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https://www.readbyqxmd.com/read/29157113/assessing-performance-of-sequential-analysis-methods-for-active-drug-safety-surveillance-using-observational-data
#1
Xiaofeng Zhou, Warren Bao, Mike Gaffney, Rongjun Shen, Sarah Young, Andrew Bate
The routine use of sequential methods is well established in clinical studies. Recently, there has been increasing interest in applying these methods to prospectively monitor the safety of newly approved drugs through accrual of real-world data. However, the application to marketed drugs using real-world data has been limited and work is needed to determine which sequential approaches are most suited to such data. In this study, the conditional sequential sampling procedure (CSSP), a group sequential method, was compared with a log-linear model with Poisson distribution (LLMP) through a SAS procedure (PROC GENMOD) combined with an alpha-spending function on two large longitudinal US administrative health claims databases...
November 20, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29156048/unmet-needs-in-clinical-and-basic-hepatitis-b-virus-research
#2
Tung-Hung Su, Jia-Horng Kao
Chronic hepatitis B (CHB) has become a treatable and controllable disease. The current nucleos(t)ide analogue (NUC) and pegylated interferon therapies effectively help slow disease progression and reduce the risk of cirrhosis, hepatocellular carcinoma (HCC), and CHB-associated mortality. Long-term viral suppression is easily achievable by NUC therapy, with limited adverse reactions. However, several unmet requirements still exist, including safety and risk-stratified HCC surveillance among patients who received long-term NUC therapy...
November 16, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29153952/surveillance-of-the-safety-and-efficacy-of-recombinant-human-soluble-thrombomodulin-in-patients-with-obstetrical-disseminated-intravascular-coagulation
#3
Takao Kobayashi, Masahiro Kajiki, Katsuhito Nihashi, Goichi Honda
BACKGROUND: Recombinant human soluble thrombomodulin (TM-α) has been shown to be useful in the treatment of disseminated intravascular coagulation (DIC) in a heparin-controlled study, and has been available for clinical use in Japan since 2008. However, use of TM-α for obstetrical DIC has not yet been established, so efficacy and safety were analyzed in 117 obstetrical DIC patients identified from post-marketing surveillance. MATERIALS AND METHODS: From June 2010 to March 2012, the cases of 117 patients with obstetrical DIC treated with TM-α were registered...
September 18, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/29152784/workplace-violence-injury-in-106-us-hospitals-participating-in-the-occupational-health-safety-network-ohsn-2012-2015
#4
Matthew R Groenewold, Raymond F R Sarmiento, Kelly Vanoli, William Raudabaugh, Susan Nowlin, Ahmed Gomaa
BACKGROUND: Workplace violence is a substantial occupational hazard for healthcare workers in the United States. METHODS: We analyzed workplace violence injury surveillance data submitted by hospitals participating in the Occupational Health Safety Network (OHSN) from 2012 to 2015. RESULTS: Data were frequently missing for several important variables. Nursing assistants (14.89, 95%CI 10.12-21.91) and nurses (8.05, 95%CI 6.14-10.55) had the highest crude workplace violence injury rates per 1000 full-time equivalent (FTE) workers...
November 20, 2017: American Journal of Industrial Medicine
https://www.readbyqxmd.com/read/29148911/report-from-enhanced-safety-surveillance-of-two-influenza-vaccines-vaxigrip-and-intanza-15%C3%AE-g-in-two-european-countries-during-influenza-season-2016-17-and-comparison-with-2015-16-season
#5
Anne Laure Chabanon, Hélène Bricout, Céline Ballandras, Audrey Souverain, Timothy David Caroe, Karina M Butler
Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6...
November 17, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29140750/postlicensure-safety-surveillance-of-congenital-anomaly-and-miscarriage-among-pregnancies-exposed-to-quadrivalent-human-papillomavirus-vaccine
#6
Lina S Sy, Kristin I Meyer, Nicola P Klein, Chun Chao, Christine Velicer, T Craig Cheetham, Bradley K Ackerson, Jeff M Slezak, Harpreet S Takhar, John Hansen, Kamala Deosaransingh, Kai-Li Liaw, Steven J Jacobsen
Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive observational postlicensure safety surveillance study in Kaiser Permanente Southern California and Northern California to assess congenital anomaly and miscarriage among pregnancies exposed to 4vHPV. Using electronic medical records, we identified women who received a dose of 4vHPV between August 2006 and March 2008 within 30 days preconception or any time during a possible pregnancy...
November 15, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29139248/-post-marketing-safety-surveillance-of-diemailing-kudiezi-injection-real-world-study-in-30-233-cases
#7
Xing Liao, Dan-Dan Yu, Yan-Ming Xie, Yun-Ling Zhang, Yan He, Yin Zhang, Yan Liu, Dan-Hui Yi, Yong-Yan Wang
This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29137830/efficacy-and-safety-of-tamsulosin-in-medical-expulsive-therapy-for-distal-ureteral-stones-with-renal-colic-a-multicenter-randomized-double-blind-placebo-controlled-trial
#8
Zhangqun Ye, Guohua Zeng, Huan Yang, Kun Tang, Xiaochun Zhang, Hong Li, Weibing Li, Zhong Wu, Lingwu Chen, Xingfa Chen, Xiankui Liu, Yaoliang Deng, Tiejun Pan, Jinchun Xing, Shusheng Wang, Yue Cheng, Xiaojian Gu, Wenxi Gao, Jianggen Yang, Yonghai Zhang, Qiwu Mi, Lin Qi, Jiongming Li, Weilie Hu, Peiyu Liang, Zhaolin Sun, Changbao Xu, Yongfu Long, Yongbin Liao, Siping Liu, Guoqing Liu, Xun Xu, Wei He, Zhiqiang Chen, Hua Xu
BACKGROUND: Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones. OBJECTIVE: To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo. DESIGN, SETTING, AND PARTICIPANTS: We conducted a double-blind, placebo-controlled study of 3296 patients with distal ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin...
November 11, 2017: European Urology
https://www.readbyqxmd.com/read/29135818/trends-of-magnet-ingestion-in-children-an-ironic-attraction
#9
Patrick Todd Reeves, Cade M Nylund, Jayasree Krishnamurthy, R Adam Noel, Mazen I Abbas
BACKGROUND AND OBJECTIVES: Ingestion of rare earth magnets is a serious ongoing hazard for pediatric patients. Our study aims to investigate whether 2012 Consumer Product Safety Commission (CPSC) policy action, in coordination with efforts from consumer and physician advocacy groups, decreased the incidence of magnet ingestions in children in US since 2012. METHODS: Data from the National Electronic Injury Surveillance System (NEISS) was used to evaluate trends in emergency department (ED) encounters with pediatric patients (<18 years) who presented with suspected magnet ingestions (SMI) from 2010-2015...
November 11, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/29133196/cold-endoscopic-mucosal-resection-of-large-sessile-serrated-polyps-at-colonoscopy-with-video
#10
Nicholas J Tutticci, David G Hewett
BACKGROUND AND AIMS: The optimal technique for the resection of sessile serrated polyps (SSPs) is unknown, with established limitations and risks with conventional polypectomy. Although cold snare polypectomy is safe, the efficacy of piecemeal resection for large lesions is untested. In this study, we evaluate the safety and efficacy of cold endoscopic mucosal resection (EMR) for large SSPs. METHODS: Patients presenting for elective colonoscopy at an academic endoscopy center with 1 or more SSPs ≥10mm in size were enrolled, excluding those on anticoagulants or antiplatelets other than aspirin...
November 10, 2017: Gastrointestinal Endoscopy
https://www.readbyqxmd.com/read/29131033/adverse-reactions-to-biologics-in-psoriasis
#11
Stephen J Lockwood, Lisette M Prens, Alexa B Kimball
Psoriasis is a chronic autoimmune disease which affects millions of people worldwide. Not only can psoriasis itself be debilitating and significantly reduce an individual's quality of life, but it is also a risk factor for other systemic disorders, such as metabolic syndrome, cardiovascular disease, and malignancy. Tremendous strides were made in the treatment of psoriasis during the mid-to-late-20th century, including the emergence of topical corticosteroids and vitamin D analogs, methotrexate, systemic retinoids, and phototherapy...
2018: Current Problems in Dermatology
https://www.readbyqxmd.com/read/29128379/active-sms-based-influenza-vaccine-safety-surveillance-in-australian-children
#12
Alexis Pillsbury, Helen Quinn, Patrick Cashman, Alan Leeb, Kristine Macartney
INTRODUCTION: Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. METHODS: Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey...
November 8, 2017: Vaccine
https://www.readbyqxmd.com/read/29126176/hand-arm-vibration-in-orthopaedic-surgery-a-neglected-risk
#13
F Mahmood, K B Ferguson, J Clarke, K Hill, E B Macdonald, D J M Macdonald
Background: Hand-arm vibration syndrome is an occupational disease caused by exposure to hand-arm transmitted vibration. The Health and Safety Executive has set limits for vibration exposure, including an exposure action value (EAV), where steps should be taken to reduce exposure, and an exposure limit value (ELV), beyond which vibrating equipment must not be used for the rest of the working day. Aims: To measure hand-arm transmitted vibration among orthopaedic surgeons, who routinely use hand-operated saws...
November 6, 2017: Occupational Medicine
https://www.readbyqxmd.com/read/29124242/growth-kinetics-of-small-renal-mass-initial-analysis-of-active-surveillance-registry
#14
Sung-Woo Park, Seung Soo Lee, Dong Hoon Lee, Jong Kil Nam, Moon Kee Chung
Purpose: To evaluate the clinical safety and natural history of active surveillance (AS) for incidentally diagnosed small renal mass (SRM). Materials and Methods: We analyzed prospective data for patients who underwent AS for SRM. From 2010 to 2016, 37 SRMs of less than 3 cm were registered. Computed tomography (CT) and magnetic resonance imaging were used for initial diagnosis and CT, ultrasonography, and chest CT were performed at 6-month intervals. If there was no change in size during 2 years, follow-ups were performed annually...
November 2017: Investigative and Clinical Urology
https://www.readbyqxmd.com/read/29122979/using-an-epidemiological-framework-and-bovine-spongiform-encephalopathy-investigation-questionnaire-to-investigate-suspect-bovine-spongiform-encephalopathy-cases-an-example-from-a-bovine-spongiform-encephalopathy-case-in-ireland-in-2015
#15
Jarlath T O'Connor, Justin P Byrne, Simon J More, Martin Blake, Guy McGrath, Jamie A Tratalos, Maire C Mcelroy, Paul Kiernan, Mary J Canty, Chris O'Brien-Lynch, John M Griffin
In several EU member states, bovine spongiform encephalopathy (BSE) cases have been identified in cattle born after the reinforced ban (BARB cases), for reasons that are not entirely clear. Epidemiological investigation of these cases has proved challenging. The European Food Safety Authority recently recommended the collection of a predefined set of epidemiological data from BSE suspects and confirmed BSE cases to aid future investigations. In this study, we present an epidemiological framework and BSE investigation questionnaire to aid the investigation of suspect BSE cases, and illustrate its application during the investigation of a BSE case in Ireland in 2015...
November 9, 2017: Veterinary Record
https://www.readbyqxmd.com/read/29122893/prospective-postmarketing-surveillance-of-acute-myocardial-infarction-in-new-users-of-saxagliptin-a-population-based-study
#16
Sengwee Toh, Marsha E Reichman, David J Graham, Christian Hampp, Rongmei Zhang, Melissa G Butler, Aarthi Iyer, Malcolm Rucker, Madelyn Pimentel, Jack Hamilton, Samuel Lendle, Bruce H Fireman
OBJECTIVE: The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS: We identified patients aged ≥18 years, starting from the approval date of saxagliptin in 2009 and continuing through August 2014, using data from 18 Mini-Sentinel data partners...
November 9, 2017: Diabetes Care
https://www.readbyqxmd.com/read/29119679/noise-induced-hearing-loss-an-examination-of-the-methods-of-assessment-in-a-cross-sectional-study-of-87-industrial-workers
#17
Sudip Das, Michael Mulheran, Melanie Brewster, Anil R Banerjee
OBJECTIVES: The surveillance of noise-induced hearing loss (NIHL) according to the Health & Safety Executive (HSE) differs from the medico-legal criteria used to assess NIHL. Our study compares the two systems and proposes a novel method of simplifying the medico-legal criteria and applying it to ascertain noise-induced hearing loss. DESIGN: The anonymised audiograms of a group of 87 industrial workers from a single site were analysed with both methods. RESULTS: The comparison showed approximately one-third of the workers assessed in this study had their noise-induced hearing loss underestimated by the HSE criteria...
November 9, 2017: Clinical Otolaryngology
https://www.readbyqxmd.com/read/29119538/safety-and-effectiveness-of-natalizumab-first-report-of-interim-results-of-post-marketing-surveillance-in-japan
#18
Takahiko Saida, Kazumasa Yokoyama, Ryusuke Sato, Haruki Makioka, Yukihiko Iizuka, Masakazu Hase, Yan Ling, Shinichi Torii
INTRODUCTION: Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan...
November 8, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/29114634/monitoring-outcome-of-joint-arthroplasty-in-italy-implementation-of-the-national-registry
#19
Marina Torre, Emilio Romanini, Gustavo Zanoli, Eugenio Carrani, Ilaria Luzi, Luisa Leone, Stefania Bellino
Purpose  Arthroplasty registries have an important role in improving outcomes in joint surgery. As the demand for joint arthroplasty continues to increase, growing attention is being paid to the establishment of national registries, which contribute to the enhancement of the quality of patients' care. Indeed, providing postmarketing surveillance data in terms of safety and effectiveness of medical devices, registries contribute to the best orthopaedic practice and support public health decision making. In this context, a project aimed at implementing a national arthroplasty registry in Italy has appeared to be essential, and the activities performed in the last years have consolidated data collection of hip and knee replacements...
June 2017: Joints
https://www.readbyqxmd.com/read/29112002/surveillance-of-surgical-meshes-in-ventral-hernias-and-unpredictability-of-the-their-history
#20
Francesco Gossetti, Linda D'Amore, Francesca Ceci, Maria Romana Grimaldi, Paolo Negro
: The authors read the article "The importance of registries in the postmarketing surveillance of surgical meshes" by Kockerling et al, and they completely agree on the role of a clinical follow-up of surgical meshes even if they suggest that a surveillance longer than one year is advisable, particularly in IPOM repair, to collect not only late complications but also more serious adverse events. This seems be the only way to properly assess the safety of the mesh.
November 3, 2017: Annals of Surgery
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