Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.

OBJECTIVES: To automatically populate the case report forms (CRFs) for an international, pragmatic, multifactorial, response-adaptive, Bayesian COVID-19 platform trial. METHODS: The locations of focus included 27 hospitals and 2 large electronic health record (EHR) instances (1 Cerner Millennium and 1 Epic) that are part of the same health system in the United States. This paper describes our efforts to use EHR data to automatically populate four of the trial's forms: baseline, daily, discharge, and response-adaptive randomization. RESULTS: Between April 2020 and May 2022, 417 patients from the UPMC health system were enrolled in the trial. A MySQL-based extract, transform, and load pipeline automatically populated 499 of 526 CRF variables. The populated forms were statistically and manually reviewed and then reported to the trial's international data coordinating center. CONCLUSIONS: We accomplished automatic population of CRFs in a large platform trial and made recommendations for improving this process for future trials.

Design of affordable and ruggedized biomedical devices using virtual instrumentation.

Abstract This paper presents the designs of four low-cost and ruggedized biomedical devices, including a blood pressure monitor, thermometer, weighing scale and spirometer, designed for the East African context. The design constraints included a mass-production price point of $10, accuracy and precision comparable to commercial devices and ruggedness to function effectively in the harsh environment of East Africa. The blood pressure device, thermometer and weighing scale were field-tested in Kenya and each recorded data within 6% error of the measurements from commercial devices and withstood the adverse climate and rough handling. The spirometer functioned according to specifications, but a re-design is needed to improve operability and usability by patients. This article demonstrates the feasibility of designing and commercializing virtual instrumentation-based biomedical devices in resource-constrained environments through context-driven design. The next steps for the devices include designing them such that they can be more easily manufactured, use standardized materials, are easily calibrated in the field and have more user-friendly software programs that can be updated remotely.