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

  • Author(s): 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
  • PREP-IT Investigators Executive Committee:
  • Steering Committee
  • Adjudication Committee
  • Data and Safety Monitoring Committee
  • Research Methodology Core
  • Patient Centred Outcomes Core
  • Orthopaedic Surgery Core
  • Operating Room Core
  • Infectious Disease Core
  • Military Core
  • McMaster University Methods Center
  • University of Maryland School of Medicine Administrative Center
  • University of Maryland School of Pharmacy, The PATIENTS Program
  • PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE)
  • Aqueous-PREP and PREPARE
  • Aqueous-PREP
  • PREPARE
  • PREP-IT Investigators Executive Committee
  • et al.
Abstract

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.

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