A few preliminary thoughts and questions come to mind in response to the latest update on the proposed MEGA Trial.
- Question: How are patient advisory groups to be recruited?
- The update says:
How much data we collect will depend on what our patient advisory group says will be acceptable to consenting patients and how much funding we get.
I’m concerned that this will be used as an excuse not to develop the very important Canadian Criteria cohort – Profs White and Crawley have already decided that the Canadian Criteria are not practicable
- Clinicians who diagnose at the NHS clinics can often be OTs, nurses etc. Some of these may be very good but some have very little experience of ME/CFS. It seems inevitable that they will be focussing on what they believe to be the key symptoms of ME/CFS and not necessarily taking a full and complete history.
- We know from experience that NHS notes in general can be inaccurate as often as not.
- What about the severely affected who can’t get to clinics? Some clinics provide a limited home visiting service or skype/telephone consultations but the vast majority of the severely affected do not receive these services and so will be excluded from the trial. As Prof Ron Davis says, the severely affected provide the most important data.
- There is circumstantial evidence that many patients are rediagnosed by some of the clinics as having ‘pervasive refusal syndrome’ or ‘illness anxiety’ or some other ‘psychogenic’ condition if they don’t make progress with GET or GAT or if the clinic doesn’t think they will make progress. These patients may be at the more severely affected end of moderate so their elimination will skew the cohort.
- Similarly, we know that many patients who drop out of therapy are not followed up on. It seems likely that these will not be included in the project, so once again the cohort will be skewed.
- The update says:
We don’t think we will have the money to do this for everybody or for everything.
This is already sounding a bit half-baked. We’ve had enough such research. Isn’t it better to set out to do less and do it properly?
- The clinics in general subscribe to the biopsychosoial model of the illness. Given what has happened with the now largely discredited PACE Trial, it is understandable that informed patients will be mistrustful of a study which has the NHS Clinics at its heart. In its presently proposed form and on first reading, this project seems to me to be unlikely to obtain the support of the whole ME/CFS community. This is unfortunate and I hope that another way of proceeding can be found.