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

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

SUBMITTER: Pogorzelski D 

PROVIDER: S-EPMC7873628 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature