Medical Specialty Society–Sponsored Data Registries

Abstract

Clinical data registries are commonly used worldwide and are implemented for a variety of purposes ranging from physician or facility clinic logs for tracking patients, collecting outcomes data, to measuring quality improvement or safety of medical devices. In the United States, the Food and Drug Administration has used data collected through registries to facilitate the drug and device regulatory process, ongoing surveillance during the product life-cycle, and for disease appraisals. Furthermore, the Centers for Medicare and Medicaid Services, in certain instances, base registry participation and submitting data to registries as factors for reimbursement decisions. The purpose of this article is to discuss the use of clinical data registries, the role that medical specialty societies, in particular the American Society of Plastic Surgeons and The Plastic Surgery Foundation, can have in the development and management of registries, and the opportunities for registry use in Plastic Surgery. As outcomes data are becoming essential measures of quality healthcare delivery, participating in registry development and centralized data collection has become a critical effort for Plastic Surgery to engage in to proactively participate in the national quality and performance measurement agenda.

A Multi-institutional Analysis of Insurance Status as a Predictor of Morbidity Following Breast Reconstruction

“…The TOPS registry has been previously described in detail. 29 In short, the database is a prospectively collected patient registry that was established in 2002 by the ASPS. Since its inception, more than 1300 surgeons have reported outcomes data from over 1 million plastic surgery procedures nationwide.…”

Basal thumb osteoarthritis surgery improves health state utility irrespective of technique: a study of UK Hand Registry data

“…Thus, real-world data may provide a more realistic evaluation of an intervention, which may extend beyond the limitations of what is collected in a clinical trial setting (Garrison et al., 2007; Katkade et al., 2018). Patient registries have been used in other areas of musculoskeletal surgery, collecting PROMs and other outcome measures, to enable evaluation of techniques used in routine clinical care (ASPS, 2019; BOA, 2019; Hume et al., 2013) .…”

Feasibility of Implementing a Breast Reconstruction Database

“…[12][13][14] There are numerous benefits to creating a comprehensive breast reconstruction database, including producing a better understanding of practice characteristics, diseases, the range of treatments, and both short-and long-term outcomes. 15,6,7 Complex databases can be used as resources for the generation of research hypotheses and the completion of future studies. The American Society of Plastic Surgeons believes that it is key that plastic surgeons have an effective mechanism for collecting clinically relevant information from patients over a longitudinal period of time and benchmark their patient outcomes and complications data against other groups of patients.…”

“…The American Society of Plastic Surgeons believes that it is key that plastic surgeons have an effective mechanism for collecting clinically relevant information from patients over a longitudinal period of time and benchmark their patient outcomes and complications data against other groups of patients. 15 With the usefulness of registries depending on the quality of the data, it is crucial that data be complete, contain the appropriate variables, and be validated on a regular basis to ensure accuracy.…”

“…These databases track a number of important variables including risk factors, procedural and 30-day outcome data, and tumor characteristics. 3,15,16 However, they do not capture reconstructions performed outside the initial mastectomy, patient-reported outcomes, and long-term outcome data that can be of considerable use for quality improvement initiatives and tracking complications.…”