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Noninferiority

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https://www.readbyqxmd.com/read/29161113/disseminability-of-computerized-cognitive-training-performance-across-coaches
#1
Ashley S Fournier-Goodnight, Jason M Ashford, Kellie N Clark, Karen Martin-Elbahesh, Kristina K Hardy, Thomas E Merchant, Sima Jeha, Robert J Ogg, Hui Zhang, Lei Wang, Heather M Conklin
Cogmed is a computerized cognitive intervention utilizing coaches who receive standardized instruction in analyzing training indices and tailoring feedback to remotely monitor participant's performance. The goal of this study was to examine adherence, satisfaction, and efficacy of Cogmed across coaches. Survivors of pediatric brain tumors and acute lymphoblastic leukemia (N = 68) were randomized to intervention (Cogmed) or waitlist control. The intervention group was matched with one of two coaches. Cognitive assessments were completed before and after intervention, and participants and caregivers in the intervention group completed satisfaction surveys...
November 21, 2017: Applied Neuropsychology. Child
https://www.readbyqxmd.com/read/29160046/sutureless-aortic-valve-and-tavi-pros-and-cons
#2
Thierry Folliguet
Aortic valve replacement with biological heart valves remains the gold standard for treating operable older patients with symptomatic aortic stenosis. In the last years trans aortic valve implantation (TAVI) has been shown to be superior to medical treatment in high risks patients with severe aortic stenosis. The transfemoral TAVI route has been also found in randomized controlled trials to be as good if not superior to standard AVR at 5 years in high risk patients. In intermediate risks patients TAVI was found in randomized controlled trials as a noninferior alternative to surgery, with a different pattern of adverse events associated with each procedure...
November 20, 2017: Minerva Cardioangiologica
https://www.readbyqxmd.com/read/29158696/65plus-open-label-study-of-bevacizumab-in-combination-with-pemetrexed-or-pemetrexed-carboplatin-as-first-line-treatment-of-patients-with-advanced-or-recurrent-nonsquamous-non-small-cell-lung-cancer
#3
Wolfgang Schuette, Claus-Peter Schneider, Walburga Engel-Riedel, Christian Schumann, Martin Kohlhaeufl, Monika Heidi Ursel Serke, Gert Hoeffken, Cornelius Kortsik, Martin Reck
Background: The aim of the study was to investigate in terms of noninferiority the efficacy and safety of a monochemotherapy regimen of pemetrexed plus bevacizumab (BevPem) versus carboplatin/pemetrexed plus bevacizumab (BevCPem) in elderly patients as first-line treatment for advanced metastatic or recurrent nonsquamous non-small-cell lung cancer (NSCLC). Materials and methods: 65Plus was a Phase III, randomized, open-label study. In total, 253 patients received BevPem (n=119) or BevCPem (n=134)...
2017: Lung Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/29157093/sample-size-for-a-noninferiority-clinical-trial-with-time-to-event-data-in-the-presence-of-competing-risks
#4
Dong Han, Zheng Chen, Yawen Hou
The analysis and planning methods for competing risks model have been described in the literature in recent decades, and noninferiority clinical trials are helpful in current pharmaceutical practice. Analytical methods for noninferiority clinical trials in the presence of competing risks (NiCTCR) were investigated by Parpia et al., who indicated that the proportional sub-distribution hazard (SDH) model is appropriate in the context of biological studies. However, the analytical methods of the competing risks model differ from those appropriate for analyzing noninferiority clinical trials with a single outcome; thus, a corresponding method for planning such trials is necessary...
November 20, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29156870/a-fully-liquid-dtap-ipv-hb-prp-t-hexavalent-vaccine-for-primary-and-booster-vaccination-of-healthy-turkish-infants-and-toddlers
#5
Mehmet Ceyhan, İnci Yıldırım, Hasan Tezer, İlker Devrim, Emmanuel Feroldi
Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15?18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPV-HB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPV-HB-PRP-T booster were administered...
August 23, 2017: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/29149958/efficacy-of-prolonged-and-immediate-release-tacrolimus-in-kidney-transplantation-a-pooled-analysis-of-two-large-randomized-controlled-trials
#6
B K Krämer, L Albano, B Banas, B Charpentier, L Bäckman, H Tedesco-Silva, F Lehner, G A Mondragón-Ramírez, M Glyda, E Cassuto-Viguier, O Viklický, G Mourad, P Rigotti, S Schleibner, N Kamar
BACKGROUND: Two large, prospective studies (12-03; OSAKA) compared the efficacy and tolerability of prolonged-release versus immediate-release tacrolimus in kidney transplant patients also receiving mycophenolate mofetil and low-dose corticosteroids (without induction therapy). METHODS: Data were combined into one database to compare results over 24 weeks using 3 alternative endpoints: biopsy-confirmed acute rejection (BCAR); the Food and Drug Administration composite endpoint (graft loss, BCAR, and loss to follow-up), and the European Medicines Agency composite endpoint (graft loss, BCAR, and graft dysfunction)...
November 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/29148893/reduced-intensity-delayed-intensification-in-standard-risk-pediatric-acute-lymphoblastic-leukemia-defined-by-undetectable-minimal-residual-disease-results-of-an-international-randomized-trial-aieop-bfm-all-2000
#7
Martin Schrappe, Kirsten Bleckmann, Martin Zimmermann, Andrea Biondi, Anja Möricke, Franco Locatelli, Gunnar Cario, Carmelo Rizzari, Andishe Attarbaschi, Maria Grazia Valsecchi, Claus R Bartram, Elena Barisone, Felix Niggli, Charlotte Niemeyer, Anna Maria Testi, Georg Mann, Ottavio Ziino, Beat Schäfer, Renate Panzer-Grümayer, Rita Beier, Rosanna Parasole, Gudrun Göhring, Wolf-Dieter Ludwig, Fiorina Casale, Paul-Gerhardt Schlegel, Giuseppe Basso, Valentino Conter
Purpose Delayed intensification (DI) is an integral part of treatment of childhood acute lymphoblastic leukemia (ALL), but it is associated with relevant toxicity. Therefore, standard-risk patients of trial AIEOP-BFM ALL 2000 (Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With ALL) were investigated with the specific aim to reduce treatment intensity. Patients and Methods Between July 2000 and July 2006, 1,164 patients (1 to 17 years of age) with standard-risk ALL (defined as the absence of high-risk cytogenetics and undetectable minimal residual disease on days 33 and 78) were randomly assigned to either experimental reduced-intensity DI (protocol III; P-III) or standard DI (protocol II; P-II)...
November 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29143099/-left-atrial-appendage-clusure-in-nonvalvular-atrial-fibrillation-clinical-evidence-2017
#8
REVIEW
Steffen Gloekler, Bajram Hajredini, Simon Rycerz, Sebastian Jäckle, Werner Jung
Nonvalvular atrial fibrillation (AF) is the most common arrhythmia with a prevalence of 1-2% and affects approximately 15-20% of all octogenarians. Patients are at increased risk of thromboembolic stroke, with an overall risk of 5% per year. Thrombi form almost exclusively in the left atrial appendage (LAA), a blind sac-like heterogeneous structure trabeculated by pectinate muscles. In the past five decades, life-long oral anticoagulation (OAC) with vitamin K antagonists (VKA) has been the state-of-the art treatment to prevent stroke and systemic embolism from thrombi in AF...
November 15, 2017: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/29140959/comparison-of-continuous-proximal-versus-distal-adductor-canal-blocks-for-total-knee-arthroplasty-a-randomized-double-blind-noninferiority-trial
#9
Adam W Meier, David B Auyong, Stanley C Yuan, Shin-E Lin, James M Flaherty, Neil A Hanson
BACKGROUND AND OBJECTIVES: Adductor canal blocks (ACBs) are associated with improved analgesia, preserved quadriceps strength, and decreased length of hospitalization after total knee arthroplasty (TKA). However, controversy remains regarding the ideal location of a continuous block within the adductor canal, and it remains unclear whether similar clinical benefits are obtained irrespective of block location. In this randomized, double-blind, noninferiority study, we hypothesized that a continuous proximal ACB provides postoperative analgesia that is no worse than a continuous distal ACB...
November 14, 2017: Regional Anesthesia and Pain Medicine
https://www.readbyqxmd.com/read/29140117/comparison-of-radiation-dose-and-image-quality-of-abdominopelvic-ct-using-iterative-aidr-3d-and-conventional-reconstructions
#10
Caroline Duarte de Mello-Amoedo, Aparecido Nakano Martins, Adriano Tachibana, Daniella Ferraro Pinho, Ronaldo Hueb Baroni
OBJECTIVE: The purpose of this study is to compare radiation dose and image quality of abdominopelvic CT studies reconstructed with iterative and conventional techniques. MATERIALS AND METHODS: This retrospective study enrolled 99 patients who underwent abdominopelvic CT examinations with the portal venous phase images reconstructed with both filtered back projection and Adaptive Iterative Dose Reduction 3D (AIDR 3D) at different time points. Subjective assessment of image quality was performed by two radiologists who scored axial images for overall quality, sharpness, noise, and acceptability in a blinded fashion...
November 15, 2017: AJR. American Journal of Roentgenology
https://www.readbyqxmd.com/read/29139090/tofacitinib-a-review-in-rheumatoid-arthritis
#11
Sohita Dhillon
Tofacitinib (Xeljanz(®)) is a potent, selective JAK inhibitor that preferentially inhibits Janus kinase (JAK) 1 and JAK3. In the EU, oral tofacitinib 5 mg twice daily is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant of, one or more DMARDs. Several clinical studies of ≤ 24 months' duration showed that tofacitinib monotherapy (as first- or second-line treatment) and combination therapy with a conventional synthetic DMARD (csDMARD; as second- or third-line treatment) was effective in reducing signs and symptoms of disease and improving health-related quality of life (HR-QOL), with benefits sustained during long-term therapy (≤ 96 months)...
November 14, 2017: Drugs
https://www.readbyqxmd.com/read/29137558/testing-a-web-based-trained-peer-model-to-build-capacity-for-evidence-based-practices-in-community-mental-health-systems
#12
Ramaris E German, Abby Adler, Sarah A Frankel, Shannon Wiltsey Stirman, Paola Pinedo, Arthur C Evans, Aaron T Beck, Torrey A Creed
OBJECTIVE: Use of expert-led workshops plus consultation has been established as an effective strategy for training community mental health (CMH) clinicians in evidence-based practices (EBPs). Because of high rates of staff turnover, this strategy inadequately addresses the need to maintain capacity to deliver EBPs. This study examined knowledge, competency, and retention outcomes of a two-phase model developed to build capacity for an EBP in CMH programs. METHODS: In the first phase, an initial training cohort in each CMH program participated in in-person workshops followed by expert-led consultation (in-person, expert-led [IPEL] phase) (N=214 clinicians)...
November 15, 2017: Psychiatric Services: a Journal of the American Psychiatric Association
https://www.readbyqxmd.com/read/29135678/can-it-be-done-opioid-free-recovery-commentary-on-an-article-by-gijs-t-t-helmerhorst-md-et-al-pain-relief-after-operative-treatment-of-an-extremity-fracture-a-noninferiority-randomized-controlled-trial
#13
https://www.readbyqxmd.com/read/29135664/pain-relief-after-operative-treatment-of-an-extremity-fracture-a-noninferiority-randomized-controlled-trial
#14
Gijs T T Helmerhorst, Ruben Zwiers, David Ring, Peter Kloen
BACKGROUND: Opioid pain medication is frequently given to patients recovering from a surgical procedure for an extremity fracture in spite of evidence that acetaminophen may be adequate. The aim of this study was to determine whether prescription of step 1 pain medication (acetaminophen) is noninferior to step 2 pain medication (acetaminophen and tramadol) after operative treatment of an extremity fracture. METHODS: Fifty-two patients with a single extremity fracture were randomized from July 2012 to March 2015 in this 2-week follow-up, noninferiority trial in a level-I trauma center in the Netherlands...
November 15, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/29133604/canagliflozin-for-primary-and-secondary-prevention-of-cardiovascular-events-results-from-the-canvas-program-canagliflozin-cardiovascular-assessment-study
#15
Kenneth W Mahaffey, Bruce Neal, Vlado Perkovic, Dick de Zeeuw, Greg Fulcher, Ngozi Erondu, Wayne Shaw, Elisa Fabbrini, Tao Sun, Qiang Li, Mehul Desai, David R Matthews
BACKGROUND : Canagliflozin is a sodium glucose cotransporter 2 inhibitor that significantly reduces the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients with type 2 diabetes mellitus and elevated cardiovascular risk. The comparative effects among participants with and without a history of cardiovascular disease (secondary versus primary prevention) were prespecified for evaluation. METHODS : The CANVAS Program (Canagliflozin Cardiovascular Assessment Study) randomly assigned 10 142 participants with type 2 diabetes mellitus to canagliflozin or placebo...
November 13, 2017: Circulation
https://www.readbyqxmd.com/read/29133186/a-novel-protocol-for-contact-isolation-for-multi-drug-resistant-organisms-mdros-in-children-on-inpatient-rehabilitation-and-effects-on-functional-outcomes-a-noninferiority-study
#16
Kelly L D Pham, Kristie F Bjornson, Marisa Osorio, Kathryn B Whitlock, Teresa L Massagli
BACKGROUND: The incidence of contact isolation for multidrug resistant organisms is increasing in acute hospitals and inpatient rehabilitation units alike. There is limited evidence on the effect of contact isolation on functional outcomes during inpatient rehabilitation. OBJECTIVE: To determine whether the use of a modified contact isolation protocol (MCI) resulted in non-inferior functional outcomes compared to children without contact isolation (NCI) on inpatient rehabilitation...
November 10, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/29130845/restrictive-or-liberal-red-cell-transfusion-for-cardiac-surgery
#17
C David Mazer, Richard P Whitlock, Dean A Fergusson, Judith Hall, Emilie Belley-Cote, Katherine Connolly, Boris Khanykin, Alexander J Gregory, Étienne de Médicis, Shay McGuinness, Alistair Royse, François M Carrier, Paul J Young, Juan C Villar, Hilary P Grocott, Manfred D Seeberger, Stephen Fremes, François Lellouche, Summer Syed, Kelly Byrne, Sean M Bagshaw, Nian C Hwang, Chirag Mehta, Thomas W Painter, Colin Royse, Subodh Verma, Gregory M T Hare, Ashley Cohen, Kevin E Thorpe, Peter Jüni, Nadine Shehata
Background The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. Methods In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7...
November 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29129253/rationale-of-a-novel-study-design-for-the-bioflow-v-study-a-prospective-randomized-multicenter-study-to-assess-the-safety-and-efficacy-of-the-orsiro-sirolimus-eluting-coronary-stent-system-using-a-bayesian-approach
#18
Gheorghe Doros, Joseph M Massaro, David E Kandzari, Ron Waksman, Jacques J Koolen, Donald E Cutlip, Laura Mauri
BACKGROUND: Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution...
November 2017: American Heart Journal
https://www.readbyqxmd.com/read/29127431/effect-of-cornea-preservation-time-on-success-of-descemet-stripping-automated-endothelial-keratoplasty-a-randomized-clinical-trial
#19
George O Rosenwasser, Loretta B Szczotka-Flynn, Allison R Ayala, Wendi Liang, Anthony J Aldave, Steven P Dunn, Tyrone McCall, Lisa C Navarro, Sudeep Pramanik, Kevin W Ross, R Doyle Stulting, Mark A Terry, Elmer Y Tu, David D Verdier, Craig Kollman, Robin L Gal, Roy W Beck, Jonathan H Lass
Importance: Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. Objective: To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. Design, Setting, and Participants: A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks...
November 10, 2017: JAMA Ophthalmology
https://www.readbyqxmd.com/read/29125220/a-dynamic-power-prior-for-borrowing-historical-data-in-noninferiority-trials-with-binary-endpoint
#20
G Frank Liu
Traditionally, noninferiority hypotheses have been tested using a frequentist method with a fixed margin. Given that information for the control group is often available from previous studies, it is interesting to consider a Bayesian approach in which information is "borrowed" for the control group to improve efficiency. However, construction of an appropriate informative prior can be challenging. In this paper, we consider a hybrid Bayesian approach for testing noninferiority hypotheses in studies with a binary endpoint...
November 10, 2017: Pharmaceutical Statistics
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