UK:ME Association funds research for a new clinical assessment toolkit in NHS ME/CFS specialist services, 2023

I agree there is a big problem here.

I think I recall that the first version of this questionnaire did not include PEM at all, with the second questionnaire called PASS being intended to collect detailed information about the pwME's PEM experiences over the last month, but instead it conflated PEM and fatiguability into a single confused and lengthy set of ambiguous questions about 'symptoms after exertion'.

We spelled out this problem in our letter to the MEA:
https://www.s4me.info/threads/open-...g-proms-led-by-sarah-tyson.37937/#post-524406

I wonder whether, following our and other feedback, they have junked PASS and decided instead to include a single PEM question in this TIMES questionnaire.

I think in my feedback I may have suggested that they define PEM and ask whether the pwME experiences it, so I guess that's what they are trying to do here.

The NICE guideline defines PEM as:

I agree, the emphasis in the definition in the questionnaire is wrong, with reference to trivial and immediate, and may last hours, which to me seems to deliberately include fatiguability. Why not use the NICE definition? It's not perfect, because to my mind it should emphasise not just worsening symptoms, but significant reduction in ability to function, but it's better than Tyson's version, and she is supposed to be creating NICE compliant materials.

I agree asking how often this definition of PEM happened in the last month is nonsensical. Do I answer 'all the time' because I feel worse after every activity, or do I only count crashes, and their duration or severity is ignored.

 

I agree. It's unsuitable because of length and wordiness for anyone with severe ME/CFS. I got around it by not reading all the detail, and just taking a quick stab at choosing an option for each question without taking time to think about it, simply because I wanted to be able to copy and paste it here for discussion. Also although my ME is physically severe, my cognitive function is less affected than most pwME describe. Anyone with cognitive problems would give up after the first page.

I also agree with all the concerns about it being completely useless for the model of care we are supposed to be getting according to NICE, with doctor led medical care, not therapist led 'rehabilitation' style clinics.

I am even more worried about the intentions for the guidance 'toolkit' Tyson and Gladwell are planning to go with this set of PROMS, now that we've seen what Gladwell says about finding baselines then increasing activity, ie pacing-up, and his nonsensical stuff about assessing each activity in isolation instead of cumulative activity. His whole approach is wrong, and is not NICE compliant.
See this thread:
Open letter to Action for ME with concerns about their promotion of a problematic Care and Support Plan Template
AfME have recognised this, and withdrawn his awful 'care and support plan' document, yet the MEA are supporting this project still. I don't get it.

 

MEA article:

Research: Retesting the Post Activity Symptom Scale (PASS)
October 3, 2024


We are asking adults in the UK who have been diagnosed with myalgic encephalomyelitis (ME), which is also known as chronic fatigue syndrome (CFS) to complete this online questionnaire. People whose ME/CFS was triggered by a covid infection (i.e. long covid) are also invited to take part.

This is the final stage of the research to develop an assessment of post-exertional malaise, or the worsening of symptoms that people experience when they overdo it or exceed their ‘energy envelope’.

People with ME/CFS have generously completed the initial survey to test out this assessment, and we have used the feedback and data to make revisions. We now need to test out the revised version to double check it produces robust data.

Many thanks to the people who signed up for the survey to test out revised version of the ME symptoms questionnaire.

We have had an amazing response and have now closed the survey to new participants, as we have reached the numbers needed, but we will leave the survey open a while longer so people can complete their submissions.

Professor Sarah Tyson
Here's the link which is still available for those who need to finish an original saved entry:

Complete saved entry for survey
In the meantime, we have a new survey which we'd like to invite people to take part in. This one is to test out the revised version of the Post Activity Symptom Scale (PASS) which assesses post-exertional malaise.

Those of you who took part in the first PASS survey will see that it is now much shorter and simpler.
Here is the link to the new survey:

Enter new PASS survey
If you have any questions, please do not hesitate to contact Prof Tyson on Sarah.tyson@manchester.ac.uk

 

Page 1 of revised PASS

Spoiler: PASS version 2 page 1 - Blurb and consent

Developing a clinical assessment toolkit for people with ME/CFS and clinical services.
Retesting The Post Activity Symptom Scale (PASS)

We are asking adults in the UK who have been diagnosed with myalgic encephalomyelitis (ME), which is also known as chronic fatigue syndrome (CFS) to complete this online questionnaire. People whose ME/CFS was triggered by a covid infection (i.e. long covid) are also invited to take part.

This is the final stage of the research to develop an assessment of post exertional malaise, or the worsening of symptoms that people experience when they overdo it or exceed their ‘energy envelope’. People with ME/CFS have generously completed the initial survey to test out this assessment, and we have used the feedback and data to make revisions. We now need to test out the revised version to double check it produces robust data. So, we are asking you to complete this online survey.

The assessment is now much shorter and simpler. If you would like more information about the toolkit project and some frequently asked questions (FAQs) please click here, and the participant information sheet is found here. If you would like to progress to the survey, please tick the consent questions at the bottom of this page. For further details about the questionnaire please continue reading.

There are 24 questions in total. We appreciate this quite a lot, but we want to be comprehensive. We realise people’s post-exertional malaise (or worsening of symptoms when you overdo it) vary so the idea of the questionnaire is to take a snapshot of how you are ‘at present’ (ie on an average day over the last month) rather than trying to record the whole history. This can help you and other people understand what you are able to do, how you adapt, and start discussions about how to manage your activity levels.

The assessment starts with some questions about you, then the PASS which asks about different aspects of your post exertional malaise. Finally, there is opportunity to tell us anything else about your ME/CFS or the questionnaire.

There is a ‘% Completed’ marker at the top of each page so you can keep track of how far you have got.

It takes about 10-15 minutes to complete in one go. but you can take as long as you want to complete it. Your answers will be saved automatically so you can take breaks and come back to same place when you return. However, there is no ‘save’ button or confirmation of the save as it is contained in the inner workings of the survey tool. Please trust us, you’re your work has been saved. You can take as many breaks as you wish. If you need help from another person, or another person to complete the survey on your behalf, that is fine.

There is a ‘back’ button so you can go backwards and check your answers if you wish. Usually, the button is at the bottom of the screen, but sometimes it appears at the top. If the back button does not show, it may appear if you try on a different browser or device, or if you delete the cookie cache.

The work is led by Prof Sarah Tyson (University of Manchester), who has ME herself. If you have any questions, would prefer a paper copy or complete the survey by phone; or any other accommodations, please do not hesitate to contact her on sarah.tyson@manchester.ac.uk to arrange.



Consent (you must select all fields below to proceed)

• I have read the participant information sheet (PIS v4 23rd Jan 2024) and have had opportunity to consider the information and ask questions and had these answered satisfactorily.
  
  
• I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason and without detriment to myself. I understand that it will not be possible to remove my data. I agree to take part on this basis.
  
  
• I understand that any anonymised data collected may be made available to other researchers.
  
  
• I understand that data collected during the study may be looked at by individuals from The University of Manchester or regulatory authorities, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my data.
  
  
• I agree to take part in this study.

Spoiler: Section 1 - About you

SECTION 1: ABOUT YOU


1. Have you been diagnosed with Myalgic encephalomyelitis (ME, also known as Chronic Fatigue Syndrome (CFS)?

• Yes
  
  
• No

2. Have you been diagnosed with Long-Covid OR was your ME/CFS triggered by a Covid infection?

• Yes
  
  
• No

3. Where do you live?

• England
  
  
• Wales
  
  
• Scotland
  
  
• Northern Ireland
  
  
• Other Islands and Crown Dependencies
  
  
• Somewhere else

4. Gender

• Male
  
  
• Female
  
  
• Non-binary / third gender
  
  
• Prefer not to say
  

5. Age

6. Time (years or months) since you developed ME/CFS/long covid

7. Severity of ME/CFS or Long-Covid
Please pick which of these levels best describes how ME/CFS affects you at the moment.
PLEASE NOTE: Activities can be physical, cognitive, social, emotional etc.

• Level 1 1-20% Disability - Adapting activity. Able to manage the things that are important to you but need to adapt how, or how much you do.
  
  
• Level 1-2. In between levels 1 and 2.
  
  
• Level 2: 21-40% Disability - Prioritising Activities. Able to manage the things that are most important to you but have adapted how you do them and/or limited other activities to prioritise them. Eg. Stopped hobbies to prioritise work (or vice versa).
  
  
• Level 2-3. In between levels 2 and 3.
  
  
• Level 3: 41%-60% Disability - Limited independence. Able to carry out some light activities but need rest periods; needs assistance with domestic activities. Mobility outside the home is restricted.
  
  
• Level 3-4. In between levels 3 and 4.
  
  
• Level 4: 61-80% disability - Essentially housebound. Require help with all domestic and some personal care. Mobility severely restricted - usually confined to the house, needs a wheelchair (or similar) if going outside.
  
  
• Level 4-5. In between levels 4 and 5.
  
  
• Level 5: 81-100% disability- essentially bedbound. Requires 24 hour care for personal care which may include difficulty eating and the need to be artificially fed, severe cognitive impairments, and sensitivity to sound, light and/or touch which require environmental adaptations. Cannot manage any domestic tasks, employment or education. Social and leisure activities very severely limited.
  

 

Spoiler: Section 2 The PASS scale

Section 2: The Post Activity Symptoms Scale (PASS)
The following questions are about the worsening of symptoms people with ME/CFS get when they exceed their baseline, or ‘energy envelope’. Other terms you may come across are post exertional malaise (PEM), a crash, flare up, payback, setback, or relapse. It is most commonly experienced as an increase in symptoms, but it can also involve the onset of different symptoms to your usual baseline, so we refer to a ‘worsening of symptoms'. Overall, we want to capture how things get worse or are more of a struggle when you overdo it (i.e. trigger PEM). We know this is very variable, so the idea is to take an overall snapshot of how it is affecting you at present, rather than trying to record every aspect, and the whole history. This can help you and other people understand the impact it is having and start discussions about how to manage it.


8. Do you experience a worsening of symptoms when you overdo it?

• No
  
  
• Yes

9. Triggers Which of the following have triggered a worsening of symptoms (ie PEM) over the last month.
No Yes
I do not know what triggers the worsening of symptoms
Physical activity
Cognitive activity,
Social activity
Emotional activity/stress
Other illnesses e.g. a viral infection
Sensory stimulus (e.g. bright lights, loud environments)
Allergies / intolerances (e.g. foods, smells)
Pain
Sleep problems
Change in the weather/ seasonal changes or temperature extremes
Hormonal changes e.g. menstrual cycle or (peri)menopause
Something else (please state)


9a. Which triggers have been most problematic in the last month, in order of how problematic they are:
1st. most problematic

9b. Which triggers have been most problematic in the last month, in order of how problematic they are:
2nd. most problematic

9c. Which triggers have been most problematic in the last month, in order of how problematic they are:
3rd. most problematic

10. Warning signs: Do you have warning signs, so you know in advance that you are about to overdo it/ trigger PEM?

• No
  
  
• Yes

10b. If yes, what are the warning signs?

11. Symptoms: Which symptoms have worsened when you have ‘overdone it’ (i.e. triggered PEM) in the last month?
No Yes
I do not experience a worsening of symptoms when I overdo it / PEM
Fatigue
Musculo-skeletal symptoms. (e.g. weakness, stiffness, clumsiness)
Pain
Cognitive symptoms: difficulty with thinking and memory (brain fog)
Sleep disturbance (e.g. difficulty getting to sleep, or staying asleep, sleeping during the day)
Neurological symptoms (e.g. headaches, migraine, sensitivities to sound, light etc, altered sensation, tinnitus)
Gastrointestinal symptoms (e.g. nausea, stomach pain, bloating)
Cardio-respiratory symptoms (e.g. palpitations, breathlessness, chest pain, circulation changes)
Orthostatic intolerance (changes in heart rate, breathlessness etc) when becoming more upright (i.e. when sitting or standing up) for a period of time
Dizziness
Loss of temperature control (feeling hot or cold which is not related to the environment)
Allergy symptoms (e.g. sore throat, tender glands/lymph nodes, runny eyes, skin changes, wheezing, flu-like symptoms)
Emotional symptoms (e.g. increased irritability, anxiety or low mood)
Something else (please state)


11a. Please list which symptoms have most troublesome when you have overdone it (ie triggered PEM) in the last month, in order of how problematic they are:
1st. most troublesome

11b. Please list which symptoms have most troublesome when you have overdone it (ie triggered PEM) in the last month, in order of how problematic they are:
2nd. most troublesome

11c. Please list which symptoms have most troublesome when you have overdone it (ie triggered PEM) in the last month, in order of how problematic they are:
3rd. most troublesome

11d. Is there anything else you would like to tell us about the symptoms you experience when you have overdone it/ triggered PEM?

 

Spoiler: Questions 12 to 18 (end)

12. Level of activity triggering a worsening of symptoms / PEM
NB. This question refers to what is strenuous, demanding or stressful activity for you at present. Essentially, we are asking for a ballpark figure about how much you can do without triggering a worsening of symptoms. This indicates the size of your ‘energy envelope’, which is an important issue when it comes to managing energy and activity levels, and pacing. We are not asking about a comparison with other people with ME/CFS, healthy people, or how you were before you became ill. We understand that the baseline levels of symptoms fluctuate, which will impact on how much you can do.


12. Overall, in the last month what level of activity has typically triggered a worsening of symptoms when you overdo it?

• I do not experience a worsening of symptoms /PEM
  
  
• Strenuous or stressful activity (for you)
  
  
• Moderately demanding or stressful activity (for you)
  
  
• Mildly demanding or stressful activity (for you)

13. Frequency: Over the last month, how often have you overdone it and triggered a worsening of symptoms/ post exertional malaise?

• I do not experience a worsening of symptoms /PEM
  
  
• Constantly
  
  
• Daily
  
  
• Weekly
  
  
• Occasionally (less than weekly)

14. Delay: In the last month, has the worsening symptoms (i.e. onset of PEM) typically been delayed after you have overdone it?

• I do not experience a worsening of symptoms /PEM
  
  
• Yes, delay of less than an hour
  
  
• Yes, delay of an hour or more
  
  
• Yes, delay of a day or more
  
  
• The changes involve both rapid onset and later onset changes

15. Duration of the change in symptoms: In the last month, how long does the worsening of symptoms typically last/ take to recover after you have overdone it / triggered PEM?

• I do not experience a worsening of symptoms /PEM
  
  
• A day or less
  
  
• Several days
  
  
• About a week
  
  
• More than a week

16. Impact on daily life: In the last month, what impact has worsening symptoms when you overdo it / post-exertional malaise typically had on your day-to-day life?

• I do not experience a worsening of symptoms /PEM
  
  
• Significant issue
  
  
• Major issue
  
  
• Very major issue

17. Is there anything else you would like us to know about your symptom worsening when you overdo it/ post exertional malaise?

18. Is there anything else about the questionnaire you would like to tell us?

 

There are still significant problems with this, such as the meaningless question 12 about what level of activity triggers PEM, with no benchmarks for what is strenuous or mild etc, but it's much better than before. At least this time it's about PEM, not muddling together all activity after exertion.