Collection and Reporting of Patient-reported Outcome Measures in Arthroplasty Registries: Multinational Survey and Recommendations.

BACKGROUND: Patient-reported outcome measures (PROMs) are validated questionnaires that are completed by patients. Arthroplasty registries vary in PROM collection and use. Current information about registry collection and use of PROMs is important to help improve methods of PROM data analysis, reporting, comparison, and use toward improving clinical practice. QUESTIONS/PURPOSES: To characterize PROM collection and use by registries, we asked: (1) What is the current practice of PROM collection by arthroplasty registries that are current or former members of the International Society of Arthroplasty Registries, and are there sufficient similarities in PROM collection between registries to enable useful international comparisons that could inform the improvement of arthroplasty care? (2) How do registries differ in PROM administration and demographic, clinical, and comorbidity index variables collected for case-mix adjustment in data analysis and reporting? (3) What quality assurance methods are used for PROMs, and how are PROM results reported and used by registries? (4) What recommendations to arthroplasty registries may improve PROM reporting and facilitate international comparisons? METHODS: An electronic survey was developed with questions about registry structure and collection, analysis, reporting, and use of PROM data and distributed to directors or senior administrators of 39 arthroplasty registries that were current or former members of the International Society of Arthroplasty Registries. In all, 64% (25 of 39) of registries responded and completed the survey. Missing responses from incomplete surveys were captured by contacting the registries, and up to three reminder emails were sent to nonresponding registries. Recommendations about PROM collection were drafted, revised, and approved by the International Society of Arthroplasty Registries PROMs Working Group members. RESULTS: Of the 25 registries that completed the survey, 15 collected generic PROMs, most frequently the EuroQol-5 Dimension survey; 16 collected joint-specific PROMs, most frequently the Knee Injury and Osteoarthritis Outcome Score and Hip Disability and Osteoarthritis Outcome Score; and 11 registries collected a satisfaction item. Most registries administered PROM questionnaires within 3 months before and 1 year after surgery. All 16 registries that collected PROM data collected patient age, sex or gender, BMI, indication for the primary arthroplasty, reason for revision arthroplasty, and a comorbidity index, most often the American Society of Anesthesiologists classification. All 16 registries performed regular auditing and reporting of data quality, and most registries reported PROM results to hospitals and linked PROM data to other data sets such as hospital, medication, billing, and emergency care databases. Recommendations for transparent reporting of PROMs were grouped into four categories: demographic and clinical, survey administration, data analysis, and results. CONCLUSION: Although registries differed in PROM collection and use, there were sufficient similarities that may enable useful data comparisons. The International Society of Arthroplasty Registries PROMs Working Group recommendations identify issues that may be important to most registries such as the need to make decisions about survey times and collection methods, as well as how to select generic and joint-specific surveys, handle missing data and attrition, report data, and ensure representativeness of the sample. CLINICAL RELEVANCE: By collecting PROMs, registries can provide patient-centered data to surgeons, hospitals, and national entities to improve arthroplasty care.

Higher mid-term revision rates of posterior stabilized compared with cruciate retaining total knee arthroplasties: 133,841 cemented arthroplasties for osteoarthritis in the Netherlands in 2007-2016.

Background and purpose - The preference for a cruciate retaining (CR) or posterior stabilized (PS) TKA (total knee arthroplasty) system varies greatly between Dutch hospitals, independent of patient characteristics. We examined mid-term revision rates for men and women of different age categories. Patients and methods - We included all 133,841 cemented fixed-bearing primary CR or PS TKAs for osteoarthritis reported in the Dutch Arthroplasty Register (LROI) in 2007-2016. Revision procedures were defined as minor when only insert and/or patella were revised and as major when fixed components (tibia and femur) were revised or removed. 8-year all-cause revision rates of CR and PS TKAs were calculated using competing-risk analyses. Cox-regression analyses were performed, adjusted for age at surgery, sex, ASA -score, and previous operations. Results - PS TKAs were 1.5 (95% CI 1.4-1.6) times more likely to be revised within 8 years of the primary procedure, compared with CR TKAs. When stratified for sex and age category, 8-year revision rate of PS TKAs in men <60 years was 13% (CI 11-15), compared to 7.2% (CI 6.1-8.5) of CR TKAs. Less prominent differences were found in older men and women. For men <60 years differences were found for minor (CR 1.8% (CI 1.4-2.5); PS 3.7% (CI 3.0-4.7)) and major revisions (CR 4.2% (CI 3.3-5.3); PS 7.0% (CI 5.6-8.7)). Interpretation - Patients who received a cemented fixed-bearing primary PS TKA for osteoarthritis are more likely to undergo either a minor or a major revision within 8 years. This is especially prominent for younger men.

Patient-reported outcome measures in arthroplasty registries.

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).

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.

- 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.

More than 95% completeness of reported procedures in the population-based Dutch Arthroplasty Register.

BACKGROUND AND PURPOSE: A complete and correct national arthroplasty register is indispensable for the quality of arthroplasty outcome studies. We evaluated the coverage, completeness, and validity of the Dutch Arthroplasty Register (LROI) for hip and knee arthroplasty. PATIENTS AND METHODS: The LROI is a nationwide population-based registry with information on joint arthroplasties in the Netherlands. Completeness of entered procedures was validated in 2 ways: (1) by comparison with the number of reimbursements for arthroplasty surgeries (Vektis database), and (2) by comparison with data from hospital information systems (HISs). The validity was examined by conducting checks on missing or incorrectly coded values in the LROI. RESULTS: The LROI contains over 300,000 hip and knee arthroplasties performed since 2007. Coverage of all Dutch hospitals (n = 100) was reached in 2012. Completeness of registered procedures was 98% for hip arthroplasty and 96% for knee arthroplasty in 2012, based on Vektis data. Based on comparison with data from the HIS, completeness of registered procedures was 97% for primary total hip arthroplasty and 96% for primary knee arthroplasty in 2013. Completeness of revision arthroplasty was 88% for hips and 90% for knees in 2013. The proportion of missing or incorrectly coded values of variables was generally less than 0.5%, except for encrypted personal identity numbers (17% of which were missing) and ASA scores (10% of which were missing). INTERPRETATION: The LROI now contains over 300,000 hip and knee arthroplasty procedures, with coverage of all hospitals. It has a good level of completeness (i.e. more than 95% for primary hip and knee arthroplasty procedures in 2012 and 2013) and the database has high validity.

Generic implant classification enables comparison across implant designs: the Dutch Arthroplasty Register implant library.

In the Dutch Arthroplasty Register (LROI), the product and batch number of prosthetic components and cement are registered for traceability. Registration of the product number provides opportunities to extend the information about a specific prosthesis. All product numbers used from the beginning of the registration in 2007 were characterized to develop and maintain an implant library.The Scientific Advisory Board developed a core-set that contains the most important characteristics needed to form an implant library. The final core-set contains the brand name, type, coating and material of the prosthesis. In total, 35 676 product numbers were classified, resulting in a complete implant library of all product numbers used in the LROI.To improve quality of the data and increase convenience of registration, the LROI implemented barcode scanning for data entry into the database. In 2017, 82% of prosthetic components and cement stickers had a GS1 barcode. The remaining product stickers used HIBCC barcodes and custom-made barcodes.With this implant library, implants can be grouped for analyses at group level, e.g. evaluation of the effect of a material of a prosthesis on survival of the implant. Apart from that, the implant library can be used for data quality control within the LROI database.The implant library reduces the registration burden and increases accuracy of the database. Such a system will facilitate new designs (learning from the past) and thus improve implant quality and ultimately patient safety. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180063.

[Evidence-based hip prostheses: more high-quality prostheses used after introduction of a classification system]. / Bewezen goed presterende heupprothesen: meer bewezen goede prothesen geplaatst na invoering classificatiesysteem.

OBJECTIVE: To determine the effect of an evidence-based classification list on use of total hip prostheses of proven quality in the Netherlands. DESIGN: Observational study. METHOD: The Netherlands Orthopaedic Association (NOV) drew up a classification list for total hip prostheses in 2013. This classification list considered total hip prostheses to be of proven quality when the average percent of revision was ≤ 10% after 10 years of follow-up (category 1A) or ≤ 5% after 5 years of follow-up (category 1B). Data from the Dutch National Orthopaedic Implant Registry Register (LROI) were used to determine the effect of the classification list on the use of hip prostheses of proven quality in the Netherlands. All patients, operations and prosthesis characteristics of the hip prostheses used in the Netherlands were registered in the LROI. We selected details of all interventions in which a hip prosthesis was implanted in patients with 'osteoarthritis' as primary diagnosis between 2012 and 2014 from the LROI. The prostheses could be classified as 1A, 1B or 'not 1A or 1B' by means of the implant code of the acetabular and femoral components. We took 2012 as the reference year. RESULTS: In the reference year, 84% of the acetabular components and 94% of the femoral components were category 1A or 1B. In 2013 these percentages had increased to 89% and 95%, respectively; in 2014 the percentages had increased to 92% and 97%. CONCLUSION: After implementation of the NOV classification list there was an increase in the percentage of total hip prostheses of proven quality, which means that patient care has become better and safer.