Version 1.0 of ME/CFS Common Data Elements now available

nih emailed it today. if it is a duplicate, then we should delete the thread.

eta: have we been keeping versions of all major websites? so it can be compared using diff or whatever windows has to offer? it would be good to regularly download all major web pages and keep them under version control.
 
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https://www.commondataelements.ninds.nih.gov/Doc/MECFS/Fatigue_Subgroup_Summary.pdf is interesting ...
Members reviewed each existing instrument as they are currently being used in ME/CFS and identified the appropriate classification for them. The reviews included whether the measures had been used in ME/CFS research, the advantages and limitations for use in ME/CFS research, psychometric properties, availability, and whether the validation relied on Oxford or Reeves definition cohorts, as these are now considered inappropriate for use in ME/CFS.
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A patient and a patient advocate were involved at the start and at the end of subgroup deliberations and were able to provide input on the patient experience of fatigue. Additional patient involvement will be essential in future initiatives to clarify this important symptom and identify the best tools to assess it.
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They are acknowledging that fatigue measurements are lacking, though I would argue that fatigue isn't going to be suitable for defining cases. They might be starting to understand that at least:
Currently, there is a long list of instruments used to assess fatigue, each with advantages and disadvantages. Unfortunately, there is not a single encompassing instrument that measures all facets of fatigue across the range of severity with the needed sensitivity. Further, while a core instrument is needed to assess fatigue as a case defining criteria, we have not made a recommendation for such an instrument at this time.
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This probably refers to the Chalder Fatigue Questionnaire:
In a few instruments, reported thresholds for ME/CFS were based on studies using case definitions that have since been downgraded by the NIH Pathways to Prevention report or the 2015 Institute of Medicine report because those definitions could encompass patients with other conditions. Those instruments are both rated exploratory and a note added about the issue.
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I think this approach will get them to the right answers eventually, and it's a pretty firm rejection of the symptom-lumping seen in psychosomatic approaches:
As mentioned above, the first priority is to further clarify the meaning of fatigue and define what the types of fatigue are and rationalize these against other domains. For instance, how is mental fatigue defined separate from the cognitive impairment that is part of the cognitive domain? And is post-exertional fatigue an aspect of fatigue or of PEM.
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That document also lists the fatigue scales examined, and briefly describes what they measure and how useful they are.
 
PEM summary: https://www.commondataelements.ninds.nih.gov/Doc/MECFS/PEM_Subgroup_Summary.pdf

This is also looking pretty good, though I still strongly object to including immediate symptoms of exercise intolerance as part of PEM. I think they took the patient recommendations (the survey some patients here started) into account:
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, days or even longer.

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.
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Though it does look like they want to pin it down better, including in objective terms:
These recommendations will comprise patient-reported questionnaires, research and clinic-based report forms, and objective tests researchers can use to a) identify the existence of PEM for use in case assessment, b) consistently and systematically capture the various ways PEM is experienced by study participants and c) capture the effect of exertion on various symptoms and d) assess the relationship of PEM and objective measures of physiological changes, for example those in gene expression, brain function, and energy metabolism.
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This is where they're currently at. Unfortunately the DSQ PEM subscale seems to be the only thing available:
The 2-day cardiopulmonary exercise test (CPET) objectively demonstrates the loss of function that occurs following exertion but does not evaluate the exacerbation of symptoms that is also part of PEM. Further, the test cannot be used across all studies because of cost, expertise, the level of severity of some participants, and other factors. There are also few well-tested patient-reported tools specifically designed to ascertain PEM. The DePaul Symptom Questionnaire (DSQ), has been tested and used in several ME/CFS studies, has been evaluated in multiple diseases, includes a PEM subscale, and has been used by different researchers. The PEM subscale of the DSQ was chosen as the basis of the Core CDE Instrument and associated Case Report Form for assessing PEM in all study participants across all ME/CFS studies.
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The PEM subgroup is also pushing hard for more research into various aspects of PEM, and Fukuda gets slammed a bit in the process :D:
Our recommendations for PEM-focused studies assume that all study participants experience PEM. However, if the 1994 Fukuda et al definition is being used, some study participants may not experience PEM as Fukuda does not require it. Studies focused on PEM should recruit subjects who report experiencing PEM.
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Despite the current promotion of the DSQ PEM subscale, they seem to understand the limitations in the approach taken to develop it (choose the least-inappropriate option from a list);
a. The definition of PEM is based primarily on clinician experience, patient reports and a few formal studies. There is a dearth of studies asking participants about their experiences of PEM in an open-ended manner, which is needed. There is also a lack of research on PEM in subgroups like the severely ill patients, ethnic minorities, the elderly and children.
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And a way to assess subjective changes in PEM is needed, for study endpoints:
Studies should include objective outcome measures that go beyond patient-reported or researcher-assessed measures (e.g. Clinician Global Impression Scale). Currently, there exists no patient-reported outcome measure that is both specifically designed for and covers comprehensively the characteristics of PEM. Such an instrument is urgently needed.
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The DSQ isn't suitable for it:
The currently recommended Core PEM Assessment Instrument to assess the presence or absence of PEM across all studies uses the PEM subscale of the DSQ. This was chosen because it is the only suitable existing instrument. However, it is recognized that DSQ has some limitations, particularly in terms of the breadth of the symptoms covered, and in its ability to detect PEM triggered by stressors other than physical activity. Patients who already modify their activities to avoid or reduce PEM may potentially show up as false-negatives on the PEM subscale. Therefore, the further development, refinement and validation of a tool is a priority that needs to be addressed as quickly as possible.
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