Contemporary Clinical Trials Communications (Mar 2021)

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

  • David Pogorzelski,
  • Uyen Nguyen,
  • Paula McKay,
  • Lehana Thabane,
  • Megan Camara,
  • Lolita Ramsey,
  • Rachel Seymour,
  • J. Brett Goodman,
  • Sheketha McGee,
  • Joanne Fraifogl,
  • Andrea Hudgins,
  • Stephanie L. Tanner,
  • Mohit Bhandari,
  • Gerard P. Slobogean,
  • Sheila Sprague,
  • Gerard P. Slobogean,
  • Sheila Sprague,
  • Jeffrey Wells,
  • Mohit Bhandari,
  • Gerard P. Slobogean,
  • Mohit Bhandari,
  • Sheila Sprague,
  • Jean-Claude D'Alleyrand,
  • Anthony D. Harris,
  • Daniel C. Mullins,
  • Lehana Thabane,
  • Jeffrey Wells,
  • Amber Wood,
  • Gregory J. Della Rocca,
  • Anthony D. Harris,
  • Joan Hebden,
  • Kyle J. Jeray,
  • Lucas Marchand,
  • Lyndsay M. O'Hara,
  • Robert Zura,
  • Michael J. Gardner,
  • Jenna Blasman,
  • Jonah Davies,
  • Stephen Liang,
  • Monica Taljaard,
  • P.J. Devereaux,
  • Gordon H. Guyatt,
  • Lehana Thabane,
  • Diane Heels-Ansdell,
  • Debra Marvel,
  • Jana Palmer,
  • Jeffrey Wells,
  • Jeff Friedrich,
  • Daniel C. Mullins,
  • Nathan N. O'Hara,
  • Ms. Frances Grissom,
  • Gregory J. Della Rocca,
  • I. Leah Gitajn,
  • Kyle J. Jeray,
  • Saam Morshed,
  • Robert V. O'Toole,
  • Bradley A. Petrisor,
  • Megan Camara,
  • Franca Mossuto,
  • Anthony D. Harris,
  • Manjari G. Joshi,
  • Jean-Claude D'Alleyrand,
  • Justin Fowler,
  • Jessica Rivera,
  • Max Talbot,
  • Sheila Sprague,
  • Mohit Bhandari,
  • Shannon Dodds,
  • Alisha Garibaldi,
  • Silvia Li,
  • Uyen Nguyen,
  • David Pogorzelski,
  • Alejandra Rojas,
  • Taryn Scott,
  • Gina Del Fabbro,
  • Olivia Paige Szasz,
  • Diane Heels-Ansdell,
  • Paula McKay,
  • Gerard P. Slobogean,
  • Nathan N. O'Hara,
  • Andrea Howe,
  • Joshua Rudnicki,
  • Haley Demyanovich,
  • Kelly Little,
  • C. Daniel Mullins,
  • Michelle Medeiros,
  • Eric Kettering,
  • Diamond Hale,
  • Robert V. O'Toole,
  • Jean-Claude D'Alleyrand,
  • Andrew Eglseder,
  • Aaron Johnson,
  • Christopher Langhammer,
  • Christopher Lebrun,
  • Theodore Manson,
  • Jason Nascone,
  • Ebrahim Paryavi,
  • Raymond Pensy,
  • Andrew Pollak,
  • Marcus Sciadini,
  • Gerard P. Slobogean,
  • Yasmin Degani,
  • Haley K. Demyanovich,
  • Andrea Howe,
  • Nathan N. O'Hara,
  • Katherine Joseph,
  • Joshua Rudnicki,
  • Megan Camara,
  • Brad A. Petrisor,
  • Herman Johal,
  • Bill Ristevski,
  • Dale Williams,
  • Matthew Denkers,
  • Krishan Rajaratnam,
  • Jamal Al-Asiri,
  • Jordan Leonard,
  • Francesc A. Marcano-Fernández,
  • Jodi Gallant,
  • Federico Persico,
  • Marko Gjorgjievski,
  • Annie George,
  • Roman M. Natoli,
  • Greg E. Gaski,
  • Todd O. McKinley,
  • Walter W. Virkus,
  • Anthony T. Sorkin,
  • Jan P. Szatkowski,
  • Joseph R. Baele,
  • Brian H. Mullis,
  • Lauren C. Hill,
  • Andrea Hudgins,
  • Patrick Osborn,
  • Justin Fowler,
  • Sarah Pierrie,
  • Eric Martinez,
  • Joseph Kimmel,
  • Kyle J. Jeray,
  • John D. Adams,
  • Michael L. Beckish,
  • Christopher C. Bray,
  • Timothy R. Brown,
  • Andrew W. Cross,
  • Timothy Dew,
  • Gregory K. Faucher,
  • Richard W. Gurich, Jr.,
  • David E. Lazarus,
  • S. John Millon,
  • M. Jason Palmer,
  • Scott E. Porter,
  • Thomas M. Schaller,
  • Michael S. Sridhar,
  • John L. Sanders,
  • L. Edwin Rudisill, Jr.,
  • Michael J. Garitty,
  • Andrew S. Poole,
  • Michael L. Sims,
  • Clark M. Walker,
  • Robert M. Carlisle, II,
  • Erin Adams Hofer,
  • Brandon S. Huggins,
  • Michael D. Hunter,
  • William A. Marshall,
  • Shea Bielby Ray,
  • Cory D. Smith,
  • Kyle M. Altman,
  • Julia C. Bedard,
  • Markus F. Loeffler,
  • Erin R. Pichiotino,
  • Austin A. Cole,
  • Ethan J. Maltz,
  • Wesley Parker,
  • T. Bennett Ramsey,
  • Alex Burnikel,
  • Michael Colello,
  • Russell Stewart,
  • Jeremy Wise,
  • M. Christian Moody,
  • Stephanie L. Tanner,
  • Rebecca G. Snider,
  • Christine E. Townsend,
  • Kayla H. Pham,
  • Abigail Martin,
  • Emily Robertson,
  • Saam Morshed,
  • Theodore Miclau,
  • Utku Kandemir,
  • Meir Marmor,
  • Amir Matityahu,
  • R. Trigg McClellan,
  • Eric Meinberg,
  • David Shearer,
  • Paul Toogood,
  • Anthony Ding,
  • Erin Donohue,
  • Tigist Belaye,
  • Eleni Berhaneselase,
  • Alexandra Paul,
  • Kartik Garg,
  • Joshua L. Gary,
  • Stephen J. Warner,
  • John W. Munz,
  • Andrew M. Choo,
  • Timothy S. Achor,
  • Milton L. “Chip” Routt,
  • Mayank Rao,
  • Guillermo Pechero,
  • Adam Miller,
  • Jennifer E. Hagen,
  • Matthew Patrick,
  • Richard Vlasak,
  • Thomas Krupko,
  • Kalia Sadasivan,
  • Chris Koenig,
  • Daniel Bailey,
  • Daniel Wentworth,
  • Chi Van,
  • Justin Schwartz,
  • Niloofar Dehghan,
  • Clifford B. Jones,
  • J Tracy Watson,
  • Michael McKee,
  • Ammar Karim,
  • Michael Talerico,
  • Debra L. Sietsema,
  • Alyse Williams,
  • Tayler Dykes,
  • William T. Obremskey,
  • Amir Alex Jahangir,
  • Manish Sethi,
  • Robert Boyce,
  • Daniel J. Stinner,
  • Phillip Mitchell,
  • Karen Trochez,
  • Andres Rodriguez,
  • Vamshi Gajari,
  • Elsa Rodriguez,
  • Charles Pritchett,
  • Christina Boulton,
  • Jason Lowe,
  • Jason Wild,
  • John T. Ruth,
  • Michel Taylor,
  • Andrea Seach,
  • Sabina Saeed,
  • Hunter Culbert,
  • Alejandro Cruz,
  • Thomas Knapp,
  • Colin Hurkett,
  • Maya Lowney,
  • Michael Prayson,
  • Indresh Venkatarayappa,
  • Brandon Horne,
  • Jennifer Jerele,
  • Linda Clark,
  • Francesc Marcano-Fernández,
  • Montsant Jornet-Gibert,
  • Laia Martínez-Carreres,
  • David Martí-Garín,
  • Jorge Serrano-Sanz,
  • Joel Sánchez-Fernández,
  • Matsuyama Sanz-Molero,
  • Alejandro Carballo,
  • Xavier Pelfort,
  • Francesc Acerboni-Flores,
  • Anna Alavedra-Massana,
  • Neus Anglada-Torres,
  • Alexandre Berenguer,
  • Jaume Cámara-Cabrera,
  • Ariadna Caparros-García,
  • Ferran Fillat-Gomà,
  • Ruben Fuentes-López,
  • Ramona Garcia-Rodriguez,
  • Nuria Gimeno-Calavia,
  • Guillem Graells-Alonso,
  • Marta Martínez-Álvarez,
  • Patricia Martínez-Grau,
  • Raúl Pellejero-García,
  • Ona Ràfols-Perramon,
  • Juan Manuel Peñalver,
  • Mònica Salomó Domènech,
  • Albert Soler-Cano,
  • Aldo Velasco-Barrera,
  • Christian Yela-Verdú,
  • Mercedes Bueno-Ruiz,
  • Estrella Sánchez-Palomino,
  • Ernesto Guerra,
  • Yaiza García,
  • Nicholas M. Romeo,
  • Heather A. Vallier,
  • Mary A. Breslin,
  • Joanne Fraifogl,
  • Eleanor S. Wilson,
  • Leanne K. Wadenpfuhl,
  • Paul G. Halliday,
  • Darius G. Viskontas,
  • Kelly L. Apostle,
  • Dory S. Boyer,
  • Farhad O. Moola,
  • Bertrand H. Perey,
  • Trevor B. Stone,
  • H. Michael Lemke,
  • Mauri Zomar,
  • Ella Spicer,
  • Chen “Brenda” Fan,
  • Kyrsten Payne,
  • Kevin Phelps,
  • Michael Bosse,
  • Madhav Karunakar,
  • Laurence Kempton,
  • Stephen Sims,
  • Joseph Hsu,
  • Rachel Seymour,
  • Christine Churchill,
  • Claire Bartel,
  • Robert Miles Mayberry,
  • Maggie Brownrigg,
  • Cara Girardi,
  • Ada Mayfield,
  • Robert A. Hymes,
  • Cary C. Schwartzbach,
  • Jeff E. Schulman,
  • A. Stephen Malekzadeh,
  • Michael A. Holzman,
  • Lolita Ramsey,
  • James S. Ahn,
  • Farhanaz Panjshiri,
  • Sharmistha Das,
  • Antoinisha D. English,
  • Sharon M. Haaser,
  • Jaslynn A.N. Cuff,
  • Holly Pilson,
  • Eben A. Carroll,
  • Jason J. Halvorson,
  • Sharon Babcock,
  • J. Brett Goodman,
  • Martha B. Holden,
  • Debra Bullard,
  • Wendy Williams,
  • Thomas F. Higgins,
  • Justin M. Haller,
  • David L. Rothberg,
  • Ashley Neese,
  • Mark Russell,
  • I. Leah Gitajn,
  • Marcus Coe,
  • Kevin Dwyer,
  • Devin S. Mullin,
  • Clifford A. Reilly,
  • Peter DePalo,
  • Amy E. Hall,
  • Marilyn Heng,
  • Mitchel B. Harris,
  • R. Malcolm Smith,
  • David W. Lhowe,
  • John G. Esposito,
  • Mira Bansal,
  • Patrick F. Bergin,
  • George V. Russell,
  • Matthew L. Graves,
  • John Morellato,
  • Heather K. Champion,
  • Leslie N. Johnson,
  • Sheketha L. McGee,
  • Eldrin L. Bhanat,
  • Samir Mehta,
  • Derek Donegan,
  • Jaimo Ahn,
  • Annamarie Horan,
  • Mary Dooley,
  • Ashley Kuczinski,
  • Ashley Iwu,
  • David Potter,
  • Robert VanDemark, III,
  • Branden Pfaff,
  • Troy Hollinsworth,
  • Michael J. Weaver,
  • Arvind G. von Keudell,
  • Michael F. McTague,
  • Elizabeth M. Allen,
  • Todd Jaeblon,
  • Robert Beer,
  • Haley K. Demyanovich,
  • Mark J. Gage,
  • Rachel M. Reilly,
  • Cindy Sparrow

Journal volume & issue
Vol. 21
p. 100730

Abstract

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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.

Keywords