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https://www.readbyqxmd.com/read/28944731/the-fda-unapproved-drugs-initiative-an-observational-study-of-the-consequences-for-drug-prices-and-shortages-in-the-united-states
#1
Ravi Gupta, Sanket S Dhruva, Erin R Fox, Joseph S Ross
BACKGROUND: Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944173/hypertrophic-obstructive-cardiomyopathy-the-mayo-clinic-experience
#2
Kunal D Kotkar, Sameh M Said, Joseph A Dearani, Hartzell V Schaff
BACKGROUND: Hypertrophic cardiomyopathy (HCM) is a primary myocardial disease characterized by left ventricular hypertrophy in the absence of other etiologies. Clinical presentation may vary from asymptomatic to sudden cardiac death. Medical treatment is the first-line therapy for symptomatic patients. Extended left ventricular septal myectomy is the procedure of choice if medical treatment is unsuccessful or intolerable. MAYO CLINIC EXPERIENCE: More than 3,000 patients have had septal myectomy for HCM at the Mayo Clinic (MN, USA) from 1993 to 2016...
July 2017: Annals of Cardiothoracic Surgery
https://www.readbyqxmd.com/read/28943495/percutaneous-transcatheter-biopsy-for-intracardiac-mass-diagnosis
#3
Gautam Reddy, Elad Maor, Melanie C Bois, Krishnaswamy Chandrasekharan, Charanjit S Rihal, Rick A Nishimura, David R Holmes, Guy S Reeder, Joseph J Maleszewski, Kyle W Klarich
AIMS: The differential diagnosis of intracardiac masses (ICM) is wide. While imaging modalities cansuggest a diagnosis, clinical decision making usually requires histopathologic diagnosis. The aimwas to describe procedural technique, safety outcomes, diagnostic accuracy and clinical utilityof percutaneous transcatheter biopsy (TCB) for histopathologic diagnosis of ICM. The records ofall patients undergoing TCB of ICM at the Mayo Clinic catheterization laboratories in RochesterMinnesota between 2002 and 2017 were retrieved and reviewed...
September 26, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28940587/liver-dysfunction-in-chronic-lymphocytic-leukemia-prevalence-outcomes-and-pathological-findings
#4
Paul J Hampel, Kari G Chaffee, Rebecca L King, Douglas Simonetto, Melissa C Larson, Sara Achenbach, Timothy G Call, Wei Ding, Saad S Kenderian, Jose F Leis, Asher A Chanan-Khan, Deborah A Bowen, Michael J Conte, Susan M Schwager, Curtis A Hanson, Susan L Slager, Neil E Kay, Tait D Shanafelt, Sameer A Parikh
The prevalence of liver dysfunction and its association with outcomes in patients with previously untreated chronic lymphocytic leukemia (CLL) is unknown. Newly diagnosed (<12 months) previously untreated CLL patients seen at Mayo Clinic, Rochester, MN between 9/1993 and 4/2016 who had baseline assessment of at least one liver function test (LFT) were included in this analysis. The prevalence of liver dysfunction at baseline, proportion of patients who acquired LFT abnormalities, time to first therapy (TTFT) and overall survival (OS) were assessed...
September 22, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28939374/factors-associated-with-early-outcomes-following-standardised-therapy-in-children-with-ulcerative-colitis-protect-a-multicentre-inception-cohort-study
#5
Jeffrey S Hyams, Sonia Davis, David R Mack, Brendan Boyle, Anne M Griffiths, Neal S LeLeiko, Cary G Sauer, David J Keljo, James Markowitz, Susan S Baker, Joel Rosh, Robert N Baldassano, Ashish Patel, Marian Pfefferkorn, Anthony Otley, Melvin Heyman, Joshua Noe, Maria Oliva-Hemker, Paul Rufo, Jennifer Strople, David Ziring, Stephen L Guthery, Boris Sudel, Keith Benkov, Prateek Wali, Dedrick Moulton, Jonathan Evans, Michael D Kappelman, Alison Marquis, Francisco A Sylvester, Margaret H Collins, Suresh Venkateswaran, Marla Dubinsky, Vin Tangpricha, Krista L Spada, Ashley Britt, Bradley Saul, Nathan Gotman, Jessie Wang, Jose Serrano, Subra Kugathasan, Thomas Walters, Lee A Denson
BACKGROUND: Previous retrospective studies of paediatric ulcerative colitis have had limited ability to describe disease progression and identify predictors of treatment response. In this study, we aimed to identify characteristics associated with outcomes following standardised therapy after initial diagnosis. METHODS: The PROTECT multicentre inception cohort study was based at 29 centres in the USA and Canada and included paediatric patients aged 4-17 years who were newly diagnosed with ulcerative colitis...
September 19, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28936610/tight-fitting-radial-head-prosthesis-does-stem-size-help-prevent-painful-loosening
#6
Pierre Laumonerie, Nicolas Reina, Claudia Gutierrez, Stephanie Delclaux, Meagan E Tibbo, Nicolas Bonnevialle, Pierre Mansat
INTRODUCTION: The most common reason for removal of well-fixed radial head prostheses is painful loosening. We hypothesised that short-stemmed prostheses, used for radial head arthroplasty, are not associated with an increased risk of implant loosening. METHODS: From 2002 to 2014, 65 patients were enrolled in a retrospective single-centre study. The radial head prostheses were classified as having either a long (30-mm) or short (16- to 22-mm) stem. The long-stemmed implants comprised 30 GUEPAR® DePuy Synthes (West Chester, PA, USA) and 20 Evolutive® Aston Medical (Saint-Etienne, France) devices; the short-stemmed implants comprised nine RECON and six STANDARD rHead® SBI-Stryker (Morrisville, PA, USA) devices...
September 21, 2017: International Orthopaedics
https://www.readbyqxmd.com/read/28934315/usefulness-of-fecal-calprotectin-for-the-early-prediction-of-short-term-outcomes-of-remission-induction-treatments-in-ulcerative-colitis-in-comparison-with-two-item-patient-reported-outcome
#7
Takahiko Toyonaga, Taku Kobayashi, Masaru Nakano, Eiko Saito, Satoko Umeda, Shinji Okabayashi, Ryo Ozaki, Toshifumi Hibi
BACKGROUND: Fecal calprotectin (FC) is well accepted as a non-invasive biomarker which objectively reflects colonic inflammation in ulcerative colitis (UC). However, its value as a marker of response during the early phase of remission induction treatment has not been well studied. The aim of this study is to evaluate the significance of FC for predicting the short-term outcomes of remission induction treatment in patients with UC. METHODS: A prospective observational study was conducted among 31 patients with active UC...
2017: PloS One
https://www.readbyqxmd.com/read/28932959/the-role-and-regulation-of-the-11-beta-hydroxysteroid-dehydrogenase-enzyme-system-in-patients-with-inflammatory-bowel-disease
#8
M Hussey, G Holleran, S Smith, Mark Sherlock, D McNamara
INTRODUCTION: Glucocorticoids are known to modulate a number of immunological responses including counteracting inflammation. Within tissues expressing the glucocorticoid and mineralocorticoid receptors including the colon, glucocorticoid metabolism is regulated by the isoenzymes of 11ß-hydroxysteroid dehydrogenase (11β-HSD). 11β-HSD1 acts as an oxidoreductase converting inactive cortisone into active cortisol, while 11β-HSD2 acts as a dehydrogenase converting active cortisol to inactive cortisone...
September 20, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28932267/clinical-performance-of-an-infliximab-rapid-quantification-assay
#9
Fernando Magro, Joana Afonso, Susana Lopes, Rosa Coelho, Raquel Gonçalves, Paulo Caldeira, Paula Lago, Helena Tavares de Sousa, Jaime Ramos, Ana Rita Gonçalves, Paula Ministro, Isadora Rosa, Tânia Meira, Patrícia Andrade, João-Bruno Soares, Diana Carvalho, Paula Sousa, Ana Isabel Vieira, Joanne Lopes, Cláudia Camila Dias, Karel Geboes, Fátima Carneiro
BACKGROUND: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. METHODS: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28932212/comparative-genomics-of-burkholderia-singularis-sp-nov-a-low-g-c-content-free-living-bacterium-that-defies-taxonomic-dissection-of-the-genus-burkholderia
#10
Peter Vandamme, Charlotte Peeters, Birgit De Smet, Erin P Price, Derek S Sarovich, Deborah A Henry, Trevor J Hird, James E A Zlosnik, Mark Mayo, Jeffrey Warner, Anthony Baker, Bart J Currie, Aurélien Carlier
Four Burkholderia pseudomallei-like isolates of human clinical origin were examined by a polyphasic taxonomic approach that included comparative whole genome analyses. The results demonstrated that these isolates represent a rare and unusual, novel Burkholderia species for which we propose the name B. singularis. The type strain is LMG 28154(T) (=CCUG 65685(T)). Its genome sequence has an average mol% G+C content of 64.34%, which is considerably lower than that of other Burkholderia species. The reduced G+C content of strain LMG 28154(T) was characterized by a genome wide AT bias that was not due to reduced GC-biased gene conversion or reductive genome evolution, but might have been caused by an altered DNA base excision repair pathway...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28929365/management-of-comminuted-fractures-of-the-distal-humerus-clinical-outcome-after-primary-external-fixation-versus-immediate-fixation-with-locking-plates
#11
Clemens Kösters, Simon Lenschow, Esther Schulte-Zurhausen, Steffen Roßlenbroich, Michael J Raschke, Benedikt Schliemann
OBJECTIVES: The surgical treatment of comminuted fractures of the distal humerus remains a challenging problem. The aim of the present study was to compare the clinical outcomes of primary external fixation with second-staged open reduction and internal fixation (ORIF) and initial definitive internal fixation in surgically treated patients with comminuted distal humerus fractures. DESIGN: Retrospective comparative study. SETTING: Level one trauma center...
September 19, 2017: Archives of Orthopaedic and Trauma Surgery
https://www.readbyqxmd.com/read/28927668/societal-costs-in-displaced-transverse-olecranon-fractures-using-decision-analysis-tools-to-find-the-most-cost-effective-strategy-between-tension-band-wiring-and-locked-plating
#12
Tittu Francis, Travis Washington, Karan Srivastava, Vasilios Moutzouros, Eric C Makhni, William Hakeos
BACKGROUND: Tension band wiring (TBW) and locked plating are common treatment options for Mayo IIA olecranon fractures. Clinical trials have shown excellent functional outcomes with both techniques. Although TBW implants are significantly less expensive than a locked olecranon plate, TBW often requires an additional operation for implant removal. To choose the most cost-effective treatment strategy, surgeons must understand how implant costs and return to the operating room influence the most cost-effective strategy...
September 15, 2017: Journal of Shoulder and Elbow Surgery
https://www.readbyqxmd.com/read/28923698/trends-of-inguinal-hernia-repairs-performed-for-recurrence-in-the-united-states
#13
Brittany L Murphy, Daniel S Ubl, Jianying Zhang, Elizabeth B Habermann, David R Farley, Keith Paley
BACKGROUND: One of the main complications of inguinal hernia repair continues to be recurrence. Commonly cited prior reports from relatively small studies estimate this rate to be 1% to 5% in the United States. Although some reports have found higher recurrence rates, they get little attention on the national stage or in other large studies. We sought to determine the trend of inguinal hernia repairs performed for recurrence over time using large national databases. METHODS: We identified patients aged ≥18 years who underwent inguinal hernia repair from three sources: the Premier database (January 2010 to September 2015), the American College of Surgeons National Surgical Quality Improvement Program database (January 2005 to December 2014), and the Mayo Clinic institutions (January 2005 to December 2014)...
September 15, 2017: Surgery
https://www.readbyqxmd.com/read/28923551/cardiac-melanoma-retrospective-review-of-a-rare-disease-at-the-mayo-clinic-1988-2015
#14
Chung Sang Tse, Nicholas Tan, Dame Idossa, Roger Click
BACKGROUND: Melanoma metastasizing to the heart (cardiac melanoma) is a rare entity that has been described only in autopsy studies or isolated pre-mortem case reports. We aim to better characterize cardiac melanoma, and describe its presenting features, imaging findings, and disease course with a case series collected over nearly 30years. METHODS: We performed a retrospective review of all patients diagnosed with cardiac melanoma at the Mayo Clinic from 1988 to 2015...
September 6, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28922435/effectiveness-and-safety-of-golimumab-in-treating-outpatient-ulcerative-colitis-a-real-life-prospective-multicentre-observational-study-in-primary-inflammatory-bowel-diseases-centers
#15
Antonio Tursi, Leonardo Allegretta, Nello Buccianti, Nicola Della Valle, Walter Elisei, Giacomo Forti, Roberto Faggiani, Sara Gallina, Yusef Hadad, Tiziana Larussa, Angelo Lauria, Francesco Luzza, Roberto Lorenzetti, Giammarco Mocci, Antonio Penna, Natale Polimeni, Giuseppe Pranzo, Cristina Ricciardelli, Costantino Zampaletta, Marcello Picchio
BACKGROUND AND AIMS: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres. METHODS: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score </=2, at 6-month follow-up...
September 2017: Journal of Gastrointestinal and Liver Diseases: JGLD
https://www.readbyqxmd.com/read/28922304/estimated-blood-loss-during-vaginal-hysterectomy-and-adnexal-surgery-described-with-an-intraoperative-pictographic-tool
#16
Nancy C Nelson, Stuart A Ostby, Amy L Weaver, Michaela E McGree, John B Gebhart, Jamie N Bakkum-Gamez
OBJECTIVE: We describe a novel way to calculate estimated blood loss (EBL) using an intraoperative pictographic tool in gynecologic surgery. METHODS: A pictographic tool to estimate sponge saturation was developed to calculate EBL during surgery. A prospective cohort of women 18 years or older undergoing benign vaginal hysterectomy with planned adnexal surgery at Mayo Clinic were consented for use of the pictographic tool. Demographic, preoperative, intraoperative, and postoperative data were abstracted...
September 15, 2017: Female Pelvic Medicine & Reconstructive Surgery
https://www.readbyqxmd.com/read/28921446/can-a-novel-icu-data-display-positively-affect-patient-outcomes-and-save-lives
#17
Natalia Olchanski, Mikhail A Dziadzko, Ing C Tiong, Craig E Daniels, Steve G Peters, John C O'Horo, Michelle N Gong
The aim of this study was to quantify the impact of ProCCESs AWARE, Ambient Clinical Analytics, Rochester, MN, a novel acute care electronic medical record interface, on a range of care process and patient health outcome metrics in intensive care units (ICUs). ProCCESs AWARE is a novel acute care EMR interface that contains built-in tools for error prevention, practice surveillance, decision support and reporting. We compared outcomes before and after AWARE implementation using a prospective cohort and a historical control...
September 18, 2017: Journal of Medical Systems
https://www.readbyqxmd.com/read/28919059/rates-of-hippocampal-atrophy-and-presence-of-post-mortem-tdp-43-in-patients-with-alzheimer-s-disease-a-longitudinal-retrospective-study
#18
Keith A Josephs, Dennis W Dickson, Nirubol Tosakulwong, Stephen D Weigand, Melissa E Murray, Leonard Petrucelli, Amanda M Liesinger, Matthew L Senjem, Anthony J Spychalla, David S Knopman, Joseph E Parisi, Ronald C Petersen, Clifford R Jack, Jennifer L Whitwell
BACKGROUND: Post-mortem studies have not identified an association between β-amyloid or tau and rates of hippocampal atrophy in patients with Alzheimer's disease. TAR DNA binding protein 43 (TDP-43) is another protein linked to Alzheimer's disease. We aimed to investigate whether hippocampal TDP-43 is associated with increased rates of hippocampal atrophy. METHODS: In this longitudinal retrospective study, we analysed post-mortem brain tissue of all individuals with an Alzheimer's disease spectrum pathological diagnosis who had antemortem head MRI scans between Jan 1, 1999, and Dec 31, 2012, and who had been recruited into the Mayo Clinic Alzheimer's Disease Research Center, Mayo Clinic Alzheimer's Disease Patient Registry, or the Mayo Clinic Study of Aging...
September 11, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28917680/effusive-constrictive-pericarditis-after-pericardiocentesis-incidence-associated-findings-and-natural-history
#19
Kye Hun Kim, William R Miranda, Larry J Sinak, Faisal F Syed, Rowlens M Melduni, Raul E Espinosa, Garvan C Kane, Jae K Oh
OBJECTIVES: This study sought to investigate the incidence, associated findings, and natural history of effusive-constrictive pericarditis (ECP) after pericardiocentesis. BACKGROUND: ECP is characterized by the coexistence of tense pericardial effusion and constriction of the heart by the visceral pericardium. Echocardiography is currently the main diagnostic tool in the assessment of pericardial disease, but limited data have been published on the incidence and prognosis of ECP diagnosed by echo-Doppler...
September 9, 2017: JACC. Cardiovascular Imaging
https://www.readbyqxmd.com/read/28913177/big-data-in-designing-clinical-trials-opportunities-and-challenges
#20
Charles S Mayo, Martha M Matuszak, Matthew J Schipper, Shruti Jolly, James A Hayman, Randall K Ten Haken
Emergence of big data analytics resource systems (BDARSs) as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs) have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events...
2017: Frontiers in Oncology
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