Good reporting practices and the CONSORT

EDITORIAL EDITORIAL

Good reporting practices and the CONSORT

Rodrigo Pessoa Cavalcanti Lira; Carlos Eduardo Leite Arieta

Physician, Departamento de Oftalmologia da Universidade Estadual de Campinas - UNICAMP - Campinas (SP), Brasil

Increasing attention has been paid to the importance of good reporting practices as they relate to the po­tential utility of a manuscrip⁽¹⁾.

Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigor⁽²⁾. To assess a trial accurately, readers of a paper need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide complete descriptions of that critical information^(3,4).

The CONSORT (Consolidated Standards of Reporting Trials) statement, originally published in 1996 and updated in 2001 and 2010, provides a 25 item checklist for a minimum set of recommendations for reporting the trial design, analysis, and result⁽⁵⁾. It was developed to assist authors in writing reports of randomised controlled trials, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type-individually randomised, two group, parallel trials, which accounts for over half of trials in the literature.

The evidence based approach that has been used for CONSORT also served as a model for development of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interventions [PRISMA]⁽⁶⁾, and observational studies [STROBE]⁽⁷⁾.

However, as a potential drawback, a reporting guideline might encourage some authors to report fictitiously the information suggested by the guidance rather than what was actually done. Readers, peer reviewers, and editors should vigilantly guard against that potential drawback and refer, for example, to trial protocols, to information on trial registers, and to regulatory agency websites.

Although the Arquivos Brasileiros de Oftalmologia has not yet officially adopted the CONSORT, we encourage its use as well as other pro­tocols such as STROBE and PRISM. This attitude will contribute to the improvement of our global insertion.

REFERENCES

1. Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med. 2010;8:24.

2. Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323(7303):42-6.

3. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365(9465):1159-62.

4. 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.

5. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche 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;63(8):e1-37. Comment in: J Clin Epidemiol. 2010: 63(8):813-4.

6. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analysis: the PRISMA statement. BMJ. 2009;339:b2535.

7. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806-8. Comment in: BMJ. 2007;335(7624):783-4. Arch Dermatol. 2008; 144(9):1200-4. BMJ. 2007; 335(7626):900.

Submitted for publication: April 11, 2012

Accepted for publication: April 11, 2012

Funding: No specific financial support was available for this study.

Disclosure of potential conflicts of interest: R.P.C.Lira, None; C.E.L.Arieta, None.

Publication Dates

• Publication in this collection
  15 June 2012
• Date of issue
  Apr 2012