LETTER TO THE EDITOR

Updated 2010 ConsolidatedStandards of Reporting Trialsguidelines and selective reportingof clinical trial outcomes: Inresponse to Babl and Davidsonemm_1383 108

Dear Editor,I commend Babl and Davidson on their primer series1

for clinical researchers in the ED. As testament to theconstantly evolving nature of clinical trials methodol-ogy and reporting, the Consolidated Standards ofReporting Trials (CONSORT) 2001 guidelines and theCONSORT E-Flowchart 2005 used in their series(accepted for publication in EMA on 22 June 2010) hadalready been superseded by the CONSORT 2010 guide-lines published in Annals of Internal Medicine2 on the 1June 2010. CONSORT 2010 was published earlier in theBMJ3 on the 27 March 2010. During protocol develop-ment or critical appraisal of clinical trials, researchersand peer reviewers are advised to use the latest avail-able clinical research method and reporting guidelinesas there could have been substantial revisions and addi-tions from previous recommendations.

Regarding clinical trials registration, Babl andDavidson state that this process ‘reduces risk of inten-tional and unintentional alteration of outcomes’.1

Although study outcomes could have been accidentallyaltered or deliberately manipulated by the authors toexaggerate estimated effect of treatment, enhancearticle publication prospects or noteworthiness ofstudy findings, pre-commencement clinical trial regis-tration primarily aims to reduce selective reporting of

multiple outcomes. In this context, only statisticallysignificant outcomes are reported, with findings notfound to reach statistical or clinical significance andthose not consistent with the thrust of an article con-veniently ignored.4 Selective reporting holds potentialto introduce minimally beneficial or even harmful treat-ment into clinical practice, such as has occurred withantidepressants in depression.5

Competing interestsNone declared.

References

1. Babl FZ, Davidson A. A primer for clinical researchers in theemergency department: part II: research science and conduct.Emerg. Med. Australas. 2010; 22: 407–17.

2. Schulz KF, Altman DG, Moher D, for the CONSORT Group.CONSORT 2010 Statement: updated guidelines for reporting par-allel group randomized trials. Ann. Intern. Med. 2010; 152: 1–7.

3. Schulz KF, Altman DG, Moher D, for the CONSORT Group.CONSORT 2010 Statement: updated guidelines for reporting par-allel group randomized trials. BMJ 2010; 340: 698–702.

4. Scoggins JF, Patrick DL. The use of patient-reported outcomesinstruments in registered clinical trials: evidence from Clinical-Trials.gov. Contemp. Clin. Trials 2009; 30: 289–92.

5. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R.Selective publication of antidepressant trials and its influence onapparent efficacy. N. Engl. J. Med. 2008; 358: 252–60.

Joseph Ting

Mater Public Hospitals – Emergency Department, Raymond

Tce South Brisbane Brisbane, Queensland, Australia

Joseph Ting, MBBS, MSc, BmedSci, PGDipEpi, FACEM, Senior Staff Specialist, Mater Public Hospitals.

doi: 10.1111/j.1742-6723.2010.01383.xEmergency Medicine Australasia (2011) 23, 108

© 2011 The AuthorEMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine