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Transparent Reporting and Disclosure: an Introduction to Reporting

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Transparent Reporting and Disclosure: an Introduction to Reporting Transparent Reporting and Disclosure: An Introduction to Reporting Guidelines Presentation Goals • Present history, purpose, and strengths/limitations of reporting guidelines • Encourage use of reporting guidelines for all future manuscripts • Promote use of reporting guidelines (and other research transparency tools) to other stakeholders Slide 2 Session Outline • 10:45 to 11:05 - Introduction to Reporting Guidelines • 11:05 to 11:45 - Interactive Exercise • 11:45 to 12:00 – Lessons Learned in Evaluations of Reporting Guidelines Slide 3 Transparent Reporting and Disclosure: Guidelines and Practices Part 1. An Introduction to Reporting Guidelines Sean Grant RAND Corporation BITSS RT2 2017 Research practices to increase the proportion of true findings • Large-scale collaborative research • Adoption of replication culture and reproducibility practices • Registration (studies, protocols, analysis codes, datasets, raw data) • Sharing (data, protocols, materials, software, and other tools) • Containment of conflicted sponsors and authors • More appropriate statistical methods • Standardization of definitions and analyses • More stringent thresholds for claiming discoveries or ‘‘successes’’ • Improvement of study design standards • Improvements in peer review, reporting, and dissemination of research • Better training of scientific workforce in methods and statistical literacy Enhancing the Quality and Transparency of Health Research (EQUATOR) Network Ioannidis, J. P. (2014). How to make more published research true. PLoS Med, 11(10), e1001747. Slide 5 Stages in research production that lead to waste Moher et al. (2016). Increasing value and reducing waste in biomedical research: who's listening?. The Lancet, 387(10027), 1573-1586. Slide 6 Key Problems of Poor Reporting • Difficulties in critical appraisal of study quality • Uncertain generalizability and applicability • Difficulties in reproducibility/replicability • Risks of bias in synthesized parameters – Apples and oranges – Garbage in, garbage out Slide 7 Making reports “fit for purpose” • Published research article is a permanent record • Will be used by different users for different purposes which means different needs for reporting – Brief scanning for information – Rigorous scrutiny of methodology and findings Adapted from EQUATOR Network 8 Stage of reporting in the research cycle • Research article is ‘end product’ of one process … Research study Design Conduct Publication • …and often ‘raw material’ of other processes Further primary research Systematic Practice Publication review guideline Informs policies and practice Adapted from EQUATOR Network 9 Making reports “fit for purpose” • Published research article is a permanent record • Will be used by different users for different purposes which means different needs for reporting – Brief scanning for information – Rigorous scrutiny of methodology and findings • Published article should be fit for these multiple purposes – “Whole story” rather than a “good story” Adapted from EQUATOR Network 10 Aspects of responsible research reporting • Report results clearly and honestly – No fabrication, falsification, inappropriate data manipulation • Describe their methods clearly and unambiguously – So findings can be confirmed by others • Adhere to publication requirements – Original, not plagiarised, not published elsewhere • Disclose funding sources and relevant competing interests Reproduced from the International standards for authors of scholarly publications 11 (http://publicationethics.org/international-standards-editors-and-authors) Reporting guidelines (RGs) • Focus on scientific content of the article – Specific sets of items required for accurate, comprehensive, and transparent reports of what was done and found • Reflect particular issues that might: – Introduce bias into the research – Influence generalizability – Are needed for reproducibility/replication • Ideally evidence- and consensus-based Moher et al. PLoS Med 2010 12 Typical article sections (IMRAD) • Title – attracts readers to key aspects of study • Abstract – summarises the study/paper – helps reader identify if paper is relevant • Introduction – explains rationale and objectives • Methods – describes what was done • Results – presents what was found • Discussion – considers what the findings mean Adapted from EQUATOR Network 13 Format: checklist and flow diagram Slide 14 Focus on study design / methodology • Generally applicable, key methodology features, no details specific to diseases, etc. Core RG (“Must”) • Generic framework for reporting key aspects of: – Main study designs / types (generic guidelines) • Framework for a complete research paper (examples: CONSORT, STARD, STROBE) • Framework for only a part of research study / paper (examples: CONSORT for abstracts) – More specialised designs • Often extending the generic guidelines • Examples: CONSORT for cluster trials – Specific methods, evaluations, analyses • Generic statistical guidelines • Cost-effectiveness analysis • Quality of life assessment Adapted from EQUATOR Network 15 Focus on study design / methodology • STUDY DESIGN / METHODOLOGY – Main study designs / types (generic guidelines) – More specialised designs – Specific methods, evaluations, analyses Adapted from EQUATOR 16 Network Focus on specific discipline / problem area • Key focus is on discipline / problem area specific issues Should be used with relevant generic – Different ‘degree’ of specificity methodology guidelines as they often focus only on • May or may not address general content specifics methodology items • May focus on a complete research study / paper or only on a part Adapted from EQUATOR Network 17 EQUATOR Network: one-stop shop for research reporting guidelines Adapted from EQUATOR Network 18 Library for health research reporting Adapted from EQUATOR Network 19 Reporting guidelines database Adapted from EQUATOR Network 20 Various stakeholders can benefit from the adoption of reporting guidelines. • Researchers: study design and final report • Editors and peer-reviewers: improve manuscripts • Research funders: improve submissions and utility of funded projects • Policy-makers and practitioners: promoting RGs could lead to publications they can use • Faculty/students: education and training of next generation of researchers Slide 21 Proposed stakeholders, actions, and benefits: PRISMA-P Shamseer et al. (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ, 349, g7647. Slide 22 Proposed stakeholders, actions, and benefits: SPIRIT Chan, A. W., et al. (2013). SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine, 158(3), 200-207. Slide 23 How to improve reporting of your research studies • Find out about reporting requirements early, when planning your research study • When writing up your research, check the EQUATOR and BITSS websites for any new relevant guidelines to help improve the quality of your manuscript • Adhere to the relevant reporting guideline(s). • When not reporting on certain items, explain why. • Remember that other details specific to your particular study not in the reporting guideline might be relevant for a clear and complete account of what was done and found • It is important to provide enough information to allow your study to be critically appraised and potentially reproducible by others. Adapted from EQUATOR Network 24.
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