constructed an online MOLGENIS-based international patient registry (www.MVID-central.org). This easily accessible database currently contains detailed information of 137 MVID patients together with reported clinical/phenotypic details and 41 unique MYO5B mutations, of which several unpublished. The future expansion and prospective nature of this registry is expected to improve disease diagnosis, prognosis, and genetic counseling. © 2013 WILEY PERIODICALS, INC.

Prospective study on the potential of RAAS blockade to halt renal disease in Alport syndrome patients with heterozygous mutations.

PubMed

Stock, Johanna; Kuenanz, Johannes; Glonke, Niklas; Sonntag, Joseph; Frese, Jenny; Tönshoff, Burkhard; Höcker, Britta; Hoppe, Bernd; Feldkötter, Markus; Pape, Lars; Lerch, Christian; Wygoda, Simone; Weber, Manfred; Müller, Gerhard-Anton; Gross, Oliver

2017-01-01

Patients with autosomal or X-linked Alport syndrome (AS) with heterozygous mutations in type IV collagen genes have a 1-20 % risk of progressing to end-stage renal disease during their lifetime. We evaluated the long-term renal outcome of patients at risk of progressive disease (chronic kidney disease stages 1-4) with/without nephroprotective therapy. This was a prospective, non-interventional, observational study which included data from a 4-year follow-up of AS patients with heterozygous mutations whose datasets had been included in an analysis of the 2010 database of the European Alport Registry. Using Kaplan-Meier estimates and logrank tests, we prospectively analyzed the updated datasets of 52 of these patients and 13 new datasets (patients added to the Registry after 2011). The effects of therapy, extrarenal symptoms and inheritance pattern on renal outcome were analyzed. The mean prospective follow-up was 46 ± 10 months, and the mean time on therapy was 8.4 ± 4.4 (median 7; range 2-18) years. The time from the appearance of the first symptom to diagnosis was 8.1 ± 14.2 (range 0-52) years. At the time of starting therapy, 5.4 % of patients had an estimated glomerular filtration rate of <60 ml/min, 67.6 % had proteinuria and 27.0 % had microalbuminuria. Therapeutic strategies included angiotensin-converting enzymer inhibitors (97.1 %), angiotensin receptor antagonists (1 patient), dual therapy (11.8 %) and statins (8.8 %). Among patients included in the prospective dataset, prevented the need for dialysis. Among new patients, no patient at risk for renal failure progressed to the next disease stage after 4 years follow-up; three patients even regressed to a lower stage during therapy. Treatment with blockers of the renin-angiotensin-aldosterone system prevents progressive renal failure in AS patients with heterozygous mutations in the genes causing AS. Considerable numbers of aging AS patients on dialysis may have heterozygous mutations in these genes (present in 1 % of total population) as underlying disease. Hence, greater alertness towards timely diagnosis and therapy has the potential to prevent progressive renal failure in most-if not all-AS patients with heterozygous mutations in the causal genes.

The Human Oocyte Preservation Experience (HOPE) a phase IV, prospective, multicenter, observational oocyte cryopreservation registry.

PubMed

Ezcurra, Diego; Rangnow, Jennifer; Craig, Maryellen; Schertz, Joan

2009-05-27

It has been recommended by the American Society of Clinical Oncology and the American Society of Reproductive Medicine that options to preserve fertility be presented at the outset of treatment for cancer. This recommendation may have arisen, in part, to the increasing survival of patients with cancer and the realization that certain forms of cancer treatment can lead to infertility. One option for these patients, particularly those with ethical or religious objections to freezing embryos is oocyte cryopreservation. However universal acceptance of these procedures has yet to be established, most likely due to a poor history of success and concerns that there has yet to be a comprehensive approach to evaluating these techniques. In light of this, a registry of patients undergoing oocyte cryopreservation, called the HOPE registry, is being implemented. The intent of the HOPE Registry is to enroll approximately 400 women of reproductive age who will undergo thawing/warming of oocytes and subsequent transfer. Data from the patients enrolled will be collected via a uniform, standardized form and will document important parameters such as demographics, laboratory procedures and outcomes, including following the outcomes of babies born for one year after birth. The results of the registry will be published on a yearly basis. A patient registry has been established in order to systematically document the techniques and outcomes of oocyte cryopreservation procedures. The results will be published in order to provide a widely accessible resource that will allow patients who are considering these procedures validated information in order to make informed decisions as to how their treatment will proceed.

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

PubMed

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

2018-02-28

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

Evaluation of Selection Bias in an Internet-based Study of Pregnancy Planners

PubMed Central

Hatch, Elizabeth E.; Hahn, Kristen A.; Wise, Lauren A.; Mikkelsen, Ellen M.; Kumar, Ramya; Fox, Matthew P.; Brooks, Daniel R.; Riis, Anders H.; Sorensen, Henrik Toft; Rothman, Kenneth J.

2016-01-01

Selection bias is a potential concern in all epidemiologic studies, but it is usually difficult to assess. Recently, concerns have been raised that internet-based prospective cohort studies may be particularly prone to selection bias. Although use of the internet is efficient and facilitates recruitment of subjects that are otherwise difficult to enroll, any compromise in internal validity would be of great concern. Few studies have evaluated selection bias in internet-based prospective cohort studies. Using data from the Danish Medical Birth Registry from 2008 to 2012, we compared six well-known perinatal associations (e.g., smoking and birth weight) in an inter-net-based preconception cohort (Snart Gravid n = 4,801) with the total population of singleton live births in the registry (n = 239,791). We used log-binomial models to estimate risk ratios (RRs) and 95% confidence intervals (CIs) for each association. We found that most results in both populations were very similar. For example, maternal obesity was associated with an increased risk of delivering a macrosomic infant in Snart Gravid (RR = 1.5; 95% CI: 1.2, 1.7) and the total population (RR = 1.5; 95% CI: 1.45, 1.53), and maternal smoking of >10 cigarettes per day was associated with a higher risk of low birth weight (RR = 2.7; 95% CI: 1.2, 5.9 vs. RR = 2.9; 95% CI: 2.6, 3.1) in Snart Gravid and the total population, respectively. We cannot be certain that our results would apply to other associations or different populations. Nevertheless, our results suggest that recruitment of reproductive aged women via the internet may be no more prone to selection bias than traditional methods of recruitment. PMID:26484423

Characteristics and outcomes of patients admitted to Spanish ICU: A prospective observational study from the ENVIN-HELICS registry (2006-2011).

PubMed

Olaechea, P M; Álvarez-Lerma, F; Palomar, M; Gimeno, R; Gracia, M P; Mas, N; Rivas, R; Seijas, I; Nuvials, X; Catalán, M

2016-05-01

To describe the case-mix of patients admitted to intensive care units (ICUs) in Spain during the period 2006-2011 and to assess changes in ICU mortality according to severity level. Secondary analysis of data obtained from the ENVN-HELICS registry. Observational prospective study. Spanish ICU. Patients admitted for over 24h. None. Data for each of the participating hospitals and ICUs were recorded, as well as data that allowed to knowing the case-mix and the individual outcome of each patient. The study period was divided into two intervals, from 2006 to 2008 (period 1) and from 2009 to 2011 (period 2). Multilevel and multivariate models were used for the analysis of mortality and were performed in each stratum of severity level. The study population included 142,859 patients admitted to 188 adult ICUs. There was an increase in the mean age of the patients and in the percentage of patients >79 years (11.2% vs. 12.7%, P<0.001). Also, the mean APACHE II score increased from 14.35±8.29 to 14.72±8.43 (P<0.001). The crude overall intra-UCI mortality remained unchanged (11.4%) but adjusted mortality rate in patients with APACHE II score between 11 and 25 decreased modestly in recent years (12.3% vs. 11.6%, odds ratio=0.931, 95% CI 0.883-0.982; P=0.008). This study provides observational longitudinal data on case-mix of patients admitted to Spanish ICUs. A slight reduction in ICU mortality rate was observed among patients with intermediate severity level. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Prospective registration of clinical trials in India: strategies, achievements & challenges.

PubMed

Tharyan, Prathap

2009-02-01

This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by first hand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of existing legislative opportunities to complement these efforts. © 2009 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Analysis of the time and workers needed to conduct systematic reviews of medical interventions using data from the PROSPERO registry.

PubMed

Borah, Rohit; Brown, Andrew W; Capers, Patrice L; Kaiser, Kathryn A

2017-02-27

To summarise logistical aspects of recently completed systematic reviews that were registered in the International Prospective Register of Systematic Reviews (PROSPERO) registry to quantify the time and resources required to complete such projects. Meta-analysis. All of the 195 registered and completed reviews (status from the PROSPERO registry) with associated publications at the time of our search (1 July 2014). All authors extracted data using registry entries and publication information related to the data sources used, the number of initially retrieved citations, the final number of included studies, the time between registration date to publication date and number of authors involved for completion of each publication. Information related to funding and geographical location was also recorded when reported. The mean estimated time to complete the project and publish the review was 67.3 weeks (IQR=42). The number of studies found in the literature searches ranged from 27 to 92 020; the mean yield rate of included studies was 2.94% (IQR=2.5); and the mean number of authors per review was 5, SD=3. Funded reviews took significantly longer to complete and publish (mean=42 vs 26 weeks) and involved more authors and team members (mean=6.8 vs 4.8 people) than those that did not report funding (both p<0.001). Systematic reviews presently take much time and require large amounts of human resources. In the light of the ever-increasing volume of published studies, application of existing computing and informatics technology should be applied to decrease this time and resource burden. We discuss recently published guidelines that provide a framework to make finding and accessing relevant literature less burdensome. 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/.

[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.

Use of ACE inhibitors in Fontan: Rational or irrational?

PubMed

Wilson, Thomas G; Iyengar, Ajay J; Winlaw, David S; Weintraub, Robert G; Wheaton, Gavin R; Gentles, Thomas L; Ayer, Julian; Grigg, Leeanne E; Justo, Robert N; Radford, Dorothy J; Bullock, Andrew; Celermajer, David S; Dalziel, Kim; Schilling, Chris; d'Udekem, Yves

2016-05-01

Despite a lack of evidence supporting the use of angiotensin-converting enzyme (ACE) inhibitors in patients with a Fontan circulation, their use is frequent. We decided to identify the rationale for ACE inhibitor therapy in patients within the Australia and New Zealand Fontan Registry. All patients in the Registry taking an ACE inhibitor at last follow up were identified, and a review of medical records was undertaken to determine the rationale for treatment initiation and reasons for treatment continuation or dose increase. In 2015, 36% of the surviving patients in the Registry (462/1268) were taking an ACE inhibitor. Indications for initiation of therapy were ventricular systolic or diastolic dysfunction (29%), atrioventricular valve regurgitation (19%), preservation of normal ventricular function (7%), prolonged effusions at Fontan (6%), hypertension (6%), other (6%) and unknown (2%). No indication was stated in the remaining patients (25%). Those with hypoplastic left heart syndrome were more likely to be on an ACE inhibitor than those with an alternative primary morphology (70% vs 32%; p<0.001). Only 36% of the patients treated with an ACE inhibitor at last follow up (166/462) had an indication that would generally justify treatment in a two-ventricle circulation. It is likely that the use of ACE inhibitors in patients with a Fontan circulation is excessive within our region. The coordination of prospective, multicentre studies and initiatives such as the Australia and New Zealand Fontan Registry will facilitate further investigations to guide treatment decisions in the growing Fontan population. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Laparoscopic versus open distal pancreatectomy-a propensity score-matched analysis from the German StuDoQ|Pancreas registry.

PubMed

Wellner, Ulrich Friedrich; Lapshyn, Hryhoriy; Bartsch, Detlef K; Mintziras, Ioannis; Hopt, Ulrich Theodor; Wittel, Uwe; Krämling, Hans-Jörg; Preissinger-Heinzel, Hubert; Anthuber, Matthias; Geissler, Bernd; Köninger, Jörg; Feilhauer, Katharina; Hommann, Merten; Peter, Luisa; Nüssler, Natascha C; Klier, Thomas; Mansmann, Ulrich; Keck, Tobias

2017-02-01

The aim of this study was to assess intraoperative, postoperative, and oncologic outcome in patients undergoing laparoscopic distal pancreatectomy (LDP) versus open distal pancreatectomy (ODP) for benign and malignant lesions of the pancreas. Data from patients undergoing distal pancreatic resection were extracted from the StuDoQ|Pancreas registry of the German Society for General and Visceral Surgery. After propensity score case matching, groups of LDP and ODP were compared regarding demography, comorbidities, operative details, histopathology, and perioperative outcome. At the time of data extraction, the StuDoQ|Pancreas registry included over 3000 pancreatic resections from over 50 surgical departments in Germany. Data from 353 patients undergoing ODP (n = 254) or LDP (n = 99) from September 2013 to February 2016 at 29 institutions were included in the analysis. Baseline data showed a strong selection bias in LDP patients, which disappeared after 1:1 propensity score matching. A comparison of the matched groups disclosed a significantly longer operation time, higher rate of spleen preservation, more grade A pancreatic fistula, shorter hospital stay, and increased readmissions for LDP. In the small group of patients operated for pancreatic cancer, a lower lymph node yield with a lower lymph node ratio was apparent in LDP. LDP needed more time but potential advantages include increased spleen preservation and shorter hospital stay, as well as a trend for less transfusion, ventilation, and mortality. LDP for pancreatic cancer was performed rarely and will need critical evaluation in the future. Data from a prospective randomized registry trial is needed to confirm these results.

Predicting the evolution of low back pain patients in routine clinical practice: results from a registry within the Spanish National Health Service.

PubMed

Kovacs, Francisco M; Seco, Jesús; Royuela, Ana; Corcoll Reixach, Josep; Abraira, Víctor

2012-11-01

The Spanish National Health Service (SNHS) is a tax-funded public organization that provides free health care to every resident in Spain. To develop models for predicting the evolution of low back pain (LBP) in routine clinical practice within SNHS. Analysis of a prospective registry in routine clinical practice, in 17 centers across SNHS. Patient sample includes 4,477 acute and chronic LBP patients treated in primary and hospital care. Pain and disability, measured through validated instruments. Patients treated for LBP were assessed at baseline and 3 months later. Data gathered were the following: sex, age, employment status, duration of pain, severity of LBP, pain down to the leg (LP) and disability, history of lumbar surgery, diagnostic procedures undertaken, imaging findings, and treatments used throughout the study period. Three separate multivariate logistic regression models were developed for predicting a clinically relevant improvement in LBP, LP, and disability at 3 months. In total, 4,261 patients (95.2%) attended follow-up. For all the models, calibration was reasonable and the area under the receiver operating characteristic curve was ≥0.640. For LBP, LP, and disability, factors associated with a higher probability of improvement at 3 months were the following: not having undergone lumbar surgery, higher baseline scores for the corresponding variable, lower ones for the rest, and being treated with neuroreflexotherapy. Additional factors were the following: for LBP, shorter pain duration; for LP, not undergoing electromyography; and for disability, shorter pain duration, not being diagnosed with disc degeneration, and being treated with muscle relaxants and not opioids. A prospective registry can be used for developing predictive models to quantify the odds that a given LBP patient will experience a clinically relevant improvement. This may empower patients for an informed shared decision making. Copyright © 2012 Elsevier Inc. All rights reserved.

Prospective registry of symptomatic severe aortic stenosis in octogenarians: a need for intervention.

PubMed

Martínez-Sellés, M; Gómez Doblas, J J; Carro Hevia, A; García de la Villa, B; Ferreira-González, I; Alonso Tello, A; Andión Ogando, R; Ripoll Vera, T; Arribas Jiménez, A; Carrillo, P; Rodríguez Pascual, C; Casares i Romeva, M; Borras, X; Cornide, L; López-Palop, R

2014-06-01

To study the factors associated with choice of therapy and prognosis in octogenarians with severe symptomatic aortic stenosis (AS). Prospective, observational, multicenter registry. Centralized follow-up included survival status and, if possible, mode of death and Katz index. Transnational registry in Spain. We included 928 patients aged ≥80 years with severe symptomatic AS. Aortic-valve replacement (AVR), transcatheter aortic-valve implantation (TAVI) or conservative therapy. All-cause death. Mean age was 84.2 ± 3.5 years, and only 49.0% were independent (Katz index A). The most frequent planned management was conservative therapy in 423 (46%) patients, followed by TAVI in 261 (28%) and AVR in 244 (26%). The main reason against recommending AVR in 684 patients was high surgical risk [322 (47.1%)], other medical motives [193 (28.2%)], patient refusal [134 (19.6%)] and family refusal in the case of incompetent patients [35 (5.1%)]. The mean time from treatment decision to AVR was 4.8 ± 4.6 months and to TAVI 2.1 ± 3.2 months, P < 0.001. During follow-up (11.2-38.9 months), 357 patients (38.5%) died. Survival rates at 6, 12, 18 and 24 months were 81.8%, 72.6%, 64.1% and 57.3%, respectively. Planned intervention, adjusted for multiple propensity score, was associated with lower mortality when compared with planned conservative treatment: TAVI Hazard ratio (HR) 0.68 (95% confidence interval [CI] 0.49-0.93; P = 0.016) and AVR HR 0.56 (95% CI 0.39-0.8; P = 0.002). Octogenarians with symptomatic severe AS are frequently managed conservatively. Planned conservative management is associated with a poor prognosis. © 2013 The Association for the Publication of the Journal of Internal Medicine.

Cohort profile: LIFEWORK, a prospective cohort study on occupational and environmental risk factors and health in the Netherlands

PubMed Central

Peeters, Petra H; Korevaar, Joke C; Bueno-de-Mesquita, Bas; Verschuren, W M Monique; Verheij, Robert A; Pieterson, Inka; van Leeuwen, Flora E

2018-01-01

Purpose LIFEWORK is a large federated prospective cohort established in the Netherlands to quantify the health effects of occupational and environmental exposures. This cohort is also the Dutch contribution to the international Cohort Study of Mobile Phone Use and Health (COSMOS). In this paper, we describe the study design, ongoing data collection, baseline characteristics of participants and the repeatability of key questionnaire items. Participants 88 466 participants were enrolled in three cohort studies in 2011–2012. Exposure information was collected by a harmonised core questionnaire, or modelled based on occupational and residential histories; domains include air pollution (eg, nitrogen dioxide (NO2), particulate matter with diameter ≤2.5 µm (PM2.5)), noise, electromagnetic fields (EMF), mobile phone use, shift work and occupational chemical exposures. Chronic and subacute health outcomes are assessed by self-report and through linkage with health registries. Findings to date Participants had a median age of 51 years at baseline (range 19–87), and the majority are female (90%), with nurses being over-represented. Median exposure levels of NO2, PM2.5, EMF from base stations and noise at the participants’ home addresses at baseline were 22.9 µg/m3, 16.6 µg/m3, 0.003 mWm2 and 53.1 dB, respectively. Twenty-two per cent of participants reported to have started using a mobile phone more than 10 years prior to baseline. Repeatability for self-reported exposures was moderate to high (weighted kappa range: 0.69–1) for a subset of participants (n=237) who completed the questionnaire twice. Future plans We are actively and passively observing participants; we plan to administer a follow-up questionnaire every 4–5 years—the first follow-up will be completed in 2018—and linkage to cause-of-death and cancer registries occurs on a (bi)annual basis. This prospective cohort offers a unique, large and rich resource for research on contemporary occupational and environmental health risks and will contribute to the large international COSMOS study on mobile phone use and health. PMID:29431129

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.

The Dialysis Outcomes and Practice Patterns Study (DOPPS) in Turkey.

PubMed

Ecder, Tevfik; Utas, Cengiz; Ates, Kenan; Bieber, Brian; Robinson, Bruce M; Pisoni, Ronald L; Süleymanlar, Gültekin

2017-07-01

Turkey has one of the largest treated end-stage renal disease (ESRD) patient populations in Europe (N = 66,711). In 2013, the international Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective study of hemodialysis (HD) practices and outcomes, initiated data collection in Turkey. Here we provide comparisons of HD patients in DOPPS-Turkey with other international regions and with patients in the Registry of Turkish Nephrology, Dialysis and Transplantation. DOPPS-Turkey study sites were randomly selected from all Turkish HD units treating ≥25 in-center chronic HD patients. Detailed patient- and facility-level data were collected for 20-30 randomly selected prevalent HD patients per facility. Demographic and comorbidity profiles for DOPPS-Turkey patients were similar to HD patients overall in the 2013 Turkish Registry Report. In Turkey: diabetes was the most common ESRD cause (37%); arteriovenous fistula use was 83%; mean single pool Kt/V was 1.61. Compared with other international regions, Turkey had the highest mean hemoglobin (11.5 g/dL), ferritin (771 ng/mL), and interdialytic weight gain (3.28%), while Turkey had the lowest mean systolic blood pressure (127 mmHg) and erythropoiesis stimulating agent prescription (57%). Turkish patients also reported the highest depression scores. In this first DOPPS-Turkey report, the DOPPS sample agrees well with national Turkish Registry data. Treatment and laboratory data, and patient-reported outcomes, demonstrate similarities and previously unrecognized contrasts to DOPPS findings in Europe, Japan, and North America. Long-term follow-up of these patients will describe how these differences relate to clinical outcomes within Turkey. © 2016 International Society for Hemodialysis.

Comparisons of Patient Demographics in Prospective Sports, Shoulder, and National Database Initiatives.

PubMed

Saltzman, Bryan M; Cvetanovich, Gregory L; Bohl, Daniel D; Cole, Brian J; Bach, Bernard R; Romeo, Anthony A

2016-09-01

There has been increased emphasis in orthopaedics on high-quality prospective research to provide evidence-based treatment guidelines, particularly in sports medicine/shoulder surgery. The external validity of these studies has not been established, and the generalizability of the results to clinical practice in the United States is unknown. Comparison of patient demographics in major prospective studies of arthroscopic sports and shoulder surgeries to patients undergoing the same procedures in the National Surgical Quality Improvement Program (NSQIP) database will show substantial differences to question the generalizability and external validity of those studies. Cross-sectional study; Level of evidence, 3. This study utilized patients undergoing arthroscopic anterior cruciate ligament reconstruction (ACLR), meniscectomy (MX), rotator cuff repair (RCR), and shoulder stabilization (SS) from the NSQIP database (2005-2013). Two prospective studies (either randomized controlled trials or, in 1 case, a major cohort study) were identified for each of the 4 procedures for comparison. Demographic variables available for comparison in both the identified prospective studies and the NSQIP included age, sex, and body mass index (BMI). From the NSQIP database, 5576 ACLR patients, 18,882 MX patients, 7282 RCR patients, and 993 SS patients were identified. The comparison clinical studies included cohort sizes as follows: ACLR, n = 121 and 2683; MX, n = 146 and 330; RCR, n = 90 and 103; SS, n = 88 and 196. Age differed significantly between the NSQIP and the patients in 6 of the 8 prospective clinical studies. Sex differed significantly between the NSQIP and the patients in 7 of the 8 prospective clinical studies. BMI differed significantly between the NSQIP and the patients of all 4 of the prospective clinical studies that reported this demographic variable. Significant differences exist for patient age, sex, and BMI between patients included in major sports medicine/shoulder prospective studies and corresponding patients undergoing the same procedures in a nationwide database of academic and community centers in the United States. Future work is needed to understand whether major prospective clinical studies-frequently performed in high-volume, specialized practices-are truly indicative of the types of patients treated and expected results in the general orthopaedic practice. This study additionally argues for the importance of initiating a national registry dedicated to patients undergoing orthopaedic procedures in the United States.

The cost of institutional care in Alzheimer's disease: nursing home and hospital use in a prospective cohort.

PubMed

Welch, H G; Walsh, J S; Larson, E B

1992-03-01

To assess the nursing home and hospital use of patients with Alzheimer's Type Dementia. A prospective cohort study of 126 patients entered into an Alzheimer's disease registry after diagnosis at a university hospital clinic between 1980 and 1982. Only four patients were in nursing homes at enrollment. Data regarding nursing home use came from the registry and the individual nursing homes themselves. Hospital-use data were obtained using Medicare claims files. Follow-up was obtained on 123 patients (98%). Eighty-five (69%) had died by July 1, 1989. Three-quarters of the cohort (92) eventually resided in nursing homes. The median nursing home length of stay was 2.75 years (mean 2.95, 95% CI = 2.5, 3.4), over 10 times the national median length of stay for all diagnoses. Based on prevailing rates in the region, nursing home charges for the cohort were estimated to be between $4.3 and $6.4 million ($35,000-$52,000 per patient). During the 5-year period 1983-1988, 69 patients filed Part A (hospital) claims to Medicare for 76 admissions and 616 inpatient days. Part A Medicare reimbursement for the cohort totaled $460,000 over 5 years ($3,700 per patient), an expenditure comparable to what a random Medicare cohort might incur. The combination of a high rate of nursing home entry and lengthy stays makes long-term care the largest determinant of the cost of care in Alzheimer's disease. While Alzheimer's Type Dementia undoubtedly has profound indirect costs, this study demonstrates that the direct institutional costs alone are considerable.

CTRI – Clicking to greater transparency and accountability

PubMed Central

George, Bobby

2012-01-01

A clinical trial registry (CTR) is an official platform for registering a clinical trial (CT) with an objective of providing increased transparency and access to CTs to the public at large. Clinical Trials Registry - India (CTRI) is a free online public record system for registration of CTs being conducted in India. The vision of the CTRI is to ensure that every CT conducted in the region is prospectively registered with full disclosure of the trial data set items. With more number of CTs being conducted in the country, with a large number being global multicentre trials, it is binding on the industry/investigators/sponsor to comply with the requirements laid down. While there are pros and cons, there is enough scope for improvement of CTRI. PMID:23293758

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

PubMed Central

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

2008-01-01

Background The Paul Coverdell National Acute Stroke Registry (PCNASR) is a U.S. based national registry designed to monitor and improve the quality of acute stroke care delivered by hospitals. The registry monitors care through specific performance measures, the accuracy of which depends in part on the reliability of the individual data elements used to construct them. This study describes the inter-rater reliability of data elements collected in Michigan's state-based prototype of the PCNASR. Methods Over a 6-month period, 15 hospitals participating in the Michigan PCNASR prototype submitted data on 2566 acute stroke admissions. Trained hospital staff prospectively identified acute stroke admissions, abstracted chart information, and submitted data to the registry. At each hospital 8 randomly selected cases were re-abstracted by an experienced research nurse. Inter-rater reliability was estimated by the kappa statistic for nominal variables, and intraclass correlation coefficient (ICC) for ordinal and continuous variables. Factors that can negatively impact the kappa statistic (i.e., trait prevalence and rater bias) were also evaluated. Results A total of 104 charts were available for re-abstraction. Excellent reliability (kappa or ICC > 0.75) was observed for many registry variables including age, gender, black race, hemorrhagic stroke, discharge medications, and modified Rankin Score. Agreement was at least moderate (i.e., 0.75 > kappa ≥; 0.40) for ischemic stroke, TIA, white race, non-ambulance arrival, hospital transfer and direct admit. However, several variables had poor reliability (kappa < 0.40) including stroke onset time, stroke team consultation, time of initial brain imaging, and discharge destination. There were marked systematic differences between hospital abstractors and the audit abstractor (i.e., rater bias) for many of the data elements recorded in the emergency department. Conclusion The excellent reliability of many of the data elements supports the use of the PCNASR to monitor and improve care. However, the poor reliability for several variables, particularly time-related events in the emergency department, indicates the need for concerted efforts to improve the quality of data collection. Specific recommendations include improvements to data definitions, abstractor training, and the development of ED-based real-time data collection systems. PMID:18547421

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

PubMed Central

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

2016-01-01

Introduction Heart failure (HF) is a medical condition with a rapidly increasing incidence both in Taiwan and worldwide. The objective of the TSOC-HFrEF registry was to assess epidemiology, etiology, clinical management, and outcomes in a large sample of hospitalized patients presenting with acute decompensated systolic HF. Methods The TSOC-HFrEF registry was a prospective, multicenter, observational survey of patients presenting to 21 medical centers or teaching hospitals in Taiwan. Hospitalized patients with either acute new-onset HF or acute decompensation of chronic HFrEF were enrolled. Data including demographic characteristics, medical history, primary etiology of HF, precipitating factors for HF hospitalization, presenting symptoms and signs, diagnostic and treatment procedures, in-hospital mortality, length of stay, and discharge medications, were collected and analyzed. Results A total of 1509 patients were enrolled into the registry by the end of October 2014, with a mean age of 64 years (72% were male). Ischemic cardiomyopathy and dilated cardiomyopathy were diagnosed in 44% and 33% of patients, respectively. Coronary artery disease, hypertension, diabetes, and chronic renal insufficiency were the common comorbid conditions. Acute coronary syndrome, non-compliant to treatment, and concurrent infection were the major precipitating factors for acute decompensation. The median length of hospital stay was 8 days, and the in-hospital mortality rate was 2.4%. At discharge, 62% of patients were prescribed either angiotensin-converting enzyme-inhibitors or angiotensin receptor blockers, 60% were prescribed beta-blockers, and 49% were prescribed mineralocorticoid receptor antagonists. Conclusions The TSOC-HFrEF registry provided important insights into the current clinical characteristics and management of hospitalized decompensated systolic HF patients in Taiwan. One important observation was that adherence to guideline-directed medical therapy was suboptimal. PMID:27471353

French registry of workers handling engineered nanomaterials as an instrument of integrated system for surveillance and research

NASA Astrophysics Data System (ADS)

Guseva Canu, I.; Boutou-Kempf, O.; Delabre, L.; Ducamp, S.; Iwatsubo, Y.; Marchand, J. L.; Imbernon, E.

2013-04-01

Despite the lack of data on the human health potential risks related to the engineered nanomaterials (ENM) exposure, ENM handling spreads in industry. The French government officially charged the InVS to develop an epidemiological surveillance of workers occupationally exposed to ENM. An initial surveillance plan was proposed on the basis of literature review and discussions with national and international ENM and occupational safety and health (OSH) experts. In site investigations and technical visits were then carried out to build an adequate surveillance system and to assess its feasibility. The current plan consists of a multi-step methodology where exposure registry construction is paramount. Workers potentially exposed to carbon nanotubes (CNT) or nanometric titanium dioxide (TiO2) will be identified using a 3-level approach: 1-identification and selection of companies concerned with ENM exposure (based on compulsory declaration and questionnaires), 2-in site exposure assessment and identification of the jobs/tasks with ENM exposure (based on job-expose matrix, further supplemented with measurements), and 3-identification of workers concerned. Data of interest will be collected by questionnaire. Companies and workers inclusion questionnaires are designed and currently under validation. This registration is at the moment planned for three years but could be extended and include other ENM. A prospective cohort study will be established from this registry, to pursue surveillance objectives and serve as an infrastructure for performing epidemiological and panel studies with specific research objectives.

The Polish National Registry for Fetal Cardiac Pathology: organization, diagnoses, management, educational aspects and telemedicine endeavors.

PubMed

Slodki, Maciej; Szymkiewicz-Dangel, Joanna; Tobota, Zdzislaw; Seligman, Neil S; Weiner, Stuart; Respondek-Liberska, Maria

2012-05-01

We describe the National Registry for Fetal Cardiac Pathology, a program under the Polish Ministry of Health aimed at improving the prenatal diagnosis, care, and management of congenital heart disease (CHD). An online database was created to prospectively record diagnosis, prenatal care, delivery, follow-up, and still images and video for fetuses with CHD. A certification program in fetal cardiac ultrasound was also implemented. Optimal screening and referral centers were identified by number of fetuses entered in the Registry yearly by each center. From 2004 to 2009, 2910 fetuses with CHD were registered (2473 structural, 437 functional anomalies). The most common reasons for referral for fetal echocardiography were abnormal four-chamber view (56.0%) and extra-cardiac anomalies (8.2% ), while the most common diagnoses were atrioventricular septal defects (10.2%) and hypoplastic left heart syndrome (9.7%). Prenatal diagnosis increased yearly, from 10.0% of neonatal diagnoses in 2003 to 38.0% in 2008. From inception of the registry up to 2009 there has been a fourfold increase in the number of neonates referred for cardiac surgery in whom the condition was prenatally diagnosed. Equally important achievements include the establishment of a certification program for fetal echocardiography and the organization of prenatal and neonatal management. © 2012 John Wiley & Sons, Ltd.

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. PMID:24999409

Stenting of aortic coarctation: acute, intermediate, and long-term results of a prospective multi-institutional registry--Congenital Cardiovascular Interventional Study Consortium (CCISC).

PubMed

Holzer, Ralf; Qureshi, Shakeel; Ghasemi, Abdolrahim; Vincent, Julie; Sievert, Horst; Gruenstein, Daniel; Weber, Howard; Alday, Luis; Peirone, Alejandro; Zellers, Thomas; Cheatham, John; Slack, Michael; Rome, Jonathan

2010-10-01

Since the 1980s, stent implantation has evolved as an important therapeutic strategy for coarctation of the aorta. However, available data is frequently flawed by short follow-up, lack of adequate follow-up imaging, and retrospective nature of data collection. Data was prospectively collected using a multicenter registry congenital cardiovascular interventional study consortium (CCISC). Between 2000 and 2009, 302 patients from 34 centers with a median weight of 58 kg underwent stent implantation for coarctation. Eligible patients (44%) completed intermediate follow-up (3-18 months) with integrated imaging (cath, CT, MRI), whereas 21% completed long-term follow-up (>18-60 months). Procedural success was defined as UL/LL systolic gradient of less than 20 mm Hg, lack of significant recurrent obstruction, and freedom from unplanned repeat intervention. Acute procedural success was 96%. Cumulative intermediate success was 86%, and cumulative long-term success was 77%. Unplanned repeat interventions were required in 4%, and aortic wall complications were seen in 1% of patients (dissection n = 1 and aneurysm n = 3). Other adverse events (n = 15) occurred mainly acutely and included technical complications such as stent malposition (n = 9). At long-term follow-up, 23% of patients continued to have systolic blood pressure above the 95th centile, 9% had an upper-to-lower limb blood pressure gradient in excess of 20 mm Hg, and 32% were taking antihypertensive medication. This study documented acute, intermediate, and long-term outcome data comparable or superior with other surgical or interventional series. However, even with successful initial stent therapy, patients continue to require long-term follow-up and have associated long-term morbidity, relating to aortic wall complications, systemic hypertension, recurrent obstruction as well as need for repeat intervention. © 2010 Wiley-Liss, Inc.

A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions.

PubMed

Centeno, Christopher J; Al-Sayegh, Hasan; Freeman, Michael D; Smith, Jay; Murrell, William D; Bubnov, Rostyslav

2016-08-01

The purpose of the present investigation is to report on detailed complications among a much larger group of 2372 orthopaedic patients treated with stem cell injections who were followed in a treatment registry for up to nine years. All patients underwent an MSC-based, percutaneous injection treatment of an orthopaedic condition between December 2005 and September 2014 at one of 18 clinical facilities. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. The patients were followed prospectively via enrollment in a treatment registry. Patients were followed prospectively at one, three, six and 12 months, and annually thereafter, using an electronic system, ClinCapture software. A total of 3012 procedures were performed on 2372 patients with follow-up period of 2.2 years. A total of 325 adverse events were reported. The majority were pain post-procedure (n = 93, 3.9 % of the study population) and pain due to progressive degenerative joint disease (n = 90, 3.8 % of the study population). Seven cases reported neoplasms, a lower rate than in the general population. The lowest rate of adverse events was observed among patients injected with BMC alone. Lowest rate of adverse events was among those patients receiving BMC injections alone, but the higher rate of AEs for BMC plus adipose and cultured cells was readily explained by the nature of the therapy or the longer follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.

A nationwide structure for valid long-term oxygen therapy: 29-year prospective data in Sweden.

PubMed

Ekström, Magnus; Ahmadi, Zainab; Larsson, Hillevi; Nilsson, Tove; Wahlberg, Josefin; Ström, Kerstin E; Midgren, Bengt

2017-01-01

Long-term oxygen therapy (LTOT) improves prognosis in COPD with severe hypoxemia. However, adherence to criteria for eligibility and quality of LTOT is often insufficient and varies between countries. The aim of this study was to evaluate a national structure for prescription and management of LTOT over three decades in Sweden. The study was a prospective, population-based study of 23,909 patients on LTOT from 1987 to 2015 in the Swedish National Register of Respiratory Failure (Swedevox). We assessed the prevalence, incidence, and structure of LTOT; completeness of registration in Swedevox; and validity of prescription and management of LTOT in Sweden according to seven published quality indicators. LTOT was prescribed by 48 respiratory or medicine units and managed mainly by specialized oxygen nurses. Swedevox had a stable completeness of 85% of patients starting LTOT since 1987. The national incidence of LTOT increased from 3.9 to 14.7/100,000 inhabitants over the time period. In 2015, 2,596 patients had ongoing therapeutic LTOT in the registry, a national prevalence of 31.6/100,000. Adherence to prescription recommendations and fulfillment of quality criteria was stable or improved over time. Of patients starting LTOT in 2015, 88% had severe hypoxemia (partial pressure of arterial oxygen [PaO 2 ] <7.4 kPa) and 97% had any degree of hypoxemia (PaO 2 <8.0 kPa); 98% were prescribed oxygen ≥15 hours/day or more; 76% had both stationary and mobile oxygen equipment; 75% had a mean PaO 2 >8.0 kPa breathing oxygen; and 98% were non-smokers. We present a structure for prescription, management, and follow-up of LTOT. The national registry effectively monitored adherence to prescription recommendations and most likely contributed to improved quality of care.

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.

2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study.

PubMed

Gyöngyösi, Mariann; Christ, Günter; Lang, Irene; Kreiner, Gerhard; Sochor, Heinz; Probst, Peter; Neunteufl, Thomas; Badr-Eslam, Rosa; Winkler, Susanne; Nyolczas, Noemi; Posa, Aniko; Leisch, Franz; Karnik, Ronald; Siostrzonek, Peter; Harb, Stefan; Heigert, Matthias; Zenker, Gerald; Benzer, Werner; Bonner, Gerhard; Kaider, Alexandra; Glogar, Dietmar

2009-08-01

The multicenter AUTAX (Austrian Multivessel TAXUS-Stent) registry investigated the 2-year clinical/angiographic outcomes of patients with multivessel coronary artery disease after implantation of TAXUS Express stents (Boston Scientific, Natick, Massachusetts), in a "real-world" setting. The AUTAX registry included patients with 2- or 3-vessel disease, with/without previous percutaneous coronary intervention (PCI) and concomitant surgery. Patients (n = 441, 64 +/- 12 years, 78% men) (n = 1,080 lesions) with possible complete revascularization by PCI were prospectively included. Median clinical follow-up was 753 (quartiles 728 to 775) days after PCI in 95.7%, with control angiography of 78% at 6 months. The primary end point was the composite of major adverse cardiac (nonfatal acute myocardial infarction [AMI], all-cause mortality, target lesion revascularization [TLR]) and cerebrovascular events (MACCE). Potential risk factor effects on 2-year MACCE were evaluated using Cox regression. Complete revascularization was successful in 90.5%, with left main PCI of 6.8%. Rates of acute, subacute, and late stent thrombosis were 0.7%, 0.5%, and 0.5%. Two-year follow-up identified AMI (1.4%), death (3.6%), stroke (0.2%), and TLR (13.1%), for a composite MACCE of 18.3%. The binary restenosis rate was 10.8%. The median of cumulative SYNTAX score was 23.0 (range 12.0 to 56.5). The SYNTAX score did not predict TLR or MACCE, due to lack of scoring of restenotic or bypass stenoses (29.8%). Age (hazard ratio [HR]: 1.03, p = 0.019) and acute coronary syndrome (HR: 2.1, p = 0.001) were significant predictors of 2-year MACCE. Incomplete revascularization predicted death or AMI (HR: 3.84, p = 0.002). With the aim of complete revascularization, TAXUS stent implantations can be safe for patients with multivessel disease. The AUTAX registry including patients with post-PCI lesions provides additional information to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) study. (Austrian Multivessel TAXUS-Stent Registry; NCT00738686).

Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

PubMed

Chen, Jinghan Jenny; Chan, Parco; Paes, Bosco; Mitchell, Ian; Li, Abby; Lanctôt, Krista L

2015-01-01

To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice. High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by Chi-square or Fisher Exact Tests to examine group differences in proportions. 13025 infants received 57392 injections. Hospitalizations for respiratory-related illness (RIH) were reported in 915 patients, and SAEs other than RIH were reported in 52 patients. Of these, 6 (0.05%) patients had a total of 14 hypersensitivity reactions that were deemed possibly or probably related to palivizumab (incidence: 2.8 per 10,000 patient-months). The SAEs of 42 patients were assessed as not related to palivizumab. SAEs in the remaining 4 patients were not classifiable as their records were incomplete. There were no significant demographic predictors of SAE occurrence. Under active surveillance, a small proportion of infants in the CARESS registry experienced SAEs that had a potential relationship with palivizumab and these appeared to be unpredictable in terms of onset. Palivizumab appears to be a safe and well-tolerated antibody for RSV prophylaxis in high-risk children in routine practice.

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

PubMed

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

2015-12-09

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

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT).

PubMed

Bramlage, Peter; Strauch, Justus; Schröfel, Holger

2014-11-18

In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required. Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning. Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis. ClinicalTrials.gov Identifier: NCT02127580.

Rural-Urban Disparity in Emergency Care for Acute Myocardial Infarction in Japan.

PubMed

Masuda, Jun; Kishi, Mikio; Kumagai, Naoto; Yamazaki, Toru; Sakata, Kenji; Higuma, Takumi; Ogimoto, Akiyoshi; Dohi, Kaoru; Tanigawa, Takashi; Hanada, Hiroyuki; Nakamura, Mashio; Sokejima, Shigeru; Takayama, Morimasa; Higaki, Jitsuo; Yamagishi, Masakazu; Okumura, Ken; Ito, Masaaki

2018-05-25

There are few reports examining regional differences between rural prefectures and metropolitan areas in the management of acute myocardial infarction (AMI) in Japan.Methods and Results:In the Rural AMI registry, a prospective, multi-prefectural registry of AMI in 4 rural prefectures (Ishikawa, Aomori, Ehime and Mie), a total of 1,695 consecutive AMI patients were registered in 2013. Among them, 1,313 patients who underwent primary percutaneous coronary intervention (PPCI) within 24 h of onset were enrolled in this study (Rural group), and compared with the cohort data from the Tokyo CCU Network registry for AMI in the same period (Metropolitan group, 2,075 patients). The prevalence of direct ambulance transport to PCI-capable facilities in the Rural group was significantly lower than that in the Metropolitan group (43.8% vs. 60.3%, P<0.01), which resulted in a longer onset-to-balloon time (OTB: 225 vs. 210 min, P=0.02) and lower prevalence of PPCI in a timely fashion (OTB ≤2 h: 11.5% vs. 20.7%, P<0.01) in the Rural group. Multivariate analysis revealed that direct ambulance transport was the strongest predictor for PPCI in a timely fashion (odds ratio=4.13, P<0.001). AMI patients in rural areas were less likely to be transported directly to PCI-capable facilities, resulting in time delay to PPCI compared with those in metropolitan areas.

Cardiovascular ischemic event rates in outpatients with symptomatic atherothrombosis or risk factors in the united states: insights from the REACH Registry.

PubMed

Eagle, Kim A; Hirsch, Alan T; Califf, Robert M; Alberts, Mark J; Steg, P Gabriel; Cannon, Christopher P; Brennan, Danielle M; Bhatt, Deepak L

2009-06-01

Atherothrombosis, defined as coronary artery, cerebrovascular, and peripheral arterial disease, is the leading cause of death in the United States. Limited data are available from outpatient populations to describe contemporary cardiovascular ischemic event rates and associated use of risk reduction treatments in patients with clinically manifest, or at risk for, atherothrombosis. The REduction of Atherothrombosis for Continued Health (REACH) Registry is an international, prospective, observational study of patients with either documented atherothrombotic syndromes or 3 or more risk factors designed to fill this knowledge gap. Baseline demographics and 1-year outcomes were evaluated for US patients enrolled in the REACH Registry. Multivariate analytic models were constructed using baseline characteristics to determine independent predictors of 1-year event rates. In the United States, 25,686 patients were enrolled into the registry. Among symptomatic patients (n = 19,069), 19% had disease in >or=1 arterial bed. As of July 2006, 1-year outcomes were available for 93.4% (n = 23,985) of patients. The composite cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke event rate was 4.3% for the overall population and highest in patients with triple bed disease (9.9%). There was a relatively high use of risk reduction medications among symptomatic patients. However, opportunity for improvement remains. Approximately 9% of symptomatic patients were not using any antithrombotic, 7% were not using any antihypertensive agents, and 17% were not taking a lipid-lowering agent, whereas >80% of patients suffered from hypertension or dyslipidemia. US patients with established atherothrombotic disease continue to experience high cardiovascular ischemic event rates; these rates increase in close association with polyvascular disease. Despite the use of risk reduction interventions, ideal secondary prevention of ischemic events has not been achieved.

Changing demographics, epidemiology, and survival of incident pulmonary arterial hypertension: results from the pulmonary hypertension registry of the United Kingdom and Ireland.

PubMed

Ling, Yi; Johnson, Martin K; Kiely, David G; Condliffe, Robin; Elliot, Charlie A; Gibbs, J Simon R; Howard, Luke S; Pepke-Zaba, Joanna; Sheares, Karen K K; Corris, Paul A; Fisher, Andrew J; Lordan, James L; Gaine, Sean; Coghlan, J Gerry; Wort, S John; Gatzoulis, Michael A; Peacock, Andrew J

2012-10-15

Incident pulmonary arterial hypertension was underrepresented in most pulmonary hypertension registries and may have a different disease profile to prevalent disease. To determine the characteristics and outcome of a purely incident, treatment-naive cohort of idiopathic, heritable, and anorexigen-associated pulmonary arterial hypertension and to determine the changes in presentations and survival over the past decade in the United Kingdom and Ireland. All consecutive newly diagnosed patients from 2001 to 2009 were identified prospectively. A total of 482 patients (93% idiopathic, 5% heritable, and 2% anorexigen-associated pulmonary arterial hypertension) were diagnosed, giving rise to an estimated incidence of 1.1 cases per million per year and prevalence of 6.6 cases per million in 2009. Younger patients (age ≤ 50 yrs) had shorter duration of symptoms, fewer comorbidities, better functional and exercise capacity, higher percent diffusing capacity of carbon monoxide, more severe hemodynamic impairment, but better survival compared with older patients. In comparison with the earlier cohorts, patients diagnosed in 2007-2009 were older, more obese, had lower percent diffusing capacity of carbon monoxide,(,) and more comorbidities, but better survival. Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL) equation, REVEAL risk score, and Pulmonary Hypertension Connection Registry survival equation accurately predicted survival of our incident cohort at 1 year. This study highlights the influence of age on phenotypes of incident pulmonary arterial hypertension and has shown the changes in demographics and epidemiology over the past decade in a national setting. The results suggest that there may be two subtypes of patients: the younger subtype with more severe hemodynamic impairment but better survival, compared with the older subtype who has more comorbidities.

Chinese SLE Treatment and Research group (CSTAR) registry: II. Prevalence and risk factors of pulmonary arterial hypertension in Chinese patients with systemic lupus erythematosus.

PubMed

Li, M; Wang, Q; Zhao, J; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Tian, Z; Liu, Y; He, J; Zhang, F; Zhao, Y; Zeng, X

2014-09-01

To estimate the prevalence of pulmonary arterial hypertension (PAH) and risk factors for PAH in patients registered in the Chinese SLE Treatment and Research group (CSTAR) database, the first online registry of Chinese patients with systemic lupus erythematosus (SLE). A prospective cross-sectional study of patients with SLE was conducted using the CSTAR registry. Resting transthoracic echocardiography was used to estimate pulmonary artery pressure (PAP); PAH was defined as systolic PAP (PASP)≥40 mmHg. Patients with interstitial lung disease, valvular disease or cardiomyopathy were excluded because of disease influence on PAP. We explored potential risk factors for PAH including patient characteristics, organ involvement, laboratory findings and SLE disease activity. Of 1934 patients with SLE, 74 had PASP with 54.2±17.1 (40,106) mmHg and were diagnosed with probable PAH. The incidences of lupus nephritis, pleuritis, pericarditis, hypocomplementemia, anti-SSA, and anti-ribonucleoprotein (RNP) were significantly higher in patients with PAH than in those without (p<0.05). SLE disease activity was significantly higher in patients with PAH than in unaffected patients (p<0.05). Multivariate analysis indicated that pericarditis (odds ratio (OR)=4.248), pleuritis (OR=3.061) and anti-RNP (OR=2.559) were independent risk factors for PAH in patients with SLE (p<0.05). The possible prevalence of PAH was 3.8% in Chinese patients with SLE in the CSTAR registry. The significant association of pericarditis, pleuritis and anti-RNP positivity with PAH suggests that higher disease activity and vasculopathy may both contribute to the development of PAH in SLE, which need be treated aggressively to improve prognosis. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry.

PubMed

Stemmer, Salomon M; Steiner, Mariana; Rizel, Shulamith; Soussan-Gutman, Lior; Ben-Baruch, Noa; Bareket-Samish, Avital; Geffen, David B; Nisenbaum, Bella; Isaacs, Kevin; Fried, Georgeta; Rosengarten, Ora; Uziely, Beatrice; Svedman, Christer; McCullough, Debbie; Maddala, Tara; Klang, Shmuel H; Zidan, Jamal; Ryvo, Larisa; Kaufman, Bella; Evron, Ella; Karminsky, Natalya; Goldberg, Hadassah; Shak, Steven; Liebermann, Nicky

2017-01-01

The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RS-testing through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18-30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan-Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18-30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan-Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 ( n  = 304) and 11-25 ( n  = 1037) (TAILORx categorizatio n ) had 5-year Kaplan-Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan-Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11-25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

Objectives and methodology of BIOBADASER phase iii.

PubMed

Sanchez-Piedra, Carlos; Hernández Miguel, M Victoria; Manero, Javier; Roselló, Rosa; Sánchez-Costa, Jesús Tomás; Rodríguez-Lozano, Carlos; Campos, Cristina; Cuende, Eduardo; Fernández-Lopez, Jesús Carlos; Bustabad, Sagrario; Martín Domenech, Raquel; Pérez-Pampín, Eva; Del Pino-Montes, Javier; Millan-Arcineas, Ana Milena; Díaz-González, Federico; Gómez-Reino, Juan Jesús

2017-09-18

Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Febrile urinary tract infection after pediatric kidney transplantation: a multicenter, prospective observational study.

PubMed

Weigel, Friederike; Lemke, Anja; Tönshoff, Burkhard; Pape, Lars; Fehrenbach, Henry; Henn, Michael; Hoppe, Bernd; Jungraithmayr, Therese; Konrad, Martin; Laube, Guido; Pohl, Martin; Seeman, Tomáš; Staude, Hagen; Kemper, Markus J; John, Ulrike

2016-06-01

Febrile urinary tract infections (fUTIs) are common after kidney transplantation (KTx); however, prospective data in a multicenter pediatric cohort are lacking. We designed a prospective registry to record data on fUTI before and after pediatric KTx. Ninety-eight children (58 boys and 40 girls) ≤ 18 years from 14 mid-European centers received a kidney transplant and completed a 2-year follow-up. Posttransplant, 38.7% of patients had at least one fUTI compared with 21.4% before KTx (p = 0.002). Before KTx, fUTI was more frequent in patients with congenital anomalies of kidneys and urinary tract (CAKUT) vs. patients without (38% vs. 12%; p = 0.005). After KTx, fUTI were equally frequent in both groups (48.7% vs. 32.2%; p = 0.14). First fUTI posttransplant occurred earlier in boys compared with girls: median range 4 vs. 13.5 years (p = 0.002). Graft function worsened (p < 0.001) during fUTI, but no difference was recorded after 2 years. At least one recurrence of fUTI was encountered in 58%. This prospective study confirms a high incidence of fUTI after pediatric KTx, which is not restricted to patients with CAKUT; fUTIs have a negative impact on graft function during the infectious episode but not on 2-year graft outcome.

Is the use of minimally invasive fusion technologies associated with improved outcomes after elective interbody lumbar fusion? Analysis of a nationwide prospective patient-reported outcomes registry.

PubMed

McGirt, Matthew J; Parker, Scott L; Mummaneni, Praveen; Knightly, John; Pfortmiller, Deborah; Foley, Kevin; Asher, Anthony L

2017-07-01

Over the last decade, clinical investigators and biomedical industry groups have used significant resources to develop advanced technologies that enable less invasive spine fusions. These minimally invasive surgery (MIS) technologies often require increased expenditures by hospitals and payers. Although several small single center studies have suggested MIS technologies decrease surgical morbidity and reduce hospital stay, evidence documenting benefit from a patient perspective remains limited. Furthermore, MIS outcomes have yet to be evaluated from the perspective of multiple practice types representing the broad spectrum of US spine surgery. This study aimed to examine a population of patients who underwent one- or two-level interbody lumbar fusion diagnosed with lumbar stenosis or Grade 1 spondylolisthesis in an observational, prospective national registry for the purposes of determining how MIS and traditional open technologies affect postsurgical and patient-reported outcomes (PROs). This study used observational analysis of prospectively collected data. The sample consisted of cases from the National Neurosurgery Quality and Outcomes Database (N 2 QOD). Numeric rating scale for back and leg pain, Oswestry Disability Index, EuroQol-5D, return to work, and perioperative morbidity were the outcome measures. The N 2 QOD is a prospective PROs registry enrolling patients undergoing elective spine surgery from 60 hospitals in 27 US states via representative sampling. We analyzed the N 2 QOD aggregate dataset (2010-2014) to identify one- and two-level lumbar interbody fusion procedures performed for lumbar stenosis or Grade 1 spondylolisthesis with 12 months' follow-up where surgical instrumentation and implant types were clearly identified. Perioperative and 1-year outcomes were compared between cases performed with MIS enabling technologies versus traditional open technologies before and after propensity matching. There were 467 (24%) patients who underwent elective interbody lumbar fusion using MIS enabling technologies whereas 1,480 (76%) underwent the procedure using traditional open technologies. The MIS patients were slightly healthier (American Society of Anesthesiologists grade), had private insurance more frequently, and underwent two-level fusion less frequently. Unmatched, the MIS cohort was associated with reduced blood loss, a 0.7-day reduction in mean length of hospital stay, and 5% reduced need for post-discharge inpatient rehabilitation, but equivalent 90-day safety measures. After propensity matching, the MIS cohort remained associated with reduced blood loss and a shorter length of stay for one-level fusion (p<.05) but had equivalent length of stay for two-level fusion. Outcomes in all other 90-day safety measures were similar. In both unadjusted and propensity-matched comparison, MIS versus open technologies were associated with equivalent return to work, patient-reported pain, physical disability, and quality of life at 3 and 12 months' follow-up. In a representative sampling registry of elective interbody lumbar spine fusion procedures spanning 27 US states, nearly a quarter of procedures performed from 2010 to 2014 used minimally invasive enabling technologies. Regardless of approach, interbody lumbar fusion was associated with significant and sustained improvements in all measured health domains. When used in everyday care by a wide spectrum of spine surgeons in non-research settings, the use of MIS technologies was associated with reduced intraoperative blood loss but only a half-day reduction in mean length of hospital stay for one-level fusions. Minimally invasive surgery was not associated with any improved perioperative safety measures or 12-month outcomes. Although MIS enabling technologies may increase some in-hospital care efficiencies, MIS clinical outcomes are similar to open surgery for patients undergoing one- and two-level interbody lumbar fusions. Copyright © 2017 Elsevier Inc. All rights reserved.

Quality of outcome data in knee arthroplasty

PubMed Central

Pabinger, Christof; Lumenta, David Benjamin; Cupak, Daniel; Berghold, Andrea; Boehler, Nikolaus; Labek, Gerold

2015-01-01

Background and purpose Recent reports on developer bias in unicondylar knee arthroplasty led to concerns about quality of publications regarding knee implants. We therefore compared revision rates of registry and non-registry studies from the beginning of knee arthroplasty up to the present. We assessed the time interval between market introduction of an implant and emergence of reliable data in non-registry studies. Material and methods We systematically reviewed registry studies (n = 6) and non-registry studies (n = 241) on knee arthroplasty published in indexed, peer-reviewed international scientific journals. The main outcome measure was revision rate per 100 observed component years. Results and interpretation For 82% of the 34 knee implants assessed, revision data from non-registry studies are either absent or poor. 91% of all studies were published in the second and third decade after market introduction. Only 5% of all studies and 1% of all revisions were published in the first decade. The first publications on revision rates of total knee arthroplasty (TKA) started 6 years after market introduction, and reliable data were found from year 12 onward in non-registry studies. However, in unicondylar knee arthroplasty (UKA) the first publications on revision rates could be found first 13 years after market introduction. Revision rates of TKA from non-registry studies were reliable after year 12 following market introduction. UKA revision rates remained below the threshold of registry indices, and failed to demonstrate adjustment towards registries. Thus, the superiority of registry data over non-registry data regarding outcome measurement was validated. PMID:25191934

Endocarditis in patients with ascending aortic prosthetic graft: a case series from a national multicentre registry.

PubMed

Ramos, Antonio; García-Montero, Carlos; Moreno, Alfonso; Muñoz, Patricia; Ruiz-Morales, Josefa; Sánchez-Espín, Gemma; Porras, Carlos; Sousa, Dolores; Castelo, Laura; Del Carmen Fariñas, María; Gutiérrez, Francisco; Reguera, José María; Plata, Antonio; Bouza, Emilio; Antorrena, Isabel; de Alarcón, Arístides; Pericás, José Manuel; Gurguí, Mercedes; Rodríguez-Abella, Hugo; Ángel Goenaga, Miguel; Antonio Oteo, José; García-Pavía, Pablo

2016-12-01

Endocarditis in patients with ascending aortic prosthetic graft (AAPG) is a life-threatening complication. The purpose of this study was to examine the clinical presentation and prognosis of patients with AAPG endocarditis included in a large prospective infectious endocarditis multicentre study. From January 2008 to April 2015, 3200 consecutive patients with infectious endocarditis according to the modified Duke criteria, were prospectively included in the 'Spanish Collaboration on Endocarditis Registry (GAMES)' registry. Twenty-seven definite episodes of endocarditis (0.8%) occurred in patients with AAPG. During the study period, 27 cases of endocarditis were detected in patients with AAPG. The median age of patients was 61 years [interquartile range (IQR) 51-68 years] and 23 (85.2%) patients were male. The median time from AAPG surgery to the episode of AAPG infection was 24 months (IQR 6-108 months). The most frequently isolated micro-organisms were coagulase-negative staphylococci and S. aureus (11 patients, 40.7%). Four patients (14.8%) underwent medical treatment, whereas surgery was performed in 21 (77.7%). Two patients (7.4%) died before surgery could be performed. The median hospital stay prior to surgery was 7 days (IQR 4-21 days). Surgery consisted of replacing previous grafts with a composite aortic graft (10 cases) or aortic homograft (2 patients), and removal of a large vegetation attached to the valve of a composite tube (1 case). Nine patients had an infected aortic valve prosthesis without evidence of involvement of the AAPG. Isolated redo-aortic valve replacement was performed in 8 (88.9%) of these patients. Reinfection occurring during 1 year of follow-up was not detected in any patient. Two patients (7.4%) died while awaiting surgery and 6 did so after surgery (22.2%). A New York Heart Association (NYHA) Class IV was associated with mortality in patients undergoing surgery (P < 0.019). Most cases of endocarditis in patients with AAPG occur late after initial surgery. Mortality rate of patients with AAPG endocarditis who undergo surgery is acceptable. NYHA Class IV before surgery is associated with an increased postoperative mortality. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

PubMed

Starling, Randall C; Naka, Yoshifumi; Boyle, Andrew J; Gonzalez-Stawinski, Gonzalo; John, Ranjit; Jorde, Ulrich; Russell, Stuart D; Conte, John V; Aaronson, Keith D; McGee, Edwin C; Cotts, William G; DeNofrio, David; Pham, Duc Thinh; Farrar, David J; Pagani, Francis D

2011-05-10

The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

Ward, John F; Jones, J Stephen

2012-06-01

Study Type - Therapy (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Selective destruction of targeted prostate tissue is now technically feasible. Much has been theorized but little is known about the proper patient selection or treatment outcomes to determine if this organ preserving approach to prostate cancer has merit for further study and diffusion into wider practice. Herein we present the largest retrospective registry report of men treated with sub-total prostate cryotherapy in order to begin to understand how this treatment is being applied despite the paucity of data. •  To identify recent trends in focal cryotherapy from a prospectively maintained treatment registry. •  To describe treatment outcomes after uncontrolled application of focally ablative techniques within community practice. •  We conducted an analysis of the COLD Registry to identify patients treated with partial gland prostate cryoablation between 1997 and 2007. •  Preoperative characteristics and postoperative cancer-specific and functional outcomes were assembled for analysis. •  The COLD Registry contained information for 5853 patients and focal cryotherapy was the codified procedure in 1160 patients (19.8%). •  A dramatic increase in focal treatments was observed, from 46 in 1999 to 567 in 2005 (P < 0.01). •  The biochemical recurrence-free rate (ASTRO definition) at 36 months was 75.7%. •  Prostate biopsy, performed in 164/1160 of patients (14.1%), was positive in 43 (26.3%) of those suspected of cancer recurrence, but in only 3.7% (43/1160) of treated patients. •  Urinary continence (defined as use of 0 pads) was 98.4%. Maintenance of spontaneous erections was 58.1%. Prolonged urinary retention (>30 days) occurred in six (1.1%) patients. Rectourethral fistula was observed in one (0.1%) patient. •  Focal cryoablation is increasingly used for selected patients with prostate cancer. •  Oncological efficacy in the present series appears similar to that of whole-gland cryoablation. •  The impact of focal cryoablation on urinary, sexual and bowel function appears to be less than that of radical therapies, although preservation of sexual function is not as high as might be expected. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry.

PubMed

Oldgren, Jonas; Healey, Jeff S; Ezekowitz, Michael; Commerford, Patrick; Avezum, Alvaro; Pais, Prem; Zhu, Jun; Jansky, Petr; Sigamani, Alben; Morillo, Carlos A; Liu, Lisheng; Damasceno, Albertino; Grinvalds, Alex; Nakamya, Juliet; Reilly, Paul A; Keltai, Katalin; Van Gelder, Isabelle C; Yusufali, Afzal Hussein; Watanabe, Eiichi; Wallentin, Lars; Connolly, Stuart J; Yusuf, Salim

2014-04-15

Atrial fibrillation (AF) is the most common sustained arrhythmia; however, little is known about patients in a primary care setting from high-, middle-, and low-income countries. This prospective registry enrolled patients presenting to an emergency department with AF at 164 sites in 46 countries representing all inhabited continents. Patient characteristics were compared among 9 major geographic regions. Between September 2008 and April 2011, 15,400 patients were enrolled. The average age was 65.9, standard deviation 14.8 years, ranging from 57.2, standard deviation 18.8 years in Africa, to 70.1, standard deviation 13.4 years in North America, P<0.001. Hypertension was globally the most common risk factor for AF, ranging in prevalence from 41.6% in India to 80.7% in Eastern Europe, P<0.001. Rheumatic heart disease was present in only 2.2% of North American patients, in comparison with 21.5% in Africa and 31.5% in India, P<0.001. The use of oral anticoagulation among patients with a CHADS2 score of ≥2 was greatest in North America (65.7%) but was only 11.2% in China, P<0.001. The mean time in the therapeutic range was 62.4% in Western Europe, 50.9% in North America, but only between 32% and 40% in India, China, Southeast Asia, and Africa, P<0.001. There is a large global variation in age, risk factors, concomitant diseases, and treatment of AF among regions. Improving outcomes globally requires an understanding of this variation and the conduct of research focused on AF associated with different underlying conditions and treatment of AF and predisposing conditions in different socioeconomic settings.

Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119).

PubMed

Tittl, L; Endig, S; Marten, S; Reitter, A; Beyer-Westendorf, I; Beyer-Westendorf, J

2018-07-01

Direct acting non-Vitamin K antagonist oral anticoagulants (NOAC) are characterized by a fixed dosing regimen. Despite the potential for relative underdosing due to large distribution volumes, dose adjustments for patients with high body mass index (BMI) are not recommended. Since efficacy and safety data in obese patients are scarce, we evaluated the impact of BMI on clinical outcomes in daily care patients treated with NOAC for stroke prevention in atrial fibrillation or venous thromboembolism. Using prospectively collected data from a non-interventional registry, cardiovascular (CV), major bleeding events (MB) and all-cause mortality were evaluated according to BMI classes. All outcome events were centrally adjudicated using standard scientific definitions. Between November 1st 2011 and December 31st 2016, 3432 patients were enrolled into the registry (61.3% rivaroxaban; 20% apixaban; 10.1% dabigatran, 8.6% edoxaban; mean follow-up 998.1 ± 542.9 days; median 1004 days). With increasing BMI (range 13.7-57.2 kg/m 2 ), the proportion of patients receiving standard (vs. reduced) NOAC dose increased from 64.7% (underweight) to 78.9% (obesity). Although obese patients had more cardiovascular risk factors compared to normal weight patients, on-treatment rates of clinical outcomes (CV, MB, all-cause-mortality) were lowest in overweight and obese patients. In a large set of real-life NOAC recipients we found no indication that high BMI is associated with inferior NOAC effectiveness or safety, which is in line with recent epidemiological data of a "BMI paradox" that indicates a somewhat protective effect of higher BMI regarding unfavourable outcomes also in patients receiving fixed dose NOAC anticoagulation without dose adjustment for higher BMI. Copyright © 2018 Elsevier B.V. All rights reserved.

The German Lipoprotein Apheresis Registry (GLAR) - almost 5 years on.

PubMed

Schettler, V J J; Neumann, C L; Peter, C; Zimmermann, T; Julius, U; Roeseler, E; Heigl, F; Grützmacher, P; Blume, H; Vogt, A

2017-03-01

Since 2005 an interdisciplinary German apheresis working group has been established by members of both German Societies of Nephrology and of Lipidologists and completed the data set for the registry according to the current guidelines and the German indication guideline for apheresis in 2009. In 2011 the German Lipoprotein Apheresis Registry (GLAR) was launched and data are available over nearly 5 years now. During the time period 2012-2016, 71 German apheresis centers collected retrospective and prospective observational data of 1435 patients undergoing lipoprotein apheresis (LA) treatment of high LDL-C levels and/or high Lp (a) levels suffering from cardiovascular disease (CVD) or progressive CVD. A total of 15,527 completely documented LA treatments were entered into the database. All patients treated by LA showed a median LDL-C reduction rate of 67.5%, and a median Lp (a) reduction rate of 71.1%. Analog to the Pro(a)LiFe pattern, patient data were analyzed to the incidence rate of coronary events (MACE) 1 and 2 years before the beginning of LA treatment (y-2 and y‑1) and prospectively two years on LA treatment (y + 1 and y + 2). During two years of LA treatment a MACE reduction of 78% was observed. In the years considered, side effects of LA treatment were low (5.9%) and mainly comprised puncture problems. The data generated by the GLAR shows that LA lowers the incidence rate of cardiovascular events in patients with high LDL-C and/or high Lp (a) levels, progressive CVD, and maximally tolerated lipid lowering medication. In addition, LA treatments were found to be safe with a low rate of side effects.

Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry.

PubMed

Ohlow, Marc-Alexander; von Korn, Hubertus; Gunkel, Oliver; Farah, Ahmed; Fuhrmann, Joerg T; Lauer, Bernward

2014-12-01

Drug-eluting stents (DES) constitute a major achievement in preventing re-stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer-free sirolimus-eluting stent system YUKON-Choice (Yukon-DES, Translumina, Germany). From 01/2006-09/2008 all patients receiving Yukon-DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long-term major adverse cardiac events (MACE). 701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6-months angiographic follow-up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between "on-label" and "off-label" indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%. Our data suggests that the implantation of the sirolimus-coated polymer-free YUKON-DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels. © 2013 Wiley Periodicals, Inc.

Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry.

PubMed

Walther, Thomas; Hamm, Christian W; Schuler, Gerhard; Berkowitsch, Alexander; Kötting, Joachim; Mangner, Norman; Mudra, Harald; Beckmann, Andreas; Cremer, Jochen; Welz, Armin; Lange, Rüdiger; Kuck, Karl-Heinz; Mohr, Friedrich W; Möllmann, Helge

2015-05-26

Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The adverse association of diabetes with risk of first acute myocardial infarction is modified by physical activity and body mass index: prospective data from the HUNT Study, Norway.

PubMed

Moe, Børge; Augestad, Liv B; Flanders, W Dana; Dalen, Håvard; Nilsen, Tom I L

2015-01-01

Diabetes increases the risk of acute myocardial infarction (AMI) and effective means for primary prevention are warranted. We prospectively examined the joint association of diabetes and leisure-time physical activity, as well as of diabetes and BMI, with the risk of AMI. A total of 55,534 men and women in the Norwegian HUNT Study were followed-up for first AMI by hospital admission registries and the Cause of Death Registry. Cox proportional adjusted HRs with 95% CIs were estimated. Overall, 1,887 incident AMIs occurred during 12.3 years. Compared with inactive people without diabetes, inactive people with diabetes had an HR of 2.37 (95% CI 1.58, 3.57), whereas the HR among highly active persons with diabetes was 1.04 (95% CI 0.62, 1.74). Normal-weight (BMI 18.5-25 kg/m(2)) persons with diabetes had an HR of 1.60 (95% CI 1.05, 2.44) and obese (BMI > 30 kg/m(2)) persons with diabetes had an HR of 2.55 (95% CI 1.97, 3.29) compared with normal-weight persons without diabetes. The data suggest biological interaction between diabetes and physical activity, with a relative excess risk of inactivity and diabetes of 1.43 (95% CI 0.08, 2.78). For obesity and diabetes, the excess risk due to interaction was smaller (0.67; 95% CI -0.24, 1.58). Body weight and, in particular, physical activity modified the association between diabetes and risk of first AMI. This highlights the potential importance of physical activity and weight maintenance in primary prevention of AMI among people with diabetes.

Mode of childbirth and neonatal outcome after external cephalic version: A prospective cohort study.

PubMed

Rosman, A N; Vlemmix, F; Ensing, S; Opmeer, B C; Te Hoven, S; Velzel, J; de Hundt, M; van den Berg, S; Rota, H; van der Post, J A M; Mol, B W J; Kok, M

2016-08-01

to assess the mode of childbirth and adverse neonatal outcomes in women with a breech presentation with or without an external cephalic version attempt, and to compare the mode of childbirth among women with successful ECV to women with a spontaneous cephalic presentation. prospective matched cohort study. 25 clusters (hospitals and its referring midwifery practices) in the Netherlands. Data of the Netherlands perinatal registry for the matched cohort. singleton pregnancies from January 2011 to August 2012 with a fetus in breech presentation and a childbirth from 36 weeks gestation onwards. Spontaneous cephalic presentations (selected from national registry 2009 and 2010) were matched in a 2:1 ratio to cephalic presentations after a successful version attempt. Matching criteria were maternal age, parity, gestational age at childbirth and fetal gender. Main outcomes were mode of childbirth and neonatal outcomes. of 1613 women eligible for external cephalic version, 1169 (72.5%) received an ECV attempt. The overall caesarean childbirth rate was significantly lower compared to women who did not receive a version attempt (57% versus 87%; RR 0.66 (0.62-0.70)). Women with a cephalic presentation after ECV compared to women with a spontaneous cephalic presentation had a decreased risk for instrumental vaginal childbirth (RR 0.52 (95% CI 0.29-0.94)) and an increased risk of overall caesarean childbirth (RR 1.7 (95%CI 1.2-2.5)). women who had a successful ECV are at increased risk for a caesarean childbirth but overall, ECV is an important tool to reduce the caesarean rate. ECV is an important tool to reduce the caesarean section rates. Copyright © 2016. Published by Elsevier Ltd.

Normative data for female adolescents with eating disorders on the Children's Depression Inventory.

PubMed

Watson, Hunna J; Egan, Sarah J; Limburg, Karina; Hoiles, Kimberley J

2014-09-01

Given the importance of assessing depressive symptoms and suicidal ideation in adolescents with eating disorders (EDs), the aim was to provide normative data on the Children's Depression Inventory (CDI) for female adolescents presenting for treatment of an ED. The data source was the Helping to Outline Paediatric Eating Disorders (HOPE) Project registry (N = 1000), a prospective, ongoing registry study comprising consecutive pediatric tertiary ED referrals. Females (N = 256; 12-17 years) with DSM-5 EDs completed the CDI at intake. Results on the CDI revealed a pattern of increasing depressive scores with age and higher scores among patients with anorexic spectrum disorders. The prevalence of suicidal ideation was high and had the same pattern as CDI scores. The mean score on the CDI in the sample was higher than community samples and clinical samples of adolescents with post-traumatic stress disorder, obsessive compulsive disorder, and other clinical disorders. Females adolescents with EDs are at high-risk of depression and suicidal ideation. These data provide information about variation in CDI scores to guide clinicians in interpretation of scores. © 2014 Wiley Periodicals, Inc.

Design and rationale of dabigatran's stroke prevention in real life in Turkey (D-SPIRIT).

PubMed

Türk, Uğur Önsel; Alioğlu, Emin; Tunçer, Eşref; Özpelit, Mehmet Emre; Pekel, Nihat; Tengiz, İstemihan; Çetin, Nurullah; Dalgıç, Onur; Topaloğlu, Caner; Bilgin, Nazile; Altın, Cihan; Özdemirkıran, Tolga; Tülüce, Kamil; Türkoğlu, Ebru İpek; Özpelit, Ebru

2016-04-01

The D-SPIRIT registry is designed to investigate the safety and efficacy of dabigatran etexilate in patients with nonvalvular atrial fibrillation (NVAF) and to collect data on outcomes in clinical practice. The D-SPIRIT is a national, prospective, observational, post-marketing registry involving patients with NVAF who have been taking dabigatran etexilate therapy for stroke prevention for a minimum of 6 months prior to enrollment. The registry will collect and analyze data from routine care, enrolling up to 600 patients in 9 centers. Patients will be followed up for 2 years to evaluate effectiveness and safety. A sample size of 600 subjects is proposed based on the following assumptions; Two-sided significance level of 0.05 (1-sided significance level of 0.025), ischemic stroke incidence rate of 0.768%-1.111%, hemorrhagic stroke incidence rate of 0.109%-0.130%, transient ischemic attack incidence rate of 0.722%-0.623%, therapy discontinuation incidence rate of 40% at day 730, and duration of enrollment period of 12 months with non-uniformed enrollment rate. Ethics approval was given by Dokuz Eylül University Ethics Committee of Clinical Research (2014/54) and approved by the Turkish Ministry of Health. Potential results of D-SPIRIT registry will add data from clinical practice to those from the RE-LY trial to expand knowledge of dabigatran etexilate treatment in patients with NVAF.

Validated Risk Score for Predicting 6-Month Mortality in Infective Endocarditis.

PubMed

Park, Lawrence P; Chu, Vivian H; Peterson, Gail; Skoutelis, Athanasios; Lejko-Zupa, Tatjana; Bouza, Emilio; Tattevin, Pierre; Habib, Gilbert; Tan, Ren; Gonzalez, Javier; Altclas, Javier; Edathodu, Jameela; Fortes, Claudio Querido; Siciliano, Rinaldo Focaccia; Pachirat, Orathai; Kanj, Souha; Wang, Andrew

2016-04-18

Host factors and complications have been associated with higher mortality in infective endocarditis (IE). We sought to develop and validate a model of clinical characteristics to predict 6-month mortality in IE. Using a large multinational prospective registry of definite IE (International Collaboration on Endocarditis [ICE]-Prospective Cohort Study [PCS], 2000-2006, n=4049), a model to predict 6-month survival was developed by Cox proportional hazards modeling with inverse probability weighting for surgery treatment and was internally validated by the bootstrapping method. This model was externally validated in an independent prospective registry (ICE-PLUS, 2008-2012, n=1197). The 6-month mortality was 971 of 4049 (24.0%) in the ICE-PCS cohort and 342 of 1197 (28.6%) in the ICE-PLUS cohort. Surgery during the index hospitalization was performed in 48.1% and 54.0% of the cohorts, respectively. In the derivation model, variables related to host factors (age, dialysis), IE characteristics (prosthetic or nosocomial IE, causative organism, left-sided valve vegetation), and IE complications (severe heart failure, stroke, paravalvular complication, and persistent bacteremia) were independently associated with 6-month mortality, and surgery was associated with a lower risk of mortality (Harrell's C statistic 0.715). In the validation model, these variables had similar hazard ratios (Harrell's C statistic 0.682), with a similar, independent benefit of surgery (hazard ratio 0.74, 95% CI 0.62-0.89). A simplified risk model was developed by weight adjustment of these variables. Six-month mortality after IE is ≈25% and is predicted by host factors, IE characteristics, and IE complications. Surgery during the index hospitalization is associated with lower mortality but is performed less frequently in the highest risk patients. A simplified risk model may be used to identify specific risk subgroups in IE. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Germline BRCA mutation evaluation in a prospective triple-negative breast cancer registry: implications for hereditary breast and/or ovarian cancer syndrome testing

PubMed Central

Klemp, Jennifer R.; Kimler, Bruce F.; Mahnken, Jonathan D.; Geier, Larry J.; Khan, Qamar J.; Elia, Manana; Connor, Carol S.; McGinness, Marilee K.; Mammen, Joshua M. W.; Wagner, Jamie L.; Ward, Claire; Ranallo, Lori; Knight, Catherine J.; Stecklein, Shane R.; Jensen, Roy A.; Fabian, Carol J.; Godwin, Andrew K.

2014-01-01

NCCN guidelines recommend genetic testing for all triple-negative breast cancer (TNBC) patients aged ≤60 years. However, due to the lack of prospective information in unselected patients, these guidelines are not uniformly adopted by clinicians and insurance carriers. The aim of this study was to determine the prevalence of BRCA mutations and evaluate the utility of NCCN guidelines in unselected TNBC population. Stage I–IV TNBC patients were enrolled on a prospective registry at academic and community practices. All patients underwent BRCA1/2 testing. Significant family history (SFH) was defined >1 relative with breast cancer at age ≤50 or ≥1 relative with ovarian cancer. Mutation prevalence in the entire cohort and subgroups was calculated. 207 TNBC patients were enrolled between 2011 and 2013. Racial/ethnic distribution: Caucasian (80 %), African–American (14 %), Ashkenazi (1 %). Deleterious BRCA1/2 mutations were identified in 15.4 % (32/207) of patients (BRCA1:11.1 %, BRCA2:4.3 %). SFH reported by 36 % of patients. Mutation prevalence in patients with and without SFH was 31.6 and 6.1 %, respectively. When assessed by age at TNBC diagnosis, the mutation prevalences were 27.6 % (≤50 years), 11.4 % (51–60 years), and 4.9 % (≥61 years). Using SFH or age ≤50 as criteria, 25 and 34 % of mutations, respectively, were missed. Mutation prevalence in patients meeting NCCN guidelines was 18.3 % (32/175) and 0 % (0/32) in patients who did not meet guidelines (p = .0059). In this unselected academic and community population with negligible Ashkenazi representation, we observed an overall BRCA mutation prevalence rate of 15.4 %. BRCA testing based on NCCN guidelines identified all carriers supporting its routine application in clinical practice for TNBC. PMID:24807107

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

PubMed

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

2011-08-01

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

Adaptive servo-ventilation to treat central sleep apnea in heart failure with reduced ejection fraction: the Bad Oeynhausen prospective ASV registry.

PubMed

Oldenburg, Olaf; Wellmann, Birgit; Bitter, Thomas; Fox, Henrik; Buchholz, Anika; Freiwald, Eric; Horstkotte, Dieter; Wegscheider, Karl

2018-04-13

Central sleep apnea (CSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HF-REF). The Bad Oeynhausen Adaptive Servo-ventilation (ASV) registry (NCT01657188) was designed to investigate whether treatment of CSA with ASV improved survival in HF-REF patients; the effects of ASV on symptoms and cardiopulmonary performance were also investigated. From January 2004 to October 2013, the registry prospectively enrolled HF-REF patients [NYHA class ≥ II, left ventricular ejection fraction (LVEF) ≤ 45%] with moderate to severe predominant CSA [apnea-hypopnea index (AHI) ≥ 15/h]. ASV-treated patients were followed up at 3, 6, 12 and 24 months, including natriuretic peptide concentrations, blood gas analyses, echocardiography, 6-min walk distance (6MWD), and cardiopulmonary exercise (CPX) testing. 550 patients were included [age 67.7 ± 10 years, 90% male, 52% in NYHA class ≥ III, LVEF 29.9 ± 8%, AHI 35.4 ± 13.6/h, and time with nocturnal oxygen saturation < 90% (T < 90%) 58 ± 73 min]; ASV was prescribed to 224 patients. Over a median follow-up of 6.6 years, 109 (48.7%) ASV-treated patients and 191 (58.6%) controls died (adjusted Cox modelling hazard ratio of 0.95, 95% confidence interval 0.68-1.24; p = 0.740); older age, lower LVEF, impaired renal function, low sodium concentration, and nocturnal hypoxemia were significant predictors of mortality. Patient reported NYHA functional class improved in the ASV group, but LVEF, CPX, 6MWD, natriuretic peptides and blood gases remained unchanged. Long-term ASV treatment of predominant CSA in HF-REF patients included in our registry had no statistically significant effect on survival. ASV improved HF symptoms, but had no significant effects on exercise capacity, LVEF, natriuretic peptide concentrations or blood gases during follow-up as compared to control patients.

The efficacy of hypotonic and near-isotonic saline for parenteral fluid therapy given at low maintenance rate in preventing significant change in plasma sodium in post-operative pediatric patients: protocol for a prospective randomized non-blinded study

PubMed Central

2011-01-01

Background Hyponatremia is the most frequent electrolyte abnormality observed in post-operative pediatric patients receiving intravenous maintenance fluid therapy. If plasma sodium concentration (p-Na+) declines to levels below 125 mmol/L in < 48 h, transient or permanent brain damage may occur. There is an intense debate as to whether the administered volume (full rate vs. restricted rate of infusion) and the composition of solutions used for parenteral maintenance fluid therapy (hypotonic vs. isotonic solutions) contribute to the development of hyponatremia. So far, there is no definitive pediatric data to support a particular choice of parenteral fluid for maintenance therapy in post-surgical patients. Methods/Design Our prospective randomized non-blinded study will be conducted in healthy children and adolescents aged 1 to 14 years who have been operated for acute appendicitis. Patients will be randomized either to intravenous hypotonic (0.23% or 0.40% sodium chloride in glucose, respectively) or near-isotonic (0.81% sodium chloride in glucose) solution given at approximately three-fourths of the average maintenance rate. The main outcome of interest from this study is to evaluate 24 h post-operatively whether differences in p-Na+ between treatment groups are large enough to be of clinical relevance. In addition, water and electrolyte balance as well as regulatory hormones will be measured. Discussion This study will provide valuable information on the efficacy of hypotonic and near-isotonic fluid therapy in preventing a significant decrease in p-Na+. Finally, by means of careful electrolyte and water balance and by measuring regulatory hormones our results will also contribute to a better understanding of the physiopathology of post-operative changes in p-Na+ in a population at risk for hyponatremia. Trial registration The protocol for this study is registered with the current controlled trials registry; registry number: ISRCTN43896775. PMID:21729308

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

PubMed

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

2008-05-14

Population-based electronic immunization registries create the possibility of using registry data to conduct vaccine effectiveness studies which could have methodological advantages over traditional observational studies. For study validity, the base population would have to be clearly defined and the immunization status of members of the population accurately recorded in the registry. We evaluated a city-wide immunization registry, focusing on its potential as a tool to study pertussis vaccine effectiveness, especially in adolescents. We conducted two evaluations - one in sites that were active registry participants and one in sites that had implemented an electronic medical record with plans for future direct data transfer to the registry - of the ability to match patients' medical records to registry records and the accuracy of immunization records in the registry. For each site, records from current pediatric patients were chosen randomly. Data regarding pertussis-related immunizations, clinic usage, and demographic and identifying information were recorded; for 11-17-year-old subjects, information on MMR, hepatitis B, and varicella immunizations was also collected. Records were then matched, when possible, to registry records. For records with a registry match, immunization data were compared. Among 350 subjects from sites that were current registry users, 307 (87.7%) matched a registry record. Discrepancies in pertussis-related data were common for up-to-date status (22.6%), number of immunizations (34.7%), dates (10.2%), and formulation (34.4%). Among 442 subjects from sites that planned direct electronic transfer of immunization data to the registry, 393 (88.9%) would have matched a registry record; discrepancies occurred frequently in number of immunizations (11.9%), formulation (29.1%), manufacturer (94.4%), and lot number (95.1%.) Inability to match and immunization discrepancies were both more common in subjects who were older at their first visit to the provider site. For 11-17-year-old subjects, discrepancies were also common for MMR, hepatitis B, and varicella vaccination data. Provider records frequently could not be matched to registry records or had discrepancies in key immunization data. These issues were more common for older children and were present even with electronic data transfer. These results highlight general challenges that may face investigators wishing to use registry-based immunization data for vaccine effectiveness studies, especially in adolescents.

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

PubMed Central

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

2008-01-01

Background Population-based electronic immunization registries create the possibility of using registry data to conduct vaccine effectiveness studies which could have methodological advantages over traditional observational studies. For study validity, the base population would have to be clearly defined and the immunization status of members of the population accurately recorded in the registry. We evaluated a city-wide immunization registry, focusing on its potential as a tool to study pertussis vaccine effectiveness, especially in adolescents. Methods We conducted two evaluations – one in sites that were active registry participants and one in sites that had implemented an electronic medical record with plans for future direct data transfer to the registry – of the ability to match patients' medical records to registry records and the accuracy of immunization records in the registry. For each site, records from current pediatric patients were chosen randomly. Data regarding pertussis-related immunizations, clinic usage, and demographic and identifying information were recorded; for 11–17-year-old subjects, information on MMR, hepatitis B, and varicella immunizations was also collected. Records were then matched, when possible, to registry records. For records with a registry match, immunization data were compared. Results Among 350 subjects from sites that were current registry users, 307 (87.7%) matched a registry record. Discrepancies in pertussis-related data were common for up-to-date status (22.6%), number of immunizations (34.7%), dates (10.2%), and formulation (34.4%). Among 442 subjects from sites that planned direct electronic transfer of immunization data to the registry, 393 (88.9%) would have matched a registry record; discrepancies occurred frequently in number of immunizations (11.9%), formulation (29.1%), manufacturer (94.4%), and lot number (95.1%.) Inability to match and immunization discrepancies were both more common in subjects who were older at their first visit to the provider site. For 11–17-year-old subjects, discrepancies were also common for MMR, hepatitis B, and varicella vaccination data. Conclusion Provider records frequently could not be matched to registry records or had discrepancies in key immunization data. These issues were more common for older children and were present even with electronic data transfer. These results highlight general challenges that may face investigators wishing to use registry-based immunization data for vaccine effectiveness studies, especially in adolescents. PMID:18479517

Ketamine use for rapid sequence intubation in Australian and New Zealand emergency departments from 2010 to 2015: A registry study.

PubMed

Ferguson, Ian; Alkhouri, Hatem; Fogg, Toby; Aneman, Anders

2018-06-11

This study aimed to quantify the proportion of patients undergoing rapid sequence intubation using ketamine in Australian and New Zealand EDs between 2010 and 2015. The Australian and New Zealand Emergency Department Airway Registry is a multicentre airway registry prospectively capturing data from 43 sites. Data on demographics and physiology, the attending staff and indication for intubation were recorded. The primary outcome was the annual percentage of patients intubated with ketamine. A logistic regression analysis was conducted to evaluate the factors associated with ketamine use. A total of 4658 patients met inclusion criteria. The annual incidence of ketamine use increased from 5% to 28% over the study period (P < 0.0001). In the logistic regression analysis, the presence of an emergency physician as a team leader was the strongest predictor of ketamine use (odds ratio [OR] 1.83, 95% confidence interval [CI] 1.44-2.34). The OR for an increase in one point on the Glasgow Coma Scale was 1.10 (95% CI 1.07-1.12), whereas an increase of 1 mmHg of systolic blood pressure had an OR of 0.98 (95% CI 0.98-0.99). Intubation occurring in a major referral hospital had an OR of 0.68 (95% CI 0.56-0.82), while trauma conferred an OR of 1.38 (95% CI 1.25-1.53). Ketamine use increased between 2010 and 2015. Lower systolic blood pressure, the presence of an emergency medicine team leader, trauma and a higher Glasgow Coma Scale were associated with increased odds of ketamine use. Intubation occurring in a major referral centre was associated with lower odds of ketamine use. © 2018 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Etiology of Bronchiectasis in a Cohort of 2047 Patients. An Analysis of the Spanish Historical Bronchiectasis Registry.

PubMed

Olveira, Casilda; Padilla, Alicia; Martínez-García, Miguel-Ángel; de la Rosa, David; Girón, Rosa-María; Vendrell, Montserrat; Máiz, Luis; Borderías, Luis; Polverino, Eva; Martínez-Moragón, Eva; Rajas, Olga; Casas, Francisco; Cordovilla, Rosa; de Gracia, Javier

2017-07-01

Bronchiectasis is caused by many diseases. Establishing its etiology is important for clinical and prognostic reasons. The aim of this study was to evaluate the etiology of bronchiectasis in a large patient sample and its possible relationship with demographic, clinical or severity factors, and to analyze differences between idiopathic disease, post-infectious disease, and disease caused by other factors. Multicenter, cross-sectional study of the SEPAR Spanish Historical Registry (RHEBQ-SEPAR). Adult patients with bronchiectasis followed by pulmonologists were included prospectively. Etiological studies were based on guidelines and standardized diagnostic tests included in the register, which were later included in the SEPAR guidelines on bronchiectasis. A total of 2,047 patients from 36 Spanish hospitals were analyzed. Mean age was 64.9years and 54.9% were women. Etiology was identified in 75.8% of cases (post-Infection: 30%; cystic fibrosis: 12.5%; immunodeficiencies: 9.4%; COPD: 7.8%; asthma: 5.4%; ciliary dyskinesia: 2.9%, and systemic diseases: 1.4%). The different etiologies presented different demographic, clinical, and microbiological factors. Post-infectious bronchiectasis and bronchiectasis caused by COPD and asthma were associated with an increased risk of poorer lung function. Patients with post-infectious bronchiectasis were older and were diagnosed later. Idiopathic bronchiectasis was more common in female non-smokers and was associated with better lung function, a higher body mass index, and a lower rate of Pseudomonas aeruginosa than bronchiectasis of known etiology. The etiology of bronchiectasis was identified in a large proportion of patients included in the RHEBQ-SEPAR registry. Different phenotypes associated with different causes could be identified. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

I RBH - First Brazilian Hypertension Registry.

PubMed

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

2016-08-01

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

Cumulative exposure to biologics and risk of cancer in psoriasis patients: A meta-analysis of Psonet studies from Israel, Italy, Spain, United Kingdom and Republic of Ireland.

PubMed

Garcia-Doval, I; Descalzo, M A; Mason, K J; Cohen, A D; Ormerod, A D; Gómez-García, F J; Cazzaniga, S; Feldhamer, I; Ali, H; Herrera-Acosta, E; Griffiths, C E M; Stern, R; Naldi, L

2018-05-03

Cancer risk following long-term exposure to systemic immunomodulatory therapies in psoriasis patients is possible. To assess a dose-response relationship between cumulative length of exposure to biologic therapy and risk of cancer. Four national studies (a healthcare database from Israel, and prospective cohorts form Italy, Spain and UK/ROI) collaborating through Psonet (European Registry of Psoriasis) participated in these nested case-control studies, including nearly 60.000 person-years of observation. Cases were patients who developed an incident cancer. Patients with previous cancers and benign or in-situ tumours were excluded. Four cancer-free controls were matched to each case on year of birth, gender, geographic area, and registration year. Follow-up for controls was censored at the date of cancer diagnosis for the matched case. Conditional logistic regression was performed by each registry. Results were pooled using random effects meta-analysis. 728 cases and 2671 controls were identified. After matching, differences between cases and controls were present for the Charlson comorbidity index in all three registries, and in the prevalence of previous exposure to psoralen-ultraviolet-A (PUVA) and smoking (BADBIR only). The risk of first cancers was not significantly associated with cumulative exposure to biologics (adjusted odds ratio per year of exposure 1.02; 95%CI 0.92, 1.13). Results were similar if squamous and basal cell carcinomas were included in the outcome. Cumulative length of exposure to biologic therapies of psoriasis patients in real-world clinical practice does not appear to be linked to a higher risk of cancer after several years of use. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Executive Functions Do Not Mediate Prospective Relations between Indices of Physical Activity and Academic Performance: The Active Smarter Kids (ASK) Study.

PubMed

Aadland, Katrine N; Ommundsen, Yngvar; Aadland, Eivind; Brønnick, Kolbjørn S; Lervåg, Arne; Resaland, Geir K; Moe, Vegard F

2017-01-01

Changes in cognitive function induced by physical activity have been proposed as a mechanism for the link between physical activity and academic performance. The aim of this study was to investigate if executive function mediated the prospective relations between indices of physical activity and academic performance in a sample of 10-year-old Norwegian children. The study included 1,129 children participating in the Active Smarter Kids (ASK) trial, followed over 7 months. Structural equation modeling (SEM) with a latent variable of executive function (measuring inhibition, working memory, and cognitive flexibility) was used in the analyses. Predictors were objectively measured physical activity, time spent sedentary, aerobic fitness, and motor skills. Outcomes were performance on national tests of numeracy, reading, and English (as a second language). Generally, indices of physical activity did not predict executive function and academic performance. A modest mediation effect of executive function was observed for the relation between motor skills and academic performance. Trial registration: Clinicaltrials.gov registry, trial registration number: NCT02132494.

Executive Functions Do Not Mediate Prospective Relations between Indices of Physical Activity and Academic Performance: The Active Smarter Kids (ASK) Study

PubMed Central

Aadland, Katrine N.; Ommundsen, Yngvar; Aadland, Eivind; Brønnick, Kolbjørn S.; Lervåg, Arne; Resaland, Geir K.; Moe, Vegard F.

2017-01-01

Changes in cognitive function induced by physical activity have been proposed as a mechanism for the link between physical activity and academic performance. The aim of this study was to investigate if executive function mediated the prospective relations between indices of physical activity and academic performance in a sample of 10-year-old Norwegian children. The study included 1,129 children participating in the Active Smarter Kids (ASK) trial, followed over 7 months. Structural equation modeling (SEM) with a latent variable of executive function (measuring inhibition, working memory, and cognitive flexibility) was used in the analyses. Predictors were objectively measured physical activity, time spent sedentary, aerobic fitness, and motor skills. Outcomes were performance on national tests of numeracy, reading, and English (as a second language). Generally, indices of physical activity did not predict executive function and academic performance. A modest mediation effect of executive function was observed for the relation between motor skills and academic performance. Trial registration: Clinicaltrials.gov registry, trial registration number: NCT02132494. PMID:28706500

Cohort profile: LIFEWORK, a prospective cohort study on occupational and environmental risk factors and health in the Netherlands.

PubMed

Reedijk, Marije; Lenters, Virissa; Slottje, Pauline; Pijpe, Anouk; Peeters, Petra H; Korevaar, Joke C; Bueno-de-Mesquita, Bas; Verschuren, W M Monique; Verheij, Robert A; Pieterson, Inka; van Leeuwen, Flora E; Rookus, Matti A; Kromhout, Hans; Vermeulen, Roel C H

2018-02-03

LIFEWORK is a large federated prospective cohort established in the Netherlands to quantify the health effects of occupational and environmental exposures. This cohort is also the Dutch contribution to the international Cohort Study of Mobile Phone Use and Health (COSMOS). In this paper, we describe the study design, ongoing data collection, baseline characteristics of participants and the repeatability of key questionnaire items. 88 466 participants were enrolled in three cohort studies in 2011-2012. Exposure information was collected by a harmonised core questionnaire, or modelled based on occupational and residential histories; domains include air pollution (eg, nitrogen dioxide (NO 2 ), particulate matter with diameter ≤2.5 µm (PM 2.5 )), noise, electromagnetic fields (EMF), mobile phone use, shift work and occupational chemical exposures. Chronic and subacute health outcomes are assessed by self-report and through linkage with health registries. Participants had a median age of 51 years at baseline (range 19-87), and the majority are female (90%), with nurses being over-represented. Median exposure levels of NO 2 , PM 2.5 , EMF from base stations and noise at the participants' home addresses at baseline were 22.9 µg/m 3 , 16.6 µg/m 3 , 0.003 mWm 2 and 53.1 dB, respectively. Twenty-two per cent of participants reported to have started using a mobile phone more than 10 years prior to baseline. Repeatability for self-reported exposures was moderate to high (weighted kappa range: 0.69-1) for a subset of participants (n=237) who completed the questionnaire twice. We are actively and passively observing participants; we plan to administer a follow-up questionnaire every 4-5 years-the first follow-up will be completed in 2018-and linkage to cause-of-death and cancer registries occurs on a (bi)annual basis. This prospective cohort offers a unique, large and rich resource for research on contemporary occupational and environmental health risks and will contribute to the large international COSMOS study on mobile phone use and health. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed Central

2015-01-01

Background The Global Network for Women's and Children's Health Research (Global Network) supports and conducts clinical trials in resource-limited countries by pairing foreign and U.S. investigators, with the goal of evaluating low-cost, sustainable interventions to improve the health of women and children. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to efforts to discover strategies for improving pregnancy outcomes in resource-limited settings. Because most of the sites in the Global Network have weak registration within their health care systems, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnancies at the Global Network sites to provide precise data on health outcomes and measures of care. Methods Pregnant women are enrolled in the MNHR if they reside in or receive healthcare in designated groups of communities within sites in the Global Network. For each woman, demographic, health characteristics and major outcomes of pregnancy are recorded. Data are recorded at enrollment, the time of delivery and at 42 days postpartum. Results From 2010 through 2013 Global Network sites were located in Argentina, Guatemala, Belgaum and Nagpur, India, Pakistan, Kenya, and Zambia. During this period, 283,496 pregnant women were enrolled in the MNHR; this number represented 98.8% of all eligible women. Delivery data were collected for 98.8% of women and 42-day follow-up data for 98.4% of those enrolled. In this supplement, there are a series of manuscripts that use data gathered through the MNHR to report outcomes of these pregnancies. Conclusions Developing public policy and improving public health in countries with poor perinatal outcomes is, in part, dependent upon understanding the outcome of every pregnancy. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. Study Registration: The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). PMID:26063166

The Fukuoka Kidney disease Registry (FKR) Study: design and methods.

PubMed

Tanaka, Shigeru; Ninomiya, Toshiharu; Fujisaki, Kiichiro; Yoshida, Hisako; Nagata, Masaharu; Masutani, Kosuke; Tokumoto, Masanori; Mitsuiki, Koji; Hirakata, Hideki; Fujimi, Satoru; Kiyohara, Yutaka; Kitazono, Takanari; Tsuruya, Kazuhiko

2017-06-01

Chronic kidney disease (CKD) is an established independent risk factor for progression to end-stage renal disease (ESRD) and incidence of cardiovascular disease (CVD). The onset and progression of CKD are associated with both genetic predisposition and various lifestyle-related factors, but little is known about the influence of genetic-environmental interactions on the incidence of ESRD or CVD in patients with CKD. The Fukuoka Kidney disease Registry (FKR) Study is designed as one of the largest prospective, multicenter, observational cohort studies in non-dialysis dependent CKD patients. The FKR Study aims to enroll approximately 5000 individuals at multiple clinical centers and follow them for up to at least 5 years. At baseline, subjects enrolled in the FKR Study will fill out extensive lifestyle-related questionnaires. Further, their health status and treatments will be monitored annually through a research network of nephrology centers. Blood and urine samples, including DNA/RNA, will be collected at the time of enrolment and every 5-years follow-up. The FKR Study will provide many insights into the onset and progression of CKD, which will suggest hypothesis-driven interventional clinical trials aimed at reducing the burden of CKD. The features of the FKR Study may also facilitate innovative research to identify and validate novel risk factors, including genetic susceptibility and biomarkers, using biomaterials by high-throughput omics technologies.

The Adherence eValuation After Ischemic Stroke Longitudinal (AVAIL) registry: design, rationale, and baseline patient characteristics.

PubMed

Bushnell, Cheryl; Zimmer, Louise; Schwamm, Lee; Goldstein, Larry B; Clapp-Channing, Nancy; Harding, Tina; Drew, Laura; Zhao, Xin; Peterson, Eric

2009-03-01

Approximately one third of the 780,000 people in the United States who have a stroke each year have recurrent events. Although efficacious secondary prevention measures are available, levels of adherence to these strategies in patients who have had stroke are largely unknown. Understanding medication-taking behavior in this population is an important step to optimizing the appropriate use of proven secondary preventive therapies and reducing the risk of recurrent stroke. The Adherence eValuation After Ischemic Stroke Longitudinal (AVAIL) registry is a prospective study of adherence to stroke prevention medications from hospital discharge to 1 year in patients admitted with stroke or transient ischemic attack. The primary outcomes are medication usage as determined by patient interviews after 3 and 12 months. Potential patient-, provider-, and system-level barriers to persistence of medication use are also collected. Secondary outcomes include the rates of recurrent stroke or transient ischemic attack, vascular events, and rehospitalization and functional status as measured by the modified Rankin score. The AVAIL enrolled about 2,900 subjects from 106 hospitals from July 2006 through July 2008. The 12-month follow-up will be completed in August 2009. The AVAIL registry will document the current state of adherence and persistence to stroke prevention medications among a nationwide sample of patients. These data will be used to design interventions to improve the quality of care post acute hospitalization and reduce the risks of future stroke and cardiovascular events.

Real-world Outcomes of Multiple Myeloma: Retrospective Analysis of the Czech Registry of Monoclonal Gammopathies.

PubMed

Hájek, Roman; Jarkovsky, Jiri; Maisnar, Vladimír; Pour, Ludek; Špička, Ivan; Minařík, Jiri; Gregora, Evžen; Kessler, Petr; Sýkora, Michal; Fraňková, Hana; Campioni, Marco; DeCosta, Lucy; Treur, Maarten; Gonzalez-McQuire, Sebastian; Bouwmeester, Walter

2018-06-01

Real-world data on patient outcomes and treatment patterns in multiple myeloma (MM) are limited. The present noninterventional, observational, retrospective analysis of prospectively collected Czech patient medical record data from the Registry of Monoclonal Gammopathies estimated real-world outcomes in adults with a diagnosis of symptomatic MM made between May 2007 and June 2014. In total, 2446 patients had initiated first-line treatment. The median overall survival since the diagnosis (primary endpoint) was 50.3 months (95% confidence interval, 46.1-54.5 months) and decreased with each successive treatment line. A similar trend was observed for progression-free survival and the depth of response. In line with European guidelines and clinical practice, bortezomib-, thalidomide-, and lenalidomide-based regimens were most commonly used across all treatment lines (42.3%, 28.9%, and 18.4%, respectively). In the first line, bortezomib and thalidomide were used most often, with lenalidomide the most commonly used agent in the relapse setting (second to fourth lines). Exploratory analyses revealed that younger age (≤ 65 years), lower international staging system stage, and previous stem cell transplantation were associated with significant improvements in overall and progression-free survival, especially in the early treatment lines. The present study is the first analysis of Czech data from the Registry of Monoclonal Gammopathies, and it provides important insights into the real-world management of MM for physicians and healthcare providers. Copyright © 2018 Elsevier Inc. All rights reserved.

Validation and Potential Mechanisms of Red Cell Distribution Width as a Prognostic Marker in Heart Failure

PubMed Central

ALLEN, LARRY A.; FELKER, G. MICHAEL; MEHRA, MANDEEP R.; CHIONG, JUN R.; DUNLAP, STEPHANIE H.; GHALI, JALAL K.; LENIHAN, DANIEL J.; OREN, RON M.; WAGONER, LYNNE E.; SCHWARTZ, TODD A.; ADAMS, KIRKWOOD F.

2014-01-01

Background: Adverse outcomes have recently been linked to elevated red cell distribution width (RDW) in heart failure. Our study sought to validate the prognostic value of RDW in heart failure and to explore the potential mechanisms underlying this association. Methods and Results: Data from the Study of Anemia in a Heart Failure Population (STAMINA-HFP) registry, a prospective, multicenter cohort of ambulatory patients with heart failure supported multivariable modeling to assess relationships between RDW and outcomes. The association between RDW and iron metabolism, inflammation, and neurohormonal activation was studied in a separate cohort of heart failure patients from the United Investigators to Evaluate Heart Failure (UNITE-HF) Biomarker registry. RDW was independently predictive of outcome (for each 1% increase in RDW, hazard ratio for mortality 1.06, 95% CI 1.01-1.12; hazard ratio for hospitalization or mortality 1.06; 95% CI 1.02-1.10) after adjustment for other covariates. Increasing RDW correlated with decreasing hemoglobin, increasing interleukin-6, and impaired iron mobilization. Conclusions: Our results confirm previous observations that RDW is a strong, independent predictor of adverse outcome in chronic heart failure and suggest elevated RDW may indicate inflammatory stress and impaired iron mobilization. These findings encourage further research into the relationship between heart failure and the hematologic system. PMID:20206898

Validation and potential mechanisms of red cell distribution width as a prognostic marker in heart failure.

PubMed

Allen, Larry A; Felker, G Michael; Mehra, Mandeep R; Chiong, Jun R; Dunlap, Stephanie H; Ghali, Jalal K; Lenihan, Daniel J; Oren, Ron M; Wagoner, Lynne E; Schwartz, Todd A; Adams, Kirkwood F

2010-03-01

Adverse outcomes have recently been linked to elevated red cell distribution width (RDW) in heart failure. Our study sought to validate the prognostic value of RDW in heart failure and to explore the potential mechanisms underlying this association. Data from the Study of Anemia in a Heart Failure Population (STAMINA-HFP) registry, a prospective, multicenter cohort of ambulatory patients with heart failure supported multivariable modeling to assess relationships between RDW and outcomes. The association between RDW and iron metabolism, inflammation, and neurohormonal activation was studied in a separate cohort of heart failure patients from the United Investigators to Evaluate Heart Failure (UNITE-HF) Biomarker registry. RDW was independently predictive of outcome (for each 1% increase in RDW, hazard ratio for mortality 1.06, 95% CI 1.01-1.12; hazard ratio for hospitalization or mortality 1.06; 95% CI 1.02-1.10) after adjustment for other covariates. Increasing RDW correlated with decreasing hemoglobin, increasing interleukin-6, and impaired iron mobilization. Our results confirm previous observations that RDW is a strong, independent predictor of adverse outcome in chronic heart failure and suggest elevated RDW may indicate inflammatory stress and impaired iron mobilization. These findings encourage further research into the relationship between heart failure and the hematologic system. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Comprehensive Assessment of Coronary Artery Disease in Sports-Related Sudden Cardiac Arrest.

PubMed

Karam, Nicole; Pechmajou, Louis; Dumas, Florence; Bougouin, Wulfran; Sharifzadehgan, Ardalan; Beganton, Frankie; Bonnet, Guillaume; Jost, Daniel; Lamhaut, Lionel; Varenne, Olivier; Aubry, Pierre; Sideris, Georgios; Spaulding, Christian; Cariou, Alain; Marijon, Eloi; Jouven, Xavier

2018-05-02

Despite the cardiovascular benefits of regular sports, sudden cardiac arrest (SCA) risk is increased during or shortly after exercise. Association with coronary artery disease (CAD) has been described in small studies, mainly autopsic with potential bias given the high sports-related SCA survival, and focusing on young competitive athletes, whereas sports-related SCA occurs mostly in recreational athletes. 1-5 Through the Paris Sudden Death Expertise Center prospective registry that includes all SCAs in Paris and suburbs since May 2011, we performed the first broad comprehensive CAD description in sports-related SCAs, with a comparison with matched non-sports-related SCAs.

[Secondary malignancies after breast cancer surgery. Comparison of retro- and prospective findings].

PubMed

Holdener, E E; Osterwalder, J; Senn, H J; Enderlin, F; Gloor, F

1982-12-04

Second malignancies (SM) represent one of the potential hazards of modern cancer treatment and especially of radio- and chemotherapy after surgery for breast cancer. For this reason, regional tumor registry data (1960-1975) on 1985 breast cancer patients were analyzed for SM in the retrospective part of our study. These data were compared with the prospective part of the study in which 241 patients were randomly assigned to either mastectomy or mastectomy and chemoimmunotherapy (CT + IT). In the retrospective part of the study, SM were observed in 83 cases (4.2%), 49% of which were SM of the contralateral breast. Most frequent extramammary SM were of gastrointestinal (25%), gynecologic (8%) and cerebral (5%) origin. Leukemias were found in 4% of all SM. Median time interval to SM was 5 years and 1 month. Within 5, 10 and 15 years after mastectomy 60%, 85% and 95% of SM were observed respectively. Median survival of patients with SM was 6 1/2 years. In the prospective part of the study, SM were observed in 9 cases (3.7%), 4.1% in the surgical control group and 3.4% in the adjuvant CT + IT group with a median observation time of 6 years post mastectomy. These data are compared to other current adjuvant breast trials and do not indicate as of now an increase in SM under present adjuvant therapy.

EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

PubMed

Oberbichler, S; Hackl, W O; Hörbst, A

2017-10-18

Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the Radiotherapeutics dose distribution as the cause for induction) as a case study. The proposed building blocks cover the topics of "Context Analysis", "Requirements Analysis", "Requirements Validation", "Electronic Case Report (eCRF) Design" and "Overall Concept Creation". Additional methods are attached with regards to each topic. The goals of each block can be met by applying those methods. The proposed methods are proven methods as applied in e.g. existing Medical Data Registry projects, as well as in software or requirements engineering. Several building blocks and attached methods could be identified in the creation of a generic ethics committee proposal. Hence, an Ethics Committee can make informed decisions on the suggested study via said blocks, using the suggested methods such as "Defining Clinical Questions" within the Context Analysis. The study creators have to confirm that they adhere to the proposed procedure within the ethic proposal statement. Additional existing Medical Data Registry projects can be compared to EsPRit for conformity to the proposed procedure. This allows for the identification of gaps, which can lead to amendments requested by the ethics committee.

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 participation. Few parents of vaccinated (6.8%) and exempt children (6.7%) were aware of laws authorizing immunization registries. Support for laws authorizing registries and requiring health care providers to report to registries was more common among parents of vaccinated than exempt children. Most parents believed that the government, vaccine companies or insurance companies should pay for registries. Parental support for registries was relatively high. Parental support for immunization registries may increase with greater parental awareness of the risks of vaccine preventable diseases and utility of vaccination.

The Cardiomyopathy Registry of the EURObservational Research Programme of the European Society of Cardiology: baseline data and contemporary management of adult patients with cardiomyopathies.

PubMed

Charron, Philippe; Elliott, Perry M; Gimeno, Juan R; Caforio, Alida L P; Kaski, Juan Pablo; Tavazzi, Luigi; Tendera, Michal; Maupain, Carole; Laroche, Cécile; Rubis, Pawel; Jurcut, Ruxandra; Calò, Leonardo; Heliö, Tiina M; Sinagra, Gianfranco; Zdravkovic, Marija; Kavoliuniene, Aušra; Felix, Stephan B; Grzybowski, Jacek; Losi, Maria-Angela; Asselbergs, Folkert W; García-Pinilla, José Manuel; Salazar-Mendiguchia, Joel; Mizia-Stec, Katarzyna; Maggioni, Aldo P

2018-05-21

The Cardiomyopathy Registry of the EURObservational Research Programme is a prospective, observational, and multinational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM). We report the baseline characteristics and management of adults enrolled in the registry. A total of 3208 patients were enrolled by 69 centres in 18 countries [HCM (n = 1739); DCM (n = 1260); ARVC (n = 143); and RCM (n = 66)]. Differences between cardiomyopathy subtypes (P < 0.001) were observed for age at diagnosis, history of familial disease, history of sustained ventricular arrhythmia, use of magnetic resonance imaging or genetic testing, and implantation of defibrillators. When compared with probands, relatives had a lower age at diagnosis (P < 0.001), but a similar rate of symptoms and defibrillators. When compared with the Long-Term phase, patients of the Pilot phase (enrolled in more expert centres) had a more frequent rate of familial disease (P < 0.001), were more frequently diagnosed with a rare underlying disease (P < 0.001), and more frequently implanted with a defibrillator (P = 0.023). Comparing four geographical areas, patients from Southern Europe had a familial disease more frequently (P < 0.001), were more frequently diagnosed in the context of a family screening (P < 0.001), and more frequently diagnosed with a rare underlying disease (P < 0.001). By providing contemporary observational data on characteristics and management of patients with cardiomyopathies, the registry provides a platform for the evaluation of guideline implementation. Potential gaps with existing recommendations are discussed as well as some suggestions for improvement of health care provision in Europe.

Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry.

PubMed

Yamamoto, Hideya; Awai, Kazuo; Kuribayashi, Sachio; Kihara, Yasuki

2014-01-01

At least two-thirds of cases of acute coronary syndrome are caused by disruption of an atherosclerotic plaque. The natural history of individual plaques is unknown and needs to be established. The Plaque Registration and Evaluation Detected In Computed Tomography (PREDICT) registry is a prospective, multicenter, longitudinal, observational registry. This registry was designed to examine the relationships among coronary CT angiography (CTA) findings and clinical findings, mortality, and morbidity. The relationships among progression of coronary atherosclerosis, including changes in plaque characteristics on coronary CTA, and serum lipid levels and modification of coronary risk factors will also be evaluated. From October 2009 to December 2012, 3015 patients who underwent coronary CTA in 29 centers in Japan were enrolled. These patients were followed for 2 years. The primary end points were considered as all-cause mortality and major cardiac events, including cardiac death, nonfatal myocardial infarction, and unstable angina that required hospitalization. The secondary end points were heart failure that required administration of diuretics, target vessel revascularization, cerebral infarction, peripheral arterial disease, and invasive coronary angiography. Blood pressure, serum lipid, and C-reactive protein levels and all cardiovascular events were recorded at 1 and 2 years. If the initial coronary CTA showed any stenosis or plaques, follow-up coronary CTA was scheduled at 2 years to determine changes in coronary lesions, including changes in plaque characteristics. Analysis of the PREDICT registry data will clarify the relationships between coronary CTA findings and cardiovascular mortality and morbidity in a collaborative multicenter fashion. This trial is registered at www.clinicaltrials.gov as NCT 00991835. Copyright © 2014 Society of Cardiovascular Computed Tomography. All rights reserved.

Rationale and design of the extracranial carotid artery aneurysm registry.

PubMed

Welleweerd, J C; Bots, M L; Kappelle, L J; Rinkel, G J; Ruigrok, Y M; Baas, A F; van der Worp, H B; Vergouwen, M D; Bleys, R L; Hendrikse, J; Lo, T H; Moll, F L; de Borst, G J

2015-02-06

Aneurysms of the extracranial carotid artery (ECAA) are rare. Although most ECAA are identified in asymptomatic patients, serious neurological complications may occur. Current literature on treatment outcome contains mainly case reports and small case series with incomplete data and lack of long--term follow--up. There is clear lack on natural follow--up data, and there is no clear treatment algorithm. An international web--based registry to collect data on patients with ECAA is designed to provide clinical guidance on this scarce pathology. The Carotid Aneurysm Registry (CAR) is open for inclusion of all patients with a fusiform or saccular ECAA. Patients with primary or secondary ECAA can be enrolled in CAR independent of the type of treatment (conservative or invasive). CAR participation does not interfere with the local physician's treatment policy. Follow--up and imaging can also be scheduled according to local clinical practice. The primary endpoint of the CAR in conservative patients is occurrence of symptoms related to the aneurysm at 30 days, one, three, and five years. The primary endpoint in invasively treated patients is freedom from symptoms of the aneurysm at 30 days, one, three, and five years. Analyses will relate outcome to etiology, imaging characteristics, ECAA growth patterns, and (if applicable) revascularization technique applied. The aim of the registry is to prospectively collect follow--up data on patients with an ECAA, being either treated conservatively or by invasive aneurysm exclusion strategies. The CAR database will be used to address diagnostic and therapeutic research questions. Collecting and analyzing the data gained from the registry could be the first step towards development of treatment guidelines and expert consensus for the management of ECAA.

DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols.

PubMed

Neugebauer, Hermann; Heuschmann, Peter U; Jüttler, Eric

2012-10-02

Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18-60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e.g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76% mRS ≤ 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies. (ICTRP and DRKS): DRKS00000624.

Persian Registry Of cardioVascular diseasE (PROVE): Design and methodology.

PubMed

Givi, Mahshid; Sarrafzadegan, Nizal; Garakyaraghi, Mohammad; Yadegarfar, Ghasem; Sadeghi, Masoumeh; Khosravi, Alireza; Azhari, Amir Hossein; Samienasab, Mohammad Reza; Shafie, Davood; Saadatnia, Mohammad; Roohafza, Hamidreza; Paydari, Navid; Soleimani, Azam; Hosseinzadeh, Mohsen; Ahmadi, Seyed Abdulah; Dehghani, Leila; Najafian, Jamshid; Andalib, Elham; Shahabi, Javad; Sabri, Mohammad Reza

2017-09-01

Our aim was to create and establish a database called "Persian Registry Of cardioVascular diseasE (PROVE)" in order to be used for future research and in addition, as a tool to develop national guidelines for diagnosis, treatment, and prevention of cardiovascular disease (CVD). In this paper, the design and methodology of the PROVE pilot study will be discussed, launched in Isfahan, Iran, in 2015-2016. Through establishing PROVE, patients' data were collected from hospitals and outpatient clinics prospectively or retrospectively and followed up for a maximum of three years based on the type of CVDs. The inclusion criteria were as patients with acute coronary syndrome (ACS), ST elevation myocardial infarction (STEMI), stroke, atrial fibrillation (AF), heart failure (HF), congenital heart disease (CHD), percutaneous coronary intervention (PCI), and chronic ischemic cardiovascular disease (CICD). Specific protocols, questionnaires, and glossaries were developed for each registry. In order to ensure the validation of the protocols, questionnaires, data collection, management, and analysis, a well-established quality control (QC) protocol was developed and implemented. Data confidentiality was considered. In order to register patients with ACS, STEMI, stroke, HF, PCI, and CICD, the hospital recorded data were used, whereas, in case of AF and CHD registries, the data were collected from hospitals and outpatient clinics. During the pilot phase of the study in Isfahan, from March 2015 to September 2016, 9427 patients were registered as ACS including 809 as STEMI, 1195 patients with HF, 363 with AF, 761 with stroke, 1136 with CHD, 1200 with PCI, and 9 with CICD. Data collection and management were performed under the supervision of the QC group. PROVE was developed and implemented in Isfahan as a pilot study, in order to be implemented at national level in future. It provides a valuable source of valid data that could be used for future research, re-evaluation of current CVD management and more specifically, gap analysis and as a tool for assessment of the type of CVDs, prevention, treatment, and control by health care decision makers.

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

PubMed Central

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

2002-01-01

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

Testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE) Study.

PubMed

Biondi-Zoccai, Giuseppe G L; Sangiorgi, Giuseppe M; Antoniucci, David; Grube, Eberhard; Di Mario, Carlo; Reimers, Bernard; Tamburino, Corrado; Agostoni, Pierfrancesco; Cosgrave, John; Colombo, Antonio

2007-05-02

Paclitaxel-eluting stents (PES) have been proved effective in randomized trials enrolling highly selected patients. Yet, given the uncertainty concerning results of PES implantation in very high-risk patients and lesions, we designed a prospective multicenter registry, the Taxus in Real-life Usage Evaluation (TRUE) Study. STUDY DESIGN, PATIENT CHARACTERISTICS AND IN-HOSPITAL OUTCOMES: Consecutive patients undergoing PES implantation were enrolled provided that the target lesion treated with PES was an unprotected left main (ULM), a true bifurcation, a chronic total occlusion (CTO), a long lesion (>28 mm), located in a small vessel (<2.75 mm), or the patient had diabetes mellitus. Clinical events will be adjudicated at 1, 7 and 12 months, with 4- to 8-month angiographic follow-up. The primary end-point will be the 7-month occurrence of major adverse cardiovascular events (MACE, i.e. the composite of cardiac death, non-fatal myocardial infarction [MI], coronary artery bypass grafting [CABG] and percutaneous target vessel revascularization [TVR]). To date, patient enrollment has been completed reaching the target of 1065 subjects. These included 322 (30.2%) diabetics, 115 (10.8%) subjects undergoing PES implantation for ULM, 229 (21.5%) in a bifurcation, 191 (17.9%) in a CTO, 430 (40.4%) in a small vessel, and 289 (27.1%) in a long lesion. An average of 1.5+/-0.6 vessels and 2.0+/-1.0 lesions were treated per patient, with 2.0+/-1.2 PES implanted per patient, and a 46+/-30 mm total PES length per patient. In-hospital MACE occurred in 39 (3.7%) patients, with 2 (0.2%) cardiac deaths, 32 (3.0%) MI, 5 (0.5%) TVR, no CABG, and 4 (0.4%) acute stent thromboses. Despite the availability of randomized trials, only carefully designed and prospective registries can provide timely and accurate assessment of the risk-benefit profile of PES in very high-risk patients. Indeed, the TRUE Study, including as much as 115 ULM and 229 bifurcation interventions, should give important insights into the outcome of PES in such an unprecedented and challenging context.

WRN Mutation Update: Mutation Spectrum, Patient Registries, and Translational Prospects.

PubMed

Yokote, Koutaro; Chanprasert, Sirisak; Lee, Lin; Eirich, Katharina; Takemoto, Minoru; Watanabe, Aki; Koizumi, Naoko; Lessel, Davor; Mori, Takayasu; Hisama, Fuki M; Ladd, Paula D; Angle, Brad; Baris, Hagit; Cefle, Kivanc; Palanduz, Sukru; Ozturk, Sukru; Chateau, Antoinette; Deguchi, Kentaro; Easwar, T K M; Federico, Antonio; Fox, Amy; Grebe, Theresa A; Hay, Beverly; Nampoothiri, Sheela; Seiter, Karen; Streeten, Elizabeth; Piña-Aguilar, Raul E; Poke, Gemma; Poot, Martin; Posmyk, Renata; Martin, George M; Kubisch, Christian; Schindler, Detlev; Oshima, Junko

2017-01-01

Werner syndrome (WS) is a rare autosomal recessive disorder characterized by a constellation of adult onset phenotypes consistent with an acceleration of intrinsic biological aging. It is caused by pathogenic variants in the WRN gene, which encodes a multifunctional nuclear protein with exonuclease and helicase activities. WRN protein is thought to be involved in optimization of various aspects of DNA metabolism, including DNA repair, recombination, replication, and transcription. In this update, we summarize a total of 83 different WRN mutations, including eight previously unpublished mutations identified by the International Registry of Werner Syndrome (Seattle, WA) and the Japanese Werner Consortium (Chiba, Japan), as well as 75 mutations already reported in the literature. The Seattle International Registry recruits patients from all over the world to investigate genetic causes of a wide variety of progeroid syndromes in order to contribute to the knowledge of basic mechanisms of human aging. Given the unusually high prevalence of WS patients and heterozygous carriers in Japan, the major goal of the Japanese Consortium is to develop effective therapies and to establish management guidelines for WS patients in Japan and elsewhere. This review will also discuss potential translational approaches to this disorder, including those currently under investigation. © 2016 WILEY PERIODICALS, INC.

WRN Mutation Update: Mutation Spectrum, Patient Registries, and Translational Prospects

PubMed Central

Yokote, Koutaro; Chanprasert, Sirisak; Lee, Lin; Eirich, Katharina; Takemoto, Minoru; Watanabe, Aki; Koizumi, Naoko; Lessel, Davor; Mori, Takayasu; Hisama, Fuki M.; Ladd, Paula D.; Angle, Brad; Baris, Hagit; Cefle, Kivanc; Palanduz, Sukru; Ozturk, Sukru; Chateau, Antoinette; Deguchi, Kentaro; Easwar, T.K.M; Federico, Antonio; Fox, Amy; Grebe, Theresa A.; Hay, Beverly; Nampoothiri, Sheela; Seiter, Karen; Streeten, Elizabeth; Piña-Aguilar, Raul E.; Poke, Gemma; Poot, Martin; Posmyk, Renata; Martin, George M.; Kubisch, Christian; Schindler, Detlev; Oshima, Junko

2017-01-01

Werner syndrome (WS) is a rare autosomal recessive disorder characterized by a constellation of adult onset phenotypes consistent with an acceleration of intrinsic biological aging. It is caused by pathogenic variants in the WRN gene, which encodes a multifunctional nuclear protein with exonuclease and helicase activities. WRN protein is thought to be involved in optimization of various aspects of DNA metabolism, including DNA repair, recombination, replication, and transcription. In this update, we summarize a total of 83 different WRN mutations, including eight previously unpublished mutations identified by the International Registry of Werner Syndrome (Seattle, WA) and the Japanese Werner Consortium (Chiba, Japan), as well as 75 mutations already reported in the literature. The Seattle International Registry recruits patients from all over the world to investigate genetic causes of a wide variety of progeroid syndromes in order to contribute to the knowledge of basic mechanisms of human aging. Given the unusually high prevalence of WS patients and heterozygous carriers in Japan, the major goal of the Japanese Consortium is to develop effective therapies and to establish management guidelines for WS patients in Japan and elsewhere. This review will also discuss potential translational approaches to this disorder, including those currently under investigation. PMID:27667302

Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

PubMed

Chen, Ronald C; Carpenter, William R; Kim, Mimi; Hendrix, Laura H; Agans, Robert P; Meyer, Anne-Marie; Hoffmeyer, Anna; Reeve, Bryce B; Nielsen, Matthew E; Usinger, Deborah S; Strigo, Tara S; Jackman, Anne M; Anderson, Mary; Godley, Paul A

2015-01-01

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

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

PubMed

Kuwatsuka, Yachiyo

2016-01-01

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

Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry.

PubMed

Das, Tony; Mustapha, Jihad; Indes, Jeffrey; Vorhies, Robert; Beasley, Robert; Doshi, Nilesh; Adams, George L

2014-01-01

The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA. Methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below-the-knee. Patients (3135) undergoing OA by more than 350 physicians at over 200 US institutions were enrolled on an "all-comers" basis, resulting in registries that provided site-reported patient demographics, ABI, Rutherford classification, co-morbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes. Treatment with OA reduced pre-procedural stenosis from an average of 88-35%. Final residual stenosis after adjunctive treatments, typically low-pressure percutaneous transluminal angioplasty (PTA), averaged 10%. Plaque removal was most effective for severely calcified lesions and least effective for soft plaque. Shorter spin times and smaller crown sizes significantly lowered procedural complications which included slow flow (4.4%), embolism (2.2%), and spasm (6.3%), emphasizing the importance of treatment regimens that focus on plaque modification over maximizing luminal gain. The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, corresponded to a lower incidence of adverse events irrespective of calcium burden or co-morbidities. Copyright © 2013 The Authors. Wiley Periodicals, Inc.

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

PubMed

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

2017-02-01

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

Acute coronary syndrome registry from four large centres in United Arab Emirates (UAE-ACS Registry)

PubMed Central

Yusufali, Afzalhussein M; AlMahmeed, Wael; Tabatabai, Sadeq; Rao, Kabad; Binbrek, Azan

2010-01-01

Objective To identify the characteristics, treatments and hospital outcomes of patients diagnosed as having acute coronary syndrome (ACS) in the United Arab Emirates (UAE). Design A 3-year prospective registry. Setting Four tertiary care hospitals in three major cities of UAE from December 2003 to December 2006. Patients 1842 eligible consecutive patients with suspected ACS. Interventions None. Main outcome measures Characteristics, treatments and in-hospital outcomes were recorded. Results The mean age was 50.8±10.0 years, and 93.1% were male. More than half (51%) had ST elevation myocardial infarction (STEMI). The smoking rate was 46.4%, and diabetes was present in 38.9%. Only a minority (17.3%) used the ambulance services. For patients with STEMI, the median symptom to hospital time was 127 (IQR 60–256) min, and the median diagnostic ECG to thrombolysis time was 28 (IQR 16–50) min. Reperfusion in STEMI was in 81.4% (64.8% thrombolysis and 16.6% primary percutaneous coronary intervention). During hospitalisation, only a minority of the patients did not receive antiplatelets, anticoagulants, beta-blockers, ACE inhibitors and statin therapy. In-hospital complications were not common in our registry cohort. In-hospital mortality was 1.68%. Conclusions ACS patients in UAE are young but have higher risk factors such as smoking and diabetes. Almost half present as STEMI. Only a minority use ambulance services. PMID:27325958

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

PubMed Central

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

2006-01-01

Background 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. Methods 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. Results 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 participation. Few parents of vaccinated (6.8%) and exempt children (6.7%) were aware of laws authorizing immunization registries. Support for laws authorizing registries and requiring health care providers to report to registries was more common among parents of vaccinated than exempt children. Most parents believed that the government, vaccine companies or insurance companies should pay for registries. Conclusion Parental support for registries was relatively high. Parental support for immunization registries may increase with greater parental awareness of the risks of vaccine preventable diseases and utility of vaccination. PMID:16995946

[The significance of introducing registry study in the post-marketing safety research for Chinese medicine and pharmacy].

PubMed

Liao, Xing; Xie, Yan-Ming; Yang, Wei; Chang, Yan-Peng

2014-03-01

There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.

A brief review of vaccination coverage in immunization registries.

PubMed

Goldstein, Neal D; Maiese, Brett A

2011-01-01

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

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.

PubMed

Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim; De Bruin, Marie L; Arlett, Peter; Kurz, Xavier

2017-12-01

Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. European Public Assessment Reports were consulted to identify products for which a request for a registry was made as a condition of the marketing authorisation. All centrally authorised products that received a positive opinion of the EMA Committee for Medicinal Products for Human Use between 1 January 2005 and 31 December 2013 were included. Data regarding registry design and experiences were collected from EMA electronic record keeping systems. Of 392 products that received a positive Committee for Medicinal Products for Human Use opinion during 2005-2013, 31 registries were requested for 30 products in total. Sixty-five percent were product registries whereas 35% were disease registries and 71% of the registries had a primary safety objective. Most commonly reported issues with registries were delayed time to start and low patient accrual rates. The delays found in getting new registries up and running support the need to improve the timeliness of data collection in the post-marketing setting. Methodological challenges met in conducting this study highlighted the need for a clarification of definitions and epidemiological concepts around patient registries. The results will inform the EMA Patient Registry initiative to support use of existing patient registries for the post-authorisation benefit-risk monitoring of medicinal products. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd.

Value of coronary computed tomography as a prognostic tool.

PubMed

Contractor, Tahmeed; Parekh, Maansi; Ahmed, Shameer; Martinez, Matthew W

2012-08-01

Coronary computed tomography angiography (CCTA) has become an important part of our armamentarium for noninvasive diagnosis of coronary artery disease (CAD). Emerging technologies have produced lower radiation dose, improved spatial and temporal resolution, as well as information about coronary physiology. Although the prognostic role of coronary artery calcium scoring is known, similar evidence for CCTA has only recently emerged. Initial, small studies in various patient populations have indicated that CCTA-identified CAD may have a prognostic value. These findings were confirmed in a recent analysis of the international, prospective Coronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter (CONFIRM) registry. An incremental increase in mortality was found with a worse severity of CAD on a per-patient, per-vessel, and per-segment basis. In addition, age-, sex-, and ethnicity-based differences in mortality were also found. Whether changing our management algorithms based on these findings will affect outcomes is unclear. Large prospective studies utilizing targeted management strategies for obstructive and nonobstructive CAD are required to incorporate these recent findings into our daily practice. © 2012 Wiley Periodicals, Inc.

Tobacco use, body mass index and the risk of malignant lymphomas--a nationwide cohort study in Sweden.

PubMed

Fernberg, Pia; Odenbro, Asa; Bellocco, Rino; Boffetta, Paolo; Pawitan, Yudi; Adami, Johanna

2006-05-01

In the search for risk factors involved in the etiology of lymphoproliferative malignancies there is still inconsistent evidence regarding effects of smoking tobacco, and the role of smokeless tobacco is poorly investigated. New evidence indicates that excess body weight increases the risk of NHL and HD. To determine if tobacco use of various forms and high Body Mass Index (BMI) affect the occurrence of these neoplasms, we conducted a prospective cohort study on over 330,000 Swedish construction workers included in the Construction Industry Working Environment and Health program. Information on smoking, snuff dipping, height and weight was gathered by self administered questionnaires together with personal interviews. Cancer incidence was ascertained through the year 2000 by record linkage to the nationwide Swedish Cancer Registry, Migration Registry and Cause of Death Registry. At the end of follow up, 1,309 subjects had been diagnosed with NHL (including chronic lymphocytic leukemia) and 205 with HD respectively. Age adjusted incidence rate ratios were computed using Cox proportional Hazard regression modeling. Smoking cigarette, pipe or cigar was not associated with NHL or HD. There was no evidence indicating a relation between quantity and duration of smoking and NHL or HD risk. No link was found between NHL and usage of smokeless tobacco. Having a BMI of 30 or higher did not convey excess risk of developing NHL or HD compared to normal weight (BMI 18.6-24.9). We conclude that tobacco smoking and high BMI do not entail an increased risk of NHL and HD. Our findings of a relation between the duration of snuff dipping and HD need further investigation. 2005 Wiley-Liss, Inc.

Disparities in stroke type and vascular risk factors between 2 Hispanic populations in Miami and Mexico city.

PubMed

Romano, Jose G; Arauz, Antonio; Koch, Sebastian; Dong, Chuanhui; Marquez, Juan M; Artigas, Carol; Merlos, Marlon; Hernandez, Bernardo; Roa, Luis F; Rundek, Tatjana; Sacco, Ralph L

2013-08-01

The heterogeneous nature and determinants of stroke among different Hispanic groups was examined by comparing hospitalized Hispanic stroke patients in Miami, where the Hispanic population is largely of Caribbean origin, to a Mestizo population in Mexico City. Consecutive Hispanic patients who were admitted with stroke or transient ischemic attack (TIA) and included in the prospective stroke registries of 2 tertiary care teaching hospitals were studied. Demographic factors, stroke subtypes, vascular risk factors, stroke severity, and outcomes were compared. Vascular risk factor definitions were standardized. A total of 928 patients (520 Mexicans and 408 Miami Hispanics) were analyzed. Mexicans were younger, with a greater proportion of women. More cerebral venous thromboses (CVTs) were admitted in Mexico, while TIA and stroke mimics were more commonly admitted in Miami; cardioembolic strokes were more commonly ascertained in Miami, and more cryptogenic strokes in Mexico. Stroke severity was similar for intracerebral hemorrhages, but more severe ischemic strokes and CVTs were included in the Mexican registry. Outcome at 1 and 3 months was similar in both registries after adjusting for age and baseline stroke severity. After adjusting for age and sex, hypertension, dyslipidemia, and atrial fibrillation were more frequent, and diabetes mellitus was less frequent, among Miami Hispanics compared to Mexicans. We found significant differences in the frequency of hypertension, diabetes, dyslipidemia, and atrial fibrillation in Miami Hispanics and Mexican stroke patients, highlighting the heterogeneity of the Hispanic ethnic group. Future studies are needed to clarify the relative contribution of genetic and environmental disparities amongst Mexican and Caribbean Hispanic stroke patients. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Extralevator Abdominoperineal Excision for Low Rectal Cancer—Extensive Surgery to Be Used With Discretion Based on 3-Year Local Recurrence Results

PubMed Central

Prytz, Mattias; Angenete, Eva; Bock, David; Haglind, Eva

2016-01-01

Objectives: The aim of this prospective registry-based population study was to investigate the efficacy of extralevator abdominoperineal excision (ELAPE) regarding local recurrence rates within 3 years after surgery. Background: Local recurrence of rectal cancer is more common after abdominoperineal excision (APE) than after anterior resection. Extralevator abdominoperineal excision was introduced to address this problem. No large-scale studies with long-term oncological outcomes have been published. Methods: All Swedish patients operated on with an APE and registered in the Swedish ColoRectal Cancer Registry 2007 to 2009 were included (n = 1397) and analyzed with emphasis on the perineal part of the operation. Local recurrence at 3 years was collected from the registry. Results: The local recurrence rates at 3 years [median follow-up, 3.43 years (APE, 3.37 years; ELAPE, 3.41 years; not stated: 3.43 years)] were significantly higher for ELAPE compared with APE (relative risk, 4.91). Perioperative perforation was also associated with an increased risk of local recurrence (relative risk, 3.62). There was no difference in 3-year overall survival between APE and ELAPE. In the subgroup of patients with very low tumors (≤4 cm from the anal verge), no significant difference in the local recurrence rate could be observed. Conclusions: Extralevator abdominoperineal excision results in a significantly increased 3-year local recurrence rate as compared with standard APE. Intraoperative perforation seems to be an important risk factor for local recurrence. In addition to significantly increased 3-year local recurrence rates, the significantly increased incidence of wound complications leads to the conclusion that ELAPE should only be considered in selected patients at risk of intraoperative perforation. PMID:25906414

Pooling and expanding registries of familial hypercholesterolaemia to assess gaps in care and improve disease management and outcomes: Rationale and design of the global EAS Familial Hypercholesterolaemia Studies Collaboration.

PubMed

Vallejo-Vaz, Antonio J; Akram, Asif; Kondapally Seshasai, Sreenivasa Rao; Cole, Della; Watts, Gerald F; Hovingh, G Kees; Kastelein, John J P; Mata, Pedro; Raal, Frederick J; Santos, Raul D; Soran, Handrean; Freiberger, Tomas; Abifadel, Marianne; Aguilar-Salinas, Carlos A; Alnouri, Fahad; Alonso, Rodrigo; Al-Rasadi, Khalid; Banach, Maciej; Bogsrud, Martin P; Bourbon, Mafalda; Bruckert, Eric; Car, Josip; Ceska, Richard; Corral, Pablo; Descamps, Olivier; Dieplinger, Hans; Do, Can T; Durst, Ronen; Ezhov, Marat V; Fras, Zlatko; Gaita, Dan; Gaspar, Isabel M; Genest, Jaques; Harada-Shiba, Mariko; Jiang, Lixin; Kayikcioglu, Meral; Lam, Carolyn S P; Latkovskis, Gustavs; Laufs, Ulrich; Liberopoulos, Evangelos; Lin, Jie; Lin, Nan; Maher, Vincent; Majano, Nelson; Marais, A David; März, Winfried; Mirrakhimov, Erkin; Miserez, André R; Mitchenko, Olena; Nawawi, Hapizah; Nilsson, Lennart; Nordestgaard, Børge G; Paragh, György; Petrulioniene, Zaneta; Pojskic, Belma; Reiner, Željko; Sahebkar, Amirhossein; Santos, Lourdes E; Schunkert, Heribert; Shehab, Abdullah; Slimane, M Naceur; Stoll, Mario; Su, Ta-Chen; Susekov, Andrey; Tilney, Myra; Tomlinson, Brian; Tselepis, Alexandros D; Vohnout, Branislav; Widén, Elisabeth; Yamashita, Shizuya; Catapano, Alberico L; Ray, Kausik K

2016-12-01

The potential for global collaborations to better inform public health policy regarding major non-communicable diseases has been successfully demonstrated by several large-scale international consortia. However, the true public health impact of familial hypercholesterolaemia (FH), a common genetic disorder associated with premature cardiovascular disease, is yet to be reliably ascertained using similar approaches. The European Atherosclerosis Society FH Studies Collaboration (EAS FHSC) is a new initiative of international stakeholders which will help establish a global FH registry to generate large-scale, robust data on the burden of FH worldwide. The EAS FHSC will maximise the potential exploitation of currently available and future FH data (retrospective and prospective) by bringing together regional/national/international data sources with access to individuals with a clinical and/or genetic diagnosis of heterozygous or homozygous FH. A novel bespoke electronic platform and FH Data Warehouse will be developed to allow secure data sharing, validation, cleaning, pooling, harmonisation and analysis irrespective of the source or format. Standard statistical procedures will allow us to investigate cross-sectional associations, patterns of real-world practice, trends over time, and analyse risk and outcomes (e.g. cardiovascular outcomes, all-cause death), accounting for potential confounders and subgroup effects. The EAS FHSC represents an excellent opportunity to integrate individual efforts across the world to tackle the global burden of FH. The information garnered from the registry will help reduce gaps in knowledge, inform best practices, assist in clinical trials design, support clinical guidelines and policies development, and ultimately improve the care of FH patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Predicting trauma patient mortality: ICD [or ICD-10-AM] versus AIS based approaches.

PubMed

Willis, Cameron D; Gabbe, Belinda J; Jolley, Damien; Harrison, James E; Cameron, Peter A

2010-11-01

The International Classification of Diseases Injury Severity Score (ICISS) has been proposed as an International Classification of Diseases (ICD)-10-based alternative to mortality prediction tools that use Abbreviated Injury Scale (AIS) data, including the Trauma and Injury Severity Score (TRISS). To date, studies have not examined the performance of ICISS using Australian trauma registry data. This study aimed to compare the performance of ICISS with other mortality prediction tools in an Australian trauma registry. This was a retrospective review of prospectively collected data from the Victorian State Trauma Registry. A training dataset was created for model development and a validation dataset for evaluation. The multiplicative ICISS model was compared with a worst injury ICISS approach, Victorian TRISS (V-TRISS, using local coefficients), maximum AIS severity and a multivariable model including ICD-10-AM codes as predictors. Models were investigated for discrimination (C-statistic) and calibration (Hosmer-Lemeshow statistic). The multivariable approach had the highest level of discrimination (C-statistic 0.90) and calibration (H-L 7.65, P= 0.468). Worst injury ICISS, V-TRISS and maximum AIS had similar performance. The multiplicative ICISS produced the lowest level of discrimination (C-statistic 0.80) and poorest calibration (H-L 50.23, P < 0.001). The performance of ICISS may be affected by the data used to develop estimates, the ICD version employed, the methods for deriving estimates and the inclusion of covariates. In this analysis, a multivariable approach using ICD-10-AM codes was the best-performing method. A multivariable ICISS approach may therefore be a useful alternative to AIS-based methods and may have comparable predictive performance to locally derived TRISS models. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

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

Xu, Dong; You, Xin; Wang, Zhengang; 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

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. 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. 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). 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.

Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project

PubMed Central

Frank, Bernd; Ariza, Liana; Lamparter, Heidrun; Grossmann, Vera; Prochaska, Jürgen H; Ullmann, Alexander; Kindler, Florentina; Weisser, Gerhard; Walter, Ulrich; Lackner, Karl J; Espinola-Klein, Christine; Münzel, Thomas; Konstantinides, Stavros V; Wild, Philipp S

2015-01-01

Introduction Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date. Methods and analysis The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three ‘all-comer’ studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings. Ethics and dissemination The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and international scientific meetings. Trial registration number NCT02156401. PMID:26133379

Does perceived risk predict breast cancer screening use? Findings from a prospective cohort study of female relatives from the Ontario site of the breast cancer family registry.

PubMed

Walker, Meghan J; Mirea, Lucia; Glendon, Gord; Ritvo, Paul; Andrulis, Irene L; Knight, Julia A; Chiarelli, Anna M

2014-08-01

While the relationship between perceived risk and breast cancer screening use has been studied extensively, most studies are cross-sectional. We prospectively examined this relationship among 913 women, aged 25-72 with varying levels of familial breast cancer risk from the Ontario site of the Breast Cancer Family Registry. Associations between perceived lifetime breast cancer risk and subsequent use of mammography, clinical breast examination (CBE) and genetic testing were assessed using logistic regression. Overall, perceived risk did not predict subsequent use of mammography, CBE or genetic testing. Among women at moderate/high familial risk, those reporting a perceived risk greater than 50% were significantly less likely to have a CBE (odds ratio (OR) = 0.52, 95% confidence interval (CI): 0.30-0.91, p = 0.04), and non-significantly less likely to have a mammogram (OR = 0.70, 95% CI: 0.40-1.20, p = 0.70) or genetic test (OR = 0.61, 95% CI: 0.34-1.10, p = 0.09) compared to women reporting a perceived risk of 50%. In contrast, among women at low familial risk, those reporting a perceived risk greater than 50% were non-significantly more likely to have a mammogram (OR = 1.13, 95% CI: 0.59-2.16, p = 0.78), CBE (OR = 1.11, 95% CI: 0.63-1.95, p = 0.74) or genetic test (OR = 1.29, 95% CI: 0.50-3.33, p = 0.35) compared to women reporting a perceived risk of 50%. Perceived risk did not significantly predict screening use overall, however this relationship may be moderated by level of familial risk. Results may inform risk education and management strategies for women with varying levels of familial breast cancer risk. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders. Methods/design Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate. Discussion This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies. Systematic review registration PROSPERO CRD42014009506 PMID:25312992

Efficacy and safety of rituximab in pemphigus: experience of the German Registry of Autoimmune Diseases.

PubMed

Kasperkiewicz, Michael; Eming, Rüdiger; Behzad, Melika; Hunzelmann, Nicolas; Meurer, Michael; Schulze-Koops, Hendrik; von Wussow, Peter; Hertl, Michael; Zillikens, Detlef; Freivogel, Klaus; Dörner, Thomas; Schmidt, Enno

2012-10-01

Rituximab has been reported to be effective in various small case series of patients with severe and/or refractory pemphigus. However, no systematic evaluation is available to corroborate this observation. The aim of this study was to systematically determine efficacy and safety of rituximab in treatment-resistant pemphigus. Multicenter retrospective, observational study of 36 patients with severe pemphigus vulgaris (n = 33) and pemphigus foliaceus (n = 3) treated with rituximab before August 31(st) , 2008 and enrolled in a national observational registery between December 2008 and June 2009. Within a mean period of observation of 11 (1-37) months, 21 (58 %) pemphigus patients showed complete, 13 (36 %) partial, and 2 (6 %) no response to rituximab treatment. This correlates with a mean improvement of the visual analog scale for well-being of 34 (20-60) at baseline to 75 (40-95) at the last control visit. In 4 (11 %) patients, severe adverse events were recorded including 1 (3 %) serious infection. Data collected in this systematic registry indicate that rituximab is an effective and relatively safe adjuvant treatment option for refractory pemphigus. To further extend our knowledge on efficacy and safety of this drug, controlled prospective trials are required. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

Chocolate consumption and risk of stroke: a prospective cohort of men and meta-analysis.

PubMed

Larsson, Susanna C; Virtamo, Jarmo; Wolk, Alicja

2012-09-18

To investigate the association between chocolate consumption and risk of stroke in men and conduct a meta-analysis to summarize available evidence from prospective studies of chocolate consumption and stroke. We prospectively followed 37,103 men in the Cohort of Swedish Men. Chocolate consumption was assessed at baseline using a food-frequency questionnaire. Cases of first stroke were ascertained from the Swedish Hospital Discharge Registry. For the meta-analysis, pertinent studies were identified by searching the PubMed and EMBASE databases through January 13, 2012. Study-specific results were combined using a random-effects model. During 10.2 years of follow-up, we ascertained 1,995 incident stroke cases, including 1,511 cerebral infarctions, 321 hemorrhagic strokes, and 163 unspecified strokes. High chocolate consumption was associated with a lower risk of stroke. The multivariable relative risk of stroke comparing the highest quartile of chocolate consumption (median 62.9 g/week) with the lowest quartile (median 0 g/week) was 0.83 (95 % CI 0.70-0.99). The association did not differ by stroke subtypes. In a meta-analysis of 5 studies, with a total of 4,260 stroke cases, the overall relative risk of stroke for the highest vs lowest category of chocolate consumption was 0.81 (95% CI 0.73-0.90), without heterogeneity among studies (p = 0.47). These findings suggest that moderate chocolate consumption may lower the risk of stroke.

Clinical phenotypes and outcome of patients hospitalized for acute heart failure: the ESC Heart Failure Long-Term Registry.

PubMed

Chioncel, Ovidiu; Mebazaa, Alexandre; Harjola, Veli-Pekka; Coats, Andrew J; Piepoli, Massimo Francesco; Crespo-Leiro, Maria G; Laroche, Cecile; Seferovic, Petar M; Anker, Stefan D; Ferrari, Roberto; Ruschitzka, Frank; Lopez-Fernandez, Silvia; Miani, Daniela; Filippatos, Gerasimos; Maggioni, Aldo P

2017-10-01

To identify differences in clinical epidemiology, in-hospital management and 1-year outcomes among patients hospitalized for acute heart failure (AHF) and enrolled in the European Society of Cardiology Heart Failure Long-Term (ESC-HF-LT) Registry, stratified by clinical profile at admission. The ESC-HF-LT Registry is a prospective, observational study collecting hospitalization and 1-year follow-up data from 6629 AHF patients. Among AHF patients enrolled in the registry, 13.2% presented with pulmonary oedema (PO), 2.9% with cardiogenic shock (CS), 61.1% with decompensated heart failure (DHF), 4.8% with hypertensive heart failure (HT-HF), 3.5% with right heart failure (RHF) and 14.4% with AHF and associated acute coronary syndromes (ACS-HF). The 1-year mortality rate was 28.1% in PO, 54.0% in CS, 27.2% in DHF, 12.8% in HT-HF, 34.0% in RHF and 20.6% in ACS-HF patients. When patients were classified by systolic blood pressure (SBP) at initial presentation, 1-year mortality was 34.8% in patients with SBP <85 mmHg, 29.0% in those with SBP 85-110 mmHg, 21.2% in patients with SBP 110-140 mmHg and 17.4% in those with SBP >140 mmHg. These differences tended to diminish in the months post-discharge, and 1-year mortality for the patients who survived at least 6 months post-discharge did not vary significantly by either clinical profile or SBP classification. Rates of adverse outcomes in AHF remain high, and substantial differences have been found when patients were stratified by clinical profile or SBP. However, patients who survived at least 6 months post-discharge represent a more homogeneous group and their 1-year outcome is less influenced by clinical profile or SBP at admission. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Comparative study on the National Renal Disease Registry in America, England and Iran.

PubMed

Ajami, Sima; Askarianzadeh, Mahdi; Saghaeiannejad-Isfahani, Sakineh; Mortazavi, Mojgan; Ehteshami, Asghar

2014-01-01

A disease registry is a database that includes information about people diagnosed with specific types of diseases. The registry collects information that can be used for capturing, managing, and organizing specific information for patients. The aim of this study was to identify and compare the National Renal Disease Registry (NRDR) in selected countries including the United States, United Kingdom, and Iran. Retrieval of data of the NRDR performed through scholars responsible in related agencies, including the Ministry of Health and Medical Education, and Renal Disease charity, and data registries in the United States, United Kingdom, and Iran. This research was an applied and descriptive, comparative study. The study population consisted of the National Renal Disease Registry of the selected countries including the United States, United Kingdom, and Iran, from which data were collected using forms that were designed according to the study objectives. Sources of data were researchers, scholars responsible in related agencies, including the Ministry of Health and Medical Education, and Renal Disease charity, data registries, articles, books, journals, databases, websites, and related documents. Data were gathered through phone, e-mail, study, observation, and interview. The researchers collected data for each country based on the study objectives and then put them in comparative tables. Data were analyzed by descriptive, comparative, and theoretical methods. There is no NRDR in Iran to report the short- and long-term results of renal disease. Most of the renal transplant teams report their own results as single-center experiences. America and Britain have pre-eminent national registry of renal disease, compared to other countries. The Iranian Society of Nephrology should be actively involved to create a National Renal Registry in Iran. The registry should have representatives from the universities, government, armed forces, and private sectors. Researchers proposed to design the Iran National Renal Registry according to the UK Renal Disease Registry model because of its prominent healthcare system.

Assessment of iron deficiency and anemia in pregnant women: an observational French study.

PubMed

Harvey, Thierry; Zkik, Asmaa; Auges, Marie; Clavel, Thierry

2016-01-01

We explored the prevalence and management of iron deficiency and anemia among pregnant women in France. In this prospective, observational, multicenter registry study, randomly selected investigators (gynecologists/obstetricians/midwives registered in the CEGEDIM(®) database) assessed pregnant women presenting for a consultation. Participants completed a questionnaire at study inclusion. A total of 1506 patients were enrolled by 95 investigators. Overall, investigators estimated a moderate or significant risk of iron deficiency in almost 60% of women. The overall prevalence of anemia (15.8%) increased with longer pregnancy duration. Medication (mainly iron-based) was prescribed to 57.3% of patients. In French clinical practice, the estimated risk of iron deficiency and prevalence of anemia during pregnancy align with expectations and are managed according to national/international recommendations.

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

PubMed

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

2017-06-01

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

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

PubMed Central

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

2017-01-01

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

Evidence and practice in spine registries

PubMed Central

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

2015-01-01

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

Novel use of the Wii Balance Board to prospectively predict falls in community-dwelling older adults.

PubMed

Kwok, Boon-Chong; Clark, Ross A; Pua, Yong-Hao

2015-06-01

The Wii Balance Board has received increasing attention as a balance measurement tool; however its ability to prospectively predict falls is unknown. This exploratory study investigated the use of the Wii Balance Board and other clinical-based measures for prospectively predicting falls among community-dwelling older adults. Seventy-three community-dwelling men and women, aged 60-85years were followed-up over a year for falls. Standing balance was indexed by sway velocities measured using the Wii Balance Board interfaced with a laptop. Clinical-based measures included Short Physical Performance Battery, gait speed and Timed-Up-and-Go test. Multivariable regression analyses were used to assess the ability of the Wii Balance Board measure to complement the TUG test in fall screening. Individually, the study found Wii Balance Board anteroposterior (odds ratio 1.98, 95% CI 1.16 to 3.40, P=0.01) and mediolateral (odds ratio 2.80, 95% CI 1.10 to 7.13, p=0.03) sway velocity measures predictive of prospective falls. However, when each velocity measure was adjusted with body mass index and Timed-Up-and-Go, only anteroposterior sway velocity was predictive of prospective falls (odds ratio 2.21, 95% CI 1.18 to 4.14). A faster anteroposterior velocity was associated with increased odds of falling. Area-under-the-curves for Wii Balance Board sway velocities were 0.67 and 0.71 for anteroposterior and mediolateral respectively. The Wii Balance Board-derived anteroposterior sway velocity measure could complement existing clinical-based measures in predicting future falls among community-dwelling older adults. Australian New Zealand Clinical Trials Registry number: ACTRN12610001099011. Copyright © 2015 Elsevier Ltd. All rights reserved.

Health risk in the offspring of female semiconductor workers.

PubMed

Lin, Ching-Chun; Wang, Jung-Der; Hsieh, Gong-Yih; Chang, Yu-Yin; Chen, Pau-Chung

2008-09-01

There are no published studies focusing on adverse birth outcomes or infant mortality in the semiconductor industry. To investigate whether female workers have higher risks of any adverse birth outcome or death from congenital malformation. A total of 27,610 female workers had been employed in eight semiconductor companies in Taiwan between 1980 and 2000. Using the national birth registry, their live born children were identified, and then any deaths under 5 years of age with or without congenital malformations were identified by linking with the national death registry. Periconceptional exposure was defined as the mother having been employed in the semiconductor industry 3 months before and 3 months after conception of the live born infants. A total of 24,223 live births were included. No significant association between adverse birth outcomes or death with congenital malformation and maternal employment in semiconductor industry was found either in the period of 1980-94 or 1995-2000. There is no convincing evidence that female workers employed during the periconceptional period in the semiconductor industry had higher risks of having adverse birth outcomes or death due to congenital malformations. However, prospective research is warranted to confirm these findings.

Epidemiology and outcomes of invasive candidiasis due to non-albicans species of Candida in 2,496 patients: data from the Prospective Antifungal Therapy (PATH) registry 2004-2008.

PubMed

Pfaller, Michael A; Andes, David R; Diekema, Daniel J; Horn, David L; Reboli, Annette C; Rotstein, Coleman; Franks, Billy; Azie, Nkechi E

2014-01-01

This analysis describes the epidemiology and outcomes of invasive candidiasis caused by non-albicans species of Candida in patients enrolled in the Prospective Antifungal Therapy Alliance (PATH Alliance) registry from 2004 to 2008. A total of 2,496 patients with non-albicans species of Candida isolates were identified. The identified species were C. glabrata (46.4%), C. parapsilosis (24.7%), C. tropicalis (13.9%), C. krusei (5.5%), C. lusitaniae (1.6%), C. dubliniensis (1.5%) and C. guilliermondii (0.4%); 111 infections involved two or more species of Candida (4.4%). Non-albicans species accounted for more than 50% of all cases of invasive candidiasis in 15 of the 24 sites (62.5%) that contributed more than one case to the survey. Among solid organ transplant recipients, patients with non-transplant surgery, and patients with solid tumors, the most prevalent non-albicans species was C. glabrata at 63.7%, 48.0%, and 53.8%, respectively. In 1,883 patients receiving antifungal therapy on day 3, fluconazole (30.5%) and echinocandins (47.5%) were the most frequently administered monotherapies. Among the 15 reported species, 90-day survival was highest for patients infected with either C. parapsilosis (70.7%) or C. lusitaniae (74.5%) and lowest for patients infected with an unknown species (46.7%) or two or more species (53.2%). In conclusion, this study expands the current knowledge of the epidemiology and outcomes of invasive candidiasis caused by non-albicans species of Candida in North America. The variability in species distribution in these centers underscores the importance of local epidemiology in guiding the selection of antifungal therapy.

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

PubMed

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

2015-01-01

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

Aminocaproic acid administration is associated with reduced perioperative blood loss and transfusion in pediatric craniofacial surgery.

PubMed

Hsu, G; Taylor, J A; Fiadjoe, J E; Vincent, A M; Pruitt, E Y; Bartlett, S P; Stricker, P A

2016-02-01

Severe blood loss is a common complication of craniofacial reconstruction surgery. The antifibrinolytic ε-aminocaproic acid (EACA) reduces transfusion requirements in children undergoing cardiac surgery and in older children undergoing spine surgery. Tranexamic acid (TXA), another antifibrinolytic with a similar mechanism of action, has been shown to reduce blood loss and transfusion requirements in children undergoing craniofacial surgery. However, TXA has been associated with an increase in post-operative seizures and is more expensive than EACA. There is currently little published data evaluating the efficacy of EACA in children undergoing craniofacial surgery. This is a retrospective study of prospectively collected data from our craniofacial perioperative registries for children under 6 years of age who underwent anterior or posterior cranial vault reconstruction. We compared calculated blood loss, blood donor exposures, and post-operative drain output between subjects who received EACA and those who did not. The registry queries returned data from 152 subjects. Eighty-six did not receive EACA and 66 received EACA. The EACA group had significantly lower calculated blood loss (82 ± 43 vs. 106 ± 63 ml/kg, P = 0.01), fewer intraoperative blood donor exposures (median 2, interquartile range 1-2 vs. median 2, interquartile range 1-3; P = 0.02) and lower surgical drain output in the first post-operative 24 h (28 ml/kg vs. 37 ml/kg, P = 0.001) than the non-EACA group. In this analysis of prospectively captured observational data, EACA administration was associated with less calculated blood loss, intraoperative blood donor exposures, and post-operative surgical drain output. © 2015 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Long-term outcome after arterial ischemic stroke in children and young adults.

PubMed

Goeggel Simonetti, Barbara; Cavelti, Ariane; Arnold, Marcel; Bigi, Sandra; Regényi, Mária; Mattle, Heinrich P; Gralla, Jan; Fluss, Joel; Weber, Peter; Hackenberg, Annette; Steinlin, Maja; Fischer, Urs

2015-05-12

To compare long-term outcome of children and young adults with arterial ischemic stroke (AIS) from 2 large registries. Prospective cohort study comparing functional and psychosocial long-term outcome (≥2 years after AIS) in patients who had AIS during childhood (1 month-16 years) or young adulthood (16.1-45 years) between January 2000 and December 2008, who consented to follow-up. Data of children were collected prospectively in the Swiss Neuropediatric Stroke Registry, young adults in the Bernese stroke database. Follow-up information was available in 95/116 children and 154/187 young adults. Median follow-up of survivors was 6.9 years (interquartile range 4.7-9.4) and did not differ between the groups (p = 0.122). Long-term functional outcome was similar (p = 0.896): 53 (56%) children and 84 (55%) young adults had a favorable outcome (modified Rankin Scale 0-1). Mortality in children was 14% (13/95) and in young adults 7% (11/154) (p = 0.121) and recurrence rate did not differ (p = 0.759). Overall psychosocial impairment and quality of life did not differ, except for more behavioral problems among children (13% vs 5%, p = 0.040) and more frequent reports of an impact of AIS on everyday life among adults (27% vs 64%, p < 0.001). In a multivariate regression analysis, low Pediatric NIH Stroke Scale/NIH Stroke Scale score was the most important predictor of favorable outcome (p < 0.001). There were no major differences in long-term outcome after AIS in children and young adults for mortality, disability, quality of life, psychological, or social variables. © 2015 American Academy of Neurology.

Risk stratification of patients with severe heart failure awaiting heart transplantation-prospective national registry POLKARD HF.

PubMed

Zieliński, T; Browarek, A; Zembala, M; Sadowski, J; Zakliczyński, M; Przybylowski, P; Roguski, K; Kosakowska, A B; Korewicki, J

2009-10-01

Most methods used in the risk assessment of heart transplant candidates do not include new biomarkers. The aim of the study was to examine the value of NTproBNP and hsCRP and their combined use together with HFSS score in the risk assessment of patients with heart failure enlisted for heart transplantation. Data of 658 patients enlisted for heart transplantation in all active transplantation centers were stored in a prospective registry. The composite end point-death or urgent transplantation was recorded during the follow-up. Death or urgent transplantation was recorded in 161 (24%) of pts. 102 (15%) patients died and 59 (9%) were transplanted urgently. Kaplan-Meier curves for risk of death or urgent transplantation where highly significant when pts were stratified by the quartiles of NT proBNP (P < .000001) or quartiles according to the hsCRP level on admission (P < .002). In the multivariate Cox proportional hazard model, the significance was observed for NTproBNP (P < .01) and HFSS (P < .02), and borderline significance for hsCRP (P = .057). When ROC analyses of the area under the curve (AUC) values were considered, AUC area was for HFSS - 0.645, for NTproBNP - 0.653 and for hsCRP - 0.566. When all those variables were included together in the model, the AUC value rose to 0.6943. Based on those results a weighted risk model with all three parameters was proposed. HFSS, NTproBNP and hsCRP levels are independent stratification variables of survival or need for urgent heart transplantation. Their predictive value is moderately increased when they are analyzed together.

Do measures of surgical effectiveness at 1 year after lumbar spine surgery accurately predict 2-year outcomes?

PubMed

Adogwa, Owoicho; Elsamadicy, Aladine A; Han, Jing L; Cheng, Joseph; Karikari, Isaac; Bagley, Carlos A

2016-12-01

OBJECTIVE With the recent passage of the Patient Protection and Affordable Care Act, there has been a dramatic shift toward critical analyses of quality and longitudinal assessment of subjective and objective outcomes after lumbar spine surgery. Accordingly, the emergence and routine use of real-world institutional registries have been vital to the longitudinal assessment of quality. However, prospectively obtaining longitudinal outcomes for patients at 24 months after spine surgery remains a challenge. The aim of this study was to assess if 12-month measures of treatment effectiveness accurately predict long-term outcomes (24 months). METHODS A nationwide, multiinstitutional, prospective spine outcomes registry was used for this study. Enrollment criteria included available demographic, surgical, and clinical outcomes data. All patients had prospectively collected outcomes measures and a minimum 2-year follow-up. Patient-reported outcomes instruments (Oswestry Disability Index [ODI], SF-36, and visual analog scale [VAS]-back pain/leg pain) were completed before surgery and then at 3, 6, 12, and 24 months after surgery. The Health Transition Index of the SF-36 was used to determine the 1- and 2-year minimum clinically important difference (MCID), and logistic regression modeling was performed to determine if achieving MCID at 1 year adequately predicted improvement and achievement of MCID at 24 months. RESULTS The study group included 969 patients: 300 patients underwent anterior lumbar interbody fusion (ALIF), 606 patients underwent transforaminal lumbar interbody fusion (TLIF), and 63 patients underwent lateral interbody fusion (LLIF). There was a significant correlation between the 12- and 24-month ODI (r = 0.82; p < 0.0001), SF-36 Physical Component Summary score (r = 0.89; p < 0.0001), VAS-back pain (r = 0.90; p < 0.0001), and VAS-leg pain (r = 0.85; p < 0.0001). For the ALIF cohort, patients achieving MCID thresholds for ODI at 12 months were 13-fold (p < 0.0001) more likely to achieve MCID at 24 months. Similarly, for the TLIF and LLIF cohorts, patients achieving MCID thresholds for ODI at 12 months were 13-fold and 14-fold (p < 0.0001) more likely to achieve MCID at 24 months. Outcome measures obtained at 12 months postoperatively are highly predictive of 24-month outcomes, independent of the surgical procedure. CONCLUSIONS In a multiinstitutional prospective study, patient-centered measures of surgical effectiveness obtained at 12 months adequately predict long-term (24-month) outcomes after lumbar spine surgery. Patients achieving MCID at 1 year were more likely to report meaningful and durable improvement at 24 months, suggesting that the 12-month time point is sufficient to identify effective versus ineffective patient care.

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

PubMed

Paxton, Elizabeth W; Kiley, Mary-Lou; Love, Rebecca; Barber, Thomas C; Funahashi, Tadashi T; Inacio, Maria C S

2013-06-01

In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

The association between mammographic calcifications and breast cancer prognostic factors in a population-based registry cohort.

PubMed

Nyante, Sarah J; Lee, Sheila S; Benefield, Thad S; Hoots, Tiffany N; Henderson, Louise M

2017-01-01

Mammographic calcifications can be a marker of malignancy, but their association with prognosis is less well established. In the current study, the authors examined the relationship between calcifications and breast cancer prognostic factors in the population-based Carolina Mammography Registry. The current study included 8472 invasive breast cancers diagnosed in the Carolina Mammography Registry between 1996 and 2011 for which information regarding calcifications occurring within 2 years of diagnosis was reported. Calcification-specific Breast Imaging Reporting and Data System (BI-RADS) assessments were reported prospectively by a radiologist. Tumor characteristic data were obtained from the North Carolina Central Cancer Registry and/or pathology reports. Multivariable-adjusted associations between the presence of calcifications in the breast affected by cancer and tumor characteristics were estimated using logistic regression. Statistical tests were 2-sided. The presence of calcifications was found to be positively associated with tumors that were high grade (vs low grade: odds ratio [OR], 1.43; 95% confidence interval [95% CI], 1.10-1.88) or had an in situ component (vs without: OR, 2.15; 95% CI, 1.81-2.55). Calcifications were found to be inversely associated with hormone receptor-negative status (vs positive status: OR, 0.73; 95% CI, 0.57-0.93), size >35 mm (vs ≤8 mm: OR, 0.47; 95% CI, 0.37-0.61), and lobular tumors (vs ductal: OR, 0.39; 95% CI, 0.22-0.69). The association between the presence of calcifications and an in situ component was limited to BI-RADS category 4 and 5 calcifications and was absent for BI-RADS category 2 or 3 calcifications (P for heterogeneity <.01). The association with tumor size was found to be strongest for BI-RADS categories 3 and 4 (P for heterogeneity <.01). Calcifications were found to be associated with both unfavorable (high grade) and favorable (small size, hormone receptor positivity) prognostic factors. Detailed analysis of the biological features of calcifications is necessary to understand the mechanisms driving these associations. Cancer 2017;123:219-227. © 2016 American Cancer Society. © 2016 American Cancer Society.

Fully Transradial Versus Transfemoral Approach for Percutaneous Intervention of Coronary Chronic Total Occlusions Applying the Hybrid Algorithm: Insights From RECHARGE Registry.

PubMed

Bakker, Erik Jan; Maeremans, Joren; Zivelonghi, Carlo; Faurie, Benjamin; Avran, Alexandre; Walsh, Simon; Spratt, James C; Knaapen, Paul; Hanratty, Colm G; Bressollette, Erwan; Kayaert, Peter; Bagnall, Alan J; Egred, Mohaned; Smith, David; McEntegart, Margaret B; Smith, William H T; Kelly, Paul; Irving, John; Smith, Elliot J; Strange, Julian W; Dens, Joseph; Agostoni, Pierfrancesco

2017-09-01

Small observational studies demonstrate the feasibility of transradial approach for chronic total occlusion (CTO) percutaneous coronary intervention. The aim of the current study is to assess technical success, complication rates, and procedural efficiency in fully transradial approach (fTRA) and transfemoral approach (TFA) in a large prospective European registry adopting the hybrid algorithm for CTO percutaneous coronary intervention (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom, RECHARGE registry). We analyzed 1253 CTO percutaneous coronary intervention procedures performed according to the hybrid protocol in 17 European centers, comparing fTRA (single or biradial access) and TFA (single or bifemoral or combined radial and femoral access). fTRA was applied in 306 (24%) and TFA in 947 (76%) cases. The average Japanese CTO score was 2.1±1.2 in fTRA and 2.3±1.1 in TFA ( P =0.06). Technical success was achieved in 85% in fTRA and 86% in TFA ( P =0.51). Technical success was comparable for fTRA and TFA in different Japanese CTO score subgroups after multivariable analysis and after propensity adjustment. In-hospital major adverse cardiac and cerebral events occurred in 2.0% in fTRA and 2.9% in TFA ( P =0.40). Major access site bleeding occurred in 0.3% in fTRA and 0.5% in TFA ( P =0.66). fTRA compared with TFA had similar procedural duration (80 minutes [54-120 minutes] versus 90 minutes [60-121 minutes]; P =0.07), similar radiation dose (dose area product 89 Gray×cm 2 [52-163 Gray×cm 2 ] versus 101 Gray×cm 2 [59-171 Gray×cm 2 ]; P =0.06), and lower contrast agent use (200 mL [150-310 mL] versus 250 mL [200-350 mL]; P <0.01). fTRA CTO percutaneous coronary intervention is a valid alternative to TFA with a high rate of success, low complication rates, and no decrease in procedural efficiency. © 2017 American Heart Association, Inc.

Baseline characteristics, management practices, and in-hospital outcomes of patients with acute coronary syndromes: Results of the Saudi project for assessment of coronary events (SPACE) registry

PubMed Central

AlHabib, Khalid F.; Hersi, Ahmad; AlFaleh, Hussam; AlNemer, Khalid; AlSaif, Shukri; Taraben, Amir; Kashour, Tarek; Bakheet, Anas; Qarni, Ayed Al; Soomro, Tariq; Malik, Asif; Ahmed, Waqar H.; Abuosa, Ahmed M.; Butt, Modaser A.; AlMurayeh, Mushabab A.; Zaidi, Abdulaziz Al; Hussein, Gamal A.; Balghith, Mohammed A.; Abu-Ghazala, Tareg

2011-01-01

Objectives The Saudi Project for Assessment of Coronary Events (SPACE) registry is the first in Saudi Arabia to study the clinical features, management, and in-hospital outcomes of acute coronary syndrome (ACS) patients. Methods We conducted a prospective registry study in 17 hospitals in Saudi Arabia between December 2005 and December 2007. ACS patients included those with ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction and unstable angina; both were reported collectively as NSTEACS (non-ST elevation acute coronary syndrome). Results 5055 patients were enrolled with mean age ± SD of 58 ± 12.9 years; 77.4% men, 82.4% Saudi nationals; 41.5% had STEMI, and 5.1% arrived at the hospital by ambulance. History of diabetes mellitus was present in 58.1%, hypertension in 55.3%, hyperlipidemia in 41.1%, and 32.8% were current smokers; all these were more common in NSTEACS patients, except for smoking (all P < 0.0001). In-hospital medications were: aspirin (97.7%), clopidogrel (83.7%), beta-blockers (81.6%), angiotensin converting enzyme inhibitors/angiotensin receptor blockers (75.1%), and statins (93.3%). Median time from symptom onset to hospital arrival for STEMI patients was 150 min (IQR: 223), 17.5% had primary percutaneous coronary intervention (PCI), 69.1% had thrombolytic therapy, and 14.8% received it at less than 30 min of hospital arrival. In-hospital outcomes included recurrent myocardial infarction (1.5%), recurrent ischemia (12.6%), cardiogenic shock (4.3%), stroke (0.9%), major bleeding (1.3%). In-hospital mortality was 3.0%. Conclusion ACS patients in Saudi Arabia present at a younger age, have much higher prevalence of diabetes mellitus, less access to ambulance use, delayed treatment by thrombolytic therapy, and less primary PCI compared with patients in the developed countries. This is the first national ACS registry in our country and it demonstrated knowledge-care gaps that require further improvements. PMID:23960654

The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients.

PubMed

Gomes, Walter J; Moreira, Rita Simone; Zilli, Alexandre Cabral; Bettiati, Luiz Carlos; Figueira, Fernando Augusto Marinho Dos Santos; D' Azevedo, Stephanie Steremberg Pires; Soares, Marcelo José Ferreira; Fernandes, Marcio Pimentel; Ardito, Roberto Vito; Bogdan, Renata Andrea Barberio; Campagnucci, Valquíria Pelisser; Nakasako, Diana; Kalil, Renato Abdala Karam; Rodrigues, Clarissa Garcia; Rodrigues, Anilton Bezerra; Cascudo, Marcelo Matos; Atik, Fernando Antibas; Lima, Elson Borges; Nina, Vinicius José da Silva; Heluy, Renato Albuquerque; Azeredo, Lisandro Gonçalves; Henrique, Odilon Silva; Mendonça, José Teles de; Silva, Katharina Kelly de Oliveira Gama; Pandolfo, Marcelo; Lima, José Dantas de; Faria, Renato Max; Santos, Jonas Pereira Dos; Paez, Rodrigo Pereira; Coelho, Guilherme Henrique Biachi; Pereira, Sergio Nunes; Senger, Roberta; Buffolo, Enio; Caputi, Guido Marco; Santo, José Amalth do Espírito; Oliveira, Juliana Aparecida Borges de; Berwanger, Otavio; Cavalcanti, Alexandre Biasi; Jatene, Fabio B

2017-01-01

To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.

CARESS: the Canadian registry of palivizumab.

PubMed

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

2011-08-01

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

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.

PubMed

Worthington-Kirsch, Robert; Spies, James B; Myers, Evan R; Mulgund, Jyotsna; Mauro, Matthew; Pron, Gaylene; Peterson, Eric D; Goodwin, Scott

2005-07-01

To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. II-3.

Embolic strokes of undetermined source in a cohort of Polish stroke patients.

PubMed

Bembenek, Jan Pawel; Karlinski, Michal Adam; Kurkowska-Jastrzebska, Iwona; Czlonkowska, Anna

2018-03-19

We aimed to provide a descriptive analysis of embolic stroke of undetermined etiology (ESUS) population based on a long-term prospective stroke registry. We retrospectively analyzed data collected in a detailed registry regarding consecutive patients admitted for first-ever ischemic stroke (IS) between January 2001 and December 2015. We used Org 10172 in Acute Stroke Treatment classification supplemented with ESUS criteria proposed by the Cryptogenic Stroke/ESUS International Working Group. Within the ESUS group, we additionally compared patients ≤ 60 and > 60 years of age. During the study period, there was a total of 3008 (1615 females and 1393 males) admissions of first-ever strokes. The most frequent cause was undetermined (38.7%), followed by cardioembolic (27.7%), large artery atherosclerosis (18.2%), small vessel disease (11.9%), and other determined (3.6%). We identified 326 patients as ESUS, which accounted for 10.8% of all strokes and 28% of strokes of undetermined etiology. ESUS patients were the youngest. Compared to all types of stroke but for those with small vessel disease, ESUS patients were most often independent before stroke and had the least severe neurological deficit at admission and the best outcome at discharge. ESUS patients ≤ 60 years were more frequently independent at discharge than ESUS patients > 60 years. Approximately 11% of patients from our registry met ESUS criteria. ESUS patients were younger when compared to all other stroke etiologies, suffered less severe strokes, and had more favorable outcome at discharge than other groups except for those with small vessel disease strokes.

PEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions.

PubMed

Lichtenberg, Michael; Kolks, Oliver; Hailer, Birgit; Stahlhoff, Wilhelm-Friedrich; Tiefenbacher, Christiane; Nolte-Ernsting, Claus; Arjumand, Jawed; Wittenberg, Guenther

2014-06-01

To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry. Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months. The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions. In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.

The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials. Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Design BASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0–3. Discussion The BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755). PMID:23835026

Risks of neurological and immune-related diseases, including narcolepsy, after vaccination with Pandemrix: a population- and registry-based cohort study with over 2 years of follow-up.

PubMed

Persson, I; Granath, F; Askling, J; Ludvigsson, J F; Olsson, T; Feltelius, N

2014-02-01

To investigate the association between vaccination with Pandemrix and risk of selected neurological and immune-related diseases including narcolepsy. Population-based prospective cohort study using data from regional vaccination registries and national health registries. Seven healthcare regions in Sweden comprising 61% of the Swedish population. Study population of 3,347,467 vaccinated and 2,497,572 nonvaccinated individuals (vaccination coverage ≈ 60%) followed between 2009 and 2011 for 6.9 million person-years after exposure and 6.0 million person-years without exposure. First recorded diagnosis of neurological and immune-related diseases. Relative risks [hazard ratios (HRs) with 95% confidence intervals (CIs)] assessed using Cox regression, adjusted for covariates. For all selected neurological and immune-related outcomes under study, other than allergic vaccine reactions (for which we verified an expected increase in risk) and narcolepsy, HRs were close to 1.0 and always below 1.3. We observed a three-fold increased risk of a diagnosis of narcolepsy (HR: 2.92, 95% CI: 1.78-4.79; that is, four additional cases per 100,000 person-years) in individuals ≤ 20 years of age at vaccination and a two-fold increase (HR: 2.18, 95% CI: 1.00-4.75) amongst young adults between 21 and 30 years of age. The excess risk declined successively with increasing age at vaccination; no increase in risk was seen after 40 years of age. For a large number of selected neurological and immune-related diseases, we could neither confirm any causal association with Pandemrix nor refute entirely a small excess risk. We confirmed an increased risk for a diagnosis of narcolepsy in individuals ≤ 20 years of age and observed a trend towards an increased risk also amongst young adults between 21 and 30 years. © 2013 The Association for the Publication of the Journal of Internal Medicine.

Application of data mining techniques and data analysis methods to measure cancer morbidity and mortality data in a regional cancer registry: The case of the island of Crete, Greece.

PubMed

Varlamis, Iraklis; Apostolakis, Ioannis; Sifaki-Pistolla, Dimitra; Dey, Nilanjan; Georgoulias, Vassilios; Lionis, Christos

2017-07-01

Micro or macro-level mapping of cancer statistics is a challenging task that requires long-term planning, prospective studies and continuous monitoring of all cancer cases. The objective of the current study is to present how cancer registry data could be processed using data mining techniques in order to improve the statistical analysis outcomes. Data were collected from the Cancer Registry of Crete in Greece (counties of Rethymno and Lasithi) for the period 1998-2004. Data collection was performed on paper forms and manually transcribed to a single data file, thus introducing errors and noise (e.g. missing and erroneous values, duplicate entries etc.). Data were pre-processed and prepared for analysis using data mining tools and algorithms. Feature selection was applied to evaluate the contribution of each collected feature in predicting patients' survival. Several classifiers were trained and evaluated for their ability to predict survival of patients. Finally, statistical analysis of cancer morbidity and mortality rates in the two regions was performed in order to validate the initial findings. Several critical points in the process of data collection, preprocessing and analysis of cancer data were derived from the results, while a road-map for future population data studies was developed. In addition, increased morbidity rates were observed in the counties of Crete (Age Standardized Morbidity/Incidence Rates ASIR= 396.45 ± 2.89 and 274.77 ±2.48 for men and women, respectively) compared to European and world averages (ASIR= 281.6 and 207.3 for men and women in Europe and 203.8 and 165.1 in world level). Significant variation in cancer types between sexes and age groups (the ratio between deaths and reported cases for young patients, less than 34 years old, is at 0.055 when the respective ratio for patients over 75 years old is 0.366) was also observed. This study introduced a methodology for preprocessing and analyzing cancer data, using a combination of data mining techniques that could be a useful tool for other researchers and further enhancement of the cancer registries. Copyright © 2017 Elsevier B.V. All rights reserved.

Predicting medical complications after spine surgery: a validated model using a prospective surgical registry.

PubMed

Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

2014-02-01

The possibility and likelihood of a postoperative medical complication after spine surgery undoubtedly play a major role in the decision making of the surgeon and patient alike. Although prior study has determined relative risk and odds ratio values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of medical complication, rather than relative risk or odds ratio values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of medical complication during and after spine surgery. Statistical analysis using a prospective surgical spine registry that recorded extensive demographic, surgical, and complication data. Outcomes examined are medical complications that were specifically defined a priori. This analysis is a continuation of statistical analysis of our previously published report. Using a prospectively collected surgical registry of more than 1,476 patients with extensive demographic, comorbidity, surgical, and complication detail recorded for 2 years after surgery, we previously identified several risk factor for medical complications. Using the beta coefficients from those log binomial regression analyses, we created a model to predict the occurrence of medical complication after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created two predictive models: one predicting the occurrence of any medical complication and the other predicting the occurrence of a major medical complication. The final predictive model for any medical complications had a receiver operator curve characteristic of 0.76, considered to be a fair measure. The final predictive model for any major medical complications had receiver operator curve characteristic of 0.81, considered to be a good measure. The final model has been uploaded for use on SpineSage.com. We present a validated model for predicting medical complications after spine surgery. The value in this model is that it gives the user an absolute percent likelihood of complication after spine surgery based on the patient's comorbidity profile and invasiveness of surgery. Patients are far more likely to understand an absolute percentage, rather than relative risk and confidence interval values. A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery. In addition, a tool such as this can be of great use particularly as health care trends toward pay-for-performance, quality metrics, and risk adjustment. To facilitate the use of this model, we have created a website (SpineSage.com) where users can enter in patient data to determine likelihood of medical complications after spine surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

Review of patient registries in dermatology.

PubMed

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

2016-10-01

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

Increased Incidence of Fatigue in Patients with Primary Immunodeficiency Disorders: Prevalence and Associations Within the US Immunodeficiency Network Registry.

PubMed

Hajjar, Joud; Guffey, Danielle; Minard, Charles G; Orange, Jordan S

2017-02-01

Patients with primary immunodeficiency (PID) often report fatigue, yet this symptom has not been studied in PID. Fatigue affects 6-7.5% of healthy adults. The goal of this study is to estimate the prevalence of fatigue in patients with PID and investigate its associated factors. We analyzed 2537 PID patients registered in USIDNET to determine responses to the field "fatigue" in the core registry form. Demographics, immune phenotypes, and comorbid conditions were compared between fatigued and non-fatigued patients to identify relevant associations and potential drivers. A focused analysis was performed for patients with predominantly antibody deficiency disorders (PADs). Fatigue was reported in 25.9% (95% CI 23.7-28.3) of PAD patients, compared to 6.4% (95% CI 4.9-8.2) of non-PAD. Patients with common variable immunodeficiency (CVID) had the highest prevalence of fatigue (p < 0.001) among all PID diagnoses. Other factors that were associated with a higher rate of fatigue among PAD patients included female sex, higher BMI, depression, bronchiectasis, and autoimmunity. Additionally, fatigued PAD patients had lower absolute lymphocyte, CD3, CD4, and CD8 counts compared to non-fatigued patients. Our findings suggest that fatigue is overrepresented in PAD patients. Prospective studies to estimate prevalence, risk factors, and fatigue etiology in PID are warranted, so therapeutic interventions can be considered.

Ventricular Arrhythmias in the North American Multidisciplinary Study of ARVC

PubMed Central

Link, Mark S.; Laidlaw, Douglas; Polonsky, Bronislava; Zareba, Wojciech; McNitt, Scott; Gear, Kathleen; Marcus, Frank; Mark Estes, NA

2015-01-01

BACKGROUND Arrhythmogenic right ventricular cardiomyopathy (ARVC) is associated with sudden cardiac death. However, the selection of patients for implanted cardioverter-defibrillators (ICDs), as well as programming of the ICD, is unclear. OBJECTIVES The objective of this study was to identify predictors, characteristics, and treatment of ventricular arrhythmias in patients with ARVC. METHODS The Multidisciplinary Study of Right Ventricular Cardiomyopathy established the North American ARVC Registry and enrolled patients with a diagnosis of ARVC. Patients were followed prospectively. RESULTS Of 137 patients enrolled, 108 received ICDs. Forty-eight patients had 502 sustained episodes of ventricular arrhythmias, including 489 that were monomorphic and 13 that were polymorphic. In the patients with ICDs, independent predictors of ventricular arrhythmias in follow-up included spontaneous sustained ventricular arrhythmias before ICD implantation and T-wave inversions inferiorly. The only independent predictor for life-threatening arrhythmias, defined as sustained ventricular tachycardia (VT) ≥240 beats/min or ventricular fibrillation, was a younger age at enrollment. Anti-tachycardia pacing (ATP), independent of the cycle length of the VT, was successful in terminating 92% of VT episodes. CONCLUSIONS In the North American ARVC Registry, the majority of ventricular arrhythmias in follow-up are monomorphic. Risk factors for ventricular arrhythmias were spontaneous ventricular arrhythmias before enrollment and a younger age at ICD implantation. ATP is highly successful in terminating VT, and all ICDs should be programmed for ATP, even for rapid VT. PMID:25011714

Constructing a Local Potential Participant Registry to Improve Alzheimer's Disease Clinical Research Recruitment.

PubMed

Grill, Joshua D; Hoang, Dan; Gillen, Daniel L; Cox, Chelsea G; Gombosev, Adrijana; Klein, Kirsten; O'Leary, Steve; Witbracht, Megan; Pierce, Aimee

2018-01-01

Potential participant registries are tools to address the challenge of slow recruitment to clinical research. In particular, registries may aid recruitment to secondary prevention clinical trials for Alzheimer's disease (AD), which enroll cognitively normal older individuals meeting specific genetic or biomarker criteria. Evidence of registry effectiveness is sparse, as is guidance on optimal designs or methods of conduct. We report our experiences of developing a novel local potential participant registry that implemented online enrollment and data collection. In the first year of operation, 957 individuals submitted email addresses to the registry, of whom 592 self-reported demographic, family history, and medical data. In addition, registrants provided information related to their interest and willingness to be contacted about studies. Local earned media and community education were the most effective methods of recruitment into the registry. Seventy-six (26%) of 298 registrants contacted about studies in the first year enrolled in those studies. One hundred twenty-nine registrants were invited to enroll in a preclinical AD trial, of whom 25 (18%) screened and 6 were randomized. These results indicate that registries can aid recruitment and provide needed guidance for investigators initiating new local registries.

PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial.

PubMed

Cameron, Jan; Rendell, Peter G; Ski, Chantal F; Kure, Christina E; McLennan, Skye N; Rose, Nathan S; Prior, David L; Thompson, David R

2015-04-29

Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life. The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours. If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs. Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

Novel percutaneous suture-mediated patent foramen ovale closure technique. Early results of the NobleStitch EL Italian Registry.

PubMed

Gaspardone, Achille; De Marco, Federico; Sgueglia, Gregory A; De Santis, Antonella; Iamele, Maria; D'Ascoli, Emanuela; Tusa, Maurizio; Corciu, Anca; Mullen, Michael; Nobles, Anthony; Carminati, Mario; Bedogni, Francesco

2018-04-03

To assess the efficacy of a novel percutaneous "device-less" suture mediated patent foramen ovale (PFO) closure system. Between June 2016 and October 2017, a prospective registry aimed at assessing the safety and efficacy of the NobleStitch EL (HeartStitch, Fountain Valley, CA) suture-based PFO closure system was carried out at 12 sites in Italy. Among 200 consecutive evaluated patients, 192 were considered suitable for suture-mediated PFO closure (44±13 years, 114 women). Suture of the septum with the NobleStitch EL system was carried out successfully in 186 (96%) patients. Median fluoroscopy time was 16.1 (13.0-22.5) minutes and contrast volume 200 (150-270) ml. At 206±130 days follow-up, microbubbles transthoracic echocardiography with Valsalva maneuver revealed no RLS (grade 0) in 139 (75%) patients and RLS grade ≤1 in 166 (89%) patients. Significant RLS was present in 20 (11%) patients (grade 2 and 3 in 11 and 9 patients, respectively). There were no device-related complications. The early results of this first Italian Registry indicates that the suture mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, provides an effective closure of PFO comparable to traditional devices with an excellent safety profile at medium term follow-up.

Renal denervation reduces office and ambulatory heart rate in patients with uncontrolled hypertension: 12-month outcomes from the global SYMPLICITY registry.

PubMed

Böhm, Michael; Ukena, Christian; Ewen, Sebastian; Linz, Dominik; Zivanovic, Ina; Hoppe, Uta; Narkiewicz, Krzysztof; Ruilope, Luis; Schlaich, Markus; Negoita, Manuela; Schmieder, Roland; Williams, Bryan; Zeymer, Uwe; Zirlik, Andreas; Mancia, Giuseppe; Mahfoud, Felix

2016-12-01

Renal denervation (RDN) can reduce sympathetic activity and blood pressure (BP) in patients with hypertension. The effects on resting and ambulatory heart rate (HR), also regulated by the sympathetic nervous system, are not established. Herein, we report 12-month outcomes from the Global SYMPLICITY Registry on office and ambulatory HR and BP in patients with uncontrolled hypertension (n = 846). HR declined in correlation with the HR at baseline and at 12 months, in particular, in patients in the upper tertile of HR (>74 bpm). BP reduction was similar in the tertiles of HR at baseline. Similar effects were observed when 24-h ambulatory HR and SBP were determined. Office HR was similarly decreased when patients were on a β-blocker or not. Antihypertensive treatment remained unchanged during the 12-month period of the Global SYMPLICITY Registry. RDN reduces BP independent from HR. A HR reduction is dependent on baseline HR and unchanged by β-blocker treatment. The effects of RDN on SBP and HR are durable up to 1 year. HR reduction might be a target for RDN in patients with high HR at baseline, which needs to be scrutinized in prospective trials.

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

PubMed

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

2012-12-01

In 2010, the American College of Medical Toxicology established its Case Registry, the Toxicology Investigators Consortium (ToxIC). ToxIC is a prospective registry, which exclusively compiles suspected and confirmed toxic exposure cases cared for at the bedside by medical toxicologists at its participating sites. The Registry aims to fulfill two important gaps in the field: a real-time toxicosurveillance system to identify current poisoning trends and a powerful research tool in toxicology. ToxIC allows extraction of information from medical records making it the most robust multicenter database on chemical toxicities in existence. All cases seen by medical toxicologists at participating institutions were entered in a database. Information characterizing patients entered in 2011 was tabulated. 2010 data was also included so that cumulative total numbers could be described as well. The current report is a summary of the data collected in 2011 in comparison to 2010 entries and also includes cumulative data through December 31st, 2011. During 2011, 28 sites with 49 specific institutions contributed a total of 6,456 cases to the Registry. The total number of cases entered into the registry at the end of 2011 was 10,392. Emergency departments remained the most common source of consultations in 2011, accounting for 53 % of cases. The most common reason for consultation was for pharmaceutical overdoses, which occurred in 48 % of patients, including intentional (37 %) and unintentional (11 %) exposures. The most common classes of agents were sedative-hypnotics (1,492 entries in 23 % of cases), non-opioid analgesics (1,368 cases in 21 % of cases), opioids (17 %), antidepressants (16 %), stimulants/sympathomimetics (12 %), and ethanol (8 %). N-acetylcysteine was the most commonly administered antidote during 2011, similar to 2010, followed by the opioid antagonist naloxone, sodium bicarbonate, physostigmine and flumazenil. Anti-crotalid Fab fragments (CroFab) were administered in 106 out of 131 cases in which an envenomation occurred. There were 35 deaths recorded in the Registry during 2011. The most common associated agents, including when reported as sole agent or in combination with other agents, were opioids and analgesics (acetaminophen, aspirin, NSAIDS) with ten and eight deaths, respectively. Oxycodone was reported in six of the ten opioid-related deaths and heroin in three. Acetaminophen was the most common single agent reported overall being identified in all eight of the death cases attributed to analgesics. There were significant trends identified during 2011. Cases involving designer drugs including psychoactive bath salts and synthetic cannabinoids increased substantially from 2010 to 2011. The psychoactive bath salts were responsible for a large increase in stimulant/sympathomimetic-related cases reported to the Registry in 2011 with overall numbers doubling from 6 % of all Registry entries in 2010 to 12 % in 2011. Entries involving psychoactive drugs of abuse also increased twofold from 2010 to 2011 jumping 3 to 6 %, primarily due to increasing frequency of synthetic cannabinoid ("K2") related intoxications as 2011 progressed. The 2011 Registry included over 600 ADR's (10 % of Registry Cases) with 115 agents causing at least 2 ADR's. This is up from only 3 % of cases (116 total cases) in 2010. The ToxIC Case Registry continues to grow. At the end of 2011, over 10,000 cases had been entered into the Registry. As demonstrated by the trends identified in psychoactive bath salt and synthetic cannabinoid reports, the Registry is a valuable toxicosurveillance and research tool. The ToxIC Registry is a unique tool for identifying and characterizing confirmed cases of significant or potential toxicity or complexity to require bedside consultation by a medical toxicologist.

Technique Optimization of Orbital Atherectomy in Calcified Peripheral Lesions of the Lower Extremities: The CONFIRM Series, A Prospective Multicenter Registry

PubMed Central

Das, Tony; Mustapha, Jihad; Indes, Jeffrey; Vorhies, Robert; Beasley, Robert; Doshi, Nilesh; Adams, George L

2014-01-01

Objectives The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA. Background Methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below-the-knee. Methods Patients (3135) undergoing OA by more than 350 physicians at over 200 US institutions were enrolled on an “all-comers” basis, resulting in registries that provided site-reported patient demographics, ABI, Rutherford classification, co-morbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes. Results Treatment with OA reduced pre-procedural stenosis from an average of 88–35%. Final residual stenosis after adjunctive treatments, typically low-pressure percutaneous transluminal angioplasty (PTA), averaged 10%. Plaque removal was most effective for severely calcified lesions and least effective for soft plaque. Shorter spin times and smaller crown sizes significantly lowered procedural complications which included slow flow (4.4%), embolism (2.2%), and spasm (6.3%), emphasizing the importance of treatment regimens that focus on plaque modification over maximizing luminal gain. Conclusion The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, corresponded to a lower incidence of adverse events irrespective of calcium burden or co-morbidities. © 2013 The Authors. Wiley Periodicals, Inc. PMID:23737432

Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years.

PubMed

Patti, Francesco

2016-01-01

In Italy, all prescriptions for THC:CBD oromucosal spray for treatment of multiple sclerosis (MS) spasticity are linked to the official Agenzia Italiana del Farmaco (AIFA) web-based registry, which tracks the effectiveness and tolerability of medications in a prospective and observational manner. AIFA e-registry data for THC:CBD oromucosal spray collected between January 2014 and February 2015 for 1,534 patients from 30 large Italian specialized MS centres were compiled. Patients had a long disease history (17.6 ± 8.6 years) and significant impairment (mean Expanded Disability Status Scale score 6.4 ± 1.2). MS spasticity was evaluated using the 0-10 numerical rating scale (NRS). After the first month titration and trial period, 61.9% of patients achieved sufficient improvement in spasticity (≥20% NRS) to qualify for continued treatment. After 6 months, clinically meaningful ≥30% NRS improvement was recorded in 40.2% of patients continuing with treatment. Spasticity-associated symptoms such as cramps and nocturnal spasms improved in most responding patients. Mean reported doses of THC:CBD oromucosal spray (6.2-6.7 sprays/day) were lower than those reported in clinical trials. Adverse events (mainly mild to moderate) were reported by 15% of patients; no new safety concerns beyond the approved label were identified. The results of the AIFA e-registry analysis align with those of other THC:CBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom. © 2016 S. Karger AG, Basel.

Postoperative Perfection: Ceiling Effects and Lack of Discrimination With Both SRS-22 and -24 Outcomes Instruments in Patients With Adolescent Idiopathic Scoliosis.

PubMed

Bastrom, Tracey P; Bartley, Carrie; Marks, Michelle C; Yaszay, Burt; Newton, Peter O

2015-12-01

Review of a prospective database registry. To compare the Scoliosis Research Society (SRS)-22 and SRS-24 outcomes instruments in terms of scores, rate of ceiling effects, and discriminant ability in patients with pre- and postoperative adolescent idiopathic scoliosis. Despite improvements noted with the SRS-22, the SRS-24 is still occasionally used prospectively and for comparisons with previous studies reporting SRS-24 scores. Previous work has demonstrated that postoperative scores from the 2 versions are not interchangeable. A multicenter prospective registry of patients who underwent surgical correction of adolescent idiopathic scoliosis was queried for preoperative and 2-year postoperative SRS-22 and SRS-24 scores. Scores were compared between versions and ceiling effects were identified. Groups of deformity severity were created to evaluate discriminant ability. 829 patients were identified. The SRS-22 scores for pain and general function were significantly greater than SRS-24 scores (P < 0.001), whereas the SRS-22 scores were significantly lower than the SRS-24 for self-image (P < 0.001). Preoperative ceiling effect was only noted in 1 domain each. Both versions were able to discriminate between large (80°+) and small (<45°) preoperative curves in all domains and total scores (P < 0.05). Postoperatively, the SRS-22 scores for all shared domains and total score were significantly greater than SRS-24 scores (P < 0.001). Ceiling effects in 5 of 5 domain scores were noted postoperatively for SRS-22 and in 4 of 7 for SRS-24. With a smaller range of deformity postoperatively, only the SRS-22 self-image domain was able to discriminate between large (29°+) and small (≤11°) residual curves (P < 0.05). Scores obtained by the SRS-22 and the SRS-24 are not translatable despite shared domains. Whereas both versions demonstrated preoperative discriminant ability, postoperative discrimination of residual deformity is lacking in both. Patient-reported outcomes of treatment are crucial in advancing treatment, and improvement in the ability to assess subjective outcomes is essential. 3.

Long-Term Testosterone Therapy Improves Cardiometabolic Function and Reduces Risk of Cardiovascular Disease in Men with Hypogonadism: A Real-Life Observational Registry Study Setting Comparing Treated and Untreated (Control) Groups.

PubMed

Traish, Abdulmaged M; Haider, Ahmad; Haider, Karim Sultan; Doros, Gheorghe; Saad, Farid

2017-09-01

In the absence of large, prospective, placebo-controlled studies of longer duration, substantial evidence regarding the safety and risk of testosterone (T) therapy (TTh) with regard to cardiovascular (CV) outcomes can only be gleaned from observational studies. To date, there are limited studies comparing the effects of long-term TTh in men with hypogonadism who were treated or remained untreated with T, for obvious reasons. We have established a registry to assess the long-term effectiveness and safety of T in men in a urological setting. Here, we sought to compare the effects of T on a host of parameters considered to contribute to CV risk in treated and untreated men with hypogonadism (control group). Observational, prospective, cumulative registry study in 656 men (age: 60.7 ± 7.2 years) with total T levels ≤12.1 nmol/L and symptoms of hypogonadism. In the treatment group, men (n = 360) received parenteral T undecanoate (TU) 1000 mg/12 weeks following an initial 6-week interval for up to 10 years. Men (n = 296) who had opted against TTh served as controls. Median follow-up in both groups was 7 years. Measurements were taken at least twice a year, and 8-year data were analyzed. Mean changes over time between the 2 groups were compared by means of a mixed-effects model for repeated measures, with a random effect for intercept and fixed effects for time, group, and their interaction. To account for baseline differences between the 2 groups, changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure, and lipids. There were 2 deaths in the T-treated group, none was related to CV events. There were 21 deaths in the untreated (control) group, 19 of which were related to CV events. The incidence of death in 10 patient-years was 0.1145 in the control group (95% confidence interval [CI]: 0.0746-0.1756; P < .000) and 0.0092 in the T-treated group (95% CI: 0.0023-0.0368; P < .000); the estimated difference between groups was 0.0804 (95% CI: 0.0189-0.3431; P < .001). The estimated reduction in mortality for the T-group was between 66% and 92%. There were also 30 nonfatal strokes and 26 nonfatal myocardial infarctions in the control group and none in the T-treated group. Long-term TU was well tolerated with excellent adherence suggesting a high level of patient satisfaction. Mortality related to CV disease was significantly reduced in the T-group.

Diagnostic Yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

PubMed Central

2011-01-01

Background: New transbronchial needle aspiration (TBNA) technologies have been developed, but their clinical effectiveness and determinants of diagnostic yield have not been quantified. Prospective data are needed to determine risk-adjusted diagnostic yield. Methods: We prospectively enrolled patients undergoing TBNA of mediastinal lymph nodes in the American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education (AQuIRE) multicenter database and recorded clinical, procedural, and provider information. All clinical decisions, including type of TBNA used (conventional vs endobronchial ultrasound-guided), were made by the attending bronchoscopist. The primary outcome was obtaining a specific diagnosis. Results: We enrolled 891 patients at six hospitals. Most procedures (95%) were performed with ultrasound guidance. A specific diagnosis was made in 447 cases. Unadjusted diagnostic yields were 37% to 54% for different hospitals, with significant between-hospital heterogeneity (P = .0001). Diagnostic yield was associated with annual hospital TBNA volume (OR, 1.003; 95% CI, 1.000-1.006; P = .037), smoking (OR, 1.55; 95% CI, 1.02-2.34; P = .042), biopsy of more than two sites (OR, 0.57; 95% CI, 0.38-0.85; P = .015), lymph node size (reference > 1-2 cm, ≤ 1 cm: OR, 0.51; 95% CI, 0.34-0.77; P = .003; > 2-3 cm: OR, 2.49; 95% CI, 1.61-3.85; P < .001; and > 3 cm: OR, 3.61; 95% CI, 2.17-6.00; P < .001), and positive PET scan (OR, 3.12; 95% CI, 1.39-7.01; P = .018). Biopsy was performed on more and smaller nodes at high-volume hospitals (P < .0001). Conclusions: To our knowledge, this is the first bronchoscopy study of risk-adjusted diagnostic yields on a hospital-level basis. High-volume hospitals were associated with high diagnostic yields. This study also demonstrates the value of procedural registries as a quality improvement tool. A larger number and variety of participating hospitals is needed to verify these results and to further investigate other determinants of diagnostic yield. PMID:21659432

Real-world use of fractional flow reserve in Germany: results of the prospective ALKK coronary angiography and PCI registry.

PubMed

Härle, Tobias; Zeymer, Uwe; Hochadel, Matthias; Zahn, Ralf; Kerber, Sebastian; Zrenner, Bernhard; Schächinger, Volker; Lauer, Bernward; Runde, Thorsten; Elsässer, Albrecht

2017-02-01

There is growing evidence for beneficial prognostic and economic effects of FFR-guided treatment of stable coronary artery disease. We sought to evaluate the real-world use of FFR measurements in patients undergoing elective coronary angiography. We analyzed the data of the prospective ALKK coronary angiography and PCI registry including data of 38 hospitals from January 2010 to December 2013. A total of 100,977 patients undergoing coronary angiography were included. In 3240 patients (3.2 %) intracoronary pressure measurement was performed. There was a wide range of use of FFR measurement in the different analyzed ALKK hospitals from 0.1 to 8.8 % in elective patients with suspected or known coronary artery disease (median 2.7 %, quartiles 0.9 and 5.3 %), with a successive increase of use over time during the study period. Overall, it was performed in 3.2 % of coronary angiographies. Use in patients with three-vessel disease (2.5 %) and recommendation for bypass surgery (1.6 %) was less frequent. In procedures without PCI, dose area product was higher in the FFR group (2641 cGy × cm 2 vs. 2368 cGy × cm 2 , p < 0.001), while it was lower in procedures with ad hoc PCI (4676 cGy × cm 2 vs. 5143 cGy × cm 2 , p < 0.001). The performing center turned out to be the strongest predictor. The use of FFR measurement was very heterogeneous between different hospitals and in general relatively low, in particular in patients with multivessel disease or recommendation for bypass surgery, but there was a positive trend during the study period. Technically, FFR measurement was not associated with an increased periprocedural complication rate.

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 data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.

Current situation and challenge of registry in China.

PubMed

Zhang, Yang; Feng, Yuji; Qu, Zhi; Qi, Yali; Zhan, Siyan

2014-09-01

Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30,400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.

Use of insulin pump therapy in children and adolescents with type 1 diabetes and its impact on metabolic control: comparison of results from three large, transatlantic paediatric registries.

PubMed

Sherr, Jennifer L; Hermann, Julia M; Campbell, Fiona; Foster, Nicole C; Hofer, Sabine E; Allgrove, Jeremy; Maahs, David M; Kapellen, Thomas M; Holman, Naomi; Tamborlane, William V; Holl, Reinhard W; Beck, Roy W; Warner, Justin T

2016-01-01

While the use of insulin pumps in paediatrics has expanded dramatically, there is still considerable variability among countries in the use of pump technology. The present study sought to describe differences in metabolic control and pump use in young people with type 1 diabetes using data collected in three multicentre registries. Data for the years 2011 and 2012 from 54,410 children and adolescents were collected from the Prospective Diabetes Follow-up Registry (DPV; n = 26,198), T1D Exchange (T1DX; n = 13,755) and the National Paediatric Diabetes Audit (NPDA; n = 14,457). The modality of insulin delivery, based on age, sex and ethnic minority status, and the impact of pump use on HbA1c levels were compared. The overall mean HbA1c level was higher in the NPDA (8.9 ± 1.6% [74 ± 17.5 mmol/mol]) than in the DPV (8.0 ± 1.6% [64 ± 17.0 mmol/mol], p < 0.001) and T1DX (8.3 ± 1.4% [68 ± 15.4 mmol/mol], p < 0.001). Conversely, pump use was much lower in the NPDA (14%) than in the DPV (41%, p < 0.001) and T1DX (47%, p < 0.001). In a pooled analysis, pump use was associated with a lower mean HbA1c (pump: 8.0 ± 1.2% [64 ± 13.3 mmol/mol] vs injection: 8.5 ± 1.7% [69 ± 18.7 mmol/mol], p < 0.001). In all three registries, those with an ethnic minority status were less likely to be treated with a pump (p < 0.001) and boys were treated with a pump less often compared with girls (p < 0.001). Despite similar clinical characteristics and proportion of minority participants, substantial differences in metabolic control exist across the three large transatlantic registries of paediatric patients with type 1 diabetes, which appears to be due in part to the frequency of insulin pump therapy.

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice.

PubMed

Yoshizawa, K; Kawai, K; Fujie, M; Suzuki, J; Ogawa, Y; Yajima, T; Yokomori, J

2015-11-01

To evaluate the overall safety profile and clinical effectiveness of tramadol hydrochloride/acetaminophen (TA) combination tablets in Japanese patients with chronic noncancer pain unrelieved by non-opioid drugs for up to 12 weeks in real-world practice. This survey was a multicenter, prospective, longitudinal registry on the use of TA as a newly initiated pain treatment for chronic noncancer pain incurable by non-opioid analgesics that was conducted under the Good Post Marketing Study Practice regulation controlled by the Japan Ministry of Health, Labor and Welfare. Collected data included socio-demographics, treatment information, incidence of adverse drug reactions (ADRs), numerical rating scale for intensity of pain, EuroQol-5D (EQ-5D) scale, and physician's global impression (PGI) during the 12 week observation period. A total of 1316 patients were registered. ADRs were reported in 259 patients (20.5%); most events were nonserious (99.4%), including nausea (n = 87 [6.9%]), constipation (n = 63 [5.0%]), dizziness and somnolence (n = 29 [2.3%] each), and vomiting (n = 21 [1.7%]). No event related to drug dependence or respiratory depression was reported. In addition, 82.8% of patients showed acceptable effectiveness based on PGI at Week 4. Numerical rating scale for intensity of pain and EQ-5D utility scores were improved by -2.7 (SD 2.3) and 0.16 (SD 0.20) at Week 4, respectively, and the improvement was maintained until Week 12. This is a first report to evaluate the risk-benefit profile of TA in Japanese real-world practice using large size registry data. It is suggested that the favorable risk-benefit balance of TA was confirmed for patients with chronic noncancer pain unrelieved by non-opioid drugs in real-world practice. Limitations of this study were those inherent to open-label and non-interventional study designs. This registry survey is registered at umin.ac.jp (identifier: UMIN000015901).

Azathioprine-induced Acute Pancreatitis in Patients with Inflammatory Bowel Diseases—A Prospective Study on Incidence and Severity

PubMed Central

Mohl, Wolfgang; Bokemeyer, Bernd; Bündgens, Burkhard; Büning, Jürgen; Miehlke, Stephan; Hüppe, Dietrich; Maaser, Christian; Klugmann, Tobias; Kruis, Wolfgang; Siegmund, Britta; Helwig, Ulf; Weismüller, Joseph; Drabik, Attyla; Stallmach, Andreas

2016-01-01

Background and Aims: Azathioprine [AZA] is recommended for maintenance of steroid-free remission in inflammatory bowel disease IBD. The aim of this study has been to establish the incidence and severity of AZA-induced pancreatitis, an idiosyncratic and major side effect, and to identify specific risk factors. Methods: We studied 510 IBD patients [338 Crohn’s disease, 157 ulcerative colitis, 15 indeterminate colitis] with initiation of AZA treatment in a prospective multicentre registry study. Acute pancreatitis was diagnosed in accordance with international guidelines. Results: AZA was continued by 324 [63.5%] and stopped by 186 [36.5%] patients. The most common cause of discontinuation was nausea [12.2%]. AZA-induced pancreatitis occurred in 37 patients [7.3%]. Of these: 43% were hospitalised with a median inpatient time period of 5 days; 10% had peripancreatic fluid collections; 24% had vomiting; and 14% had fever. No patient had to undergo nonsurgical or surgical interventions. Smoking was the strongest risk factor for AZA-induced acute pancreatitis [p < 0.0002] in univariate and multivariate analyses. Conclusions: AZA-induced acute pancreatitis is a common adverse event in IBD patients, but in this study had a mild course in all patients. Smoking is the most important risk factor. PMID:26468141

The Québec BCG Vaccination Registry (1956-1992): assessing data quality and linkage with administrative health databases.

PubMed

Rousseau, Marie-Claude; Conus, Florence; Li, Jun; Parent, Marie-Élise; El-Zein, Mariam

2014-01-09

Vaccination registries have undoubtedly proven useful for estimating vaccination coverage as well as examining vaccine safety and effectiveness. However, their use for population health research is often limited. The Bacillus Calmette-Guérin (BCG) Vaccination Registry for the Canadian province of Québec comprises some 4 million vaccination records (1926-1992). This registry represents a unique opportunity to study potential associations between BCG vaccination and various health outcomes. So far, such studies have been hampered by the absence of a computerized version of the registry. We determined the completeness and accuracy of the recently computerized BCG Vaccination Registry, as well as examined its linkability with demographic and administrative medical databases. Two systematically selected verification samples, each representing ~0.1% of the registry, were used to ascertain accuracy and completeness of the electronic BCG Vaccination Registry. Agreement between the paper [listings (n = 4,987 records) and vaccination certificates (n = 4,709 records)] and electronic formats was determined along several nominal and BCG-related variables. Linkage feasibility with the Birth Registry (probabilistic approach) and provincial Healthcare Registration File (deterministic approach) was examined using nominal identifiers for a random sample of 3,500 individuals born from 1961 to 1974 and BCG vaccinated between 1970 and 1974. Exact agreement was observed for 99.6% and 81.5% of records upon comparing, respectively, the paper listings and vaccination certificates to their corresponding computerized records. The proportion of successful linkage was 77% with the Birth Registry, 70% with the Healthcare Registration File, 57% with both, and varied by birth year. Computerization of this Registry yielded excellent results. The registry was complete and accurate, and linkage with administrative databases was highly feasible. This study represents the first step towards assembling large scale population-based epidemiological studies which will enable filling important knowledge gaps on the potential health effects of early life non-specific stimulation of the immune function, as resulting from BCG vaccination.

Neurovascular manifestations of connective-tissue diseases: A review

PubMed Central

Kim, Sarasa T; Lanzino, Giuseppe; Kallmes, David F

2016-01-01

Patients with connective tissue diseases are thought to be at a higher risk for a number of cerebrovascular diseases such as intracranial aneurysms, dissections, and acute ischemic strokes. In this report, we aim to understand the prevalence and occurrences of such neurovascular manifestations in four heritable connective tissue disorders: Marfan syndrome, Ehlers-Danlos syndrome, Neurofibromatosis Type 1, and Loeys-Dietz syndrome. We discuss the fact that although there are various case studies reporting neurovascular findings in these connective tissue diseases, there is a general lack of case-control and prospective studies investigating the true prevalence of these findings in these patient populations. Furthermore, the differences observed in the manifestations and histology of such disease pathologies encourages future multi-center registries and studies in better characterizing the pathophysiology, prevalence, and ideal treatment options of neurovascular lesions in patents with connective tissue diseases. PMID:27511817

Workplace bullying and sickness absence: a systematic review and meta-analysis of the research literature.

PubMed

Nielsen, Morten Birkeland; Indregard, Anne-Marthe Rustad; Øverland, Simon

2016-09-01

The association between workplace bullying and sickness absence remains unclear. This paper presents a systematic review and meta-analysis of research on the association. We conducted a systematic review and meta-analysis of published primary studies on workplace bullying and sickness absence. Studies based on prospective design or registry data on sickness absence were included. Cross-sectional studies with self-reported sickness absence were excluded. Seventeen primary studies were included in the review, sixteen originated from the Nordic countries and fifteen included registry data on sickness absence. All but one study found that exposure to workplace bullying was associated with increased risk of sickness absence. A meta-analysis of ten independent studies showed that exposure to bullying increased the risk of sickness absence (odds ratio 1.58, 95% CI 1.39-1.79). Five studies included variables that moderated the association between bullying and absenteeism. None of the studies included mediating variables. No studies examined sickness absence as a risk factor for later exposure to bullying. Following the GRADE guidelines, the evidence for an association between bullying and sickness absence is moderate. Workplace bullying is a risk factor for sickness absence, but the mechanisms to explain this relationship are not sufficiently described. It is unclear whether sickness absence predicts later exposure to bullying. While, the methodological quality of the reviewed studies was high, the knowledge base is small. There is a need for more research on how and when bullying is related to sickness absence and the possible bidirectional relationships involved.

Outcomes from sudden cardiac arrest in US high schools: a 2-year prospective study from the National Registry for AED Use in Sports.

PubMed

Drezner, Jonathan A; Toresdahl, Brett G; Rao, Ashwin L; Huszti, Ella; Harmon, Kimberly G

2013-12-01

Sudden cardiac arrest (SCA) is the leading cause of death in athletes during exercise. The effectiveness of school-based automated external defibrillator (AED) programmes has not been established through a prospective study. A total of 2149 high schools participated in a prospective observational study beginning 1 August 2009, through 31 July 2011. Schools were contacted quarterly and reported all cases of SCA. Of these 95% of schools confirmed their participation for the entire 2-year study period. Cases of SCA were reviewed to confirm the details of the resuscitation. The primary outcome was survival to hospital discharge. School-based AED programmes were present in 87% of participating schools and in all but one of the schools reporting a case of SCA. Fifty nine cases of SCA were confirmed during the study period including 26 (44%) cases in students and 33 (56%) in adults; 39 (66%) cases occurred at an athletic facility during training or competition; 55 (93%) cases were witnessed and 54 (92%) received prompt cardiopulmonary resuscitation. A defibrillator was applied in 50 (85%) cases and a shock delivered onsite in 39 (66%). Overall, 42 of 59 (71%) SCA victims survived to hospital discharge, including 22 of 26 (85%) students and 20 of 33 (61%) adults. Of 18 student-athletes 16 (89%) and 8 of 9 (89%) adults who arrested during physical activity survived to hospital discharge. High school AED programmes demonstrate a high survival rate for students and adults who suffer SCA on school campus. School-based AED programmes are strongly encouraged.

Prospective observational cohort studies for studying rare diseases: the European PedNet Haemophilia Registry.

PubMed

Fischer, K; Ljung, R; Platokouki, H; Liesner, R; Claeyssens, S; Smink, E; van den Berg, H M

2014-07-01

Haemophilia is a rare disease. To improve knowledge, prospective studies of large numbers of subjects are needed. To establish a large well-documented birth cohort of patients with haemophilia enabling studies on early presentation, side effects and outcome of treatment. Twenty-one haemophilia treatment centres have been collecting data on all children with haemophilia with FVIII/IX levels up to 25% born from 2000 onwards. Another eight centres collected data on severe haemophilia A only. At baseline, details on delivery and diagnosis, gene mutation, family history of haemophilia and inhibitors are collected. For the first 75 exposure days, date, reason, dose and product are recorded for each infusion. Clinically relevant inhibitors are defined as follows: at least two positive inhibitor titres and a FVIII/IX recovery <66% of expected. For inhibitor patients, results of all inhibitor- and recovery tests are collected. For continued treatment, data on bleeding, surgery, prophylaxis and clotting factor consumption are collected annually. Data are downloaded for analysis annually. In May 2013, a total of 1094 patients were included: 701 with severe, 146 with moderate and 247 with mild haemophilia. Gene defect data were available for 87.6% of patients with severe haemophilia A. The first analysis, performed in May 2011, lead to two landmark publications. The outcome of this large collaborative research confirms its value for the improvement of haemophilia care. High-quality prospective observational cohorts form an ideal source to study natural history and treatment in rare diseases such as haemophilia. © 2014 John Wiley & Sons Ltd.

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.

The Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) Registry: Rationale and Design.

PubMed

Stewart, Elizabeth A; Lytle, Barbara L; Thomas, Laine; Wegienka, Ganesa R; Jacoby, Vanessa; Diamond, Michael P; Nicholson, Wanda K; Anchan, Raymond M; Venable, Sateria; Wallace, Kedra; Marsh, Erica E; Maxwell, George L; Borah, Bijan J; Catherino, William H; Myers, Evan R

2018-05-08

To design and establish a uterine fibroid (UF) registry based in the United States (US) to provide comparative effectiveness data regarding UF treatment. We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality (AHRQ) in collaboration with the-Patient-Centered Outcomes Research Institute (PCORI). COMPARE-UF is designed to help answer critical questions about treatment options for women with symptomatic UF. Women undergoing a procedure for UF (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance guided focused ultrasound or progestin-releasing intrauterine device insertion) at one of the COMPARE-UF sites are invited to participate in a prospective registry with three years follow-up for post-procedural outcomes. Enrolled participants provide annual follow-up through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. We built a network of nine clinical sites across the US with expertise in the care of women with UF to capture geographic, racial, ethnic and procedural diversity. Of the initial 2031 women enrolled in COMPARE-UF, 42% are self-identified as Black or African-American and 40% are age 40 years or younger with 16% of participants under age 35. Women undergoing myomectomy comprise the largest treatment group at 46% of all procedures with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all procedures. Hysterectomy is the second most common treatment within the registry at 38%. In response to priorities identified by our patient stakeholders, the initial aims within COMPARE-UF will address how different procedures used to treat UF compare in terms of long-lasting symptom relief, potential for recurrence, medical complications, improvement in quality of life and sexual function, age at menopause, and fertility and pregnancy outcomes. COMPARE-UF will generate evidence on the comparative effectiveness of different procedural options for UF, in order to help patients and their caregivers make informed decisions that best meet an individual patient's short- and long-term preferences. Building upon this infrastructure, the COMPARE-UF team of investigators and stakeholders, including patients, collaborate to identify future priorities for expanding the registry, such assessing the efficacy of medical therapies for UF. COMPARE-UF results will be disseminated directly to patients, providers, and other stakeholders using traditional academic pathways, as well as innovative methods, including a variety of social media platforms. Given demographic differences among women undergoing different UF treatments, assessing comparative effectiveness for this disease through clinical trials will remain difficult. Therefore, this registry provides optimized evidence to help patients and their providers better understand the pros and cons of different treatment options so that they can make more informed decisions. Copyright © 2018. Published by Elsevier Inc.

Dengue epidemics and adverse obstetrical outcomes in French Guiana: a semi-ecological study

PubMed Central

Hanf, Matthieu; Friedman, Eleanor; Basurko, Celia; Roger, Amaury; Bruncher, Pascal; Dussart, Philippe; Flamand, Claude; Carles, Gabriel; Buekens, Pierre; Breart, Gerard; Carme, Bernard; Nacher, Mathieu

2014-01-01

There are few studies on the obstetrical consequences of dengue fever during pregnancy. To determine whether dengue epidemics were associated with an increase in adverse obstetrical outcomes, a semi-ecological study combining individual data on obstetrical events from the perinatal registry and aggregated exposure data from the epidemiologic surveillance of dengue was conducted in Cayenne French Guiana between 2004 and 2007. After adjustment for individual risk factors, this semi-ecological analysis showed that an epidemic level of dengue transmission during the first trimester was associated with an increased risk of postpartum hemorrhage and preterm birth. The associated risks seemed to depend on the epidemic level. Despite its limitations, the present study suggests that dengue in the first trimester may be related to preterm birth and to postpartum bleeding, thus leading to specific hypotheses that should be tested in prospective studies. PMID:24341915

Decision counseling and participation in a pancreas cancer registry.

PubMed

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

2014-01-01

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

Is ApoE ε4 Associated with Cognitive Functioning in African Americans Diagnosed with Alzheimer Disease? An Exploratory Study

PubMed Central

Mount, David L.; Ashley, Angela V.; Lah, James J.; Levey, Allan I.; Goldstein, Felicia C.

2015-01-01

Objective The effect of the apolipoprotein ε4 allele (ApoE ε4) on cognitive performance in patients with probable Alzheimer disease (AD) has been studied in primarily Caucasian samples. The aim of this exploratory study was to examine whether the presence of ApoE ε4 is associated with cognitive performance in African American AD patients. Methods A cross-sectional, retrospective design was used to address the study objective. Data were extracted from the records of 65 African American patients who participated in the National Institutes of Health-National Institute on Aging (NIH-NIA) Emory University Alzheimer Disease Center Registry. Inclusion criteria were a clinical diagnosis of probable AD, cognitive testing using the Mattis Dementia Rating Scale and the Consortium to Establish a Registry for Alzheimer Disease (CERAD) neuropsychological battery, and ApoE genotyping. Results Seventy percent of the patients were ApoE ε4 positive. Multiple regression analyses indicated that ApoE ε4 was significantly associated with poorer design copying (CERAD Constructional Praxis subtest), but other significant relationships were not observed between positive ε4 status and cognitive performance. Conclusions These preliminary findings suggest that the ApoE ε4 allele is not strongly associated with a particular pattern of cognitive functioning in African Americans once they are diagnosed with AD. However, these findings require replication in a large prospectively recruited and population-based sample of African American AD patients before firm conclusions can be reached. PMID:19668025

Data that empower: The success and promise of CF patient registries.

PubMed

Fink, Aliza K; Loeffler, Deena R; Marshall, Bruce C; Goss, Christopher H; Morgan, Wayne J

2017-11-01

In this article, we describe existing CF registries with a focus on US registry data collected through the CF Foundation Patient Registry (CFFPR) and the Epidemiologic Study of CF (ESCF); highlight what registries have taught us regarding epidemiology of CF; showcase the impact of registries on research and clinical care; and discuss future directions. This manuscript complements the plenary address given by Dr Wayne Morgan at the 2016 North American CF Conference by summarizing the key points from the presentation and providing additional detail and information. © 2017 Wiley Periodicals, Inc.

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

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

PubMed Central

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

2013-01-01

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

DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols

PubMed Central

2012-01-01

Background Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18–60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e.g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. Methods/Design DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76% mRS ≤ 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. Discussion The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies. Trial registration (ICTRP and DRKS): DRKS00000624 PMID:23031451

Aspergillus Bronchitis in Patients with Cystic Fibrosis.

PubMed

Brandt, Claudia; Roehmel, Jobst; Rickerts, Volker; Melichar, Volker; Niemann, Nadja; Schwarz, Carsten

2018-02-01

Aspergillus fumigatus frequently colonizes the airways of patients with cystic fibrosis (CF) and may cause various severe infections, such as bronchitis. Serological data, sputum dependent markers and longitudinal data of treated cases of Aspergillus bronchitis were evaluated for further description of this infection. This study, which comprises three substudies, aimed to analyze epidemiological data of Aspergillus in CF and the entity of Aspergillus bronchitis. In a first step, data of the German Cystic Fibrosis Registry were used to evaluate the frequency of Aspergillus colonization in patients with CF (n = 2599). Then a retrospective analysis of 10 cases of Aspergillus bronchitis was performed to evaluate longitudinal data for lung function and clinical presentation parameters: sputum production, cough and physical capacity. Finally, a prospective cohort study (n = 22) was conducted to investigate serological markers for Aspergillus bronchitis: total serum IgE, specific serum IgE, specific serum IgG, as well as sputum galactomannan, real-time PCR detection of Aspergillus DNA in sputum and fungal cultures. Analysis of the German CF registry revealed an Aspergillus colonization rate of 32.5% among the 2599 patients. A retrospective data analysis of 10 treated cases revealed the clinical course of Aspergillus bronchitis, including repeated positive sputum culture findings for A. fumigatus, no antibiotic treatment response, total serum IgE levels <200 kU/l, no observation of new pulmonary infiltrates and appropriate antifungal treatment response. Antifungal treatment durations of 4 ± 1.6 (2-6) weeks significantly reduced cough (P = 0.0067), sputum production (P < 0.0001) and lung function measures (P = 0.0358) but not physical capacity (P = 0.0794). From this retrospective study, a prevalence of 1.6% was calculated. In addition, two cases of Aspergillus bronchitis were identified in the prospective cohort study according to immunological, molecular and microbiological parameters. A prevalence of 9% was assessed. Aspergillus bronchitis appears to occur in a minority of colonized CF patients. Antifungal treatment may reduce respiratory symptoms and restore lung function.

Yes, We Are Still Talking about Cylosporin vs. Infliximab in Steroid Resistant Acute Severe Ulcerative Colitis.

PubMed

Bernstein, Charles N; Kornbluth, Asher

2017-11-01

The Spanish IBD Registry (ENEIDA) is reporting in this issue of the Journal on a retrospective assessment of outcomes of cyclosporine use and infliximab use to treat steroid refractory acute severe ulcerative colitis (SR-ASUC) between 1989 and 2013. Overall, they found similar outcomes in terms of 3 month and 1 year colectomy rates. Serious adverse events were lower in cyclosporine users. While this study does not meet the standard of a prospective randomized controlled trial, it does remind us that cyclosporine can be effective in (SR-ASUC) and should be considered in those who have already failed antibody to tumor necrosis factor therapy or as a bridge to immunomodulators that have a slower onset of action.

The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients

PubMed Central

Gomes, Walter J.; Moreira, Rita Simone; Zilli, Alexandre Cabral; Bettiati Jr, Luiz Carlos; Figueira, Fernando Augusto Marinho dos Santos; D'Azevedo, Stephanie Steremberg Pires; Soares, Marcelo José Ferreira; Fernandes, Marcio Pimentel; Ardito, Roberto Vito; Bogdan, Renata Andrea Barberio; Campagnucci, Valquíria Pelisser; Nakasako, Diana; Kalil, Renato Abdala Karam; Rodrigues, Clarissa Garcia; Rodrigues Junior, Anilton Bezerra; Cascudo, Marcelo Matos; Atik, Fernando Antibas; Lima, Elson Borges; Nina, Vinicius José da Silva; Heluy, Renato Albuquerque; Azeredo, Lisandro Gonçalves; Henrique Junior, Odilon Silva; de Mendonça, José Teles; Silva, Katharina Kelly de Oliveira Gama; Pandolfo, Marcelo; de Lima Júnior, José Dantas; Faria, Renato Max; dos Santos, Jonas Pereira; Paez, Rodrigo Pereira; Coelho, Guilherme Henrique Biachi; Pereira, Sergio Nunes; Senger, Roberta; Buffolo, Enio; Caputi, Guido Marco; Santo, José Amalth do Espírito; de Oliveira, Juliana Aparecida Borges; Berwanger, Otavio; Cavalcanti, Alexandre Biasi; Jatene, Fabio B.

2017-01-01

Objective To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. Conclusion This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols. PMID:28492786

Twenty years of the Italian Fanconi Anemia Registry: where we stand and what remains to be learned.

PubMed

Risitano, Antonio M; Marotta, Serena; Calzone, Rita; Grimaldi, Francesco; Zatterale, Adriana

2016-03-01

The natural history of Fanconi anemia remains hard to establish because of its rarity and its heterogeneous clinical presentation; since 1994, the Italian Fanconi Anemia Registry has collected clinical, epidemiological and genetic data of Italian Fanconi Anemia patients. This registry includes 180 patients with a confirmed diagnosis of Fanconi anemia who have either been enrolled prospectively, at diagnosis, or later on. After enrollment, follow-up data were periodically collected to assess the clinical course, possible complications and long-term survival; the median follow up was 15.6 years. The main goal of the study was to describe the natural history of Fanconi anemia, focusing on the following variables: family history, disease presentation, development of hematological manifestations, development of malignancies, occurrence of hematopoietic stem cell transplantation and survival. Typical morphological and/or hematological abnormalities and/or growth retardation were the most common manifestations at diagnosis; the majority of patients (77%) exhibited hematological abnormalities at the initial presentation, and almost all (96%) eventually developed hematological manifestations. More than half of the patients (57%) underwent a bone-marrow transplant. The occurrence of cancer was quite rare at diagnosis, whereas the cumulative incidence of malignancies at 10, 20 and 30 years was 5%, 8% and 22%, respectively, for hematological cancers and 1%, 15% and 32%, respectively, for solid tumors. Overall survival at 10, 20 and 30 years were 88%, 56% and 37%, respectively; the main causes of death were cancer, complications of the hematological presentation and complications of transplantation. These data clearly confirm the detrimental outcome of Fanconi anemia, with no major improvement in the past decades. Copyright© Ferrata Storti Foundation.

Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry.

PubMed

Maggioni, Aldo P; Anker, Stefan D; Dahlström, Ulf; Filippatos, Gerasimos; Ponikowski, Piotr; Zannad, Faiez; Amir, Offer; Chioncel, Ovidiu; Leiro, Marisa Crespo; Drozdz, Jaroslaw; Erglis, Andrejs; Fazlibegovic, Emir; Fonseca, Candida; Fruhwald, Friedrich; Gatzov, Plamen; Goncalvesova, Eva; Hassanein, Mahmoud; Hradec, Jaromir; Kavoliuniene, Ausra; Lainscak, Mitja; Logeart, Damien; Merkely, Bela; Metra, Marco; Persson, Hans; Seferovic, Petar; Temizhan, Ahmet; Tousoulis, Dimitris; Tavazzi, Luigi

2013-10-01

To evaluate how recommendations of European guidelines regarding pharmacological and non-pharmacological treatments for heart failure (HF) are adopted in clinical practice. The ESC-HF Long-Term Registry is a prospective, observational study conducted in 211 Cardiology Centres of 21 European and Mediterranean countries, members of the European Society of Cardiology (ESC). From May 2011 to April 2013, a total of 12,440 patients were enrolled, 40.5% with acute HF and 59.5% with chronic HF. Intravenous treatments for acute HF were heterogeneously administered, irrespective of guideline recommendations. In chronic HF, with reduced EF, renin-angiotensin system (RAS) blockers, beta-blockers, and mineralocorticoid antagonists (MRAs) were used in 92.2, 92.7, and 67.0% of patients, respectively. When reasons for non-adherence were considered, the real rate of undertreatment accounted for 3.2, 2.3, and 5.4% of the cases, respectively. About 30% of patients received the target dosage of these drugs, but a documented reason for not achieving the target dosage was reported in almost two-thirds of them. The more relevant reasons for non-implantation of a device, when clinically indicated, were related to doctor uncertainties on the indication, patient refusal, or logistical/cost issues. This pan-European registry shows that, while in patients with acute HF, a large heterogeneity of treatments exists, drug treatment of chronic HF can be considered largely adherent to recommendations of current guidelines, when the reasons for non-adherence are taken into account. Observations regarding the real possibility to adhere fully to current guidelines in daily clinical practice should be seriously considered when clinical practice guidelines have to be written.

Male gynecomastia and risk for malignant tumours – a cohort study

PubMed Central

Olsson, H; Bladstrom, A; Alm, P

2002-01-01

Background Men with gynecomastia may suffer from absolute or relative estrogen excess and their risk of different malignancies may be increased. We tested whether men with gynecomastia were at greater risk of developing cancer. Methods A cohort was formed of all the men having a histopathological diagnosis of gynecomastia at the Department of Pathology, University of Lund, following an operation for either uni- or bilateral breast enlargement between 1970–1979. All possible causes of gynecomastia were accepted, such as endogenous or exogenous hormonal exposure as well as cases of unknown etiology. Prior to diagnosis of gynecomastia eight men had a diagnosis of prostate carcinoma, two men a diagnosis of unilateral breast cancer and one had Hodgkin's disease. These patients were included in the analyses. The final cohort of 446 men was matched to the Swedish Cancer Registry, Death Registry and General Population Registry. Results At the end of the follow up in December 1999, the cohort constituted 8375.2 person years of follow-up time. A total of 68 malignancies versus 66.07 expected were observed; SIR = 1.03 (95% CI 0.80–1.30). A significantly increased risk for testicular cancer; SIR = 5.82 (95% CI 1.20–17.00) and squamous cell carcinoma of the skin; SIR = 3.21 (95% CI 1.71–5.48) were noted. The increased risk appeared after 2 years of follow-up. A non-significantly increased risk for esophageal cancer was also seen while no new cases of male breast cancer were observed. However, in the prospective cohort, diagnostic operations for gynecomastia may substantially have reduced this risk Conclusions There is a significant increased risk of testicular cancer and squamous cell carcinoma of the skin in men who have been operated on for gynecomastia. PMID:12383352

Contemporary management of acute coronary syndromes: does the practice match the evidence? The global registry of acute coronary events (GRACE).

PubMed

Carruthers, K F; Dabbous, O H; Flather, M D; Starkey, I; Jacob, A; Macleod, D; Fox, K A A

2005-03-01

To determine to what extent evidence based guidelines are followed in the management of acute coronary syndromes (ACS) in the UK, elsewhere in Europe, and multinationally, and what the outcomes are. Multinational, prospective, observational registry (GRACE, global registry of acute coronary events) with six months' follow up. Patients presenting to a cluster of hospitals. The study was designed to collect data representative of the full spectrum of ACS in specific geographic populations. Patients admitted with a working diagnosis of unstable angina or suspected myocardial infarction (MI). Death during hospitalisation and at six months' follow up (adjusted for baseline risks). In ST elevation MI, reperfusion was applied more often in the UK (71%) than in Europe (65%) and multinationally (59%) (p < 0.01). However, this was almost entirely by lytic treatment, in contrast with elsewhere (primary percutaneous coronary intervention 1%, 29%, 16%, respectively). Statins were applied more frequently in the UK for all classes of patients with ACS (p < 0.0001). In contrast there was lower use of revascularisation procedures in non-ST MI (20% v 37% v 28%, respectively) and glycoprotein IIb/IIIa antagonists (6% v 25% v 26%, respectively). In-hospital death rates, adjusted for baseline risk, were not significantly different but six month death rates were higher in the UK for ST elevation MI (7.2% UK, 4.3% Europe, 5.3% multinationally; p < 0.0001) and non-ST elevation MI (7.5%, 6.2%, and 6.7%, respectively; p = 0.012, UK v Europe). Current management of ACS in the UK more closely follows the recommendations of the National Service Framework than British or European guidelines. Differences in practice may account for the observed higher event rates in the UK after hospital discharge.

Usage patterns and 1-year outcomes with the TAXUS Liberté stent: results of the TAXUS OLYMPIA registry.

PubMed

Ahmed, Waqar H; Mendiz, Oscar A; Thomas, Martyn R

2011-06-01

The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice. The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year. Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting. Copyright © 2010 Wiley-Liss, Inc.

Part-time work or social benefits as predictors for disability pension: a prospective study of Swedish twins.

PubMed

Ropponen, Annina; Alexanderson, Kristina; Svedberg, Pia

2014-04-01

To a large extent, it is unknown whether work absences other than sickness absence (SA) covered by social benefits such as parental leave, rehabilitation, or unemployment would predict disability pension (DP). We investigated whether part-time work or having received social benefits for sick leave, rehabilitation, or parental leave would be predictors for DP taking into account familial confounding (genetics and shared environment, e.g., social background) in these associations. A sample of 17,640 same-sex Swedish twin ndividuals [corrected] was followed from 2000 to 2008 via national registries for their receipt of social benefits and DP including additional baseline questionnaire data. Cox proportional hazard ratios were estimated. Full-time work was less common (47 %) among those being granted DP during the follow-up compared to those without DP (69 %). Self-reported full-time work, part-time work (≥50 %), and self-employment and registry data of caring for a child were the direct protective factors, whereas self-reported part-time work (<50 %) and long-term SA and registry data on SA, compensation for rehabilitation, and benefits during return to work were the direct risk factors for DP, i.e., independent of familial confounding. Part-time work and social benefits play different roles in predicting DP. Thus, full-time work, part-time work (≥50 %), self-employment, and benefits for parental leave seem to protect from DP. In contrast, SA and part-time work (<50 %) carry a highly increased risk for DP. Although these associations were mainly independent from several mediating factors, some of the associations seem to be influenced by family situation, social benefits, or severity of diseases.

Prevalence and control of cardiovascular risk factors in stable coronary artery outpatients in India compared with the rest of the world: An analysis from international CLARIFY registry.

PubMed

KauL, Upendra; Natrajan, Subramaniam; Dalal, Jamshed; Saran, Ram Kirti

We describe the clinical characteristics, prevalence and control of coronary artery disease (CAD) risk factors of the Indian cohort enrolled in the CLARIFY registry and compare them with data from rest of the world (ROW). CLARIFY is an international, prospective, observational, longitudinal cohort study in stable CAD outpatients. The baseline data of Indian cohort (n=709) were compared to ROW (n=31994). The CLARIFY India patients were significantly younger than the ROW (59.6±10.9 vs 64.3±10.4). Indian patients were more likely than those in ROW to have diabetes (42.9% vs 28.8%) and angina (27.8% vs 21.9%). Mean heart rate was significantly greater in Indians measured by either palpatory method (76.1±10.4 vs 68.0±10.5) or ECG (74.9±12.9 vs 67.0±11.3). The use of aspirin (85.6% vs 87.8%), β-blockers (69.4% vs 75.4%), and lipid-lowering agents (90% vs 92.4%) was lower in India. A significantly greater proportion of patients in India exhibited low HDL cholesterol (41.6% vs 31.2%), and heart rate ≥70bpm (82.2% vs 48.5%). The risk factors control was poor in India with heart rate goal of ≤60bpm achieved in 2.5%; HbA1c <7% in 9.9%; and HbA1c <6.5% in 4.6% patients. The CLARIFY registry demonstrates a high prevalence and poor control of cardiovascular risk factors in Indian patients. Systematic efforts to improve risk factor control are required. Copyright © 2017. Published by Elsevier B.V.

One-year outcomes with the Taxus Liberté stent in the real world: the Taxus Olympia registry (phase I).

PubMed

Ahmed, Waqar Habib; Zambahari, Robaayah; Al-Rashdan, Ibrahim; Al Naeemi, Abdullah; Saeed, Fuad A; Mascioli, Stephen

2008-12-01

The Taxus Olympia registry is a prospective, postapproval registry collecting clinical outcomes data on patients receiving the Taxus Liberté paclitaxel-eluting stent during routine interventional cardiology practice. Between February and July 2005, 529 patients receiving the Taxus Liberté stent at 16 centers in the Middle East, South/Central America, and Asia/Pacific regions were enrolled in Phase I of Olympia. The primary end-point was Taxus Liberté stent-related cardiac events (cardiac death, MI, and revascularization) at 30 days postimplant. Additional clinical assessment was conducted at 6 and 12 months. Olympia phases II and III are in clinical follow-up and will be reported separately. One-year clinical follow-up is available for 98% of patients. Complex patients and lesions were prevalent, including: 50% diabetes mellitus, 49% multivessel disease, 30% multiple stenting, 48% AHA/ACC type B2/C lesions, 19% long lesions (>26 mm), and 40% small vessels (30 days postprocedure. One-year cardiac event rates among complex subpopulations (diabetics 5.0%, multiple stents 3.8%, long lesions 3.1%, and small vessels 2.9%) were comparable to the overall study population. In conclusion, this first report of real-world experience with the Taxus Liberté stent demonstrates the safety and clinical utility of this stent in the broader spectrum of coronary disease treated in everyday practice.

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2002-10-01

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

Published intimate partner violence studies often differ from their trial registration records.

PubMed

Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

2017-12-27

Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

Catheter ablation of atrial fibrillation in patients with concomitant sinus bradycardia-Insights from the German Ablation Registry.

PubMed

Zylla, Maura M; Brachmann, Johannes; Lewalter, Thorsten; Hoffmann, Ellen; Kuck, Karl-Heinz; Andresen, Dietrich; Willems, Stephan; Hochadel, Matthias; Senges, Jochen; Katus, Hugo A; Thomas, Dierk

2016-01-01

This investigation addresses procedural characteristics of catheter ablation in patients with atrial fibrillation (AF) and sinus bradycardia. From the prospective, multi-center German Ablation Registry 1073 patients with sinus rhythm at the time of AF ablation were divided into two groups according to heart rate at start of procedure (A, <60 beats per minute (bpm), n=197; B, 60-99bpm, n=876). Acute procedural success was high (≥98%) and similar between groups. Procedure duration and energy application time were increased in group A (180min vs. 155min and 2561s vs. 1879s, respectively). Major complications were more frequent in group A (2.2% vs. 0.5%), and a greater proportion of these patients was discharged under antiarrhythmic medication (64% vs. 52%). Catheter ablation of AF with concomitant sinus bradycardia is associated with high procedural efficacy, longer procedure- and energy application durations, and a slightly elevated complication rate. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of emergency medical services in the second gulf registry of acute coronary events.

PubMed

AlHabib, Khalid F; Alfaleh, Hussam; Hersi, Ahmad; Kashour, Tarek; Alsheikh-Ali, Alawi A; Suwaidi, Jassim Al; Sulaiman, Kadhim; Saif, Shukri Al; Almahmeed, Wael; Asaad, Nidal; Amin, Haitham; Al-Motarreb, Ahmed; Thalib, Lukman

2014-09-01

Data are scarce regarding emergency medical service (EMS) usage by patients with acute coronary syndrome (ACS) in the Arabian Gulf region. This 9-month in-hospital prospective ACS registry was conducted in Arabian Gulf countries, with 30-day and 1-year follow-up mortality rates. Of 5184 patients with ACS, 1293 (25%) arrived at the hospital by EMS. The EMS group (vs non-EMS) was more likely to be male, have cardiac arrest on presentation, be current or exsmokers, and have moderate or severe left ventricular dysfunction and ST-segment elevation myocardial infarction (STEMI). The EMS group had higher crude mortality rates during hospitalization and after hospital discharge but not after adjustment for clinical factors and treatments. The EMSs are underused in the Arabian Gulf region. Short- and long-term mortality rates in patients with ACS are similar between those who used and did not use EMS. Quality improvement in the EMS infrastructure and establishment of integrated STEMI networks are urgently needed. © The Author(s) 2013.

Melanoma of the Skin in the Danish Cancer Registry and the Danish Melanoma Database: A Validation Study.

PubMed

Pedersen, Sidsel Arnspang; Schmidt, Sigrun Alba Johannesdottir; Klausen, Siri; Pottegård, Anton; Friis, Søren; Hölmich, Lisbet Rosenkrantz; Gaist, David

2018-05-01

The nationwide Danish Cancer Registry and the Danish Melanoma Database both record data on melanoma for purposes of monitoring, quality assurance, and research. However, the data quality of the Cancer Registry and the Melanoma Database has not been formally evaluated. We estimated the positive predictive value (PPV) of melanoma diagnosis for random samples of 200 patients from the Cancer Registry (n = 200) and the Melanoma Database (n = 200) during 2004-2014, using the Danish Pathology Registry as "gold standard" reference. We further validated tumor characteristics in the Cancer Registry and the Melanoma Database. Additionally, we estimated the PPV of in situ melanoma diagnoses in the Melanoma Database, and the sensitivity of melanoma diagnoses in 2004-2014. The PPVs of melanoma in the Cancer Registry and the Melanoma Database were 97% (95% CI = 94, 99) and 100%. The sensitivity was 90% in the Cancer Registry and 77% in the Melanoma Database. The PPV of in situ melanomas in the Melanoma Database was 97% and the sensitivity was 56%. In the Melanoma Database, we observed PPVs of ulceration of 75% and Breslow thickness of 96%. The PPV of histologic subtypes varied between 87% and 100% in the Cancer Registry and 93% and 100% in the Melanoma Database. The PPVs for anatomical localization were 83%-95% in the Cancer Registry and 93%-100% in the Melanoma Database. The data quality in both the Cancer Registry and the Melanoma Database is high, supporting their use in epidemiologic studies.

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

PubMed

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

2016-06-27

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

[Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].

PubMed

Dal-Ré, Rafael; Delgado, Miguel; Bolumar, Francisco

2015-01-01

Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

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. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries. PMID:23936257

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

PubMed

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

2015-06-01

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

Results of the post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE).

PubMed

Strueber, Martin; Larbalestier, Robert; Jansz, Paul; Zimpfer, Daniel; Fiane, Arnt E; Tsui, Steven; Simon, André; Schmitto, Jan D; Khaghani, Asghar; Wieselthaler, George M; Najarian, Kevin; Schueler, Stephan

2014-05-01

The post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated registry established to collect post-CE Mark Trial clinical data on patients receiving a HeartWare ventricular assist device (HVAD) in the European Union and Australia. The ReVOLVE is a multi-center, prospective, single-arm registry performed at seven centers in Europe and two in Australia. Herein we describe a total of 254 commercial HVAD implants according to labeled indications between February 2009 and November 2012. Summary statistics included patients' demographics, adverse events, length of support and outcomes. Compared with the clinical trial supporting the CE Mark of the HeartWare system, patient selection differed in that patients were older, and there were higher proportions of females and patients with idiopathic cardiomyopathies in the ReVOLVE cohort. Duration of support ranged from 1 to 1,057 days, with a mean of 363 ± 280 days (median 299.5 days). Transplantation was done in 56 patients (22%), explant for recovery was performed in 3 patients (1%), 43 died while on support (17%), and 152 (60%) remain on the device. Success in patients with the HeartWare system was 87% at 6 months, 85% at 1 year, 79% at 2 years and 73% at 3 years. Adverse event rates were low, comparable or improved when compared to the CE Mark Trial. Real-world use of the HeartWare system continues to demonstrate excellent clinical outcomes in patients supported with the device. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Baseline Characteristics of the Korean Registry of Pulmonary Arterial Hypertension.

PubMed

Chung, Wook-Jin; Park, Yong Bum; Jeon, Chan Hong; Jung, Jo Won; Ko, Kwang-Phil; Choi, Sung Jae; Seo, Hye Sun; Lee, Jae Seung; Jung, Hae Ok

2015-10-01

Despite recent advances in understanding of the pathobiology and targeted treatments of pulmonary arterial hypertension (PAH), epidemiologic data from large populations have been limited to western countries. The aim of the Korean Registry of Pulmonary Arterial Hypertension (KORPAH) was to examine the epidemiology and prognosis of Korean patients with PAH. KORPAH was designed as a nationwide, multicenter, prospective data collection using an internet webserver from September 2008 to December 2011. A total of 625 patients were enrolled. The patients' mean age was 47.6 ± 15.7 yr, and 503 (80.5%) were women. The diagnostic methods included right heart catheterization (n = 249, 39.8%) and Doppler echocardiography (n = 376, 60.2%). The etiologies, in order of frequency, were connective tissue disease (CTD), congenital heart disease, and idiopathic PAH (IPAH) (49.8%, 25.4%, and 23.2%, respectively). Patients with WHO functional class III or IV at diagnosis were 43.4%. In total, 380 (60.8%) patients received a single PAH-specific treatment at the time of enrollment, but only 72 (18.9%) patients received combination therapy. Incident cases during the registry represented 297 patients; therefore, the incidence rate of PAH was 1.9 patients/yr/million people. The 1st-, 2nd-, and 3rd-yr estimated survival rates were 90.8%, 87.8%, and 84.4%, respectively. Although Korean PAH patients exhibited similar age, gender, and survival rate compared with western registries, they showed relatively more CTD-PAH in the etiology and also systemic lupus erythematosus among CTD-PAH. The data suggest that earlier diagnosis and more specialized therapies should be needed to improve the survival of PAH patients.

Misdiagnosis of primary immune thrombocytopenia and frequency of bleeding: lessons from the McMaster ITP Registry

PubMed Central

Nazy, Ishac; Clare, Rumi; Jaffer, Anushka M.; Aubie, Brandon; Li, Na; Kelton, John G.

2017-01-01

Nonspecific diagnostic criteria and uncertain estimates of severe bleeding events are fundamental gaps in knowledge of primary immune thrombocytopenia (ITP). To address these issues, we created the McMaster ITP Registry. In this report, we describe the methodology of the registry, the process for arriving at the diagnosis, and the frequency of bleeding. Consecutive patients with platelets <150 × 109/L from a tertiary hematology clinic in Canada were eligible. Patients completed a panel of investigations and were managed per clinical need. Two hematologists initially determined the cause of the thrombocytopenia using standard criteria and reevaluated the diagnosis over time, which was adjudicated at regular team meetings. Bleeding was graded from 0 (none) to 2 (severe) prospectively using an ITP-specific tool. Data were validated by duplicate chart review and source verification. Between 2010 and 2016, 614 patients were enrolled. Median follow-up for patients with >1 visit was 1.7 years (interquartile range, 0.8-3.4). At registration, 295 patients were initially diagnosed with primary ITP; of those, 36 (12.2%) were reclassified as having a different diagnosis during follow-up. At registration, 319 patients were initially diagnosed with another thrombocytopenic condition; of those, 10 (3.1%) were ultimately reclassified as having primary ITP. Of 269 patients with a final diagnosis of primary ITP, 56.5% (95% confidence interval [CI], 50.4-62.5] experienced grade 2 bleeding at 1 or more anatomical site, and 2.2% (95% CI, 0.8-4.8) had intracranial hemorrhage. Nearly 1 in 7 patients with primary ITP were misdiagnosed. Grade 2 bleeding was common. Registry data can help improve the clinical and laboratory classification of patients with ITP. PMID:29296891

The Victorian Lung Cancer Registry pilot: improving the quality of lung cancer care through the use of a disease quality registry.

PubMed

Stirling, Rob G; Evans, S M; McLaughlin, P; Senthuren, M; Millar, J; Gooi, J; Irving, L; Mitchell, P; Haydon, A; Ruben, J; Conron, M; Leong, T; Watkins, N; McNeil, J J

2014-10-01

Lung cancer remains a major disease burden in Victoria (Australia) and requires a complex and multidisciplinary approach to ensure optimal care and outcomes. To date, no uniform mechanism is available to capture standardized population-based outcomes and thereby provide benchmarking. The establishment of such a data platform is, therefore, a primary requisite to enable description of process and outcome in lung cancer care and to drive improvement in the quality of care provided to individuals with lung cancer. A disease quality registry pilot has been established to capture prospective data on all adult patients with clinical or tissue diagnoses of small cell and non-small cell lung cancer. Steering and management committees provide clinical governance and supervise quality indicator selection. Quality indicators were selected following extensive literature review and evaluation of established clinical practice guidelines. A minimum dataset has been established and training and data capture by data collectors is facilitated using a web-based portal. Case ascertainment is established by regular institutional reporting of ICD-10 discharge coding. Recruitment is optimized by provision of opt-out consent. The collection of a standardized minimum data set optimizes capacity for harmonized population-based data capture. Data collection has commenced in a variety of settings reflecting metropolitan and rural, and public, and private health care institutions. The data set provides scope for the construction of a risk-adjusted model for outcomes. A data access policy and a mechanism for escalation policy for outcome outliers has been established. The Victorian Lung Cancer Registry provides a unique capacity to provide and confirm quality assessment in lung cancer and to drive improvement in quality of care across multidisciplinary stakeholders.

Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

PubMed

Gadler, Fredrik; Valzania, Cinzia; Linde, Cecilia

2015-01-01

The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Epidemiology of severe trauma in Spain. Registry of trauma in the ICU (RETRAUCI). Pilot phase.

PubMed

Chico-Fernández, M; Llompart-Pou, J A; Guerrero-López, F; Sánchez-Casado, M; García-Sáez, I; Mayor-García, M D; Egea-Guerrero, J; Fernández-Ortega, J F; Bueno-González, A; González-Robledo, J; Servià-Goixart, L; Roldán-Ramírez, J; Ballesteros-Sanz, M Á; Tejerina-Alvarez, E; García-Fuentes, C; Alberdi-Odriozola, F

2016-01-01

To describe the characteristics and management of severe trauma disease in Spanish Intensive Care Units (ICUs). Registry of trauma in the ICU (RETRAUCI). Pilot phase. A prospective, multicenter registry. Thirteen Spanish ICUs. Patients with trauma disease admitted to the ICU. None. Epidemiology, out-of-hospital attention, registry of injuries, resources utilization, complications and outcome were evaluated. Patients, n=2242. Mean age 47.1±19.02 years. Males 79%. Blunt trauma 93.9%. Injury Severity Score 22.2±12.1, Revised Trauma Score 6.7±1.6. Non-intentional in 84.4% of the cases. The most common causes of trauma were traffic accidents followed by pedestrian and high-energy falls. Up to 12.4% were taking antiplatelet medication or anticoagulants. Almost 28% had a suspected or confirmed toxic influence in trauma. Up to 31.5% required an out-of-hospital artificial airway. The time from trauma to ICU admission was 4.7±5.3hours. At ICU admission, 68.5% were hemodynamically stable. Brain and chest injuries predominated. A large number of complications were documented. Mechanical ventilation was used in 69.5% of the patients (mean 8.2±9.9 days), of which 24.9% finally required a tracheostomy. The median duration of stay in the ICU and in hospital was 5 (range 3-13) and 9 (5-19) days, respectively. The ICU mortality rate was 12.3%, while the in-hospital mortality rate was 16.0%. The pilot phase of the RETRAUCI offers a first impression of the epidemiology and management of trauma disease in Spanish ICUs. Copyright © 2015 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Changes in the management and comorbidities of acromegaly over three decades: the French Acromegaly Registry.

PubMed

Maione, Luigi; Brue, Thierry; Beckers, Albert; Delemer, Brigitte; Petrossians, Patrick; Borson-Chazot, Françoise; Chabre, Olivier; François, Patrick; Bertherat, Jérôme; Cortet-Rudelli, Christine; Chanson, Philippe

2017-05-01

Acromegaly is a rare disease associated with chronic multisystem complications. National registries have been created in several countries. The French Registry contains data on acromegaly epidemiology, management and comorbidities recorded over more than three decades, retrospectively until 1999 and prospectively from 1999 to 2012. Data could be analyzed for 999 of the 1034 patients included in the registry (46% males). Disease control, defined as IGF-I normalization (adjusted for age and sex), was achieved in 75% of patients at the last follow-up visit. Half the patients with uncontrolled disease had IGF-I levels below 1.5 times the upper limit of normal (ULN). The proportion of patients with surgically cured disease did not change markedly over time, whereas the proportion of patients with uncontrolled disease fell and the proportion of patients with medically controlled disease rose. Cardiovascular, metabolic, respiratory and rheumatologic comorbidities and their outcomes were recorded for most patients, and no noteworthy overall deterioration was noted over time. Cancer occurred in 10% of patients, for a standardized incidence ratio of 1.34 (95% CI: 0.94-1.87) in men and 1.24 (0.77-1.73) in women. Forty-one patients died during follow-up, for a standardized mortality ratio of 1.05 (0.70-1.42). Most deaths were due to cancer. The majority of patients with acromegaly now have successful disease control thanks to the multistep management. The incidence of comorbidities following diagnosis of acromegaly is very low. Life expectancy is now close to that of the general population, probably owing to better management of the GH/IGF-I excess and comorbidities. © 2017 European Society of Endocrinology.

Nordic registry-based cohort studies: Possibilities and pitfalls when combining Nordic registry data.

PubMed

Maret-Ouda, John; Tao, Wenjing; Wahlin, Karl; Lagergren, Jesper

2017-07-01

All five Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) have nationwide registries with similar data structure and validity, as well as personal identity numbers enabling linkage between registries. These resources provide opportunities for medical research that is based on large registry-based cohort studies with long and complete follow-up. This review describes practical aspects, opportunities and challenges encountered when setting up all-Nordic registry-based cohort studies. Relevant articles describing registries often used for medical research in the Nordic countries were retrieved. Further, our experiences of conducting this type of study, including planning, acquiring permissions, data retrieval and data cleaning and handling, and the possibilities and challenges we have encountered are described. Combining data from the Nordic countries makes it possible to create large and powerful cohorts. The main challenges include obtaining all permissions within each country, usually in the local language, and retrieving the data. These challenges emphasise the importance of having experienced collaborators within each country. Following the acquisition of data, data management requires the understanding of the differences between the variables to be used in the various countries. A concern is the long time required between initiation and completion. Nationwide Nordic registries can be combined into cohorts with high validity and statistical power, but the considerable expertise, workload and time required to complete such cohorts should not be underestimated.

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 fragments were administered in 109 cases or 82 % of cases in which a snake envenomation occurred. There were 57 deaths reported in the Registry in 2012. The most common associated agent alone or in combination was the non-opioid analgesic acetaminophen, being reported in 10 different cases. Other common agents and agent classes involved in death cases included ethanol, opioids, the anti-diabetic agent metformin, sedatives-hypnotics and cardiovascular agents, in particular amlodipine. There were significant trends identified during 2012. Abuse of over-the-counter medications such as dextromethorphan remains prevalent. Cases involving dextromethorphan continued to be reported at frequencies higher than other commonly abused drugs including many stimulants, phencyclidine, synthetic cannabinoids and designer amphetamines such as bath salts. And, while cases involving synthetic cannabinoids and psychoactive bath salts remained relatively constant from 2011 to 2012 several designer amphetamines and novel psychoactive substances were first reported in the Registry in 2012 including the NBOME compounds or "N-bomb" agents. LSD cases also spiked dramatically in 2012 with an 18-fold increase from 2011 although many of these cases are thought to be ultra-potent designer amphetamines misrepresented as "synthetic" LSD. The 2012 Registry included over 400 Adverse Drug Reactions (ADRs) involving 4 % of all Registry cases with 106 agents causing at least 2 ADRs. Additional data including supportive cares, decontamination, and chelating agent use are also included in the 2012 annual report. The Registry remains a valuable toxico-surveillance and research tool. The ToxIC Registry is a unique tool for identifying and characterizing confirmed cases of significant or potential toxicity or complexity to require bedside care by a medical toxicologist.

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

PubMed Central

Kolominsky-Rabas, Peter L.

2017-01-01

Introduction 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. Materials and methods 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. Results 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. Conclusion 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 patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers. PMID:28910289

The Québec BCG Vaccination Registry (1956–1992): assessing data quality and linkage with administrative health databases

PubMed Central

2014-01-01

Background Vaccination registries have undoubtedly proven useful for estimating vaccination coverage as well as examining vaccine safety and effectiveness. However, their use for population health research is often limited. The Bacillus Calmette-Guérin (BCG) Vaccination Registry for the Canadian province of Québec comprises some 4 million vaccination records (1926-1992). This registry represents a unique opportunity to study potential associations between BCG vaccination and various health outcomes. So far, such studies have been hampered by the absence of a computerized version of the registry. We determined the completeness and accuracy of the recently computerized BCG Vaccination Registry, as well as examined its linkability with demographic and administrative medical databases. Methods Two systematically selected verification samples, each representing ~0.1% of the registry, were used to ascertain accuracy and completeness of the electronic BCG Vaccination Registry. Agreement between the paper [listings (n = 4,987 records) and vaccination certificates (n = 4,709 records)] and electronic formats was determined along several nominal and BCG-related variables. Linkage feasibility with the Birth Registry (probabilistic approach) and provincial Healthcare Registration File (deterministic approach) was examined using nominal identifiers for a random sample of 3,500 individuals born from 1961 to 1974 and BCG vaccinated between 1970 and 1974. Results Exact agreement was observed for 99.6% and 81.5% of records upon comparing, respectively, the paper listings and vaccination certificates to their corresponding computerized records. The proportion of successful linkage was 77% with the Birth Registry, 70% with the Healthcare Registration File, 57% with both, and varied by birth year. Conclusions Computerization of this Registry yielded excellent results. The registry was complete and accurate, and linkage with administrative databases was highly feasible. This study represents the first step towards assembling large scale population-based epidemiological studies which will enable filling important knowledge gaps on the potential health effects of early life non-specific stimulation of the immune function, as resulting from BCG vaccination. PMID:24400924

[Causes of death in amyotrophic lateral sclerosis : Results from the Rhineland-Palatinate ALS registry].

PubMed

Wolf, J; Safer, A; Wöhrle, J C; Palm, F; Nix, W A; Maschke, M; Grau, A J

2017-08-01

Amyotrophic lateral sclerosis (ALS) is associated with an increased mortality. Knowledge of possible causes of death could lead to an individualization of the palliative treatment concept and result in a differentiated palliative treatment pathway. Currently, only few systematic data are available on the heterogeneity of causes of death associated with ALS. Analysis of the various causes of death in a prospective population-based German cohort of ALS patients. Analysis of data of the Rhineland-Palatinate ALS registry in which newly diagnosed patients who had been identified between October 2009 and September 2012 were prospectively enrolled and followed up at regular intervals. From this prospective cohort study the causes of death were elicited based on information provided by the attending physicians, family members and by means of death certificates registered by the regional health authorities in Rhineland-Palatinate. Out of 200 ALS patients registered 148 died between register initiation on 1 October 2009 and the end of follow-up on 30 September 2015 (78 males and 70 females, death rate 74%). The most frequent cause of death was respiratory failure as a consequence of weakness of respiratory muscles (n = 91, 61%). Less frequent causes of death were pneumonia (n = 13, 9%), terminal cachexia (n = 9, 6%) and death from cardiovascular causes including sudden death (n = 9, 6%). Cases of suicide were rare (n = 3, 2%) as were deaths due to concurrent diseases (n = 2). In 21 cases (14%) the exact cause of death could not be clarified. Differences in the causes of death only showed a tendency towards the ALS phenotype. Respiratory failure was the cause of death in all patients with a respiratory phenotype and in 78% of patients with flail arm syndrome. Despite the low number of patients (8%) with additional frontotemporal dementia (FTD) a distinct difference in causes of death between those with and without FTD could be observed. Death due to respiratory failure was less frequent in ALS patients with FTD (33% vs. 65%) while pneumonia was more frequent (27% vs. 7%). Respiratory failure was the most frequent cause of death in our cohort of ALS patients. In contrast, pneumonia and nutritional disorders played a less important role as the cause of death. The phenotypic expression of ALS might in part allow the cause of the prospective death to be predicted. Differentiation of ALS phenotypes is an important foundation for patient counseling on the process of dying to be expected and for the determination of an individual palliative concept.

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

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

2017-02-01

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.

Safety of the HPV Bivalent and Quadrivalent Vaccines During Pregnancy.

PubMed

Forinash, Alicia B; Yancey, Abigail M; Pitlick, Jamie M; Myles, Thomas D

2011-02-01

To evaluate the safety of the human papillomavirus (HPV) bivalent and quadrivalent vaccines in pregnancy. PubMed (1966-August 2010) was searched using the terms human papillomavirus, human papillomavirus vaccine, and pregnancy. References were reviewed for relevant information. All studies including humans that were published in English with data describing HPV vaccine administration in pregnancy were evaluated. Two combined analyses of 7 Phase 3 efficacy trials have retrospectively evaluated the safety of unintentional administration of either the bivalent (n = 1786) or quadrivalent (n = 2085) HPV vaccine during pregnancy. In addition, postmarketing pregnancy registry surveillance data (prospective, n = 787; retrospective, n = 76) for the quadrivalent HPV vaccine have been published. However, only 279 pregnancies from the studies and 90 pregnancies from the registry occurred within 30 days of receiving the vaccination. Overall, the vaccine does not appear to be associated with an increased risk of spontaneous abortion, fetal malformations, or adverse pregnancy outcomes beyond that found in the general population. Although the data are limited, neither HPV vaccine appears to be associated with an increased risk of adverse pregnancy outcomes. However, limitations of the data include small patient populations, minimal to no adjustments for factors known to influence pregnancy outcomes or malformations, and the majority of the available pregnancy data are from retrospective analysis of Phase 3 efficacy trials. Neither HPV vaccine should be routinely administered during pregnancy. If a pregnancy occurs midseries, the remaining vaccines should be given after pregnancy completion. Further studies are required to determine actual risk. © 2011 SAGE Publications.

Physical activity and risk of end-stage kidney disease in the Singapore Chinese Health Study.

PubMed

Jafar, Tazeen Hasan; Jin, Aizhen; Koh, Woon-Puay; Yuan, Jian-Min; Chow, Khuan Yew

2015-02-01

To explore the relationship between physical activity and risk of end-stage kidney disease (ESKD). We analysed data on a prospective cohort of 59,552 Chinese adults aged 45-74 years enrolled in the Singapore Chinese Health Study. Information on physical activity was collected with a structured questionnaire. Physically active individuals were defined as those who engaged in any moderate activities for 2 h or more per week and any strenuous activities 30 min or more per week. Incident ESKD was identified via record linkage with the Singapore Registry of Birth and Death and Singapore Renal Registry. Cox proportional hazards regression method was used for analysis for risk of incident ESKD alone or ESKD plus death associated with physical activity. During a median follow-up of 15.3 years, a total of 642 incident ESKD occurred, and 9808 study participants died. A 24% lower adjusted risk of ESKD (hazard ratio: 0.76; 95% confidence interval: 0.62-0.93) was associated with moderate or strenuous physical activities compared with no regular physical activity. This association appeared to be dose dependent with the lowest risk for subjects at highest intensity of physical activity (P trend <0.003). Similar results were observed for risk of ESKD plus death. Higher levels of physical activity are associated with lower risk of ESKD. Our findings highlight the role of physical activity for prevention of ESKD, which deserves further evaluation in intervention trials. © 2014 Asian Pacific Society of Nephrology.

Women hospitalized with atrial fibrillation: gender differences, trends and outcome from a 20-year registry in a Middle Eastern country (1991-2010).

PubMed

Salam, Amar M; AlBinali, Hajar A; Al-Mulla, Abdul Wahid; Asaad, Nidal; Singh, Rajvir; Al-Qahtani, Awad; Al Suwaidi, Jassim

2013-09-30

Most of the published research on atrial fibrillation (AF) is limited to studies in the developed world and included mainly Caucasian patients. Data about women with AF among other ethnicities is very limited. The aim of this study was to compare the clinical characteristics, treatment and outcome of women to men hospitalized with AF in a middle-eastern country. Retrospective analysis of prospective registry of all patients hospitalized with AF in Qatar from 1991 through 2010 was made. Clinical characteristics, management, and outcomes of AF patients were compared according to gender. During the 20-years period; 1417 women and 2432 men were hospitalized for AF. Women were 5 years older and more likely to have diabetes mellitus, hypertension, and chronic renal impairment and were also less likely to be current smokers and to have ischemic heart disease and impaired left ventricular function when compared to men. There was no gender preference in the use of anticoagulation. The prevalence of concomitant ischemic heart disease and hypertension increased, while the prevalence of valvular heart disease and heart failure decreased among patients hospitalized with AF over the study period. In-hospital mortality and stroke rates were comparable between the two groups. Women hospitalized with atrial fibrillation were older in age and had higher prevalence of co-morbid cardiovascular risk factors compared to men whereas, mortality and stroke rates were comparable. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Increased Incidence of Fatigue in Patients with Primary Immunodeficiency Disorders: Prevalence and Associations Within the US Immunodeficiency Network Registry

PubMed Central

Guffey, Danielle; Minard, Charles G.; Orange, Jordan S.

2017-01-01

Introduction Patients with primary immunodeficiency (PID) often report fatigue, yet this symptom has not been studied in PID. Fatigue affects 6–7.5% of healthy adults. The goal of this study is to estimate the prevalence of fatigue in patients with PID and investigate its associated factors. Methods We analyzed 2537 PID patients registered in USIDNET to determine responses to the field “fatigue” in the core registry form. Demographics, immune phenotypes, and comorbid conditions were compared between fatigued and non-fatigued patients to identify relevant associations and potential drivers. A focused analysis was performed for patients with predominantly antibody deficiency disorders (PADs). Results Fatigue was reported in 25.9%(95% CI 23.7–28.3) of PAD patients, compared to 6.4% (95% CI 4.9–8.2) of non-PAD. Patients with common variable immunodeficiency (CVID) had the highest prevalence of fatigue (p < 0.001) among all PID diagnoses. Other factors that were associated with a higher rate of fatigue among PAD patients included female sex, higher BMI, depression, bronchiectasis, and autoimmunity. Additionally, fatigued PAD patients had lower absolute lymphocyte, CD3, CD4, and CD8 counts compared to non-fatigued patients. Conclusion Our findings suggest that fatigue is overrepresented in PAD patients. Prospective studies to estimate prevalence, risk factors, and fatigue etiology in PID are warranted, so therapeutic interventions can be considered. PMID:28124237

Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry.

PubMed

Goodwin, Scott C; Spies, James B; Worthington-Kirsch, Robert; Peterson, Eric; Pron, Gaylene; Li, Shuang; Myers, Evan R

2008-01-01

To assess long-term clinical outcomes of uterine artery embolization across a wide variety of practice settings in a large patient cohort. The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization was a 3-year, single-arm, prospective, multi-center longitudinal study of the short- and long-term outcomes of uterine artery embolization for leiomyomata. Two thousand one hundred twelve patients with symptomatic leiomyomata were eligible for long-term follow-up at 27 sites representing a geographically diverse set of practices, including academic centers, community hospitals, and closed-panel health maintenance organizations. At 36 months after treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The primary measures of outcome were the symptom and health-related quality-of-life scores from the Uterine Fibroid Symptom and Quality of Life questionnaire. Mean symptom scores improved 41.41 points (P<.001), and the quality of life scores improved 41.47 points (P<.001), both moving into the normal range for this questionnaire. The improvements were independent of practice setting. During the 3 years of the study, Kaplan-Meier estimates of hysterectomy, myomectomy, or repeat uterine artery embolization were 9.79%, 2.82%, and 1.83% of the patients, respectively. Uterine artery embolization results in a durable improvement in quality of life. These results are achievable when the procedure is performed in any experienced community or academic interventional radiology practice. III.

Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database.

PubMed

Etoh, Tsuyoshi; Honda, Michitaka; Kumamaru, Hiraku; Miyata, Hiroaki; Yoshida, Kazuhiro; Kodera, Yasuhiro; Kakeji, Yoshihiro; Inomata, Masafumi; Konno, Hiroyuki; Seto, Yasuyuki; Kitano, Seigo; Hiki, Naoki

2018-06-01

Controversy persists regarding the technical feasibility of laparoscopic total gastrectomy (LTG), and to our knowledge, no prospective study with a sample size sufficient to investigate its safety has been reported. We aimed to compare the postoperative morbidity and mortality rates in patients undergoing LTG and open total gastrectomy (OTG) for gastric cancer in prospectively enrolled cohort using nationwide web-based registry. From August 2014 to July 2015, consecutive patients undergoing LTG or OTG (925 and 1569 patients, respectively) at the participating institutions were enrolled prospectively into the National Clinical Database registration system. We constructed propensity score (PS) models separately in four facility yearly case-volume groups, and evaluated the postoperative morbidity and mortality in PS-matched 1024 patients undergoing LTG or OTG. The incidence of overall morbidity were 84 (16.4%) in the OTG and 54 (10.3%) in the LTG groups (p = 0.01).The incidence of anastomotic leakage and pancreatic fistula grade B or above were not significantly different between the two groups (LTG 5.3% vs. OTG 6.1%, p = 0.59, LTG 2.7% vs. OTG 3.7%, p = 0.38, respectively). There were also no significant differences in the 30-day and in-hospital mortality rates between the two groups (LTG 0.2% vs. OTG 0.4%, p = 0.56; LTG 0.4% vs. OTG 0.4%, p = 1.00, respectively). The results from our nationally representative data analysis showed that LTG could be a safe procedure to treat gastric cancer compared to OTG. The indication for LTG should be considered carefully in a clinical setting.

A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.

PubMed

Naber, Christoph K; Pyxaras, Stylianos A; Ince, Hüseyin; Frambach, Peter; Colombo, Antonio; Butter, Christian; Gatto, Fernando; Hink, Ulrich; Nickenig, Georg; Bruschi, Giuseppe; Brueren, Guus; Tchétché, Didier; Den Heijer, Peter; Schillinger, Wolfgang; Scholtz, Smita; Van der Heyden, Jan; Lefèvre, Thierry; Gilard, Martine; Kuck, Karl-Heinz; Schofer, Joachim; Divchev, Dimitar; Baumgartner, Helmut; Asch, Federico; Wagner, Daniel; Latib, Azeem; De Marco, Federico; Kische, Stephan

2016-12-10

Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%). The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy--rationale and design of the EARLY hypertension registry.

PubMed

Gitt, Anselm K; Baumgart, Peter; Bramlage, Peter; Mahfoud, Felix; Potthoff, Sebastian A; Senges, Jochen; Schneider, Steffen; Buhck, Hartmut; Schmieder, Roland E

2013-07-02

Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions. The "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013. The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice.

Meat intake and bladder cancer risk in a Swedish prospective cohort.

PubMed

Larsson, Susanna C; Johansson, Jan-Erik; Andersson, Swen-Olof; Wolk, Alicja

2009-02-01

High meat consumption could potentially increase the risk of bladder cancer, but findings from epidemiologic studies are inconsistent. We prospectively examined the association between meat intake and bladder cancer risk in a population-based cohort study. We prospectively followed 82,002 Swedish women and men who were free from cancer and completed a food-frequency questionnaire in 1997. Incident cases of bladder cancer were identified in the Swedish cancer registries. Cox proportional hazards models were used to calculate hazard ratios (HR) with 95% confidence intervals (CI), adjusted for age, sex, education, smoking status, pack-years of smoking, and total energy intake. During a mean follow-up of 9.4 years, 485 incident cases of bladder cancer (76 women and 409 men) were ascertained in the cohort. We observed no association between the intake of total or any specific type of meat and the risk of bladder cancer. The multivariate HRs (95% CIs) comparing the highest and the lowest category of intake were 1.05 (0.71-1.55) for total meat, 1.00 (0.71-1.41) for red meat, 1.01 (0.80-1.28) for processed meats, 0.96 (0.70-1.30) for chicken/poultry, and 0.92 (0.65-1.30) for fried meats/fish. The associations did not vary by sex or smoking status. These results do not support the hypothesis that intake of red meat, processed meat, poultry, or fried meats/fish is associated with the risk of developing bladder cancer.

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research

PubMed Central

Rider, Lisa G.; Dankó, Katalin; Miller, Frederick W.

2016-01-01

Purpose of review Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers’ collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. Recent findings We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Summary Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways. PMID:25225838

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research.

PubMed

Rider, Lisa G; Dankó, Katalin; Miller, Frederick W

2014-11-01

Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers' collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here, we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways.

Temporal trend of in-hospital major bleeding among patients with non ST-elevation acute coronary syndromes.

PubMed

Elbarouni, Basem; Elmanfud, Omran; Yan, Raymond T; Fox, Keith A A; Kornder, Jan M; Rose, Barry; Spencer, Frederick A; Welsh, Robert C; Wong, Graham C; Goodman, Shaun G; Yan, Andrew T

2010-09-01

Although randomized controlled trials support the use of intensive medical and invasive therapies for non-ST segment elevation acute coronary syndromes (NSTE-ACS), major bleeding is a serious treatment complication. We sought to determine the temporal trend of in-hospital major bleeding among patients with NSTE-ACS, in relation to the evolving management pattern. We identified 14 111 NSTE-ACS patients enrolled in 4 successive, prospective, multicenter registries (ACS I, 1999-2001; ACS II, 2002-2003; GRACE, 2004-2007; and CANRACE, 2008) in Canada between 1999 and 2008. We collected data on patient characteristics, use of cardiac medications and procedures on standardized case report forms. In all registries, major bleeding was defined a priori as life threatening or fatal bleeding, bleeding requiring transfusion of ≥2 U of packed red cells, or resulting in an absolute decrease in hemoglobin of >30g/L. A total of 14 111 patients had a final diagnosis of NSTE-ACS and were included in this study (3294 in the ACS-I registry, 1956 in the ACS-II registry, 7543 in GRACE, and 1318 in CANRACE). Over time, there was a substantial increase in the use of dual anti-platelet (aspirin and thienopyridine) therapy (P for trend <.001), and in rates of in-hospital cardiac catheterization and percutaneous coronary intervention (both Ps for trend <.001). Overall, major bleeding was relatively infrequent (1.7%). There was no significant increase in the unadjusted rates of major bleeding over time (P for trend = .19). In multivariable analysis adjusting for GRACE risk score and intensive treatment, enrolment period was not an independent predictor of bleeding (P for trend = .98). There was no interaction between the enrolment period and the use of intensive medical and invasive management. Despite more widespread use of dual anti-platelet therapies and invasive cardiac procedures in the management of NSTE-ACS, the rate of major bleeding remains relatively low and has not increased significantly over time. Our findings suggest that physicians selectively target treatment for their patients, and these evidence-based therapies can be safely administered to ACS patients in clinical practice. 2010 Mosby, Inc. All rights reserved.

Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2).

PubMed

de la Torre Hernández, José M; Alfonso, Fernando; Gimeno, Federico; Diarte, Jose A; Lopez-Palop, Ramón; Pérez de Prado, Armando; Rivero, Fernando; Sanchis, Juan; Larman, Mariano; Diaz, Jose F; Elizaga, Jaime; Moreiras, Javier Martín; Gomez Jaume, Alfredo; Hernández, José M; Mauri, Josepa; Recalde, Angel Sánchez; Bullones, Juan A; Rumoroso, Jose R; Del Blanco, Bruno García; Baz, Jose A; Bosa, Francisco; Botas, Javier; Hernández, Felipe

2010-09-01

This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice. First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES). A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology. From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03). In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A RIETE registry analysis of recurrent thromboembolism and hemorrhage in patients with catheter-related thrombosis.

PubMed

Baumann Kreuziger, Lisa; Cote, Lauren; Verhamme, Peter; Greenberg, Steven; Caprini, Joseph; Muñoz, Francisco José; Valle, Reina; Monreal Bosch, Manuel

2015-07-01

Few studies have investigated the treatment and the outcomes of patients with catheter-related thrombosis (CRT). The RIETE registry (Registro Informatizado de Enfermedad TromboEmbólica [Computerized Registry of Patients with Venous Thromboembolism]) is a prospective international registry of consecutive patients with objectively confirmed venous thromboembolism (VTE). We analyzed the characteristics, treatment, and outcomes of patients with CRT. Of 558 patients with CRT, 45 (8%) presented with a pulmonary embolism (PE) concomitantly. More patients had central line-associated thrombosis compared with port systems, but catheter type did not influence the risk of presenting with a PE. Patients with only CRT were more often prescribed low-molecular-weight heparin for the duration of their anticoagulant treatment compared with patients presenting with concomitant PE. VTE recurrences and major bleeding events occurred frequently during treatment with anticoagulation (7 per 100 patient-years and 8.9 per 100 patient years, respectively). The rates of fatal PE recurrences (1.85 per 100 patient-years) and fatal bleeding (2.32 per 100 patient-years) were similar. Patients with an additional transient risk factor for VTE had the lowest risk for VTE recurrences (odds ratio [OR], 0.07; 90% confidence interval [CI], 0.01-0.45) compared with patients with CRT and no additional transient risk factors. PE at presentation increased the risk of recurrent thrombosis by 2.4 times. Renal insufficiency was also an independent predictor of recurrent thrombosis (OR, 3.93; 90% CI, 2.0-7.7). The odds of recurrent thrombosis was decreased by 77% in patients who received anticoagulation therapy for >90 days compared with patients with a shorter treatment (OR, 0.23; 90% CI, 0.1-0.56). Concomitant PE occurs less frequently in CRT than lower extremity deep venous thrombosis, but it is associated with a worse outcome. CRT occurs in high-risk patients, and duration of anticoagulation must be predicated on balancing these risks. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

How complete are immunization registries? The Philadelphia story.

PubMed

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

2006-01-01

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

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Treatment of triple-negative breast cancer with Chinese herbal medicine: A prospective cohort study protocol.

PubMed

Meng, Hui; Peng, Nan; Yu, Mingwei; Sun, Xu; Ma, Yunfei; Yang, Guowang; Wang, Xiaomin

2017-11-01

Triple-negative breast cancer (TNBC) is featured with the biological properties of strong aggressive behaviors, rapid disease progression, high risk of recurrence and metastasis, and low disease free survival. Patients with this tumor are insensitive to the endocrine therapy and target treatment for HER-2; therefore, chemotherapy is often used as routine treatment in clinical. Because of the fact that a considerable number of patients seek for Chinese herbal medicine (CHM) treatment after operation and chemotherapy and (or) radiotherapy, it is thus need to evaluate the correlation between Chinese herbal medicine treatment and prognosis. This is a multicenter, prospective cohort study started in March 2016 in Beijing. A simple of 220 participants diagnosed with TNBC were recruited from nine hospitals and are followed up every 3 to 6 months till March 2020. Detailed information of participants includes personal information, history of cancer, quality of life, symptoms of traditional Chinese medicine and fatigue status is taken face-to-face at baseline. The study has received ethical approval from the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (No.2016BL-014-01). Articles summarizing the primary results and ancillary analyses will be published in peer-reviewed journals. Chinese Clinical Trial Registry: ChiCTR-OOC-16008246.

Recreational physical activity and the risk of preeclampsia: a prospective cohort of Norwegian women.

PubMed

Magnus, Per; Trogstad, Lill; Owe, Katrine M; Olsen, Sjurdur F; Nystad, Wenche

2008-10-15

Previous case-control studies suggest that recreational physical activity protects against preeclampsia. Using a prospective design, the authors estimated the risk of preeclampsia for pregnant women according to level of physical activity, taking other variables that influence risk into consideration. The data set comprised 59,573 pregnancies from the Norwegian Mother and Child Cohort Study (1999-2006). Information on physical activity and other exposures was extracted from questionnaire responses given in pregnancy weeks 14-22, whereas diagnosis of preeclampsia was retrieved from the Medical Birth Registry of Norway. Estimation and confounder control was performed with multiple logistic regression. About 24% of pregnant women reported no physical activity, and 7% reported more than 25 such activities per month. The adjusted odds ratio was 0.79 (95% confidence interval: 0.65, 0.96) for preeclampsia when comparing women who exercised 25 times or more per month with inactive women. The association appeared strongest among women whose body mass index was less than 25 kg/m(2) and was absent among women whose body mass index was higher than 30 kg/m(2). These results suggest that the preventive effect of recreational physical activity during pregnancy may be more limited than has been shown in case-control studies and may apply to nonobese women only.

Recreational Physical Activity and the Risk of Preeclampsia: A Prospective Cohort of Norwegian Women

PubMed Central

Trogstad, Lill; Owe, Katrine M.; Olsen, Sjurdur F.; Nystad, Wenche

2008-01-01

Previous case-control studies suggest that recreational physical activity protects against preeclampsia. Using a prospective design, the authors estimated the risk of preeclampsia for pregnant women according to level of physical activity, taking other variables that influence risk into consideration. The data set comprised 59,573 pregnancies from the Norwegian Mother and Child Cohort Study (1999–2006). Information on physical activity and other exposures was extracted from questionnaire responses given in pregnancy weeks 14–22, whereas diagnosis of preeclampsia was retrieved from the Medical Birth Registry of Norway. Estimation and confounder control was performed with multiple logistic regression. About 24% of pregnant women reported no physical activity, and 7% reported more than 25 such activities per month. The adjusted odds ratio was 0.79 (95% confidence interval: 0.65, 0.96) for preeclampsia when comparing women who exercised 25 times or more per month with inactive women. The association appeared strongest among women whose body mass index was less than 25 kg/m2 and was absent among women whose body mass index was higher than 30 kg/m2. These results suggest that the preventive effect of recreational physical activity during pregnancy may be more limited than has been shown in case-control studies and may apply to nonobese women only. PMID:18701444

A Cohort Study of Vitamin D Intake and Melanoma Risk

PubMed Central

Asgari, Maryam M.; Maruti, Sonia S.; Kushi, Lawrence H.; White, Emily

2009-01-01

Data suggest that vitamin D intake may have chemopreventive efficacy against melanoma, but there have been no published epidemiologic studies examining the association between vitamin D intake and melanoma risk in a large prospective cohort. We examined whether dietary and supplemental vitamin D intake was associated with melanoma risk among 68,611 men and women who were participants of the Vitamins and Lifestyle cohort study. Participants reported dietary vitamin D intake over the past year and 10-year use of multivitamin and individual vitamin D supplements on a baseline questionnaire. After follow-up through 2006, 455 incident melanomas were identified through linkage to the Surveillance, Epidemiology, and End Results cancer registry. Cox proportional hazards regression models were used to estimate relative risks (RRs) and 95% confidence intervals (CIs) for vitamin D intake after adjustment for melanoma risk factors. Compared with the lowest quartile, we did not detect a risk reduction of melanoma in the highest quartiles of dietary vitamin D intake (RR = 1.31, CI = 0.94–1.82), 10-year average supplemental vitamin D intake (RR = 1.13, CI = 0.89–1.43), or combined dietary and supplemental intake (1.05, CI = 0.79–1.40). In this large prospective cohort, we did not find an association between vitamin D intake and melanoma risk. PMID:19194478

Walking Distance as a Predictor of Falls in People With Multiple Sclerosis.

PubMed

Nilsagård, Ylva; Westerdahl, Elisabeth; Wittrin, Anna; Gunnarsson, Martin

2016-06-01

People with multiple sclerosis (PwMS) experience falls, usually when walking and transferring. The aim was to investigate if walking distance and patient overestimate of walking distance are predictors of falls in PwMS. A prospective study was conducted, with a single test occasion followed by prospective registration of falls for 3 months. All PwMS in Region Örebro County with a previously registered Expanded Disability Status Scale score between 3.0 and 7.0 in the Swedish MS Registry were invited to participate (n = 149). Altogether, data from 49 PwMS being relapse free for at least 3 months and with a confirmed Expanded Disability Status Scale between 1.5 and 7.0 upon study entry were analysed. Twenty-two PwMS (45%) fell during the study period, providing information of 66 falls. Walking distance or overestimate of one's walking distance, as compared with test results, did not predict falls in this MS sample. Walking and standing activities are associated with numerous falls in PwMS. Our data do not clearly support routine measurements of walking distance in assessing individual fall risk. © 2015 The Authors. Physiotherapy Research International published by John Wiley & Sons, Ltd. © 2015 The Authors. Physiotherapy Research International published by John Wiley & Sons, Ltd.

Everolimus as first line therapy for pancreatic neuroendocrine tumours: current knowledge and future perspectives.

PubMed

Gallo, Marco; Malandrino, Pasqualino; Fanciulli, Giuseppe; Rota, Francesca; Faggiano, Antongiulio; Colao, Annamaria

2017-07-01

Everolimus has been shown to be effective for advanced pancreatic neuroendocrine tumours (pNETs), but its positioning in the therapeutic algorithm for pNETs is matter of debate. With the aim to shed light on this point, we performed an up-to-date critical review taking into account the results of both retrospective and prospective published studies, and the recommendations of international guidelines. In addition, we performed an extensive search on the Clinical Trial Registries databases worldwide, to gather information on the ongoing clinical trials related to this specific topic. We identified eight retrospective published studies, two prospective published studies, and five registered clinical trials. Moreover, we analyzed the content of four widespread international guidelines. Our critical review confirms the lack of high-quality data to recommend everolimus as the first line therapy for pNETs. The ongoing clinical trials reported in this review will hopefully help clinicians, in the near future, to better evaluate the role of everolimus as the first line therapy for pNETs. However, at the moment, there is already enough evidence to recommend everolimus as the first line therapy for patients with symptomatic malignant unresectable insulin-secreting pNETs, to control the endocrine syndrome regardless of tumour growth.

Baseline Characteristics and Prescription Patterns of Standard Drugs in Patients with Angiographically Determined Coronary Artery Disease and Renal Failure (CAD-REF Registry)

PubMed Central

Reinecke, Holger; Breithardt, Günter; Engelbertz, Christiane; Schmieder, Roland E.; Fobker, Manfred; Pinnschmidt, Hans O.; Schmitz, Boris; Bruland, Philipp; Wegscheider, Karl; Pavenstädt, Hermann; Brand, Eva

2016-01-01

Background Chronic kidney disease (CKD) is strongly associated with coronary artery disease (CAD). We established a prospective observational nationwide multicenter registry to evaluate current treatment and outcomes in patients with both CKD and angiographically documented CAD. Methods In 32 cardiological centers 3,352 CAD patients with ≥50% stenosis in at least one coronary artery were enrolled and classified according to their estimated glomerular filtration rate and proteinuria into one of five stages of CKD or as a control group. Results 2,723 (81.2%) consecutively enrolled patients suffered from CKD. Compared to controls, CKD patients had a higher prevalence of diabetes, hypertension, peripheral artery diseases, heart failure, and valvular heart disease (each p<0.001). Myocardial infarctions (p = 0.02), coronary bypass grafting, valve replacements and pacemaker implantations had been recorded more frequently (each p<0.001). With advanced CKD, the number of diseased coronary vessels and the proportion of patients with reduced left ventricular ejection fraction (LVEF) increased significantly (both p<0.001). Percutaneous coronary interventions were performed less frequently (p<0.001) while coronary bypass grafting was recommended more often (p = 0.04) with advanced CKD. With regard to standard drugs in CAD treatment, prescriptions were higher in our registry than in previous reports, but beta-blockers (p = 0.008), and angiotensin-converting-enzyme inhibitors and/or angiotensin-receptor blockers (p<0.001) were given less often in higher CKD stages. In contrast, in the subgroup of patients with moderately to severely reduced LVEF the prescription rates did not differ between CKD stages. In-hospital mortality increased stepwise with each CKD stage (p = 0.02). Conclusions In line with other studies comprising CKD cohorts, patients’ morbidity and in-hospital mortality increased with the degree of renal impairment. Although cardiologists’ drug prescription rates in CAD-REF were higher than in previous studies, they were still lower especially in advanced CKD stages compared to cohorts treated by nephrologists. PMID:26859890

Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project.

PubMed

Frank, Bernd; Ariza, Liana; Lamparter, Heidrun; Grossmann, Vera; Prochaska, Jürgen H; Ullmann, Alexander; Kindler, Florentina; Weisser, Gerhard; Walter, Ulrich; Lackner, Karl J; Espinola-Klein, Christine; Münzel, Thomas; Konstantinides, Stavros V; Wild, Philipp S

2015-07-01

Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date. The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three 'all-comer' studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings. The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and international scientific meetings. NCT02156401. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A prospective, observational registry of patients with severe sepsis: the Canadian Sepsis Treatment and Response Registry.

PubMed

Martin, Claudio M; Priestap, Fran; Fisher, Harold; Fowler, Robert A; Heyland, Daren K; Keenan, Sean P; Longo, Christopher J; Morrison, Teresa; Bentley, Diane; Antman, Neil

2009-01-01

To determine the location of acquisition, timing, and outcomes associated with severe sepsis in community and teaching hospital critical care units. Prospective, observational study. Twelve Canadian community and teaching hospital critical care units. All patients admitted between March 17, 2003, and November 30, 2004 to the study critical care units with at least a 24-hr length of stay or severe sepsis identified during the first 24 hrs. Daily monitoring for severe sepsis. We recorded data describing characteristics of patients, infections, systemic responses, and organ dysfunction. Severe sepsis occurred in 1238 patients (overall rate, 19.0%; range, 8.2%-35.3%). Hospital mortality was 38.1% (95% confidence interval [CI]: 35.4-40.8). Median intensive care unit length of stay was 10.3 days (interquartile range: 5.5, 17.9). Variables associated with mortality in multivariable analysis included age (odds ratio [OR] by decade 1.50; 95% CI: 1.36-1.65), acquisition location of severe sepsis (with community as the reference-hospital [OR: 1.69; CI: 1.16-2.46], early intensive care unit [OR: 2.15; CI: 1.42-3.25], late intensive care unit [OR: 2.65; CI: 1.82-3.87]), late intensive care unit (OR: 2.65; CI: 1.82-3.87), any comorbidity (OR: 1.42; CI: 1.04-1.93), chronic renal failure (OR: 2.03; CI: 1.10-3.76), oliguria (OR: 1.34; CI: 1.02-1.76), thrombocytopenia (OR: 2.12; CI: 1.43-3.13), metabolic acidosis (OR: 1.54; CI: 1.13-2.10), Multiple Organ Dysfunction Score (OR: 1.15; CI: 1.09-1.21) and Acute Physiology and Chronic Health Evaluation II predicted risk (OR: 3.75; CI: 2.08-6.76). These data confirm that sepsis is common and has high mortality in general intensive care unit populations. Our results can inform healthcare system planning and clinical study designs. Modifiable variables associated with worse outcomes, such as nosocomial infection (hospital acquisition), and metabolic acidosis indicate potential targets for quality improvement initiatives that could decrease mortality and morbidity.

Blood Lead Levels and Decreased Kidney Function in a Population-Based Cohort.

PubMed

Harari, Florencia; Sallsten, Gerd; Christensson, Anders; Petkovic, Marinka; Hedblad, Bo; Forsgard, Niklas; Melander, Olle; Nilsson, Peter M; Borné, Yan; Engström, Gunnar; Barregard, Lars

2018-04-23

Environmental lead exposure has been associated with decreased kidney function, but evidence from large prospective cohort studies examining low exposure levels is scarce. We assessed the association of low levels of lead exposure with kidney function and kidney disease. Prospective population-based cohort. 4,341 individuals aged 46 to 67 years enrolled into the Malmö Diet and Cancer Study-Cardiovascular Cohort (1991-1994) and 2,567 individuals subsequently followed up (2007-2012). Blood lead concentrations in quartiles (Q1-Q4) at baseline. Change in estimated glomerular filtration rate (eGFR) between the baseline and follow-up visit based on serum creatinine level alone or in combination with cystatin C level. Chronic kidney disease (CKD) incidence (185 cases) through 2013 detected using a national registry. Multivariable-adjusted linear regression models to assess associations between lead levels and eGFRs at baseline and follow-up and change in eGFRs over time. Cox regression was used to examine associations between lead levels and CKD incidence. Validation of 100 randomly selected CKD cases showed very good agreement between registry data and medical records and laboratory data. At baseline, 60% of study participants were women, mean age was 57 years, and median lead level was 25 (range, 1.5-258) μg/L. After a mean of 16 years of follow-up, eGFR decreased on average by 6mL/min/1.73m 2 (based on creatinine) and 24mL/min/1.73m 2 (based on a combined creatinine and cystatin C equation). eGFR change was higher in Q3 and Q4 of blood lead levels compared with Q1 (P for trend = 0.001). The HR for incident CKD in Q4 was 1.49 (95% CI, 1.07-2.08) compared with Q1 to Q3 combined. Lead level measured only at baseline, moderate number of CKD cases, potential unmeasured confounding. Low-level lead exposure was associated with decreased kidney function and incident CKD. Our findings suggest lead nephrotoxicity even at low levels of exposure. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Comparison of minimally invasive spine surgery using intraoperative computed tomography integrated navigation, fluoroscopy, and conventional open surgery for lumbar spondylolisthesis: a prospective registry-based cohort study.

PubMed

Wu, Meng-Huang; Dubey, Navneet Kumar; Li, Yen-Yao; Lee, Ching-Yu; Cheng, Chin-Chang; Shi, Chung-Sheng; Huang, Tsung-Jen

2017-08-01

To date, the surgical approaches for the treatment of lumbar spondylolisthesis by transforaminal lumbar interbody fusion (TLIF) using minimally invasive spine surgery assisted with intraoperative computed tomography image-integrated navigation (MISS-iCT), fluoroscopy (MISS-FS), and conventional open surgery (OS) are debatable. This study compared TLIF using MISS-iCT, MISS-FS, and OS for treatment of one-level lumbar spondylolisthesis. This is a prospective, registry-based cohort study that compared surgical approaches for patients who underwent surgical treatment for one-level lumbar spondylolisthesis. One hundred twenty-four patients from January 2010 to March 2012 in a medical center were recruited. The outcome measures were clinical assessments, including Short-Form 12, visual analog scale (VAS), Oswestry Disability Index, Core Outcome Measurement Index, and patient satisfaction, and blood loss, hospital stay, operation time, postoperative pedicle screw accuracy, and superior-level facet violation. All surgeries were performed by two senior surgeons together. Ninety-nine patients (40M, 59F) who had at least 2 years' follow-up were divided into three groups according to the operation methods: MISS-iCT (N=24), MISS-FS (N=23), and OS (N=52) groups. Charts and surgical records along with postoperative CT images were assessed. MISS-iCT and MISS-FS demonstrated a significantly lowered blood loss and hospital stay compared with OS group (p<.01). Operation time was significantly lower in the MISS-iCT and OS groups compared with the MISS-FS group (p=.002). Postoperatively, VAS scores at 1 year and 2 years were significantly improved in the MISS-iCT and MISS-FS groups compared with the OS groups. No significant difference in the number of pedicle screw breach (>2 mm) was found. However, a lower superior-level facet violation rate was observed in the MISS-iCT and OS groups (p=.049). MISS-iCT TLIF demonstrated reduced operation time, blood loss, superior-level facet violation, hospital stay, and improved functional outcomes compared with the MISS-FS and OS approaches. Copyright © 2017 Elsevier Inc. All rights reserved.

Design and implementation of the canadian kidney disease cohort study (CKDCS): A prospective observational study of incident hemodialysis patients

PubMed Central

2011-01-01

Background Many nephrology observational studies use renal registries, which have well known limitations. The Canadian Kidney Disease Cohort Study (CKDCS) is a large prospective observational study of patients commencing hemodialysis in five Canadian centers. This study focuses on delineating potentially reversible determinants of adverse outcomes that occur in patients receiving dialysis for end-stage renal disease (ESRD). Methods/Design The CKDCS collects information on risk factors and outcomes, and stores specimens (blood, dialysate, hair and fingernails) at baseline and in long-term follow-up. Such specimens will permit measurements of biochemical markers, proteomic and genetic parameters (proteins and DNA) not measured in routine care. To avoid selection bias, all consenting incident hemodialysis patients at participating centers are enrolled, the large sample size (target of 1500 patients), large number of exposures, and high event rates will permit the exploration of multiple potential research questions. Preliminary Results Data on the baseline characteristics from the first 1074 subjects showed that the average age of patients was 62 (range; 50-73) years. The leading cause of ESRD was diabetic nephropathy (41.9%), and the majority of the patients were white (80.0%). Only 18.7% of the subjects received dialysis in a satellite unit, and over 80% lived within a 50 km radius of the nearest nephrologist's practice. Discussion The prospective design, detailed clinical information, and stored biological specimens provide a wealth of information with potential to greatly enhance our understanding of risk factors for adverse outcomes in dialysis patients. The scientific value of the stored patient tissue will grow as new genetic and biochemical markers are discovered in the future. PMID:21324196

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

PubMed

Conrotto, Federico; D'Ascenzo, Fabrizio; D'Onofrio, Augusto; Agrifoglio, Marco; Chieffo, Alaide; Cioni, Micaela; Regesta, Tommaso; Tarantini, Giuseppe; Gabbieri, Davide; Saia, Francesco; Tamburino, Corrado; Ribichini, Flavio; Cugola, Diego; Aiello, Marco; Sanna, Francesco; Iadanza, Alessandro; Pompei, Esmeralda; Stolcova, Miroslava; Cappai, Antioco; Minati, Alessandro; Cassese, Mauro; Martinelli, Gian Luca; Agostinelli, Andrea; Gerosa, Gino; Gaita, Fiorenzo; Rinaldi, Mauro; Salizzoni, Stefano

2016-11-01

Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS 2 and CHA 2 DS 2 -VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA 2 DS 2 -VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS 2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA 2 DS 2 -VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA 2 DS 2 -VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS 2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). In TAVI patients, CHA 2 DS 2 -VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Ethical aspects of registry-based research in the Nordic countries.

PubMed

Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

2015-01-01

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.

Ethical aspects of registry-based research in the Nordic countries

PubMed Central

Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

2015-01-01

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies. PMID:26648756

Does sex affect anticoagulant use for stroke prevention in nonvalvular atrial fibrillation? The prospective global anticoagulant registry in the FIELD-Atrial Fibrillation.

PubMed

Lip, Gregory Y H; Rushton-Smith, Sophie K; Goldhaber, Samuel Z; Fitzmaurice, David A; Mantovani, Lorenzo G; Goto, Shinya; Haas, Sylvia; Bassand, Jean-Pierre; Camm, Alan John; Ambrosio, Giuseppe; Janský, Petr; Al Mahmeed, Wael; Oh, Seil; van Eickels, Martin; Raatikainen, Pekka; Steffel, Jan; Oto, Ali; Kayani, Gloria; Accetta, Gabriele; Kakkar, Ajay K

2015-03-01

Among patients with atrial fibrillation (AF), women are at higher risk of stroke than men. Using prospective cohort data from a large global population of patients with nonvalvular AF, we sought to identify any differences in the use of anticoagulants for stroke prevention in women and men. This was a prospective multicenter observational registry with 858 randomly selected sites in 30 countries. A total of 17 184 patients with newly diagnosed (≤6 weeks) nonvalvular AF and ≥1 additional investigator-defined stroke risk factor(s) were recruited (March 2010 to June 2013). The main outcome measure was the use of anticoagulants (vitamin K antagonists, factor Xa inhibitors, and direct thrombin inhibitors) for stroke prevention at AF diagnosis. Of 17 184 patients enrolled, 43.8% were women. More women than men were at moderate-to-high risk of stroke (CHADS2 score ≥2: 65.1% versus 54.7%). Rates of anticoagulant use were not different overall (60.9% of men versus 60.8% of women) and in patients with a CHADS2 score ≥2 (adjusted odds ratio for women versus men, 1.00; 95% confidence interval, 0.92-1.09). In patients at low risk (CHA2DS2-VASc of 0 in men and 1 in women), 41.8% of men and 41.1% of women received an anticoagulant. In patients at high risk (CHA2DS2-VASc score ≥2), 35.4% of men and 38.4% of women did not receive an anticoagulant. These contemporary global data show that anticoagulant use for stroke prevention is no different in men and women with nonvalvular AF. Thromboprophylaxis was, however, suboptimal in substantial proportions of men and women, with underuse in those at moderate-to-high risk of stroke and overuse in those at low risk. http://www.clinicaltrials.gov. Unique identifier: NCT01090362. © 2015 American Heart Association, Inc.

Childhood Vesicoureteral Reflux Studies: Registries and Repositories Sources and Nosology

PubMed Central

Chesney, Russell W.; Patters, Andrea B.

2012-01-01

Despite several recent studies, the advisability of antimicrobial prophylaxis and certain imaging studies for urinary tract infections (UTIs) remains controversial. The role of vesicoureteral reflux (VUR) on the severity and re-infection rates for UTIs is also difficult to assess. Registries and repositories of data and biomaterials from clinical studies in children with VUR are valuable. Disease registries are collections of secondary data related to patients with a specific diagnosis, condition or procedure. Registries differ from indices in that they contain more extensive data. A research repository is an entity that receives, stores, processes and/or disseminates specimens (or other materials) as needed. It encompasses the physical location as well as the full range of activities associated with its operation. It may also be referred to as a biorepository. This report provides information about some current registries and repositories that include data and samples from children with VUR. It also describes the heterogeneous nature of the subjects, as some registries and repositories include only data or samples from patients with primary reflux while others also include those from patients with syndromic or secondary reflux. PMID:23044377

Associations between inadequate knee function detected by KOOS and prospective graft failure in an anterior cruciate ligament-reconstructed knee.

PubMed

Granan, Lars-Petter; Baste, Valborg; Engebretsen, Lars; Inacio, Maria C S

2015-04-01

First, to evaluate whether the 2 year post-operative Knee injury and Osteoarthritis Outcome Score (KOOS) in primary anterior cruciate ligament reconstructions (ACLRs) was significantly different between patients that did not go on to have a subsequent revision after the 2 year post-operative control and the ones that did. Second, to test whether the "clinically failure" value of KOOS quality of life (QoL) < 44 was indicative of a clinically relevant difference in the risk of subsequent revision ACLR. ACLRs reported to the Norwegian Knee Ligament Registry between June 2004 and December 2009. 5,517 primary ACLRs with at least 2-year follow-up with KOOS QoL before revision surgery. There were clinically significant differences, adjusted and unadjusted, in both the KOOS Sport and Recreation and QoL subscales in patients with a later revision surgery compared to those that did not have a revision surgery. In adjusted models, the risk of later ACLR revision was 3.7 (95 % CI 2.2-6.0) higher in patients with a 2-year KOOS QoL < 44 compared to patients with a KOOS QoL ≥ 44. For every 10-point reduction in the KOOS QoL, a 33.6 % (95 % CI 21.2-47.5 %) higher risk for later ACLR revision was observed. This study reveals an association between inadequate knee function, as measured by KOOS, and a prospective ACL-reconstructed graft failure. Prognostic study (prospective cohort study), Level II.

The Value of Serum CA125 in the Diagnosis of Borderline Tumors of the Ovary: A Subanalysis of the Prospective Multicenter ROBOT Study.

PubMed

Fotopoulou, Christina; Sehouli, Jalid; Ewald-Riegler, Nina; de Gregorio, Nikolaus; Reuss, Alexander; Richter, Rolf; Mahner, Sven; Kommoss, Friedrich; Schmalfeldt, Barbara; Fehm, Tanja; Hanker, Lars; Wimberger, Pauline; Canzler, Ulrich; Pfisterer, Jacobus; Kommoss, Stefan; Hauptmann, Steffen; du Bois, Andreas

2015-09-01

The value of the serum tumor marker CA125 in borderline tumors of the ovary (BOTs) is not well defined, with unclear benefit in both diagnosis and follow-up. The aim of the present project was to identify the predictive value of CA125 for stage and relapse. CA125 data were extracted from the ROBOT multicenter study of patients with BOT treated between 1998 and 2008 in 24 German centers. While patients' data were retrieved retrospectively from hospital records and clinical tumor registries, follow-up and independent central pathology review were performed prospectively. We identified 127 patients from the ROBOT database fulfilling the eligibility criterion of available CA125 at initial diagnosis. Eighty-three (65.3%) patients had increased CA125 levels (>35 U/L). Of the patients, 85.0% presented with serous and 13.4% with mucinous BOT histology, whereas 29.9% had stage I disease. Fifteen (11.8%) patients experienced a relapse. Multivariate analysis identified raised CA125, young age, and serous histology as independent predictors of peritoneal implants of any type at initial presentation. Raised CA125 at initial diagnosis was, however, not an independent predictor of future relapse. Elevated CA125 seems to be associated with the presence of peritoneal implants of any type at initial diagnosis of serous BOT, but failed to have any independent predictive value on future relapse. Prospective multicenter studies are warranted to evaluate CA125 measurements in the follow-up management of BOT.

The Vietnam Era Twin Registry: a resource for medical research.

PubMed Central

Henderson, W G; Eisen, S; Goldberg, J; True, W R; Barnes, J E; Vitek, M E

1990-01-01

The Vietnam Era Twin Registry consists of 4,774 male-male twin pairs born between 1939 and 1957 with both brothers having served in the United States military during the Vietnam War. The registry was originally developed to provide the best control group for Vietnam-exposed servicemen to study the long-term health consequences of service in Vietnam. Recognizing the potential value of the registry for other areas of medical research, the Department of Veterans Affairs in 1988 opened the registry for use by both VA and non-VA investigators. The existence of centralized VA data bases for deaths and VA hospitalizations will strengthen future followup of the twins. This article describes the characteristics of the registry population and the process for accessing the registry. PMID:2116638

Economic evaluation of Mumbai and its satellite cancer registries: Implications for expansion of data collection☆

PubMed Central

Koyande, Shravani; Subramanian, Sujha; Edwards, Patrick; Hoover, Sonja; Deshmane, Vinay; Tankga, Florence; Dikshit, Rajesh; Saraiya, Mona

2018-01-01

Background The Mumbai Cancer Registry is a population-based cancer registry that has been in operation for more than five decades and has successfully initiated and integrated three satellite registries in Pune, Nagpur, and Aurangabad, each covering specific urban populations of the Indian state Maharashtra. Data collectors at the satellites perform data abstraction, but Mumbai carries out all other core registration activities such as data analysis and quality assurance. Each of the three satellite registries follows the same data collection methodology as the main Mumbai Cancer Registry. This study examines the cost of operating the Mumbai and its satellite cancer registries. Methods We modified and used the Centers for Disease Control and Prevention’s (CDC’s) International Registry Costing Tool (IntRegCosting Tool) to collect cost and resource use data for the Mumbai Cancer Registry and three satellites. Results Almost 60% of the registration expenditure was borne by the Indian Cancer Society, which hosts the Mumbai Cancer Registry, and more than half of the registry expenditure was related to data collection activities. Across the combined registries, 93% of the expenditure was spent on labor. Overall, registration activities had a low cost per case of 226.10 Indian rupees (or a little less than 4.00 US dollars in 2014 [used average exchange rate in 2014: 1 US $ = 60 Indian rupees]). Conclusion The centralization of fixed-cost activities in Mumbai likely resulted in economies of scale in operating the Mumbai and satellite registries, which, together, report on almost 20,000 cancer cases annually. In middle-income countries like India, where financial resources are limited, the operational framework provided by the Mumbai and satellite registries can serve as a model for other registries looking to expand data collection. PMID:27726981

Economic evaluation of Mumbai and its satellite cancer registries: Implications for expansion of data collection.

PubMed

Koyande, Shravani; Subramanian, Sujha; Edwards, Patrick; Hoover, Sonja; Deshmane, Vinay; Tankga, Florence; Dikshit, Rajesh; Saraiya, Mona

2016-12-01

The Mumbai Cancer Registry is a population-based cancer registry that has been in operation for more than five decades and has successfully initiated and integrated three satellite registries in Pune, Nagpur, and Aurangabad, each covering specific urban populations of the Indian state Maharashtra. Data collectors at the satellites perform data abstraction, but Mumbai carries out all other core registration activities such as data analysis and quality assurance. Each of the three satellite registries follows the same data collection methodology as the main Mumbai Cancer Registry. This study examines the cost of operating the Mumbai and its satellite cancer registries. We modified and used the Centers for Disease Control and Prevention's (CDC's) International Registry Costing Tool (IntRegCosting Tool) to collect cost and resource use data for the Mumbai Cancer Registry and three satellites. Almost 60% of the registration expenditure was borne by the Indian Cancer Society, which hosts the Mumbai Cancer Registry, and more than half of the registry expenditure was related to data collection activities. Across the combined registries, 93% of the expenditure was spent on labor. Overall, registration activities had a low cost per case of 226.10 Indian rupees (or a little less than 4.00 US dollars in 2014 [used average exchange rate in 2014: 1 US $=60 Indian rupees]). The centralization of fixed-cost activities in Mumbai likely resulted in economies of scale in operating the Mumbai and satellite registries, which, together, report on almost 20,000 cancer cases annually. In middle-income countries like India, where financial resources are limited, the operational framework provided by the Mumbai and satellite registries can serve as a model for other registries looking to expand data collection. Copyright © 2016 Elsevier Ltd. All rights reserved.

Dietary cholesterol, fats and risk of Parkinson's disease in the Singapore Chinese Health Study

PubMed Central

Tan, Louis C; Methawasin, Kulthida; Tan, Eng-King; Tan, June H; Au, Wing-Lok; Yuan, Jian-Min; Koh, Woon-Puay

2016-01-01

Background Prospective studies on lipids and risk of Parkinson's disease (PD) in Asian populations are sparse. This study prospectively examined the associations between dietary cholesterol and major fatty acids, and risk of PD among the Chinese in Singapore. Methods This study used data from the Singapore Chinese Health Study, a population-based prospective cohort of 63 257 men and women aged 45–74 years in Singapore enrolled in 1993–1998. Dietary intakes of cholesterol and fatty acids were derived from a validated semiquantitative food frequency questionnaire and the Singapore Food Composition Table. Incident PD cases were identified either through follow-up interviews or record linkage analysis with hospital discharge and PD outpatient registries. Results After an average of 14.6 years, 218 men and 193 women in the cohort developed PD. Dietary cholesterol was associated with statistically significantly lower risk of PD in a dose–dependent manner among men after adjustment for established risk factors for PD and intakes of major fatty acids. Compared to the lowest quartile, HR (95% CI) for the highest quartile was 0.53 (95% CI 0.33 to 0.84) (P for trend=0.006). Among women, dietary monounsaturated fatty acid was inversely associated with PD risk (P for trend=0.033). Compared to the lowest quartile, HR for the highest quartile was 0.44 (95% CI 0.22 to 0.88). There was no statistically significant association between dietary saturated, n-3 and n-6 fatty acids and PD risk. Conclusions Higher intakes of cholesterol and monounsaturated fatty acids may reduce risk of PD in men and women, respectively. PMID:25669745

Dietary cholesterol, fats and risk of Parkinson's disease in the Singapore Chinese Health Study.

PubMed

Tan, Louis C; Methawasin, Kulthida; Tan, Eng-King; Tan, June H; Au, Wing-Lok; Yuan, Jian-Min; Koh, Woon-Puay

2016-01-01

Prospective studies on lipids and risk of Parkinson's disease (PD) in Asian populations are sparse. This study prospectively examined the associations between dietary cholesterol and major fatty acids, and risk of PD among the Chinese in Singapore. This study used data from the Singapore Chinese Health Study, a population-based prospective cohort of 63 257 men and women aged 45-74 years in Singapore enrolled in 1993-1998. Dietary intakes of cholesterol and fatty acids were derived from a validated semiquantitative food frequency questionnaire and the Singapore Food Composition Table. Incident PD cases were identified either through follow-up interviews or record linkage analysis with hospital discharge and PD outpatient registries. After an average of 14.6 years, 218 men and 193 women in the cohort developed PD. Dietary cholesterol was associated with statistically significantly lower risk of PD in a dose-dependent manner among men after adjustment for established risk factors for PD and intakes of major fatty acids. Compared to the lowest quartile, HR (95% CI) for the highest quartile was 0.53 (95% CI 0.33 to 0.84) (P for trend=0.006). Among women, dietary monounsaturated fatty acid was inversely associated with PD risk (P for trend=0.033). Compared to the lowest quartile, HR for the highest quartile was 0.44 (95% CI 0.22 to 0.88). There was no statistically significant association between dietary saturated, n-3 and n-6 fatty acids and PD risk. Higher intakes of cholesterol and monounsaturated fatty acids may reduce risk of PD in men and women, respectively. 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/

Self-esteem and Mortality: Prospective Evidence from a Population-based Study

PubMed Central

STAMATAKIS, KATHERINE A.; LYNCH, JOHN; EVERSON, SUSAN A.; RAGHUNATHAN, TRIVELLORE; SALONEN, JUKKA T.; KAPLAN, GEORGE A.

2011-01-01

OBJECTIVE Self-esteem is considered to be importantly associated with both psychosocial states such as depression as well as physical health. There are no population-based studies that examine the association between self-esteem and mortality. The objective of this study was to assess whether low self-esteem was prospectively associated with increased risk of death in a population-based sample of Finnish men. METHODS A sample of 2682 male residents of Kuopio, Finland were interviewed and followed prospectively as part of the Kuopio Ischemic Heart Disease Risk Factor Study (KIHD). Characteristics of the KIHD sample at baseline included self-esteem, measured by the Rosenberg ten-item scale, socioeconomic factors, behavioral risk factors, other psychosocial characteristics, and prevalent diseases. Mortality was ascertained through linkage to the Finnish national death registry. We assessed the relationship between self-esteem and all-cause mortality using Cox proportional hazards models. RESULTS Low self-esteem was associated with a two-fold [hazard ratio (HR) = 2.0, 95% confidence interval (CI) = 1.3–3.2] increase in age-adjusted mortality. This relationship was partially explained by behavioral and socioeconomic factors, and prevalent diseases, and fully explained by other psychosocial characteristics (hopelessness, depression, cynical hostility, and sullenness). When adjusted for hopelessness alone there was no increased risk associated with low self-esteem (HR = 1.3, 95% CI = 0.8–2.2). CONCLUSIONS This study found no association between self-esteem and all-cause mortality after adjustment for other psychosocial characteristics, primarily hopelessness. Our understanding of the observed relationships between some psychosocial factors and mortality may be improved by simultaneous measurement of multiple psychosocial domains, thus diminishing the potential for residual confounding. PMID:14664781

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 as well as the western European data.

Current insights into the German Lipoprotein Apheresis Registry (GLAR) - Almost 5 years on.

PubMed

Schettler, V J J; Neumann, C L; Peter, C; Zimmermann, T; Julius, U; Roeseler, E; Heigl, F; Grützmacher, P; Blume, H

2017-11-01

In recent years the Federal Joint Committee (G-BA), a paramount decision-making body of the German health care system required a reassessment of the approval of chronic lipoprotein apheresis therapy for regular reimbursement. Since 2005 an interdisciplinary German apheresis working group has been established by members of both German Societies of Nephrology. In 2009 the working group completed the indication for lipoprotein apheresis with respect to current cardiovascular guidelines and current scientific knowledge for the registry. In 2011 the German Lipoprotein Apheresis Registry (GLAR) was launched and data acquired over nearly 5 years can now be reported. All data were collected and analyzed during the time period 2012-2015. Over this time interval, 68 German apheresis centers collected retrospective and prospective observational data of 1.283 patients undergoing lipoprotein apheresis (LA) treatment of high LDL-cholesterol (LDL-C) levels and/or high lipoprotein(a) (Lp(a)) levels suffering from progressive cardiovascular disease (CVD). A total of 15,167 documented LA treatments were investigated. All patients treated by LA exhibited a median LDL-C reduction rate of 68.6%, and a median Lp(a) reduction rate of 70.4%. Analogue to the Pro(a)LiFe pattern, patient data were analyzed and compared with respect to the incidence rate of coronary events (MACE) 1 and 2 years before the start of LA treatment (y-2 and y-1) and prospectively one year on LA treatment (y+1). During the first year of LA treatment a MACE reduction of 97% was be observed. In the years considered, LA treatment side effects occurred at a low rate (ca. 5%) and mainly comprised puncture problems. For the first time data generated by the GLAR shows that LA lowers the incidence rate of cardiovascular events in patients with high LDL-C and/or high Lp(a) levels, progressive CVD and maximally tolerated lipid lowering medication. In addition LA treatments were found to be safe, exhibiting a low rate of side effects. Copyright © 2017 Elsevier B.V. All rights reserved.

[Predicting the outcome in severe injuries: an analysis of 2069 patients from the trauma register of the German Society of Traumatology (DGU)].

PubMed

Rixen, D; Raum, M; Bouillon, B; Schlosser, L E; Neugebauer, E

2001-03-01

On hospital admission numerous variables are documented from multiple trauma patients. The value of these variables to predict outcome are discussed controversially. The aim was the ability to initially determine the probability of death of multiple trauma patients. Thus, a multivariate probability model was developed based on data obtained from the trauma registry of the Deutsche Gesellschaft für Unfallchirurgie (DGU). On hospital admission the DGU trauma registry collects more than 30 variables prospectively. In the first step of analysis those variables were selected, that were assumed to be clinical predictors for outcome from literature. In a second step a univariate analysis of these variables was performed. For all primary variables with univariate significance in outcome prediction a multivariate logistic regression was performed in the third step and a multivariate prognostic model was developed. 2069 patients from 20 hospitals were prospectively included in the trauma registry from 01.01.1993-31.12.1997 (age 39 +/- 19 years; 70.0% males; ISS 22 +/- 13; 18.6% lethality). From more than 30 initially documented variables, the age, the GCS, the ISS, the base excess (BE) and the prothrombin time were the most important prognostic factors to predict the probability of death (P(death)). The following prognostic model was developed: P(death) = 1/1 + e(-[k + beta 1(age) + beta 2(GCS) + beta 3(ISS) + beta 4(BE) + beta 5(prothrombin time)]) where: k = -0.1551, beta 1 = 0.0438 with p < 0.0001, beta 2 = -0.2067 with p < 0.0001, beta 3 = 0.0252 with p = 0.0071, beta 4 = -0.0840 with p < 0.0001 and beta 5 = -0.0359 with p < 0.0001. Each of the five variables contributed significantly to the multifactorial model. These data show that the age, GCS, ISS, base excess and prothrombin time are potentially important predictors to initially identify multiple trauma patients with a high risk of lethality. With the base excess and prothrombin time value, as only variables of this multifactorial model that can be therapeutically influenced, it might be possible to better guide early and aggressive therapy.

Changes in oral anticoagulation for elective cardioversion: results from a European cardioversion registry

PubMed Central

Papp, Judit; Zima, Endre; Bover, Ramon; Karaliute, Rasa; Rossi, Andrea; Szymanski, Catherine; Troccoli, Rossella; Schneider, Jonas; Fagerland, Morten Wang; Camm, A John; Atar, Dan

2017-01-01

Abstract Aims In patients with atrial fibrillation (AF) pharmacological or electrical cardioversion may be performed to restore sinus rhythm. The procedure is associated with an increased risk of thromboembolic events, which can be significantly reduced by adequate anticoagulation (OAC). Our aim was to create a partly prospective, partly retrospective cardioversion registry, particularly focusing on OAC strategies in different European countries, and on emerging choice of OAC over time. Methods From September 2014 to October 2015, cardioversions due to AF performed in six European city hospitals in five European countries (Hungary: Budapest-1 and -2; Italy: Bari and Pisa; France: Amiens; Spain: Madrid; and Lithuania: Kaunas) were recorded in the registry. Results A total of 1101 patients (retrospective/prospective: 679/422, male/female: 742/359, mean age: 67.3 years ± 11.2) were registered. Most of the cardioversions were electrical (97%). Oral anticoagulants were administered in 87% of the patient, the usage of non-VKA oral anticoagulants (NOACs) vs Vitamin K antagonists (VKA) was 31.5% vs 68.5%, respectively. Seventy seven percent of the patients were given oral anticoagulants more than 3 weeks prior to the procedure, and 86% more than 4 weeks after the procedure. When using VKA, international normalized ratio (INR) at cardioversion was above 2.0 in 76% of the cases. A decline in VKA usage (P = 0.033) in elective cardioversion over approximately 1 year was observed. During the observation period, there was an increase in apixaban (P < 0.001), a slight increase in rivaroxaban (P = 0.028) and no changes in dabigatran (P = 0.34) usage for elective cardioversion. There were differences in use of OAC between the countries: Spain used most VKA (89%), while France used least VKA (39%, P < 0.001). Conclusion According to current AF guidelines, NOACs are adequate alternatives to VKA for thromboembolic prevention in AF patients undergoing elective cardioversion. Our results indicate that NOAC use is increasing and there is a significant decrease in VKA use. PMID:28329309

Changes in oral anticoagulation for elective cardioversion: results from a European cardioversion registry.

PubMed

Papp, Judit; Zima, Endre; Bover, Ramon; Karaliute, Rasa; Rossi, Andrea; Szymanski, Catherine; Troccoli, Rossella; Schneider, Jonas; Fagerland, Morten Wang; Camm, A John; Atar, Dan

2017-07-01

In patients with atrial fibrillation (AF) pharmacological or electrical cardioversion may be performed to restore sinus rhythm. The procedure is associated with an increased risk of thromboembolic events, which can be significantly reduced by adequate anticoagulation (OAC). Our aim was to create a partly prospective, partly retrospective cardioversion registry, particularly focusing on OAC strategies in different European countries, and on emerging choice of OAC over time. From September 2014 to October 2015, cardioversions due to AF performed in six European city hospitals in five European countries (Hungary: Budapest-1 and -2; Italy: Bari and Pisa; France: Amiens; Spain: Madrid; and Lithuania: Kaunas) were recorded in the registry. A total of 1101 patients (retrospective/prospective: 679/422, male/female: 742/359, mean age: 67.3 years ± 11.2) were registered. Most of the cardioversions were electrical (97%). Oral anticoagulants were administered in 87% of the patient, the usage of non-VKA oral anticoagulants (NOACs) vs Vitamin K antagonists (VKA) was 31.5% vs 68.5%, respectively. Seventy seven percent of the patients were given oral anticoagulants more than 3 weeks prior to the procedure, and 86% more than 4 weeks after the procedure. When using VKA, international normalized ratio (INR) at cardioversion was above 2.0 in 76% of the cases. A decline in VKA usage (P = 0.033) in elective cardioversion over approximately 1 year was observed. During the observation period, there was an increase in apixaban (P < 0.001), a slight increase in rivaroxaban (P = 0.028) and no changes in dabigatran (P = 0.34) usage for elective cardioversion. There were differences in use of OAC between the countries: Spain used most VKA (89%), while France used least VKA (39%, P < 0.001). According to current AF guidelines, NOACs are adequate alternatives to VKA for thromboembolic prevention in AF patients undergoing elective cardioversion. Our results indicate that NOAC use is increasing and there is a significant decrease in VKA use. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Quality and Safety in Health Care, Part XXIX: The Transcatheter Valve Therapy Registry.

PubMed

Harolds, Jay A

2017-11-01

The American College of Cardiology, the Society of Thoracic Surgeons, and other organizations cooperated to form the Transcatheter Valve Therapy Registry. This registry studies information on the outcome of valve therapy device placement with a transcatheter approach. The companies that manufacture these devices can use the registry to meet the post-product sale surveillance requirements of the US Food and Drug Administration. There will also be linkage to the registry information from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, which has information on open cardiac valve surgery.

Resource requirements for cancer registration in areas with limited resources: Analysis of cost data from four low- and middle-income countries☆

PubMed Central

Tangka, Florence K.L.; Subramanian, Sujha; Edwards, Patrick; Cole-Beebe, Maggie; Parkin, D. Maxwell; Bray, Freddie; Joseph, Rachael; Mery, Les; Saraiya, Mona

2018-01-01

Background The key aims of this study were to identify sources of support for cancer registry activities, to quantify resource use and estimate costs to operate registries in low- and middle-income countries (LMIC) at different stages of development across three continents. Methods Using the Centers for Disease Control and Prevention’s (CDC’s) International Registry Costing Tool (IntRegCosting Tool), cost and resource use data were collected from eight population-based cancer registries, including one in a low-income country (Uganda [Kampala)]), two in lower to middle-income countries (Kenya [Nairobi] and India [Mumbai]), and five in an upper to middle-income country (Colombia [Pasto, Barranquilla, Bucaramanga, Manizales and Cali cancer registries]). Results Host institution contributions accounted for 30%–70% of total investment in cancer registry activities. Cancer registration involves substantial fixed cost and labor. Labor accounts for more than 50% of all expenditures across all registries. The cost per cancer case registered in low-income and lower-middle-income countries ranged from US $3.77 to US $15.62 (United States dollars). In Colombia, an upper to middle-income country, the cost per case registered ranged from US $41.28 to US $113.39. Registries serving large populations (over 15 million inhabitants) had a lower cost per inhabitant (less than US $0.01 in Mumbai, India) than registries serving small populations (under 500,000 inhabitants) [US $0.22] in Pasto, Colombia. Conclusion This study estimates the total cost and resources used for cancer registration across several countries in the limited-resource setting, and provides cancer registration stakeholders and registries-with opportunities to identify cost savings and efficiency improvements. Our results suggest that cancer registration involve substantial fixed costs and labor, and that partnership with other institutions is critical for the operation and sustainability of cancer registries in limited resource settings. Although we included registries from a variety of limited-resource areas, information from eight registries in four countries may not be large enough to capture all the potential differences among the registries in limited-resource settings. PMID:27793574

Resource requirements for cancer registration in areas with limited resources: Analysis of cost data from four low- and middle-income countries.

PubMed

Tangka, Florence K L; Subramanian, Sujha; Edwards, Patrick; Cole-Beebe, Maggie; Parkin, D Maxwell; Bray, Freddie; Joseph, Rachael; Mery, Les; Saraiya, Mona

2016-12-01

The key aims of this study were to identify sources of support for cancer registry activities, to quantify resource use and estimate costs to operate registries in low- and middle-income countries (LMIC) at different stages of development across three continents. Using the Centers for Disease Control and Prevention's (CDC's) International Registry Costing Tool (IntRegCosting Tool), cost and resource use data were collected from eight population-based cancer registries, including one in a low-income country (Uganda [Kampala)]), two in lower to middle-income countries (Kenya [Nairobi] and India [Mumbai]), and five in an upper to middle-income country (Colombia [Pasto, Barranquilla, Bucaramanga, Manizales and Cali cancer registries]). Host institution contributions accounted for 30%-70% of total investment in cancer registry activities. Cancer registration involves substantial fixed cost and labor. Labor accounts for more than 50% of all expenditures across all registries. The cost per cancer case registered in low-income and lower-middle-income countries ranged from US $3.77 to US $15.62 (United States dollars). In Colombia, an upper to middle-income country, the cost per case registered ranged from US $41.28 to US $113.39. Registries serving large populations (over 15 million inhabitants) had a lower cost per inhabitant (less than US $0.01 in Mumbai, India) than registries serving small populations (under 500,000 inhabitants) [US $0.22] in Pasto, Colombia. This study estimates the total cost and resources used for cancer registration across several countries in the limited-resource setting, and provides cancer registration stakeholders and registries with opportunities to identify cost savings and efficiency improvements. Our results suggest that cancer registration involve substantial fixed costs and labor, and that partnership with other institutions is critical for the operation and sustainability of cancer registries in limited resource settings. Although we included registries from a variety of limited-resource areas, information from eight registries in four countries may not be large enough to capture all the potential differences among the registries in limited-resource settings. Copyright © 2016 Elsevier Ltd. All rights reserved.

Prospective study of proton-beam radiation therapy for limited-stage small cell lung cancer.

PubMed

Rwigema, Jean-Claude M; Verma, Vivek; Lin, Liyong; Berman, Abigail T; Levin, William P; Evans, Tracey L; Aggarwal, Charu; Rengan, Ramesh; Langer, Corey; Cohen, Roger B; Simone, Charles B

2017-11-01

Existing data supporting the use of proton-beam therapy (PBT) for limited-stage small cell lung cancer (LS-SCLC) are limited to a single 6-patient case series. This is the first prospective study to evaluate clinical outcomes and toxicities of PBT for LS-SCLC. This study prospectively analyzed patients with primary, nonrecurrent LS-SCLC definitively treated with PBT and concurrent chemotherapy from 2011 to 2016. Clinical backup intensity-modulated radiotherapy (IMRT) plans were generated for each patient and were compared with PBT plans. Outcome measures included local control (LC), recurrence-free survival (RFS), and overall survival (OS) rates and toxicities. Thirty consecutive patients were enrolled and evaluated. The median dose was 63.9 cobalt gray equivalents (range, 45-66.6 cobalt gray equivalents) in 33 to 37 fractions delivered daily (n = 18 [60.0%]) or twice daily (n = 12 [40.0%]). The concurrent chemotherapy was cisplatin/etoposide (n = 21 [70.0%]) or carboplatin/etoposide (n = 9 [30.0%]). In comparison with the backup IMRT plans, PBT allowed statistically significant reductions in the cord, heart, and lung mean doses and the volume receiving at least 5 Gy but not in the esophagus mean dose or the lung volume receiving at least 20 Gy. At a median follow-up of 14 months, the 1-/2-year LC and RFS rates were 85%/69% and 63%/42%, respectively. The median OS was 28.2 months, and the 1-/2-year OS rates were 72%/58%. There was 1 case each (3.3%) of grade 3 or higher esophagitis, pneumonitis, anorexia, and pericardial effusion. Grade 2 pneumonitis and esophagitis were seen in 10.0% and 43.3% of patients, respectively. In the first prospective registry study and largest analysis to date of PBT for LS-SCLC, PBT was found to be safe with a limited incidence of high-grade toxicities. Cancer 2017;123:4244-4251. © 2017 American Cancer Society. © 2017 American Cancer Society.

Participation in Clinical Research Registries: A Focus Group Study Examining Views From Patients With Arthritis and Other Chronic Illnesses.

PubMed

Lee, Sara B; Zak, Agnes; Iversen, Maura D; Polletta, Valerie L; Shadick, Nancy A; Solomon, Daniel H

2016-07-01

Patient registries have contributed substantially to progress in clinical research in rheumatic diseases. However, not much is known about how to optimize the patient experience in such registries. We assessed patient views, motivations, and potential barriers towards participation in registry research to better understand how registries can be improved to maximize patient engagement. Focus groups were held with 23 patients (mean ± SD age 59 ± 13 years) from the Boston area and led by a bilingual moderator trained in focus group methodology, using a semistructured moderator guide. Three separate focus groups were conducted to thematic saturation: patients with rheumatoid arthritis (RA) who had registry experience, patients with any chronic illness, and Spanish-speaking patients with RA or osteoarthritis. Patients in the latter 2 groups had no prior registry experience. Focus groups were audiotaped and transcribed. Four researchers independently analyzed transcripts using open data coding to identify themes. A normative group process was used to consolidate and refine themes. Seven major themes were identified, including personalization/convenience of data collection, trust and confidentiality, camaraderie, learning about yourself and your disease, altruism, material motivators, and capturing mental health and other elements of the lived experience. We observed distinct differences in the discussion content of the Spanish-speaking patients compared to the English-speaking patients. This study identified patient attitudes towards registry research among those with and without prior experience in a registry. The results provide insight into strategies for registry design to maximize patient engagement, which can lead to more robust registry data. © 2016, American College of Rheumatology.

Promoting Organ Donor Registries Through Public Education: What Is the Cost of Securing Organ Donors?

PubMed

Razdan, Manik; Smith, Kenneth J; Bryce, Cindy L; Degenholtz, Howard B

2016-06-01

Transplant medicine's impact on America's public health is seriously limited by acute shortage of transplantable organs. Consequently, the United Sates has witnessed considerable investment in the promotion of organ donor registries. Although there is no evidence to support that donor registry promotion alleviates organ shortage, this belief continues to drive investments into registry promotion. In this study, return on investment in donor registry promotion was examined using cost-outcomes analysis. Cost of promoting the donor registry was estimated in US dollars whereas the outcome was measured as the number of individuals who join the registry (registrants) and their value in terms of organ donors. The study was conducted from the perspective of a regional Organ Procurement Organization (OPO). Costs were directly obtained from the OPO. The number of new registrants was obtained from the OPO and the departments of motor vehicles that maintain the donor registry. The value of registrants in terms of organ donors was computed based on a registrant's age-dependent risk of dying and age-dependent probability of becoming an organ donor. Six thousand seven hundred eight individuals joined the organ donor registry (95% confidence interval [95% CI], 5429-7956) at a cost of $455 per registrant (95% CI, US $383-US $562). These individuals result in 4.2 present-day donors (95% CI, 2.5-6.6) at a cost of US $726 000 (95% CI, US $462000-US $1.2 million). Because the cost per registrant and cost per donor is less than society's willingness to pay, donor registry promotion offers positive return on investment. Investment in registry promotion should at the minimum be maintained at current levels.

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation

PubMed Central

Panikker, Sandeep; Lord, Joanne; Jarman, Julian W.E.; Armstrong, Shannon; Jones, David G.; Haldar, Shouvik; Butcher, Charles; Khan, Habib; Mantziari, Lilian; Nicol, Edward; Hussain, Wajid; Clague, Jonathan R.; Foran, John P.; Markides, Vias; Wong, Tom

2016-01-01

Aims The aim of this study was to analyse randomized controlled study and real-world outcomes of patients with non-valvular atrial fibrillation (NVAF) undergoing left atrial appendage closure (LAAC) with the Watchman device and to compare costs with available antithrombotic therapies. Methods and results Registry data of LAAC from two centres were prospectively collected from 110 patients with NVAF at risk of stroke, suitable and unsuitable for long-term anticoagulation (age 71.3 ± 9.2 years, CHADS2 2.8 ± 1.2, CHA2DS2-VASc 4.5 ± 1.6, and HAS-BLED 3.8 ± 1.1). Outcomes from PROTECT AF and registry study LAAC were compared with warfarin, dabigatran, rivaroxaban, apixaban, aspirin, and no treatment using a network meta-analysis. Costs were estimated over a 10-year horizon. Uncertainty was assessed using sensitivity analyses. The procedural success rate was 92% (103/112). Follow-up was 24.1 ± 4.6 months, during which annual rates of stroke, major bleeding, and all-cause mortality were 0.9% (2/223 patient-years), 0.9% (2/223 patient-years), and 1.8% (4/223 patient-years), respectively. Anticoagulant therapy was successfully stopped in 91.2% (93/102) of implanted patients by 12 months. Registry study LAAC stroke and major bleeding rates were significantly lower than PROTECT AF results: mean absolute difference of stroke, 0.89% (P = 0.02) and major bleeding, 5.48% (P < 0.001). Left atrial appendage closure achieved cost parity between 4.9 years vs. dabigatran 110 mg and 8.4 years vs. warfarin. At 10 years, LAAC was cost-saving against all therapies (range £1162–£7194). Conclusion Left atrial appendage closure in NVAF in a real-world setting may result in lower stroke and major bleeding rates than reported in LAAC clinical trials. Left atrial appendage closure in both settings achieves cost parity in a relatively short period of time and may offer substantial savings compared with current therapies. Savings are most pronounced among higher risk patients and those unsuitable for anticoagulation. PMID:26935273

Follow-up of the first patients with a totally subcutaneous ICD in Germany from implantation till battery depletion.

PubMed

Bettin, Markus; Rath, Benjamin; Ellermann, Christian; Leitz, Patrick; Reinke, Florian; Köbe, Julia; Eckardt, Lars; Frommeyer, Gerrit

2018-06-12

The subcutaneous ICD is a promising treatment option in patients at risk for sudden cardiac death. Approved in 2009, the first S-ICD ® in Germany was implanted in June 2010. Although large prospective registry studies have shown safety and efficacy of the system, there is a lack of long-term data with regard to battery longevity of the S-ICD ® . Therefore, we report follow-up of our first initial S-ICD ® cases from implantation till battery depletion. All S-ICD ® patients with device replacement for battery depletion in our large single-center S-ICD ® registry were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a median follow-up of 75.9 ± 6.8 months. Twenty-eight patients with S-ICD ® systems were included in this study. Of these patients, 21 were male and 7 were female, with an overall mean age of 41.9 ± 12.6 years. Primary prevention of sudden cardiac death was the indication in 19 patients (67.9%). Ventricular tachycardia was adequately terminated in two patients (7.1%). In 7 patients, non-sustained ventricular arrhythmias were not treated. A total of three inappropriate shocks occurred in three patients (10.7%). Mean time from implantation till battery depletion was 65.8 ± 8.1 months. Only one patient presented premature elective replacement criteria because of rapid battery depletion. No lead-related complication occurred during follow-up and no complications were seen regarding device replacement. In one patient (3.6%), the system was explanted without replacement due to patient's preference. The estimated battery longevity of S-ICD ® of about 5 years was reached in all but one patient. Compared to larger S-ICD ® registry studies, frequency of inappropriate shocks was relatively high in the initial S-ICD ® cases. Both technological improvement as well as programming and operators' experience have led to a reduction of complications. Replacement of the S-ICD ® seems to be a safe and effective procedure.

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

PubMed

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

A prospective observational study to examine the relationship between quality of life and adverse events of first-line chemotherapy plus cetuximab in patients with KRAS wild-type unresectable metastatic colorectal cancer: QUACK Trial.

PubMed

Ooki, Akira; Ando, Masahiko; Sakamoto, Junichi; Sato, Atushi; Fujii, Hirofumi; Yamaguchi, Kensei

2014-04-01

We have planned a multicentre prospective study to examine the relative impact of the efficacy and adverse events of cetuximab plus first-line chemotherapy on the quality of life in Japanese patients with KRAS wild-type unresectable colorectal cancer. The Dermatology Life Quality Index and the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 will be used to assess dermatology-specific and health-related quality of life. The severity of adverse events will be assessed by using the National Cancer Institute Common Terminology Criteria for adverse Events ver. 4.0. The endpoints will be the following associations: adverse events, including skin toxicity and quality of life; efficacy and skin toxicity; efficacy and quality of life; and skin-related quality of life and health-related quality of life. A total of 140 patients are considered to be appropriate for inclusion in this study. The results of this study will provide more information to both patients and physicians regarding the practical use of cetuximab and its impact on quality of life in patients with unresectable colorectal cancer in Japan. This study was registered at the University Hospital Medical Information Network Clinical Trial Registry as UMIN000010985.

A prospective randomized comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying occurrence and long-term nutritional status.

PubMed

Matsumoto, Ippei; Shinzeki, Makoto; Asari, Sadaki; Goto, Tadahiro; Shirakawa, Sachiyo; Ajiki, Tetsuo; Fukumoto, Takumi; Suzuki, Yasuyuki; Ku, Yonson

2014-06-01

Pylorus-preserving pancreatoduodenectomy (PPPD) has been associated with a high incidence of delayed gastric emptying (DGE). There are few studies comparing DGE associated with PPPD and subtotal stomach-preserving pancreatoduodenectomy (SSPPD). Moreover, differences between the procedures with respect to long-term results have not been reported. A prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with PPPD and SSPPD. One hundred patients with periampullary lesions were randomized to receive either PPPD (n = 50) or SSPPD (n = 50). All patients were followed up for 3 years after surgery or to the time of recurrence to evaluate nutritional status for the study. The effects of the procedure, age, and malignancy on changes in nutritional indicators were estimated with linear mixed models. This study was registered at UMIN Clinical Trials Registry (UMIN 000012337). The incidence of DGE assessed by the International Study Group of Pancreatic Surgery was 20% with PPPD and 12% with SSPPD (P = 0.414). There were no significant differences between the two procedures on postoperative serum albumin levels, serum total cholesterol levels, and body mass index during the 3-year follow-up period. SSPPD is equally effective in DGE occurrence rate and long-term nutritional status comparing to PPPD. © 2014 Wiley Periodicals, Inc.

Treatment for Sleep Problems in Children with Autism and Caregiver Spillover Effects.

PubMed

Tilford, J Mick; Payakachat, Nalin; Kuhlthau, Karen A; Pyne, Jeffrey M; Kovacs, Erica; Bellando, Jayne; Williams, D Keith; Brouwer, Werner B F; Frye, Richard E

2015-11-01

Sleep problems in children with autism spectrum disorders (ASD) are under-recognized and under-treated. Identifying treatment value accounting for health effects on family members (spillovers) could improve the perceived cost-effectiveness of interventions to improve child sleep habits. A prospective cohort study (N = 224) was conducted with registry and postal survey data completed by the primary caregiver. We calculated quality of life outcomes for the child and the primary caregiver associated with treatments to improve sleep in the child based on prior clinical trials. Predicted treatment effects for melatonin and behavioral interventions were similar in magnitude for the child and for the caregiver. Accounting for caregiver spillover effects associated with treatments for the child with ASD increases treatment benefits and improves cost-effectiveness profiles.

TREATMENT FOR SLEEP PROBLEMS IN CHILDREN WITH AUTISM AND CAREGIVER SPILLOVER EFFECTS

PubMed Central

Tilford, J. Mick; Payakachat, Nalin; Kuhlthau, Karen; Pyne, Jeffrey M.; Kovacs, Erica; Bellando, Jayne; Williams, D. Keith; Brouwer, Werner; Frye, Richard E.

2015-01-01

Sleep problems in children with autism spectrum disorders (ASD) are under-recognized and under-treated. Identifying treatment value accounting for health effects on family members (spillovers) could improve the perceived cost-effectiveness of interventions to improve child sleep habits. A prospective cohort study (N=224) was conducted with registry and postal survey data completed by the primary caregiver. We calculated quality of life outcomes for the child and the primary caregiver associated with treatments to improve sleep in the child based on prior clinical trials. Predicted treatment effects for melatonin and behavioral interventions were similar in magnitude for the child and for the caregiver. Accounting for caregiver spillover effects associated with treatments for the child with ASD increases treatment benefits and improves cost-effectiveness profiles. PMID:26126749

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

PubMed Central

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

2013-01-01

Purpose Cancer epidemiology is challenging in developing nations, in the absence of reliable pathology-based cancer registries. Clinical experience suggests that the incidence of gastric cancer is high in Honduras, in contrast to the limited available national statistics at the time of study initiation (IARC GLOBOCAN 2002: males 15.2, females 10.8). We estimate the incidence of gastric cancer for Honduras using an endoscopy registry as a complimentary resource. Methods We conducted a retrospective analysis of incident noncardia gastric adenocarcinoma cases in Western Honduras for the period 2000–2009. This region is well circumscribed geopolitically with a single district hospital and established referral patterns, to provide a unique epidemiological niche to facilitate estimation of incidence rates. A prospective, comprehensive database of all endoscopy procedures from this hospital was utilized at the primary data source. The catchment area for gastroenterology services for the at-risk population was validated by calculating the overall endoscopy utilization rates for each municipality in western Honduras. Incident cases of gastric adenocarcinoma were determined by the endoscopic diagnosis. Pathology services are not financed by the Ministry of Health, and histology data was incorporated when available. Population statistics were obtained from the Honduras National Statistics Institute (INE). Age standardized incidence rates (ASIRs) were calculated using world standard population fractions. Results The catchment area for Western Honduras was validated with the municipality threshold of 30 endoscopies per 106 person-years, with inclusion of a total of 40 municipalities. In the Western Honduras catchment area, there were 670 incident cases (439 M, 231 F) of noncardia gastric adenocarcinoma during the study decade 2000–2009. Notably, 67 (10.0%) and 165 (24.6%) of cases were under the ages of 45 and 55, respectively. The case-finding rate was 5.1 endoscopies performed for each new diagnosis of gastric cancer. The ASIRs for the decade were 30.8 for males and 13.9 for females. Clinically, 60.3% of gastric cancers were Borrmann type 3 (ulcerated mass), and evidence of advanced disease with pyloric obstruction was common (35.2%). Subtypes by the Lauren classification were distributed among diffuse (56%), intestinal (34%) and indeterminate (9.9%), in subjects with available pathology (526/670). Conclusions The endoscopy procedure registry may serve as a complimentary data resource for gastric cancer incidence estimation in resource-limited nation settings wherein pathology services and cancer registries are absent. The results remain an underestimation in this setting due to the challenges of access-to-care and related factors. The methodology helps to more fully characterize the high incidence of gastric cancer in western Honduras and this region of Central America, and demonstrate the need for additional epidemiology research and interventions focused on prevention and treatment. PMID:23263776

Tenacity of Collateral Perfusion in Proximal Cerebral Arterial Occlusions 6-12 h after Onset.

PubMed

Kim, Beom Joon; Kim, Hyeran; Jeong, Han-Gil; Yang, Mi Hwa; Jung, Cheol Kyu; Han, Moon-Ku; Kim, Jae Hyoung; Demchuk, Andrew M; Bae, Hee-Joon

2018-06-07

Clinical trials have shown that benefits of endovascular recanalization (EVT) for acute ischemic stroke patients with sizable penumbral tissues seems plausible even beyond 6 h after their last seen normal (LSN). Persistency of ischemic penumbra remains unclear in delayed periods. From a prospective stroke registry database, we identified 111 acute ischemic stroke patients who had internal carotid artery or middle cerebral artery occlusion with baseline National Institutes of Health Stroke Scale scores ≥6 points and arrived 6-12 h after LSN. Baseline information and functional outcomes were prospectively collected as a clinical registry. Attending physicians made treatment decisions for EVT based on the current guidelines and institutional protocols. MR image parameters, including the volume of diffusion-restricted lesions and mapping of the -hypoperfused area, were quantified using automated commercial software. Binary logistic regression analysis models, with modified Rankin Scale (mRS) scores of 0-1 at 3 months after stroke included as a dependent variable, were constructed. Between 6 and 12 h after onset, 58% had a mismatch ratio of ≥1.8 at baseline and 42% had favorable imaging profiles as determined by DEFUSE 2 study. After 9 h, there was a mismatch ratio of ≥1.8 in 47 and 38% favorable profiles. EVT was performed in 54% of cases. A 3-month mRS score of 0-1 was found in 19% (25% in EVT and 12% in medical treatment groups) of cases. EVT was associated with an increased OR of having a mRS score of 0-1 at 3 months after stroke (adjusted OR 7.59 [95% CI 1.28-61.60]). Penumbral tissues were persistent in a substantial proportion of anterior circulation occlusion cases 6-12 h after LSN. EVT at 6-12 h in a predominantly Asian cohort resulted in better outcomes. © 2018 S. Karger AG, Basel.

End-of-Treatment Positron Emission Tomography After Uniform First-Line Therapy of B-Cell Posttransplant Lymphoproliferative Disorder Identifies Patients at Low Risk of Relapse in the Prospective German PTLD Registry.

PubMed

Zimmermann, Heiner; Denecke, Timm; Dreyling, Martin H; Franzius, Christiane; Reinke, Petra; Subklewe, Marion; Amthauer, Holger; Kneba, Michael; Riess, Hanno; Trappe, Ralf U

2018-05-01

Fluorine-18 fluorodeoxyglucose (18F-FDG)-positron emission tomography (PET) is a recommended standard in the staging and response assessment of 18F-FDG-avid lymphoma. Posttransplant lymphoproliferative disorder (PTLD) can be detected by 18F-FDG-PET at diagnosis with high sensitivity and specificity. However, the role of response assessment by end-of-treatment (EOT) PET has only been addressed in small case series. We performed a retrospective, multicenter study of 37 patients with CD20-positive PTLD after solid organ transplantation treated with uniform, up-to-date, first-line protocols in the prospective German PTLD registry who had received EOT 18F-FDG-PET between 2006 and 2014. Median follow-up was 5.0 years. Any nonphysiological 18F-FDG uptake (Deauville score greater 2) was interpreted as PET-positive. By computed tomography (CT) final staging, 18 of 37 patients had a complete response, 18 had a partial response and 1 patient had stable disease. EOT PET was negative in 24 of 37 patients and positive in 13 of 37 patients. The positive predictive value of EOT PET for PTLD relapse was 38%, and the negative predictive value was 92%. Time to progression (TTP) and progression-free-survival were significantly longer in the PET negative group (P = 0.019 and P = 0.013). In the 18 patients in a partial response by CT staging, we noted highly significant differences in overall survival (P = 0.001), time to progression (P = 0.007), and progression-free survival (P < 0.001) by EOT PET. Even without baseline imaging, EOT PET in PTLD identifies patients at low risk of relapse and offers clinically relevant information, particularly in patients in a partial remission by CT staging.

Endocrine Dysfunction in Diamond-Blackfan Anemia (DBA): A Report from the DBA Registry (DBAR).

PubMed

Lahoti, Amit; Harris, Yael T; Speiser, Phyllis W; Atsidaftos, Evangelia; Lipton, Jeffrey M; Vlachos, Adrianna

2016-02-01

Diamond-Blackfan anemia (DBA) is a rare inherited bone marrow failure syndrome. The mainstays of treatment involve chronic red cell transfusions, long-term glucocorticoid therapy, and stem cell transplantation. Systematic data concerning endocrine function in DBA are limited. We studied patients in the DBA Registry (DBAR) of North America to assess the prevalence of various endocrinopathies. In a pilot study, retrospective data were collected for 12 patients with DBA. Subsequently, patients with DBA aged 1-39 years were recruited prospectively. Combined, 57 patients were studied; 38 chronically transfused, 12 glucocorticoid-dependent, and seven in remission. Data were collected on anthropometric measurements, systematic screening of pituitary, thyroid, parathyroid, adrenal, pancreatic, and gonadal function, and ferritin levels. Descriptive statistics were tabulated and group differences were assessed. Fifty-three percent of patients had ≥ 1 endocrine disorder, including adrenal insufficiency (32%), hypogonadism (29%), hypothyroidism (14%), growth hormone dysfunction (7%), diabetes mellitus (2%), and/or diabetes insipidus (2%). Ten of the 33 patients with available heights had height standard deviation less than -2. Low 25-hydroxy vitamin D (25(OH)D) levels were present in 50%. A small proportion also had osteopenia, osteoporosis, or hypercalciuria. Most with adrenal insufficiency were glucocorticoid dependent; other endocrinopathies were more common in chronically transfused patients. Endocrine dysfunction is common in DBA, as early as the teenage years. Although prevalence is highest in transfused patients, patients taking glucocorticoids or in remission also have endocrine dysfunction. Longitudinal studies are needed to better understand the etiology and true prevalence of these disorders. © 2015 Wiley Periodicals, Inc.

Form of presentation, natural history and course of postoperative venous thromboembolism in patients operated on for pelvic and abdominal cancer. Analysis of the RIETE registry.

PubMed

Bustos Merlo, Ana Belén; Arcelus Martínez, Juan Ignacio; Turiño Luque, Jesús Damián; Valero, Beatriz; Villalobos, Aurora; Aibar, Miguel Ángel; Monreal Bosch, Manuel

Venous thromboembolism (VTE) represents a serious complication after oncologic surgery. Recent studies have shown that the risk of VTE persists several weeks after surgery. This study assesses the form of presentation and time course of VTE after abdominal and pelvic cancer surgery. Prospective, multicenter, observational study that analyzes data from an international registry (RIETE) that includes consecutive patients with symptomatic VTE. Our study assesses the form and time of presentation of postoperative VTE, as well as main outcomes, in patients operated for abdominopelvic cancer 8 weeks prior to VTE diagnosis. Variables related to the presentation of VTE after hospital discharge are identified. Out of the 766 analyzed patients with VTE, 395 (52%) presented pulmonary embolism (PE). Most VTE cases (84%) were detected after the first postoperative week, and 38% after one month. Among patients with VTE in the first postoperative week, 70% presented PE. VTE presented after hospital discharge in 54% of cases. Colorectal, urologic, and gynecologic tumors, the use of radiotherapy, and blood hemoglobin levels were independently associated with VTE diagnosis after hospital discharge. Complications (thrombosis recurrence, bleeding, and death) occurred in 34% of patients with VTE detected before hospital discharge, compared to 24% in VTE after hospital discharge (P<0.01). VTE occurs after hospital discharge in most patients, particularly in those operated for colorectal, urologic, and gynecologic cancer. Pulmonary embolism is more frequent in patients who develop early VTE, who also have worse prognosis. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

PubMed Central

Shin, Jae-Young; Lee, Jun-Hwan; Ku, Boncho; Bae, Jang Han; un, Min-Ho; Kim, Jaeuk U.; Kim, Tae-Hun

2016-01-01

Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization’s (WHO’s) Registry Network. PMID:27695628

Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation: results of the German STARR registry.

PubMed

Schwandner, Oliver; Fürst, Alois

2010-06-01

Internal rectal prolapse and rectocele are frequent clinical findings in patients with obstructed defecation syndrome (ODS). However, there is still no evidence whether stapled transanal rectal resection (STARR) provides a safe and effective surgical option. Therefore, the German STARR registry was initiated to assess safety, effectiveness, and quality of life. The German STARR registry was designed as an interventional, prospective, multicenter audit. Primary outcomes include safety (morbidity and adverse events), effectiveness (ODS, symptom severity, and incontinence scores), and quality of life (PAC-QoL and EQ-5D) documented at baseline and at 6 and 12 months. Statistical evaluation was performed by an independent research organization of clinical epidemiology. Complete data of 379 patients (78% females, mean age 57.8 years) were entered into the registry database. Mean operative time was 40 min, mean hospitalization was 5.5 days. A total of 103 complications and adverse events were reported in 80 patients (21.1%) including staple line complications (minor bleeding, infection, or partial dehiscence; 7.1%), major bleeding (2.9%), and postsurgical stenosis (2.1%). Comparisons of ODS and symptom severity scores (SSS) demonstrated a significant reduction in ODS score between baseline (mean 11.14) and 6 months (mean 6.43), which was maintained at 12 months (mean 6.45), and SSS at preoperative and at 6- and 12-month follow-up (13.02 vs. 7.34 vs. 6.59; paired t test, p < 0.001). Significant reduction in ODS symptoms was matched by an improvement in quality of life as judged by symptom-specific PAC-QoL and generic ED-5Q (utility and visual analog scale) scores and was not associated with an impairment of incontinence score following STARR (p > 0.05). However, 11 patients (2.9%) showed de novo incontinence, and new-onset symptoms of fecal urgency were observed in 25.3% of patients. These data indicate that STARR is a safe and effective procedure. However, conclusions are limited due to the selection and reporting bias of a registry. The problem of fecal urgency needs cautious reassessment.

British Society of Interventional Radiology (BSIR) Inferior Vena Cava (IVC) Filter Registry

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

Uberoi, Raman, E-mail: raman.Uberoi@orh.nhs.uk; Tapping, Charles Ross; Chalmers, Nicholas

Purpose: The British Society of Interventional Radiology (BSIR) Inferior Vena Cava (IVC) Filter Registry was produced to provide an audit of current United Kingdom (UK) practice regarding placement and retrieval of IVC filters to address concerns regarding their safety. Methods: The IVC filter registry is a web-based registry, launched by the BSIR on behalf of its membership in October 2007. This report is based on prospectively collected data from October 2007 to March 2011. This report contains analysis of data on 1,434 IVC filter placements and 400 attempted retrievals performed at 68 UK centers. Data collected included patient demographics, insertionmore » and retrieval data, and patient follow-up. Results: IVC filter use in the majority of patients in the UK follows accepted CIRSE guidelines. Filter placement is usually a low-risk procedure, with a low major complication rate (<0.5 %). Cook Gunther Tulip (560 filters: 39 %) and Celect (359 filters: 25 %) filters constituted the majority of IVC filters inserted, with Bard G2, Recovery filters, Cordis Trapease, and OptEase constituting most of the remainder (445 filters: 31 %). More than 96 % of IVC filters deployed as intended. Operator inexperience (<25 procedure) was significantly associated with complications (p < 0.001). Of the IVC filters initially intended for temporary placement, retrieval was attempted in 78 %. Of these retrieval was technically successful in 83 %. Successful retrieval was significantly reduced for implants left in situ for >9 weeks versus those with a shorter dwell time. New lower limb deep vein thrombosis (DVT) and/or IVC thrombosis was reported in 88 patients following filter placement, there was no significant difference of incidence between filter types. Conclusions: This registry report provides interventional radiologists and clinicians with an improved understanding of the technical aspects of IVC filter placement to help improve practice, and the potential consequences of IVC filter placement so that we are better able to advise patients. There is a significant learning curve associated with IVC filter insertion, and when a filter is placed with the intention of removal, procedures should be in place to avoid the patient being lost to follow-up.« less

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

PubMed

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

2016-12-01

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

Optimization of Inflammatory Bowel Disease Cohort Studies in Asia.

PubMed

Leung, Wai K

2015-07-01

With the incidence of inflammatory bowel disease (IBD) increasing rapidly in many Asian countries, including Hong Kong, it is important that patient characteristics are better understood. For example, are the phenotypes, behaviors, complications, and even treatment responses found in Asian patients similar to those of their Western counterparts? To formally address these questions, a properly designed local cohort study is needed. Whilst IBD is still relatively uncommon in Asia, the establishment of a local IBD registry will significantly contribute to the answering of these questions. The Hong Kong IBD registry was established to fill the gap in the understanding of IBD patients, and to foster research into IBD in Hong Kong. The Hong Kong IBD registry is a territory-wide registry that includes all public hospitals in Hong Kong. We included all IBD patients who were currently receiving medical care at these hospitals. With the help of the central computer medical record system of the Hospital Authority of Hong Kong, all clinical events, medications usage, endoscopy records, and laboratory results of patients in the registry were captured. Apart from data collection, the registry is also establishing a bio-specimen bank of blood and stool samples of IBD patients for future research. The IBD registry is a very useful platform for population-based studies on IBD in Asia.

Quality of Life After Transcatheter Aortic Valve Replacement: Prospective Data From GARY (German Aortic Valve Registry).

PubMed

Lange, Rüdiger; Beckmann, Andreas; Neumann, Till; Krane, Markus; Deutsch, Marcus-André; Landwehr, Sandra; Kötting, Joachim; Welz, Armin; Zahn, Ralf; Cremer, Jochen; Figulla, Hans R; Schuler, Gerhard; Holzhey, David M; Funkat, Anne-Kathrin; Heusch, Gerd; Sack, Stefan; Pasic, Miralem; Meinertz, Thomas; Walther, Thomas; Kuck, Karl-Heinz; Beyersdorf, Friedhelm; Böhm, Michael; Möllmann, Helge; Hamm, Christian W; Mohr, Friedrich W

2016-12-26

This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Time to administration of epinephrine and outcome after in-hospital cardiac arrest with non-shockable rhythms: retrospective analysis of large in-hospital data registry

PubMed Central

Salciccioli, Justin D; Howell, Michael D; Cocchi, Michael N; Giberson, Brandon; Berg, Katherine; Gautam, Shiva; Callaway, Clifton

2014-01-01

Objective To determine if earlier administration of epinephrine (adrenaline) in patients with non-shockable cardiac arrest rhythms is associated with increased return of spontaneous circulation, survival, and neurologically intact survival. Design Post hoc analysis of prospectively collected data in a large multicenter registry of in-hospital cardiac arrests (Get With The Guidelines-Resuscitation). Setting We utilized the Get With The Guidelines-Resuscitation database (formerly National Registry of Cardiopulmonary Resuscitation, NRCPR). The database is sponsored by the American Heart Association (AHA) and contains prospective data from 570 American hospitals collected from 1 January 2000 to 19 November 2009. Participants 119 978 adults from 570 hospitals who had a cardiac arrest in hospital with asystole (55%) or pulseless electrical activity (45%) as the initial rhythm. Of these, 83 490 arrests were excluded because they took place in the emergency department, intensive care unit, or surgical or other specialty unit, 10 775 patients were excluded because of missing or incomplete data, 524 patients were excluded because they had a repeat cardiac arrest, and 85 patients were excluded as they received vasopressin before the first dose of epinephrine. The main study population therefore comprised 25 095 patients. The mean age was 72, and 57% were men. Main outcome measures The primary outcome was survival to hospital discharge. Secondary outcomes included sustained return of spontaneous circulation, 24 hour survival, and survival with favorable neurologic status at hospital discharge. Results 25 095 adults had in-hospital cardiac arrest with non-shockable rhythms. Median time to administration of the first dose of epinephrine was 3 minutes (interquartile range 1-5 minutes). There was a stepwise decrease in survival with increasing interval of time to epinephrine (analyzed by three minute intervals): adjusted odds ratio 1.0 for 1-3 minutes (reference group); 0.91 (95% confidence interval 0.82 to 1.00; P=0.055) for 4-6 minutes; 0.74 (0.63 to 0.88; P<0.001) for 7-9 minutes; and 0.63 (0.52 to 0.76; P<0.001) for >9 minutes. A similar stepwise effect was observed across all outcome variables. Conclusions In patients with non-shockable cardiac arrest in hospital, earlier administration of epinephrine is associated with a higher probability of return of spontaneous circulation, survival in hospital, and neurologically intact survival. PMID:24846323

Percutaneous patent foramen ovale closure: the Paradoxical Cerebral Embolism Prevention Registry.

PubMed

Paiva, Luís; Dinis, Paulo; Providência, Rui; Costa, Marco; Margalho, Susana; Goncalves, Lino

2015-03-01

The natural history and therapeutic interventions for secondary prevention after a cerebrovascular event in patients with patent foramen ovale (PFO) are not yet established. This study aims to assess the safety and efficacy of percutaneous PFO closure in a population of patients with ischemic cerebrovascular disease of unknown etiology. This prospective observational study included patients with a history of cryptogenic transient ischemic attack (TIA) or stroke who underwent percutaneous PFO closure. The effectiveness of the device for the secondary prevention of TIA or stroke was assessed by comparing observed events in the sample with expected events for this clinical setting. The sample included 193 cases of percutaneous PFO closure (age 46.4 ± 13.1 years, 62.2% female) with a mean follow-up of 4.3 ± 2.2 years, corresponding to a total exposure to ischemic events of 542 patient-years. The high-risk characteristics of the PFO were assessed prior to device implantation. There were seven primary endpoint events during follow-up (1.3 per 100 patient-years), corresponding to a relative risk reduction of 68.2% in recurrent TIA or stroke compared to medical therapy alone. The procedure was associated with a low rate of device- or intervention-related complications (1.5%). In this long-term registry, percutaneous PFO closure was shown to be a safe and effective therapy for the secondary prevention of cryptogenic stroke or TIA. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Occupation and relative risk of cutaneous squamous cell carcinoma (cSCC): A 45-year follow-up study in 4 Nordic countries.

PubMed

Alfonso, Jose Hernán; Martinsen, Jan Ivar; Pukkala, Eero; Weiderpass, Elisabete; Tryggvadottir, Laufey; Nordby, Karl-Christian; Kjærheim, Kristina

2016-09-01

The age-adjusted incidence of cutaneous squamous cell carcinoma (cSCC) in the Nordic countries has increased during the last 60 years, and the identification of occupational variation in the relative risk of cSCC may have preventive implications. We sought to describe variation in the relative risk of cSCC between occupational categories in Finland, Iceland, Norway, and Sweden. This is a historical prospective cohort study based on record linkages between census data for 12.9 million people and cancer registry data from 1961 to 2005. Standardized incidence ratios for cSCC were estimated for 53 occupational categories with the cSCC incidence rates for the national population of each country used as reference. During follow-up, 87,619 incident cases of cSCC were reported to the national cancer registries. In all countries combined, significant increased standardized incidence ratios were observed among seamen, military personnel, public safety workers, technical workers, teachers, transport workers, physicians, dentists, nurses, other health workers, religious workers, clerical workers, administrators, and sale agents (standardized incidence ratios between 1.08 and 1.77). Information on occupation was based on 1 point in time only. The occupational variation of the relative risk of cSCC might be associated with socioeconomic factors, and to some extent to occupational exposures. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Irregular menses predicts ovarian cancer: Prospective evidence from the Child Health and Development Studies.

PubMed

Cirillo, Piera M; Wang, Erica T; Cedars, Marcelle I; Chen, Lee-May; Cohn, Barbara A

2016-09-01

We tested the hypothesis that irregular menstruation predicts lower risk for ovarian cancer, possibly due to less frequent ovulation. We conducted a 50-year prospective study of 15,528 mothers in the Child Health and Development Studies cohort recruited from the Kaiser Foundation Health Plan from 1959 to 1966. Irregular menstruation was classified via medical record and self-report at age 26. We identified 116 cases and 84 deaths due to ovarian cancer through 2011 via linkage to the California Cancer Registry and Vital Statistics. Contrary to expectation, women with irregular menstrual cycles had a higher risk of ovarian cancer incidence and mortality over the 50-year follow-up. Associations increased with age (p <0.05). We observed a 2-fold increased incidence and mortality by age 70 (95% confidence interval [CI] = 1.1, 3.4) rising to a 3-fold increase by age 77 (95% CI = 1.5, 6.7 for incidence; 95% CI = 1.4, 5.9 for mortality). We also found a 3-fold higher risk of mortality for high-grade serous tumors (95% CI = 1.3, 7.6) that did not vary by age. This is the first prospective study to show an association between irregular menstruation and ovarian cancer-we unexpectedly found higher risk for women with irregular cycles. These women are easy to identify and many may have polycystic ovarian syndrome. Classifying high-risk phenotypes such as irregular menstruation creates opportunities to find novel early biomarkers, refine clinical screening protocols and potentially develop new risk reduction strategies. These efforts can lead to earlier detection and better survival for ovarian cancer. © 2016 UICC.

A prospective cohort study on the association between coffee drinking and risk of non-gallstone-related acute pancreatitis.

PubMed

Oskarsson, Viktor; Sadr-Azodi, Omid; Orsini, Nicola; Wolk, Alicja

2016-05-28

Only one previous study has examined the association between coffee consumption and risk of acute pancreatitis, and it found a reduced risk for alcohol-related episodes among high consumers of coffee. Therefore, we examined (1) the association between coffee consumption and risk of non-gallstone-related acute pancreatitis and (2) whether this association was modified by alcohol intake. Data were obtained from two prospective cohorts, the Cohort of Swedish Men and the Swedish Mammography Cohort, including 76 731 men and women (born 1914-1952). Coffee consumption was assessed at baseline with a FFQ, and the cohorts were followed up between 1998 and 2012 via linkage to national health registries. Hazard ratios were estimated using Cox models, with adjustment for potential confounding factors. During 1 035 881 person-years of total follow-up, 383 cases (246 in men and 137 in women) of incident non-gallstone-related acute pancreatitis were identified. Overall, and irrespective of whether a categorical or a continuous exposure model was used, we observed no association between coffee consumption and risk of non-gallstone-related acute pancreatitis (e.g. the multivariable-adjusted hazard ratio for each 1 cup/d increase in coffee consumption was 0·97; 95 % CI 0·92, 1·03). There was no evidence of effect modification by alcohol intake (P interaction=0·77). In conclusion, coffee consumption was not associated with risk of non-gallstone-related acute pancreatitis in this large prospective cohort study. Because of the limited number of epidemiological studies and their conflicting results, further research is needed to elucidate this potential association.

Social support and ovarian cancer incidence - A Swedish prospective population-based study.

PubMed

Idahl, Annika; Hermansson, Andrea; Lalos, Ann

2018-05-01

Low social support is associated with worse prognosis for epithelial ovarian cancer (EOC) patients. However, few studies have explored the relation between low social support and incidence of EOC. The aim of this prospective nested case-control study was to examine whether self-perceived low social support was associated with the incidence of EOC. The Swedish Cancer Registry was used to identify participants in the Västerbotten Intervention Programme (VIP) comprising 58,000 women, who later developed EOC. Each case was matched to four cancer free controls. The VIP uses the Social Support questionnaire, a modified version of the validated questionnaire "The Interview Schedule for Social Interaction" (ISSI) measuring quantitative (AVSI) and qualitative (AVAT) aspects of social support. The risk of EOC in relation to AVSI and AVAT was similar between the 239 cases and the 941 controls after adjustment for educational level, smoking, BMI, Cambridge Physical Activity Index and age (aOR 0.85, 95% CI 0.72-1.01 and aOR 0.54, 95% CI 0.16-1.81). Lagtime was found to have no impact. A decreased risk of serous ovarian cancer was seen in women with fewer persons available for informal socializing (aOR 0.75, 95% CI 0.59-0.95). Adjusted analyses showed non-significant odds ratios below 1.0 in the vast majority of histotypes. A general trend towards a decreased risk of ovarian cancer associated with low AVSI and AVAT was identified. Solely the serous subtype was significantly associated with low scores of AVSI. Prospective pathophysiological and epidemiological studies regarding social support are needed. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Childhood vesicoureteral reflux studies: registries and repositories sources and nosology.

PubMed

Chesney, Russell W; Patters, Andrea B

2013-12-01

Despite several recent studies, the advisability of antimicrobial prophylaxis and certain imaging studies for urinary tract infections (UTIs) remains controversial. The role of vesicoureteral reflux (VUR) on the severity and re-infection rates for UTIs is also difficult to assess. Registries and repositories of data and biomaterials from clinical studies in children with VUR are valuable. Disease registries are collections of secondary data related to patients with a specific diagnosis, condition or procedure. Registries differ from indices in that they contain more extensive data. A research repository is an entity that receives, stores, processes and/or disseminates specimens (or other materials) as needed. It encompasses the physical location as well as the full range of activities associated with its operation. It may also be referred to as a biorepository. This report provides information about some current registries and repositories that include data and samples from children with VUR. It also describes the heterogeneous nature of the subjects, as some registries and repositories include only data or samples from patients with primary reflux while others also include those from patients with syndromic or secondary reflux. Copyright © 2012 Journal of Pediatric Urology Company. All rights reserved.

Presenting an Evaluation Model for the Cancer Registry Software.

PubMed

Moghaddasi, Hamid; Asadi, Farkhondeh; Rabiei, Reza; Rahimi, Farough; Shahbodaghi, Reihaneh

2017-12-01

As cancer is increasingly growing, cancer registry is of great importance as the main core of cancer control programs, and many different software has been designed for this purpose. Therefore, establishing a comprehensive evaluation model is essential to evaluate and compare a wide range of such software. In this study, the criteria of the cancer registry software have been determined by studying the documents and two functional software of this field. The evaluation tool was a checklist and in order to validate the model, this checklist was presented to experts in the form of a questionnaire. To analyze the results of validation, an agreed coefficient of %75 was determined in order to apply changes. Finally, when the model was approved, the final version of the evaluation model for the cancer registry software was presented. The evaluation model of this study contains tool and method of evaluation. The evaluation tool is a checklist including the general and specific criteria of the cancer registry software along with their sub-criteria. The evaluation method of this study was chosen as a criteria-based evaluation method based on the findings. The model of this study encompasses various dimensions of cancer registry software and a proper method for evaluating it. The strong point of this evaluation model is the separation between general criteria and the specific ones, while trying to fulfill the comprehensiveness of the criteria. Since this model has been validated, it can be used as a standard to evaluate the cancer registry software.

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

PubMed

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

2015-01-01

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

Tea Drinking and Its Association with Active Tuberculosis Incidence among Middle-Aged and Elderly Adults: The Singapore Chinese Health Study

PubMed Central

Soh, Avril Zixin; Pan, An; Chee, Cynthia Bin Eng; Wang, Yee-Tang; Yuan, Jian-Min; Koh, Woon-Puay

2017-01-01

Experimental studies showed that tea polyphenols may inhibit growth of Mycobacterium tuberculosis. However, no prospective epidemiologic study has investigated tea drinking and the risk of active tuberculosis. We investigated this association in the Singapore Chinese Health Study, a prospective population-based cohort of 63,257 Chinese aged 45–74 years recruited between 1993 and 1998 in Singapore. Information on habitual drinking of tea (including black and green tea) and coffee was collected via structured questionnaires. Incident cases of active tuberculosis were identified via linkage with the nationwide tuberculosis registry up to 31 December 2014. Cox proportional hazard models were used to estimate the relation of tea and coffee consumption with tuberculosis risk. Over a mean 16.8 years of follow-up, we identified 1249 incident cases of active tuberculosis. Drinking either black or green tea was associated with a dose-dependent reduction in tuberculosis risk. Compared to non-drinkers, the hazard ratio (HR) (95% confidence interval (CI)) was 1.01 (0.85–1.21) in monthly tea drinkers, 0.84 (0.73–0.98) in weekly drinkers, and 0.82 (0.71–0.96) in daily drinkers (p for trend = 0.003). Coffee or caffeine intake was not significantly associated with tuberculosis risk. In conclusion, regular tea drinking was associated with a reduced risk of active tuberculosis. PMID:28587081

Tea Drinking and Its Association with Active Tuberculosis Incidence among Middle-Aged and Elderly Adults: The Singapore Chinese Health Study.

PubMed

Soh, Avril Zixin; Pan, An; Chee, Cynthia Bin Eng; Wang, Yee-Tang; Yuan, Jian-Min; Koh, Woon-Puay

2017-05-25

Experimental studies showed that tea polyphenols may inhibit growth of Mycobacterium tuberculosis . However, no prospective epidemiologic study has investigated tea drinking and the risk of active tuberculosis. We investigated this association in the Singapore Chinese Health Study, a prospective population-based cohort of 63,257 Chinese aged 45-74 years recruited between 1993 and 1998 in Singapore. Information on habitual drinking of tea (including black and green tea) and coffee was collected via structured questionnaires. Incident cases of active tuberculosis were identified via linkage with the nationwide tuberculosis registry up to 31 December 2014. Cox proportional hazard models were used to estimate the relation of tea and coffee consumption with tuberculosis risk. Over a mean 16.8 years of follow-up, we identified 1249 incident cases of active tuberculosis. Drinking either black or green tea was associated with a dose-dependent reduction in tuberculosis risk. Compared to non-drinkers, the hazard ratio (HR) (95% confidence interval (CI)) was 1.01 (0.85-1.21) in monthly tea drinkers, 0.84 (0.73-0.98) in weekly drinkers, and 0.82 (0.71-0.96) in daily drinkers ( p for trend = 0.003). Coffee or caffeine intake was not significantly associated with tuberculosis risk. In conclusion, regular tea drinking was associated with a reduced risk of active tuberculosis.

Matching colonoscopy and pathology data in population-based registries: development of a novel algorithm and the initial experience of the New Hampshire Colonoscopy Registry.

PubMed

Greene, Mary Ann; Butterly, Lynn F; Goodrich, Martha; Onega, Tracy; Baron, John A; Lieberman, David A; Dietrich, Allen J; Srivastava, Amitabh

2011-08-01

The quality of polyp-level data in a population-based registry depends on the ability to match each polypectomy recorded by the endoscopist to a specific diagnosis on the pathology report. To review impediments encountered in matching colonoscopy and pathology data in a population-based registry. New Hampshire Colonoscopy Registry data from August 2006 to November 2008 were analyzed for prevalence of missing reports, discrepancies between colonoscopy and pathology reports, and the proportion of polyps that could not be matched because of multiple polyps submitted in the same container. New Hampshire Colonoscopy Registry. This study involved all consenting patients during the study period. Develop an algorithm for capturing number, size, location, and histology of polyps and for defining and flagging discrepancies to ensure data quality. The proportion of polyps with no assumption or discrepancy, the proportion of patient records eligible for determining the adenoma detection rate (ADR), and the number of patients with ≥3 adenomas. Only 50% of polyps removed during this period were perfectly matched, with no assumption or discrepancy. Records from only 69.9% and 29.7% of eligible patients could be used to determine the ADR and the number of patients with ≥3 adenomas, respectively. Rates of missing reports may have been higher in the early phase of establishment of the registry. This study highlights the impediments in collecting polyp-level data in a population-based registry and provides useful parameters for evaluating the quality and accuracy of data obtained from such registries. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Eye Care Professionals' Perspectives on Eye Donation and an Eye Donation Registry for Research: A Single-Institution, Cross-Sectional Study.

PubMed

Williams, Andrew M; Allingham, R Rand; Stamer, W Daniel; Muir, Kelly W

2016-06-01

A centralized eye donation registry for research could help to bridge the gap between patients interested in donating their eyes to science and scientists who conduct research on human eye tissue. Previous research has demonstrated patient and family support for such a registry. In this study, we assessed the views that eye care professionals have toward an eye donation registry for research. Surveys were distributed to all 46 clinical faculty members of the Duke University Eye Center. In addition to collecting demographic information, the surveys assessed clinicians' experience with discussing eye donation with patients, described the proposed eye donation registry for research and asked how the registry would affect the clinicians' practice. A total of 21 eye care professionals returned the survey. Thirty-three percent reported discussing eye donation with patients, and 43% reported that a patient has asked about donating their eyes for research on their disease. Eighty-six percent of eye care professionals reported that a centralized registry would improve the way they work with patients who express a desire to donate their eyes for research. The majority of eye care professionals at our academic institution indicated that an eye donation registry for research would improve how they work with patients who are interested in donating their eyes for research on their disease. Future research should examine how best to communicate this registry to ophthalmic patients.

Sports participation with Chiari I malformation.

PubMed

Strahle, Jennifer; Geh, Ndi; Selzer, Béla J; Bower, Regina; Himedan, Mai; Strahle, MaryKathryn; Wetjen, Nicholas M; Muraszko, Karin M; Garton, Hugh J L; Maher, Cormac O

2016-04-01

OBJECT There is currently no consensus on the safety of sports participation for patients with Chiari I malformation (CM-I). The authors' goal was to define the risk of sports participation for children with the imaging finding of CM-I. METHODS A prospective survey was administered to 503 CM-I patients at 2 sites over a 46-month period. Data were gathered on imaging characteristics, treatment, sports participation, and any sport-related injuries. Additionally, 81 patients completed at least 1 subsequent survey following their initial entry into the registry and were included in a prospective group, with a mean prospective follow-up period of 11 months. RESULTS Of the 503 CM-I patients, 328 participated in sports for a cumulative duration of 4641 seasons; 205 of these patients participated in contact sports. There were no serious or catastrophic neurological injuries. One patient had temporary extremity paresthesias that resolved within hours, and this was not definitely considered to be related to the CM-I. In the prospective cohort, there were no permanent neurological injuries. CONCLUSIONS No permanent or catastrophic neurological injuries were observed in CM-I patients participating in athletic activities. The authors believe that the risk of such injuries is low and that, in most cases, sports participation by children with CM-I is safe.

Validation of the revised International Prognostic Scoring System in patients with myelodysplastic syndrome in Japan: results from a prospective multicenter registry.

PubMed

Kawabata, Hiroshi; Tohyama, Kaoru; Matsuda, Akira; Araseki, Kayano; Hata, Tomoko; Suzuki, Takahiro; Kayano, Hidekazu; Shimbo, Kei; Zaike, Yuji; Usuki, Kensuke; Chiba, Shigeru; Ishikawa, Takayuki; Arima, Nobuyoshi; Nogawa, Masaharu; Ohta, Akiko; Miyazaki, Yasushi; Mitani, Kinuko; Ozawa, Keiya; Arai, Shunya; Kurokawa, Mineo; Takaori-Kondo, Akifumi

2017-09-01

The Japanese National Research Group on Idiopathic Bone Marrow Failure Syndromes has been conducting prospective registration, central review, and follow-up study for patients with aplastic anemia and myelodysplastic syndrome (MDS) since 2006. Using this database, we retrospectively analyzed the prognosis of patients with MDS. As of May 2016, 351 cases were registered in this database, 186 of which were eligible for the present study. Kaplan-Meier analysis showed that overall survival (OS) curves of the five risk categories stipulated by the revised international prognostic scoring system (IPSS-R) were reasonably separated. 2-year OS rates for the very low-, low-, intermediate-, high-, and very high-risk categories were 95, 89, 79, 35, and 12%, respectively. In the same categories, incidence of leukemic transformation at 2 years was 0, 10, 8, 56, and 40%, respectively. Multivariate analysis revealed that male sex, low platelet counts, increased blast percentage (>2%), and high-risk karyotype abnormalities were independent risk factors for poor OS. Based on these data, we classified Japanese MDS patients who were classified as intermediate-risk in IPSS-R, into the lower risk MDS category, highlighting the need for careful assessment of treatments within low- and high-risk treatment protocols.

Incidence of childhood and adolescence epilepsy: a community-based prospective study in the province of Ferrara and in Copparo, Italy, 1996-2005.

PubMed

Casetta, I; Pugliatti, M; Faggioli, R; Cesnik, E; Simioni, V; Bencivelli, D; De Carlo, L; Granieri, E

2012-02-01

The annual incidence of childhood and adolescence epilepsy ranges from 41 to 97 diagnoses per 100,000 people in western Countries, with a reported decline over time. We aimed at studying the incidence of epilepsy in children and adolescents (1 month to 14 years) and its temporal trend in the province of Ferrara, northern Italy. We implemented a community-based prospective multi-source registry. All children with newly diagnosed epilepsy in the period 1996-2005 were recorded. The incidence rate of newly diagnosed epilepsy in the considered age range was 57 per 100,000 person-years, (95% CI: 49.3-65.9), with a peak in the first year of life (109.4; 95% CI: 69.4-164.1), without differences between the two gender. The estimates were significantly lower than those observed previously (97.3; 95% CI: 81.9-115.7). Incidence rates for epilepsy in the Italian population aged 1 month to 14 years are in line with those of other European and Northern American Countries. The incidence of childhood epilepsy has declined over time in our area. A reduced impact of serious perinatal adverse events could partly explain the decline. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

Gender, ethnicity and smoking affect pain and function in patients with rotator cuff tears.

PubMed

Maher, Anthony; Leigh, Warren; Brick, Matt; Young, Simon; Millar, James; Walker, Cameron; Caughey, Michael

2017-09-01

This study is a collation of baseline demographic characteristics of those presenting for rotator cuff repair in New Zealand, and exploration of associations with preoperative function and pain. Data were obtained from the New Zealand Rotator Cuff Registry; a multicentre, nationwide prospective cohort of rotator cuff repairs undertaken from 1 March 2009 until 31 December 2010. A total of 1383 patients were included in the study. This required complete demographic information, preoperative Flex-SF (functional score) and pain scores. Following univariate analysis, a multivariate model was used. The average age was 58 years (69% males and 11% smokers). New Zealand Europeans made up 90% and Maori 5%. The average preoperative Flex-SF was significantly lower (poorer function) in those over 65 years, females, smokers and Maori, in the non-dominant patients, using a multivariate model. Average preoperative pain scores were significantly worse (higher scores) in females, Maori, Polynesians, smokers, using a multivariate model. This is the largest reported prospective cohort of patients presenting for rotator cuff surgery. Results can be used to understand the effect of rotator cuff tears on the different patients, for example Maori patients who are under-represented, present younger, with more pain and poorer function. © 2017 Royal Australasian College of Surgeons.

Using Arden Syntax to Identify Registry-Eligible Very Low Birth Weight Neonates from the Electronic Health Record

PubMed Central

Sarkar, Indra Neil; Chen, Elizabeth S.; Rosenau, Paul T.; Storer, Matthew B.; Anderson, Beth; Horbar, Jeffrey D.

2014-01-01

Condition-specific registries are essential resources for supporting epidemiological, quality improvement, and clinical trial studies. The identification of potentially eligible patients for a given registry often involves a manual process or use of ad hoc software tools. With the increased availability of electronic health data, such as within Electronic Health Record (EHR) systems, there is potential to develop healthcare standards based approaches for interacting with these data. Arden Syntax, which has traditionally been used to represent medical knowledge for clinical decision support, is one such standard that may be adapted for the purpose of registry eligibility determination. In this feasibility study, Arden Syntax was explored for its ability to represent eligibility criteria for a registry of very low birth weight neonates. The promising performance (100% recall; 97% precision) of the Arden Syntax approach at a single institution suggests that a standards-based methodology could be used to robustly identify registry-eligible patients from EHRs. PMID:25954412

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 advanced online registries could be used to improve the content and functionality of the JPRN portal.

Presenting an evaluation model of the trauma registry software.

PubMed

Asadi, Farkhondeh; Paydar, Somayeh

2018-04-01

Trauma is a major cause of 10% death in the worldwide and is considered as a global concern. This problem has made healthcare policy makers and managers to adopt a basic strategy in this context. Trauma registry has an important and basic role in decreasing the mortality and the disabilities due to injuries resulted from trauma. Today, different software are designed for trauma registry. Evaluation of this software improves management, increases efficiency and effectiveness of these systems. Therefore, the aim of this study is to present an evaluation model for trauma registry software. The present study is an applied research. In this study, general and specific criteria of trauma registry software were identified by reviewing literature including books, articles, scientific documents, valid websites and related software in this domain. According to general and specific criteria and related software, a model for evaluating trauma registry software was proposed. Based on the proposed model, a checklist designed and its validity and reliability evaluated. Mentioned model by using of the Delphi technique presented to 12 experts and specialists. To analyze the results, an agreed coefficient of %75 was determined in order to apply changes. Finally, when the model was approved by the experts and professionals, the final version of the evaluation model for the trauma registry software was presented. For evaluating of criteria of trauma registry software, two groups were presented: 1- General criteria, 2- Specific criteria. General criteria of trauma registry software were classified into four main categories including: 1- usability, 2- security, 3- maintainability, and 4-interoperability. Specific criteria were divided into four main categories including: 1- data submission and entry, 2- reporting, 3- quality control, 4- decision and research support. The presented model in this research has introduced important general and specific criteria of trauma registry software and sub criteria related to each main criteria separately. This model was validated by experts in this field. Therefore, this model can be used as a comprehensive model and a standard evaluation tool for measuring efficiency and effectiveness and performance improvement of trauma registry software. Copyright © 2018 Elsevier B.V. All rights reserved.

[Etiologic classification of cerebral infarct. Experience from a prospective data register].

PubMed

Brainin, M

1990-12-01

Most classifications of stroke include clinically heterogeneous subgroups and therefore are of limited value for comparative studies or clinical protocols. The view is held that a classification according to stroke etiology is clinically more reasonable and more consistent for therapeutic strategies. In order to determine the frequency of various etiological subgroups in a series of stroke cases, the results of the Klosterneuburger Schlaganfall-Datenbank (KSDB) are reported. This stroke registry has prospectively recorded over 300 items on all stroke cases referred to one center since March 1988. Investigation rates include CT in almost 100% and the investigation of cerebral vessels in over 90% of all cases. By applying defined etiological categories (undetermined etiology, atherosclerosis of the large craniocervical vessels, cardiogenic embolism, lacunar, primary hemorrhage, and multiple and other causes) to the first 420 patients registered within the first two years it can be shown that even with CT and neurosonology in routine use, in 29% of all cases the cause of the stroke cannot be determined. To investigate this largest subgroup by means of additional new methods as well as by investigating the long-term natural course represents an important challenge for clinical stroke research.

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

PubMed

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

2016-12-01

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

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.

EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy – rationale and design of the EARLY hypertension registry

PubMed Central

2013-01-01

Background Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions. Methods/Design The “Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy” (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013. Conclusions The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice. PMID:23819631

Use of ClinicalTrials.gov to estimate condition-specific nocebo effects and other factors affecting outcomes of analgesic trials.

PubMed

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

2013-04-01

ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted worldwide. We sought to answer: what are the characteristics of pain trials; how frequently are these trials stopped and why; what is the magnitude of attrition due to lack of efficacy or adverse events; and whether the withdrawal rates depend on pain syndrome. To facilitate this and subsequent studies, we have developed a system called Sherlock that automatically downloads data from ClinicalTrials.gov into a relational database. We included pain interventional trials. To evaluate attrition, we restricted consideration to prospective randomized, parallel, double-blind, placebo-controlled trials. Of the 82,867 trials, 6% reported results and 5.6% terminated before the planned number of subjects was accrued. Of these early terminations, 38% were due to enrollment difficulties. In the placebo arms, 3.8% of participants withdrew due to lack of efficacy and 4.9% due to adverse events, with proportions differing among pain conditions. Compared with migraine trials, in fibromyalgia trials 5.1% more participants withdrew due to lack of efficacy (95% confidence interval [CI], 2.5-7.8%), and 6.4% more withdrew due to adverse events (95% CI, 4.3-8.6%). Nonsteroidal anti-inflammatory drugs were the treatment class with the lowest adverse events withdrawals. Recruitment challenges account for the largest proportion of noncompleted trials. Attrition rates differ across pain conditions. Migraine studies had the lowest withdrawal rate. Tools like Sherlock facilitate conducting research in the ClinicalTrials.gov registry. ClinicalTrials.gov registry enables researchers to get a snapshot of a specific field and observe changes over time in trial design, including numbers of subjects accrued, and it can inform clinical trial design. We learned that recruitment challenges account for the largest proportion of noncompleted trials, attrition rates differed across pain conditions, and migraine studies had the lowest withdrawal rate. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

French brain tumor database: 5-year histological results on 25 756 cases.

PubMed

Rigau, Valérie; Zouaoui, Sonia; Mathieu-Daudé, Hélène; Darlix, Amélie; Maran, Aurélie; Trétarre, Brigitte; Bessaoud, Faiza; Bauchet, Fabienne; Attaoua, Redha; Fabbro-Peray, Pascale; Fabbro, Michel; Kerr, Christine; Taillandier, Luc; Duffau, Hugues; Figarella-Branger, Dominique; Costes, Valérie; Bauchet, Luc

2011-11-01

This work aimed to prospectively record all primary central nervous system tumor (PCNST) cases in France, for which histological diagnosis is available. The objectives were to (i) create a national registry and a network to perform epidemiological studies; (ii) implement clinical and basic research protocols; and (iii) harmonize the health care of patients affected by PCNST. For 5 years, 25 756 cases of newly diagnosed and histologically confirmed PCNST have been recorded. Histological diagnoses included glioma (48.9%), all other neuroepithelial tumors (5%), meningioma (28.8%), nerve sheath tumors (8.4%), lymphoma (3.2%) and others (5.7%). Cryopreservation was reported for 6018 PCNST specimens. Tumor resections (R) were performed in 78% cases, while biopsies accounted for 22%. Median age (MA), sex, percentage R and number of cryopreserved tumors were detailed for each histology; for example, out of 6053 glioblastomas (MA 63 years, male 59.4%, R 62%, 1611 were cryopreserved), and out of 37 atypical teratoid/rhabdoid tumors (MA 2 years, male 56.8%, R 94%, 17 were cryopreserved). This database or databank dedicated to PCNST cases contains detailed data on clinical, histological and other characteristics, such as the inclusion of data on cryopreserved specimens that are not available in other European registries. Therefore, this is a valuable resource that can be used for planning future epidemiological and clinical research. © 2011 The Authors; Brain Pathology © 2011 International Society of Neuropathology.

Use of peripherally inserted central catheters as an alternative to central catheters in neurocritical care units.

PubMed

DeLemos, Christi; Abi-Nader, Judy; Akins, Paul T

2011-04-01

Patients in neurological critical care units often have lengthy stays that require extended vascular access and invasive hemodynamic monitoring. The traditional approach for these patients has relied heavily on central venous and pulmonary artery catheters. The aim of this study was to evaluate peripherally inserted central catheters as an alternative to central venous catheters in neurocritical care settings. Data on 35 patients who had peripherally inserted central catheters rather than central venous or pulmonary artery catheters for intravascular access and monitoring were collected from a prospective registry of neurological critical care admissions. These data were cross-referenced with information from hospital-based data registries for peripherally inserted central catheters and subarachnoid hemorrhage. Complete data were available on 33 patients with Hunt-Hess grade IV-V aneurysmal subarachnoid hemorrhage. Catheters remained in place a total of 649 days (mean, 19 days; range, 4-64 days). One patient (3%) had deep vein thrombosis in an upper extremity. In 2 patients, central venous pressure measured with a peripherally inserted catheter was higher than pressure measured concurrently with a central venous catheter. None of the 33 patients had a central catheter bloodstream infection or persistent insertion-related complications. CONCLUSIONS Use of peripherally inserted central catheters rather than central venous catheters or pulmonary artery catheters in the neurocritical care unit reduced procedural and infection risk without compromising patient management.

Incidence and survival patterns of rare anal canal neoplasms using the surveillance epidemiology and end results registry.

PubMed

Metildi, Cristina; McLemore, Elisabeth C; Tran, Thuy; Chang, David; Cosman, Bard; Ramamoorthy, Sonia L; Saltzstein, Sidney L; Sadler, Georgia Robins

2013-10-01

Small cell, neuroendocrine tumors, and melanoma of the anus are rare. Limited data exist on the incidence and management for these rare tumors. A large, prospective, population-based database was used to determine incidence and survival patterns of rare anal neoplasms. The Surveillance, Epidemiology and End Results registry was queried to identify patients diagnosed with anal canal neoplasms. Incidence and survival patterns were evaluated with respect to age, sex, race, histology, stage, and therapy. We identified 7078 cases of anal canal neoplasms: melanoma (n = 149), neuroendocrine (n = 61), and small cell neuroendocrine (n = 26). Squamous cell carcinoma (SCC) (n = 6842) served as the comparison group. Anal melanoma (AM) demonstrated the lowest survival rate at 2.5 per cent. Neuroendocrine tumors (NETs) demonstrated similar survival as SCC (10-year survival for regional disease of 25 and 22.3%, respectively). Ten-year survival of small cell NETs resembled AM (5.3 vs 2.5%). Age 60 years or older, sex, black race, stage, and surgery were independent predictors of survival. This study presents the largest patient series of rare anal neoplasms. NETs of the anal canal demonstrate similar survival patterns to SCC, whereas small cell NETs more closely resemble AM. Accurate histologic diagnosis is vital to determine treatment and surgical management because survival patterns can differ among rare anal neoplasms.

Recurrent Primary Spontaneous Pneumothorax is Common Following Chest Tube and Conservative Treatment.

PubMed

Olesen, Winnie Hedevang; Lindahl-Jacobsen, Rune; Katballe, Niels; Sindby, Jesper Eske; Titlestad, Ingrid Louise; Andersen, Poul Erik; Licht, Peter Bjørn

2016-09-01

Previous studies on primary spontaneous pneumothorax reported variable recurrence rates, but they were based on heterogeneous patient populations including secondary pneumothorax. We investigated young patients with primary spontaneous pneumothorax exclusively and used a national registry to track readmissions and calculate independent predictors of recurrence. A prospective cohort study of consecutive young patients who were admitted over a 5-year period with their first episode of primary spontaneous pneumothorax and treated conservatively with a chest tube. Baseline characteristics were obtained from questionnaires presented on admittance. All patients were discharged with fully expanded lungs on chest radiography. Patient charts were identified in the national electronic patient registry for detailed information on readmissions due to recurrent spontaneous pneumothorax. We included 234 patients. Male/female = ratio 5/1. After a median observation period of 3.6 years (range 1-6 years), recurrent pneumothorax was observed in 54 %. Ipsilateral recurrence was the most common (79 %) but 30 % also experienced contralateral pneumothorax during the study period. Females had a significantly higher age at debut (p < 0.01) and experienced significantly more recurrences over time (p < 0.01). Low body weight (<60 kg) was an independent predictor of recurrence and patients with repeated recurrences were significantly younger at debut (p = 0.01). Primary spontaneous pneumothorax in younger patients with their first episode had a much higher recurrence rate than previously reported. Every doctor who treats patients with primary spontaneous pneumothorax should be aware and patients informed.

Outcomes following trauma laparotomy for hypotensive trauma patients: a UK military and civilian perspective.

PubMed

Marsden, Max; Carden, Rich; Navaratne, Lalin; Smith, Iain M; Penn-Barwell, Jowan G; Kraven, Luke M; Brohi, Karim; Tai, Nigel R M; Bowley, Douglas M

2018-05-25

The management of trauma patients has changed radically in the last decade and studies have shown overall improvements in survival. However, reduction in mortality for the many may obscure a lack of progress in some high-risk patients. We sought to examine the outcomes for hypotensive patients requiring laparotomy in UK military and civilian cohorts. We undertook a review of two prospectively maintained trauma databases; the UK Joint Theatre Trauma Registry (JTTR) for the military cohort (4th February 2003 to 21st September 2014), and the trauma registry of the Royal London Hospital MTC (1st January 2012 to 1st January 2017) for civilian patients. Adults undergoing trauma laparotomy within 90 minutes of arrival at the Emergency Department (ED) were included. Hypotension was present on arrival at the ED in 155/761 (20.4%) military patients. Mortality was higher in hypotensive casualties 25.8% vs 9.7% normotensive casualties (p<0.001). Hypotension was present on arrival at the ED in 63/176 (35.7%) civilian patients. Mortality was higher in hypotensive patients 47.6% vs 12.4% normotensive patients (p<0.001). In both cohorts of hypotensive patients neither the average injury severity, the prehospital time, the ED arrival SBP, nor mortality rate changed significantly during the study period. Despite improvements in survival after trauma for patients overall, the mortality for patients undergoing laparotomy who arrive at the Emergency Department with hypotension has not changed and appears stubbornly resistant to all efforts. Specific enquiry and research should continue to be directed at this high-risk group of patients. IV; Observational Cohort Study.