Q&A: IDSA Public Input Period
On February 2, 2009, the IDSA announced the opening of the 60-day public input period. The period expires at 5 pm on April 3, 2009. While many issues remain to be sorted out, this posting presents some of the currents Q&A issues that patients are raising.
Who can submit evidence? Any interested individual or organization.
How long can the submission be? The IDSA has requested that documents be no longer than 5 pages and that references not be longer than 2 pages. The settlement agreement does not have a page limitation on the evidence that can be submitted.
Is it important to tie my documents to the guidelines? Yes. The panel is only empowered to review recommendations in the IDSA guidelines to determine whether they are supported by scientific evidence. Any document that you submit should state the recommendation that you are refuting and the basis for your refutation. I recommend that this be placed at the top of the page, for example, “Contested Recommendation” and then describe the recommendation you contest.
What about things not included in the guidelines—can I contest those? Yes, you can address an issue not covered in the guidelines.
Where should I submit my documents?Submissions should be made to the attention of the “IDSA Lyme Disease Review Panel” at: email@example.com.
Who should make submissions? Physicians and organizations have been working on this for the past couple of months, compiling the most compelling evidence and research. This will be an orchestrated effort to group evidence by subject matter with consideration given to selecting our strongest, least contestable evidence.
This process is about submitting the best research studies that support our viewpoint. If there is too much duplication, we risk losing the forest for the trees. For instance, sometimes people think the most useful thing to do is to send over all the evidence—so they send over boxes of studies. But sometimes the real value is the act of selecting the few studies from the many so that they stand out and can be seen. In other words, it may be better to submit fewer well reasoned and scientifically supported documents, than to inundate the panel.
The panel is primarily researchers and so the evidence that will carry the most weight will be research and analysis of research. Patient stories are less likely to be effective in persuading this panel, but are permitted. Patient organizations may be the best way to submit patient views because they represent groups of patients. Some patient organizations are working on this. You might contact them.
Will the submissions be made available to the public? The IDSA states that it “may” post submissions online for public viewing. We are trying to get further clarity on this.
Who will be the presenters and how will this be decided? The presenters are not yet determined. It is expected that the IDSA will post a process for those who would like to present to apply for that opportunity. The Connecticut Attorney General Office will have a role in the selection process for those who are presenting to ensure that there is a balance of viewpoints.
When is the public hearing scheduled? The public hearing, which will be aired live over the internet, is scheduled for April 27th.
Where will the public hearing be held? The hearing will be held in Washington, DC. The precise location has not yet been determined.