IOM Criteria to Be used in Research for NIH Center of Excellence

[Nielk]

This will probably come as surprise to you: the Canadian criteria were explicitly created for clinical use in response to the Fukuda criteria which were created for research purposes.

It is not surprising to me and that is why I prefer the ICC which I have commented on above.

The argument that diagnostic criteria are not good for research unless they were created for this purpose is completely invalid.

I totally disagree.

 

[anciendaze]

Unfortunately, the IOM diagnostic criteria were never reduced to usable clinical form. In NIH jargon this would be "operationalized", a transmogrification that turned the Fukuda definition into a BPS version. Both the CCC and ICC forms have been used in clinical practice, even though they have never been used by the NIH or CDC. We are left with the feeling that, once again, the disease will be whatever the NIH says it is, which will vary with political pressure from above.

 

[A.B.]

Patients diagnosed with Myalgic encephalomyelitis/chronic fatigue syndrome also fit systemic exertion intolerance disease criteria

Background: Myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) remains undiagnosed in up to 91% of patients. Recently, the United States-based Institute of Medicine (IOM) developed new diagnostic criteria, naming it systemic exertion intolerance disease (SEID).

Purpose: We examined how subjects fit SEID criteria and existing ME/CFS case definitions early in their illness.

Methods: A total of 131 subjects fitting 1994 Fukuda CFS criteria at the time of study recruitment completed a survey of symptoms they experienced during their first 6 months of illness. Symptoms were drawn from SEID and existing criteria (1994 Fukuda, 2003 Canadian Consensus Criteria (CCC), and 2011 Myalgic Encephalomyelitis-International Consensus Criteria (ME-ICC)). We calculated and compared the number/percentage of subjects fitting single or combinations of case definitions and the number/percentage of subjects with SEID experiencing orthostatic intolerance (OI) and/or cognitive impairment.

Results: At 6 months of illness, SEID criteria identified 72% of all subjects, similar to when Fukuda criteria (79%) or the CCC (71%) were used, whereas the ME-ICC selected for a significantly lower percentage (61%, p < .001). When severity/frequency thresholds were added to the Fukuda criteria, CCC and ME-ICC, the percentage of these subjects also fitting SEID criteria increased to 93%, 97%, and 95%. Eighty-seven percent of SEID subjects endorsed cognitive impairment and 92%, OI; 79% experienced both symptoms.

Conclusions: SEID criteria categorize a similar percentage of subjects as Fukuda criteria early in the course of ME/CFS and contain the majority of subjects identified using other criteria while requiring fewer symptoms. The advantage of SEID may be in its ease of use.

http://www.tandfonline.com/doi/abs/10.1080/21641846.2017.1299079

 

[A.B.]

To which Leonard Jason et al responded with:

Mistaken conclusions about systemic exercise intolerance disease being comparable to research case definitions of CFS: A rebuttal to Chu et al.
The recent article by Chu et al. contrasted different case definitions that have been used to describe chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). In particular, their study compared the new Institute of Medicine (IOM) criteria for systemic exertion intolerance disease (SEID) with three other ME and CFS case definitions. We appreciate these investigators attempting to use and operationalize the new IOM criteria; however, we disagree with their main conclusion that the percentage of patients selected by the IOM criteria is comparable to the percentage selected by other research case definitions. This conclusion could potentially encourage investigators to use the IOM criteria for research purposes. In this commentary, we discuss our observations of the Chu et al. article with respect to their methodology, illustrating how the conclusions of an investigation can be influenced by the manner in which case definitions are operationalized.

http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1362780?src=recsys

The response by Lily Chu et al:

Differences of opinion on systemic exercise intolerance disease are not ‘mistakes’: a rejoinder to Jason Sunnquist, Gleason and Fox
Differences of opinion about how case definitions are operationalized should not be characterized as ‘mistaken.’ Despite limitations, our study provides insight into how systemic exertion intolerance disease (SEID) criteria perform early in the course of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) compared to other case definitions. To facilitate early, accurate diagnosis, research needs to be performed, ideally, prospectively with subjects who have not been ill for years. In addition, results of past treatment studies may not be applicable to many ME/CFS patients because criteria used for research differed from patients’ clinical presentations. To avoid this potential mismatch between research employing the new clinically-focused SEID criteria should be promoted, rather than discouraged.

http://www.tandfonline.com/doi/abs/10.1080/21641846.2017.1362750

They make some excellent arguments here.

 

[Nielk]

Lily Chu should not be analyzing the IOM criteria. She served on the panel.

 

[Wally]

What bothers me is that some of the I.O.M. Report recommendations are now being cherry picked for use in the newly funded research projects. I am not aware that this Report was ever "officially" reviewed or ratified (approved) by the HHS. In using the word "officially", I mean that there was never any public announcement of the report going through a review process by the HHS nor was any formal public input sought to comment on the Report nor has the HHS ever made a public announcement of the ratification of this document for use by its Department. Why was this not done?

All that time, effort and expense that went into developing a Report and then it is not presented for comments/suggestions to the community that it was developed to help. If the HHS was satisfied with its own review of this Report, why was it never ratified?

If this Report has not been ratified, why has the HHS allowed its agencies, such as the CDC and the NIH, to use this Report for developing programs and criteria for research?

Did the HHS not like that the I.O.M. Report gave a strong recommendation as to the amount of funds needed to be allocated in order to address this serious biological illness?

These are just some of questions that I believe the patient community should be asking.

 

[A.B.]

It's worth mentioning that Jason attempted to identify the core symptoms of the illness and arrived at almost the same set of symptoms as the ones required by the IOM criteria:

Chronic Fatigue Syndrome and Myalgic Encephalomyelitis: Toward An Empirical Case Definition

Current case definitions of Myalgic Encephalomyelitis (ME) and chronic fatigue syndrome (CFS) have been based on consensus methods, but empirical methods could be used to identify core symptoms and thereby improve the reliability. In the present study, several methods (i.e., continuous scores of symptoms, theoretically and empirically derived cut off scores of symptoms) were used to identify core symptoms best differentiating patients from controls. In addition, data mining with decision trees was conducted. Our study found a small number of core symptoms that have good sensitivity and specificity, and these included fatigue, post-exertional malaise, a neurocognitive symptom, and unrefreshing sleep. Outcomes from these analyses suggest that using empirically selected symptoms can help guide the creation of a more reliable case definition.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443921/

Fatigue, PEM, unrefreshing sleep, cognitive impairment or orthostatic intollerance are the symptoms required by the IOM criteria.

 

[A.B.]

The disagreement is about other aspects. I will write more about this when I get my brain function back.

 

[Nielk]

It's worth mentioning that Jason attempted to identify the core symptoms of the illness and arrived at almost the same set of symptoms as the ones required by the IOM criteria:

Chronic Fatigue Syndrome and Myalgic Encephalomyelitis: Toward An Empirical Case Definition


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443921/

Fatigue, PEM, unrefreshing sleep, cognitive impairment or orthostatic intollerance are the symptoms required by the IOM criteria.

Yes - because if one looks at the majority of studies done on CFS/Fukuda (the majority of studies are based on these parameters), one will come to the same conclusion.

If one were to look at studies based on the CCC or on the ICC, they will see a different picture.

 

[Wally]

Lily Chu should not be analyzing the IOM criteria. She served on the panel.

This is what I am finding so frustrating to see the HHS play everyone like they are conducting a friendly puppet show around this Report. Pull the strings on the puppets that serve your purpose, but ignore the inconvenient truths in the Report. Correction - I am not just frustrated - I am mad and sick and tried of being lied to and manipulated by my government!

Now let's rely on members of the I.O.M. panel to justify individual recommendations found in the Report. How convenient is it to not allow the public to critique the Report as a whole in any type of government sponsored public Forum. How nice for the HHS that they can let these distractions go on and avoid having to step up to the plate to take a position about this Report. I cry foul on how this whole I.O.M. contract and subsequent Report has been handled by my government.

 

[Nielk]

Also, the excuse that HHS gave for not using the International Consensus Criteria (ICC) was because it was new and inverted so they didn't know if the criteria would work.

Yet, here they are fully adopting the IOM criteria. They already Revised the CDC website with the IOM criteria and preparing medical educational material with it.

Even worse, they are simultaneously recommending it's use for research in the new consortia.

This is unreal.

 

[Hope123]

Lily Chu should not be analyzing the IOM criteria. She served on the panel.

Researchers and clinicians conduct research on theories, treatments, questionnaires, diagnostic tests, etc. that they originate all the time. Your argument would be similar as saying Jason cannot conduct research on the DePaul Symptom Questionnaire because he developed the Questionnaire.

All scientific articles also require at least a financial conflict of interest disclosure and in this case, the conflict - ideological but not financial -- was declared so that readers can judge for themselves. In contrast, most researchers do not necessarily declare ideological conflicts (see PACE!) etc. they are researching but they will cite themselves often in the body of the article (as Jason and others do).

 

[Nielk]

Researchers and clinicians conduct research on theories, treatments, questionnaires, diagnostic tests, etc. that they originate all the time. Your argument would be similar as saying Jason cannot conduct research on the DePaul Symptom Questionnaire because he developed the Questionnaire.

All scientific articles also require at least a financial conflict of interest disclosure and in this case, the conflict - ideological but not financial -- was declared so that readers can judge for themselves. In contrast, most researchers do not necessarily declare ideological conflicts (see PACE!) etc. they are researching but they will cite themselves often in the body of the article (as Jason and others do).

It is not the same as saying that Jason cannot use his questionnaires.

I'm not saying Chu cannot use IOM criteria if she were to care for patients.

What I'm saying is that she should not be reviewing her own work.

 

[A.B.]

What I'm saying is that she should not be reviewing her own work.

I have good news: she isn't reviewing her own work.

 

[Nielk]

I have good news: she isn't reviewing her own work.

She compare her work (the resulting Criteria) to other criteria.

 

[Wally]

Please note that a discussion related to this thread was first started on the Forum at this location -

http://forums.phoenixrising.me/inde...management-center-announcements.54655/page-14

This additional discussion can be found in the replies to the thread linked above at Reply Nos. 261, 262 -264, 267, 270 - 279, 281 - 298, and 300. (pages 14 -15)

 

[alex3619]

We need to find out how to diagnose PEM using objective criteria. That will change a lot, including the major flaw in SEID. Candidates right now include cytokines (the Light's research) and repeat CPET (Workwell). We need more verification though, especially specificity. I think we have enough sensitivity in tests.

 

[Nielk]

Please note that a discussion related to this thread was first started on the Forum at this location -

http://forums.phoenixrising.me/inde...management-center-announcements.54655/page-14

This additional discussion can be found in the replies to the thread linked above at Reply Nos. 261, 262 -264, 267, 270 - 279, 281 - 298, and 300. (pages 14 -15)

Thank you, @Wally for taking the time to clarify this. I appreciate it.

 

[viggster]

Both the CCC and ICC forms have been used in clinical practice, even though they have never been used by the NIH or CDC. We are left with the feeling that, once again, the disease will be whatever the NIH says it is, which will vary with political pressure from above

The NIH is using CCC in its ongoing intramural study.
From https://mecfs.ctss.nih.gov/faq.html

7. How are the enrolled participants being evaluated for ME/CFS?
The study team will provide information from the initial study visit for ME/CFS participants to the adjudication committee. The adjudication committee will then review the data and medical records to determine if the participant with ME/CFS can proceed to the exercise stress visit.

8. Why is there an adjudication committee that determines which ME/CFS patients are eligible to participate in the exercise stress visit?
An adjudication process ensures fairness and uniformity in the selection process.

9. Who are members of the adjudication committee?
Committee members are recognized experts in ME/CFS. The initial members include: Lucinda Bateman, Andy Kogolnik, Tony Komaroff, Benjamin Natelson, and Daniel Peterson. The chair of the adjudication panel is the Principal Investigator, Dr. Avindra Nath (http://irp.nih.gov/pi/avindra-nath).

10. Are diagnostic criteria going to be used in the adjudication process?
The adjudication committee will consider the 1994 Fukuda, 2003 Canadian Consensus criteria, and additional information collected during the initial study visit in the adjudication process.

My note: This "additional information" collected during visit 1 includes a thorough evaluation for other diagnoses. E.g. The NIH docs evaluated me for degenerative muscle disorders but I didn't fit the bill (thankfully).

 

[Forbin]

In the 2015 Lipkin/Hornig cytokine study from Columbia, patients met both the Fukuda and the Canadian Consensus Criteria. I would suspect that, if the IOM criteria were indeed required, it wouldn't be impossible to find patients who also met the CCC or ICC. As I recall, the thing that stands out about the IOM criteria is that it does not exclude co-morbid conditions, but that doesn't mean that you have to include patients with co-morbid conditions in a research study.