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Pre-specified outcomes must be followed

  • Hans-Joachim PriebeEmail author
Letter to the Editor
  • 2 Downloads

To the Editor

The publication by Licker et al. [1] raises several considerable concerns. First, in the abstract the authors claim that this was a randomized controlled trial. This, however, is not the case. The article merely reports the findings of an a priori non-defined subset of patients in whom transesophageal echocardiographic (TEE) examination was of good quality following coronary artery bypass surgery with or without aortic valve replacement (AVR). These patients were part of a previously reported study by the same group of authors [2]. The unequal number of patients in each group (46 vs. 54) documents the lack of randomization.

Second, the authors claim that the reported investigation in this subset of patients was pre-planned as per trial registration [3]. This, again, is an incorrect statement. The respective trial registration lists as primary outcome measure 48 h postcardiotomy ventricular dysfunction (PCVD), and as secondary outcome measures intraoperative systolic and...

Notes

Compliance with ethical standards

Conflict of interest

The author does not have any conflict of interest.

References

  1. 1.
    Licker M, Reynaud T, Garofano N, et al. Pretreatment with glucose–insulin–potassium improves ventricular performances after coronary artery bypass surgery: a randomized controlled trial. J Clin Monit Comput. 2019.  https://doi.org/10.1007/s10877-019-00280-5.Google Scholar
  2. 2.
    Ellenberger C, Sologashvili T, Kreienbuhl L, Cikirikcioglu M, Diaper J, Licker M. Myocardial protection by glucose-insulin-potassium in moderate- to high-risk patients undergoing elective on-pump cardiac surgery: a randomized controlled trial. Anesth Analg. 2018;126:1133–41.CrossRefGoogle Scholar
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    Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340:c332.CrossRefGoogle Scholar
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    Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.CrossRefGoogle Scholar
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    Jones CW, Keil LG, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med. 2015;13:282.CrossRefGoogle Scholar
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    Goldacre B, Drysdale H, Dale A, et al. COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials. 2019;20:118.CrossRefGoogle Scholar

Copyright information

© Springer Nature B.V. 2019

Authors and Affiliations

  1. 1.Department of Anesthesiology and Critical CareMedical Center University of FreiburgFreiburgGermany

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