Stories from the Frontline: Patient-Centered Medical Home Care Transitions

The Massachusetts Patient-Centered Medical Home Initiative (MA PCMHI) was a three-year multi-payer demonstration designed to promote clinical model transformation in practices across the state and prepare the practices for PCMHI recognition. It was a partnership between MassHealth, the Massachusetts Medicaid program, and UMass Medical School. An analysis of the project at 46 participating practices finds that primary care practice transformation takes time; care transitions, including emergency room and post-discharge follow-up care, require the development of new clinical workflows; and the processes of care are more likely to improve before outcomes are affected. These lessons learned can aid provider organizations nationwide: focus on highest-risk patients, prioritize high-volume hospital systems for information-sharing; streamline documentation of the workflow in the electronic health record; and clearly identify the role and function of each care team member in the new process

Suitability of external controls for drug evaluation in Duchenne muscular dystrophy

OBJECTIVE: To evaluate the suitability of real-world data (RWD) and natural history data (NHD) for use as external controls in drug evaluations for ambulatory Duchenne muscular dystrophy (DMD). METHODS: The consistency of changes in the 6-minute walk distance (Δ6MWD) was assessed across multiple clinical trial placebo arms and sources of NHD/RWD. Six placebo arms reporting 48-week Δ6MWD were identified via literature review and represented 4 sets of inclusion/exclusion criteria (n = 383 patients in total). Five sources of RWD/NHD were contributed by Universitaire Ziekenhuizen Leuven, DMD Italian Group, The Cooperative International Neuromuscular Research Group, ImagingDMD, and the PRO-DMD-01 study (n = 430 patients, in total). Mean Δ6MWD was compared between each placebo arm and RWD/NHD source after subjecting the latter to the inclusion/exclusion criteria of the trial for baseline age, ambulatory function, and steroid use. Baseline covariate adjustment was investigated in a subset of patients with available data. RESULTS: Analyses included ∼1,200 patient-years of follow-up. Differences in mean Δ6MWD between trial placebo arms and RWD/NHD cohorts ranged from -19.4 m (i.e., better outcomes in RWD/NHD) to 19.5 m (i.e., worse outcomes in RWD/NHD) and were not statistically significant before or after covariate adjustment. CONCLUSIONS: We found that Δ6MWD was consistent between placebo arms and RWD/NHD subjected to equivalent inclusion/exclusion criteria. No evidence for systematic bias was detected. These findings are encouraging for the use of RWD/NHD to augment, or possibly replace, placebo controls in DMD trials. Multi-institution collaboration through the Collaborative Trajectory Analysis Project rendered this study feasible

Fabrication of Integrated Diffractive Micro-Optics for MEMS Applications

We investigated the fabrication of integrated diffractive micro-optical features on MEMS structures for the purpose of motion detection. The process of producing the diffractive features and the MEMS structures by focused ion beam milling is described in detail, as is the ion beam sputtering process used to produce coatings on these structures. The diffractive features of the circular Fresnel zone plate (FZP) and spiral FZP were fabricated on MEMS structures and the relevant diffraction theory is discussed. The spiral FZP diffractive features produced well defined foci whose intensity varies with distance from the FZP. Observation of these intensity variations enabled us to detect the motion of the MEMS structure, and the resulting device was used to scan an IR image of a hot object