Project Overview
As is the case in many fields, but particularly those that have undergone a period of rapid expansion, there is enormous variability in the methodology associated with using digital tools in clinical research. From a technological standpoint, for example, it is common to see the same or similar tools with varying sampling units, frequencies, epoch durations, and data processing algorithms. From a study design and reporting standpoint, the recent CTTI systematic review of feasibility studies promoting the effective use of mobile technologies noted substantial variability in the way that digital tools were deployed in clinical research studies, as well as the endpoints reported within a single clinical domain. Although there will - and should - always be some variability in how a particular tool is used in research to maximize the likelihood of a successful study, the current level of variability in the field of digital medicine has drawbacks including, for example, the unnecessary confusion that comes from adopting different units for a given sensor, the inability to make comparisons across studies, and the inability to pool different data sources for meta-analyses.
Project Goal
The purpose of this study is to discuss the advantages of adopting common methodologies in the field, and establishing common data elements allowing for straightforward comparison and merging of data. This project could include collection of original data allowing comparison of the various methodological decisions that are made during the study design phase. The overall goal is to highlight the advantages of common methodologies, not necessarily to recommend what those common methodologies should be.
Interested in participating?
Already a member?
Not yet a member?