CLINICAL RESEARCH WEEK

Transcription

1 CONFLICTS OF INTEREST CLINICAL RESEARCH WEEK PUBLICATION SCIENCE WORKSHOP I have no conflicts of interest Member of EQUATOR Canada KELLY COBEY, PHD SENIOR CLINICAL RESEARCH ASSOCIATE/ PUBLICATIONS OFFICER CLINICAL EPIDEMIOLOGY PROGRAM OCTOBER 17 TH, 2016 Affiliated with the University of Stirling, Scotland 2 LEARNING OBJECTIVES To understand the services and remit of the Centre for Journalology How are publications failing? To obtain knowledge of internal OHRI publication policies OHRI data sharing guideline OHRI authorship guideline OHRI publication guideline To obtain information on how to access resources for publishing Selecting a journal to submit to Writing your manuscript Getting feedback INCREASING EFFICIENCY OF THE RESEARCH CONTINUUM PROBLEMS IN SCIENCE Publication bias (File drawer effect) Of 79 studies presented at a scientific meeting only 53% were subsequently published after nine years (Scherer et al., 2007) 1/3 completed clinical trials of patients undergoing surgery remain unpublished ~5 years after study completion (Chapman et al., 2014) (Chalmers and Glasziou, 2009; Macloed et al., 2014) 1

2 PROBLEMS IN SCIENCE Scanner and Transplant Heart Patients Protocol 41/ 80 studies (RCTs & SRs) published in Evidence Based Medicine had usable information missing about the intervention (Glasziou et al. 2008) Only 11% of 262 RCTs in prominent oncology journals contained 10 essential elements about interventions (e.g. route, premedication) (Duff et al. 2010) Discrepancies between registry entries and published articles for primary and non primary outcomes are very prevalent; 39% omitted their primary outcome (Fleming et al., 2015) A cross sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012, showed that of (31.7%) registered studies had their primary outcome changed after the listed study start and completion dates (Ramagopalan et al., 2015) Cardiac allograft vasculopathy after heart transplant coronary angiogram Primary outcome: sensitivity of CT Secondary outcome: specificity predictive value, negative predictive value of CT HOW CAN SCIENTIFIC PUBLICATIONS BE SO BROKEN? Little/no evidence based training on how to write and published No widespread system of audit COMPare (CEBM Outcome Monitoring Project) October 2015 and January 2016, the COMPare team systematically checked every trial published in the top five medical journals COMPARE STUDY FINDINGS COMMUNITY RESPONSIBILITY trials.org/ 2

3 Dr. Kelly Cobey CONSULTING THE PUBLICATIONS OFFICER How to select and use a reporting guideline What are the criteria for authorship (i.e., authorship disputes) Publication metrics (altmetrics, h index, journal impact factor) Publication models (open access, predatory journals, funding for article processing fees) How to select a journal How to complete a peer review/ how to respond to a peer reviewers comments Publication policies OHRI data sharing guideline OHRI authorship guideline OHRI publication guideline PUBLICATION POLICIES CASE 1: DATA SHARING Name three places where you can store data when you publish a manuscript so that it is openly available. RUOR; uottawa repository With the article via the publishers webpage Open Science Framework *see Data Sharing Guideline for a table of resource OPEN SCIENCE FRAMEWORK WHY SHARE DATA? 1. You are more likely to get formal attribution of your data in 2. It s already a responsibility sharing data at the time of publication helps researchers to manage future requests 3. Records are kept for one s own future use Especially important for those supervising others/students 3

4 CASE 2A: AUTHORSHIP GUIDELINE Michelle worked as a master s student at TOH. During her studies she contributed to a research project where patient records were analyzed as part of a project looking at predictors of diabetes. She spent many hours screening records and extracting the needed project data. Michelle left TOH to take a job in Toronto after her master s. After she left, she did not contribute to the project any longer. She is weak at statistics so will not be able to contribute to the studies analysis. Should Michelle be an author on the manuscript resulting from this project? CASE 2B: AUTHORSHIP GUIDELINE Zarah is a research manager. She frequently edits study protocols, seeks and obtains ethics approval and recruits participants to clinical trials for her PI. Zarah s PI recently gave her additional responsibilities to help with, such as adding references in their appropriate format to a manuscript and collating data for archiving. Should Zarah be acknowledge for her work or named as a coauthor? ICMJE AUTHORSHIP CRITERIA Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or revising it critically for important intellectual content; AND Final approval of the version to be published; AND Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. CASE 3: PUBLICATION GUIDELINE Justin submitted a manuscript for publication but it was quickly rejected by the journal editor who felt the paper was not within the journals scope. Justin knows of another strong journal in the field where he can resubmit the paper to. All of his co authors already approved of the final version of the manuscript. Is it appropriate for Jason to re submit the paper without contacting his co authors so as not to delay publication? PUBLISH OR PERISH Publishing skills tend to be learned on the job Along with publishing comes important responsibility RESOURCES FOR PUBLISHING Selecting a journal Writing your manuscript Getting feedback 4

5 SELECTING A JOURNAL How do you do this? SELECTING A JOURNAL: PRACTICALITIES Check with your colleagues/co authors Journal selector tools: Check your references The places you reference are probably good potential outlets for the work you are reporting SELECTING A JOURNAL: PRACTICALITIES SELECTING A JOURNAL: CONSIDERATIONS 1. Is it open access? What is the impact factor? 3. Does the journal you are considering submitting to conduct itself transparently? Is it rigorous? WHAT IS OPEN ACCESS (OA)? OA is digital, online, free of charge, and free of most copyright and licensing restrictions Peter Suber OA removes price barriers (subscriptions, licensing fees, pay perview fees) and permission barriers (most copyright and licensing restrictions) WHY PUBLISH OA? Moral imperative: Researchers in developing countries can access your work Tax payers get value for money (relevant in Canada): The public can access your findings Better reach: More exposure for your work More exposure may translate into higher citation rates or practical application of your findings Scales with the growth of knowledge! Compliant with granting agencies: Tri Agency OA policy 5

6 SPECTRUM OF OPEN ACCESS Journals entirely open access (gold open access) Journals with research articles open access (hybrid open access) Journals with some research articles open access (hybrid open access) (hybrid /delayed open access) Journals with delayed open access (delayed open access) Journals permitting self archiving of articles (green open access) all PLoS BMJ CMAJ Pediatrics Curr Cardiol Rev F1000 / others PubMed Central RESOURCES FOR ARTICLE PROCESSING FEES initiatives/financial support PeerJ Lifetime basic membership (1 article per year free) Frontiers 50% discount Canadian Science Publishing 50% discount Sage 40% discount 50% off of all open access articles (Except for BMC Journals) NOTE: Changes to this system of discounts occur often 1. Is it open access? 2. What is the impact factor? SELECTING A JOURNAL: CONSIDERATIONS 3. Does the journal you are considering submitting to conduct itself transparently? Is it rigorous? WHAT IS THE IMPACT FACTOR? Many journals proudly claim an impact factor Originally devised as a way to discern journals for purchasing by libraries Calculation: is calculated by dividing the number of citations in the year by the total number of articles published in the two previous years Readership Open access or not? Practicalities: When does it publish? What are the article types? What are the article formats? 1. Is it open access? 2. What is the impact factor? SELECTING A JOURNAL: CONSIDERATIONS 3. Does the journal you are considering submitting to conduct itself transparently? Is it rigorous? DOES THE JOURNAL YOU ARE CONSIDERING SUBMITTING TO CONDUCT ITSELF TRANSPARENTLY? IS IT RIGOROUS? Predatory Journals Take advantage of article processing charges May not be peer reviewed Many not be indexed May lie about impact factor May try to mimic other legitimate journals 6

7 Dear Dr. Kelly D Cobey, Hope this mail finds you in good spirit. Journal name here, invites experts in Gynecology and Obstetrics research to submit original, review, case reports, short communications, mini reviews, etc., within the scope of the Journal. Dear Dr. Kelly D Cobey, Hope this mail finds you in good spirit. Journal name here, invites experts in Gynecology and Obstetrics research to submit original, review, case reports, short communications, mini reviews, etc., within the scope of the Journal. The objective of this Journal is to create awareness and apprehension about the developments in the field of Gynecology and Obstetrics Research. To know the current trends, recent articles published and any other information please visit: link. The objective of this Journal is to create awareness and apprehension about the developments in the field of Gynecology and Obstetrics Research. To know the current trends, recent articles published and any other information please visit: LINK. Our eminent editorial panel who does peer reviewing of all the articles submitted which ensures credibility of the article submitted. We will ensure publication of your paper within 7 10 days of submission if accepted. Our eminent editorial panel who does peer reviewing of all the articles submitted which ensures credibility of the article submitted. We will ensure publication of your paper within 7 10 days of submission if accepted. Please contact us at: 123@435.com for any queries regarding the journal updates/suggestions if any for making the journal to accomplish its goal. Looking forward for a Fruitful Association. Please contact us at: 123@435.com for any queries regarding the journal updates/suggestions if any for making the journal to accomplish its goal. Looking forward for a Fruitful Association. BEALL S LIST OF PREDATORY JOURNALS Avoiding Predatory Journals Check for ISSN number Check if it is indexed Check editorial board and policies Does it refer to COPE? How are submissions made? Is it on Beall s list? Is it in the DOAJ? Consult the publications officer DETECTING A PREDATORY JOURNAL: EXERCISE Journal Link Article fee Impact factor Beall s list? Predatory? Journal of AIDS & Clinical Research Infectious Agents & Cancer csonline.org/aids clinicalresearch.php ntscancer.biome dcentral.com/ Navigating Beall s list it s really two lists! DEBATE RESOURCES FOR PUBLISHING Selecting a journal Writing your manuscript Who is responsible for ensuring that research is not published in predatory journals? Getting feedback 7

8 WHAT ARE REPORTING GUIDELINES? Explicit text to guide authors in reporting a specific type of research Focus on scientific content Using explicit methods via a consensus process (e.g., considers journal editors, methodologists and content experts) RESOURCES FOR REPORTING GUIDELINES Searchable library of reporting guidelines available via the EQUATOR Network (>250 reporting guidelines) (Enhancing the QUAlity and Transparency Of health Research: network.org) A minimum set of items that need to be addressed when reporting a study Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PloS Medicine, 2010; 7(2):e Canadian EQUATOR Centre EXERCISE : GIVING A PEER REVIEW USING A REPORTING GUIDELINE Please read the paper provided and: Provide a short summary of the articles findings for the editor (2 3 lines) Complete evaluation of the article against the STROBE reporting guideline (tick box exercise) EXERCISE 1: GIVING A PEER REVIEW USING A REPORTING GUIDELINE Provide a short summary of the articles findings for the editor (2 3 lines) Using a multi centre retrospective cohort design, this study reports on an association between nighttime discharge from the ICU and hospital mortality. The authors find that ~17% of patients are discharged during the nighttime and that nighttime discharge is associated with significantly greater hospital mortality EXERCISE 1: GIVING A PEER REVIEW Participants 1 Participants 2 EXERCISE 1: GIVING A PEER REVIEW Participants 1 Participants 2 The aim of our study was to examine the impact nighttime discharge of patients

9 EXERCISE 1: GIVING A PEER REVIEW EXERCISE 1: GIVING Why July A 1, PEER 2002 REVIEW December 31, 2009? Study Participants Design and 1 :..was preformed at all of Edmonton s adult hospitals. This study was performed at all five of Edmonton s adult hospitals which includes three community hospitals and two tertiary hospitals. Participants EXERCISE 1: GIVING A PEER REVIEW EXERCISE 1: GIVING A PEER REVIEW Participants 1 Participants DO THEY WORK? Yes! Initial studies suggest reporting guidelines lead to improvements: CONSORT: Turner et al STARD: Smidt et al. 2006; Korevaar et al STRICTA and CONSORT: Prady et al PRISMA: Stevens et al. 2014; Tunis et al. 2013; Panic et al., 2013 Implementation: Baker D, Lidster K, Sottomayor A, Amor S (2014) Two Years Later: Journals Are Not Yet Enforcing the ARRIVE Guidelines on Reporting Standards for Pre Clinical Animal Studies. PLoS Biol,12(1): e RESOURCES FOR PUBLISHING Selecting a journal Writing your manuscript Getting feedback 9

10 PROMPT NETWORK Peer Review Of Manuscripts for Promoting Transparency Internal manuscript pre submission network for author s to get feedback prior to journal submission Researchers choice to opt in Anticipate a 3 4 week turnaround time Circular system You submit, you agree to review in the future Reviews do not focus on content but rather of reporting quality Each submitted manuscript is cross checked using a relevant reporting guideline Thanks for your time! Kelly Cobey, PhD kcobey@toh.on.ca Senior Clinical Research Associate/ Publications Officer Clinical Epidemiology PROGRAM ONCE YOU HAVE PUBLISHED. What s next? SETTING UP A METRICS PORTFOLIO up a metrics portfolio: 1) Set up a Google Scholar account: Log on to scholar.google.com and click the My Citations link at the top of the page to get your account setup started. 2) Check out your article Altmetric scores: 58 DOWNLOAD ALTMETRIC BOOKMARKLET