Research article structure: W here can reporting guidelines help? Iveta Simera

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 Primary research Design Conduct Publication Use in further research Clinical practice guideline Publication Systematic review 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

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

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

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 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 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) Moher et al. PLoS Med 2010

9. Reporting guidelines database

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 Core RG (“Must”) • See your handout: Structure of a medical research paper: key content elements, writing tips, and examples of RG

11. Different focus of RG: specific discipline / clinical area • Key focus is on discipline / clinical areaspecific 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 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) • See your handout: Structure of a medical research paper: key content elements, writing tips, and examples of RG

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

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 Reproduced from the International standards for authors of scholarly publications (http://publicationethics.org/international-standards-editors-and-authors)

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