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Trial sequential analysis

Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Stefano Salciccia, Alessandro Gentilucci, Susanna Cattarino, Alessandro Sciarra
On the basis of the trials available, are we ready to consider GnRH antagonists better than agonists? Is there a population of patients who may benefit from antagonists more than agonists?We specifically focused our analysis on the significance of oncological results obtained in phase III trials directly comparing Degarelix with GnRH agonists. Oncological results were evaluated only in 1 trial (CS21) with some subanalysis and they were not the primary endpoints of the study. The follow-up duration was 364 days, and therefore, the number of events (all causes deaths and prostate cancer (PC), Prostate Specific Antigen (PSA), Hazard ratio (HR)-related deaths) was very low in both groups and this aspect strongly reduces the significance of overall survival evaluation...
October 15, 2016: Urologia
O Karam, F Gebistorf, J Wetterslev, A Afshari
Acute respiratory distress syndrome is associated with high mortality and morbidity. Inhaled nitric oxide has been used to improve oxygenation but its role remains controversial. Our primary objective in this systematic review was to examine the effects of inhaled nitric oxide administration on mortality in adults and children with acute respiratory distress syndrome. We included all randomised, controlled trials, irrespective of date of publication, blinding status, outcomes reported or language. Our primary outcome measure was all-cause mortality...
October 20, 2016: Anaesthesia
Yao Lu, Han Zhang, Fang Teng, Wen-Jun Xia, Gui-Xiang Sun, Ai-Qing Wen
INTRODUCTION: The Surviving Sepsis Campaign guidelines recommend early goal-directed therapy (EGDT) for the resuscitation of patients with sepsis; however, the recent evidences quickly evolve and convey conflicting results. We performed a meta-analysis to evaluate the effect of EGDT on mortality in adults with severe sepsis and septic shock. METHODS: We searched electronic databases to identify randomized controlled trials that compared EGDT with usual care or lactate-guided therapy in adults with severe sepsis and septic shock...
October 18, 2016: Journal of Intensive Care Medicine
Margarida Mendes, Julie Dubourg, Anne Blanchard, Damien Bergerot, Pierre-Yves Courand, Valentina Forni, Michael Frank, Guillaume Bobrie, Joel Menard, Michel Azizi
OBJECTIVES: The participation of vasopressin in the mechanisms of resistant hypertension is unclear. We compared plasma copeptin concentration, a surrogate marker for vasopressin secretion, between patients with resistant hypertension and those with controlled blood pressure (CBP), in a post hoc analysis of the Prise en charge de l'Hypertension Artérielle RESistante au traitement trial. METHODS: After 4-week treatment with irbesartan 300 mg/day, hydrochlorothiazide 12...
October 15, 2016: Journal of Hypertension
Marcelo Epsztein Kanczuk, Nicholas Martin Barrett, Cristian Arzola, Kristi Downey, Xiang Y Ye, Jose C A Carvalho
BACKGROUND: Most studies that have compared programmed intermittent epidural bolus (PIEB) with continuous epidural infusion regimens have included patient-controlled epidural analgesia and/or manual bolus as rescue analgesia for breakthrough pain. Consequently, the optimal time interval between PIEB is yet to be determined. We designed a study to establish the optimal time interval between PIEB of 10 mL of bupivacaine 0.0625% with fentanyl 2 μg/mL to produce effective analgesia in 90% of women during first stage of labor without breakthrough pain...
October 11, 2016: Anesthesia and Analgesia
Helen S Marshall, Peter C Richmond, Johannes Beeslaar, Qin Jiang, Kathrin U Jansen, Maria Garcés-Sánchez, Federico Martinón-Torres, Leszek Szenborn, Jacek Wysocki, Joseph Eiden, Shannon L Harris, Thomas R Jones, Su-San Lee, John L Perez
BACKGROUND: Bivalent rLP2086 is a recombinant factor H binding protein-based vaccine approved in the USA for prevention of meningococcal serogroup B disease in 10-25-year-olds. We aimed to assess the persistence of bactericidal antibodies up to 4 years after a three-dose schedule of bivalent rLP2086. METHODS: We did this randomised, single-blind, placebo-controlled, phase 2 trial at 25 sites in Australia, Poland, and Spain. In stage 1 of the study (February, 2009-May, 2010), healthy adolescents (aged 11-18 years) were randomly assigned, via an interactive voice and web-response system with computer-generated sequential random numbers, to receive either ascending doses of vaccine (60 μg, 120 μg, and 200 μg) or placebo at months 0, 2, and 6...
October 10, 2016: Lancet Infectious Diseases
Anirban Som, Souvik Maitra, Sulagna Bhattacharjee, Dalim K Baidya
BACKGROUND AND AIMS: Optimum perioperative fluid administration may improve postoperative outcome after major surgery. This meta-analysis and systematic review has been aimed to determine the effect of dynamic goal directed fluid therapy (GDFT) on postoperative morbidity and mortality in non-cardiac surgical patients. MATERIAL AND METHODS: Meta-analysis of published prospective randomized controlled trials where GDFT based on non-invasive flow based hemodynamic measurement has been compared with a standard care...
October 13, 2016: Journal of Anesthesia
Adwoa Hughes-Morley, Bridget Young, Roelie J Hempel, Ian T Russell, Waquas Waheed, Peter Bower
BACKGROUND: Trials increasingly experience problems in recruiting participants. Understanding the causes of poor recruitment is critical to developing solutions. We interviewed people who had declined a trial of an innovative psychological therapy for depression (REFRAMED) about their response to the trial invitation, in order to understand their decision and identify ways to improve recruitment. METHODS: Of 214 people who declined the trial, 35 (16 %) gave permission to be contacted about a qualitative study to explore their decision...
October 12, 2016: Trials
Bing-Cheng Zhao, Tong-Yi Huang, Qi-Wen Deng, Wei-Feng Liu, Jian Liu, Wen-Tao Deng, Ke-Xuan Liu, Cai Li
BACKGROUND: Postoperative atrial fibrillation/flutter (POAF) is associated with significant morbidity and mortality after general thoracic surgery, but the need and the best agent for prophylaxis remains obscure. METHODS: A systematic literature search was performed to identify randomized controlled trials that compared regimens for POAF prophylaxis after general thoracic surgery. Random-effects meta-analyses with trial sequential analyses were performed to compare the effects of medical prophylaxis versus placebo/usual care...
October 8, 2016: Chest
Greta Castellini, Emil Eik Nielsen, Christian Gluud
Trial Sequential Analysis is a frequentist method to help researchers control the risks of random errors in meta-analyses (1). Fisher and colleagues used Trial Sequential Analysis on cell therapy for heart diseases (2). The present article discusses the usefulness of Trial Sequential Analysis and its dependence on the choice of the parameters for calculation of the required information size and the adjacent monitoring boundaries, and comments on the approach by Fisher et al. (2). This article is protected by copyright...
October 11, 2016: Clinical Pharmacology and Therapeutics
Si-Wei Wang, Song-Yang Zhong, Li-Jun Lou, Ze-Fu Hu, Hua-Yu Sun, Hai-Yan Zhu
The aim of this study was to investigate the effect of passive immunotherapy using intravenous immunoglobulin (IVIG) on unexplained recurrent spontaneous abortion (RSA). Live birth rates were analysed and binary data were calculated using risk ratio and 95% confidence interval. Meta-analysis of 11 studies showed that the difference in the live birth rate between the IVIG treatment and placebo groups was on the margin of significance (RR = 1.25, 95% CI 1.00 to 1.56, P = 0.05). Both cumulative and trial sequential meta-analyses indicated potential beneficial effect of IVIG but the evidence was inconclusive...
September 16, 2016: Reproductive Biomedicine Online
Liming Lu, Meiling Xuan, Yuhong Yan, Geng Li, Li Zhou, Zehuai Wen, Chuanjian Lu
BACKGROUND: Psoriasis vulgaris (PV) has been causing increasing concern due to its highly prevalent, harmful and therapy-resistant characteristics. The YXBCM01 (Chinese herbal medicine) for PV trial evaluates the effects of YXBCM01 on relapse rate in patients suffering from PV. As an update to the published design and method for the trial, this paper presents the statistical plan for the main publication to avoid the risk of outcome reporting bias, selective reporting, and data-driven results...
October 3, 2016: Trials
M Heesen, M Klimek, R Rossaint, G Imberger, S Straube
We examined whether paravertebral block has an effect on the prevalence of persistent postsurgical pain after breast surgery. Seven randomised, controlled trials (559 patients) which had the outcome assessor blinded were included, comparing patients who received paravertebral blocks after breast surgery with patients who did not. The risk ratio (95% CI) was 0.75 (0.48-1.15) for the incidence of postoperative pain at 3 months (four studies, 317 patients); the risk ratio (95% CI) obtained from three studies including 301 patients reporting on pain after 6 months was 0...
October 7, 2016: Anaesthesia
Jennifer C Nelson, Robert Wellman, Onchee Yu, Andrea J Cook, Judith C Maro, Rita Ouellet-Hellstrom, Denise Boudreau, James S Floyd, Susan R Heckbert, Simone Pinheiro, Marsha Reichman, Azadeh Shoaibi
INTRODUCTION: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings. EXISTING METHODS: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects-two national observational electronic health care database safety monitoring programs...
2016: EGEMS
Jean-Francois Timsit, Elie Azoulay, Carole Schwebel, Pierre Emmanuel Charles, Muriel Cornet, Bertrand Souweine, Kada Klouche, Samir Jaber, Jean-Louis Trouillet, Fabrice Bruneel, Laurent Argaud, Joel Cousson, Ferhat Meziani, Didier Gruson, Adeline Paris, Michael Darmon, Maité Garrouste-Orgeas, Jean-Christophe Navellou, Arnaud Foucrier, Bernard Allaouchiche, Vincent Das, Jean-Pierre Gangneux, Stéphane Ruckly, Daniele Maubon, Vincent Jullien, Michel Wolff
Importance: Although frequently used in treating intensive care unit (ICU) patients with sepsis, empirical antifungal therapy, initiated for suspected fungal infection, has not been shown to improve outcome. Objective: To determine whether empirical micafungin reduces invasive fungal infection (IFI)-free survival at day 28. Design, Setting, and Participants: Multicenter double-blind placebo-controlled study of 260 nonneutropenic, nontransplanted, critically ill patients with ICU-acquired sepsis, multiple Candida colonization, multiple organ failure, exposed to broad-spectrum antibacterial agents, and enrolled between July 2012 and February 2015 in 19 French ICUs...
October 5, 2016: JAMA: the Journal of the American Medical Association
Chao Liu, Zhi Mao, Mengmeng Yang, Hongjun Kang, Hui Liu, Liang Pan, Jie Hu, Jun Luo, Feihu Zhou
BACKGROUND: Skin and soft tissue infections (SSTIs) are significant indications for antibiotic treatment. Daptomycin, a novel antibiotic, has been registered and licensed to be used in the treatment of these infections. However, its efficacy and safety remain controversial. OBJECTIVE: The objective of this study was to conduct a systematic review with trial sequential analysis (TSA) to evaluate the efficacy and safety of daptomycin for the treatment of SSTIs and to analyze whether the available sample size has been large enough and is conclusive...
2016: Therapeutics and Clinical Risk Management
Niko C Bock, Laura Seibold, Christian Heumann, Erhard Gnandt, Miriam Röder, Sabine Ruf
BACKGROUND: White spot lesions (WSL) frequently occur as side-effect of multibracket appliance treatment. The clinical effects of local fluoridation on post-orthodontic WSL and oral health development are however inconclusive. OBJECTIVE: In vivo monitoring of clinical WSL and oral health changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment. TRIAL DESIGN: Randomized, single-centre, double-blind, parallel-group, placebo-controlled study...
October 4, 2016: European Journal of Orthodontics
Niko C Bock, Laura Seibold, Christian Heumann, Erhard Gnandt, Miriam Röder, Sabine Ruf
BACKGROUND: White spot lesions (WSLs) are a frequent side-effect of multibracket appliance treatment. The effect of local fluoridation on post-orthodontic WSL is however inconclusive. OBJECTIVE: Assessment of WSL changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment. TRIAL DESIGN: Randomized, single-centre, double-blind, parallel-group, placebo-controlled study. PARTICIPANTS: Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding...
October 4, 2016: European Journal of Orthodontics
Shun-Li Kan, Zhi-Fang Yuan, Guang-Zhi Ning, Fei-Fei Liu, Jing-Cheng Sun, Shi-Qing Feng
OBJECTIVE: Cervical disc arthroplasty (CDA) has been designed as a substitute for anterior cervical discectomy and fusion (ACDF) in the treatment of symptomatic cervical disc disease (CDD). Several researchers have compared CDA with ACDF for the treatment of symptomatic CDD; however, the findings of these studies are inconclusive. Using recently published evidence, this meta-analysis was conducted to further verify the benefits and harms of using CDA for treatment of symptomatic CDD. METHODS: Relevant trials were identified by searching the PubMed, EMBASE, and Cochrane Library databases...
October 2, 2016: International Journal of Surgery
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