In August, the NIH Office of Women’s Health announced its intent to contract with the Institute of Medicine (IOM) to form a committee to propose diagnostic criteria for ME/CFS. On Tuesday, December 3, the IOM announced the provisional committee slate for this work. It has been posted and all are invited to review the slate and provide feedback.
We’ve reached this conclusion because there is:
- Sufficient and diverse clinical experience and expertise with ME/CFS
- Patient representation among committee members
- Expertise in developing diagnostic criteria and outcome measures
- Expertise in the dissemination of information in areas of unmet medical need
Sufficient and diverse clinical experience and expertise with ME/CFS – Eight of the fifteen committee members have significant experience and expertise in ME/CFS, as long time physicians, clinical researchers, and published investigators. Many of them have close ties to the patient community and advocacy organizations. In fact, a number of them signed the anti-IOM contract letter but have agreed to serve to help ensure the best possible outcome.
Patient representation among committee members – Of critical importance is a basic understanding of the severity and complexity of the illness; those with first-hand experience can best express this. Two on the committee have been diagnosed and two have close family ties to ME/CFS. This first-hand knowledge paired with relevant expertise will greatly inform the whole of the committee and their proceedings.
Expertise in developing diagnostic criteria and outcome measures – There is a great need for broadly accepted clinical tools that can accurately define the core signs and symptoms, or reductions in specific functioning, experienced in the ME/CFS population. Currently the tools that exist are not widely used and some (like the Canadian Consensus Criteria or CCC) are limited to those specializing in ME/CFS treatment, of which there are very few. This leaves a majority of doctors lacking the tools they need to objectively detect and diagnose ME/CFS early. Three of the panel members have direct experience in developing case definitions and even more have related, relevant expertise to inform this committee work.
Expertise in the dissemination of information in areas of unmet medical need – Operationalization and widespread dissemination and adoption of a clinical diagnostic tool are critical for the ME/CFS population. When diagnosed early, the chances of recovery improve. This means primary care providers – the first line of defense in our medical system – must understand and be able to diagnose ME/CFS. Without this capability, patients are left to fend for themselves and many have suffered undiagnosed for years as they search for answers. There are members with expertise in screening for disease. It is important to note that in order to be fully effective, the resultant clinical diagnostic criteria must be widely disseminated – reaching doctors that meet the needs of under-served populations. There is significant expertise among committee members in regard to the methodology and service delivery issues that will be encountered with the full and proper distribution and implementation of such diagnostic criteria.
The Solve ME/CFS Initiative believes that the committee proposed for the IOM, with open minds and critical thinking about the evidence coupled with the right inclusive process, can have the impact necessary to make the disease-defining concepts of ME/CFS widely understood and available. Indeed the CCC has provided an important foundation for clinically defining ME/CFS but it is has not been widely used or adopted by the U.S. medical community. The credibility and authority of the IOM – the health arm of the National Academy of Sciences – is critical to making ME/CFS widely recognized and diagnosed by the nation’s medical community.
To review, the IOM was issued a charge with four important aspects that are critically important for progress:
- Identify and evaluate the evidence – The research and medical communities have learned much since the CCC was written in 2003. Reviewing and building on it, along with other evidence, will produce a current, scientifically valid criteria for clinical use.
- Develop diagnostic criteria for use by clinicians – This is critical to put tools for diagnosis in as many physician’s hands as possible, because the core signs, symptoms and decreases in specific functioning must be “easily” and reliably measured in order to detect an effect.
- Look at changing the name of the illness –This is very important as the “Chronic Fatigue Syndrome” name undermines and trivialized the disease. We are hopeful that a recommendation will be made to change the name to a more appropriate and better defining disease name.
- Develop an outreach strategy to disseminate the definition nationwide to health professionals – We strongly support this charge, recognizing that most clinicians are uninformed about ME/CFS. Widely distributed diagnostic criteria that has the ‘stamp of approval’ from the IOM will result in wider and faster recognition and diagnosis of ME/CFS.
The Solve ME/CFS Initiative believes that the committee roster demonstrates that the IOM understands the charges and the extreme importance of the committee’s success. And at the same time, we will stay vigilant and engaged in the process. We aim to “stand in the gap” alongside other advocacy groups and individuals as the process unfolds, bringing patients information, informed perspective and opportunities for involvement in the process.
The formation of the IOM committee to develop clinical diagnostic criteria is a strong, unprecedented opportunity in the history of ME/CFS. This important activity can build an emboldened base of federal support, opening the door to validation, funding and future research. There is much urgent work to be done. The Solve ME/CFS Initiative will continue to contribute as we work to fulfill our mission: Making ME/CFS understood, diagnosable and treatable. We look forward to a world free of ME/CFS.