What to Read This Week
The March 2021 publication of the Journal of Orthopaedic Trauma includes a rich set of information regarding the use of Real-World Data (RWD) focused on the Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program.
The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This observational study incorporated a unique study design that could stand as a model for other studies using a real-world, external comparator approach to evaluate treatment effectiveness, potentially for regulatory approval.
The overall supplement is described by Dr. Robert Zura:
Overall, the issue provides a rationale and example for use of RWD and nontraditional study design in orthopaedic research. Our intention is not to downplay the value of RCTs, but rather to instill confidence in the use of RWD as an alternative approach to further understand the diseases, conditions, and events experienced by our patients and to highlight the potential of their use in regulatory decision-making.
This Supplement includes:
Introduction
Real-World Evidence: A Primer
Real-World Evidence: A Review of Real-World Data Sources Used in Orthopaedic Research
Leveraging Real-World Evidence: A Paradigm Shift in Regulation
Randomized Clinical Trial or Real-World Evidence: How Historical Events, Public Demand, and the Resulting Laws and Regulations Shaped the Body of Medical Evidence
Breaking Barriers: Studying Fracture Healing in the BONES Program
Methodologies for Validation of Diagnoses in Real-World Data: BONES—A Case Study
BSC's Principal Statistician Greg Maislin coauthored the Breaking Barriers: Studying Fracture Healing in the BONES Program (Mack et al.).
Congratulations to the whole Team!
The papers can be found here: https://journals.lww.com/jorthotrauma/toc/2021/03001#-1403981750