TY - JOUR
T1 - Engaging ALS patients and caregivers (the ALS research ambassadors) to help design the REFINE-ALS biomarker study
AU - Berry, James D.
AU - Bedlack, Richard
AU - Mathews, Debra
AU - Agnese, Wendy
AU - Apple, Stephen
N1 - Funding Information:
The authors would like to thank the ALS Research Ambassadors for taking part in the advisory board meetings and for providing invaluable feedback that helped in the development of the REFINE-ALS study, and in particular, Kathleen Fowler and Madeline Kennedy, for their contributions to this manuscript. MTPA did not have any input into this report beyond that provided by the present or former MTPA employees listed as authors. p-value communications provided technical writing, editing, and publication assistance and was funded by MTPA.
Publisher Copyright:
© 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - In the planning and design of the Radicava/Edaravone Findings in Biomarkers From Amyotrophic Lateral Sclerosis (REFINE-ALS) study, we sought to elicit feedback from patients with ALS and their caregivers to ensure that patient-centric issues would be addressed. Ten ALS Clinical Research Learning Institute (ALS-CRLI) Research Ambassadors participated in 2 meetings. They provided perspectives on patients’ interest in the study, the schedule of study visits, and data sharing. The findings were used to help revise the study design, as appropriate. Key concerns identified were (1) the frequency of sample collections, (2) participant travel burden, (3) enrollment criteria, and (4) data reporting and sharing with participants. Several of the identified issues were promptly addressed. The number of visits was reduced, travel optimized, entry criteria clarified, and plans for sharing participants’ data with them were codified. The feedback from the Ambassadors was substantive and resulted in constructive patient-centric changes to the study protocol.
AB - In the planning and design of the Radicava/Edaravone Findings in Biomarkers From Amyotrophic Lateral Sclerosis (REFINE-ALS) study, we sought to elicit feedback from patients with ALS and their caregivers to ensure that patient-centric issues would be addressed. Ten ALS Clinical Research Learning Institute (ALS-CRLI) Research Ambassadors participated in 2 meetings. They provided perspectives on patients’ interest in the study, the schedule of study visits, and data sharing. The findings were used to help revise the study design, as appropriate. Key concerns identified were (1) the frequency of sample collections, (2) participant travel burden, (3) enrollment criteria, and (4) data reporting and sharing with participants. Several of the identified issues were promptly addressed. The number of visits was reduced, travel optimized, entry criteria clarified, and plans for sharing participants’ data with them were codified. The feedback from the Ambassadors was substantive and resulted in constructive patient-centric changes to the study protocol.
KW - REFINE-ALS
KW - amyotrophic lateral sclerosis
KW - biomarkers
KW - caregivers
KW - patients
KW - research ambassadors
UR - http://www.scopus.com/inward/record.url?scp=85089856636&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85089856636&partnerID=8YFLogxK
U2 - 10.1080/21678421.2020.1804939
DO - 10.1080/21678421.2020.1804939
M3 - Article
C2 - 32838576
AN - SCOPUS:85089856636
SN - 2167-8421
VL - 22
SP - 147
EP - 150
JO - Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
JF - Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
IS - 1-2
ER -