Protocol Template (Protocol)
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The Effective Health Care Research Consortium (EHCRC) Publication
Consortium Publication Policy, 20 February 2013 The Effective Health Care Research Consortium (EHCRC) Publication policy The Effective Health Care Research Consortium (the Consortium) has extensive experience in medical publishing, research ethics, and principles of research integrity. Using this experience, and helped by a specialist in the field, we have drawn up this policy document to help promote capacity development in research integrity. 1 This policy applies to all supported Consortium activities. In addition, we encourage partners to use this to prompt their own departments and institutions to develop similar explicit policies. 1. Scope This policy relates to academic publications in peer-reviewed journals including systematic reviews published on The Cochrane Library. This includes authors working with the Cochrane Infectious Diseases Group (CIDG), all Consortium supported Cochrane authors, and all Consortium supported research publications. The policy applies to all outputs from the programme and associated grants (for example, self-published material, reports, newsletters, and blogs). 2. General principles Work supported by the Consortium will be published in a timely and responsible manner. All reports and publications will endeavour to present findings in a responsible, objective and accurate manner and without undue delays. Those who have made a significant contribution to the research will be recognised appropriately by authorship or acknowledgement. 3. Registration of systematic reviews and clinical trials All systematic reviews initiated by the consortium that are not registered as Cochrane Reviews will be prospectively registered on a suitable register (such as PROSPERO). We expect anyone receiving Consortium funds as support to their work (as money, or in kind, such as payment of travel) will, should they be involved in a clinical trial, ensure this trial is registered prospectively (i.e. -
Cochrane Collaboration Conversation with Givewell
Meeting between Cochrane Collaboration representatives and GiveWell at the U.S. Cochrane Center, May 8, 2012. From the Cochrane Collaboration: Kay Dickersin Director of the U.S. Cochrane Center and the Eyes and Vision Review Group, U.S. Satellite Lorne Becker Director of the Cochrane Collaboration Trading Company and Cochrane Innovations Jeremy Grimshaw Co-Chair, Cochrane Steering Group, Director of the Canadian Cochrane Center, and Coordinating Editor of the Cochrane Effective Practice and Organization of Care Roger Soll Coordinating Editor of the Neonatal Review Group and Member of the Executive Board of the Review Group Coordinating Editors Lisa Bero Director, U.S. Cochrane Center (San Francisco Branch) and Cochrane World Health Organization delegate George Rutherford Coordinating Editor, HIV/AIDS Review Group From GiveWell: Holden Karnofsky and Stephanie Wykstra These notes reflect answers that Cochrane representatives gave during our conversation. Cochrane Collaboration’s aims: • Cochrane Collaboration’s primary aim is to produce high quality systematic reviews of existing health-related research. The organization also trains researchers to do systematic reviews, develops better methods for analyzing and comparing studies in its systematic reviews and educates researchers in the use of these methods, and advocates for evidence-based decision- making within the World Health Organization (WHO), governments, professional associations, consumers and other groups. Structure of the organization: • The Cochrane Collaboration uses a multilevel level organizational and governance structure, comprising a group of “entities” that are organized around functions related to conducting and disseminating systematic reviews of the evidence. Each Cochrane organization (or “entity”) provides its own governance structure and is responsible for raising its own funding. -
Evaluation of NIHR Investment in Cochrane Report
Evaluation of NIHR investment in Cochrane infrastructure and systematic reviews Committee members: Professor Jos Kleijnen (Chair), Dr Phil Alderson, Dr Jane Aubin, Professor John Cairns, Ms Sally Crowe, and Professor Paul Garner Report writer: Kate Misso 10 February 2017 1 TABLE OF CONTENTS LIST OF TABLES ............................................................................................................................ 5 LIST OF FIGURES ........................................................................................................................... 6 LIST OF ABBREVIATIONS ............................................................................................................... 7 EXECUTIVE SUMMARY ............................................................................................................... 10 1. The global landscape of systematic reviews ............................................................................. 10 2. The performance of NIHR funded Cochrane Review Groups (CRGs) ....................................... 11 3. Cochrane’s impact on key clinical and policy issues in the NHS ............................................... 13 4. The economic impact of systematic reviews ............................................................................ 14 5. Current and planned developments in Cochrane and stakeholders’ views ............................. 14 Conclusions ...................................................................................................................................... -
How to Develop a Search Strategy for an Intervention Review
How to develop a search strategy for an intervention review Based on the Peer Review of Electronic Search Strategies (PRESS) criteria* PRESS Guide Examples 1 Translation If possible, structure the search strategy into 1. Index term(s) for Patient/Population/Problem Is the search question search concepts (groups of words) according to 2. Text word(s) for Patient/Population/Problem translated well into search relevant elements from PICOS: 3. 1 OR 2 (P) concepts? 4. Index term(s) for Intervention(s) Patient/Population/Problem 5. Text word(s) for Intervention(s) Intervention Comparator 6. 4 OR 5 (I) Outcome 7. Publication type(s) Study design (methods filter) 8. Index term(s) for Study design(s) 9. Text word(s) for Study design(s) 10. 7 OR 8 OR 9 (S) 11. 3 AND 6 AND 10 (P AND I AND S) You might want to omit the Comparator and the Outcome elements as they are not often described adequately in the title, abstract or indexing. 2 Operators See the database’s help file to find available Are there any mistakes in operators used to combine individual terms and the use of Boolean or search concepts proximity operators? AND, OR , NOT, NEXT, NEAR/n, adj/n are common operators AND between terms or concepts narrows the search OR between terms or concepts broaden the 1 2019 03 13 search Use the NOT operator with caution – you might A search for: ‘NOT-out’ terms you want to keep private health NOT public health will exclude papers that are about private health and also about public health 3 Subject headings/index Subject headings or index terms (like MeSH used Vaccination terms in MEDLINE for example) are terms that describe Guidelines as Topic Are any important subject the content of an article – what it is about Randomized Controlled Trials as Topic headings missing or have Publication type terms describe what kind of Guideline any irrelevant ones been publication the article is Randomized Controlled Trial included? Check all relevant index terms for each of the databases you will search Some index terms cover the P and also the I in 1. -
Developing a Protocol
FACILITATOR/MENTOR GUIDE Developing a Protocol Created: 2013 Developing a Protocol. Atlanta, GA: Centers for Disease Control and Prevention (CDC), 2013. DEVELOPING A PROTOCOL Table of Contents LEARNING OBJECTIVES ................................................................................................... 3 ESTIMATED COMPLETION TIME ........................................................................................ 3 TARGET AUDIENCE ......................................................................................................... 3 PRE-WORK AND PREREQUISITES ..................................................................................... 3 MATERIALS .................................................................................................................... 4 OPTIONS FOR FACILITATING THIS TRAINING ....................................................................... 4 ICON GLOSSARY ............................................................................................................ 5 ACKNOWLEDGEMENTS .................................................................................................... 5 FACILITATOR RESPONSIBILITIES ...................................................................................... 7 SECTIONS 1 & 2: INTRODUCTION AND OVERVIEW .............................................................. 8 SECTION 3: WRITING A PROPOSAL OR CONCEPT PAPER ..................................................... 9 SECTION 4: WRITING A DRAFT OF THE PROTOCOL ........................................................... -
Searching the Cochrane Library Training Guide[Pdf]
Searching the Cochrane Library To book your place on the course contact the library team: www.epsom-sthelier.nhs.uk/lis E: [email protected] T: 020 8296 2430 Learning objectives At the end of this session you should be able to: Identify when to use Cochrane Log on to the Cochrane Library databases from home and work Formulate a search string, using basic Boolean logic Search using Keywords and MeSH terms Use the search history function to combine search results Refine search criteria by author or title View records from each database and navigate through a review Print records from each database View graphs and tables from a review What is the Cochrane Library? The Cochrane Library is a database of reliable evidence on the effectiveness of healthcare interventions. It is regarded as the best resource available of this type. The Cochrane Library is put together by the Cochrane Collaboration, the NHS Centre for Reviews and Dissemination and other related organisations and is updated quarterly. When should you use the Cochrane Library? The Cochrane Library should be used when looking for the best evidence on the effectiveness of treatment and health promotion interventions. The best type of evidence comes from systematic reviews and randomised controlled trials (RCTs). It is also a source of information on the methodology of systematic reviews. It should be used when looking for information on the effectiveness of an intervention, for example: What is the effectiveness of treatment y? What is the effectiveness of treatment -
Efficacy of Low-Level Laser Therapy for Tinnitus
brain sciences Article Efficacy of Low-Level Laser Therapy for Tinnitus: A Systematic Review with Meta-Analysis and Trial Sequential Analysis Chih-Hao Chen 1, Chii-Yuan Huang 1,2, Chun-Yu Chang 3 and Yen-Fu Cheng 1,2,4,5,* 1 Department of Otolaryngology-Head and Neck Surgery, Taipei Veterans General Hospital, Taipei 112, Taiwan; [email protected] (C.-H.C.); [email protected] (C.-Y.H.) 2 Faculty of Medicine, National Yang-Ming University, Taipei 112, Taiwan 3 Department of Anesthesiology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City 231, Taiwan; [email protected] 4 Department of Medical Research, Taipei Veterans General Hospital, Taipei 112, Taiwan 5 Institute of Brain Science, National Yang-Ming University, Taipei 112, Taiwan * Correspondence: [email protected]; Tel.: +886-2-2871-2121 (ext. 1292) Received: 13 November 2020; Accepted: 30 November 2020; Published: 2 December 2020 Abstract: Study Objective: Tinnitus is a common disorder characterized by sound in the ear in the absence of external or internal stimuli. Low-level laser therapy (LLLT) was discovered enhancing tissue repair via increasing the blood microcirculation and cell proliferation in 1960s. In the last two decades, LLLT delivered to the cochlea has frequently been used to reduce the severity of tinnitus. However, whether LLLT effectively attenuates the severity of tinnitus remains controversial. We aimed to evaluate the efficacy of low-level laser therapy on adult patients with complaints of tinnitus. Design: Systematic review and meta-analysis with trial sequential analysis. Interventions: Low-level laser therapy (LLLT). Measurements: Tinnitus Handicap Inventory (THI) score; improvement rates of the visual analog scale (VAS), verbal rating scale (VRS) and numeric rating scale (NRS) scores. -
Scientific Literature Resources: a Guide for CNRA Employees
Scientific Literature Resources: A Guide for CNRA Employees GAVIN NEWSOM, GOVERNOR FEBRUARY 2020 PREPARED BY Nicole Waugh, California Energy Commission Library Amy Loseth, California Geological Survey Library Jenny Woo, California Energy Commission Library CDFW Literature Access SIFT (Science Institute Focus Group) 2 TABLE OF CONTENTS INTRODUCTION ............................................................................................................................... 7 SECTION 1: ONLINE RESOURCES ..................................................................................................... 8 1.1 Citation Databases ................................................................................................................ 8 Scopus ...................................................................................................................................... 8 Google Scholar ......................................................................................................................... 8 Pubmed .................................................................................................................................... 8 1.2 Databases .............................................................................................................................. 9 Biodiversity Heritage Library ................................................................................................... 9 Birds of North America ........................................................................................................... -
Sample Size for Clinical Trials Martin Bland Prof
British Standards Institution Study Day Sample size for clinical trials Martin Bland Prof. of Health Statistics University of York http://martinbland.co.uk Outcome variables for trials An outcome variable is one which we hope to change, predict or estimate in a trial. Examples: • Systolic blood pressure in a hypertension trial • Caesarean section rate in an obstetric trial • Survival time in a cancer trial How many outcome variables should I have? If we have many outcome variables: • all possibilities would be covered, • we would be less likely to miss something, • the risk of false positives, finding an apparent effect when there is none in reality, would be increased. If we have few outcome variables: • the trial would be easier and quicker to check and analyse, • the trial would be cheaper, • the trial would be easier for research subjects, • we would avoid multiple testing and the high risk of a false positive result. We get round the problem of multiple testing by having one outcome variable on which the main conclusion stands or falls, the primary outcome variable. If we do not find an effect for this variable, the study has a negative result. Usually we have several secondary outcome variables, to answer secondary questions. A significant difference for one of these would generate further questions to investigate rather than provide clear evidence for a treatment effect. The primary outcome variable must relate to the main aim of the study. Choose one and stick to it. How large a sample should I take? A significance test for comparing two means is more likely to detect a large difference between two populations than a small one. -
Phase 3 Clinical Study Protocol
ModernaTX, Inc. 20 Aug 2020 Protocol mRNA-1273-P301, Amendment 3 mRNA-1273 CLINICAL STUDY PROTOCOL Protocol Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older Protocol Number: mRNA-1273-P301 Sponsor Name: ModernaTX, Inc. Legal Registered Address: 200 Technology Square Cambridge, MA 02139 Sponsor Contact and Tal Zaks, MD, PhD, Chief Medical Officer Medical Monitor: ModernaTX, Inc. 200 Technology Square, Cambridge, MA 02139 Telephone: 1-617-209-5906 e-mail: [email protected] Regulatory Agency Identifier Number(s): IND: 19745 Amendment Number: 3 Date of Amendment 3: 20 Aug 2020 Date of Amendment 2: 31 Jul 2020 Date of Amendment 1: 26 Jun 2020 Date of Original Protocol: 15 Jun 2020 CONFIDENTIAL All financial and nonfinancial support for this study will be provided by ModernaTX, Inc. The concepts and information contained in this document or generated during the study are considered proprietary and may not be disclosed in whole or in part without the expressed written consent of ModernaTX, Inc. The study will be conducted according to the International Council for Harmonisation (ICH) Technical Requirements for Registration of Pharmaceuticals for Human Use, E6(R2) Good Clinical Practice (GCP) Guidance. Confidential Page 1 ModernaTX, Inc. 20 Aug 2020 Protocol mRNA-1273-P301, Amendment 3 mRNA-1273 PROTOCOL APPROVAL – SPONSOR SIGNATORY Study Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older Protocol Number: mRNA-1273-P301 Protocol Version Date: 20 Aug 2020 Protocol accepted and approved by: See esignature and date signed on last page of document. -
Chapter 13*: EPIDEMIOLOGY
Monitoring Bathing Waters - A Practical Guide to the Design and Implementation of Assessments and Monitoring Programmes Edited by Jamie Bartram and Gareth Rees © 2000 WHO. ISBN 0-419-24390-1 Chapter 13*: EPIDEMIOLOGY * This chapter was prepared by D. Kay and A. Dufour Epidemiological data are frequently used to provide a basis for public health decisions and as an aid to the regulatory process. This is certainly true when developing safeguards for recreational waters where hazardous substances or pathogens discharged to coastal and inland waters may pose a serious risk of illness to individuals who use the waters. Epidemiological studies of human populations not only provide evidence that swimming-associated illness is related to environmental exposure, but also can establish an exposure-response gradient which is essential for developing risk- based regulations. Epidemiology has played a significant role in providing information that characterises risks associated with exposure to faeces contaminated recreational waters. The use of epidemiological studies to define risk associated with swimming in contaminated waters has been criticised because the approach used to collect the data is not experimental in nature. This perception is unlikely to change, given the highly variable environments where recreational exposures take place. Although the variables may be difficult to control, it is possible to carry out credible studies by following certain standard practices that are given below. This Chapter discusses the place of epidemiological investigations in providing information to support recreational water management and the scientific basis of "health-based" regulation. 13.1 Methods employed in recreational water studies Epidemiology is the scientific study of disease patterns in time and space. -
Sample Research Protocol
Protocol REVITA 2018 April 9, 2018 A Clinical Investigation Evaluating Efficacy of a Full- Thickness Placental Allograft (Revita®) in Lumbar Microdiscectomy Outcomes Primary Investigator: Thomas Morrison III, MD Northside Hospital 1000 Johnson Ferry RD. N.E., Atlanta, GA 30342 Phone: 404-256-2633 Fax: 404-255-6532 Sponsor: StimLabs 1225 Northmeadow Parkway, Suite 104, Roswell, GA 30076 Phone: 888-346-9802 Fax: 470-719-2085 Confidential Page 1 of 19 Protocol REVITA 2018 April 9, 2018 STUDY SUMMARY A Clinical Investigation Evaluating Efficacy of a Full-Thickness Title Placental Allograft (Revita) in Lumbar Microdiscectomy Outcomes Methodology Randomized, controlled trial, blind study Estimated duration for the main protocol (e.g. from start of Study Duration screening to last subject processed and finishing the study) is approximately 2.5 years Multi-center (Polaris Spine and Neurosurgery Center, Atlanta, GA Study Center(s) and Northside Hospital, Atlanta, GA) Primary Objective: To evaluate the efficacy of Revita full thickness placental allograft in improving back and leg pain post- microdiscectomy Objectives Secondary Objectives: To evaluate post-microdiscectomy reherniation rate in patients treated with Revita Number of 182 randomized patients in two arms; Treatment and Control Subjects Inclusion Criteria - Male and female patients, 18-70 years old, in any distribution. - Symptomatic with radiating low back and leg pain for greater than 6 months prior to surgery with a clinical diagnosis of lumbar protruding disc. Diagnosis and - Consent and compliance with all aspects of the study Main Inclusion protocol, methods, providing data during follow-up contact Criteria - See methods section for full list of inclusion criteria Exclusion Criteria - Male and female patients younger than 18 years old or older than 70 years old.