Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

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...

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Published in:	Contemporary clinical trials communications Vol. 21; p. 100730
Main Authors:	Slobogean, Gerard P., Sprague, Sheila, Thabane, Lehana, Wood, Amber, Della Rocca, Gregory J., O'Hara, Lyndsay M., Davies, Jonah, Taljaard, Monica, Heels-Ansdell, Diane, Marvel, Debra, Joshi, Manjari G., Bhandari, Mohit, Nguyen, Uyen, Pogorzelski, David, Rojas, Alejandra, Demyanovich, Haley, Mullins, C. Daniel, Medeiros, Michelle, Degani, Yasmin, Howe, Andrea, Camara, Megan, Petrisor, Brad A., Marcano-Fernández, Francesc A., Persico, Federico, Gaski, Greg E., Virkus, Walter W., Szatkowski, Jan P., Hill, Lauren C., Osborn, Patrick, Kimmel, Joseph, Adams, John D., Bray, Christopher C., Cross, Andrew W., Gurich, Richard W., Lazarus, David E., Schaller, Thomas M., Carlisle, Robert M., Hofer, Erin Adams, Ray, Shea Bielby, Smith, Cory D., Bedard, Julia C., Maltz, Ethan J., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Morshed, Saam, Miclau, Theodore, Marmor, Meir, Berhaneselase, Eleni, Patrick, Matthew, Krupko, Thomas, Koenig, Chris, Bailey, Daniel, Dehghan, Niloofar, Sethi, Manish, Mitchell, Phillip, Pritchett, Charles, Boulton, Christina, Wild, Jason, Taylor, Michel, Cruz, Alejandro, Hurkett, Colin, Martí-Garín, David, Pelfort, Xavier, Cámara-Cabrera, Jaume, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Pellejero-García, Raúl, Peñalver, Juan Manuel, Domènech, Mònica Salomó, Soler-Cano, Albert, Velasco-Barrera, Aldo, Romeo, Nicholas M., Breslin, Mary A., Fraifogl, Joanne, Zomar, Mauri, Spicer, Ella, Payne, Kyrsten, Karunakar, Madhav, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Bartel, Claire, Girardi, Cara, Mayfield, Ada, Hymes, Robert A., Schwartzbach, Cary C., Bullard, Debra, Mullin, Devin S., Reilly, Clifford A., DePalo, Peter, Hall, Amy E., Harris, Mitchel B., Morellato, John, Bhanat, Eldrin L., Kuczinski, Ashley, Iwu, Ashley, VanDemark, Robert, Hollinsworth, Troy, Beer, Robert
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Inc 01-03-2021 Elsevier
Subjects:	Cluster crossover Pragmatic Sampling Sampling framework Sampling strategy Work flow Work flow Sampling framework Sampling strategy Pragmatic Sampling Cluster crossover
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Summary:	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. 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. 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). 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Individual is no longer actively working on the Aqueous-PREP and/or PREPARE trial.
ISSN:	2451-8654 2451-8654
DOI:	10.1016/j.conctc.2021.100730