Registries Collecting Level-I through IV Data: Institutional and Multicenter Use

第一作者:Victor J. Hansen

2014-12-04 点击量:524   我要说

Victor J. Hansen,Meredith E. Greene,Marc A. Bragdon,Audrey K. Nebergall

Christopher J. Barr,J.I. Huddleston,Charles R. Bragdon,Henrik Malchau


TOTAL JOINT REPLACEMENT (TJR) REGISTRIES WORLDWIDE


What Is a TJR Registry?


TJR registries represent ongoing prospective observational studies in which primary and revision TJR procedures are recorded. Registries may be local, regional, national, or international. The data set collected must include a patient identifier and details regarding demographic, surgical, and clinical outcome data.


A registry can collect up to four levels of data. Level-I data include patient, surgeon, and hospital identifiers and procedure data, allowing monitoring of revision rates after TJR. Level-II data consist of patient factors, comorbidities, surgical data, perioperative care, and complications. Changes in complication rates over time can be evaluated and compared with changes in care. Level-III data include patient-reported outcome measures, which increase the ability of the registry to detect poor outcomes after TJR by assessing the patient’s perspective. Generic and disease-specific self-administered questionnaires measure general health, symptoms, function, activity level, and patient satisfaction. These allow for identification of risk factors for poor outcomes, assessment of overall health improvement after surgery, and analysis of the cost-effectiveness of TJR. Finally, radiographs are considered level-IV data. Inclusion of level-IV data increases the ability to detect subclinical implant failure. Storage of digital radiographic images in an organized registry framework facilitates analysis of large numbers of patient images for implant wear, osteolysis, alignment, and/or component positioning. Addition of level-V data to registries has been discussed; such data would comprise explanted components and would be used for assessing the relationship between device damage and the reason for revision.


National TJR registries aim to capture all TJR procedures performed and are generally maintained by the national orthopaedic society and funded by the government6. Data quality is highly dependent on compliance by the hospitals performing TJRs. Full membership in the International Society of Arthroplasty Registers (ISAR) requires participation of >80% of national hospitals (high compliance) and …

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