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https://www.readbyqxmd.com/read/29909880/informing-the-tolerability-of-cancer-treatments-using-patient-reported-outcome-measures-summary-of-an-fda-and-critical-path-institute-workshop
#1
Paul G Kluetz, Bindu Kanapuru, Steven Lemery, Laura Lee Johnson, Mallorie H Fiero, Karen Arscott, Yolanda Barbachano, Ethan Basch, Michelle Campbell, Joseph C Cappelleri, David Cella, Charles Cleeland, Corneel Coens, Selena Daniels, Crystal S Denlinger, Dianne L Fairclough, James R Hillard, Lori Minasian, Sandra A Mitchell, Daniel O'Connor, Sheetal Patel, Eric H Rubin, Anna Ryden, Katherine Soltys, Rajeshwari Sridhara, Gita Thanarajasingam, Galina Velikova, Stephen Joel Coons
The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measurement science provided perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anticancer agents. Speakers and panelists explored the utility of information derived from existing and emerging PRO measures, focusing on the PRO version of the National Cancer Institute's Common Terminology Criteria for Adverse Events...
June 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29896020/biomechanical-assessment-of-an-alternative-method-of-staple-fixation-for-anchoring-the-bone-patellar-tendon-bone-graft-to-the-tibia
#2
Thomas Matthai, Vinu M George, Anbu S Rao, Anil T Oommen, Ravi J Korula, Suresh Devasahayam, Pradeep M Poonnoose
Introduction: The Anterior cruciate ligament (ACL) is the most commonly injured ligament around the knee and is best reconstructed with a biological graft. For ideal graft fixation, there should be sufficient initial strength to avoid failure of fixation and sufficient stiffness to restore the stability of the knee and to avoid gradual loosening in the post-operative period.When considering fixation of Bone Patellar Tendon Bone (BPTB) grafts to the tibia, the interference screw is considered to be the gold standard...
April 2018: Journal of Clinical Orthopaedics and Trauma
https://www.readbyqxmd.com/read/29895572/pulseless-electrical-activity-a-misdiagnosed-entity-during-asphyxia-in-newborn-infants
#3
Sparsh Patel, Po-Yin Cheung, Anne Lee Solevåg, Keith J Barrington, C Omar Farouk Kamlin, Peter G Davis, Georg M Schmölzer
BACKGROUND: The 2015 neonatal resuscitation guidelines added ECG as a recommended method of assessment of an infant's heart rate (HR) when determining the need for resuscitation at birth. However, a recent case report raised concerns about this technique in the delivery room. OBJECTIVES: To compare accuracy of ECG with auscultation to assess asystole in asphyxiated piglets. METHODS: Neonatal piglets had the right common carotid artery exposed and enclosed with a real-time ultrasonic flow probe and HR was continuously measured and recorded using ECG...
June 12, 2018: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/29895157/construction-identification-and-immunogenic-assessments-of-an-hsv-1-mutant-vaccine-with-a-ul18-deletion
#4
L Wang, Q Aoli Wang, F Jin, S Fang, F Luo, Y Wu, F Li, J Liu, Y Wang, J Jin, X Liao, Z Ren, Y Wang
HSV-1 is a mucosal and nerve pathogen, whose morbidity shows an increasing tendency. Although several antiviral drugs exist, there is no cure for viral latency for virtually all carriers. There is an urgent need for an HSV-1 vaccine to control infection and limit its spread and recurrence. The UL18 gene, encoding a vital component of capsids, is one of the essential genes of HSV-1. Deletion of UL18 from HSV-1 may be exploited as a new approach to develop an attenuated vaccine. The purpose of this study was to construct a DNA vaccine with a full-length UL18 gene deletion of the HSV-1 genome that can induce an effective immune response...
2018: Acta Virologica
https://www.readbyqxmd.com/read/29890445/evidence-of-aortic-dissection-and-marfan-syndrome-in-a-mummy-from-the-capuchin-catacombs-of-palermo-sicily
#5
Stephanie Panzer, Randall C Thompson, Klaus Hergan, Albert R Zink, Dario Piombino-Mascali
The authors report on the assessment of an anthropogenic mummy of a young man from the Capuchin Catacombs of Palermo, Sicily, tentatively dated from the mid- to late 19th century AD. The mummy was investigated by full-body CT examination. CT images clearly showed aortic dissection classified as Stanford-A. Due to the relation of aortic dissection to inherited connective tissue diseases in young people, such as Marfan syndrome, conspicuous and pathological findings possibly indicating the presence of underlying Marfan syndrome were assessed...
June 8, 2018: International Journal of Paleopathology
https://www.readbyqxmd.com/read/29852487/monitoring-neonatal-resuscitation-why-is-it-needed
#6
Colin J Morley
Stabilisation and resuscitation of babies at birth is one of the most frequently performed procedures and requires considerable skill. If it is not done well, the baby may suffer prolonged hypoxia and bradycardia. Over the last few years there has been a growing interest in carefully evaluating an infant's condition at birth and the details of what is happening during resuscitation. Clinical assessment of an infant at this time is difficult and often inaccurate. Assessments of heart rate, colour, chest excursions, mask leak, tidal volume, inflation and expiration times, endotracheal intubation, and spontaneous breathing are imprecise...
2018: Neonatology
https://www.readbyqxmd.com/read/29802102/comparison-of-infant-heart-rate-assessment-by-auscultation-ecg-and-oximetry-in-the-delivery-room
#7
Madeleine C Murphy, Laura De Angelis, Lisa K McCarthy, Colm Patrick Finbarr O'Donnell
Clinical assessment of an infant's heart rate (HR) in the delivery room (DR) has been reported to be inaccurate. We compared auscultation of the HR using a stethoscope with electrocardiography (ECG) and pulse oximetry (PO) for determining the HR in 92 low-risk newborn infants in the DR. Caregivers auscultated the HR while masked to the HR on the monitor. Auscultation underestimated ECG HR (mean difference (95% CI) by -9 (-15 to -2) beats per minute (bpm)) and PO HR (mean difference (95% CI) by -5 (-12 to 2) bpm)...
May 25, 2018: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/29797671/cd7-is-expressed-on-a-subset-of-normal-cd34-positive-myeloid-precursors
#8
Katharina Kriegsmann, Harald Löffler, Volker Eckstein, Renate Schulz, Sandra Kräker, Ute Braun, Thomas Luft, Ute Hegenbart, Stefan Schönland, Peter Dreger, Alwin Krämer, Anthony D Ho, Carsten Müller-Tidow, Michael Hundemer
OBJECTIVE: To improve monitoring of myeloid neoplasms by flow cytometry-based minimal residual disease (MRD) analysis, we analyzed the significance of leukemia-associated immunophenotype (LAIP) markers in 44 patients. METHODS: In a pilot study cohort, peripheral blood or bone marrow samples from 13 patients with myeloid neoplasms and one case of B lymphoblastic leukemia in complete hematologic remission after allogeneic bone marrow or stem cell transplantation were subjected to selection for leukemia-specific phenotypes by fluorescence-activated cell sorting using individual marker combinations, followed by PCR-based chimerism analysis...
May 24, 2018: European Journal of Haematology
https://www.readbyqxmd.com/read/29795931/ats-pd-an-adaptive-testing-system-for-psychological-disorders
#9
Ivan Donadello, Andrea Spoto, Francesco Sambo, Silvana Badaloni, Umberto Granziol, Giulio Vidotto
The clinical assessment of mental disorders can be a time-consuming and error-prone procedure, consisting of a sequence of diagnostic hypothesis formulation and testing aimed at restricting the set of plausible diagnoses for the patient. In this article, we propose a novel computerized system for the adaptive testing of psychological disorders. The proposed system combines a mathematical representation of psychological disorders, known as the "formal psychological assessment," with an algorithm designed for the adaptive assessment of an individual's knowledge...
October 2017: Educational and Psychological Measurement
https://www.readbyqxmd.com/read/29792068/loneliness-life-satisfaction-and-psychological-distress-among-out-of-school-adolescents-in-a-nigerian-urban-city
#10
Friday E Okwaraji, Kenechukwu I Obiechina, Godwin C Onyebueke, Ogechukwu N Udegbunam, Godfrey S Nnadum
Loneliness is the feeling of distress that arises when an individual perceives his or her social relationships as being less satisfying than what is desired. Life satisfaction is a global assessment of an individual's quality of life based on his chosen criteria. This descriptive cross sectional study assessed loneliness, life satisfaction and psychological distress among 480 out of school adolescents using the UCLA loneliness scale, the Satisfaction with life scale (SWLS) and the General Health questionnaire...
May 23, 2018: Psychology, Health & Medicine
https://www.readbyqxmd.com/read/29777106/clinical-prediction-models-to-support-the-diagnosis-of-asthma-in-primary-care-a-systematic-review-protocol
#11
L Daines, S McLean, A Buelo, S Lewis, A Sheikh, H Pinnock
Substantial over-diagnosis and under-diagnosis of asthma in adults and children has recently been reported. As asthma is mostly diagnosed in non-specialist settings, a clinical prediction model (CPM) to aid the diagnosis of asthma in primary care may help improve diagnostic accuracy. We aim to systematically identify, describe, compare, and synthesise existing CPMs designed to support the diagnosis of asthma in children and adults presenting with symptoms suggestive of the disease, in primary care settings or equivalent populations...
May 18, 2018: NPJ Primary Care Respiratory Medicine
https://www.readbyqxmd.com/read/29774515/eating-disorder-or-oesophageal-achalasia-during-adolescence-diagnostic-difficulties
#12
REVIEW
Aurélie Letranchant, Bénédicte Pigneur, Martine Flament, Nathalie Godart
Marine was a fourteen and a half-year-old adolescent female hospitalized for an eating disorder (ED) of the anorexic type with purging behaviors. She has had a complicated life course, made up of disruptions and discontinuities, both family and school. Since the age of five, Marine had been intermittently treated in psychiatry for a diagnosis of oppositional defiant disorder. The current illness started with spontaneous and induced vomiting associated with major weight loss (body mass index, 15.27 kg m-2 )...
May 17, 2018: Eating and Weight Disorders: EWD
https://www.readbyqxmd.com/read/29769290/assessment-of-an-organ-specific-de-novo-transcriptome-of-the-nematode-trap-crop-solanum-sisymbriifolium
#13
Alexander Q Wixom, N Carol Casavant, Joseph C Kuhl, Fangming Xiao, Louise-Marie Dandurand, Allan B Caplan
Solanum sisymbriifolium , also known as "Litchi Tomato" or "Sticky Nightshade," is an undomesticated and poorly researched plant related to potato and tomato. Unlike the latter species, S. sisymbriifolium induces eggs of the cyst nematode, Globodera pallida , to hatch and migrate into its roots, but then arrests further nematode maturation. In order to provide researchers with a partial blueprint of its genetic make-up so that the mechanism of this response might be identified, we used single molecule real time (SMRT) sequencing to compile a high quality de novo transcriptome of 41,189 unigenes drawn from individually sequenced bud, root, stem, and leaf RNA populations...
May 16, 2018: G3: Genes—Genomes—Genetics
https://www.readbyqxmd.com/read/29768529/cross-cultural-psychometric-assessment-of-an-appetite-questionnaire-for-patients-with-cancer
#14
Maria Claudia Bernardes Spexoto, Sergio Vicente Serrano, Vanessa Halliday, João Maroco, Andrew Wilcock, Juliana Alvares Duarte Bonini Campos
OBJECTIVE: To evaluate the psychometric properties, along with cross-cultural invariance analysis, of the Cancer Appetite and Symptom Questionnaire (CASQ). METHOD: Data from 555 United Kingdom (UK) cancer patients were used to evaluate the psychometric properties of the CASQ. Construct validity was assessed through factorial and convergent validity. We conducted a confirmatory factor analysis using as indices the chi-square ratio by degrees of freedom (χ2/df), the comparative fit index (CFI), the goodness of fit index (GFI), and the root mean square error of approximation (RMSEA)...
May 14, 2018: Trends in Psychiatry and Psychotherapy
https://www.readbyqxmd.com/read/29750112/efficacy-and-economic-impact-evaluation-of-a-navigation-system-for-assisted-lung-biopsy
#15
Sara Giannatiempo, Giorgio Carpino, Tommasangelo Petitti, Bruno B Zobel, Rosario F Grasso, Eugenio Guglielmelli
This Letter reports on the testing and assessment of an optical computed tomography-navigation system for percutaneous lung interventional, SIRIO, showing how the lesion diameter affects the bioptic procedure. Clinical data, relating to 501 patients, were collected at the Department of Interventional Radiology of Policlinico Universitario Campus Bio-Medico. This Letter shows that the diameter of lesion affects only the procedure duration (50.91 ± 18.87 min for lesions of diameter ≤20 mm and 44.98 ± 19.43 min for lesions of diameter >20 and ≤40 mm)...
April 2018: Healthcare Technology Letters
https://www.readbyqxmd.com/read/29730215/inter-rater-reliability-for-metrics-scored-in-a-binary-fashion-performance-assessment-for-an-arthroscopic-bankart-repair
#16
Anthony G Gallagher, Richard K N Ryu, Robert A Pedowitz, Patrick Henn, Richard L Angelo
PURPOSE: To determine the inter-rater reliability (IRR) of a procedure-specific checklist scored in a binary fashion for the evaluation of surgical skill and whether it meets a minimum level of agreement (≥0.8 between 2 raters) required for high-stakes assessment. METHODS: In a prospective randomized and blinded fashion, and after detailed assessment training, 10 Arthroscopy Association of North America Master/Associate Master faculty arthroscopic surgeons (in 5 pairs) with an average of 21 years of surgical experience assessed the video-recorded 3-anchor arthroscopic Bankart repair performance of 44 postgraduate year 4 or 5 residents from 21 Accreditation Council for Graduate Medical Education orthopaedic residency training programs from across the United States...
May 2, 2018: Arthroscopy: the Journal of Arthroscopic & related Surgery
https://www.readbyqxmd.com/read/29705819/paradoxical-pustular-psoriasis-induced-by-ustekinumab-in-a-patient-with-crohn-s-disease-associated-spondyloarthropathy
#17
REVIEW
Michael Benzaquen, Benoit Flachaire, Frank Rouby, Philippe Berbis, Sandrine Guis
Palmoplantar pustular psoriasis (PPP) is a clinical form of psoriasis, for which tumor necrosis factor alpha inhibitors (TNFi) or interleukins 12/23 inhibitor (ustekinumab) can be a therapeutic option. Paradoxical psoriatic reactions induced by TNFi are now well known. We present the exceptional case of a paradoxical PPP appeared under ustekinumab in a patient with Crohn's disease-associated spondyloarthropathy. A 58-year-old woman presented with recent peripheral inflammatory arthralgias appeared in the context of a Crohn's disease diagnosed in 2008...
July 2018: Rheumatology International
https://www.readbyqxmd.com/read/29700712/toxicity-prediction-and-assessment-of-an-environmentally-realistic-pesticide-mixture-to-daphnia-magna-and-raphidocelis-subcapitata
#18
E Silva, C Martins, A S Pereira, S Loureiro, M J Cerejeira
In a regulatory perspective addressing the cumulative effect of co-occurring chemicals is the first and most important step in providing a more realistic hazard assessment of chemical cocktails to both man and environment. This study was conducted to show if joint effects on the immobilisation of the crustacean Daphnia magna and on the growth inhibition of algae Raphidocelis subcapitata follow additivity (concentration addition (CA) or independent action (IA) predictions) or if there is an interaction between chemicals in the organisms upon exposure to an environmentally realistic mixture of chlorpyrifos and terbuthylazine, with expected different molecular sites of action...
April 26, 2018: Ecotoxicology
https://www.readbyqxmd.com/read/29671615/patient-reported-outcomes-for-the-detection-quantification-and-evaluation-of-chronic-obstructive-pulmonary-disease-exacerbations
#19
Alex J Mackay, Konstantinos Kostikas, Lindsey Murray, Fernando J Martinez, Marc Miravitlles, Gavin Donaldson, Donald Banerji, Francesco Patalano, Jadwiga A Wedzicha
An exacerbation of Chronic Obstructive Pulmonary Disease (COPD) is an acute worsening of respiratory symptoms, accompanied by a variable degree of physiological deterioration. The traditional assessment of an exacerbation consists of the reporting of symptoms directly by the patient to a clinician and subsequent clinical assessment. It would be valuable to also gather symptom reports directly from patients and thus patient-reported outcome (PRO) tools should be ideally suited to the evaluation of COPD exacerbations...
April 19, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29670379/assessment-of-an-accessorized-pre-filled-syringe-for-home-administered-benralizumab-in-severe-asthma
#20
Gary T Ferguson, Adel H Mansur, Joshua S Jacobs, Jacques Hebert, Corbin Clawson, Wenli Tao, Yanping Wu, Mitchell Goldman
Background: Patients prefer at-home subcutaneous administration of biologics across different diseases, yet no biologic is approved for at-home use for severe, uncontrolled asthma. Objective: We assessed at-home functionality, reliability, and performance of an accessorized pre-filled syringe (APFS) for subcutaneous benralizumab administration, an anti-eosinophil monoclonal antibody indicated for add-on maintenance treatment of patients with severe eosinophilic asthma...
2018: Journal of Asthma and Allergy
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