Chronic lower back pain (CLBP) affects 25% of U.S. adults and is associated with high costs due to physician visits and reduced productivity. Research shows that massage and yoga can be effective nonpharmacological treatments for CLBP, but the feasibility, scalability, individual treatment, and adverse-event heterogeneity of these treatments are unknown. The current study evaluated the feasibility and acceptability of a series of personalized (N-of-1) interventions for virtual delivery of massage and yoga or usual-care treatment for CLBP in 57 participants. We hypothesized that this study would provide valuable information about implementing a virtual, personalized platform for randomized controlled trials of personalized (N-of-1) interventions among individuals with CLBP. The study will do so by determining participants' ratings of usability and satisfaction with the virtual, personalized intervention delivery system and, in the long term, identifying ways to integrate these personalized trials into patient care. Of the 57 participants enrolled, two withdrew from the study and were not eligible to receive the primary outcome assessment. Thirty-seven of the remaining 55 participants (67.3%) completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Participants rated the usability of the personalized trial as excellent (average SUS score = 85.8), 95% were satisfied with the personalized trial overall, and 100% stated they would recommend the trial to others. These results suggest that personalized trials of massage and yoga are highly feasible and acceptable to participants with CLBP. This trial was approved by the Northwell Health Institutional Review Board (IRB). The trial results will be published in a peer-reviewed journal. This trial is registered on www.ClinicalTrials.gov (number NCT04203888).
Evaluation design decisions for a large-scale child care provider training program are discussed as a function of three program characteristics: decentralization, local autonomy, and multiple delivery strategies. The fact that delivery strategies were not assigned, but evolved as a logical result of local autonomy, presented particular difficulties to evaluation. Rather than using a sampling plan, we gathered data for all training courses and trainees. While decentralized process data were gathered, only centralized outcome data were collected. Consideration of the relative merits of the approaches taken indicated that the decisions made wereappropriateforaprogram with such diverse implementation.
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