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

[Nielk]

I was asked to start a new thread on the criteria issue to be used for the new NIH consortia. I initially posted here.

For those who were wondering which criteria will be used for these studies, Dr. Bateman replied on her FB page that the IOM diagnostic criteria will be used for research. She will be providing the patient samples (200) for the JAX clinic site.

This is maddening to me bc the IOM are overly broad criteria, to begin with. The gov't stated and the IOM committee stated the definition was to be used for clinical diagnostic purposes.

But, as warned by knowledgeable advocates, what the gov't states is not what they end up doing. They warned that once the IOM criteria are created it will be used for research as well.

 

[A.B.]

Dr. Bateman replied on her FB page that the IOM diagnostic criteria will be used for research. She will be providing the patient samples (200) for the JAX clinic site.

Can you please provide a link to this post? Is this a decision by these researchers or a NIH mandate?

My guess is that these criteria will be used because Dr Bateman was part of the IOM committee and uses them in clinical practice.

 

[Nielk]

Can you please provide a link to this post? Is this a decision by these researchers or a NIH mandate?

My guess is that these criteria will be used because Dr Bateman was part of the IOM committee and uses them in clinical practice.

The IOM panel, of which Dr. Bateman was a member, was charged by HHS to create clinical diagnostic criteria. Not research criteria. You can view Dr. Lee's charge in the video below.

 

[A.B.]

The IOM panel, of which Dr. Bateman was a member, was charged by HHS to create clinical diagnostic criteria. Not research criteria. You can view Dr. Lee's charge in the video below.

This doesn't answer my question. I asked for a link to the post on facebook where Dr Bateman says that IOM criteria will be used for research. I looked myself and could not find it.

 

[Nielk]

This doesn't answer my question. I asked for a link to the post on facebook where Dr Bateman says that IOM criteria will be used for research. I looked myself and could not find it.

I posted on the initial thread which I was asked to move from. You can find it there.

 

[Nielk]

The IOM criteria have been widely criticized as being overly broad for clinical purposes. They would include many who do not have the disease and would muddy the waters.

Why are Case Definitions Consequential?
In the preface to the ICC, its authors explain the need for accurate definitions: “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome’. We believe this is the foremost cause of diluted and inconsistent research findings, which hinders progress, fosters skepticism, and wastes limited research monies.”

Some have argued that since the IOM criteria are to be used for clinical diagnostic purposes, and not for research, there is no need for such “tight” criteria. One problem with this line of thought is the fact that the US government has a history of muddling the aim of previous criteria. For example, the Fukuda criteria were created for research purposes yet, they have been used for diagnosis as well.

No request has been made by HHS to come up with new research criteria. Which criteria do you think will be used for federal research going forward? Will they continue to use the inefficient Fukuda? There is evidence, as in Francis Collins’ recent statements of support of the IOM report, that they will start using the new IOM criteria for their research initiatives.

Another complication and confusion will arise when the medical profession starts diagnosing patients with the IOM criteria. Clinicians may observe that many of their ME/CFS patients will have contrasting symptoms or treatment responses compared to the patient populations that are evaluated in the research studies or in other international patient populations such as Canada. Thus, if the research studies find certain treatments successful but the same results are not carried in the clinical settings, the research may be thrown out as uncredible by the medical community.

Quoted from the blog -

Analysis of CFSAC August 2015 Recommendations for the IOM Criteria

 

[A.B.]

Thanks, here is the link: https://www.facebook.com/lucinda.bateman.1/posts/10212764555181011

I was asked to start a new thread on the criteria issue to be used for the new NIH consortia

As far as I can see, there is nothing that suggests NIH research centers are required to use IOM criteria for research. So this appears to have nothing to do with the government. Dr Bateman is using the IOM criteria because she believes them to be good criteria.

 

[Nielk]

Thanks, here is the link: https://www.facebook.com/lucinda.bateman.1/posts/10212764555181011


As far as I can see, there is nothing that suggests NIH research centers are required to use IOM criteria for research. So this appears to have nothing to do with the government. Dr Bateman is using the IOM criteria because she believes them to be good criteria.

Not exactly. This is from NIH regarding the parameters of the new consortia. They recommend the IOM criteria as well for the research. https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-17-021.html#_Section_I._Funding

Besides the fact that Dr. Bateman deciding on her own to use specific clinical criteria for research - because she likes them is unacceptable.

 

[A.B.]

Not exactly. This is from NIH regarding the parameters of the new consortia. They recommend the IOM criteria as well for the research. https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-17-021.html#_Section_I._Funding

The NIH wrote:

... there is currently no gold standard for case definition of ME/CFS. For studies proposed under this FOA, it is recommended that the investigators utilize the Canadian Consensus Criteria for ME/CFS as proposed by Carruther and colleagues in 2003 and revised by Jason and colleagues in 2010, and the recent case definition from the Institute of Medicine Report on ME/CFS.

This looks sensible to me. Researchers can use whatever case definition they want, but Canadian and IOM are the recommended ones. In conclusion, researchers are not being forced to use the IOM criteria.

There is also an issue with the idea that IOM criteria should not be used for research. The IOM criteria were developed for clinical use. Do you think that this is sufficient to invalidate a definition for use in research?

 

[trishrhymes]

I get very confused about all the different criteria. It helps me in discussions like this to be reminded of them.
Here's what I've found with a quick google search:

IOM criteria:

• • A substantial reduction in activity
    • More specifically: A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest
  • Post exertional malaise
  • Unrefreshing sleep
  • Either cognitive impairment or orthostatic intolerance

Canadian Consensus Criteria:
A patient with ME/CFS will meet the criteria for fatigue, Post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of (a) autonomic, (b) neuroendocrine, and (c) immune manifestations; and adhere to item 7: The illness persists for at least six months: It usually has a distinct onset, **although it may be gradual. Preliminary diagnosis may be possible earlier. Three months is appropriate for children.

1. Fatigue: The patient must have a significant degree of new onset, unexplained, persistent, or recurrent physical and mental fatigue that substantially reduces activity level.
2. Post-exertional malaise and/or Fatigue: There is an inappropriate loss of physical and mental stamina, rapid muscular and cognitive fatigability, post exertional malaise and/or fatigue and/or pain and a tendency for other associated symptoms within the patient’s cluster of symptoms to worsen. There is a pathologically slow recovery period - usually 24 hours or longer.
3. Sleep Dysfunction:* There is unrefreshed sleep or sleep quantity or rhythm disturbances such as reversed or chaotic diurnal sleep rhythms.
4. Pain:* There is a significant degree of myalgia. Pain can be experienced in the muscles, and/or joints, and is often widespread and migratory in nature. Often there are significant headaches of new type, pattern or severity.
5. Neurological/Cognitive Manifestations: Two or more of the following difficulties should be present: confusion, impairment of concentration and short-term memory consolidation, disorientation, difficulty with information processing, categorizing and word retrieval (Word-finding problems), and perceptual and sensory disturbances – e.g. spatial instability and disorientation and inability to focus vision. Ataxia, muscle weakness and fasciculations are common. There may be overload phenomena: cognitive, sensory – e.g. photophobia and hypersensitivity to noise - and/or emotional overload, which may lead to “crash” periods and/or anxiety.
6. At Least One Symptom from Two of the Following 3 Categories:

1. • Autonomic Manifestations: Orthostatic intolerance - Neurally mediated hypotension (NMH), Postural orthostatic tachycardia syndrome (POTS), delayed postural hypotension; light-headedness; extreme pallor; nausea and irritable bowel syndrome; urinary frequency and bladder dysfunction; palpitations with or without cardiac arrhythmias; exertional dyspnea.
   • Neuroendocrine Manifestations: loss of thermostatic stability – subnormal body temperature and marked diurnal fluctuation, sweating episodes, recurrent feelings of feverishness and cold extremities; intolerance of extremes of heat and cold; marked weight change - anorexia or abnormal appetite; loss of adaptability and worsening of symptoms with stress.
   • Immune Manifestations: tender lymph nodes, recurrent sore throat, recurrent flu-like symptoms, general malaise, new food sensitivities, medications and/or chemical sensitivities.

 

[duncan]

Researchers can use whatever case definition they want

Yep. We have learned this the hard way far too many times.

 

[A.B.]

@trishrhymes the IOM criteria also include the requirement that symptoms be at least of moderate severity, be present for at least 50% of the time for at least 6 months.

 

[Hajnalka]

Hi @Nielk, you wrote in the other thread that you'd prefer the ICC. I'd be interested why you chose the ICC over the CCC? I like the ICC but for research purposes (not for clinical purposes) I'd be concerned that there's no waiting period necessary:

The 6-month waiting period before diagnosis is no longer required. No other disease criteria require that diagnoses be withheld until after the patient has suffered with the affliction for 6 months. Notwithstanding periods of clinical investigation will vary and may be prolonged, diagnosis should be made when the clinician is satisfied that the patient has ME rather than having the diagnosis restricted by a specified time factor. Early diagnoses may elicit new insights into the early stages of pathogenesis; prompt treatment may lessen the severity and impact.

(http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full)

Wouldn't it be difficult to distinguish cases of self resolving post infectious illness after e.g. EBV from ME during the first weeks/months? I'm not arguing, I'm genuinely interested in your opinion. I wouldn't feel comfortable with people who have been sick for 1-3 months ending up in studies for ME (unless the onset or early stages etc are studied) because I think that sometimes only time will tell if they have ME or recover. So in this regard I'd prefer the CCC.

 

[Snowdrop]

If research is in the hands of people who we know understand this disease my thinking is that the use of a criteria may be simply politic to declare the use of a diagnostic tool that will be acceptable to the granter of funds and that there is nothing stopping researchers from ensuring that the research subjects meet that criteria as well as whatever else they feel is necessary to ensure they are studying this disease and not fatigue.

 

[A.B.]

If research is in the hands of people who we know understand this disease my thinking is that the use of a criteria may be simply politic

It is expected that new researchers will enter the field. In my view the IOM criteria recommendation is to prevent further use of the Fukuda or Reeves criteria which are effectively considered outdated.

 

[Nielk]

The chronic fatigue syndrome advisory committee recognized that te IOM clinical criteria were weak and they created several recommendations to HHS, at their August 2015 meeting, in order to strengthen the diagnostic criteria. The recommendations to improve the IOM criteria were never acted upon.

CFSAC also recognized that since the IOM criteria were created for Diagnostic purposes only, there was a need for research criteria. In their recommendation #4, they recommended HHS adopt the Canadian Consensus Criteria (CCC) for research. https://www.hhs.gov/sites/default/files/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf

 

[Nielk]

@trishrhymes the IOM criteria also include the requirement that symptoms be at least of moderate severity, be present for at least 50% of the time for at least 6 months.

Yes, they do but this was left off of the CDC website revision where they feature the IOM criteria.

 

[Nielk]

It is expected that new researchers will enter the field. In my view the IOM criteria recommendation is to prevent further use of the Fukuda or Reeves criteria which are effectively considered outdated.

Why did they just not recommend the CCC? Why even mention the IOM which are not research criteria.

 

[A.B.]

Why did they just not recommend the CCC? Why even mention the IOM which are not research criteria.

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.

As the CDC definition was primarily created to standardize research, it may not be appropriate to use for clinical diagnoses, a purpose for which it was never intended. There has been a growing demand within the medical community for a clinical case definition for ME/CFS for the benefit of the family physician and other treating clinicians.

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

 

[Nielk]

Hi @Nielk, you wrote in the other thread that you'd prefer the ICC. I'd be interested why you chose the ICC over the CCC? I like the ICC but for research purposes (not for clinical purposes) I'd be concerned that there's no waiting period necessaryhttp://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full)

Wouldn't it be difficult to distinguish cases of self resolving post infectious illness after e.g. EBV from ME during the first weeks/months? I'm not arguing, I'm genuinely interested in your opinion. I wouldn't feel comfortable with people who have been sick for 1-3 months ending up in studies for ME (unless the onset or early stages etc are studied) because I think that sometimes only time will tell if they have ME or recover. So in this regard I'd prefer the CCC.

Which other disease requires that one suffers for 6 months before they can get a diagnosis. I trust that the many authors of the ICC many of which have hands-on experience treating and researching ME, were able to create criteria that can distinguish those with other fatiguing conditions and those who suffer from ME. They include in their guidelines specific testing which in tandem with the multisystem symptoms can identify and distinguish those who suffer from ME.

The reason that I personally prefer the ICC to the CCC are the following:

The ICC distinguishes CFS from ME. I believe that the reason we have not progressed scientifically as much as we should have in the past decades is that ME has been conflated with chronic fatigue which is due to many other conditions whether physical or psychological. Patients who suffer from those other conditions should get their proper diagnosis and should be treated for their condition or for their symptoms. No one wins when several conditions or diseases are mixed together.

I prefer the ICC to CCC because of their core symptom of PENE as opposed to PEM.

I think that there are other diseases like some cardiac ones where patients do feel post-exertional malaise. I believe that the neurological (mental) exasperation when overdoing it is unique to ME.

I also like the fact that the ICC was created for diagnostic and research purposes. It is too confusing to have different criteria for clinical and research purposes and as we have seen they are often used for the wrong venue.