Post-exertional malaise as an outcome measure in any ME/CFS trials?

[Tom Kindlon]

A researcher has asked me: does anyone know of any ME/CFS trials that have used a measure of post-exertional malaise as an outcome measure apart from the PACE Trial*

*Aside: which published a yes/no measure (they had used a Likert scale but published a yes/no result)

Edited to Add: The researcher wants it for a study already completed. So they are not looking for the perfect measure, they just want to be able to cite one or more existing papers. The Rituximab study I found I'm guessing isn't going to be suitable as it is only part of the measure.

 

[Tom Kindlon]

I found this:

The Fatigue score was calculated every second week as the mean of the four symptoms: Fatigue, Post-exertional malaise, Need for rest, Daily functioning.

Fluge Ø, Risa K, Lunde S, Alme K, Rekeland IG, Sapkota D, et al. (2015) B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment. PLoS ONE 10(7): e0129898. doi:10.1371/journal.pone.0129898

 

[Denise]

I found this:

@Tom Kindlon - In addition to whether or not a study uses PEM as an outcome measure, it would be important to know how PEM was characterized for any study that says it uses PEM as an outcome measure. (Severity, duration, onset, etc....)

 

[Sean]

It's a two part question: Did they use a measure, and if they did then which measure? The single subjective self-report question used in PACE is useless. It has to be an objective physical measure, or at least include one.

 

[Barry]

It's a two part question: Did they use a measure, and if they did then which measure? The single subjective self-report question used in PACE is useless. It has to be an objective physical measure, or at least include one.

Does a proper objective measure for PEM exist yet though? I also suspect that PEM varies a lot between individuals ... delay, severity, duration, symptoms, etc.

 

[Tom Kindlon]

A researcher has asked me: does anyone know of any ME/CFS trials that have used a measure of post-exertional malaise as an outcome measure apart from the PACE Trial*

*Aside: which published a yes/no measure (they had used a Likert scale but published a yes/no result)

The researcher wants it for a study already completed. So they are not looking for the perfect measure, they just want to be able to cite one or more existing papers. The Rituximab study I found I'm guessing isn't going to be suitable as it is only part of the measure.

 

[Sean]

Does a proper objective measure for PEM exist yet though? I also suspect that PEM varies a lot between individuals ... delay, severity, duration, symptoms, etc.

I agree.

 

[Trish]

I'm having trouble understanding what the researcher wants. Do they want a study that:

1. Checks whether subjects have PEM as one of their symptoms by asking before the trial for diagnostic purposes, eg whether they should be included in the trial?

2.Or records episodes of PEM during the trial, either by patient report or, for example by continuous actometer monitoring alongside symptom diaries? (This is surely essential to monitor compliance in activity based trials, as well as monitoring the effects.)


3. Or measures existence and degree of PEM with a challenge such as a before and after the trial doing a 2day CPET, to see whether there has been an objective improvement in both anaerobic threshold and second day recoverability and record how many days the resulting PEM lasts?

I expect there are studies that do the first of these as part of initial screening for the trial. I think all clinical trials of treatments for ME should do both 2 and 3, but I don't think any have done.

Edit to add: I've just re-read the question at the start of the thread. Outcome measure is specified in the request, so my number 1. would have to include asking again at the end of the trial whether they still get PEM at all (ie are cured), or whether their frequency or severity of PEM had changed? Sorry, this probably isn't helpful, I seem to be meandering off in all directions!

 

[Tom Kindlon]

I said they are interested in "trials"; another term is "interventional studies". So studies that measured post-exertional symptoms before and after a treatment of any sort, most likely a questionnaire.

 

[Invisible Woman]

I said they are interested in "trials"; another term is "interventional studies". So studies that measured post-exertional symptoms before and after a treatment of any sort, most likely a questionnaire.

Guessing wildly here but wonder if it's worth checking work by Prof Mark Van Ness and his team. Given that exercise is their speciality and they seem very aware of PEM.

 

[Joh]

On MEPedia is a "notable studies" section on the PEM page: http://me-pedia.org/wiki/Post-exertional_malaise. But I think none of these is an interventional study, that you're looking for @Tom Kindlon?