INTRODUCTION EVIDENCE-BASED RESEARCH NETWORK MEETING Bergen, Norway December 1st and 2nd, 2014 Radisson Blu Royal Hotel BACKGROUND Nanos Gigantum Humeris Insidentes "If I have seen further it is by standing on the shoulders of giants" BACKGROUND “If, as is sometimes supposed, science consisted in nothing but the laborious accumulation of facts, it would soon come to a standstill, crushed, as it were, under its own weight…… The work which deserves, but I am afraid does not always receive, the most credit is that in which discovery and explanation go hand in hand, in which not only are new facts presented, but their relation to old ones is Lord Rayleigh BACKGROUND "The Helsinki Declaration states that biomedical research involving people should be based on a thorough knowledge of the scientific literature. That is, it is unethical to expose human subjects unnecessarily to the risks of research. Ideally, the introduction should include a reference to a systematic review of previous similar trials or a note of the absence of such The PhD program • Bergen University College is obliged to get their PhD programs accredited. • One criteria is a common theme of each PhD program. • Different health areas lead us to argue for demanding all PhD students to be systematic in their preparation and completion of their PhD project. • Our PhD program tried to described how The PhD program We have identified a presentation by Iain Chalmers: • "The scandalous failure of scientists to cumulate scientifically", and the four papers by • Clarke & Chalmers. By reference and citation search we identified several other studies all showing the same result. The PhD program We suggested the approach to be called: Evidence-based Research • Rapid response in BMJ to "All trials must be registered and the results published" (12 November 2013) • Article in Norwegian Medical Journal (www.tidsskriftet.no 29.11.2013) The PhD program We meet several opposing arguments, such as: • “We can’t expect all PhD students to prepare a systematic Review before doing the research”, and • “We will have too many references if we should include a systematic search in the Background”. Thus, there was an apparent need for The PhD program The committee wrote e.g.: “The notion that research doesn’t build upon an update of our present knowledge seems very simplified. That kind of research may occur, but the committee thinks that an update of the present knowledge is necessary for the quality, the ethics and the originality of research supported by external grants. Thus the “need” for an EBR approach in the PhD program may be undermined”, and further “Strictly speaking it seems hard to imagine any research not evidence-based. At least it seems impossible to imagine that articles published in journals with a high impact factor do not relates to earlier research" … and THEN we realized Karen Robinson wrote in her thesis in 2009: “Research synthesis, the cornerstone of evidence-based health care, is cumulative in nature. To limit bias, all relevant studies must be identified and considered in a synthesis of existing evidence. While the use of research synthesis to make evidence-informed decisions is now expected in health care, there is also a need for clinical trials to be conducted in away that is evidence-based (1). Evidence-based research is one way to reduce waste in the production and reporting of trials, through the initiation of trials that are needed to address outstanding questions and through the design of new trials in away that maximizes the information gained (2).” Thesis (2009) page Do we need an EBR approach? A short view of the evidence Lau 1992 (i.v. streptokinase) Clarke & Chalmers 1998 (Islands in search of a continent?) – 2002, 2007, 2010 Fergusson 2005 After 1994: More than 2500 received unnecessary placebo! Fergusson 2005 Wetterslev, Hemmingsen (2008, 2009, 2011)(Trial Sequential Analysis) Chalmers, Glasziou 2009 Greenberg 2009 Citation is both an impartial scholarly method and a powerful form of social communication. Through distortions in its social use that include bias, amplification, and invention, citation can be used to generate information cascades resulting in unfounded authority of claims. Construction and analysis of a claim specific citation network may clarify the nature of a published belief system and Sutton (2009) Evidence synthesis as the key to more coherent and efficient research. Bastian 2010 Bastian 2010 Seventy-five trials and eleven systematic reviews a day: how will we ever Goudie 2010 • More than half (56%) of the 27 trials referred to previous individual trial(s) in the introduction section of the report • six (22%) referred to a meta-analysis • two (7%) a systematic review • one (4%) a review combining both observational studies and trials • leaving three (11%) not citing any of these sources. Goudie 2010 Consulting previous research before embarking on a new trial and basing decisions about future research on the impact on an updated meta-analysis will make the reporting of research more coherent and the Robinson 2011 A Systematic Examination of the Citation of Prior Research in Reports of Randomized, Controlled Trials Robinson 2011 Sheth 2011 Our review of studies of hip fracture treatment suggests poor citation of the previous literature. Studies in higher-impact journals with positive results are more likely to be cited in subsequent studies. Therefore, redundancy in publication and unnecessary surgical trials often occur. Andrade 2013 Jones 2013 Trials that have been funded by the NIHR HTA program during the period of 2006 to 2008 Research Waste – Lancet 2014 Habre 2014 Robinson 2014 • For 46% (118 of 259) of networks, the RCTs formed a single connected citation group - one island. • For the other 54% of networks, where at least one RCT group was not cited by others, 39% had two citation islands and 4% (10 of 257) had 10 or more islands. • On average, the citation networks had 38% of the possible citations to other trials (if each trial had cited all earlier Robinson 2014 Why having a network? Here and now: 1. Inspire and spar to work with EBR 2. Secure no double work – together we will be strong 3. PUBLICATIONS Later: 4. Conference 5. Website 6. PhD courses 7. Education 8. Txt books EQUATOR The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. INASP INASP is an international development charity working with a global network of partners to improve access, production and use of research information and knowledge, so that countries are equipped to solve their development challenges. IASP IASP brings together scientists, clinicians, healthcare providers, and policymakers to stimulate and support the study of pain and to translate that knowledge into improved pain relief worldwide. Aim and Tasks for EBRNetwork AIM Suggestion for aim of the network: Inspiring and promoting researchers aim to use of the totality of evidence to identify important answerable questions, to design and apply research methods to answer those questions, and to place the results within the context of the totality of earlier research. WORK PROCEDURE 1. Define competencies, knowledge and skills for researchers. The competencies should be formulated so different levels are clearly separated 2. Formulate some criteria of how to evaluate whether the competencies are achieved. Funding agencies, ethics committees and editors/reviewers could use these criteria to evaluate the systematic use of earlier research in application/projects/papers. 3. Prepare methods and tools. A method is a process or series of steps to organize e.g. a framework to prioritize among research questions. A tool is an instrument to e.g. evaluate the introduction or discussion paragraph of a research proposal or research paper. Methods and tools should be formulated within different areas; TASKS 1. Should researchers, and if so, how can researchers perform Evidence-Based Research (EBR) – i.e. formulate a framework/method. 2. The network should facilitate collaborative research within EBR. 3. Define criteria and methods by which Funding Agencies can evaluate the evidence-based foundation of a research application. 4. Define criteria and methods by which ethics committees can evaluate the evidence-based foundation for a research project. 5. Define criteria and methods by which editors and