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Faulty risk-of-bias assessment in a meta-analysis of hydroxyethyl starch for non-septic ICU patients: a rebuttal

The Original Article was published on 01 December 2015

The Fluids in Resuscitation of Severe Trauma (FIRST) study meets all of the criteria for assessment as a low risk of bias study, contrary to the unsupported allegations by Bayer and Reinhardt.

We dispute the letter from Bayer and Reinhart together with the response from He et al. [1]. Bayer and Reinhart claim that the FIRST study [2] has a high risk of bias and cite two non-peer-reviewed letters from themselves and Finfer to support this claim. However, these authors fail to cite the extensive responses that more than adequately cover their queries [3].

Bayer and Reinhart claim that there was selective outcome reporting, but all of the outcomes listed in the methods of the FIRST trial have been reported. As with all published work, space constraints imposed by the journal limit the amount of detail that can be included. In our paper all statistically significant results were reported in detail and other outcomes that were not significant were only reported briefly as is the norm. These non-significant outcomes were more than adequately addressed in the subsequent correspondence. There is therefore no basis for the claim that this study shows a high risk of bias. Indeed, in the initial letter from Bayer and Reinhart, their own bias is clearly illustrated in their attempts to draw inferences from non-significant data.

In our view, the FIRST study meets all of the criteria for assessment as a low risk of bias study and we dispute the concession made by He et al. [4] regarding the risk of bias of this study. Our view is that the original analysis in the published paper reflects the correct scientific position and that the modified Jadad score of 6 allocated to this study is appropriate.

Abbreviations

FIRST:

Fluids in Resuscitation of Severe Trauma

References

  1. 1.

    Bayer O, Reinhart K. Faulty risk-of-bias assessment in a meta-analysis of hydroxyethyl starch for nonseptic ICU patients. Crit Care. 2015;19:357.

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  2. 2.

    James MF, Michell WL, Joubert IA, Nicol AJ, Navsaria PH, Gillespie RS. Resuscitation with hydroxyethyl starch improves renal function and lactate clearance in penetrating trauma in a randomized controlled study: the FIRST trial (Fluids in Resuscitation of Severe Trauma). Br J Anaesth. 2011;107:693–702.

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  3. 3.

    James MFM, Michell WL, Joubert IA, Nicol AJ, Navsaria PH, Gillespie RS. Reply from the authors. Br J Anaesth. 2012;108:160–1.

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  4. 4.

    He B, Xu B, Xu X, Li L, Ren R, Chen Z, et al. Hydroxyethyl starch versus other fluids for non-septic patients in the intensive care unit: a meta-analysis of randomized controlled trials. Crit Care. 2015;19:92.

    Article  Google Scholar 

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Correspondence to Michael James.

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Competing interests

No funding or other support was provided for this letter. None of the authors have current conflicts of interest other than those disclosed previously in the original publication of the FIRST trial.

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All authors contributed to the content and have read and approved the final manuscript.

See related letter by Bayer and Reinhart, http://www.ccforum.com/content/19/1/357

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James, M., Joubert, I., Michell, W.L. et al. Faulty risk-of-bias assessment in a meta-analysis of hydroxyethyl starch for non-septic ICU patients: a rebuttal. Crit Care 19, 444 (2015). https://doi.org/10.1186/s13054-015-1168-2

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  • DOI: https://doi.org/10.1186/s13054-015-1168-2

Keywords

  • High Risk
  • Starch
  • Emergency Medicine
  • Hydroxyethyl
  • Outcome Reporting