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I thought they switched the CFQ marking scheme to one that was defined in the protocol as a secondary outcome.

He seems to be looking for the easy popular targets along with bashing business (big phama although I'm not sure what views he would have one small phama). He ignores the fact that it is universities and academics that now have the worst record of publishing outcomes.

I often think when people credit different things with helping them that they start to get a bit better and that then starts them looking for things that may help. Then if they continue to get better they credit the things that they found that helped.

Would they equally have agreed with this version "An experiment with subjective outcome measures not blinded to test versus control is unreliable and therefore unsatisfactory unless the experiment involves ME"

I think timing can be quite random. I can only think of one rapid response what was not published which was when Alem Matthees wrote to correct a claim that Nigel Hawkes made in a story on the information tribunal - that he had tried to contact Alem. He did put it up on pubmed commons but that...

I always thought is was between Wessely and Chadler at Kings and White at QMUL but I assumed that there needed to be a political compromise to say each of the favoured methods were equally effective.

I believe that the version I had was obtained by a FoI. I think I got it form @Tom Kindlon but not sure. The published version came later and is a summary and not the full protocol. They say "This paper should not be used as the protocol for executing the study, and is not the complete...

The step test and the Borg scale were also missing from the stats plan. My belief is they justified the post hoc recovery criteria without approval because they dropped the formal recovery secondary outcomes from the stats plan (but I don't think there was a new protocol). So yes. I also think...

Or was he given a selected set of things. We have not seen the minutes of the meeting when the stats plan was accepted and so don't know what evidence was provided to them in terms of justifying changes or whether anything was said. I remember getting the impression when reading the minutes to...

I've put a searchable version of the full PACE protocol here https://www.s4me.info/docs/PACEProtocolSearchable.pdf

I'm wondering if it would be worth someone pulling together a detailed explanation for Norman Lamb to explain the issues that are being glossed over by the HRA response and their attitude that if there is paper work filed then that is ok.

My point was not one about harm but that the protocol wasn't good enough to give any solid results because the relied too heavily on subjective measures. If the results from an experiment aren't able to judge the hypothesis then there is no point in doing the experiment. In this case where human...

To me they failed with PACE because the weak protocol means there could be few benefits of taking part in the research and hence it wasn't worth the potential risk to patients. The RECs need to take a view on whether a proposal will produce sound scientific evidence otherwise they allow patients...

I think they filed the right forms but were they accurate. I've posted this comment on Brian's blog One thing I've wondered about is whether the paperwork filed with the ethics committees was accurate and therefore whether the decisions made by the ethics committees can be accurate. For...

I suspect so I know with other government funded research they like to have dissemination plans to communicate the main ideas with a variety of different stakeholders through many sources.

I got the feeling that the HRA are covering themselves because the ethics committees approved stuff like the patient leaflet they then seem to go on to say that issue needs more examination. To me this statement makes it look like something dodgy went on but they could interpret the current...

From the amendment list Not quite sure what this means but I wonder if it is the trick of using pilot patients in a full trial?

So they basically reflect back to their only defense PACE is ok because Cochrane say its ok.

Since PACE hasn't published all the secondary outcomes as defined in the protocol (although patients published the recovery one) the HRA don't have high expectations over transparency.

Hads isn't reliable for this the questions some questions don't distinguish between fatigue and depression