By K. Kimberly McCleary, President & CEO
The challenge of comparing results from CFS research studies conducted in different laboratories was one of the barriers to progress identified at the April 2011 ME/CFS State of the Knowledge Workshop sponsored by the National Institutes of Health. Variability arises from a lack of standard sampling methods, patient characteristics and clinical assessments and the frequent failure for these parameters to be described in the manuscripts reporting results.
To address this problem, eight members of the federal CFS Advisory Committee (plus a colleague from Harvard) have published a consensus set of minimum data elements with the goal of improved consistency of reported methods and better comparisons among published studies.
“Minimum Data Elements for Research Reports on CFS”
Jason LA, Unger ER, Dimitrakoff J, Fagin A, Houghton M, Cook D, Marshall GD, Klimas NG, Snell C.
Brain, Behavior and Immunity
E-publication ahead of print available Jan. 26, 2012
Link to abstract*: http://bit.ly/zT5dO0
The paper includes two tables that outline the minimal and additional data elements recommended (table 1) and additional elements (table 2). Table 1 includes study design, demographics of study population, case definition, symptom inventory, medical and psychiatric exclusions and co-morbidities (including screening laboratory tests and current medications) and self-reported functional impairment/levels of activity. For the last item, they recommend six validated instruments.
Table 2 recommends collection and reporting of nine additional elements: functional assessment, cognition, allostatic load, HPA-axis activity, immune functioning and allergies, sympathetic activity (salivary amylase and heart rate variability), coping, genomic and transcription studies and proteomic studies. They note in the text, “As post-exertional malaise is a key symptom of all CFS case definitions, it would be appropriate to measure the extent of activity and how such activity might result in symptoms of fatigue and malaise.” They go on to describe different measurement tools that might be employed, acknowledging the limitations where appropriate.
As stated in the opening paragraphs of the paper, “…it would be both scientifically and clinically useful and informative to sub-categorize patients according to disease-relevant variables including clinical criteria, co-morbidities, biomarkers, etc.” The authors indicate that they at work on another paper that outlines domains of illness (e.g., fatigue, pain, sleep disturbance, etc.) and specific and reliable measures to measure them.
In the paper’s final paragraph, the authors state,
“Additional work that needs to be done involves the collection of standardized data fully characterizing CFS patients across clinical settings will make collection of biologic samples and establishment of a biorepositories a crucial resource for the next generation of molecular testing. Having standardized data and biologic samples in the hands of experienced investigators, will increase the chance of validating findings and establishing meaningful sub-groups of CFS linked to biologic alterations amenable to therapeutic interventions. At the present time, there are three groups that are attempting to do just this; one headed by the Chronic Fatigue Initiative, the other by the CFS group at the CDC, and a third by the CFIDS Association’s [SolveCFS] BioBank.
It’s encouraging to see this kind of collaborative effort to build tools that will improve comparability of studies and strengthen the design of news ones. It is essential for validation of biomarkers, identification of objective diagnostics and subtyping tools and demonstrating the efficacy of various treatments for CFS.
*We are seeking to provide access to the full text of this paper through our collaboration with patientINFORM. Please check back in a few days for updates.
K. Kimberly McCleary has served as the Association’s chief staff executive since 1991.
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I will read the full paper of course, but this appears very encouraging and a highly noble (if ambitious perhaps) aim.
It would be great to be able to truly compare like-for-like research into our condition. Though unless those who need to accept these parameters adhere to them in such a way as to empower others to similarly do so, then it might be impossible to pull it off.
Still if you can get (in the US) the NIH and other regulatory bodies on board with it then it might cascade over the pond to the UK and Europe. But I think – using the Canadian Criteria and more recently the ME criteria as precedents – it will be an uphill and possibly fruitless battle.
That doesn’t mean we shouldn’t try!
The move to consistancy in diagnosis of ME/CFS should be applauded, since there is longstanding concern about different research groups potentially diagnosing different patient groups as having ME/CFS, thereby distorting and/or polluting the research base. The CDC itself is one of the prime targets of such concerns regarding its creation and use of the 2005 Empirical definition, which despite using standardized tools, measurements and cut-offs to diagnose individuals, were never even validated as being a legitimate or valid diagnostic tool. The Empirical definition specifically allows individuals with fatigue as a result of emotional disturbances to be classed as ‘CFS’ patients, despite the rest of the ME/CFS research field spending great amounts of time and energy excluding such individuals from research studies. Also of concern is the fact that no other group besides the CDC has used the Empiricial definition even though the ED was published over half a dozen years ago, which raises the issue of whether research published by the CDC is comparable to that published by other groups.
However since the CDC has gradually stopped referring to the 2005 Empirical definition altogether in it’s publications on ME/CFS, instead only referring to various and vague permutations re: ‘standardized’ or ‘operationalized’ 1994 Fukuda criteria, shouldn’t the first rule of consistancy involve researchers being open and forthcoming about what definition and/or criteria they used to diagnose patients to begin with?
Nice summary, John.
It is hard to spot empirical criteria studies sometimes. A rule of thumb is to assume, unless it says otherwise, that samples from the Wichita 2-day study 2002/2003 and subsequent CDC cohorts (mainly Georgia at the moment) use the empirical definition
I don’t see why the information in the ME criteria document cant be made available as a formal document. A work in progress if you will. Its as if they don’t care that our disease is ignored in general by the entire medical community.
My husband and I cannot get help even though he has many illnesses – recently operated on for cancer – and has cognitive issues – I need help – but because ME is not recognized, its as if there’s nothing wrong with me.
Don’t anyone tell that this can’t be changed in a more timely fashion. I used to be a patient person. No longer. Soon I’ll be dead, then it won’t matter. So far 27 years of this suffering. How many more before I’m ashes!!!!!!!!
I’m sorry to hear of your problems Nancy. I agree that we
could be helped more than we are. I think part of the
problem is that non-profitable solutions are ignored.
If it must be that we die with this, I hope we’ll at
least go down protesting the way ME people are treated.
And rest assured, there are numerous ME people who
lead healthy lives by avoiding dangerous types of mould
or going close to tropical seas.
I feel just like you Nancy!!! I’ve been severely ill and worsening for 27 years. I’ve been to every doctor and tried every med. I can’t tolerate meds of any kind. No one in the medical field does anything but send me to another place!!! I’m too sick to even make it to doctor appointments!!!! We are so sick and so ignored… I feel I will not get to feel wellness either. Many days I just want the torture to end…. They just don’t get it. It just goes on and on. No use getting your hopes up because it’s always a let down.
I hear what you’re all saying. I don’t know how people with this are supposed to survive, I was affected by this just about 13 years ago after my last child was born, they tried to tell me I had the flu, allergies, was sore and tired because I had just a baby, all kinds of BS, until one doctor (from Canada, here on some program) finally diagnosed me, and I thought oh thank goodness! I will finally get some help! Nope, most doctors act like it’s all in your head… or if not it, well there is nothing much we can do for you and then your sent from doctor to doctor to doctor and none can help you. I am in SO much pain all the time, and not because of family hardship, I am working and working for me is like being tortured daily, it’s ALL I can do, I rest before and then after work… But what option do I have I have 3 kids to take care of and getting disability is a joke, you have to have someone on the inside or something! My kids are practically being forced to raise themselves because I am truly sick but can not get any help from anywhere, and I am getting worse daily since I took on the job, I truly don’t know how much longer I will be able to do it, and then what?
To Wynter:
Did you consult with a disability attorney? Also, you “have” to have a doctor who will document thoroughly just how disabled you are. And even then its difficult but many do succeed in getting it. We have a support group here in Charlotte and we have speakers come from both the SSDA and from local disability attorney’s offices to help people understand how to get disability and why they might not qualify. It can be very difficult. But my heart goes out to you having 3 children to care for besides yourself. I presume you have no family to help?
Nancy
I just had my 26th anniversary with this darned disease, and I know now that I can’t do things I did 1 1/2 years ago, even with it.
I could sometimes make doctors’ appointments. Now I’ve cancelled so many as I just can’t take a shower, get dressed and go to find a cab (that’s the only way I can get anywhere in my city). Bills take longer to pay and sometimes they’re in late, if I remember to deal with them.
Grocery shopping rarely happens and I can’t really cook, unless putting frozen food in an oven or boiling eggs or heating up a can of soup counts as cooking. For the last few winters I could cook a big pot of vegetables and potatoes. Now I can’t stand up to cut up this food. Cleaning messy pots is out.
Had stress with one thing a few weeks ago, didn’t even go out. It was by phone and email. It wiped me out completely.
I know more research is going on: Kudos to Ian Lipkin, Drs. Kamaroff, Klimar, the Lights, Englander, Mikovits, Ruscetti, Fluge and Mella — and all others trying to find the cause, treatments, biomarkers. Something has to give here.
Meanwhile, I’m trying to find a decent painkiller to help with muscle pain and headaches that doesn’t make me hyper and wired and then rev up my heartbeat. Every medication affects me.
So, here’s hoping 2012 is the year of discovery. I’d like to be able to enjoy the rest of my life.
I am coming up to 24yrs. This whole disease is about loss, my career, relationships, dreams but also the loss of control of my body. No walking the dog, getting the mail, cooking a decent meal, meeting friends or family for any occasion. The pain is my companion. I’m a prisoner in my own home and my bed. How did this go on so long?
I have testified before members of the United States Congress concerning my suffering from illness that has symptoms that match what “CFS/ME” patients report. The difference is that my illness is present only after exposure to indoor molds.
I work as a professional rock climbing and fly fishing guide, and I can assure you that post exertional malaise is not something that is compatible with this.
In light of this and in my opinion, “CFS/ME” is an environmental illness, caused by inflammatory response to ongoing exposure to ubiquitous biological agents in the built environment. CFS research appears to be ignoring this massively documented etiological evidence because of it’s politically inconvenient truth.
Dear Kim,
will you be able to provide access to the full text of this paper? (Perhaps not clear yet?)
Thanks!
Emma
Hi Emma, We are working on it! Please check back again. Sorry for the inconvenience.