Is the NIH/CDC going to use the right PEM definition for all their future research? Do patients need to act? Deadline 31 Jan

JemPD said:
Its not that there is an abnormal amount or severity of pain/fatigue after exertion, but that there is abnormal Type of pain/'fatigue'/flu like symptoms/cognitive decline etc.
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In my case it's three things:
1) The muscles are weaker from the beginning compared to pre-illness; they burn nearly istantly and then weaken faster than I knew it from training. No short-time recovery (e.g. as in HIT).
2) More and longer muscle ache after "too much" training, and muscle ache occurrs with very low-level usage, i.e. abnormal severity/amount of pain/fatigue during/after exertion.
3) Another type of pain and exhaustion.
 
Leonard Jason said:
I would like to provide some more information to the larger community about recent work we have done on the DSQ. Over the last 2 years, our group has published several articles on PEM, and we had collected data from 704 patients in an international convenience sample of adult patients self-identifying as having ME or CFS. Our results suggest that post-exertional malaise is composed of two empirically different experiences, one for generalized fatigue and one for muscle-specific fatigue in these findings are in the following publication (you can find this article on ResearhGate under my name): McManimen, S. L., Sunnquist, M. L., & Jason, L. A. (in press). Deconstructing post-exertional malaise: An exploratory factor analysis. Journal of Health Psychology, 1-11. Published online August 25, 2016. doi: 10.1177/1359105316664139

In data that is still not published, we also found that the item that was liked by the highest percentage of patients (89%) was from the Ramsay criteria (Prolonged worsening of symptoms after physical activity; and two Ramsay items were: Muscle fatigability after minor exertion, and muscle weakness after minor exertion). In addition, the second highest rating (88%) was for symptoms worsen with exertion, an item from the ME-ICC. In part, because of these findings, our second version of the DSQ that we have been using over the past year has included the following three PEM items: Muscle fatigue after mild physical activity, worsening of symptoms after mild physical activity, and worsening of symptoms after mild mental activity.

As is evident, our first version of the DSQ was modified in this PEM area and in other areas based on patient input, and we are grateful for constantly trying to improve our instruments based on feedback from the larger patient community. We are now working on projects to validate the PEM score with a number of physiological measures.

Our group has tried to operationalize the criteria that the CDE has proposed for PEM, and we needed 30 questions to measure this construct. The Questionnaire that we developed is at the end of this email. And as is evident, specifying domains of importance is only a first step, and it is critical to designate explicit ways to measure the symptom and then how to score it for whether it meets the criterion being assessed.


Here's the draft definition of PEM that a Common Date Elements group is now working on.

PEM is defined as an abnormal response to minimal amounts of physical or cognitive exertion that is characterized by:

1. Exacerbation of some or all of an individual study participant's ME/CFS symptoms. Symptoms exacerbated can include physical fatigue, cognitive fatigue, problems thinking (e.g. slowed information processing speed, memory, concentration), unrefreshing sleep, muscle pain, joint pain, headaches, weakness/instability, light-headedness, flu-like symptoms, sore throat, nausea, and other symptoms. Study participants can experience new or non-typical symptoms as well as exacerbation of their more typical symptoms.

2. Loss of stamina and/or functional capacity

3. An onset that can be immediate or delayed after the exertional stimulus by hours or days but the exact timing is not well understood.

4. A prolonged, unpredictable recovery period that may last days, weeks, or even months.

5. Severity and duration of symptoms that is often out-of-proportion to the type, intensity, frequency, and/or duration of the exertion. For some study participants, even basic activities of daily living like toileting, bathing, dressing, communicating, and reading can trigger PEM.

Some other precipitants of PEM that have been identified include positional changes and emotional stress. In some instances, the specific precipitant cannot be identified. The threshold for a precipitant to trigger PEM can vary between individuals as well as within the same individual, at different times during their illness.

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Here is what would need to occur to operationalize these criteria, and it is still a bit uncertain what scores would be needed to designate that a person had PEM. Therefore data would need to be collected to answer this important question.

Post Exertional Malaise Questionnaire


1.Do you experience an abnormal response to minimal amounts of physical exertion?

Yes____ No_____


2. Do you experience an abnormal response to minimal amounts of cognitive exertion?

Yes____ No_____


If you experience this abnormal response to physical or cognitive exertion, which symptoms below are made worse:


3.Physical fatigue: Yes____ No_____


4.Cognitive fatigue: Yes____ No_____


5.Problems thinking (e.g. slowed information processing speed, memory, concentration):

Yes____ No_____


6.Unrefreshing sleep: Yes____ No_____


7.Muscle pain: Yes____ No_____


8.Joint pain: Yes____ No_____


9.Headaches: Yes____ No_____


10.Weakness/instability: Yes____ No_____


11.Light-headedness: Yes____ No_____


12.Flu-like symptoms: Yes____ No_____


13.Sore throats: Yes____ No_____


14.Nausea: Yes____ No_____

15.Loss of stamina and/or functional capacity: Yes____ No_____

16.Other symptoms please specify: ____________________

17.The onset of your abnormal response to physical or cognitive exertion is immediate after the exertion: Yes____ No_____

18.The onset of your abnormal response to physical or cognitive exertion is delayed after the exertion: Yes____ No_____

19. If your onset is delayed, your abnormal response to physical or cognitive exertion is delayed after the exertion by (check one box below):

 1 hour or less

 2-3 Hrs

 4-10 Hrs

 11-13 Hrs

 14-23 Hrs

 More than 24 Hrs (Please specify__________)



20.Your prolonged, unpredictable recovery period from abnormal response to physical or cognitive exertion may last days, weeks, or even months.

Yes____ No_____


21. If yes, your prolonged, unpredictable recovery period that may last (check one box below):

 Within 24 hours

 Over 1 week

 Over 1 month

 Over 2-6 months

 Over 7-12 months

 Over 1-2 years

22.The severity and duration of your abnormal response to physical or cognitive exertion symptoms is often out-of-proportion to the type of the exertion. Yes____ No_____


23.The severity and duration of your abnormal response to physical or cognitive exertion symptoms is often out-of-proportion to the intensity of the exertion. Yes____ No_____


24.The severity and duration of your abnormal response to physical or cognitive exertion symptoms is often out-of-proportion to the frequency of the exertion. Yes____ No_____


25.The severity and duration of your abnormal response to physical or cognitive exertion symptoms is often out-of-proportion to the duration of the exertion. Yes____ No_____


26. Do basic activities of daily living like toileting, bathing, dressing, communicating, and reading trigger your abnormal response to physical or cognitive exertion? Yes____ No_____


27. Precipitants of your abnormal response to physical or cognitive exertion include positional changes (e.g., your body position is shifted from the standing to lying down). Yes____ No_____


28. Precipitants of your abnormal response to physical or cognitive exertion include emotional stress. Yes____ No_____


29.In some instances, the specific precipitant of your abnormal response to physical or cognitive exertion cannot be identified. Yes____ No_____


30. The threshold for a precipitant to trigger your abnormal response to physical or cognitive exertion varies as it occurs at different times during your illness. Yes____ No_____
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Thank you for this. I recognise the experience much better in these questions.

A couple of possible tweaks:

I know that questionnaire methods all tend to use this sort of repeat the sentence with just one word changed format.
I find it very hard to read on bad days. Perhaps if you can’t simplify the question you could bold the word that changes?
Eg 23.The severity and duration of your abnormal response to physical or cognitive exertion symptoms is often out-of-proportion to the intensity of the exertion. Yes____ No_____
Etc.

When I first discovered PEM and got it more under control I had a very distinct delay of 24hrs.
Before I figured out the pattern, and when I am not managing myself as well, I can experience some symptoms (usually relatively subtle but I take them much more seriously because of what I have learned that they mean for further exacerbation) almost immediately (during a long exertion or just after).
I might therefore be tempted to say yes to immediate symptoms as well as delayed.
I think this might be confusing to the data as my most significantly abnormal response is delayed. The other, more immediate response, is milder and only important to my learned management of it.
If you have space for it, perhaps some indication of severity (degree of abnormality) might help here.

The first symptoms listed have this problem for me too.
I can say yes to a lot of things but some yeses are a shout of recognition and the others are a cautious agreement.
Maybe a “yes definitely” and a “yes, a little”? Not to distinguish between patients nor absolute severity but to distinguish between answers from the same person.
Or else some indication that you want only the most definite symptoms, the symptoms that are more than just a little.

I could be wrong about that as I also know that a new symptom seems more significant to me than an old one despite severity. A patient will tend to measure against their own normal.

Again, this looks much more useful to me. Thank you.

NB I haven’t finished reading the responses so apologies for double-ups. Will try to edit down when I have read more. Others may manage to be more succinct.
 
Inara said:
In my case it's three things:
1) The muscles are weaker from the beginning compared to pre-illness; they burn nearly istantly and then weaken faster than I knew it from training. No short-time recovery (e.g. as in HIT).
2) More and longer muscle ache after "too much" training, and muscle ache occurrs with very low-level usage, i.e. abnormal severity/amount of pain/fatigue during/after exertion.
3) Another type of pain and exhaustion.
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Yes sorry @Inara i realise i should have said "not that there is merely/only an abnormal amount or severity of pain/fatigue.... etc"

will edit that.
 
Thank you, @Leonard Jason , for including your team's latest efforts to define PEM. I have four comments:

1. I'm not sure if, on a bad day, I could understand and answer such a lengthy questionnaire, so the circumstances under which the questionnaire would be used are key;

2. This iteration is a big improvement over the one provisionally chosen by the PEM subgroup;

3. Shouldn't it be stated that the questionnaire is looking for a negative abnormal response? and

4. There needs to be more attention paid to other kinds of exertions or bodily insults that can trigger PEM.

I, for example, have had my worst episodes of PEM triggering (from which I never recovered to previous levels) from a bad fall, a near-drowning event, ehrlichiosis, and a 5 minute cardiac and respiratory arrest in 2003 for which I received CPR and broken ribs. This occurred during an angiogram and I almost died.

I'm not sure I've ever been out of PEM since first becoming ill in 1990. At that time, I don't think anyone understood that resting and pacing could be helpful in recovery. So I tried unsuccessfully to carry on a life for many years---always feeling like s**t---and I was still somewhat functional until the angiogram. My ME/CFS was much worse afterwards. Since then I have been mostly housebound.
 
Melanie said:
This is true. But it may no longer be PEM and more the reality of just how far into the disease they now are. Plus, they are not trying to diagnose severity with PEM checklist, only use it as part of the diagnostic tool of this initial research. Once they can diagnose for research, they can look for biomarkers and then with the most severe use that diagnostic test to prove and diagnose they have ME/CFS. What they aim to do with biomarker tests is if a patient is exhibiting unexplained symptoms and don't come up positive with MS or EDS and don't fit criteria for say ALS, they could give a new biomarker for ME/CFS test to rule in or out they have ME/CFS.
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I am severely affected - bedridden 24/7, can mobilise on to my chemical toilet at the end of my bed but no further. However, I am not as severely affected as others who are bedridden - as I experienced for 16 months 13 years go - as I can type a little most days, watch a little tv, have conservations up to 20 minutes with long breaks in between. Therefore, I still experience a form of PEM as if I exceed the small acitivies I can do within my bed such as some talking, typing, reading, my symptoms, pain, sensory sensitivity, energy levels and sleep function will deteriorate further and I develop flu like symptoms/feeling of being poisoned. My pem is also a combination of immediate and delayed.

EDIT : apologies, writing this when too exhausted to do it well. My above comment was intended as a reply to your previous post saying severely affected may not get pem as many experience it as even walking for bathroom can be too much. I accidentally wrote this post under your subsequent comment.

I will say pem if one hugely extends can trigger permanent deterioration as the person commented. After it the disease may have descended further but the exertion, physical, mental or emotional, can be the direct cause of the permanent deterioration. For example, I did a short walk 8 years ago that caused a deterioration that 8 years on I still have not recovered from. Finally, at the lower level of functioning, pem will happen again, and if extend too much, most are careful to not extend too much, further permanent deterioration.
 
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@Leonard Jason has made a comment here around patients looking at PEM

https://www.linkedin.com/pulse/pem-patient-poll-soon-released-leonard-jason/?published=t

Starts with:
I would like to thank the patient community for engaging in a poll to assess parts of the DePaul Symptom Questionnaire (DSQ) that focuses on PEM items. The results of this poll will soon be released, and as I have been thinking about the findings, I have reflected on my 27 years of working in the ME area, and the incredible good fortune that my team has had ideas generated from patients to guide my work. Let me explain.
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Invisible Woman said:
Enviromental factors: heat, sensory stimulation (noise, lots of fast moving visual info such as travelling in a car) are also common triggers. In my own case environmental factors are far more likely to trigger PEM than emotional one, but that may not be true for others.
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i hope this is not redundant, but given these things, and various things like orthostatic intolerance, looming, and poor sleep [produces identical symptoms in my case], are we still going to use the word exertion?

it's possible the many misperceptions could be reinforced by focusing only on exertion. even montoya's "toolkit" focused on exertion.

maybe "overload"? "dysequilibrium"? just brainstorming.
 
Adrian said:
@Leonard Jason has made a comment here around patients looking at PEM
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Leonard Jason said:
I think that if the patients were to develop a PEM instrument that does justice to this critical symptom, the instrument would be at least as long as our current DSQ, which is about 100 items. That would no longer be a screen, but rather an instrument. I have mentioned that if the patients were to collectively work on such a scale, that would be a unique event in the history of our illness, and I welcome them trying to do this. Patients have the lived experience to know what PEM is and to know what items need to be placed on such a measure. If they were to develop such an instrument, and to specify how it would be scored to signify whether a person has PEM, I would be happy to compare how well such an instrument compared to our PEM screening questions in the DSQ.
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That's a good offer. It could be interesting to engage with and contribute to?
 
Indigophoton said:
That's a good offer. It could be interesting to engage with and contribute to?
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Yes, but I thought we'd tried, others much more than I, to come up with a definition as to what constitute different aspects of PEM and failed? I can't even remember most of my own PEM without triggers, let alone come up with a more general definition, broad strokes maybe, but specifics not so much.
 
@Wonko I think he's talking about developing a new questionnaire, or instrument, as he puts it, that would give a way of screening patients specifically for the presence or absence of PEM,
Leonard Jason said:
Patients have requested that a PEM instrument be developed, and our group never had that as our objective. I have now read hundreds of accounts on the internet about what might be needed for such an instrument. I think that the NIH/CDC Common Data Elements on PEM working group (and I was not a member of this group) has tried to specify some of the areas that would be worth assessing, and those are descriptions and they have not developed a scale that has been operationalized.
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So I think he's suggesting that if the patient community want to develop an operational test specifically for PEM, ie a kind of diagnostic instrument in questionnaire form, and give an idea of what score would, in our opinion, confirm the presence of PEM as a symptom, then he'll do the research needed to assess it/(in)validate it against his DSQ measure.
 
Indigophoton said:
@Wonko I think he's talking about developing a new questionnaire, or instrument, as he puts it, that would give a way of screening patients specifically for the presence or absence of PEM,


So I think he's suggesting that if the patient community want to develop an operational test specifically for PEM, ie a kind of diagnostic instrument in questionnaire form, and give an idea of what score would, in our opinion, confirm the presence of PEM as a symptom, then he'll do the research needed to assess it/(in)validate it against his DSQ measure.
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Surely before you can come up with a questionnaire you need to define what you are looking for? Or how would you know what questions to ask and what there relevance was?
 
Wonko said:
Surely before you can come up with a questionnaire you need to define what you are looking for? Or how would you know what questions to ask and what there relevance was?
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Wonko said:
I thought we'd tried, others much more than I, to come up with a definition as to what constitute different aspects of PEM and failed? I can't even remember most of my own PEM without triggers, let alone come up with a more general definition, broad strokes maybe, but specifics not so much.
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I agree that brain fog makes thinking anything tricky, but I guess the point is that we, the patients, live with this symptom, and so we're well placed to say how it should be decided upon, or assessed.
Leonard Jason said:
Patients have the lived experience to know what PEM is and to know what items need to be placed on such a measure.
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It may not be something everyone is able to get involved with, depending on (remaining!) cognitive function, but once a questionnaire was developed, perhaps anyone could have a go at answering it, to help in figuring out how the scoring should be done, and where the threshold for confirmation of PEM should be set.
 
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I think the threads we have on this show it could be done.

In isolation it is very hard to remember all of the symptoms and triggers, but once someone else mentions it you remember. You add your tuppence worth and somebody else qualifies it. Triggering a new memory from yet another pwME...

I think, in the discussions we have had so far we, there is a huge amount of information about PEM. It certainly highlighted how complex it is and a high level of skill is needed tease out all the info. Many, many variables.

I think collaboration is essential with this. We certainly need better than the CFQ!
 
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