Korean translation of the CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials

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Epidemiol Health. 2014;36.e2014029
Publication date (electronic) : 2014 November 8
doi : https://doi.org/10.4178/epih/e2014029
1Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, Catholic University of Korea, Seoul, Korea
2Division of Statistics, Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Korea
3Department of Radiology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
4Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Correspondence: Soyeon Ahn  Division of Statistics, Medical Research Collaborating Center, Seoul National University Bundang Hospital, 82 Gumi-ro 173 beon-gil, Bundang-gu, Seongnam 463-707, Korea  Tel: +82-31-787-4894, Fax: +82-31-787-4825, E-mail: ahnsoyeon@snubh.org
Received 2014 August 23; Accepted 2014 November 8.

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement, updated in March 2010, includes a 25-item checklist and flow diagram. Adherence to this statement is a minimum requirement for the complete, clear, and transparent reporting of randomized trials. We translated the CONSORT 2010 Statement into Korean to promote the widespread adherence to CONSORT in South Korea and to facilitate the adoption of complete, clear, and transparent reporting. The Korean version of the CONSORT is available at http://www.e-epih.org/.

THE CONSORT 2010 STATEMENT

The Consolidated Standards of Reporting Trials (CONSORT) statement is a reporting guideline for randomized controlled trials (RCTs). It is expected that the use of CONSORT facilitates high quality reporting and therefore improves the assessment of RCTs [1-3].

The CONSORT 2010 Statement, updated in March 2010, includes a 25-item checklist and flow diagram, which are minimum requirements that should be adhered to for the complete, clear, and transparent reporting of RCTs. We translated the CONSORT 2010 Statement into Korean to promote the widespread use of the CONSORT statement in South Korea.

THE TRANSLATION PROCESS

Between June 2012 and February 2013, the CONSORT 2010 Statement was translated into Korean. Volunteers who understand the value of the CONSORT 2010 Statement and the need of its introduction to Korean readers performed the translation. We obtained permission from the CONSORT 2010 group for Korean translation, and the translation process was done according to the guidelines provided by the CONSORT 2010 group. One translator (S.A.) proceeded with the forward translation of the CONSORT 2010 Statement [4]. Another bilingual (Korean-English) translator (J.S.L.), who was not involved in the forward translation, performed the backward translation. The penultimate version of translation was sent to the CONSORT group for review, and some discrepancies were noted in the backward translation. The translators modified these discrepancies as well as several other ambiguous expressions, and then two independent reviewers (K.H.L and J.H.K) reviewed these discrepancies. All translators and reviewers were born in South Korea, had lived in an English-speaking country for at least 1 year prior to translation, and are fluent in both Korean and English.

IMPLICATIONS

We believe that the translation of the CONSORT 2010 Statement will facilitate the widespread adoption of the CONSORT statement in South Korea and the clear, complete, and transparent reporting of future RCTs. For trialists, adherence to the CONSORT statement helps to not only report but also design and conduct trials. For reviewers and readers, the completeness of reported trials supports the critical appraisal and interpretation of these data, and aids in the synthesis of evidence subject to systematic review. For participants, a translated version of the terminology and process may help to broaden their understanding of these trials. The Korean version of the CONOSRT 2010 Statement is available at http://www.e-epih.org/ as a supplemental material.

Acknowledgements

This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT and Future Planning (NRF-2013R1A1A3012306).

Notes

The authors have no conflicts of interest to declare for this study.

SUPPLEMENTARY MATERIAL

Supplementary material is available at http://www.e-epih.org/.

References

1. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010;340c723.
2. Moher D, Jones A, Lepage L, ; CONSORT Group (Consolidated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001;285:1992–1995.
3. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006;185:263–267.
4. Schulz KF, Altman DG, Moher D, ; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726–732.

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