Andreas Schröder
December 8, 2016 at 7:36 pm
I am surprised by this blog – its timing, its false claims, and its author’s attitude towards me and my work.
In the scientific world, I live in, scientific studies are discussed within the scientific community in the scientific literature, not on random blogs. Why is this critique not put forward as a letter to the Editor? And why comes it now, years after the publication of our trial?
I was not contacted by James Coyne with his critique of our trial, or with questions regarding our clinical work. Most points of critique in his blog are already discussed in the limitations section of the trial report (British Journal of Psychiatry 2012; 200:499-507), so they are not new in any way. Others are relevant issues regarding psychotherapy trials in general, such as lack of blinding. I will not discuss these issues here.
The trial report’s quality has been evaluated by independent researchers in two meta-analyses that used data from the trial (Cochrane Database of Systematic Reviews 2014, Issue 11. Art. No.: CD011142, and Clinical Psychology Review 2017, 51: 142–152). Obviously, these researchers do not share James Coyne’s dismay.
Some of this blog’s claims are clearly wrong, either deliberately, or due to superficial evaluation of my work. As they may discourage patients to seek evidence-based treatment for their functional somatic syndromes, I will comment on these claims once. However, I will not participate in further discussions on this blog.
1. James Coyne claims that we propose bodily distress syndrome as a psychiatric disorder.
This claim is misleading – I have never stated that bodily distress syndrome is a psychiatric disorder. Years ago, I wrote a letter to the editor regarding the problems with psychiatric diagnoses in these patients (Journal of Psychosomatic Research 2010; 68: 95–96). In the classification paper cited in the blog (Journal of Psychosomatic Research 2010; 68: 415-26), we propose – based on empirical data – a simpler classification that may help unifying research efforts in the discipline of functional somatic syndromes across medical specialties. This paper is highly cited and has received considerable attention from other scientists.
2. James Coyne is concerned about our switch of the primary outcome. The switch of the primary outcome measure was based on findings reported in the Journal of Clinical Epidemiology (Journal of Clinical Epidemiology 2012; 65: 30-41) and is fully reported in the methods section of the trial report. The need to change the primary outcome is furthermore discussed in the limitations section. Moreover, we report results for the original primary outcome, the SF-36 PCS (British Journal of Psychiatry 2012; 200, pages 503-504):
“The outcome measures by the more widely used SF-36 PCS were similar; these are provided here for comparison and were not part of the primary analysis. The adjusted difference in mean change from baseline to 16 months on the SF-36 PCS was 6.2 points (95% CI 2.5–9.9, P= 0.001). Participants allocated to STreSS improved by 5.6 points (95% CI 2.5–8.7, P<0.001), whereas participants allocated to usual care remained substantially unchanged (-0.6 points, 95% CI -2.7 to 1.4; P = 0.54).”
The analysis based on the original primary outcome (SF-36 PCS) hence leads to the same conclusion as the “switched” outcome used in the primary trial analysis (the SF-36 aggregate score of the scales physical functioning, bodily pain and vitality).
Why should we have done all the work with the publication of outcome measurement problems and reporting a switch of the primary outcome, if this was a dishonest change of the primary outcome measure?
3. James Coyle claims that 50 % of patients in the control group deteriorated. This is misleading. The distribution of change scores in the enhanced usual care group resembles a normal distribution around zero (Figure 4), which is expected, given the flat line of the mean score in Figure 3A.
4. James Coyle states that we have not followed patients regarding emerging physical disease. This is wrong. We have done one of the few long-term follow up studies in the field (General Hospital Psychiatry 2014; 36: 38–45), which is cited both by an expert clinical review in the Annals of Internal Medicine (Annals of Internal Medicine 2014, 161: 579-586), and by a recent systematic review (Journal of Psychosomatic Research 2016; 88: 60-67).
5. James Coyle accuses us for conflicts of interests regarding our clinic. The Danish Health system is tax financed, and neither the authors of the trial report nor our employees have any financial interests in this work. We try to help patients, based on the best evidence available. I do not know who James Coyle is trying to help with his blog.