“Independent” reanalysis of landmark starch solutions trial was published by original authorsBMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3552 (Published 21 July 2017) Cite this as: BMJ 2017;358:j3552
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The commentary by Doshi raises apposite questions about the analysis of the CHEST data. Doshi points out that the ongoing refusal of the CHEST authors to make their data available for open analysis remains a cause for concern, as the recently presented re-analysis is open to question.
The adverse events analysis (and re-analysis) was performed on a so-called “safety set” of all patients who received HES regardless of randomisation. However, this analysis could only have been performed post hoc. The original statistical plan stipulated that all data would be analysed by intention to treat, but the adverse events data using intention to treat analysis have not been presented (as they ought to have been) prior to the safety set analysis. As far as can be ascertained from available data, the intention to treat analysis of the original data suggested no significant between-group differences for the adverse events.
This raises a further question. In terms of the original protocol, renal replacement therapy (RRT) was not a specified endpoint, but could be regarded as an adverse event. It is surely reasonable to analyse the RRT data using the “safety set” grouping. Such an analysis would show if all patients exposed to starch at any stage were at risk of increased need for RRT.
We echo the call by Doshi and others for the full data set from this study to be available to the scientific community as a whole.
Competing interests: I have received honoraria for fluid-related lectures from various fluid companies including Fresenius-Kabi
In the letter ‘ “Independent” reanalysis of landmark starch solutions trial was published by original authors’ by Peter Doshi, I was quoted as stating that I did not know whether the Duke Clinical Research Institute (DCRI) had the right to publish independently. I would like to clarify. When my response was emailed to Dr Doshi, I was under the impression the article was on the way to publication and I did not feel comfortable assuming anything about a contract without first verifying. My emailed response was to let him know I could not get him an answer at that moment. Since the ability to publish independently is discussed in Dr. Doshi’s letter as a component of the definition of independent review, I would like to have on record that the DCRI does indeed have the right to publish the results that we generated for this reanalysis study.
Competing interests: No competing interests