An approach to virtual clinical trial site visits: Lessons from the MeTeOR trial.

Objective: 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. The preparation phase involved a review of relevant site-specific documents and a written report on the findings prior to the visit. The virtual visit itself was focused on any questions the site staff had about the pre-visit report, observing a mock study visit, touring physical spaces, and understanding the site staff's work environment. In the follow-up phase, we wrote a post-visit report summarizing the discussion during the visit and feedback given by the coordinating site. Results: We found that the virtual site visits conducted as part of the MeTeOR trial follow-up ran smoothly. Although we could not directly compare in-person and virtual site visits, site staff unanimously appreciated the efficiency and effectiveness of the virtual site visits. We noted that displaying physical workspaces over videoconferencing was difficult, and a notable drawback to this method. Conclusions: To our knowledge, this is the first published framework for conducting virtual clinical trial site visits. Conducting these visits virtually confer several advantages in terms of time, money, and efficiency.

Objective performance tests assess aspects of function not captured by self-report in knee osteoarthritis.

Objective: Knee osteoarthritis (OA) can substantially limit function, which can be assessed both objectively and subjectively. We examined whether objective performance tests are associated with self-reported function. Methods: We analyzed baseline data from the Osteoarthritis Registry of Biomarker and Imaging Trajectories (ORBIT) of participants ≥40 years old with symptomatic and radiographic knee OA. Subjects completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Activities of Daily Living (ADL) scales and other assessments of pain and comorbidity. Subjects performed the timed single leg balance test (SLB), 30-s sit-to-stand (30s STS), Timed-Up-and-Go (TUG), and 40-m fast paced walk (40 â€‹m Walk). We used Pearson correlation coefficients to examine associations between performance and KOOS subscales. We adjusted for potential confounders using partial correlations. Results: We enrolled 101 subjects (mean age 63.7 (standard deviation (SD) 10.1), mean BMI 30.0 (SD 5.6), and 63% female). The mean (SD) values for the performance tests were: SLB 20.1 (18.9) seconds, 30s STS 11.7 (4.6) stands, TUG 9.4 (2.3) seconds, and 40 â€‹m Walk 27.6 (6.5) seconds. Correlations between performance tests and self-report measures did not exceed 0.39, with the absolute value of correlations between KOOS ADL and performance measures ranging from 0.24 to 0.39. Adjusted partial correlations were largely similar to the crude correlations. Conclusions: Self-reported function in persons with knee OA had weak to modest correlations with objective function. Objective performance tests capture elements of physical function that self-report data do not and point to the potential value of including objective measures of functional status in OA trials.