Discrepancies between pre-specified and reported outcomes in Gilbody et al
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Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial
Discrepancies between pre-specified and reported outcomes in Gilbody et al
Dear Editor,
Your recent publication Gilbody et al [1] reports outcomes that are different to those initially registered [2].
There was one pre-specified primary outcome, which was incompletely reported in the paper. The PHQ-9 score was reported as a dichotomous outcome that was not pre-specified, and the ICD-10 depression score was not reported in the paper. There were 4 pre-specified secondary outcomes, of which 3 were reported; while one (EQ-5D) is not reported anywhere in the publication. The paper also reports three new secondary outcomes, PHQ-9 > 10 at three separate timepoints. These were not pre-specified, and not declared as such.
The BMJ has endorsed the CONSORT guidelines on best practice in trial reporting [3]. In order to reduce the risk of selective outcome reporting, CONSORT includes a commitment that all pre-specified primary and secondary outcomes should be reported; and that, where new outcomes are reported, it should be made clear that these were added at a later date, with an explanation of when and for what reason.
This letter has been sent as part of the COMPare project [4]. We aim to review all trials published from now in a sample of top journals, including the BMJ. Where outcomes have been incorrectly reported we are writing letters to correct the record, and to audit the extent of this problem, in the hope that this will reduce its prevalence. We are maintaining a website at COMPare-Trials.org where we are posting a summary of the results for each trial that we analyse. We hope that the BMJ will publish this response, to ensure that those using the results of this trial to inform clinical decision-making are aware of the discrepancies.
Yours faithfully,
Henry Drysdale, Eirion Slade and Kamal Mahtani on behalf of the COMPare project team.
[1] Gilbody S et al, Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial), BMJ 2015;351:h5627.
Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, New Radcliffe House, 2nd floor Radcliffe Observatory Quarter, Woodstock Road , Oxford OX2 6GG
Rapid Response:
Discrepancies between pre-specified and reported outcomes in Gilbody et al
Dear Editor,
Your recent publication Gilbody et al [1] reports outcomes that are different to those initially registered [2].
There was one pre-specified primary outcome, which was incompletely reported in the paper. The PHQ-9 score was reported as a dichotomous outcome that was not pre-specified, and the ICD-10 depression score was not reported in the paper. There were 4 pre-specified secondary outcomes, of which 3 were reported; while one (EQ-5D) is not reported anywhere in the publication. The paper also reports three new secondary outcomes, PHQ-9 > 10 at three separate timepoints. These were not pre-specified, and not declared as such.
The BMJ has endorsed the CONSORT guidelines on best practice in trial reporting [3]. In order to reduce the risk of selective outcome reporting, CONSORT includes a commitment that all pre-specified primary and secondary outcomes should be reported; and that, where new outcomes are reported, it should be made clear that these were added at a later date, with an explanation of when and for what reason.
This letter has been sent as part of the COMPare project [4]. We aim to review all trials published from now in a sample of top journals, including the BMJ. Where outcomes have been incorrectly reported we are writing letters to correct the record, and to audit the extent of this problem, in the hope that this will reduce its prevalence. We are maintaining a website at COMPare-Trials.org where we are posting a summary of the results for each trial that we analyse. We hope that the BMJ will publish this response, to ensure that those using the results of this trial to inform clinical decision-making are aware of the discrepancies.
Yours faithfully,
Henry Drysdale, Eirion Slade and Kamal Mahtani on behalf of the COMPare project team.
[1] Gilbody S et al, Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial), BMJ 2015;351:h5627.
[2] Trial registry entry: http://www.isrctn.com/ISRCTN91947481?q=91947481&filters=&sort=&offset=1&...
[3] Moher D et al, CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ 2010; 340:c869.
[4] COMPare project website www.COMPare-Trials.org
Competing interests: No competing interests