Health Research Reporting Guidelines

 

Checklists improve quality in scientific communications. Reporting health research in an accurate, transparent, and timely manner supports the professional and educational needs of the readers of scientific medical journals. This is a shared responsibility of all healthcare stakeholders and supports the effective incorporation of external evidence into clinical practice. [Moher 2010] Health research reporting guidelines guide authors in writing manuscripts and support critical appraisal by editors and those participating in peer review. All healthcare stakeholders benefit from familiarity with health research reporting guidelines.

Food and Drug Administration (FDA) Requirements and Clinical Trials. In 1962 the Kefauver-Harris amendment to the Food, Drug and Cosmetic Act in the United States instituted a requirement for preapproval efficacy and safety testing of all new pharmaceutical drugs and medical devices. This led to the rapid growth and expansion of randomized controlled trials (RCTs).

Conflicting Clinical Trial Evidence Drive Development of Reporting Standards and Guidelines. In 1993 a group of journal editors, clinical trialists, epidemiologists and methodologists met to develop quality assessment tools for randomized controlled trials in order to develop accurate, evidence-based recommendation for clinical practice.   This led to the formation of the CONSORT group and the publication of the first Consolidated Standards of Reporting Trials (CONSORT) Statement in 1996. [Begg 1996] The CONSORT explanation and elaboration article and an update to the CONSORT statement were published in 2010.

Evolution of Health Research Reporting Guidelines. In 2006, the EQUATOR Network program formed as an international initiative promoting the principles of responsible reporting and the use of reporting guidelines to improve the accuracy, completeness and transparency of health research. Over the last 10 years the EQUATOR online Library for Health Research Reporting and its practical toolkits and training have become an indispensable resource for researchers, journals, and organizations producing health research evidence, with more than 1.5 million visitors to date.

Health Research Reporting Guidelines Take Different Forms. Reporting guidelines help improve the accuracy, completeness, and transparency of reporting in health research. Usually in the form of checklists, flow diagrams and manuals (elaboration and explanation articles), reporting guidelines provide guidance on the data set that needs to be presented in a research report so that others can judge its relevance and reliability, use it in their clinical or research practice, and if needed successfully reproduce it. [Simera 2010, Hirst 2012]

Health Research Reporting Guidelines for Different Study Types. Guidelines provide a reporting framework for a research article and are an excellent starting point when writing up a study from any clinical area. Other reporting guidelines provide guidance on reporting specific aspects of study methods, procedures or medical conditions. They can be found on the guidelines database at the EQUATOR Network. The EQUATOR team, based in Oxford, UK, systematically collects and classifies reporting guidelines to ensure researchers can easily find those guidelines that are relevant to their work. The reporting guidelines database is an important resource for researchers writing and publishing health research studies.

Checklists Add Value. Using checklists is a good practice in many fields, minimizing omissions in areas of our lives from aviation to surgical theatres, helping authors write accurate, complete, and transparent articles.  [Gawande 2010].

“Toolkits” Improve Implementation of Reporting Guidelines. Medical journal editors (and peer reviewers) benefit from familiarity with reporting guidelines and can select and utilize guidelines and checklists most appropriate for articles submitted to their journals. The EQUATOR Network has a “toolkit” to support journal editors in their mission to publish manuscripts that address the professional and educational needs of its readers. [EQUATOR toolkits 2016a]. This toolkit provides practical information and support for effective implementation of reporting guidelines in journals including summary of major reporting issues in the current research literature, common myths and misconceptions about reporting guidelines, evidence of their effectiveness, practical tools and templates, and shared experience from other journals. To facilitate writing, the EQUATOR team also developed the “Writing research toolkit.” [EQUATOR Toolkits 2016b].  Examples of some of the health research reporting guidelines available from the EQUATOR Network that might prove useful to authors, editors, and reviewers include:

  • CONSORT Statement (and extensions) for RCTs [Moher 2010]

  • STROBE Statement for reporting observational studies in epidemiology [Vandenbroucke 2007]

  • CARE for reporting case reports [Gagnier, 2013, Riley 2017]

  • SQUIRE for quality improvement studies [Ogrinc 2015]

  • STARD Statement for reporting diagnostic accuracy studies [Bossuyt 2003]

  • PRISMA Statement for reporting systematic reviews and meta-analyses [Liberati 2009]

Improving Quality of Published Reports. The growth in health research reporting guideline development has been largely motivated by the uneven quality of published reports. Over time, as authors, editors and peer reviewers incorporate guidelines into their workflow the quality of manuscripts is likely to improve. [Turner 2012]

Summary. Health Research Reporting Guidelines are simple and efficient tools, and their use maximizes potential benefit of new research on our knowledge and patients’ care. Familiarity with reporting guidelines is emerging as a core competency of journal editors. [Galipeau 2016] However, reporting guidelines can only be effective if they are routinely used in practice. Journal editors play an important role in this process. They act as gatekeepers of good reporting quality but they can also raise awareness of reporting shortcomings and direct authors to reliable reporting tools.

Course on Case Report Writing. For those interested in publishing case reports, take a look at SWIHM’s comprehensive training for writing case reports based on the CARE Guidelines. The course consists of 12 lectures and videos, almost sixty handouts and an online tool to create a case report summary and timeline.  Click here to learn more or enroll in the case report writing course.

Iveta Simera, PhD and David Riley, MD

Iveta Simera PhD. Iveta helped found the EQUATOR Network and is Senior Operations & Development Manager at The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford. She has a long standing interest in improving the quality of health research studies and scientific publications, including the ethical conduct and publication of medical research, development of education and training, research synthesis, knowledge management, and project management. Iveta earned her PhD in Plant Genetics from Charles University in Prague, as well as a degree in Business Administration from Swinburne University of Technology in Melbourne.

Supporting References and Links

  • Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med 2010;7:e1000217.

  • Barnes C, Boutron I, Giraudeau B, Porcher R, Altman DG, Ravaud P. Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial. BMC Medicine 2015 13:221

  • Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D,Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996 Aug 28;276(8):637-9.

  • Galipeau J, Barbour V, Baskin P, Bell-Syer S, Cobey K, Cumpston M, Deeks J, et al. A scoping review of compentencies for scietnfic editors of biomedical journals. BMC Medicine (2016) 14:16

  • Moher D, Hopewell S, Schulz KF, Montori V, Gm Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010 Aug;63(8):e1-37.

  • Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.

  • Simera I, Moher D, Hirst A, Hoey J, Schulz K, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and EQUATOR Network. BMC Med. 2010; 8: 24. doi:1186/1741-7015-8-24 PMCID: PMC2874506.

  • Hirst A, Altman DG 2012 Are Peer Reviewers Encouraged to Use Reporting Guidelines? A Survey of 116 Health Research Journals. PLoS ONE 7(4): e35621. doi:10.1371/journal.pone.0035621

  • EQUATOR Library (http://www.equator-network.org/library/), accessed December 3, 2016.

  • EQUATOR Network: (http://www.equator-network.org/wp-content/uploads/2015/03/Implementing-reporting-guidelines-in-journals-March-2015.pdf) Accessed November 1, 2016.

  • EQUATOR Reporting guidelines database (http://www.equator-network.org/reporting-guidelines/), accessed December 3, 2016.

  • Autl Gawande. The Checklist Manifesto – How to get things right. Metropolitan Books, Henry Holt and Company LLC, NY, NY 2009.

  • EQUATOR Toolkits: Using guidelines in your journal (http://www.equator-network.org/toolkits/), accessed December 3, 2016a.

  • EQUATOR Toolkits: Writing research (http://www.equator-network.org/toolkits/writing-research/), accessed December 3, 2016b.

  • Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev 2012;1(1):60. http://dx.doi.org:10.1186/2046-4053-1-60.

  • Moher D, Schulz KF, Montori V, Gøtzsche PC, Deveraux PJ, Elbourne D, Egger M, Altman DG. CONSORT 201 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials. BMJ 2010;340:c869.

  • Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE):explanation and elaboration. Epidemiology. 2007 Nov;18(6):805-35. PMID: 18049195

  • Gagnier JJ, Kienle GS, Altman DG, David Moher D r, Sox H, Riley DS, and the CARE Group. The CARE guidelines: consensus-based clinical case report guideline development. Journal of Clinical Epidemiology 67 (2014) 46e51. Epub ahead of print – 2013. DOI:10.1016/j.jclinepi.2013.08.003

  • Riley DS, Barber MS, Kienle GS, Aronson JA, Tugwell P, Kiene H, Helfand M, Sox H, G Altman DG, Moher D, G et al. CARE 2013 Explanations and Elaborations: Reporting Guidelines for Case Reports. Journal of Clinical Epidemiology Epub ahead of print. DOI: 10.1016/j.jclinepi.2017.04.026.

  • Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. Perm J. PMID: 26517437

  • Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration. Ann Intern Med. 2003;138:W1-12. doi: 10.7326/0003-4819-138-1-200301070-00012-w1

  • Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, et al. The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration. PLoS Med 6(7): e1000100. doi:10.1371/journal.pmed.1000100

 
Iveta Simera PhD