Clinical research design and reporting: always room for improvement!

In the 1970s, TRANSFUSION was predominantly a serologic journal. Today, the journal reflects the growth and diversity within the transfusion medicine field where serology has expanded from blood cells to infectious organisms, agglutination stands in the shadows of molecular techniques, and clinical research has moved us to the bedside to identify efficacious and effective transfusion practices. As clinical research studies become more and more prevalent, it is our responsibility as transfusion medicine professionals to ensure that study design and clinical research result reporting is the best that it can possibly be. Some transfusion medicine researchers have had the benefit of formal training in clinical research method, whereas others are faced with the challenge of learning on the job. The reviewers, editorial board, and editors of TRANSFUSION work hard to ensure that accepted publications are of high quality and methodologically sound; however, like many aspects of transfusion medicine, continuous quality improvement should always be the ultimate goal. The journal editors have identified a number of tools that can assist in this process, which we describe in this editorial. Anyone involved in clinical research will benefit from utilizing the CONSORT guidelines when designing clinical research studies and reporting study results.1 CONSORT activities started in 1996 when a group of individuals with expertise in clinical research method met to develop guidelines for reporting randomized trials. The CONSORT statement evolved into an important research tool that comprises a checklist and flow diagram to assist researchers to improve the quality of reports. The checklist includes a list and description of items that need to be addressed when designing and reporting a study, and the recommended flow diagram allows readers to clearly understand the progress of all participants in the trial. These guidelines also serve as a useful tool when designing a clinical study as it forces the researcher to consider many methodological issues before any patients are enrolled. The CONSORT guidelines are available in a number of languages and can be accessed at the Web site http://www.consort-statement.org/.1 This Web site also provides information on other CONSORT activities including guidelines for cluster trials, randomized controlled trials of herbal interventions, reporting of noninferiority and equivalence trials, and issues related to the reporting of meta-analyses of observational studies.2,3 Although some journals have made it mandatory for submissions to follow the CONSORT guidelines, at this point in time TRANSFUSION is strongly recommending that both authors and reviewers utilize the guidelines to improve clinical research reporting in the journal. Although we are not mandating CONSORT as a formal requirement at this time, we may elect to do so when we are convinced that our readership is more aware of these issues. The second clinical research tool endorsed by the editors of TRANSFUSION is to ensure that all clinical trials are registered before the first patient is enrolled. This task can be performed on the Web site http://www.clinicaltrials.gov/.4 The concept of clinical trial registration was first proposed by the International Committee of Medical Journal Editors (ICMJE) in 2004 to deal with the problem of selective trial reporting.5 It is well acknowledged that trials showing a significant treatment effect are more likely to be published than inconclusive or negative trials. The solution to this problem proposed by the ICMJE was to register all trials before enrollment is started on a registry that is accessible to the public, open to all prospective registrants, and operated by a not-for-profit organization.5-7 Such a registry would also provide a comprehensive publicly available database of clinical trials and “would be a fitting way to thank the thousands of participants who have placed themselves at risk by volunteering for clinical trials.”6 Although TRANSFUSION has not currently made this registration a mandatory requirement, the editors strongly endorse the concept and encourage all transfusion researchers to register their trials. Finally, to assist the transfusion community to improve clinical research reporting, the journal has established a section entitled “Clinical Research Focus.” This series is currently scheduled to run bimonthly and will contain short articles focusing on a specific aspect of clinical research method. We hope that these topics will be of interest to researchers, reviewers, and trainees and will improve the awareness of the many aspects of clinical research design that must be considered to ensure internaland external validity of the results. The first article in this series appears in this volume of the journal and is focused on the most important aspect of a research project—the question. We hope that the readers of TRANSFUSION enjoy this series and find the articles useful tools to continuously improve research and educational activities in transfusion medicine.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.