Objective: Walk With Ease (WWE) is an effective low-cost walking program. We estimated the budget impact of implementing WWE in persons with knee osteoarthritis (OA) as a measure of affordability that can inform payers' funding decisions.
Methods: We estimated changes in two-year healthcare costs with and without WWE.
Objective: Randomized controlled trials (RCTs) are a gold standard for estimating the benefits of clinical interventions, but their decision-making utility can be limited by relatively short follow-up time. Longer-term follow-up of RCT participants is essential to support treatment decisions. However, as time from randomization accrues, loss to follow-up and competing events can introduce biases and require covariate adjustment even for intention-to-treat effects.
View Article and Find Full Text PDFObjective: To provide a framework for conducting clinical trial site visits virtually over videoconference, and to report on our experience doing so during the twelve-year follow-up of the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial.
Design: Using published FDA guidance and prior literature, we created a structure for virtual site visits that prioritized monitoring for protocol compliance, safety, and data integrity. We conducted site visits in three stages: preparation for the visit, the virtual meeting itself, and follow-up.