Over the weekend, members of the US Action Working Group (USAWG) were alerted to the publication of the National Institutes of Health’s study protocol (as posted originally). The content of the published protocol caused a number of concerns across the community, chief among them that the Reeves criteria were apparently being used as the basis for selecting patients.
On Tuesday, NIH informed the community that the protocol that had been posted online was incomplete and prematurely published and that version of the protocol has been taken down. The NIH and the study’s Principal Investigator, Dr. Avi Nath, provided some encouraging clarifications: post-exertional malaise (PEM) would be required and study participants would meet multiple criteria, including the Canadian Consensus Criteria. Additionally, NIH said that Dr. Ian Lipkin is involved in study design and the study will include 40 patients, not including control groups.
There are, however, a number of open questions. Wednesday, the USAWG submitted a list of questions to the NIH regarding the study, engagement with the community on the protocol, the disease name, the study objectives, the subject selection criteria, symptom assessments, and study design.
Submit your questions
We invite everyone in this community to take a look at these questions and add your suggestions for additional questions or changes below. We plan to collate them and submit an additional list of questions.