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

[dave30th]

The complexity of describing education participation probably does make it unsuitable as an outcome, as Crawley et al found out. As others have said, the correct response to that awareness should have been the use of another, better objective outcome such as some form of automated activity monitoring, rather than making the primary outcome a subjective survey.

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

 

[Liie]

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.

 

[Utsikt]

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.

 

[Liie]

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:

Healthcare professionals should consider the possibility of CFS/ME if a person
has:

fatigue with all of the following features:

* new or had a specific onset (that is, it is not lifelong)
* persistent and/or recurrent
* unexplained by other conditions
* has resulted in a substantial reduction in activity level
* characterised by post-exertional malaise and/or fatigue (typically delayed, for
example by at least 24 hours, with slow recovery over several days)

and

one or more of the following symptoms:

* difficulty with sleeping, such as insomnia, hypersomnia, unrefreshing sleep, a
* disturbed sleep–wake cycle
* muscle and/or joint pain that is multi-site and without evidence of inflammation
* headaches
* painful lymph nodes without pathological enlargement
* sore throat
* cognitive dysfunction, such as difficulty thinking, inability to concentrate,
* impairment of short-term memory, and difficulties with word-finding, planning/
* organising thoughts and information processing
* physical or mental exertion makes symptoms worse
* general malaise or 'flu-like' symptoms
* dizziness and/or nausea
* palpitations in the absence of identified cardiac pathology.

 

[Hutan]

It is close to requiring PEM, but not quite

characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)

Post-exertional fatigue is an option, and, given it does not need to be delayed, it is a pretty loose requirement.

That said, differentiating between chronic fatigue and ME/CFS often isn't the biggest problem of these sorts of studies. People can get excited about reported diagnostic criteria when criticising an ME/CFS study, but I think it is usually a second order problem. First order problems are often:

• is the study design so bad that it doesn't produce reliable evidence of benefit for the participants?
• is the reported benefit so small that it isn't important (especially when combined with poor study design)?

The reported use of a good ME/CFS criteria is not a guarantee that everyone in the study had ME/CFS. The reported use of a criteria that is closer to describing chronic fatigue is strongly associated with poor trial design.

 

[Trish]

A big flaw in the 2007 diagnosis is giving PEF as an alternative to PEM.

 

[Jonathan Edwards]

It is close to requiring PEM, but not quite

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'.

 

[Liie]

It is close to requiring PEM, but not quite. Post-exertional fatigue is an option, and, given it does not need to be delayed, it is a pretty loose requirement.

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.)

 

[Hutan]

Yes, the option was PEM or PEF.

 

[Utsikt]

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.

characterised by post-exertional malaise and/or fatigue

 

[Jonathan Edwards]

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'.)

 

[Utsikt]

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!