Getting to the Heart of Being the Match: A Qualitative Analysis of Bone Marrow Donor Recruitment and Retention Among College Students

PubMed Central

Rogers, Charles R.; Jeon, Kwon Chan; Rosen, Brittany

2014-01-01

Introduction For those with certain blood or bone cancers, bone marrow donation can mean the difference between life and death. The National Marrow Donor Program® (NMDP) operates the largest bone marrow registry of potential donors; however, at times when potential matches are identified, many donors opt not to donate. The purpose of this study was to describe perspectives from college-aged students on recruitment to a bone marrow donation registry and retention to the registry/follow-through with the donation process. Methods Researchers employed a one-time qualitative study using 7 focus groups comprised of 10 – 11 college students each (n = 76). Results Results yielded three overarching themes: donor recruitment, donor retention, and factors contributing to the overall donation process. More specifically, this study identified key factors affecting bone marrow donation in an essential population: facilitators, barriers, knowledge, and ‘goodness’. Additionally, marketing and communication were found to be major determinants of potential donors staying with the NMDP. Conclusion Better explanations and awareness/promotion campaigns are necessary for recruiting potential donors to the NMDP and to increase the likelihood that the donor will follow through with the donation should a potential match be identified. Recommendations from this study may improve recruitment and retention rates among the NMDP campaigns targeting college students. PMID:25632376

Charting improvements in US registry HLA typing ambiguity using a typing resolution score.

PubMed

Paunić, Vanja; Gragert, Loren; Schneider, Joel; Müller, Carlheinz; Maiers, Martin

2016-07-01

Unrelated stem cell registries have been collecting HLA typing of volunteer bone marrow donors for over 25years. Donor selection for hematopoietic stem cell transplantation is based primarily on matching the alleles of donors and patients at five polymorphic HLA loci. As HLA typing technologies have continually advanced since the beginnings of stem cell transplantation, registries have accrued typings of varied HLA typing ambiguity. We present a new typing resolution score (TRS), based on the likelihood of self-match, that allows the systematic comparison of HLA typings across different methods, data sets and populations. We apply the TRS to chart improvement in HLA typing within the Be The Match Registry of the United States from the initiation of DNA-based HLA typing to the current state of high-resolution typing using next-generation sequencing technologies. In addition, we present a publicly available online tool for evaluation of any given HLA typing. This TRS objectively evaluates HLA typing methods and can help define standards for acceptable recruitment HLA typing. Copyright © 2016 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.

Reliability of recording uterine cancer in death certification in France and age-specific proportions of deaths from cervix and corpus uteri.

PubMed

Rogel, Agnès; Belot, Aurélien; Suzan, Florence; Bossard, Nadine; Boussac, Marjorie; Arveux, Patrick; Buémi, Antoine; Colonna, Marc; Danzon, Arlette; Ganry, Olivier; Guizard, Anne-Valérie; Grosclaude, Pascale; Velten, Michel; Jougla, Eric; Iwaz, Jean; Estève, Jacques; Chérié-Challine, Laurence; Remontet, Laurent

2011-06-01

French uterine cancer recordings in death certificates include 60% of "uterine cancer, Not Otherwise Specified (NOS)"; this hampers the estimation of mortalities from cervix and corpus uteri cancers. The aims of this work were to study the reliability of uterine cancer recordings in death certificates using a case matching with cancer registries and estimate age-specific proportions of deaths from cervix and corpus uteri cancers among all uterine cancer deaths by a statistical approach that uses incidence and survival data. Deaths from uterine cancer between 1989 and 2001 were extracted from the French National database of causes of death and case-to-case matched to women diagnosed with uterine cancer between 1989 and 1997 in 8 cancer registries. Registry data were considered as "gold-standard". Among the 1825 matched deaths, cancer registries recorded 830 cervix and 995 corpus uteri cancers. In death certificates, 5% and 40% of "true" cervix cancers were respectively coded "corpus" and "uterus, NOS" and 5% and 59% of "true" corpus cancers respectively coded "cervix" and "uterus, NOS". Miscoding cervix cancers was more frequent at advanced ages at death and in deaths at home or in small urban areas. Miscoding corpus cancers was more frequent in deaths at home or in small urban areas. From the statistical method, the estimated proportion of deaths from cervix cancer among all uterine cancer deaths was higher than 95% in women aged 30-40 years old but declined to 35% in women older than 70 years. The study clarifies the reason for poor encoding of uterus cancer mortality and refines the estimation of mortalities from cervix and corpus uteri cancers allowing future studies on the efficacy of cervical cancer screening. Copyright © 2010 Elsevier Ltd. All rights reserved.

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.

Applying openEHR's Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study.

PubMed

Anani, Nadim; Mazya, Michael V; Chen, Rong; Prazeres Moreira, Tiago; Bill, Olivier; Ahmed, Niaz; Wahlgren, Nils; Koch, Sabine

2017-01-10

Interoperability standards intend to standardise health information, clinical practice guidelines intend to standardise care procedures, and patient data registries are vital for monitoring quality of care and for clinical research. This study combines all three: it uses interoperability specifications to model guideline knowledge and applies the result to registry data. We applied the openEHR Guideline Definition Language (GDL) to data from 18,400 European patients in the Safe Implementation of Treatments in Stroke (SITS) registry to retrospectively check their compliance with European recommendations for acute stroke treatment. Comparing compliance rates obtained with GDL to those obtained by conventional statistical data analysis yielded a complete match, suggesting that GDL technology is reliable for guideline compliance checking. The successful application of a standard guideline formalism to a large patient registry dataset is an important step toward widespread implementation of computer-interpretable guidelines in clinical practice and registry-based research. Application of the methodology gave important results on the evolution of stroke care in Europe, important both for quality of care monitoring and clinical research.

Using administrative claims to identify children with chronic conditions in a statewide immunization registry.

PubMed

Dombkowski, Kevin J; Costello, Lauren; Dong, Shiming; Clark, Sarah J

2014-05-01

To demonstrate the feasibility and utility of using administrative claims data from commercial health plans to establish a high-risk indicator in a statewide immunization registry for enrollees with chronic conditions. Retrospective cohort analysis. Administrative data were used to identify children with 1 or more chronic conditions enrolled in 2 commercial health plans during the 2008-2009 and 2009-2010 influenza seasons and matched with a statewide immunization registry. The proportion of cases that successfully matched and historical health services utilization, including influenza vaccinations and missed opportunities, were assessed. A total of 93% of children with chronic conditions identified through administrative claims were successfully matched with the statewide registry. Less than one-third of children received the seasonal influenza vaccine in either the 2008-2009 (29%) or 2009-2010 (32%) seasons; 30% of children received the H1N1 vaccination in 2009-2010. Most children in the 2008-2009 (63%) and 2009-2010 (63%) seasons had at least 1 missed opportunity for seasonal influenza vaccination. Younger children had the highest percentage of missed opportunities while adolescents had the lowest rate of missed opportunities for vaccination. Conclusions It is feasible to identify children with chronic conditions using administrative data and to link them with a statewide immunization registry. Low influenza vaccination rates and high occurrences of missed opportunities among children with chronic conditions suggest the utility of integrating administrative claims data with statewide registries to support various outreach mechanisms, including physician-focused and parent-targeted reminder/recall, based on target age to improve vaccination rates.

Matching study to registry data: maintaining data privacy in a study on family based colorectal cancer.

PubMed

Nasseh, Daniel; Engel, Jutta; Mansmann, Ulrich; Tretter, Werner; Stausberg, Jürgen

2014-01-01

Confidentiality of patient data in the field of medical informatics is an important task. Leaked sensitive information within this data can be adverse to and being abused against a patient. Therefore, when working with medical data, appropriate and secure models which serve as guidelines for different applications are needed. Consequently, this work presents a model for performing a privacy preserving record linkage between study and registry data. The model takes into account seven requirements related to data privacy. Furthermore, this model is exemplified with a study on family based colorectal cancer in Germany. The model is very strict and excludes possible violations towards data privacy protection to a reasonable degree. It should be applicable to similar use cases which are in need of a mapping between medical data of a study and a registry database.

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.

ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening.

PubMed

Pfiffner, Pascal B; Oh, JiWon; Miller, Timothy A; Mandl, Kenneth D

2014-01-01

Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. 24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format.

Chest compression quality management and return of spontaneous circulation: a matched-pair registry study.

PubMed

Lukas, Roman-Patrik; Gräsner, Jan Thorsten; Seewald, Stephan; Lefering, Rolf; Weber, Thomas Peter; Van Aken, Hugo; Fischer, Matthias; Bohn, Andreas

2012-10-01

Investigating the effects of any intervention during cardiac arrest remains difficult. The ROSC after cardiac arrest score was introduced to facilitate comparison of rates of return of spontaneous circulation (ROSC) between different ambulance services. To study the influence of chest compression quality management (including training, real-time feedback devices, and debriefing) in comparison with conventional cardiopulmonary resuscitation (CPR), a matched-pair analysis was conducted using data from the German Resuscitation Registry, with the calculated ROSC after cardiac arrest score as the baseline. Matching for independent ROSC after cardiac arrest score variables yielded 319 matched cases from the study period (January 2007-March 2011). The score predicted a 45% ROSC rate for the matched pairs. The observed ROSC increased significantly with chest compression quality management, to 52% (P=0.013; 95% CI, 46-57%). No significant differences were seen in the conventional CPR group (47%; 95% CI, 42-53%). The difference between the observed ROSC rates was not statistically significant. Chest compression quality management leads to significantly higher ROSC rates than those predicted by the prognostic score (ROSC after cardiac arrest score). Matched-pair analysis shows that with conventional CPR, the observed ROSC rate was not significantly different from the predicted rate. Analysis shows a trend toward a higher ROSC rate for chest compression quality management in comparison with conventional CPR. It is unclear whether a single aspect of chest compression quality management or the combination of training, real-time feedback, and debriefing contributed to this result. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Certification and Career Success: A LEADS Project

ERIC Educational Resources Information Center

Russ-Eft, Darlene; Dickison, Phil; Levine, Roger

2008-01-01

This study examines the relationship between certification examination test results and Emergency Medical Technician (EMT) career success. The sample was drawn from the Longitudinal Emergency Medical Technician Attributes and Demographics Study (LEADS). LEADS participants were matched with National Registry of Emergency Medical Technician (NREMT)…

Modeling coverage gaps in haplotype frequencies via Bayesian inference to improve stem cell donor selection.

PubMed

Louzoun, Yoram; Alter, Idan; Gragert, Loren; Albrecht, Mark; Maiers, Martin

2018-05-01

Regardless of sampling depth, accurate genotype imputation is limited in regions of high polymorphism which often have a heavy-tailed haplotype frequency distribution. Many rare haplotypes are thus unobserved. Statistical methods to improve imputation by extending reference haplotype distributions using linkage disequilibrium patterns that relate allele and haplotype frequencies have not yet been explored. In the field of unrelated stem cell transplantation, imputation of highly polymorphic human leukocyte antigen (HLA) genes has an important application in identifying the best-matched stem cell donor when searching large registries totaling over 28,000,000 donors worldwide. Despite these large registry sizes, a significant proportion of searched patients present novel HLA haplotypes. Supporting this observation, HLA population genetic models have indicated that many extant HLA haplotypes remain unobserved. The absent haplotypes are a significant cause of error in haplotype matching. We have applied a Bayesian inference methodology for extending haplotype frequency distributions, using a model where new haplotypes are created by recombination of observed alleles. Applications of this joint probability model offer significant improvement in frequency distribution estimates over the best existing alternative methods, as we illustrate using five-locus HLA frequency data from the National Marrow Donor Program registry. Transplant matching algorithms and disease association studies involving phasing and imputation of rare variants may benefit from this statistical inference framework.

Survival of Patients Receiving a Primary Prevention Implantable Cardioverter-Defibrillator in Clinical Practice vs Clinical Trials

PubMed Central

Al-Khatib, Sana M.; Hellkamp, Anne; Bardy, Gust H.; Hammill, Stephen; Jackson Hall, W.; Mark, Daniel B.; Anstrom, Kevin J.; Curtis, Jeptha; Al-Khalidi, Hussein; Curtis, Lesley H.; Heidenreich, Paul; Peterson, Eric D.; Sanders, Gillian; Clapp-Channing, Nancy; Lee, Kerry L.; Moss, Arthur J.

2013-01-01

Importance Randomized clinical trials have shown that implantable cardioverter-defibrillator (ICD) therapy saves lives. Whether the survival of patients who received an ICD in primary prevention clinical trials differs from that of trial-eligible patients receiving a primary prevention ICD in clinical practice is unknown. Objective To determine whether trial-eligible patients who received a primary prevention ICD as documented in a large national registry have a survival rate that differs from the survival rate of similar patients who received an ICD in the 2 largest primary prevention clinical trials, MADIT-II (n=742) and SCD-HeFT (n=829). Design, Setting, and Patients Retrospective analysis of data for patients enrolled in the National Cardiovascular Data Registry ICD Registry between January 1, 2006, and December 31, 2007, meeting the MADIT-II criteria (2464 propensity score–matched patients) or the SCD-HeFT criteria (3352 propensity score–matched patients). Mortality data for the registry patients were collected through December 31, 2009. Main Outcome Measures Cox proportional hazards models were used to compare mortality from any cause. Results The median follow-up time in MADIT-II, SCD-HeFT, and the ICD Registry was 19.5, 46.1, and 35.2 months, respectively. Compared with patients enrolled in the clinical trials, patients in the ICD Registry were significantly older and had a higher burden of comorbidities. In the matched cohorts, there was no significant difference in survival between MADIT-II–like patients in the registry and MADIT-II patients randomized to receive an ICD (2-year mortality rates: 13.9% and 15.6%, respectively; adjusted ICD Registry vs trial hazard ratio, 1.06; 95% CI, 0.85–1.31; P=.62). Likewise, the survival among SCD-HeFT–like patients in the registry was not significantly different from survival among patients randomized to receive ICD therapy in SCD-HeFT (3-year mortality rates: 17.3% and 17.4%, respectively; adjusted registry vs trial hazard ratio, 1.16; 95% CI, 0.97–1.38; P=.11). Conclusions and Relevance There was no significant difference in survival between clinical trial patients randomized to receive an ICD and a similar group of clinical registry patients who received a primary prevention ICD. Our findings support the continued use of primary prevention ICDs in similar patients seen in clinical practice. Trial Registration clinicaltrials.gov Identifier: NCT00000609 PMID:23280225

A Comparative Reference Study for the Validation of HLA-Matching Algorithms in the Search for Allogeneic Hematopoietic Stem Cell Donors and Cord Blood Units

DTIC Science & Technology

2016-08-15

HLA ISSN 2059-2302 A comparative reference study for the validation of HLA-matching algorithms in the search for allogeneic hematopoietic stem cell...from different inter- national donor registries by challenging them with simulated input data and subse- quently comparing the output. This experiment...original work is properly cited, the use is non-commercial and no modifications or adaptations are made. Comparative reference validation of HLA

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.

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register.

PubMed

Fleminger, Jessica; Goldacre, Ben

2018-01-01

Trial registries are a key source of information for clinicians and researchers. While building OpenTrials, an open database of public trial information, we identified errors and omissions in registries, including discrepancies between descriptions of the same trial in different registries. We set out to ascertain the prevalence of discrepancies in trial completion status using a cohort of trials registered on both the European Union Clinical Trials Register (EUCTR) and ClinicalTrials.gov. We used matching titles and registry IDs provided by both registries to build a cohort of dual-registered trials. Completion statuses were compared; we calculated descriptive statistics on the prevalence of discrepancies. 11,988 dual-registered trials were identified. 1,496 did not provide a comparable completion status, leaving 10,492 trials. 16.2% were discrepant on completion status. The majority of discrepancies (90.5%) were a 'completed' trial on ClinicalTrials.gov inaccurately marked as 'ongoing' on EUCTR. Overall, 33.9% of dual-registered trials described as 'ongoing' on EUCTR were listed as 'completed' on ClinicalTrials.gov. Completion status on registries is commonly inaccurate. Previous work on publication bias may underestimate non-reporting. We describe simple steps registry owners and trialists could take to improve accuracy.

The impact of HLA matching on long-term transplant outcome after allogeneic hematopoietic stem cell transplantation for CLL: a retrospective study from the EBMT registry.

PubMed

Michallet, M; Sobh, M; Milligan, D; Morisset, S; Niederwieser, D; Koza, V; Ruutu, T; Russell, N H; Verdonck, L; Dhedin, N; Vitek, A; Boogaerts, M; Vindelov, L; Finke, J; Dubois, V; van Biezen, A; Brand, R; de Witte, T; Dreger, P

2010-10-01

We analyzed 368 chronic lymphocytic leukemia patients who underwent allogeneic hematopoietic stem cell transplantation reported to the EBMT registry between 1995 and 2007. There were 198 human leukocyte antigen (HLA)-identical siblings; among unrelated transplants, 31 were well matched in high resolution ('well matched' unrelated donor, WMUD), and 139 were mismatched (MM), including 30 matched in low resolution; 266 patients (72%) received reduced-intensity conditioning and 102 (28%) received standard. According to the EBMT risk score, 11% were in scores 1-3, 23% in score 4, 40% in score 5, 22% in score 6 and 4% in score 7. There was no difference in overall survival (OS) at 5 years between HLA-identical siblings (55% (48-64)) and WMUD (59% (41-84)), P=0.82. In contrast, OS was significantly worse for MM (37% (29-48) P=0.005) due to a significant excess of transplant-related mortality. Also OS worsened significantly when EBMT risk score increased. HLA matching had no significant impact on relapse (siblings: 24% (21-27); WMUD: 35% (26-44), P=0.11 and MM: 21% (18-24), P=0.81); alemtuzumab T-cell depletion and stem cell source (peripheral blood) were associated with an increased risk. Our findings support the use of WMUD as equivalent alternative to HLA-matched sibling donors for allogeneic HSCT in CLL, and justify the application of EBMT risk score in this disease.

Testicular cancer and occupational exposure to polyvinyl chloride plastics: a case-control study.

PubMed

Hardell, Lennart; Malmqvist, Nils; Ohlson, Carl-Göran; Westberg, Håkan; Eriksson, Mikael

2004-04-10

Exposure to polyvinyl chloride (PVC) plastics as a risk factor for testicular cancer was investigated. In total, 981 cases who were 20-75 years old and had reported to the Swedish Cancer Registry during 1993-1997 were included. One matched control from the population registry was used. Exposure was assessed by a questionnaire that was supplemented over the phone. Furthermore, an occupational hygienist qualified all exposures. In all, 791 matched pairs completed the questionnaire. Overall exposure to PVC plastics gave the odds ratio (OR)=1.35, 95% confidence interval (CI)=1.06-1.71, increasing with >10 year latency period to OR=1.45, 95% CI=1.06-1.98. No dose-response relationships were found but rather an inverse relationship with the highest odds ratios in the lowest exposure category. In conclusion, no clear association with testicular cancer and exposure to PVC could be found in our study in contrast to a previous observation. Copyright 2004 Wiley-Liss, Inc.

Use of Proton Pump Inhibitors and the Risk of Listeriosis: A Nationwide Registry-based Case-Control Study.

PubMed

Kvistholm Jensen, Anne; Simonsen, Jacob; Ethelberg, Steen

2017-04-01

Recent studies suggest that proton pump inhibitors (PPIs) may increase the risk for listeriosis. We investigated a potential association in cases of nonpregnancy-associated listeriosis using registry data. We conducted a population-based, case-control study using Danish health registries. Cases (n = 721) were defined as patients aged ≥45 years notified with listeriosis from July 1994 to December 2012. We selected 34800 controls using risk-set sampling. Controls were individually matched for age, sex, and municipality. Data on use of PPIs and other drugs and hospitalization diagnoses over a 5-year period were extracted from nationwide health registries. A comorbidity index (CMI) was constructed. We calculated the association between use of PPIs and related drugs within 30 days (current use) and other time windows before the index date. Using conditional logistic regression, matched odds ratios (ORs) adjusted for CMI and confounders were estimated. The adjusted OR for current use of PPIs and development of listeriosis was 2.81 (95% confidence interval [CI], 2.14-3.69). PPI usage up to 90 days before the index date remained statistically significant. Subgroup analyses revealed increasing ORs with decreasing age and level of comorbidity and an increased OR for concurrent glucocorticoid treatment (OR, 4.61; 95% CI, 3.01-7.06). No significant association was found for current use of histamine-2-receptor antagonists (adjusted OR, 1.82; 95% CI, 0.89-3.71). Prescribed PPIs were associated with increased risk of listeriosis. The risk waned with time since last prescription redemption. PPIs may have unwanted side effects in vulnerable populations. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Tuberculosis screening among homeless persons with AIDS living in single-room-occupancy hotels.

PubMed

Layton, M C; Cantwell, M F; Dorsinville, G J; Valway, S E; Onorato, I M; Frieden, T R

1995-11-01

Congregate facilities for homeless persons with the acquired immunodeficiency syndrome (AIDS) are often endemic for tuberculosis. We evaluated tuberculosis screening methods at single-room-occupancy hotels housing persons with AIDS. Residents were screened by cross matching the New York City Tuberculosis Registry, interviewing for tuberculosis history, skin testing, and chest radiography. Cases were classified as either previously or newly diagnosed. Among the 106 participants, 16 (15%) previously diagnosed tuberculosis cases were identified. Participants' tuberculosis histories were identified by the questionnaire (100%) or by registry match (69%). Eight participants (50%) were noncompliant with therapy. These findings prompted the establishment of a directly observed therapy program on site.

Acute kidney injury and edaravone in acute ischemic stroke: the Fukuoka Stroke Registry.

PubMed

Kamouchi, Masahiro; Sakai, Hironori; Kiyohara, Yutaka; Minematsu, Kazuo; Hayashi, Kunihiko; Kitazono, Takanari

2013-11-01

A free radical scavenger, edaravone, which has been used for the treatment of ischemic stroke, was reported to cause acute kidney injury (AKI) as a fatal adverse event. The aim of the present study was to clarify whether edaravone is associated with AKI in patients with acute ischemic stroke. From the Fukuoka Stroke Registry database, 5689 consecutive patients with acute ischemic stroke who were hospitalized within 24 hours of the onset of symptoms were included in this study. A logistic regression analysis for the Fukuoka Stroke Registry cohort was done to identify the predictors for AKI. A propensity score-matched nested case-control study was also performed to elucidate any association between AKI and edaravone. Acute kidney injury occurred in 128 of 5689 patients (2.2%) with acute ischemic stroke. A multivariate analysis revealed that the stroke subtype, the basal serum creatinine level, and the presence of infectious complications on admission were each predictors of developing AKI. In contrast, a free radical scavenger, edaravone, reduced the risk of developing AKI (multivariate-adjusted odds ratio [OR] .45, 95% confidence interval [CI] .30-.67). Propensity score-matched case-control study confirmed that edaravone use was negatively associated with AKI (propensity score-adjusted OR .46, 95% CI .29-.74). Although AKI has a significant impact on the clinical outcome of hospital inpatients, edaravone has a protective effect against the development of AKI in patients with acute ischemic stroke. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of rituximab as maintenance treatment for relapsed follicular lymphoma: results of a population-based study.

PubMed

Blommestein, Hedwig M; Issa, Djamila E; Pompen, Marjolein; Ten Hoor, Gerhard; Hogendoorn, Mels; Joosten, Peter; Zweegman, Sonja; Huijgens, Peter C; Uyl-de Groot, Carin A

2014-01-01

On the basis of two population-based registries, our study aims to calculate the real-world cost-effectiveness of rituximab maintenance compared with observation in relapsed or refractory follicular lymphoma patients who responded to second-line chemotherapy. Data were obtained from the EORTC20981 trial, the Netherlands Cancer Registry and two population-based registries. A Markov model was developed to calculate cost per life year gained (LYG) and quality-adjusted life years (QALYs) for three scenarios. Our real-world patients were (62 years) 6 to 7 years older and had higher complete response rates to second-line chemotherapy than the trial population. Differences between the real-world rituximab and observation group were observed for second-line chemotherapy and disease progression. Groups were more balanced after using propensity matching. Relying entirely on updated trial results (scenario1) in combination with local cost data resulted in ratios of €11,259 per LYG and €12,655 per QALY. For scenario2, consisting of trial efficacy and matched real-world costs, ratios of €21,202 per LYG and €23,821 per QALY were calculated. Using real-world matched evidence (scenario3) for both effectiveness and costs showed ratios of €10,591 per LYG and €11,245 per QALY. Although differences in real-world and trial population were found, using real-world data as well as results from long-term trial follow-up showed favourable ICERs for rituximab maintenance. Nevertheless, results showed that caution is required with data synthesis, interpretation and generalisability of results. As different scenarios provide answers to different questions, we recommend healthcare decision-makers to recognise the importance of calculating several cost-effectiveness scenarios. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Australian Twin Registry: a nationally funded resource for medical and scientific research, incorporating match and WATCH.

PubMed

Hopper, John L; Treloar, Susan A; de Klerk, Nicholas H; Morley, Ruth

2006-12-01

The Australian Twin Registry (ATR) has, since the late 1970s, enrolled more than 30,000 pairs of all zygosity types and ages willing to consider participation in approved research studies. Its core functions are the recruitment to, and maintenance of, an up-to-date database containing contact details and baseline information, and the management of fair and equitable access so as to enhance medical and scientific research. The ATR has facilitated more than 430 studies producing 525 peer-reviewed publications using a variety of designs including classic biometrical twin and twin family studies, co-twin control studies, intervention studies, longitudinal studies, and studies of issues relevant specifically to twins. The ATR is supported for 2004 to 2009 by an Australian National Health and Medical Research Council (NHMRC) Enabling Grant, a new form of funding which recognizes the importance of long-term support for shared national resources. New initiatives include: integration with the Western Australian Twin Child Health (WATCH) cohort and the new Western Australian Twin Registry (WATR); foundation of a cohort of mothers and their twin children recruited from the time of diagnosis of the multiple gestation (match); a national Twins Festival run in collaboration with the Australian Multiple Birth Association (AMBA); promotion of the ATR at medical conferences; and fostering an active network of researchers from a range of disciplines and providing financial support for new researchers to attend international twin research workshops. Consistent with its mission statement, the long-term goal of the ATR is to make twin studies a standard component of medical and scientific research.

Increased Prevalence of Renal and Urinary Tract Anomalies in Children with Congenital Hypothyroidism

PubMed Central

Kumar, Juhi; Gordillo, Roberto; Kaskel, Frederick J.; Druschel, Charlotte M.; Woroniecki, Robert P.

2013-01-01

Objective We investigated the prevalence of congenital renal and urologic anomalies in children with congenital hypothyroidism to determine whether further renal and urologic investigations would be of benefit. Study design Prevalence of congenital hypothyroidism was obtained from the New York State Congenital Malformation Registry. The occurrence of urinary tract anomalies were calculated for children with congenital hypothyroidism and compared to children without congenital hypothyroidism. In addition we obtained congenital hypothyroidism data from New York State newborn screening, and the cases were matched to Congenital Malformation Registry. Results Analysis of Congenital Malformation Registry data showed 980 children with congenital hypothyroidism and 3 661 585 children without congenital hypothyroidism born in New York State (1992-2005). Children with congenital hypothyroidism have a significantly increased risk of congenital renal and urological anomalies with the odds ratio (OR) of 13.2 (10.6-16.5). The other significantly increased defects in congenital hypothyroidism were cardiac, gastrointestinal, and skeletal. Analysis of matched data confirmed an increase of congenital renal and urologic anomalies with OR of 4.8 (3.7-6.3). Conclusions Children with congenital hypothyroidism have an increased prevalence of congenital renal and urologic anomalies. We suggest that these children should be evaluated for the presence of congenital renal and urologic anomalies with renal ultrasonography, and that further studies of common genes involved in thyroid and kidney development are warranted. PMID:18823909

Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry.

PubMed

Fiorentino, David; Ho, Vincent; Lebwohl, Mark G; Leite, Luiz; Hopkins, Lori; Galindo, Claudia; Goyal, Kavitha; Langholff, Wayne; Fakharzadeh, Steven; Srivastava, Bhaskar; Langley, Richard G

2017-11-01

The effect of systemic therapy on malignancy risk among patients with psoriasis is not fully understood. Evaluate the impact of systemic treatment on malignancy risk among patients with psoriasis in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Nested case-control analyses were performed among patients with no history of malignancy. Cases were defined as first malignancy (other than nonmelanoma skin cancer) in the Psoriasis Longitudinal Assessment and Registry, and controls were matched by age, sex, geographic region, and time on registry. Study therapies included methotrexate, ustekinumab, and tumor necrosis factor-α (TNF-α) inhibitors. Exposure was defined as 1 or more doses of study therapy within 12 months of malignancy onset and further stratified by duration of therapy. Multivariate conditional logistic regression, adjusted for potential confounders, was used to estimate odds ratios of malignancies associated with therapy. Among 12,090 patients, 252 malignancy cases were identified and 1008 controls were matched. Treatment with methotrexate or ustekinumab for more than 0 months to less than 3 months, 3 months to less than 12 months, or 12 months or longer was not associated with increased malignancy risk versus no exposure. Longer-term (≥12 months) (odds ratio, 1.54; 95% confidence interval, 1.10-2.15; P = .01), but not shorter-term treatment, with a TNF-α inhibitor was associated with increased malignancy risk. Cases and controls could belong to 1 or more therapy categories. Long-term (≥12 months) treatment with a TNF-α inhibitor, but not methotrexate and ustekinumab, may increase risk for malignancy in patients with psoriasis. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Disparities in cancer stage at diagnosis and survival of Aboriginal and non-Aboriginal South Australians.

PubMed

Banham, David; Roder, David; Keefe, Dorothy; Farshid, Gelareh; Eckert, Marion; Cargo, Margaret; Brown, Alex

2017-06-01

This study tested the utility of retrospectively staging cancer registry data for comparing stage and stage-specific survivals of Aboriginal and non-Aboriginal people. Differences by area level factors were also explored. This test dataset comprised 950 Aboriginal cases and all other cases recorded on the South Australian cancer registry with a 1977-2010 diagnosis. A sub-set of 777 Aboriginal cases diagnosed in 1990-2010 were matched with randomly selected non-Aboriginal cases by year of birth, diagnostic year, sex, and primary site of cancer. Competing risk regression summarised associations of Aboriginal status, stage, and geographic attributes with risk of cancer death. Aboriginal cases were 10 years younger at diagnosis, more likely to present in recent diagnostic years, to be resident of remote areas, and have primary cancer sites of head & neck, lung, liver and cervix. Risk of cancer death was associated in the matched analysis with more advanced stage at diagnosis. More Aboriginal than non-Aboriginal cases had distant metastases at diagnosis (31.3% vs 22.0, p<0.001). After adjusting for stage, remote-living Aboriginal residents had higher risks of cancer death than Aboriginal residents of metropolitan areas. Non-Aboriginal cases had the lowest risk of cancer death. Retrospective staging proved to be feasible using registry data. Results indicated more advanced stages for Aboriginal than matched non-Aboriginal cases. Aboriginal people had higher risks of cancer death, which persisted after adjusting for stage, and applied irrespective of remoteness of residence, with highest risk of death occurring among Aboriginal people from remote areas. Copyright © 2017 Elsevier Ltd. All rights reserved.

Look Local: The Value of Cancer Surveillance and Reporting by American Indian Clinics

PubMed Central

Creswell, Paul D.; Stephenson, Laura; Pierce-Hudson, Kimmine; Matloub, Jacqueline; Waukau, Jerry; Adams, Alexandra; Kaur, Judith; Remington, Patrick L.

2013-01-01

Introduction Cancer incidence and mortality rates for American Indians in the Northern Plains region of the United States are among the highest in the nation. Reliable cancer surveillance data are essential to help reduce this burden; however, racial data in state cancer registries are often misclassified, and cases are often underreported. Methods We used a community-based participatory research approach to conduct a retrospective ascertainment of cancer cases in clinic medical records over a 9-year period (1995–2003) and compared the results with the state cancer registry to evaluate missing or racially misclassified cases. Six tribal and/or urban Indian clinics participated in the study. The project team consisted of participating clinics, a state cancer registry, a comprehensive cancer center, an American Indian/Alaska Native Leadership Initiative on Cancer, and a set of diverse organizational partners. Clinic personnel were trained by project staff to accurately identify cancer cases in clinic records. These records were then matched with the state cancer registry to assess misclassification and underreporting. Results Forty American Indian cases were identified that were either missing or misclassified in the state registry. Adding these cases to the registry increased the number of American Indian cases by 21.3% during the study period (P = .05). Conclusions Our results indicate that direct reporting of cancer cases by tribal and urban Indian health clinics to a state cancer registry improved the quality of the data available for cancer surveillance. Higher-quality data can advance the efforts of cancer prevention and control stakeholders to address disparities in Native communities. PMID:24286271

Look local: the value of cancer surveillance and reporting by American Indian clinics.

PubMed

Creswell, Paul D; Strickland, Rick; Stephenson, Laura; Pierce-Hudson, Kimmine; Matloub, Jacqueline; Waukau, Jerry; Adams, Alexandra; Kaur, Judith; Remington, Patrick L

2013-11-27

Cancer incidence and mortality rates for American Indians in the Northern Plains region of the United States are among the highest in the nation. Reliable cancer surveillance data are essential to help reduce this burden; however, racial data in state cancer registries are often misclassified, and cases are often underreported. We used a community-based participatory research approach to conduct a retrospective ascertainment of cancer cases in clinic medical records over a 9-year period (1995-2003) and compared the results with the state cancer registry to evaluate missing or racially misclassified cases. Six tribal and/or urban Indian clinics participated in the study. The project team consisted of participating clinics, a state cancer registry, a comprehensive cancer center, an American Indian/Alaska Native Leadership Initiative on Cancer, and a set of diverse organizational partners. Clinic personnel were trained by project staff to accurately identify cancer cases in clinic records. These records were then matched with the state cancer registry to assess misclassification and underreporting. Forty American Indian cases were identified that were either missing or misclassified in the state registry. Adding these cases to the registry increased the number of American Indian cases by 21.3% during the study period (P = .05). Our results indicate that direct reporting of cancer cases by tribal and urban Indian health clinics to a state cancer registry improved the quality of the data available for cancer surveillance. Higher-quality data can advance the efforts of cancer prevention and control stakeholders to address disparities in Native communities.

Tuberculosis screening among homeless persons with AIDS living in single-room-occupancy hotels.

PubMed Central

Layton, M C; Cantwell, M F; Dorsinville, G J; Valway, S E; Onorato, I M; Frieden, T R

1995-01-01

Congregate facilities for homeless persons with the acquired immunodeficiency syndrome (AIDS) are often endemic for tuberculosis. We evaluated tuberculosis screening methods at single-room-occupancy hotels housing persons with AIDS. Residents were screened by cross matching the New York City Tuberculosis Registry, interviewing for tuberculosis history, skin testing, and chest radiography. Cases were classified as either previously or newly diagnosed. Among the 106 participants, 16 (15%) previously diagnosed tuberculosis cases were identified. Participants' tuberculosis histories were identified by the questionnaire (100%) or by registry match (69%). Eight participants (50%) were noncompliant with therapy. These findings prompted the establishment of a directly observed therapy program on site. PMID:7485672

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

PubMed

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

2016-01-01

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

Increased prevalence of diabetes mellitus and the metabolic syndrome in patients with primary aldosteronism of the German Conn's Registry.

PubMed

Hanslik, Gregor; Wallaschofski, Henri; Dietz, Anna; Riester, Anna; Reincke, Martin; Allolio, Bruno; Lang, Katharina; Quack, Ivo; Rump, Lars C; Willenberg, Holger S; Beuschlein, Felix; Quinkler, Marcus; Hannemann, Anke

2015-11-01

Abnormalities in glucose homeostasis have been described in patients with primary aldosteronism (PA) but most studies show inconsistent results. Therefore, we aimed to compare the prevalence of type 2 diabetes mellitus and metabolic syndrome (MetS) in newly diagnosed PA patients to a matched control cohort of the background population. In total, 305 PA patients of the prospective German Conn's Registry were compared to the population-based Study of Health In Pomerania (SHIP1; n=2454). A 1:1 match regarding sex, age, and BMI resulted in 269 matched pairs regarding type 2 diabetes and 183 matched pairs regarding MetS. Of the total, 153 PA patients underwent oral glucose tolerance testing (OGTT) at diagnosis and 38 PA patients were reevaluated at follow-up. Type 2 diabetes and MetS were significantly more frequent in PA patients than in the control population (17.2% vs 10.4%, P=0.03; 56.8% vs 44.8%, P=0.02 respectively). Also, HbA1c levels were higher in PA patients than in controls (P<0.01). Of the total, 35.3% of non-diabetic PA patients showed an abnormal OGTT (¼ newly diagnosed type 2 diabetes and ¾ impaired glucose tolerance). PA patients with an abnormal OGTT at baseline presented with significantly improved 2 h OGTT glucose (P=0.01) at follow-up. We detected a negative correlation between 2 h OGTT glucose levels and serum potassium (P<0.01). Type 2 diabetes and MetS are more prevalent in patients with PA than in controls matched for sex, age, BMI, and blood pressure. This may explain in part the increased cardiovascular disease morbidity and mortality in PA patients. © 2015 European Society of Endocrinology.

Anatomic distribution and mortality of arterial injury in the wars in Afghanistan and Iraq with comparison to a civilian benchmark.

PubMed

Markov, Nickolay P; DuBose, Joseph J; Scott, Daniel; Propper, Brandon W; Clouse, W Darrin; Thompson, Billy; Blackbourne, Lorne H; Rasmussen, Todd E

2012-09-01

The purpose of this study was to examine the anatomic distribution and associated mortality of combat-related vascular injuries comparing them to a contemporary civilian standard. The Joint Trauma Theater Registry (JTTR) was queried to identify patients with major compressible arterial injury (CAI) and noncompressible arterial injury (NCAI) sites, and their outcomes, among casualties in Iraq and Afghanistan from 2003 to 2006. The National Trauma Data Bank (NTDB) was then queried over the same time frame to identify civilian trauma patients with similar arterial injuries. Propensity score-based matching was used to create matched patient cohorts from both populations for analysis. Registry queries identified 380 patients from the JTTR and 7020 patients from the NTDB who met inclusion criteria. Propensity score matching for age, elevated Injury Severity Score (ISS; >15), and hypotension on arrival (systolic blood pressure [SBP] <90) resulted in 167 matched patients from each registry. The predominating mechanism of injury among matched JTTR patients was explosive events (73.1%), whereas penetrating injury was more common in the NTDB group (61.7%). In the matched cohorts, the incidence of NCAI did not differ (22.2% JTTR vs 26.6% NTDB; P = .372), but the NTDB patients had a higher incidence of CAI (73.7% vs 59.3%; P = .005). The JTTR cohort was also found to have a higher incidence of associated venous injury (57.5% vs 23.4%; P < .001). Overall, the matched JTTR cohort had a lower mortality than NTDB counterparts (4.2% vs 12.6%; P = .006), a finding that was also noted among patients with NCAI (10.8% vs 36.4%; P = .008). There was no difference in mortality between matched JTTR and NTDB patients with CAI overall (2.0% vs 4.1%; P = .465), or among those presenting with Glasgow Coma Scale (GCS) <8 (28.6% vs 40.0%; P = 1.00) or shock (SBP <90; 10.5% vs 7.7%; P = 1.00). The JTTR mortality rate among patients with CAI was, however, lower among patients with ISS >15 compared with civilian matched counterparts (10.7% vs 42.4%; P = .006). Mortality of injured service personnel who reach a medical treatment facility after major arterial injury compares favorably to a matched civilian standard. Acceptable mortality rates within the military cohort are related to key aspects of an organized Joint Trauma System, including prehospital tactical combat casualty care, rapid medical evacuation to forward surgical capability, and implementation of clinical practice guidelines. Aspects of this comprehensive combat casualty care strategy may translate and be of value to management of arterial injury in the civilian sector. Published by Mosby, Inc.

The Brustkrebs-Studien.de website for breast cancer patients: User acceptance of a German internet portal offering information on the disease and treatment options, and a clinical trials matching service

PubMed Central

2010-01-01

Background The internet portal http://www.brustkrebs-studien.de (BKS) was launched in 2000 by the German Society of Senology (DGS) and the Baden-Württemberg Institute for Women's Health (IFG) to provide expert-written information on breast cancer online and to encourage and facilitate the participation of breast cancer patients in clinical trials. We describe the development of BKS and its applications, and report on website statistics and user acceptance. Methods Existing registries, including ClinicalTrials.gov, were analysed before we designed BKS, which combines a trial registry, a knowledge portal, and an online second opinion service. An advisory board guided the process. Log files and patient enquiries for trial participation and second opinions were analysed. A two-week user satisfaction survey was conducted online. Results During 10/2005-06/2010, the portal attracted 702,655 visitors, generating 15,507,454 page views. By 06/2010, the website's active scientific community consisted of 189 investigators and physicians, and the registry covered 163 clinical trial protocols. In 2009, 143 patients requested trial enrolment and 119 sought second opinions or individual treatment advice from the expert panel. During the two-week survey in 2008, 5,702 BKS visitors submitted 507 evaluable questionnaires. Portal acceptance was high. Respondents trusted information correctness (80%), welcomed self-matching to clinical trials (79%) and planned to use the portal in the future (76%) and recommend it to others (81%). Conclusions BKS is an established and trusted breast cancer information platform offering up-to-date resources and protocols to the growing physician and patient community to encourage participation in clinical trials. Further studies are needed to assess potential increases in trial enrolment by eligibility matching services. PMID:21126358

High mortality after ALPPS for perihilar cholangiocarcinoma: case-control analysis including the first series from the international ALPPS registry

PubMed Central

Olthof, Pim B.; Coelen, Robert J.S.; Wiggers, Jimme K.; Koerkamp, Bas Groot; Malago, Massimo; Hernandez-Alejandro, Roberto; Topp, Stefan A.; Vivarelli, Marco; Aldrighetti, Luca A.; Campos, Ricardo Robles; Oldhafer, Karl J.; Jarnagin, William R.; van Gulik, Thomas M.

2017-01-01

Introduction Resection of perihilar cholangiocarcinoma (PHC) entails high-risk surgery with substantial postoperative mortality reported up to 18%, even in specialized centers. The aim of this study was to compare outcomes of PHC patients who underwent associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) to patients with a small functional liver remnant who underwent resection without ALPSS. Methods All patients who underwent ALPPS for PHC were identified from the international ALPPS registry and matched controls were selected from a standard resection cohort from two centers based on future remnant liver size. Outcomes included morbidity, mortality, and overall survival. Results Of the 37 patients who had undergone ALPPS for PHC in the registry, 29 had sufficient data for analyses. ALPPS for PHC was associated with a 48% (14/29) 90-day mortality and median OS of 6 months. A total of 257 patients underwent major liver resection for PHC without ALPPS. The 90-day mortality was 13% and median OS 46 months. The 29 ALPPS patients were matched to 29 patients resected without ALPPS, with similar future liver remnant volume (P=0.480). Mortality in the matched control group was 24% (P=0.100) and median OS was 27 months (P = 0.064). Discussion Outcomes of ALPPS for PHC appear inferior when compared to standard extended resections in high-risk patients. Considering these outcomes, portal vein embolization should remain the preferred method to increase future remnant liver volume in PHC patients. ALPPS is not recommended for PHC due to the 48% 90-day mortality in expert centers. PMID:28279621

In-Hospital Vital Status and Heart Transplants After Intervention for Congenital Heart Disease in the Pediatric Cardiac Care Consortium: Completeness of Ascertainment Using the National Death Index and United Network for Organ Sharing Datasets.

PubMed

Spector, Logan G; Menk, Jeremiah S; Vinocur, Jeffrey M; Oster, Matthew E; Harvey, Brian A; St Louis, James D; Moller, James; Kochilas, Lazaros K

2016-08-09

The long-term outcomes of patients undergoing interventions for congenital heart disease (CHD) remain largely unknown. We linked the Pediatric Cardiac Care Consortium (PCCC) with the National Death Index (NDI) and the United Network for Organ Sharing Dataset (UNOS) registries to study mortality and transplant occurring up to 32 years postintervention. The objective of the current analysis was to determine the sensitivity of this linkage in identifying patients who are known to have died or undergone heart transplant. We used direct identifiers from 59 324 subjects registered in the PCCC between 1982 and 2003 to test for completeness of case ascertainment of subjects with known vital and heart transplant status by linkage with the NDI and UNOS registries. Of the 4612 in-hospital deaths, 3873 were identified by the NDI as "true" matches for a sensitivity of 84.0% (95% CI, 82.9-85.0). There was no difference in sensitivity across 25 congenital cardiovascular conditions after adjustment for age, sex, race, presence of first name, death year, and residence at death. Of 455 known heart transplants in the PCCC, there were 408 matches in the UNOS registry, for a sensitivity of 89.7% (95% CI, 86.9-92.3). An additional 4851 deaths and 363 transplants that occurred outside the PCCC were identified through 2014. The linkage of the PCCC with the NDI and UNOS national registries is feasible with a satisfactory sensitivity. This linkage provides a conservative estimate of the long-term death and heart transplant events in this cohort. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Definitions of histocompatibility typing terms.

PubMed

Nunes, Eduardo; Heslop, Helen; Fernandez-Vina, Marcelo; Taves, Cynthia; Wagenknecht, Dawn R; Eisenbrey, A Bradley; Fischer, Gottfried; Poulton, Kay; Wacker, Kara; Hurley, Carolyn Katovich; Noreen, Harriet; Sacchi, Nicoletta

2011-12-01

Histocompatibility testing for stem cell and solid organ transplantation has become increasingly complex as newly discovered HLA alleles are described. HLA typing assignments reported by laboratories are used by physicians and donor registries for matching donors and recipients. To communicate effectively, a common language for histocompatibility terms should be established. In early 2010, representatives from Clinical, Registry, and Histocompatibility organizations joined together as the Harmonization of Histocompatibility Typing Terms Working Group to define a consensual language for laboratories, physicians, and registries to communicate histocompatibility typing information. The Working Group defined terms for HLA typing resolution, HLA matching, and a format for reporting HLA assignments. In addition, definitions of verification typing and extended typing were addressed. The original draft of the Definitions of Histocompatibility Typing Terms was disseminated to colleagues from each organization to gain feedback and create a collaborative document. Commentary gathered during this 90-day review period were discussed and implemented for preparation of this report. Histocompatibility testing continues to evolve; thus, the definitions agreed on today probably will require refinement and perhaps additional terminology in the future.

CNS sites cooperate to detect duplicate subjects with a clinical trial subject registry.

PubMed

Shiovitz, Thomas M; Wilcox, Charles S; Gevorgyan, Lilit; Shawkat, Adnan

2013-02-01

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

Effect of Warfarin Treatment on Survival of Patients With Pulmonary Arterial Hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL)

PubMed Central

Preston, Ioana R.; Roberts, Kari E.; Miller, Dave P.; Sen, Ginny P.; Selej, Mona; Benton, Wade W.; Hill, Nicholas S.

2015-01-01

Background— Long-term anticoagulation is recommended in idiopathic pulmonary arterial hypertension (IPAH). In contrast, limited data support anticoagulation in pulmonary arterial hypertension (PAH) associated with systemic sclerosis (SSc-PAH). We assessed the effect of warfarin anticoagulation on survival in IPAH and SSc-PAH patients enrolled in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL), a longitudinal registry of group I PAH. Methods and Results— Patients who initiated warfarin on study (n=187) were matched 1:1 with patients never on warfarin, by enrollment site, etiology, and diagnosis status. Descriptive analyses were conducted to compare warfarin users and nonusers by etiology. Survival analyses with and without risk adjustment were performed from the time of warfarin initiation or a corresponding quarterly update in matched pairs to avoid immortal time bias. Time-varying covariate models were used as sensitivity analyses. Mean warfarin treatment was 1 year; mean international normalized ratios were 1.9 (IPAH) and 2.0 (SSc-PAH). Two-thirds of patients initiating warfarin discontinued treatment before the last study assessment. There was no survival difference with warfarin in IPAH patients (adjusted hazard ratio, 1.37; P=0.21) or in SSc-PAH patients (adjusted hazard ratio, 1.60; P=0.15) in comparison with matched controls. However, SSc-PAH patients receiving warfarin within the previous year (hazard ratio, 1.57; P=0.031) or any time postbaseline (hazard ratio, 1.49; P=0.046) had increased mortality in comparison with warfarin-naïve patients. Conclusions— No significant survival advantage was observed in IPAH patients who started warfarin. In SSc-PAH patients, long-term warfarin was associated with poorer survival than in patients not receiving warfarin, even after adjusting for confounders. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00370214. PMID:26510696

Effect of Warfarin Treatment on Survival of Patients With Pulmonary Arterial Hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL).

PubMed

Preston, Ioana R; Roberts, Kari E; Miller, Dave P; Sen, Ginny P; Selej, Mona; Benton, Wade W; Hill, Nicholas S; Farber, Harrison W

2015-12-22

Long-term anticoagulation is recommended in idiopathic pulmonary arterial hypertension (IPAH). In contrast, limited data support anticoagulation in pulmonary arterial hypertension (PAH) associated with systemic sclerosis (SSc-PAH). We assessed the effect of warfarin anticoagulation on survival in IPAH and SSc-PAH patients enrolled in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL), a longitudinal registry of group I PAH. Patients who initiated warfarin on study (n=187) were matched 1:1 with patients never on warfarin, by enrollment site, etiology, and diagnosis status. Descriptive analyses were conducted to compare warfarin users and nonusers by etiology. Survival analyses with and without risk adjustment were performed from the time of warfarin initiation or a corresponding quarterly update in matched pairs to avoid immortal time bias. Time-varying covariate models were used as sensitivity analyses. Mean warfarin treatment was 1 year; mean international normalized ratios were 1.9 (IPAH) and 2.0 (SSc-PAH). Two-thirds of patients initiating warfarin discontinued treatment before the last study assessment. There was no survival difference with warfarin in IPAH patients (adjusted hazard ratio, 1.37; P=0.21) or in SSc-PAH patients (adjusted hazard ratio, 1.60; P=0.15) in comparison with matched controls. However, SSc-PAH patients receiving warfarin within the previous year (hazard ratio, 1.57; P=0.031) or any time postbaseline (hazard ratio, 1.49; P=0.046) had increased mortality in comparison with warfarin-naïve patients. No significant survival advantage was observed in IPAH patients who started warfarin. In SSc-PAH patients, long-term warfarin was associated with poorer survival than in patients not receiving warfarin, even after adjusting for confounders. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00370214. © 2015 The Authors.

Feasibility of Linking Population-Based Cancer Registries and Cancer Center Biorepositories

PubMed Central

McCusker, Margaret E.; Allen, Mark; Fernandez-Ami, Allyn; Gandour-Edwards, Regina

2012-01-01

Purpose: Biospecimen-based research offers tremendous promise as a way to increase understanding of the molecular epidemiology of cancers. Population-based cancer registries can augment this research by providing more clinical detail and long-term follow-up information than is typically available from biospecimen annotations. In order to demonstrate the feasibility of this concept, we performed a pilot linkage between the California Cancer Registry (CCR) and the University of California, Davis Cancer Center Biorepository (UCD CCB) databases to determine if we could identify patients with records in both databases. Methods: We performed a probabilistic data linkage between 2180 UCD CCB biospecimen records collected during the years 2005–2009 and all CCR records for cancers diagnosed from 1988–2009 based on standard data linkage procedures. Results: The 1040 UCD records with a unique medical record number, tissue site, and pathology date were linked to 3.3 million CCR records. Of these, 844 (81.2%) were identified in both databases. Overall, record matches were highest (100%) for cancers of the cervix and testis/other male genital system organs. For the most common cancers, matches were highest for cancers of the lung and respiratory system (93%), breast (91.7%), and colon and rectum (89.5%), and lower for prostate (72.9%). Conclusions: This pilot linkage demonstrated that information on existing biospecimens from a cancer center biorepository can be linked successfully to cancer registry data. Linkages between existing biorepositories and cancer registries can foster productive collaborations and provide a foundation for virtual biorepository networks to support population-based biospecimen research. PMID:24845042

National Kidney Registry: 213 transplants in three years.

PubMed

Veale, Jeffrey; Hil, Garet

2010-01-01

Since its establishment in 2008, the National Kidney Registry has facilitated 213 kidney transplants between unrelated living donors and recipients at 28 transplant centers. Rapid innovations in matching strategies, advanced computer technologies, good communication and an evolving understanding of the processes at participating transplant centers and histocompatibility laboratories are among the factors driving the success of the NKR. Virtual cross match accuracy has improved from 43% to 91% as a result of changes to the HLA typing requirements for potential donors and improved mechanisms to list unacceptable HLA antigens for sensitized patients. A uniform financial agreement among participating centers eliminated a major roadblock to facilitate unbalanced donor kidney exchanges among centers. The NKR transplanted 64% of the patients registered since 2008 and the average waiting time for those transplanted in 2010 was 11 months.

Thrombus aspiration in patients with ST-elevation myocardial infarction: results of a national registry of interventional cardiology.

PubMed

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

2018-04-24

We aimed to evaluate the impact of thrombus aspiration (TA) during primary percutaneous coronary intervention (P-PCI) in 'real-world' settings. We performed a retrospective study, using data from the National Registry of Interventional Cardiology (RNCI 2006-2012, Portugal) with ST-elevation myocardial infarction (STEMI) patients treated with P-PCI. The primary outcome, in-hospital mortality, was analysed through adjusted odds ratio (aOR) and 95% confidence intervals (95%CI). We assessed data for 9458 STEMI patients that undergone P-PCI (35% treated with TA). The risk of in-hospital mortality with TA (aOR 0.93, 95%CI:0.54-1.60) was not significantly decreased. After matching patients through the propensity score, TA reduced significantly the risk of in-hospital mortality (OR 0.58, 95%CI:0.35-0.98; 3500 patients). The whole cohort data does not support the routine use of TA in P-PCI, but the results of the propensity-score matched cohort suggests that the use of selective TA may improve the short-term risks of STEMI.

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.

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.

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

PubMed Central

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

2014-01-01

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

Computer algorithms in the search for unrelated stem cell donors.

PubMed

Steiner, David

2012-01-01

Hematopoietic stem cell transplantation (HSCT) is a medical procedure in the field of hematology and oncology, most often performed for patients with certain cancers of the blood or bone marrow. A lot of patients have no suitable HLA-matched donor within their family, so physicians must activate a "donor search process" by interacting with national and international donor registries who will search their databases for adult unrelated donors or cord blood units (CBU). Information and communication technologies play a key role in the donor search process in donor registries both nationally and internationaly. One of the major challenges for donor registry computer systems is the development of a reliable search algorithm. This work discusses the top-down design of such algorithms and current practice. Based on our experience with systems used by several stem cell donor registries, we highlight typical pitfalls in the implementation of an algorithm and underlying data structure.

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.

Case-control study of renal cell carcinoma in relation to occupation, smoking, and alcohol consumption

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brownson, R.C.

1988-05-01

A case-control study based on data from a cancer registry was conducted to evaluate the effects of smoking, alcohol use, and occupation on renal cell cancer risk. Information was obtained for 326 male and female cases and 978 age- and sex-matched controls. Elevated risks were identified for cigarette smokers and for men employed as truck drivers. No relationship between alcohol consumption and renal cancer was observed.

High-Resolution Analyses of Human Leukocyte Antigens Allele and Haplotype Frequencies Based on 169,995 Volunteers from the China Bone Marrow Donor Registry Program

PubMed Central

Zhou, Xiao-Yang; Zhu, Fa-Ming; Li, Jian-Ping; Mao, Wei; Zhang, De-Mei; Liu, Meng-Li; Hei, Ai-Lian; Dai, Da-Peng; Jiang, Ping; Shan, Xiao-Yan; Zhang, Bo-Wei; Zhu, Chuan-Fu; Shen, Jie; Deng, Zhi-Hui; Wang, Zheng-Lei; Yu, Wei-Jian; Chen, Qiang; Qiao, Yan-Hui; Zhu, Xiang-Ming; Lv, Rong; Li, Guo-Ying; Li, Guo-Liang; Li, Heng-Cong; Zhang, Xu; Pei, Bin; Jiao, Li-Xin; Shen, Gang; Liu, Ying; Feng, Zhi-Hui; Su, Yu-Ping; Xu, Zhao-Xia; Di, Wen-Ying; Jiang, Yao-Qin; Fu, Hong-Lei; Liu, Xiang-Jun; Liu, Xiang; Zhou, Mei-Zhen; Du, Dan; Liu, Qi; Han, Ying; Zhang, Zhi-Xin; Cai, Jian-Ping

2015-01-01

Allogeneic hematopoietic stem cell transplantation is a widely used and effective therapy for hematopoietic malignant diseases and numerous other disorders. High-resolution human leukocyte antigen (HLA) haplotype frequency distributions not only facilitate individual donor searches but also determine the probability with which a particular patient can find HLA-matched donors in a registry. The frequencies of the HLA-A, -B, -C, -DRB1, and -DQB1 alleles and haplotypes were estimated among 169,995 Chinese volunteers using the sequencing-based typing (SBT) method. Totals of 191 HLA-A, 244 HLA-B, 146 HLA-C, 143 HLA-DRB1 and 47 HLA-DQB1 alleles were observed, which accounted for 6.98%, 7.06%, 6.46%, 9.11% and 7.91%, respectively, of the alleles in each locus in the world (IMGT 3.16 Release, Apr. 2014). Among the 100 most common haplotypes from the 169,995 individuals, nine distinct haplotypes displayed significant regionally specific distributions. Among these, three were predominant in the South China region (i.e., the 20th, 31st, and 81sthaplotypes), another three were predominant in the Southwest China region (i.e., the 68th, 79th, and 95th haplotypes), one was predominant in the South and Southwest China regions (the 18th haplotype), one was relatively common in the Northeast and North China regions (the 94th haplotype), and one was common in the Northeast, North and Northwest China (the 40th haplotype). In conclusion, this is the first to analyze high-resolution HLA diversities across the entire country of China, based on a detailed and complete data set that covered 31 provinces, autonomous regions, and municipalities. Specifically, we also evaluated the HLA matching probabilities within and between geographic regions and analyzed the regional differences in the HLA diversities in China. We believe that the data presented in this study might be useful for unrelated HLA-matched donor searches, donor registry planning, population genetic studies, and anthropogenesis studies. PMID:26421847

Occupational risk factors for Wilms' tumor

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bunin, G.; Kramer, S.; Nass, C.

A matched case-control study of Wilms' tumor investigated parental occupational risk factors. Cases diagnosed in 1970-1983 were identified through a population-based tumor registry and hospital registries in the Greater Philadelphia area. Controls were selected by random digit dialing and were matched to cases on race, birth date (+/- 3 years), and the area code and exchange of the case's telephone number at diagnosis. Parents of 100 matched pairs were interviewed by telephone. Parents of patients and controls were generally similar in demographic characteristics, except that mothers differed in religion. Published schemes were used to group jobs into clusters of similarmore » exposures and to determine exposures from industry and job title. Analyses were done for preconception, pregnancy, and postnatal time periods. More case than control fathers had jobs in a cluster that includes machinists and welders (odds ratios (ORs) = 4.0-5.7, p less than or equal to 0.04). Paternal exposures to lead, silver, tin, and iron (some exposures of this cluster) were associated with Wilms' tumor in some analyses, with moderate odds ratios (ORs = 1.5-3.4). In general, the highest odds ratios were found for the preconception period among the genetic (prezygotic) cases. No maternal job clusters or exposures gave significantly elevated odds ratios. These results support a previous finding that lead is a risk factor, but not radiation, hydrocarbon, or boron exposures.« less

Evaluation of the sensitivity of the 'Wiley registry of tandem mass spectral data, MSforID' with MS/MS data of the 'NIST/NIH/EPA mass spectral library'.

PubMed

Oberacher, Herbert; Whitley, Graeme; Berger, Bernd

2013-04-01

Tandem mass spectral libraries are versatile tools for small molecular identification finding application in forensic science, doping control, drug monitoring, food and environmental analysis, as well as metabolomics. Two important libraries are the 'Wiley Registry of Tandem Mass Spectral Data, MSforID' (Wiley Registry MSMS) and the collection of MS/MS spectra part of the 2011 edition of the 'NIST/NIH/EPA Mass Spectral Library' (NIST 11 MSMS). Herein, the sensitivity and robustness of the Wiley Registry MSMS were evaluated using spectra extracted from the NIST 11 MSMS library. The sample set was found to be heterogeneous in terms of mass spectral resolution, type of CID, as well as applied collision energies. Nevertheless, sensitive compound identification with a true positive identification rate ≥95% was possible using either the MSforID Search program or the NIST MS Search program 2.0g for matching. To rate the performance of the Wiley Registry MSMS, cross-validation experiments were repeated using subcollections of NIST 11 MSMS as reference library and spectra extracted from the Wiley Registry MSMS as positive controls. Unexpectedly, with both search algorithms tested, correct results were obtained in less than 88% of cases. We examined possible causes for the results of the cross validation study. The large number of precursor ions represented by a single tandem mass spectrum only was identified as the basic cause for the comparably lower sensitivity of the NIST library. Copyright © 2013 John Wiley & Sons, Ltd.

Gaps along the HIV care continuum: findings among a population seeking sexual health care services in New York City.

PubMed

Pathela, Preeti; Jamison, Kelly; Braunstein, Sarah L; Schillinger, Julia A; Tymejczyk, Olga; Nash, Denis

2018-03-02

Linkage/re-linkage to HIV care for virally unsuppressed persons with new sexually transmitted infections is critical for ending the HIV epidemic. We quantified HIV care continuum gaps, and viral suppression, among HIV-positive patients attending New York City (NYC) sexual health clinics (SHC). 1,649 HIV-positive patients and a 10% sample of 11,954 patients with unknown HIV status on clinic visit date (DOV) were matched against the NYC HIV registry. Using registry diagnosis dates, we categorized matched HIV-positive patients as "new-positives" (newly diagnosed on DOV), "recent-positives (diagnosed ≤90 days before DOV), "prevalent-positives" (diagnosed >90 days before DOV), and "unknown-positives" (previously diagnosed, but status unknown to clinic on DOV). We assessed HIV care continuum outcomes before and after DOV for new-positives, prevalent-positives, and unknown-positives using registry laboratory data. In addition to 1,626 known HIV-positive patients, 5% of the unknown sample (63/1,196) matched to the registry, signifying that about 630 additional HIV-positive patients attended SHCs. Of new-positives, 65% were linked to care after DOV. Of prevalent-positives, 66% were in care on DOV; 43% of the out-of-care were re-linked after DOV. Of unknown-positives, 40% were in care on DOV; 21% of the out-of-care re-linked after DOV. Viral suppression was achieved by: 88% of in-care unknown-positives, 76% in-care prevalent-positives, 50% new-positives, 42% out-of-care prevalent-positives, and 16% out-of-care unknown-positives. Many HIV-positive persons, including those with uncontrolled HIV infection, attend SHCs and potentially contribute to HIV spread. However, HIV status often is not known to staff, resulting in missed linkage/re-linkage to care opportunities. Better outcomes could be facilitated by real-time ascertainment of HIV status and HIV care status.

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

PubMed

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

2016-03-01

A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

Matched unrelated donor transplants-State of the art in the 21st century.

PubMed

Altaf, Syed Y; Apperley, Jane F; Olavarria, Eduardo

2016-10-01

Hematopoietic stem cell transplantation (HSCT) is the therapy of choice in many hematological malignant and non-malignant diseases by using human leukocyte antigen (HLA)-matched siblings as stem cell source but only one third of the patients will have HLA-matched siblings. Hence, physicians rely on the availability of matched unrelated donors (URD). The possibility of finding a matched URD is now more than 70% due to continuous expansion of URD registries around the world. The use of URD in adult patients is steadily increasing and in the last 8 years has superseded the numbers of matched sibling donor transplants and has become the most commonly used stem cell source. There is also an increasing trend to use peripheral blood (PB) stem cells rather than bone marrow (BM) stem cells. Outcomes following URD transplants depend mainly upon the indication and urgency of transplant, age and comorbidities of recipients, cytomegalovirus (CMV) matching/mismatching between donor and the recipient, and degree of HLA matching. In some studies outcome of unrelated stem cell transplants in terms of treatment-related mortality (TRM), disease-free survival (DFS), and overall survival (OS) is comparable to sibling donors. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of hospital-related health care among Health Links enrollees in the Central Ontario health region: a propensity-matched difference-in-differences study

PubMed Central

Mondor, Luke; Walker, Kevin; Bai, Yu Qing; Wodchis, Walter P.

2017-01-01

Background: Health Links are a new model of providing care coordination for high-cost, high-needs patients in Ontario. We evaluated use of hospital-related health care services among Health Links patients in the Central Local Health Integration Network (LHIN) of Ontario in the year before versus after program enrolment and compared rates of use with those among similar patients with complex needs not enrolled in the program (comparator group). Methods: We identified all patients who received a Health Links coordinated care plan before Jan. 1, 2015, using linked registry and health administrative data. We used propensity scores to match (1:1) enrollees (registry) with comparator patients (administrative data). Using a difference-in-differences approach with generalized estimating equations, we evaluated 5 measures of Health Link performance: rates of hospital admission, emergency department visits, days in acute care, 30-day readmissions and 7-day postdischarge primary care follow-up. Results: Of the 344 enrollees in the registry, we matched 313 [91.0%] to comparator patients. All measured sociodemographic, comorbidity and health care use characteristics were balanced between the 2 groups (all standardized differences < 0.10). For enrollees, the rate of days in acute care per person-year increased by 35% (incidence rate ratio 1.35 [confidence interval 1.11-1.65]) after versus before the index date, but differences were nonsignificant for all other measures. Difference-in-differences analyses revealed greater reductions in hospital admissions, emergency department visits and acute care days after the index date in the comparator group than among enrollees. Interpretation: Initial implementation of the Health Link program in the Central LHIN did not reduce selected indicators of Health Link performance among enrollees. As the Health Link program evolves and standardization is implemented, future research may reveal effects from the initiative in other outcomes or with longer follow-up. PMID:29025737

Getting to the Heart of Being the Match: A Qualitative Analysis of Bone Marrow Donor Recruitment and Retention among College Students

ERIC Educational Resources Information Center

Kaster, Elizabeth C.; Rogers, Charles R.; Jeon, Kwon Chan; Rosen, Brittany

2014-01-01

Introduction: For those with certain blood or bone cancers, bone marrow donation can mean the difference between life and death. The National Marrow Donor Program® (NMDP) operates the largest bone marrow registry of potential donors; however, at times when potential matches are identified, many donors opt not to donate. The purpose of this study…

Long-term Mortality of Patients With Tuberculous Meningitis in New York City: A Cohort Study.

PubMed

Vinnard, Christopher; King, Liza; Munsiff, Sonal; Crossa, Aldo; Iwata, Kentaro; Pasipanodya, Jotam; Proops, Douglas; Ahuja, Shama

2017-02-15

Tuberculous meningitis (TBM) is the most devastating clinical presentation of infection with Mycobacterium tuberculosis; delayed initiation of effective antituberculosis therapy is associated with poor treatment outcomes. Our objective was to determine the relationship between drug resistance and 10-year mortality among patients with TBM. We conducted a retrospective cohort study of 324 patients with culture-confirmed TBM, susceptibility results reported for isoniazid and rifampin, and initiation of at least 2 antituberculosis drugs, reported to the tuberculosis registry in New York City between 1 January 1992 and 31 December 2001. Date of death was ascertained by matching the tuberculosis registry with death certificate data for 1992-2012 from the New York Office of Vital Statistics. Human immunodeficiency virus (HIV) status was ascertained by medical records review, matching with the New York City HIV Surveillance registry, and review of cause of death. Among 257 TBM patients without rifampin-resistant isolates, isoniazid resistance was associated with mortality after the first 60 days of treatment when controlling for age and HIV infection (adjusted hazard ratio, 1.94 [95% confidence interval, 1.08-3.94]). Death occurred before completion of antituberculosis therapy in 63 of 67 TBM patients (94%) with rifampin-resistant disease. Among patients with culture-confirmed TBM, we observed rapid early mortality in patients with rifampin-resistant isolates, and an independent association between isoniazid-resistant isolates and death after 60 days of therapy. These findings support the continued evaluation of rapid diagnostic techniques and the empiric addition of second-line drugs for patients with clinically suspected drug-resistant TBM. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Impact of Remote Monitoring on Long-Term Prognosis in Heart Failure Patients in a Real-World Cohort: Results From All-Comers COMMIT-HF Trial.

PubMed

Kurek, Anna; Tajstra, Mateusz; Gadula-Gacek, Elzbieta; Buchta, Piotr; Skrzypek, Michal; Pyka, Lukasz; Wasiak, Michal; Swietlinska, Malgorzata; Hawranek, Michal; Polonski, Lech; Gasior, Mariusz; Kosiuk, Jedrzej

2017-04-01

Randomized controlled trials demonstrate that remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) may improve quality of care and prognosis in heart failure (HF) patients. However, the impact of RM on long-term mortality in a real-world cohort is still not well examined. This study was designed as a matched cohort study based on the COMMIT-HF trial--a single-center, ongoing prospective observational registry (NCT02536443). Complete patient demographics, medical history, in-hospital results, hospitalizations, and mortality data were collected based on institutional registries and healthcare providers' records. Patients were divided into 2 groups based on RM presence and matched by means of propensity scores according to clinical characteristics. The primary endpoint of this study was the long-term all-cause mortality. Out of 1,429 consecutive patients, 822 patients with a first implantation of an ICD/CRT-D were included in the analysis. The final matched study population contained 574 patients in RM and in a control group. Although demographic and echocardiographic parameters as well as pharmacological treatments were similar in both groups, a significantly lower 1-year mortality was detected in the RM group (2.1% vs. 11.5%, P < 0.0001). This was also maintained during a 3-year follow-up (4.9% vs. 22.3%, P < 0.0001). Multivariate analysis showed that RM was associated with an improved prognosis (hazard ratio 0.187, 95% confidence interval 0.075-0.467, P = 0.0003). RM of HF patients with ICDs/CRT-Ds significantly reduced long-term mortality in a real-world clinical condition. © 2017 Wiley Periodicals, Inc.

Using linked administrative and disease-specific databases to study end-of-life care on a population level.

PubMed

Maetens, Arno; De Schreye, Robrecht; Faes, Kristof; Houttekier, Dirk; Deliens, Luc; Gielen, Birgit; De Gendt, Cindy; Lusyne, Patrick; Annemans, Lieven; Cohen, Joachim

2016-10-18

The use of full-population databases is under-explored to study the use, quality and costs of end-of-life care. Using the case of Belgium, we explored: (1) which full-population databases provide valid information about end-of-life care, (2) what procedures are there to use these databases, and (3) what is needed to integrate separate databases. Technical and privacy-related aspects of linking and accessing Belgian administrative databases and disease registries were assessed in cooperation with the database administrators and privacy commission bodies. For all relevant databases, we followed procedures in cooperation with database administrators to link the databases and to access the data. We identified several databases as fitting for end-of-life care research in Belgium: the InterMutualistic Agency's national registry of health care claims data, the Belgian Cancer Registry including data on incidence of cancer, and databases administrated by Statistics Belgium including data from the death certificate database, the socio-economic survey and fiscal data. To obtain access to the data, approval was required from all database administrators, supervisory bodies and two separate national privacy bodies. Two Trusted Third Parties linked the databases via a deterministic matching procedure using multiple encrypted social security numbers. In this article we describe how various routinely collected population-level databases and disease registries can be accessed and linked to study patterns in the use, quality and costs of end-of-life care in the full population and in specific diagnostic groups.

Incidence of Second Malignancies Among Patients Treated With Proton Versus Photon Radiation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chung, Christine S., E-mail: chungc1@sutterhealth.org; Yock, Torunn I.; Nelson, Kerrie

2013-09-01

Purpose: Proton radiation, when compared with photon radiation, allows delivery of increased radiation dose to the tumor while decreasing dose to adjacent critical structures. Given the recent expansion of proton facilities in the United States, the long-term sequelae of proton therapy should be carefully assessed. The objective of this study was to compare the incidence of second cancers in patients treated with proton radiation with a population-based cohort of matched patients treated with photon radiation. Methods and Materials: We performed a retrospective cohort study of 558 patients treated with proton radiation from 1973 to 2001 at the Harvard Cyclotron inmore » Cambridge, MA and 558 matched patients treated with photon therapy in the Surveillance, Epidemiology, and End Results (SEER) Program cancer registry. Patients were matched by age at radiation treatment, sex, year of treatment, cancer histology, and site. The main outcome measure was the incidence of second malignancies after radiation. Results: We matched 558 proton patients with 558 photon patients from the Surveillance, Epidemiology, and End Results registry. The median duration of follow-up was 6.7 years (interquartile range, 7.4) and 6.0 years (interquartile range, 9.3) in the proton and photon cohorts, respectively. The median age at treatment was 59 years in each cohort. Second malignancies occurred in 29 proton patients (5.2%) and 42 photon patients (7.5%). After we adjusted for sex, age at treatment, primary site, and year of diagnosis, proton therapy was not associated with an increased risk of second malignancy (adjusted hazard ratio, 0.52 [95% confidence interval, 0.32-0.85]; P=.009). Conclusions: The use of proton radiation therapy was not associated with a significantly increased risk of secondary malignancies compared with photon therapy. Longer follow-up of these patients is needed to determine if there is a significant decrease in second malignancies. Given the limitations of the study, these results should be viewed as hypothesis generating.« less

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.

Haematopoietic stem cell transplantation for Diamond Blackfan anaemia: a report from the Italian Association of Paediatric Haematology and Oncology Registry.

PubMed

Fagioli, Franca; Quarello, Paola; Zecca, Marco; Lanino, Edoardo; Corti, Paola; Favre, Claudio; Ripaldi, Mimmo; Ramenghi, Ugo; Locatelli, Franco; Prete, Arcangelo

2014-06-01

Allogeneic haematopoietic stem cell transplantation (HSCT) is the only curative option for patients with Diamond Blackfan anaemia (DBA). We report the transplantation outcome of 30 Italian DBA patients referred to the Italian Association of Paediatric Haematology and Oncology Registry between 1990 and 2012. This is one of the largest national registry cohorts of transplanted DBA patients. Most patients (83%) were allografted after 2000. A matched sibling donor was employed in 16 patients (53%), the remaining 14 patients (47%) were transplanted from matched unrelated donors. Twenty-eight of the 30 patients engrafted. One patient died at day +6 due to veno-occlusive disease without achieving neutrophil recovery and another patient remained transfusion-dependent despite the presence of a full donor chimerism. The 5-year overall survival and transplant-related mortality was 74·4% and 25·6%, respectively. Patients younger than 10 years as well as those transplanted after 2000 showed a significantly higher overall survival and a significantly lower risk of transplant-related mortality. No difference between donor type was observed. Our data suggest that allogeneic HSCT from a related or unrelated donor was a reasonable alternative to transfusion therapy in young and well chelated DBA patients. © 2014 John Wiley & Sons Ltd.

Four years of experience with the Australian kidney paired donation programme.

PubMed

Cantwell, Linda; Woodroffe, Claudia; Holdsworth, Rhonda; Ferrari, Paolo

2015-03-01

New approaches to increase kidney transplantation rates through expansion of live donor kidney transplantation have become necessary due to ongoing shortage of deceased donor organs. These strategies include desensitization in antibody-incompatible transplants to overcome the barrier of blood group incompatibility or human leucocyte antigen antibodies between recipient and donor and kidney paired donation (KPD) programmes. In KPD, a kidney transplant candidate with an incompatible live donor joins a registry of other incompatible pairs in order to find potentially compatible transplant solutions. To match the largest possible number of donor-recipient pairs while minimizing immunologic risk, KPD programmes use sophisticated algorithms to identify suitable matches with simultaneous two-way or more complex multi-way exchanges as well as including non-directed anonymous donors to start a chain of compatible transplantations. Because of the significant immunologic barriers when fewer donor options are available, the optimal solution for difficult-to-match, highly sensitized patients is access to more potential donors using large multi-centre or national KPD registries. This review focuses on the first 4 years of experience with the Australian multi-centre KPD programme that was established in October 2010. © 2014 Asian Pacific Society of Nephrology.

Association Between Prophylactic Implantable Cardioverter-Defibrillators and Survival in Patients With Left Ventricular Ejection Fraction Between 30% and 35%

PubMed Central

Al-Khatib, Sana M.; Hellkamp, Anne S.; Fonarow, Gregg C.; Mark, Daniel B.; Curtis, Lesley H.; Hernandez, Adrian F.; Anstrom, Kevin J.; Peterson, Eric D.; Sanders, Gillian D.; Al-Khalidi, Hussein R.; Hammill, Bradley G.; Heidenreich, Paul A.; Hammill, Stephen C.

2014-01-01

IMPORTANCE Clinical trials of prophylactic implantable cardioverter-defibrillators (ICDs) have included a minority of patients with a left ventricular ejection fraction (LVEF) between 30% and 35%. Because a large number of ICDs in the United States are implanted in such patients, it is important to study survival associated with this therapy. OBJECTIVE To characterize patients with LVEF between 30% and 35% and compare the survival of those with and without ICDs. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of Medicare beneficiaries in the National Cardiovascular Data Registry ICD registry (January 1, 2006, through December 31, 2007) with an LVEF between 30% and 35% who received an ICD during a heart failure hospitalization and similar patients in the Get With The Guidelines–Heart Failure (GWTG-HF) database (January 1, 2005, through December 31, 2009) with no ICD. The analysis was repeated in patients with an LVEF less than 30%. There were 3120 patients with an LVEF between 30% and 35% (816 in matched cohorts) and 4578 with an LVEF less than 30% (2176 in matched cohorts). Propensity score matching and Cox models were applied. MAIN OUTCOMES AND MEASURES The primary outcome was all-cause mortality; data were obtained from Medicare claims through December 31, 2011. RESULTS There were no significant differences in the baseline characteristics of the matched groups (n = 408 for both groups). Among patients with an LVEF between 30% and 35%, there were 248 deaths in the ICD Registry group, within a median follow-up of 4.4 years (interquartile range, 2.7-4.9) and 249 deaths in the GWTG HF group, within a median follow-up of 2.9 years (interquartile range, 2.1-4.4). The risk of all-cause mortality in patients with an LVEF between 30% and 35% and an ICD was significantly lower than that in matched patients without an ICD (3-year mortality rates: 51.4% vs 55.0%; hazard ratio, 0.83 [95% CI, 0.69-0.99]; P = .04). Presence of an ICD also was associated with better survival in patients with an LVEF less than 30% (3-year mortality rates: 45.0% vs 57.6%; 634 and 660 total deaths; hazard ratio, 0.72 [95% CI, 0.65-0.81]; P < .001) (P = .20 for interaction). CONCLUSIONS AND RELEVANCE Among Medicare beneficiaries hospitalized for heart failure and with an LVEF between 30% and 35% and less than 30%, survival at 3 years was better in patients who received a prophylactic ICD than in comparable patients with no ICD. These findings support guideline recommendations to implant prophylactic ICDs in eligible patients with an LVEF of 35% or less. PMID:24893088

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

PubMed Central

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

2014-01-01

Data on familial recurrence rates of complex diseases such as multiple sclerosis give important hints to aetiological factors such as the importance of genes and environment. By linking national registries, we sought to avoid common limitations of clinic-based studies such as low numbers, poor representation of the population and selection bias. Through the Swedish Multiple Sclerosis Registry and a nationwide hospital registry, a total of 28 396 patients with multiple sclerosis were identified. We used the national Multi-Generation Registry to identify first and second degree relatives as well as cousins, and the Swedish Twin Registry to identify twins of patients with multiple sclerosis. Crude and age corrected familial risks were estimated for cases and found to be in the same range as previously published figures. Matched population-based controls were used to calculate relative risks, revealing lower estimates of familial multiple sclerosis risks than previously reported, with a sibling recurrence risk (λs = 7.1; 95% confidence interval: 6.42–7.86). Surprisingly, despite a well-established lower prevalence of multiple sclerosis amongst males, the relative risks were equal among maternal and paternal relations. A previously reported increased risk in maternal relations could thus not be replicated. An observed higher transmission rate from fathers to sons compared with mothers to sons suggested a higher transmission to offspring from the less prevalent sex; therefore, presence of the so-called ‘Carter effect’ could not be excluded. We estimated the heritability of multiple sclerosis using 74 757 twin pairs with known zygosity, of which 315 were affected with multiple sclerosis, and added information from 2.5 million sibling pairs to increase power. The heritability was estimated to be 0.64 (0.36–0.76), whereas the shared environmental component was estimated to be 0.01 (0.00–0.18). In summary, whereas multiple sclerosis is to a great extent an inherited trait, the familial relative risks may be lower than usually reported. PMID:24441172

Assessment of immunization registry databases as supplemental sources of data to improve ascertainment of vaccination coverage estimates in the national immunization survey.

PubMed

Khare, Meena; Piccinino, Linda; Barker, Lawrence E; Linkins, Robert W

2006-08-01

To evaluate the use of immunization registry data to supplement missing or incomplete vaccination data reported by immunization providers (referred to as "providers" hereafter) in the National Immunization Survey. Cross-sectional, random-digit-dialing, telephone survey to measure vaccination coverage among children aged 19 to 35 months in the United States. Four sites with mature (with >67% of provider participation in the area) immunization registries. Of the 639 children with complete household interviews, interviewers had consent from the respondents for 569 (89.0%) children to contact their providers and for 556 (87.0%) children to contact both providers and registries. Percentages of children up-to-date for vaccines based on data from providers, registries, and both sources combined. According to provider-reported data, weighted estimates of coverage for the recommended childhood vaccine series 4:3:1:3 at the 4 sites were 65.6%, 78.8%, 81.6%, and 77.0%. According to registry data, these coverage rates were consistently lower: 31.7% (P<.05), 65.4%, 71.9%, and 61.8%, respectively. When all unique vaccine doses were combined from both sources, the pooled 4:3:1:3 coverage rates increased to 72.0%, 92.0%, 88.7%, and 80.2%, respectively. The quality and completeness of vaccination histories from the registries were inconsistent and varied by sites. Vaccination coverage estimates were the lowest when only registry-reported data were used and were the highest when provider- and registry-reported histories were combined. Although registries enrolled and matched more children, vaccination histories were missing, incomplete, and inconsistent. The quality and completeness of the registry data must be improved and must be comparable across all states before further consideration may be given to supplement or replace the provider-reported National Immunization Survey data.

Total disc arthroplasty versus anterior cervical interbody fusion: use of the Spine Tango registry to supplement the evidence from randomized control trials.

PubMed

Staub, Lukas P; Ryser, Christoph; Röder, Christoph; Mannion, Anne F; Jarvik, Jeffrey G; Aebi, Max; Aghayev, Emin

2016-02-01

Several randomized controlled trials (RCTs) have compared patient outcomes of anterior (cervical) interbody fusion (AIF) with those of total disc arthroplasty (TDA). Because RCTs have known limitations with regard to their external validity, the comparative effectiveness of the two therapies in daily practice remains unknown. This study aimed to compare patient-reported outcomes after TDA versus AIF based on data from an international spine registry. A retrospective analysis of registry data was carried out. Inclusion criteria were degenerative disc or disc herniation of the cervical spine treated by single-level TDA or AIF, no previous surgery, and a Core Outcome Measures Index (COMI) completed at baseline and at least 3 months' follow-up. Overall, 987 patients were identified. Neck and arm pain relief and COMI score improvement were the outcome measures. Three separate analyses were performed to compare TDA and AIF surgical outcomes: (1) mimicking an RCT setting, with admission criteria typical of those in published RCTs, a 1:1 matched analysis was carried out in 739 patients; (2) an analysis was performed on 248 patients outside the classic RCT spectrum, that is, with one or more typical RCT exclusion criteria; (3) a subgroup analysis of all patients with additional follow-up longer than 2 years (n=149). Matching resulted in 190 pairs with an average follow-up of 17 months that had no residual significant differences for any patient characteristics. Small but statistically significant differences in outcome were observed in favor of TDA, which are potentially clinically relevant. Subgroup analyses of atypical patients and of patients with longer-term follow-up showed no significant differences in outcome between the treatments. The results of this observational study were in accordance with those of the published RCTs, suggesting substantial pain reduction both after AIF and TDA, with slightly greater benefit after arthroplasty. The analysis of atypical patients suggested that, in patients outside the spectrum of clinical trials, both surgical interventions appeared to work to a similar extent to that shown for the cohort in the matched study. Also, in the longer-term perspective, both therapies resulted in similar benefits to the patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Study design: Evaluating gene–environment interactions in the etiology of breast cancer – the WECARE study

PubMed Central

Bernstein, Jonine L; Langholz, Bryan; Haile, Robert W; Bernstein, Leslie; Thomas, Duncan C; Stovall, Marilyn; Malone, Kathleen E; Lynch, Charles F; Olsen, Jørgen H; Anton-Culver, Hoda; Shore, Roy E; Boice, John D; Berkowitz, Gertrud S; Gatti, Richard A; Teitelbaum, Susan L; Smith, Susan A; Rosenstein, Barry S; Børresen-Dale, Anne-Lise; Concannon, Patrick; Thompson, W Douglas

2004-01-01

Introduction Deficiencies in cellular responses to DNA damage can predispose to cancer. Ionizing radiation can cause cluster damage and double-strand breaks (DSBs) that pose problems for cellular repair processes. Three genes (ATM, BRCA1, and BRCA2) encode products that are essential for the normal cellular response to DSBs, but predispose to breast cancer when mutated. Design To examine the joint roles of radiation exposure and genetic susceptibility in the etiology of breast cancer, we designed a case-control study nested within five population-based cancer registries. We hypothesized that a woman carrying a mutant allele in one of these genes is more susceptible to radiation-induced breast cancer than is a non-carrier. In our study, 700 women with asynchronous bilateral breast cancer were individually matched to 1400 controls with unilateral breast cancer on date and age at diagnosis of the first breast cancer, race, and registry region, and counter-matched on radiation therapy. Each triplet comprised two women who received radiation therapy and one woman who did not. Radiation absorbed dose to the contralateral breast after initial treatment was estimated with a comprehensive dose reconstruction approach that included experimental measurements in anthropomorphic and water phantoms applying patient treatment parameters. Blood samples were collected from all participants for genetic analyses. Conclusions Our study design improves the potential for detecting gene–environment interactions for diseases when both gene mutations and the environmental exposures of interest are rare in the general population. This is particularly applicable to the study of bilateral breast cancer because both radiation dose and genetic susceptibility have important etiologic roles, possibly by interactive mechanisms. By using counter-matching, we optimized the informativeness of the collected dosimetry data by increasing the variability of radiation dose within the case–control sets and enhanced our ability to detect radiation–genotype interactions. PMID:15084244

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.

Temporal Trends in the Risk Profile of Patients Undergoing Outpatient Percutaneous Coronary Intervention: A Report from the National Cardiovascular Data Registry's CathPCI Registry.

PubMed

Vora, Amit N; Dai, Dadi; Gurm, Hitinder; Amin, Amit P; Messenger, John C; Mahmud, Ehtisham; Mauri, Laura; Wang, Tracy Y; Roe, Matthew T; Curtis, Jeptha; Patel, Manesh R; Dauerman, Harold L; Peterson, Eric D; Rao, Sunil V

2016-03-01

Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality. Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care. © 2016 American Heart Association, Inc.

Comparison of risk of acute kidney injury after primary percutaneous coronary interventions with the transradial approach versus the transfemoral approach (from the PRIPITENA urban registry).

PubMed

Cortese, Bernardo; Sciahbasi, Alessandro; Sebik, Rodrigo; Rigattieri, Stefano; Alonzo, Alessandro; Silva-Orrego, Pedro; Belloni, Flavia; Seregni, Romano G; Giovannelli, Francesca; Tespili, Maurizio; Ricci, Roberto; Berni, Andrea

2014-09-15

The risk of acute kidney injury (AKI) is a major issue after percutaneous coronary interventions (PCIs), especially in the setting of ST-elevation myocardial infarction. Preliminary data from large retrospective registries seem to show a reduction of AKI when a transradial (TR) approach for PCI is adopted. Little is known about the relation between vascular access and AKI after emergent PCI. We here report the results of the Primary PCI from Tevere to Navigli (PRIPITENA), a retrospective database of primary PCI performed at high-volume centers in the urban areas of Rome and Milan. Primary end point of this study was the occurrence of AKI in the TR and transfemoral (TF) access site groups. Secondary end points were major adverse cardiovascular events, stent thrombosis, and Thrombolysis in Myocardial Infarction major and minor bleedings. The database included 1,330 patients, 836 treated with a TR and 494 with a TF approach. After a propensity-matched analysis performed to exclude possible confounders, we identified 450 matched patients (225 TR and 225 TF). The incidence of AKI in the 2 matched groups was lower in patients treated with TR primary PCI (8.4% vs 16.9%, p = 0.007). Major adverse cardiovascular events and stent thrombosis were not different among study groups, whereas major bleedings were more often seen in the TF group. At multivariate analysis, femoral access was an independent predictor of AKI (odds ratio 1.654, 95% confidence interval 1.084 to 2.524, p = 0.042). In conclusion, in this database of primary PCI, the risk of AKI was lower with a TR approach, and the TF approach was an independent predictor for the occurrence of this complication. Copyright © 2014 Elsevier Inc. All rights reserved.

Does Certification as Bariatric Surgery Center and Volume Influence the Outcome in RYGB-Data Analysis of German Bariatric Surgery Registry.

PubMed

Stroh, Christine; Köckerling, F; Lange, V; Wolff, S; Knoll, C; Bruns, C; Manger, Th

2017-02-01

To examine the association between the certification as bariatric surgery center and volume and patient outcome, data collected in the German Bariatric Surgery Registry were evaluated. All data were registered prospectively in cooperation with the Institute of Quality Assurance in Surgery at Otto-von-Guericke University Magdeburg. Data collection began in 2005 for all bariatric procedures in an online database. Participation in the quality assurance study is required for all certified bariatric surgery centers in Germany. Descriptive evaluation and matched pairs analysis were performed. Patients were matched via propensity score taking into account BMI, age, and incidence of comorbidities. During the period from 2005 to 2013, 3083 male and 10,639 female patients were operated on with the RYGB primary approach. In Centers of Competence (77.2 %) and non-accredited hospitals (76.3 %), the proportion of female patients was significantly lower than in Centers of Reference/Excellence (78.7 %; p = 0.002). The mean age in Centers of Reference/Excellence (41.2 years) was significantly lower than in Centers of Competence (43.2 years; p < 0.05). Propensity score analysis was performed to compare matched patients with regard to BMI, age, and incidence of comorbidities. The rate of general and surgical postoperative complications and mortality rate was significantly lower in certified Centers of Reference/Excellence compared to Centers of Competence with 29 and non-certified hospitals. There is evidence of improved patient outcome in certified bariatric surgery centers with higher volume. The study supports the concept of certification. There are different factors which can and cannot be preoperatively modified and influence the perioperative outcome.

Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry.

PubMed

Hosoba, Soh; Yamamoto, Masanori; Shioda, Kayoko; Sago, Mitsuru; Koyama, Yutaka; Shimura, Tetsuro; Kagase, Ai; Tada, Norio; Naganuma, Toru; Araki, Motoharu; Yamanaka, Futoshi; Shirai, Shinichi; Watanabe, Yusuke; Hayashida, Kentaro

2018-03-01

Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P ≤ 0.0002). MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease.

PubMed

Lee, Pil Hyung; Kang, Se Hun; Han, Seungbong; Ahn, Jung-Min; Bae, Jae Seok; Lee, Cheol Hyun; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Lee, Cheol Whan; Park, Seong-Wook; Park, Duk-Woo; Park, Seung-Jung

2017-12-01

The aim of this study was to determine how trial-based findings of EXCEL and NOBLE might be interpreted and generalizable in 'real-world' settings with comparison of data from the large-scaled, all-comer Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry. We compared baseline clinical and procedural characteristics and also determined how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) was different in EXCEL and NOBLE, compared with those of the multicenter, IRIS-MAIN registry (n=2481). The primary outcome for between-study comparison was a composite of death, myocardial infarction (MI), or stroke. There were between-study differences in patient risk profiles (age, BMI, diabetes, and clinical presentation), lesion complexities, and procedural characteristics (stent type, the use of off-pump surgery, and radial artery); the proportion of diabetes and acute coronary syndrome was particularly lower in NOBLE than in other studies. Although there was interstudy heterogeneity for the protocol definition of MI, the risks for serious composite outcome of death, MI, or stroke were similar between PCI and CABG in EXCEL [hazard ratio (HR): 1.00; 95% confidence interval (CI): 0.79-1.26; P=0.98] and in the matched cohort of IRIS-MAIN (HR: 1.08; 95%CI: 0.85-1.38; P=0.53), whereas it was significantly higher after PCI than after CABG in NOBLE (HR: 1.47; 95%CI: 1.06-2.05; P=0.02), which was driven by more common MI and stroke after PCI. In the comparison of a large-sized, all-comer registry, the EXCEL trial might represent better generalizability with respect to baseline characteristics and observed clinical outcomes compared with the NOBLE trial.

Construction and validation of a list of common Middle Eastern surnames for epidemiological research

PubMed Central

Nasseri, Kiumarss

2007-01-01

Purpose Middle Eastern (ME) population is rapidly growing in the US but cannot be easily identified in cancer registry or other databases for epidemiological research. The purpose of this study was to develop a list of common Middle Eastern surnames and validate it by linking with a cancer registry incidence files. Methods Surnames and place of birth in the Middle East were obtained from various sources. After exclusion of the non-specific entries, the final combined list included 49,610 surnames and was matched with the California Cancer Registry incidence file for 1988-2003. Results Overall, 1.4% of all registered cases were positively identified as ME that is similar to the proportion of ME population in California. Two third of the identified cases had known place of birth in the Middle East and of those, 70% were non-Arabs. The sensitivity of the list in detecting ME birth in men and women are 91% and 86%, respectively. The positive predictive values for men and women are 72% and 65%. The specificity and negative predictive values are universally over 99 percent. Conclusion The high accuracy reported for this Middle Eastern surname list (MESL) makes it a valuable tool for epidemiological studies of this ethnic population. PMID:18023539

Registry based trauma outcome: perspective of a developing country.

PubMed

Zafar, H; Rehmani, R; Raja, A J; Ali, A; Ahmed, M

2002-09-01

To report trauma outcome from a developing country based on the Trauma and Injury Severity Scoring (TRISS) method and compare the outcome with the registry data from Major Trauma Outcome Study (MTOS). Registry based audit of all trauma patients over two years. Emergency room of a teaching university hospital. 279 injured patients meeting trauma team activation criteria including all deaths in the emergency room. TRISS methodology to compare expected and observed outcome. W, M, and Z statistics and comparison with MTOS data. 279 patients meeting the trauma triage criteria presented to the emergency room, 235 (84.2%) were men and 44 (15.8%) women. Blunt injury accounted for 204 (73.1%) and penetrating for 75 (26.9%) patients. Seventy two patients had injury severity score of more than 15. Only 18 (6.4%) patients were transported in an ambulance. A total of 142 (50.9%) patients were transferred from other hospitals with a mean prehospital delay of 7.1 hours. M statistic of our study subset was 0.97, indicating a good match between our patients and MTOS cohort. There were 18 deaths with only one unexpected survivor. The expected number of deaths based on MTOS dataset should have been 12. Present injury severity instruments using MTOS coefficients do not accurately correlate with observed survival rates in a developing country.

The Three Mile Island Population Registry.

PubMed

Goldhaber, M K; Tokuhata, G K; Digon, E; Caldwell, G G; Stein, G F; Lutz, G; Gur, D

1983-01-01

Shortly after the March 28, 1979, accident at the Three Mile Island (TMI) nuclear plant outside Harrisburg, Pa., the Pennsylvania Department of Health, in conjunction with the Centers for Disease Control and the U.S. Bureau of the Census, conducted a census of the 35,930 persons residing within 5 miles of the plant. With the help of 150 enumerators, demographic and health-related information was collected on each person to provide baseline data for future short- and long-term epidemiologic studies of the effects of the accident. Individual radiation doses were estimated on the basis of residential location and the amount of time each person spent in the 5-mile area during the 10 days after the accident. Health and behavioral resurveys of the population will be conducted approximately every 5 years. Population-mobility, morbidity, and mortality will be studied yearly by matching the TMI Population Registry with postal records, cancer registry records, and death certificate data. Because the radiation dose from TMI was extremely small, any increase in morbidity or mortality attributable to the accident would be so small as not to be measurable by present methods; however, adverse health effects as a result of psychological stress may occur. Also, a temporary increase in reporting of disease could occur because of increased surveillance and attention to health.

The Three Mile Island Population Registry.

PubMed Central

Goldhaber, M K; Tokuhata, G K; Digon, E; Caldwell, G G; Stein, G F; Lutz, G; Gur, D

1983-01-01

Shortly after the March 28, 1979, accident at the Three Mile Island (TMI) nuclear plant outside Harrisburg, Pa., the Pennsylvania Department of Health, in conjunction with the Centers for Disease Control and the U.S. Bureau of the Census, conducted a census of the 35,930 persons residing within 5 miles of the plant. With the help of 150 enumerators, demographic and health-related information was collected on each person to provide baseline data for future short- and long-term epidemiologic studies of the effects of the accident. Individual radiation doses were estimated on the basis of residential location and the amount of time each person spent in the 5-mile area during the 10 days after the accident. Health and behavioral resurveys of the population will be conducted approximately every 5 years. Population-mobility, morbidity, and mortality will be studied yearly by matching the TMI Population Registry with postal records, cancer registry records, and death certificate data. Because the radiation dose from TMI was extremely small, any increase in morbidity or mortality attributable to the accident would be so small as not to be measurable by present methods; however, adverse health effects as a result of psychological stress may occur. Also, a temporary increase in reporting of disease could occur because of increased surveillance and attention to health. PMID:6419276

Gene therapy in rare diseases: the benefits and challenges of developing a patient-centric registry for Strimvelis in ADA-SCID.

PubMed

Stirnadel-Farrant, Heide; Kudari, Mahesh; Garman, Nadia; Imrie, Jessica; Chopra, Bikramjit; Giannelli, Stefania; Gabaldo, Michela; Corti, Ambra; Zancan, Stefano; Aiuti, Alessandro; Cicalese, Maria Pia; Batta, Rohit; Appleby, Jonathan; Davinelli, Mario; Ng, Pauline

2018-04-06

Strimvelis (autologous CD34+ cells transduced to express adenosine deaminase [ADA]) is the first ex vivo stem cell gene therapy approved by the European Medicines Agency (EMA), indicated as a single treatment for patients with ADA-severe combined immunodeficiency (ADA-SCID) who lack a suitable matched related bone marrow donor. Existing primary immunodeficiency registries are tailored to transplantation outcomes and do not capture the breadth of safety and efficacy endpoints required by the EMA for the long-term monitoring of gene therapies. Furthermore, for extended monitoring of Strimvelis, the young age of children treated, small patient numbers, and broad geographic distribution of patients all increase the risk of loss to follow-up before sufficient data have been collected. Establishing individual investigator sites would be impractical and uneconomical owing to the small number of patients from each location receiving Strimvelis. An observational registry has been established to monitor the safety and effectiveness of Strimvelis in up to 50 patients over a minimum of 15 years. To address the potential challenges highlighted above, data will be collected by a single investigator site at Ospedale San Raffaele (OSR), Milan, Italy, and entered into the registry via a central electronic platform. Patients/families and the patient's local physician will also be able to submit healthcare information directly to the registry using a uniquely designed electronic platform. Data entry will be monitored by a Gene Therapy Registry Centre (funded by GlaxoSmithKline) who will ensure that necessary information is collected and flows between OSR, the patient/family and the patient's local healthcare provider. The Strimvelis registry sets a precedent for the safety monitoring of future gene therapies. A unique, patient-focused design has been implemented to address the challenges of long-term follow-up of patients treated with gene therapy for a rare disease. Strategies to ensure data completeness and patient retention in the registry will help fulfil pharmacovigilance requirements. Collaboration with partners is being sought to expand from a treatment registry into a disease registry. Using practical and cost-efficient approaches, the Strimvelis registry is hoped to encourage further innovation in registry design within orphan drug development.

Which is the best antiaggregant or anticoagulant therapy after TAVI? A propensity-matched analysis from the ITER registry. The management of DAPT after TAVI.

PubMed

D'Ascenzo, Fabrizio; Benedetto, Umberto; Bianco, Matteo; Conrotto, Federico; Moretti, Claudio; D'Onofrio, Augusto; Agrifoglio, Marco; Colombo, Antonio; Ribichini, Flavio; Tarantini, Giuseppe; D'Amico, Maurizio; Salizzoni, Stefano; Rinaldi, Mauro

2017-12-08

The safety and efficacy of single vs. dual antiplatelet therapy (DAPT) in patients undergoing TAVI remain to be addressed. The aim of our study was to evaluate the usefulness of a DAPT compared to a single platelet therapy in patients undergoing TAVI with a balloon-expandable prosthesis. All consecutive patients enrolled in the ITER registry were included. Patients undergoing TAVI discharged with aspirin alone were compared to those taking DAPT before and after selection using propensity score with matching. Subgroup analysis was performed for those on OAT. Prosthetic heart valve dysfunction at follow-up was the primary endpoint, whereas all-cause death, cardiovascular death, bleedings, vascular complications and cerebrovascular accidents were the secondary ones. From 1,364 patients, after propensity score with matching, 605 were selected for each group (aspirin alone vs. DAPT). At 30 days, rates of VARC mortality were lower in patients with aspirin alone (1.5% vs. 4.1%, p=0.003), mainly driven by a reduction of major vascular complications (5.3% vs. 10.7%, p<0.001) and of major bleedings (6.6% vs. 11.5%, p<0.001), without a difference in prosthetic heart valve dysfunction after 45±14 months (2.8% vs. 3.0%, p=0.50). These results were confirmed on multivariable analysis. After TAVI with a balloon-expandable prosthesis, aspirin alone does not increase the risk of prosthetic valve dysfunction, and reduces the risk of periprocedural complications and of 30-day all-cause death.

Two decades' experience with interfacility transport on extracorporeal membrane oxygenation.

PubMed

Bryner, Benjamin; Cooley, Elaine; Copenhaver, William; Brierley, Kristin; Teman, Nicholas; Landis, Denise; Rycus, Peter; Hemmila, Mark; Napolitano, Lena M; Haft, Jonathan; Park, Pauline K; Bartlett, Robert H

2014-10-01

Interfacility transport of patients on extracorporeal membrane oxygenation (ECMO) has been performed in large numbers at only a few programs. Limited data are available on outcomes after ECMO transport to justify expanding or discontinuing these programs. This was a retrospective review of a 20-year, single-institution experience with interhospital ECMO transport as well as a systematic review of reports of transfers of patients on ECMO. Results of both were compared with historical data from the international registry of the Extracorporeal Life Support Organization (ELSO). Between 1990 and 2012, ECMO was used to facilitate transport of 221 patients to our institution, and 135 (62%) survived to discharge. Review of an additional 27 case series describing ECMO transport of 643 patients showed an overall survival of 61%. After stratifying by age and primary indication for ECMO, survival of transported patients was not significantly different compared with all ECMO patients in the ELSO registry, with the exception of pediatric patients treated for respiratory failure (transported patients in this category had higher survival than those in the ELSO registry). Interfacility transport on ECMO is feasible and can be accomplished safely in the critically ill. Survival of transported patients is comparable to age-matched and treatment-matched ECMO patients at large. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Development of a statewide trauma registry using multiple linked sources of data.

PubMed Central

Clark, D. E.

1993-01-01

In order to develop a cost-effective method of injury surveillance and trauma system evaluation in a rural state, computer programs were written linking records from two major hospital trauma registries, a statewide trauma tracking study, hospital discharge abstracts, death certificates, and ambulance run reports. A general-purpose database management system, programming language, and operating system were used. Data from 1991 appeared to be successfully linked using only indirect identifying information. Familiarity with local geography and the idiosyncracies of each data source were helpful in programming for effective matching of records. For each individual case identified in this way, data from all available sources were then merged and imported into a standard database format. This inexpensive, population-based approach, maintaining flexibility for end-users with some database training, may be adaptable for other regions. There is a need for further improvement and simplification of the record-linkage process for this and similar purposes. PMID:8130556

Alcohol and Drug-Related Mortality among Enrollees in the World Trade Center Health Registry (WTCHR), 2004-12.

PubMed

Welch, Alice E; Zweig, Kimberly Caramanica; Liao, Tim; Yip, Jennifer; Davidson, Alexander; Jordan, Hannah; Brackbill, Robert; Cone, James

2018-06-13

Have World Trade Center Health Registry (WTCHR) enrollees experienced increased alcohol and drug-related mortality associated with exposures to the events of 9/11/01? Cases involving death due to alcohol or drugs between 2003 and 2012 in New York City (NYC) were obtained through a match of the Registry with NYC Vital Records. We compared ICD-10-coded deaths where alcohol and/or drug use was the underlying cause of death to deaths from all other causes. Of 1,193 deaths, 66 (5.5%) were alcohol/drug-related. Adjusted odds ratios for dying from alcohol/drug-related causes were significantly elevated for enrollees who were male, age 18-44 years, smoked at enrollment, had 9/11-related probable PTSD, were rescue/recovery workers, or sustained an injury on 9/11/01. Following a major disaster, alcohol and drug-related mortality may be increased.

Therapeutic priorities for solitary large hepatocellular carcinoma in a hepatitis B virus endemic area; an analysis of a nationwide cancer registry database.

PubMed

Jin, Young-Joo; Lee, Jin-Woo

2017-03-01

We compared overall survival (OS) of patients with a solitary large (>5 cm) hepatocellular carcinoma (HCC) treated surgically or by transarterial chemoembolization (TACE). The archived records of HCC patients registered at the Korean Central Cancer Registry from 2003 through 2005 (registry A, n = 4 520) or from 2008 through 2010 (registry B, n = 4 596) were retrospectively analyzed. In these registries, 578 and 315 patients had a single large HCC, respectively. In registry A, 442 (cohort A) underwent surgery (n = 96) or TACE (n = 346). In registry B, 253 (cohort B) underwent surgery (n = 110) or TACE (n = 143). Cohort C (n = 695) was constructed by combining cohorts A and B, and thus, 206 and 489 patients received surgery and TACE, respectively. In cohort C, cumulative OS rates at 1-, 3-, and 5-years were significantly higher for surgery than TACE (89.3%, 67.4%, and 58.0% vs 67.7%, 38.2%, and 27.2%, respectively, P < 0.001). Similar results were obtained for cohorts A and B, even after propensity-score matching in three cohorts (P values for all <0.05). TACE (HR 2.18, P < 0.001), serum albumin (HR 0.77, P = 0.015), and tumor size (HR 1.06, P < 0.001) were predictors of post-treatment mortality. Surgery is associated with improved OS for a solitary large HCC of BCLC stage A. © 2016 Wiley Periodicals, Inc.

One Chance in a Million: Altruism and the Bone Marrow Registry.

PubMed

Bergstrom, Theodore C; Garratt, Rodney J; Sheehan-Connor, Damien

2009-09-01

Stem cell transplants save lives of many patients with blood diseases. Donation is painful, but rarely has lasting adverse effects. Patients can accept transplants only from donors with compatible immune systems. Those lacking a sibling match must seek donations from the general population. The probability that two unrelated persons are compatible is less than 1/10,000. Health authorities maintain a registry of several million genetically tested potential donors who agree to donate if asked. We find that the benefits of adding registrants of every race exceed costs. We also explore the peculiar structure of voluntary public good provision that faces potential donors.

Association of Biocompatible Peritoneal Dialysis Solutions with Peritonitis Risk, Treatment, and Outcomes

PubMed Central

Cho, Yeoungjee; Badve, Sunil V.; Hawley, Carmel M.; McDonald, Stephen P.; Brown, Fiona G.; Boudville, Neil; Bannister, Kym M.; Clayton, Philip A.

2013-01-01

Summary Background and objectives The effect of biocompatible peritoneal dialysis (PD) solutions on PD-related peritonitis is unclear. This study sought to evaluate the relationship between use of biocompatible solutions and the probability of occurrence or clinical outcomes of peritonitis. Design, setting, participants, & measurements The study included all incident Australian patients receiving PD between January 1, 2007, and December 31, 2010, using Australia and New Zealand Dialysis and Transplant Registry data. All multicompartment PD solutions of neutral pH were categorized as biocompatible solutions. The independent predictors of peritonitis and the use of biocompatible solutions were determined by multivariable, multilevel mixed-effects Poisson and logistic regression analysis, respectively. Sensitivity analyses, including propensity score matching, were performed. Results Use of biocompatible solutions gradually declined (from 7.5% in 2007 to 4.2% in 2010), with preferential use among smaller units and among younger patients without diabetes mellitus. Treatment with biocompatible solution was associated with significantly greater overall rate of peritonitis (0.67 versus 0.47 episode per patient-year; incidence rate ratio, 1.49; 95% confidence interval [CI], 1.19 to 1.89) and with shorter time to first peritonitis (hazard ratio [HR], 1.48; 95% CI, 1.17 to 1.87), a finding replicated in propensity score–matched cohorts (HR, 1.36; 95% CI, 1.09 to 1.71). Conclusions In an observational registry study, use of biocompatible PD solutions was associated with higher overall peritonitis rates and shorter time to first peritonitis. Further randomized studies adequately powered for a primary peritonitis outcome are warranted. PMID:23949232

Follow-Up After Cardiac Surgery Should be Extended to at Least 120 Days When Benchmarking Cardiac Surgery Centers.

PubMed

Hansen, Laura S; Sloth, Erik; Hjortdal, Vibeke E; Jakobsen, Carl-Johan

2015-08-01

Short-term (30 days) mortality frequently is used as an outcome measure after cardiac surgery, although it has been proposed that the follow-up period should be extended to 120 days to allow for more accurate benchmarking. The authors aimed to evaluate whether mortality rates 120 days after surgery were comparable to general mortality and to compare causes of death between the cohort and the general population. A multicenter descriptive cohort study using prospectively entered registry data. University hospital. The cohort was obtained from the Western Denmark Heart Registry and matched to the Danish National Hospital Register as well as the Danish Register of Causes of Death. A weighted, age-matched general population consisting of all Danish patients who died within the study period was identified through the central authority on Danish statistics. A total of 11,988 patients (>15 years) who underwent cardiac-surgery at Aarhus, Aalborg and Odense University Hospitals from April 1, 2006 to December 31, 2012 were included. Coronary artery bypass grafting, valve surgery and combinations. Mortality after cardiac surgery matches with mortality in the general population after 140 days. Mortality curves run almost parallel from this point onwards, regardless of The European system for cardiac operative risk evaluation (EuroSCORE) and intervention. The causes of death in the cohort differed statistically significantly from the background population (p<0.0001; one-sample t-test) throughout the first postoperative year. The leading cause of death in the cohort was cardiac (38%); 53% of which was categorized as heart failure. A total of 54% of these patients were assessed preoperatively as having normal or mildly impaired heart function (EuroSCORE). This study supported an extended follow-up period after cardiac surgery when benchmarking cardiac surgery centers. Regardless of preoperative heart function, heart failure was the consistent leading cause of death. Copyright © 2015 Elsevier Inc. All rights reserved.

Statins attenuate but do not eliminate the reverse epidemiology of total serum cholesterol in patients with non-ischemic chronic heart failure.

PubMed

Fröhlich, Hanna; Raman, Nandita; Täger, Tobias; Schellberg, Dieter; Goode, Kevin M; Kazmi, Syed; Grundtvig, Morten; Hole, Torstein; Cleland, John G F; Katus, Hugo A; Agewall, Stefan; Clark, Andrew L; Atar, Dan; Frankenstein, Lutz

2017-07-01

In patients with chronic heart failure (CHF) increasing levels of total serum cholesterol are associated with improved survival - while statin usage is not. The impact of statin treatment on the "reverse epidemiology" of cholesterol is unclear. 2992 consecutive patients with non-ischemic CHF due to left ventricular systolic dysfunction from the Norwegian CHF Registry and the CHF Registries of the Universities of Hull, UK, and Heidelberg, Germany, were studied. 1736 patients were individually double-matched on both cholesterol levels and the individual propensity scores for statin treatment. All-cause mortality was analyzed as a function of baseline cholesterol and statin use in both the general and the matched sample. 1209 patients (40.4%) received a statin. During a follow-up of 13,740 patient-years, 360 statin users (29.8%) and 573 (32.1%) statin non-users died. When grouped according to total cholesterol levels as low (≤3.6mmol/L), moderate (3.7-4.9mmol/L), high (4.8-6.2mmol/L), and very high (>6.2mmol/L), we found improved survival with very high as compared with low cholesterol levels. This association was present in statin users and non-users in both the general and matched sample (p<0.05 for each group comparison). The negative association of total cholesterol and mortality persisted when cholesterol was treated as a continuous variable (HR 0.83, 95%CI 0.77-0.90, p<0.001 for matched patients), but it was less pronounced in statin users than in non-users (F-test p<0.001). Statins attenuate but do not eliminate the reverse epidemiological association between increasing total serum cholesterol and improved survival in patients with non-ischemic CHF. Copyright © 2017 Elsevier B.V. All rights reserved.

Case control study of neuroblastoma in west-Germany after the Chernobyl accident.

PubMed

Michaelis, J; Haaf, H G; Zöllner, J; Kaatsch, P; Krummenauer, F; Berthold, F

1996-01-01

To explore possible causes of a 1988 incidence peak of infant neuroblastoma in west German regions which were contaminated with more than 6000 Bq/m2 Cs137 from the Chernobyl accident. The primary working hypothesis was that parents of the diseased children had been contaminated by an excessive intake of locally produced food, especially mushrooms or deer. Case control study with 1:2 (cases:controls) matching. Data were collected from the children's parents by questionnaires and telephone interviews. Nation-wide study (former FRG) based on the German Childhood Cancer Registry. Cases born in 1988 and reported with a neuroblastoma to the registry until March 1992. Population-based healthy controls, matched for age, sex and residence at time of diagnosis. The working hypothesis could not be confirmed by the study, because the parents of cases tended to eat less locally grown food than the parents of controls (RR = 0.63, 95% CI:0.20-1.97). Possible influence factors which previously have been described to be associated with neuroblastoma incidence could not be confirmed by the study. Parental exposure to herbicides and pesticides was associated with the occurrence of neuroblastoma (RR = 4.2, 95% CI:1.4-12.9). Neuroblastoma stage distribution in the contaminated regions was shifted towards lower stages as compared to the less contaminated regions and previous age cohorts. The study does not show additional evidence that the observed increase in neuroblastoma incidence might have been caused by exposure to fallout from the Chernobyl accident. The observed shift towards lower clinical stages may rather indicate increased diagnostic awareness. The association between neuroblastoma and parental exposure with herbicides and pesticides resulted from an extensive exploratory data analysis and needs to be confirmed in further studies.

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

Spatial Relative Risk Patterns of Autism Spectrum Disorders in Utah

ERIC Educational Resources Information Center

Bakian, Amanda V.; Bilder, Deborah A.; Coon, Hilary; McMahon, William M.

2015-01-01

Heightened areas of spatial relative risk for autism spectrum disorders (ASD), or ASD hotspots, in Utah were identified using adaptive kernel density functions. Children ages four, six, and eight with ASD from multiple birth cohorts were identified by the Utah Registry of Autism and Developmental Disabilities. Each ASD case was gender-matched to…

The effect of enteral tube feeding in cystic fibrosis: A registry based study.

PubMed

Libeert, Denis; Declercq, Dimitri; Wanyama, Simeon; Thomas, Muriel; Van Daele, Sabine; De Baets, Frans; Van Biervliet, Stephanie

2018-03-01

Long-term effect of enteral tube feeding (ETF) in cystic fibrosis (CF) remains equivocal. A Belgian CF registry based, retrospective, longitudinal study, evaluated the pre- and post- ETF (n = 113) clinical evolution and compared each patient with 2 age, gender, pancreatic status and genotype class-matched controls. At baseline ETF had a worse BMI z-score (p < 0.0001) and FEV1% (p < 0.0001) compared to controls. Patients eventually receiving ETF, had already a significant worse nutritional status and pulmonary function at first entry in the registry. Both parameters displayed a significant decline before ETF-introduction. ETF had more hospitalization and intravenous antibiotic (IVAB) treatment days (p < 0.0001). After ETF introduction hospitalizations and IVAB decreased significantly. After ETF-introduction BMI z-score recuperated towards the original curve before the decline, but remained below the controls. Starting ETF had no effect on rate of height gain in children. The pre-index FEV1 decline (-1.52%/year (p = 0.002)) stabilized to +0.39%/year afterwards. Controls displayed decline of -0.48%/year (p < 0.0001). ETF introduction improved BMI z-score and stabilized FEV1, associated with less hospitalizations and IVAB treatments. Higher mortality and transplantation in the ETF cases, leading to drop-outs, made determination of the effect size difficult. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry.

PubMed

Husson, Olga; Nieuwlaat, Willy-Anne; Oranje, Wilma A; Haak, Harm R; van de Poll-Franse, Lonneke V; Mols, Floortje

2013-10-01

The aims of this study were (i) to obtain insight into the prevalence of fatigue among short- and long-term thyroid cancer (TC) survivors, by comparing a sample of TC survivors with an age- and sex-matched normative population, and (ii) to investigate which demographic, clinical, and TC-specific health-related quality of life (HRQoL) characteristics were associated with fatigue. All patients found to have TC between 1990 and 2008, as registered in the Eindhoven Cancer Registry, received a cross-sectional survey on fatigue (Fatigue Assessment Scale), TC-specific HRQoL (THYCA-QoL), and psychological distress (Hospital Anxiety and Depression Scale). The fatigue scores were compared with those of an age- and sex-matched normative population (n=530). Multiple logistic regression analyses were conducted to investigate the independent associations between clinical and demographic characteristics, TC-specific HRQoL, and psychological distress with fatigue. Eighty-six percent (n=306) responded. TC survivors were more often classified as fatigued or very fatigued (short-term <5 years: 43%; long-term 5-10 years: 44%; long-term 10-15 years: 47%; long-term >15 years: 39%) compared to the normative population (25%; p<0.001). Anxiety (odds ratio (OR) 1.15, 95% confidence interval [CI] 1.03-1.28) and depression (OR 1.43 [CI 1.22-1.68]) were associated with fatigue, as was also the case for TC-specific neuromuscular (OR 1.03 [CI 1.01-1.06]), concentration (OR 1.03 [CI 1.01-1.06]), and psychological TC-specific HRQoL (OR 1.06 [CI 1.02-1.10]). Short- and long-term TC survivors report higher levels of fatigue than an age- and sex-matched normative population do. Both TC-specific HRQoL and psychological distress were associated with fatigue.

The use of a national transplant registry to benchmark transplant outcome for patients undergoing autologous and allogeneic stem cell transplantation in the United Kingdom and Ireland.

PubMed

Russell, N H; Szydlo, R; McCann, S; Potter, M N; Craddock, C; Towlson, K; Apperley, J F

2004-02-01

As part of its clinical governance programme the British Society for Blood and Marrow Transplantation (BSBMT) undertook an analysis of transplant outcome for adults undergoing human leucocyte antigen - identical sibling allogeneic transplantation for chronic myeloid leukaemia (CML) in first chronic phase (CP1) or autologous transplantation for Hodgkin's disease (HD). The study aimed to compare transplant-related mortality (TRM) and survival for patients reported to the BSBMT with patients transplanted in the rest of Europe, reported to the European Group for Blood and Marrow Transplantation (EBMT). The outcomes for 104 allogeneic transplants for CML in 24 UK/Irish centres were compared with 775 allografts in 145 other European centres. For HD, 241 autografts from 38 UK/Irish centres were compared with 1145 transplants in 239 other European centres. For both diseases, the cohorts were broadly matched with the exception of CML, where 85% of patients were transplanted <1 year from diagnosis in the UK/Ireland compared with 68% in the EBMT (P = 0.001). Cox regression analysis was undertaken using known delineated variables affecting transplant outcome in addition to the registry of origin. The adjusted survival curves for CML showed no significant differences between the two groups, with 3-year survival probabilities of 70.2% and 67.1% for the EBMT and BSBMT cohorts respectively. Likewise, the analysis for HD showed overlapping survival curves, with 3-year survival probabilities of 71.8% (EBMT) and 70.8% (BSBMT). TRM was not statistically different in either disease. This study demonstrates the potential for using national registries to benchmark transplant outcome against the EBMT registry.

Mineralocorticoid Receptor Antagonism in Patients With Atrial Fibrillation: Findings From the ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) Registry.

PubMed

Fudim, Marat; Liu, Peter R; Shrader, Peter; Blanco, Rosalia G; Allen, Larry A; Fonarow, Gregg C; Gersh, Bernard J; Kowey, Peter R; Mahaffey, Kenneth W; Hylek, Elaine; Go, Alan S; Thomas, Laine; Peterson, Eric D; Piccini, Jonathan P

2018-04-13

Mineralocorticoid receptor antagonist (MRA) therapy may be beneficial to patients with atrial fibrillation (AF), but little is known about their use in patients with AF and subsequent outcomes. In order to better understand MRA use and subsequent outcomes, we performed a retrospective cohort study of the contemporary ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry. AF progression and cardiovascular outcomes were compared using propensity-matched Cox proportional hazards modeling according to MRA use at baseline and new MRA use at follow-up versus patients with no MRA use. Among 7012 patients with nonpermanent AF, 320 patients were taking MRA at enrollment, and 416 patients initiated MRA use during follow-up. The mean patient age was 72.5 years, 56.3% were men, and 70.4% had paroxysmal AF. Among all patients taking MRAs, 434 (59.0%) had heart failure, 655 (89.0%) had hypertension, and 380 (51.6%) had both. After adjustment, new MRA use was not associated with reduced AF progression (hazard ratio, 1.18; 95% confidence interval, 0.88-1.58; P =0.27) but showed a trend towards lower risk of stroke, transient ischemic attack, or systemic embolism (hazard ratio, 0.17; 95% confidence interval, 0.02-1.23; P =0.08). Results were similar for a comparison of new MRA users and baseline MRA users compared with nonusers. In community-based outpatients with AF, the majority of MRA use was for heart failure and hypertension. MRA use also trended towards lower adjusted stroke risk. Future studies should test the hypothesis that MRA use may decrease the risk of stroke in patients with AF. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Using EasyMatch® to anticipate the identification of an HLA identical unrelated donor: A validated efficient time and cost saving method.

PubMed

Dubois, Valérie; Detrait, Marie; Sobh, Mohamad; Morisset, Stéphane; Labussière, Hélène; Giannoli, Catherine; Nicolini, Franck; Moskovtchenko, Philippe; Mialou, Valérie; Ducastelle, Sophie; Rey, Sylvie; Thomas, Xavier; Barraco, Fiorenza; Tedone, Nathalie; Marry, Evelyne; Garnier, Federico; Bertrand, Yves; Michallet, Mauricette

2016-11-01

In the absence of an HLA matched familial donor, a search for an unrelated donor or cord blood unit is initiated through worldwide registries. Although a first look-up on available HLA information of donors in the "book" at BMDW (Bone Marrow Donor Worldwide) can provide a good estimation of the number of compatible donors, the variety of resolution typing levels requires confirmatory typing (CT) which are expensive and time consuming. In order to help recipient centers in their work. The French donor registry (France Greffe de Moelle/Agence de la Biomedecine) has recently developed a software program called "EasyMatch®" that uses haplotype frequencies to compute the likelihood of phenotypic match in donors according to various typing resolution levels. The goal of our study is to report a single monocentric user-experience with EasyMatch®, demonstrating that its routine use reduced the cost and the delay of the donor search in our center, allowing the definition of a new strategy to search compatible unrelated donors. The strategy was first established on a retrospective cohort of 217 recipients (185 adults and 32 children=before score) and then validated on a prospective cohort of 171 recipients (160 adults and 11 children=after score). For all patients, we calculated the delay between the registration day and the donor identification day, and the number of CT requested to the donor centre. Considering both groups, we could observe a significant decrease of the number of CT from 8 to 2 (p<0,001), and a significant decrease of the median delay to identify a suitable donor from 43 to 31days (p<0.0001). EasyMatch® estimates the number of potentially identical donors, but doesn't foresee availability of the donors. It provides us an easy tracking of mismatches, an estimation of the number of potential donors, the selection of population following ethnic origin of patients and a high prediction when probability is high or low. It affords a new approach of donor search in our daily work and improves the efficiency in the great challenge of the compatible donor identification. Copyright © 2016 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.

Health, social and economic consequences of dementias: a comparative national cohort study.

PubMed

Frahm-Falkenberg, S; Ibsen, R; Kjellberg, J; Jennum, P

2016-09-01

Dementia causes morbidity, disability and mortality, and as the population ages the societal burden will grow. The direct health costs and indirect costs of lost productivity and social welfare of dementia were estimated compared with matched controls in a national register based cohort study. Using records from the Danish National Patient Registry (1997-2009) all patients with a diagnosis of Alzheimer's disease, vascular dementia or dementia not otherwise specified and their partners were identified and compared with randomly chosen controls matched for age, gender, geographical area and civil status. Direct health costs included primary and secondary sector contacts, medical procedures and medication. Indirect costs included the effect on labor supply. All cost data were extracted from national databases. The entire cohort was followed for the entire period - before and after diagnosis. In all, 78 715 patients were identified and compared with 312 813 matched controls. Patients' partners were also identified and matched with a control group. Patients had lower income and higher mortality and morbidity rates and greater use of medication. Social- and health-related vulnerability was identified years prior to diagnosis. The average annual additional cost of direct healthcare costs and lost productivity in the years before diagnosis was 2082 euros per patient over and above that of matched controls, and 4544 euros per patient after the time of diagnosis. Dementias cause significant morbidity and mortality, consequently generating significant socioeconomic costs. © 2016 EAN.

Morbidity and Mortality Differences Between Hematopoietic Cell Transplantation Survivors and Other Cancer Survivors.

PubMed

Chow, Eric J; Cushing-Haugen, Kara L; Cheng, Guang-Shing; Boeckh, Michael; Khera, Nandita; Lee, Stephanie J; Leisenring, Wendy M; Martin, Paul J; Mueller, Beth A; Schwartz, Stephen M; Baker, K Scott

2017-01-20

Purpose To compare the risks of serious health outcomes among hematopoietic cell transplantation (HCT) survivors versus a matched population of patients with cancer who did not undergo HCT, where the primary difference may be exposure to HCT. Methods Two-year HCT survivors treated at a comprehensive cancer center from 1992 through 2009 who were Washington State residents (n = 1,792; 52% allogeneic and 90% hematologic malignancies) were frequency matched by demographic characteristics and underlying cancer diagnosis (as applicable) to non-HCT 2-year cancer survivors, using the state cancer registry (n = 5,455) and the general population (n = 16,340) using driver's license files. Late outcomes for all three cohorts were ascertained from the state hospital discharge and death registries; subsequent cancers were ascertained from the state cancer registry. Results After median follow-up of 7.1 years, HCT survivors experienced significantly greater rates of hospitalization compared with matched non-HCT cancer survivors (280 v 173 episodes per 1,000 person-years, P < .001) and greater all-cause mortality (hazard ratio [HR], 1.1; 95% CI, 1.01 to 1.3). HCT survivors had more hospitalizations or death with infections (10-year cumulative incidence, 31% v 22%; HR, 1.4; 95% CI, 1.3 to 1.6) and respiratory complications (cumulative incidence, 27% v 20%; HR, 1.4; 95% CI, 1.2 to 1.5). Risks of digestive, skin, and musculoskeletal complications also were greater among HCT versus non-HCT cancer survivors. The two groups had similar risks of circulatory complications and second cancers. Both HCT and non-HCT cancer survivors had significantly greater 10-year cumulative incidences of all major organ-system outcomes versus the general population. Conclusion History of HCT was associated with late morbidity and mortality among cancer survivors. In particular, clinicians who care for HCT survivors should be aware of their high rates of late respiratory and infectious complications.

Parental Occupational Exposure to Heavy Metals and Welding Fumes and Risk of Testicular Germ Cell Tumors in Offspring: A Registry-Based Case-Control Study.

PubMed

Togawa, Kayo; Le Cornet, Charlotte; Feychting, Maria; Tynes, Tore; Pukkala, Eero; Hansen, Johnni; Olsson, Ann; Oksbjerg Dalton, Susanne; Nordby, Karl-Christian; Uuksulainen, Sanni; Wiebert, Pernilla; Woldbæk, Torill; Skakkebæk, Niels E; Fervers, Béatrice; Schüz, Joachim

2016-10-01

Data are scarce on the association between prenatal/preconception environmental exposure and testicular germ cell tumor (TGCT) in offspring. We examined parental occupational exposures to heavy metals and welding fumes in relation to TGCT in offspring in a registry-based case-control study (NORD-TEST Study). We identified TGCT cases diagnosed at ages 14-49 years in Finland (1988-2012), Norway (1978-2010), and Sweden (1979-2011) through nationwide cancer registries. These cases were individually matched by country and year of birth to controls selected from population registries. Information on parental occupations was retrieved from censuses. From this, we estimated prenatal/preconception exposures of chromium, iron, nickel, lead, and welding fumes (all three countries), and cadmium (Finland only) for each parent using job-exposure matrices specifying prevalence (P) and mean exposure level (L). Exposure indices were calculated as a product of P and L (P × L), and exposure categories were based on P × L or different combinations of P and L. The study comprised 8,112 cases and 26,264 controls. We observed no statistically significant TGCT risk associated with presence of heavy metals/welding fumes (P × L > 0) and no dose-response relationship (P trend ≥ 0.32). A statistically significant elevated TGCT risk was found in paternal exposure category where both P and L of chromium were high (vs. no chromium; OR = 1.37, 95% confidence interval; 1.05-1.79). Our study provides little evidence of associations between parental exposures to heavy metals/welding fumes and TGCT in offspring with the potential exception of high paternal chromium exposure. Further research on paternal chromium exposure is warranted. Cancer Epidemiol Biomarkers Prev; 25(10); 1426-34. ©2016 AACR. ©2016 American Association for Cancer Research.

Risk of MS is not associated with exposure to crude oil, but increases with low level of education.

PubMed

Riise, Trond; Kirkeleit, Jorunn; Aarseth, Jan Harald; Farbu, Elisabeth; Midgard, Rune; Mygland, Åse; Eikeland, Randi; Mørland, Tore Jørgen; Telstad, Wenche; Førland, Per Tore; Myhr, Kjell-Morten

2011-07-01

Offshore workers in the Norwegian upstream petroleum industry are exposed to a number of chemicals such as organic solvents, mineral oils and other hydrocarbons, possibly contributing to an increased risk of multiple sclerosis (MS). To estimate the risk of MS in this population compared with the general working population in Norway, adjusting for education. Using the Norwegian Registry of Employers and Employees we included all 27,900 offshore workers registered from 1981 to 2003 and 366,805 referents from the general working population matched by gender, age and community of residence. The cohort was linked to the Norwegian MS Registry and the Norwegian Education Registry. There was no increased risk of MS among the offshore workers. We found a marked and linear inverse relationship between level of education and the risk of MS in the total study population, with a rate ratio of 0.48 (95% CI, 0.53 to 0.88) for workers with a graduate degree compared to workers with elementary school only. These findings do not support a major aetiological role of petroleum-based products, but rather point to smoking and other lifestyle factors related to the level of education as being important for the risk of MS.

Type 2 diabetes mellitus is associated with increased risk of pancreatic cancer: A veteran administration registry study.

PubMed

Makhoul, Issam; Yacoub, Abdulraheem; Siegel, Eric

2016-01-01

The etiology of pancreatic cancer remains elusive. Several studies have suggested a role for diabetes mellitus, but the magnitude of its contribution remains controversial. Utilizing a large administrative database, this retrospective cohort study was designed to investigate the relationship between type 2 diabetes mellitus and pancreatic cancer. Using the Veterans Integrated Services Network 16 database, 322,614 subjects were enrolled in the study, including 110,919 with type 2 diabetes mellitus and 211,695 diabetes-free controls matched by gender, year of birth and healthcare facility. A significantly higher incidence of pancreatic cancer was observed in patients with type 2 diabetes mellitus, with an adjusted hazard ratio (95% confidence interval) of 2.17 (1.70-2.77) for type 2 diabetes mellitus compared to controls (p < 10 -9 ) after controlling for the matching factors. The association between type 2 diabetes mellitus and pancreatic cancer was statistically significant and may, in part, explain the rising incidence of pancreatic cancer.

Increased congenital heart defects in children born to women with systemic lupus erythematosus: results from the offspring of Systemic Lupus Erythematosus Mothers Registry Study.

PubMed

Vinet, Évelyne; Pineau, Christian A; Scott, Susan; Clarke, Ann E; Platt, Robert W; Bernatsky, Sasha

2015-01-13

In a large population-based study, we aimed to determine whether children born to women with systemic lupus erythematosus (SLE) have an increased risk of congenital heart defects (CHDs) in comparison with children born to women without SLE. The Offspring of SLE Mothers Registry (OSLER) includes all women who had ≥1 hospitalization for delivery after SLE diagnosis, identified through Quebec's healthcare databases (1989-2009), and a randomly selected control group of women, matched ≥4:1 for age and year of delivery. We identified children born live to SLE mothers and their matched controls, and ascertained CHD based on ≥1 hospitalization or physician visit with relevant diagnostic codes, within the first 12 months of life. We performed multivariable logistic regression analyses, using the generalized estimating equation method, to adjust for relevant covariates. Five hundred nine women with SLE had 719 children, whereas 5824 matched controls had 8493 children. In comparison with controls, children born to women with SLE experienced more CHD (5.2% [95% confidence interval (CI), 3.7-7.1] versus 1.9% [95% CI, 1.6-2.2], difference 3.3% [95% CI, 1.9-5.2]). In multivariable analyses, children born to women with SLE had a substantially increased risk of CHD (odds ratio, 2.62; 95% CI, 1.77-3.88) in comparison with controls. In addition, in comparison with controls, offspring of SLE mothers had a substantially increased risk of having a CHD repair procedure (odds ratio, 5.82; 95% CI, 1.77-19.09). In comparison with children from the general population, children born to women with SLE have an increased risk of CHD, and an increased risk of having a CHD repair procedure, as well. © 2014 American Heart Association, Inc.

Sarcoidosis diagnosed after September 11, 2001, among adults exposed to the World Trade Center disaster.

PubMed

Jordan, Hannah T; Stellman, Steven D; Prezant, David; Teirstein, Alvin; Osahan, Sukhminder S; Cone, James E

2011-09-01

Explore relationships between World Trade Center (WTC) exposures and sarcoidosis. Sarcoidosis has been reported after exposure to the WTC disaster. We ascertained biopsy-proven post-9/11 sarcoidosis among WTC Health Registry enrollees. Cases diagnosed after Registry enrollment were included in a nested case-control study. Controls were matched to cases on age, sex, race or ethnicity, and eligibility group (eg, rescue or recovery worker). We identified 43 cases of post-9/11 sarcoidosis. Twenty-eight incident cases and 109 controls were included in the case-control analysis. Working on the WTC debris pile was associated with sarcoidosis (odds ratio 9.1, 95% confidence interval 1.1 to 74.0), but WTC dust cloud exposure was not (odds ratio 1.0, 95% confidence interval 0.4 to 2.8). Working on the WTC debris pile was associated with an elevated risk of post-9/11 sarcoidosis. Occupationally exposed workers may be at increased risk. (C)2011The American College of Occupational and Environmental Medicine

ALS and the Military: A Population-Based Study in the Danish Registries

PubMed Central

Seals, Ryan M.; Kioumourtzoglou, Marianthi-Anna; Gredal, Ole; Hansen, Johnni; Weisskopf, Marc G.

2016-01-01

Background Prior studies have suggested that military service may be associated with the development of amyotrophic lateral sclerosis. We conducted a population-based case-control study in Denmark to assess whether occupation in the Danish military is associated with an increased risk of developing amyotrophic lateral sclerosis. Methods There were 3,650 incident cases of amyotrophic lateral sclerosis recorded in the Danish National Patient Registry between 1982 and 2009. Each case was matched to 100 age- and sex-matched population controls alive and free of amyotrophic lateral sclerosis on the date of the case diagnosis. Comprehensive occupational history was obtained from the Danish Pension Fund database, which began in 1964. Results 2.4% (n=8,922) of controls had a history of employment in the military prior to the index date. Military employees overall had an elevated rate of ALS (OR=1.3; 95% CI: 1.1-1.6). A ten-year increase in years employed by the military was associated with an odds ratio of 1.2 (95% CI: 1.0-1.4), and all quartiles of time employed were elevated. There was little suggestion of a pattern across calendar year of first employment, but there was some evidence that increasing age at first employment was associated with increased ALS rates. Rates were highest in the decade immediately following the end of employment (OR=1.6; 95% CI: 1.2-2.2). Conclusions In this large population-based case-control study, employment by the military is associated with increased rates of ALS. These findings are consistent with earlier findings that military service or employment may entail exposure to risk factors for ALS. PMID:26583610

Educational achievements of children of parents with multiple sclerosis: A nationwide register-based cohort study.

PubMed

Moberg, J Y; Magyari, M; Koch-Henriksen, N; Thygesen, L C; Laursen, B; Soelberg Sørensen, P

2016-11-01

Little is known about the impact of parental multiple sclerosis (MS) on offspring's educational attainment. The objective of the study was to examine educational achievements in offspring of parents with MS compared with matched children of parents without MS in a nationwide register-based cohort study. Children of all Danish-born residents with onset between 1950 and 1986 were identified by linking the Danish Multiple Sclerosis Registry with the Civil Registration System. Twins, children with MS, and emigrated persons were excluded. The reference cohort consisted of randomly drawn individuals from the Civil Registration System without parental MS matched 8:1 to the MS offspring by sex and year of birth. Information about education was linked to the cohorts from nationwide educational registries. We included 4177 children of MS parents and 33,416 reference persons. Children of MS parents achieved statistically significant higher average grades than the reference cohort in their final exam of basic school with a mean grade difference of 0.46 (95 % CI 0.22-0.69; p = 0.0002). We found no difference in achievement of educational level above basic school (OR 1.04; 95 % CI 0.98-1.10; p = 0.20). There was a trend toward more MS offspring attaining health-related educations (OR 1.10; 95 % CI 1.00-1.21; p = 0.06). In conclusion, children of MS parents showed a small advantage in grade point average in final examinations in basic school, and they more often tended toward health-related educations. This study revealed no negative consequences of parental MS on grades and highest educational level achieved.

An Innovative Approach to Improve Completeness of Treatment and Other Key Data Elements in a Population-Based Cancer Registry: A15-Month Data Submission.

PubMed

Hsieh, Mei-Chin; Mumphrey, Brent; Pareti, Lisa; Yi, Yong; Wu, Xiao-Cheng

2017-01-01

BACKGROUND: In order to comply with the Louisiana legislative obligation and meet funding agencies’ requirement of case completeness for 12-month data submission, hospital cancer registries are mandated to submit cancer incidence data to the Louisiana Tumor Registry (LTR) within 6 months of diagnosis. However, enforcing compliance with timely reporting may result in incomplete data on adjuvant treatment received by the LTR. Although additional treatment information can be obtained via retransmission of the North American Association of Central Cancer Registries (NAACCR)–modified abstracts, consolidating multiple NAACCR-modified abstracts for the same case is extremely time consuming. To avoid a huge amount of work while obtaining timely and complete data, the LTR has requested hospital cancer registries resubmit their data 15 months after the close of the diagnosis year. The purpose of this report is to assess the improvement in the completeness of data items related to treatment, staging and site specific factors. METHODS: The LTR requested that hospital cancer registries resubmit 15-month data between April 1, 2016 and April 15, 2016 for cases diagnosed in 2014. Microsoft Visual Studio Visual Basic script was used to link and compare resubmitted data with existing data in the LTR database. Data elements used for matching same patient/tumor were name, Social Security number, date of birth, primary site, laterality, and hospital identifier number. Treatment data items were compared as known vs none/ unknown and known vs known with different code. Matched records with updated information were imported into the LTR database and flagged as modified abstract records for manual consolidation. Nonmatched records were also loaded in the LTR database as potential new cases for further investigation. RESULTS: A total of 25,207 resubmitted NAACCR abstracts were received from 38 hospitals and freestanding radiation centers. About 11.1% had at least 1 update related to treatment and/or other data item; an average of 3.3 updates per updated abstract. The majority of the updates (45.7%) for treatment were changes from none/unknown to known value and 42.6% of the updates were related to radiation treatment fields. In addition, 172 potential new cases were identified. Approximately 10.5% (18 cases) of these new cases were confirmed to be truly missed cases after investigation. CONCLUSION: The 15-month data resubmission is a cost-effective approach to obtaining complete information on treatment and other key data items from reporting facilities and can also be used to identify potential missed cases.

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

PubMed

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

2017-10-01

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

Is the National Registration website (Australian Health Practitioner Regulation Agency) effective in tracking Australian medical graduates' rural work?

PubMed

Playford, Denese; Power, Phoebe; Boothroyd, Alarna; Manickavasagar, Usha; Ng, Wen Qi; Riley, Geoff

2013-10-01

This study compared rural location identified through the National Registration (AHPRA) registry with location obtained through labour-intensive personal contact. Longitudinal cohort study with two methods to identify the work locations of medical graduates from The Rural Clinical School of Western Australia (RCSWA). Consenting alumni from the University of Western Australia and the University of Notre Dame Fremantle participating in RCSWA between 2002 and 2009 inclusive and available to contact in 2011. Percentage location matches between two contact methods. There was 80% agreement for principal suburb, 92% agreement for principal city and 94% agreement for principal state between RCSWA personal contact and the AHPRA registry. AHPRA identified nearly two times as many graduate locations. However, there was only 31% agreement for a rural placement location (of any length). In more detail, for year-long rural placement, personal contact was 88% concordant with AHPRA; work six months or more were less concordant (44% agreement); work less than six months were not concordant (4% agreement). AHPRA data matched RCSWA alumni data only for graduates in full-time rural work. Since medical alumni spend up to 10 years in pre-vocational and vocational training, which includes many rural options, personal contact was able to pick up the myriad of rural choices, whereas the AHPRA database was not sensitive enough to identify them. Until graduates have stably finished training, the optimal method to identify rural work is through personal contact but statistical correction for missing data needs to be considered. © 2013 The Authors. Australian Journal of Rural Health © National Rural Health Alliance Inc.

European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis.

PubMed

Woodford Guegan, Eleanor; Cook, Andrew

2014-06-01

The European network for Health Technology Assessment Joint Action (EUnetHTA JA) project's overarching objective was to 'establish an effective and sustainable HTA [Health technology assessment] collaboration in Europe that brings added value at the regional, national and European level'. Specific objectives were to develop a strategy and business model for sustainable European collaboration on HTA, develop HTA tools and methods and promote good practice in HTA methods and processes. We describe activities performed on behalf of the National Institute for Health Research HTA programme; evaluating the project processes and developing a data set for a registry of planned clinical studies of relevance to public funders. Annual self-completion online questionnaires were sent to project participants and external stakeholders to identify their views about the project processes. Documentary review was undertaken at the project end on the final technical reports from the work packages to examine whether or not their deliverables had been achieved. The project's impact was assessed by whether or not the deliverables were produced, the objectives met and additional 'added value' generated. The project's effectiveness was evaluated by its processes, communication, administration, workings of individual work packages and involvement of external stakeholders. A two-stage Delphi exercise was undertaken to identify the data elements that should be included in a registry of planned clinical studies of relevance to public funders. The data set was validated by an efficacy testing exercise. High response rates were achieved for the questionnaires sent to project participants and this was attributed to the evidence-based strategy implemented. Response rates to questionnaires sent to external stakeholders were disappointingly lower. Most of the high-level objectives were achieved, although applying the developed tools in practice will be implemented in the European network for Health Technology Assessment Joint Action 2 (EUnetHTA JA2). Most work packages produced their planned deliverables. Networking emerged as one of the main benefits of the project and face-to-face meetings were important. However, the overarching objective did not appear to have been met because there will be a follow-up EUnetHTA JA2 project (reliant on project funding) before the establishment of any permanent network. Twelve organisations from three continents participated in the Delphi exercise to develop the data set. It was demonstrated that a registry for matching pragmatic clinical studies under consideration by funders could be built on a very small data set. This would include 10 unique items, of which five are required to describe a study and the rest are metadata. In the test sample the data set with an appropriate matching rule was able to deliver a sensitivity of between 50% and 100% and a specificity of between 43% and 86% for matching different elements. A number of recommendations have been made for the next EUnetHTA JA2 project and its evaluation. This included that the evaluation of the EUnetHTA JA2 project should extend beyond the end of the project to allow assessment of its impact; that the quality, usability and cost-effectiveness of tools in 'real-world HTA practice' should be assessed and tangible benefits of international networking should be evaluated. It is worth proceeding to develop a database registry aimed at identifying trials in development based on the data set developed. The study was funded by the National Institute for Health Research Health Technology Assessment programme (50%) and the European Union Commission (50%).

European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis.

PubMed Central

Woodford Guegan, Eleanor; Cook, Andrew

2014-01-01

BACKGROUND The European network for Health Technology Assessment Joint Action (EUnetHTA JA) project's overarching objective was to 'establish an effective and sustainable HTA [Health technology assessment] collaboration in Europe that brings added value at the regional, national and European level'. Specific objectives were to develop a strategy and business model for sustainable European collaboration on HTA, develop HTA tools and methods and promote good practice in HTA methods and processes. We describe activities performed on behalf of the National Institute for Health Research HTA programme; evaluating the project processes and developing a data set for a registry of planned clinical studies of relevance to public funders. METHODS Annual self-completion online questionnaires were sent to project participants and external stakeholders to identify their views about the project processes. Documentary review was undertaken at the project end on the final technical reports from the work packages to examine whether or not their deliverables had been achieved. The project's impact was assessed by whether or not the deliverables were produced, the objectives met and additional 'added value' generated. The project's effectiveness was evaluated by its processes, communication, administration, workings of individual work packages and involvement of external stakeholders. A two-stage Delphi exercise was undertaken to identify the data elements that should be included in a registry of planned clinical studies of relevance to public funders. The data set was validated by an efficacy testing exercise. RESULTS AND DISCUSSION High response rates were achieved for the questionnaires sent to project participants and this was attributed to the evidence-based strategy implemented. Response rates to questionnaires sent to external stakeholders were disappointingly lower. Most of the high-level objectives were achieved, although applying the developed tools in practice will be implemented in the European network for Health Technology Assessment Joint Action 2 (EUnetHTA JA2). Most work packages produced their planned deliverables. Networking emerged as one of the main benefits of the project and face-to-face meetings were important. However, the overarching objective did not appear to have been met because there will be a follow-up EUnetHTA JA2 project (reliant on project funding) before the establishment of any permanent network. Twelve organisations from three continents participated in the Delphi exercise to develop the data set. It was demonstrated that a registry for matching pragmatic clinical studies under consideration by funders could be built on a very small data set. This would include 10 unique items, of which five are required to describe a study and the rest are metadata. In the test sample the data set with an appropriate matching rule was able to deliver a sensitivity of between 50% and 100% and a specificity of between 43% and 86% for matching different elements. CONCLUSIONS A number of recommendations have been made for the next EUnetHTA JA2 project and its evaluation. This included that the evaluation of the EUnetHTA JA2 project should extend beyond the end of the project to allow assessment of its impact; that the quality, usability and cost-effectiveness of tools in 'real-world HTA practice' should be assessed and tangible benefits of international networking should be evaluated. It is worth proceeding to develop a database registry aimed at identifying trials in development based on the data set developed. FUNDING The study was funded by the National Institute for Health Research Health Technology Assessment programme (50%) and the European Union Commission (50%). PMID:24913263

The National Kidney Registry: 175 transplants in one year.

PubMed

Veale, Jeffrey; Hil, Garet

2011-01-01

Since organizing its first swap in 2008, the National Kidney Registry had facilitated 389 kidney transplants by the end of 2011 across 45 U.S. transplant centers. Rapid innovations, advanced computer technologies, and an evolving understanding of the processes at participating transplant centers and histocompatibility laboratories are among the factors driving the success of the NKR. Virtual cross match accuracy has improved from 43% to 94% as a result of improvements in the HLA typing process for donor antigens and enhanced mechanisms to list unacceptable HLA antigens for sensitized patients. By the end of 2011, the NKR had transplanted 66% of the patients enrolled since 2008. The 2011 wait time (from enrollment to transplant) for the 175 patients transplanted that year averaged 5 months.

Domain-specific Web Service Discovery with Service Class Descriptions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rocco, D; Caverlee, J; Liu, L

2005-02-14

This paper presents DynaBot, a domain-specific web service discovery system. The core idea of the DynaBot service discovery system is to use domain-specific service class descriptions powered by an intelligent Deep Web crawler. In contrast to current registry-based service discovery systems--like the several available UDDI registries--DynaBot promotes focused crawling of the Deep Web of services and discovers candidate services that are relevant to the domain of interest. It uses intelligent filtering algorithms to match services found by focused crawling with the domain-specific service class descriptions. We demonstrate the capability of DynaBot through the BLAST service discovery scenario and describe ourmore » initial experience with DynaBot.« less

Traumatic injuries among adult obese patients in southern Taiwan: a cross-sectional study based on a trauma registry system.

PubMed

Chuang, Jung-Fang; Rau, Cheng-Shyuan; Kuo, Pao-Jen; Chen, Yi-Chun; Hsu, Shiun-Yuan; Hsieh, Hsiao-Yun; Hsieh, Ching-Hua

2016-03-18

The adverse impact of obesity has been extensively studied in the general population; however, the added risk of obesity on trauma-related mortality remains controversial. This study investigated and compared mortality as well injury patterns and length of stay (LOS) in obese and normal-weight patients hospitalized for trauma in the hospital and intensive care unit (ICU) of a Level I trauma center in southern Taiwan. Detailed data of 880 obese adult patients with body mass index (BMI) ≥ 30 kg/m(2) and 5391 normal-weight adult patients (25 > BMI ≥ 18.5 kg/m(2)) who had sustained a trauma injury between January 1, 2009 and December 31, 2013 were retrieved from the Trauma Registry System. Pearson's chi-squared, Fisher's exact, and independent Student's t-tests were used to compare differences between groups. Propensity score matching with logistic regression was used to evaluate the effect of obesity on mortality. In this study, obese patients were more often men, motorcycle riders and pedestrians, and had a lower proportion of alcohol intoxication compared to normal-weight patients. Analysis of Abbreviated Injury Scale scores revealed that obese trauma patients presented with a higher rate of injury to the thorax, but a lower rate of facial injuries than normal-weight patients. No significant differences were found between obese and normal-weight patients regarding Injury Severity Score (ISS), Trauma-Injury Severity Score (TRISS), mortality, the proportion of patients admitted to the ICU, or LOS in ICU. After propensity score matching, logistic regression of 66 well-matched pairs did not show a significant influence of obesity on mortality (odds ratio: 1.51, 95% confidence interval: 0.54-4.23 p = 0.438). However, significantly longer hospital LOS (10.6 vs. 9.5 days, respectively, p = 0.044) was observed in obese patients than in normal-weight patients, particularly obese patients with pelvic, tibial, or fibular fractures. Compared to normal-weight patients, obese patients presented with different injury characteristics and bodily injury patterns but no difference in mortality.

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

PubMed Central

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

2015-01-01

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

Childhood cancer registration in New Zealand: A registry collaboration to assess and improve data quality.

PubMed

Ballantine, Kirsten R; Hanna, Susan; Macfarlane, Scott; Bradbeer, Peter; Teague, Lochie; Hunter, Sarah; Cross, Siobhan; Skeen, Jane

2018-06-11

To evaluate the completeness and accuracy of child cancer registration in New Zealand. Registrations for children aged 0-14 diagnosed between 1/1/2010 and 31/12/2014 were obtained from the New Zealand Cancer Registry (NZCR) and the New Zealand Children's Cancer Registry (NZCCR). Six key data fields were matched using National Health Index numbers in order to identify and resolve registration discrepancies. Capture-recapture methods were used to assess the completeness of cancer registration. 794 unique cases were reported; 718 from the NZCR, 721 from the NZCCR and 643 from both registries. 27 invalid cancer registrations were identified, including 19 residents of the Pacific Islands who had travelled to New Zealand for treatment. The NZCCR provided 55 non-malignant central nervous system tumour and 16 Langerhans cell histiocytosis cases which were not registered by the NZCR. The NZCR alerted the NZCCR to 18 cases missed due to human error and 23 cases that had not been referred to the specialist paediatric oncology centres. 762 cases were verified as true incident cases, an incidence rate of 166.8 per million. Registration accuracy for six key data fields was 98.6%. According to their respective inclusion criteria case completeness was 99.3% for the NZCR and 94.4% for the NZCCR. For childhood malignancies covered by both registries, capture-recapture methods estimated case ascertainment at greater than 99.9%. With two national registries covering childhood cancers, New Zealand is uniquely positioned to undertake regular cooperative activities to ensure high quality data is available for research and patient care. Copyright © 2018 Elsevier Ltd. All rights reserved.

Determinants of first trimester attendance at antenatal care clinics in the Amazon region of Peru: A case-control study

PubMed Central

Moore, Nora; Blouin, Brittany; Razuri, Hugo; Casapia, Martin; Gyorkos, Theresa W.

2017-01-01

Objective To identify determinants which influence the timing of the first antenatal care (ANC) visit in pregnant women. Design Retrospective matched nested case-control study. Setting Two health centres, Belén and 6 de Octubre, in the Peruvian Amazon. Population All pregnant women who had attended ANC during the years 2010, 2011, and 2012. Methods All cases (819 women initiating ANC in their first trimester) were selected from ANC registries from 2010 to 2012. A random sample of controls (819 women initiating ANC in their second or third trimester) was matched 1:1 to cases on health centre and date of first ANC visit. Data were obtained from ANC registries. Conditional logistic regression analyses were performed. Main outcome measure Case-control status of each woman determined by the gestational age at first ANC visit. Results Cases had higher odds of: 1) being married or cohabiting (aOR = 1.69; 95% CI: 1.19, 2.41); 2) completing secondary school or attending post-secondary school (aOR = 1.45; 95% CI: 1.02, 2.06); 3) living in an urban environment (aOR = 1.79; 95% CI: 1.04, 3.10) and 4) having had a previous miscarriage (aOR = 1.56; 95% CI: 1.13, 2.15), compared to controls. No statistically significant difference in odds was found for parity (aOR = 1.08; 95% CI: 0.85, 1.36). Conclusions This study provides empirical evidence of determinants of first ANC attendance. These findings are crucial to the planning and timing of local interventions, like deworming, aimed at pregnant women so that they can access and benefit fully from all government-provided ANC services. PMID:28207749

Determinants of first trimester attendance at antenatal care clinics in the Amazon region of Peru: A case-control study.

PubMed

Moore, Nora; Blouin, Brittany; Razuri, Hugo; Casapia, Martin; Gyorkos, Theresa W

2017-01-01

To identify determinants which influence the timing of the first antenatal care (ANC) visit in pregnant women. Retrospective matched nested case-control study. Two health centres, Belén and 6 de Octubre, in the Peruvian Amazon. All pregnant women who had attended ANC during the years 2010, 2011, and 2012. All cases (819 women initiating ANC in their first trimester) were selected from ANC registries from 2010 to 2012. A random sample of controls (819 women initiating ANC in their second or third trimester) was matched 1:1 to cases on health centre and date of first ANC visit. Data were obtained from ANC registries. Conditional logistic regression analyses were performed. Case-control status of each woman determined by the gestational age at first ANC visit. Cases had higher odds of: 1) being married or cohabiting (aOR = 1.69; 95% CI: 1.19, 2.41); 2) completing secondary school or attending post-secondary school (aOR = 1.45; 95% CI: 1.02, 2.06); 3) living in an urban environment (aOR = 1.79; 95% CI: 1.04, 3.10) and 4) having had a previous miscarriage (aOR = 1.56; 95% CI: 1.13, 2.15), compared to controls. No statistically significant difference in odds was found for parity (aOR = 1.08; 95% CI: 0.85, 1.36). This study provides empirical evidence of determinants of first ANC attendance. These findings are crucial to the planning and timing of local interventions, like deworming, aimed at pregnant women so that they can access and benefit fully from all government-provided ANC services.

Use of recombinant factor VIIA for control of combat-related haemorrhage.

PubMed

Woodruff, Susan I; Dougherty, Amber L; Dye, Judy L; Mohrle, Charlene R; Galarneau, Michael R

2010-02-01

Recombinant activated human coagulation factor VII (rFVIIa), an intravascular strategy to promote clotting, is being used as an adjunct to surgical control of bleeding in combat trauma patients. To describe the initial experiences with rFVIIa administered to combat casualties at US Navy-Marine Corps medical treatment facilities in Iraq, and to compare survival outcomes of those treated with rFVIIa to controls not receiving rFVIIa. Medical encounter data from the US Navy-Marine Corps Combat Trauma Registry were retrospectively reviewed to identify all battle-injured patients documented as having received rFVIIa during the period May 2004 to January 2006 of Operation Iraqi Freedom. Available clinical and injury related data are presented to characterise the patients. To assess effects of rFVIIa on survival outcomes, rFVIIa cases were matched to controls on injury severity and age. 22 battle-injured patients from the Combat Trauma Registry received rFVIIa. Primarily young US Marines, these patients typically had penetrating injuries from improvised explosive devices and gunshot wounds. Injuries were often abdominal. The average dose used was similar to that reported in another study of civilian trauma patients, although dosing varies widely in the existing experimental and anecdotal literature. Over two-thirds (68%) of the rFVIIa patients survived-an identical outcome seen for a matched control group of 22 patients. Survival of seriously injured combat casualties was good, although identical to that of a control group. Methodological limitations of this retrospective study preclude making firm conclusions about the effectiveness of rFVIIa. Future controlled studies are needed for safety and efficacy testing of rFVIIa in combat trauma patients.

Impact of case volume on outcome and performance of targeted temperature management in out-of-hospital cardiac arrest survivors.

PubMed

Lee, Seung Joon; Jeung, Kyung Woon; Lee, Byung Kook; Min, Yong Il; Park, Kyu Nam; Suh, Gil Joon; Kim, Kyung Su; Kang, Gu Hyun

2015-01-01

This study aimed to determine the effect of case volume on targeted temperature management (TTM) performance, incidence of adverse events, and neurologic outcome in comatose out-of-hospital cardiac arrest (OHCA) survivors treated with TTM. We used a Web-based, multicenter registry (Korean Hypothermia Network registry), to which 24 hospitals throughout the Republic of Korea participated to study adult (≥18 years) comatose out-of-hospital cardiac arrest patients treated with TTM between 2007 and 2012. The primary outcome was neurologic outcome at hospital discharge. The secondary outcomes were inhospital mortality, TTM performance, and adverse events. We extracted propensity-matched cohorts to control for bias. Multivariate logistic regression analysis was performed to assess independent risk factors for neurologic outcome. A total of 901 patients were included in this study; 544 (60.4%) survived to hospital discharge, and 248 (27.5%) were discharged with good neurologic outcome. The high-volume hospitals initiated TTM significantly earlier and had lower rates of hyperglycemia, bleeding, hypotension, and rebound hyperthermia. However, neurologic outcome and inhospital mortality were comparable between high-volume (27.7% and 44.6%, respectively) and low-volume hospitals (21.1% and 40.5%) in the propensity-matched cohorts. The adjusted odds ratio for the high-volume hospitals compared with low-volume hospitals was 1.506 (95% confidence interval, 0.875-2.592) for poor neurologic outcome. Higher TTM case volume was significantly associated with early initiation of TTM and lower incidence of adverse events. However, case volume had no association with neurologic outcome and inhospital mortality. Copyright © 2014 Elsevier Inc. All rights reserved.

Disease-related costs of care and survival among Medicare-enrolled patients with myelodysplastic syndromes.

PubMed

Zeidan, Amer M; Wang, Rong; Davidoff, Amy J; Ma, Shuangge; Zhao, Yinjun; Gore, Steven D; Gross, Cary P; Ma, Xiaomei

2016-05-15

Although newer treatments for myelodysplastic syndromes (MDS), particularly hypomethylating agents (HMAs), are expensive, it is unclear whether MDS-related costs of care are associated with overall survival. This study evaluated the relation between MDS-related costs and survival among Medicare beneficiaries with MDS. Eligible patients were identified from the Surveillance, Epidemiology, and End Results-Medicare database with codes for MDS from International Classification of Diseases for Oncology, 3rd edition. The patients were diagnosed between January 1, 2005 and December 31, 2011, were 66 years old or older, and were followed through death or the end of study (December 31, 2012). Medicare payments were used to estimate costs. Cumulative costs in a propensity score-matched group of cancer-free Medicare beneficiaries were subtracted from costs in the MDS cohort in each registry to estimate MDS-related costs. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived from multivariate Cox proportional hazards models adjusted for patient and disease characteristics. There were 8580 eligible patients, and 1,267 (14.7%) received HMAs. The overall 2-year survival rate was 48.7%, and the 2-year registry-specific MDS-related cost per patient ranged from $40,793 to $78,156 across 16 registries. The 2-year MDS-related cost was not associated with survival in the overall study population (first tertile, reference; second tertile, HR, 0.96; 95% CI, 0.89-1.04; P = .29; third tertile, HR, 0.98; 95% CI, 0.91-1.06; P = .64) or in subgroups of patients who did or did not receive HMAs. Medicare expenditures for elderly patients with MDS varied across registries but were not associated with survival. A lack of an association between costs and outcomes warrants additional research because it may help to identify potential areas for cost-saving interventions without compromising patient outcomes. Cancer 2016;122:1598-607. © 2016 American Cancer Society. © 2016 American Cancer Society.

Association of High-Dose Ibuprofen Use, Lung Function Decline, and Long-Term Survival in Children with Cystic Fibrosis.

PubMed

Konstan, Michael W; VanDevanter, Donald R; Sawicki, Gregory S; Pasta, David J; Foreman, Aimee J; Neiman, Evgueni A; Morgan, Wayne J

2018-04-01

Cystic fibrosis deaths result primarily from lung function loss, so chronic respiratory therapies, intended to preserve lung function, are cornerstones of cystic fibrosis care. Although treatment-associated reduction in rate of lung function loss should ultimately improve cystic fibrosis survival, no such relationship has been described for any chronic cystic fibrosis therapy. In part, this is because the ages of most rapid lung function decline-early adolescence-precede the median age of cystic fibrosis deaths by more than a decade. To study associations of high-dose ibuprofen treatment with the rate of forced expiratory volume in 1 second decline and mortality among children followed in the Epidemiologic Study of Cystic Fibrosis and subsequently in the U.S. Cystic Fibrosis Foundation Patient Registry. We performed a matched cohort study using data from Epidemiologic Study of Cystic Fibrosis. Exposure was defined as high-dose ibuprofen use reported at ≥80% of encounters over 2 years. Unexposed children were matched to exposed children 5:1 using propensity scores on the basis of demographic, clinical, and treatment covariates. The rate of decline of percent predicted forced expiratory volume in 1 second during the 2-year follow-up period was estimated by mixed-effects modeling with random slopes and intercepts. Survival over 16 follow-up years in the U.S. Cystic Fibrosis Foundation Patient Registry was compared between treatment groups by using proportional hazards modeling controlling for matching and covariates. We included 775 high-dose ibuprofen users and 3,665 nonusers who were well matched on demographic, clinical, and treatment variables. High-dose ibuprofen users declined on average 1.10 percent predicted forced expiratory volume in 1 second/yr (95% confidence interval; 0.51, 1.69) during the 2-year treatment period, whereas nonusers declined at a rate of 1.76% percent predicted forced expiratory volume in 1 second/yr (95% confidence interval; 1.48, 2.04) during the corresponding 2-year period, a 37.5% slower decline among users compared with nonusers (95% confidence interval; 0.4%, 71.3%; P = 0.046). The users had better subsequent survival (P < 0.001): the unadjusted and adjusted hazard ratios for mortality (high-dose ibuprofen/non-high-dose ibuprofen) (95% confidence interval) were 0.75 (0.64, 0.87) and 0.82 (0.69, 0.96). In a propensity-score matched cohort study of children with cystic fibrosis, we observed an association between high-dose ibuprofen use and both slower lung function decline and improved long-term survival. These results are consistent with the hypothesis that treatment-associated reduction of lung function decline in children with cystic fibrosis leads to improved survival.

Outcome of prosthesis matched and unmatched patella components in primary and revision total knee replacement.

PubMed

Lewis, Peter L; Gamboa, Ai E; Campbell, David G; Lorimer, Michelle

2017-10-01

Although knee replacements have specifically designed patella prostheses that correspond to the geometry of their femoral components, a patella prosthesis that is unmatched to the femoral component may occasionally be inserted. In revision total knee arthroplasty (TKA), an originally resurfaced patella may be left, but the femoral component revised to one that does not match the patella. Few studies have compared the outcome of matched and unmatched patella components in TKA. This study compared the primary or revision TKA outcome of procedures where patella components matched to their femoral counterparts were inserted, with procedures using patella and femoral components that were unmatched. Data on all primary and revision TKA procedures without a patella component or a matched or an unmatched patella component were obtained from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Revision surgery was the outcome measure. Cumulative percent revised (CPR) were calculated and Hazard ratios with p values were used to test statistical significance. In primary TKA, there were higher rates of revision where unmatched patella components were used, regardless of implant design. There was no difference in the second revision rates of unmatched versus matched patella component groups. This was evident where delayed resurfacing was carried out, and where the patella prosthesis was left alone but the femoral component was changed. All primary TKA procedures require a patella component corresponding to the femoral component if the patella is resurfaced. Conversely, revision knee arthroplasties are not affected by the use of dissimilar patella and femoral components. Copyright © 2017 Elsevier B.V. All rights reserved.

HLA AND CROSS·REACTIVE ANTIGEN GROUP MATCHING FOR CADAVER KIDNEY ALLOCATION1

PubMed Central

Starzl, Thomas E.; Eliasziw, Michael; Gjertson, David; Terasaki, Paul I.; Fung, John J.; Trucco, Massimo; Martell, Joan; McMichael, John; Scantlebury, Velma; Shapiro, Ron; Donner, Allan

2010-01-01

Background Allocation of cadaver kidneys by graded human leukocyte antigen (HLA) compatibility scoring arguably has had little effect on overall survival while prejudicing the transplant candidacy of African-American and other hard to match populations. Consequently, matching has been proposed of deduced amino acid residues of the individual HLA molecules shared by cross-reactive antigen groups (CREGs). We have examined the circumstances under which compatibility with either method impacted graft survival. Methods Using Cox proportional hazards regression modeling, we studied the relationship between levels of conventional HLA mismatch and other donor and recipient factors on primary cadaver kidney survival between 1981 and 1995 at the University of Pittsburgh (n=1,780) and in the United Network for Organ Sharing (UNOS) Scientific Registry during 1991–1995 (n=31,291). The results were compared with those obtained by the matching of amino acid residues that identified CREG-compatible cases with as many as four (but not five and six) HLA mismatches. Results With more than one HLA mismatch (>85% of patients in both series), most of the survival advantage of a zero mismatch was lost. None of the HLA loci were “weak.” In the UNOS (but not Pittsburgh) category of one-HLA mismatch (n=1334), a subgroup of CREG-matched recipients (35.3%) had better graft survival than the remaining 64.7%, who were CREG-mismatched. There was no advantage of a CREG match in the two- to four-HLA incompatibility tiers. Better graft survival with tacrolimus was observed in both the Pittsburgh and UNOS series. Conclusions Obligatory national sharing of cadaver kidneys is justifiable only for zero-HLA-mismatched kidneys. The potential value of CREG matching observed in the one-HLA-mismatched recipients of the UNOS (but not the Pittsburgh) experience deserves further study. PMID:9381546

A Directory of Sources of Information and Data Bases on Education and Training.

DTIC Science & Technology

1980-09-01

ACADO07 National Opinion Research Center (NORC) ... ............. ... ACADOO8 U of California Union Catalog Supp. (1963-1967...Records (RSR) ...... .................. ... ARMYO30 Union Central Registry System (UCRSYS) .... .............. ... ARMY032 Training Control Card Report...research. Your query directs a computer search of the Compre- hensive Dissertation Database. The search produces a list of all titles matching your

Risk and Timing of Tuberculosis Among Close Contacts of Persons with Infectious Tuberculosis.

PubMed

Reichler, Mary R; Khan, Awal; Sterling, Timothy R; Zhao, Hui; Moran, Joyce; McAuley, James; Bessler, Patricia; Mangura, Bonita

2018-05-15

The risk and timing of tuberculosis (TB) among recently exposed close contacts of patients with infectious TB is not well established. We prospectively enrolled culture-confirmed pulmonary TB patients ≥15 years of age and their close contacts at nine health departments in the United States and Canada. Close contacts were screened and cross-matched with TB registries to identify those who developed TB. TB was diagnosed in 158 (4%) of 4490 contacts to 718 index TB patients. Of those with TB, cumulative totals of 81 (51%), 119 (75%), 128 (81%) and 145 (92%) were diagnosed by 1, 3, 6, and 12 months after index case diagnosis, respectively. TB rates among contacts were 2644, 115, 46, 69, and 25 per 100,000 persons, respectively, in the five consecutive years after index patient diagnosis. Of the TB cases among contacts, 121 (77%) were identified by contact investigation and 37 (23%) by TB registry cross-match. Close contacts to infectious TB patients had high rates of TB, with most disease diagnosed before or within 3 months after index patient diagnosis. Contact investigations need to be prompt to detect TB and maximize the opportunity to identify and treat latent infection in order to prevent disease.

Influence of alcohol use on mortality and expenditure during hospital admission: a cross-sectional study

PubMed Central

Peng, Shu-Hui; Hsu, Shiun-Yuan; Kuo, Pao-Jen; Rau, Cheng-Shyuan; Cheng, Ya-Ai; Hsieh, Ching-Hua

2016-01-01

Objectives This study was designed to investigate the effect of alcohol intoxication on clinical presentation of hospitalised adult trauma patients at a Level I trauma centre using propensity score matching. Design Cross-sectional study. Setting Taiwan. Participants Detailed data of 929 hospitalised adult trauma patients with alcohol intoxication, aged 20–65 years, and 10 104 corresponding patients without alcohol intoxication were retrieved from the Trauma Registry System between 1 January 2009 and 31 December 2014. Alcohol intoxication was defined as a blood alcohol concentration (BAC) ≥50 mg/dL. Main outcome measures In-hospital mortality and expenditure. Results Patients with alcohol intoxication presented with significantly higher short-term mortality (OR: 3.0, 95% CI 2.0 to 4.4; p<0.001) than patients without alcohol intoxication. However, on comparison with propensity score-matched patients with respect to sex, age, comorbidity, Glasgow Coma Scale (GCS), injury region based on Abbreviated Injury Scale (AIS) and Injury Severity Score (ISS), alcohol intoxication did not significantly influence mortality (OR: 0.8, 95% CI 0.5 to 1.4; p=0.563). This implied that the higher mortality of alcohol-intoxicated patients was attributable to patient characteristics such as a higher injury severity rather than alcohol intoxication. Even on comparison with sex-matched, age-matched and comorbidity-matched patients without alcohol intoxication, patients with alcohol intoxication still had significantly higher total expenditure (17.4% higher), cost of operation (40.3% higher), cost of examination (52.8% higher) and cost of pharmaceuticals (38.3% higher). Conclusions The associated higher mortality of adult trauma patients with alcohol intoxication was completely attributable to other patient characteristics and associated injury severity rather than the effects of alcohol. However, patients with alcohol intoxication incurred significantly higher expenditure than patients without alcohol intoxication, even on comparison with sex-matched, age-matched and comorbidity-matched patients without alcohol intoxication. PMID:27803110

Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Replacement: The German Aortic Valve Registry.

PubMed

Husser, Oliver; Fujita, Buntaro; Hengstenberg, Christian; Frerker, Christian; Beckmann, Andreas; Möllmann, Helge; Walther, Thomas; Bekeredjian, Raffi; Böhm, Michael; Pellegrini, Costanza; Bleiziffer, Sabine; Lange, Rüdiger; Mohr, Friedrich; Hamm, Christian W; Bauer, Timm; Ensminger, Stephan

2018-03-26

The aims of this study were to report on the use of local anesthesia or conscious sedation (LACS) and general anesthesia in transcatheter aortic valve replacement and to analyze the impact on outcome. Transcatheter aortic valve replacement can be performed in LACS or general anesthesia. Potential benefits of LACS, such as faster procedures and shorter hospital stays, need to be balanced with safety. A total of 16,543 patients from the German Aortic Valve Registry from 2011 to 2014 were analyzed, and propensity-matched analyses were performed to correct for potential selection bias. LACS was used in 49% of patients (8,121 of 16,543). In hospital, LACS was associated with lower rates of low-output syndrome, respiratory failure, delirium, cardiopulmonary resuscitation, and death. There was no difference in paravalvular leakage (II+) between LACS and general anesthesia in the entire population (5% vs. 4.8%; p = 0.76) or in the matched population (3.9% vs. 4.9%, p = 0.13). The risk for prolonged intensive care unit stay (≥3 days) was significantly reduced with LACS (odds ratio: 0.82; 95% confidence interval [CI]: 0.73 to 0.92; p = 0.001). Thirty-day mortality was lower with LACS in the entire population (3.5% vs. 4.9%; hazard ratio [HR]: 0.72; 95% CI: 0.60 to 0.86; p < 0.001) and in the matched population (2.8% vs. 4.6%; HR: 0.6; 95% CI: 0.45 to 0.8; p < 0.001). However, no differences in 1-year mortality between both groups in the entire population (16.5% vs. 16.9%; HR: 0.93; 95% CI: 0.85 to 1.02; p = 0.140) and in the propensity-matched population (14.1% vs. 15.5%; HR: 0.90; 95% CI: 0.78 to 1.03; p = 0.130) were observed. Use of LACS in transcatheter aortic valve replacement is safe, with fewer post-procedural complications and lower early mortality, suggesting its broad application. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Acute myeloid leukemia risk by industry and occupation.

PubMed

Tsai, Rebecca J; Luckhaupt, Sara E; Schumacher, Pam; Cress, Rosemary D; Deapen, Dennis M; Calvert, Geoffrey M

2014-11-01

Acute myeloid leukemia (AML) is the most common type of leukemia found in adults. Identifying jobs that pose a risk for AML may be useful for identifying new risk factors. A matched case-control analysis was conducted using California Cancer Registry data from 1988 to 2007. This study included 8999 cases of AML and 24 822 controls. Industries with a statistically significant increased AML risk were construction (matched odds ratio [mOR] = 1.13); crop production (mOR = 1.41); support activities for agriculture and forestry (mOR = 2.05); and animal slaughtering and processing (mOR = 2.09). Among occupations with a statistically significant increased AML risk were miscellaneous agricultural workers (mOR = 1.76); fishers and related fishing workers (mOR = 2.02); nursing, psychiatric and home health aides (mOR = 1.65); and janitors and building cleaners (mOR = 1.54). Further investigation is needed to confirm study findings and to identify specific exposures responsible for the increased risks.

Acute myeloid leukemia risk by industry and occupation

PubMed Central

Tsai, Rebecca J.; Luckhaupt, Sara E.; Schumacher, Pam; Cress, Rosemary D.; Deapen, Dennis M.; Calvert, Geoffrey M.

2015-01-01

Acute myeloid leukemia (AML) is the most common type of leukemia found in adults. Identifying jobs that pose a risk for AML may be useful for identifying new risk factors. A matched case–control analysis was conducted using California Cancer Registry data from 1988 to 2007. This study included 8999 cases of AML and 24 822 controls. Industries with a statistically significant increased AML risk were construction (matched odds ratio [mOR] = 1.13); crop production (mOR = 1.41); support activities for agriculture and forestry (mOR = 2.05); and animal slaughtering and processing (mOR = 2.09). Among occupations with a statistically significant increased AML risk were miscellaneous agricultural workers (mOR = 1.76); fishers and related fishing workers (mOR = 2.02); nursing, psychiatric and home health aides (mOR = 1.65); and janitors and building cleaners (mOR = 1.54). Further investigation is needed to confirm study findings and to identify specific exposures responsible for the increased risks. PMID:24547710

Benefit of immediate coronary angiography after out-of-hospital cardiac arrest in France: A nationwide propensity score analysis from the RéAC Registry.

PubMed

Jaeger, Déborah; Dumas, Florence; Escutnaire, Josephine; Sadoune, Sonia; Lauvray, Adrien; Elkhoury, Carlos; Bassand, Adrien; Girerd, Nicolas; Gueugniaud, Pierre Yves; Tazarourte, Karim; Hubert, Hervé; Cariou, Alain; Chouihed, Tahar

2018-05-01

The survival rate of out-of-hospital cardiac arrest (OHCA) remains extremely low, generally under 10%. Post-resuscitation care, and particularly early coronary reperfusion, may improve this outcome. The main objective of the present study was to determine whether patients with immediate coronary angiography at hospital admission (CAA) had a better outcome than patients without immediate CAA. This cohort analysis study was based on data extracted from the French National Cardiac Arrest registry (RéAC). To control for attribution bias, patients were matched using a propensity score, which included age clusters, low flow and no flow delays, initial rhythm and bystander cardiopulmonary resuscitation (CPR). The main endpoint was survival at day 30 (D30). Secondary endpoint was neurological recovery of survivors assessed by the Cerebral Performance Category (CPC) scale, with CPC 1 and 2 at D30 considered as a favorable outcome. From July 1st, 2011 to October 1st, 2016, 63394 OHCA were registered in the database, of which 39444 were of an unknown or suspected cardiac origin. After on-site resuscitation by a mobile medical team, 7584 patients were transported to a hospital facility. Among these patients, 4046 were retained in the analysis after matching for the aforementioned factors and constituted into 2 groups: immediate coronary angiography (iCAA) group (n = 2023) and non-immediate coronary angiography (niCAA) group (n = 2023). The survival rate at D30 after matching was 43.3% in the iCAA group versus 34.5% in the niCAA group (OD = 0.66 [0.58; 0.75], p < 0.001). In the iCAA group, (n = 707) 36% of the patients at D30 were CPC 1-2 comparatively to (n = 539) 27.3% in the niCAA group (p < 0.01). Both the survival and proportion of patients with favorable neurological recovery were significantly higher in patients who underwent an immediate coronary angiography after a resuscitated OHCA. These observational results warrant further exploration of the benefit of this invasive strategy in randomized studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Kidney Disease Among Registered Métis Citizens of Ontario: A Population-Based Cohort Study

PubMed Central

Hayward, Jade S.; McArthur, Eric; Nash, Danielle M.; Sontrop, Jessica M.; Russell, Storm J.; Khan, Saba; Walker, Jennifer D.; Nesrallah, Gihad E.; Sood, Manish M.; Garg, Amit X.

2017-01-01

Background: Indigenous peoples in Canada have higher rates of kidney disease than non-Indigenous Canadians. However, little is known about the risk of kidney disease specifically in the Métis population in Canada. Objective: To compare the prevalence of chronic kidney disease and incidence of acute kidney injury and end-stage kidney disease among registered Métis citizens in Ontario and a matched sample from the general Ontario population. Design: Population-based, retrospective cohort study using data from the Métis Nation of Ontario’s Citizenship Registry and administrative databases. Setting: Ontario, Canada; 2003-2013. Patients: Ontario residents ≥18 years. Measurements: Prevalence of chronic kidney disease and incidence of acute kidney injury and end-stage kidney disease. Secondary outcomes among patients hospitalized with acute kidney injury included non-recovery of kidney function and mortality within 1 year of discharge. Methods: Database codes and laboratory values were used to determine study outcomes. Métis citizens were matched (1:4) to Ontario residents on age, sex, and area of residence. The analysis included 12 229 registered Métis citizens and 48 916 adults from the general population. Results: We found the prevalence of chronic kidney disease was slightly higher among Métis citizens compared with the general population (3.1% vs 2.6%, P = 0.002). The incidence of acute kidney injury was 1.2 per 1000 person-years in both Métis citizens and the general population (P = 0.54). Of those hospitalized with acute kidney injury, outcomes were similar among Métis citizens and the general population except 1-year mortality, which was higher for Métis citizens (24.5% vs 15.3%, P = 0.03). The incidence of end-stage kidney disease did not differ between groups (<3.0 per 10 000 person-years, P = 0.73). Limitations: The Métis Nation of Ontario Citizenship Registry only captures about 20% of Métis people in Ontario. Administrative health care codes used to identify kidney disease are highly specific but have low sensitivity. Conclusions: Rates of kidney disease were similar or slightly higher for Métis citizens in Ontario compared with the matched general population. PMID:28491337

Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

PubMed Central

Kalincik, Tomas; Jokubaitis, Vilija; Zhang, Annie; Pellegrini, Fabio; Wiendl, Heinz; Belachew, Shibeshih; Hyde, Robert; Verheul, Freek; Lugaresi, Alessandra; Havrdová, Eva; Horáková, Dana; Grammond, Pierre; Duquette, Pierre; Prat, Alexandre; Iuliano, Gerardo; Terzi, Murat; Izquierdo, Guillermo; Hupperts, Raymond M.M.; Boz, Cavit; Pucci, Eugenio; Giuliani, Giorgio; Sola, Patrizia; Spitaleri, Daniele L.A.; Lechner-Scott, Jeannette; Bergamaschi, Roberto; Grand'Maison, François; Granella, Franco; Kappos, Ludwig; Trojano, Maria; Butzkueven, Helmut

2016-01-01

Abstract Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-β (IFN-β)/glatiramer acetate (GA) therapies, using propensity score–matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-β/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ≥3 months of on-treatment follow-up, and had active RRMS, defined as ≥1 gadolinium-enhancing lesion on cerebral MRI at baseline or ≥1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity. Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-β/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28–0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58–0.93; p = 0.01), compared with first-line IFN-β/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale–time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups. Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-β/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients. Classification of evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-β/GA. PMID:27104064

Targeted next-generation sequencing reveals MODY in up to 6.5% of antibody-negative diabetes cases listed in the Norwegian Childhood Diabetes Registry.

PubMed

Johansson, Bente B; Irgens, Henrik U; Molnes, Janne; Sztromwasser, Paweł; Aukrust, Ingvild; Juliusson, Petur B; Søvik, Oddmund; Levy, Shawn; Skrivarhaug, Torild; Joner, Geir; Molven, Anders; Johansson, Stefan; Njølstad, Pål R

2017-04-01

MODY can be wrongly diagnosed as type 1 diabetes in children. We aimed to find the prevalence of MODY in a nationwide population-based registry of childhood diabetes. Using next-generation sequencing, we screened the HNF1A, HNF4A, HNF1B, GCK and INS genes in all 469 children (12.1%) negative for both GAD and IA-2 autoantibodies and 469 antibody-positive matched controls selected from the Norwegian Childhood Diabetes Registry (3882 children). Variants were classified using clinical diagnostic criteria for pathogenicity ranging from class 1 (neutral) to class 5 (pathogenic). We identified 58 rare exonic and splice variants in cases and controls. Among antibody-negative patients, 6.5% had genetic variants of classes 3-5 (vs 2.4% in controls; p = 0.002). For the stricter classification (classes 4 and 5), the corresponding number was 4.1% (vs 0.2% in controls; p = 1.6 × 10 -5 ). HNF1A showed the strongest enrichment of class 3-5 variants, with 3.9% among antibody-negative patients (vs 0.4% in controls; p = 0.0002). Antibody-negative carriers of variants in class 3 had a similar phenotype to those carrying variants in classes 4 and 5. This is the first study screening for MODY in all antibody-negative children in a nationwide population-based registry. Our results suggest that the prevalence of MODY in antibody-negative childhood diabetes may reach 6.5%. One-third of these MODY cases had not been recognised by clinicians. Since a precise diagnosis is important for treatment and genetic counselling, molecular screening of all antibody-negative children should be considered in routine diagnostics.

Semi-Automated Annotation of Biobank Data Using Standard Medical Terminologies in a Graph Database.

PubMed

Hofer, Philipp; Neururer, Sabrina; Goebel, Georg

2016-01-01

Data describing biobank resources frequently contains unstructured free-text information or insufficient coding standards. (Bio-) medical ontologies like Orphanet Rare Diseases Ontology (ORDO) or the Human Disease Ontology (DOID) provide a high number of concepts, synonyms and entity relationship properties. Such standard terminologies increase quality and granularity of input data by adding comprehensive semantic background knowledge from validated entity relationships. Moreover, cross-references between terminology concepts facilitate data integration across databases using different coding standards. In order to encourage the use of standard terminologies, our aim is to identify and link relevant concepts with free-text diagnosis inputs within a biobank registry. Relevant concepts are selected automatically by lexical matching and SPARQL queries against a RDF triplestore. To ensure correctness of annotations, proposed concepts have to be confirmed by medical data administration experts before they are entered into the registry database. Relevant (bio-) medical terminologies describing diseases and phenotypes were identified and stored in a graph database which was tied to a local biobank registry. Concept recommendations during data input trigger a structured description of medical data and facilitate data linkage between heterogeneous systems.

Impact of prestroke selective serotonin reuptake inhibitor treatment on stroke severity and mortality.

PubMed

Mortensen, Janne Kaergaard; Larsson, Heidi; Johnsen, Søren Paaske; Andersen, Grethe

2014-07-01

Selective serotonin reuptake inhibitors (SSRIs) have been associated with an increased risk of bleeding but also a possible neuroprotective effect in stroke. We aimed to examine the implications of prestroke SSRI use in hemorrhagic and ischemic stroke. We conducted a registry-based propensity score-matched follow-up study among first-ever patients with hemorrhage and ischemic stroke in Denmark (2003-2012). Multiple conditional logistic regression was used to compute adjusted odds ratios of severe stroke and death within 30 days. Among 1252 hemorrhagic strokes (626 prestroke SSRI users and 626 propensity score-matched nonusers), prestroke SSRI use was associated with an increased risk of the strokes being severe (adjusted propensity score-matched odds ratios, 1.41; confidence interval, 1.08-1.84) and an increased risk of death within 30 days (adjusted propensity score-matched odds ratios, 1.60; confidence interval, 1.17-2.18). Among 8956 patients with ischemic stroke (4478 prestroke SSRI users and 4478 propensity score-matched nonusers), prestroke SSRI use was not associated with the risk of severe stroke or death within 30 days. Prestroke SSRI use is associated with increased stroke severity and mortality in patients with hemorrhagic stroke. Although prestroke depression in itself may increase stroke severity and mortality, this was not found in SSRI users with ischemic stroke. © 2014 American Heart Association, Inc.

Inverse Association Between Cancer and Dementia: A Population-based Registry Study in Taiwan.

PubMed

Lin, Hsiu-Li; Lin, Hsiu-Chen; Tseng, Yuan-Fu; Chen, Shih-Chang; Hsu, Chien-Yeh

2016-01-01

Dementia and cancer are 2 common diseases in the elderly. This retrospective cohort study used a population-based insurance claim dataset, merged with a cancer registry, to test whether risk reduction of cancers occurs at various primary sites after diagnosis of dementia. The study included a cohort of 3282 patients who were first diagnosed with dementia between 2001 and 2002. A control cohort consisted of 13,128 subjects matched for age, sex, and year of enrollment. The site of cancer and duration between the diagnosis of dementia and cancer were analyzed. Among the dementia cases, 169 patients (5.2%) were diagnosed with cancer during a median observation period of 40 months. In the control group, 976 subjects (7.4%) were diagnosed with cancer, during a median observation period of 46 months. During a 7-year follow-up period, the adjusted hazard ratio for cancer among dementia patients was 0.77 (95% confidence interval, 0.65-0.91), and significantly lower for colon (0.54, 0.29-0.99) and prostate cancers (0.44, 0.20-0.98). This study showed an inverse association between cancer and dementia. Further studies focusing on colon and prostate cancers may help elucidate the underlying mechanism and expand the therapeutic strategies.

Birth characteristics and Wilms tumors in children in the Nordic countries: a register-based case-control study.

PubMed

Schüz, Joachim; Schmidt, Lisbeth Samsø; Kogner, Per; Lähteenmäki, Päivi M; Pal, Niklas; Stokland, Tore; Schmiegelow, Kjeld

2011-05-01

Little is known about causes of Wilms tumor. Because of the young age at diagnosis, several studies have looked at various birth characteristics. We conducted a registry-based case-control study involving 690 cases of Wilms tumor aged 0-14 years, occurring in Denmark, Finland, Norway or Sweden during 1985-2006, individually matched to five controls drawn randomly from the Nordic childhood population. Information on birth characteristics was obtained from the population-based medical birth registries. We estimated odds ratios (ORs) and 95% confidence intervals (CIs) using conditional logistic regression analysis. We observed a distinct association between Wilms tumor and high birth weight (≥4 kg) for girls (OR 1.97, CI 1.50-2.59) but not for boys (1.04, 0.78-1.38); overall, the OR was 1.43 (1.17-1.74). Among girls, risk increased by 28% (15-42%) per 500 g increase in birth weight. Large-for-gestational age girls also had a higher risk (2.48, 1.51-4.05), whereas no effect was seen for boys (1.12, 0.60-2.07). An association was seen with Apgar score at 5 min < 7 for both sexes combined (5.13, 2.55-10.3). ORs close to unity were seen for parental age and birth order. In our large-scale, registry-based study, we confirmed earlier observations of an association between high birth weight and risk of Wilms tumor, but we found an effect only in girls. The higher risk of infants with low Apgar score might reflect hypoxia causing cell damage, adverse side effects of neonatal treatment or reverse causation as low Apgar score might indicate the presence of a tumor. Copyright © 2010 UICC.

Decreased activation along the dorsal visual pathway after a 3-month treatment with galantamine in mild Alzheimer disease: a functional magnetic resonance imaging study.

PubMed

Bokde, Arun L W; Karmann, Michaela; Teipel, Stefan J; Born, Christine; Lieb, Martin; Reiser, Maximilian F; Möller, Hans-Jürgen; Hampel, Harald

2009-04-01

Visual perception has been shown to be altered in Alzheimer disease (AD) patients, and it is associated with decreased cognitive function. Galantamine is an active cholinergic agent, which has been shown to lead to improved cognition in mild to moderate AD patients. This study examined brain activation in a group of mild AD patients after a 3-month open-label treatment with galantamine. The objective was to examine the changes in brain activation due to treatment. There were 2 tasks to visual perception. The first task was a face-matching task to test the activation along the ventral visual pathway, and the second task was a location-matching task to test neuronal function along the dorsal pathway. Brain activation was measured using functional magnetic resonance imaging. There were 5 mild AD patients in the study. There were no differences in the task performance and in the cognitive scores of the Consortium to Establish a Registry for Alzheimer's Disease battery before and after treatment. In the location-matching task, we found a statistically significant decrease in activation along the dorsal visual pathway after galantamine treatment. A previous study found that AD patients had higher activation in the location-matching task compared with healthy controls. There were no differences in activation for the face-matching task after treatment. Our data indicate that treatment with galantamine leads to more efficient visual processing of stimuli or changes the compensatory mechanism in the AD patients. A visual perception task recruiting the dorsal visual system may be useful as a biomarker of treatment effects.

Regional vs. general anesthesia for total knee and hip replacement: An analysis of postoperative pain perception from the international PAIN OUT registry.

PubMed

Donauer, Katharina; Bomberg, Hagen; Wagenpfeil, Stefan; Volk, Thomas; Meissner, Winfried; Wolf, Alexander

2018-05-14

Total hip and knee replacements are common surgeries, and an optimal pain treatment is essential for early rehabilitation. Since data from randomized controlled trails on the use of regional anesthesia in joint replacements of the lower extremities are conflicting, we analyzed the international PAIN OUT registry for comparison of regional anesthesia vs. general anesthesia regarding pain and morphine consumption on the first postoperative day. International Classification of Diseases-9 (ICD-9) codes were used to identify 2,346 cases for knee and 2,315 for hip arthroplasty between 2010 and 2016 from the PAIN OUT registry. Those were grouped according to anesthesia provided (general, regional, and a combination of both). At the first day after surgery, pain levels and opioid consumption was compared. Adjusted odds ratios (aOR [95% CI]) were calculated with logistic regression and propensity matching was used as a sensitivity analysis. After adjustment for confounders, regional anesthesia was associated with reduced opioid consumption (0.20 [0.13-0.30], p<0.001) and less pain (0.53 [0.36-0.78], p=0.001) than general anesthesia in knee surgery. In hip surgery, regional anesthesia was only associated with reduced opioid consumption (0.17 [0.11-0.26], p<0.001), whereas pain was comparable (1.23 [0.94-1.61], p=0.1). Results from a propensity-matched sensitivity analysis were similar. In total knee arthroplasty, regional anesthesia was associated with less pain and lower opioid consumption. In total hip arthroplasty, regional anesthesia was associated with a lower opioid consumption, however not with reduced pain levels. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Hospital Adoption of Health Information Technology to Support Public Health Infrastructure.

PubMed

Walker, Daniel M; Diana, Mark L

2016-01-01

Health information technology (IT) has the potential to improve the nation's public health infrastructure. In support of this belief, meaningful use incentives include criteria for hospitals to electronically report to immunization registries, as well as to public health agencies for reportable laboratory results and syndromic surveillance. Electronic reporting can facilitate faster and more appropriate public health response. However, it remains unclear the extent that hospitals have adopted IT for public health efforts. To examine hospital adoption of IT for public health and to compare hospitals capable of using and not using public health IT. Cross-sectional design with data from the 2012 American Hospital Association annual survey matched with data from the 2013 American Hospital Association Information Technology Supplement. Multivariate logistic regression was used to compare hospital characteristics. Inverse probability weights were applied to adjust for selection bias because of survey nonresponse. All acute care general hospitals in the United States that matched across the surveys and had complete data available were included in the analytic sample. Three separate outcome measures were used: whether the hospital could electronically report to immunization registries, whether the hospital could send electronic laboratory results, and whether the hospital can participate in syndromic surveillance. A total of 2841 hospitals met the inclusion criteria. Weighted results show that of these hospitals, 62.7% can electronically submit to immunization registries, 56.6% can electronically report laboratory results, and 54.4% can electronically report syndromic surveillance. Adjusted and weighted results from the multivariate analyses show that small, rural hospitals and hospitals without electronic health record systems lag in the adoption of public health IT capabilities. While a majority of hospitals are using public health IT, the infrastructure still has significant room for growth. Differences in hospitals' adoption of public health IT may exacerbate existing health disparities.

The CERAD Neuropsychological Assessment Battery Is Sensitive to Alcohol-Related Cognitive Deficiencies in Elderly Patients: A Retrospective Matched Case-Control Study.

PubMed

Kaufmann, Liane; Huber, Stefan; Mayer, Daniel; Moeller, Korbinian; Marksteiner, Josef

2018-04-01

Adverse effects of heavy drinking on cognition have frequently been reported. In the present study, we systematically examined for the first time whether clinical neuropsychological assessments may be sensitive to alcohol abuse in elderly patients with suspected minor neurocognitive disorder. A total of 144 elderly with and without alcohol abuse (each group n=72; mean age 66.7 years) were selected from a patient pool of n=738 by applying propensity score matching (a statistical method allowing to match participants in experimental and control group by balancing various covariates to reduce selection bias). Accordingly, study groups were almost perfectly matched regarding age, education, gender, and Mini Mental State Examination score. Neuropsychological performance was measured using the CERAD (Consortium to Establish a Registry for Alzheimer's Disease). Classification analyses (i.e., decision tree and boosted trees models) were conducted to examine whether CERAD variables or total score contributed to group classification. Decision tree models disclosed that groups could be reliably classified based on the CERAD variables "Word List Discriminability" (tapping verbal recognition memory, 64% classification accuracy) and "Trail Making Test A" (measuring visuo-motor speed, 59% classification accuracy). Boosted tree analyses further indicated the sensitivity of "Word List Recall" (measuring free verbal recall) for discriminating elderly with versus without a history of alcohol abuse. This indicates that specific CERAD variables seem to be sensitive to alcohol-related cognitive dysfunctions in elderly patients with suspected minor neurocognitive disorder. (JINS, 2018, 24, 360-371).

Pregnancy Complications and Subsequent Breast Cancer Risk in the Mother: A Nordic population-based case-control study.

PubMed

Troisi, Rebecca; Gulbech Ording, Anne; Grotmol, Tom; Glimelius, Ingrid; Engeland, Anders; Gissler, Mika; Trabert, Britton; Ekbom, Anders; Madanat-Harjuoja, Laura; Toft Sørensen, Henrik; Tretli, Steinar; Bjørge, Tone

2018-05-11

Certain features of pregnancy are important risk factors for breast cancer, such as protection afforded by young age at first birth. Preeclampsia, a pregnancy complication, is associated with reduced maternal breast cancer risk. However, questions remain regarding causality, biological mechanisms and the relation of other hypertensive conditions to risk. We conducted a population-based case-control study of breast cancer cases (n=116,196) in parous women identified through linkage of birth and cancer registries in Denmark, Finland, Norway and Sweden (1967-2013), including up to 10 matched controls per case (n=1,147,192) sampled from the birth registries (complete data were not available on all variables). Odds ratios (ORs) with 95% confidence intervals (CIs) were derived from unconditional logistic regression models including matching factors (country, maternal birth year) and parity. Hypertension diagnosed before pregnancy (OR 0.87; 95% CI 0.78-0.97), gestational hypertension (OR 0.90; 95% CI 0.86-0.93) and preeclampsia (OR 0.91; 95% CI 0.88-0.95) were associated with reduced breast cancer risk. Results remained similar after adjustment for smoking and maternal body mass index before first pregnancy, and were generally similar stratified by parity, age at breast cancer diagnosis, time since first and last birth, sex of the offspring and calendar time. Except for retained placenta (OR 1.14; 95% CI 0.98-1.32), no other pregnancy complication appeared associated with breast cancer risk. The mechanisms mediating the modest risk reductions for history of preeclampsia or hypertension preceding or arising during pregnancy, and possible increased risk with history of retained placenta are unknown and warrant further laboratory, clinical and epidemiological investigation. This article is protected by copyright. All rights reserved. © 2018 UICC.

Congenital Abnormalities and Hepatoblastoma: A Report from the Children’s Oncology Group (COG) and the Utah Population Database (UPDB)

PubMed Central

Venkatramani, Rajkumar; Spector, Logan G.; Georgieff, Michael; Tomlinson, Gail; Krailo, Mark; Malogolowkin, Marcio; Kohlmann, Wendy; Curtin, Karen; Fonstad, Rachel K.; Schiffman, Joshua D.

2014-01-01

Beckwith-Wiedemann Syndrome (BWS) and Familial Adenomatous Polyposis (FAP) are known to predispose to hepatoblastoma (HB). A case control study was conducted through the Children’s Oncology Group (COG) to study the association of HB with isolated congenital abnormalities. Cases (N = 383) were diagnosed between 2000 and 2008. Controls (N = 387) were recruited from state birth registries, frequency matched for sex, region, year of birth, and birth weight. Data on congenital abnormalities among subjects and covariates were obtained by maternal telephone interview. Odds ratios (OR) and 95% confidence intervals (CI) describing the association between congenital abnormalities with HB, adjusted for sex, birth weight, maternal age and maternal education, were calculated using unconditional logistic regression. There was a significant association of HB with kidney, bladder, or sex organ abnormalities (OR = 4.75; 95% CI: 1.74–13) which appeared to be specific to kidney/bladder defects (OR = 4.3; 95% CI: 1.2–15.3) but not those of sex organs (OR = 1.24; 95% CI: 0.37–4.1). Elevated but non-significant ORs were found for spina bifida or other spinal defects (OR = 2.12; 95% CI: 0.39–11.7), large or multiple birthmarks (OR = 1.33; 95% CI: 0.81–2.21). The results were validated through the Utah Population Database (UPDB), a statewide population-based registry linking birth certificates, medical records, and cancer diagnoses. In the UPDB, there were 29 cases and 290 population controls matched 10:1 on sex and birth year. Consistent with the COG findings, kidney/bladder defects were associated with hepatoblastoma. These results confirm the association of HB with kidney/bladder abnormalities. PMID:24934283

Carvedilol Compared With Metoprolol Succinate in the Treatment and Prognosis of Patients With Stable Chronic Heart Failure: Carvedilol or Metoprolol Evaluation Study.

PubMed

Fröhlich, Hanna; Zhao, Jingting; Täger, Tobias; Cebola, Rita; Schellberg, Dieter; Katus, Hugo A; Grundtvig, Morten; Hole, Torstein; Atar, Dan; Agewall, Stefan; Frankenstein, Lutz

2015-09-01

β-Blockers exert a prognostic benefit in the treatment of chronic heart failure. Their pharmacological properties vary. The only substantial comparative trial to date-the Carvedilol or Metoprolol European Trial-has compared carvedilol with short-acting metoprolol tartrate at different dose equivalents. We therefore addressed the relative efficacy of equal doses of carvedilol and metoprolol succinate on survival in multicenter hospital outpatients with chronic heart failure. Four thousand sixteen patients with stable systolic chronic heart failure who were using either carvedilol or metoprolol succinate were identified in the Norwegian Heart Failure Registry and The Heart Failure Registry of the University of Heidelberg, Germany. Patients were individually matched on both the dose equivalents and the respective propensity scores for β-blocker treatment. During a follow-up for 17 672 patient-years, it was found that 304 (27.2%) patients died in the carvedilol group and 1066 (36.8%) in the metoprolol group. In a univariable analysis of the general sample, metoprolol therapy was associated with higher mortality compared with carvedilol therapy (hazard ratio, 1.49; 95% confidence interval, 1.31-1.69; P<0.001). This difference was not seen after multivariable adjustment (hazard ratio, 0.93; 95% confidence interval, 0.57-1.50; P=0.75) and adjustment for propensity score and dose equivalents (hazard ratio, 1.06; 95% confidence interval, 0.94-1.20; P=0.36) or in the propensity and dose equivalent-matched sample (hazard ratio, 1.00; 95% confidence interval, 0.82-1.23; P=0.99). These results were essentially unchanged for all prespecified subgroups. In outpatients with chronic heart failure, no conclusive association between all-cause mortality and treatment with carvedilol or metoprolol succinate was observed after either multivariable adjustment or multilevel propensity score matching. © 2015 American Heart Association, Inc.

Fatigue Among Short- and Long-Term Thyroid Cancer Survivors: Results from the Population-Based PROFILES Registry

PubMed Central

Nieuwlaat, Willy-Anne; Oranje, Wilma A.; Haak, Harm R.; van de Poll-Franse, Lonneke V.; Mols, Floortje

2013-01-01

Background The aims of this study were (i) to obtain insight into the prevalence of fatigue among short- and long-term thyroid cancer (TC) survivors, by comparing a sample of TC survivors with an age- and sex-matched normative population, and (ii) to investigate which demographic, clinical, and TC-specific health-related quality of life (HRQoL) characteristics were associated with fatigue. Methods All patients found to have TC between 1990 and 2008, as registered in the Eindhoven Cancer Registry, received a cross-sectional survey on fatigue (Fatigue Assessment Scale), TC-specific HRQoL (THYCA-QoL), and psychological distress (Hospital Anxiety and Depression Scale). The fatigue scores were compared with those of an age- and sex-matched normative population (n=530). Multiple logistic regression analyses were conducted to investigate the independent associations between clinical and demographic characteristics, TC-specific HRQoL, and psychological distress with fatigue. Results Eighty-six percent (n=306) responded. TC survivors were more often classified as fatigued or very fatigued (short-term <5 years: 43%; long-term 5–10 years: 44%; long-term 10–15 years: 47%; long-term >15 years: 39%) compared to the normative population (25%; p<0.001). Anxiety (odds ratio (OR) 1.15, 95% confidence interval [CI] 1.03–1.28) and depression (OR 1.43 [CI 1.22–1.68]) were associated with fatigue, as was also the case for TC-specific neuromuscular (OR 1.03 [CI 1.01–1.06]), concentration (OR 1.03 [CI 1.01–1.06]), and psychological TC-specific HRQoL (OR 1.06 [CI 1.02–1.10]). Conclusion Short- and long-term TC survivors report higher levels of fatigue than an age- and sex-matched normative population do. Both TC-specific HRQoL and psychological distress were associated with fatigue. PMID:23578315

Clinical and Administrative Data on the Research of Acute Coronary Syndrome in Spain. Minimum Basic Data Set Validity.

PubMed

Bernal, José Luis; Barrabés, José A; Íñiguez, Andrés; Fernández-Ortiz, Antonio; Fernández-Pérez, Cristina; Bardají, Alfredo; Elola, Francisco Javier

2018-05-07

Health outcomes research is done from clinical registries or administrative databases. The aim of this work was to evaluate the concordance of the Minimum Basic Data Set (MBDS) with the DIOCLES (Descripción de la Cardiopatía Isquémica en el Territorio Español) registry and to analyze the implications of use of the MBDS in the study of acute coronary syndrome in Spain. Through indirect identifiers, DIOCLES was linked with MBDS and unique matches were selected. Some of most relevant variables for risk adjustment of in-hospital mortality due to acute myocardial infarction were considered. Kappa coefficient was used to evaluate the concordance; sensitivity, specificity and positive and negative predictive values to measure the validity of the MBDS, and the area under ROC (receiver operating characteristic) curve to calculate its discrimination. The results were compared among hospitals quintiles according to their contribution to DIOCLES. The influence of unmatched episodes on results was assessed by a sensitivity analysis, using looser linking criteria. Overall, 1539 (60.85%) unique matches were achieved. The prevalence was higher in DIOCLES (acute myocardial infarction: 71.09%; Killip 3-4: 9.17%; cerebrovascular accident: 0.97%; thrombolysis: 8.64%; angioplasty: 61.92% and coronary bypass: 1.75%) than in the MBDS (P < .001). The agreement level observed was almost perfect (κ = 0.863). The MBDS showed a sensitivity of 85.10% and a specificity of 98.31%. Most results were confirmed by using sensitivity analysis (79.95% episodes matched). The MBDS can be a useful tool for outcomes research of acute coronary syndrome in Spain. The contrast of DIOCLES and MBDS with medical records could verify their validity. Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. 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

Adverse Influence of Pre-Stroke Dementia on Short-Term Functional Outcomes in Patients with Acute Ischemic Stroke: The Fukuoka Stroke Registry.

PubMed

Wakisaka, Yoshinobu; Matsuo, Ryu; Hata, Jun; Kuroda, Junya; Kitazono, Takanari; Kamouchi, Masahiro; Ago, Tetsuro

2017-01-01

Dementia and stroke are major causes of disability in the elderly. However, the association between pre-stroke dementia and functional outcome after stoke remains unresolved. We aimed to determine this association in patients with acute ischemic stroke. Among patients registered in the Fukuoka Stroke Registry from June 2007 to May 2015, 4,237 patients with ischemic stroke within 24 h of onset, who were functionally independent before the onset, were enrolled in this study. Pre-stroke dementia was defined as any type of dementia that was present prior to the index stroke. Primary and secondary study outcomes were poor functional outcome (modified Rankin Scale 3-6) at 3 months after the stroke onset and neurological deterioration (≥2-point increases on the National Institutes of Health Stroke Scale score during hospitalization), respectively. For propensity score (PS)-matched cohort study to control confounding variables for pre-stroke dementia, 318 pairs of patients with and without pre-stroke dementia were also selected on the basis of 1:1 matching. Multivariable logistic regression models and conditional logistic regression analysis were used to quantify associations between pre-stroke dementia and study outcomes. Of all 4,237 participants, 347 (8.2%) had pre-stroke dementia. The frequencies of neurological deterioration and poor functional outcome were significantly higher in patients with pre-stroke dementia than in those without pre-stroke dementia (neurological deterioration, 16.1 vs. 7.1%, p < 0.01; poor functional outcome, 63.7 vs. 27.1%, p < 0.01). Multivariable analysis showed that pre-stroke dementia was significantly associated with neurological deterioration (OR 1.67; 95% CI 1.14-2.41; p < 0.01) and poor functional outcome (OR 2.91; 95% CI 2.17-3.91; p < 0.01). In the PS-matched cohort study, the same trends were observed between the pre-stroke dementia and neurological deterioration (OR 2.60; 95% CI 1.17-5.78; p < 0.01) and between the dementia and poor functional outcome (OR 3.62; 95% CI 1.89-6.95; p < 0.01). Pre-stroke dementia was significantly associated with higher risks for poor functional outcome at 3 months after stroke onset as well as for neurological deterioration during hospitalization in patients with acute ischemic stroke. © 2016 S. Karger AG, Basel.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty　- Propensity Score-Matched Registry.

PubMed

Janas, Adam; Buszman, Piotr P; Milewski, Krzysztof P; Wiernek, Szymon; Janas, Ksenia; Pruski, Maciej; Wojakowski, Wojciech; Błachut, Aleksandra; Picheta, Wojciech; Buszman, Pawel; Kiesz, Stefan

2017-02-24

The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

Risk of poor neonatal outcome at term after medically assisted reproduction: a propensity score-matched study.

PubMed

Ensing, Sabine; Abu-Hanna, Ameen; Roseboom, Tessa J; Repping, Sjoerd; van der Veen, Fulco; Mol, Ben Willem J; Ravelli, Anita C J

2015-08-01

To study risk of birth asphyxia and related morbidity among term singletons born after medically assisted reproduction (MAR). Population cohort study. Not applicable. A total of 1,953,932 term singleton pregnancies selected from a national registry for 1999-2011. None. Primary outcome Apgar score <4; secondary outcomes Apgar score <7, intrauterine fetal death, perinatal mortality, congenital anomalies, small for gestational age, asphyxia related morbidity, and cesarean delivery. The risks of birth asphyxia and related morbidity were calculated in women who conceived either through MAR or spontaneously (SC), with a subgroup analysis for in vitro fertilization (IVF). An additional propensity score matching analysis was performed with matching on multiple maternal baseline covariates (maternal age, ethnicity, socioeconomic status, parity, year of birth, and preexistent diseases). Each MAR pregnancy was matched to three SC controls. Relative to SC, the MAR singletons had an increased risk of adverse neonatal outcomes including Apgar score <4 (adjusted odds ratio [OR] 1.29; 95% CI, 1.14-1.46) and intrauterine fetal death (adjusted OR 1.61; 95% CI, 1.35-1.91). After propensity score matching, the risk of an Apgar score <4 was comparable between MAR and SC singletons (OR 0.99; 95% CI, 0.87-1.14). Cesarean delivery for both fetal distress and nonprogressive labor occurred more among MAR pregnancies compared with SC pregnancies. Term singletons conceived after MAR have an increased risk of morbidity related to birth asphyxia. Because this is mainly due to maternal characteristics, obstetric caregivers should be aware that the increased rates of cesareans reflect the behavior of women and physicians rather than increased perinatal complications. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

[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.

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.

Outcomes of haploidentical stem cell transplantation for chronic lymphocytic leukemia: a retrospective study on behalf of the chronic malignancies working party of the EBMT.

PubMed

van Gorkom, Gwendolyn; van Gelder, Michel; Eikema, Dirk-Jan; Blok, Henric-Jan; van Lint, M T; Koc, Yener; Ciceri, Fabio; Beelen, Dietrich; Chevallier, Patrice; Selleslag, Dominik; Blaise, Didier; Foá, Roberto; Corradini, Paolo; Castagna, Luca; Moreno, Carol; Solano, Carlos; Müller, Lutz Peter; Tischer, Johanna; Hilgendorf, Inken; Hallek, Michael; Bittenbring, Jörg; Theobald, Matthias; Schetelig, Johannes; Kröger, Nicolaus

2018-03-01

Allogeneic hematopoietic stem cell transplantation (HCT) may result in long-term disease control in high-risk chronic lymphocytic leukemia (CLL). Recently, haploidentical HCT is gaining interest because of better outcomes with post-transplantation cyclophosphamide (PTCY). We analyzed patients with CLL who received an allogeneic HCT with a haploidentical donor and whose data were available in the EBMT registry. In total 117 patients (74% males) were included; 38% received PTCY as GVHD prophylaxis. For the whole study cohort OS at 2 and 5 yrs was 48 and 38%, respectively. PFS at 2 and 5 yrs was 38 and 31%, respectively. Cumulative incidence (CI) of NRM in the whole group at 2 and 5 years were 40 and 44%, respectively. CI of relapse at 2 and 5 yrs were 22 and 26%, respectively. All outcomes were not statistically different in patients who received PTCY compared to other types of GVHD prophylaxis. In conclusion, results of haploidentical HCT in CLL seem almost identical to those with HLA-matched donors. Thereby, haploidentical HCT is an appropriate alternative in high risk CLL patients with a transplant indication but no available HLA-matched donor. Despite the use of PTCY, the CI of relapse seems not higher than observed after HLA-matched HCT.

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

PubMed Central

Travers, Karin; Sallum, Rachel H; Burns, Meghan D; Barr, Charles E; Beattie, Mary S; Pashos, Chris L; Luce, Bryan R

2015-01-01

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25079108

Cancer risk in relatives of patients with a primary disorder of lymphocyte cytotoxicity: a retrospective cohort study.

PubMed

Löfstedt, Alexandra; Chiang, Samuel C C; Onelöv, Erik; Bryceson, Yenan T; Meeths, Marie; Henter, Jan-Inge

2015-12-01

Mutations in genes for perforin-dependent lymphocyte cytotoxicity are associated with haemophagocytic lymphohistiocytosis, a rare disease of severe hyperinflammation that typically becomes evident in early childhood. It has been suggested that individuals with hypomorphic biallelic mutations in genes associated with haemophagocytic lymphohistiocytosis are at increased risk of developing haematological malignancies. We aimed to assess whether relatives of patients with primary haemophagocytic lymphohistiocytosis (ie, heterozygous carriers of these mutated genes) were more likely to develop cancer. In this retrospective cohort study, we used a multigeneration registry to identify relatives (parents and grandparents) of 79 Swedish children (<15 years) with primary haemophagocytic lymphohistiocytosis diagnosed between 1971 and 2011. For each relative, we randomly selected eight matched individuals from the Swedish total population registry, stratified for sex, birth year, and birth region. Relatives and matched controls were cross-linked with the Swedish Cancer Registry to establish cancer incidence rate. We then calculated the incidence rate ratio between first-degree and second-degree relatives and the matched controls. Additionally, we assessed natural-killer-cell-mediated cytotoxicity in a subgroup of first-degree relatives using standard 4 h (51)Cr assay and flow cytometry quantification of the upregulation of surface CD107a. We identified 346 first-degree and second-degree relatives from 67 families (67 mothers, 66 fathers, 106 grandmothers, and 107 grandfathers) and 2768 matched controls. Median follow-up was 49 years, range 0-54 years. By death or last follow-up (Dec 31, 2012), first-degree relatives had a significantly increased incidence rate of malignancies than did controls (incidence rate per 1000 person-years 2.78 [95% CI 1.42-4.15] vs 1.56 [1.16-1.95]; incidence rate ratio 1.79 [95% CI 1.06-3.03]; p=0.030). Mothers had a particularly increased risk (incidence rate per 1000 person-years 4.43 [95% CI 1.99-6.87] vs 1.60 [1.08-2.11]; incidence rate ratio 2.78 [95% CI 1.48-5.21]; p=0.0014), whereas no difference was found between fathers and controls (1.24 [0.00-2.51] vs 1.52 [0.89-2.15]; 0.82 [0.29-2.29]; p=0.70) or between grandparents and controls (7.24 [5.44-9.04] vs 6.36 [5.70-7.03]; 1.14 [0.88-1.48]; p=0.33). Functional analysis of heterozygous carriers of mutations associated with haemophagocytic lymphohistiocytosis could not show significantly reduced lymphocyte cytotoxicity. Heterozygous mutations in genes associated with haemophagocytic lymphohistiocytosis might be a new risk factor for cancer. The increased risk of cancer might imply haploinsufficiency of cytotoxic lymphocyte-mediated immunosurveillance of cancer in carriers of these mutations. Our findings might support intensified screening for malignancies in relatives of patients with haemophagocytic lymphohistiocytosis. Swedish Children's Cancer Foundation, Swedish Research Council, Histiocytosis Association, Swedish Cancer Society, Swedish Cancer and Allergy Foundation, Mary Béve Foundation, Karolinska Institutet Research Foundation, Stockholm County Council (ALF-project). Copyright © 2015 Elsevier Ltd. All rights reserved.

Trauma registry record linkage: methodological approach to benefit from complementary data using the example of the German Pelvic Injury Register and the TraumaRegister DGU®

PubMed Central

2013-01-01

Background In Germany, hospitals can deliver data from patients with pelvic fractures selectively or twofold to two different trauma registries, i.e. the German Pelvic Injury Register (PIR) and the TraumaRegister DGU® (TR). Both registers are anonymous and differ in composition and content. We describe the methodological approach of linking these registries and reidentifying twofold documented patients. The aim of the approach is to create an intersection set that benefit from complementary data of each registry, respectively. Furthermore, the concordance of data entry of some clinical variables entered in both registries was evaluated. Methods PIR (4,323 patients) and TR (34,134 patients) data from 2004-2009 were linked together by using a specific match code including code of the trauma department, dates of admission and discharge, patient’s age, and sex. Data entry concordance was evaluated using haemoglobin and blood pressure levels at emergency department arrival, Injury Severity Score (ISS), and mortality. Results Altogether, 420 patients were identified as documented in both data sets. Linkage rates for the intersection set were 15.7% for PIR and 44.4% for TR. Initial fluid management for different Tile/OTA types of pelvic ring fractures and the patient’s posttraumatic course, including intensive care unit data, were now available for the PIR population. TR is benefiting from clinical use of the Tile/OTA classification and from correlation with the distinct entity “complex pelvic injury.” Data entry verification showed high concordance for the ISS and mortality, whereas initial haemoglobin and blood pressure data showed significant differences, reflecting inconsistency at the data entry level. Conclusions Individually, the PIR and the TR reflect a valid source for documenting injured patients, although the data reflect the emphasis of the particular registry. Linking the two registries enabled new insights into care of multiple-trauma patients with pelvic fractures even when linkage rates were poor. Future considerations and development of the registries should be done in close bilateral consultation with the aim of benefiting from complementary data and improving data concordance. It is also conceivable to integrate individual modules, e.g. a pelvic fracture module, into the TR likewise a modular system in the future. PMID:23496832

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.

Who's doing the math? Are we really compensating research participants?

PubMed

Ripley, Elizabeth; Macrina, Francis; Markowitz, Monika; Gennings, Chris

2010-09-01

Although compensation for expenses to participants in research projects is considered important and the primary reason for paying, there is no evidence to support that investigators and IRB members actually calculate participant cost. Payment recommendations for six hypothetical studies were obtained from a national survey of IRB chairpersons (N = 353) and investigators (N = 495). Survey respondents also recommended payment for specific study procedures. We calculated participant cost for the six hypothetical cases both by procedures and by time involvement. A large percentage recommended only token payments for survey, registry, and medical record review studies. Most chose payment for pharmaceutical studies but the recommended payment did not compensate for calculated costs. Results suggest that compensation and reimbursement as the primary reasons for paying research participants may not match actual practice.

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

Associations of aldosterone and renin concentrations with inflammation-the Study of Health in Pomerania and the German Conn's Registry.

PubMed

Grotevendt, A; Wallaschofski, H; Reincke, M; Adolf, C; Quinkler, M; Nauck, M; Hoffmann, W; Rettig, R; Hannemann, A

2017-08-01

Chronic inflammation is an age-independent and body mass index-independent contributor to the development of multi-morbidity. Alterations of the renin-angiotensin-aldosterone system are observed within the context of proinflammatory states. We assessed circulating aldosterone, renin, and inflammatory biomarker concentrations in healthy, normotensive subjects and patients with primary aldosteronism. We included 1177 normotensive individuals from the population-based Study of Health in Pomerania (first follow-up, Study of Health in Pomerania-1) and 103 primary aldosteronism patients from the German Conn's Registry. A 1:1 matching for sex, age, body mass index, smoking status, diabetes mellitus, and the estimated glomerular filtration rate was performed to determine whether primary aldosteronism patients exhibit higher inflammatory biomarker concentrations than normotensive controls. The associations of plasma aldosterone concentration or plasma renin concentration with circulating fibrinogen concentrations, white blood cell count, and high sensitive C-reactive protein concentrations in the normotensive sample were determined with multivariable linear and logistic regression analyses. 1:1 matched primary aldosteronism patients demonstrated significantly (p < 0.01) higher plasma aldosterone concentration (198 vs. 47 ng/l), lower plasma renin concentration (3.1 vs. 7.7 ng/l) and higher high sensitive C-reactive protein concentrations (1.5 vs. 1.0 mg/l) than normotensive controls. Within the normotensive cohort, plasma renin concentration but not plasma aldosterone concentration was positively associated with fibrinogen concentrations and white blood cell count. Further, a J-shaped association between plasma renin concentration and high sensitive C-reactive protein concentrations was detected. High plasma aldosterone concentration in a primary aldosteronism cohort and high plasma renin concentration in normotensive subjects are associated with increased concentrations of inflammatory biomarkers. This suggests a link between the renin-angiotensin-aldosterone system and inflammatory processes in patients with primary aldosteronism and even in normotensive subjects.

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.

Drake Chemical Workers' Health Registry: coping with community tension over toxic exposures.

PubMed Central

Leviton, L C; Marsh, G M; Talbott, E; Pavlock, D; Callahan, C

1991-01-01

BACKGROUND: Programs to communicate health risk information and to protect the health of groups exposed to toxic substances need to tailor interventions to the political, economic, and cultural situation of the at-risk group. In particular, such programs must often cope with exceptional community tension and conflict over these exposures. METHODS: This article uses interviews and written materials to document and describe the state of affairs that led up to community tension over an occupational exposure to a bladder carcinogen. The article describes the planning and design of a program to provide medical surveillance to workers, which also alleviated community concern. RESULTS: The Drake Chemical Workers' Health Registry coped successfully with community conflict and obtained a high participation rate. CONCLUSIONS: General recommendations include the following: avoid identification with extraneous agendas; know the community and maintain communication; and match the intervention to the evolution of the community conflict. PMID:2029036

Patterns of diagnostic imaging and associated radiation exposure among long-term survivors of young adult cancer: a population-based cohort study.

PubMed

Daly, Corinne; Urbach, David R; Stukel, Thérèse A; Nathan, Paul C; Deitel, Wayne; Paszat, Lawrence F; Wilton, Andrew S; Baxter, Nancy N

2015-09-03

Survivors of young adult malignancies are at risk of accumulated exposures to radiation from repetitive diagnostic imaging. We designed a population-based cohort study to describe patterns of diagnostic imaging and cumulative diagnostic radiation exposure among survivors of young adult cancer during a survivorship time period where surveillance imaging is not typically warranted. Young adults aged 20-44 diagnosed with invasive malignancy in Ontario from 1992-1999 who lived at least 5 years from diagnosis were identified using the Ontario Cancer Registry and matched 5 to 1 to randomly selected cancer-free persons. We determined receipt of 5 modalities of diagnostic imaging and associated radiation dose received by survivors and controls from years 5-15 after diagnosis or matched referent date through administrative data. Matched pairs were censored six months prior to evidence of recurrence. 20,911 survivors and 104,524 controls had a median of 13.5 years observation. Survivors received all modalities of diagnostic imaging at significantly higher rates than controls. Survivors received CT at a 3.49-fold higher rate (95% Confidence Interval [CI]:3.37, 3.62) than controls in years 5 to 15 after diagnosis. Survivors received a mean radiation dose of 26 miliSieverts solely from diagnostic imaging in the same time period, a 4.57-fold higher dose than matched controls (95% CI: 4.39, 4.81). Long-term survivors of young adult cancer have a markedly higher rate of diagnostic imaging over time than matched controls, imaging associated with substantial radiation exposure, during a time period when surveillance is not routinely recommended.

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.

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

Primary Prevention Implantable Cardioverter-Defibrillators and Survival in Older Women

PubMed Central

Zeitler, Emily P.; Hellkamp, Anne S.; Fonarow, Gregg C.; Hammill, Stephen C.; Curtis, Lesley H.; Hernandez, Adrian F.; Al-Khalidi, Hussein R.; Curtis, Jeptha P.; Heidenreich, Paul A.; Anstrom, Kevin J.; Peterson, Eric D.; Mark, Daniel B.; Hammill, Bradley G.; Sanders, Gillian D.; Al-Khatib, Sana M.

2015-01-01

OBJECTIVES The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women. BACKGROUND Clinical trials of primary prevention ICDs enrolled a limited number of women. METHODS Using a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men. RESULTS Median follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44). CONCLUSIONS Among older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex. PMID:25543969

Impact of External Beam Adjuvant Radiotherapy on Health-Related Quality of Life for Long-Term Survivors of Endometrial Adenocarcinoma: A Population-Based Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poll-Franse, Lonneke V. van de; Mols, Floortje; Department of Psychology and Health, Tilburg University, Tilburg

2007-09-01

Purpose: To compare the health-related quality of life (HRQOL) among 5-10-year survivors of Stage I-II endometrial (adeno-)carcinoma (EC) treated with surgery alone or surgery with external beam adjuvant radiotherapy (EBRT) and an age-matched norm population. Methods and Materials: A population-based, cross-sectional survey was conducted by the Eindhoven Cancer Registry. All patients were included who had been diagnosed with EC between 1994 and 1998 (n = 462). Information from the questionnaires returned was linked to data from the Eindhoven Cancer Registry on patient, tumor, and treatment characteristics. Results: Responses were received from 75% of the patients. The analyses were restricted tomore » women with Stage I-II disease at diagnosis, treated with either surgery alone or surgery with adjuvant EBRT, and without recurrent disease or new primary malignancies (n = 264). The patients who had received adjuvant EBRT (n = 80) had had a significantly higher tumor stage and grade at diagnosis (p < 0.0001) and a longer mean time since diagnosis (p = 0.04). Age, number of comorbid diseases, current marital status, nulliparity, education, and occupation were similar for both treatment groups. On multivariate analyses, adjuvant EBRT was independently and negatively associated with the vitality and physical and social well-being scale scores. The HRQOL scores of both treatment groups, however, were similar to those of an age-matched norm population. Conclusion: In general, the HRQOL of EC survivors is good. EC survivors treated with surgery alone had a better HRQOL than women treated with surgery and adjuvant EBRT, although for both groups, the HRQOL was in the range of the norm population.« less

Cancer Among Children With Perinatal Exposure to HIV and Antiretroviral Medications--New Jersey, 1995-2010.

PubMed

Ivy, Wade; Nesheim, Steve R; Paul, Sindy M; Ibrahim, Abdel R; Chan, Miranda; Niu, Xiaoling; Lampe, Margaret A

2015-09-01

Concerns remain regarding the cancer risk associated with perinatal antiretroviral (ARV) exposure among infants. No excessive cancer risk has been found in short-term studies. Children born to HIV-infected women (HIV-exposed) in New Jersey from 1995 to 2008 were identified through the Enhanced HIV/AIDS Reporting System and cross-referenced with data from the New Jersey State Cancer Registry to identify new cases of cancer among children who were perinatally exposed to ARV. Matching of individuals in the Enhanced HIV/AIDS Reporting System to the New Jersey State Cancer Registry was conducted based on name, birth date, Social Security number, residential address, and sex using AutoMatch. Age- and sex-standardized incidence ratio (SIR) and exact 95% confidence intervals (CIs) were calculated using New Jersey (1979-2005) and US (1999-2009) cancer rates. Among 3087 children (29,099 person-years; median follow-up: 9.8 years), 4 were diagnosed with cancer. Cancer incidence among HIV-exposed children who were not exposed to ARV prophylaxis (22.5 per 100,000 person-years) did not differ significantly from the incidence among children who were exposed to any perinatal ARV prophylaxis (14.3 per 100,000 person-years). Furthermore, the number of cases observed among individuals exposed to ARV did not differ significantly from cases expected based on state (SIR = 1.21; 95% CI: 0.25 to 3.54) and national (SIR = 1.27; 95% CI: 0.26 to 3.70) reference rates. Our findings are reassuring that current use of ARV for perinatal HIV prophylaxis does not increase cancer risk. We found no evidence to alter the current federal guidelines of 2014 that recommend ARV prophylaxis of HIV-exposed infants.

Cardiac events in football and strategies for first-responder treatment on the field.

PubMed

Schmied, Christian; Drezner, Jonathan; Kramer, Efraim; Dvorak, Jiri

2013-12-01

The incidence and outcomes of sudden cardiac arrest (SCA) and global strategies for prevention of sudden cardiac death (SCD) in football are not known. The aim of this study was to estimate the occurrence of cardiac events in football and to investigate the preventive measures taken among the Fédération International de Football Association (FIFA) member associations internationally. A questionnaire was sent to the member associations of FIFA. The first section addressed the previous events of SCA, SCD or unexplained sports-related sudden death within the last 10 years. Further questions focused on football player medical screening strategies and SCA resuscitation response protocols on the field. 126 of 170 questionnaires were returned (response rate 74.1%), and 103 questionnaires (60.6%) were completed sufficiently to include in further analysis. Overall, 107 cases of SCA/SCD and 5 unexplained football-associated sudden deaths were reported. These events occurred in 52 of 103 responding associations (50.5%). 23 of 112 (20.5%) footballers survived. 12 of 22 (54.5%) players treated with an available automated external defibrillators (AED) on the pitch survived. A national registry to monitor cardiac events was established in only 18.4% of the associations. Most associations (85.4%) provide regular cardiac screening for their national teams while 75% screen teams of the national leagues. An AED is available at all official matches in 68% of associations. National registries to accurately measure SCA/SCD in football are rare and greatly needed. Deficiencies in emergency preparations, undersupply of AEDs on the field during matches, and variability in resuscitation response protocols and training of team-staff members should be addressed to effectively prevent SCD in football.

[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.

Evaluation of a hepatitis C clinical care coordination programme's effect on treatment initiation and cure: A surveillance-based propensity score matching approach.

PubMed

Deming, R; Ford, M M; Moore, M S; Lim, S; Perumalswami, P; Weiss, J; Wyatt, B; Shukla, S; Litwin, A; Reynoso, S; Laraque, F

2018-05-14

Hepatitis C (HCV) is a viral infection that if left untreated can severely damage the liver. Project INSPIRE was a 3 year HCV care coordination programme in New York City (NYC) that aimed to address barriers to treatment initiation and cure by providing patients with supportive services and health promotion. We examined whether enrolment in Project INSPIRE was associated with differences in HCV treatment and cure compared with a demographically similar group not enrolled in the programme. INSPIRE participants in 2015 were matched with a cohort of HCV-infected persons identified in the NYC surveillance registry, using full optimal matching on propensity scores and stratified by INSPIRE enrolment status. Conditional logistic regression was used to assess group differences in the two treatment outcomes. Two follow-up sensitivity analyses using individual pair-matched sets and the full unadjusted cohort were also conducted. Treatment was initiated by 72% (790/1130) of INSPIRE participants and 36% (11 960/32 819) of study-eligible controls. Among initiators, 65% (514/790) of INSPIRE participants compared with 47% (5641/11 960) of controls achieved cure. In the matched analysis, enrolment in INSPIRE increased the odds of treatment initiation (OR: 5.25, 95% CI: 4.47-6.17) and cure (OR: 2.52, 95% CI: 2.00-3.16). Results from the sensitivity analyses showed agreement with the results from the full optimal match. Participation in the HCV care coordination programme significantly increased the probability of treatment initiation and cure, demonstrating that care coordination for HCV-infected individuals improves treatment outcomes. © 2018 John Wiley & Sons Ltd.

Obesity is associated with increased risk of invasive penile cancer.

PubMed

Barnes, Kerri T; McDowell, Bradley D; Button, Anna; Smith, Brian J; Lynch, Charles F; Gupta, Amit

2016-07-13

To validate the association between obesity and penile cancer at a population level, we conducted a matched case-control study linking the Iowa Department of Motor Vehicles Drivers' License Database (DLD) with cancer surveillance data collected by the State Health Registry of Iowa (SHRI). All men diagnosed with invasive penile squamous cell carcinoma from 1985 to 2010 were identified by SHRI. Two hundred sixty-six cancer cases and 816 cancer-free male controls, selected from the Iowa DLD, were matched within 5-year age and calendar year strata. Body mass index (BMI) was calculated using self-reported height and weight from the DLD. Conditional logistic regression was used to evaluate the association between BMI and the risk of developing invasive penile cancer. Obesity was significantly associated with an increased risk of developing penile cancer. For every five-unit increase in BMI the risk of invasive penile cancer increased by 53 % (OR 1.53, 95 % CI 1.29-1.81, p < 0.0001). We previously reported an association between obesity and higher risk of invasive penile cancer and advanced cancer stage at diagnosis in a hospital-based retrospective study. This population-based study confirms an association between obesity and invasive penile cancer.

Prehospital antiplatelet use and functional status on admission of patients with non-haemorrhagic moyamoya disease: a nationwide retrospective cohort study (J-ASPECT study)

PubMed Central

Onozuka, Daisuke; Hagihara, Akihito; Nishimura, Kunihiro; Kada, Akiko; Nakagawara, Jyoji; Ogasawara, Kuniaki; Ono, Junichi; Shiokawa, Yoshiaki; Aruga, Toru; Miyachi, Shigeru; Nagata, Izumi; Toyoda, Kazunori; Matsuda, Shinya; Suzuki, Akifumi; Kataoka, Hiroharu; Nakamura, Fumiaki; Kamitani, Satoru; Nishimura, Ataru; Kurogi, Ryota; Sayama, Tetsuro; Iihara, Koji

2016-01-01

Objectives To elucidate the association between antiplatelet use in patients with non-haemorrhagic moyamoya disease before hospital admission and good functional status on admission in Japan. Design Retrospective, multicentre, non-randomised, observational study. Setting Nationwide registry data in Japan. Participants A total of 1925 patients with non-haemorrhagic moyamoya disease admitted between 1 April 2012 and 31 March 2014 in Japan. Main outcome measure We performed propensity score-matched analysis to examine the association between prehospital antiplatelet use and no significant disability on hospital admission, as defined by a modified Rankin Scale score of 0 or 1. Results Propensity-matched patients who received prehospital antiplatelet drugs were associated with a good outcome on hospital admission (OR adjusted for all covariates, 3.82; 95% CI 1.22 to 11.99) compared with those who did not receive antiplatelet drugs prior to hospital admission. Conclusions Prehospital antiplatelet use was significantly associated with good functional status on hospital admission among patients with non-haemorrhagic moyamoya disease in Japan. Our results suggest that prehospital antiplatelet use should be considered when evaluating outcomes of patients with non-haemorrhagic moyamoya disease. PMID:27008684

Malignancy in Pediatric-onset Systemic Lupus Erythematosus.

PubMed

Bernatsky, Sasha; Clarke, Ann E; Zahedi Niaki, Omid; Labrecque, Jeremy; Schanberg, Laura E; Silverman, Earl D; Hayward, Kristen; Imundo, Lisa; Brunner, Hermine I; Haines, Kathleen A; Cron, Randy Q; Oen, Kiem; Wagner-Weiner, Linda; Rosenberg, Alan M; O'Neil, Kathleen M; Duffy, Ciarán M; von Scheven, Emily; Joseph, Lawrence; Lee, Jennifer L; Ramsey-Goldman, Rosalind

2017-10-01

To determine cancer incidence in a large pediatric-onset systemic lupus erythematosus (SLE) population. Data were examined from 12 pediatric SLE registries in North America. Patients were linked to their regional cancer registries to detect cancers observed after cohort entry, defined as date first seen in the clinic. The expected number of malignancies was obtained by multiplying the person-years in the cohort (defined from cohort entry to end of followup) by the geographically matched age-, sex-, and calendar year-specific cancer rates. The standardized incidence ratio (SIR; ratio of cancers observed to expected) was generated, with 95% CI. A total of 1168 patients were identified from the registries. The mean age at cohort entry was 13 years (SD 3.3), and 83.7% of the subjects were female. The mean duration of followup was 7.6 years, resulting in a total observation period of 8839 years spanning the calendar period 1974-2009. During followup, fourteen invasive cancers occurred (1.6 cancers per 1000 person-yrs, SIR 4.13, 95% CI 2.26-6.93). Three of these were hematologic (all lymphomas), resulting in an SIR for hematologic cancers of 4.68 (95% CI 0.96-13.67). SIR were increased for both male and female patients, and across age groups. Although cancer remains a relatively rare outcome in pediatric-onset SLE, our data do suggest an increase in cancer for patients followed an average of 7.6 years. About one-fifth of the cancers were hematologic. Longer followup, and study of drug effects and disease activity, is warranted.

Measuring Adolescent Human Papillomavirus Vaccine Coverage: A Match of Sexually Transmitted Disease Clinic and Immunization Registry Data.

PubMed

Pathela, Preeti; Jamison, Kelly; Papadouka, Vikki; Kabir, Rezaul; Markowitz, Lauri E; Dunne, Eileen F; Schillinger, Julia A

2016-12-01

Human papillomavirus (HPV) vaccine is recommended for adolescents. By the end of 2013, 64% of female and 40% of male New York City residents aged 13-18 years had received ≥1 HPV vaccine dose. Adolescents attending sexually transmitted disease (STD) clinics are at high risk for HPV exposure and could benefit from vaccination. Our objective was to estimate HPV vaccination coverage for this population. We matched records of New York City's STD clinic patients aged 13-18 years during 2010-2013 with the Citywide Immunization Registry. We assessed HPV vaccine initiation (≥1 dose) and series completion (≥3 doses among those who initiated) as of clinic visit date and by patient demographics. We compared receipt of ≥1 dose for HPV, tetanus-diphtheria-acellular pertussis, and meningococcal conjugate vaccine. Eighty-two percent of clinic attendees (13,505/16,364) had records in the Citywide Immunization Registry. Receipt of ≥1 HPV dose increased during 2010-2013 (females: 57.6%-69.7%; males: 1.5%-36.3%). Among females, ≥1-dose coverage was lowest among whites (53.4%) and highest among Hispanics (73.3%); among males, ≥1-dose coverage was lowest among whites (6.9%) and highest among Asians (20.9%). Series completion averaged 57.7% (females) and 28.0% (males), with little variation by race/ethnicity or poverty level. Receipt of ≥1 dose was 59.7% for HPV, 82% for tetanus-diphtheria-acellular pertussis, and 76% for meningococcal conjugate vaccines. HPV vaccine initiation and completion were low among adolescent STD clinic patients; coverage was lower compared with other recommended vaccines. STD clinics may be good venues for delivering HPV vaccine, thereby enhancing efforts to improve HPV vaccination. Copyright © 2016 Society for Adolescent Health and Medicine. All rights reserved.

Glutathione S-transferase Pi expression predicts response to adjuvant chemotherapy for stage C colon cancer: a matched historical control study

PubMed Central

2012-01-01

Background This study examined the association between overall survival and Glutathione S-transferase Pi (GST Pi) expression and genetic polymorphism in stage C colon cancer patients after resection alone versus resection plus 5-fluourouracil-based adjuvant chemotherapy. Methods Patients were drawn from a hospital registry of colorectal cancer resections. Those receiving chemotherapy after it was introduced in 1992 were compared with an age and sex matched control group from the preceding period. GST Pi expression was assessed by immunohistochemistry. Overall survival was analysed by the Kaplan-Meier method and Cox regression. Results From an initial 104 patients treated with chemotherapy and 104 matched controls, 26 were excluded because of non-informative immunohistochemistry, leaving 95 in the treated group and 87 controls. Survival did not differ significantly among patients with low GST Pi who did or did not receive chemotherapy and those with high GST Pi who received chemotherapy (lowest pair-wise p = 0.11) whereas patients with high GST Pi who did not receive chemotherapy experienced markedly poorer survival than any of the other three groups (all pair-wise p <0.01). This result was unaffected by GST Pi genotype. Conclusion Stage C colon cancer patients with low GST Pi did not benefit from 5-fluourouracil-based adjuvant chemotherapy whereas those with high GST Pi did. PMID:22639861

Glutathione S-transferase Pi expression predicts response to adjuvant chemotherapy for stage C colon cancer: a matched historical control study.

PubMed

Jankova, Lucy; Robertson, Graham; Chan, Charles; Tan, King L; Kohonen-Corish, Maija; Fung, Caroline L-S; Clarke, Candice; Lin, Betty P C; Molloy, Mark; Chapuis, Pierre H; Bokey, Les; Dent, Owen F; Clarke, Stephen J

2012-05-28

This study examined the association between overall survival and Glutathione S-transferase Pi (GST Pi) expression and genetic polymorphism in stage C colon cancer patients after resection alone versus resection plus 5-fluourouracil-based adjuvant chemotherapy. Patients were drawn from a hospital registry of colorectal cancer resections. Those receiving chemotherapy after it was introduced in 1992 were compared with an age and sex matched control group from the preceding period. GST Pi expression was assessed by immunohistochemistry. Overall survival was analysed by the Kaplan-Meier method and Cox regression. From an initial 104 patients treated with chemotherapy and 104 matched controls, 26 were excluded because of non-informative immunohistochemistry, leaving 95 in the treated group and 87 controls. Survival did not differ significantly among patients with low GST Pi who did or did not receive chemotherapy and those with high GST Pi who received chemotherapy (lowest pair-wise p = 0.11) whereas patients with high GST Pi who did not receive chemotherapy experienced markedly poorer survival than any of the other three groups (all pair-wise p <0.01). This result was unaffected by GST Pi genotype. Stage C colon cancer patients with low GST Pi did not benefit from 5-fluourouracil-based adjuvant chemotherapy whereas those with high GST Pi did.

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.

Efficiency of allogeneic hematopoietic SCT from HLA fully-matched non-sibling relatives: a new prospect of exploiting extended family search.

PubMed

Hamidieh, A A; Dehaghi, M Ostadali; Paragomi, P; Navaei, S; Jalali, A; Eslami, G Ghazizadeh; Behfar, M; Ghavamzadeh, A

2015-04-01

The best donors for hematopoietic SCT (HSCT) are fully-matched siblings. In patients without fully-matched siblings, HLA registries or cord blood banks are alternative strategies with some restrictions. Owing to the high rate of consanguineous marriage in our country, between 2006 and 2013, extended family searches were undertaken in Hematology-Oncology Research Center and Stem Cell Transplantation (HORCSCT), Tehran, Iran, in 523 HSCT candidates with parental consanguinity and no available HLA identical sibling. Fully-matched other-relative donors were found for 109 cases. We retrospectively studied the HSCT outcome in these patients. Median time to neutrophil engraftment was 13 days (range: 9-31days). In 83 patients, full chimerism and in 17 patients, mixed chimerism was achieved. Acute GvHD (aGvHD) grade II-IV appeared in 36 patients (33%). The frequency of aGvHD development in various familial subgroups was NS. Five patients expired before day+100. In the surviving 104 cases, chronic GvHD developed in 20 patients (19.2%). The distantly related subgroup had significantly a higher rate of cGvHD (P=0.04). The 2-year OS and disease-free survival (DFS) were 76.7±4.5% and 71.7±4.7%, respectively. No significant difference in OS (P=0.30) and DFS (P=0.80) was unraveled between various familial relationships. Our considerable rate of fully-matched non-sibling family members and the favorable outcome support the rationale for extended family search in regions where consanguineous marriage is widely practiced.

Antidepressant Use After Aneurysmal Subarachnoid Hemorrhage: A Population-Based Case-Control Study.

PubMed

Huttunen, Jukka; Lindgren, Antti; Kurki, Mitja I; Huttunen, Terhi; Frösen, Juhana; von Und Zu Fraunberg, Mikael; Koivisto, Timo; Kälviäinen, Reetta; Räikkönen, Katri; Viinamäki, Heimo; Jääskeläinen, Juha E; Immonen, Arto

2016-09-01

To elucidate the predictors of antidepressant use after subarachnoid hemorrhage from saccular intracranial aneurysm (sIA-SAH) in a population-based cohort with matched controls. The Kuopio sIA database includes all unruptured and ruptured sIA cases admitted to the Kuopio University Hospital from its defined catchment population in Eastern Finland, with 3 matched controls for each patient. The use of all prescribed medicines has been fused from the Finnish national registry of prescribed medicines. In the present study, 2 or more purchases of antidepressant medication indicated antidepressant use. The risk factors of the antidepressant use were analyzed in 940 patients alive 12 months after sIA-SAH, and the classification tree analysis was used to create a predicting model for antidepressant use after sIA-SAH. The 940 12-month survivors of sIA-SAH had significantly more antidepressant use (odds ratio, 2.6; 95% confidence interval, 2.2-3.1) than their 2676 matched controls (29% versus 14%). Classification tree analysis, based on independent risk factors, was used for the best prediction model of antidepressant use after sIA-SAH. Modified Rankin Scale until 12 months was the most potent predictor, followed by condition (Hunt and Hess Scale) and age on admission for sIA-SAH. The sIA-SAH survivors use significantly more often antidepressants, indicative of depression, than their matched population controls. Even with a seemingly good recovery (modified Rankin Scale score, 0) at 12 months after sIA-SAH, there is a significant risk of depression requiring antidepressant medication. © 2016 American Heart Association, Inc.

First-line treatment for severe aplastic anemia in children: bone marrow transplantation from a matched family donor versus immunosuppressive therapy.

PubMed

Yoshida, Nao; Kobayashi, Ryoji; Yabe, Hiromasa; Kosaka, Yoshiyuki; Yagasaki, Hiroshi; Watanabe, Ken-Ichiro; Kudo, Kazuko; Morimoto, Akira; Ohga, Shouichi; Muramatsu, Hideki; Takahashi, Yoshiyuki; Kato, Koji; Suzuki, Ritsuro; Ohara, Akira; Kojima, Seiji

2014-12-01

The current treatment approach for severe aplastic anemia in children is based on studies performed in the 1980s, and updated evidence is required. We retrospectively compared the outcomes of children with acquired severe aplastic anemia who received immunosuppressive therapy within prospective trials conducted by the Japanese Childhood Aplastic Anemia Study Group or who underwent bone marrow transplantation from an HLA-matched family donor registered in the Japanese Society for Hematopoietic Cell Transplantation Registry. Between 1992 and 2009, 599 children (younger than 17 years) with severe aplastic anemia received a bone marrow transplant from an HLA-matched family donor (n=213) or immunosuppressive therapy (n=386) as first-line treatment. While the overall survival did not differ between patients treated with immunosuppressive therapy or bone marrow transplantation [88% (95% confidence interval: 86-90) versus 92% (90-94)], failure-free survival was significantly inferior in patients receiving immunosuppressive therapy than in those undergoing bone marrow transplantation [56% (54-59) versus 87% (85-90); P<0.0001]. There was no significant improvement in outcomes over the two time periods (1992-1999 versus 2000-2009). In multivariate analysis, age <10 years was identified as a favorable factor for overall survival (P=0.007), and choice of first-line immunosuppressive therapy was the only unfavorable factor for failure-free survival (P<0.0001). These support the current algorithm for treatment decisions, which recommends bone marrow transplantation when an HLA-matched family donor is available in pediatric severe aplastic anemia. Copyright© Ferrata Storti Foundation.

First-line treatment for severe aplastic anemia in children: bone marrow transplantation from a matched family donor versus immunosuppressive therapy

PubMed Central

Yoshida, Nao; Kobayashi, Ryoji; Yabe, Hiromasa; Kosaka, Yoshiyuki; Yagasaki, Hiroshi; Watanabe, Ken-ichiro; Kudo, Kazuko; Morimoto, Akira; Ohga, Shouichi; Muramatsu, Hideki; Takahashi, Yoshiyuki; Kato, Koji; Suzuki, Ritsuro; Ohara, Akira; Kojima, Seiji

2014-01-01

The current treatment approach for severe aplastic anemia in children is based on studies performed in the 1980s, and updated evidence is required. We retrospectively compared the outcomes of children with acquired severe aplastic anemia who received immunosuppressive therapy within prospective trials conducted by the Japanese Childhood Aplastic Anemia Study Group or who underwent bone marrow transplantation from an HLA-matched family donor registered in the Japanese Society for Hematopoietic Cell Transplantation Registry. Between 1992 and 2009, 599 children (younger than 17 years) with severe aplastic anemia received a bone marrow transplant from an HLA-matched family donor (n=213) or immunosuppressive therapy (n=386) as first-line treatment. While the overall survival did not differ between patients treated with immunosuppressive therapy or bone marrow transplantation [88% (95% confidence interval: 86–90) versus 92% (90–94)], failure-free survival was significantly inferior in patients receiving immunosuppressive therapy than in those undergoing bone marrow transplantation [56% (54–59) versus 87% (85–90); P<0.0001]. There was no significant improvement in outcomes over the two time periods (1992–1999 versus 2000–2009). In multivariate analysis, age <10 years was identified as a favorable factor for overall survival (P=0.007), and choice of first-line immunosuppressive therapy was the only unfavorable factor for failure-free survival (P<0.0001). These support the current algorithm for treatment decisions, which recommends bone marrow transplantation when an HLA-matched family donor is available in pediatric severe aplastic anemia. PMID:25193958

The experience of linking Victorian emergency medical service trauma data

PubMed Central

Boyle, Malcolm J

2008-01-01

Background The linking of a large Emergency Medical Service (EMS) dataset with the Victorian Department of Human Services (DHS) hospital datasets and Victorian State Trauma Outcome Registry and Monitoring (VSTORM) dataset to determine patient outcomes has not previously been undertaken in Victoria. The objective of this study was to identify the linkage rate of a large EMS trauma dataset with the Department of Human Services hospital datasets and VSTORM dataset. Methods The linking of an EMS trauma dataset to the hospital datasets utilised deterministic and probabilistic matching. The linking of three EMS trauma datasets to the VSTORM dataset utilised deterministic, probabilistic and manual matching. Results There were 66.7% of patients from the EMS dataset located in the VEMD. There were 96% of patients located in the VAED who were defined in the VEMD as being admitted to hospital. 3.7% of patients located in the VAED could not be found in the VEMD due to hospitals not reporting to the VEMD. For the EMS datasets, there was a 146% increase in successful links with the trauma profile dataset, a 221% increase in successful links with the mechanism of injury only dataset, and a 46% increase with sudden deterioration dataset, to VSTORM when using manual compared to deterministic matching. Conclusion This study has demonstrated that EMS data can be successfully linked to other health related datasets using deterministic and probabilistic matching with varying levels of success. The quality of EMS data needs to be improved to ensure better linkage success rates with other health related datasets. PMID:19014622

Chronic Azithromycin Use in Cystic Fibrosis and Risk of Treatment-Emergent Respiratory Pathogens.

PubMed

Cogen, Jonathan D; Onchiri, Frankline; Emerson, Julia; Gibson, Ronald L; Hoffman, Lucas R; Nichols, David P; Rosenfeld, Margaret

2018-02-23

Azithromycin has been shown to improve lung function and reduce the number of pulmonary exacerbations in cystic fibrosis patients. Concerns remain, however, regarding the potential emergence of treatment-related respiratory pathogens. To determine if chronic azithromycin use (defined as thrice weekly administration) is associated with increased rates of detection of eight specific respiratory pathogens. We performed a new-user, propensity-score matched retrospective cohort study utilizing data from the Cystic Fibrosis Foundation Patient Registry. Incident azithromycin users were propensity-score matched 1:1 with contemporaneous non-users. Kaplan-Meier curves and Cox proportional hazards regression were used to evaluate the association between chronic azithromycin use and incident respiratory pathogen detection. Analyses were performed separately for each pathogen, limited to patients among whom that pathogen had not been isolated in the two years prior to cohort entry. After propensity score matching, mean age of the cohorts was ~12 years. Chronic azithromycin users had a significantly lower risk of detection of new methicillin-resistant Staphylococcus aureus, non-tuberculous mycobacteria, and Burkholderia cepacia complex compared to non-users. The risk of acquiring the remaining five pathogens was not significantly different between users and non-users. Using an innovative new-user, propensity-score matched study design to minimize indication and selection biases, we found in a predominantly pediatric cohort that chronic azithromycin users had a lower risk of acquiring several cystic fibrosis-related respiratory pathogens. These results may ease concerns that chronic azithromycin exposure increases the risk of acquiring new respiratory pathogens among pediatric cystic fibrosis patients.

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

An exploratory analysis of the relationship between ambient ...

EPA Pesticide Factsheets

Background: Associations between ozone (O3) and fine particulate matter (PM2.5) concentrations and birth outcomes have been previously demonstrated. We perform an exploratory analysis of O3 and PM2.5 concentrations during early pregnancy and multiple types of birth defects. Methods: Data on births were obtained from the Texas Birth Defects Registry and the National Birth Defects Prevention Study (NBDPS) in Texas. Air pollution concentrations were determined using a Bayesian hierarchical model that combined modeled air pollution concentrations with air monitoring data to create bias-corrected concentrations and matched to residential address at birth. Average air pollution concentrations during the first trimester were calculated. Results: The analysis generated hypotheses for future, confirmatory studies; although many of the observed associations between the air pollutants and birth defects were null. The hypotheses are provided by an observed association between O3 and craniosynostosis [adjusted OR 1.28 (95% CI 1.04, 1.58) per 13.3 ppb increase) and observed inverse associations between PM2.5 concentrations and septal heart defects and obstructive heart defects [adjusted ORs 0.79 (95% CI 0.75, 0.82) and 0.88 (95% CI 0.79, 0.97) per 5.0 µg/m3 increase, respectively] in the Texas Birth Defects Registry study. Septal heart defects and ventricular outflow tract obstructions were also examined using the NBDPS but the associations with PM2.5 were null [adj

Long-term follow-up of atomic bomb survivors.

PubMed

Sakata, Ritsu; Grant, Eric J; Ozasa, Kotaro

2012-06-01

The Life Span Study (LSS) is a follow-up study of atomic bomb (A-bomb) survivors to investigate the radiation effects on human health and has collected data for over 60 years. The LSS cohort consists of 93,741 A-bomb survivors and another 26,580 age and sex-matched subjects who were not in either city at the time of the bombing. Radiation doses have been computed based on individual location and shielding status at the time of the bombings. Age at death and cause of death are gathered through the Japanese national family registry system and cancer incidence data have been collected through the Hiroshima and Nagasaki cancer registries. Noncancer disease incidence and health information are collected through biannual medical examinations among a subset of the LSS. Radiation significantly increases the risks of death (22% at 1 Gy), cancer incidence (47% at 1 Gy), death due to leukemia (310% at 1 Gy), as well as the incidence of several noncancer diseases (e.g. thyroid nodules, chronic liver disease and cirrhosis, uterine myoma, and hypertension). Significant effects on maturity (e.g. growth reduction and early menopause) were also observed. Long-term follow-up studies of the A-bomb survivors have provided reliable information on health risks for the survivors and form the basis for radiation protection standards for workers and the public. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The First 500 Registrations to the Research Registry®: Advancing Registration of Under-Registered Study Types.

PubMed

Agha, Riaz; Fowler, Alexander J; Limb, Christopher; Al Omran, Yasser; Sagoo, Harkiran; Koshy, Kiron; Jafree, Daniyal J; Anwar, Mohammed Omer; McCullogh, Peter; Orgill, Dennis Paul

2016-01-01

The Declaration of Helsinki 2013 encourages the registration of all research studies involving human participants. However, emphasis has been placed on prospective clinical trials, and it is estimated that only 10% of observational studies are registered. In response, Research Registry ® was launched in February 2015; a retrospectively curated registry that is free and easy to use. Research Registry ® enables prospective or retrospective registration of studies, including those study types that cannot be registered on existing registries. In this study, we describe the first 500 registrations on Research Registry ® . Since the launch of Research Registry ® in February 2015, data of registrations have been collected, including type of studies registered, country of origin, and data curation activity. Inappropriate registrations, such as duplicates, were identified by the data curation process. These were removed from the database or modified as required. A quality score was assigned for each registration, based on Sir Austin Bradford Hill's criteria on what research studies should convey. Changes in quality scores over time were assessed. A total of 500 studies were registered on Research Registry ® from February 2015 to October 2015, with a total of 1.7 million patients enrolled. The most common study types were retrospective cohort studies (37.2%), case series (14.8%), and first-in-man case reports (10.4%). Registrations were received from 57 different countries; the most submissions were received from Turkey, followed by China and the United Kingdom. Retrospective data curation identified 80 studies that were initially registered as the incorrect study type, and were subsequently correct. The Kruskal-Wallis test identified a significant improvement in quality scores for registrations from February 2015 to October 2015 ( p  < 0.0001). Since its conception in February 2015, Research Registry ® has established itself as a new registry that is free, easy to use, and enables the registration of various study types, including observational studies and first-in-man case reports. Going forward, our plan is to continue developing Research Registry ® in line with user feedback and usability studies. We plan to further promote Research Registry ® to advance the cause of registration of research, to increase compliance with the Declaration of Helsinki 2013.

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.

Process improvement: a multi-registry database abstraction success story.

PubMed

Abrich, Victor; Rokey, Roxann; Devadas, Christopher; Uebel, Julie

2014-01-01

The St. Joseph Hospital/Marshfield Clinic Cardiac Database Registry submits data to the National Cardiovascular Data Registry (NCDR) and to the Society of Thoracic Surgeons (STS) National Database. Delayed chart abstraction is problematic, since hospital policy prohibits patient care clarifications made to the medical record more than 1 month after hospital discharge. This can also lead to late identification of missed care opportunities and untimely notification to providers. Our institution was 3.5 months behind in retrospective postdischarge case abstraction. A process improvement plan was implemented to shorten this delay to 1 month postdischarge. Daily demand of incoming cases and abstraction capacity were determined for 4 employees. Demand was matched to capacity, with the remaining time allocated to reducing backlog. Daily demand of new cases was 17.1 hours. Daily abstraction capacity was 24 hours, assuming 6 hours of effective daily abstraction time per employee, leaving 7 hours per day for backlogged case abstraction. The predicted time to reach abstraction target was 10 weeks. This was accomplished after 10 weeks, as predicted, leading to a 60% reduction of backlogged cases. The delay of postdischarge chart abstraction was successfully shortened from 3.5 months to 1 month. We intend to maintain same-day abstraction efficiency without reaccumulating substantial backlog.

Transfusion medicine and solid organ transplant - Update and review of some current issues.

PubMed

Sarkar, R S; Philip, J; Yadav, Pramod

2013-04-01

Transfusion medicine holds a place of prime importance in organ transplant surgeries. There is a huge demand of organs worldwide with long waiting periods before the organ is available for transplant. Currently the dependency on ABO and HLA matching has decreased considerably with the use of modern immunosuppressant drugs and transplant techniques. The greatest advance in clinical implementation of ABO-incompatible transplants came about through desensitization and isoagglutinin elimination techniques with immunoadsorption and anti-CD20 antibodies becoming the norm, and spleenectomy fading out. The implications and practices of transfusion medicine in organ transplant are also undergoing drastic changes. The practice of infusion of one unit of donor's blood preoperatively for immunomodulation is no longer practiced. Use of leuco-reduced products has shown decreasing trends of alloimmunization and graft rejection in cases of multiple surgeries related to organ transplants. Worldwide donor and recipient registry programmes are being setup and existing ones are being upgraded. Such a registry system has been opened in India for kidney transplant cases very recently. Due to such registry programmes the dependency on siblings and directed donations have decreased considerably. This review deals with some of the current issues contributing to the successful outcome of mismatched transplants and the changing concepts of transfusion medicine related to it.

Administrative data linkage to evaluate a quality improvement program in acute stroke care, Georgia, 2006-2009.

PubMed

Ido, Moges Seyoum; Bayakly, Rana; Frankel, Michael; Lyn, Rodney; Okosun, Ike S

2015-01-15

Tracking the vital status of stroke patients through death data is one approach to assessing the impact of quality improvement in stroke care. We assessed the feasibility of linking Georgia hospital discharge data with mortality data to evaluate the effect of participation in the Georgia Coverdell Acute Stroke Registry on survival rates among acute ischemic stroke patients. Multistage probabilistic matching, using a fine-grained record integration and linkage software program and combinations of key variables, was used to link Georgia hospital discharge data for 2005 through 2009 with mortality data for 2006 through 2010. Data from patients admitted with principal diagnoses of acute ischemic stroke were analyzed by using the extended Cox proportional hazard model. The survival times of patients cared for by hospitals participating in the stroke registry and of those treated at nonparticipating hospitals were compared. Average age of the 50,579 patients analyzed was 69 years, and 56% of patients were treated in Georgia Coverdell Acute Stroke Registry hospitals. Thirty-day and 365-day mortality after first admission for stroke were 8.1% and 18.5%, respectively. Patients treated at nonparticipating facilities had a hazard ratio for death of 1.14 (95% confidence interval, 1.03-1.26; P = .01) after the first week of admission compared with patients cared for by hospitals participating in the registry. Hospital discharge data can be linked with death data to assess the impact of clinical-level or community-level chronic disease control initiatives. Hospitals need to undertake quality improvement activities for a better patient outcome.

Semantic Integration for Marine Science Interoperability Using Web Technologies

NASA Astrophysics Data System (ADS)

Rueda, C.; Bermudez, L.; Graybeal, J.; Isenor, A. W.

2008-12-01

The Marine Metadata Interoperability Project, MMI (http://marinemetadata.org) promotes the exchange, integration, and use of marine data through enhanced data publishing, discovery, documentation, and accessibility. A key effort is the definition of an Architectural Framework and Operational Concept for Semantic Interoperability (http://marinemetadata.org/sfc), which is complemented with the development of tools that realize critical use cases in semantic interoperability. In this presentation, we describe a set of such Semantic Web tools that allow performing important interoperability tasks, ranging from the creation of controlled vocabularies and the mapping of terms across multiple ontologies, to the online registration, storage, and search services needed to work with the ontologies (http://mmisw.org). This set of services uses Web standards and technologies, including Resource Description Framework (RDF), Web Ontology language (OWL), Web services, and toolkits for Rich Internet Application development. We will describe the following components: MMI Ontology Registry: The MMI Ontology Registry and Repository provides registry and storage services for ontologies. Entries in the registry are associated with projects defined by the registered users. Also, sophisticated search functions, for example according to metadata items and vocabulary terms, are provided. Client applications can submit search requests using the WC3 SPARQL Query Language for RDF. Voc2RDF: This component converts an ASCII comma-delimited set of terms and definitions into an RDF file. Voc2RDF facilitates the creation of controlled vocabularies by using a simple form-based user interface. Created vocabularies and their descriptive metadata can be submitted to the MMI Ontology Registry for versioning and community access. VINE: The Vocabulary Integration Environment component allows the user to map vocabulary terms across multiple ontologies. Various relationships can be established, for example exactMatch, narrowerThan, and subClassOf. VINE can compute inferred mappings based on the given associations. Attributes about each mapping, like comments and a confidence level, can also be included. VINE also supports registering and storing resulting mapping files in the Ontology Registry. The presentation will describe the application of semantic technologies in general, and our planned applications in particular, to solve data management problems in the marine and environmental sciences.

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/

The present and the future of AIDS and tuberculosis in Illinois.

PubMed Central

Coté, T R; Nelson, M R; Anderson, S P; Martin, R J

1990-01-01

The relation between the acquired immune deficiency syndrome (AIDS) and tuberculosis (TB) was examined by matching the Illinois AIDS and TB registries. The match group was examined and compared with patients with only one disease by race, method of human immunodeficiency virus (HIV) transmission, site of tuberculous disease, radiographic findings, and results of Mantoux tests. The time of TB diagnosis was centrally distributed around the time of AIDS diagnosis; from this, it was determined that 4.1 percent of AIDS patients develop active TB. Projections for future AIDS cases were made by fitting a polynomial model to historical data. These projections were then used to predict the future impact of AIDS-related TB upon state TB rates. The rise in TB rates call for special efforts to minimize this impact. PMID:2368856

Effect of dialyzer membrane materials on survival in chronic hemodialysis patients: Results from the annual survey of the Japanese Nationwide Dialysis Registry

PubMed Central

Hamano, Takayuki; Wada, Atsushi; Nakai, Shigeru; Masakane, Ikuto

2017-01-01

Background Little information is available regarding which type of dialyzer membrane results in good prognosis in patients on chronic hemodialysis. Therefore, we conducted a cohort study from a nationwide registry of hemodialysis patients in Japan to establish the association between different dialyzer membranes and mortality rates. Methods We followed 142,412 patients on maintenance hemodialysis (female, 39.1%; mean age, 64.8 ± 12.3 years; median dialysis duration, 7 [4–12] years) for a year from 2008 to 2009. We included patients treated with seven types of high-flux dialyzer membranes at baseline, including cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS). Cox regression was used to estimate the association between baseline dialyzers and all-cause mortality as hazard ratios (HRs) and 95% confidence intervals for 1-year mortality adjusting for potential confounders, and propensity score matching analysis was performed. Results The distribution of patients treated with each membrane was as follows: PS (56.0%), CTA (17.3%), PES (12.0%), PEPA (7.5%), PMMA (4.9%), PAN (1.2%), and EVAL (1.1%). When data were adjusted using basic factors, with PS as a reference group, the mortality rate was significantly higher in all groups except for the PES group. When data were further adjusted for dialysis-related factors, HRs were significantly higher for the CTA, EVAL, and PEPA groups. When the data were further adjusted for nutrition-and inflammation-related factors, HRs were significantly lower for the PMMA and PES groups compared with the PS group. After propensity score matching, HRs were significantly lower for the PMMA group than for the PS group. Conclusion The results suggest that the use of different membrane types may affect mortality in hemodialysis patients. However, further long-term prospective studies are needed to clarify these findings, including whether the use of the PMMA membrane can improve prognosis. PMID:28910324

Effect of dialyzer membrane materials on survival in chronic hemodialysis patients: Results from the annual survey of the Japanese Nationwide Dialysis Registry.

PubMed

Abe, Masanori; Hamano, Takayuki; Wada, Atsushi; Nakai, Shigeru; Masakane, Ikuto

2017-01-01

Little information is available regarding which type of dialyzer membrane results in good prognosis in patients on chronic hemodialysis. Therefore, we conducted a cohort study from a nationwide registry of hemodialysis patients in Japan to establish the association between different dialyzer membranes and mortality rates. We followed 142,412 patients on maintenance hemodialysis (female, 39.1%; mean age, 64.8 ± 12.3 years; median dialysis duration, 7 [4-12] years) for a year from 2008 to 2009. We included patients treated with seven types of high-flux dialyzer membranes at baseline, including cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS). Cox regression was used to estimate the association between baseline dialyzers and all-cause mortality as hazard ratios (HRs) and 95% confidence intervals for 1-year mortality adjusting for potential confounders, and propensity score matching analysis was performed. The distribution of patients treated with each membrane was as follows: PS (56.0%), CTA (17.3%), PES (12.0%), PEPA (7.5%), PMMA (4.9%), PAN (1.2%), and EVAL (1.1%). When data were adjusted using basic factors, with PS as a reference group, the mortality rate was significantly higher in all groups except for the PES group. When data were further adjusted for dialysis-related factors, HRs were significantly higher for the CTA, EVAL, and PEPA groups. When the data were further adjusted for nutrition-and inflammation-related factors, HRs were significantly lower for the PMMA and PES groups compared with the PS group. After propensity score matching, HRs were significantly lower for the PMMA group than for the PS group. The results suggest that the use of different membrane types may affect mortality in hemodialysis patients. However, further long-term prospective studies are needed to clarify these findings, including whether the use of the PMMA membrane can improve prognosis.

More frequent use of health care services among distressed compared with nondistressed survivors of lymphoma and chronic lymphocytic leukemia: Results from the population-based PROFILES registry.

PubMed

Arts, Lindy P J; Oerlemans, Simone; Tick, Lidwine; Koster, Ad; Roerdink, Henk T J; van de Poll-Franse, Lonneke V

2018-04-26

Follow-up care for a growing population of survivors of lymphoma and chronic lymphocytic leukemia (CLL) together with the adverse effects these survivors may experience as a result of their cancer and treatment have led to more pressure being placed on health care services. The objectives of the current study were to: 1) compare the use of medical care services by survivors with that of a normative population; 2) evaluate the use of medical and psychosocial care services among distressed and nondistressed survivors; and 3) identify associated sociodemographic and clinical factors. Survivors of lymphoma and CLL diagnosed between 1999 and 2012 were selected via the population-based Netherlands Cancer Registry and completed the Hospital Anxiety and Depression Scale questionnaire and questions regarding health care. Outcomes were compared with an age-matched and sex-matched normative population. A total of 1444 survivors responded (69%). Survivors of lymphoma and CLL contacted their general practitioner (3.8 vs 2.3; P<.001) and medical specialist (5.7 vs 1.6; P<.001) more often within the last year compared with a normative population. In addition, psychologically distressed survivors had even more medical contacts and received psychosocial care more often compared with nondistressed survivors. In addition to psychological distress, comorbidity, female sex, and older age were found to be associated with a greater use of medical services, whereas younger age was associated with receiving psychosocial care. Survivors of lymphoma and CLL, especially those who are psychologically distressed, report an increased use of health care services compared with a normative population. Further studies are needed to explore whether the use of widely applicable psychosocial interventions could reduce the frequency of medical contacts. Cancer 2018. © 2018 Netherlands Comprehensive Cancer Organisation. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. © 2018 Netherlands Comprehensive Cancer Organisation. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.

PubMed

Earley, Amy; Lau, Joseph; Uhlig, Katrin

2013-01-18

A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Registry-based study of clinical trial results reporting. ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications–a cross-sectional study

PubMed Central

Earley, Amy; Lau, Joseph; Uhlig,, Katrin

2013-01-01

Context A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. Objective To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Design Registry-based study of clinical trial results reporting. Setting ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. Selection criteria A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. Main outcome measure ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. Results In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Conclusions Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications. PMID:23335556

On the Effect of Triplet or Doublet Chemotherapy in Advanced Gastric Cancer: Results From a National Cancer Registry.

PubMed

Carmona-Bayonas, Alberto; Jiménez-Fonseca, Paula; Lorenzo, Maria Luisa Sánchez; Ramchandani, Avinash; Martínez, Elena Asensio; Custodio, Ana; Garrido, Marcelo; Echavarría, Isabel; Cano, Juana María; Barreto, Jose Enrique Lorenzo; García, Teresa García; Manceñido, Felipe Álvarez; Lacalle, Alejandra; Cardona, Marta Ferrer; Mangas, Monserrat; Visa, Laura; Buxó, Elvira; Azkarate, Aitor; Díaz-Serrano, Asunción; Montes, Ana Fernández; Rivera, Fernando

2016-11-01

There is currently no consensus regarding first-line chemotherapy for patients with advanced gastric cancer (AGC) who are ineligible to receive trastuzumab. The objective of this study was to evaluate the efficacy and tolerance of triplets versus doublets by analyzing a national gastric cancer registry. Patients with AGC treated with polychemotherapy without associating trastuzumab were included from 2008 through 2016. The effect of triplets versus doublets was compared using 3 methods: Cox proportional hazards regression, propensity score matching (PSM), and coarsened exact matching (CEM). A total of 970 patients were recruited (doublets: n=569; triplets: n=401). In the multivariate Cox model, the use of triplets was associated with better overall survival (OS), with a hazard ratio (HR) of 0.84 (95% CI, 0.72-0.98; P=.035). After PSM, the sample contained 340 pairs. A significant increase in OS, 11.14 months (95% CI, 9.60-12.68) versus 9.60 months (95% CI, 8.44-10.75), was seen in favor of triplets (HR, 0.77; 95% CI, 0.65-0.92; stratified log-rank test, P=.004). The effect appeared to be comparable for anthracycline-based (HR, 0.78; 95% CI, 0.64-0.94) or docetaxel-based triplets (HR, 0.78; 95% CI, 0.60-1.009). The trend was similar after applying the CEM algorithm, with an HR of 0.78 (95% CI, 0.63-0.97; P=.03). Triplet therapy was viable and relative dose intensities exceeded 85%, except for cisplatin in DCX (docetaxel, cisplatin, capecitabine). Triplets had more severe toxicity overall, especially hematologic, hepatic, and mucosal adverse events. With the limitations of a retrospective study that examines a heterogeneous set of chemotherapy regimens, we found that triplets are feasible in daily practice and are associated with a discreet benefit in efficacy at the expense of a moderate increase in toxicity. Copyright © 2016 by the National Comprehensive Cancer Network.

Upfront haploidentical transplant for acquired severe aplastic anemia: registry-based comparison with matched related transplant.

PubMed

Xu, Lan-Ping; Jin, Song; Wang, Shun-Qing; Xia, Ling-Hui; Bai, Hai; Gao, Su-Jun; Liu, Qi-Fa; Wang, Jian-Min; Wang, Xin; Jiang, Ming; Zhang, Xi; Wu, De-Pei; Huang, Xiao-Jun

2017-01-21

Haploidentical donor (HID) hematopoietic stem cell transplantation (HSCT) is an alternative treatment method for severe aplastic anemia (SAA) patients lacking suitable identical donors and those who are refractory to immunosuppressive therapy (IST). The current study evaluated the feasibility of upfront haploidentical HSCT in SAA patients. We conducted a multicenter study based on a registry database. One hundred fifty-eight SAA patients who underwent upfront transplantation between June 2012 and September 2015 were enrolled. Eighty-nine patients had haploidentical donors (HIDs), and 69 had matched related donors (MRDs) for HSCT. The median times for myeloid engraftment in the HID and MRD cohorts were 12 (range, 9-20) and 11 (range, 8-19) days, with a cumulative incidence of 97.8 and 97.1% (P = 0.528), respectively. HID recipients had an increased cumulative incidence of grades II-IV acute graft-versus-host disease (aGVHD) (30.3 vs. 1.5%, P < 0.001), grades III-IV aGVHD (10.1 vs. 1.5%, P = 0.026), and chronic GVHD (cGVHD) (30.6 vs. 4.4%, P < 0.001) at 1 year but similar extensive cGVHD (3.4 vs. 0%, P = 0.426). The three-year estimated overall survival (OS) rates were 86.1 and 91.3% (P = 0.358), while the three-year estimated failure-free survival (FFS) rates were 85.0 and 89.8% (P = 0.413) in the HID and MRD cohorts, respectively. In multivariate analysis, survival outcome for the entire population was significantly adversely associated with increased transfusions and poor performance status pre-SCT. We did not observe differences in primary engraftment and survival outcomes by donor type. Haploidentical SCT as upfront therapy was an effective and safe option for SAA patients, with favorable outcomes in experienced centers.

Cancer survival in people with AIDS: A population-based study from São Paulo, Brazil.

PubMed

Tanaka, Luana F; Latorre, Maria do Rosário D O; Gutierrez, Eliana B; Curado, Maria P; Dal Maso, Luigino; Herbinger, Karl-Heinz; Froeschl, Guenter; Heumann, Christian

2018-02-01

Cancer survival among people with AIDS (PWA) has been described in developed countries, but there is lack of data from developing countries. The aim of this study was to evaluate survival after cancer diagnosis in PWA and compare it with people without AIDS (non-PWA) in São Paulo, Brazil. A probabilistic record linkage was carried out between the databases of the Population-based Cancer Registry of São Paulo (PBCR-SP) and the AIDS registry of SP (SINAN) to identify PWA who developed cancer. For comparison, non-PWA were frequency matched from the PBCR-SP by cancer site/type, sex, age, and period. Hazard ratio (HR) stratified by matching variables was estimated using a Cox proportional hazards model. A total of 1,294 PWA (20 patients with two primary site tumors) were included in the site/type-specific analyses. AIDS-defining cancers (ADC) comprised 51.9% of cases assessed. The all-cancer 5-year overall survival in PWA was 49.4% versus 72.7% in non-PWA (HR = 2.64; 95%CI = 2.39-2.91). Survival was impaired in PWA for both ADC (HR = 2.93; 95%CI = 2.49-3.45) and non-ADC (HR = 2.51; 95%CI = 2.21-2.84), including bladder (HR = 8.11; 95% CI = 2.09-31.52), lung (HR = 2.93; 95%CI = 1.97-4.36) and anal cancer (HR = 2.53; 95%CI = 1.63-3.94). These disparities were seen mainly in the first year after cancer diagnosis. The overall survival was significantly lower in PWA in comparison with non-PWA in São Paulo, as seen in high-income countries. Efforts to enhance early diagnosis and ensure proper cancer treatment in PWA should be emphasized. © 2017 UICC.

Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

PubMed

de la Torre Hernández, José M; Oteo Domínguez, Juan F; Hernández, Felipe; García Camarero, Tamara; Abdul-Jawad Altisent, Omar; Rivero Crespo, Fernando; Cascón, José D; Zavala, Germán; Gimeno, Federico; Arrebola Moreno, Antonio L; Andraka, Leire; Gómez Menchero, Antonio; Bosa, Francisco; Carrillo, Xavier; Sánchez Recalde, Ángel; Alfonso, Fernando; Pérez de Prado, Armando; López Palop, Ramón; Sanchis, Juan; Diarte de Miguel, José A; Jiménez Navarro, Manuel; Muñoz, Luz; Ramírez Moreno, Antonio; Tizón Marcos, Helena

2015-10-01

The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Development of an Unrelated Donor Selection Score Predictive of Survival after HCT: Donor Age Matters Most.

PubMed

Shaw, Bronwen E; Logan, Brent R; Spellman, Stephen R; Marsh, Steven G E; Robinson, James; Pidala, Joseph; Hurley, Carolyn; Barker, Juliet; Maiers, Martin; Dehn, Jason; Wang, Hailin; Haagenson, Mike; Porter, David; Petersdorf, Effie W; Woolfrey, Ann; Horowitz, Mary M; Verneris, Michael; Hsu, Katharine C; Fleischhauer, Katharina; Lee, Stephanie J

2018-05-01

Donor factors, in addition to HLA matching status, have been associated with recipient survival in unrelated donor (URD) hematopoietic cell transplantation (HCT); however, there is no hierarchical algorithm that weights the characteristics of individual donors against each other in a quantitative manner to facilitate donor selection. The goal of this study was to develop and validate a donor selection score that prioritizes donor characteristics associated with better survival in 8/8 HLA-matched URDs. Two separate patient/donor cohorts, the first receiving HCT between 1999 and 2011 (n = 5952, c1), and the second between 2012 and 2014 (n = 4510, c2) were included in the analysis. Both cohorts were randomly spilt, 2:1, into training and testing sets. Despite studying over 10,000 URD transplants, we were unable to validate a donor selection score. The only donor characteristic associated with better survival was younger age, with 2-year survival being 3% better when a donor 10 years younger is selected. These results support previous studies suggesting prioritization of a younger 8/8 HLA-matched donor. This large dataset also shows that none of the other donor clinical factors tested were reproducibly associated with survival, and hence flexibility in selecting URDs based on other characteristics is justified. These data support a simplified URD selection process and have significant implications for URD registries. Copyright © 2018 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

ClinicalTrials.gov

2018-02-24

Cancer, Metastatic; Cancer; Cancer of Pancreas; Cancer of Liver; Cancer of Stomach; Cancer Liver; Cancer of Rectum; Cancer of Kidney; Cancer of Esophagus; Cancer of Cervix; Cancer of Colon; Cancer of Larynx; Cancer, Lung; Cancer, Breast; Cancer, Advanced; Cancer Prostate; Cancer of Neck; Cancer of Skin; Neuroendocrine Tumors; Carcinoma; Mismatch Repair Deficiency; BRCA Gene Rearrangement; Non Hodgkin Lymphoma; Leukemia; Non Small Cell Lung Cancer; Cholangiocarcinoma; Glioblastoma; Central Nervous System Tumor; Melanoma; Urothelial Carcinoma; Bladder Cancer; Ovarian Cancer; Endometrial Cancer; Testicular Cancer; Breast Cancer

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.

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.

The effect of multiple primary rules on population-based cancer survival

PubMed Central

Weir, Hannah K.; Johnson, Christopher J.; Thompson, Trevor D.

2015-01-01

Purpose Different rules for registering multiple primary (MP) cancers are used by cancer registries throughout the world, making international data comparisons difficult. This study evaluates the effect of Surveillance, Epidemiology, and End Results (SEER) and International Association of Cancer Registries (IACR) MP rules on population-based cancer survival estimates. Methods Data from five US states and six metropolitan area cancer registries participating in the SEER Program were used to estimate age-standardized relative survival (RS%) for first cancers-only and all first cancers matching the selection criteria according to SEER and IACR MP rules for all cancer sites combined and for the top 25 cancer site groups among men and women. Results During 1995–2008, the percentage of MP cancers (all sites, both sexes) increased 25.4 % by using SEER rules (from 14.6 to 18.4 %) and 20.1 % by using IACR rules (from 13.2 to 15.8 %). More MP cancers were registered among females than among males, and SEER rules registered more MP cancers than IACR rules (15.8 vs. 14.4 % among males; 17.2 vs. 14.5 % among females). The top 3 cancer sites with the largest differences were melanoma (5.8 %), urinary bladder (3.5 %), and kidney and renal pelvis (2.9 %) among males, and breast (5.9 %), melanoma (3.9 %), and urinary bladder (3.4 %) among females. Five-year survival estimates (all sites combined) restricted to first primary cancers-only were higher than estimates by using first site-specific primaries (SEER or IACR rules), and for 11 of 21 sites among males and 11 of 23 sites among females. SEER estimates are comparable to IACR estimates for all site-specific cancers and marginally higher for all sites combined among females (RS 62.28 vs. 61.96 %). Conclusion Survival after diagnosis has improved for many leading cancers. However, cancer patients remain at risk of subsequent cancers. Survival estimates based on first cancers-only exclude a large and increasing number of MP cancers. To produce clinically and epidemiologically relevant and less biased cancer survival estimates, data on all cancers should be included in the analysis. The multiple primary rules (SEER or IACR) used to identify primary cancers do not affect survival estimates if all first cancers matching the selection criteria are used to produce site-specific survival estimates. PMID:23558444

[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.

Body mass index trend in haemodialysis patients: the shift of nutritional disorders in two Italian regions.

PubMed

Postorino, Maurizio; Mancini, Elena; D'Arrigo, Graziella; Marino, Carmela; Vilasi, Antonio; Tripepi, Giovanni; Gallus, Silvano; Lugo, Alessandra; Santoro, Antonio; Zoccali, Carmine

2016-10-01

In the USA, the increase in the prevalence of obesity in the general population has been accompanied by a marked increase in the prevalence and incidence of obesity in the dialysis population. However, secular trends of body mass index (BMI) have not been investigated in European renal registries. We investigated the secular trend of BMI across 18 years (1994-2011) in two haemodialysis (HD) registries (Calabria in southern Italy and Emilia in northern Italy) on a total of 16 201 prevalent HD patients and in a series of 3559 incident HD patients. We compared trends in BMI for HD patients with those in the background general population of the same regions. The average BMI rose from 23.5 kg/m(2) in 1994 to 25.5 (+8.5%) in 2011 in the Calabria registry and from 23.7 in 1998 to 25.4 (+7.1%) in 2011 in the Emilia registry (P < 0.001). The proportion of obese patients (i.e. with BMI >30 kg/m(2)) rose from 6 to 14% in Calabria and from 6 to 16% in Emilia (P < 0.001). These patterns were fully confirmed in incident patients and were mirrored by a substantial decline in the prevalence of underweight-normal and underweight (P < 0.001) patients. Of note, the steepness of the increase in BMI in haemodialysis patients was 3.7 times more pronounced than that in the coeval, age- and sex-matched general population of Calabria and Emilia. In two regional haemodialysis registries in Italy a steady increase in overweight and obese patients is observed. These patterns are more pronounced than those found in the general population. If further confirmed in other European haemodialysis cohorts, these findings may have relevant public health implications. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

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.

Evaluating the Use of Existing Data Sources, Probabilistic Linkage, and Multiple Imputation to Build Population-based Injury Databases Across Phases of Trauma Care

PubMed Central

Newgard, Craig; Malveau, Susan; Staudenmayer, Kristan; Wang, N. Ewen; Hsia, Renee Y.; Mann, N. Clay; Holmes, James F.; Kuppermann, Nathan; Haukoos, Jason S.; Bulger, Eileen M.; Dai, Mengtao; Cook, Lawrence J.

2012-01-01

Objectives The objective was to evaluate the process of using existing data sources, probabilistic linkage, and multiple imputation to create large population-based injury databases matched to outcomes. Methods This was a retrospective cohort study of injured children and adults transported by 94 emergency medical systems (EMS) agencies to 122 hospitals in seven regions of the western United States over a 36-month period (2006 to 2008). All injured patients evaluated by EMS personnel within specific geographic catchment areas were included, regardless of field disposition or outcome. The authors performed probabilistic linkage of EMS records to four hospital and postdischarge data sources (emergency department [ED] data, patient discharge data, trauma registries, and vital statistics files) and then handled missing values using multiple imputation. The authors compare and evaluate matched records, match rates (proportion of matches among eligible patients), and injury outcomes within and across sites. Results There were 381,719 injured patients evaluated by EMS personnel in the seven regions. Among transported patients, match rates ranged from 14.9% to 87.5% and were directly affected by the availability of hospital data sources and proportion of missing values for key linkage variables. For vital statistics records (1-year mortality), estimated match rates ranged from 88.0% to 98.7%. Use of multiple imputation (compared to complete case analysis) reduced bias for injury outcomes, although sample size, percentage missing, type of variable, and combined-site versus single-site imputation models all affected the resulting estimates and variance. Conclusions This project demonstrates the feasibility and describes the process of constructing population-based injury databases across multiple phases of care using existing data sources and commonly available analytic methods. Attention to key linkage variables and decisions for handling missing values can be used to increase match rates between data sources, minimize bias, and preserve sampling design. PMID:22506952

Risk of depressive disorder among patients with head and neck cancer: A nationwide population-based study.

PubMed

Fan, Chao-Yueh; Chao, Hsing-Lung; Lin, Chun-Shu; Huang, Wen-Yen; Chen, Chang-Ming; Lin, Kuen-Tze; Lin, Cheng-Li; Kao, Chia-Hung

2018-02-01

The purpose of this study was to assess the incidence and risk of depressive disorder among patients with head and neck cancer. We identified 48 548 patients from the National Health Insurance Research Database (NHIRD) in Taiwan who were newly diagnosed with head and neck cancer between 2000 and 2010. Each patient was randomly frequency-matched with an individual without head and neck cancer, based on index year, sex, age, occupation category, urbanization level, monthly income, and comorbidities. The Cox proportional Registry of Catastrophic Illnesses Patient Database regression analysis was performed to estimate the effect of head and neck cancer on the risk of depressive disorder. Patients with head and neck cancer had a significantly higher risk of depressive disorder than the matched cohort (adjusted hazard ratio [HR] 3.32; 95% confidence interval [CI] 3.05-3.61), with the highest risk seen in the hypopharynx and oropharynx. Patients with head and neck cancer had >3 times the incidence of depressive disorder, relative to the comparison group. Psychological evaluation and support are essential in head and neck cancer survivors. © 2017 Wiley Periodicals, Inc.

An overview of international literature from cystic fibrosis registries 2. Neonatal screening and nutrition/growth.

PubMed

Salvatore, Donatello; Buzzetti, Roberto; Baldo, Ermanno; Forneris, Maria Pia; Lucidi, Vincenzina; Manunza, Daniela; Marinelli, Italo; Messore, Barbara; Neri, Anna Silvia; Raia, Valeria; Furnari, Maria Lucia; Mastella, Gianni

2010-03-01

This is the second article related to a review of the literature based on data from national cystic fibrosis (CF) registries up to June 2008 and covering a total of 115 studies. It focuses on two topics: neonatal screening (NS) and nutritional status, with particular reference to growth. Ten papers meeting the inclusion criteria were found on the topic of NS and its impact on the course of the disease, and were analyzed according to a dedicated grid. The issue of nutrition was addressed by 14 studies, analyzed according to similar criteria. Most of the studies report benefits of early diagnosis by NS, albeit to variable degrees. The benefits were assessed in terms of better nutritional status and growth, but also in terms of lower overall morbidity rate as compared to subjects diagnosed by symptoms. The main biases of these studies, which partly undermine the validity of their results, are also analyzed. A part of our analysis on nutrition/growth is dedicated to the identification of the most suitable parameters to define malnutrition: in children older than two years the body mass index percentile (BMIp) appears to be the most sensitive and significantly associated with respiratory function. Better nutritional status and satisfactory growth appear to be associated with better lung function and lower risk of death. The relationship between nutritional status and socio-economic status is also of interest. CF registry studies support the outcome of cohort observational studies i.e. that pre-symptomatic early diagnosis is beneficial, especially in terms of nutritional status and growth. Studies on nutrition indicate that good nutritional status is associated with better respiratory function and prognosis. Regarding methods, the need emerged to manage potential biases of this kind of non randomized studies, resorting to suitable statistical techniques, such as matching and stratification and, above all, to multivariate methods able to provide estimates adjusted for the main covariates tested. Copyright (c) 2009 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

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.

Endemic cryptosporidiosis and exposure to municipal tap water in persons with acquired immunodeficiency syndrome (AIDS): A case-control study

PubMed Central

Aragón, Tomás J; Novotny, Suzanne; Enanoria, Wayne; Vugia, Duc J; Khalakdina, Asheena; Katz, Mitchell H

2003-01-01

Background In persons with acquired immunodeficiency syndrome (AIDS), Cryptosporidium parvum causes a prolonged, severe diarrheal illness to which there is no effective treatment, and the risk of developing cryptosporidiosis from drinking tap water in non-outbreak settings remains uncertain. To test the hypothesis that drinking tap water was associated with developing cryptosporidiosis, we conducted a matched case-control study among persons with AIDS in San Francisco. Methods Among patients reported to the San Francisco AIDS Registry from May 1996 through September 1998, we compared patients who developed cryptosporidiosis to those who did not. Cases were individually matched to controls based on age, sex, race/ethnicity, CD4+ T lymphocyte count, date of CD4+ count, and date of case diagnosis. Population attributable fractions (PAFs) were calculated. Results The study consisted of 49 cases and 99 matched controls. In the multivariable analysis with adjustments for confounders, tap water consumption inside and outside the home at the highest exposure categories was associated with the occurrence of cryptosporidiosis (inside the home: odds ratio (OR), 6.76; 95% CI 1.37–33.5, and outside the home: OR 3.16; 95% CI 1.23–8.13). The PAF was 85%; that is, the proportion of cases of cryptosporidiosis in San Francisco AIDS patients attributable to tap water consumption could have been as high as 85%. Conclusions Although the results from this observational study cannot be considered definitive, until there is more data, we recommend persons with AIDS, especially those with compromised immune systems, consider avoiding tap water. PMID:12515584

Endemic cryptosporidiosis and exposure to municipal tap water in persons with acquired immunodeficiency syndrome (AIDS): a case-control study.

PubMed

Aragón, Tomás J; Novotny, Suzanne; Enanoria, Wayne; Vugia, Duc J; Khalakdina, Asheena; Katz, Mitchell H

2003-01-06

In persons with acquired immunodeficiency syndrome (AIDS), Cryptosporidium parvum causes a prolonged, severe diarrheal illness to which there is no effective treatment, and the risk of developing cryptosporidiosis from drinking tap water in non-outbreak settings remains uncertain. To test the hypothesis that drinking tap water was associated with developing cryptosporidiosis, we conducted a matched case-control study among persons with AIDS in San Francisco. Among patients reported to the San Francisco AIDS Registry from May 1996 through September 1998, we compared patients who developed cryptosporidiosis to those who did not. Cases were individually matched to controls based on age, sex, race/ethnicity, CD4+ T lymphocyte count, date of CD4+ count, and date of case diagnosis. Population attributable fractions (PAFs) were calculated. The study consisted of 49 cases and 99 matched controls. In the multivariable analysis with adjustments for confounders, tap water consumption inside and outside the home at the highest exposure categories was associated with the occurrence of cryptosporidiosis (inside the home: odds ratio (OR), 6.76; 95% CI 1.37-33.5, and outside the home: OR 3.16; 95% CI 1.23-8.13). The PAF was 85%; that is, the proportion of cases of cryptosporidiosis in San Francisco AIDS patients attributable to tap water consumption could have been as high as 85%. Although the results from this observational study cannot be considered definitive, until there is more data, we recommend persons with AIDS, especially those with compromised immune systems, consider avoiding tap water.

Soya food intake and risk of endometrial cancer among Chinese women in Shanghai: population based case-control study

PubMed Central

Xu, Wang Hong; Zheng, Wei; Xiang, Yong Bing; Ruan, Zhi Xian; Cheng, Jia Rong; Dai, Qi; Gao, Yu Tang; Shu, Xiao Ou

2004-01-01

Objective To evaluate the association of intake of soya food, a rich source of phytoestrogens, with the risk of endometrial cancer. Design Population based case-control study, with detailed information on usual soya food intake over the past five years collected by face to face interview using a food frequency questionnaire. Setting Urban Shanghai, China. Participants 832 incident cases of endometrial cancer in women aged of 30 to 69 years diagnosed during 1997-2001 and identified from the Shanghai Cancer Registry; 846 control women frequency matched to cases on age and randomly selected from the Shanghai Residential Registry. Main outcome measures Odds ratios for risk of endometrial cancer in women with different intakes of soya foods. Results Regular consumption of soya foods, measured as amount of either soya protein or soya isoflavones, was inversely associated with the risk of endometrial cancer. Compared with women with the lowest quarter of intake, the adjusted odds ratio of endometrial cancer was reduced from 0.93 to 0.85 and 0.67 with increasing quarter of soya protein intake (P for trend 0.01). A similar inverse association was observed for soya isoflavones and soya fibre intake. The inverse association seemed to be more pronounced among women with high body mass index and waist:hip ratio. Conclusion Regular intake of soya foods is associated with a reduced risk of endometrial cancer. PMID:15136343

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.

Spironolactone Treatment and Effect on Survival in Chronic Heart Failure Patients with Reduced Renal Function: A Propensity-Matched Study

PubMed Central

Stubnova, Viera; Os, Ingrid; Grundtvig, Morten; Atar, Dan; Waldum-Grevbo, Bård

2017-01-01

Background/Aims Spironolactone may be hazardous in heart failure (HF) patients with renal dysfunction due to risk of hyperkalemia and worsened renal function. We aimed to evaluate the effect of spironolactone on all-cause mortality in HF outpatients with renal dysfunction in a propensity-score-matched study. Methods A total of 2,077 patients from the Norwegian Heart Failure Registry with renal dysfunction (eGFR <60 mL/min/1.73 m2) not treated with spironolactone at the first visit at the HF clinic were eligible for the study. Patients started on spironolactone at the outpatient HF clinics (n = 206) were propensity-score-matched 1:1 with patients not started on spironolactone, based on 16 measured baseline characteristics. Kaplan-Meier and Cox regression analyses were used to investigate the independent effect of spironolactone on 2-year all-cause mortality. Results Propensity score matching identified 170 pairs of patients, one group receiving spironolactone and the other not. The two groups were well matched (mean age 76.7 ± 8.1 years, 66.4% males, and eGFR 46.2 ± 10.2 mL/min/1.73 m2). Treatment with spironolactone was associated with increased potassium (delta potassium 0.31 ± 0.55 vs. 0.05 ± 0.41 mmol/L, p < 0.001) and decreased eGFR (delta eGFR −4.12 ± 12.2 vs. −0.98 ± 7.88 mL/min/1.73 m2, p = 0.006) compared to the non-spironolactone group. After 2 years, 84% of patients were alive in the spironolactone group and 73% of patients in the non-spironolactone group (HR 0.59, 95% CI 0.37-0.92, p = 0.020). Conclusion In HF outpatients with renal dysfunction, treatment with spironolactone was associated with improved 2-year survival compared to well-matched patients not treated with spironolactone. Favorable survival was observed despite worsened renal function and increased potassium in the spironolactone group. PMID:28611786

Intellectual and language functions in children of mothers with epilepsy.

PubMed

Thomas, Sanjeev V; Sukumaran, Sajith; Lukose, Neetha; George, Annamma; Sarma, P S

2007-12-01

To compare the intellectual and language functions of children of mothers with epilepsy (CME) with that of controls matched for age and socioeconomic status. Cases were CME, aged six years or more (n = 71), drawn from a prospective cohort in the Kerala Registry of Epilepsy and Pregnancy. Controls were 201 children of parents without epilepsy, matched for age and socioeconomic status. The outcome measures included Indian adaptation of Wechsler Intelligence Scale for children and MLT-a locally developed proficiency test for regional language. All relevant data were abstracted from the registry records. The Full Scale IQ and MLT scores were significantly lower for the cases (87.7 +/- 22.6 and 73.4 +/- 17.3) compared to controls (93.0 +/- 14.4 and 83.2 +/- 11.8). Compared to controls, CME scored poor on all subtests of MLT but their impairment was confined to only some of the subtests of IQ. Maternal education and maternal IQ significantly correlated with low IQ and MLT scores for CME whereas type of epilepsy, seizures during pregnancy or low birth weight did not have any significant association with these outcome measures. Polytherapy and higher dosage of antiepileptic drugs (AEDs) were associated with significant impairment in outcome measures. Infants with low developmental quotient at one year of age continued to have low scores on outcome measures at six years. Low maternal IQ, maternal education, and antenatal AED exposure were associated with significant impairment of intellectual and language functions for CME at six years.

Automated clinical annotation of tissue bank specimens.

PubMed

Gilbertson, John R; Gupta, Rajnish; Nie, Yimin; Patel, Ashokkumar A; Becich, Michael J

2004-01-01

Modern, molecular bio-medicine is driving a growing demand for extensively annotated tissue bank specimens. With careful clinical, pathologic and outcomes annotation, samples can be better matched to the research question at hand and experimental results better understood and verified. However, the difficulty and expense of detailed specimen annotation is well beyond the capability of most banks and has made access to well documented tissue a major limitation in medical re-search. In this context, we have implemented automated annotation of banked tissue by integrating data from three clinical systems--the cancer registry, the pathology LIS and the tissue bank inventory system--through a classical data warehouse environment. The project required modification of clinical systems, development of methods to identify patients between and map data elements across systems and the creation of de-identified data in data marts for use by researchers. The result has been much more extensive and accurate initial tissue annotation with less effort in the tissue bank, as well as dynamic ongoing annotation as the cancer registry follows patients over time.

Increased risk of oesophageal adenocarcinoma among upstream petroleum workers

PubMed Central

Kirkeleit, Jorunn; Riise, Trond; Bjørge, Tone; Moen, Bente E; Bråtveit, Magne; Christiani, David C

2013-01-01

Objectives To investigate cancer risk, particularly oesophageal cancer, among male upstream petroleum workers offshore potentially exposed to various carcinogenic agents. Methods Using the Norwegian Registry of Employers and Employees, 24 765 male offshore workers registered from 1981 to 2003 was compared with 283 002 male referents from the general working population matched by age and community of residence. The historical cohort was linked to the Cancer Registry of Norway and the Norwegian Cause of Death Registry. Results Male offshore workers had excess risk of oesophageal cancer (RR 2.6, 95% CI 1.4 to 4.8) compared with the reference population. Only the adenocarcinoma type had a significantly increased risk (RR 2.7, 95% CI 1.0 to 7.0), mainly because of an increased risk among upstream operators (RR 4.3, 95% CI 1.3 to 14.5). Upstream operators did not have significant excess of respiratory system or colon cancer or mortality from any other lifestyle-related diseases investigated. Conclusion We found a fourfold excess risk of oesophageal adenocarcinoma among male workers assumed to have had the most extensive contact with crude oil. Due to the small number of cases, and a lack of detailed data on occupational exposure and lifestyle factors associated with oesophageal adenocarcinoma, the results must be interpreted with caution. Nevertheless, given the low risk of lifestyle-related cancers and causes of death in this working group, the results add to the observations in other low-powered studies on oesophageal cancer, further suggesting that factors related to the petroleum stream or carcinogenic agents used in the production process might be associated with risk of oesophageal adenocarcinoma. PMID:19858535

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.

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.

Evaluation of pre-hospital administration of adrenaline (epinephrine) by emergency medical services for patients with out of hospital cardiac arrest in Japan: controlled propensity matched retrospective cohort study

PubMed Central

Tomio, Jun; Takahashi, Hideto; Ichikawa, Masao; Nishida, Masamichi; Morimura, Naoto; Sakamoto, Tetsuya

2013-01-01

Objectives To evaluate the effectiveness of pre-hospital adrenaline (epinephrine) administered by emergency medical services to patients with out of hospital cardiac arrest. Design Controlled propensity matched retrospective cohort study, in which pairs of patients with or without (control) adrenaline were created with a sequential risk set matching based on time dependent propensity score. Setting Japan’s nationwide registry database of patients with out of hospital cardiac arrest registered between January 2007 and December 2010. Participants Among patients aged 15-94 with out of hospital cardiac arrest witnessed by a bystander, we created 1990 pairs of patients with and without adrenaline with an initial rhythm of ventricular fibrillation or pulseless ventricular tachycardia (VF/VT) and 9058 pairs among those with non-VF/VT. Main outcome measures Overall and neurologically intact survival at one month or at discharge, whichever was earlier. Results After propensity matching, pre-hospital administration of adrenaline by emergency medical services was associated with a higher proportion of overall survival (17.0% v 13.4%; unadjusted odds ratio 1.34, 95% confidence interval 1.12 to 1.60) but not with neurologically intact survival (6.6% v 6.6%; 1.01, 0.78 to 1.30) among those with VF/VT; and higher proportions of overall survival (4.0% v 2.4%; odds ratio 1.72, 1.45 to 2.04) and neurologically intact survival (0.7% v 0.4%; 1.57, 1.04 to 2.37) among those with non-VF/VT. Conclusions Pre-hospital administration of adrenaline by emergency medical services improves the long term outcome in patients with out of hospital cardiac arrest, although the absolute increase of neurologically intact survival was minimal. PMID:24326886

Evaluation of pre-hospital administration of adrenaline (epinephrine) by emergency medical services for patients with out of hospital cardiac arrest in Japan: controlled propensity matched retrospective cohort study.

PubMed

Nakahara, Shinji; Tomio, Jun; Takahashi, Hideto; Ichikawa, Masao; Nishida, Masamichi; Morimura, Naoto; Sakamoto, Tetsuya

2013-12-10

To evaluate the effectiveness of pre-hospital adrenaline (epinephrine) administered by emergency medical services to patients with out of hospital cardiac arrest. Controlled propensity matched retrospective cohort study, in which pairs of patients with or without (control) adrenaline were created with a sequential risk set matching based on time dependent propensity score. Japan's nationwide registry database of patients with out of hospital cardiac arrest registered between January 2007 and December 2010. Among patients aged 15-94 with out of hospital cardiac arrest witnessed by a bystander, we created 1990 pairs of patients with and without adrenaline with an initial rhythm of ventricular fibrillation or pulseless ventricular tachycardia (VF/VT) and 9058 pairs among those with non-VF/VT. Overall and neurologically intact survival at one month or at discharge, whichever was earlier. After propensity matching, pre-hospital administration of adrenaline by emergency medical services was associated with a higher proportion of overall survival (17.0% v 13.4%; unadjusted odds ratio 1.34, 95% confidence interval 1.12 to 1.60) but not with neurologically intact survival (6.6% v 6.6%; 1.01, 0.78 to 1.30) among those with VF/VT; and higher proportions of overall survival (4.0% v 2.4%; odds ratio 1.72, 1.45 to 2.04) and neurologically intact survival (0.7% v 0.4%; 1.57, 1.04 to 2.37) among those with non-VF/VT. Pre-hospital administration of adrenaline by emergency medical services improves the long term outcome in patients with out of hospital cardiac arrest, although the absolute increase of neurologically intact survival was minimal.

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.

Physical Activity and Function in Older, Long-term Colorectal Cancer Survivors

PubMed Central

Johnson, Brent L.; Trentham-Dietz, Amy; Koltyn, Kelli F.; Colbert, Lisa H.

2009-01-01

Objective Increasing age and cancer history are related to impaired physical function. Since physical activity has been shown to ameliorate age-related functional declines, we evaluated the association between physical activity and function in older, long-term colorectal cancer survivors. Methods In 2006–2007, mailed surveys were sent to colorectal cancer survivors, aged ≥65 years when diagnosed during 1995 – 2000, and identified through a state cancer registry. Information on physical activity, physical function and relevant covariates was obtained and matched to registry data. Analysis of covariance and linear regression were used to compare means and trends in physical function across levels of activity in the final analytic sample of 843 cases. Results A direct, dose-dependent association between physical activity and function was observed (ptrend <.001), with higher SF-36 physical function subscores in those reporting high vs. low activity levels (65.0 ± 1.7 vs. 42.7 ± 1.7 (mean ± standard error)). Walking, gardening, housework, and exercise activities were all independently related to better physical function. Moderate-vigorous intensity activity (ptrend <.001) was associated with function, but light activity (ptrend =0.39) was not. Conclusion Results from this cross-sectional study indicate significant associations between physical activity and physical function in older, long-term colorectal cancer survivors. PMID:19123055

Determining the sensitivity of transrectal ultrasonography on a consecutive series of prostate cancers in a clinical and screening setting.

PubMed

Ciatto, Stefano; Bonardi, Rita; Lombardi, Claudio; Zappa, Marco; Gervasi, Ginetta

2002-01-01

To evaluate the sensitivity at transrectal ultrasonography (TRUS) for prostate cancer. A consecutive series of 170 prostate cancers identified by matching local cancer registry and TRUS archives at the Centro per lo Studio e la Prevenzione Oncologica of Florence. TRUS sensitivity was determined as the ratio of TRUS positive to total prostate cancers occurring at different intervals from TRUS date. Univariate and multivariate analyses of sensitivity determinants were performed. Sensitivity at 6 months, 1, 2 and 3 years after the test was 94.1% (95% CI, 90-98), 89.8% (95% CI, 85-95), 80.4% (95% CI, 74-87) and 74.1% (95% CI, 68-81%), respectively. A higher sensitivity (statistically significant) of TRUS was observed only if digital rectal examination was suspicious, whereas no association to sensitivity was observed for age, prostate-specific antigen or prostate-specific antigen density. The study provided a reliable estimate of TRUS sensitivity, particularly reliable being checked against a cancer registry: observed sensitivity was high, at least of the same magnitude of other cancer screening tests. TRUS, which is known to allow for considerable diagnostic anticipation and is more specific than prostate-specific antigen, might still be considered for its contribution to a screening approach.

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.

The Privilege of Induction Avoidance and Calcineurin Inhibitors Withdrawal in 2 Haplotype HLA Matched White Kidney Transplantation.

PubMed

Brifkani, Zaid; Brennan, Daniel C; Lentine, Krista L; Horwedel, Timothy A; Malone, Andrew F; Delos Santos, Rowena; Maw, Thin Thin; Alhamad, Tarek

2017-03-01

White recipients of 2-haplotype HLA-matched living kidney transplants are perceived to be of low immunologic risk. Little is known about the safety of induction avoidance and calcineurin inhibitor withdrawal in these patients. We reviewed our experience at a single center and compared it to Organ Procurement and Transplantation Network (OPTN) registry data and only included 2-haplotype HLA-matched white living kidney transplants recipients between 2000 and 2013. There were 56 recipients in a single center (where no induction was given) and 2976 recipients in the OPTN. Among the OPTN recipients, 1285 received no induction, 903 basiliximab, 608 thymoglobulin, and 180 alemtuzumab. First-year acute rejection rates were similar after induction-free transplantation among the center and induced groups nationally. Compared with induction-free transplantation in the national data, there was no decrease in graft failure risk over 13 years with use of basiliximab (adjusted hazard ratio [aHR], 0.86; confidence interval [CI], 0.68-1.08), Thymoglobulin (aHR, 0.92; CI, 0.7-1.21) or alemtuzumab (aHR, 1.18; CI, 0.72-1.93). Among induction-free recipients at the center, calcineurin inhibitor withdrawal at 1 year (n = 27) did not significantly impact graft failure risk (HR,1.62; CI, 0.38-6.89). This study may serve as a foundation for further studies to provide personalized, tailored, immunosuppression for this very low-risk population of kidney transplant patients.

Epidemiology of the Viral Hepatitis-HIV Syndemic in San Francisco: A Collaborative Surveillance Approach

PubMed Central

Scheer, Susan; Shallow, Sue; Pipkin, Sharon; Huang, Sandra

2014-01-01

Objectives To describe the epidemiology of people coinfected with hepatitis B virus (HBV) or hepatitis C virus (HCV) and HIV in San Francisco, the San Francisco Department of Public Health's Communicable Disease Control and Prevention Section and the HIV Epidemiology Section collaborated to link their registries. Methods In San Francisco, hepatitis reporting is primarily through passive laboratory-based surveillance, and HIV/AIDS reporting is primarily through laboratory-initiated active surveillance. We conducted the registry linkage in 2010 using a sequential algorithm. Results The registry match included 31,997 HBV-infected people who were reported starting in 1984; 10,121 HCV-infected people who were reported starting in 2001; and 34,551 HIV/AIDS cases reported beginning in 1981. Of the HBV and HCV cases, 6.3% and 12.6% were coinfected with HIV, respectively. The majority of cases were white males; however, black people were disproportionately affected. For more than 90% of the HBV/HIV cases, male-to-male sexual contact (men who have sex with men [MSM]) was the risk factor for HIV infection. Injection drug use was the most frequent risk factor for HIV infection among the HCV/HIV cases; however, 35.6% of the HCV/HIV coinfected males were MSM but not injection drug users. Conclusions By linking the two registries, we found new ways to foster collaborative work and expand our programmatic flexibility. This analysis identified particular populations at risk for coinfection, which can be used by viral hepatitis and HIV screening, prevention, and treatment programs to integrate, enhance, target, and prioritize prevention services and clinical care within the community to maximize health outcomes. PMID:24385655

The distribution of HLA haplotypes in the ethnic groups that make up the Brazilian Bone Marrow Volunteer Donor Registry (REDOME).

PubMed

Halagan, Michael; Oliveira, Danielli Cristina; Maiers, Martin; Fabreti-Oliveira, Raquel A; Moraes, Maria Elisa Hue; Visentainer, Jeane Eliete Laguila; Pereira, Noemi Farah; Romero, Matilde; Cardoso, Juliana Fernandes; Porto, Luís Cristóvão

2018-04-26

The Registries of Bone Marrow Donors around the world include more than 30 million volunteer donors from 57 different countries, and were responsible for over 17,000 hematopoietic stem cell transplants in 2016. The Brazilian Bone Marrow Volunteer Donor Registry (REDOME) was established in 1993 and is the third largest registry in the world with more than 4.3 million donors. We characterized HLA allele and haplotypes frequencies from REDOME comparing them with the donor self-reported race group classification. Five-locus haplotype frequencies (A~C~B~DRB1~DQB1) were estimated for each of the six race groups, resolving phase and allelic ambiguity using the expectation-maximization (EM) algorithm. The top 100 haplotypes in the race groups were separated into eight clusters of haplotypes, based on haplotype similarity, using CLUTO. We present HLA allele and haplotype frequency data from six race groups from 2,938,259 individuals from REDOME. The most frequent haplotype was the same for all groups: A*01:01g~C*07:01g~B*08:01g~DRB1*03:01g~DQB1*02:01g. Some frequent haplotypes such as A*02:01g~C*16:01g~B*44:03~DRB1*07:01g~DQB1*02:01g was not found in people with Preta (Sub-Saharan African descent). A cluster including Branca (European) and Parda or non-informed (admixed) could be distinguished from both Preta (SubSaharan) and Indígena (Amerindian) groups, and from the Amarela (Asian) ones, which clustered with their original population. These results have implications on cross-population matching and can help in donor searches and population-based recruitment strategies.

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

[Is cancer incidence different between type 2 diabetes patients compared to non-diabetics in hemodialysis? A study from the REIN registry].

PubMed

Le Guillou, Aurélie; Pladys, Adelaide; Kihal, Wahida; Siebert, Muriel; Haddj-Elmrabet, Atman; Cernon, Charlotte; Bernard, Anne; Charasse, Christophe; Mandart, Lise; Hamel, Didier; Tanquerel, Tugdual; Strullu, Bernard; Richer, Christine; Siohan, Pascale; Sawadogo, Théophile; Baleynaud, Juliette; Baluta, Simona; Bayat, Sahar; Vigneau, Cécile

2018-05-01

In France, diabetes mellitus is now the second cause of end stage renal disease. In a large previous French national study, we observed that dialyzed diabetics have a significant lower risk of death by cancer. This first study was focused on cancer death but did not investigate cancer incidence. In this context, the aim of this second study was to compare the incidence of cancer in diabetic dialyzed patients compared to non-diabetic dialyzed patients in a French region. This epidemiologic multicentric study included 588 diabetic and non-diabetic patients starting hemodialysis between 2002 and 2007 in Bretagne. Data were issued from REIN registry and cancer incidence were individually collected from medical records. Diabetics and non-diabetics were matched one by one on age, sex and year of dialysis initiation. During the follow-up, we observed 28 cancers (9.4%) in diabetic patients and 26 cancers (8.9%) in non-diabetics patients. The cumulative incidence to develop a cancer 2 years after the dialysis start was approximately 6% in both diabetics and non-diabetics patients. In univariate Fine and Gray analysis, BMI, hemoglobin, statin use had P-value<0.2. However, in the adjusted model, these variables were not significantly associated with cancer incidence. This study lead on a little number of dialyzed patients did not show any significant difference on cancer incidence between diabetic and non-diabetic patients after hemodialysis start. Copyright © 2017 Société francophone de néphrologie, dialyse et transplantation. Published by Elsevier Masson SAS. All rights reserved.

Identification of Occupational Cancer Risks in British Columbia, Canada: A Population-Based Case—Control Study of 1,155 Cases of Colon Cancer

PubMed Central

Fang, Raymond; Le, Nhu; Band, Pierre

2011-01-01

Objective Cancer has been recognized to have environmental origin, but occupational cancer risk studies have not been fully documented. The objective of this paper was to identify occupations and industries with elevated colon cancer risk based on lifetime occupational histories collected from 15,463 incident cancer cases. Method A group matched case-control design was used. All cases were diagnosed with histologically proven colon cancers, with cancer controls being all other cancer sites, excluding rectum, lung and unknown primary, diagnosed at the same period of time from the British Columbia Cancer Registry. Data analyses were done on all 597 Canadian standard occupation titles and 1,104 standard industry titles using conditional logistic regression for matched data sets and the likelihood ratio test. Results Excess colon cancer risks was observed in a number of occupations and industries, particularly those with low physical activity and those involving exposure to asbestos, wood dusts, engine exhaust and diesel engine emissions, and ammonia. Discussion The results of our study are in line with those from the literature and further suggest that exposure to wood dusts and to ammonia may carry an increased occupational risk of colon cancer. PMID:22073015

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.

Japan Diabetic Nephropathy Cohort Study: study design, methods, and implementation.

PubMed

Furuichi, Kengo; Shimizu, Miho; Toyama, Tadashi; Koya, Daisuke; Koshino, Yoshitaka; Abe, Hideharu; Mori, Kiyoshi; Satoh, Hiroaki; Imanishi, Masahito; Iwano, Masayuki; Yamauchi, Hiroyuki; Kusano, Eiji; Fujimoto, Shouichi; Suzuki, Yoshiki; Okuda, Seiya; Kitagawa, Kiyoki; Iwata, Yasunori; Kaneko, Shuichi; Nishi, Shinichi; Yokoyama, Hitoshi; Ueda, Yoshihiko; Haneda, Masakazu; Makino, Hirofumi; Wada, Takashi

2013-12-01

Diabetic nephropathy, leading to end-stage renal disease, has a considerable impact on public health and the social economy. However, there are few national registries of diabetic nephropathy in Japan. The aims of this prospective cohort study are to obtain clinical data and urine samples for revising the clinical staging of diabetic nephropathy, and developing new diagnostic markers for early diabetic nephropathy. The Japanese Society of Nephrology established a nationwide, web-based, and prospective registry system. On the system, there are two basic registries; the Japan Renal Biopsy Registry (JRBR), and the Japan Kidney Disease Registry (JKDR). In addition to the two basic registries, we established a new prospective registry to the system; the Japan Diabetic Nephropathy Cohort Study (JDNCS), which collected physical and laboratory data. We analyzed the data of 321 participants (106 female, 215 male; average age 65 years) in the JDNCS. Systolic and diastolic blood pressure was 130.1 and 72.3 mmHg, respectively. Median estimated glomerular filtration rate (eGFR) was 33.3 ml/min/1.73 m(2). Proteinuria was 1.8 g/gCr, and serum levels of albumin were 3.6 g/dl. The majority of the JDNCS patients presented with preserved eGFR and low albuminuria or low eGFR and advanced proteinuria. In the JRBR and JKDR registries, 484 and 125 participants, respectively, were enrolled as having diabetes mellitus. In comparison with the JRBR and JKDR registries, the JDNCS was characterized by diabetic patients presenting with low proteinuria with moderately preserved eGFR. There are few national registries of diabetic nephropathy to evaluate prognosis in Japan. Future analysis of the JDNCS will provide clinical insights into the epidemiology and renal and cardiovascular outcomes of type 2 diabetic patients in Japan.

Socioeconomic factors do not but GH treatment does affect mortality in adult-onset growth hormone deficiency.

PubMed

Stochholm, Kirstine; Berglund, Agnethe; Juul, Svend; Gravholt, Claus Højbjerg; Christiansen, Jens S

2014-11-01

GH deficiency is associated with changes in body composition, increased cardiovascular risk markers, and reduced bone mineral density. There seem to be multiple causes of the reported increased morbidity and mortality. The objective was to study the socioeconomic status in patients with adult-onset GH deficiency and its impact on mortality. This is a nationwide registry study in which the socioeconomic status in adult-onset GH deficient patients was identified in the Danish registries and compared with controls matched on age and gender. The socio-economic status included cohabitation, education, income, parenthood, convictions, and retirement. All patients had adult-onset GH deficiency and were born between 1950 and 1980. Two-hundred seventy-six patients (53.6% men) and 25 717 controls were included. GH-treated patients had a reduced mortality in total and due to malignancy compared with untreated patients. This difference remained after adjustment for cohabitation and education. Compared with the background population, the incidence of cohabitation, parenthood, and convictions was significantly reduced in patients, whereas education was unaffected. Retirement was significantly increased. Mortality was increased in patients, especially among patients not treated with GH. In GH-treated patients, mortality was decreased in total and due to malignancy compared with untreated patients, even after adjustment for all possible measured confounders. The patients had an impaired socioeconomic profile on most parameters compared with controls. This study does not support the suggestion that GH replacement therapy causes increased mortality.

Measuring Ambiguity in HLA Typing Methods

PubMed Central

Madbouly, Abeer; Freeman, John; Maiers, Martin

2012-01-01

In hematopoietic stem cell transplantation, donor selection is based primarily on matching donor and patient HLA genes. These genes are highly polymorphic and their typing can result in exact allele assignment at each gene (the resolution at which patients and donors are matched), but it can also result in a set of ambiguous assignments, depending on the typing methodology used. To facilitate rapid identification of matched donors, registries employ statistical algorithms to infer HLA alleles from ambiguous genotypes. Linkage disequilibrium information encapsulated in haplotype frequencies is used to facilitate prediction of the most likely haplotype assignment. An HLA typing with less ambiguity produces fewer high-probability haplotypes and a more reliable prediction. We estimated ambiguity for several HLA typing methods across four continental populations using an information theory-based measure, Shannon's entropy. We used allele and haplotype frequencies to calculate entropy for different sets of 1,000 subjects with simulated HLA typing. Using allele frequencies we calculated an average entropy in Caucasians of 1.65 for serology, 1.06 for allele family level, 0.49 for a 2002-era SSO kit, and 0.076 for single-pass SBT. When using haplotype frequencies in entropy calculations, we found average entropies of 0.72 for serology, 0.73 for allele family level, 0.05 for SSO, and 0.002 for single-pass SBT. Application of haplotype frequencies further reduces HLA typing ambiguity. We also estimated expected confirmatory typing mismatch rates for simulated subjects. In a hypothetical registry with all donors typed using the same method, the entropy values based on haplotype frequencies correspond to confirmatory typing mismatch rates of 1.31% for SSO versus only 0.08% for SBT. Intermediate-resolution single-pass SBT contains the least ambiguity of the methods we evaluated and therefore the most certainty in allele prediction. The presented measure objectively evaluates HLA typing methods and can help define acceptable HLA typing for donor recruitment. PMID:22952712

Completeness and accuracy of the wisconsin immunization registry: an evaluation coinciding with the beginning of meaningful use.

PubMed

Koepke, Ruth; Petit, Ashley B; Ayele, Roman A; Eickhoff, Jens C; Schauer, Stephanie L; Verdon, Matthew J; Hopfensperger, Daniel J; Conway, James H; Davis, Jeffrey P

2015-01-01

Vaccination coverage rates can be improved through the application of complete and accurate immunization information systems (IISs). Evaluate the completeness and accuracy of Wisconsin's IIS, the Wisconsin Immunization Registry (WIR). Cross-sectional evaluation, comparing vaccination medical records (MRs) from provider clinics with WIR records. Medical records of patients born during 2009 were randomly selected from 251 Wisconsin clinics associated with the Vaccines for Children Program. Completeness: percentage of patients with client records in the WIR, percentage of patients up-to-date (%UTD) with the 4:3:1:3:3:1:4 vaccination series, and percentage of patients' MR vaccinations matched by administration date (±10 days) and type to vaccinations documented in the WIR. Accuracy: percentages of matched vaccinations with the same administration date, same trade name (TN), and same lot number. Of the 1863 selected patient MRs, 98% (n = 1833) had WIR client records and 97% of their 30 899 vaccinations were documented in the WIR. The %UTD was 49.3% using the MR only, 76.5% using the WIR only, and 75.2% as estimated by the National Immunization Survey. Among matched vaccinations, 99% had the same administration date, 96% had the same TN, and 95% had the same lot number. Compared with patients from clinics that entered data into the WIR using data exchange from electronic health records, patients from clinics that entered data using the Web-based user interface were less likely to have client records in the WIR (odds ratio: 0.3; 95% confidence interval: 0.1-0.9) and less likely to have accurate TNs (odds ratio: 0.3; 95% confidence interval: 0.1-0.5). The WIR was complete and accurate among this sample of children born during 2009 and provided a vaccination coverage assessment similar to the National Immunization Survey. Our results provide support for the expectation that meaningful use and other initiatives that increase data exchange from electronic health records to IISs will improve IIS data quality.

Association Between Use of Long-Acting Nitrates and Outcomes in Heart Failure With Preserved Ejection Fraction.

PubMed

Lim, Shir Lynn; Benson, Lina; Dahlström, Ulf; Lam, Carolyn S P; Lund, Lars H

2017-04-01

Nitrates may be beneficial in heart failure with preserved ejection fraction (HFpEF) by enhancing cGMP signaling and improving hemodynamics, but real-world data on potential efficacy are lacking. We linked the Swedish Heart Failure Registry to national registries with International Classification of Diseases, Tenth Revision comorbidity diagnoses and demographic and socioeconomic data. In HFpEF, defined as left ventricular ejection fraction ≥40%, we derived propensity scores for nitrate use using 52 baseline variables. The association between nitrate use and all-cause mortality and the composite of all-cause mortality or first heart failure hospitalization was assessed in a cohort matched 2:1 untreated to treated based on age and propensity score. In the overall HFpEF cohort (n=19 047; mean [SD] age, 76 [12] years; 46% women), nitrates were used in 17%, and the crude 1-year survival for treated versus untreated patients was 79% (95% confidence interval [CI], 78%-80%) versus 84% (95% CI, 83%-84%) respectively; hazard ratio was 1.48 (95% CI, 1.40-1.56; P <0.001) during a median 755-day follow-up. Matching yielded 2235 treated versus 4470 untreated patients, with 1-year survival of 80% (95% CI, 78%-82%) versus 79% (95% CI, 78%-81%) and hazard ratio of 1.06 (95% CI, 0.98-1.15; P =0.12). Nitrates were associated with worse composite outcome in the matched HFpEF cohort, with 1-year event-free survival of 62% (95% CI, 60%-64%) versus 65% (95% CI, 63%-66%) and hazard ratio of 1.11 (95% CI, 1.04-1.18; P =0.003). These patterns were reproduced in several consistency analyses. In HFpEF, the use of nitrates was not associated with improvements in all-cause mortality or heart failure hospitalization. © 2017 American Heart Association, Inc.

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.

Long-term mental wellbeing of adolescents and young adults diagnosed with venous thromboembolism: results from a multistage mixed methods study.

PubMed

Højen, A A; Sørensen, E E; Dreyer, P S; Søgaard, M; Larsen, T B

2017-12-01

Essentials Long-term mental wellbeing of adolescents and young adults with venous thromboembolism is unclear. This multistage mixed methods study was based on Danish nationwide registry data and interviews. Mental wellbeing is negatively impacted in the long-term and uncertainty of recurrence is pivotal. The perceived health threat is more important than disease severity for long-term mental wellbeing. Background Critical and chronic illness in youth can lead to impaired mental wellbeing. Venous thromboembolism (VTE) is a potentially traumatic and life-threatening condition. Nonetheless, the long-term mental wellbeing of adolescents and young adults (AYAS) with VTE is unclear. Objectives To investigate the long-term mental wellbeing of AYAS (aged 13-33 years) diagnosed with VTE. Methods We performed a multistage mixed method study based on data from the Danish nationwide health registries, and semistructured interviews with 12 AYAS diagnosed with VTE. An integrated mixed methods interpretation of the findings was conducted through narrative weaving and joint displays. Results The integrated mixed methods interpretation showed that the mental wellbeing of AYAS with VTE had a chronic perspective, with a persistently higher risk of psychotropic drug purchase among AYAS with a first-time diagnosis of VTE than among sex-matched and age-matched population controls and AYAS with a first-time diagnosis of insulin-dependent diabetes mellitus. Impaired mental wellbeing was largely connected to a fear of recurrence and concomitant uncertainty. Therefore, it was important for the long-term mental wellbeing to navigate uncertainty. The perceived health threat played a more profound role in long-term mental wellbeing than disease severity, as the potential life threat was the pivot which pointed back to the initial VTE and forward to the perception of future health threat and the potential risk of dying of a recurrent event. Conclusion Our findings show that the long-term mental wellbeing of AYAS diagnosed with VTE is negatively affected, and highlights these patients' need for adequate support. © 2017 International Society on Thrombosis and Haemostasis.

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.

Mental health outcomes of burn: A longitudinal population-based study of adults hospitalized for burns.

PubMed

Logsetty, Sarvesh; Shamlou, Amir; Gawaziuk, Justin P; March, Justin; Doupe, Malcolm; Chateau, Dan; Hoppensack, Mike; Khan, Sazzadul; Medved, Maria; Leslie, William D; Enns, Murray W; Stein, Murray B; Asmundson, Gordon J G; Sareen, Jitender

2016-06-01

This study investigates the increased risk of mental health outcomes and health care utilization associated with burn with two year of follow-up using a longitudinal population-based matched cohort design. Adult burn survivors (n=157) were identified from a provincial burn registry and matched 1:5 with non-burn control subjects from the general population (matching variables age and gender). The prevalence of mental health outcomes and the rates of health care utilization between the groups were compared for the 2years pre and post index date using anonymously linked population-based administrative health care data. Rates were adjusted for age, gender and sociodemographic characteristics. While the burn cohort had an increased prevalence of mental health problems after burn compared to the control cohort, the burn group also had an increased prevalence of pre-burn depression (16.6% vs 7.8%; p=0.0005) and substance use disorders (8.9% vs 3.2%; p=0.001) when compared to controls. Once the pre-existing prevalence of mental illness was taken into account there was no significant change in the prevalence of mental health problems when comparing the burn group to controls over time. Although burns may not increase rates of mental health issues and health care utilization, burn survivors are a vulnerable group who already demonstrate increased rates of psychopathology and need for care. The present study highlights the importance of assessment and treatment of mental health outcomes in this population. Copyright © 2016 Elsevier Ltd and ISBI. 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

Developing clinical strength-of-evidence approach to define HIV-associated malignancies for cancer registration in Kenya.

PubMed

Korir, Anne; Mauti, Nathan; Moats, Pamela; Gurka, Matthew J; Mutuma, Geoffrey; Metheny, Christine; Mwamba, Peter M; Oyiro, Peter O; Fisher, Melanie; Ayers, Leona W; Rochford, Rosemary; Mwanda, Walter O; Remick, Scot C

2014-01-01

Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a "strength-of-evidence" approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis. The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1) documentation of positive HIV serology; 2) antiretroviral drug prescription; 3) CD4+ lymphocyte count; and 4) WHO HIV clinical stage or immune suppression syndrome (ISS), which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3%) met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association - Kaposi's sarcoma, cervical cancer, non-Hodgkin's and Hodgkin's lymphoma, and conjunctiva carcinoma) and 31% (53) were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27%) cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria. This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease in the backdrop of HIV infection.

Perioperative Mortality, 2010 to 2014: A Retrospective Cohort Study Using the National Anesthesia Clinical Outcomes Registry.

PubMed

Whitlock, Elizabeth L; Feiner, John R; Chen, Lee-Lynn

2015-12-01

The National Anesthesia Clinical Outcomes Registry collects demographic and outcome data from anesthesia cases, with the goal of improving safety and quality across the specialty. The authors present a preliminary analysis of the National Anesthesia Clinical Outcomes Registry database focusing on the rates of and associations with perioperative mortality (within 48 h of anesthesia induction). The authors retrospectively analyzed 2,948,842 cases performed between January 1, 2010, and May 31, 2014. Cases without procedure information and vaginal deliveries were excluded. Mortality and other outcomes were reported by the anesthesia provider. Hierarchical logistic regression was performed on cases with complete information for patient age group, sex, American Society of Anesthesiologists physical status, emergency case status, time of day, and surgery type, controlling for random effects within anesthesia practices. The final analysis included 2,866,141 cases and 944 deaths (crude mortality rate, 33 per 100,000). Increasing American Society of Anesthesiologists physical status, emergency case status, cases beginning between 4:00 PM and 6:59 AM, and patient age less than 1 yr or greater than or equal to 65 yr were independently associated with higher perioperative mortality. A post hoc subgroup analysis of 279,154 patients limited to 22 elective case types, post hoc models incorporating either more granular estimate of surgical risk or work relative value units, and a post hoc propensity score-matched cohort confirmed the association with time of day. Several factors were associated with increased perioperative mortality. A case start time after 4:00 PM was associated with an adjusted odds ratio of 1.64 (95% CI, 1.22 to 2.21) for perioperative death, which suggests a potentially modifiable target for perioperative risk reduction. Limitations of this study include nonstandardized mortality reporting and limited ability to adjust for missing data.

Association between spironolactone added to beta-blockers and ACE inhibition and survival in heart failure patients with reduced ejection fraction: a propensity score-matched cohort study.

PubMed

Frankenstein, L; Katus, H A; Grundtvig, M; Hole, T; de Blois, J; Schellberg, D; Atar, D; Zugck, C; Agewall, S

2013-10-01

Heart failure (CHF) guidelines recommend mineralocorticoid receptor antagonists for all symptomatic patients treated with a combination of ACE inhibitors/angiotensin receptor blockers (ARBs) and beta-blockers. As opposed to both eplerenone trials, patients in RALES (spironolactone) received almost no beta-blockers. Since pharmacological properties differ between eplerenone and spironolactone, the prognostic benefit of spironolactone added to this baseline combination therapy needs clarification. We included 4,832 CHF patients with chronic systolic dysfunction from the Norwegian Heart Failure Registry and the heart failure outpatients' clinic of the University of Heidelberg. Propensity scores for spironolactone receipt were calculated for each patient and used for matching to patients without spironolactone. During a total follow-up of 17,869 patient-years, 881 patients (27.0 %) died in the non-spironolactone group and 445 (28.4 %) in the spironolactone group. Spironolactone was not associated with improved survival, neither in the complete sample (HR 0.82; 95 % CI 0.64-1.07; HR 1.03; 95 % CI 0.88-1.20; multivariate and propensity score adjusted respectively), nor in the propensity-matched cohort (HR 0.98; 95 % CI 0.82-1.18). In CHF outpatients we were unable to observe an association between the use of spironolactone and improved survival when administered in addition to a combination of ACE/ARB and beta-blockers.

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

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.

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

Impact of donor-recipient sex match on long-term survival after heart transplantation in children: An analysis of 5797 pediatric heart transplants.

PubMed

Kemna, Mariska; Albers, Erin; Bradford, Miranda C; Law, Sabrina; Permut, Lester; McMullan, D Mike; Law, Yuk

2016-03-01

The effect of donor-recipient sex matching on long-term survival in pediatric heart transplantation is not well known. Adult data have shown worse survival when male recipients receive a sex-mismatched heart, with conflicting results in female recipients. We analyzed 5795 heart transplant recipients ≤ 18 yr in the Scientific Registry of Transplant Recipients (1990-2012). Recipients were stratified based on donor and recipient sex, creating four groups: MM (N = 1888), FM (N = 1384), FF (N = 1082), and MF (N = 1441). Males receiving sex-matched donor hearts had increased unadjusted allograft survival at five yr (73.2 vs. 71%, p = 0.01). However, this survival advantage disappeared with longer follow-up and when adjusted for additional risk factors by multivariable Cox regression analysis. In contrast, for females, receiving a sex-mismatched heart was associated with an 18% higher risk of allograft loss over time compared to receiving a sex-matched heart (HR 1.18, 95% CI: 1.00-1.38) and a 26% higher risk compared to sex-matched male recipients (HR 1.26, 95% CI: 1.10-1.45). Females who receive a heart from a male donor appear to have a distinct long-term survival disadvantage compared to all other groups. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effects of statin therapy on clinical outcomes after acute myocardial infarction in patients with advanced renal dysfunction: A propensity score-matched analysis.

PubMed

Kim, Jin Sug; Kim, Weon; Park, Ji Yoon; Woo, Jong Shin; Lee, Tae Won; Ihm, Chun Gyoo; Kim, Yang Gyun; Moon, Ju-Young; Lee, Sang Ho; Jeong, Myung Ho; Jeong, Kyung Hwan

2017-01-01

Lipid lowering therapy is widely used for the prevention of cardiovascular complications after acute myocardial infarction (AMI). However, some studies show that this benefit is uncertain in patients with renal dysfunction, and the role of statins is based on the severity of renal dysfunction. In this study, we investigated the impact of statin therapy on major adverse cardiac events (MACEs) and all-cause mortality in patients with advanced renal dysfunction undergoing percutaneous coronary intervention (PCI) after AMI. This study was based on the Korea Acute Myocardial Infarction Registry database. We included 861 patients with advanced renal dysfunction from among 33,205 patients who underwent PCI after AMI between November 2005 and July 2012. Patients were divided into two groups: a statin group (n = 537) and a no-statin group (n = 324). We investigated the 12-month MACEs (cardiac death, myocardial infarction, repeated PCI or coronary artery bypass grafting) and all-cause mortality of each group. Subsequently, a propensity score-matched analysis was performed. In the total population studied, no significant differences were observed between the two groups with respect to the rate of recurrent MI, repeated PCI, coronary artery bypass grafting (CABG), or all-cause mortality. However, the cardiac death rate was significantly lower in the statin group (p = 0.009). Propensity score-matched analysis yielded 274 pairs demonstrating, results similar to those obtained from the total population. However, there was no significant difference in the cardiac death rate in the propensity score-matched population (p = 0.103). Cox-regression analysis revealed only left ventricular ejection fraction to be an independent predictor of 12-month MACEs (Hazard ratio [HR] of 0.979, 95% confidence interval [CI], 0962-0.996, p = 0.018). Statin therapy was not significantly associated with a reduction in the 12-month MACEs or all-cause mortality in patients with advanced renal dysfunction undergoing PCI after AMI.

Analysis of the Influence of HLA-A Matching Relative to HLA-B and -DR Matching on Heart Transplant Outcomes

PubMed Central

Ansari, David; Bućin, Dragan; Höglund, Peter; Ohlsson, Mattias; Andersson, Bodil; Nilsson, Johan

2015-01-01

Background There are conflicting reports on the effect of donor-recipient HLA matching on outcomes in heart transplantation. The objective of this study was to investigate the effects of HLA-A matching relative to HLA-B and -DR matching on long-term survival in heart transplantation. Methods A total of 25 583 patients transplanted between 1988 and 2011 were identified from the International Society for Heart and Lung Transplantation registry. Transplants were divided into 2 donor-recipient matching groups: HLA-A–compatible (no HLA-A mismatches) and HLA-A–incompatible (1-2 HLA-A mismatches). Primary outcome was all-cause mortality. Secondary outcomes were graft failure-, cardiovascular-, infection-, or malignancy-related deaths. Results The risk of all-cause mortality 15 years after transplantation was higher for HLA-A–compatible (vs HLA-A–incompatible) grafts in patients who had HLA-B–, HLA-DR–, or HLA-B,DR–incompatible grafts (P = 0.027, P = 0.007, and P = 0.002, respectively) but not in HLA-B– and/or HLA-DR–compatible grafts. This was confirmed in multivariable Cox regression analysis where HLA-A compatibility (vs HLA-A incompatibility) was associated with higher mortality in transplants incompatible for HLA-DR or HLA-B and -DR (hazard ratio [HR], 1.59; 95% confidence interval [95% CI], 1.11-2.28; P = 0.012 and HR, 1.69; 95% CI, 1.17-2.43; P = 0.005, respectively). In multivariable analysis, the largest compromise in survival for HLA-A compatibility (vs HLA-incompatibility) was for chronic rejection in HLA-B– and -DR–incompatible grafts (HR, 1.91; 95% CI, 1.22-3.01; P = 0.005). Conclusions Decreased long-term survival in heart transplantation was associated with HLA-A compatibility in HLA-B,DR–incompatible grafts. PMID:27500238

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.

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.

Evaluation of the impact of statin therapy on the obesity paradox in patients with acute myocardial infarction: A propensity score matching analysis from the Korea Acute Myocardial Infarction Registry.

PubMed

Won, Ki-Bum; Hur, Seung-Ho; Nam, Chang-Wook; Ann, Soe Hee; Park, Gyung-Min; Lee, Sang-Gon; Kim, Hyo-Eun; Cho, Yun-Kyeong; Yoon, Hyuck-Jun; Park, Hyoung-Seob; Kim, Hyungseop; Han, Seongwook; Jeong, Myung-Ho; Ahn, Young-Keun; Rha, Seung-Woon; Kim, Chong-Jin; Cho, Myeong-Chan; Kim, Hyo-Soo; Chae, Shung-Chull; Kim, Kee-Sik; Kim, Young-Jo; Kim, Kwon-Bae; Barter, Philip

2017-09-01

The phenomenon of obesity paradox after acute myocardial infarction (AMI) has been reported under strong recommendation of statin therapy. However, the impact of statin therapy on this paradox has not been investigated. This study investigated the impact of statin therapy on 1-year mortality according to obesity after AMI. A total of 2745 AMI patients were included from the Korea Acute Myocardial Infarction Registry after 1:4 propensity score matching analysis (n = 549 for nonstatin group and n = 2196 for statin group). Primary and secondary outcomes were all-cause and cardiac death, respectively. During 1-year follow-up, the incidence of all-cause (8.4% vs 3.7%) and cardiac (6.2% vs 2.3%) death was higher in nonstatin group than in statin (P < .001, respectively). In nonstatin group, the incidence of all-cause (7.2% vs 9.0%) and cardiac (5.5% vs 6.5%) death did not differ significantly between obese and nonobese patients. However, in statin group, obese patients had lower 1-year rate of all-cause (1.7% vs 4.8%) and cardiac (1.2% vs 2.9%) death (P < .05, respectively), and lower cumulative rates by Kaplan-Meier analysis of all-cause and cardiac death compared with nonobese patients (log-rank P < .05, respectively). The overall risk of all-cause death was significantly lower in obese than in nonobese patients only in statin group (hazard ratio: 0.35; P = .001). After adjusting for confounding factors, obesity was independently associated with decreased risk of all-cause death in statin group. In conclusion, the greater benefit of statin therapy for survival in obese patients is further confirmation of the obesity paradox after AMI.

Pulmonary function in individuals who underwent liver transplantation: from the US cystic fibrosis foundation registry.

PubMed

Miller, Melissa R; Sokol, Ronald J; Narkewicz, Michael R; Sontag, Marci K

2012-05-01

Severe liver disease affects 4.5% to 10% of individuals with cystic fibrosis (CF) and is the third-leading cause of death. Liver transplantation (LT) is an accepted therapy, but the effects of liver disease and LT on pulmonary function in patients with CF are controversial. Our aim was to characterize changes in pulmonary function in LT patients with CF. Using mixed effect models, we analyzed pulmonary function before and after transplantation in 168 LT patients and 840 non-LT patients with CF who were matched by age, sex, pancreatic status, infections with US CF Foundation Patient Registry data (1989-2007). The primary outcome was the change in the forced expiratory volume in 1 second (FEV(1); percent predicted) in LT and non-LT in the 3-years periods before or after transplantation; second we compared FEV(1) changes. In the 3 years before transplantation, LT had lower initial FEV(1) values (71.5% ± 1.9%, P < 0.001) and a slower decline (+0.1% ± 0.4%/year, P < 0.001) than non-LT (79.6% ± 1.3% and -1.3% ± 0.2%/year, respectively). There was no difference in the FEV(1) decline after transplantation (-1.4% ± 0.4%/year for LT versus -2.1% ± 0.2%/year for non-LT, P = 0.14). Both the (P = 0.003) and (P = 0.001) had a slower FEV(1) decline in the period before transplantation versus after transplantation. In conclusion, pulmonary function is lower and declines more slowly in patients with CF before LT versus, but parallels the decline in non-LT after transplantation. LT is neither beneficial nor detrimental to pulmonary function in CF but returns FEV(1) decline to the same trajectory found for matched non-LT individuals with CF. Copyright © 2012 American Association for the Study of Liver Diseases.

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

Impact of a personalised active labour market programme for persons with disabilities.

PubMed

Adamecz-Völgyi, Anna; Lévay, Petra Zsuzsa; Bördős, Katalin; Scharle, Ágota

2018-02-01

The paper estimates the impact of a supported employment programme implemented in Hungary. This is a non-experimental evaluation using a matching identification strategy supported by rich data on individual characteristics, personal employment and unemployment history and the local labour market situation. We use a time-window approach to ensure that programme participants and matched controls entered unemployment at the same point in time, and thus faced very similar labour market conditions. We find that the programme had a positive effect of 16 percentage points on the probability of finding a job among men and 25 percentage points among women. The alternative outcome indicator of not re-entering the unemployment registry shows somewhat smaller effects in the case of women. In comparison to similarly costly programmes that do not facilitate employment in the primary labour market, rehabilitation services represent a viable alternative.

Support of Unrelated Stem Cell Donor Searches by Donor Center-Initiated HLA Typing of Potentially Matching Donors

PubMed Central

Schmidt, Alexander H.; Solloch, Ute V.; Baier, Daniel; Grathwohl, Alois; Hofmann, Jan; Pingel, Julia; Stahr, Andrea; Ehninger, Gerhard

2011-01-01

Large registries of potential unrelated stem cell donors have been established in order to enable stem cell transplantation for patients without HLA-identical related donors. Donor search is complicated by the fact that the stored HLA information of many registered donors is incomplete. We carried out a project that was aimed to improve chances of patients with ongoing donor searches to find an HLA-matched unrelated donor. For that purpose, we carried out additional donor center-initiated HLA-DRB1 typing of donors who were only typed for the HLA loci A and B so far and were potential matches for patients in need of a stem cell transplant. In total, 8,861 donors were contacted for donor center-initiated HLA-DRB1 typing within 1,089 donor searches. 12 of these donors have donated stem cells so far, 8 thereof for their respective target patients. We conclude that chances of patients with ongoing donor searches to find an HLA-matched unrelated donor can indeed be improved by donor-center initiated typing that is carried out in addition to the standard donor search process. Our results also raise questions regarding the appropriate use of incompletely typed donors within unrelated donor searches. PMID:21625451

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

The incidence risk of type 2 diabetes mellitus in female nurses: a nationwide matched cohort study.

PubMed

Huang, Hsiu-Ling; Pan, Cheng-Chin; Wang, Shun-Mu; Kung, Pei-Tseng; Chou, Wen-Yu; Tsai, Wen-Chen

2016-05-26

Diabetes is one of the most common chronic illnesses worldwide. This study was to assess whether the incidence risk of type 2 diabetes mellitus between female nurses and female non-nurses. Study data were obtained from the Longitudinal Health Insurance Research Database, and nurses were sampled from the Registry for medical personnel. Nurses and non-nurses with similar traits and health conditions were selected via 1:1 propensity score matching. A total of 111,670 subjects were selected (55,835 nurses and 55,835 non-nurses). Stages of diabetes development were monitored until December 31, 2009. The Cox proportional hazards model was used to discuss risks and influencing factors related to diabetes. Poisson distribution methods were used to examine the incidence rate of diabetes per 1,000 person-years. The propensity matching results show that on average, female nurses who were diagnosed with diabetes were younger compared with the non-nurses (46.98 ± 10.80 vs. 48.31 ± 10.43, p <0.05). However, the results of the Cox proportional hazards model show that the nurses showed a lower risk of developing diabetes compared with the non-nurses (Adj. HR = 0.84, 95 % CI: 0.79-0.90). Factors influencing diabetes development risks among the nurses include advanced age and high Charlson Comorbidity Index levels. The low degree of diabetes development among the nurses may be attributable to the fact that nurses possess substantial knowledge on health care and on healthy behaviors. The results of this study can be used as a reference to assess occupational risks facing nursing staff, to prevent diabetes development, and to promote health education.

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

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

PubMed Central

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

2017-01-01

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

More Than Numbers: Effects of Social Media Virality Metrics on Intention to Help Unknown Others in the Context of Bone Marrow Donation.

PubMed

Lee-Won, Roselyn J; Abo, Melissa M; Na, Kilhoe; White, Tiffany N

2016-06-01

A bone marrow transplant is often the only key to recovery and survival for patients suffering from blood cancers. Social media platforms have allowed nonprofit organizations as well as family members and friends of patients in need of a matching donor to make their solicitation messages go viral and reach out to the broadest possible audience to increase the likelihood of finding a matching donor. Noting that social media audiences are exposed not only to the content of a social media message but also to the metrics representing the virality of the message (i.e., how many times the content has been shared), we conducted an online experiment to investigate the effects of virality metrics on perceived social norms and behavioral intention to join a bone marrow registry. In doing so, we considered the potential moderating role of perceived threat posed by blood cancers. The experiment was conducted with 152 participants who met the general eligibility guidelines set by the National Marrow Donor Program (NMDP). The results of the experiment showed that exposure to high virality metrics led to greater perceived injunctive norms. The results also revealed that the effect of virality metrics on perceived injunctive norms was significant among those perceiving low levels of blood cancer threat. Furthermore, the results demonstrated that high virality metrics led to greater intention to join a bone marrow registry through perceived injunctive norms only when perceived threat of blood cancers was low. Theoretical and practical implications of these findings are discussed.

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.

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.

Dietary habits after myocardial infarction - results from a cross-sectional study.

PubMed

Wallström, P; Mattisson, I; Tydén, P; Berglund, G; Janzon, L

2005-04-01

Comparing habitual nutrient intakes in persons with a history of acute myocardial infarction (AMI), and age-matched controls. Design. Cross-sectional study. Subjects. Men and women (525 cases and 1890 matched controls), aged 47-73 years, of the population-based Malmö Diet and Cancer cohort. Nutrient intakes were assessed by a validated modified diet history method. Body fatness was assessed by bioimpedance analysis. Case ascertainment was provided by national and regional registries. Men and women were analysed separately. Median time since AMI was 5.5 years in men and 3.8 years in women. Cases reported lower energy intakes (EIs) than controls, despite having similar basal metabolic rates. After adjustment for total EI, both male and female cases had lower fat intake and higher intake of several micronutrients, such as ascorbic acid, folate, and vitamin E, than controls, the difference being largest in men. Most of the cases reporting dietary change quoted 'disease' as their main reason for change. They had lower EI and lower energy-adjusted intake of fat than other cases. Survivors of AMI reported dietary habits more in line with current recommendations, particularly those who afterwards reported having changed their dietary habits. The possible bias introduced by social desirability is discussed.

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.

A multinational case-control study on childhood brain tumours, anthropogenic factors, birth characteristics and prenatal exposures: A validation of interview data.

PubMed

Vienneau, Danielle; Infanger, Denis; Feychting, Maria; Schüz, Joachim; Schmidt, Lisbeth Samsø; Poulsen, Aslak Harbo; Tettamanti, Giorgio; Klæboe, Lars; Kuehni, Claudia E; Tynes, Tore; Von der Weid, Nicolas; Lannering, Birgitta; Röösli, Martin

2016-02-01

Little is known about the aetiology of childhood brain tumours. We investigated anthropometric factors (birth weight, length, maternal age), birth characteristics (e.g. vacuum extraction, preterm delivery, birth order) and exposures during pregnancy (e.g. maternal: smoking, working, dietary supplement intake) in relation to risk of brain tumour diagnosis among 7-19 year olds. The multinational case-control study in Denmark, Sweden, Norway and Switzerland (CEFALO) included interviews with 352 (participation rate=83.2%) eligible cases and 646 (71.1%) population-based controls. Interview data were complemented with data from birth registries and validated by assessing agreement (Cohen's Kappa). We used conditional logistic regression models matched on age, sex and geographical region (adjusted for maternal age and parental education) to explore associations between birth factors and childhood brain tumour risk. Agreement between interview and birth registry data ranged from moderate (Kappa=0.54; worked during pregnancy) to almost perfect (Kappa=0.98; birth weight). Neither anthropogenic factors nor birth characteristics were associated with childhood brain tumour risk. Maternal vitamin intake during pregnancy was indicative of a protective effect (OR 0.75, 95%-CI: 0.56-1.01). No association was seen for maternal smoking during pregnancy or working during pregnancy. We found little evidence that the considered birth factors were related to brain tumour risk among children and adolescents. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Adjuvant treatment for resected rectal cancer: impact of standard and intensified postoperative chemotherapy on disease-free survival in patients undergoing preoperative chemoradiation-a propensity score-matched analysis of an observational database.

PubMed

Garlipp, Benjamin; Ptok, Henry; Benedix, Frank; Otto, Ronny; Popp, Felix; Ridwelski, Karsten; Gastinger, Ingo; Benckert, Christoph; Lippert, Hans; Bruns, Christiane

2016-12-01

Adjuvant chemotherapy for resected rectal cancer is widely used. However, studies on adjuvant treatment following neoadjuvant chemoradiotherapy (CRT) and total mesorectal excision (TME) have yielded conflicting results. Recent studies have focused on adding oxaliplatin to both preoperative and postoperative therapy, making it difficult to assess the impact of adjuvant oxaliplatin alone. This study was aimed at determining the impact of (i) any adjuvant treatment and (ii) oxaliplatin-containing adjuvant treatment on disease-free survival in CRT-pretreated, R0-resected rectal cancer patients. Patients undergoing R0 TME following 5-fluorouracil (5FU)-only-based CRT between January 1, 2008, and December 31, 2010, were selected from a nationwide registry. After propensity score matching (PSM), comparison of disease-free survival (DFS) using Kaplan-Meier analysis and log-rank test was performed in (i) patients receiving no vs. any adjuvant treatment and (ii) patients treated with adjuvant 5FU/capecitabine without vs. with oxaliplatin. Out of 1497 patients, 520 matched pairs were generated for analysis of no vs. any adjuvant treatment. Mean DFS was significantly prolonged with adjuvant treatment (81.8 ± 2.06 vs. 70.1 ± 3.02 months, p < 0.001). One hundred forty-eight matched pairs were available for analysis of adjuvant therapy with or without oxaliplatin, showing no improvement in DFS in patients receiving oxaliplatin (76.9 ± 4.12 vs. 79.3 ± 4.44 months, p = 0.254). Local recurrence rate was not significantly different between groups in either analysis. In this cohort of rectal cancer patients treated with neoadjuvant CRT and TME surgery under routine conditions, adjuvant chemotherapy significantly improved DFS. No benefit was observed for the addition of oxaliplatin to adjuvant chemotherapy in this setting.

Clinical disease registries in acute myocardial infarction.

PubMed

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

2014-06-26

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

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

PubMed

Barbanti, Marco; Gulino, Simona; Capranzano, Piera; Immè, Sebastiano; Sgroi, Carmelo; Tamburino, Claudia; Ohno, Yohei; Attizzani, Guilherme F; Patanè, Martina; Sicuso, Rita; Pilato, Gerlando; Di Landro, Alessio; Todaro, Denise; Di Simone, Emanuela; Picci, Andrea; Giannetto, Giuliana; Costa, Giuliano; Deste, Wanda; Giannazzo, Daniela; Grasso, Carmelo; Capodanno, Davide; Tamburino, Corrado

2015-10-01

The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

L-arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis: A Randomised, Double-Blind, Placebo-Controlled Trial

PubMed Central

Ralph, Anna P.; Waramori, Govert; Pontororing, Gysje J.; Kenangalem, Enny; Wiguna, Andri; Tjitra, Emiliana; Sandjaja; Lolong, Dina B.; Yeo, Tsin W.; Chatfield, Mark D.; Soemanto, Retno K.; Bastian, Ivan; Lumb, Richard; Maguire, Graeme P.; Eisman, John; Price, Ric N.; Morris, Peter S.; Kelly, Paul M.; Anstey, Nicholas M.

2013-01-01

Background Vitamin D (vitD) and L-arginine have important antimycobacterial effects in humans. Adjunctive therapy with these agents has the potential to improve outcomes in active tuberculosis (TB). Methods In a 4-arm randomised, double-blind, placebo-controlled factorial trial in adults with smear-positive pulmonary tuberculosis (PTB) in Timika, Indonesia, we tested the effect of oral adjunctive vitD 50,000 IU 4-weekly or matching placebo, and L-arginine 6.0 g daily or matching placebo, for 8 weeks, on proportions of participants with negative 4-week sputum culture, and on an 8-week clinical score (weight, FEV1, cough, sputum, haemoptysis). All participants with available endpoints were included in analyses according to the study arm to which they were originally assigned. Adults with new smear-positive PTB were eligible. The trial was registered at ClinicalTrials.gov NCT00677339. Results 200 participants were enrolled, less than the intended sample size: 50 received L-arginine + active vitD, 49 received L-arginine + placebo vit D, 51 received placebo L-arginine + active vitD and 50 received placebo L-arginine + placebo vitD. According to the factorial model, 99 people received arginine, 101 placebo arginine, 101 vitamin D, 99 placebo vitamin D. Results for the primary endpoints were available in 155 (4-week culture) and 167 (clinical score) participants. Sputum culture conversion was achieved by week 4 in 48/76 (63%) participants in the active L-arginine versus 48/79 (61%) in placebo L-arginine arms (risk difference −3%, 95% CI −19 to 13%), and in 44/75 (59%) in the active vitD versus 52/80 (65%) in the placebo vitD arms (risk difference 7%, 95% CI −9 to 22%). The mean clinical outcome score also did not differ between study arms. There were no effects of the interventions on adverse event rates including hypercalcaemia, or other secondary outcomes. Conclusion Neither vitD nor L-arginine supplementation, at the doses administered and with the power attained, affected TB outcomes. Registry ClinicalTrials.gov. Registry number: NCT00677339 PMID:23967066

Long-term health outcomes in patients with Prader-Willi Syndrome: a nationwide cohort study in Denmark.

PubMed

Hedgeman, E; Ulrichsen, S P; Carter, S; Kreher, N C; Malobisky, K P; Braun, M M; Fryzek, J; Olsen, M S

2017-10-01

Prader-Willi syndrome (PWS) is a rare congenital disease that affects growth, sexual development, cognitive function and behavior. Individuals exhibit food preoccupation and hyperphagia, which may lead to obesity with premature morbidity and mortality. The aim of this work was to evaluate the risk of venous thromboembolisms (VTEs), myocardial infarction, pulmonary hypertension, sleep apnea, depression, anxiety and all-cause mortality among persons with PWS as compared with an age- and sex-matched general-population cohort. All persons diagnosed with PWS (n=155) were identified in the Danish Health Registries; an age- and sex-matched comparison group was selected from the general population of Denmark (n=15 500); diseases of interest were identified through the health registry and cause of death register. Follow-up began on date of birth or first medical record availability through to first occurrence of an outcome of interest; follow-up ceased at emigration from Denmark or end of study. Incidence rates (IRs) were calculated and Cox's proportional hazards models were used to understand the relative risk (RR) of disease. The IRs for VTE among patients with PWS was 144 (60-347) per 100 000 person-years. Risks for VTE events and all-cause mortality were 9.4 times (95% confidence interval (CI): 3.7-23.5) and 11.0 times (95% CI: 5.7-21.1) higher, respectively, for patients with PWS versus the general population. Increased risks were also found individually for deep venous thromboses (DVTs) (RR: 9.1; 95% CI: 3.2-25.2), pulmonary embolisms (RR: 11.0; 95% CI: 1.4-86.9), myocardial infarction (RR: 7.2; 95% CI: 1.7-30.2) and anxiety (RR: 2.8; 95% CI: 1.0-7.5). No cases of pulmonary hypertension, sleep apnea or depressive disorders were identified within this PWS cohort. Multiple cardiovascular and behavioral illnesses are more likely to occur among patients with PWS than within the general population. These increased risks may provide an impetus for enhanced disease prevention, screening, diagnosis and treatment.

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.

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.

Traffic-related air pollution and risk for leukaemia of an adult population.

PubMed

Raaschou-Nielsen, Ole; Ketzel, Matthias; Harbo Poulsen, Aslak; Sørensen, Mette

2016-03-01

Air pollution causes lung cancer, but associations with other cancers have not been established. We investigated whether long-term exposure to traffic-related air pollution is associated with the risk of the general population for leukaemia. We identified 1,967 people in whom leukaemia was diagnosed in 1992-2010 from a nation-wide cancer registry and selected 3,381 control people at random, matched on sex and year of birth, from the entire Danish population. Residential addresses since 1971 were traced in a population registry, and outdoor concentrations of NOx and NO2 , as indicators of traffic-related air pollution, were calculated at each address in a dispersion model. We used conditional logistic regression to estimate the risk for leukaemia after adjustment for income, educational level, cohabitation status and co-morbidity. In linear analyses, we found odds ratios for acute myeloid leukaemia of 1.20 (95% confidence interval: 1.04-1.38) per 20 µg/m(3) increase in NOx and 1.31 (1.02-1.68) per 10 µg/m(3) increase in NO2 , calculated as time-weighted average exposure at all addresses since 1971. We found no association with chronic myeloid or lymphocytic leukaemia. This study indicates an association between long-term exposure to traffic-related air pollution and acute myeloid leukaemia in the general population, but not for other subtypes of leukaemia. © 2015 UICC.

Management of bleeding in acquired hemophilia A: results from the European Acquired Haemophilia (EACH2) Registry.

PubMed

Baudo, Francesco; Collins, Peter; Huth-Kühne, Angela; Lévesque, Hervé; Marco, Pascual; Nemes, László; Pellegrini, Fabio; Tengborn, Lilian; Knoebl, Paul

2012-07-05

Acquired hemophilia A is a rare bleeding disorder caused by autoantibodies to coagulation FVIII. Bleeding episodes at presentation are spontaneous and severe in most cases. Optimal hemostatic therapy is controversial, and available data are from observational and retrospective studies only. The EACH2 registry, a multicenter, pan-European, Web-based database, reports current patient management. The aim was to assess the control of first bleeding episodes treated with a bypassing agent (rFVIIa or aPCC), FVIII, or DDAVP among 501 registered patients. Of 482 patients with one or more bleeding episodes, 144 (30%) received no treatment for bleeding; 31 were treated with symptomatic therapy only. Among 307 patients treated with a first-line hemostatic agent, 174 (56.7%) received rFVIIa, 63 (20.5%) aPCC, 56 (18.2%) FVIII, and 14 (4.6%) DDAVP. Bleeding was controlled in 269 of 338 (79.6%) patients treated with a first-line hemostatic agent or ancillary therapy alone. Propensity score matching was applied to allow unbiased comparison between treatment groups. Bleeding control was significantly higher in patients treated with bypassing agents versus FVIII/DDAVP (93.3% vs 68.3%; P = .003). Bleeding control was similar between rFVIIa and aPCC (93.0%; P = 1). Thrombotic events were reported in 3.6% of treated patients with a similar incidence between rFVIIa (2.9%) and aPCC (4.8%).

Diagnosis and mortality in 47,XYY persons: a registry study

PubMed Central

2010-01-01

Background Sex chromosomal abnormalities are relatively common, yet many aspects of these syndromes remain unexplored. For instance epidemiological data in 47,XYY persons are still limited. Methods Using a national Danish registry, we identified 208 persons with 47,XYY or a compatible karyotype, whereof 36 were deceased; all were diagnosed from 1968 to 2008. For further analyses, we identified age matched controls from the male background population (n = 20,078) in Statistics Denmark. We report nationwide prevalence data, data regarding age at diagnosis, as well as total and cause specific mortality data in these persons. Results The average prevalence was 14.2 47,XYY persons per 100,000, which is reduced compared to the expected 98 per 100,000. Their median age at diagnosis was 17.1 years. We found a significantly decreased lifespan from 77.9 years (controls) to 67.5 years (47,XYY persons). Total mortality was significantly increased compared to controls, with a hazard ratio of 3.6 (2.6-5.1). Dividing the causes of deaths according to the International Classification of Diseases, we identified an increased hazard ratio in all informative chapters, with a significantly increased ratio in cancer, pulmonary, neurological and unspecified diseases, and trauma. Conclusion We here present national epidemiological data regarding 47,XYY syndrome, including prevalence and mortality data, showing a significantly delay to diagnosis, reduced life expectancy and an increased total and cause specific mortality. PMID:20509956

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.

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.

Major histocompatibility complex (MHC) class I and II alleles which confer susceptibility or protection in the Morphea in Adults and Children (MAC) cohort

PubMed Central

Jacobe, Heidi; Ahn, Chul; Arnett, Frank; Reveille, John D.

2014-01-01

Objective To determine human leukocyte antigen class I (HLA-class I) and II (HLA-class II) alleles associated with morphea (localized scleroderma) in the Morphea in Adults and Children (MAC) cohort by a nested case–control association study. Methods Morphea patients were included from MAC cohort and matched controls from the NIH/NIAMS Scleroderma Family Registry and DNA Repository and Division of Rheumatology at the University of Texas Health Science Center at Houston. HLA- Class II genotyping and SSCP typing was performed of HLA-A, -B, -C alleles. Associations between HLA-Class I and II alleles and morphea as well as its subphenotypes were determined. Results There were 211 cases available for HLA-class I typing with 726 matched controls and 158 cases available for HLA Class-II typing with 1108 matched controls. The strongest associations were found with DRB1*04:04 (OR 2.3, 95% CI 1.4–4.0 P=0.002) and HLA-B*37 conferred the highest OR among Class I alleles (3.3, 95% CI 1.6–6.9, P= 0.0016). Comparison with risk alleles in systemic sclerosis determined using the same methods and control population revealed one common allele (DRB*04:04). Conclusion Results of the present study demonstrate specific HLA Class I and II alleles are associated with morphea and likely generalized and linear subtypes. The associated morphea alleles are different than in scleroderma, implicating morphea is also immunogenetically distinct. Risk alleles in morphea are also associated with conditions such as rheumatoid arthritis (RA) and other autoimmune conditions. Population based studies indicate patients with RA have increased risk of morphea, implicating a common susceptibility allele. PMID:25223600

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.

Hospital Resource Use with Donation after Cardiac Death Allografts in Liver Transplantation: A Matched Controlled Analysis from 2007 to 2011.

PubMed

Singhal, Ashish; Wima, Koffi; Hoehn, Richard S; Quillin, R Cutler; Woodle, E Steve; Paquette, Ian M; Paterno, Flavio; Abbott, Daniel E; Shah, Shimul A

2015-05-01

Although donation after cardiac death (DCD) liver allografts have been used to expand the donor pool, concerns exist regarding primary nonfunction and biliary complications. Our aim was to compare resource use and outcomes of DCD allografts with donation after brain death (DBD) liver allografts. Using a linkage between the University HealthSystem Consortium and Scientific Registry of Transplant Recipients databases, we identified 11,856 patients who underwent deceased donor liver transplantation (LT) from 2007 to 2011. Patients were divided into 2 cohorts based on type of allograft (DCD vs DBD). Matched pair analysis (n = 613 in each group) was used to compare outcomes of the 2 donor types. Donation after cardiac death allografts comprised 5.2% (n = 613) of all LTs in the studied cohort; DCD allograft recipients were healthier and had lower median Model of End-Stage Liver Disease (MELD) score (17 vs 19; p < 0.0001). Post LT, there was no significant difference in length of stay, perioperative mortality, and discharge to home rates. However, DCD allografts were associated with higher direct cost ($110,414 vs $99,543; p < 0.0001) and 30-day readmission rates (46.4% vs 37.1%; p < 0.0001). Matched analysis revealed that DCD allografts were associated with higher direct cost, readmission rates, and inferior graft survival. While confirming the previous reports of inferior graft survival associated with DCD allografts, this is the first national report to show increased financial and resource use associated with DCD compared with DBD allografts in a matched recipient cohort. Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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.

Outcomes of Male Patients with Alport Syndrome Undergoing Renal Replacement Therapy

PubMed Central

Temme, Johanna; Kramer, Anneke; Jager, Kitty J.; Lange, Katharina; Peters, Frederick; Müller, Gerhard-Anton; Kramar, Reinhard; Heaf, James G.; Finne, Patrik; Palsson, Runolfur; Reisæter, Anna V.; Hoitsma, Andries J.; Metcalfe, Wendy; Postorino, Maurizio; Zurriaga, Oscar; Santos, Julio P.; Ravani, Pietro; Jarraya, Faical; Verrina, Enrico; Dekker, Friedo W.

2012-01-01

Summary Background and objectives Patients with the hereditary disease Alport syndrome commonly require renal replacement therapy (RRT) in the second or third decade of life. This study compared age at onset of RRT, renal allograft, and patient survival in men with Alport syndrome receiving various forms of RRT (peritoneal dialysis, hemodialysis, or transplantation) with those of men with other renal diseases. Design, setting, participants, & measurements Patients with Alport syndrome receiving RRT identified from 14 registries in Europe were matched to patients with other renal diseases. A linear spline model was used to detect changes in the age at start of RRT over time. Kaplan-Meier method and Cox regression analysis were used to examine patient and graft survival. Results Age at start of RRT among patients with Alport syndrome remained stable during the 1990s but increased by 6 years between 2000–2004 and 2005–2009. Survival of patients with Alport syndrome requiring dialysis or transplantation did not change between 1990 and 2009. However, patients with Alport syndrome had better renal graft and patient survival than matched controls. Numbers of living-donor transplantations were lower in patients with Alport syndrome than in matched controls. Conclusions These data suggest that kidney failure in patients with Alport syndrome is now being delayed compared with previous decades. These patients appear to have superior patient survival while undergoing dialysis and superior patient and graft survival after deceased-donor kidney transplantation compared with patients receiving RRT because of other causes of kidney failure. PMID:22997344

Outcomes of male patients with Alport syndrome undergoing renal replacement therapy.

PubMed

Temme, Johanna; Kramer, Anneke; Jager, Kitty J; Lange, Katharina; Peters, Frederick; Müller, Gerhard-Anton; Kramar, Reinhard; Heaf, James G; Finne, Patrik; Palsson, Runolfur; Reisæter, Anna V; Hoitsma, Andries J; Metcalfe, Wendy; Postorino, Maurizio; Zurriaga, Oscar; Santos, Julio P; Ravani, Pietro; Jarraya, Faical; Verrina, Enrico; Dekker, Friedo W; Gross, Oliver

2012-12-01

Patients with the hereditary disease Alport syndrome commonly require renal replacement therapy (RRT) in the second or third decade of life. This study compared age at onset of RRT, renal allograft, and patient survival in men with Alport syndrome receiving various forms of RRT (peritoneal dialysis, hemodialysis, or transplantation) with those of men with other renal diseases. Patients with Alport syndrome receiving RRT identified from 14 registries in Europe were matched to patients with other renal diseases. A linear spline model was used to detect changes in the age at start of RRT over time. Kaplan-Meier method and Cox regression analysis were used to examine patient and graft survival. Age at start of RRT among patients with Alport syndrome remained stable during the 1990s but increased by 6 years between 2000-2004 and 2005-2009. Survival of patients with Alport syndrome requiring dialysis or transplantation did not change between 1990 and 2009. However, patients with Alport syndrome had better renal graft and patient survival than matched controls. Numbers of living-donor transplantations were lower in patients with Alport syndrome than in matched controls. These data suggest that kidney failure in patients with Alport syndrome is now being delayed compared with previous decades. These patients appear to have superior patient survival while undergoing dialysis and superior patient and graft survival after deceased-donor kidney transplantation compared with patients receiving RRT because of other causes of kidney failure.

Autism with intellectual disability related to dynamics of head circumference growth during early infancy.

PubMed

McKeague, Ian W; Brown, Alan S; Bao, Yuanyuan; Hinkka-Yli-Salomäki, Susanna; Huttunen, Jukka; Sourander, Andre

2015-05-01

It is not yet definitively known whether dynamic features of head circumference growth are associated with autism. To address this issue, we carried out a nested matched case-control study using data from national well baby clinics in Finland; autism cases were identified from the Finnish Hospital and Outpatient Discharge Registry. A nonparametric Bayesian method was used to construct growth velocity trajectories between birth and 2 years of age in autism cases and matched control subjects (n = 468 in main analyses, 1:1 matched control subjects). Estimates of odds ratios for autism risk in relation to the growth velocities were obtained using conditional logistic regression. Growth velocity of head circumference at 3 months of age, adjusting for gestational age at birth and maternal age, is significantly associated with autism (p = .014); the finding was observed in subjects with comorbid intellectual disability (ID) (p = .025) but not in those without ID (p = .15). Height growth velocity among subjects with autism and without ID is significantly associated with autism at 6 months (p = .007), and weight growth velocity at 18 months without ID (p = .02) and 24 months without ID (p = .042) and with ID (p = .037). Acceleration in head circumference growth is associated with autism with comorbid ID at 3 months but not subsequently. This association is unrelated to acceleration in height and weight, which are not strongly associated with autism until after 6 months. Copyright © 2015 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

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.

Does vagotomy protect against multiple sclerosis?

PubMed

Sundbøll, Jens; Horváth-Puhó, Erzsébet; Adelborg, Kasper; Svensson, Elisabeth

2017-07-01

To examine the association between vagotomy and multiple sclerosis. We conducted a matched cohort study of all patients who underwent truncal or super-selective vagotomy and a comparison cohort, by linking Danish population-based medical registries (1977-1995). Hazard ratios (HRs) for multiple sclerosis, adjusting for potential confounders were computed by means of Cox regression analysis. Median age of multiple sclerosis onset corresponded to late onset multiple sclerosis. No association with multiple sclerosis was observed for truncal vagotomy (0-37 year adjusted HR=0.91, 95% confidence interval [CI]: 0.48-1.74) or super-selective vagotomy (0-37 year adjusted HR=1.28, 95% CI: 0.79-2.09) compared with the general population. We found no association between vagotomy and later risk of late onset multiple sclerosis. Copyright © 2017 Elsevier B.V. All rights reserved.

[Drug registries: post-marketing evaluation of the benefit-risk profile and promotion of appropriateness. The regional point of view].

PubMed

Martelli, Luisa; Venegoni, Mauro

2013-06-01

Italian Regions and the Italian regulatory agency share a common interest in promoting the appropriateness of drug use, containing drug expenditure and acquiring additional evidence on the effectiveness and safety of drugs. Drug registries can help attaining these objectives. Specifically, the registries implemented in Italy were able to cover the first two objectives, whereas some critical issues were raised on the third one. For instance, the data recorded in the registries are not available at regional level to conduct safety and effectiveness investigations. This is a paradox, when considering that drugs included in the registries have a risk-benefit profile that is only partially defined at the moment of marketing. Currently, researchers and regions can conduct epidemiological research (cohort and case control studies), on the basis of record-linkage procedures, on all drugs prescribed in general practice (which are older drugs with a better defined risk-benefit profile). The expected outcomes of registries should be more clearly defined: when the main aim is to promote appropriateness, the recording of only a very limited amount of data should be required (to avoid a bureaucratic burden on clinicians).The Italian centers of the ENCePP network might play an important role in planning and conducting drug registries: through the presence in the steering committees of the registries, and in conducting epidemiological studies that make the most of this powerful instrument.

OOSTethys - Open Source Software for the Global Earth Observing Systems of Systems

NASA Astrophysics Data System (ADS)

Bridger, E.; Bermudez, L. E.; Maskey, M.; Rueda, C.; Babin, B. L.; Blair, R.

2009-12-01

An open source software project is much more than just picking the right license, hosting modular code and providing effective documentation. Success in advancing in an open collaborative way requires that the process match the expected code functionality to the developer's personal expertise and organizational needs as well as having an enthusiastic and responsive core lead group. We will present the lessons learned fromOOSTethys , which is a community of software developers and marine scientists who develop open source tools, in multiple languages, to integrate ocean observing systems into an Integrated Ocean Observing System (IOOS). OOSTethys' goal is to dramatically reduce the time it takes to install, adopt and update standards-compliant web services. OOSTethys has developed servers, clients and a registry. Open source PERL, PYTHON, JAVA and ASP tool kits and reference implementations are helping the marine community publish near real-time observation data in interoperable standard formats. In some cases publishing an OpenGeospatial Consortium (OGC), Sensor Observation Service (SOS) from NetCDF files or a database or even CSV text files could take only minutes depending on the skills of the developer. OOSTethys is also developing an OGC standard registry, Catalog Service for Web (CSW). This open source CSW registry was implemented to easily register and discover SOSs using ISO 19139 service metadata. A web interface layer over the CSW registry simplifies the registration process by harvesting metadata describing the observations and sensors from the “GetCapabilities” response of SOS. OPENIOOS is the web client, developed in PERL to visualize the sensors in the SOS services. While the number of OOSTethys software developers is small, currently about 10 around the world, the number of OOSTethys toolkit implementers is larger and growing and the ease of use has played a large role in spreading the use of interoperable standards compliant web services widely in the marine community.

Two Suspected Worksite or Occupational Cancer Clusters Investigated Using the Cancer Data Registry and Multiple Primary Standardized Incidence Ratios in SEER *Stat-Idaho, 2013-2014.

PubMed

Rosenthal, Mariana; Johnson, Christopher J; Scoppa, Steve; Carter, Kris

2016-01-01

Investigations of suspected cancer clusters are resource intensive and rarely identify true clusters: among 428 publicly reported US investigations during 1990-2011, only 1 etiologic cluster was identified. In 2013, the Cancer Data Registry of Idaho (CDRI) was contacted regarding a suspected cancer cluster at a worksite (Cluster A) and among an occupational cohort (Cluster B). We investigated to determine whether these were true clusters. We derived investigation cohorts for Cluster A from facility-provided employee records and for Cluster B from professional licensing records. We used Registry PlusTM Link Plus to conduct probabilistic linkage of cohort members to the CDRI registry and completed matching through manual review by using LexisNexis®, Accurint®, and the Social Security Death Index. We calculated standardized incidence ratios (SIR) using the MP-SIR session type in SEER*Stat and Idaho and US referent populations. For Cluster A, we identified 34 cancer cases during 9,689 person-years; compared with Idaho and US rates, 95 percent CIs for SIRs included 1.0 for 24 of 24 primary site categories. For Cluster B, we identified 78 cancer cases during 15,154 person-years; compared with Idaho rates, 95 percent CI for SIRs included 1.0 for 23 of 24 primary site categories and was less than 1.0 for lung and bronchus cancers, and compared with US rates, 95 percent CI for SIRs included 1.0 for 22 of 24 primary site categories and was less than 1.0 for lung and bronchus and colorectal cancers. We identified no statistically significant excess in cancer incidence in either cohort. SEER*Stat's MP-SIR is an efficient tool for performing SIR assessments, a Centers for Disease Control and Prevention/Council of State and Territorial Epidemiologists-recommended step when investigating suspected cancer clusters.

Ensuring quality in studies linking cancer registries and biobanks.

PubMed

Langseth, Hilde; Luostarinen, Tapio; Bray, Freddie; Dillner, Joakim

2010-04-01

The Nordic countries have a long tradition of providing comparable and high quality cancer data through the national population-based cancer registries and the capability to link the diverse large-scale biobanks currently in operation. The joining of these two infrastructural resources can provide a study base for large-scale studies of etiology, treatment and early detection of cancer. Research projects based on combined data from cancer registries and biobanks provides great opportunities, but also presents major challenges. Biorepositories have become an important resource in molecular epidemiology, and the increased interest in performing etiological, clinical and gene-environment-interaction studies, involving information from biological samples linked to population-based cancer registries, warrants a joint evaluation of the quality aspects of the two resources, as well as an assessment of whether the resources can be successfully combined into a high quality study. While the quality of biospecimen handling and analysis is commonly considered in different studies, the logistics of data handling including the linkage of the biobank with the cancer registry is an overlooked aspect of a biobank-based study. It is thus the aim of this paper to describe recommendations on data handling, in particular the linkage of biobank material to cancer registry data and the quality aspects thereof, based on the experience of Nordic collaborative projects combining data from cancer registries and biobanks. We propose a standard documentation with respect to the following topics: the quality control aspects of cancer registration, the identification of cases and controls, the identification and use of data confounders, the stability of serum components, historical storage conditions, aliquoting history, the number of freeze/thaw cycles and available volumes.

Classification of Topographical Pattern of Spasticity in Cerebral Palsy: A Registry Perspective

ERIC Educational Resources Information Center

Reid, Susan M.; Carlin, John B.; Reddihough, Dinah S.

2011-01-01

This study used data from a population-based cerebral palsy (CP) registry and systematic review to assess the amount of heterogeneity between registries in topographical patterns when dichotomised into unilateral (USCP) and bilateral spastic CP (BSCP), and whether the terms diplegia and quadriplegia provide useful additional epidemiological…

Utility of an Australasian registry for children undergoing radiation treatment.

PubMed

Ahern, Verity

2014-12-01

The aim of this study was to evaluate the utility of an Australasian registry ('the Registry') for children undergoing radiation treatment (RT). Children under the age of 16 years who received a course of radiation between January 1997 and December 2010 and were enrolled on the Registry form the subjects of this study. A total of 2232 courses of RT were delivered, predominantly with radical intent (87%). Registrations fluctuated over time, but around one-half of children diagnosed with cancer undergo a course of RT. The most prevalent age range at time of RT was 10-15 years, and the most common diagnoses were central nervous system tumours (34%) and acute lymphoblastic leukaemia (20%). The Registry provides a reflection of the patterns of care of children undergoing RT in Australia and a mechanism for determining the resources necessary to manage children by RT (human, facilities and emerging technologies, such as proton therapy). It lacks the detail to provide information on radiotherapy quality and disease outcomes which should be the subject of separate audit studies. The utility of the Registry has been hampered by its voluntary nature and varying needs for consent. Completion of registry forms is a logical requirement for inclusion in the definition of a subspecialist in paediatric radiation oncology. © 2014 The Royal Australian and New Zealand College of Radiologists.

Private provider participation in statewide immunization registries

PubMed Central

Clark, Sarah J; Cowan, Anne E; Bartlett, Diana L

2006-01-01

Background Population-based registries have been promoted as an effective method to improve childhood immunization rates, yet rates of registry participation in the private sector are low. We sought to describe, through a national overview, the perspectives of childhood immunization providers in private practice regarding factors associated with participation or non-participation in immunization registries. Methods Two mailed surveys, one for 264 private practices identified as registry non-participants and the other for 971 identified as registry participants, from 15 of the 31 states with population-based statewide immunization registries. Frequency distributions were calculated separately for non-participants and participants regarding the physician-reported factors that influenced decisions related to registry participation. Pearson chi-square tests of independence were used to assess associations among categorical variables. Results Overall response rate was 62% (N = 756). Among non-participants, easy access to records of vaccines provided at other sites (N = 101, 68%) and printable immunization records (N = 82, 55%) were most often cited as "very important" potential benefits of a registry, while the most commonly cited barriers to participation were too much cost/staff time (N = 36, 38%) and that the practice has its own system for recording and monitoring immunizations (N = 35, 37%). Among registry participants, most reported using the registry to input data on vaccines administered (N = 326, 87%) and to review immunization records of individual patients (N = 302, 81%). A minority reported using it to assess their practice's immunization coverage (N = 110, 29%) or generate reminder/recall notices (N = 54, 14%). Few participants reported experiencing "significant" problems with the registry; the most often cited was cost/staff time to use the registry (N = 71, 20%). Conclusion Most registry participants report active participation with few problems. The problems they report are generally consistent with the barriers anticipated by non-participants, but did not impede participation. Recruitment efforts should focus on demonstrating the benefits of the registry to providers. In addition, many participants are not utilizing the full range of registry features; further study is needed to determine how best to increase use of these features. PMID:16480494

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

PubMed

Dekkers, Olaf M; Cevallos, Myriam; Bührer, Jonas; Poncet, Antoine; Ackermann Rau, Sabine; Perneger, Thomas V; Egger, Matthias

2015-05-01

To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. The margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. The reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries. Copyright © 2015 Elsevier Inc. All rights reserved.

Patients with inflammatory bowel disease have increased risk of autoimmune and inflammatory diseases

PubMed Central

Halling, Morten L; Kjeldsen, Jens; Knudsen, Torben; Nielsen, Jan; Hansen, Lars Koch

2017-01-01

AIM To investigate whether immune mediated diseases (IMD) are more frequent in patients with inflammatory bowel disease (IBD). METHODS In this population based registry study, a total of 47325 patients with IBD were alive and registered in the Danish National Patient Registry on December 16, 2013. Controls were randomly selected from the Danish Civil Registration System (CRS) and matched for sex, age, and municipality. We used ICD 10 codes to identify the diagnoses of the included patients. The IBD population was divided into three subgroups: Ulcerative colitis (UC), Crohn’s disease (CD) and Both the latter referring to those registered with both diagnoses. Subsequently, odds-ratios (OR) and 95%CI were obtained separately for each group and their respective controls. The use of Bonferoni post-test correction adjusted the significance level to P < 0.00125. P-values were estimated using Fisher’s exact test. RESULTS There were significantly more women than men in the registry, and a greater percentage of comorbidity in the IBD groups (P < 0.05). Twenty different IMDs were all significantly more frequent in the IBD group. Sixteen were associated with UC versus twelve with CD. In both UC and CD ORs were significantly increased (P < 0.00125) for primary sclerosing cholangitis (PSC), celiac disease, type 1 diabetes (T1D), sarcoidosis, asthma, iridocyclitis, psoriasis, pyoderma gangrenosum, rheumatoid arthritis, and ankylosing spondylitis. Restricted to UC (P < 0.00125) were autoimmune hepatitis, primary biliary cholangitis, Grave’s disease, polymyalgia rheumatica, temporal arteritis , and atrophic gastritis. Restricted to CD (P < 0.00125) were psoriatic arthritis and episcleritis. Restricted to women with UC (P < 0.00125) were atrophic gastritis, rheumatoid arthritis, temporal arteritis, and polymyalgia rheumatica. Restricted to women with CD were episcleritis, rheumatoid arthritis, and psoriatic arthritis. The only disease restricted to men (P < 0.00125) was sarcoidosis. CONCLUSION Immune mediated diseases were significantly more frequent in patients with IBD. Our results strengthen the hypothesis that some IMDs and IBD may have overlapping pathogenic pathways. PMID:28970729

Factors associated with survival among patients with AIDS-related primary central nervous system lymphoma

PubMed Central

Uldrick, Thomas S.; Pipkin, Sharon; Scheer, Susan; Hessol, Nancy A.

2014-01-01

Objective AIDS-related primary central nervous system lymphoma (AR-PCNSL) has a poor prognosis. Improved understanding of specific patient, infectious, diagnostic, and treatment-related factors that affect overall survival (OS) are required to improve outcomes. Design Population-based registry linkage study. Methods Adult cases from the San Francisco AIDS registry (1990–2000) were matched with the California Cancer Registry (1985–2002) to ascertain AR-PCNSL data. Survival time was assessed through 31 December 2007. Risk factors and temporal trends for death were measured using two-sided Kaplan–Meier and Cox analyses. Results Two hundred and seven AR-PCNSL patients were identified: 68% were white, 20% Hispanic, 10% African–American, and 2% Asian. Nineteen percent of patients had central nervous system (CNS) opportunistic infections diagnosed prior to AR-PCNSL. Fifty seven percent of patients received radiation and/or chemotherapy and 12% used HAART prior to or within 30 days of AR-PCSNL diagnosis. One hundred and ninety-nine patients died (34 deaths/100 person-years). In adjusted analysis, prior CNS opportunistic infections diagnosis increased risk of death (hazard ratio 1.9, P = 0.0006) whereas radiation and/or chemotherapy decreased risk (hazard ratio 0.6, P <0.0001). AR-PCNSL diagnosis 1999–2002 had a lower mortality risk (hazard ratio = 0.4, P = 0.02) compared to 1990–1995. African–Americans had an increased risk of death compared to whites or Asians (hazard ratio = 2.0, P = 0.007). Conclusion OS among AR-PCSNL patients improved over time but remains poor, especially among African–Americans. Prospective evaluation of curative therapy in AR-PCNSL is urgently needed. Accurate diagnosis of CNS mass lesions in patients with AIDS is required and for those with AR-PCNSL, antiretroviral therapy with concomitant AR-PCNSL therapy, and antimicrobial supportive care may improve OS. PMID:24076659

Risk of Ischemic and Hemorrhagic Strokes in Occult and Manifest Cancers.

PubMed

Andersen, Klaus Kaae; Olsen, Tom Skyhøj

2018-06-04

Manifest cancer is associated with increased risk of stroke. The risk of stroke in people with occult cancer in comparison to the risk in the background population without cancer has not been investigated. Smoking is a risk factor for both cancer and stroke, but the role of smoking for the risk of stroke in cancer has not been investigated. We identified all incident cases of cancer in Denmark 2003 to 2012 (n=264.376) from the Danish Cancer Registry. Each person with cancer was matched by age, sex, and income with 10 randomly selected persons without cancer at index date (n=2.571.260). Linking data to the Danish Stroke Registry, we studied risk of ischemic/hemorrhagic stroke the year before (occult cancer) and after cancer diagnosis was established in the Danish Stroke Registry (manifest cancer) and stratified into the 15 most common cancer types related (lung, colon, bladder, rectum, pancreas, kidney, stomach, and head and neck cancer) and unrelated (non-Hodgkin lymphoma, breast, prostate, melanoma, central nervous system, ovary and endometrial) to smoking. Risk of ischemic/hemorrhagic stroke was increased for both occult (relative risk, 1.75/2.00) and manifest cancers (relative risk, 1.30/1.41). For occult cancer, risk of ischemic stroke was increased for all of the smoking-related cancers, but among cancers unrelated to smoking, only lymphoma, central nervous system, and endometrial cancer were associated with increased risk of stroke; breast, prostate, melanoma, and ovarian cancers were not. For occult cancer, risk of hemorrhagic stroke was generally increased for smoking-related cancers while not for cancers unrelated to smoking. For manifest cancer, risk of ischemic and hemorrhagic stroke was generally increased for cancers related to smoking while not for cancers unrelated to smoking. Cancer, occult and manifest, is associated with increased risks for stroke. The increased risk is linked mainly to cancers related to smoking. © 2018 American Heart Association, Inc.

How well are we managing fragility hip fractures? A narrative report on the review with the attempt to setup a Fragility Fracture Registry in Hong Kong.

PubMed

Leung, K S; Yuen, W F; Ngai, W K; Lam, C Y; Lau, T W; Lee, K B; Siu, K M; Tang, N; Wong, S H; Cheung, W H

2017-06-01

In setting up a disease registry for fragility fractures in Hong Kong, we conducted a retrospective systematic study on the management of fragility hip fractures. Patient outcomes were compared with the standards from our orthopaedic working group and those from the British Orthopaedic Association that runs a mature fracture registry in the United Kingdom. Clinical data on fragility hip fracture patients admitted to six acute major hospitals in Hong Kong in 2012 were captured. These included demographics, pre- and post-operative assessments, discharge details, complications, and 1-year follow-up information. Analysis was performed according to the local standards with reference to those from the British Orthopaedic Association. Overall, 91.0% of patients received orthopaedic care within 4 hours of admission and 60.5% received surgery within 48 hours. Preoperative geri-orthopaedic co-management was received by 3.5% of patients and was one of the reasons for the delayed surgery in 22% of patients. Only 22.9% were discharged with medication that would promote bone health. Institutionalisation on discharge significantly increased by 16.2% (P<0.001). Only 35.1% of patients attended out-patient follow-up 1 year following fracture, and mobility had deteriorated in 69.9% compared with the premorbid state. Death occurred in 17.3% of patients within a year of surgery compared with 1.6% mortality rate in a Hong Kong age-matched population. The efficiency and quality of acute care for fragility hip fracture patients was documented. Regular geri-orthopaedic co-management can enhance acute care. Much effort is needed to improve functional recovery, prescription of bone health medications, attendance for follow-up, and to decrease institutionalisation. A Fracture Liaison Service is vital to improve long-term care and prevent secondary fractures.

Patients with inflammatory bowel disease have increased risk of autoimmune and inflammatory diseases.

PubMed

Halling, Morten L; Kjeldsen, Jens; Knudsen, Torben; Nielsen, Jan; Hansen, Lars Koch

2017-09-07

To investigate whether immune mediated diseases (IMD) are more frequent in patients with inflammatory bowel disease (IBD). In this population based registry study, a total of 47325 patients with IBD were alive and registered in the Danish National Patient Registry on December 16, 2013. Controls were randomly selected from the Danish Civil Registration System (CRS) and matched for sex, age, and municipality. We used ICD 10 codes to identify the diagnoses of the included patients. The IBD population was divided into three subgroups: Ulcerative colitis (UC), Crohn's disease (CD) and Both the latter referring to those registered with both diagnoses. Subsequently, odds-ratios (OR) and 95%CI were obtained separately for each group and their respective controls. The use of Bonferoni post-test correction adjusted the significance level to P < 0.00125. P -values were estimated using Fisher's exact test. There were significantly more women than men in the registry, and a greater percentage of comorbidity in the IBD groups ( P < 0.05). Twenty different IMDs were all significantly more frequent in the IBD group. Sixteen were associated with UC versus twelve with CD. In both UC and CD ORs were significantly increased ( P < 0.00125) for primary sclerosing cholangitis (PSC), celiac disease, type 1 diabetes (T1D), sarcoidosis, asthma, iridocyclitis, psoriasis, pyoderma gangrenosum, rheumatoid arthritis, and ankylosing spondylitis. Restricted to UC ( P < 0.00125) were autoimmune hepatitis, primary biliary cholangitis, Grave's disease, polymyalgia rheumatica, temporal arteritis , and atrophic gastritis. Restricted to CD ( P < 0.00125) were psoriatic arthritis and episcleritis. Restricted to women with UC ( P < 0.00125) were atrophic gastritis, rheumatoid arthritis, temporal arteritis, and polymyalgia rheumatica. Restricted to women with CD were episcleritis, rheumatoid arthritis, and psoriatic arthritis. The only disease restricted to men ( P < 0.00125) was sarcoidosis. Immune mediated diseases were significantly more frequent in patients with IBD. Our results strengthen the hypothesis that some IMDs and IBD may have overlapping pathogenic pathways.

Data from the US and UK cystic fibrosis registries support disease modification by CFTR modulation with ivacaftor.

PubMed

Bessonova, Leona; Volkova, Nataliya; Higgins, Mark; Bengtsson, Leif; Tian, Simon; Simard, Christopher; Konstan, Michael W; Sawicki, Gregory S; Sewall, Ase; Nyangoma, Stephen; Elbert, Alexander; Marshall, Bruce C; Bilton, Diana

2018-05-10

Ivacaftor is the first cystic fibrosis transmembrane conductance regulator (CFTR) modulator demonstrating clinical benefit in patients with cystic fibrosis (CF). As ivacaftor is intended for chronic, lifelong use, understanding long-term effects is important for patients and healthcare providers. This ongoing, observational, postapproval safety study evaluates clinical outcomes and disease progression in ivacaftor-treated patients using data from the US and the UK CF registries following commercial availability. Annual analyses compare ivacaftor-treated and untreated matched comparator patients for: risks of death, transplantation, hospitalisation, pulmonary exacerbation; prevalence of CF-related complications and microorganisms and lung function changes in a subset of patients who initiated ivacaftor in the first year of commercial availability. Results from the 2014 analyses (2 and 3 years following commercial availability in the UK and USA, respectively) are presented here. Analyses included 1256 ivacaftor-treated and 6200 comparator patients from the USA and 411 ivacaftor-treated and 2069 comparator patients from the UK. No new safety concerns were identified based on the evaluation of clinical outcomes included in the analyses. As part of safety evaluations, ivacaftor-treated US patients were observed to have significantly lower risks of death (0.6% vs 1.6%, p=0.0110), transplantation (0.2% vs 1.1%, p=0.0017), hospitalisation (27.5% vs 43.1%, p<0.0001) and pulmonary exacerbation (27.8% vs 43.3%, p<0.0001) relative to comparators; trends were similar in the UK. In both registries, ivacaftor-treated patients had a lower prevalence of CF-related complications and select microorganisms and had better preserved lung function. While general limitations of observational research apply, analyses revealed favourable results for clinically important outcomes among ivacaftor-treated patients, adding to the growing body of literature supporting disease modification by CFTR modulation with ivacaftor. EUPAS4270. © 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 Role of Procurement Biopsies in Acceptance Decisions for Kidneys Retrieved for Transplant

PubMed Central

Stewart, Darren E.; Bista, Bipin R.; Salkowski, Nicholas; Snyder, Jon J.; Israni, Ajay K.; Crary, Gretchen S.; Rosendale, John D.; Matas, Arthur J.; Delmonico, Francis L.

2014-01-01

Background and objectives There is a shortage of kidneys for transplant, and many patients on the deceased donor kidney transplant waiting list would likely benefit from kidneys that are currently being discarded. In the United States, the most common reason given for discarding kidneys retrieved for transplant is procurement biopsy results. This study aimed to compare biopsy results from discarded kidneys with discard attributed to biopsy findings, with biopsy results from comparable kidneys that were successfully transplanted. Design, setting, participants, & measurements In this retrospective, observational, case-control study, biopsy reports were examined from 83 kidneys discarded in 2010 due to biopsy findings (cases), 83 contralateral transplanted kidneys from the same donor (contralateral controls), and 83 deceased donors randomly matched to cases by donor risk profile (randomly matched controls). A second procurement biopsy was obtained in 64 of 332 kidneys (19.3%). Results The quality of biopsy reports was low, with amounts of tubular atrophy, interstitial inflammation, arteriolar hyalinosis, and acute tubular necrosis often not indicated; 69% were wedge biopsies and 94% used frozen tissue. The correlation between first and second procurement biopsies was poor; only 25% of the variability (R2) in glomerulosclerosis was explained by biopsies being from the same kidney. The percentages of glomerulosclerosis overlapped substantially between cases, contralateral controls, and randomly matched controls: 17.1%±15.3%, 9.0%±6.6%, and 5.0%±5.9%, respectively. Of all biopsy findings, only glomerulosclerosis>20% was independently correlated with discard (cases versus contralateral controls; odds ratio, 15.09; 95% confidence interval, 2.47 to 92.41; P=0.003), suggesting that only this biopsy result was used in acceptance decisions. One-year graft survival was 79.5% and 90.7% in contralateral and randomly matched controls, respectively, versus 91.6% among all deceased donor transplants in the Scientific Registry of Transplant Recipients. Conclusions Routine use of biopsies could lead to unnecessary kidney discards. PMID:24558053

Warfarin Use in Patients With Atrial Fibrillation Undergoing Hemodialysis: A Nationwide Population-Based Study.

PubMed

Yoon, Chang-Yun; Noh, Juhwan; Jhee, Jong Hyun; Chang, Tae Ik; Kang, Ea Wha; Kee, Youn Kyung; Kim, Hyoungnae; Park, Seohyun; Yun, Hae-Ryong; Jung, Su-Young; Oh, Hyung Jung; Park, Jung Tak; Han, Seung Hyeok; Kang, Shin-Wook; Kim, Changsoo; Yoo, Tae-Hyun

2017-09-01

The aim of this study is to elucidate the effects of warfarin use in patients with atrial fibrillation undergoing dialysis using a population-based Korean registry. Data were extracted from the Health Insurance Review and Assessment Service, which is a nationwide, mandatory social insurance database of all Korean citizens enrolled in the National Health Information Service between 2009 and 2013. Thromboembolic and hemorrhagic outcomes were analyzed according to warfarin use. Overall and propensity score-matched cohorts were analyzed by Cox proportional hazards models. Among 9974 hemodialysis patients with atrial fibrillation, the mean age was 66.6±12.2 years, 5806 (58.2%) were men, and 2921 (29.3%) used warfarin. After propensity score matching to adjust for all described baseline differences, 5548 subjects remained, and differences in baseline variables were distributed equally between warfarin users and nonusers. During a mean follow-up duration of 15.9±11.1 months, ischemic and hemorrhagic stroke occurred in 678 (6.8%) and 227 (2.3%) patients, respectively. In a multiple Cox model, warfarin use was significantly associated with an increased risk of hemorrhagic stroke (hazard ratio, 1.44; 95% confidence interval, 1.09-1.91; P =0.010) in the overall cohort. Furthermore, a significant relationship between warfarin use and hemorrhagic stroke was found in propensity-matched subjects (hazard ratio, 1.56; 95% confidence interval, 1.10-2.22; P =0.013). However, the ratios for ischemic stroke were not significantly different in either the propensity-matched (hazard ratio, 0.95; 95% confidence interval, 0.78-1.15; P =0.569) or overall cohort (hazard ratio, 1.06; 95% confidence interval, 0.90-1.26; P =0.470). Our findings suggest that warfarin should be used carefully in hemodialysis patients, given the higher risk of hemorrhagic events and the lack of ability to prevent thromboembolic complications. © 2017 American Heart Association, Inc.

Association between renin-angiotensin system antagonist use and mortality in heart failure with severe renal insufficiency: a prospective propensity score-matched cohort study.

PubMed

Edner, Magnus; Benson, Lina; Dahlström, Ulf; Lund, Lars H

2015-09-07

In heart failure (HF) with reduced ejection fraction (EF), renin-angiotensin receptor (RAS) antagonists reduce mortality. However, severe renal insufficiency was an exclusion criterion in trials. We tested the hypothesis that RAS antagonists are associated with reduced mortality also in HF with severe renal insufficiency. We studied patients with EF ≤39% registered in the prospective Swedish Heart Failure Registry. In patients with creatinine >221 µmol/L or creatinine clearance <30 mL/min, propensity scores for RAS-antagonist use were derived from 36 variables. The association between RAS antagonist use and all-cause mortality was assessed with Cox regression in a cohort matched 1:1 based on age and propensity score. To assess consistency, we performed the same analysis as a 'positive control' in patients without severe renal insufficiency. Between 2000 and 2013, there were 24 283 patients of which 2410 [age, mean (SD), 82 (9), 45% women] had creatinine >221 µmol/L or creatinine clearance <30 mL/min and were treated (n = 1602) or not treated (n = 808) with RAS antagonists. In the matched cohort of 602 vs. 602 patients [age 83 (8), 42% women], RAS antagonist use was associated with 55% [95% confidence interval (CI) 51-59] vs. 45% (41-49) 1-year survival, P < 0.001, with a hazard ratio (HR) for mortality of 0.76 (95% CI 0.67-0.86, P < 0.001). In positive control patients without severe renal insufficiency [n = 21 873; age 71 (12), 27% women], the matched HR was 0.79 (95% CI 0.72-0.86, P < 0.001). In HF with severe renal insufficiency, the use of RAS antagonists was associated with lower all-cause mortality. Prospective randomized trials are needed before these findings can be applied to clinical practice. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Case Report of Kidney Paired Donation (KPD) with Desensitization: the Strategy and Experience of 3-Way KPD in Samsung Medical Center.

PubMed

Oh, Dongkyu; Kang, Eun Suk; Yu, Shinae; Chun, Kyoungsuk; Huh, Wooseong; Jang, Hye Ryoun; Cho, Chan Woo; Lee, Nuri; Lee, Kyo Won; Park, Hyojun; Park, Jae Berm; Kim, Sung Joo

2018-01-29

As the need for the organ donation increases, strategies to increase kidney transplantation (KT) through expanded living donation have become essential. These include kidney paired donation (KPD) programs and desensitization in incompatible transplantations. KPD enables kidney transplant candidates with incompatible living donors to join a registry with other incompatible pairs in order to find potentially compatible living donor. Positive cross match and ABO incompatible transplantation has been successfully accomplished in selective cases with several pre-conditionings. Patients who are both difficult-to-match due to broad sensitization and hard-to-desensitize because of donor conditions can often be successfully transplanted through a combination of KPD and desensitization. According to the existing data, KPD can increase the number of KTs from living donors with excellent clinical results. This is also a cost-effective treatment as compared with dialysis and desensitization protocols. We carried out 3-way KPD transplantation with one highly sensitized, positive cross match pair and with two ABO incompatible pairs. Herein we report our first successful 3-way KPD transplantation in a single center. To maximize donor-recipient matching and minimize immunologic risk, KPD programs should use proper algorithms with desensitization to identify optimal donor with simultaneous two-, three- or more complex multi-way exchanges. © 2018 The Korean Academy of Medical Sciences.

Self-reported work ability in long-term breast cancer survivors. A population-based questionnaire study in Denmark.

PubMed

Carlsen, Kathrine; Jensen, Anette Jung; Rugulies, Reiner; Christensen, Jane; Bidstrup, Pernille Envold; Johansen, Christoffer; Huitfeldt Madsen, Ida Elisabeth; Dalton, Susanne O

2013-02-01

Although up to 80% of women can return to work after treatment for breast cancer, maintaining an affiliation to the labour market may be a challenge, as shown by the fact that the risks for unemployment and early retirement are increased in the years after treatment of cancer. It is important to understand the work problems experienced by cancer survivors, including their ability to work. The aim of this study was to determine whether the ability of long-term breast cancer survivors to work was different from that of a cancer-free control group. In this population-based cross-sectional questionnaire study, 776 breast cancer survivors were matched with 1552 cancer-free women. Women with breast cancer diagnosed in 1997-2000 were identified in the Danish Cancer Registry, and the cancer-free controls were sampled from the Central Population Registry. Work ability was measured from a single question on the 'work ability index'. Furthermore, the questionnaire contained questions on socioeconomic factors, health-related factors and factors related to the workplace. The overall response rate was 57% (493 survivors and 830 controls). After exclusions, the study population consisted of 170 survivors and 391 controls. Women with a diagnosis of breast cancer who had survived at least five years and had returned to work reported significantly poorer work ability than cancer-free controls. In models with adjustment for socioeconomic factors, health-related factors and support at work, the factors most strongly associated with impaired work ability were low income, fatigue and little help and support from a supervisor. Our findings indicate that the work ability of long-term breast cancer survivors who are disease-free and back in work is impaired in comparison with that of cancer-free women.

Unprovoked seizures after traumatic brain injury: A population-based case-control study.

PubMed

Mahler, Benno; Carlsson, Sofia; Andersson, Tomas; Adelöw, Cecilia; Ahlbom, Anders; Tomson, Torbjörn

2015-09-01

To quantify the risk of unprovoked seizures after traumatic brain injury (TBI) METHODS: We used the Stockholm Incidence Registry on Epilepsy to carry out a population-based case-control study, including 1,885 cases with incident unprovoked seizures from September 1, 2000 through August 31, 2008, together with 15,080 matched controls. Information of prior hospitalizations for TBI was obtained through record linkage with the Swedish National Inpatient Registry for the period 1980-2008. Relative risks (RRs) for unprovoked seizures were estimated after various TBI diagnoses, and influences of TBI severity and time since trauma were studied in detail. After hospitalization for mild TBI, the RR was 2.0 (95% confidence interval [CI] 1.5-2.7). The RR was higher after brain contusion (5.9, 95% CI 2.4-15.0) or intracranial hemorrhage (ICH) (4.5, 95% CI 2.2-9.0), whereas a combination of both diagnoses led to a further sevenfold increase in RR (42.6, 95% CI 12.2-148.5). The risk was greatest during the first 6 months after severe TBI (RR 48.9, 95% CI 10.9-218.9) or mild TBI (RR 8.1, 95% CI 3.1-21.7), but was still elevated >10 years after any TBI. Herein we present a large population-based case-control study on TBI as a risk factor for unprovoked epileptic seizures, including cases of all ages with individually validated seizure diagnoses. The risk for epileptic seizures was substantially increased after TBI, especially during the first 6 months after the injury and in patients with a combination of ICH and brain contusion. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Parental Occupational Exposure to Organic Solvents and Testicular Germ Cell Tumors in their Offspring: NORD-TEST Study.

PubMed

Le Cornet, Charlotte; Fervers, Béatrice; Pukkala, Eero; Tynes, Tore; Feychting, Maria; Hansen, Johnni; Togawa, Kayo; Nordby, Karl-Christian; Oksbjerg Dalton, Susanne; Uuksulainen, Sanni; Wiebert, Pernilla; Woldbæk, Torill; Skakkebæk, Niels E; Olsson, Ann; Schüz, Joachim

2017-06-30

Testicular germ cell tumors (TGCT) were suggested to have a prenatal environmentally related origin. The potential endocrine disrupting properties of certain solvents may interfere with the male genital development in utero . We aimed to assess the association between maternal and paternal occupational exposures to organic solvents during the prenatal period and TGCT risk in their offspring. This registry-based case control study included TGCT cases aged 14–49 y ( n =8,112) diagnosed from 1978 to 2012 in Finland, Norway, and Sweden. Controls ( n =26,264) were randomly selected from the central population registries and were individually matched to cases on year and country of birth. Occupational histories of parents prior to the child’s birth were extracted from the national censuses. Job codes were converted into solvent exposure using the Nordic job-Nordic Occupational Cancer Study Job-Exposure Matrix. Conditional logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (CI). Overall, no association was found between prenatal maternal exposure to solvents and TGCT risk. In subset analyses using only mothers for whom occupational information was available in the year of or in the year prior to the child’s birth, there was an association with maternal exposure to aromatic hydrocarbon solvents (ARHC) (OR=1.53; CI: 1.08, 2.17), driven by exposure to toluene (OR=1.67; CI: 1.02, 2.73). No association was seen for any paternal occupational exposure to solvents with the exception of exposure to perchloroethylene in Finland (OR=2.42; CI: 1.32, 4.41). This study suggests a modest increase in TGCT risk associated with maternal prenatal exposure to ARHC. https://doi.org/10.1289/EHP864.

Parental Occupational Exposure to Organic Solvents and Testicular Germ Cell Tumors in their Offspring: NORD-TEST Study

PubMed Central

Le Cornet, Charlotte; Fervers, Béatrice; Pukkala, Eero; Tynes, Tore; Feychting, Maria; Hansen, Johnni; Togawa, Kayo; Nordby, Karl-Christian; Oksbjerg Dalton, Susanne; Uuksulainen, Sanni; Wiebert, Pernilla; Woldbæk, Torill; Skakkebæk, Niels E.; Olsson, Ann

2017-01-01

Background: Testicular germ cell tumors (TGCT) were suggested to have a prenatal environmentally related origin. The potential endocrine disrupting properties of certain solvents may interfere with the male genital development in utero. Objectives: We aimed to assess the association between maternal and paternal occupational exposures to organic solvents during the prenatal period and TGCT risk in their offspring. Methods: This registry-based case control study included TGCT cases aged 14–49 y (n=8,112) diagnosed from 1978 to 2012 in Finland, Norway, and Sweden. Controls (n=26,264) were randomly selected from the central population registries and were individually matched to cases on year and country of birth. Occupational histories of parents prior to the child’s birth were extracted from the national censuses. Job codes were converted into solvent exposure using the Nordic job-Nordic Occupational Cancer Study Job-Exposure Matrix. Conditional logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (CI). Results: Overall, no association was found between prenatal maternal exposure to solvents and TGCT risk. In subset analyses using only mothers for whom occupational information was available in the year of or in the year prior to the child’s birth, there was an association with maternal exposure to aromatic hydrocarbon solvents (ARHC) (OR=1.53; CI: 1.08, 2.17), driven by exposure to toluene (OR=1.67; CI: 1.02, 2.73). No association was seen for any paternal occupational exposure to solvents with the exception of exposure to perchloroethylene in Finland (OR=2.42; CI: 1.32, 4.41). Conclusions: This study suggests a modest increase in TGCT risk associated with maternal prenatal exposure to ARHC. https://doi.org/10.1289/EHP864 PMID:28893722

High-Performance Membrane Dialyzers and Mortality in Hemodialysis Patients: A 2-Year Cohort Study from the Annual Survey of the Japanese Renal Data Registry.

PubMed

Abe, Masanori; Hamano, Takayuki; Wada, Atsushi; Nakai, Shigeru; Masakane, Ikuto

2017-01-01

Little information is available regarding the type of dialyzer which results in good prognosis. This study is aimed at investigating the association between 7 types of dialyzers and 2-year mortality. We conducted a cohort study using data from a nationwide registry of the Japanese Society for Dialysis Therapy. Subjects were 136,676 patients on maintenance hemodialysis (HD) between 2009 and 2011 who underwent maintenance HD for at least 2 years and were treated with one of the following 7 types of high-performance membrane dialyzers: cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS). Cox regression was used to estimate the association between baseline dialyzers and all-cause 2-year mortality, adjusting for potential confounders. Data were adjusted using basic factors, with PS as a reference group, and the hazard ratio (HR) was significantly higher in CTA, PMMA, PAN, and EVAL groups. Further data adjustment for Kt/V yielded the same results as were obtained from data adjusted for basic factors. After further adjustment for nutrition- and inflammation-related factors, HR was significantly lowered for the PES and PMMA groups compared with the PS group (HR 0.88; 95% CI 0.82-0.94 and HR 0.84 95% CI 0.76-0.93, respectively). After propensity score matching, HR for the PES and PMMA groups was significantly lowered compared with the PS group. The use of different membrane types may affect mortality. Further long-term prospective studies are needed to clarify whether the PES and PMMA membranes can improve prognosis. © 2017 S. Karger AG, Basel.

Health, social and economic consequences of hypersomnia: a controlled national study from a national registry evaluating the societal effect on patients and their partners.

PubMed

Jennum, Poul; Ibsen, Rikke; Avlund, Kirsten; Kjellberg, Jakob

2014-04-01

Hypersomnia causes significant socioeconomic burden, but there is insufficient information about the time course and the effect on the partner. The aim of this study was to estimate the factual direct and productivity costs of hypersomnia in a controlled study including all national patients and their partners. Using records from the Danish National Patient Registry (1997-2009), we identified all patients with a diagnosis of hypersomnia and compared these patients and their partners with randomly chosen controls matched for age, gender, geographic area and marital status. Direct and productivity costs, including frequencies of primary and sector contacts and procedures, medication, labour supply and social transfer payments were extracted from the national databases. A total of 2,855 national patients was compared to 11,382 controls. About 70 % of patients and controls were married or cohabiting. Patients with hypersomnia had significantly higher rates of health-related contact, medication use and socioeconomic cost. Furthermore, they had slightly lower employment rates, and those in employment had a lower income level than control subjects. The annual mean excess health-related cost including social transfers was 3,498 for patients with hypersomnia and 3,851 for their partners. The social and health-related consequences could be identified up to 11 years before the first diagnosis among both the patients and their partners and became more pronounced as the disease advanced. The health effects were present in all age groups and in both genders. On the basis of this retrospective controlled study in the Danish population, symptoms and findings of hypersomnia are associated with major socioeconomic consequences for patients, their partners and society.

Haemopoietic stem cell transplantation for children in Australia and New Zealand, 1998-2006: a report on behalf of the Australasian Bone Marrow Transplant Recipient Registry and the Australian and New Zealand Children's Haematology Oncology Group.

PubMed

Moore, Andrew S; Shaw, Peter J; Hallahan, Andrew R; Carter, Tina L; Kilo, Tatjana; Nivison-Smith, Ian; O'Brien, Tracey A; Tapp, Heather; Teague, Lochie; Wilson, Shaun R; Tiedemann, Karin

2009-02-02

To document haemopoietic stem cell transplantation (HSCT) activity and trends among paediatric patients in Australia and New Zealand. A retrospective analysis of data reported to the Australasian Bone Marrow Transplant Recipient Registry by the seven paediatric HSCT institutions in Australia and New Zealand over the 9-year period 1998-2006, with particular focus on the most recent years (2002-2006). Types of HSCT performed; transplant-related mortality (TRM); stem cell sources; indications for HSCT; causes of death after HSCT. Over the period 1998-2006, 522 autologous HSCT procedures (41%) and 737 allogeneic procedures (59%) were performed. About 60% of allogeneic transplants involved alternative donors (donors other than a human leukocyte antigen-matched sibling). The use of umbilical cord blood as a source of haemopoietic stem cells has doubled since 1998, with 34% of allogeneic transplants in 2006 using cord blood. Over the period 2002-2006, the median age of patients receiving transplants was 7 years (range, 0-19 years). The most common indications for allogeneic HSCT were acute lymphoblastic leukaemia (33%) and acute myeloid leukaemia (24%). The most common indications for autologous HSCT were neuroblastoma (23%), medulloblastoma (21%) and Ewing sarcoma (10%). TRM at 1 year after transplant was 22% for alternative donor transplants, 7% for matched-sibling transplants and 5% for autologous transplants. Relapse or persistence of a child's underlying condition accounted for 54% of all deaths within 1 year after transplant. HSCT is an important procedure for children with a range of life-threatening illnesses. Local trends in the indications for HSCT, donor selection and TRM reflect contemporary international practice.

Mini- or Less-open Sublay Operation (MILOS): A New Minimally Invasive Technique for the Extraperitoneal Mesh Repair of Incisional Hernias.

PubMed

Reinpold, Wolfgang; Schröder, Michael; Berger, Cigdem; Nehls, Jennifer; Schröder, Alexander; Hukauf, Martin; Köckerling, Ferdinand; Bittner, Reinhard

2018-01-16

Improvement of ventral hernia repair. Despite the use of mesh and other recent improvements, the currently popular techniques of ventral hernia repair have specific disadvantages and risks. We developed the endoscopically assisted mini- or less-open sublay (MILOS) concept. The operation is performed transhernially via a small incision with light-holding laparoscopic instruments either under direct, or endoscopic visualization. An endoscopic light tube was developed to facilitate this approach (EndotorchTM Wolf Company). Each MILOS operation can be converted to standard total extraperitoneal gas endoscopy once an extraperitoneal space of at least 8 cm has been created. All MILOS operations were prospectively documented in the German Hernia registry with 1 year questionnaire follow-up. Propensity score matching of incisional hernia operations comparing the results of the MILOS operation with the laparoscopic intraperitoneal onlay mesh operation (IPOM) and open sublay repair from other German Hernia registry institutions was performed. Six hundred fifteen MILOS incisional hernia operations were included. Compared with laparoscopic IPOM incisional hernia operation, the MILOS repair is associated with significantly a fewer postoperative surgical complications (P < 0.001) general complications (P < 0.004), recurrences (P < 0.001), and less chronic pain (P < 0.001). Matched pair analysis with open sublay repair revealed significantly a fewer postoperative complications (P < 0.001), reoperations (P < 0.001), infections (P = 0.007), general complications (P < 0.001), recurrences (P = 0.017), and less chronic pain (P < 0.001). The MILOS technique allows minimally invasive transhernial repair of incisional hernias using large retromuscular/preperitoneal meshes with low morbidity. The technique combines the advantages of open sublay and the laparoscopic IPOM repair.ClinicalTrials.gov Identifier NCT03133000.

Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching "new" outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned.

Effect of HLA-C and DQ matching on Pediatric Heart Transplant Graft Survival

PubMed Central

Butts, Ryan J.; Savage, Andrew J.; Nietert, Paul J.; Kavarana, Minoo; Moussa, Omar; Burnette, Ali L.; Atz, Andrew M.

2014-01-01

Background Higher degree of HLA matching at the A, B, and DR-loci has been associated with improved long-term survival after pediatric heart transplantation in multiple ISHLT registry reports. The aim of this study was to investigate the association of HLA matching at the C and DQ loci with pediatric graft survival. Methods The UNOS database was queried for isolated heart transplants that occurred from 1988 to 2012 with a recipient age of 17 or less and at least one postoperative follow up encounter. When analyzing HLA matching at the C or DQ loci, only those transplants with complete typing of donor and recipient at the respective loci were included. Transplants were divided into patients with at least one match at the C-locus (C-match) versus no match (C-no), and at least one match at the DQ locus versus no match (DQ-match versus DQ-no). Primary outcome was graft loss. Univariate analysis was performed with log-rank test. Cox regression analysis was performed with following patient factors included in the model: recipient age, ischemic time; recipient on ventilator, ECMO, ventricular assist device or inotropes at transplant; recipient serum bilirubin and creatinine closest to transplant, donor-recipient weight ratio, underlying cardiac diagnosis, crossmatch results, transplant year, and HLA matching at the A, B, and DR loci. Results Complete typing at the C-locus occurred in 2429/4731 (51%) transplants and 3498/4731 (74%) transplants had complete typing at the DQ locus. C-match did not differ from C-no with respect to patient factors, except for year of transplant; [C-match median year 2007 (IQR 1997–2010) vs. C-no median year 2005 (IQR 1996–2009), p=0.03] and degree of HLA matching at A, B, and DR loci (11.9% of C-match with high level of HLA matching v. 3% of C-no, p<0.01). Matching at the C-locus was not associated with decreased risk of graft loss [C-no median graft survival 13.1 yrs (95%CI 11.5–14.8) vs. C-match 15.1 yrs (95%CI 13.5–16.6) p=0.44, log-rank, hazard ratio 0.93 (95%CI 0.76–1.15, p=0.52)]. DQ-match did not differ from DQ-no in any of the above-mentioned patient factors, except DQ-match was more likely to have high degree of matching at the A, B, and DR loci versus DQ-no (9.8% v. 3.2%, p<0.01). Matching at the DQ-locus was not associated with decreased risk of graft loss [DQ-no median graft survival 13.1yrs (95%CI 11.7–14.6) vs. DQ-match 13.0 yrs (11.4–14.6) p=0.80, log rank, hazard ratio 0.95 (0.81–1.1), p=0.51]. Conclusion Complete typing at the C-locus of both donor and recipient occurs less often then typing at the DQ locus. A higher degree of donor-recipient HLA matching at the C-locus or the DQ-locus appears not to confer any graft survival advantage. PMID:25128416

Artificial Nutritional Support Registries: systematic review.

PubMed

Castelló-Botía, I; Wanden-Berghe, C; Sanz-Valero, J

2009-01-01

The nutritional registries are data bases through which we obtain the information to understand the nutrition of populations. Several main nutrition societies of the world have these types of registries, outstanding the NADYA (Home artificial and Ambulatory nutrition) group in Spain. The object of this study is to determine by means of a systematic review, the existent scientific production in the international data bases referred to nutritional support registries. Descriptive transversal study of the results of a critical bibliographic research done in the bioscience data bases: MEDLINE, EMBASE, The Cochrane Library, ISI (Web of Sciences), LILACS, CINHAL. A total of 20 original articles related to nutritional registries were found and recovered. Eleven registries of eight countries were identified: Australia, Germany, Italy, Japan, Spain, Sweden, United Status and United Kingdom. The Price Index was of 65% and all the articles were published in the last 20 years. The Price Index highlights the innovativeness of this practice. The articles related to nutritional support are heterogeneous with respect to data and population, which exposes this as a limitation for a combined analysis.

Effectiveness of new antiplatelets in the prevention of recurrent myocardial infarction.

PubMed

Grimaldi-Bensouda, Lamiae; Danchin, Nicolas; Dallongeville, Jean; Falissard, Bruno; Furber, Alain; Cottin, Yves; Bonello, Laurent; Morel, Olivier; Leclercq, Florence; Puymirat, Etienne; Ghanem, Fahmi; Delarche, Nicolas; Benichou, Jacques; Abenhaim, Lucien

2018-03-13

To compare ticagrelor and prasugrel with clopidogrel for recurrent fatal and non-fatal myocardial infarction (reMI) in real-life conditions. Case-referent study using the Pharmacoepidemiological General Research eXtension (PGRx)-acute coronary syndrome (ACS) registry. Cases were patients with reMI from a cohort with index ACS or external to the cohort (same sites). Referents from the cohort, without recurrent event, were matched on index ACS type and date, age and sex with reMI cases. Multivariate conditional logistic regression assessed the OR (95% CI) for reMI associated with ticagrelor and prasugrel vs clopidogrel, adjusted for aspirin use and cardiovascular risk factors. 1047 cases and 2234 matched referents were included. Compared with clopidogrel, ticagrelor and prasugrel were associated with respective ORs of 0.65 (95% CI 0.52 to 0.81) and 0.71 (95% CI 0.53 to 0.96) for reMI occurrence. ORs for ticagrelor and prasugrel vs clopidogrel were: 0.50 (95% CI 0.38 to 0.67) and 0.66 (95% CI 0.45 to 0.95), 0.39 (95% CI 0.24 to 0.62) and 0.44 (95% CI 0.26 to 0.75), 0.63 (95% CI 0.43 to 0.92) and 1.20 (95% CI 0.69 to 2.07), 1.11 (95% CI 0.72 to 1.72) and 0.82 (95% CI 0.44 to 1.54) when index ACS was a first MI, a first ST-elevated MI (STEMI), a first non-STEMI and a recurrent ACS, respectively, and 0.63 (95% CI 0.45 to 0.87) and 0.77 (95% CI 0.41 to 1.45) forpatients aged ≥70 years. This real-world study showed a significant reduction of reMI with new antiplatelets compared with clopidogrel, ticagrelor being associated with a greater decrease of risk notably for first, either STEMI or non-STEMI. The larger magnitude of effect may be attributed to potential residual confounding or higher effectiveness compared with efficacy reported in trials (EMA Post Authorisation Study Registry Number EUPAS5905). © 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.

Ethnicity matching and outcomes after kidney transplantation in the United Kingdom.

PubMed

Pisavadia, Bhavini; Arshad, Adam; Chappelow, Imogen; Nightingale, Peter; Anderson, Benjamin; Nath, Jay; Sharif, Adnan

2018-01-01

Kidneys from non-white donors have inferior outcomes, but it is unclear if ethnicity matching between donors and recipients achieves better post kidney transplant outcomes. We undertook a retrospective, population cohort study utilising UK Transplant Registry data. The cohort comprised adult, kidney-alone, transplant recipients receiving their first kidney transplant between 2003-2015, with data censored at 1st October 2016. We included 27,970 recipients stratified into white (n = 23,215), black (n = 1,679) and south Asian (n = 3,076) ethnicity, with median post-transplant follow-up of 1,676 days (IQR 716-2,869 days). Unadjusted and adjusted Cox regression survival analyses were performed to investigate ethnicity effect on risk for graft loss and mortality. In unadjusted analyses, matched ethnicity between donors-recipients resulted in better outcomes for delayed graft function, one-year creatinine, graft and patient survival but these differed by ethnicity matches. Compared to white-to-white transplants, risk for death-censored graft loss was higher in black-to-black and similar among Asian-to-Asian transplants, but mortality risk was lower for both black-to-black and Asian-to-Asian transplants. In Cox regression models, compared to white donors, we observed higher risk for graft loss with both south Asian (HR 1.38, 95%CI 1.12-1.70, p = 0.003) and black (HR 1.66, 95%CI 1.30-2.11, p<0.001) donated kidneys independent of recipient ethnicity. We observed no mortality difference with south Asian donated kidneys but increased mortality with black donated kidneys (HR 1.68, 95%CI 1.21-2.35, p = 0.002). Matching ethnicities made no significant difference in any Cox regression model. Similar results were observed after stratifying our analysis by living and deceased-donor kidney transplantation. Our data confirm inferior outcomes associated with non-white kidney donors for kidney transplant recipients of any ethnicity in a risk-adjusted model for the United Kingdom population. However, contrary to non-renal transplant literature, we did not identify any survival benefits associated with donor-recipient ethnicity matching.

[Individual linkage of primary data with secondary and registry data within large cohort studies - capabilities and procedural proposals].

PubMed

Stallmann, C; Ahrens, W; Kaaks, R; Pigeot, I; Swart, E; Jacobs, S

2015-02-01

Some German cohort studies have already linked secondary and registry data with primary data from interviews and medical examinations. This offers the opportunity to obtain more valid information by taking advantage of the strengths of these data synergistically and overcome their individual weaknesses at the same time. The potential and the requirements for linking secondary and registry data with primary data from cohort studies is described generally and illustrated by the example of the "German National Cohort" (GNC). The transfer and usage of secondary and registry data require that administrative and logistic efforts be made over the whole study period. In addition, rigid data protection regulations for using social data have to be observed. The particular strengths of secondary and registry data, namely their objectivity and independence from recall bias, add to the strengths of newly collected primary data and improve the assessment of morbidity endpoints, exposure history and need of patient care. Moreover, new insights on quality and on the added value of linking different data sources may be obtained. © Georg Thieme Verlag KG Stuttgart · New York.

Occupational Disease Registries-Characteristics and Experiences.

PubMed

Davoodi, Somayeh; Haghighi, Khosro Sadeghniat; Kalhori, Sharareh Rostam Niakan; Hosseini, Narges Shams; Mohammadzadeh, Zeinab; Safdari, Reza

2017-06-01

Due to growth of occupational diseases and also increase of public awareness about their consequences, attention to various aspects of diseases and improve occupational health and safety has found great importance. Therefore, there is the need for appropriate information management tools such as registries in order to recognitions of diseases patterns and then making decision about prevention, early detection and treatment of them. These registries have different characteristics in various countries according to their occupational health priorities. Aim of this study is evaluate dimensions of occupational diseases registries including objectives, data sources, responsible institutions, minimum data set, classification systems and process of registration in different countries. In this study, the papers were searched using the MEDLINE (PubMed) Google scholar, Scopus, ProQuest and Google. The search was done based on keyword in English for all motor engines including "occupational disease", "work related disease", "surveillance", "reporting", "registration system" and "registry" combined with name of the countries including all subheadings. After categorizing search findings in tables, results were compared with each other. Important aspects of the registries studied in ten countries including Finland, France, United Kingdom, Australia, Czech Republic, Malaysia, United States, Singapore, Russia and Turkey. The results show that surveyed countries have statistical, treatment and prevention objectives. Data sources in almost the rest of registries were physicians and employers. The minimum data sets in most of them consist of information about patient, disease, occupation and employer. Some of countries have special occupational related classification systems for themselves and some of them apply international classification systems such as ICD-10. Finally, the process of registration system was different in countries. Because occupational diseases are often preventable, but not curable, it is necessary to all countries, to consider prevention and early detection of occupational diseases as the objectives of their registry systems. Also it is recommended that all countries reach an agreement about global characteristics of occupational disease registries. This enables country to compare their data at international levels.

The pot calling the kettle black: the extent and type of errors in a computerized immunization registry and by parent report.

PubMed

MacDonald, Shannon E; Schopflocher, Donald P; Golonka, Richard P

2014-01-04

Accurate classification of children's immunization status is essential for clinical care, administration and evaluation of immunization programs, and vaccine program research. Computerized immunization registries have been proposed as a valuable alternative to provider paper records or parent report, but there is a need to better understand the challenges associated with their use. This study assessed the accuracy of immunization status classification in an immunization registry as compared to parent report and determined the number and type of errors occurring in both sources. This study was a sub-analysis of a larger study which compared the characteristics of children whose immunizations were up to date (UTD) at two years as compared to those not UTD. Children's immunization status was initially determined from a population-based immunization registry, and then compared to parent report of immunization status, as reported in a postal survey. Discrepancies between the two sources were adjudicated by review of immunization providers' hard-copy clinic records. Descriptive analyses included calculating proportions and confidence intervals for errors in classification and reporting of the type and frequency of errors. Among the 461 survey respondents, there were 60 discrepancies in immunization status. The majority of errors were due to parent report (n = 44), but the registry was not without fault (n = 16). Parents tended to erroneously report their child as UTD, whereas the registry was more likely to wrongly classify children as not UTD. Reasons for registry errors included failure to account for varicella disease history, variable number of doses required due to age at series initiation, and doses administered out of the region. These results confirm that parent report is often flawed, but also identify that registries are prone to misclassification of immunization status. Immunization program administrators and researchers need to institute measures to identify and reduce misclassification, in order for registries to play an effective role in the control of vaccine-preventable disease.

The pot calling the kettle black: the extent and type of errors in a computerized immunization registry and by parent report

PubMed Central

2014-01-01

Background Accurate classification of children’s immunization status is essential for clinical care, administration and evaluation of immunization programs, and vaccine program research. Computerized immunization registries have been proposed as a valuable alternative to provider paper records or parent report, but there is a need to better understand the challenges associated with their use. This study assessed the accuracy of immunization status classification in an immunization registry as compared to parent report and determined the number and type of errors occurring in both sources. Methods This study was a sub-analysis of a larger study which compared the characteristics of children whose immunizations were up to date (UTD) at two years as compared to those not UTD. Children’s immunization status was initially determined from a population-based immunization registry, and then compared to parent report of immunization status, as reported in a postal survey. Discrepancies between the two sources were adjudicated by review of immunization providers’ hard-copy clinic records. Descriptive analyses included calculating proportions and confidence intervals for errors in classification and reporting of the type and frequency of errors. Results Among the 461 survey respondents, there were 60 discrepancies in immunization status. The majority of errors were due to parent report (n = 44), but the registry was not without fault (n = 16). Parents tended to erroneously report their child as UTD, whereas the registry was more likely to wrongly classify children as not UTD. Reasons for registry errors included failure to account for varicella disease history, variable number of doses required due to age at series initiation, and doses administered out of the region. Conclusions These results confirm that parent report is often flawed, but also identify that registries are prone to misclassification of immunization status. Immunization program administrators and researchers need to institute measures to identify and reduce misclassification, in order for registries to play an effective role in the control of vaccine-preventable disease. PMID:24387002

Mammographic screening in Sami speaking municipalities and a control group. Are early outcome measures influenced by ethnicity?

PubMed

Norum, Jan; Hofvind, Solveig; Nieder, Carsten; Schnell, Edrun Andrea; Broderstad, Ann Ragnhild

2012-04-16

Female citizens of Sami (the indigenous people of Norway) municipalities in northern Norway have a low risk of breast cancer. The objective of this study was to describe the attendance rate and outcome of the Norwegian Breast Cancer Screening Program (NBCSP) in the Sami-speaking municipalities and a control group. A retrospective registry-based study. The 8 municipalities included in the administration area of the Sami language law (Sami) were matched with a control group of 11 municipalities (non-Sami). Population data were accessed from Statistics Norway. Data regarding invitations and outcome in the NBCSP during the period 2001-2010 was derived from the Cancer Registry of Norway (CRN). The NBCSP targets women aged 50-69 years. Rates and percentages were compared using chi-square test with a p-value<0.05 as statistical significant. The attendance rate in the NBCSP was 78% in the Sami and 75% in the non-Sami population (p< 0.01). The recall rates were 2.4 and 3.3% in the Sami and non-Sami population, respectively (p<0.01). The rate of invasive screen detected cancer was not significantly lower in the Sami group (p=0.14). The percentage of all breast cancers detected in the NBCSP among the Sami (67%) was lower compared with the non-Sami population (86%, p=0.06). Despite a lower risk of breast cancer, the Sami attended the NBCSP more frequently than the control group. The recall and cancer detection rate was lower among the Sami compared with the non-Sami group.

Trauma center finances and length of stay: identifying a profitability inflection point.

PubMed

Fakhry, Samir M; Couillard, Debbie; Liddy, Casey T; Adams, David; Norcross, E Douglass

2010-05-01

Trauma centers frequently report unfavorable financial results for the care of injured patients. Many variables contribute to these results. The objective of this study was to determine the relationship of adult trauma patient hospital length of stay (LOS) to trauma center profitability. The trauma registry of a Level I trauma center was queried for patients older than 18 years for the period July 1, 2003 to June 30, 2008. Hospital financial records were matched to patient trauma registry data. There were 7,990 patients who met selection criteria: 71% were men, mean age was 40 years, mean Injury Severity Score was 12 +/-10, 84.2% of injuries were blunt, and mean LOS was 6.23 days. In the 5 years of the study, total charges were $329,315,191, total costs were $137,680,039, and overall profit was $7,644,894. Total costs rose each year and percent collections fell. The bulk of the profit was realized from patients with LOS < 11 days, with progressively escalating cost per case, lower collections, and resultant lower profitability as LOS increased. A notable "inflection point" at 11 days defined the cohort of profitable patients. Trauma patient LOS correlates closely with profitability. In this center, the vast majority of profit was realized from patients with LOS < 11 days and was eroded by most patient cohorts with longer LOS. Identification of an institution's "inflection point" may help direct efforts at increasing profitability and reflects the current reimbursement environment, which rewards shorter LOS over severity and quality. Copyright 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Transatlantic Comparison of CT Radiation Doses in the Era of Radiation Dose-Tracking Software.

PubMed

Parakh, Anushri; Euler, Andre; Szucs-Farkas, Zsolt; Schindera, Sebastian T

2017-12-01

The purpose of this study is to compare diagnostic reference levels from a local European CT dose registry, using radiation-tracking software from a large patient sample, with preexisting European and North American diagnostic reference levels. Data (n = 43,761 CT scans obtained over the course of 2 years) for the European local CT dose registry were obtained from eight CT scanners at six institutions. Means, medians, and interquartile ranges of volumetric CT dose index (CTDI vol ), dose-length product (DLP), size-specific dose estimate, and effective dose values for CT examinations of the head, paranasal sinuses, thorax, pulmonary angiogram, abdomen-pelvis, renal-colic, thorax-abdomen-pelvis, and thoracoabdominal angiogram were obtained using radiation-tracking software. Metrics from this registry were compared with diagnostic reference levels from Canada and California (published in 2015), the American College of Radiology (ACR) dose index registry (2015), and national diagnostic reference levels from local CT dose registries in Switzerland (2010), the United Kingdom (2011), and Portugal (2015). Our local registry had a lower 75th percentile CTDI vol for all protocols than did the individual internationally sourced data. Compared with our study, the ACR dose index registry had higher 75th percentile CTDI vol values by 55% for head, 240% for thorax, 28% for abdomen-pelvis, 42% for thorax-abdomen-pelvis, 128% for pulmonary angiogram, 138% for renal-colic, and 58% for paranasal sinus studies. Our local registry had lower diagnostic reference level values than did existing European and North American diagnostic reference levels. Automated radiation-tracking software could be used to establish and update existing diagnostic reference levels because they are capable of analyzing large datasets meaningfully.

Nationwide population-based cohort study of psychiatric disorders in individuals with Ehlers-Danlos syndrome or hypermobility syndrome and their siblings.

PubMed

Cederlöf, Martin; Larsson, Henrik; Lichtenstein, Paul; Almqvist, Catarina; Serlachius, Eva; Ludvigsson, Jonas F

2016-07-04

To assess the risk of psychiatric disorders in Ehlers-Danlos syndrome (EDS) and hypermobility syndrome. Nationwide population-based matched cohort study. EDS, hypermobility syndrome and psychiatric disorders were identified through Swedish national registries. Individuals with EDS (n = 1,771) were matched with comparison individuals (n = 17,710). Further, siblings to individuals with EDS who did not have an EDS diagnosis themselves were compared with matched comparison siblings. Using conditional logistic regression, risk of autism spectrum disorder (ASD), bipolar disorder, attention deficit hyperactivity disorder (ADHD), depression, attempted suicide, suicide and schizophrenia were estimated. The same analyses were conducted in individuals with hypermobility syndrome (n = 10,019) and their siblings. EDS was associated with ASD: risk ratio (RR) 7.4, 95 % confidence interval (95 % CI) 5.2-10.7; bipolar disorder: RR 2.7, CI 1.5-4.7; ADHD: RR 5.6, CI 4.2-7.4; depression: RR 3.4, 95 % CI 2.9-4.1; and attempted suicide: RR 2.1, 95 % CI 1.7-2.7, but not with suicide or schizophrenia. EDS siblings were at increased risk of ADHD: RR 2.1, 95 % CI 1.4-3.3; depression: RR 1.5, 95 % CI 1.1-1.8; and suicide attempt: RR 1.8, 95 % CI 1.4-2.3. Similar results were observed for individuals with hypermobility syndrome and their siblings. Individuals with EDS and hypermobility syndrome are at increased risks of being diagnosed with psychiatric disorders. These risk increases may have a genetic and/or early environmental background as suggested by evidence showing that siblings to patients have elevated risks of certain psychiatric disorders.

Alcohol Use at Time of Injury and Survival Following Traumatic Brain Injury: Results From the National Trauma Data Bank

PubMed Central

Chen, Chiung M.; Yi, Hsiao-Ye; Yoon, Young-Hee; Dong, Chuanhui

2012-01-01

Objective: Premised on biological evidence from animal research, recent clinical studies have, for the most part, concluded that elevated blood alcohol concentration levels are independently associated with higher survival or decreased mortality in patients with moderate to severe traumatic brain injury (TBI). This study aims to provide some counterevidence to this claim and to further future investigations. Method: Incident data were drawn from the largest U.S. trauma registry, the National Trauma Data Bank, for emergency department admission years 2002–2006. TBI was identified according to the National Trauma Data Bank’s definition using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), codes. To eliminate confounding, the exact matching method was used to match alcohol-positive with alcohol-negative incidents on sex, age, race/ethnicity, and facility. Logistic regression compared in-hospital mortality between 44,043 alcohol-positive and 59,817 matched alcohol-negative TBI incidents, with and without causes and intents of TBI and Injury Severity Score as covariates. A sensitivity analysis was performed within a subsample of isolated moderate to severe TBI incidents. Results: Alcohol use at the time of injury was found to be significantly associated with an increased risk for TBI. Including varied causes and intents of TBI and Injury Severity Score as potential confounders in the regression model explained away the statistical significance of the seemingly protective effect of alcohol against TBI mortality for all TBIs and for isolated moderate to severe TBIs. Conclusions: The null finding shows that the purported reduction in TBI mortality attributed to positive blood alcohol likely is attributable to residual confounding. Accordingly, the risk of TBI associated with alcohol use should not be overlooked. PMID:22630791

Alcohol use at time of injury and survival following traumatic brain injury: results from the National Trauma Data Bank.

PubMed

Chen, Chiung M; Yi, Hsiao-Ye; Yoon, Young-Hee; Dong, Chuanhui

2012-07-01

Premised on biological evidence from animal research, recent clinical studies have, for the most part, concluded that elevated blood alcohol concentration levels are independently associated with higher survival or decreased mortality in patients with moderate to severe traumatic brain injury (TBI). This study aims to provide some counterevidence to this claim and to further future investigations. Incident data were drawn from the largest U.S. trauma registry, the National Trauma Data Bank, for emergency department admission years 2002-2006. TBI was identified according to the National Trauma Data Bank's definition using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), codes. To eliminate confounding, the exact matching method was used to match alcohol-positive with alcohol-negative incidents on sex, age, race/ethnicity, and facility. Logistic regression compared in-hospital mortality between 44,043 alcohol-positive and 59,817 matched alcohol-negative TBI incidents, with and without causes and intents of TBI and Injury Severity Score as covariates. A sensitivity analysis was performed within a subsample of isolated moderate to severe TBI incidents. Alcohol use at the time of injury was found to be significantly associated with an increased risk for TBI. Including varied causes and intents of TBI and Injury Severity Score as potential confounders in the regression model explained away the statistical significance of the seemingly protective effect of alcohol against TBI mortality for all TBIs and for isolated moderate to severe TBIs. The null finding shows that the purported reduction in TBI mortality attributed to positive blood alcohol likely is attributable to residual confounding. Accordingly, the risk of TBI associated with alcohol use should not be overlooked.

Assessment of motivations for return donation among deferred blood donors. American Red Cross ARCNET Study Group.

PubMed

Munsterman, K A; Grindon, A J; Sullivan, M T; Trouern-Trend, J; Blackmon, M J; Watkins, J; Williams, A E

1998-01-01

The recent addition of a computerized donor deferral registry to American Red Cross blood donation procedures has enabled blood center staffs to identify, before donation, persons who attempt to donate despite previous deferral. The current study investigated reasons that deferred donors return to donate, despite having been notified that they are ineligible. Anonymous mail surveys requesting demographic information, details of last donation or attempted donation, and assessments of incentives for donating were sent to 311 donors presenting inappropriately at blood drives and 849 matched controls in three American Red Cross regions between April and July 1996. Responses were received from a total of 113 deferred donors and 388 matched controls. Analysis of the 49 permanently deferred donors indicated that they were more likely than controls to donate blood to receive test results or to be awarded community service credit. Responses also revealed that some deferred donors may return to donate blood because of a misunderstanding of the deferral message or erroneous recruitment by blood center staff. There is a need before donation for the provision of educational materials regarding the window period of infection and for careful consideration of the use of incentives to attract donors to blood centers. It is also important to provide to donors a clear and consistent message regarding their test results and deferral status.

Deviating running kinematics and hamstring injury susceptibility in male soccer players: Cause or consequence?

PubMed

Schuermans, Joke; Van Tiggelen, Damien; Palmans, Tanneke; Danneels, Lieven; Witvrouw, Erik

2017-09-01

Although the vast majority of hamstring injuries in male soccer are sustained during high speed running, the association between sprinting kinematics and hamstring injury vulnerability has never been investigated prospectively in a cohort at risk. This study aimed to objectify the importance of lower limb and trunk kinematics during full sprint in hamstring injury susceptibility. Cohort study; level of evidence, 2. At the end of the 2013 soccer season, three-dimensional kinematic data of the lower limb and trunk were collected during sprinting in a cohort consisting of 30 soccer players with a recent history of hamstring injury and 30 matched controls. Subsequently, a 1.5 season follow up was conducted for (re)injury registry. Ultimately, joint and segment motion patterns were submitted to retro- and prospective statistical curve analyses for injury risk prediction. Statistical analysis revealed that index injury occurrence was associated with higher levels of anterior pelvic tilting and thoracic side bending throughout the airborne (swing) phases of sprinting, whereas no kinematic differences during running were found when comparing players with a recent hamstring injury history with their matched controls. Deficient core stability, enabling excessive pelvis and trunk motion during swing, probably increases the primary injury risk. Although sprinting encompasses a relative risk of hamstring muscle failure in every athlete, running coordination demonstrated to be essential in hamstring injury prevention. Copyright © 2017 Elsevier B.V. All rights reserved.

Nordic Cancer Registries - an overview of their procedures and data comparability.

PubMed

Pukkala, Eero; Engholm, Gerda; Højsgaard Schmidt, Lise Kristine; Storm, Hans; Khan, Staffan; Lambe, Mats; Pettersson, David; Ólafsdóttir, Elínborg; Tryggvadóttir, Laufey; Hakanen, Tiina; Malila, Nea; Virtanen, Anni; Johannesen, Tom Børge; Larønningen, Siri; Ursin, Giske

2018-04-01

The Nordic Cancer Registries are among the oldest population-based registries in the world, with more than 60 years of complete coverage of what is now a combined population of 26 million. However, despite being the source of a substantial number of studies, there is no published paper comparing the different registries. Therefore, we did a systematic review to identify similarities and dissimilarities of the Nordic Cancer Registries, which could possibly explain some of the differences in cancer incidence rates across these countries. We describe and compare here the core characteristics of each of the Nordic Cancer Registries: (i) data sources; (ii) registered disease entities and deviations from IARC multiple cancer coding rules; (iii) variables and related coding systems. Major changes over time are described and discussed. All Nordic Cancer Registries represent a high quality standard in terms of completeness and accuracy of the registered data. Even though the information in the Nordic Cancer Registries in general can be considered more similar than any other collection of data from five different countries, there are numerous differences in registration routines, classification systems and inclusion of some tumors. These differences are important to be aware of when comparing time trends in the Nordic countries.

Connecting communities to health research: development of the Project CONNECT minority research registry.

PubMed

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

2013-05-01

Prevention and treatment standards are based on evidence obtained in behavioral and clinical research. However, racial and ethnic minorities remain relatively absent from the science that develops these standards. While investigators have successfully recruited participants for individual studies using tailored recruitment methods, these strategies require considerable time and resources. Research registries, typically developed around a disease or condition, serve as a promising model for a targeted recruitment method to increase minority participation in health research. This study assessed the tailored recruitment methods used to populate a health research registry targeting African-American community members. We describe six recruitment methods applied between September 2004 and October 2008 to recruit members into a health research registry. Recruitment included direct (existing studies, public databases, community outreach) and indirect methods (radio, internet, and email) targeting the general population, local universities, and African American communities. We conducted retrospective analysis of the recruitment by method using descriptive statistics, frequencies, and chi-square statistics. During the recruitment period, 608 individuals enrolled in the research registry. The majority of enrollees were African American, female, and in good health. Direct and indirect methods were identified as successful strategies for subgroups. Findings suggest significant associations between recruitment methods and age, presence of existing health condition, prior research participation, and motivation to join the registry. A health research registry can be a successful tool to increase minority awareness of research opportunities. Multi-pronged recruitment approaches are needed to reach diverse subpopulations. Copyright © 2013. Published by Elsevier Inc.

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

PubMed Central

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

2013-01-01

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

Effect of human leukocyte antigen-C and -DQ matching on pediatric heart transplant graft survival.

PubMed

Butts, Ryan J; Savage, Andrew J; Nietert, Paul J; Kavarana, Minoo; Moussa, Omar; Burnette, Ali L; Atz, Andrew M

2014-12-01

A higher degree of human leukocyte antigen (HLA) matching at the A, B, and DR loci has been associated with improved long-term survival after pediatric heart transplantation in multiple International Society for Heart and Lung Transplantation registry reports. The aim of this study was to investigate the association of HLA matching at the C and DQ loci with pediatric graft survival. The United Network of Organ Sharing database was queried for isolated heart transplants that occurred from 1988 to 2012 with a recipient age of 17 or younger and at least 1 postoperative follow-up encounter. When HLA matching at the C or DQ loci were analyzed, only transplants with complete typing of donor and recipient at the respective loci were included. Transplants were divided into patients with at least 1 match at the C locus (C-match) vs no match (C-no), and at least 1 match at the DQ (DQ-match) locus vs no match (DQ-no). Primary outcome was graft loss. Univariate analysis was performed with the log-rank test. Cox regression analysis was performed with the following patient factors included in the model: recipient age, ischemic time; recipient on ventilator, extracorporeal membrane oxygenation, ventricular assist device, or inotropes at transplant; recipient serum bilirubin and creatinine closest to transplant, ratio of donor weight to recipient weight, underlying cardiac diagnosis, crossmatch results, transplant year, and HLA matching at the A, B, and DR loci. Complete typing at the C locus occurred in 2,429 of 4,731 transplants (51%), and complete typing at the DQ locus occurred in 3,498 of 4,731 transplants (74%). Patient factors were similar in C-match and C-no, except for year of transplant (median year, 2007 [interquartile range, 1997-2010] vs year 2005 [interquartile range, 1996-2009], respectively; p = 0.03) and the degree of HLA matching at the A, B, and DR loci (high level of HLA matching in 11.9% vs 3%, respectively; p < 0.01). Matching at the C locus was not associated with a decreased risk of graft loss (median graft survival: 13.1 years [95% confidence interval {CI}, 11.5-14.8] in C-no vs 15.1 years [95% CI, 13.5-16.6) in C-match, p = 0.44 log-rank; hazard ratio, 0.93; 95% CI, 0.76-1.15; p = 0.52). DQ-match did not differ from DQ-no in any of the analyzed patient factors, except DQ-match was more likely to have high degree of matching at the A, B, and DR loci vs DQ-no (9.8% vs 3.2%, p < 0.01). Matching at the DQ locus was not associated with decreased risk of graft loss (median graft survival: DQ-no, 13.1 years [95% CI, 11.7-14.6) vs DQ-match, 13.0 years [95% CI, 11.4-14.6], p = 0.80, log-rank; hazard ratio, 0.95; 95% CI, 0.81-1.1; p = 0.51. Complete typing at the C locus of both donor and recipient occurs less often then typing at the DQ locus. A higher degree of donor-recipient HLA matching at the C locus or the DQ locus appears not to confer any graft survival advantage. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2016-11-09

While national quality registries (NQRs) are suggested to provide opportunities for systematic follow-up and learning opportunities, and thus clinical improvements, features in registries and contexts triggering such processes are not fully known. This study focuses on one of the world's largest stroke registries, the Swedish NQR Riksstroke, investigating what aspects of the registry and healthcare organisations facilitate or hinder the use of registry data in clinical quality improvement. Following particular qualitative studies, we performed a quantitative survey in an exploratory sequential design. The survey, including 50 items on context, processes and the registry, was sent to managers, physicians and nurses engaged in Riksstroke in all 72 Swedish stroke units. Altogether, 242 individuals were presented with the survey; 163 responded, representing all but two units. Data were analysed descriptively and through multiple linear regression. A majority (88%) considered Riksstroke data to facilitate detection of stroke care improvement needs and acknowledged that their data motivated quality improvements (78%). The use of Riksstroke for quality improvement initiatives was associated (R 2 =0.76) with 'Colleagues' call for local results' (p=<0.001), 'Management Request of Registry data' (p=<0.001), and it was said to be 'Simple to explain the results to colleagues' (p=0.02). Using stepwise regression, 'Colleagues' call for local results' was identified as the most influential factor. Yet, while 73% reported that managers request registry data, only 39% reported that their colleagues call for the unit's Riksstroke results. While an NQR like Riksstroke demonstrates improvement needs and motivates stakeholders to make progress, local stroke care staff and managers need to engage to keep the momentum going in terms of applying registry data when planning, performing and evaluating quality initiatives. 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/.

European Prevention of Alzheimer's Dementia Registry: Recruitment and prescreening approach for a longitudinal cohort and prevention trials.

PubMed

Vermunt, Lisa; Veal, Colin D; Ter Meulen, Lea; Chrysostomou, Charalambos; van der Flier, Wiesje; Frisoni, Giovanni B; Guessous, Idris; Kivipelto, Miia; Marizzoni, Moira; Martinez-Lage, Pablo; Molinuevo, José Luis; Porteous, David; Ritchie, Karen; Scheltens, Philip; Ousset, Pierre-Jean; Ritchie, Craig W; Luscan, Gerald; Brookes, Anthony J; Visser, Pieter Jelle

2018-06-01

It is a challenge to find participants for Alzheimer's disease (AD) prevention trials within a short period of time. The European Prevention of Alzheimer's Dementia Registry (EPAD) aims to facilitate recruitment by preselecting subjects from ongoing cohort studies. This article introduces this novel approach. A virtual registry, with access to risk factors and biomarkers for AD through minimal data sets of ongoing cohort studies, was set up. To date, ten cohorts have been included in the EPAD. Around 2500 participants have been selected, using variables associated with the risk for AD. Of these, 15% were already recruited in the EPAD longitudinal cohort study, which serves as a trial readiness cohort. This study demonstrates that a virtual registry can be used for the preselection of participants for AD studies. Copyright © 2018 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Traffic-Related Air Pollution and Parkinson’s Disease in Denmark: A Case–Control Study

PubMed Central

Ritz, Beate; Lee, Pei-Chen; Hansen, Johnni; Lassen, Christina Funch; Ketzel, Matthias; Sørensen, Mette; Raaschou-Nielsen, Ole

2015-01-01

Background Very little is currently known about air pollutants’ adverse effects on neurodegenerative diseases even though recent studies have linked particulate exposures to brain pathologies associated with Parkinson’s and Alzheimer’s disease. Objective In the present study, we investigated long-term exposure to traffic-related air pollution and Parkinson’s disease. Methods In a case–control study of 1,696 Parkinson’s disease (PD) patients identified from Danish hospital registries and diagnosed 1996–2009 and 1,800 population controls matched by sex and year of birth, we assessed long-term traffic-related air pollutant exposures (represented by nitrogen dioxide; NO2) from a dispersion model, using residential addresses from 1971 to the date of diagnosis or first cardinal symptom for cases and the corresponding index date for their matched controls. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated with logistic regression, adjusting for matching factors and potential confounders. Results We found ambient air pollution from traffic sources to be associated with risk of PD, with a 9% higher risk (95% CI: 3, 16.0%) per interquartile range increase (2.97 μg/m3) in modeled NO2. For participants living for ≥ 20 years in the capital city, ORs were larger (OR = 1.21; 95% CI: 1.11, 1.31) than in provincial towns (OR = 1.10; 95% CI: 0.97, 1.26), whereas there was no association among rural residents. Conclusions Our findings raise concerns about potential effects of air pollution from traffic and other sources on the risk of PD, particularly in populations with high or increasing exposures. Citation Ritz B, Lee PC, Hansen J, Funch Lassen C, Ketzel M, Sørensen M, Raaschou-Nielsen O. 2016. Traffic-related air pollution and Parkinson’s disease in Denmark: a case–control study. Environ Health Perspect 124:351–356; http://dx.doi.org/10.1289/ehp.1409313 PMID:26151951

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

PubMed

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

2012-03-01

Few studies have investigated the natural history of post-traumatic stress disorder (PTSD). Project VALOR (Veterans' After-discharge Longitudinal Registry) was designed as a longitudinal patient registry assessing the course of combat-related PTSD among 1600 male and female Veterans who served in Operation Enduring Freedom (OEF) in Afghanistan or Operation Iraqi Freedom (OIF). Aims of the study include investigating patterns and predictors of progression or remission of PTSD and treatment utilization. The study design was based on recommendations from the Agency for Healthcare Quality and Research for longitudinal disease registries and used a pre-specified theoretical model to select the measurement domains for data collection and interpretation of forthcoming results. The registry will include 1200 male and female Veterans with a recent diagnosis of PTSD in the Department of Veteran Affairs (VA) electronic medical record and a comparison group of 400 Veterans without a medical record-based PTSD diagnosis, to also allow for case-control analyses. Data are collected from administrative databases, electronic medical records, a self-administered questionnaire, and a semi-structured diagnostic telephone interview. Project VALOR is a unique and timely registry study that will evaluate the clinical course of PTSD, psychosocial correlates, and health outcomes in a carefully selected cohort of returning OEF/OIF Veterans. Copyright © 2011 John Wiley & Sons, Ltd.

Stage I non-small-cell lung cancer: long-term results of lobectomy versus sublobar resection from the Polish National Lung Cancer Registry.

PubMed

Dziedzic, Robert; Zurek, Wojciech; Marjanski, Tomasz; Rudzinski, Piotr; Orlowski, Tadeusz M; Sawicka, Wioletta; Marczyk, Michal; Polanska, Joanna; Rzyman, Witold

2017-08-01

Anatomical lobar resection and mediastinal lymphadenectomy remain the standard for the treatment of early stage non-small-cell lung cancer (NSCLC) and are preferred over procedures such as segmentectomy or wedge resection. However, there is an ongoing debate concerning the influence of the extent of the resection on overall survival. The aim of this article was to assess the overall survival for different types of resection for Stage I NSCLC. We performed a retrospective analysis of the results of the surgical treatment of Stage I NSCLC. Between 1 January 2007 and 31 December 2013, the data from 6905 patients who underwent Stage I NSCLC operations were collected in the Polish National Lung Cancer Registry (PNLCR) and overall survival was assessed. A propensity score-matched analysis was used to compare 3 groups of patients, each consisting of 231 patients who underwent lobectomy, segmentectomy, or wedge resection. In the unmatched and matched patient groups, lobectomy and segmentectomy were associated with a significant benefit compared to wedge resection regarding overall survival (log-rank P  < 0.001 and P  = 0.001). The Cox proportional hazard ratio comparing segmentectomy and lobectomy to wedge resection was 0.54 [95% confidence interval (CI): 0.37-0.77) and 0.44 (95% CI: 0.38-0.50), respectively, indicating a significant improvement in survival. There was no difference in the 5-year survival of patients after lobectomy (79.1%; 95% CI: 77.7-80.4%) or segmentectomy (78.3%; 95% CI: 70.6-86.0%). The 30-day mortality rate was 1.6, 2.6 and 1.4% for lobectomy, segmentectomy and wedge resection, respectively. Wedge resection was associated with a significantly lower 5-year survival rate (58.1%; 95% CI: 53.6-62.5%) compared to segmentectomy (78.3%; 95% CI: 70.6-86.0%) and lobectomy (79.1%; 95% CI: 77.7-80.5%). The propensity score matched analysis confirmed most of the results of the comparisons of unmatched study groups. Wedge resection was associated with significantly lower 3-year and 5-year survival rates compared to the other methods of resection. There was no significant difference in 3-year or 5-year survival rates between lobectomy and segmentectomy. Segmentectomy, but not wedge resection, could be considered an alternative to lobectomy in the treatment of patients with Stage I NSCLC. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Sick leave patterns among 5-year cancer survivors: a registry-based retrospective cohort study.

PubMed

Torp, Steffen; Nielsen, Roy A; Gudbergsson, Sævar B; Fosså, Sophie D; Dahl, Alv A

2012-09-01

The aims of this study were to observe the sick leave rates of cancer survivors for five consecutive years following a first lifetime diagnosis of invasive cancer and to identify socio-demographic and clinical predictors of sick leave taken in the fifth year after diagnosis. This registry study comprised 2,008 Norwegian individuals (18-61 years old) with their first lifetime diagnosis of invasive cancer in 1999 and alive in 2004 and a cancer-free control group (n = 3,240) matched by sex, age, educational level, and employment status in 1998. Sick leave was defined as at least one sick leave period >16 days within the year in question. A total of 75 % of the long-term cancer survivors (LTCSs) took sick leave within the first 12 months after their diagnosis. The sick leave rate stabilized at a slightly higher level in the following 4 years compared to the year before diagnosis, with approximately 23 % of the male and 31 % of the female LTCSs taking sick leave. Being single with children, having low education, working in health and social work sector, or having taken sick leave the year before diagnosis (1998) predicted the sick leave taken 5 years after diagnosis (2004) among LTCSs. Compared to the controls, LTCSs with rectal, lymphogenic, breast, or "other" types of cancer had significantly higher sick leave rates 5 years after diagnosis. Socio-demographic factors explained more of the variance in sick leave than did clinical factors. Employed LTCSs struggle with their ability to work 5 years after diagnosis. More research is needed to identify factors that would promote LTCSs' health and ability. A socioeconomic and work environmental perspective seems necessary for achieving effective occupational rehabilitation and preventing sick leave among LTCSs.

Hyperthyroidism and psychiatric morbidity: evidence from a Danish nationwide register study.

PubMed

Brandt, Frans; Thvilum, Marianne; Almind, Dorthe; Christensen, Kaare; Green, Anders; Hegedüs, Laszlo; Brix, Thomas Heiberg

2014-02-01

Thyroid hormones are essential for the normal development of the fetal brain, while hyperthyroidism in adults is associated with mood symptoms and reduced quality of life. In this study, we aimed to investigate the association and temporal relationship between hyperthyroidism and psychiatric morbidity. Register-based nationwide cohort study. Data on hyperthyroidism and psychiatric morbidity were obtained by record linkage of the Danish National Patient Registry and the Danish National Prescription Registry. A total of 2631 hyperthyroid individuals were identified and matched 1:4 with non-hyperthyroid controls and followed for a mean duration of 6 years (range 0-13). Logistic and Cox regression models were used to assess the risk of psychiatric morbidity before and after the diagnosis of hyperthyroidism respectively. BEFORE THE DIAGNOSIS OF HYPERTHYROIDISM, SUCH INDIVIDUALS HAD AN INCREASED RISK OF BEING HOSPITALIZED WITH PSYCHIATRIC DIAGNOSES (ODDS RATIO (OR): 1.33; 95% CI: 0.98-1.80) and an increased risk of being treated with antipsychotics (OR: 1.17; 95% CI: 1.00-1.38), antidepressants (OR: 1.13; 95% CI: 1.01-1.27), or anxiolytics (OR: 1.28; 95% CI: 1.16-1.42). After the diagnosis of hyperthyroidism, there was a higher risk of being hospitalized with psychiatric diagnoses (hazard ratio (HR): 1.51; 95% CI: 1.11-2.05) and an increased risk of being treated with antipsychotics (HR: 1.46; 95% CI: 1.20-1.79), antidepressants (HR: 1.54; 95% CI: 1.36-1.74), or anxiolytics (HR: 1.47; 95% CI: 1.27-1.69). Hyperthyroid individuals have an increased risk of being hospitalized with psychiatric diagnoses and being treated with antipsychotics, antidepressants, and anxiolytics, both before and after the diagnosis of hyperthyroidism.

Poor oral health is associated with an increased risk of esophageal squamous cell carcinoma - a population-based case-control study in China.

PubMed

Chen, Xingdong; Yuan, Ziyu; Lu, Ming; Zhang, Yuechan; Jin, Li; Ye, Weimin

2017-02-01

To further examine the association between oral hygiene and esophageal squamous cell carcinoma (ESCC) risk and the effect modification of other exposures, we conducted a population-based case-control study between 2010 and 2012 in Taixing, China, a high-risk area for ESCC. Cases were primarily recruited from endoscopy units at local hospitals, supplemented by linkage to the local Cancer Registry. Control subjects were frequency matched to cases by sex and age (5-year groups) and were randomly selected from the Taixing Population Registry. For the current analysis, data from 616 histopathologically confirmed cases and 770 controls with complete information on oral hygiene were analyzed. Unconditional logistic regression models, including oral hygiene indicators and potential behavioral confounders, were used to derive odds ratios (ORs) and 95% confidence intervals (CIs). Tooth loss was only marginally significantly associated with ESCC risk (yes vs. no, OR = 1.29, 95% CI 0.94-1.74). However, the excess risk increased with increasing numbers of lost teeth (more than 6 teeth lost vs. none, OR = 1.48, 95% CI 1.04-2.11). Tooth brushing once or less per day, compared with tooth brushing twice or more per day, was associated with a 1.81-fold increased risk of ESCC. In the stratification analyses, the increased risks associated with these indicators of oral health were more pronounced in older subjects (age ≥ 70 years), women, non-smokers, and non-drinkers. Further studies are warranted to verify these findings and to explore the underlying mechanisms, e.g., changed oral microbiota, associated with poor oral hygiene. © 2016 UICC.

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

PubMed

Ito, Tatsuya

2016-01-01

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

Hematopoietic stem cell transplantation (HSCT): an approach to autoimmunity.

PubMed

Alaez, Carmen; Loyola, Mariana; Murguía, Andrea; Flores, Hilario; Rodríguez, Araceli; Ovilla, Roberto; Ignacio, Gregorio; Amador, Raquel; Salinas, Victor; Perez, Fernanda; Rodríguez, Danaee; Morales, Zoila; Llinguin, Gonzalo; Vazquez, Alejandra; Altamirano, Analia; Gorodezky, Clara

2006-03-01

HSCT provides the opportunity to replace a damaged tissue. It is the most important treatment for high risk hematologic malignant and non malignant disorders. An important challenge in the identification of matched donors/patients is the HLA diversity. The Mexican Bone Marrow Registry (DONORMO) has nowadays > 5000 donors. The prevalent alleles are Amerindian, Mediterranean (Semitic and Spanish genes) and African. In theory, it is possible to find 11% of 6/6 A-B-DR low resolution matches for 70% of patients with Mexican ancestry. We contributed with 39 unrelated, cord blood and autologous HSCT for patients with malignant, genetic and autoimmune disorders. Overall disease survival was 50% (2-7 years) depending on the initial diagnosis, conditioning, disease evolution or other factors. Clinical studies using autologous and unrelated HSC are performed on patients with refractory autoimmune diseases producing mixed results: mainly, T1D, RA, MS, SLE. Improvement has been observed in skin damage and quality of life in SLE and systemic sclerosis. Disease stabilization in 2/3 of MS patients. However, in RA and T1D, initial benefits have been followed by eventual relapse. With growing clinical experience and protocol improvement, treatment-related mortality is decreasing. Proof efficacy will be achieved by comparing HSCT with standard therapy in autoimmunity.

The impact of socio-economic factors on treatment choice and mortality in chronic myeloid leukaemia.

PubMed

Larfors, Gunnar; Sandin, Fredrik; Richter, Johan; Själander, Anders; Stenke, Leif; Lambe, Mats; Höglund, Martin

2017-04-01

To evaluate the influence of socio-economic variables on treatment selection and survival of patients with chronic myeloid leukaemia (CML). Using information available in population-based Swedish registries, we evaluated indices of health, education and economy from the 980 patients in the Swedish CML register diagnosed between 2002 and 2012. Apart from internal comparisons, five age-, gender- and region-matched control subjects per patient served as control cohort. Median follow-up time from CML diagnosis was 4.8 years. Among patients with CML, low personal or household income, short education, living alone, poor performance status and high age (>60 years) were significantly associated with an inferior survival (in univariate analyses). However, similar findings were noted also in the matched control group, and in comparisons adjusted for calendar year, age and performance status, socio-economic variables were not significantly associated with CML survival. Meanwhile, both education and income were independently linked to TKI treatment overall and to upfront treatment with second-generation TKIs. In conclusion, socio-economic conditions were associated with survival in the studied CML cohort but these associations could be explained by differences at baseline. Meanwhile, socio-economic conditions appeared to influence treatment choice. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Using a State Birth Registry as a Quality Improvement Tool.

PubMed

Lannon, Carole; Kaplan, Heather C; Friar, Kelly; Fuller, Sandra; Ford, Susan; White, Beth; Besl, John; Paulson, John; Marcotte, Michael; Krew, Michael; Bailit, Jennifer; Iams, Jay

2017-08-01

Background  Birth registry data are universally collected, generating large administrative datasets. However, these data are typically not used for quality improvement (QI) initiatives in perinatal medicine because the quality and timeliness of the information is uncertain. Objective  We sought to identify and address causes of inaccuracy in recording birth registry information so that birth registry data could support statewide obstetrical quality initiatives in Ohio. Study Design  The Ohio Perinatal Quality Collaborative and the Ohio Department of Health Vital Statistics used QI techniques in 15 medium-sized maternity hospitals to identify and remove systemic sources of inaccuracy in birth registry data. The primary outcome was the rate of scheduled deliveries without medical indication between 37 0/7 and 38 6/7 weeks at participating hospitals from birth registry data. Results  Inaccurate birth registry data most commonly resulted from limited communication between clinical and medical record staff. The rate of scheduled births between 37 0/7 and 38 6/7 weeks' gestation without a documented medical indication as recorded in the birth registry declined by 35%. Conclusion  A QI initiative aimed at increasing the accuracy of birth registry information demonstrated the utility of these data for surveillance of perinatal outcomes and has led to ongoing efforts to support birth registrars in submitting accurate data. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The Brain Health Registry: An internet-based platform for recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies.

PubMed

Weiner, Michael W; Nosheny, Rachel; Camacho, Monica; Truran-Sacrey, Diana; Mackin, R Scott; Flenniken, Derek; Ulbricht, Aaron; Insel, Philip; Finley, Shannon; Fockler, Juliet; Veitch, Dallas

2018-05-08

Recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies and clinical trials limit the development of new treatments. Widespread Internet use allows data capture from participants in an unsupervised setting. The Brain Health Registry, a website and online registry, collects data from participants and their study partners. The Brain Health Registry obtains self and study partner report questionnaires and neuropsychological data, including the Cogstate Brief Battery, Lumos Labs Neurocognitive Performance Test, and MemTrax Memory Test. Participants provide informed consent before participation. Baseline and longitudinal data were obtained from nearly 57,000 and 28,000 participants, respectively. Over 18,800 participants were referred to, and nearly 1800 were enrolled in, clinical Alzheimer's disease and aging studies, including five observational studies and seven intervention trials. Online assessments of participants and study partners provide useful information at relatively low cost for neuroscience studies and clinical trials and may ultimately be used in routine clinical practice. Copyright © 2018 the Alzheimer's Association. All rights reserved.

Hereditary and acquired thrombophilia in patients with upper extremity deep-vein thrombosis. Results from the MAISTHRO registry.

PubMed

Linnemann, Birgit; Meister, Florian; Schwonberg, Jan; Schindewolf, Marc; Zgouras, Dimitrios; Lindhoff-Last, Edelgard

2008-09-01

The prevalence of coagulation disorders in patients with upper extremity deep-vein thrombosis (UE-DVT) is unknown due to only a few observational studies of limited size reporting varying results. Therefore, we aimed to evaluate the prevalence of thrombophilia in patients with UE-DVT compared to patients with lower extremity deep vein thrombosis (LE-DVT). One hundred fifty consecutive patients (15 to 91 years of age) with UE-DVT were recruited from the MAISTHRO (MAin-ISar-THROmbosis) registry. Three hundred LE-DVT patients matched for gender and age served as controls. Thrombophilia screening included tests for the factor V Leiden mutation, the prothrombin G20210A mutation, antiphospholipid antibodies and factor VIII (FVIII), protein C, protein S and antithrombin activities. At least one thrombophilia was present in 34.2% of UE-DVT and 39.2% in UE-DVT that was unrelated to venous catheters relative to 55.3% in LE-DVT patients (p<0.001). In particular, a persistently elevated FVIII is less likely to be found in UE-DVT patients than in those with LE-DVT and is the only thrombophilia that is differentially expressed after controlling for established VTE risk factors [OR 0.46, (95% CI 0.25-0.83)]. Although less prevalent than in LE-DVT patients, thrombophilia is a common finding in patients with UE-DVT, especially in those with thrombosis that is unrelated to venous catheters.

Cancer in first-degree relatives and risk of testicular cancer in Denmark

PubMed Central

Nordsborg, Rikke Baastrup; Meliker, Jaymie R.; Wohlfahrt, Jan; Melbye, Mads; Raaschou-Nielsen, Ole

2011-01-01

Familial aggregation of testicular cancer has been reported consistently, but it is less clear if there is any association between risk of testicular cancer and other cancers in the family. We conducted a population based case-control study to examine the relationship between risk of testicular cancer and 22 different cancers in first-degree relatives. We included 3297 cases of testicular cancer notified to the Danish Cancer Registry between 1991 and 2003. 6594 matched controls were selected from the Danish Civil Registration System, which also provided the identity of 40,104 first-degree relatives of case and controls. Familial cancer was identified by linkage to the Danish Cancer Registry, and we used conditional logistic regression to analyse whether cancer among first-degree relatives was associated with higher risk of testicular cancer. Rate ratio (RR) for testicular cancer was 4.63 (95% CI: 2.41–8.87) when a father, 8.30(95% CI: 3.81–18.10) when a brother and 5.23 (95% CI: 1.35–20.26) when a son had testicular cancer compared with no familial testicular cancer. Results were similar when analyses were stratified by histologic subtypes of testicular cancer. Familial Non-Hodgkin lymphoma and oesophageal cancer were associated with testicular cancer; however these may be chance findings. The familial aggregation of testicular and possibly other cancers may be explained by shared genes and/or shared environmental factors, but the mutual importance of each of these is difficult to determine. PMID:21207375

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.

PubMed

Pranić, Shelly; Marušić, Ana

2016-02-01

To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA). Observational study of a cohort of ClinicalTrials.gov registered FDAAA-covered RCTs found through ClinicalTrials.gov between 2009 and 2012 and data from corresponding publications. WHO Minimum Data Set items were abstracted by one author and verified by the other author. Among 81 eligible trials, most were industry-funded, with a drug intervention in parallel assignment. Secondary outcomes at the initial and last registration were omitted for 17% and 19.7% of RCTs, respectively. RCT registration changes mostly involved scientific title (18.8%). Inclusion criteria omission was most common (88%) in publications. Inferential statistical methods for primary and secondary outcomes matched between registry and publication for 53.4% and 28.6% of RCTs, respectively. Serious and other adverse events (AEs) that were absent for 23.8% and 4.8% of RCTs, respectively, were published as nonoccurring. Discrepancies remain relatively high between registered and published outcomes, particularly regarding registered omissions in publications and concomitant reporting, nature of statistical method used, and reporting of AEs. This seriously undermines transparency of clinical trials and needs immediate attention of all stakeholders in health research. Copyright © 2016 Elsevier Inc. All rights reserved.

Scripts for TRUMP data analyses. Part II (HLA-related data): statistical analyses specific for hematopoietic stem cell transplantation.

PubMed

Kanda, Junya

2016-01-01

The Transplant Registry Unified Management Program (TRUMP) made it possible for members of the Japan Society for Hematopoietic Cell Transplantation (JSHCT) to analyze large sets of national registry data on autologous and allogeneic hematopoietic stem cell transplantation. However, as the processes used to collect transplantation information are complex and differed over time, the background of these processes should be understood when using TRUMP data. Previously, information on the HLA locus of patients and donors had been collected using a questionnaire-based free-description method, resulting in some input errors. To correct minor but significant errors and provide accurate HLA matching data, the use of a Stata or EZR/R script offered by the JSHCT is strongly recommended when analyzing HLA data in the TRUMP dataset. The HLA mismatch direction, mismatch counting method, and different impacts of HLA mismatches by stem cell source are other important factors in the analysis of HLA data. Additionally, researchers should understand the statistical analyses specific for hematopoietic stem cell transplantation, such as competing risk, landmark analysis, and time-dependent analysis, to correctly analyze transplant data. The data center of the JSHCT can be contacted if statistical assistance is required.

Aging, practice effects, and genetic risk in the Wisconsin Registry for Alzheimer’s Prevention

PubMed Central

Jonaitis, Erin M.; Koscik, Rebecca L.; La Rue, Asenath; Johnson, Sterling C.; Hermann, Bruce; Sager, Mark A.

2015-01-01

BACKGROUND In the last five years, a consensus has developed that Alzheimer’s disease (AD) may begin years before overt cognitive impairment (Sperling et al., 2011). Accordingly, the focus has shifted to identifying preclinical disease in order to match treatments to those most likely to benefit. Subtle cognitive changes, including reduced benefit from practice, may be one such preclinical sign. In this paper, we explore cognitive aging trajectories within a large cohort of clinically intact late-middle-aged adults. METHOD Longitudinal cognitive data were analyzed from 594 participants in the Wisconsin Registry for Alzheimer’s Prevention. Mixed models were used to examine trajectories, adjusting for prior exposure, and the moderation thereof by markers of dementia risk, APOE-ε4 status, and family history of AD. RESULTS Practice effects were observed for Verbal Learning & Memory, Working Memory, Speed & Flexibility, and Visual Learning. However, for Working Memory and Speed & Flexibility, these effects were attenuated for FH+ subjects. CONCLUSION Reduced practice effects have previously been observed in clinical groups (Cooper et al., 2001; Machulda et al., 2013). These results in middle-aged adults suggest that they may also indicate preclinical changes on the path to AD. PMID:26012360

Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials.

PubMed

Mathes, Tim; Buehn, Stefanie; Prengel, Peggy; Pieper, Dawid

2018-01-01

The objective of this study was to analyze the features of registry-based randomized trials (rRCTs). We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics. The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%. rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

Adoption and implementation of mandated diabetes registries by community health centers.

PubMed

Helfrich, Christian D; Savitz, Lucy A; Swiger, Kathleen D; Weiner, Bryan J

2007-07-01

Innovations adopted by healthcare organizations are often externally mandated. However, few studies examine how mandated innovations progress from adoption to sustained effective use. This study uses Rogers's model of organizational innovation to explore community health centers' (CHCs') mandated adoption and implementation of disease registries in the federal Health Disparities Collaborative (HDC). Case studies were conducted on six CHCs in North Carolina participating in the HDC on type 2 diabetes mellitus. Data were collected from semistructured interviews with key staff, and from site-level and individual-level surveys. Although disease registry adoption and implementation were mandated, CHCs exercised prerogative in the timing of registry adoption and the functions emphasized. Executive and medical director involvement, often directly on the HDC teams, was the single most salient influence on adoption and implementation. Staff members' personal experience with diabetes also provided context and gave registries added significance. Participants lauded HDC's technique of small-scale, rapid-cycle change, but valued even more shared problem solving and peer learning among HDC teams. However, lack of cross-training, inadequate resources, and staff turnover posed serious threats to sustainability of the registries. The present study illustrates the usefulness of Rogers's model for studying mandated innovation and highlights several key factors, including direct, personal involvement of organizational leadership, and shared problem solving and peer learning facilitated by the HDC. However, these six CHCs elected to participate early in the HDC, and may not be typical of North Carolina's remaining CHCs. Furthermore, most face important long-term challenges that threaten routinization.

Patient registries: useful tools for clinical research in myasthenia gravis.

PubMed

Baggi, Fulvio; Mantegazza, Renato; Antozzi, Carlo; Sanders, Donald

2012-12-01

Clinical registries may facilitate research on myasthenia gravis (MG) in several ways: as a source of demographic, clinical, biological, and immunological data on large numbers of patients with this rare disease; as a source of referrals for clinical trials; and by allowing rapid identification of MG patients with specific features. Physician-derived registries have the added advantage of incorporating diagnostic and treatment data that may allow comparison of outcomes from different therapeutic approaches, which can be supplemented with patient self-reported data. We report the demographic analysis of MG patients in two large physician-derived registries, the Duke MG Patient Registry, at the Duke University Medical Center, and the INNCB MG Registry, at the Istituto Neurologico Carlo Besta, as a preliminary study to assess the consistency of the two data sets. These registries share a common structure, with an inner core of common data elements (CDE) that facilitate data analysis. The CDEs are concordant with the MG-specific CDEs developed under the National Institute of Neurological Disorders and Stroke Common Data Elements Project. © 2012 New York Academy of Sciences.

Drugs with potential chemopreventive properties in relation to epithelial ovarian cancer--a nationwide case-control study.

PubMed

Baandrup, Louise

2015-07-01

Ovarian cancer has a poor prognosis because the disease in the majority of patients is diagnosed at an advanced stage as a result of nonspecific symptoms and lack of efficient screening methods. Because of the poor prognosis of ovarian cancer and the challenge of early detection of the disease, identification of protective factors is important. It has been suggested that some commonly used drugs may have a protective effect against cancer, including ovarian cancer; however, the literature on chemopreventive measures for ovarian cancer is sparse and the results are inconclusive. Most previous studies have substantial methodological constraints, including limited study size and self-reporting of drug use, which introduces potential recall bias and misclassification. This PhD thesis includes a nationwide case-control study to evaluate associations between use of drugs with potential chemopreventive properties and risk of epithelial ovarian cancer. The study is nested in the entire Danish female population using data from the following nationwide registries: the Danish Cancer Registry, the Danish Civil Registration System, the Danish Prescription Registry, the Danish National Patient Register, and registries in Statistics Denmark on fertility, education, and income. Information from the included registries is linked by use of the unique personal identification number assigned to all Danish citizens. The cases were all women in Denmark with epithelial ovarian cancer diagnosed during 2000-2009 (Paper 1) and 2000-2011 (Papers 2 and 3), identified in the Cancer Registry. Age-matched female population controls were randomly selected from the Civil Registration System by risk-set sampling. We required that cases and controls have no history of cancer (except non-melanoma skin cancer) and that controls not previously have undergone bilateral oophorectomy or salpingo-oophorectomy. The total study population comprised 3741 epithelial ovarian cancer cases and 50,576 controls in Paper 1, and 4103 epithelial ovarian cancer cases and 58,706 controls in Papers 2 and 3. We used the Danish Prescription Registry to assess use (≥2 prescriptions on separate dates) of paracetamol, non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), low-dose aspirin, and statins. Conditional logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for epithelial ovarian cancer associated with use of the study drugs, with adjustment for potential confounding factors selected a priori. We performed detailed analyses according to duration, intensity, and continuity of study drug use, and the analyses were stratified according to specific histologic types of epithelial ovarian cancer. In all studies, non-use (< 2 prescriptions) of the individual study drugs was defined as the reference group. A striking result of the PhD thesis was a strong inverse association between prescription use of paracetamol and risk of epithelial ovarian cancer. The risk estimates decreased with increasing duration and intensity of paracetamol use, reaching a more than 50% reduction for the longest duration (>10 years) and the highest doses (OR: 0.45; 95% CI: 0.24-0.86). In contrast, we did not observe an inverse association between use of non-aspirin NSAIDs and risk of epithelial ovarian cancer. Moreover, this thesis provides further evidence that use of low-dose aspirin is associated with a reduced risk of epithelial ovarian cancer. In particular, long-term (≥5 years) continuous use of low-dose aspirin, defined as overlapping prescription coverage periods, was associated with a large reduction in risk (OR: 0.56; 95% CI: 0.32-0.97). Finally, we found no apparent association between statin use and epithelial ovarian cancer risk, although the analysis by histologic type suggested an inverse association with the risk of mucinous tumors. The results of this PhD thesis add important knowledge to the area of chemoprevention in relation to epithelial ovarian cancer. As for any observational study, we cannot exclude potential con-founding and exposure misclassification; however, methodological limitations appear unlikely to fully explain the observed reductions in epithelial ovarian cancer risk associated with paracetamol and low-dose aspirin use. Additional research, ideally from clinical trials, is needed before our observations may lead to recommendations for chemopreventive measures against ovarian cancer. In case consensus points to a true protective effect of paracetamol or low-dose aspirin, comprehensive risk-benefit evaluations will also have to be performed. We hope that our results will encourage researchers to look more deeply into the potential chemo-preventive effects of the study drugs against epithelial ovarian cancer risk.

Comparison of self-report influenza vaccination coverage with data from a population based computerized vaccination registry and factors associated with discordance.

PubMed

Jiménez-García, Rodrigo; Hernandez-Barrera, Valentín; Rodríguez-Rieiro, Cristina; Carrasco Garrido, Pilar; López de Andres, Ana; Jimenez-Trujillo, Isabel; Esteban-Vasallo, María D; Domínguez-Berjón, Maria Felicitas; de Miguel-Diez, Javier; Astray-Mochales, Jenaro

2014-07-31

We aim to compare influenza vaccination coverages obtained using two different methods; a population based computerized vaccination registry and self-reported influenza vaccination status as captured by a population survey. The study was conducted in the Autonomous Community of Madrid (ACM), Spain, and refers to the 2011/12 influenza vaccination campaign. Information on influenza vaccination status according to a computerized registry was extracted from the SISPAL database and crossed with the electronic clinical records in primary care (ECRPC). Self-reported vaccine uptake was obtained from subjects living in the ACM included in the 2011-12 Spanish National Health Survey (SNHS). Independent study variables included: age, sex, immigrant status and the presence of high risk chronic conditions. Vaccination coverages were calculated according to study variables. Crude and adjusted prevalence ratios were computed to assess concordance. The study population included 5,245,238 adults living in the ACM in year 2011 with an individual ECRPC and 1449 adult living the ACM and interviewed in the SNHS from October 2011 to June 2012. The weighted vaccination coverage for the study population according to self-reported data was 19.77% and 15.04% from computerized registries resulting in a crude prevalence ratio (cPR) of 1.31 (95% CI 1.20-1.44) so self-reported data significantly overestimated 31% the registry coverage. Self-reported coverages are always higher than registry based coverages when the study population is stratified by the study variables. Self-reported overestimation was higher among men than women, younger age groups, immigrants and those without chronic conditions. Both methods provide the most concordant estimations for the target population of the influenza vaccine. Self-report influenza vaccination uptake overestimates vaccination registries coverages. The validity of self-report seems to be negatively affected by socio-demographic variables and the absence of chronic conditions. Possible strategies must be considered and implemented to improve both coverage estimation methods. Copyright © 2014 Elsevier Ltd. All rights reserved.

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.

Novel Multivalent Wound-Healing Ointment Provides Bioburden Control and Moisture Management: A Retrospective Registry Data Analysis.

PubMed

Serena, Thomas; Connell, Heather; McConnell, Sharon; Patel, Keyur; Doner, Bryan; Sabo, Matthew; Miller, Michael; Serena, Laura; Le, Lam T; Goldsmith, David; Chung, Jane

2016-10-01

The purpose of this retrospective registry data analysis was to explore the effectiveness of a novel multivalent topical ointment (Terrasil Infection Control Wound Care Ointment; Aspiera Medical, Woonsocket, Rhode Island), containing a patented mineral complex and 0.2% benzethonium chloride in the treatment of nonhealing acute and chronic wounds. Aspiera Medical designed a registry to capture physician experiences and treatment results with Terrasil Infection Control Wound Care Ointment. Physicians were asked to enter deidentified patient data into an online registry. Wound clinics in the United States were asked to participate in the registry. Physicians at 4 wound clinics treated 30 patients (26 of whom completed the treatment) with various chronic wounds that had persisted for an average of 6 months and entered treatment data into the registry. Patients applied the ointment according to physician orders. Concurrent treatments used by patients included offloading, compression wraps, and dressings, such as collagen and calcium alginate. Patients were treated until complete wound closure or lost to follow-up. Physicians calculated each patient's percentage wound reduction at each visit. Thirty patients were entered into the registry. Pretreatment and posttreatment measurements were available for 26 of them. Patients achieved an average surface area reduction of 84% in a mean of 23 days' treatment. The antimicrobial and moisturizing ointment studied appears to be effective in promoting wound closure in a variety of acute and chronic wounds. Wounds studied included diabetic foot ulcers, venous leg ulcers, venous stasis ulcers, surgical infections, burns, and insect bites. The results of this registry data analysis will be used to inform planned clinical trials.

Use of Patient Registries and Administrative Datasets for the Study of Pediatric Cancer

PubMed Central

Rice, Henry E.; Englum, Brian R.; Gulack, Brian C.; Adibe, Obinna O.; Tracy, Elizabeth T.; Kreissman, Susan G.; Routh, Jonathan C.

2015-01-01

Analysis of data from large administrative databases and patient registries is increasingly being used to study childhood cancer care, although the value of these data sources remains unclear to many clinicians. Interpretation of large databases requires a thorough understanding of how the dataset was designed, how data were collected, and how to assess data quality. This review will detail the role of administrative databases and registry databases for the study of childhood cancer, tools to maximize information from these datasets, and recommendations to improve the use of these databases for the study of pediatric oncology. PMID:25807938

Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry.

PubMed

Bangalore, Sripal; Pencina, Michael J; Kleiman, Neal S; Cohen, David J

2014-06-01

The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% [-0.8% to -5.8%]; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% [4.1% to -1.8%]; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [1.3% to -1.3%]; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% [-0.4% to -3.3%]; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% [2.3% to -1.5%]; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [0.7% to -0.7%]; P=1.00) when compared with unfractionated heparin monotherapy. Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use during percutaneous coronary intervention when compared with unfractionated heparin monotherapy was associated with lower bleeding without significant increase in ischemic outcomes or stent thrombosis. © 2014 American Heart Association, Inc.

Unemployment risk and income change after testicular cancer diagnosis: A population-based study.

PubMed

Rottenberg, Yakir; Ratzon, Navah Z; Jacobs, Jeremy M; Cohen, Miraim; Peretz, Tamar; de Boer, Angela G E M

2016-01-01

Among patients with cancer, returning to full working may serve as an indicator for return to normal lifestyle following illness, as opposed to unemployment or shifting to part-time work. The aim of the project was to clarify the association between unemployment risk and decreased income at 4 years after the diagnosis of testicular cancer (TC). A case control in a cohort study includes baseline measurement of people participating in the Israeli Central Bureau of Statistics 1995 National Census, and follow-up until 2011. Cancer incidence, employment status, and income level were ascertained through the Israel Cancer Registry and Tax Authority, respectively. A matched group was sampled from the population in the census. Binary logistic regression analyses were used to assess odds ratios (ORs) for study׳s outcomes, while controlling for age, ethnicity, education, and socioeconomic and employment status at 2 years before diagnosis. A total of 113 cases of TC and 468 persons in the matched group were included in the study after excluding persons who died during the study period. No association was found between TC and subsequent risk after the 4 years of unemployment (OR = 1.12, 95% CI: 0.65-1.95) or decreased income (OR = 1.41, 95% CI: 0.84-2.36). Predictors of subsequent unemployment were unemployment 2 years before diagnosis (OR = 6.91, 95% CI: 4.39-10.86) and increasing age (OR = 1.03 per year, 95% CI: 1.01-1.06). TC survivorship is not associated with subsequent unemployment or decreased income at 4 years after diagnosis. Copyright © 2016 Elsevier Inc. All rights reserved.

Factors That Contribute to Differences in Survival of Black vs White Patients With Colorectal Cancer.

PubMed

Sineshaw, Helmneh M; Ng, Kimmie; Flanders, W Dana; Brawley, Otis W; Jemal, Ahmedin

2018-03-01

Previous studies reported that black vs white disparities in survival among elderly patients with colorectal cancer (CRC) were because of differences in tumor characteristics (tumor stage, grade, nodal status, and comorbidity) rather than differences in treatment. We sought to determine the contribution of differences in insurance, comorbidities, tumor characteristics, and treatment receipt to disparities in black vs white patients with CRC 18-64 years old. We used data from the National Cancer Database, a hospital-based cancer registry database sponsored by the American College of Surgeons and the American Cancer Society, on non-Hispanic black (black) and non-Hispanic white (white) patients, 18-64 years old, diagnosed from 2004 through 2012 with single or first primary invasive stage I-IV CRC. Each black patient was matched, based on demographic, insurance, comorbidity, tumor, and treatment features, with 5 white patients, from partially overlapping subgroups, using propensity score and greedy matching algorithms. We used the Kaplan-Meier method to estimate 5-year survival and Cox proportional hazards models to generate hazard ratios. The absolute 5-year survival difference between black and white unmatched patients with CRC was 9.2% (57.3% for black patients vs 66.5% for white patients; P < .0001). The absolute difference in survival did not change after patient groups were matched for demographics, but decreased to 4.9% (47% relative decrease [4.3% of 9.2%]) when they were matched for insurance and to 2.3% when they were matched for tumor characteristics (26% relative decrease [2.4% of 9.2%]). Further matching by treatment did not reduce the difference in 5-year survival between black and white patients. In proportional hazards model, insurance and tumor characteristics matching accounted for the 54% and 27% excess risk of death in black patients, respectively. In an analysis of data from the National Cancer Database, we found that insurance coverage differences accounted for approximately one half of the disparity in survival rate of black vs white patients with CRC, 18-64 years old; tumor characteristics accounted for a quarter of the disparity. Affordable health insurance coverage for all populations could substantially reduce differences in survival times of black vs white patients with CRC. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

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

PubMed Central

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

2015-01-01

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

An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

PubMed

Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita

2015-05-01

The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

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

PubMed

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

2012-10-10

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

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

PubMed Central

Shereff, Denise; Andrews, James Everett

2012-01-01

Background Patient registries are often a helpful first step in estimating the impact and understanding the etiology of rare diseases - both requisites for the development of new diagnostics and therapeutics. The value and utility of patient registries rely on the use of both well-constructed structured research questions and relevant answer sets accompanying them. There are currently no clear standards or specifications for developing registry questions, and there are no banks of existing questions to support registry developers. Objective This paper introduces the [Rare Disease] PRISM (Patient Registry Item Specifications and Metadata for Rare Disease) project, a library of standardized questions covering a broad spectrum of rare diseases that can be used to support the development of new registries, including Internet-based registries. Methods A convenience sample of questions was identified from well-established (>5 years) natural history studies in various diseases and from several existing registries. Face validity of the questions was determined by review by many experts (both terminology experts at the College of American Pathologists (CAP) and research and informatics experts at the University of South Florida (USF)) for commonality, clarity, and organization. Questions were re-worded slightly, as needed, to make the full semantics of the question clear and to make the questions generalizable to multiple diseases where possible. Questions were indexed with metadata (structured and descriptive information) using a standard metadata framework to record such information as context, format, question asker and responder, and data standards information. Results At present, PRISM contains over 2,200 questions, with content of PRISM relevant to virtually all rare diseases. While the inclusion of disease-specific questions for thousands of rare disease organizations seeking to develop registries would present a challenge for traditional standards development organizations, the PRISM library could serve as a platform to liaison between rare disease communities and existing standardized controlled terminologies, item banks, and coding systems. Conclusions If widely used, PRISM will enable the re-use of questions across registries, reduce variation in registry data collection, and facilitate a bottom-up standardization of patient registries. Although it was initially developed to fulfill an urgent need in the rare disease community for shared resources, the PRISM library of patient-directed registry questions can be a valuable resource for registries in any disease – whether common or rare. Trial Registration N/A PMID:23611924

Premature trial discontinuation often not accurately reflected in registries: comparison of registry records with publications.

PubMed

Alturki, Reem; Schandelmaier, Stefan; Olu, Kelechi Kalu; von Niederhäusern, Belinda; Agarwal, Arnav; Frei, Roy; Bhatnagar, Neera; Hooft, Lotty; von Elm, Erik; Briel, Matthias

2017-01-01

One quarter of randomized clinical trials (RCTs) are prematurely discontinued and frequently remain unpublished. Trial registries can document whether a trial is ongoing, suspended, discontinued, or completed and therefore represent an important source for trial status information. The accuracy of this information is unclear. To examine the accuracy of completion status and reasons for discontinuation documented in trial registries as compared to corresponding publications of discontinued RCTs and to investigate potential predictors for accurate trial status information in registries. We conducted a cross-sectional study comparing information provided in publications (reference standard) to corresponding registry entries. First, we reviewed publications of RCTs providing information on both discontinuation and registration. We identified eligible publications through systematic searches of MEDLINE and EMBASE (2010-2014) and an international cohort of 1,017 RCTs initiated between 2000 and 2003. Second, pairs of investigators independently and in duplicate extracted data from publications and corresponding registry records. Third, for each discontinued RCT, we compared publication information to registry information. We used multivariable regression to examine whether accurate labeling of trials as discontinued (vs. other status) in the registry was associated with recent initiation of RCT, industry sponsorship, multicenter design, or larger sample size. We identified 173 publications of RCTs that were discontinued due to slow recruitment (55%), harm (16%), futility (11%), benefit (5%), other reasons (3%), or multiple reasons (9%). Trials were registered with clinicaltrials.gov (77%), isrctn.com (14%), or other registries (8%). Of the 173 corresponding registry records, 77 (45%) trials were labeled as discontinued and 57 (33%) provided a reason for discontinuation (of which 53, 93%, provided the same reason as in the publication). Labeling of discontinued trials as discontinued (vs. other label) in corresponding trial registry records improved over time (adjusted odds ratio 1.16 per year, confidence interval 1.04-1.30) and was possibly associated with industry sponsorship (2.01, 0.99-4.07) but unlikely with multicenter status (0.81, 0.32-2.04) or sample size (1.07, 0.89-1.29). Less than half of published discontinued RCTs were accurately labelled as discontinued in corresponding registry records. One-third of registry records provided a reason for discontinuation. Current trial status information in registries should be viewed with caution. Copyright © 2016 Elsevier Inc. All rights reserved.

Systematic Review of Cerebral Palsy Registries/Surveillance Groups: Relationships between Registry Characteristics and Knowledge Dissemination

PubMed Central

Hurley, Donna S; Sukal-Moulton, Theresa; Gaebler-Spira, Deborah; Krosschell, Kristin J; Pavone, Larissa; Mutlu, Akmer; Dewald, Julius PA; Msall, Michael E

2016-01-01

The aims of this study were to provide a comprehensive summary of the body of research disseminated by Cerebral Palsy (CP) registries and surveillance programs from January 2009 through May 2014 in order to describe the influence their results have on our overall understanding of CP. Secondly, registries/surveillance programs and the work they produced were evaluated and grouped using standardized definitions and classification systems. Method A systematic review search in PubMed, CINAH and Embase for original articles published from 1 January 2009 to 20 May 2014 originating from or supported by population based CP registries and surveillance programs or population based national registries including CP were included. Articles were grouped by 2009 World CP Registry Congress aim, registry/surveillance program classification, geographical region, and the International Classification of Function, Disability and Health (ICF) domain. Registry variables were assessed using the ICF-CY classification. Results Literature searches returned 177 articles meeting inclusion criteria. The majority (69%) of registry/surveillance program productivity was related to contributions as a Resource for CP Research. Prevention (23%) and Surveillance (22%) articles were other areas of achievement, but fewer articles were published in the areas of Planning (17%) and Raising the Profile of CP (2%). There was a range of registry/surveillance program classifications contributing to this productivity, and representation from multiple areas of the globe, although most of the articles originated in Europe, Australia, and Canada. The domains of the ICF that were primarily covered included body structures and function at the early stages of life. Encouragingly, a variety of CP registry/surveillance program initiatives included additional ICF domains of participation and environmental and personal factors. Interpretation CP registries and surveillance programs, including novel non-traditional ones, have significantly contributed to the understanding of how CP affects individuals, families and society. Moving forward, the global CP registry/surveillance program community should continue to strive for uniformity in CP definitions, variables collected and consistency with international initiatives like the ICF so that databases can be consolidated for research use. Adaptation to new technologies can improve access, reduce cost and facilitate information transfer between registrants, researchers and registries/surveillance programs. Finally, increased efforts in documenting variables of individuals with CP into adulthood should be made in order to expand our understanding of CP across the lifespan. PMID:27790626

MAOA promoter methylation and susceptibility to carotid atherosclerosis: role of familial factors in a monozygotic twin sample

PubMed Central

2012-01-01

Background Atherosclerosis is a complex process involving both genetic and epigenetic factors. The monoamine oxidase A (MAOA) gene regulates the metabolism of key neurotransmitters and has been associated with cardiovascular risk factors. This study investigates whether MAOA promoter methylation is associated with atherosclerosis, and whether this association is confounded by familial factors in a monozygotic (MZ) twin sample. Methods We studied 84 monozygotic (MZ) twin pairs drawn from the Vietnam Era Twin Registry. Carotid intima-media thickness (IMT) was measured by ultrasound. DNA methylation in the MAOA promoter region was quantified by bisulfite pyrosequencing using genomic DNA isolated from peripheral blood leukocytes. The association between DNA methylation and IMT was first examined by generalized estimating equation, followed by matched pair analyses to determine whether the association was confounded by familial factors. Results When twins were analyzed as individuals, increased methylation level was associated with decreased IMT at four of the seven studied CpG sites. However, this association substantially reduced in the matched pair analyses. Further adjustment for MAOA genotype also considerably attenuated this association. Conclusions The association between MAOA promoter methylation and carotid IMT is largely explained by familial factors shared by the twins. Because twins reared together share early life experience, which may leave a long-lasting epigenetic mark, aberrant MAOA methylation may represent an early biomarker for unhealthy familial environment. Clarification of familial factors associated with DNA methylation and early atherosclerosis will provide important information to uncover clinical correlates of disease. PMID:23116433

MAOA promoter methylation and susceptibility to carotid atherosclerosis: role of familial factors in a monozygotic twin sample.

PubMed

Zhao, Jinying; Forsberg, Christopher W; Goldberg, Jack; Smith, Nicholas L; Vaccarino, Viola

2012-11-02

Atherosclerosis is a complex process involving both genetic and epigenetic factors. The monoamine oxidase A (MAOA) gene regulates the metabolism of key neurotransmitters and has been associated with cardiovascular risk factors. This study investigates whether MAOA promoter methylation is associated with atherosclerosis, and whether this association is confounded by familial factors in a monozygotic (MZ) twin sample. We studied 84 monozygotic (MZ) twin pairs drawn from the Vietnam Era Twin Registry. Carotid intima-media thickness (IMT) was measured by ultrasound. DNA methylation in the MAOA promoter region was quantified by bisulfite pyrosequencing using genomic DNA isolated from peripheral blood leukocytes. The association between DNA methylation and IMT was first examined by generalized estimating equation, followed by matched pair analyses to determine whether the association was confounded by familial factors. When twins were analyzed as individuals, increased methylation level was associated with decreased IMT at four of the seven studied CpG sites. However, this association substantially reduced in the matched pair analyses. Further adjustment for MAOA genotype also considerably attenuated this association. The association between MAOA promoter methylation and carotid IMT is largely explained by familial factors shared by the twins. Because twins reared together share early life experience, which may leave a long-lasting epigenetic mark, aberrant MAOA methylation may represent an early biomarker for unhealthy familial environment. Clarification of familial factors associated with DNA methylation and early atherosclerosis will provide important information to uncover clinical correlates of disease.

Update of literature from cystic fibrosis registries 2012-2015. Part 6: Epidemiology, nutrition and complications.

PubMed

Salvatore, Donatello; Buzzetti, Roberto; Mastella, Gianni

2017-03-01

Patient registries provide useful information to afford more knowledge on rare diseases like Cystic Fibrosis (CF). Twenty-two studies originating from national CF registries, focusing on demographics, survival, genetics, nutritional status, and non-pulmonary complications, were published between December 2011 and March 2015. The purpose of this review article is to examine these reports, aiming attention to the clinical characteristics of CF patients included in the registries, current, and estimated future epidemiological data, the role of gender gap, the increasing survival in different countries. Some studies offer insights into pubertal growth and non-pulmonary complications, such as liver disease, nephropathy, and cancer. Pediatr Pulmonol. 2017;52:390-398. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Usefulness of the ElliPro epitope predictor program in defining the repertoire of HLA-ABC eplets.

PubMed

Duquesnoy, Rene J; Marrari, Marilyn

HLA matching at the epitope level offers new opportunities to identify suitable donors for transplant patients. The International HLA Epitope Registry (www.Epregistry.com.br) describes for the various HLA loci, repertoires of eplets including those that correspond to epitopes experimentally verified with specific antibodies. There are also many eplets which have remained as theoretical entities because no informative antibodies have been found. Which of them have immunogenic potential or conversely, might be considered as non-epitopes that cannot elicit specific antibody responses? This question is important for the application of epitope-based HLA matching in clinical transplantation. Correct predictions of B-cell epitopes on antigenic proteins are essential to the effective design of microbial vaccines and the development of specific antibodies used in immunotherapy and immunodiagnostics but prediction programs based on structural and physiochemical properties of amino acid residues are generally ineffective. Recent prediction programs based on three-dimensional structures of antigen-antibody complexes are more promising. One such program is called ElliPro developed by Ponomarenko. This report describes studies demonstrating that ElliPro can predict alloantibody responses to HLA-ABC eplets. Antibody-verified eplets have amino acid residues with much higher ElliPro scores than eplets for which no specific antibodies have been found. The latter group includes residues with very low ElliPro scores; they appear to represent eplets that might be classified as non-epitopes. In conclusion, ElliPro offers a new approach to characterize epitope repertoires that are clinically relevant in HLA matching. Copyright © 2017. Published by Elsevier Inc.

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.

The effect of previous traumatic injury on homicide risk.

PubMed

Griffin, Russell L; Davis, Gregory G; Levitan, Emily B; MacLennan, Paul A; Redden, David T; McGwin, Gerald

2014-07-01

Research has reported that a strong risk factor for traumatic injury is having a previous injury (i.e., recidivism). To date, the only study examining the relationship between recidivism and homicide reported strong associations, but was limited by possible selection bias. The current matched case-control study utilized coroner's data from 2004 to 2008. Subjects were linked to trauma registry data to determine whether the person had a previous traumatic injury. Conditional logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (95% CIs) for the association between homicide and recidivism. Homicide risk was increased for those having a previous traumatic injury (OR 1.81, 95% CI 1.09-2.99) or a previous intentional injury (OR 2.53, 95% CI 1.24-5.17). These results suggest an association between homicide and injury recidivism, and that trauma centers may be an effective setting for screening individuals for secondary prevention efforts of homicide through violence prevention programs. © 2014 American Academy of Forensic Sciences.

Functional outcome after primary endovascular therapy or IV thrombolysis alone for stroke. An observational, comparative effectiveness study.

PubMed

Abilleira, Sònia; Ribera, Aida; Dávalos, Antonio; Ribó, Marc; Chamorro, Angel; Cardona, Pere; Molina, Carlos A; Martínez-Yélamos, Antonio; Urra, Xabier; Dorado, Laura; Roquer, Jaume; Martí-Fàbregas, Joan; Aja, Lucía; Tomasello, Alejandro; Castaño, Carlos; Blasco, Jordi; Cánovas, David; Castellanos, Mar; Krupinski, Jerzy; Guimaraens, Leopoldo; Perendreu, Joan; Ustrell, Xavier; Purroy, Francisco; Gómez-Choco, Manuel; Baiges, Joan Josep; Cocho, Dolores; Saura, Júlia; Gallofré, Miquel

2014-01-01

Among the acute ischemic stroke patients with large vessel occlusions and contraindications for the use of IV thrombolysis, mainly on oral anticoagulation or presenting too late, primary endovascular therapy is often performed as an alternative to the standard therapy even though evidence supporting the use of endovascular reperfusion therapies is not yet established. Using different statistical approaches, we compared the functional independence rates at 3 months among patients undergoing primary endovascular therapy and patients treated only with IV thrombolysis. We used data from a prospective, government-mandated and externally audited registry of reperfusion therapies for ischemic stroke (January 2011 to November 2012). Patients were selected if treated with either IV thrombolysis alone (n = 1,582) or primary endovascular thrombectomy (n = 250). A series of exclusions were made to homogenize the clinical characteristics among the two groups. We then carried out multivariate logistic regression and propensity score matching analyses on the final study sample (n = 1,179) to compare functional independence at 3 months, as measured by the modified Rankin scale scores 0-2, between the two groups. The unadjusted likelihood of good outcome was poorer among the endovascular group (OR: 0.69; 95% CI: 0.47-1.0). After adjustment, no differences by treatment modality were seen (OR: 1.51; 95% CI: 0.93-2.43 for primary endovascular therapy). Patients undergoing endovascular thrombectomy within 180-270 min (OR: 2.89; 95% CI: 1.17-7.15) and patients with severe strokes (OR: 1.84; 95% CI: 1.02-3.35) did better than their intravenous thrombolysis counterparts. The propensity score-matched analyses with and without adjustment by additional covariates showed that endovascular thrombectomy was as effective as intravenous thrombolysis alone in achieving functional independence (OR for unadjusted propensity score matched: 1.35; 95% CI: 0.9-2.02, OR for adjusted propensity score matched: 1.45; 95% CI: 0.91-2.32). This comparative effectiveness study shows that in ischemic stroke patients with contraindications for IV thrombolysis, primary endovascular treatment might be an alternative therapy at least as effective as IV thrombolysis alone. Randomized controlled trials are urgently needed. © 2014 S. Karger AG, Basel.

Beta-blocker usage after malignant melanoma diagnosis and survival: a population-based nested case-control study.

PubMed

McCourt, C; Coleman, H G; Murray, L J; Cantwell, M M; Dolan, O; Powe, D G; Cardwell, C R

2014-04-01

Beta-blockers have potential antiangiogenic and antimigratory activity. Studies have demonstrated a survival benefit in patients with malignant melanoma treated with beta-blockers. To investigate the association between postdiagnostic beta-blocker usage and risk of melanoma-specific mortality in a population-based cohort of patients with malignant melanoma. Patients with incident malignant melanoma diagnosed between 1998 and 2010 were identified within the U.K. Clinical Practice Research Datalink and confirmed using cancer registry data. Patients with malignant melanoma with a melanoma-specific death (cases) recorded by the Office of National Statistics were matched on year of diagnosis, age and sex to four malignant melanoma controls (who lived at least as long after diagnosis as their matched case). A nested case-control approach was used to investigate the association between postdiagnostic beta-blocker usage and melanoma-specific death and all-cause mortality. Conditional logistic regression was applied to generate odds ratios (ORs) and 95% confidence intervals (CIs) for beta-blocker use determined from general practitioner prescribing. Beta-blocker medications were prescribed after malignant melanoma diagnosis to 20·2% of 242 patients who died from malignant melanoma (cases) and 20·3% of 886 matched controls. Consequently, there was no association between beta-blocker use postdiagnosis and cancer-specific death (OR 0·99, 95% CI 0·68-1·42), which did not markedly alter after adjustment for confounders including stage (OR 0·87, 95% CI 0·56-1·34). No significant associations were detected for individual beta-blocker types, by defined daily doses of use or for all-cause mortality. Contrary to some previous studies, beta-blocker use after malignant melanoma diagnosis was not associated with reduced risk of death from melanoma in this U.K. population-based study. © 2014 British Association of Dermatologists.

Labour market participation and sick leave among patients diagnosed with myasthenia gravis in Denmark 1997-2011: a Danish nationwide cohort study.

PubMed

Frost, Asger; Svendsen, Marie Louise; Rahbek, Jes; Stapelfeldt, Christina Malmose; Nielsen, Claus Vinther; Lund, Thomas

2016-11-17

To examine labour market participation and long-term sick leave following a diagnosis with myasthenia gravis (MG) compared with the general Danish population and for specific subgroups of MG patients. A nationwide matched cohort study from 1997 to 2011 using data from population-based medical and social registries. The study includes 330 MG patients aged 18 to 65 years old identified from hospital diagnoses and dispensed prescriptions, and twenty references from the Danish population matching each MG patient on age, gender, and profession. Main outcome measures are labour market participation (yes/no) and long-term sick leave ≥9 weeks (yes/no) with follow-up at 1- and 2 years after the time of MG diagnosis or match. Based on complete person-level information on all public transfer payments in Denmark, persons having no labour market participation are defined as individuals receiving social benefits for severely reduced workability, flexijob, and disability pension. MG is consistently associated with higher odds of having no labour market participation and long-term sick leave compared with the general Danish population (no labour market participation & ≥9 weeks sick leave at 2-year follow-up, adjusted OR (95% CI): 5.76 (4.13 to 8.04) & 8.60 (6.60 to 11.23)). Among MG patients, females and patients treated with both acetylcholinesterase inhibitors and immunosuppression have higher odds of lost labour market participation and long-term sick leave. This study suggests that MG patients have almost 6 times higher odds of no labour market participation and almost 9 times higher odds of long-term sick leave 2 years after diagnosis compared with the general Danish population. In particular female MG patients and patients treated with both acetylcholinesterase and immunosuppression have high odds of a negative labour market outcome. Future research should focus on predictors in workplace and labour market policy of labour market participation among MG patients.

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

PubMed

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

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.

The Matchmaker Exchange API: automating patient matching through the exchange of structured phenotypic and genotypic profiles

PubMed Central

Buske, Orion J.; Schiettecatte, François; Hutton, Benjamin; Dumitriu, Sergiu; Misyura, Andriy; Huang, Lijia; Hartley, Taila; Girdea, Marta; Sobreira, Nara; Mungall, Chris; Brudno, Michael

2016-01-01

Despite the increasing prevalence of clinical sequencing, the difficulty of identifying additional affected families is a key obstacle to solving many rare diseases. There may only be a handful of similar patients worldwide, and their data may be stored in diverse clinical and research databases. Computational methods are necessary to enable finding similar patients across the growing number of patient repositories and registries. We present the Matchmaker Exchange Application Programming Interface (MME API), a protocol and data format for exchanging phenotype and genotype profiles to enable matchmaking among patient databases, facilitate the identification of additional cohorts, and increase the rate with which rare diseases can be researched and diagnosed. We designed the API to be straightforward and flexible in order to simplify its adoption on a large number of data types and workflows. We also provide a public test data set, curated from the literature, to facilitate implementation of the API and development of new matching algorithms. The initial version of the API has been successfully implemented by three members of the Matchmaker Exchange and was immediately able to reproduce previously-identified matches and generate several new leads currently being validated. The API is available at https://github.com/ga4gh/mme-apis. PMID:26255989

The Matchmaker Exchange API: automating patient matching through the exchange of structured phenotypic and genotypic profiles.

PubMed

Buske, Orion J; Schiettecatte, François; Hutton, Benjamin; Dumitriu, Sergiu; Misyura, Andriy; Huang, Lijia; Hartley, Taila; Girdea, Marta; Sobreira, Nara; Mungall, Chris; Brudno, Michael

2015-10-01

Despite the increasing prevalence of clinical sequencing, the difficulty of identifying additional affected families is a key obstacle to solving many rare diseases. There may only be a handful of similar patients worldwide, and their data may be stored in diverse clinical and research databases. Computational methods are necessary to enable finding similar patients across the growing number of patient repositories and registries. We present the Matchmaker Exchange Application Programming Interface (MME API), a protocol and data format for exchanging phenotype and genotype profiles to enable matchmaking among patient databases, facilitate the identification of additional cohorts, and increase the rate with which rare diseases can be researched and diagnosed. We designed the API to be straightforward and flexible in order to simplify its adoption on a large number of data types and workflows. We also provide a public test data set, curated from the literature, to facilitate implementation of the API and development of new matching algorithms. The initial version of the API has been successfully implemented by three members of the Matchmaker Exchange and was immediately able to reproduce previously identified matches and generate several new leads currently being validated. The API is available at https://github.com/ga4gh/mme-apis. © 2015 WILEY PERIODICALS, INC.

Substantial underreporting of anastomotic leakage after anterior resection for rectal cancer in the Swedish Colorectal Cancer Registry.

PubMed

Rutegård, Martin; Kverneng Hultberg, Daniel; Angenete, Eva; Lydrup, Marie-Louise

2017-12-01

The causes and effects of anastomotic leakage after anterior resection are difficult to study in small samples and have thus been evaluated using large population-based national registries. To assess the accuracy of such research, registries should be validated continuously. Patients who underwent anterior resection for rectal cancer during 2007-2013 in 15 different hospitals in three healthcare regions in Sweden were included in the study. Registry data and information from patient records were retrieved. Registered anastomotic leakage within 30 postoperative days was evaluated, using all available registry data and using only the main variable anastomotic insufficiency. With the consensus definition of anastomotic leakage developed by the International Study Group on Rectal Cancer as reference, validity measures were calculated. Some 1507 patients were included in the study. The negative and positive predictive values for registered anastomotic leakage were 96 and 88%, respectively, while the κ-value amounted to 0.76. The false-negative rate was 29%, whereas the false-positive rate reached 1.3% (the vast majority consisting of actual leaks, but occurring after postoperative day 30). Using the main variable anastomotic insufficiency only, the false-negative rate rose to 41%. There is considerable underreporting of anastomotic leakage after anterior resection for rectal cancer in the Swedish Colorectal Cancer Registry. It is probable that this causes an underestimation of the true effects of leakage on patient outcomes, and further quality control is needed.

Feasibility of evaluating quality cancer care using registry data and electronic health records: a population-based study.

PubMed

Caldarella, Adele; Amunni, Gianni; Angiolini, Catia; Crocetti, Emanuele; Di Costanzo, Francesco; Di Leo, Angelo; Giusti, Francesco; Pegna, Andrea Lopes; Mantellini, Paola; Luzzatto, Lucio; Paci, Eugenio

2012-08-01

To evaluate the quality of patients care, a set of indicators of the standards of cancer care were defined. We developed a set of indicators to assess the implementation in daily practice of recommendation produced by a regional network (Istituto Toscano Tumori). This set was tested in a retrospective study in the resident population of the Tuscany Region; the regional health system is organized on 12 local health authorities which refer to three macro areas (Area Vasta). The study included incident colorectal, lung and breast cancer cases listed in 2004 for the Tuscan Cancer Registry, a population-based registry which collected tumor cases diagnosed in all residents in Tuscany. Electronic data from registry database were used to determine the compliance with each indicator for patients in 2004. To validate the results, an ad hoc clinical survey including the same geographical area for the year 2006 was performed. None. The proportion of patients who fulfilled each of the indicators. Our study showed the feasibility of the evaluation of the quality of cancer care using cancer registry population-based data and major computerized information systems. The estimation of the selected indicators confirmed a good homogeneity among areas, and globally revealed a good intraregional performance. Further work is needed to develop specific quality measures, particularly about structural data and to continually revise indicators of quality of care. Data from a cancer registry, however, can be useful to evaluate quality of cancer care.

Meta-Analysis of Survival Curve Data Using Distributed Health Data Networks: Application to Hip Arthroplasty Studies of the International Consortium of Orthopaedic Registries

ERIC Educational Resources Information Center

Cafri, Guy; Banerjee, Samprit; Sedrakyan, Art; Paxton, Liz; Furnes, Ove; Graves, Stephen; Marinac-Dabic, Danica

2015-01-01

The motivating example for this paper comes from a distributed health data network, the International Consortium of Orthopaedic Registries (ICOR), which aims to examine risk factors for orthopedic device failure for registries around the world. Unfortunately, regulatory, privacy, and propriety concerns made sharing of raw data impossible, even if…

Unequal care for dying patients in Sweden: a comparative registry study of deaths from heart disease and cancer.

PubMed

Brännström, Margareta; Hägglund, Lena; Fürst, Carl Johan; Boman, Kurt

2012-12-01

The Swedish Palliative Registry is a nationwide quality registry aimed at facilitating improvement in end-of-life care. The goal is for the registry to list and report quality indicators related to care during the last week of life in all cases expected death in Sweden. To examine the quality of care during the last week of life as reported to the registry for patients with heart disease compared to those with cancer. A retrospective registry study. Patients dying of heart disease compared to those dying from cancer had more shortness of breath, fewer drugs prescribed as needed against the usual symptoms and often died alone. Furthermore, they and their close relatives received less information about the imminence of death and bereavement follow-up was less common. The healthcare personnel were less aware of the heart disease patients' symptoms and less often knew about where they wished to die. Great differences were found in registered end-of-life care suggesting that the care given to patients with heart disease and cancer was unequal even after adjustment for age, sex and setting at the time of death. If our observational findings are confirmed in future studies there is obviously a need for new models for end-of-life management in order to facilitate the provision of equal care to dying patients regardless of diagnosis.

A UK medical devices regulator's perspective on registries.

PubMed

Wilkinson, John; Crosbie, Andy

2016-04-01

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

Big Data in Organ Transplantation: Registries and Administrative Claims

PubMed Central

Massie, Allan B.; Kucirka, Lauren; Segev, Dorry L.

2015-01-01

The field of organ transplantation benefits from large, comprehensive, transplant-specific national datasets available to researchers. In addition to the widely-used OPTN-based registries (the UNOS and SRTR datasets) and USRDS datasets, there are other publicly available national datasets, not specific to transplantation, which have historically been underutilized in the field of transplantation. Of particular interest are the Nationwide Inpatient Sample (NIS) and State Inpatient Databases (SID), produced by the Agency for Healthcare Research and Quality (AHRQ). The United States Renal Data System (USRDS) database provides extensive data relevant to studies of kidney transplantation. Linkage of publicly available datasets to external data sources such as private claims or pharmacy data provides further resources for registry-based research. Although these resources can transcend some limitations of OPTN-based registry data, they come with their own limitations, which must be understood to avoid biased inference. This review discusses different registry-based data sources available in the United States, as well as the proper design and conduct of registry-based research. PMID:25040084

Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial

PubMed Central

2013-01-01

Background Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting at-risk family members involves contacting the original cancer cases and asking them to provide information about their at-risk relatives, who must then be contacted for study enrollment. Though this recruitment strategy is common in family trials, few studies have compared influences of patient and relative participation to nonparticipation. Furthermore, although use of cancer registries to identify initial cases has increased, to our knowledge no study has examined the relationship between registries and family recruitment outcomes. Methods This study assessed predictors of case participation and relative enrollment in a recruitment process that utilized state cancer registries. Participation characteristics were analyzed with separate multivariable logistic regressions in three stages: (1) cancer registry-contacted colorectal cancer (CRC) cases who agreed to study contact; (2) study-contacted CRC cases who provided at-risk relative information; and (3) at-risk relatives contacted for intervention participation. Results Cancer registry source was predictive of participation for both CRC cases and relatives, though relative associations (odds ratios) varied across registries. Cases were less likely to participate if they were Hispanic or nonwhite, and were more likely to participate if they were female or younger than 50 at cancer diagnosis. At-risk relatives were more likely to participate if they were from Utah, if another family member was also participating in the study, or if they had previously had a colonoscopy. The number of eligible cases who had to be contacted to enroll one eligible relative varied widely by registry, from 7 to 81. Conclusions Family recruitment utilizing cancer registry-identified cancer cases is feasible, but highly dependent on both the strategies and protocols of those who are recruiting and on participant characteristics such as sex, race, or geography. Devising comprehensive recruitment protocols that specifically target those less likely to enroll may help future research meet recruitment goals. Trial registration Family Colorectal Cancer Awareness and Risk Education Project NCT01274143. PMID:23782890

Quality registry, a tool for patient advantages - from a preventive caring perspective.

PubMed

Rosengren, Kristina; Höglund, Pär J; Hedberg, Berith

2012-03-01

The aim of this study was to describe nurses' experiences of a recently implemented quality register, Senior Alert, at two hospitals in Sweden. In Sweden, in recent decades, a system of national quality registries has been established in health and medical services for better outcomes for patients, professional development and a better functioning system. Senior Alert (SA) is one quality registry, aimed at preventing malnutrition, pressure ulcers and falls in elderly care. The study comprised a total of eight interviews with nurses working with SA at the ward level. The interviews were analysed using manifest qualitative content analysis. Respect for the individuals was a main concern in the study. All persons who were asked to participate in the study consented to do so. One category 'Patient Advantages' and three subcategories 'Conscious Persevering', 'Supporting Structure' and 'Committed Leadership' were identified to describe staff experiences of implementing SA. Implementation processes need to be sustainable at both staff and managerial levels. A key factor in implementing and using a quality registry in prevention care could be described as keeping the flame burning. However, further research is needed on how patient advantages could be developed using other quality registries in order to improve care from a patient perspective. The results of this study could help other organizations implement quality registries or other change processes, for example new guidelines and treatment. Strategies concerning organizational structure and committed leadership could increase the usefulness of knowledge systems on all levels, which could enable continuous learning and quality improvement in health care. © 2012 Blackwell Publishing Ltd.

Improving Interoperability between Registries and EHRs

PubMed Central

Blumenthal, Seth

2018-01-01

National performance measurement needs clinical data that track the performance of multi disciplinary teams across episodes of care. Clinical registries are ideal platforms for this work due to their capture of structured, specific data across specialties. Because registries collect data at a national level, and registry data are captured in a consistent structure and format within each registry, registry data are useful for measurement and analysis “out of the box”. Registry business models are hampered by the cost of collecting data from EHRs and other source systems and abstracting or mapping them to fit registry data models. The National Quality Registry Network (NQRN) has launched Registries on FHIR, an initiative to lower barriers to achieving semantic interoperability between registries and source data systems. In 2017 Registries on FHIR conducted an information gathering campaign to learn where registries want better interoperability, and how to go about improving it. PMID:29888033

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.

Associations of Bariatric Surgery With Changes in Interpersonal Relationship Status: Results From 2 Swedish Cohort Studies.

PubMed

Bruze, Gustaf; Holmin, Tobias E; Peltonen, Markku; Ottosson, Johan; Sjöholm, Kajsa; Näslund, Ingmar; Neovius, Martin; Carlsson, Lena M S; Svensson, Per-Arne

2018-03-28

Bariatric surgery is a life-changing treatment for patients with severe obesity, but little is known about its association with interpersonal relationships. To investigate if relationship status is altered after bariatric surgery. Changes in relationship status after bariatric surgery were examined in 2 cohorts: (1) the prospective Swedish Obese Subjects (SOS) study, which recruited patients undergoing bariatric surgery from September 1, 1987, to January 31, 2001, and compared their care with usual nonsurgical care in matched obese control participants; and (2) participants from the Scandinavian Obesity Surgery Registry (SOReg), a prospective, electronically captured register that recruited patients from January 2007 through December 2012 and selected comparator participants from the general population matched on age, sex, and place of residence. Data was collected in surgical departments and primary health care centers in Sweden. The current analysis includes data collected up until July 2015 (SOS) and December 2012 (SOReg). Data analysis was completed from June 2016 to December 2017. In the SOS study, information on relationship status was obtained from questionnaires. In the SOReg and general population cohort, information on marriage and divorce was obtained from the Swedish Total Population Registry. The SOS study included 1958 patients who had bariatric surgery (of whom 1389 [70.9%] were female) and 1912 matched obese controls (of whom 1354 [70.8%] were female) and had a median (range) follow-up of 10 (0.5-20) years. The SOReg cohort included 29 234 patients who had gastric bypass surgery (of whom 22 131 [75.6%] were female) and 283 748 comparators from the general population (of whom 214 342 [75.5%] were female), and had a median (range) follow-up of 2.9 (0.003-7.0) years. In the SOS study, the surgical patients received gastric banding (n = 368; 18.8%), vertical banded gastroplasty (n = 1331; 68.0%), or gastric bypass (n = 259; 13.2%); controls received usual obesity care. In SOReg, all 29 234 surgical participants received gastric bypass surgery. In the SOS study, bariatric surgery was associated with increased incidence of divorce/separation compared with controls for those in a relationship (adjusted hazard ratio [aHR] = 1.28; 95% CI, 1.03-1.60; P = .03) and increased incidence of marriage or new relationship (aHR = 2.03; 95% CI, 1.52-2.71; P < .001) in those who were unmarried or single at baseline. In the SOReg and general population cohort, gastric bypass was associated with increased incidence of divorce compared with married control participants (aHR = 1.41; 95% CI, 1.33-1.49; P < .001) and increased incidence of marriage in those who were unmarried at baseline (aHR = 1.35; 95% CI, 1.28-1.42; P < .001). Within the surgery groups, changes in relationship status were more common in those with larger weight loss. In addition to its association with obesity comorbidities, bariatric surgery-induced weight loss is also associated with changes in relationship status.

Establishing of National Birth Defects Registry in Thailand.

PubMed

Pangkanon, Suthipong; Sawasdivorn, Siraporn; Kuptanon, Chulaluck; Chotigeat, Uraiwan; Vandepitte, Warunee

2014-06-01

Deaths attributed to birth defects are a major cause of infant and under-five mortality as well as lifetime disabilities among those who survive. In Thailand, birth defects contribute to 21% of neonatal deaths. There is currently no systematic registry for congenital anomalies in Thailand. Queen Sirikit National Institute of Child Health has initiated a Thailand Birth Defects Registry to capture birth defects among newborn infants. To establish the national birth defects registry in order to determine the burden of birth defects in Thailand. The birth defects data come from four main sources: National Birth Registry Database; National Health Security Office's reimbursement database; Online Birth Defect Registry Database designed to capture new cases that were detected later; and birth defects data from 20 participated hospitals. All data are linked by unique 13-digit national identification number and International Classification of Diseases (ICD)-10 codes. This registry includes 19 common structural birth defects conditions and pilots in 20 hospitals. The registry is hospital-based, hybrid reporting system, including only live births whose information was collected up to 1 year of age. 3,696 infants out of 67,813 live births (8.28% of total live births in Thailand) were diagnosed with congenital anomalies. The prevalence rate of major anomalies was 26.12 per 1,000 live births. The five most common birth defects were congenital heart defects, limb anomalies, cleft lip/cleft palate, Down syndrome, and congenital hydrocephalus respectively. The present study established the Birth Defects Registry by collecting data from four databases in Thailand. Information obtained from this registry and surveillance is essential in the planning for effective intervention programs for birth defects. The authors suggest that this program should be integrated in the existing public health system to ensure sustainability.

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

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

PubMed

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

2015-12-01

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

A comparison of operative outcomes between standard and robotic laparoscopic surgery for endometrial cancer: A systematic review and meta‐analysis

PubMed Central

Laios, Alex; Hacking, Matthew; Nobbenhuis, Marielle

2017-01-01

Abstract Background Evidence has been systematically assessed comparing robotic with standard laparoscopy for treatment of endometrial cancer. Methods A search of Medline, Embase and Cochrane databases was performed until 30th October 2016. Results Thirty‐six papers including 33 retrospective studies, two matched case–control studies and one randomized controlled study were used in a meta‐analysis. Information from a further seven registry/database studies were assessed descriptively. There were no differences in the duration of surgery but days stay in hospital were shorter in the robotic arm (0.46 days, 95%CI 0.26 to 0.66). A robotic approach had less blood loss (57.74 mL, 95%CI 38.29 to 77.20), less conversions to laparotomy (RR = 0.41, 95%CI 0.29 to 0.59), and less overall complications (RR = 0.82, 95%CI 0.72 to 0.93). A robotic approach had higher costs ($1746.20, 95%CI $63.37 to $3429.03). Conclusion A robotic approach has favourable clinical outcomes but is more expensive. PMID:28762635

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

PubMed

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

2013-01-01

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

Common data items in seven European oesophagogastric cancer surgery registries: towards a European upper GI cancer audit (EURECCA Upper GI).

PubMed

de Steur, W O; Henneman, D; Allum, W H; Dikken, J L; van Sandick, J W; Reynolds, J; Mariette, C; Jensen, L; Johansson, J; Kolodziejczyk, P; Hardwick, R H; van de Velde, C J H

2014-03-01

Seven countries (Denmark, France, Ireland, the Netherlands, Poland, Sweden, United Kingdom) collaborated to initiate a EURECCA (European Registration of Cancer Care) Upper GI project. The aim of this study was to identify a core dataset of shared items in the different data registries which can be used for future collaboration between countries. Item lists from all participating Upper GI cancer registries were collected. Items were scored 'present' when included in the registry, or when the items could be deducted from other items in the registry. The definition of a common item was that it was present in at least six of the seven participating countries. The number of registered items varied between 40 (Poland) and 650 (Ireland). Among the 46 shared items were data on patient characteristics, staging and diagnostics, neoadjuvant treatment, surgery, postoperative course, pathology, and adjuvant treatment. Information on non-surgical treatment was available in only 4 registries. A list of 46 shared items from seven participating Upper GI cancer registries was created, providing a basis for future quality assurance and research in Upper GI cancer treatment on a European level. Copyright © 2013 Elsevier Ltd. All rights reserved.

Creating an effective clinical registry for rare diseases

PubMed Central

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

2015-01-01

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

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

PubMed

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

2016-02-01

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

Enhancing Cancer Registry Data for Comparative Effectiveness Research (CER) Project: Overview and Methodology

PubMed Central

Chen, Vivien W.; Eheman, Christie R.; Johnson, Christopher J.; Hernandez, Monique N.; Rousseau, David; Styles, Timothy S.; West, Dee W.; Hsieh, Meichin; Hakenewerth, Anne M.; Celaya, Maria O.; Rycroft, Randi K.; Wike, Jennifer M.; Pearson, Melissa; Brockhouse, Judy; Mulvihill, Linda G.; Zhang, Kevin B.

2015-01-01

Following the Institute of Medicine's 2009 report on the national priorities for comparative effectiveness research (CER), funding for support of CER became available in 2009 through the American Recovery and Reinvestment Act. The Centers for Disease Control and Prevention (CDC) received funding to enhance the infrastructure of population-based cancer registries and to expand registry data collection to support CER. The CDC established 10 specialized registries within the National Program of Cancer Registries (NPCR) to enhance data collection for all cancers and to address targeted CER questions, including the clinical use and prognostic value of specific biomarkers. The project also included a special focus on detailed first course of treatment for cancers of the breast, colon, and rectum, as well as chronic myeloid leukemia (CML) diagnosed in 2011. This paper describes the methodology and the work conducted by the CDC and the NPCR specialized registries in collecting data for the 4 special focused cancers, including the selection of additional data variables, development of data collection tools and software modifications, institutional review board approvals, training, collection of detailed first course of treatment, and quality assurance. It also presents the characteristics of the study population and discusses the strengths and limitations of using population-based cancer registries to support CER as well as the potential future role of population-based cancer registries in assessing the quality of patient care and cancer control. PMID:25419602

Enhancing cancer registry data for comparative effectiveness research (CER) project: overview and methodology.

PubMed

Chen, Vivien W; Eheman, Christie R; Johnson, Christopher J; Hernandez, Monique N; Rousseau, David; Styles, Timothy S; West, Dee W; Hsieh, Meichin; Hakenewerth, Anne M; Celaya, Maria O; Rycroft, Randi K; Wike, Jennifer M; Pearson, Melissa; Brockhouse, Judy; Mulvihill, Linda G; Zhang, Kevin B

2014-01-01

Following the Institute of Medicine's 2009 report on the national priorities for comparative effectiveness research (CER), funding for support of CER became available in 2009 through the American Recovery and Re-investment Act. The Centers for Disease Control and Prevention (CDC) received funding to enhance the infrastructure of population-based cancer registries and to expand registry data collection to support CER. The CDC established 10 specialized registries within the National Program of Cancer Registries (NPCR) to enhance data collection for all cancers and to address targeted CER questions, including the clinical use and prognostic value of specific biomarkers. The project also included a special focus on detailed first course of treatment for cancers of the breast, colon, and rectum, as well as chronic myeloid leukemia (CML) diagnosed in 2011. This paper describes the methodology and the work conducted by the CDC and the NPCR specialized registries in collecting data for the 4 special focused cancers, including the selection of additional data variables, development of data collection tools and software modifications, institutional review board approvals, training, collection of detailed first course of treatment, and quality assurance. It also presents the characteristics of the study population and discusses the strengths and limitations of using population-based cancer registries to support CER as well as the potential future role of population-based cancer registries in assessing the quality of patient care and cancer control.

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

Association between Physician Orders for Life-Sustaining Treatment for Scope of Treatment and in-hospital death in Oregon.

PubMed

Fromme, Erik K; Zive, Dana; Schmidt, Terri A; Cook, Jennifer N B; Tolle, Susan W

2014-07-01

To examine the relationship between Physician Orders for Life-Sustaining Treatment (POLST) for Scope of Treatment and setting of care at time of death. Cross-sectional. Oregon in 2010 and 2011. People who died of natural causes. Oregon death records containing cause and location of death were matched with POLST orders for people with a POLST form in the Oregon POLST registry. Logistic regression was used to measure the association between POLST orders and location of death. Of 58,000 decedents, 17,902 (30.9%) had a POLST form in the registry. Their orders for Scope of Treatment were comfort measure only, 11,836 (66.1%); limited interventions, 4,787 (26.7%); and full treatment, 1,153 (6.4%). Comfort measures only (CMO) orders advise avoiding hospitalization unless comfort cannot be achieved in the current setting; 6.4% of participants with POLST CMO orders died in the hospital, compared with 44.2% of those with orders for full treatment and 34.2% for those with no POLST form in the registry. In the logistic regression, the odds of dying in the hospital of those with an order for limited interventions was 3.97 times as great (95% CI = 3.59-4.39) as of those with a CMO order, and the odds of those with an order for full treatment was 9.66 times as great (95% CI = 8.39-11.13). The association with numbers of deaths in the hospital suggests that end-of-life preferences of people who wish to avoid hospitalization as documented in POLST orders are honored. © 2014, Copyright the Authors Journal compilation © 2014, The American Geriatrics Society.

Epidemiology and outcomes of pregnancy and obstetric complications in trauma in the United Kingdom.

PubMed

Battaloglu, Emir; McDonnell, Declan; Chu, Justin; Lecky, Fiona; Porter, Keith

2016-01-01

To understand the epidemiology of pregnancy and obstetric complications encountered in the management of pregnant trauma patients. Retrospective analysis of national trauma registry for recording of pregnancy status or obstetric complication in cases of trauma. Sub-division of patient cohort by severity of trauma and stage of pregnancy. Comparison of data sets between pregnant trauma patients and age-matched non-pregnant female trauma patients to determine patterns of injury and impact upon clinical outcomes. National registry data for the United Kingdom. For the five year period between 2009 and 2014, a total of 15,140 female patients, aged between 15 years old and 50 years old were identified within the trauma registry. A record of pregnancy was identified in 173 patients (1.14%) from within this cohort. Mechanisms of injury within the cohort of pregnant trauma patients saw increased rate of vehicular collision and interpersonal violence, especially penetrating trauma. Higher abbreviated injury scores were recorded for the abdominal region in pregnancy than in the non-pregnant cohort. Maternal mortality rates were seen to be higher, when compared with the non-pregnant trauma patient. Foetal survival rate from this series was 56% following trauma. Foetal death in pregnant trauma patients most frequently occurred in the 2nd trimester. No cases of isolated foetal survival were recorded following maternal trauma. Trauma to pregnant patients is rare in the United Kingdom, encountered in 1% of female trauma patients of child bearing age. Observations in altered mechanisms of injury and clinical outcomes were recorded. This provides useful information regarding the clinical management of pregnant trauma patients and offers potential areas to investigate to optimise their care, as well as to focus injury prevention measures. IV--Case series. Copyright © 2015 Elsevier Ltd. All rights reserved.

Rectal squamous cell carcinoma in immunosuppressed populations: is this a distinct entity from anal cancer?

PubMed Central

COGHILL, Anna E.; SHIELS, Meredith S.; RYCROFT, Randi K.; COPELAND, Glenn; FINCH, Jack L.; HAKENEWERTH, Anne M.; PAWLISH, Karen S.; ENGELS, Eric A.

2015-01-01

Objective Squamous cell carcinoma (SCC) of the rectum is rare, but as with anal cancer, risk may be increased among immunosuppressed individuals. We assessed risk of rectal SCC in HIV-infected people. Design Population-based registry Methods We utilized the HIV/AIDS Cancer Match, a linkage of US HIV and cancer registries (1991–2010), to ascertain cases of anal SCC, rectal SCC, rectal non-SCC, and colon non-SCC. We compared risk in HIV-infected persons to the general population using standardized incidence ratios (SIRs) and evaluated risk factors using Poisson regression. We reviewed cancer registry case notes to confirm site and histology for a subset of cases. Results HIV-infected persons had an excess risk of rectal SCC compared to the general population (SIR=28.9; 95%CI 23.2–35.6), similar to the increase for anal SCC (SIR=37.3). Excess rectal SCC risk was most pronounced among HIV-infected men who have sex with men (MSM, SIR=61.2). Risk was not elevated for rectal non-SCC (SIR=0.88) or colon non-SCC (SIR=0.63). Individuals diagnosed with AIDS had higher rectal SCC rates than those with HIV-only (incidence rate ratio=1.86; 95%CI 1.04–3.31). Based on available information, one-third of rectal SCCs were determined to be misclassified anal cancer. Conclusions HIV-infected individuals, especially with advanced immunosuppression, appear to have substantially elevated risk for rectal SCC. As for anal SCC, rectal SCC risk was highest in MSM, pointing to involvement of a sexually transmitted infection such as human papillomavirus. Site misclassification was present, and detailed information on tumor location is needed to prove that rectal SCC is a distinct entity. PMID:26372482

Cardioversion and subsequent quality of life and natural history of atrial fibrillation.

PubMed

Pokorney, Sean D; Kim, Sunghee; Thomas, Laine; Fonarow, Gregg C; Kowey, Peter R; Gersh, Bernard J; Mahaffey, Kenneth W; Peterson, Eric D; Piccini, Jonathan P

2017-03-01

Cardioversion is a class I procedure for patients with symptomatic atrial fibrillation (AF) pursuing rhythm control. There are few contemporary reports on quality of life and outcomes after cardioversion. Using the nationwide prospective ORBIT-AF registry, cardioversion patients were propensity matched 3:1 to noncardioverted patients and Cox proportional hazards modeling evaluated hospitalization at 1 year in those with and without cardioversion. Cardiovascular outcomes, AF progression, and quality of life were evaluated for the matched cohorts with and without cardioversion. Among 9,642 patients, 817 patients (8%) underwent 906 cardioversions during a median follow-up of 12 (interquartile range 6-18) months. Among matched cardioverted and noncardioverted patients, 1-year cardiovascular hospitalization rates were 43% vs 21% (adjusted hazard ratio 2.2, 95% CI 1.8-2.8, P<.001), and sinus rhythm at both first and second follow-ups was 36% vs 27% (P=.042), respectively. Findings were similar among first-time cardioversion patients. Matched cardioversion patients did not exhibit greater symptom improvement (34% vs 42%) or less symptomatic progression (15% vs 4%) by European Heart Rhythm Association scores. Cardioversion was associated with AF progression with an odds ratio of 1.6 (95% CI 1.2-2.2, P=.001) after cardioversion and 2.7 (P<.001) after first cardioversion vs matched noncardioversion patients. After cardioversion, only 18% of patients not previously on an antiarrhythmic started one, less than 5% underwent ablation, and 22% stopped their antiarrhythmic. Cardioversion was not associated with improved AF-related quality of life or less progression. Many patients who undergo cardioversion do not receive adjunctive rhythm control therapies. These findings may help to better inform therapeutic decision making. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Association between adherence to concomitant proton pump inhibitor therapy in current NSAID users and upper gastrointestinal complications.

PubMed

Jonasson, Christian; Hatlebakk, Jan G; Lundell, Lars; Kouri, Jukka P; Andersen, Morten; Granath, Fredrik

2013-05-01

Proton pump inhibitors (PPIs) play a well-documented role as a gastroprotective agent among NSAID users at an increased risk of peptic ulcer and bleeding. Observational studies have, however, suggested that the clinical efficacy of PPI therapy may be reduced because of poor adherence. To study the association between adherence to concomitant PPI in current NSAID users and the risk of peptic ulcer and bleeding. Case-control study linking nationwide data from the Swedish Patient Registry with the Swedish Drug Prescription Database. The study population included patients admitted for a first-time peptic ulcer or bleeding and who were incident users of NSAID. Each case was matched on age, sex, NSAID duration, and calendar month with five controls. PPI adherence was calculated as the proportion of NSAID days being covered by PPI therapy. Matched and adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using conditional logistic regression. A total of 3649 cases were identified. Patients with poor adherence (<20% PPI coverage) had a significantly increased risk of upper gastrointestinal complications (OR=1.88, 95% CI 1.22-2.88) compared with fully adherent patients (≥80% PPI coverage). As a continuous variable, the risk of an event increased with 6% points for every 10% decrease in PPI adherence (OR=1.06, 95% CI 1.03-1.10). The gastroprotective effect of PPI in NSAID users is highly dependent on adherence, with about twice the risk in patients with poor adherence. Efforts to increase adherence should be an integrated part of clinical practice.

Differences in stage of disease between migrant women and native Danish women diagnosed with cancer: results from a population-based cohort study.

PubMed

Norredam, Marie; Krasnik, Allan; Pipper, Christian; Keiding, Niels

2008-06-01

The aim of the study is to compare differences in cancer stage at diagnosis between migrant women and native Danish women. The stage is used as a clinical indicator of access to healthcare until the point of diagnosis. Refugees and family reunited migrants who received residence permits in Denmark from 1 January 1993 to 31 December 1999 were included and matched 1 : 4 on age and sex with a Danish-born reference population. Our final female population included 24 734 migrants and 123 670 controls. Civil registration numbers of the cohort were linked to the Danish Cancer Registry whereby cases were identified in the period 1.1.1993-31.12.2002. Only women from Eastern Europe and the Middle East were included. This amounted to 269 migrants and 1608 native Danes. Data from the Danish Cancer Registry included diagnosis, time of diagnosis and disease stage at diagnosis. Our initial analyses of migrant subgroups showed that migrant women had decreased odds ratios of being diagnosed at the local stage and increased odds of having unknown stage, although these tendencies were mainly not statistically significant. A subsequent analysis of an overall migrant effect on all cancer sites emphasized these tendencies. This analysis reached borderline significance for local versus nonlocal stage and significance for unknown versus known stage. Our results indicate that migrant women may experience barriers in access to healthcare until cancer diagnosis compared with Danish women. More research is, however, needed to confirm our results and to find out if they indicate general problems concerning migrants' access to healthcare in Denmark.

Use of Integrative Oncology, Involvement in Decision-Making, and Breast Cancer Survivor Health-Related Quality of Life in the First 5 Years Postdiagnosis.

PubMed

Andersen, M Robyn; Sweet, Erin; Hager, Shelly; Gaul, Marcia; Dowd, Fred; Standish, Leanna J

2018-03-01

This study sought to describe changes in the health-related quality of life (HRQOL) of women who do and do not seek naturopathic oncology (NO) complementary and alternative medicine (CAM) care during and immediately after breast cancer treatment, and to explore the predictive role of NO CAM care, demographic characteristics, and involvement in decision-making on HRQOL in breast cancer survivors. Matched cohorts of breast cancer survivors who did and did not choose to supplement their breast cancer treatment with NO care within 2 years of diagnosis participated. NO users were identified through naturopathic doctors' clinics and usual care (UC) controls with similar prognosis were identified through a cancer registry. The registry provided information about all participants' age, race, ethnicity, marital status, stage of cancer at time of diagnosis, date of diagnosis, and use of conventional medical treatments (surgery, chemotherapy, radiation, and endocrine therapy). Data of participants' self-reported involvement in decision-making and HRQOL were collected at study enrollment and at 6-month follow-up. At 6-month follow-up, the NO patients reported significantly more involvement in decision-making about care and better general health than did UC patients ( P < .05). Self-reported involvement in decision-making about cancer treatment was associated with better role-physical, role-emotional, and social-functional well-being ( P < .05). Race, age, marital status, and congruence of preferred and achieved levels of involvement also predicted aspects of HRQOL in breast cancer survivors ( P < .05). Both NO CAM care and involvement in decision-making about cancer treatment may be associated with better HRQOL in breast cancer survivors.

Statin use and risk of prostate cancer: a Danish population-based case-control study, 1997-2010.

PubMed

Jespersen, Christina G; Nørgaard, Mette; Friis, Søren; Skriver, Charlotte; Borre, Michael

2014-02-01

Conflicting evidence has suggested that statins possess chemopreventive properties against prostate cancer (PCa). Therefore, we examined the association between statin use and risk of PCa in a Denmark-based case-control study. We identified 42,480 patients diagnosed with incident PCa during 1997-2010 from a national cancer registry. Five age-matched population controls (n=212,400) were selected for each case using risk-set sampling. Statin use from 1996 to the index date was obtained from the National Prescription Registry. Odds ratios (ORs) adjusted for age, comorbidity, non-steroidal anti-inflammatory drug use, and educational level for PCa associated with statin use, were computed using conditional logistic regression. Analyses were stratified by duration of statin use (0-1, 2-4, 5-9, or ≥10 years), stage of PCa (localized or advanced), and type of statin used (lipophilic or hydrophilic). In total, 7915 patients (19%) and 39,384 controls (19%) redeemed statin prescriptions prior to the index date. Overall, statin users had a 6% lower risk of PCa compared with non-users [adjusted OR (ORa), 0.94; 95% confidence interval (CI), 0.91-0.97]. Risk estimates did not differ substantially by duration or type of statin used. Slightly larger statin use-associated risk reductions were observed for advanced PCa (ORa, 0.90; 95% CI, 0.85-0.96) and with statin use ≥10 years (ORa, 0.78; 95% CI, 0.65-0.95). Statin use was associated with a risk reduction overall (6%) and, specifically with advanced PCa (10%). Differences in diagnostic measures and residual confounding by socioeconomic parameters may have influenced our results. Copyright © 2013 Elsevier Ltd. All rights reserved.

Quality of life in elderly patients with an ostomy - a study from the population-based PROFILES registry.

PubMed

Verweij, N M; Bonhof, C S; Schiphorst, A H W; Maas, H A; Mols, F; Pronk, A; Hamaker, M E

2018-04-01

Ostomies are being placed frequently in surgically treated elderly patients with colorectal cancer (CRC). An insight into the (potential) impact of ostomies on quality of life (QoL) could be useful in patient counselling as well as in the challenging shared treatment decision-making. Patients with CRC diagnosed between 2000 and 2009 and registered in the population-based Eindhoven Cancer Registry received a QoL questionnaire (EORTC QLQ-C30) in 2010. In addition, QoL was compared with an age- and sex-matched normative population. The study included 2299 CRC patients, of whom 494 had an ostomy. No differences were found in reported ostomy-related problems between patients aged ≤65, 66-75 and ≥76 years. Ostomy patients aged 66-75 and ≥76 years reported significantly lower physical functioning compared with those without an ostomy. In the elderly (those aged ≥76 years) ostomates reported a worse physical and social functioning compared with the normative population. All these differences were of small clinical relevance. The impact of an ostomy seems to be more prominent in younger (≤75 years old) ostomates, as they experience more functional limitations and a decrease in global health status compared with younger nonostomy patients and the normative population. Although elderly (≥76 years old) patients with an ostomy report significantly more limitations in functioning compared with a normative population and elderly CRC patients without an ostomy, the clinical relevance of this finding is limited. In contrast, the impact of an ostomy is more prominent in younger patients. Thus, age itself is not a reason for withholding an ostomy. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Development of Selective Lamellar Keratoplasty within an Asian Corneal Transplant Program: The Singapore Corneal Transplant Study (An American Ophthalmological Society Thesis)

PubMed Central

Tan, Donald; Ang, Marcus; Arundhati, Anshu; Khor, Wei-Boon

2015-01-01

Purpose: To evaluate outcomes of anterior lamellar keratoplasty (ALK) and endothelial keratoplasty (EK) within the Singapore Corneal Transplant Study (SCTS), with the hypothesis that both ALK and EK are able to provide equivalent or improved clinical outcomes, compared to penetrating keratoplasty (PK), and to determine changing trends globally with other international databases. Methods: Clinical data on all transplants performed was derived from our SCTS database, a prospective national keratoplasty registry, and clinical outcomes (graft survival, endothelial cell loss, complications, visual acuity) were compared between PK, ALK, and EK. Global trends on indications and forms of keratoplasty performed in 2011/2012 were obtained from national keratoplasty or eye banking registries, corneal/ophthalmological societies, national eye banks, and national ophthalmic institutions. Results: Global rates of EK surgery vary widely, from 52% (Sweden) to 0% (South Africa), with higher adoption by industrialized countries. ALK adoption rates similarly vary from 28.7% (China) to 1.0% (Philippines). SCTS data show high adoption rates in Singapore: EK 44% and ALK 28%. Our surgical modifications to big-bubble deep anterior lamellar keratoplasty (DALK) surgery resulted in visual outcomes matching PK, and a low conversion to PK of 2.1%, whereas our evolving approaches to donor insertion in Descemet’s stripping automated endothelial keratoplasty (DSAEK) show significant reduction in 1-year postoperative endothelial cell loss rates from 60% (folding), to 22% to 30% (Sheets Glide), to 15% (EndoGlide inserter). Conclusion: Improvements in various forms of ALK and EK surgery can lead to better visual outcomes, longer graft survival, and reduced complications, as compared to PK. Global trends suggest adoption of these procedures at different rates. PMID:26755854

A Population-Based Study of 30-day Incidence of Ischemic Stroke Following Surgical Neck Dissection

PubMed Central

MacNeil, S. Danielle; Liu, Kuan; Garg, Amit X.; Tam, Samantha; Palma, David; Thind, Amardeep; Winquist, Eric; Yoo, John; Nichols, Anthony; Fung, Kevin; Hall, Stephen; Shariff, Salimah Z.

2015-01-01

Abstract The objective of this study was to determine the 30-day incidence of ischemic stroke following neck dissection compared to matched patients undergoing non-head and neck surgeries. A surgical dissection of the neck is a common procedure performed for many types of cancer. Whether such dissections increase the risk of ischemic stroke is uncertain. A retrospective cohort study using data from linked administrative and registry databases (1995–2012) in the province of Ontario, Canada was performed. Patients were matched 1-to-1 on age, sex, date of surgery, and comorbidities to patients undergoing non-head and neck surgeries. The primary outcome was ischemic stroke assessed in hospitalized patients using validated database codes. A total of 14,837 patients underwent surgical neck dissection. The 30-day incidence of ischemic stroke following the dissection was 0.7%. This incidence decreased in recent years (1.1% in 1995 to 2000; 0.8% in 2001 to 2006; 0.3% in 2007 to 2012; P for trend <0.0001). The 30-day incidence of ischemic stroke in patients undergoing neck dissection is similar to matched patients undergoing thoracic surgery (0.5%, P = 0.26) and colectomy (0.5%, P = 0.1). Factors independently associated with a higher risk of stroke in 30 days following neck dissection surgery were of age ≥75 years (odds ratio (OR) 1.63, 95% confidence interval (CI) 1.05–2.53), and a history of diabetes (OR 1.60, 95% CI 1.02–2.49), hypertension (OR 2.64, 95% CI 1.64–4.25), or prior stroke (OR 4.06, 95% CI 2.29–7.18). Less than 1% of patients undergoing surgical neck dissection will experience an ischemic stroke in the following 30 days. This incidence of stroke is similar to thoracic surgery and colectomy. PMID:26287406

Brain injury as a risk factor for fever upon admission to the intensive care unit and association with in-hospital case fatality: a matched cohort study.

PubMed

Rincon, Fred; Patel, Utkal; Schorr, Christa; Lee, Elizabeth; Ross, Steven; Dellinger, R Phillip; Zanotti-Cavazzoni, Sergio

2015-02-01

To test the hypothesis that fever was more frequent in critically ill patients with brain injury when compared to nonneurological patients and to study its effect on in-hospital case fatality. Retrospective matched cohort study utilizing a single-center prospectively compiled registry. Critically ill neurological patients ≥18 years and consecutively admitted to the intensive care unit (ICU) with acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), and traumatic brain injury (TBI) were selected. Patients were matched by sex, age, and Acute Physiology and Chronic Health Evaluation II (APACHE-II) to a cohort of nonneurological patients. Fever was defined as any temperature ≥37.5°C within the first 24 hours upon admission to the ICU. The primary outcome measure was in-hospital case fatality. Mean age among neurological patients was 65.6 ± 15 years, 46% were men, and median APACHE-II was 15 (interquartile range 11-20). There were 18% AIS, 27% ICH, and 6% TBI. More neurological patients experienced fever than nonneurological patients (59% vs 47%, P = .007). The mean hospital length of stay was higher for nonneurological patients (18 ± 20 vs 14 ± 15 days, P = .007), and more neurological patients were dead at hospital discharge (29% vs 20%, P < .0001). After risk factor adjustment, diagnosis (neurological vs nonneurological), and the probability of being exposed to fever (propensity score), the following variables were associated with higher in-hospital case fatality: APACHE-II, neurological diagnosis, mean arterial pressure, cardiovascular and respiratory dysfunction in ICU, and fever (odds ratio 1.9, 95% confidence interval 1.04-3.6, P = .04). These data suggest that fever is a frequent occurrence after brain injury, and that it is independently associated with in-hospital case fatality. © The Author(s) 2013.

Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study.

PubMed

Austin, David; Oldroyd, Keith G; McConnachie, Alex; Slack, Rachel; Eteiba, Hany; Flapan, Andrew D; Jennings, Kevin P; Northcote, Robin J; Pell, Alastair C H; Starkey, Ian R; Pell, Jill P

2008-08-01

The US Food and Drug Administration recently concluded that data on off-label drug-eluting stent (DES) safety are limited. However, in actual clinical practice, DES are often used for off-label indications, and observational studies demonstrate that complications are higher when compared with on-label use. We aimed to determine whether clinical outcomes differ after DES and bare-metal stent implantation in a patient cohort defined by DES off-label indications. We used the national revascularization registry in Scotland to identify patients who underwent coronary stenting for an off-label indication between January 2003 and September 2005. Individual-level linkage to comprehensive national admission and death databases was used to ascertain the end points of death, myocardial infarction, and target-vessel revascularization. We calculated propensity scores on the basis of clinical, demographic, and angiographic variables and matched DES to bare-metal stents on a 1:1 basis. The final study population consisted of 1642 patients, well matched for important covariables at baseline. Event-free survival was calculated over 24 months with the Kaplan-Meier method. All-cause death was more common after bare-metal stent implantation during follow-up (7.7% versus 6.6%; hazard ratio 0.63; 95% confidence interval, 0.40 to 0.99; P=0.04). No difference in the rates of myocardial infarction were noted (7.3% versus 7.5%; hazard ratio 1.02; 95% confidence interval, 0.69 to 1.54; P=0.92). Target-vessel revascularization was reduced in patients treated with DES (13.9% versus 10.7%; hazard ratio 0.67; 95% confidence interval, 0.49 to 0.93; P=0.02). At 24 months, patients treated with DES for off-label indications had lower rates of death and target-vessel revascularization and similar rates of myocardial infarction, as compared with patients treated with bare-metal stents.

Comparative effectiveness of enalapril, lisinopril, and ramipril in the treatment of patients with chronic heart failure: a propensity score-matched cohort study.

PubMed

Fröhlich, Hanna; Henning, Felix; Täger, Tobias; Schellberg, Dieter; Grundtvig, Morten; Goode, Kevin; Corletto, Anna; Kazmi, Syed; Hole, Torstein; Katus, Hugo A; Atar, Dan; Cleland, John G F; Agewall, Stefan; Frankenstein, Lutz; Clark, Andrew L

2018-04-01

Angiotensin-converting enzyme inhibitors (ACEIs) are recommended as first-line therapy in patients with heart failure with reduced ejection fraction (HFrEF). The comparative effectiveness of different ACEIs is not known. A total of 4723 outpatients with stable HFrEF prescribed enalapril, lisinopril, or ramipril were identified from three registries in Norway, England, and Germany. In three separate matching procedures, patients were individually matched with respect to both dose equivalents and their respective propensity scores for ACEI treatment. During a follow-up of 21 939 patient-years, 360 (49.5%), 337 (52.4%), and 1119 (33.4%) patients died among those prescribed enalapril, lisinopril, and ramipril, respectively. In univariable analysis of the general sample, enalapril and lisinopril were both associated with higher mortality when compared with ramipril treatment [hazard ratio (HR) 1.46, 95% confidence interval (CI) 1.30-1.65, P < 0.001 and HR 1.38, 95% CI 1.22-1.56, P < 0.001, respectively). Patients prescribed enalapril or lisinopril had similar mortality (HR 1.06, 95% CI 0.92-1.24, P = 0.41). However, there was no significant association between ACEI choice and all-cause mortality in any of the matched samples (HR 1.07, 95% CI 0.91-1.25, P = 0.40; HR 1.12, 95% CI 0.96-1.32, P = 0.16; and HR 1.10, 95% CI 0.93-1.31, P = 0.25 for enalapril vs. ramipril, lisinopril vs. ramipril, and enalapril vs. lisinopril, respectively). Results were confirmed in subgroup analyses with respect to age, sex, left ventricular ejection fraction, New York Class Association functional class, cause of HFrEF, rhythm, and systolic blood pressure. Our results suggest that enalapril, lisinopril, and ramipril are equally effective in the treatment of patients with HFrEF when given at equivalent doses.

Rapid Development of Specialty Population Registries and Quality Measures from Electronic Health Record Data*. An Agile Framework.

PubMed

Kannan, Vaishnavi; Fish, Jason S; Mutz, Jacqueline M; Carrington, Angela R; Lai, Ki; Davis, Lisa S; Youngblood, Josh E; Rauschuber, Mark R; Flores, Kathryn A; Sara, Evan J; Bhat, Deepa G; Willett, DuWayne L

2017-06-14

Creation of a new electronic health record (EHR)-based registry often can be a "one-off" complex endeavor: first developing new EHR data collection and clinical decision support tools, followed by developing registry-specific data extractions from the EHR for analysis. Each development phase typically has its own long development and testing time, leading to a prolonged overall cycle time for delivering one functioning registry with companion reporting into production. The next registry request then starts from scratch. Such an approach will not scale to meet the emerging demand for specialty registries to support population health and value-based care. To determine if the creation of EHR-based specialty registries could be markedly accelerated by employing (a) a finite core set of EHR data collection principles and methods, (b) concurrent engineering of data extraction and data warehouse design using a common dimensional data model for all registries, and (c) agile development methods commonly employed in new product development. We adopted as guiding principles to (a) capture data as a byproduct of care of the patient, (b) reinforce optimal EHR use by clinicians, (c) employ a finite but robust set of EHR data capture tool types, and (d) leverage our existing technology toolkit. Registries were defined by a shared condition (recorded on the Problem List) or a shared exposure to a procedure (recorded on the Surgical History) or to a medication (recorded on the Medication List). Any EHR fields needed - either to determine registry membership or to calculate a registry-associated clinical quality measure (CQM) - were included in the enterprise data warehouse (EDW) shared dimensional data model. Extract-transform-load (ETL) code was written to pull data at defined "grains" from the EHR into the EDW model. All calculated CQM values were stored in a single Fact table in the EDW crossing all registries. Registry-specific dashboards were created in the EHR to display both (a) real-time patient lists of registry patients and (b) EDW-generated CQM data. Agile project management methods were employed, including co-development, lightweight requirements documentation with User Stories and acceptance criteria, and time-boxed iterative development of EHR features in 2-week "sprints" for rapid-cycle feedback and refinement. Using this approach, in calendar year 2015 we developed a total of 43 specialty chronic disease registries, with 111 new EHR data collection and clinical decision support tools, 163 new clinical quality measures, and 30 clinic-specific dashboards reporting on both real-time patient care gaps and summarized and vetted CQM measure performance trends. This study suggests concurrent design of EHR data collection tools and reporting can quickly yield useful EHR structured data for chronic disease registries, and bodes well for efforts to migrate away from manual abstraction. This work also supports the view that in new EHR-based registry development, as in new product development, adopting agile principles and practices can help deliver valued, high-quality features early and often.

Rapid Development of Specialty Population Registries and Quality Measures from Electronic Health Record Data.

PubMed

Kannan, Vaishnavi; Fish, Jason S; Mutz, Jacqueline M; Carrington, Angela R; Lai, Ki; Davis, Lisa S; Youngblood, Josh E; Rauschuber, Mark R; Flores, Kathryn A; Sara, Evan J; Bhat, Deepa G; Willett, DuWayne L

2017-01-01

Creation of a new electronic health record (EHR)-based registry often can be a "one-off" complex endeavor: first developing new EHR data collection and clinical decision support tools, followed by developing registry-specific data extractions from the EHR for analysis. Each development phase typically has its own long development and testing time, leading to a prolonged overall cycle time for delivering one functioning registry with companion reporting into production. The next registry request then starts from scratch. Such an approach will not scale to meet the emerging demand for specialty registries to support population health and value-based care. To determine if the creation of EHR-based specialty registries could be markedly accelerated by employing (a) a finite core set of EHR data collection principles and methods, (b) concurrent engineering of data extraction and data warehouse design using a common dimensional data model for all registries, and (c) agile development methods commonly employed in new product development. We adopted as guiding principles to (a) capture data as a byproduct of care of the patient, (b) reinforce optimal EHR use by clinicians, (c) employ a finite but robust set of EHR data capture tool types, and (d) leverage our existing technology toolkit. Registries were defined by a shared condition (recorded on the Problem List) or a shared exposure to a procedure (recorded on the Surgical History) or to a medication (recorded on the Medication List). Any EHR fields needed - either to determine registry membership or to calculate a registry-associated clinical quality measure (CQM) - were included in the enterprise data warehouse (EDW) shared dimensional data model. Extract-transform-load (ETL) code was written to pull data at defined "grains" from the EHR into the EDW model. All calculated CQM values were stored in a single Fact table in the EDW crossing all registries. Registry-specific dashboards were created in the EHR to display both (a) real-time patient lists of registry patients and (b) EDW-gener-ated CQM data. Agile project management methods were employed, including co-development, lightweight requirements documentation with User Stories and acceptance criteria, and time-boxed iterative development of EHR features in 2-week "sprints" for rapid-cycle feedback and refinement. Using this approach, in calendar year 2015 we developed a total of 43 specialty chronic disease registries, with 111 new EHR data collection and clinical decision support tools, 163 new clinical quality measures, and 30 clinic-specific dashboards reporting on both real-time patient care gaps and summarized and vetted CQM measure performance trends. This study suggests concurrent design of EHR data collection tools and reporting can quickly yield useful EHR structured data for chronic disease registries, and bodes well for efforts to migrate away from manual abstraction. This work also supports the view that in new EHR-based registry development, as in new product development, adopting agile principles and practices can help deliver valued, high-quality features early and often. Schattauer GmbH.

Comparison of the survival between coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with poor left ventricular function (ejection fraction <30%): a propensity-matched analysis.

PubMed

Shah, Shaneel; Benedetto, Umberto; Caputo, Massimo; Angelini, Gianni D; Vohra, Hunaid A

2018-06-22

Existing evidence comparing the outcomes of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with poor left ventricular function (LVF) is sparse and flawed. This is largely due to patients with poor LVF being underrepresented in major research trials and the outdated nature of some studies that do not consider drug-eluting stent PCI. Following strict inclusion criteria, 717 patients who underwent revascularization by CABG or PCI between 2002 and 2015 were enrolled. All patients had poor LVF (defined by ejection fraction <30%). By employing a propensity score analysis, 134 suitable matches (67 CABG and 67 PCI) were identified. Several outcomes were evaluated, in the matched population, using data extracted from national registry databases. CABG patients required a longer length of hospital stay post-revascularization compared to PCI in the propensity-matched population, 7 days (lower-upper quartile; 6-12) and 2 days (lower-upper quartile; 1-6), respectively (Mood's median test, P = 0.001). Stratified Cox-regression proportional-hazards analysis of the propensity-matched population found that PCI patients experienced a higher adjusted 8-year mortality rate (hazard ratio 3.291, 95% confidence interval 1.776-6.101; P < 0.001). This trend was consistent amongst urgent cases of revascularization: patients with 3 or more vessels with coronary artery disease and patients where complete revascularization was achieved. Although sub-analyses found no difference between survival distributions of on-pump versus off-pump CABG (log-rank P = 0.726), both modes of CABG were superior to PCI (stratified log-rank P = 0.002). Despite a longer length of hospital stay, patients with impaired LVF requiring intervention for coronary artery disease experienced a greater post-procedural survival benefit if they received CABG compared to PCI. We have demonstrated this at 30 days, 90 days, 1 year, 3 years, 5 years and 8 years following revascularization. At present, CABG remains a superior revascularization modality to PCI in patients with poor LVF.

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

Estimating canine cancer incidence: findings from a population-based tumour registry in northwestern Italy.

PubMed

Baioni, Elisa; Scanziani, Eugenio; Vincenti, Maria Claudia; Leschiera, Mauro; Bozzetta, Elena; Pezzolato, Marzia; Desiato, Rosanna; Bertolini, Silvia; Maurella, Cristiana; Ru, Giuseppe

2017-06-28

Canine cancer registry data can be put to good use in epidemiological studies. Quantitative comparison of tumour types may reveal unusual cancer frequencies, providing directions for research and generation of hypotheses of cancer causation in a specific area, and suggest leads for identifying risk factors. Here we report canine cancer incidence rates calculated from a population-based registry in an area without any known specific environmental hazard. In its 90 months of operation from 2001 to 2008 (the observation period in this study), the population-based Piedmont Canine Cancer Registry collected data on 1175 tumours confirmed by histopathological diagnosis. The incidence rate was 804 per 100,000 dog-years for malignant tumours and 897 per 100,000 dog-years for benign tumours. Higher rates for all cancers were observed in purebred dogs, particularly in Yorkshire terrier and Boxer. The most prevalent malignant neoplasms were cutaneous mastocytoma and hemangiopericytoma, and mammary gland complex carcinoma and simplex carcinoma. The Piedmont canine cancer registry is one of few of its kind whose operations have been consistently supported by long-term public funding. The registry-based cancer incidence rates were estimated with particular attention to the validity of data collection, thus minimizing the potential for bias. The findings on cancer incidence rates may provide a reliable reference for comparison studies. Researches conducted on dogs, used as sentinels for community exposure to environmental carcinogens, can be useful to detect excess risks in the incidence of malignant tumours in the human population.

The Genotype and Phenotype (GaP) registry: a living biobank for the analysis of quantitative traits.

PubMed

Gregersen, Peter K; Klein, Gila; Keogh, Mary; Kern, Marlena; DeFranco, Margaret; Simpfendorfer, Kim R; Kim, Sun Jung; Diamond, Betty

2015-12-01

We describe the development of the Genotype and Phenotype (GaP) Registry, a living biobank of normal volunteers who are genotyped for genetic markers related to human disease. Participants in the GaP can be recalled for hypothesis driven study of disease associated genetic variants. The GaP has facilitated functional studies of several autoimmune disease associated loci including Csk, Blk, PDRM1 (Blimp-1) and PTPN22. It is likely that expansion of such living biobank registries will play an important role in studying and understanding the function of disease associated alleles in complex disease.

Association of HLA-B*5801 allele and allopurinol-induced stevens johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis

PubMed Central

2011-01-01

Background Despite some studies suggesting a possible association between human leukocyte antigen, HLA-B*5801 and allopurinol induced Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), the evidence of association and its magnitude remain inconclusive. This study aims to systematically review and meta-analyze the association between HLA-B*5801 allele and allopurinol-induced SJS/TEN. Methods A comprehensive search was performed in databases including MEDLINE, Pre-MEDLINE, Cochrane Library, EMBASE, International Pharmaceutical Abstracts (IPA), CINAHL, PsychInfo, the WHO International, Clinical Trial Registry, and ClinicalTrial.gov from their inceptions to June 2011. Only studies investigating association between HLA-B*5801 with allopurinol-induced SJS/TEN were included. All studies were extracted by two independent authors. The primary analysis was the carrier frequency of HLA-B*5801 comparison between allopurinol-induced SJS/TEN cases and each comparative group. The pooled odds ratios were calculated using a random effect model. Results A total of 4 studies with 55 SJS/TEN cases and 678 matched-controls (allopurinol-tolerant control) was identified, while 5 studies with 69 SJS/TEN cases and 3378 population-controls (general population) were found. SJS/TEN cases were found to be significantly associated with HLA-B*5801 allele in both groups of studies with matched-control (OR 96.60, 95%CI 24.49-381.00, p < 0.001) and population-control (OR 79.28, 95%CI 41.51-151.35, p < 0.001). Subgroup analysis for Asian and Non-Asian population yielded similar findings. Conclusion We found a strong and significant association between HLA-B*5801 and allopurinol-induced SJS/TEN. Therefore, HLA-B*5801 allele screening may be considered in patients who will be treated with allopurinol. PMID:21906289

Influenza vaccination and cardiovascular risk in patients with recent TIA and stroke.

PubMed

Lavallée, Philippa C; Labreuche, Julien; Fox, Kim M; Lavados, Pablo; Mattle, Heinrich; Steg, Philippe Gabriel; Amarenco, Pierre

2014-05-27

To determine whether current influenza vaccination is associated with reduced risk of major vascular events in patients with recent ischemic stroke or TIA of mainly atherothrombotic origin. Data were pooled from 2 prospective cohort studies, the OPTIC Registry (n = 3,635) and the AMISTAD Study (n = 618), and from the randomized PERFORM Trial (n = 19,120), all of which included patients with recent ischemic stroke or TIA. Influenza vaccination status was determined in 23,110 patients. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or vascular death up to 2 years. Secondary outcomes were myocardial infarction and stroke separately. Influenza vaccination had no association with the primary outcome in the propensity score-matched cohort (hazard ratio 0.97, 95% confidence interval [CI] 0.85-1.11; p = 0.67) or in the propensity score-adjusted cohort (hazard ratio 1.00, 95% CI 0.89-1.12; p = 0.99). Similarly, the risk of stroke and myocardial infarction did not differ between the vaccinated group and the unvaccinated group; in the matched cohort, the hazard ratio was 1.01 (95% CI 0.88-1.17; p = 0.89) for stroke and 0.84 (95% CI 0.59-1.18; p = 0.30) for myocardial infarction. Influenza vaccination was not associated with reduced outcome events in patients with recent atherothrombotic ischemic stroke after considering all baseline characteristics (including concomitant medications) associated with influenza vaccination. © 2014 American Academy of Neurology.

Bowel, Urinary, and Sexual Problems Among Long-Term Prostate Cancer Survivors: A Population-Based Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mols, Floortje; Comprehensive Cancer Centre South; Korfage, Ida J.

Purpose: To obtain insight into the long-term (5- to 10-year) effects of prostate cancer and treatment on bowel, urinary, and sexual function, we performed a population-based study. Prostate-specific function was compared with an age-matched normative population without prostate cancer. Methods and Materials: Through the population-based Eindhoven Cancer Registry, we selected all men diagnosed with prostate cancer between 1994 and 1998 in the southern Netherlands. In total, 964 patients, alive in November 2004, received questionnaire; 780 (81%) responded. Results: Urinary problems were most common after a prostatectomy; bowel problems were most common after radiotherapy. Compared with an age-matched normative population bothmore » urinary and bowel functioning and bother were significantly worse among survivors. Urinary incontinence was reported by 23-48% of survivors compared with 4% of the normative population. Bowel leakage occurred in 5-14% of patients compared with 2% of norms. Erection problems occurred in 40-74% of patients compared with 18% of norms. Conclusions: These results form an important contribution to the limited information available on prostate-specific problems in the growing group of long-term prostate cancer survivors. Bowel, urinary, and sexual problems occur more often among long-term survivors compared with a reference group and cannot be explained merely by age. Because these problems persist for many years, urologists should provide patients with adequate information before treatment. After treatment, there should be an appropriate focus on these problems.« less

Review of U.S. registries for psoriasis.

PubMed

Amin, Mina; No, Daniel J; Wu, Jashin J

2017-12-01

Patient registries are databases comprised of standardized clinical data for a specific population of patients with a particular disease or medical condition. Information from patient registries allows clinicians to assess long-lasting outcomes in patients with a specific disease, such as psoriasis. Our primary objective was to identify available psoriasis registries in the United States (U.S.) and evaluate the application of patient registries compared to clinical trials. We searched Google, the Registry of Patient Registries, Orphanet and ClinicalTrials.gov to create a list of U.S. psoriasis registries. We also performed a literature review on the application of psoriasis registries using PubMed. We identified 6 psoriasis patient registries in the United States. Patient registries are frequently used for psoriasis in the U.S. and provide important information about the safety, efficacy and long-term effects of systemic therapies.

Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

PubMed Central

Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned. PMID:26107924

The USC Adult Twin Cohorts: International Twin Study and California Twin Program.

PubMed

Cozen, Wendy; Hwang, Amie E; Cockburn, Myles G; Hamilton, Ann S; Zadnick, John; Mack, Thomas M

2013-02-01

The study of twin subjects permits the documentation of crude heritability and may promote the identification of specific causal alleles. We believe that at the current time, the chief research advantage of twins as subjects, especially monozygotic twins, is that the commonality of their genetic and cultural identity simplifies the interpretation of biological associations. In order to study genetic and environmental determinants of cancer and chronic diseases, we developed two twin registries, maintained at the University of Southern California: The International Twin Study (ITS) and the California Twin Program (CTP). The ITS is a volunteer registry of twins with cancer and chronic disease consisting of 17,245 twin pairs affected by cancer and chronic disease, respectively, ascertained by advertising in periodicals from 1980-1991. The CTP is a population-based registry of California-born twin pairs ascertained by linking the California birth records to the State Department of Motor Vehicles. Over 51,000 individual California twins representing 36,965 pairs completed and returned 16-page questionnaires. Cancer diagnoses in the California twins are updated by regular linkage to the California Cancer Registry. Over 5,000 cancer patients are represented in the CTP. Twins from both registries have participated extensively in studies of breast cancer, melanoma, lymphoma, multiple sclerosis, systemic lupus erythematosus, diabetes mellitus type 1, mammographic density, smoking, and other traits and conditions.

A Thumbwheel Mechanism for APOA1 Activation of LCAT Activity in HDL.

PubMed

Cooke, Allison L; Morris, Jamie; Melchior, John T; Street, Scott E; Jerome, W Gray; Huang, Rong; Herr, Andrew B; Smith, Loren E; Segrest, Jere P; Remaley, Alan T; Shah, Amy S; Thompson, Thomas B; Davidson, W Sean

2018-05-17

APOA1 is the most abundant protein in HDL. It modulates interactions that affect HDLs cardioprotective functions, in part via its activation of the enzyme LCAT. On nascent, discoidal HDL, APOA1 comprises 10 alpha-helical repeats arranged in an anti-parallel, stacked-ring structure that encapsulates a lipid bilayer. Previous chemical cross-linking studies suggested that these APOA1 rings can adopt at least two different orientations, or registries, with respect to each other; however, the functional impact of these structural changes is unknown. Here, we placed Cys-residues at locations predicted to form disulfide bonds in each orientation and then measured APOA1s ability to adopt the two registries during HDL particle formation. We found that most APOA1 oriented with the fifth helix of one molecule across from fifth helix of the other (5/5 helical registry), but a fraction adopted a 5/2 registry. Engineered HDL that were locked in 5/5 or 5/2 registries by disulfide bonds equally promoted cholesterol efflux from macrophages - indicating functional particles. However, unlike the 5/5 registry or the wild-type, the 5/2 registry impaired LCAT cholesteryl esterification activity (p<0.001), despite LCAT binding equally to all particles. Chemical cross-linking studies suggest that full LCAT activity requires a hybrid epitope composed of helices 5-7 on one APOA1 molecule and 3-4 on the other. Thus, APOA1 may use a reciprocating, thumbwheel-like mechanism to activate HDL-remodeling proteins. Published under license by The American Society for Biochemistry and Molecular Biology, Inc.

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.

My Retina Tracker™: An On-line International Registry for People Affected with Inherited Orphan Retinal Degenerative Diseases and their Genetic Relatives - A New Resource.

PubMed

Fisher, Joan K; Bromley, Russell L; Mansfield, Brian C

2016-01-01

My Retina Tracker™ is a new on-line registry for people affected with inherited orphan retinal degenerative diseases, and their unaffected, genetic relatives. Created and supported by the Foundation Fighting Blindness, it is an international resource designed to capture the disease from the perspective of the registry participant and their retinal health care providers. The registry operates under an Institutional Review Board (IRB)-approved protocol and allows sharing of de-identified data with participants, researchers and clinicians. All participants sign an informed consent that includes selecting which data they wish to share. There is no minimum age of participation. Guardians must sign on behalf of minors, and children between the ages of 12 to 17 also sign an informed assent. Participants may compare their disease to others in the registry using graphical interpretations of the aggregate registry data. Researchers and clinicians have two levels of access. The first provides an interface to interrogate all data fields registrants have agreed to share based on their answers in the IRB informed consent. The second provides a route to contact people in the registry who may be eligible for studies or trials, through the Foundation.

United States transuranium and uranium registries - 25 years of growth, research, and service. Annual report, April 1992--September 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kathren, R.L.; Harwick, L.A.; Toohey, R.E.

The Registries originated in 1968 as the National Plutonium Registry with the name changed to the United States Transuranium Registry the following year to reflect a broader concern with the heavier actinides as well. Initially, the scientific effort of the USTR was directed towards study of the distribution and dose of plutonium and americium in occupationally exposed persons, and to assessment of the effects of exposure to the transuranium elements on health. This latter role was reassessed during the 1970`s when it was recognized that the biased cohort of the USTR was inappropriate for epidemiologic analysis. In 1978, the administrativelymore » separate but parallel United States Uranium Registry was created to carry out similar work among persons exposed to uranium and its decay products. A seven member scientific advisory committee provided guidance and scientific oversight. In 1992, the two Registries were administratively combined and transferred from the purview of a Department of Energy contractor to Washington State University under the provisions of a grant. Scientific results for the first twenty-five years of the Registries are summarized, including the 1985 publication of the analysis of the first whole body donor. Current scientific work in progress is summarized along with administrative activities for the period.« less

Effects of Cancer Stage and Treatment Differences on Racial Disparities in Survival From Colon Cancer: A United States Population-Based Study.

PubMed

Lai, Yinzhi; Wang, Chun; Civan, Jesse M; Palazzo, Juan P; Ye, Zhong; Hyslop, Terry; Lin, Jianqing; Myers, Ronald E; Li, Bingshan; Jiang, Binghua; Sama, Ashwin; Xing, Jinliang; Yang, Hushan

2016-05-01

We evaluated differences in treatment of black vs white patients with colon cancer and assessed their effects on survival, based on cancer stage. We collected data from the Surveillance, Epidemiology, and End Results-Medicare database and identified 6190 black and 61,951 white patients with colon cancer diagnosed from 1998 through 2009 and followed up through 2011. Three sets of 6190 white patients were matched sequentially, using a minimum distance strategy, to the same set of 6190 black patients based on demographic (age; sex; diagnosis year; and Surveillance, Epidemiology, and End Results registry), tumor presentation (demographic plus comorbidities, tumor stage, grade, and size), and treatment (presentation plus therapies) variables. We conducted sensitivity analyses to explore the effects of socioeconomic status in a subcohort that included 2000 randomly selected black patients. Racial differences in treatment were assessed using a logistic regression model; their effects on racial survival disparity were evaluated using the Kaplan-Meier method and the Cox proportional hazards model. After patients were matched for demographic variables, the absolute 5-year difference in survival between black and white patients was 8.3% (white, 59.2% 5-y survival; blacks, 50.9% 5-y survival) (P < .0001); this value decreased significantly, to 5.0% (P < .0001), after patients were matched for tumor presentation, and decreased to 4.9% (P < .0001) when patients were matched for treatment. Differences in treatment therefore accounted for 0.1% of the 8.3% difference in survival between black and white patients. After patients were matched for tumor presentation, racial disparities were observed in almost all types of treatment; the disparities were most prominent for patients with advanced-stage cancer (stages III or IV, up to an 11.1% difference) vs early stage cancer (stages I or II, up to a 4.3% difference). After patients were matched for treatment, there was a greater reduction in disparity for black vs white patients with advanced-stage compared with early-stage cancer. In sensitivity analyses, the 5-year racial survival disparity was 7.7% after demographic match, which was less than the 8.3% observed in the complete cohort. This reduction likely was owing to the differences between the subcohort and the complete cohort in those variables that were not included in the demographic match. This value was reduced to 6.5% (P = .0001) after socioeconomic status was included in the demographic match. The difference decreased significantly to 2.8% (P = .090) after tumor presentation match, but was not reduced further after treatment match. We observed significant disparities in treatment and survival of black vs white patients with colon cancer. The disparity in survival appears to have been affected more strongly by tumor presentation at diagnosis than treatment. The effects of treatment differences on disparities in survival were greater for patients with advanced-stage vs early-stage cancer. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Arthroplasty Implant Registries Over the Past Five Decades: Development, Current, and Future Impact.

PubMed

Malchau, Henrik; Garellick, Göran; Berry, Daniel; Harris, William H; Robertson, Otto; Kärrlholm, Johan; Lewallen, David; Bragdon, Charles R; Lidgren, Lars; Herberts, Peter

2018-04-16

Local, regional and national registries have played an important role the development of hip and knee arthroplasty and the treatment of patients with various maladies of these joints. Four arthroplasty registries stand out as leading forces behind the drive to popularize the use of registries and pursue the concept of evidence based medicine. The Mayo registry, started by Mark Coventry, is recognized as the oldest continuing registry for arthroplasty. The Harris Registry at Massachusetts General Hospital, along with the Mayo Registry, has greatly contributed to the advancement of arthroplasty surgery and have served an important role of identifying poorly performing implants and techniques in the United States. The Swedish Knee Arthroplasty Registry is the oldest national registry dedicated to joint arthroplasty and along with the Swedish Hip Arthroplasty Registry have established the infrastructure, analysis and reporting mechanisms and leadership that has enabled other countries to subsequently develop national registries around the world. As more countries have adopted the concept of national registries, a new area of research is possible by pooling the resources of large registries as is now occurring with the Nordic countries. Several international organizations have been formed to promote future collaboration and develop international standards. The process of globalization of registries is a result of continued efforts over the past 50 years in improving and disseminating the knowledge gained from the early registries. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial.

PubMed

Lucassen, Mathijs F G; Stasiak, Karolina; Crengle, Sue; Weisz, John R; Frampton, Christopher M A; Bearman, Sarah Kate; Ugueto, Ana M; Herren, Jennifer; Cribb-Su'a, Ainsleigh; Faleafa, Monique; Kingi-'Ulu'ave, Denise; Loy, Jik; Scott, Rebecca M; Hartdegen, Morgyn; Merry, Sally N

2015-10-12

Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery. This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy. If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services. Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 .

Implantable Cardioverter-Defibrillators in Patients With a Continuous-Flow Left Ventricular Assist Device: An Analysis of the INTERMACS Registry.

PubMed

Clerkin, Kevin J; Topkara, Veli K; Demmer, Ryan T; Dizon, Jose M; Yuzefpolskaya, Melana; Fried, Justin A; Mai, Xingchen; Mancini, Donna M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-12-01

This study sought to determine if the presence of implantable cardioverter-defibrillators (ICD) provided a mortality benefit during continuous-flow left ventricular assist device (LVAD) support. An ICD decreases mortality in selected patients with advanced heart failure and have been associated with reduced mortality in patients with pulsatile LVAD. However, it is unclear whether that benefit extends to patients with a contemporary continuous-flow LVAD. Propensity score matching was used to generate a cohort of patients with similar baseline characteristics. The primary outcome was freedom from death during LVAD support. Secondary endpoints included freedom from unexpected death, likelihood of transplantation and recovery, and adverse events. Among 16,384 eligible patients in the Interagency Registry for Mechanically Assisted Circulatory Support registry, 2,209 patients with an ICD and 2,209 patients without one had similar propensity scores and were included. The presence of an ICD was associated with an increased mortality risk (hazard ratio: 1.20; 95% confidence interval [CI]: 1.04 to 1.39; p = 0.013) and an increased risk of unexpected death during device support (HR: 1.33; 95% CI: 1.03 to 1.71; p = 0.03). Patients with an ICD were more likely to undergo transplantation (HR: 1.16; 95% CI: 0.99 to 1.35; p = 0.06) and less likely to have LVAD explant for recovery (HR: 0.53, 95% CI: 0.29 to 0.98; p = 0.04). Patients with an ICD had a higher rate of treated ventricular arrhythmias (rate ratio: 1.27; 95% CI: 1.10 to 1.48; p = 0.001) and rehospitalization (rate ratio: 1.08; 95% CI: 1.04 to 1.12; p < 0.0001), but rates of hemorrhagic stroke were similar (rate ratio: 1.01; 95% CI: 0.81 to 1.26; p = 0.98). Among patients with a continuous flow LVAD, the presence of an ICD was not associated with reduced mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

United States Transuranium and Uranium Registries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kathren, R.L.; Filipy, R.E.; Dietert, S.E.

1991-06-01

This report summarizes the primary scientific activities of the United States Transuranium and Uranium Registries for the period October 1, 1989 through September 30, 1990. The Registries are parallel human tissue research programs devoted to the study of the actinide elements in humans. To date there have been 261 autopsy or surgical specimen donations, which include 11 whole bodies. The emphasis of the Registry was directed towards quality improvement and the development of a fully computerized data base that would incorporate not only the results of postmortem radiochemical analysis, but also medical and monitoring information obtained during life. Human subjectsmore » reviews were also completed. A three compartment biokinetic model for plutonium distribution is proposed. 2 tabs.« less

Cost of Operating Central Cancer Registries and Factors That Affect Cost: Findings From an Economic Evaluation of Centers for Disease Control and Prevention National Program of Cancer Registries.

PubMed

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

2016-01-01

The Centers for Disease Control and Prevention (CDC) evaluated the economics of the National Program of Cancer Registries to provide the CDC, the registries, and policy makers with the economics evidence-base to make optimal decisions about resource allocation. Cancer registry budgets are under increasing threat, and, therefore, systematic assessment of the cost will identify approaches to improve the efficiencies of this vital data collection operation and also justify the funding required to sustain registry operations. To estimate the cost of cancer registry operations and to assess the factors affecting the cost per case reported by National Program of Cancer Registries-funded central cancer registries. We developed a Web-based cost assessment tool to collect 3 years of data (2009-2011) from each National Program of Cancer Registries-funded registry for all actual expenditures for registry activities (including those funded by other sources) and factors affecting registry operations. We used a random-effects regression model to estimate the impact of various factors on cost per cancer case reported. The cost of reporting a cancer case varied across the registries. Central cancer registries that receive high-quality data from reporting sources (as measured by the percentage of records passing automatic edits) and electronic data submissions, and those that collect and report on a large volume of cases had significantly lower cost per case. The volume of cases reported had a large effect, with low-volume registries experiencing much higher cost per case than medium- or high-volume registries. Our results suggest that registries operate with substantial fixed or semivariable costs. Therefore, sharing fixed costs among low-volume contiguous state registries, whenever possible, and centralization of certain processes can result in economies of scale. Approaches to improve quality of data submitted and increasing electronic reporting can also reduce cost.

Verification of Data Accuracy in Japan Congenital Cardiovascular Surgery Database Including Its Postprocedural Complication Reports.

PubMed

Takahashi, Arata; Kumamaru, Hiraku; Tomotaki, Ai; Matsumura, Goki; Fukuchi, Eriko; Hirata, Yasutaka; Murakami, Arata; Hashimoto, Hideki; Ono, Minoru; Miyata, Hiroaki

2018-03-01

Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.

Role of socio-economic and reproductive factors in the risk of multiple sclerosis.

PubMed

Magyari, M

2015-01-01

The incidence of multiple sclerosis is increasing in Danish women. Their risk of developing multiple sclerosis has more than doubled in 25 years while it has remained virtually unchanged for men. The explanation for these epidemiological changes should be sought in the environment as they are too rapid to be explained by gene alterations. We investigated the effect of numerous biological social physical and chemical environmental exposures in different periods of life. These data were available from population-based registries and were used in a case-control approach. This study database included all multiple sclerosis cases (n = 1403) from the Danish MS Registry with clinical onset between 2000 and 2004 as well as 35,045 controls drawn by random from the Danish Civil Registration System and matched by sex year of birth and residential municipality at the reference year. Having newborn children reduced the risk of multiple sclerosis (MS) in women but not in men. Childbirths reduced the risk of MS by about 46% during the following 5 years. Even pregnancies terminated early had a protective effect on the risk of developing MS suggesting a temporary immunosuppression during pregnancy. Our data on social behaviour regarding educational level income and relationship stability did not indicate reverse causality. A greater likelihood to be exposed to common infections did not show any effect on the risk of MS neither in puberty nor in adulthood. Socio-economic status and lifestyle expressed in educational level and sanitary conditions in youth were not associated with the risk of MS. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Changes in Body Mass Index in Pheochromocytoma Patients Following Adrenalectomy.

PubMed

Spyroglou, Ariadni; Adolf, Christian; Hahner, Stefanie; Quinkler, Marcus; Ladurner, Roland; Reincke, Martin; Beuschlein, Felix

2017-03-01

Catecholamine excess from pheochromocytoma results in cardiovascular symptoms such as arterial hypertension and tachycardia and induces metabolic alterations including glucose intolerance and increase in resting metabolic rate. The objective of our study was to investigate the effect of surgical cure of pheochromocytoma on body-mass-index and the correlation of body-mass-index changes to preoperative endocrine parameters. Pheochromocytoma patients from the Munich ENSAT Registry were matched (1:2) for age and gender to patients from the German Conn's Registry, who had undergone surgery for aldosterone-producing-adenomas. Thereby, 43 pheochromocytoma patients (17 males/26 females) and 86 aldosterone-producing-adenoma patients were analyzed for body-mass-index, blood pressure, and catecholamine levels before and one year after adrenalectomy. Seventy-four percent of pheochromocytoma patients were hypertensive preoperatively and 48% one year postoperatively. Systolic blood pressure did not differ significantly in pre- and postoperative measurements whereas diastolic blood pressure was significantly reduced over time. Moreover, pheochromocytoma patients gained body weight (p<0.001) one year following adrenalectomy accompanied by significant increases in body-mass-index, whereas aldosterone-producing adenoma patients displayed a slight weight loss. Despite weight gain, diagnosis of diabetes mellitus dropped from 9 of 43 investigated pheochromocytoma patients at baseline to 4 at follow-up. A significant correlation between body-mass-index changes to the preoperative catecholamine levels was found only for urinary normetanephrines. These data suggest that normalization of chronic catecholamine excess by adrenalectomy is associated with an increase in body-mass-index, which is more pronounced in patients with high preoperative levels of urinary normetanephrines. © Georg Thieme Verlag KG Stuttgart · New York.

Outcomes of left split graft transplantation in Europe: report from the European Liver Transplant Registry.

PubMed

Angelico, Roberta; Nardi, Alessandra; Adam, René; Nadalin, Silvio; Polak, Wojciech G; Karam, Vincent; Troisi, Roberto I; Muiesan, Paolo

2018-07-01

Split liver transplantation (SLT) has been widely adopted across Europe, resulting in remarkable reduction in the paediatric waiting-list mortality. Left split graft (LSG) is commonly used for paediatric recipients; however, deceased donor criteria selection are not universal. The aim of this study was to analyse the LSG outcome from the European Liver Transplant Registry and to identify risk factors for graft failure. Data from 1500 children transplanted in 2006-2014 with LSG from deceased donors were retrospectively analysed. Overall, graft losses were 343(22.9%) after 5 years from transplantation, 240(70.0%) occurred within the first 3 months. Estimated patient survival was 89.1% at 3 months and 82.9% at 5 years from SLT. Re-transplantation rate was 11.5%. At multivariable analysis, significant risk factors for graft failure at 3 months included the following: urgent SLT (HR = 1.73, P = 0.0012), recipient body weight ≤6 kg (HR = 1.91, P = 0.0029), donor age >50 years (HR = 1.87, P = 0.0039), and cold ischaemic time (CIT) [HR = 1.07 per hour, P = 0.0227]. LSG has good outcomes and SLT is excellent option for paediatric recipients in the current organ shortage era. We identified practical guidelines for LSG donor and recipient selection criteria: donor age may be safely extended up to 50 years in the absence of additional risk factors; thus, children <6 kg and urgent transplantation need CIT <6 h and appropriate graft/recipient size-matching to achieve good outcomes. © 2018 Steunstichting ESOT.

Transfusion Medicine and Molecular Genetic Methods

PubMed Central

Saleh, Rozieyati Mohamed; Zefarina, Zulkafli; Che Mat, Nor Fazila; Chambers, Geoffrey Keith; Edinur, Hisham Atan

2018-01-01

Transfusion procedures are always complicated by potential genetic mismatching between donor and recipient. Compatibility is determined by several major antigens, such as the ABO and Rhesus blood groups. Matching for other blood groups (Kell, Kidd, Duffy, and MNS), human platelet antigens, and human leukocyte antigens (HLAs) also contributes toward the successful transfusion outcomes, especially in multitransfused or highly immunized patients. All these antigens of tissue identity are highly polymorphic and thus present great challenges for finding suitable donors for transfusion patients. The ABO blood group and HLA markers are also the determinants of transplant compatibility, and mismatched antigens will cause graft rejection or graft-versus-host disease. Thus, a single and comprehensive registry covering all of the significant transfusion and transplantation antigens is expected to become an important tool in providing an efficient service capable of delivering safe blood and quickly locating matching organs/stem cells. This review article is intended as an accessible guide for physicians who care for transfusion-dependent patients. In particular, it serves to introduce the new molecular screening methods together with the biology of these systems, which underlies the tests. PMID:29899883

Peer relationships of bereaved siblings and comparison classmates after a child's death from cancer.

PubMed

Gerhardt, Cynthia A; Fairclough, Diane L; Grossenbacher, Julie C; Barrera, Maru; Gilmer, Mary Jo; Foster, Terrah L; Compas, Bruce E; Davies, Betty; Hogan, Nancy S; Vannatta, Kathryn

2012-03-01

To compare peer relationships among bereaved siblings and matched classmates, and to examine gender, grade level, and time since death as moderators. Families were recruited from cancer registries at four hospitals 3-12 months after a child's death. Measures of social behavior and peer acceptance were completed by children in the classrooms of 105 bereaved siblings (ages 8-17 years). Teachers also reported on children's social behavior. Three classmates were matched for gender, race, and age to each bereaved sibling to form a comparison group (n = 311). Teachers reported bereaved siblings were more prosocial than comparison classmates. Peers perceived bereaved boys as more sensitive-isolated and victimized, while bereaved siblings in elementary grades were perceived by peers as less prosocial, more sensitive-isolated, less accepted, and as having fewer friends. Peers and teachers viewed bereaved siblings in middle/high school grades as higher on leadership-popularity. Bereaved siblings who were male and in elementary grades were more vulnerable to social difficulties, while those in middle/high school may exhibit some strengths. Ongoing research to inform the development of interventions for bereaved siblings is warranted.

Impact of a Primary Care CKD Registry in a US Public Safety-Net Health Care Delivery System: A Pragmatic Randomized Trial.

PubMed

Tuot, Delphine S; McCulloch, Charles E; Velasquez, Alexandra; Schillinger, Dean; Hsu, Chi-Yuan; Handley, Margaret; Powe, Neil R

2018-04-23

Many individuals with chronic kidney disease (CKD) do not receive guideline-concordant care. We examined the impact of a team-based primary care CKD registry on clinical measures and processes of care among patients with CKD cared for in a public safety-net health care delivery system. Pragmatic trial of a CKD registry versus a usual-care registry for 1 year. Primary care providers (PCPs) and their patients with CKD in a safety-net primary care setting in San Francisco. The CKD registry identified at point of care all patients with CKD, those with blood pressure (BP)>140/90mmHg, those without angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) prescription, and those without albuminuria quantification in the past year. It also provided quarterly feedback pertinent to these metrics to promote "outreach" to patients with CKD. The usual-care registry provided point-of-care cancer screening and immunization data. Changes in systolic BP at 12 months (primary outcome), proportion of patients with BP control, prescription of ACE inhibitors/ARBs, quantification of albuminuria, severity of albuminuria, and estimated glomerular filtration rate. The patient population (n=746) had a mean age of 56.7±12.1 (standard deviation) years, was 53% women, and was diverse (8% non-Hispanic white, 35.7% black, 24.5% Hispanic, and 24.4% Asian). Randomization to the CKD registry (30 PCPs, 285 patients) versus the usual-care registry (49 PCPs, 461 patients) was associated with 2-fold greater odds of ACE inhibitor/ARB prescription (adjusted OR, 2.25; 95% CI, 1.45-3.49) and albuminuria quantification (adjusted OR, 2.44; 95% CI, 1.38-4.29) during the 1-year study period. Randomization to the CKD registry was not associated with changes in systolic BP, proportion of patients with uncontrolled BP, or degree of albuminuria or estimated glomerular filtration rate. Potential misclassification of CKD; missing baseline medication data; limited to study of a public safety-net health care system. A team-based safety-net primary care CKD registry did not improve BP parameters, but led to greater albuminuria quantification and more ACE inhibitor/ARB prescriptions after 1 year. Adoption of team-based CKD registries may represent an important step in translating evidence into practice for CKD management. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Gout after living kidney donation: Correlations with demographic traits and renal complications

PubMed Central

Lam, Ngan N.; Garg, Amit X.; Segev, Dorry L.; Schnitzler, Mark A.; Xiao, Huiling; Axelrod, David; Brennan, Daniel C.; Kasiske, Bertram L.; Tuttle-Newhall, Janet E.; Lentine, Krista L.

2015-01-01

Background The demographic and clinical correlates of gout after living kidney donation are not well described. Methods Using a unique database that integrates national registry identifiers of U.S. living kidney donors (1987-2007) with billing claims from a private health insurer (2000-2007), we identified post-donation gout based on medical diagnosis codes or pharmacy fills for gout therapies. The frequencies and demographic correlates of gout after donation were estimated by Cox regression with left- and right-censoring. We also compared rates of renal diagnoses among donors with and without gout, matched 1:3 by age, sex, and race. Results The study sample of 4,650 donors included 13.1% African-Americans. By seven years, African-Americans were almost twice as likely to develop gout as Caucasian donors (4.4% vs. 2.4%; adjusted hazard ratio, aHR, 1.8; 95% confidence interval, CI, 1.0–3.2). Post-donation gout risk also increased with older age at donation (aHR per year 1.05) and was higher in men (aHR 2.80). Gout rates were similar in donors and age- and sex-matched general non-donors (rate ratio 0.86, 95% CI 0.66–1.13). Compared to matched donors without gout, donors with gout had more frequent renal diagnoses, reaching significance for acute kidney failure (rate ratio 12.5; 95% CI 1.5–107.0), chronic kidney disease (rate ratio 5.0; 95% CI 2.1–11.7), and other disorders of the kidney (rate ratio 2.2; 95% CI 1.2–4.2). Conclusion Donor subgroups at increased risk of gout include African-Americans, older donors, and men. Donors with gout have a higher burden of renal complications after demographic adjustment. PMID:25896309

Modifying the clinical research infrastructure at a dedicated clinical trials unit: assessment of trial development, activation, and participant accrual

PubMed Central

Tang, Chad; Hess, Kenneth R.; Sanders, Dwana; Davis, Suzanne; Buzdar, Aman; Kurzrock, Razelle; Lee, J. Jack; Meric-Bernstam, Funda; Hong, David

2017-01-01

Purpose Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center and analyzed their effects on the trial activation timeline and enrollment. Experimental Design Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results We identified 3 facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship (industry [133 ICT and 133 non-ICT trials] or institutional [68 ICT and 68 non-ICT trials]). ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrollment (median difference of 0.3 months for industry vs. 1.2 months for institutional) (all matched P<0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional) (all matched P<0.05). Conclusions Use of a clinical research–focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. PMID:27852698

The Economic Burden of Urinary Tract Infection and Pressure Ulceration in Acute Traumatic Spinal Cord Injury Admissions: Evidence for Comparative Economics and Decision Analytics from a Matched Case-Control Study.

PubMed

White, Barry A B; Dea, Nicolas; Street, John T; Cheng, Christiana L; Rivers, Carly S; Attabib, Najmedden; Kwon, Brian K; Fisher, Charles G; Dvorak, Marcel F

2017-10-15

Secondary complications of spinal cord injury (SCI) are a burden to affected individuals and the rest of society. There is limited evidence of the economic burden or cost of complications in SCI populations in Canada, however, which is necessary for comparative economic analyses and decision analytic modeling of possible solutions to these common health problems. Comparative economic analyses can inform resource allocation decisions, but the outputs are only as good as the inputs. In this article, new evidence of the excess or incremental costs of urinary tract infection (UTI) and pressure ulceration (PU) in acute traumatic SCI from an exploratory case series analysis of admissions to a Level I specialized Canadian spine facility (2008-2013) is presented. Participants in a national SCI registry were case-control matched (1:1) on the predicted probability of experiencing UTI or PU during initial acute SCI admission. The excess costs of UTI and PU are estimated as the mean of the differences in total direct acute SCI admission costs (length of stay, accommodation, nursing, pharmacy) from the perspective of the admitting facility between participants matched or paired on demographic and SCI characteristics. Even relatively minor UTI and PU, respectively, added an average of $7,790 (standard deviation [SD] $6,267) and $18,758 (SD $27,574) to the direct cost of acute SCI admission in 2013 Canadian dollars (CAD). This case series analysis established evidence of the excess costs of UTI and PU in acute SCI admissions, which will support decision-informing analyses in SCI.

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

PubMed

Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

2017-03-15

Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P < 0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional; all matched P < 0.05). Conclusions: Use of a clinical research-focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

Unrelated alternative donor transplantation for severe acquired aplastic anemia: a study from the French Society of Bone Marrow Transplantation and Cell Therapies and the EBMT Severe Aplastic Anemia Working Party.

PubMed

Devillier, Raynier; Dalle, Jean-Hugues; Kulasekararaj, Austin; D'aveni, Maud; Clément, Laurence; Chybicka, Alicja; Vigouroux, Stéphane; Chevallier, Patrice; Koh, Mickey; Bertrand, Yves; Michallet, Mauricette; Zecca, Marco; Yakoub-Agha, Ibrahim; Cahn, Jean-Yves; Ljungman, Per; Bernard, Marc; Loiseau, Pascale; Dubois, Valérie; Maury, Sébastien; Socié, Gérard; Dufour, Carlo; Peffault de Latour, Regis

2016-07-01

Unrelated allogeneic transplantation for severe aplastic anemia is a treatment option after immunosuppressive treatment failure in the absence of a matched sibling donor. Age, delay between disease diagnosis and transplantation, and HLA matching are the key factors in transplantation decisions, but their combined impact on patient outcomes remains unclear. Using the French Society of Bone Marrow Transplantation and Cell Therapies registry, we analyzed all consecutive patients (n=139) who underwent a first allogeneic transplantation for idiopathic severe aplastic anemia from an unrelated donor between 2000 and 2012. In an adjusted multivariate model, age over 30 years (Hazard Ratio=2.39; P=0.011), time from diagnosis to transplantation over 12 months (Hazard Ratio=2.18; P=0.027) and the use of a 9/10 mismatched unrelated donor (Hazard Ratio=2.14; P=0.036) were independent risk factors that significantly worsened overall survival. Accordingly, we built a predictive score using these three parameters, considering patients at low (zero or one risk factors, n=94) or high (two or three risk factors, n=45) risk. High-risk patients had significantly shorter survival (Hazard Ratio=3.04; P<0.001). The score was then confirmed on an independent cohort from the European Group for Blood and Marrow Transplantation database of 296 patients, with shorter survival in patients with at least 2 risk factors (Hazard Ratio=2.13; P=0.005) In conclusion, a simple score using age, transplantation timing and HLA matching would appear useful to help physicians in the daily care of patients with severe aplastic anemia. Copyright© Ferrata Storti Foundation.

Clinical outcome of statin plus ezetimibe versus high-intensity statin therapy in patients with acute myocardial infarction propensity-score matching analysis.

PubMed

Ji, Mi Seon; Jeong, Myung Ho; Ahn, Young Keun; Kim, Sang Hyung; Kim, Young Jo; Chae, Shung Chull; Hong, Taek Jong; Seong, In Whan; Chae, Jei Keon; Kim, Chong Jin; Cho, Myeong Chan; Rha, Seung-Woon; Bae, Jang Ho; Seung, Ki Bae; Park, Seung Jung

2016-12-15

It is unclear whether simvastatin-ezetimibe could be an alternative therapy to high-intensity statin therapy in high-risk patients. The aim of this study was to compare the clinical outcomes of simvastatin-ezetimibe and high-intensity statin therapy in patients with acute myocardial infarction (AMI), and especially in those with high-risk factor. A total of 3520 AMI patients in the KAMIR (Korea Acute Myocardial Infarction Registry) were classified into simvastatin-ezetimibe group (n=1249) and high-intensity statin group (n=2271). Multivariate analysis and propensity-score matching analysis were performed. The primary endpoint was major adverse cardiac events (MACE) at 12-months follow-up. In overall AMI patients, MACE occurred in 116 patients (9.3%) in simvastatin-ezetimibe group and 116 patients (5.1%) in high-intensity statin group. The difference in MACE between groups was driven by repeat revascularization (5.9% vs. 2.2%). After propensity matching analysis, simvastatin-ezetimibe was associated with a higher incidence of MACE than high-intensity statin therapy (adjusted hazard ratio: 3.090, 95% confidence interval: 1.715 to 5.566, p<0.001). However, in patients with high-risk factors, such as diabetes, old age, or heart failure, simvastatin-ezetimibe had similar incidence of MACE compared with high-intensity statin therapy in further adjusted analysis. In overall AMI patients, high-intensity statin therapy had better clinical outcomes than simvastatin-ezetimibe. However, in patients with high-risk factor, simvastatin-ezetimibe had comparable clinical outcomes to high-intensity statin therapy. Therefore, simvastatin-ezetimibe could be used as an alternative to high-intensity statin therapy in such patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.