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Data standards

Poul Jennum, Anne Sabers, Jakob Christensen, Rikke Ibsen, Jakob Kjellberg
PURPOSE: Epilepsy surgery has been a standard treatment for refractory epilepsies that cannot be controlled by standard medical treatment. We aimed to evaluate the health and social consequences of resective surgery relative to controls from a study of national data. METHODS: Using the Danish National Patient Registry we identified all subjects with an epilepsy diagnosis between 1996 and 2009 and compared them with a group of patients with an epilepsy diagnosis who had had neither epilepsy surgery nor a vagus stimulation diagnosis by the index date, and who were matched by gender, index year for epilepsy diagnosis, and index year for epilepsy surgery...
October 6, 2016: Seizure: the Journal of the British Epilepsy Association
Mehmet Cemal Kahya, Oğuz Sebik, Kemal S Türker
Painful stimulation of the hand results in an inhibitory response in the hand muscles known as the cutaneous silent period (CSP). In this study, we employed probability- and frequency-based analysis methods to examine the CSP induced by laser stimuli. Subjects were asked to contract their first dorsal interosseous muscle so that selected motor units discharged at a rate of about 8Hz. Laser pulses were delivered to the palm of the hand, and reflex responses were recorded. The stimuli generated CSP in all test subjects...
October 14, 2016: Journal of Electromyography and Kinesiology
Hans-Uwe Dahms, Eun-Ji Won, Hui-Su Kim, Jeonghoon Han, Heum Gi Park, Sami Souissi, Sheikh Raisuddin, Jae-Seong Lee
Aquatic invertebrates contribute significantly to environmental impact assessment of contaminants in aquatic ecosystems. Much effort has been made to identify viable and ecologically relevant invertebrate test organisms to meet rigorous regulatory requirements. Copepods, which are ecologically important and widely distributed in aquatic organisms, offer a huge opportunity as test organisms for aquatic toxicity testing. They have a major role not only in the transfer of energy in aquatic food chains, but also as a medium of transfer of aquatic pollutants across the tropic levels...
October 14, 2016: Aquatic Toxicology
Riaz A Agha, Alexander J Fowler, Shivanchan Rajmohan, Ishani Barai, Dennis P Orgill
INTRODUCTION: Case series have been a long held tradition within the surgical literature and are still frequently published. Reporting guidelines can improve transparency and reporting quality. No guideline exists for reporting case series and our recent systematic review highlights key data being missed from such reports. Our objective was to develop reporting guidelines for surgical case series. METHODS: A Delphi consensus exercise was conducted to determine items to include in the reporting guideline...
October 19, 2016: International Journal of Surgery
Eric Lawitz, Fred Poordad, Julio A Gutierrez, Jennifer T Wells, Carmen E Landaverde, Barbara Evans, Anita Howe, Hsueh-Cheng Huang, Jerry Jing Li, Peggy Hwang, Frank J Dutko, Michael Robertson, Janice Wahl, Eliav Barr, Barbara Haber
Direct-acting antiviral agents (DAAs) represent the standard of care for patients with hepatitis C virus (HCV) infection. Combining DAAs with different mechanisms may allow for shorter treatment durations that are effective across multiple genotypes. The aim of the C-SWIFT study was to identify the minimum effective treatment duration across multiple genotypes. C-SWIFT was an open-label, single-center trial in treatment-naïve patients with chronic HCV genotype (GT)1 or 3 infection. All patients received elbasvir (EBR) 100 mg/grazoprevir (GZR) 50 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks...
October 22, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Christel Häggström, Mieke Van Hemelrijck, Björn Zethelius, David Robinson, Birgitta Grundmark, Lars Holmberg, Soffia Gudbjörnsdottir, Hans Garmo, Pär Stattin
Type 2 diabetes mellitus (T2DM) has consistently been associated with decreased risk of prostate cancer, however, if this decrease is related to the use of anti-diabetic drugs is unknown. We prospectively studied men in the comparison cohort in the Prostate Cancer data Base Sweden (PCBaSe) 3.0, with data on T2DM, use of metformin, sulphonylurea, and insulin retrieved from national health care registers and demographic databases. Cox proportional hazards regression models were used to compute hazard ratios (HR) and 95% confidence intervals (CI) of prostate cancer, adjusted for confounders...
October 22, 2016: International Journal of Cancer. Journal International du Cancer
N Gamkrelidze, N Pavliashvili, R Otarashvili
This study describes hematocrit values and quantitative changes in plasma endothelin-1 (ET-1) levels according to the severity of crush syndrome (CS) compression and decompression periods. The experiments were carried out on 50 randomly selected 200-250 gr mass Wistar rats with the use of the standard crush syndrome modeling method. The plasma level of ET-1 was determined by the immuneenzyme method with the use of ELISA REDEAR URIT 660. Hematocrit was determined using the standard method and measured according to tube column divisions...
September 2016: Georgian Medical News
Akiko Asada, Takahiro Doi, Takaomi Tagami, Akihiro Takeda, Yoshiyuki Sawabe
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA) and N-(1-adamantyl)-1-pentyl-1H-indole-3-carboxamide (APICA) are carboxamide-type synthetic cannabinoids comprising indazole/indole-3-carboxylic acid and adamantan-1-amine moieties. However, in the case of compounds like APINACA or APICA, adamantyl positional isomers exist, wherein either adamantan-1-amine or adamantan-2-amine is present. These adamantyl positional isomers have not been reported in previous studies, and no analytical data are available yet...
October 21, 2016: Drug Testing and Analysis
Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Paolo Girardi, Roberto Brugnoli, Giovanni Manfredi, Gabriele Sani
Lithium has been a gold standard in the treatment of bipolar disorder (BD) for several decades. Despite a general reduction in the use of lithium over the past several years, it is effective in the management of both manic and depressive episodes in BD and continues to be recommended as a first-line mood stabilizer. This review provides an overview of the pharmacology of lithium and highlights its clinical profile in the management of BD, focusing on the potential advantages of prolonged-release (PR) versus immediate-release (IR) formulations of lithium...
October 21, 2016: Drugs in R&D
Christoph Lübbert, Lisa Zimmermann, Julia Borchert, Bernd Hörner, Reinier Mutters, Arne C Rodloff
INTRODUCTION: Clostridium difficile infection (CDI) is the most common cause of health-care-associated infectious diarrhea. Recurrence rates are as high as 20-30% after standard treatment with metronidazole or vancomycin, and appear to be reduced for patients treated with fidaxomicin. According to the literature, the risk of CDI recurrence increases after the second relapse to 30-65%. Accurate data for Germany are not yet available. METHODS: Based on the research database of arvato health analytics (Munich, Germany), a secondary data analysis for the incidence, treatment characteristics and course of CDI was performed...
October 21, 2016: Infectious Diseases and Therapy
Lauren E Griffith, Edwin van den Heuvel, Parminder Raina, Isabel Fortier, Nazmul Sohel, Scott M Hofer, Hélène Payette, Christina Wolfson, Sylvie Belleville, Meghan Kenny, Dany Doiron
Standardization procedures are commonly used to combine phenotype data that were measured using different instruments, but there is little information on how the choice of standardization method influences pooled estimates and heterogeneity. Heterogeneity is of key importance in meta-analyses of observational studies because it affects the statistical models used and the decision of whether or not it is appropriate to calculate a pooled estimate of effect. Using 2-stage individual participant data analyses, we compared 2 common methods of standardization, T-scores and category-centered scores, to create combinable memory scores using cross-sectional data from 3 Canadian population-based studies (the Canadian Study on Health and Aging (1991-1992), the Canadian Community Health Survey on Healthy Aging (2008-2009), and the Quebec Longitudinal Study on Nutrition and Aging (2004-2005))...
October 21, 2016: American Journal of Epidemiology
Adam C Seegmiller, Annette S Kim, Claudio A Mosse, Aaron C Shaver, Mary Ann Thompson, Shaoying Li, David R Head, Mary M Zutter
OBJECTIVES: To determine the effect of iterative refinement of standard ordering protocols on test utilization and results for bone marrow biopsy specimens. METHODS: Eighteen months of test utilization and result data were used to revise the protocols that determine cytogenetic and molecular test selection on bone marrow specimens and then compared with data obtained following protocol revision. RESULTS: Revision of protocols resulted in reduction in total tests and associated charges, due to a decrease in tests both concordant and discordant with the protocols...
October 20, 2016: American Journal of Clinical Pathology
Pan Dan, Émilie Velot, Grégory Francius, Patrick Menu, Véronique Decot
: One of the outstanding goals in tissue engineering is to develop a natural coating surface which is easy to manipulate, effective for cell adhesion and fully biocompatible. The ideal surface would be derived from human tissue, perfectly controllable, and pathogen-free, thereby satisfying all of the standards of the health authorities. This paper reports an innovative approach to coating surfaces using a natural extracellular matrix (ECM) extracted from the Wharton's jelly (WJ) of the umbilical cord (referred to as WJ-ECM)...
October 18, 2016: Acta Biomaterialia
Dennis Toddenroth, Janakan Sivagnanasundaram, Hans-Ulrich Prokosch, Thomas Ganslandt
BACKGROUND: The difficulty of managing patient recruitment and documentation for clinical trials prompts a demand for instruments for closely monitoring these critical but unpredictable processes. Increasingly adopted Electronic Data Capture (EDC) applications provide novel opportunities to reutilize stored information for an efficient management of traceable trial workflows. In related clinical and administrative settings, so-called digital dashboards that continuously visualize time-dependent parameters have recently met a growing acceptance...
October 18, 2016: Journal of Biomedical Informatics
Magaly Rodriguez de Bittner, Viktor V Chirikov, Ian M Breunig, Roxanne W Zaghab, Fadia Tohme Shaya
OBJECTIVE: To determine the effectiveness and cost savings of a real-world, continuous, pharmacist-delivered service with an employed patient population with diabetes over a 5-year period. SETTING: The Patients, Pharmacists Partnerships (P(3) Program) was offered as an "opt-in" benefit to employees of 6 public and private self-insured employers in Maryland and Virginia. Care was provided in ZIP code-matched locations and at 2 employers' worksites. PRACTICE DESCRIPTION: Six hundred two enrolled patients with type 1 and 2 diabetes were studied between July 2006 and May 2012 with an average follow-up of 2...
October 18, 2016: Journal of the American Pharmacists Association: JAPhA
Alan P Brown, Philip Drew, Brian Knight, Philippe Marc, Sean Troth, Kuno Wuersch, Joyce Zandee
Histopathology data comprise a critical component of pharmaceutical toxicology studies and are typically presented as finding incidence counts and severity scores per organ, tabulated on multiple pages which can be challenging for review and aggregation of results. However, the SEND (Standard for Exchange of Nonclinical Data) standard provides a means for collecting and managing histopathology data in a uniform fashion which can allow informatics systems to archive, display and analyze data in novel ways. Various software applications have become available to convert histopathology data into graphical displays for analyses...
October 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Ana S Cravo, Jim Bush, Girish Sharma, Rebecca Savioz, Claire Martin, Simon Craige, Tanvir Walele
A randomised, parallel group clinical study was performed to evaluate the safety profile of an e-vapour product (EVP; 2.0% nicotine) in smokers of conventional cigarettes (CCs) switching to use the EVP for 12 weeks. During the study, no clinically significant product-related findings were observed in terms of vital signs, electrocardiogram, lung function tests and standard clinical laboratory parameters. Adverse events (AEs) reported by EVP subjects were more frequent during the first week after switching to the EVP...
October 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C Dueck, Nancy Devlin, Hans-Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean-Francois Hamel, Madeleine King, Paul G Kluetz, Michael Koller, Daniel C Malone, Francesca Martinelli, Sandra A Mitchell, Carol M Moinpour, Jammbe Musoro, Daniel O'Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L Pimentel, Chantal Quinten, Jaap C Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M Soltys, Martin J B Taphoorn, Galina Velikova, Corneel Coens
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established...
October 18, 2016: Lancet Oncology
Yitao Zhang, Weijie Zeng, Shiyao Cheng, Zhichong Chen, Jiaojie Xue, Qing Wang, Maode Ou, Kanglin Cheng
BACKGROUND: Pulmonary hypertension (PH) is a serious disease, and treatment is a continuing challenge. Some in vitro and in vivo studies identified that statins were effective for PH. However, results of some randomised controlled trials (RCTs) have been controversial. The objective of our study was to clarify whether statins are effective and safe for pulmonary hypertension. METHODS: We systematically searched for eligible RCTs from PubMed, EMBASE, Web of Science, and the Cochrane Library during January 2016...
September 15, 2016: Heart, Lung & Circulation
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