6. Leveraging registries as quality systems: Most healthcare enterprises participate in registries as tools for quality improvement. analyses of processes and outcomes from registries serve as feedback to inform the sites about conformance with guidelines, comparative patient outcomes, opportunities to improve care, and other critical strategic, administrative, and operational imperatives. Device use and outcomes are considered part of this function.f This infrastructure will enable medical device research and surveillance in the context of both the device and the device operator’s performance. Lessons learnt from cardiology, cardiac surgery and vascular surgeryregistries can be very helpful for the evaluation and improvement of care.g h i j Sharing best practices in provider feedback, such as use of creative data visualisation techniques, can enhance clinician and hospital participation in quality improvement registries.
Healthcare QualityImprovement domain describes the registry process for quality improvement. The registry is a healthcare delivery improvement system or is evolving into one as device technologies are diffused into practice and need continuing evaluation (including outlier identification). The registry has established mechanisms to bring about beneficial change in healthcare delivery through stakeholder participation, ownership, and integration into the relevant healthcare systems.Level 1
Early Learner
Registry does not have provider feedback benchmarking process and conducts limited device outlier assessments.
Level 2
Making Progress
Registry has more than one, and growing number of participants in provider feedback benchmarking process and conducts limited device outlier assessments.
Level 3
Defined Path to Success
Registry has initiated routine provider feedback for all participating sites. As part of that process, it is developing routine device outlier assessment.
Level 4
Well Managed
Registry has completed first major periodic feedback process. As part of the process, it has initiated device outlier assessment.
Level 5
Optimised
Registry has regular and ongoing (at least annually or similar) provider feedback in place and routinely includes device outlier assessment. Ideally, there is automation of quality process with advanced analytics and visualisation tools integrated with data collection.
fSedrakyan A, Campbell B, Graves S, Cronenwett JL. Surgical registries for advancing quality and device surveillance. Lancet (London, England). 2016;388(10052):1358-1360.
gCarroll JD, Edwards FH, Marinac-Dabic D, et al. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J Am Coll Cardiol. 2013;62(11):1026-1034.
hSedrakyan A, Campbell B, Graves S, Cronenwett JL. Surgical registries for advancing quality and device surveillance. Lancet (London, England). 2016;388(10052):1358-1360.
iShahian DM, Grover FL, Prager RL, et al. The Society of Thoracic Surgeons voluntary public reporting initiative: the first 4 years.
Ann Surg. 2015;262(3):526-535; discussion 533-525.
jDe Martino RR, Hoel AW, Beck AW, et al. Participation in the Vascular Quality Initiative is associated with improved perioperative medication use, which is associated with longer patient survival. J Vasc Surg. 2015;61(4):1010-1019.