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Clinical negligence

Alfonso Ielasi, Attilio Varricchio, Gianluca Campo, Massimo Leoncini, Bernardo Cortese, Paolo Vicinelli, Salvatore Brugaletta, Fortunato Scotto di Uccio, Azeem Latib, Maurizio Tespili
OBJECTIVES: To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. BACKGROUNDS: Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events...
October 24, 2016: Catheterization and Cardiovascular Interventions
Mwlod Ghareeb, Fatemeh Akhlaghi
Tacrolimus is a commonly used immunosuppressive agent in organ transplant recipients. Therapeutic drug monitoring (TDM) of tacrolimus is essential to adjust the dose and achieve optimal immunosuppression level. Routine TDM is practiced using whole blood samples obtained through venipuncture. However, tacrolimus concentration that is present in oral fluid (OF) can theoretically represent the free or pharmacologically active form of tacrolimus. In this study, we report the development and validation of a rapid, sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantification of tacrolimus in OF...
October 11, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Alexandra C Sundermann, Troy D Abell, Lisa C Baker, Mark B Mengel, Kathryn E Reilly, Michael A Bonow, Gregory E Hoy, Richard D Clover
BACKGROUND: The specialization of human fat deposits is an inquiry of special importance in the study of fetal growth. It has been theorized that maternal lower-body fat is designated specifically for lactation and not for the growth of the fetus. OBJECTIVE: Our goal was to compare the contributions of maternal upper-body versus lower-body adiposity to infant birth weight. We hypothesized that upper-body adiposity would be strongly associated with infant birth weight and that lower-body adiposity would be weakly or negligibly associated with infant birth weight-after adjusting for known determinants...
September 21, 2016: European Journal of Obstetrics, Gynecology, and Reproductive Biology
Luca Ivan Ardolino, Marisa Meloni, Giuseppe Brugali, Emanuela Corsini, Corrado Lodovico Galli
BACKGROUND: Polybactum (Effik International, Brussels, Belgium) is a vaginal mucoadhesive product (medical device) designed to form a film that acts as a mechanical barrier with the aim of inhibiting colonization by specific pathogens. It contains polycarbophil, a bioadhesive agent, and lauryl glucoside (LG), a nonionic surfactant that reinforces the barrier effect through its tensioactive properties. OBJECTIVE: To assess the local safety profile, tolerability, and efficacy of Polybactum formulations...
2016: Current Therapeutic Research, Clinical and Experimental
Harish Kempegowda, Raveesh Richard, Amrut Borade, Akhil Tawari, Abby M Howenstein, Erik N Kubiak, Michael Suk, Daniel S Horwitz
OBJECTIVES: The purpose of this study was to evaluate the role and the necessity of radiographs and office visits obtained during follow-up of intertrochanteric hip injuries. DESIGN: Retrospective study SETTING:: Two level I trauma centers. PATIENTS: 465 elderly patients who were surgically treated for an intertrochanteric fracture of the femur at two level I trauma centers between January 2009 and August 2014 were retrospectively identified from orthopaedic trauma databases...
August 16, 2016: Journal of Orthopaedic Trauma
Canna Ghia, Shashank Akerkar, Shailaja Sabnis, Urk Rao, Gautam Rambhad
BACKGROUND / OBJECTIVES: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs. The aim of this project was to set up and standardize an independent laboratory to test immunogenicity of anti-TNF biologics (infliximab and etanercept). METHODS: Three rheumatologists piloted this project approved by independent ethics committee and carried out in compliance with ICH/GCP guidelines...
September 2016: Journal of the Association of Physicians of India
Antonino Neri, Katia Todoerti, Marta Lionetti, Vittorio Simeon, Marzia Barbieri, Filomena Nozza, Gabriella Vona, Alessandra Pompa, Luca Baldini, Pellegrino Musto
Primary plasma cell leukemia (PPCL) is a rare and aggressive variant of multiple myeloma. The introduction of novel agents and modern technologies has recently partially changed the clinical and biological scenario of this malignancy, allowing limited, but not negligible, progresses. Areas covered: We will discuss the complex landscape of genetic alterations in PPCL, derived from conventional and high-throughput technologies; the best available treatments for PPCL; the possible future therapeutic perspectives...
October 19, 2016: Expert Review of Hematology
Junyi Che, Anqi Tao, Shun Chen, Xiaoming Li, Yi Zhao, Weien Yuan
Small interfering RNA (siRNA) has increased the hope for highly-efficient treatment of gene-related diseases. However, the stable and efficient delivery of therapeutic nucleic acids is a prerequisite for the successful clinical translation of RNA interfering therapy. To achieve this, we condensed the low molecular weight polyethyleneimine (PEI, Mw < 2000) with 2,6-pyridinedicarboxaldehyde (PDA) to synthesize a biologically responsive and degradable cationic polymer (abbreviated to PDAPEI) which was utilized as a gene vector for the delivery of a VEGF-A shRNA expression plasmid DNA (pDNA)...
October 19, 2016: Scientific Reports
A Lazaridis, M E Drosou, A Fontalis, E Prousali, S E Hadwe, O Giouleme, K Petidis
INTRODUCTION: Celiac disease is an autoimmune disease of the small intestine which occurs in genetically predisposed people of all ages. A large clinical spectrum of manifestations accompanies the onset of the disease with diarrhoea, flatulence and weight loss being the most common. However, findings like osteoporosis, iron deficiency, anaemia and hypocalcaemia could also insinuate the existence of the disease. CASE PRESENTATION: We report the case of a 55-year-old man with numbness and tingling of the upper extremities due to hypocalcaemia that proved to be an uncommon case of celiac disease...
October 16, 2016: Scottish Medical Journal
Paolo Dell'Oglio, Robert Jeffrey Karnes, Giorgio Gandaglia, Nicola Fossati, Armando Stabile, Marco Moschini, Vito Cucchiara, Emanuele Zaffuto, Pierre I Karakiewicz, Nazareno Suardi, Francesco Montorsi, Alberto Briganti
BACKGROUND: A new prostate cancer (PCa) grading system (namely, Gleason score-GS- ≤6 vs. 3 + 4 vs. 4 + 3 vs. 8 vs. ≥9) was recently proposed and assessed on biochemical recurrence (BCR) showing improved predictive abilities compared to the commonly used three-tier system (GS ≤6 vs. 7 vs. ≥8). We assessed the predictive ability of the five-tier grade group (GG) system on harder clinical endpoint, namely clinical recurrence (CR). METHODS: Between 2005 and 2014, 9,728 clinically localized PCa patients were treated with radical prostatectomy (RP) at two tertiary referral centers...
October 18, 2016: Prostate
Ping-Ping Lin, Xue-Ning Li, Fei Yuan, Wei-Li Chen, Meng-Jie Yang, Hong-Rong Xu
Huperzine A (HupA), one of the reversible and selective acetylcholinesterase inhibitors derived from Chinese herb Huperzia Serrata, possesses affirmative action of ameliorating cognitive dysfunction of Alzheimer's disease. Up to now, the effects of HupA on human cytochrome P450s (CYPs) have not been fully elucidated. The purpose of the present study was to clarify the metabolic pathway of HupA in vitro and in vivo, and to evaluate the CYPs inhibition/induction profile of HupA in vitro. The catalytic activity of CYP enzymes (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4) was measured by the quantification of specific enzyme substrates using validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) methods...
October 14, 2016: Biochemical and Biophysical Research Communications
Maudrene Ls Tan, Eric Yh Khoo, Konstadina Griva, Yung Seng Lee, Mohamed Amir, Yasmin Lm Zuniga, Jeannette Lee, E Shyong Tai, Hwee Lin Wee
INTRODUCTION: The Diabetes Health Profile-18 (DHP-18) measures diabetes-related psychological well-being in patients with type 2 diabetes mellitus (T2DM). It includes 3 subscales: psychological distress (PD), barriers to activity and disinhibited eating. The psychometric properties of the DHP have not been evaluated in Asia. The aim of this study was to determine the psychometric properties of the DHP in multiethnic Singapore. MATERIALS AND METHODS: Patients between the ages of 18 to 65 diagnosed with diabetes (either type 1 or type 2) for at least 1 year were recruited from a diabetes outpatient clinic in a tertiary hospital...
September 2016: Annals of the Academy of Medicine, Singapore
H Felix Fischer, Inka Wahl, Sandra Nolte, Gregor Liegl, Elmar Brähler, Bernd Löwe, Matthias Rose
To investigate differential item functioning (DIF) of PROMIS Depression items between US and German samples we compared data from the US PROMIS calibration sample (n = 780), a German general population survey (n = 2,500) and a German clinical sample (n = 621). DIF was assessed in an ordinal logistic regression framework, with 0.02 as criterion for R(2) -change and 0.096 for Raju's non-compensatory DIF. Item parameters were initially fixed to the PROMIS Depression metric; we used plausible values to account for uncertainty in depression estimates...
October 16, 2016: International Journal of Methods in Psychiatric Research
Tanja Mayer, Jürgen Kopitz, Konstanze Plaschke, Johanna Weiss, Hanna M Seidling, Walter E Haefeli
OBJECTIVE: The anticholinergic activity (AA) assay is a common method to determine a patient's anticholinergic load. Several limitations, however, are expected when applying the AA assay to patients or using drug scales to estimate anticholinergic burden based on AA levels. This study aims to demonstrate common pitfalls in an experimental setting and outline their clinical consequences. METHODS: The AA was analyzed for five drugs with reported interaction with muscarinic receptors...
August 4, 2016: American Journal of Geriatric Psychiatry
Robert W Aldridge, Dominik Zenner, Peter J White, Elizabeth J Williamson, Morris C Muzyamba, Poonam Dhavan, Davide Mosca, H Lucy Thomas, Maeve K Lalor, Ibrahim Abubakar, Andrew C Hayward
BACKGROUND: Tuberculosis elimination in countries with a low incidence of the disease necessitates multiple interventions, including innovations in migrant screening. We examined a cohort of migrants screened for tuberculosis before entry to England, Wales, and Northern Ireland and tracked the development of disease in this group after arrival. METHODS: As part of a pilot pre-entry screening programme for tuberculosis in 15 countries with a high incidence of the disease, the International Organization for Migration screened all applicants for UK visas aged 11 years or older who intended to stay for more than 6 months...
October 10, 2016: Lancet
Carmelo Messina, Luca Maria Sconfienza, Michele Bandirali, Giuseppe Guglielmi, Fabio Massimo Ulivieri
Several imaging methods for the diagnosis and management of osteoporosis exist. Dual-energy X-ray absorptiometry (DXA) is the most widely available and commonly used for measuring bone mineral density (BMD). Central DXA has several advantages: It has very good reproducibility, administers a negligible radiation dose to the patient, and BMD values obtained by DXA relate to fracture risk. Nevertheless, DXA has some technical limitations that should be recognized by those physicians who interpret and report this examination...
July 2016: Seminars in Musculoskeletal Radiology
Brent F B Huisman, J M Létang, É Testa, D Sarrut
There is interest in the particle therapy community in using prompt gammas (PGs), a natural byproduct of particle treatment, for range verification and eventually dose control. However, PG production is a rare process and therefore estimation of PGs exiting a patient during a proton treatment plan executed by a Monte Carlo (MC) simulation converges slowly. Recently, different approaches to accelerating the estimation of PG yield have been presented. Sterpin et al (2015 Phys. Med. Biol. 60 4915-46) described a fast analytic method, which is still sensitive to heterogeneities...
October 14, 2016: Physics in Medicine and Biology
Martin J Bobak, Matthew W Weber, Melissa A Doellman, Douglas R Schuweiler, Jeana M Athens, Steven A Juliano, Paul A Garris
Modafinil (MOD) exhibits therapeutic efficacy for treating sleep and psychiatric disorders, but its mechanism is incompletely understood. Compared to other psychostimulants inhibiting dopamine (DA) uptake, MOD weakly interacts with the dopamine transporter (DAT) and modestly elevates striatal dialysate DA, suggesting additional targets besides DAT. However, the ability of MOD to induce wakefulness is abolished with DAT knockout, conversely suggesting that DAT is necessary for MOD action. Another psychostimulant target, but one not established for MOD, is activation of phasic DA signaling...
October 12, 2016: Journal of Pharmacology and Experimental Therapeutics
Neeraj Nagpal
Physicians and Internists in India have tended to brush under the carpet legal issues affecting their profession. Of concern to all Physicians is the judgment in a recent case where the NCDRC has stated that if MD Medicine Physicians write Physician & Cardiologist on their letterhead it is Quackery. What is MD Medicine degree holder in India qualified and trained to treat ? These are issues which need debate and that can only be initiated once we recognize that there is a problem. Either an MD Medicine is a cardiologist or he is not...
February 2016: Journal of the Association of Physicians of India
Matthew T McMillan, Brett L Ecker, Stephen W Behrman, Mark P Callery, John D Christein, Jeffrey A Drebin, Douglas L Fraker, Tara S Kent, Major K Lee, Robert E Roses, Michael H Sprys, Charles M Vollmer
BACKGROUND: Evidence suggests externalized trans-anastomotic stents may be beneficial as a fistula mitigation strategy for pancreatoduodenectomy (PD); however, previous studies have not been rigorously risk-adjusted. METHODS: From 2001 to 2015, PDs were performed at three institutions, with externalized stents placed at the surgeon's discretion. The Fistula Risk Score (FRS) and the Modified Accordion Severity Grading System were used to analyze occurrence and severity of clinically relevant postoperative pancreatic fistula (CR-POPF) across various risk scenarios...
October 11, 2016: Journal of Gastrointestinal Surgery: Official Journal of the Society for Surgery of the Alimentary Tract
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