Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Comparative Effectiveness Research.

Abstract

CONTEXT\nRecently, calls to conduct comparative effectiveness research (CER) in athletic training to better support patient care decisions have been circulated. Traditional research methods (eg, randomized controlled trials [RCTs], observational studies) may be ill-suited for CER. Thus, innovative research methods are needed to support CER efforts.\n\n\nOBJECTIVES\nTo discuss the limitations of traditional research designs in CER studies, describe a novel methodologic approach called the point-of-care clinical trial (POC-CT), and highlight components of the POC-CT (eg, incorporation of an electronic medical record [EMR], Bayesian adaptive feature) that allow investigators to conduct scientifically rigorous studies at the point of care.\n\n\nDESCRIPTION\nPractical concerns (eg, high costs and limited generalizability of RCTs, the inability to control for bias in observational studies) may stall CER efforts in athletic training. In short, the aim of the POC-CT is to embed a randomized pragmatic trial into routine care; thus, patients are randomized to minimize potential bias, but the study is conducted at the point of care to limit cost and improve the generalizability of the findings. Furthermore, the POC-CT uses an EMR to replace much of the infrastructure associated with a traditional RCT (eg, research team, patient and clinician reminders) and a Bayesian adaptive feature to help limit the number of patients needed for the study. Together, the EMR and Bayesian adaptive feature can improve the overall feasibility of the study and preserve the typical clinical experiences of the patient and clinician.\n\n\nCLINICAL AND RESEARCH ADVANTAGES\nThe POC-CT includes the basic tenets of practice-based research because studies are conducted at the point of care, in real-life settings, and during routine clinical practice. If implemented effectively, the POC-CT can be seamlessly integrated into daily clinical practice, allowing investigators to establish patient-reported evidence that may be quickly applied to patient care decisions. This design appears to be a promising approach for CER investigations and may help establish a learning health care system in the sports medicine community.