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Actions taken: The CRG Editor contacted the Editor of the journal that had published the study with a neutrally worded email detailing their specific concerns about the data in the control arm, including a description of the exact method they had used to determine that they had concerns about the data. The study was placed in the “Awaiting Classification” section of the review.
Example 3
While conducting a Cochrane Review the review authors noticed a study that was eligible for inclusion that had a very unlikely distribution of patients between the intervention and control groups. The review authors contacted the study authors for further information and they responded that “There was a simple randomization by tossing coin”. The review authors still had concerns after this explanation because the chance of the distribution of the intervention and control groups occurring was 0.000000000000033%. They therefore contacted the Editor of the journal that had published the study. The journal investigated and concluded that the article did not need to be retracted, but that the term “randomization” should be substituted in the article with "single-centre, prospective and observational study" as this reflected the methodological approach of the study. This review authors still had concerns about the study following this and therefore discussed it with the Research Integrity Editors. The study was excluded from the review as in this case the review included only RCTs and the reason for not including the study was stated neutrally in the review.
7.4 Template text for Editorial Notes on a Cochrane Review
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