And The Problem Is... The Big "Therefore"

A public comments period is underway for another new component of the U.S. ALS Registry -- https://www.federalregister.gov/articles/2015/03/24/2015-06654/proposed-data-collection-submitted-for-public-comment-and-recommendations

Please read the proposal on increasing self-enrollment and comment before May 25.

Following are my comments:

"Therefore, efforts to increase Registry awareness among non-referral center neurology practices/neurologists is needed to increase self-enrollment of persons with ALS."

That's a pretty big "therefore."  They are jumping to a conclusion without data, and that's very wrong on a project that needs to be data-driven.

There is nothing in the MMWR report that addresses the completeness of the administrative databases or the self-enrollment portal.  We simply don't know now many noses were missed in their counting techniques.  We have no idea how incomplete their census of people with ALS was.

1. What basis in fact is there that the root cause of low self-enrollment is neurologists at non-referral centers?

ATSDR decided to give large, non-competitive contracts to the ALS Association (and subsequently to the MDA) for "education and outreach" for the ALS Registry.  I believe that the rationale for such no-bid contracts was that they had access to the vast majority of people with ALS in the US via their networks of ALS clinics and neurologists.  They had the captive audience to promote self-enrollment and they were being paid handsomely to deliver them to the self-enrollment portal.

How complete are the data in the MMWR report?  How many noses were not counted by either method used?  We must answer those questions before we fly off and try to solve a problem that we can't quantify.

It is clear from the MMWR report that ALSA and MDA were not able to deliver as many people with ALS through the self-enrollment portal as the administrative databases found.  Is that a problem with the size of the population of people with ALS in their clinic networks, or is it a problem with their education and outreach to motivate their own clinic neurologists and people with ALS to self-enroll?  It's time to do some measuring and to speak to data rather than to assume that the problem must be outside these contracts.

How many unique people with ALS were seen annually in ALSA and MDA clinics, starting with the MMWR report period?  That should be a first clue as to how incomplete the self-enrollment portal data were.  That is also a big clue as to the effectiveness of these no-bid contracts.  Without that introspection and some data, why would we assume that neurologists who are not involved in ALS clinics are "the problem."  

2. Even if the root cause of the low self-enrollment problem turned out to be non-clinic neurologists, what basis is there for the assumption that cold phone calls to neurologists' staffs will actually affect physician behavior to encourage people with ALS to self-enroll?  That seems to me to be an expensive, time-consuming project not based on any kind of behaviorial studies, and it certainly lacks measurable goals for outcomes. 

People with ALS, their caregivers, and American taxpayers need a more accountable, businesslike approach to a project that is important to the fight against ALS.  We need data-driven decisions and not a convenient "therefore" regarding the completeness and root problems of the ALS Registry.