NIH P2P Meeting (formerly the Evidence-based Methodology Workshop)

[jspotila]

I'm not sure if this belongs in the IOM section, but I have obtained new information about the NIH's Pathways to Prevention Workshop. This was previously called the Evidence-based Methodology Workshop, and is one of the three case definition-related efforts going on (CDC Multisite and IOM being the other two). The IOM contract specifically requires IOM to seek input from the NIH meeting.

The Working Group that is planning the meeting is getting together today and tomorrow at NIH. NIH has refused to disclose the names of the members. They will be finalizing the study questions that will be used for the AHRQ evidence review. NIH and AHRQ have also refused to disclose those questions.

However, I obtained the evidence review contract through a FOIA and it includes the draft questions. Surprise! There are some problems with the questions.

I also learned that the P2P process BY DESIGN will include NO ME/CFS experts on the Workshop panel (which is different from the Working Group). This panel will oversee the Workshop and draft the final report, which will likely include recommendations on research needs and case definition use.

This is a really big deal, and it's flying under the radar because we're all so focused on IOM. I hope you will read the full post because I think we need to pay attention, especially since this process will feed into the IOM process.

http://www.occupycfs.com/2014/01/06/behind-closed-doors/

 

[Ren]

I myself am a highly-qualified non-expert with little-to-no knowledge in an infinite number of fields. Perhaps I too can work for NIH.

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Thank you, Jennie, for your work in collecting and sharing this information.

 

[Nielk]

Thank you, @jspotila for acquiring and revealing this information. I will have to read it a few times to try to make sense of it but, I agree that it certainly belongs here as part of the IOM thread. As part of their activity page for the ME/CFS diagnostic criteria study, the IOM states: " In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS."

It seems to me that it's all one and the same.

 

[Ren]

The IOM contract specifically requires.../

Is this "the" contract? Has it been released? And if so, is there a link for public viewing? Thanx.

 

[medfeb]

The contract Jennie discusses is the one for the Pathways to Prevention initiative that NIH is conducting, not the contract for the IOM initiative. But as Neilk states, the IOM initiative s expected to get input from this effort.

 

[Nielk]

Jennie states the following tasks will be presented to the workshop:

I. How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of illnesses or do they encompass the entirety of the population?

II. What tools and measurements will help define the subsets of individuals in the entire spectrum on ME/CFS? Are some of these tools already available and can they reliably detect a subset of illnesses? Is it possible to identify which subset of individuals is not defined by the current tools and measurements? What is unique about the illness quality in those individuals not captured by the tools available?

III. What are the characteristics of the individuals who respond to specific treatments in terms of the spectrum of the disorder? Why do some individuals not respond? What aspect of the disorder is most relieved by specific treatments? For treatments that have been shown to be effective, what are (is) the underlying mechanism(s) of action of that intervention?

IV. What does clinical research on ME/CFS tell us about clinical diagnosis of ME/CFS? Are there hints in the current literature for a consistent defining characteristic? In the clinical realm, what differentiates borderline “cases” into confirmed versus probable? Do co-morbidities help define subsets of the clinical cases?

V. Have previous research findings shaped current clinical practice or are research and clinical practice completely separate with respect to the illness? How much influence does biomedical research help shape [sic] the future of ME/CFS research?

In what way are these tasks, paid for by HHS, different than the ones tasked the IOM, paid for by HHS?

In addition, if this workshop is to share and work in tandem with the IOM, how will this satisfy IOM's self reported rule of 'independent work from the sponsors'? IOM prides itself on the fact they work independently and once work on a study has started, the sponsors of the study can not have further input into the work?

I am very interested to see what and how the CAA and PANDORA will respond to this?

In my opinion, a proper response to this would be a complete and unified outcry from all our organizations and advocates.

 

[Ember]

This is a really big deal, and it's flying under the radar because we're all so focused on IOM.

It's flying under the radar because, as you point out, “Almost the entire process of this Workshop is being conducted behind closed doors:”

The Working Group roster has not been released. The Working Group meeting is not open to the public. The draft questions were obtained only through a FOIA. There is no information about when the final questions will be posted. We have no idea who will be on the Panel, or even who will make that decision.

And this is a really big deal, as you say: "The only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear."

Why has the name of this Workshop changed? The IOM Statement of Work outlines the expected NIH coordination:

Also the committee should communicate and coordinate with the Office of Disease Prevention at NIH regarding their ongoing Evidence-based Methodology Workshop for ME/CFS (sic) in an effort to minimize overlap and maximize synergy. The coordination with NIH should assure that relevant information is shared and that key messages are coordinated.

But you commented in November on the prohibition against government management and control:

I think it’s worth remembering that the Federal Advisory Committee Act restricts the degree to which HHS can interfere in this IOM panel. The Act states that a government agency cannot use recommendations from an IOM committee created at the request of the government unless a) the committee was not subject to any management or control by an agency or officer of the government....

Is the IOM/NIH coordination being surrounded by smoke and mirrors? Thanks @Ecoclimber for this quotation:

My administration is committed to creating an unprecedented level of openness in government. We will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration. Openness will strengthen our democracy and promote efficiency and effectiveness in Government.

— President Barack Obama

 

[Ember]

Concerning the Evidence-based Practice Centre (EPC) task order, thanks @jennie for this:

Each workshop process takes about a year from start to finish, and its foundation is a technical brief providing “an objective description of the state of the science, a summary of ongoing research, and information on research needs.” This brief is prepared by one of the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (EPC)....

I obtained a copy of the EPC task order through FOIA. The “Small Systematic Review for Diagnosis and Treatment of Myalgic Encephalophyelitis/Chronic Fatigue Syndrome (ME/CFS)” will be conducted by the Oregon Health & Science University for $358,211.

And to Robyn for this:

EPC investigators on a third task order will conduct a topic refinement and systematic review on diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome, a condition that affects an estimated 800,00 people in the U.S. M.E. Beth Smith, D.O., assistant professor of medicine, will lead the project, which runs from June 7, 2013 to December 6, 2014. Co-investigators at OHSU include Marian McDonagh, Pharm.D., associate professor of medical informatics and clinical epidemiology and EPC associate director, Heidi Nelson, M.D., MPH, research professor of medical informatics and clinical epidemiology, Annette Totten, Ph.D., research assistant professor of medical informatics and clinical epidemiology, and Elizabeth Haney, M.D., associate professor of medicine.

How did the investigators begin their task on June 7 without their questions?

 

[jspotila]

Is this "the" contract? Has it been released? And if so, is there a link for public viewing? Thanx.

No, not THE contract unfortunately. The Statement of Task on the IOM website is the only official version we have.

 

[jspotila]

In addition, if this workshop is to share and work in tandem with the IOM, how will this satisfy IOM's self reported rule of 'independent work from the sponsors'? IOM prides itself on the fact they work independently and once work on a study has started, the sponsors of the study can not have further input into the work?

I've corresponded with IOM about how the independence will be maintained in light of the requirement to meet monthly with NIH (which I was told was administrative only, not substantive) and to coordinate with this workshop. The answer was that NIH has been invited to present at the first IOM meeting. After that, it's up to the IOM panel. They cannot and will not share IOM deliberation information with NIH (or anyone else).

 

[jspotila]

Why has the name of this Workshop changed? The IOM Statement of Work outlines the expected NIH coordination:

The name of the workshop changed because of rebranding of the program by NIH. From the P2P website: "Previously known as the Evidence-based Methodology Workshop (EbMW) program, the P2P program was renamed in 2013 to better reflect the overarching goal of the program."

 

[jspotila]

How did the investigators begin their task on June 7 without their questions?

The contract was signed on June 7, 2013. I'm not sure what steps were taken by the EPC and now. The timeline was negatively impacted by the shutdown, and they are running behind the contractual schedule. The study questions were supposed to have been finalized in the fall.

 

[Ember]

The answer was that NIH has been invited to present at the first IOM meeting.

That allowing the NIH to present at the first IOM meeting satisfies the communication and coordination expectation outlined in the Statement of Work stretches credulity to the breaking point:

Also the committee should communicate and coordinate with the Office of Disease Prevention at NIH regarding their ongoing Evidence-based Methodology Workshop for ME/CFS (sic) in an effort to minimize overlap and maximize synergy. The coordination with NIH should assure that relevant information is shared and that key messages are coordinated.

In the context of ongoing parallel processes, how could a single presentation at the first meeting be expected to minimize overlap, maximize synergy and assure that relevant information is shared and that key messages are coordinated? Surely the key message won't have been formulated by the first meeting.

Why would monthly administrative NIH/IOM meetings be needed?

 

[Denise]

As I understand it the monthly administrative meetings are for IOM to provide status updates, expenses, etc. The meetings seem to be pretty much one-sided, IOM provides updates but keeping in mind that after the initial meeting (Jan, 27th),NIH/HHS, etc can't give input to IOM unless it is done publicly...

 

[Ember]

As I understand it the monthly administrative meetings are for IOM to provide status updates, expenses, etc. The meetings seem to be pretty much one-sided, IOM provides updates but keeping in mind that after the initial meeting (Jan, 27th), NIH/HHS, etc can't give input to IOM unless it is done publicly...

Status updates and expenses can be provided in written reports. Meetings are designed for two-way communication.

 

[Nielk]

I am really confused as to the purpose of this workshop? It is, as Ember pointed out, parallel work to the IOM with similar time frames. This workshop costs us $358,211 and the IOM study one million dollars of our taxpayer's monies. If you read the task questions carefully, you will see that they are basically what the IOM has been tasked to do.

In addition, Jennie stated that she spoke to the IOM and the NIH will only take part in the first meeting and then they have to stay out of the study. In other words, the data obtained by the EbM workshop/NIH P2P meeting cannot be shared with the IOM or else they would impinge on the independence of the IOM study.

In what way does this make sense? Does HHS really think that we believe any of these lies?

 

[Denise]

Status updates and expenses can be provided in written reports. Meetings are designed for two-way communication.

I agree Ember, that status reports and expenses can be provided in written reports.

I do not know if that it standard operating procedure for IOM though. It is possible they do things differently or that the (heretofore unseen contract) stipulates in-person meetings.

It would be good to check the IOM site http://www.iom.edu/About-IOM.aspx for more specifics and share them.

Jennie Spotila made the IOM Statement of Work available here https://dl.dropboxusercontent.com/u/57025850/MECFS IOM SOW.pdf. I find it helps me to re-read some of these things from time to time.

As for meetings being designed for two-way communication ---- ideally, yes, they are. But as we have seen with SOK, CFSAC etc, --- often meetings are one-way communication.

 

[Nielk]

From the HHS' Statement of Work (SOW) to the IOM:

Also the committee should communicate and coordinate with the Office of Disease Prevention at NIH regarding their ongoing Evidence-based Methodology Workshop for ME/CFS in an effort to minimize overlap and maximize synergy. The coordination with NIH should assure that relevant information is shared and that key messages are coordinated.

How could this be accomplished if it's true that the NIH will not communicate with the IOM past the first meeting?

 

[biophile]

How much influence does biomedical research help shape [sic] the future of ME/CFS research?

Perhaps they should also ask, how much influence has psychobabble ideology had in shaping ME/CFS research, and how much has sloppy research practices distorted the evidence base?

 

[jspotila]

I am really confused as to the purpose of this workshop? It is, as Ember pointed out, parallel work to the IOM with similar time frames. This workshop costs us $358,211 and the IOM study one million dollars of our taxpayer's monies. If you read the task questions carefully, you will see that they are basically what the IOM has been tasked to do.

In addition, Jennie stated that she spoke to the IOM and the NIH will only take part in the first meeting and then they have to stay out of the study. In other words, the data obtained by the EbM workshop/NIH P2P meeting cannot be shared with the IOM or else they would impinge on the independence of the IOM study.

In what way does this make sense? Does HHS really think that we believe any of these lies?

The NIH workshop (and evidence review) will look at diagnosis and treatment of ME/CFS, particularly the effect of the case definition on research as well as what the research can tell us about case definitions. At least, that's how I read the draft questions.

The IOM study is to come up with clinical diagnostic criteria for use by primary care providers.

Overlapping, but different to a degree. The other detail is that the evidence review contracted by AHRQ is $358,211. That is only a portion (although a significant one) of the cost of the P2P meeting (which will be covered by NIH's Office of Disease Prevention as far as I can tell). We do not know the cost of the overall meeting. I believe Susan and Beth were asked that question at the May 2013 CFSAC meeting, and an answer was never provided publicly. AND NO ONE FOLLOWED UP AT THE CFSAC MEETING. Ahem. Sorry. I'm a little frustrated that a public venue in which we could get useful information is not being used that way.