Member comments wanted: Third section (What the guideline will cover) of the NICE ME/CFS guidelines draft scope

I find this unsatisfactory.
As others have said, there is no PEM; also to me, it sounds very "PACE like" (i.e. treatment/management of a psychological disease), fatigue-centered - just my impression. Recommendation of SF-36 for assessing QUALITY OF LIFE is in my eyes not suitable.

 

"assessing the evidence"

wasn't sure if this should go under the PACE trial thread, but as she [Ellen Goudsmit] was involved in and critical of some of the evidence search methods at the last review I thought it relevant here as they [NICE] argued that there was plenty of evidence for CBT/GET even if PACE was removed:

http://journals.sagepub.com/doi/10.1177/1359105317707216

"Other studies found similar results (Sharpe et al., 2017)

Our response: This is a fair point, but it should be noted that almost all the trials which have reported positive outcomes adopted the same design, with limited measures to evaluate symptoms and without stratification of subgroups, for example, those with a post-infectious onset (Sharpe et al., 2017). Jason et al. (2007), who used a different design, failed to replicate the results obtained in the United Kingdom and the Netherlands (summarised in Bagnall et al., 2007, Table 1). There are also other factors, notably the selection of patients using broad-case definitions, which may explain the similar results reported in the United Kingdom and the Netherlands (Malouff et al., 2008).

The PACE trial assessed an approach preferred by support groups, that is, pacing (White et al., 2011; Bleijenberg and Knoop, 2011)
Our response: We are not persuaded that the trial assessed pacing as described by all except two patient groups (Bleijenberg and Knoop, 2011; White et al., 2011). This was pointed out in various articles by both Goudsmit and Jason who developed this strategy (Goudsmit et al., 2012; Jason et al., 2013). The PACE trial assessed a programme called APT which includes advice about activity management and reducing stress, and also encourages the use of the 70 per cent rule. Simply put, this rule allows people to do less than they are able to. In contrast, pacing as recommended by most support groups is based on the Envelope Theory which requires patients to match expended energy with perceived energy (Jason, 2017). Thus the claim that the PACE trial evaluated pacing based on the Energy Envelope Theory is factually incorrect (Chalder et al., 2015; White et al., 2011).

CBT is also available to people with a number of medical conditions including multiple sclerosis and cancer. Why should it not be offered to patients with ME/CFS? (Campling and Sharpe, 2006)

Our response: The protocols for these conditions do not aim to cure or deal with somatic symptoms such as diplopia or incontinence (Campling and Sharpe, 2006). They tend to address adjustment, anxiety, depression and the effects of distress. They do not challenge the patients’ view that they are suffering from a disease. See Goudsmit’s (2001) factsheet written after the first time this argument was noted. The protocols for ME/CFS which have been assessed in RCTs focus on chronic fatigue and rarely discuss symptoms such as dizziness, blurred vision and bladder disturbances which are common in ME (Goudsmit et al., 2009a). These and other symptoms are invariably attributed to misattribution, a lack of fitness and the effects of ‘worry’. For example, see articles by Powell (2005) and information on the King’s College website (various years). In the case of disequilibrium, the presumed cause (e.g. inactivity and the ‘mistaken’ belief that the consequences reflect pathology) may be applicable to a proportion of patients who report chronic fatigue, but in disorders such as ME/CFS, evidence of central nervous system deficits suggests that interventions other than CBT and GET may be more appropriate (e.g. Ash-Bernal et al., 1995; Shepherd and Chaudhuri, 2016)."

I appreciate that many will not agree with all that EG has to offer but she makes some very good points, particularly IMO with regards the plethora of other ME symptoms that make little or no appearance in most of the BPS research (particularly with regards to 'recovery').

The main outcomes list as it stands has a distinct DWP feel to it.

 

I've been having a look at the various 'fatigue' scales that are around. I wrongly thought that the CFQ was developed for the PACE trial whereas in fact it was much earlier (1993).

The study discussed in this article compared the various different scales:
http://www.dsq-sds.org/article/view/1375/1540

"The study's primary finding is that many fatigue scales do not have the sensitivity to select only those with CFS and the specificity to discriminate those without CFS. Study 1 compared those with CFS and healthy controls, and while several fatigue scales such as the Fatigue subscale (Ray et al., 1992), the Fatigue Scale (Chalder et al., 1993), the FSS (Krupp et al., 1989), the MFTQ's Energy and Brain Fog subscales (Jason, Jessen, et al., 2009) had adequate sensitivity, the scales did not identify an adequate percentage of true negatives. In contrast, the MFTQ's Post-Exertional fatigue (Jason, Jessen, et al., 2009) had adequate sensitivity and specificity. For a low prevalence illness such as CFS, it is critical for a fatigue scale to be able to accurately identify both positive and negative cases."

"The scale with the best sensitivity and specificity was the Post-Exertional subscale of the MFTQ (Jason, Jessen, et al., 2009). Post-Exertional fatigue is defined as abnormal exhaustion following a bout of physical activity (e.g., "Physically drained after mild activity"). Clearly, while almost all of the CFS participants did experience Post-Exertional fatigue, some of the participants did not experience high levels of fatigue. In other words, some patients with CFS are not chronically fatigued, but they have a problem of endurance or stamina, and lengthy times to recover following minimal degrees of activity (Hyde, 1999)."

"Although standardized fatigue scales are particularly useful in research settings, findings from this study may also have implications for clinical practice. Due to ambiguities in case definitions of CFS and because diagnoses are given after the exclusion of other fatigue-inducing illnesses, care providers are faced with a significant challenge in diagnosing this illness. Oftentimes, patients with CFS are inaccurately given psychiatric diagnoses, such as depression (Deale & Wessely, 2000), and misdiagnosis has consequences for the diagnosis and treatment of CFS. The administration of a brief questionnaire, such as the Post-Exertional subscale of the MFTQ, may assist physicians in identifying key features of CFS symptomatology. Assessing the hallmark symptom of post-exertional malaise will assist in the differential diagnosis of CFS and psychiatric disorders, as this symptom is more common and severe among patients with CFS than those with MDD (Hawk, Jason, & Torres-Harding, 2006)."

MFTQ:
https://www.researchgate.net/public...BUzoxOTA1NTEzMDk1MTI3MTBAMTQyMjQ0MjM4MDY2Ng==

(I realise LJ is currently working on a 'new' PEM definition but in the meantime something like the post-exertional subscale should be included in NICE guidelines)

eta: I would prefer the emphasis to be less on fatigue but if fatigue is to feature this might be a way to at least try and add prominence to the 'ME/CFS variety'.

 

has anyone had further thoughts about what these reliability criteria would be?

 

I do not think it is practical to try to lay out reliability criteria to cover all situations. Reliability isn't a matter of criteria anyway - it is what can reasonably be expected to be reliable. in other words common sense informed by experience with all the things that regularly go wrong in research. All that is needed here is that the standards normally used for reliability for drug trials are applied to non-drug treatments. That wipes off all the studies of CBT and GET as far as I am aware.

 

Since the CDC updated the website, can it be used here a reference??? Just a thought.

 

Michael Sharpe (and probably others) sometime try to use as a defence that PACE only claimed to trial people with CFS, not ME. The 2007 PACE protocol is a bit ambivalent about it in some ways ...

[my underliine]

... but then firmly states them both being accepted as being a single illness, as per above. To me the PACE authors are thereby claiming to be trialling treatments for a single illness, CFS/ME as they call it, despite latterly trying to claim otherwise.

Is this something the new NICE guideline should clarify better? That not only are the two terms - CFS and ME - typically used interchangeably, but that also that there is no evidence they are different? Should the guideline indicate that a diagnosis of ME, CFS, ME/CFS or of CFS/ME, will all be deemed diagnoses of the same medical condition?

The naming vagueness seems to perpetuate confusion, when in practice it seems to be something that is generally accepted (other than by MS and Co.) to be the same thing.

Feels to me it needs something stronger than just the glib "also known as" rider. Additionally in the new guideline something along the lines of "For the avoidance of doubt, ME, CFS, ME/CFS and CFS/ME, are all considered to refer to the same condition".

If this were stated in the new NICE guideline it might help stifle a lot of nonsense. Possibly with some insurance companies maybe - not sure on this though.