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Sentinel events

Ryan M Carnahan, Jennifer L Kuntz, Shirley V Wang, Candace Fuller, Joshua J Gagne, Charles E Leonard, Sean Hennessy, Tamra Meyer, Patrick Archdeacon, Chih-Ying Chen, Catherine A Panozzo, Sengwee Toh, Hannah Katcoff, Tiffany Woodworth, Aarthi Iyer, Sophia Axtman, Elizabeth A Chrischilles
PURPOSE: The Food and Drug Administration's Sentinel System developed parameterized, reusable analytic programs for evaluation of medical product safety. Research on outpatient antibiotic exposures, and Clostridium difficile infection (CDI) with non-user reference groups led us to expect a higher rate of CDI among outpatient clindamycin users vs penicillin users. We evaluated the ability of the Cohort Identification and Descriptive Analysis and Propensity Score Matching tools to identify a higher rate of CDI among clindamycin users...
March 13, 2018: Pharmacoepidemiology and Drug Safety
Kay Lash, Rachelle Oppel, Jeanette Hasse
Technology advances have made it possible to prolong life for patients with heart failure who are not transplant candidates or while awaiting transplant. Many different cardiac devices are available that can be used as a bridge to transplant (temporary support) or as a destination therapy (permanent support). Placement of these devices can cause complications that, if not addressed, could negatively impact the nutrition status of patients. Placement of nasointestinal feeding tubes using an electromagnetic sensor-guided enteral access system (EMS-EAS) has been difficult in patients with implantable devices because of the potential for interference with the EMS-EAS and the left ventricular assist device (LVAD)...
March 12, 2018: Nutrition in Clinical Practice
Mary Wang, David J Birnkrant, Dennis M Super, Irwin B Jacobs, Robert C Bahler
Objective: To describe the natural history of cardiomyopathy in patients with Duchenne muscular dystrophy (DMD) who are receiving contemporary therapies. Methods: This is a single-institution retrospective cohort study of 57 patients aged >15 years with DMD. Serial digital echocardiograms were performed over a median follow-up of 8 years. Left ventricular dysfunction (LVD) was defined as shortening fraction (SF) <29% plus focal wall motion abnormalities...
2018: Open Heart
Melanie C Bois, Michael D Eckhardt, Vincent M Cracolici, Matthew J Loe, Joseph J Ocel, William D Edwards, Robert D McBane, Thomas C Bower, Joseph J Maleszewski
OBJECTIVE: Arterial neoplastic emboli are uncommon, accounting for <1% of thromboemboli in the current literature. Nonetheless, this event may be associated with significant morbidity and mortality. Herein, we report a series of 11 cases of arterial neoplastic emboli from a single tertiary care center along with a comprehensive review of the literature to date. The aim of this study was to document the incidence, clinical presentations, and complications of arterial neoplastic emboli as well as to highlight the importance of routine histologic examination of thrombectomy specimens...
March 1, 2018: Journal of Vascular Surgery
Ingrid G M Poodt, Guusje Vugts, Adriana J G Maaskant-Braat, Robert-Jan Schipper, Adri C Voogd, Grard A P Nieuwenhuijzen
BACKGROUND: Repeat sentinel lymph node biopsy (rSLNB) has increasingly been used in patients with ipsilateral breast tumor recurrence (IBTR). The safety in terms of regional disease control after this procedure remains unclear. This study evaluates occurrence of regional recurrence as first event in patients with IBTR and negative rSLNB, treated without additional lymph node dissection. PATIENTS AND METHODS: Data were obtained from the Sentinel Node and Recurrent Breast Cancer (SNARB) study...
March 1, 2018: Annals of Surgical Oncology
Daniela N Faloon, Holly Hampe, Thomas Cline
Miscommunication is a large contributing factor to hospital sentinel events. Communication with nurses is a component of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. The HCAHPS survey not only assesses patient satisfaction but also impacts how hospitals are reimbursed. A literature review reveals that nursing bedside shift positively impacts patient satisfaction and nurse communication. There is limited research on how to implement bedside report as well as what to include during report...
April 2018: Critical Care Nursing Quarterly
Eric M Ammann, Adam Cuker, Ryan M Carnahan, Usha S Perepu, Scott K Winiecki, Marin L Schweizer, Charles E Leonard, Candace C Fuller, Crystal Garcia, Cole Haskins, Elizabeth A Chrischilles
The Sentinel Distributed Database (SDD) is a database of patient administrative healthcare records, derived from insurance claims and electronic health records, sponsored by the US Food and Drug Administration for evaluation of medical product outcomes. There is limited information on the validity of diagnosis codes for acute venous thromboembolism (VTE) in the SDD and administrative healthcare data more generally.In this chart validation study, we report on the positive predictive value (PPV) of inpatient administrative diagnosis codes for acute VTE-pulmonary embolism (PE) or lower-extremity or site-unspecified deep vein thrombosis (DVT)-within the SDD...
February 2018: Medicine (Baltimore)
Eric M Ammann, Marin L Schweizer, Jennifer G Robinson, Jayasheel O Eschol, Rami Kafa, Saket Girotra, Scott K Winiecki, Candace C Fuller, Ryan M Carnahan, Charles E Leonard, Cole Haskins, Crystal Garcia, Elizabeth A Chrischilles
BACKGROUND: The Sentinel Distributed Database (SDD) is a large database of patient-level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases. PURPOSE: In this chart validation study, we report on the positive predictive value (PPV) of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification AMI administrative diagnosis codes (410...
February 15, 2018: Pharmacoepidemiology and Drug Safety
Abdulrahman M Saadalla, Abu Osman, Michael F Gurish, Kristen L Dennis, Nichole R Blatner, Abdulmohammad Pezeshki, Kelly M McNagny, Hilde Cheroutre, Fotini Gounari, Khashayarsha Khazaie
Mast cells (MCs) are tissue resident sentinels that mature and orchestrate inflammation in response to infection and allergy. While they are also frequently observed in tumors, the contribution of MCs to carcinogenesis remains unclear. Here, we show that sequential oncogenic events in gut epithelia expand different types of MCs in a temporal-, spatial-, and cytokine-dependent manner. The first wave of MCs expands focally in benign adenomatous polyps, which have elevated levels of IL-10, IL-13, and IL-33, and are rich in type-2 innate lymphoid cells (ILC2s)...
February 13, 2018: Proceedings of the National Academy of Sciences of the United States of America
Julien Revaud, Yves Unterfinger, Nicolas Rol, Muhammad Suleman, Julia Shaw, Sandra Galea, Françoise Gavard, Sandrine A Lacour, Muriel Coulpier, Nicolas Versillé, Menzo Havenga, Bernard Klonjkowski, Gina Zanella, Stéphane Biacchesi, Nathalie Cordonnier, Blaise Corthésy, Juliette Ben Arous, Jennifer P Richardson
To define the bottlenecks that restrict antigen expression after oral administration of viral-vectored vaccines, we tracked vectors derived from the human adenovirus type 5 at whole body, tissue, and cellular scales throughout the digestive tract in a murine model of oral delivery. After intragastric administration of vectors encoding firefly luciferase or a model antigen, detectable levels of transgene-encoded protein or mRNA were confined to the intestine, and restricted to delimited anatomical zones. Expression of luciferase in the form of multiple small bioluminescent foci in the distal ileum, cecum, and proximal colon suggested multiple crossing points...
2018: Frontiers in Cellular and Infection Microbiology
Mónica Morales, Pedro Martínez-Paz, Paloma Sánchez-Argüello, Gloria Morcillo, José Luis Martínez-Guitarte
Bisphenol A (BPA), a known endocrine disrupting chemical (EDC) that can mimic the action of oestrogens by interacting with hormone receptors, is potentially able to influence reproductive functions in vertebrates and invertebrates. The freshwater pulmonate Physa acuta is a sensitive organism to xenobiotics appropriate for aquatic toxicity testing in environmental studies. This study was conducted to explore the effects of BPA on the Gastropoda endocrine system. The effects following a range of exposure times (5-96h) to BPA in P...
January 31, 2018: Ecotoxicology and Environmental Safety
Ruiling Liu, Walter A Alarcon, Geoffrey M Calvert, Kathleen G Aubin, John Beckman, Karen R Cummings, Lucia S Graham, Sheila A Higgins, Prakash Mulay, Ketki Patel, Joanne B Prado, Abby Schwartz, Derry Stover, Justin Waltz
Total release foggers (TRFs) (also known as "bug bombs") are pesticide products often used indoors to kill insects. After an earlier report found that TRFs pose a risk for acute illness (1), the Environmental Protection Agency required improved labels on TRFs manufactured after September 2012 (2). To examine the early impact of relabeling, the magnitude and characteristics of acute TRF-related illness were evaluated for the period 2007-2015. A total of 3,222 TRF-related illnesses were identified in 10 participating states, based on three data sources: Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) programs, the California Department of Pesticide Regulation (CDPR) program, and poison control centers (PCCs) in Florida, Texas, and Washington...
February 2, 2018: MMWR. Morbidity and Mortality Weekly Report
Eric M Ammann, Enrique C Leira, Scott K Winiecki, Nandakumar Nagaraja, Sudeepta Dandapat, Ryan M Carnahan, Marin L Schweizer, James C Torner, Candace C Fuller, Charles E Leonard, Crystal Garcia, Madelyn Pimentel, Elizabeth A Chrischilles
The Sentinel Distributed Database (SDD) is a large database of patient-level medical and prescription records, primarily derived from insurance claims and electronic health records, and is sponsored by the U.S. Food and Drug Administration for drug safety assessments. In this chart validation study, we report on the positive predictive value (PPV) of inpatient ICD-9-CM acute ischemic stroke (AIS) administrative diagnosis codes (433.x1, 434.xx, and 436) in the SDD.As part of an assessment of the risk of thromboembolic adverse events following treatment with intravenous immune globulin (IGIV), charts were obtained for 131 potential post-IGIV AIS cases...
December 2017: Medicine (Baltimore)
Girja S Shukla, Stephanie C Pero, Yu-Jing Sun, Chelsea L Carman, Seth Harlow, David N Krag
Autoantibodies to breast and other cancers are commonly present in cancer patients. A method to rapidly produce these anti-cancer autoantibodies in the lab would be valuable for understanding immune events and to generate candidate reagents for therapy and diagnostics. The purpose of this report is to evaluate sentinel nodes (SNs) of breast cancer patients as a source of anti-cancer antibodies. Radiotracer lymphatic mapping in 29 patients with breast cancer confirmed the identity of the SNs which provided source cells for this study...
January 27, 2018: Journal of Immunological Methods
Neetika Garg, Yuzhou Zhang, Anne Nicholson-Weller, Eliyahu V Khankin, Nicolò Ghiringhelli Borsa, Nicole C Meyer, Susan McDermott, Isaac E Stillman, Helmut G Rennke, Richard J Smith, Martha Pavlakis
Background: C3 glomerulonephritis (C3GN) is caused by alternate complement pathway over-activation. It frequently progresses to end-stage renal disease, recurs in two-thirds of transplants and in half of these cases progresses to allograft loss. There is currently no proven treatment for C3GN. Case Presentation: We describe a family segregating pathogenic alleles of complement factor H and I (CFH and CFI). The only member carrying both mutations developed C3GN. Prolonged delayed graft function after deceased donor transplantation, heavy proteinuria and isolated C3 hypocomplementemia prompted an allograft biopsy confirming diagnosis of recurrent C3GN...
January 23, 2018: Nephrology, Dialysis, Transplantation
Sarah J Higgins, Karen De Ceunynck, John Kellum, Xiuying Chen, Xuesong Gu, Sharjeel A Chaudhry, Sol Schulman, Towia A Libermann, Shulin Lu, Nathan I Shapiro, David C Christiani, Robert Flaumenhaft, Samir M Parikh
Disordered coagulation contributes to death in sepsis and lacks effective treatments. Existing markers of disseminated intravascular coagulation (DIC) reflect its sequelae rather than its causes, delaying diagnosis and treatment. Here we show that disruption of the endothelial Tie2 axis is a sentinel event in septic DIC. Proteomics in septic DIC patients revealed a network involving inflammation and coagulation with the Tie2 antagonist, Angiopoietin-2 (Angpt-2), occupying a central node. Angpt-2 was strongly associated with traditional DIC markers including platelet counts, yet more accurately predicted mortality in two large independent cohorts (combined N = 1077)...
January 23, 2018: Journal of Clinical Investigation
Craig I Coleman, Tatsiana Vaitsiakhovich, Elaine Nguyen, Erin R Weeda, Nitesh A Sood, Thomas J Bunz, Bernhard Schaefer, Anna-Katharina Meinecke, Daniel Eriksson
BACKGROUND: Schemas to identify bleeding-related hospitalizations in claims data differ in billing codes used and coding positions allowed. We assessed agreement across bleeding-related hospitalization coding schemas for claims analyses of nonvalvular atrial fibrillation (NVAF) patients on oral anticoagulation (OAC). HYPOTHESIS: We hypothesized that prior coding schemas used to identify bleeding-related hospitalizations in claim database studies would provide varying levels of agreement in incidence rates...
January 23, 2018: Clinical Cardiology
Peter D Hibbert, Matthew J W Thomas, Anita Deakin, William B Runciman, Jeffrey Braithwaite, Stephanie Lomax, Jonathan Prescott, Glenda Gorrie, Amy Szczygielski, Tanja Surwald, Catherine Fraser
Objective: To assess the strength of root cause analysis (RCA) recommendations and their perceived levels of effectiveness and sustainability. Design: All RCAs related to sentinel events (SEs) undertaken between the years 2010 and 2015 in the public health system in Victoria, Australia were analysed. The type and strength of each recommendation in the RCA reports were coded by an expert patient safety classifier using the US Department of Veteran Affairs type and strength criteria...
January 16, 2018: International Journal for Quality in Health Care
Silvio Eduardo Bromberg, Patricia Rodrigues Alves de Figueiredo Moraes, Felipe Ades
The prime incision technique is an oncoplastic surgery aimed to remove both the breast tumor and the sentinel lymph node through one incision, thus providing better aesthetic results than the conventional breast conservative two incision technique. We retrospectively evaluated 2 cohorts of 60 consecutive breast cancer patients operated by either conventional breast conservative surgery (N = 26) or one incision surgery (N = 34). There were no recurrence or death events observed in any group. No difference was seen regarding the incidence of surgical complications...
2018: PloS One
Andrea Iaboni, Karen Van Ooteghem, Meghan N Marcil, Amy Cockburn, Alastair J Flint, Daphna Grossman, Ron Keren
Falls are viewed as a preventable cause of injury, functional loss, and death in older adults with dementia, and have been used as a marker of quality of care in long-term care facilities. Despite intensive intervention around fall prevention in these settings, falls and injury remain frequent, particularly among residents in the advanced stages of dementia. In this clinical review, we consider the common challenges and pitfalls in both the management of falls and the provision of palliative care in advanced dementia...
December 11, 2017: American Journal of Geriatric Psychiatry
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