Advantages and limitations of national arthroplasty registries. The need for multicenter registries: the Rempro-SBQ

Abstract

While the value of national arthroplasty registries (NAR) for quality improvement in total hip arthroplasty (THA) has already been widely reported, some methodological limitations associated with observational epidemiological studies that may interfere with the assessment of safety and efficacy of prosthetic implants have recently been described in the literature.Among the main limitations of NAR, the need for at least 80% compliance of all health institutions covered by the registry is emphasized; completeness equal or greater than 90% of all THA performed; restricted data collection; use of revision surgery as the sole criterion for outcome; and the inability of establishing a definite causal link with prosthetic dysfunction.The present article evaluates the advantages and limitations of NAR, in the light of current knowledge, which point to the need for a broader data collection and the use of more structured criteria for defining outcomes.In this scenario, the authors describe of idealization, conceptual and operational structure, and the project of implantation and implementation of a multicenter registry model, called Rempro-SBQ, which includes healthcare institutions already linked to the Brazilian Hip Society (Sociedade Brasileira de Quadril [SBQ]). This partnership enables the collection of more reliable and comprehensive data at a higher hierarchical level, with a significant reduction in maintenance and financing costs. The quality improvement actions supported by SBQ may enhance its effectiveness and stimulate greater adherence for collecting, storing, interpreting, and disseminating information (feedback).

Design, implementation, and management of an international medical device registry

“…It is not possible to mandate data entry for a commercial patient registry; therefore, it is wise to anticipate and account for a greater attrition rate than in rigorous clinical trials [ 18 ]. This can be factored in when considering the endpoints of the registry.…”

“…All registries are in essence observational, collecting data from routine clinical practice and therapy, but they can be implemented as voluntary or mandated. Inherent in a corporate-sponsored registry like IROS is that it must be voluntary [ 18 ]. It can be a so-called patient registry, which systematically collects data concerning a defined treatment population, or a study registry that is designed to answer specific research questions or provide supporting evidence.…”

Design, Implementation and Management of an International Medical Device Registry

“…Missing data: It is not possible to mandate data entry for a commercial patient-registry; therefore, it is wise to anticipate and account for a greater attrition rate than in rigorous clinical trials [Gomes 2017].…”

“…Type: All registries are in essence observational, collecting data from routine clinical practice and therapy, but they can be implemented as voluntary or mandated. Inherent in a corporate-sponsored registry like IROS is that it must be voluntary [Gomes 2017]. It can be a so-called patient registry, which systematically collects data concerning a de ned treatment population, or a study registry that is designed to answer speci c research questions or provide supporting evidence.…”

Implementation and quality assessment of a clinical orthopaedic registry in a public hospital department

“…Clinical registries serve as repositories for the collection of patient, treatment and outcomes data, and are valuable tools for determining the natural history of a disease or condition, evaluating the clinical performance and cost-effectiveness of healthcare services, and monitoring the safety and quality of patient care [1]. While national orthopaedic registries have been implemented in numerous countries to capture survival data for prostheses, they are limited with respect to capture of potentially modifiable risk factors for revision, and typically do not capture clinically relevant outcomes such as complications and patient-reported outcome measures (PROMs) [2]. Local registries are in a key position to provide greater insight into the clinical performance of individual surgeons, hospital departments or local health districts by capturing a greater variety of data on a more representative patient population, and thus provide more relevant clinical information pertaining to specific outcomes of interest [3].…”