Russ reminds me that Table 6.1 of the GPC proposal<http://frontiersresearch.org/frontiers/sites/default/files/frontiers/documents/GPC-PCORI-CDRN-Research-Plan-Template-KUMCv44.pdf> already has a pretty good sketch of what I'm after:
Proposed Data Elements: Demographics: Age, gender, race, ethnicity Onset Phenotype: Date of initial symptom onset (defined as date of weakness onset) Initial symptom location, i.e., bulbar, respiratory, limb (arm, leg, right, left, bilateral), cognitive/behavioral, other Outcome Scales/Measures: - ALS Functional Rating Scale-Revised (ALSFRS-R) - Cognitive Behavior Screen (CBS) - ALS Quality of Life (ALS QoL) - Center for Neurologic Study-Liability Scale (CNS- LS) - Drooling Scale - Vital Capacity (VC) - Neuromuscular Examinations - Physical Examinations - Vital Signs We will use the NIH Common Data Element26 forms when appropriate as well as Target Population Size: We have documented that we have over 1115 patients being seen annually in GPC site ALSA or MDA clinics for ALS. The individual clinics across our 10 sites see ~50 to ~200 patients annually at each of their sites and Proposed Membership Sources: The designated ALS clinics at all sites that are supported by the Amyotrophic Lateral Sclerosis Association or Muscular Dystrophy Association or both will be where we will access all ALS patients. As discussed in the text, due to both the rarity and the complexity of management, once diagnosed with ALS, patients are uniformly seen in these specialty clinics ________________________________ From: Dan Connolly Sent: Sunday, January 26, 2014 9:49 PM To: Richard Barohn; Russ Waitman; Sarah Schlachter; Kieran Pemberton; Laura Herbelin; Mazen Dimachkie; '[email protected]' Cc: '[email protected]' Subject: RE: top data elements from ALS? Russ sent me one set of forms early this month; I take it you're happy to share them with gpc-dev (and hence publicly): * ALS Clinical Workflow v1.1<https://drive.google.com/file/d/0B02nuw10QdWQcjFpaTF3OERiaFk/edit?usp=sharing> That's a copy of what you sent to Russ December 16, 2013 2:40 PM. Laura, Kieran, I look forward to seeing the saliva endpoint measure etc. -- Dan ________________________________ From: Richard Barohn Sent: Monday, January 20, 2014 6:00 PM To: Dan Connolly; Russ Waitman; Sarah Schlachter; Kieran Pemberton; Laura Herbelin; Mazen Dimachkie; '[email protected]' Cc: '[email protected]' Subject: Re: top data elements from ALS? Proib need to meet Yes a simple icd 9 code 335.7 I believe We gave russ drafts of forms we would like to use that were created by a couple friends who do als that have been working w epic in wisconsin to standardize this But we have not revised the forms yet for what we want to do for gpc project I was waiting to have a conf call of the als docs at all sites to discuss this and have u and russ on phone I believe that call is being set up by either jen or abbie in our offices Russ can you send dan the forms jon and alex sent us Also laura send dan also the forms for saliva endpoint measure (the one we said we would use in project we sent to pcori. Two weeks ago) and cog screen form and the single question qol ......I think alsfrs and prob cog screen was in katz forms From: Dan Connolly Sent: Monday, January 20, 2014 10:47 AM To: Russ Waitman; Sarah Schlachter; Kieran Pemberton; Richard Barohn Cc: [email protected] <[email protected]> Subject: top data elements from ALS? Russ, Dr. Barohn, Can you update us on data needs from ALS? A sketch of an i2b2 query would be ideal, but whatever you have handy is great. What signal should we use to detect an ALS patient? Is it as simple as an ICD9 code? If you could only have a handful of other data elements, what would they be? p.s. Note the gpc-dev public archive<http://www.mail-archive.com/[email protected]/>; this is a public discussion forum. -- Dan
