TY - JOUR
T1 - Looking for opportunities to co-enroll
T2 - The DISCOVERY study experience
AU - Anisetti, Bhrugun
AU - Rost, Natalia
AU - Barrett, Kevin
AU - Gottesman, Rebecca
AU - Graff-Radford, Jonathan
AU - Kittner, Steven
AU - Boden-Albala, Bernadette
AU - Cissel, Heather
AU - Mills, Brittany
AU - Carman, Kaley
AU - Vemuri, Prashanthi
AU - Wruck, Lisa
AU - Bhapkar, Manjushri
AU - Donahue, Katy
AU - Gupta, Soumya
AU - Meschia, James F.
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/12
Y1 - 2022/12
N2 - Background: Conducting high-quality stroke trials is complex and costly. Often these trials compete for the attention of researchers and the availability of patients. Enrolling patients in more than one study concurrently has the potential to accelerate recruitment into individual studies. DISCOVERY is a multicenter, inception cohort study of cognitive impairment and dementia following ischemic or hemorrhagic stroke. At the request of site investigators, a DISCOVERY committee reviews individual studies for approval of possible concurrent co-enrollment into DISCOVERY. The purpose of this report is to summarize the characteristics and outcomes of studies reviewed by committee for possible co-enrollment. Methods: This analysis covers studies reviewed from 07/01/2020 to 04/26/2022 by the Site Management Committee (SMC) of the DISCOVERY Recruitment and Retention Core. Characterization of each study included study type, number and length of follow-up visits, and whether there were protocol-required blood draws, brain imaging studies, or cognitive tests. Studies were scored for patient burden and scientific overlap with Discovery. The primary outcome was SMC approval to co-enroll. Results: 59 studies were reviewed, and 69.5% (n = 41, 21 clinical trials; 20 observational studies) were found by the SMC to be appropriate for co-enrollment. Higher patient burden and greater scientific overlap with DISCOVERY reduced the rates of approval for co-enrollment. Conclusion: A large number of diverse stroke studies are being run concurrently across the DISCOVERY study network, however, about two-thirds of the studies were considered appropriate for consideration of co-enrollment. Future studies should study how co-enrollment might improve trial network efficiency.
AB - Background: Conducting high-quality stroke trials is complex and costly. Often these trials compete for the attention of researchers and the availability of patients. Enrolling patients in more than one study concurrently has the potential to accelerate recruitment into individual studies. DISCOVERY is a multicenter, inception cohort study of cognitive impairment and dementia following ischemic or hemorrhagic stroke. At the request of site investigators, a DISCOVERY committee reviews individual studies for approval of possible concurrent co-enrollment into DISCOVERY. The purpose of this report is to summarize the characteristics and outcomes of studies reviewed by committee for possible co-enrollment. Methods: This analysis covers studies reviewed from 07/01/2020 to 04/26/2022 by the Site Management Committee (SMC) of the DISCOVERY Recruitment and Retention Core. Characterization of each study included study type, number and length of follow-up visits, and whether there were protocol-required blood draws, brain imaging studies, or cognitive tests. Studies were scored for patient burden and scientific overlap with Discovery. The primary outcome was SMC approval to co-enroll. Results: 59 studies were reviewed, and 69.5% (n = 41, 21 clinical trials; 20 observational studies) were found by the SMC to be appropriate for co-enrollment. Higher patient burden and greater scientific overlap with DISCOVERY reduced the rates of approval for co-enrollment. Conclusion: A large number of diverse stroke studies are being run concurrently across the DISCOVERY study network, however, about two-thirds of the studies were considered appropriate for consideration of co-enrollment. Future studies should study how co-enrollment might improve trial network efficiency.
KW - Co-enrollment
KW - DISCOVERY
KW - StrokeNet
KW - Trials
UR - http://www.scopus.com/inward/record.url?scp=85142402864&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85142402864&partnerID=8YFLogxK
U2 - 10.1016/j.jstrokecerebrovasdis.2022.106862
DO - 10.1016/j.jstrokecerebrovasdis.2022.106862
M3 - Article
C2 - 36332526
AN - SCOPUS:85142402864
SN - 1052-3057
VL - 31
JO - Journal of Stroke and Cerebrovascular Diseases
JF - Journal of Stroke and Cerebrovascular Diseases
IS - 12
M1 - 106862
ER -