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https://www.readbyqxmd.com/read/28237213/value-assessment-in-the-regulatory-context
#1
Kathleen L Miller, Janet Woodcock
Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable...
February 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28236355/influence-of-surface-roughness-on-silicone-rubber-voice-prostheses-on-in-vitro-biofilm-formation-and-clinical-lifetime-in-laryngectomized-patients
#2
Kevin J D A Buijssen, Janine J H Oosterhof, Leo Basil, Mark Waters, Mari-Anne Duits, Henk J Busscher, Henny C van der Mei, Bernard F A M van der Laan
OBJECTIVES: Evaluation of the influence of a smooth surface moulding technique of silicone rubber indwelling voice prostheses on in vitro biofilm formation and analysis of the clinical in situ lifetime. DESIGN: Biofilm formation on smooth and Groningen ultra-low resistance (URL) prostheses was studied in an artificial throat model. The clinical lifetime of smooth voice prostheses were compared to the previous lifetime of URL by counting the number of replacements in a consecutive 6 months period in the same patient...
February 25, 2017: Clinical Otolaryngology
https://www.readbyqxmd.com/read/28230917/total-laryngectomy-with-primary-tracheoesophageal-puncture-intraoperative-versus-delayed-voice-prosthesis-placement
#3
Rachelle A Robinson, Virginia A Simms, Elizabeth C Ward, Molly K Barnhart, Sophie J Chandler, Robert I Smee
BACKGROUND: Studies support using intraoperative voice prosthesis insertion performed at the time of primary tracheoesophageal puncture (TEP) during laryngectomy. However, none have compared intraoperative voice prosthesis insertion with delayed voice prosthesis insertion. The purpose of this study was to prospectively examine patient, services, and cost benefits of intraoperative versus delayed voice prosthesis placement. METHODS: Voice prosthesis use, duration to the first voice prosthesis change, early communication, and costs were compared between 14 patients who underwent a laryngectomy and who received intraoperative voice prosthesis placement, and 10 patients who underwent initial catheter stenting and then delayed voice prosthesis insertion...
February 23, 2017: Head & Neck
https://www.readbyqxmd.com/read/28229892/safety-and-efficacy-of-opicinumab-in-acute-optic-neuritis-renew-a-randomised-placebo-controlled-phase-2-trial
#4
Diego Cadavid, Laura Balcer, Steven Galetta, Orhan Aktas, Tjalf Ziemssen, Ludo Vanopdenbosch, Jette Frederiksen, Mark Skeen, Glenn J Jaffe, Helmut Butzkueven, Focke Ziemssen, Luca Massacesi, Yi Chai, Lei Xu, Stefanie Freeman
BACKGROUND: The human monoclonal antibody opicinumab (BIIB033, anti-LINGO-1) has shown remyelinating activity in preclinical studies. We therefore assessed the safety and tolerability, and efficacy of opicinumab given soon after a first acute optic neuritis episode. METHODS: This randomised, double-blind, placebo-controlled, phase 2 study (RENEW) was done at 33 sites in Australia, Canada, and Europe in participants (aged 18-55 years) with a first unilateral acute optic neuritis episode within 28 days from study baseline...
March 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28227781/measuring-the-intuitive-response-of-users-when-faced-with-different-interactive-paradigms-to-control-a-gastroenterology-cad-system
#5
D Abrantes, P Gomes, D Pereira, M Coimbra, D Abrantes, P Gomes, D Pereira, M Coimbra, D Pereira, D Abrantes, P Gomes, M Coimbra
The gastroenterology specialty could benefit from the introduction of Computer Assisted Decision (CAD) systems, since gastric cancer is a serious concern in which an accurate and early diagnosis usually leads to a good prognosis. Still, the way doctors interact with these systems is very important because it will often determine its embracement or rejection, as any gains in productivity will frequently hinge on how comfortable they are with it. Using other types of interaction paradigms such as voice and motion control, is important in a way that typical inputs such as keyboard and mouse are sometimes not the best choice for certain clinical scenarios...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28225317/the-appropriate-time-for-closed-reduction-using-local-anesthesia-in-arytenoid-dislocation-caused-by-intubation-a-clinical-research
#6
Zhewei Lou, Zhihong Lin
CONCLUSION: Closed reduction is effective and safe for the treatment of arytenoid dislocation, and the selection of an appropriate time window to perform closed reduction is crucial in achieving relatively stable treatment outcomes and short treatment duration. OBJECTIVE: The aim of this study was to investigate whether there is an appropriate time window to perform closed reduction for unilateral arytenoid dislocation caused by intubation. METHODS: A retrospective chart review was carried out for the cases collected from September 2014 to May 2016 at Second Affiliated Hospital of Zhejiang University, China...
March 2017: Acta Oto-laryngologica
https://www.readbyqxmd.com/read/28222084/african-american-women-s-recollected-experiences-of-adherence-to-breast-cancer-treatment
#7
Sue P Heiney, DeAnne K Hilfinger Messias, Tisha M Felder, Kenneth W Phelps, Jada C Quinn
PURPOSE/OBJECTIVES: To explore African American women's recollected experiences of breast cancer treatment.
. RESEARCH APPROACH: Qualitative description and narrative analysis.
. SETTING: South Carolina Oncology Associates, an outpatient oncology clinic serving rural and urban populations.
. PARTICIPANTS: 16 African American women with breast cancer previously enrolled in the control arm (n = 93) of a completed randomized, controlled trial...
March 1, 2017: Oncology Nursing Forum
https://www.readbyqxmd.com/read/28220985/the-head-and-neck-cancer-patient-concern-inventory-%C3%A2-patient-concerns-prevalence-dental-concerns-impact-and-relationships-of-concerns-with-quality-of-life-measures
#8
Maria L Aguilar, Pamela Sandow, John W Werning, Lia Brenneman, Walter J Psoter
PURPOSE: The Patient Concern Inventory(©) (PCI) is a clinical tool of self-reported patient concerns to be used by the clinician to structure the patient-oncologist visit. It was developed in the United Kingdom to address the issues of quality of life (QOL) in head and neck cancer (HNC) patients. The purpose of the study reported here was to determine the prevalence of PCI(©) items, the associations between PCI(©) items and QOL, and to explore the importance of oral/dental issues in the patient's well-being...
February 21, 2017: Journal of Prosthodontics: Official Journal of the American College of Prosthodontists
https://www.readbyqxmd.com/read/28220929/increasing-the-efficiency-on-producing-radiology-reports-for-breast-cancer-diagnosis-by-means-of-structured-reports-a-comparative-study
#9
J Damian Segrelles, Rosana Medina, Ignacio Blanquer, Luis Martí-Bonmatí
BACKGROUND: Radiology reports are commonly written on free-text using voice recognition devices. Structured reports (SR) have a high potential but they are usually considered more difficult to fill-in so their adoption in clinical practice leads to a lower efficiency. However, some studies have demonstrated that in some cases, producing SRs may require shorter time than plain-text ones. This work focuses on the definition and demonstration of a methodology to evaluate the productivity of software tools for producing radiology reports...
February 21, 2017: Methods of Information in Medicine
https://www.readbyqxmd.com/read/28215362/efficacy-and-safety-of-sirukumab-in-patients-with-active-rheumatoid-arthritis-refractory-to-anti-tnf-therapy-sirround-t-a-randomised-double-blind-placebo-controlled-parallel-group-multinational-phase-3-study
#10
Daniel Aletaha, Clifton O Bingham, Yoshiya Tanaka, Prasheen Agarwal, Regina Kurrasch, Paul P Tak, Sharon Popik
BACKGROUND: Sirukumab, a human monoclonal antibody that selectively binds to the interleukin-6 cytokine with high affinity, is under development for the treatment of rheumatoid arthritis and other diseases. We aimed to assess the efficacy and safety of sirukumab for rheumatoid arthritis in a phase 3 study (SIRROUND-T). METHODS: We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre study at 183 hospitals and private rheumatology clinics in 20 countries (Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Taiwan, UK, and USA)...
February 15, 2017: Lancet
https://www.readbyqxmd.com/read/28213999/application-of-the-acoustic-voice-quality-index-for-objective-measurement-of-dysphonia-severity
#11
Faustino Núñez-Batalla, Estefanía Díaz-Fresno, Andrea Álvarez-Fernández, Gabriela Muñoz Cordero, José Luis Llorente Pendás
INTRODUCTION: Over the past several decades, many acoustic parameters have been studied as sensitive to and to measure dysphonia. However, current acoustic measures might not be sensitive measures of perceived voice quality. A meta-analysis which evaluated the relationship between perceived overall voice quality and several acoustic-phonetic correlates, identified measures that do not rely on the extraction of the fundamental period, such the measures derived from the cepstrum, and that can be used in sustained vowel as well as continuous speech samples...
February 14, 2017: Acta Otorrinolaringológica Española
https://www.readbyqxmd.com/read/28213595/qualitative-study-of-the-breather-trial-short-cycle-antiretroviral-therapy-is-it-acceptable-to-young-people-living-with-hiv
#12
Sarah Bernays, Sara Paparini, Janet Seeley, Stella Namukwaya Kihika, Diana Gibb, Tim Rhodes
OBJECTIVES: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8-24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development. SETTING: Paediatric HIV clinics in the UK (2), Ireland (1), the USA (1) and Uganda (1)...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28208177/feasibility-and-associated-limitations-of-office-based-laryngeal-surgery-using-carbon-dioxide-lasers
#13
Hao-Chun Hu, Shu-Yi Lin, Yi-Ting Hung, Shyue-Yih Chang
Importance: There are few reports evaluating awake, office-based carbon dioxide (CO2) laser surgery for laryngeal lesions. To date, this study was the largest reported case series of office-based laryngeal surgery by fiber delivery CO2 laser. Office-based laryngeal surgical procedures have become increasingly popular. Technical problems and treatment outcomes associated with the use of a CO2 laser for office-based laryngeal surgery have yet to be fully addressed. Objectives: To discuss a single institution's clinical experience with office-based CO2 laser laryngeal surgery and the feasibility and limitations associated with this procedure...
February 16, 2017: JAMA Otolaryngology—Head & Neck Surgery
https://www.readbyqxmd.com/read/28197527/laryngeal-cryptococcus-a-rare-cause-of-hoarseness-in-renal-allograft-recipient
#14
Jashan Sandhu, Jasvinder Singh Sandhu, Harpreet Kaur Puri, Manish Munjal
Cryptococcosis commonly involves central nervous system and lungs in organ transplant recipients. Isolated laryngeal infection is extremely rare. We report a rare case of cryptococcus in a renal allograft recipient that clinically presented with hoarseness of voice and mimicked laryngeal carcinoma on examination.
2017: J Nephropharmacol
https://www.readbyqxmd.com/read/28194331/-the-invisible-participant-s-experiences-in-clinical-trials
#15
Sarojini Nadimpally, Divya Bhagianadh
BACKGROUND: The paper discussing the perspectives of clinical trial participants about the various aspects of CTs is based on the primary research conducted by Sama in 2012-13. METHODOLOGY: In-depth interviews were conducted with 36 CT participants from the states of New Delhi, Gujarat, Maharashtra and Andhra Pradesh. In addition to CT participants, other key informants including investigators, representatives of Contract Research Organizations (CROs), sponsor, Ethics Committee (EC) members etc...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28188086/two-intermittent-vismodegib-dosing-regimens-in-patients-with-multiple-basal-cell-carcinomas-mikie-a-randomised-regimen-controlled-double-blind-phase-2-trial
#16
Brigitte Dréno, Rainer Kunstfeld, Axel Hauschild, Scott Fosko, David Zloty, Bruno Labeille, Jean-Jacques Grob, Susana Puig, Frank Gilberg, Daniel Bergström, Damian R Page, Gary Rogers, Dirk Schadendorf
BACKGROUND: Vismodegib, a first-in-class Hedgehog-pathway inhibitor, is approved for use in adults with advanced basal-cell carcinoma. Patients with multiple basal-cell carcinomas, including those with basal-cell nevus (Gorlin) syndrome, need extended treatment. We assessed the safety and activity of two long-term intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas. METHODS: In this randomised, regimen-controlled, double-blind, phase 2 trial, we enrolled adult patients with multiple basal-cell carcinomas, including those with basal-cell nevus syndrome, who had one or more histopathologically confirmed and at least six clinically evident basal-cell carcinomas...
February 7, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28187924/measuring-the-dysphonia-severity-index-dsi-in-the-program-praat
#17
Youri Maryn, Dominique Morsomme, Marc De Bodt
BACKGROUND: The original Dysphonia Severity Index (ie, DSI) weighs and combines four voice markers in a single number to size dysphonia gradation in the clinic: percent jitter (from Multi-Dimensional Voice Program; KayPENTAX Corp., Montvale, NJ), softest intensity and highest fundamental frequency (both from Voice Range Profile; KayPENTAX Corp.), and maximum phonation time. To be more generally applied, however, implementation of DSI in the program Praat (Paul Boersma and David Weenink, Institute for Phonetic Sciences, University of Amsterdam, The Netherlands) would be advantageous for all voice clinicians...
February 7, 2017: Journal of Voice: Official Journal of the Voice Foundation
https://www.readbyqxmd.com/read/28179705/the-forgotten-disease-lemierres-syndrome
#18
Ahmed Farhan, Yawar Ali Shah, Bushra Tariq Ali, Uzma Mumtaz, Umar Farooq
Lemierre's syndrome refers to septic thrombosis of deep veins of the neck, is a rare and often life threatening complication following upper respiratory tract infections. We present here a case of Lemierre's syndrome in a previously healthy 30 years old female who had a febrile illness for two weeks with associated dysphagia, hoarse voice and right sided neck swelling. She was investigated for retropharyngeal and parapharyngeal abscess, granulomatosis with polyangiitis, tuberculosis and thyroiditis but finally concluded as Lemierre's syndrome based on the findings of thrombosis of the deep neck veins following respiratory tract infection, septic pulmonary emboli and clinical recovery with antibiotics and supportive care...
December 2016: JPMA. the Journal of the Pakistan Medical Association
https://www.readbyqxmd.com/read/28178109/risk-factors-for-incidence-of-sexually-transmitted-infections-among-women-in-a-human-immunodeficiency-virus-chemoprevention-trial-voice-mtn-003
#19
Zvavahera Mike Chirenje, Holly M Gundacker, Barbra Richardson, Lorna Rabe, Zakir Gaffoor, Gonasagrie Lulu Nair, Brenda Gati Mirembe, Jeanna M Piper, Sharon Hillier, Jeanne Marrazzo
BACKGROUND: In sub-Saharan Africa, there are limited data on the incidence of sexually transmitted infections (STIs) among women, largely because routine screening for asymptomatic infection is not performed. We conducted a secondary analysis to measure STI incidence rates and determine risk factors for new STI acquisition among women enrolled in the VOICE trial. METHODS: We analyzed data from 4843 women screened for chlamydia, gonorrhoea, syphilis, and trichomonas infection at baseline, annually, at interim visits when clinically indicated and at their study termination visit...
March 2017: Sexually Transmitted Diseases
https://www.readbyqxmd.com/read/28171737/chronicity-of-voice-related-health-care-utilization-in-the-general-medicine-community
#20
Seth M Cohen, Hui-Jie Lee, Nelson Roy, Stephanie Misono
Objectives To examine voice-related health care utilization of patients in the general medical community without otolaryngology evaluation and explore factors associated with prolonged voice-related health care. Study Design Retrospective cohort analysis. Setting Large, national administrative US claims database. Subjects and Methods Patients with voice disorders per International Classification of Diseases, Ninth Revision, Clinical Modification ( ICD-9-CM) codes from January 1, 2010, to December 31, 2012, seen by a general medical physician, and who did not see an otolaryngologist in the subsequent year were included...
February 1, 2017: Otolaryngology—Head and Neck Surgery
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