Monitoring Outcome of Joint Arthroplasty in Italy: Implementation of the National Registry

Abstract

Purpose Arthroplasty registries have an important role in improving outcomes in joint surgery. As the demand for joint arthroplasty continues to increase, growing attention is being paid to the establishment of national registries, which contribute to the enhancement of the quality of patients' care. Indeed, providing postmarketing surveillance data in terms of safety and effectiveness of medical devices, registries contribute to the best orthopaedic practice and support public health decision making. In this context, a project aimed at implementing a national arthroplasty registry in Italy has appeared to be essential, and the activities performed in the last years have consolidated data collection of hip and knee replacements. Methods Based on a close cooperation among public health institutions, clinicians, and involved stakeholders, the architecture of the registry is built on three pillars: (1) data collected using Hospital Discharge Records (HDRs) integrated by an additional dataset, (2) implants identified and characterized in a dedicated medical devices library, and (3) a federation of regional registries coordinated by a public health institution, the Italian National Institute of Health. Results Besides the organizational structure, statistical analyses on joint arthroplasty from national HDR database (2001–2014) and Italian registry data (2014) are presented. Currently, the institutions participating in the registry on a voluntary basis show 80% of completeness for hip and 58% for knee, and represent approximately 18% of the national volume. Conclusion To make data collection effective, participation should be mandatory and ruled by a national law. Level of Study Level III, observational analytic study.

Seventeen-year trend (2001–2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups

“…Moreover, considerable human commitment and substantial economic resources are required to ensure high-quality data collection [2]. Currently, participation in Registries is still mainly voluntary, while to achieve comprehensive data, it should be mandatory and ruled at a national level [3]. Also, thorough databases can be widely variable within and across countries [4].…”

Cross-cultural adaptation and validation of the Italian version of the Hip disability and Osteoarthritis Outcome Score (HOOS)

“…The main aims of the study were developing the Italian translation of the HOOS and evaluating its psychometric properties (internal consistency, test-retest reliability, convergent validity, and responsiveness), along with its interpretability and acceptability. In addition, based on other arthroplasty registries experience [ 11 ], the present analysis was also performed in the perspective of introducing HOOS in the setting of the Italian Arthroplasty Registry project (RIAP, www.iss.it/riap ) [ 12 ].…”

New medical device regulations: the regulator’s view

“…In general, the primary aim of implantable device registries is to monitor real-world evidence concerning safety and performance over time; for example, with respect to joint replacements, device performance is primarily examined by measuring the revision rate (a surrogate marker of the rate of failure). To identify devices with lower performances or early failures, it is also important to understand the technical features of each device (characterization) in order to compare it with other similar devices; 9 these comparators are what are often referred to as the ‘state of the art’ and these are the benchmarks to which safety and performance metrics are often described. Registries which examine a range of devices have the potential to compare different devices in a standardized way.…”