Abstract
The electronic health record (EHR) is designed principally to support the provision and documentation of clinical care, as well as billing and insurance claims. Broad implementation of the EHR, however, also yields an opportunity to use EHR data for other purposes, including research and quality improvement. Indeed, effective use of clinical data for research purposes has been a long-standing goal of physicians who provide care for patients with ALS, but the quality and completeness of clinical data, as well as the burden of double data entry into the EHR and into a research database, have been persistent barriers. These factors provided motivation for the development of the ALS Toolkit, a set of interactive digital forms within the EHR that enable easy, consistent, and structured capture of information relevant to ALS patient care (as well as research and quality improvement) during clinical encounters. Routine use of the ALS Toolkit within the context of the CReATe Consortium's institutional review board–approved Clinical Procedures to Support Research in ALS (CAPTURE-ALS) study protocol, permits aggregation of structured ALS patient data, with the goals of empowering research and driving quality improvement. Widespread use of the ALS Toolkit through the CAPTURE-ALS protocol will help to ensure that ALS clinics become a driving force for collecting and aggregating clinical data in a way that reflects the true diversity of the populations affected by this disease, rather than the restricted subset of patients that currently participate in dedicated research studies.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 154-161 |
| Number of pages | 8 |
| Journal | Muscle and Nerve |
| Volume | 65 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2022 |
Bibliographical note
Funding Information:V.G. reports serving as an investigator on ALS clinical trials funded by Biogen and Orphazyme. J.W. reports receiving grants from the National Institutes of Health and Target ALS during the conduct of this study. J.K. has served as a consultant for MT Pharma, Denali, Biogen, Genentech, Amylyx, Cytokinetics, Wave, and Calico. D.W. has received research support from the ALS Association, and has served as a site investigator on clinical trials funded by Pharnext, as a sub‐investigator on clinical trials funded by Cytokinetics and Amylyx, and as a consultant for Mitsubishi Tanabe Pharma America during the conduct of this work. C.J. has received research support from Amylyx and the National Institutes of Health, and has served as a consultant for Mitsubishi Tanabe Pharma America, Cytokinetics, and Argenx, and on the data safety monitoring committee for Brainstorm Therapeutics and AveXis. J.C. served as a site investigator on clinical trials funded by Amylyx, AZ Therapeutics, and MTB Pharma. N.S. and T.Y. report being employed by Epic, a privately held and employee‐owned electronic health record software development company. M.B. reports grants from the National Institutes of Health, the ALS Association, the Muscular Dystrophy Association, the Centers for Disease Control and Prevention, the Department of Defense, and Target ALS during the conduct of the study, and has received personal fees from Roche, Biogen, Jazz Pharmaceuticals, and AveXis outside the submitted work. He has a provisional patent entitled “Determining Onset of Amyotrophic Lateral Sclerosis.” He presently serves as a site investigator on clinical trials funded by Biogen and Orphazyme, and as the global coordinating investigator for Orphazyme's trial of Arimoclomol in ALS. The remaining authors declare no potential conflict of interest.
Funding Information:
Development and early piloting of the was supported in part by funding from the ALS Association (17‐LGCA‐326) and the Muscular Dystrophy Association (376132). Early implementation of the CAPTURE‐ALS project was funded through the National Institutes of Health support for the CReATe Consortium (U54NS092091), which is part of the Rare Diseases Clinical Research Network (RDCRN), and is supported by the RDCRN Data Management and Coordinating Center (U2CTR002818). RDCRN is an initiative of the Office of Rare Diseases Research (ORDR), NCATS. CReATe is funded through a collaboration between NCATS, and the NINDS. ALS Toolkit
Publisher Copyright:
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