TY - JOUR
T1 - Managing work flow in high enrolling trials
T2 - The development and implementation of a sampling strategy in the PREPARE trial
AU - McMaster University Methods Center
AU - University of Maryland School of Medicine Administrative Center
AU - University of Maryland School of Pharmacy, The PATIENTS Program
AU - PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE)
AU - Aqueous-PREP and PREPARE
AU - Aqueous-PREP
AU - PREPARE
AU - Steering Committee
AU - Adjudication Committee
AU - Data and Safety Monitoring Committee
AU - Research Methodology Core
AU - Patient Centred Outcomes Core
AU - Orthopaedic Surgery Core
AU - Operating Room Core
AU - Infectious Disease Core
AU - Military Core
AU - Pogorzelski, David
AU - Nguyen, Uyen
AU - McKay, Paula
AU - Thabane, Lehana
AU - Camara, Megan
AU - Ramsey, Lolita
AU - Seymour, Rachel
AU - Goodman, J. Brett
AU - McGee, Sheketha
AU - Fraifogl, Joanne
AU - Hudgins, Andrea
AU - Tanner, Stephanie L.
AU - Bhandari, Mohit
AU - Slobogean, Gerard P.
AU - Sprague, Sheila
AU - Wells, Jeffrey
AU - D'Alleyrand, Jean Claude
AU - Harris, Anthony D.
AU - Mullins, Daniel C.
AU - Wood, Amber
AU - Della Rocca, Gregory J.
AU - Hebden, Joan
AU - Jeray, Kyle J.
AU - Marchand, Lucas
AU - O'Hara, Lyndsay M.
AU - Zura, Robert
AU - Gardner, Michael J.
AU - Blasman, Jenna
AU - Davies, Jonah
AU - Liang, Stephen
AU - Taljaard, Monica
AU - Devereaux, P. J.
AU - Guyatt, Gordon H.
AU - Heels-Ansdell, Diane
AU - Marvel, Debra
AU - Palmer, Jana
AU - Friedrich, Jeff
AU - O'Hara, Nathan N.
AU - Grissom, Ms Frances
AU - Gitajn, I. Leah
AU - Morshed, Saam
AU - O'Toole, Robert V.
AU - Petrisor, Bradley A.
AU - Mossuto, Franca
AU - Joshi, Manjari G.
AU - Fowler, Justin
AU - Rivera, Jessica
AU - Talbot, Max
AU - Dodds, Shannon
AU - Garibaldi, Alisha
N1 - Funding Information:
The PREPARE trial is funded by the Patient-Centered Outcomes Research Institute ( PCORI ) ( PCS-1609-36512 ) and the Canadian Institutes of Health Research ( CIHR ) (Foundation Grant); the Aqueous-PREP trial is funded by the US Department of Defense ( W81XWH-17-1-070 ) and the CIHR (Foundation Grant). McMaster University Surgical Associates funded start-up activities at the Methods Centre and The Physician Services Incorporated provided funding to the Methods Centre and Hamilton Health Sciences for the Aqueous-PREP trial. The views in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its board of governors or methodology committee.
Publisher Copyright:
© 2021 The Author(s)
PY - 2021/3
Y1 - 2021/3
N2 - Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001). Conclusions: Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
AB - Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001). Conclusions: Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
KW - Cluster crossover
KW - Pragmatic
KW - Sampling
KW - Sampling framework
KW - Sampling strategy
KW - Work flow
UR - http://www.scopus.com/inward/record.url?scp=85101219304&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2021.100730
DO - 10.1016/j.conctc.2021.100730
M3 - Article
C2 - 33605946
AN - SCOPUS:85101219304
SN - 2451-8654
VL - 21
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100730
ER -