Sally Hopewell discusses improving the transparent reporting of clinical research

Posted by Biome on 14th November 2013 - 2 Comments


Inadequate reporting of medical research distorts medical evidence and has serious implications that ultimately impact clinical practice. One way to tackle this is through the use of reporting guidelines that contain the minimum information required when reporting medical research. Reporting guidelines are available for different study designs and are part of the EQUATOR network, an initiative that aims to improve the reliability and value of medical research literature by promoting transparent and accurate reporting of research studies. Sally Hopewell, from the Centre for Statistics in Medicine at the University of Oxford, UK, explains more about the problems associated with inadequate reporting of medical research and what can be done to improve the situation.

 

Have you ever opened a copy of your favourite medical journal to read the latest research study about the effects of a new drug or procedure on patients with a particular condition, only to find that you can’t actually understand how the study was conducted, how the intervention was actually delivered, what the specific outcomes were, or whether there were any associated adverse effects? Well you are not alone, every week a study is published highlighting serious problems in the reporting of published health research. These problems are widespread and range from the failure to report and publish whole research studies depending on the nature of their research findings ‘publication bias’, to the selective publication (or no publication) of specific study outcomes i.e. ‘selective outcome reporting bias’.

Even when all study outcomes are reported the interpretation of the study results is sometimes distorted by the authors of the primary study. Other problems in the reporting of health research literature include the inadequate and misleading reporting of adverse events, the omission of information about study methods that would allow implementation of the intervention in clinical practice, and the omission or misinterpretation of results in the abstracts of study publications. Serious deficiencies in the reporting of research have been well-documented across many medical specialties and various study designs.

Transparent and clear reporting of research is therefore essential to enable users of this research to understand how the study was conducted and to assess the validity and reliability of the study findings. Failure to adequately report research findings distorts the reality of how the research was actually conducted. It prevents clinicians from applying effective interventions and can result in vast amounts of money invested in health research being wasted. Incomplete or inadequate reporting of health research also has far reaching ethical implications as the individuals who consent to participate in research, and agencies that provide funding support for these investigations, do so with the understanding that the work will make a contribution to the existing knowledge. Clearly, new knowledge that is not disseminated, or knowledge that is disseminated in a biased way, is not making a true contribution.

 

What can be done to improve the reporting of medical research?
Over the last decade there have been considerable efforts to try to improve the quality of reporting of individual research studies. One of the key developments has been the introduction of ‘reporting guidelines’ that provide structured advice on what minimum information needs to be included in a research article to allow readers to assess the study methodology, relevance and validity of the research findings. Most of the internationally recognised reporting guidelines reflect the consensus opinion of experts in a particular field, including statisticians, clinicians and journal editors and also draw on relevant empirical evidence.

Randomised trials have long been the focus of particular scrutiny because of their important direct link to health care. The CONSORT Statement (CONsolidated Standards for Reporting Trials), first published in 1996, is a reporting guideline designed to improve the transparency and quality of reporting in clinical trials. The CONSORT Statement was last updated in 2010 and published simultaneously in ten leading medical journals. The CONSORT Statement comprises a checklist of essential items that should be included in reports of randomised trials and a diagram documenting the flow of participants through the trial. Those new to CONSORT are encouraged to check out its accompanying explanatory document that provides the rationale for the importance of individual checklist items and examples of good reporting.

A number of other related initiatives have followed a similar model to CONSORT with the aim of improving the quality of reporting of other types of health research, for example the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) Statement for reporting observational studies and the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) Statement for reporting systematic reviews. These and other such reporting guidelines are part of the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network which is an international initiative that aims to improve the reliability and value of medical research literature by promoting accurate and transparent reporting of health research studies. EQUATOR is unique in that it brings together all parties involved in research publication including researchers, journal editors, publishers, scientists involved in developing reporting guidelines, educators and research funders.

The problem of poor and incomplete reporting of clinical research is a collective responsibility. Key to this responsibility are the authors of the research studies themselves, but also, journal editors, peer reviewers and publishers who should ensure that the study results are clear and transparently reported to ensure they can be used more effectively and efficiently. It is possible to apply a few simple steps towards improving reporting of medical research through ensuring better use and implementation of reporting guidelines such as CONSORT. Key for journal editors and publishers is incorporating an explicit statement about transparent, complete and accurate reporting and use of reporting guidelines into their editorial policy. They should identify which guidelines are appropriate for their journal and ask (instruct) authors to adhere to them in the ‘Instructions to Authors’, for example by requiring authors to submit a completed checklist as part of the manuscript submission process. Peer reviewers can also help by checking for adherence to checklist items as part of their review process. In addition some journals also carry out ‘in-house’ checks as part of the editorial process.  A number of resources have been developed, targeted at authors, editors and peer reviewers, to improve the completeness, transparency and value of health research. If you are interested in knowing more you can find out via the EQUATOR website.

 

More about the author(s)

Sally Hopewell, senior research fellow, Centre for Statistics in Medicine, University of Oxford, UK.

Sally Hopewell is a senior research fellow at the Centre for Statistics in Medicine, University of Oxford, UK, where she is engaged in a programme of methodological research underpinning the work of the CONSORT Group funded by the MRC Methodology Programme in the UK. She was awarded a DPhil at the University of Oxford in 2005 for her research into the effects of unpublished data in systematic reviews. Her primary research interests focus on the design, conduct and reporting of systematic reviews and randomised trials. Hopewell also works as a senior Scientist at the Centre d’Epidemiologie Clinique, France, and the French Cochrane Centre at the University Descartes Paris, France, leading research activities into the methodology of systematic reviews and randomized trials. She is an academic editor for PLoS ONE, sits on the editorial board for the journal Systematic Reviews and is also a member of the advisory board for Current Controlled Trials.