Abstract
Following the Editorial Board Meeting at the International Association for Dental Research (IADR) Congress in Vancouver, it was agreed that from July 1 1999 authors submitting manuscripts of randomised controlled trials (RCTs) to the British Dental Journal will need to adhere to the CONSORT guidelines for the reporting of RCTs. But, what is CONSORT? Why is the BDJ adopting these guidelines and how will it help our readership to make better sense of clinical research?
Main
The Consolidated Standards Of Reporting Trials (CONSORT) is an attempt to improve the reporting of randomised clinical trials. It was developed by a broad-based group of journal editors, biostatisticians and researchers, intimately involved in clinical trials, and was first published in 1996.1 Since January 1997 it has been a requirement for authors submitting to the BMJ, Lancet, JAMA and others, and is now accepted by over 70 biomedical journals. CONSORT is a checklist of items essential to the explicit reporting of RCTs, together with a flow chart of study participants, and is intended for authors, referees and editors. An explanatory paper can be found on page 258 in this issue and forms an addition to the instructions for authors submitting manuscripts of RCTs. The checklist is submitted with the manuscript and indicates to the journal reviewer where the checklist items can be located within the manuscript and will facilitate the checking of compliance with CONSORT during the peer review process.
Why are guidelines needed? One of the frustrating aspects of clinical practice can be the diversity of opinions for managing even apparently simple problems. The basis of this issue is often the uncertainty and contradiction that exists in the clinical research literature. Although the RCT is frequently awarded the 'gold standard' status of evidence, the last few years have seen the RCT itself become the subject of research, with some surprising conclusions.2 When quality assessments of RCTs published in major journals have been performed, those studies which scored low tended to over-estimate the treatment effect, compared with studies rated as high quality, and by a substantial margin of 34%.3 Other aspects of RCT conduct were similarly reported to over-estimate treatment effects by 30-40%.3,4 Unfortunately, many of the details that allow this type of evaluation to be conducted are poorly reported in individual papers and CONSORT will provide guidance to help authors achieve more complete trial reports.
Adoption of CONSORT will allow readers of RCTs published in the BDJ a greater facility to judge the quality of the trial, and greater confidence in the peer review process. It is also an important initiative in the spirit of evidence-based dentistry. Indeed, the CONSORT guidelines will change, as any evidence-based process should, thus reflecting the appearance of new evidence.5
we hope that readers and researchers will see this as a valuable contribution to increasing the quality of published papers and to facilitate clinical decision making
As far as we know the BDJ is the first dental journal to adopt these principles and we hope that readers and researchers will see this as a valuable contribution to increasing the quality of published papers and to facilitate clinical decision making.
References
Begg C, Cho M, Eastwood S et al. Improving the quality of reporting of randomized controlled trials. JAMA 1996; 276: 637–639.
Jadad A . Randomised controlled trials. A users guide. London: BMJ Books, 1998.
Moher D, Pharm B, Jones A et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998; 352: 609–613.
Schulz K F, Chalmers I, Hayes R J, Altman D G . Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects on controlled trials. JAMA 1995: 273: 408–412.
Moher D . CONSORT: An evolving tool to help improve the quality of reports of randomized controlled trials. JAMA 1998; 279: 1489–1491.
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Needleman, I. Consort. Br Dent J 186, 1 (1999). https://doi.org/10.1038/sj.bdj.4800065
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DOI: https://doi.org/10.1038/sj.bdj.4800065