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

I don't know whether Sarah Tyson will continue to read this thread, or anyone from the MEA or BACME who is involved in and has some influence on this project. In the hope of being heard, I offer the following:

I think this is key. If we are to have useful PROMS for ME/CFS they need include the disease specific phenomenon of PEM openly and clearly, eliciting first whether the person actually experiences PEM. Checking whether they experience PEF (post exercise/exertion fatigue), DOMS (delayed onset muscle soreness), EI (exertion intolerance), fatiguability, should be part of this, all of which we are likely to experience in addition to PEM, but without PEM it's not ME/CFS, in which case the person is likely to need different diagnosis and management.

And then secondly, for clinical and personal care, some information on the occurence of PEM eplsodes - frequency, duration, severity, changes in and new symptoms, changes in function - are likely to be useful, so better focused pacing advice and assistance and symptomatic treatments can be provided.

In my email comment on this questionnaire quoted in an earlier post, I suggested that questions on immediate effects of any activity be separated from those specifically on PEM, and that PEM be defined and explained before going on to ask questions about whether the pwME experiences it.

It seems that the opposite approach is being used here, with the term PEM being avoided altogether and vaguer 'post activity symptoms' being used instead. Yet the term 'baseline' is used, even though many aren't able to operate with a known and consistent baseline, leaving pwME in a quandary about which effects they are being asked to include.

The name seems designed to muddle PEM with other effects of exertion:

Post Activity Symptom Scale (PASS) gives no clue that it's about PEM, and even the acronym PASS has the unfortunate association with pass/fail as if it were a test which will be judged. But more importantly, why not PEMQ, post-exertional malalse questionnaire.

I can see some value in asking in general terms things like have you noticed whether particular types of exertion - physical activity, thinking and remembering, social activity or emotional or stressful events - have a more significant effect on triggering episodes of PEM. That might lead to some discussion about what the pwME might be able to change or get assistance with in order to reduce deleterious effects on their health.

On the subject of whether this is a scale or a questionnaire, I think there is an important distinction, in my mind at least.

A questionnaire has questions on different aspects of a subject, in clinical care terms presumably intended to ensure different aspects of the patient's condition are conveyed succinctly to the clinician as a starting point for the consultation, to enable efficient transfer of key bit of information that will affect clinical care.

So for a PEM questionnaire, the aim is presumably to check whether the person is experiencing PEM according to a clear definition, and any particular features of it, such as new or particularly troubling symptoms that might be helped by medication, and whether new assistance is needed with pacing advice and aids, sick leave or adjustments if still in employment or education, provision of mobility aids and care etc.

A few tick boxes, and short spaces for writing a few words, might be useful for this purpose that enable the patient to convey which aspects are particularly important to them in this consultation, the aim being to conserve the patient's energy and help with their concentration and memory problems at the start of the consultation. It could even be done by the patient in advance to help pacing and shorten the consultation.

A scale, on the other hand, seems to be an information/data gathering exercise for clinic evaluation, or for assessing progress with a treatment or both. Since there is no treatment for ME/CFS, any calculation of a figure that's supposed to represent progress is inappropriate, and liable to pressure both on the patient to show 'progress' and on the therapist to demonstrate effectiveness.
This is where misinformation and potential for harm to patients is a real risk.

If i fill in the questionnaire indicating that very slight activity causes an increase in symptoms every day, which is true, but not PEM, then the therapist after a few sessions convinces me that I should rate activity that causes PEM as strenuous activity, my 'score' on the scale will show marked improvement, and the service, which may be as useful to me as a chocolate teapot, will fly through its service evaluation and its therapy approach written up as exemplary.

If I start off by understanding PEM and rate activity that triggers it as very strenuous, even though it is just a 20 minute walk, and then my ME deteriorates and tottering to the bathroom triggers PEM, there is no way of indicating on the questionnaire that I am able to do far less than before. 'Very strenuous' has morphed from 20 minutes to ten seconds of walking, but the score is the same. It may even be better, if I'm crashing less often because instead of trying to maintain a job, I'm lying in bed all day being cared for by a family member. My deterioration will pass unnoticed in my PEM score, so I will be recorded in the clinics data as stable or even improving and successfully pacing.

 

A further thought on baseline.

If all increases in symptoms following any exertion are counted as PEM, then for many of us, the 'baseline' is basal metabolism, ie the use of chemical energy needed to keep the body alive, including digestion, excretion, breathing, heartbeats and basic functioning of all organs. So at its most basic, that is everyone's baseline. Any exertion above that, including stress responses to sensory stimulation and input leads to 'fatiguablity' effects which may be so slight as to go unnoticed or be experienced as, for example, increasing pain, or slowed thinking, and will contribute to the cumulative effects of exertion. For the most extremely affected, this forces them to lie immobile in the dark and silence with even nutrients provided predigested.

For everyone else with ME/CFS, I contend that all stimuli and activity have a cumulative effect on symptoms and functional capacity, and resting between exertions enables abnormally slow recovery. This recovery is usually incomplete as real life impinges on the availability of resting opportunity, and therefore incomplete recovery leads to a cumulative effect of detriment. On the PASS questionnaire, this could mean all activity causes PEM, as it includes immediate and short lasting symptom increases. This is clearly unhelpful.

This pattern of cumulative detriment and symtoms buildup over a day means that trying to identify a single activity as the trigger that tipped us into a delayed PEM state is usually a fools errand. Maybe the focus on CPET as a useful PEM trigger for studies gives a false impression that it takes a single, identifiable activity to trigger PEM in real life. Sure that will be true sometimes, but for me at least, the effect is usually a result of cumulatively doing too much over a day or more.

 

You're right about doctors being unlikely to use these sorts of PROMS. If at all it will be likely to be a single number score or scores tracked over a course of therapy sent to them in a report on a course of therapy to put in their records, and likely to be highly misleading as I outlined above.

I think it's significant that this questionnaire is being designed by therapists, with both the leads, Sarah Tyson and Peter Gladwell being physios, and the members of BACME who seem to be involved in it being largely physios, OT's and CBT and other psychological therapists. Therapists are more likely to be involved in rehabilitative treatments and to be accustomed to using lots of questionnaires, as we have witnessed over the years with all the multitudes of PROMS inflicted on us. These seem to be largely intended for the dual purpose of patient level collecting information for patient records and assessing improvement in individuals undergoing rehablitation, and at clinic level for service evaluation.

From reading her bio, it seems Sarah Tyson's professional experience is mainly with stroke rehab where improvement can happen and rehabilitiation is expected to help. I leave it to her to tell us what her experience is with ME/CFS research. Pete Gladwell works in a pain and fatigue clinic including ME/CFS, so is presumably steeped in the culture of such data collection with questionnaires, and theoretically supposed to be an expert on ME/CFS, though past experience with his contribution to AfME booklet on pacing, he's a proponent of pacing-up, which can be as harmful as GET. Whether he's changed his mind since the NICE guidelines I have no idea.

My point is, this looks very much like the product of the culture among therapists in ME/CFS clinics of using masses of different questionnaires, and the idea that if we have to have that culture, it's better to have ones designed with input from the MEA and patients to replace the dire Chalder scale and other inappropriate tools currently used. We don't seem to be able to escape that culture.

It strikes me that my only encounter with a series of visits to a physio for rehab was when I broke my shoulder. There were no questionnaires, but I was given a sheet summarising with diagrams the exercises i was supposed to do, and it changed each week with added movements and effort required.
So not all therapy uses questionnaires.

 

I agree, I think I have said similar several times on this thread. The clue is in the name PROM: 'outcome' and 'measure' are not appropriate for ME.

To give a perverse example, if the outcome measure for a PEM PROM is to be frequency of episodes of PEM on the grounds that good pacing leads to fewer crashes, then the logic is to get everyone sick enough to leave work so they can rest more. I crash less frequently now I'm sicker because I can't go to work and have had to change my lifestyle drastically. My 'baseline' is much lower, but on a PEM frequency measure I'm a success story.

 

Any definition that does not include a delayed component, to differentiate between various post-activity responses (PEM, DOMS, etc), will fail.

Worth noting here that basal metabolism is around 75-80% of all energy expenditure, and given the diagnosis of ME requires a large drop in activity levels (typically >50%), then we don't exactly have a lot of discretion in how to spend our remaining activity capacity to start with.

Basically GET with a new hat.

Many years ago I broke a bone in one hand, and it was in a cast for a few weeks. The interesting bit is when I saw the physio after the cast came off she said don't worry about any specific exercises, just do what activities you normally would with your hand, and build up to your normal level of those activities over 2-3 weeks. Worked fine for me.

This.

 

A further thought on not naming PEM and not differentiating it from PEF, DOMS, EI and fatiguability:

There is a concerted effort that has been going on for decades in the UK and some other countries to subsume ME/CFS within an umbrella term such as MUS, FND, and various functional and somatic symptom syndrome labels, all of which are proxies for what used to be called conversion disorder and before that hysteria.

They also all come under the heading psychosomatic disorders in this scenario, with any differences such as the existence of PEM wiped out of the definition and/or conflated with PEF/EI and DOMS, and attributed to deconditioning and fear/avoidance of exercise. See also Sharpe et al's invention of the Oxford Criteria in 1990 which explicitly included people with fatigue accompanying anxiety, depression and any idiopathic chronic fatigue lumped together with post infectious fatigue, and which only required chronic fatigue for diagnosis, thus attempting to wipe out any suggestion that PEM was a core feature, and make it disappear.

Still today the same people - Sharpe, White, Wessely, Chalder, Moss-Morris etc. don't seem to understand the difference between PEF/DOMS in people who are deconditioned and PEM. Far from going quiet after the NICE guideline removed the deconditioning/fear avoidance model and CBT/GET approach, it seems to have given them new impetus to spread their unfounded ideas, some even coming out of semi retirement to write articles and get them published in medical journals with all their chums adding their signatures. There are serious conflicts of interest involved.

Also the concept of fear/avoidance of exercise has led to pwME being subjected to swathes of psychological testing and PhD thesis writing trying to pin on us psychological traits such as perfectionism, catastrophising, over-focusing on symptoms, anxiety, depression, anhedonia, burn out etc, and predisposing factors they imagine we have such as childhood trauma, and, most disastrously for children with ME, accusing parents of FII. It's not uncommon to hear of therapists who are supposed to be supporting pwME spending the time digging around trying to pin these traits on them and break their imagined fear of exercise and tell them their symptoms are just normal ones they are being oversensitive to. The whole approach has been and continues to be disastrous for pwME.

Someone who understands this history would never fall into the trap of 'disappearing' the term PEM and replacing it with a vague umbrella term like "post activity symptoms", as in the proposed PASS.

This week has been traumatic for us, with the long awaited NIH study report finally being published, only to find at the heart of the abstract, and contaminating the research findings, a hypothesis of 'effort preference' leading to deconditioning -

which is eerily similar to the PACE manuals

All this may seem far removed from an attempt to create a set of PROMS useful for clinical care of pwME. I think given the strong negative reaction to our attempts to be helpful, it seems there is still a persistent view within BACME that pwME are subject to irrational fears and behaviours such as catastrophising.

Please, let's put that behind us and assume it was just a human reaction of someone who has worked hard finding their work strongly critiqued. There are important points we are raising. I would hate the human over-reaction of one individual to lead to our work being dismissed.

I would like to suggest Sarah Tyson rejoin this discussion and encourage her co-researcher Peter Gladwell to join the discussion too. If others from BACME and the MEA who are sponsoring and supporting the research want to join us, all the better.

 

I suggest this aware that it's work for someone else, but is it worth a letter* to MEA setting out major points made in this thread?

ETA: *ie email

 

Thanks, Jo.