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Table 4 Researchers’ correction of errors

From: COMPare: Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials

Theme Trialists’ response Issue
Acknowledgement of error by trialists
Clear acknowledgement of CONSORT breach and then a clarification “One prespecified secondary outcome from the protocol (assisted vaginal delivery) was omitted from the analysis plan in error, and, therefore, not reported” (and further corrections for same trial) (Trial 46, Lancet, 14/04/16). We regard a clear correction as best practice. In our cohort of 58 submitted letters, it was uncommon.
“We did not report the results of the Steatotest as we had incomplete data for this because of sample haemolysis… For the purpose of transparency, we include the median values at baseline…” “We presented data on three parameters that had not been predefined as secondary endpoints…” (Trial 56, Lancet, 11/06/16). Note that these trialists also introduced a spurious distinction regarding unreported outcomes (“none of these are key secondary endpoints”).
“We accept that our reporting of the change in the primary depression outcome in the BMJ paper could have been better ... we accept that, by rule, we have failed to be entirely transparent and we meet their criteria for such a rating” (Trial 47, BMJ, 14/01/16).  
Correcting the wrong error “We have reviewed these discrepancies and concede that we failed to fully update the trial registry” (Trial 8, Lancet, 13/02/16). The error was not failure to update the registry entry but rather failure to report pre-specified outcomes or document discrepancies.
  1. References throughout are to the correspondence archive at http://COMPare-trials.org/data containing the full public correspondence on all trials, and all correspondence with editors, organised by trial ID and date, or journal name for general correspondence. Abbreviations: BMJ British Medical Journal, CONSORT Consolidated Standards of Reporting Trials