I agree with that point Dolphin; I think one of the things to do here is to emphasise the distinction between subjective, questionnaire-based measures (which appear to show small improvements on average) and objective measures (some of which have been conspicuously removed from the protocol, the rest of which show no improvement). The authors themselves state that the objective measures of benefits and work levels showed no improvement, and they still haven't released the raw data but make vague and misleading comments about their interpretation of it. I think those are key points to highlight and it's important to react swiftly to any press coverage and get this analysis to any press contacts.
I just wrote up this reaction; a bit rough and ready and needs some references adding and some details checking and tidying, but I'm too busy right now to do that - if it's of use to anyone please feel free to modify and use it as you wish...
Although the PACE authors assert the effectiveness and cost-effectiveness of their own treatments in this paper, the PACE results on which their publications are based reveal only interpretations of unreleased data concerning subjective measures of improvement, not raw data nor data based on objective measures. As the authors acknowledge in the Limitations section of their latest paper:
"we used the EQ-5D to generate QALY values. This is a recommended method in England, but the sensitivity of the measure in relation to changes in clinical measures in the CFS area has not yet been established."
The EQ-5D is simply a measure based on asking patients (who in the case of CBT have received a year of coaching on taking a positive attitude) how well they are doing - it is designed for self-completion by respondents and takes only a few minutes to complete. Freedom of Information requests have not succeeded in obtaining details of the meetings at which it was decided to drop the use of the most useful objective measure - actometers to measure the actual activity of the patients - from the study protocols, and Freedom of Information requests seeking access to the raw data for the other objective measures like benefit take-up and lost work time have been similarly rebuffed.
Parliamentary answers have clarified that the reason for the refusal of the requests for public access to the raw data - still unavailable a year after the original publication despite the MRC's policy on Data Access - was the forthcoming publication by the authors of further findings. So the following vague hints in this latest paper as to the nature of this data (which was publicly-funded but is still privately-held) are of particular interest:
"Receipt of benefits due to illness or disability increased slightly from baseline to follow-up...the figures at follow-up were similar between groups."
"...with the exception of a difference between CBT and APT, there were no significant differences in either lost work time or benefits between the treatments during follow up. In fact, benefits increased across all four treatments."
In the absence of the raw data, one might dwell on puzzles such as how there can be "a difference" (of unspecified nature) between CBT and APT on these measures, and yet "no significant differences" between the other treatments. No "significant" difference between APT and GET, no "significant" difference between GET and CBT, but "a difference" between APT and CBT? One must presume that the sum of 2 or 3 "insignificant" differences can represent "a difference", but some actual numbers would be more helpful. Statements like these explain why so many patients are keen to see the actual data on which the authors' commentary is based.
But perhaps it would be more useful to focus on the notable findings buried away in the above quotes, which the authors choose not to emphasise in their conclusions: that with all the treatment approaches, including CBT and GET, receipt of benefits increased slightly during the trial, and no significant differences were found in either lost work time or benefits for any of the treatments. So all of the treatments were unsuccessful both in terms of returning patients to work and in terms of reducing their levels of benefits - despite the CBT patients' slightly more positive answers on questionnaires.
From what little we can determine of the still-unreleased objective measures used in the PACE trial, all we can be sure of is that this data shows no improvement in any objective measures from any of the treatments employed. Patients will continue to seek access to the study data, and their scepticism will continue regarding the real-world value of small increases in the positivity of CBT-trained patients when they complete subjective questionnaires.
