Report on ISCTM consensus meeting on clinical assessment of response to treatment of cognitive impairment in schizophrenia

Funding for this manuscript was provided by the International Society for CNS Clinical Trials and Methodology.Dr Keefe currently or in the past 3 years has received investigator-initiated research funding support from the Department of Veteran's Affair, Feinstein Institute for Medical Research, GlaxoSmithKline, National Institute of Mental Health, Novartis, Psychogenics, Research Foundation for Mental Hygiene, Inc., and the Singapore National Medical Research Council. He currently or in the past 3 years has received honoraria, served as a consultant, or advisory board member for Abbvie, Akebia, Amgen, Asubio, AviNeuro/ChemRar, BiolineRx, Biogen Idec, Biomarin, Boehringer-Ingelheim, Eli Lilly, EnVivo/FORUM, GW Pharmaceuticals, Janssen, Lundbeck, Merck, Minerva Neurosciences, Inc., Mitsubishi, Novartis, NY State Office of Mental Health, Otsuka, Pfizer, Reviva, Roche, Sanofi/Aventis, Shire, Sunovion, Takeda, Targacept, and the University of Texas South West Medical Center. Dr Keefe receives royalties from the BACS testing battery, the MATRICS battery (BACS Symbol Coding), and the Virtual Reality Functional Capacity Assessment Tool. He is also a shareholder in NeuroCog Trials, Inc. and Sengenix. Dr Haig is a full-time employee of Abbvie. Dr Marder has received consulting fees from Abbvie, Genentech, Roche, Lundbeck, Pfizer, Otsuka, Takeda, and Boeringer Ingelheim. He has received research support from Amgen, Sunovion, and Synchroneuron. Dr Harvey has received consulting fees from Abbvie, Boehringer Ingelheim, Forest Labs, Forum Pharma, Genentech, Otsuka America, Roche Pharma, Sunovion Pharma, and Takeda Pharma during the past year. He also received contract research support from Genentech. Dr Dunayevich for the past 3 years has been a full-time employee and stockholder of Amgen. Dr Medalia in the past 3 years has received research funding support from Sunovion. Dr Medalia has also currently or in the past 3 years received honoraria or served as consultant for Dainippon Sumitomo Pharma Co., Ltd., Otsuka, and Takeda Pharmaceuticals U.S.A., Inc. Dr Davidson has received research grant support and/or travel support and/or speaker fees and/or consultancy fees from Lundbeck, Eli Lilly, Servier, Abbott, Minerva and holds stocks in CTR and BiolineRx. Dr Lombardo is a full-time employee of FORUM Pharmaceuticals. Dr Bowie reports receiving grant support from Pfizer. He has also been a consultant for Lundbeck, Otsuka, Abbvie, and Takeda. Dr Buchanan reports: Advisory Board: Abbvie, Amgen, EnVivo, Roche; Consultant: Abbvie, Amgen, Bristol Myers Squibb, EnVivo, Omeros; DSMB member: Pfizer. Dr Bugarski -Kirola is a full-time employee of Hoffmann-La Roche Ltd. Dr Carpenter in the past 2 years has been a consultant to Roche/Genetech. Dr Dago in the last 3 years has received honoraria from Lundbeck, Forest Pharmaceuticals, Otsuka, Pam Labs, and Astra Zeneca for lectures given in promotion of their psychotropic medications. Dr Durand in the past year has been a consultant and received honoraria from Teva Pharmaceuticals. Dr Gold receives royalty payments from the BACS. He also has served as a consultant for Amgen, Hoffman LaRoche, and Lundbeck. Dr Hooker has served as a consultant and is currently a Co-Investigator on an NIH SBIR grant with PositScience Corporation. Dr Loebel is an employee of Sunovion Pharmaceuticals. Dr McGurk reports receiving consulting fees from Abbvie and EnVivo Pharmaceuticals. Dr Pinkham in the past year has received consulting fees from Otsuka America Pharmaceutical, Inc.The following authors have declared that there are no conflicts of interest in relation to the subject of this study: Drs Csernansky, Frese, Goff, Kopelowic, Opler, and Stern. (International Society for CNS Clinical Trials and Methodology; Department of Veteran's Affair; Feinstein Institute for Medical Research; GlaxoSmithKline; National Institute of Mental Health; Novartis; Psychogenics; Research Foundation for Mental Hygiene, Inc.; Singapore National Medical Research Council; Abbvie; Genentech; Roche; Lundbeck; Pfizer; Otsuka; Takeda; Boeringer Ingelheim; Amgen; Sunovion; Synchroneuron; Boehringer Ingelheim; Forest Labs; Forum Pharma; Otsuka America; Roche Pharma; Sunovion Pharma; Takeda Pharma; Eli Lilly; Servier; Abbott; Minerva; BACS; EnVivo Pharmaceuticals; Otsuka America Pharmaceutical, Inc.)Published versio

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial

Contains fulltext : 177872.pdf (publisher's version ) (Open Access)BACKGROUND: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. METHODS/DESIGN: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. DISCUSSION: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. TRIAL REGISTRATION: Trial registration number: NTR 4414 . Date of registration January 29th 2014