| 1. |
- Silman, A. J., et al.
(författare)
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International variation in distribution of ASA class in patients undergoing total hip arthroplasty and its influence on mortality: data from an international consortium of arthroplasty registries
- 2021
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 92:3, s. 304-310
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose - A challenge comparing outcomes from total hip arthroplasty between countries is variation in preoperative characteristics, particularly comorbidity. Therefore, we investigated between-country variation in comorbidity in patients based on ASA class distribution, and determined any variation of ASA class to mortality risk between countries. Patients and methods - All arthroplasty registries collecting ASA class and mortality data in patients with elective primary THAs performed 2012-2016 were identified. Survival analyses of the influence of ASA class on 1-year mortality were performed by individual registries, followed by meta-analysis of aggregated data. Results - 6 national registries and 1 US healthcare organization registry with 418,916 THAs were included. There was substantial variation in the proportion of ASA class III/IV, ranging from 14% in the Netherlands to 39% in Finland. Overall, 1-year mortality was 0.93% (95% CI 0.87-1.01) and increased from 0.2% in ASA class I to 8.9% in class IV. The association between ASA class and mortality measured by hazard ratios (HR) was strong in all registries even after adjustment for age and sex, which reduced them by half in all registries. Combined adjusted HRs were 2.0, 6.1, and 22 for ASA class II-IV vs. I, respectively. Associations were moderately heterogeneous across registries. Interpretation - We observed large variation in ASA class distribution between registries, possibly explained by differences in background morbidity and/or international variation in access to surgery. The similar, strong mortality trends by ASA class between countries enhance the relevance of its use as an indicator of comorbidity in international registry studies.
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| 2. |
- Pijls, B. G., et al.
(författare)
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MoM total hip replacements in Europe: a NORE report
- 2019
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Ingår i: Efort Open Reviews. - : Bioscientifica. - 2058-5241 .- 2396-7544. ; 4:6, s. 423-429
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Tidskriftsartikel (refereegranskat)abstract
- The purpose of this paper is to determine the prevalence of metal-on-metal (MoM) total hip replacement (THR) in European registries, to assess the incidence of revision surgery and to describe the national follow-up guidelines for patients with MoM THR including resurfacings. Eleven registries of the Network of Orthopaedic Registries of Europe (NORE) participated totalling 54 434 resurfacings and 58 498 large stemmed MoM THRs. The resurfacings and stemmed large head MoM had higher pooled revision rates at five years than the standard total hip arthroplasties (THA): 6.0%, 95% confidence interval (CI) 5.3 to 6.8 for resurfacings; 6.9%, 95% CI 4.4 to 9.4 for stemmed large head MoM; and 3.0%, 95% CI 2.5 to 3.6 for conventional THA. The resurfacings and stemmed large head MoM had higher pooled revision rates at ten years than the standard THAs: 12.1%, 95% CI 11.0 to 13.3 for resurfacings; 15.5%, 95% CI 9.0 to 22 for stemmed large head MoM; and 5.1%, 95% CI 3.8 to 6.4 for conventional THA. Although every national registry reports slightly different protocols for follow-up, these mostly consist of annual assessments of cobalt and chromium levels in blood and MRI (MARS) imaging.
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| 3. |
- Ferguson, R. J., et al.
(författare)
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ASA class is associated with early revision and reoperation after total hip arthroplasty: an analysis of the Geneva and Swedish Hip Arthroplasty Registries
- 2019
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 90:4, s. 324-330
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Tidskriftsartikel (refereegranskat)abstract
- - Background and purpose — Data from several joint replacement registries suggest that the rate of early revision surgery after primary total hip arthroplasty (THA) is increasing. The ASA class, now widely recorded in arthroplasty registries, may predict early revision. We investigated the influence of ASA class on the risk of revision and other reoperation within 3 months and within 5 years of primary THA. Patients and methods — We used data from the Geneva and Swedish Hip Arthroplasty Registries, on primary elective THAs performed in 1996–2016 and 2008–2016, respectively. 5,319 and 122,241 THAs were included, respectively. Outcomes were all-cause revision and other reoperations evaluated using Kaplan–Meier survival and Cox regression analyses. Results — Within 3 months after surgery, higher ASA class was associated with greater risk of revision and other reoperation. 3-month cumulative incidences of revision by ASA class I, II, and III–IV respectively, were 0.6%, 0.7%, and 2.3% in Geneva and 0.5%, 0.8%, and 1.6% in Sweden. 3-month cumulative incidences of other reoperation were 0.4%, 0.7%, and 0.9% in Geneva and 0.2%, 0.4%, and 0.7% in Sweden. Adjusted hazard ratios (ASA III–IV vs. I) for revision within 3 months were 2.7 (95% CI 1.2–5.9) in Geneva and 3.3 (CI 2.6–4.0) in Sweden. Interpretation — Assessment of ASA class of patients prior to THA will facilitate risk stratification. Targeted risk-reduction strategies may be appropriate during the very early postoperative period for patients identified as at higher risk. Systematically recording ASA class in arthroplasty registries will permit risk adjustment and facilitate comparison of revision rates internationally. © 2019, © 2019 The Author(s). Published by Taylor & Francis on behalf of the Nordic Orthopedic Federation.
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| 4. |
- Hoogervorst, Lotje A., et al.
(författare)
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Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review
- 2023
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Ingår i: International Journal of Health Policy and Management. - : Kerman University of Medical Sciences. - 2322-5939. ; 12:1, s. 1-11
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Forskningsöversikt (refereegranskat)abstract
- Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformite Europeenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.
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| 5. |
- Wilson, I., et al.
(författare)
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Orthopaedic registries with patient-reported outcome measures
- 2019
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Ingår i: Efort Open Reviews. - : Bioscientifica. - 2058-5241 .- 2396-7544. ; 4:6, s. 357-367
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Tidskriftsartikel (refereegranskat)abstract
- Total joint arthroplasty is performed to decreased pain, restore function and productivity and improve quality of life. One-year implant survivorship following surgery is nearly 100%; however, self-reported satisfaction is 80% after total knee arthroplasty and 90% after total hip arthroplasty. Patient-reported outcomes (PROs) are produced by patients reporting on their own health status directly without interpretation from a surgeon or other medical professional; a PRO measure (PROM) is a tool, often a questionnaire, that measures different aspects of patient-related outcomes. Generic PROs are related to a patient's general health and quality of life, whereas a specific PRO is focused on a particular disease, symptom or anatomical region. While revision surgery is the traditional endpoint of registries, it is blunt and likely insufficient as a measure of success; PROMs address this shortcoming by expanding beyond survival and measuring outcomes that are relevant to patients - relief of pain, restoration of function and improvement in quality of life. PROMs are increasing in use in many national and regional orthopaedic arthroplasty registries. PROMs data can provide important information on value-based care, support quality assurance and improvement initiatives, help refine surgical indications and may improve shared decision-making and surgical timing. There are several practical considerations that need to be considered when implementing PROMs collection, as the undertaking itself may be expensive, a burden to the patient, as well as being time and labour intensive.
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| 6. |
- Rolfson, Ola, 1973, et al.
(författare)
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Patient-reported outcome measures in arthroplasty registries: Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries
- 2016
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 87, s. 3-8
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Tidskriftsartikel (refereegranskat)abstract
- The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population.A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA).
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| 7. |
- Rolfson, Ola, 1973, et al.
(författare)
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Patient-reported outcome measures in arthroplasty registries: Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis
- 2016
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 87:Suppl 1; 362, s. 9-23
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Tidskriftsartikel (refereegranskat)abstract
- The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (How satisfied are you with your [right/left] [hip/knee] replacement?; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.
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