ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Thursday, September 30, 2010

Webex Session on ALS Registry Gives Some A for Q and Spawns More Q

Below are my questions and the answers to some that I think I heard on the transcript... plus some new questions that the transcript spawned --

· ALSA has published that your algorithms for mining the large administrative databases will identify 80-85 percent of ALS cases. Who are the people in the 15-20 percent who are not found via this process? I assume that there must be whole lot of people diagnosed with ALS who are somehow outside of Medicare, Medicaid, VA, etc. databases.

· One of the Achilles' heels of the many attempts at self-reporting over the years has been the inability to capture the death event in a timely and accurate manner. How does your process capture the death event? Registry data will be matched against the National Death Index periodically. People who fail to update their Quality of Life surveys on the web portal will be suspect, but the moderators did not indicate whether or how such lack of activity would be used to verify a death.

· Suppose a scientific study suggests a new environmental trigger possibility. Please describe the process you will use to expand the Registry to capture data on that possible trigger. Will it be nimble enough to do this quickly? Will additional requests for appropriations be needed to adapt?

· How much has been invested so far on the Registry project? About what proportion of that has been CDC employees’ time? … private-sector contractors?

· As I understand the process, it seems that you will be mining data in a number of administrative databases that are unique to the United States. Should we infer that the infrastructure built for this Registry will not be useful to be leveraged by other countries that might want to emulate the U.S. Registry? Is there any data standard or protocol that will enable scientists to pool data from the U.S. and other countries easily?

· If citizens of other countries are legal residents of the United States and are treated while living here, will their data be included? I could not understand the whether this question or the next question was the one that was asked on the call. The response indicated that the registry is for U.S. citizens only. Then a respondent mentioned that there were some technicalities regarding legal residents and that there would be followup on the question.

· If citizens of other countries are illegal residents of the United States and are treated while living here, will their data be included?

· If the people dealing with coordinating information in the various administrative databases and the online portal have a "is this the same person" question, will they be able to make phone calls to the individuals or sources of the administrative records to resolve the uncertainty, or are they stuck solely with the data in front of them. They don't anticipate a problem given the number of attributes that each database has on a patient.

· Many people with ALS aren't diagnosed until long after onset. Will the Registry data capture anything regarding patients' onset dates?

· Is it correct that the physician does not report anything directly to the Registry? My understanding is that the physician has nothing new to do and that cases will be identified passively from the codes on the normal medical records, Medicare billings, etc. Is that correct? ALS is not a reportable disease and therefore physicians are not required to report it as they are with other diseases such as cancers.

· What is the process for a scientist to get access to Registry data? Are the expenses of dealing with a lot of requests for data already built into the Registry budget?

· Will there be any routine publications of information from the Registry for the general public? Absolutely.

· Does the informal advisory group for the Registry still meet? If so, is it possible to coordinate meeting dates so that the ALS advocacy national meeting receives current information? It seems that in the past the advocates meeting in May has been almost a year behind on status information because of the advisory group meeting in June. Also, is there a reason why both ALS and MS surveillance were included in that advisory group?

And the transcript raised more questions in this enquiring mind --

  • There were assurances that deceased people with ALS would be captured via the national databases but not via the web portal. How far back will the registry reach to find dead people in those national databases. If somebody was on Medicare in 1990 and died from ALS, will he or she be included in the registry?
  • What would it take to make ALS reportable so that a physician diagnosing a case would simply be required to report it to the CDC?
  • The call emphasized that information would be provided to patients. This causes some concerns that general information on ALS will be maintained on yet another website. Will the CDC and ALSA and MDA coordinate so that all three organizations might share content rather than having your taxpayer/donors create and maintain redundant or competing content?
  • Are the educational materials on the patient page of the portal related to ALS in general or specifically to the ALS registry? Again, it seems appropriate that this be the go-to site for information on the ALS registry.
  • On a similar conference call sponsored by the MDA a few months ago, we heard that the registry was ready to go as soon as OMB approval came through. On this call we heard that there are two more hurdles, the CDC security hurdle and the CDC deployment process. Are there any other hurdles we should know about?
  • The state-based surveillance process described an abstract form for state health departments to supply to neurologists. Are neurologists required to respond to such requests?
  • Could you please explain exactly what was launched with the soft launch of October, 2009?
  • supplies a link to the NIH information on ALS. NIH materials have asserted for well over ten years that "As many as 20,000 Americans have ALS." When the CDC's ALS registry proves that many more than 20,000 Americans have ALS, will you be able to get the NIH to update their claim, please?
  • A feedback feature on the web portal was mentioned. Will the feedback go directly to those responsible for the ALS registry or will it be routed through the general CDC "contact us" process?

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