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FEATURES << Improving reporting standards in health research publication: How the EQUATOR Network can help medical writers
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Improving reporting standards in health research publication: How the EQUATOR Network can help medical writers
Published 13 May 2009, written by Allison Hirst and Iveta Simera
A published report of health research is generally the only tangible evidence that the research occurred. A study may have been designed, executed and analysed in an exemplary manner and may provide important clinical evidence that could lead to improvements in treatment or prevention of disease. However, if the written record of that work does not contain information to reflect this, how can we tell? The research might as well not have been done.
Extent and consequences of poor reporting
Poor reporting practice is a cause for concern. Currently the full extent and implications for patients of the discrepancy between the body of research that has been done and that has been publicly reported is not known. Evidence is accumulating that reporting in many of areas of health research (both intervention and observational studies) is unsatisfactory, leading to biases in the body of clinical evidence. Studies with less interesting findings are less likely to be published (study publication bias) and within publications the data that is reported tends to favour those measures with statistically significant results (outcome reporting bias). Furthermore, crucial descriptive information about what was done or measured may be missing, incomplete or ambiguous, misrepresenting the study and its results [1-8].
Responsible reporting
It is the responsibility of everyone involved in health research including research funding bodies, research governance and ethics committees, clinicians, researchers, report authors, journal editors, peer reviewers, publishers and health service policy makers to be accountable to patients and the wider society by producing the best possible clinical evidence reflecting the scientific truth and also to be mindful of financial resources.
It is now timely to increase awareness of the possible consequences of poor reporting and to offer assistance to all those groups involved in the process of health research on how to improve the quality of health research publications.
What are the responsibilities of medical writers?
Medical writers should play an important role in “good scientific practice” which “embraces all the procedures and practices that are necessary for planning, conducting and reporting research and scholarship within a framework of scientific integrity” [9]. They can do this by being aware of what constitutes good reporting practice and by practising high quality reporting themselves.
There are already excellent resources to guide medical writers including;
“Uniform Requirements for Manuscripts Submitted to Biomedical Journals” prepared by the International Committee of Medical Journal Editors (ICMJE) (http://www.icmje.org). This document states the ethical principles in the conduct and reporting of research and provides recommendations relating to specific elements of editing and writing. Most biomedical journals require authors to comply with these guidelines.
Good publication practice (GPP) guidance has been available since 2003
“to encourage responsible and ethical publication of the results of clinical trials sponsored by pharmaceutical companies” [10]. GPP provides “best practice” ethical guidance about peer-reviewed publications and presentations at scientific meetings, as well as recommendations for “non-peer-reviewed scientific communications”.
At the time of writing we are expecting the updated “Good Publication Practice for Communicating Research Supported by Pharmaceutical, Medical Device and Biotechnology Companies (GPP2)” to be published following its launch at the International Society for Medical Publication Professionals (ISMPP) meeting in April 2009, in Philadelphia, USA (http://www.ismpp.org). There will be new sections to provide guidance on recent developments in medical research and reporting, such as clinical trial registration and results disclosure. It is likely that a prime focus in GPP2 will be guidance on reporting (both in written form and presentations) to demonstrate integrity, completeness, transparency, accountability and responsibility. Full information will be made available through the GPP website (http://www.gpp-guidelines.org).
The practical aspects of “how” to achieve improved reliability of medical research literature is precisely the concern of a new international initiative, the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) (http://www.equator-network.org). EQUATOR has set itself the goal of facilitating a global improvement in reporting standards through the provision of reporting guidelines and other resources relating to the reporting of health research, an education programme and assistance in the development, dissemination and implementation of robust reporting guidelines.
The EQUATOR Network was officially launched in June 2008 with support from the UK National Health Service and Medical Research Council. The Network is directed by an international Executive Group of leading experts in health research methodology, statistics, reporting and editorial work (http://www.equator-network.org/about-equator/who-we-are).
What are reporting guidelines?
Reporting guidelines are statements that provide advice on how to report research methods and findings. Usually in the form of a checklist, flow diagram or explicit text, they 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.
The most widely recognised reporting guidelines are underpinned by the available evidence and reflect the consensus opinion of experts in a particular field, including research methodologists, clinical experts and journal editors. The most well known of these is probably the CONSORT (CONsolidated Standards Of Reporting Trials) Statement [11,12].
CONSORT provides a standard reporting framework for authors to prepare reports of their trial, ensuring completeness and transparency and facilitating their critical appraisal and interpretation by readers (http://www.consort-statement.org). This is essentially the role of all reporting guidelines which complement general guidance on scientific writing and a journal’s own specific “instructions for authors”.
Alongside further development, revision and extensions to CONSORT many other groups have responded to an awareness of insufficient quality of published reports in their own areas of health research. During the last decade a considerable number of reporting guidelines have been developed for various specialties of health research, many following a similar model to the CONSORT Statement. The EQUATOR Network has identified more than 90 reporting guidelines fully accessible on its online “Library for Health Research Reporting” (http://www.equator-network.org/resource-centre/library-of-health-research-reporting/).
These initiatives include:
QUOROM (recently renamed PRISMA) for systematic reviews of randomised trials
Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. QUOROM Group. Br J Surg 2000; 87(11):1448-54.
PMID: 11091231
MOOSE for systematic reviews of observational studies
Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283(15):2008-12.
PMID: 10789670
STARD for diagnostic accuracy studies
http://www.stard-statement.org STAndards for the Reporting of Diagnostic accuracy studies
REMARK for tumor marker prognostic studies
McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. REporting recommendations for tumour MARKer prognostic studies (REMARK). Br J Cancer 2005; 93(4):387-391.
PMID: 16106245
TREND for non-randomised evaluations of behavioural and public health interventions
Des Jarlais DC, Lyles C, Crepaz N, Trend Group. Improving the reporting quality of nonrandomized evaluations of behavioural and public health interventions: the TREND statement. American Journal of Public Health 2004; 94(3):361-6.
PMID: 14998794
STROBE for observational studies (cohort, case-control and cross-sectional study designs)
http://www.strobe-statement.org STrengthening the Reporting of OBservational studies in Epidemiology
Responsible medical writers should be aware of any guidelines that apply to the publications they are producing. Adherence may also increase the probability of their manuscript being published and enhance the value of this research to clinicians, other researchers and policy-makers.
How can EQUATOR help medical writers and others interested in raising the standard of health research reporting?
The EQUATOR team has established a comprehensive web-based “Resource Centre” providing free up-to-date information, tools and other materials relating to health research reporting (see box). We have organised the material to be helpful to various user groups and medical writers will probably find the material for authors most useful. Not only are there links to the various reporting guidelines but also to a number of resources developed specifically for medical writers. Other areas of the resource centre groups useful information for journal editors and peer reviewers, and for developers of reporting guidelines. We hope that our resource will enable you to access the latest developments in this field provided through one portal. The website also provides facilities for sharing ideas, experiences, and suggestions through a newly added discussion forum.
The EQUATOR Network assists in the development, dissemination and implementation of robust reporting guidelines and actively promotes their use and other good research reporting practices through an education and training programme. We are currently developing in-house educational materials, tools and training courses to raise awareness and importance of reporting guidelines.
We plan to monitor progress in the improvement of health research reporting including conducting regular assessments of how journals implement reporting guidelines and regular audits of reporting quality across the health research literature. In addition we will conduct and support specific research projects relating to the quality of reporting.
EQUATOR activities help to translate some of the principles of responsible and ethical research conduct into practice. By pulling together the available reporting guidelines into one central portal and widening awareness of their existence through training and educational materials, the EQUATOR Network expects to support their better implementation in research publication practice. The EQUATOR Network aims to substantially contribute to the prevention of poor reporting and the introduction of best reporting practice by leading a global collaboration between the research and publishing communities.
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Keep up to date with all our developments, publications and activities posted on our website http://www.equator-network.org and take an active part in raising health research reporting standards with us.
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References
1. Turner EH, Matthews AM, Linardatos E, Tell RA, and Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358 (3):252-60
2. Chan A-W. Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results. PLoS Med 2008; 5(11): e230.
3. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008;3(8):e3081.
4. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005; 365: 1159–62.
5. Smidt N, Rutjes AW, van der Windt DA, et al. Quality of reporting of diagnostic accuracy studies. Radiology 2005; 235: 347–53.
6. Ramsey S, Scoggins J. Commentary: practicing on the tip of an information iceberg? Evidence of under-publication of registered clinical trials in oncology. Oncologist 2008 Sep;13(9):925-9.
7. Glasziou P, Meats E, Heneghan C, Shepperd S: What is missing from descriptions of treatment in trials and reviews? BMJ. 2008;336(7659):1472-4.
8. Pocock SJ, Collier TJ, Dandreo KJ, de Stavola BL, Goldman MB, Kalish LA, Kasten LE, McCormack VA (2004). Issues in the reporting of epidemiological studies: A survey of recent practice. BMJ.2004; 329: 883.
9. Good Scientific Practice in Research and Scholarship. ESF Policy Briefing 10. 20 December 2000. http://www.esf.org/publications/policy-briefings.html Accessed 1 May 2009
10. Wager E, Field E, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin. 2003;19:149–154.
11. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001; 134(8):657-662.
12. Altman DG, Schulz KF, Moher D, Egger M. Davidoff F, Elbourne D, Gøtzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134(8):663-694.
About the authors
Dr Iveta Simera is Head of Programme Development; iveta.simera@csm.ox.ac.uk and Allison Hirst is Research Fellow; allison.hirst@csm.ox.ac.uk
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Feedback: Do you have any comments about this article? Contact the Publisher, Peter Llewellyn.
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