Beyond Missingness: Systematizing Methods for Comprehensive Data Fitness Assessment in Clinical Research.

Secondary use of clinical data offers unprecedented opportunities to rapidly conduct large-scale research and improve patient care. However, incomplete understanding of data quality requirements for a study often causes significant delays in executing analyses and validating results. Current practice has largely followed 2 paths. First, multi-institutional networks have developed general data quality programs, but these are typically tied to unique network characteristics and do not address study-specific requirements well. Second, models have been proposed to formalize the requirements for data fitness analyses without extending to the methods needed to meet these requirements. More recently, tools have been developed to conduct cohort-centric screening, focusing on generally applicable structural checks such as missingness or facial implausibility. These provide a first level of information but incompletely capture the fitness requirements of an analysis. In turn, investigators conduct per-study exploratory analyses, but these efforts are typically ad hoc and partially reported, which can hinder reproducible science and delay advances in patient care. Analogously to advances over the past decade in data modeling and reproducible analytics, there is a need for a more systematic, capable approach to study-specific data quality assessment (SSDQA). We discuss such a model, which guides improved SSDQA design and implementation, including metadata for consistent annotation and reporting of data quality assessment results. The model integrates theoretical principles of data quality testing with pragmatic considerations of application to clinical data, providing a consistent approach to specifying data quality assessment checks. Additionally, it proposes to regularize check application through a standard set of options. The SSDQA model builds on current practice, providing a path toward more complete, sound, and reproducible assessments. These characteristics foster multidisciplinary collaboration to identify data quality issues that, in turn, inform decisions about study design and provide important context that has a bearing on adoption of results.