Clinical and cost-effectiveness of the Lightning Process ... for paediatric chronic fatigue syndrome, 2018, Crawley et al (Smile Trial)

And certainly she needed to be honest about having swapped outcome measures rather than pretending it was 100% prospective with no outcome changes.

 

Does anyone know what the diagnostic criteria for ME/CFS that where used for participants in the study?

I can't find them in the article itself, the pre-registration information or on this forum.

I think I read somewhere that participants where requited from an ME/CFS clinic. Was the clinics criteria used? What criteria where usually used in UK at that time? Oxford?

I've read Tuller's critique of the study. But he doesn't bring up diagnostic criteria, even if that should be an obvious aspect to criticize if Oxford where used.

 

Hi, and welcome to the forum!
I believe they used the NICE 2007 guidelines. I don’t know what that means in practice.

 

Look at that! It seems like the NICE 2007 diagnostic criteria were reasonable and included PEM:

NICE 2007:

 

On the other hand it is close enough to requiring PEM to argue that the 2021 review was not selecting on the basis of some 'new disease concept'. Not only had the IOM provided a precedent but the 2007 NICE definition had at least considered a delayed and prolonged worsening of symptoms 'characteristic'.

 

Hm. To me it seems from the text like PEM/PEF was mandatory: "fatigue with ALL of the following features:"

(I edited to fix formatting in that part of the text.)

 

It says ‘and/or’ fatigue. Meaning both or just one of them. So just PEF would be fine.

 

But it stipulates for either that it has to be 'typically delayed' and lasting several days.
I think it might be hard to get a history of 'malaise' out of most people with ME/CFS. We have had lengthy discussion about the drawbacks of both malaise and fatigue. It boils down to them being terms of art and the feature that is specific to ME/CFS is surely the long time frame.

It isn't perfect but I agree with Liie that it gives a clear impression of requiring something that encapsulates the PEM concept. (And that was used by NICE to argue that the 2021 definition was not defining a 'new disease'.)

 

Fair points!