학술논문
Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial
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article
Author
Pogorzelski, David; Nguyen, Uyen; McKay, Paula; Thabane, Lehana; Camara, Megan; Ramsey, Lolita; Seymour, Rachel; Goodman, J Brett; McGee, Sheketha; Fraifogl, Joanne; Hudgins, Andrea; Tanner, Stephanie L; Bhandari, Mohit; Slobogean, Gerard P; Sprague, Sheila; Committee:, on behalf of the PREP-IT Investigators Executive; Wells, Jeffrey; Committee, Steering; D'Alleyrand, Jean-Claude; Harris, Anthony D; Mullins, Daniel C; Wood, Amber; Committee, Adjudication; Della Rocca, Gregory J; Hebden, Joan; Jeray, Kyle J; Marchand, Lucas; O'Hara, Lyndsay M; Zura, Robert; Committee, Data and Safety Monitoring; Gardner, Michael J; Blasman, Jenna; Davies, Jonah; Liang, Stephen; Taljaard, Monica; Core, Research Methodology; Devereaux, PJ; Guyatt, Gordon H; Heels-Ansdell, Diane; Core, Patient Centred Outcomes; Marvel, Debra; Palmer, Jana; Friedrich, Jeff; O'Hara, Nathan N; Grissom, Frances; Core, Orthopaedic Surgery; Gitajn, I Leah; Morshed, Saam; O'Toole, Robert V; Petrisor, Bradley A; Core, Room; Mossuto, Franca; Core, Infectious Disease; Joshi, Manjari G; Core; Fowler, Justin; Rivera, Jessica; Talbot, Max; Center, McMaster University Methods; Dodds, Shannon; Garibaldi, Alisha; Li, Silvia; Rojas, Alejandra; Scott, Taryn; Del Fabbro, Gina; Szasz, Olivia Paige; Center, University of Maryland School of Medicine Administrative; Howe, Andrea; Rudnicki, Joshua; Demyanovich, Haley; Little, Kelly; School of Pharmacy, The PATIENTS Program University of Maryland; Mullins, C Daniel; Medeiros, Michelle; Kettering, Eric; Hale, Diamond; Site, PREP-IT Clinical Sites Lead Clinical; Eglseder, Andrew; Johnson, Aaron; Langhammer, Christopher; Lebrun, Christopher; Manson, Theodore; Nascone, Jason; Paryavi, Ebrahim; Pensy, Raymond
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Abstract
IntroductionPragmatic 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.MethodsGiven 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.Results7 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