There is a lot of activity on a federal level related to ME/CFS –the IOM study, the CDC multi-site clinical assessment of CFS and now the Pathway to Prevention (P2P) initiative through the National Institutes of Health. As all of this activity stands to significantly impact the path forward for ME/CFS research and progress, the Solve ME/CFS Initiative is paying close attention to it all and is engaged where we feel we can lend a positive voice to the discussion.
In the information that follows we break down the P2P program and where ME/CFS is in the approval process so far. The Solve ME/CFS Initiative will pass along additional information as it is received. When there is an opportunity for public comment, we will report that and share the means by which you can effectively participate. If the full approval for the P2P workshop is received, it is estimated to take place in December of 2014.
The National Institutes of Health (NIH), through the Office of Disease Prevention (ODP) has a program called the Pathways to Prevention, (previously known as the Evidenced-based Methodology Workshop program.) The goal is to host workshops that identify research gaps in a selected scientific area, identify methodological and scientific weaknesses in that scientific area, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue.1 A P2P workshop can be formed for any disease or condition. Topics are submitted to NIH ODP and are selected by an independent panel based on research need.
In June of 2012, the NIH launched the process of including ME/CFS in the P2P program. Several departments within the federal government came together to recommend ME/CFS for a P2P workshop. In November of 2012, the ODP received the recommendation to consider ME/CFS and approved the submission of a full proposal in December of 2012 based on “necessity, urgency and the identification of ME/CFS as a serious unmet medical need and a public health issue. 2
This opened the door to the formation of a P2P working group to be formed in order to draft a full proposal for a P2P workshop. The working group was made up of content experts in ME/CFS – clinicians, researchers, patients, patient advocates, caregivers and Federal partners. Dr Suzanne Vernon, the Solve ME/CFS Initiative’s Director of Scientific Programs, was asked and agreed to serve in this capacity. She was unable to attend the one in-person meeting that was held in January of 2014 due to a scheduling conflict, but she remained moderately involved in the process.
The working group had three major tasks put before them:
- Refine questions for an evidence review
- You can read the refined questions the working group developed HERE, slide 16-18
- Develop the workshop agenda (topics, speakers and format)
- Nominate panel members
Once the working group completed these tasks, the workshop proposal was submitted for approval. At the time of this writing, the workshop itself has not yet been approved, though an announcement is expected this month.
Should the workshop be approved, it is anticipated to occur in December of this year. The questions proposed for the evidence review will serve to guide the process and focus the work of the P2P. Topics for the two-day workshop agenda are defined by the questions that form the evidence review. Speakers for the workshop are suggested for each question/agenda item. The speakers are all to be experts in ME/CFS and are able to speak to their personal experience and expertise as a patient, caregiver, researcher, etc.
The evidence review is a concise presentation of the ‘evidence’ and literature in ME/CFS (that relates to the study questions), boiled down and presented to the panel. The evidence report has been contracted to Oregon Health and Science University Evidence Practice Center (EPC) through the Agency for Healthcare Research and Quality (AHRQ), a division of HHS. There is an opportunity for the P2P panel to review unpublished data as well. Though we are not yet sure of the process, the Solve ME/CFS Initiative will follow developments and submit pertinent unpublished data available to us as we did with the IOM committee. The EPC exists to conduct systematic reviews of healthcare topics for federal and state agencies, professional associations, and foundations. These reviews report the evidence from clinical research studies and the quality of that evidence for use by clinicians, employers, policymakers, researchers, and others in making decisions about the provision of health care services and health research. While the EPC does not have specific ME/CFS expertise, they use a Technical Expert Panel made up of ME/CFS specialists and one patient to advise them on the study protocol.
The P2P panel will review the evidence-based report in advance of the meeting (they will receive it approximately 8 weeks in advance), and the report will be released to the public at that time. There will be opportunity to comment and offer feedback on this report.
At the two-day workshop, the P2P panel will hear from the expert speakers and be able to ask clarifying questions in a town-hall-like Q&A that will take place after each session during the meeting. The P2P Panel will be made up of experts in areas or topics that have relevance to ME/CFS and the evidence based report, but they are not to be ME/CFS experts by design – an effort to avoid bias and produce a report based on the facts presented in the evidence-based report and through the speakers.
The day after the P2P meeting, the P2P Panel will write a draft report, which will be published and the public will have 15 days for comment. Once the comment period closes, the report will be finalized and NIH will organize a robust plan to disseminate it widely. The goal would be to have a report that contains a set of recommendations based on the totality of the evidence, in the hopes of having said recommendations carried out by Federal partners in one-nine months. These recommendations are aimed at improving the robust nature of the research into ME/CFS, while the IOM committee is focused on improving diagnostics for clinical care.
We expect the announcement this month and then the workshop is anticipated to take place in December of this year. The roster of speakers and panelists will not be released until the workshop is approved. The Solve ME/CFS Initiative will pass along additional information as it is received and when there is an opportunity for public comment, we will report that and share the means by which you can effectively participate.
If the full approval for the P2P workshop is received, it is estimated to take place in December of 2014.