REEACT is entirely consistent with CONSORT and the authors exceeded reporting requirements of CONSORT and COMPare
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Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial
REEACT is entirely consistent with CONSORT and the authors exceeded reporting requirements of CONSORT and COMPare
We thank Henry Drysdale and colleagues for their interest in our trial. They correspond on behalf of the COMPare project team who are ‘analysing each trial for outcome switching, by comparing the clinical trials registry (or ideally a trial protocol)’ [1].
There is no inconsistency between our trial report and our pre-specified trial protocol which has been in the public domain for several years [2]. The transparency of our reporting exceeds all CONSORT requirements. We recorded depression severity using the PHQ9 which we analysed as both a dichotomous outcome (as validated against ICD criteria) and as a continuous outcome. The primary trial endpoint was a dichotomous outcome derived from the PHQ9 at four months, and we also reported this outcome at 12 and 24 months. We specify our primary outcome as the PHQ9 on the trial registry, where there is also a link to our full trial protocol (exceeding the level of reporting required by the ISRCTN trial registry, and representing the ‘ideal’ of the COMPare project). For the avoidance of doubt we have reproduced the relevant excerpt from the trial protocol which is presented within the ISRCTN registry [2] and included in appendix 2 of the BMJ report [3]. ‘Primary outcome measure: our primary outcome will be depression severity and symptomatology as measured by a validated self-report measure (the Patient Health Questionnaire-9) at four months. The PHQ9 is a nine-item questionnaire, which records the core symptoms of depression. There are extensive US and non-US validation and sensitivity to change data. It has most recently been validated in a UK primary care population…….The primary outcome, depressed/not depressed (at four months) will be used in a logistic regression model to compare each of the computerised packages with usual care alone.’ In the trial registry and trial protocol we also specified the PHQ9 at 12 and 24 months as secondary outcomes.
Henry Drysdale and colleagues highlight that we omitted to present one of our secondary outcomes (EQD – the ‘EuroQoL’; our chosen measure of quality adjusted life years or ‘QALYs’). The BMJ report presented the full clinical outcomes of the REEACT trial [3] and we were not asked by the editors or peer reviewers to present the results of the full economic evaluation (where QALYs and incremental cost effectiveness ratios are the metric of interest). This is not an omission on our part, but reflects a separation of clinical and economic results which sometimes happens (even in the BMJ). Far from seeking to omit this secondary outcome, we currently have a paper in preparation to report the economic dimension of cCBT. Should the BMJ wish to publish this, we will be happy to oblige.
The only deviation we can see from the ISCRTN entry is the fact that we exceeded our initial trial sample size (691 in the published report versus 600 in the trial registry). We don’t think this is a hanging offence, and we did this to ensure we maintained our level of pre-specified statistical power when follow up was a little lower than we anticipated (such things do happen). We note that trials commonly fail to achieve their pre-specified sample size and Mr Henry Drysdale and colleagues [writing as members of the Centre for Evidence Based Medicine] failed to find anything positive to say about our trial in this [or any other] respect.
We do not know whether the correspondents have extensive experience of HTA funding and publication policies, but all their trials require a full NIHR report where all outcomes will be presented in their entirety, after publication of other papers. Splitting clinical and economic outcomes is also not unusual. Although we applaud their sterling work, they might wish to consider that trial publications should really be considered in their entirety in the COMPare process. The vagaries of publications schedules means that they may need to give authors a little more time before potentially rushing to judgement about 'missing outcomes' that are 'in press' in the publication machine. A full report commissioned by the NIHR Health Technology Assessment programme is now published in the NIHR Library and we commend this report to interested readers. We include the results of the clinical, economic and quantitative evaluations of cCBT derived from the REEACT trial [4]. We wish Mr Drysdale and colleagues well with the COMPare project and thank them for the opportunity to respond to their query.
[3] Gilbody S et al, Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial), BMJ 2015;351:h5627.
[4] Littlewood E, Duarte A, Hewitt C, Knowles S, Palmer S, Walker S, et al. A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial. Health Technology Assessment 2015; Volume 19 (Number 101).
Competing interests:
No competing interests
21 December 2015
Simon Gilbody
Professor of Psychological Medicine
Prof Peter Bower, Dr Liz Littlewood, Dr Sarah Knowles
Mental Health and Addictions Research Group, Department of Health Sciences
Rapid Response:
REEACT is entirely consistent with CONSORT and the authors exceeded reporting requirements of CONSORT and COMPare
We thank Henry Drysdale and colleagues for their interest in our trial. They correspond on behalf of the COMPare project team who are ‘analysing each trial for outcome switching, by comparing the clinical trials registry (or ideally a trial protocol)’ [1].
There is no inconsistency between our trial report and our pre-specified trial protocol which has been in the public domain for several years [2]. The transparency of our reporting exceeds all CONSORT requirements. We recorded depression severity using the PHQ9 which we analysed as both a dichotomous outcome (as validated against ICD criteria) and as a continuous outcome. The primary trial endpoint was a dichotomous outcome derived from the PHQ9 at four months, and we also reported this outcome at 12 and 24 months. We specify our primary outcome as the PHQ9 on the trial registry, where there is also a link to our full trial protocol (exceeding the level of reporting required by the ISRCTN trial registry, and representing the ‘ideal’ of the COMPare project). For the avoidance of doubt we have reproduced the relevant excerpt from the trial protocol which is presented within the ISRCTN registry [2] and included in appendix 2 of the BMJ report [3]. ‘Primary outcome measure: our primary outcome will be depression severity and symptomatology as measured by a validated self-report measure (the Patient Health Questionnaire-9) at four months. The PHQ9 is a nine-item questionnaire, which records the core symptoms of depression. There are extensive US and non-US validation and sensitivity to change data. It has most recently been validated in a UK primary care population…….The primary outcome, depressed/not depressed (at four months) will be used in a logistic regression model to compare each of the computerised packages with usual care alone.’ In the trial registry and trial protocol we also specified the PHQ9 at 12 and 24 months as secondary outcomes.
Henry Drysdale and colleagues highlight that we omitted to present one of our secondary outcomes (EQD – the ‘EuroQoL’; our chosen measure of quality adjusted life years or ‘QALYs’). The BMJ report presented the full clinical outcomes of the REEACT trial [3] and we were not asked by the editors or peer reviewers to present the results of the full economic evaluation (where QALYs and incremental cost effectiveness ratios are the metric of interest). This is not an omission on our part, but reflects a separation of clinical and economic results which sometimes happens (even in the BMJ). Far from seeking to omit this secondary outcome, we currently have a paper in preparation to report the economic dimension of cCBT. Should the BMJ wish to publish this, we will be happy to oblige.
The only deviation we can see from the ISCRTN entry is the fact that we exceeded our initial trial sample size (691 in the published report versus 600 in the trial registry). We don’t think this is a hanging offence, and we did this to ensure we maintained our level of pre-specified statistical power when follow up was a little lower than we anticipated (such things do happen). We note that trials commonly fail to achieve their pre-specified sample size and Mr Henry Drysdale and colleagues [writing as members of the Centre for Evidence Based Medicine] failed to find anything positive to say about our trial in this [or any other] respect.
We do not know whether the correspondents have extensive experience of HTA funding and publication policies, but all their trials require a full NIHR report where all outcomes will be presented in their entirety, after publication of other papers. Splitting clinical and economic outcomes is also not unusual. Although we applaud their sterling work, they might wish to consider that trial publications should really be considered in their entirety in the COMPare process. The vagaries of publications schedules means that they may need to give authors a little more time before potentially rushing to judgement about 'missing outcomes' that are 'in press' in the publication machine. A full report commissioned by the NIHR Health Technology Assessment programme is now published in the NIHR Library and we commend this report to interested readers. We include the results of the clinical, economic and quantitative evaluations of cCBT derived from the REEACT trial [4]. We wish Mr Drysdale and colleagues well with the COMPare project and thank them for the opportunity to respond to their query.
[1] COMPare project website www.COMPare-Trials.org
[2] Full REEACT trial protocol at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51438/PRO-06-43-0...
[3] Gilbody S et al, Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial), BMJ 2015;351:h5627.
[4] Littlewood E, Duarte A, Hewitt C, Knowles S, Palmer S, Walker S, et al. A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial. Health Technology Assessment 2015; Volume 19 (Number 101).
Competing interests: No competing interests