Development and validation of a minimum data set for total joint arthroplasty registries.

BACKGROUND: Total joint arthroplasties (TJAs), including total knee (TKA) and total hip (THA), are common treatments for end-stage arthritis, significantly improving patients' quality of life (QoL). Clinical TJA registries play a critical role in monitoring implant performance, revision surgeries, postoperative complications, and long-term outcomes and patient-reported outcomes (PROs). However, the lack of a standardized data collection framework limits data integration, interoperability, and comparison across healthcare systems and studies. This study aims to establish a minimum data set (MDS) for the development of a TJA registry system. The proposed MDS represents the essential data elements needed to consistently capture key information related to TJA procedures. Establishing this MDS can facilitate greater agreement among stakeholders and support effective patient care, clinical research, and healthcare policy decisions.

METHODS: This mixed-method study was performed from December 2023 to March 2024 in two phases. Initially, an extensive literature review, along with the review of existing arthroplasty registries and patients' medical records, was conducted to identify potential administrative and clinical data elements. The extracted items were then organized into a researcher-developed checklist. In the second phase, a 17-member expert panel refined the data elements through a two-round Delphi survey. Clinical and administrative items were evaluated by orthopedic surgeons and other experts involved in arthroplasty care to ensure their clinical relevance and suitability for comprehensive TJA registry purposes. Data elements with ≥ 80% agreement were included in the final MDS. Finally, Quantitative validity was assessed using the content value index (CVI), Kappa, and content validity ratio (CVR).

RESULTS: A total of 154 data elements related to the TJA procedures (TKA and THA) were identified by literature review. Following expert consensus, 136 data elements that capture preoperative, intraoperative, and postoperative data of the TJA procedures were accepted. Finally, 111 data elements were confirmed through CVI and CVR calculation.

CONCLUSIONS: The finalized MDS supports standardized and interoperable data collection across healthcare settings. From a clinical perspective, the TJA-MDS may facilitate outcome monitoring, implant performance evaluation, identification of complications and revision trends, PROs assessment, evidence-based decision-making, multicenter research, quality improvement, and healthcare policy development related to TJA procedures.