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https://www.readbyqxmd.com/read/28637143/validity-and-reliability-of-an-activity-monitor-to-quantify-arm-movements-and-activity-in-adults-following-distal-radius-fracture
#1
Andrea M Bruder, Jodie A McClelland, Nora Shields, Karen J Dodd, Raphael Hau, Alexander T M van de Water, Nicholas F Taylor
PURPOSE: To examine the validity and reliability of an activity monitor to estimate upper limb activity. METHODS: Thirty-two adults after distal radial fracture were recruited. 15 adults performed five upper limb activities during two testing sessions, one week apart to investigate criterion validity against the criterion reference of three-dimensional motion analysis, convergent validity, and test-retest reliability. 17 adults in two therapy groups wore monitors for three consecutive days at baseline and six weeks post-intervention...
February 23, 2017: Disability and Rehabilitation
https://www.readbyqxmd.com/read/28636855/efficacy-of-recombinant-influenza-vaccine-in-adults-50-years-of-age-or-older
#2
Lisa M Dunkle, Ruvim Izikson, Peter Patriarca, Karen L Goldenthal, Derek Muse, Janice Callahan, Manon M J Cox
Background Improved influenza vaccines are needed to control seasonal epidemics. This trial compared the protective efficacy in older adults of a quadrivalent, recombinant influenza vaccine (RIV4) with a standard-dose, egg-grown, quadrivalent, inactivated influenza vaccine (IIV4) during the A/H3N2-predominant 2014-2015 influenza season, when antigenic mismatch between circulating and vaccine influenza strains resulted in the reduced effectiveness of many licensed vaccines. Methods We conducted a randomized, double-blind, multicenter trial of RIV4 (45 μg of recombinant hemagglutinin [HA] per strain, 180 μg of protein per dose) versus standard-dose IIV4 (15 μg of HA per strain, 60 μg of protein per dose) to compare the relative vaccine efficacy against reverse-transcriptase polymerase-chain-reaction (RT-PCR)-confirmed, protocol-defined, influenza-like illness caused by any influenza strain starting 14 days or more after vaccination in adults who were 50 years of age or older...
June 22, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28631003/yoga-physical-therapy-or-education-for-chronic-low-back-pain-a-randomized-noninferiority-trial
#3
Robert B Saper, Chelsey Lemaster, Anthony Delitto, Karen J Sherman, Patricia M Herman, Ekaterina Sadikova, Joel Stevans, Julia E Keosaian, Christian J Cerrada, Alexandra L Femia, Eric J Roseen, Paula Gardiner, Katherine Gergen Barnett, Carol Faulkner, Janice Weinberg
Background: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. Objective: To determine whether yoga is noninferior to PT for cLBP. Design: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase...
June 20, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28630980/in-severe-aortic-stenosis-with-intermediate-surgical-risk-tavr-was-noninferior-to-savr-for-death-or-disabling-stroke
#4
Frederick A Spencer, Gordon H Guyatt
No abstract text is available yet for this article.
June 20, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28630978/in-adults-at-risk-for-contrast-induced-nephropathy-no-prophylactic-hydration-was-noninferior-to-hydration
#5
Brent Wagner
No abstract text is available yet for this article.
June 20, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28627912/cognitive-behavioral-versus-psychodynamic-therapy-for-major-depression-secondary-outcomes-of-a-randomized-clinical-trial
#6
Ellen Driessen, Henricus L Van, Jaap Peen, Frank J Don, Jos W R Twisk, Pim Cuijpers, Jack J M Dekker
OBJECTIVE: In a randomized clinical trial, we compared the efficacy of cognitive-behavioral therapy (CBT) and psychodynamic therapy for adult outpatient depression on measures of psychopathology, interpersonal functioning, pain, and quality of life. METHOD: There were 341 Dutch adults (70.1% female, mean age = 38.9, SD = 10.3) meeting Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) criteria for a major depressive episode and with a Hamilton Depression Rating Scale (HAM-D) score ≥14, who were randomized to 16 sessions of individual manualized CBT or short-term psychodynamic supportive psychotherapy...
July 2017: Journal of Consulting and Clinical Psychology
https://www.readbyqxmd.com/read/28615434/a-randomized-trial-of-telemedicine-efficacy-and-safety-for-nonacute-headaches
#7
Kai I Müller, Karl B Alstadhaug, Svein I Bekkelund
OBJECTIVE: To evaluate long-term treatment efficacy and safety of one-time telemedicine consultations for nonacute headaches. METHODS: We randomized, allocated, and consulted nonacute headache patients via telemedicine (n = 200) or in a traditional manner (n = 202) in a noninferiority trial. Efficacy endpoints, assessed by questionnaires at 3 and 12 months, included change from baseline in Headache Impact Test-6 (HIT-6) (primary endpoint) and pain intensity (visual analogue scale [VAS]) (secondary endpoint)...
June 14, 2017: Neurology
https://www.readbyqxmd.com/read/28614691/a-trial-of-itraconazole-or-amphotericin-b-for-hiv-associated-talaromycosis
#8
RANDOMIZED CONTROLLED TRIAL
Thuy Le, Nguyen Van Kinh, Ngo T K Cuc, Nguyen L N Tung, Nguyen T Lam, Pham T T Thuy, Do D Cuong, Pham T H Phuc, Vu H Vinh, Doan T H Hanh, Vu Van Tam, Nguyen T Thanh, Tran P Thuy, Nguyen T Hang, Hoang B Long, Ho T Nhan, Heiman F L Wertheim, Laura Merson, Cecilia Shikuma, Jeremy N Day, Nguyen V V Chau, Jeremy Farrar, Guy Thwaites, Marcel Wolbers
BACKGROUND: Talaromyces marneffei infection is a major cause of human immunodeficiency virus (HIV)-related death in South and Southeast Asia. Guidelines recommend initial treatment with amphotericin B deoxycholate, but this drug has substantial side effects, a high cost, and limited availability. Itraconazole is available in oral form, is associated with fewer unacceptable side effects than amphotericin, and is widely used in place of amphotericin; however, clinical trials comparing these two treatments are lacking...
June 15, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28611530/comparison-between-laparoscopy-and-laparotomy-in-systematic-para-aortic-lymphadenectomy-for-patients-with-endometrial-cancer-a-retrospective-multicenter-study
#9
Tomohito Tanaka, Yoshito Terai, Shigenori Hayashi, Daisuke Aoki, Michiyasu Miki, Eiji Kobayashi, Tadashi Kimura, Tsukasa Baba, Noriomi Matsumura, Masahide Ohmichi
Objective: Laparoscopic surgery has been developed worldwide due to its minimal invasion as well as noninferiority, compared with laparotomy. However, whether or not laparoscopic systematic para-aortic lymphadenectomy for endometrial cancer is feasible and has advantages of various clinical factors, such as a short hospital stay, less blood loss, and faster recovery, compared with open surgery has not yet been clarified. The aim of this study was to compare a laparoscopic procedure with laparotomy for para-aortic lymphadenectomy for patients with endometrial cancer...
June 1, 2017: Journal of Gynecologic Surgery
https://www.readbyqxmd.com/read/28611098/ticagrelor-and-eptifibatide-bolus-versus-ticagrelor-and-eptifibatide-bolus-with-2-hour-infusion-in-high-risk-acute-coronary-syndromes-patients-undergoing-early-percutaneous-coronary-intervention
#10
Moazez J Marian, Oluseun Alli, Firas Al Solaiman, Brigitta C Brott, Mark Sasse, Tara Leesar, Sumanth D Prabhu, Massoud A Leesar
BACKGROUND: In patients with non-ST-segment elevation acute coronary syndromes, inhibition of platelet aggregation (IPA) with a potent P2Y12 inhibitor, ticagrelor, was inferior to tirofiban infusion at 2 hours, indicating that glycoprotein IIb/IIIa inhibitors are still needed. Ticagrelor and eptifibatide bolus only may maximally inhibit platelet aggregation and decrease bleeding, but IPA with ticagrelor and eptifibatide bolus versus 2-hour infusion is unknown. METHODS AND RESULTS: A total of 70 P2Y12-naïve patients, with high-risk non-ST-segment elevation acute coronary syndromes, were randomized to ticagrelor and eptifibatide bolus (group 1) versus ticagrelor and eptifibatide bolus with 2-hour infusion (group 2)...
June 13, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28610897/efficacy-and-safety-of-etomidate-based-sedation-compared-with-propofol-based-sedation-during-ercp-in-low-risk-patients-a-double-blind-randomized-non-inferiority-trial
#11
Chan Hyuk Park, Se Woo Park, Bomi Hyun, Jin Lee, Sea Hyub Kae, Hyun Joo Jang, Dong Hee Koh, Min Ho Choi
BACKGROUND AND AIMS: Etomidate is a short-acting intravenous hypnotic with a safety profile that is superior to alternative drugs such as propofol. However, there is a lack of evidence on the safety of etomidate in endoscopic retrograde cholangiopancreatography (ERCP). The objective of this study was to compare efficacy and safety profiles of etomidate and propofol for endoscopic sedation. METHODS: This single-center, randomized, double-blind, non-inferiority trial included patients with American Society of Anesthesiologists (ASA) physical status I-II who had been scheduled for ERCP...
June 10, 2017: Gastrointestinal Endoscopy
https://www.readbyqxmd.com/read/28608389/sample-size-planning-of-two-arm-superiority-and-noninferiority-survival-studies-with-discrete-follow-up
#12
Stefan Wellek
In clinical trials using lifetime as primary outcome variable, it is more the rule than the exception that even for patients who are failing in the course of the study, survival time does not become known exactly since follow-up takes place according to a restricted schedule with fixed, possibly long intervals between successive visits. In practice, the discreteness of the data obtained under such circumstances is plainly ignored both in data analysis and in sample size planning of survival time studies. As a framework for analyzing the impact of making no difference between continuous and discrete recording of failure times, we use a scenario in which the partially observed times are assigned to the points of the grid of inspection times in the natural way...
June 12, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28605608/canagliflozin-and-cardiovascular-and-renal-events-in-type-2-diabetes
#13
Bruce Neal, Vlado Perkovic, Kenneth W Mahaffey, Dick de Zeeuw, Greg Fulcher, Ngozi Erondu, Wayne Shaw, Gordon Law, Mehul Desai, David R Matthews
Background Canagliflozin is a sodium-glucose cotransporter 2 inhibitor that reduces glycemia as well as blood pressure, body weight, and albuminuria in people with diabetes. We report the effects of treatment with canagliflozin on cardiovascular, renal, and safety outcomes. Methods The CANVAS Program integrated data from two trials involving a total of 10,142 participants with type 2 diabetes and high cardiovascular risk. Participants in each trial were randomly assigned to receive canagliflozin or placebo and were followed for a mean of 188...
June 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28605603/efficacy-and-safety-of-degludec-versus-glargine-in-type-2-diabetes
#14
Steven P Marso, Darren K McGuire, Bernard Zinman, Neil R Poulter, Scott S Emerson, Thomas R Pieber, Richard E Pratley, Poul-Martin Haahr, Martin Lange, Kirstine Brown-Frandsen, Alan Moses, Simon Skibsted, Kajsa Kvist, John B Buse
Background Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. Methods We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial...
June 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28605047/stratified-exact-tests-for-the-weak-causal-null-hypothesis-in-randomized-trials-with-a-binary-outcome
#15
Yasutaka Chiba
Fisher's exact test is commonly used to compare two groups when the outcome is binary in randomized trials. In the context of causal inference, this test explores the sharp causal null hypothesis (i.e. the causal effect of treatment is the same for all subjects), but not the weak causal null hypothesis (i.e. the causal risks are the same in the two groups). Therefore, in general, rejection of the null hypothesis by Fisher's exact test does not mean that the causal risk difference is not zero. Recently, Chiba (Journal of Biometrics and Biostatistics 2015; 6: 244) developed a new exact test for the weak causal null hypothesis when the outcome is binary in randomized trials; the new test is not based on any large sample theory and does not require any assumption...
June 12, 2017: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/28602708/reduced-toxicity-with-equivalent-outcomes-using-three-dimensional-volumetric-3dv-image-based-versus-nonvolumetric-point-based-nv-brachytherapy-in-a-cervical-cancer-population
#16
Kimberly M Thomas, Genevieve Maquilan, Strahinja Stojadinovic, Paul Medin, Michael R Folkert, Kevin Albuquerque
PURPOSE: Brachytherapy (BT) techniques have historically used a two-dimensional nonvolumetric (NV) system involving dose prescribed to a point fixed in space. We compared dosimetric, toxicity, and oncologic outcomes for volumetric planning (3DV) versus CT point-based planning. METHODS AND MATERIALS: Patients treated with external beam radiation therapy and high dose rate (HDR) intracavitary BT were included (n = 71). Patients planned with NV BT treated from 2009 to 2011 (n = 37) were compared to patients planned with 3DV BT treated from 2012 to 2014 (n = 34)...
June 8, 2017: Brachytherapy
https://www.readbyqxmd.com/read/28602417/survival-outcomes-with-short-course-radiation-therapy-in-elderly-patients-with-glioblastoma-data-from-a-randomized-phase-3-trial
#17
Douglas Guedes de Castro, Juliana Matiello, Wilson Roa, Sunita Ghosh, Lucyna Kepka, Narendra Kumar, Valery Sinaika, Darejan Lomidze, Dalenda Hentati, Eduardo Rosenblatt, Elena Fidarova
PURPOSE: To perform a subset analysis of survival outcomes in elderly patients with glioblastoma from a randomized phase 3 trial comparing 2 short-course radiation therapy (RT) regimens in elderly and/or frail patients. METHODS AND MATERIALS: The original trial population included elderly and/or frail patients with a diagnosis of glioblastoma. Patients joined the phase 3, randomized, multicenter, prospective, noninferiority trial; were assigned to 1 of 2 groups in a 1:1 ratio, either short-course RT (25 Gy in 5 fractions, arm 1) or commonly used RT (40 Gy in 15 fractions, arm 2); and were stratified by age (<65 years and ≥65 years), Karnofsky Performance Status (KPS), and extent of surgery...
July 15, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28595250/prospective-split-face-randomized-long-term-blinded-objective-comparison-of-the-performance-and-tolerability-of-two-new-hyaluronic-acid-fillers
#18
Patrick Trevidic, Pierre Andre, Laurent Benadiba, Jean-Jacques Deutsch, Olivier Galatoire, Philippe Garcia, Anne Grand-Vincent, Sylvie Boisnic, Jean-Charles Kerihuel, Catherine Salomon
BACKGROUND: There are requirements for long-term, objective comparisons of hyaluronic acid (HA) dermal fillers. OBJECTIVE: To compare efficacy and tolerability of ART FILLER Universal (AFU) and ART FILLER Fine lines (AFFL) with the existing HA fillers for the treatment of nasolabial folds and crow's feet. MATERIALS AND METHODS: Prospective, randomized, rater- and patient-blind, split-face comparison of AFU with JUVEDERM Ultra 3 (JUV) and AFFL with FIRST LINES PureSense (FLPS)...
June 6, 2017: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
https://www.readbyqxmd.com/read/28594772/gestational-diabetes-mellitus-and-frequency-of-blood-glucose-monitoring-a-randomized-controlled-trial
#19
Hector Mendez-Figueroa, Meike Schuster, Lindsay Maggio, Claudia Pedroza, Suneet P Chauhan, Michael J Paglia
OBJECTIVE: To assess whether testing blood glucose four times daily compared with four times every other day would lead to similar birth weights among patients with gestational diabetes mellitus (GDM). METHODS: This noninferiority randomized controlled trial was conducted at five centers. After receiving a diagnosis of GDM, women tested their blood glucose every day for 7 days. After that period, compliant women without hyperglycemia requiring treatment were randomized to either blood glucose testing four times a day or every other day...
June 6, 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28594754/false-labor-at-term-in-singleton-pregnancies-discharge-after-a-standardized-assessment-and-perinatal-outcomes
#20
David B Nelson, Donald D McIntire, Kenneth J Leveno
OBJECTIVE: To evaluate perinatal outcomes in women sent home with a diagnosis of false labor at term and assess the time interval to return for delivery. METHODS: This was a prospective observational cohort study of women at 37 0/7 to 41 6/7 weeks of gestation without pre-existing medical complications who presented to our hospital-based triage unit with symptoms of labor and underwent a standardized evaluation. Women diagnosed as having false labor with a live singleton fetus in cephalic presentation without a prior cesarean delivery and sent home were compared with a group of similar women diagnosed to be in spontaneous labor...
June 6, 2017: Obstetrics and Gynecology
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