1. Research article structure: Where can reporting guidelines help? Iveta Simera The EQUATOR Network workshop

2. Research article Research article is ‘end product’ of one process … …and ‘raw material’ of other processes 2 DesignConductPublication Use in further research Clinical practice guideline Systematic review Publication Primary research Informs health policies and clinical practice

3. Research article: “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 –From brief scanning for information –To rigorous scrutiny of methodology and findings for possible comparison across studies in systematic reviews Published article should be fit for these multiple purposes New ways of publishing (e.g. online suppl) can aid readability without excluding crucial information 3

4. Typical medical article sections Title – attracts readers to the key aspects of the study Abstract – summarises the paper and, together with the title, helps reader identify the nature of the study and briefly summarises what was found Introduction – explains why we did the study and what question we asked Methods – describes how we did it Results – presents what we found Discussion – considers what the findings mean Conclusions – if present offers a succinct summary of the major findings 4

5. Good research paper Is based on carefully designed and well conducted study Combines: –Good logical structure –Complete and accurate description of the key study elements –Clear and concise writing style 5

6. Good research paper Is based on carefully designed and well conducted study Combines: –Good logical structure –Complete and accurate description of the key study elements –Clear and concise writing style 6 Scientific writing guidance

7. Good research paper Is based on carefully designed and well conducted study Combines: –Good logical structure –Complete and accurate description of the key study elements –Clear and concise writing style 7 Reporting guidelines Scientific writing guidance

8. Reporting guidelines (RGs) Focus on scientific content of the article Provide structured advice on what to include in a research report Definition: –Specify a minimum set of items required for a clear and transparent account of what was done and what was found in a research study, reflecting in particular issues that might introduce bias into the research –Form: often as a checklist (perhaps also a flow diagram) Most internationally accepted RGs –Based on evidence –Consensus of relevant stakeholders (multidisciplinary group) 8 Moher et al. PLoS Med 2010

9. Reporting guidelines database 9

10. Different focus of RG: study design / methodology Generally applicable, key methodology features, no details specific to diseases, etc. 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 10 Core RG (“Must”) See your handout: Structure of a medical research paper: key content elements, writing tips, and examples of RG

11. Key focus is on discipline / clinical area specific issues –Different ‘degree’ of specificity May or may not address general methodology items May focus on a complete research study / paper or only on a part Examples –RCTs in leukaemia; longitudinal studies in rheumatology –Economic evaluations in obstetrics 11 Different focus of RG: specific discipline / clinical area Should be used with relevant generic methodology guidelines as they often focus only on content specifics See your handout: Structure of a medical research paper: key content elements, writing tips, and examples of RG

12. Medical research paper (1) 12 See your handout: Structure of a medical research paper: key content elements, writing tips, and examples of RG

13. Medical research paper (2) 13 See your handout: Structure of a medical research paper: key content elements, writing tips, and examples of RG

14. 14 Common problems in research reporting –Non-reporting or delayed reporting of whole studies –Omissions or misinterpretation of results in abstracts –Omission of crucial information in the description of research methods and interventions –Inconsistencies between study protocol (or register) and publication –Incomplete reporting (data cannot be included in SR / MA) –Selective reporting of only some outcomes or analyses –Inadequate reporting of harms –Inadequate statistical reporting –Confusing or misleading presentation (e.g. presenting data & graphs in confusing or misleading ways - particularly important for presenting benefits and harms) –General misinterpretation of study findings (spin) Methods and Results

15. Responsibilities of researchers / authors Key principles for responsible research reporting 15 The research being reported should have been conducted in an ethical and responsible manner and should comply with all relevant legislation. Researchers should present their results clearly, honestly, and without fabrication, falsification or inappropriate data manipulation. Researchers should strive to describe their methods clearly and unambiguously so that their findings can be confirmed by others. Researchers should adhere to publication requirements that submitted work is original, is not plagiarised, and has not been published elsewhere. Authors should take collective responsibility for submitted and published work. The authorship of research publications should accurately reflect individuals’ contributions to the work and its reporting. Funding sources and relevant conflicts of interest should be disclosed. Reproduced from the International standards for authors of scholarly publications (http://publicationethics.org/international-standards-editors-and-authors)http://publicationethics.org/international-standards-editors-and-authors

16. 16 How I can improve reporting of my research study Find out about reporting requirements early, when planning your research study When writing up your research, check the EQUATOR website 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 reporting guidelines provide a minimum set of items; other details specific to your particular study might be relevant for a clear and complete account of what was done and found (consider in particular items that might have introduced bias into your research). It is important to provide enough information to allow your study to be potentially reproducible by others. See ‘Steps to consider’ in Simera et al. BMC Medicine 2010,8:24