Background and purpose — Radiostereometric analysis (RSA) of total knee arthroplasty (TKA) is used as an early safeguard during the phased evidence-based introduction of new implants. The goal of our study was to compare the long-term revision risk between RSA-tested implants and non-RSA-tested implants in the Netherlands using patient-level data. Methods — All primary TKAs between 2007 and 2016 from the Dutch Arthroplasty Register were included, and procedures with an RSA-tested implant were identified. Both all-cause major revision risk and revision risk because of loosening were calculated at 5 and 10 years postoperatively using Kaplan–Meier analyses. Sensitivity analyses were per-formed with stricter definitions of implant characteristics to classify procedures as RSA-tested, to avoid camouflage of different subdesigns within the same brand implant portfolio. Results — 83,638 RSA-tested and 104,105 non-RSA-tested TKAs were included. Cumulative all-cause major revision percentages for the RSA-tested group at 5 and 10 years were 2.2% (95% confidence interval [CI] 2.1–2.3) and 3.6% (CI 3.4–3.7), respectively, compared with 2.5% (CI 2.4–2.6) and 3.3% (CI 3.2–3.4) for the non-RSA-tested group. RSA-tested TKAs showed higher 10-year revision risks because of loosening than non-RSA-tested procedures (1.8%, CI 1.7– 1.9 vs 1.4%, CI 1.3–1.4, respectively). Comparable results were found after stratification by various patient characteristics and with stricter classification approaches. Conclusion — Regarding all-cause revision risk, RSA-tested TKAs had a slightly lower risk at 5 years. However, at 10 years the RSA-tested TKAs had a higher all-cause revision risk and higher revision risk because of loosening compared with the non-RSA-tested TKAs.

Introduction: Loosening of hip implants causes severe pain and disability. Revision surgery, the standard treatment, carries high risks, especially for frail patients. Therefore, a less-invasive treatment option is needed for patients with incapacitating pain. We evaluated the safety and efficacy of percutaneous periprosthetic cement injection (PPCI) to restabilise loosened hip implants. Methods: All patients treated with PPCIs of hip implants between 2004 and 2020 were retrospectively included (median follow-up 24 months, IQR 11–51). Cement was injected in the periprosthetic space of the loosened hip implant under fluoroscopy. Patient characteristics and the Charlson Comorbidity Index (CCI) were measured. Pain reduction was measured by the Harris Hip pain-subscore and adverse events were recorded. Results: 34 patients were included (mean age 83 years, median CCI 6 points). 10 patients had a second PPCI after 12 months (median, IQR 7–27). 2 patients needed revision surgery. 30 patients had pain reduction and 4 had no pain reduction. Adverse events included femoral fissure during needle placement (n = 1) and progressive migration of a loosened acetabular cup (despite the cement injection; n = 2). Conclusions: PPCIs for loosened hip implants is feasible in frail patients with pain reduction in the majority of patients and has limited adverse events.

Objective 

To investigate how task delegation for perioperative anticoagulation management is reported in protocols and daily practice, and how this translates to additional information in work-as-imagined and work-as-done using FRAM to identify improvement possibilities. 

Methods

Existing FRAM visualisations of perioperative anticoagulant management in a Dutch academic hospital were extended to include task delegation in protocols using document analysis and in daily practice using a focus group of eight healthcare professionals, analysed using content analysis.

Results

Distinguishing between formal responsibility and task execution revealed additional functions and roles in both work-as-done and work-as-imagined, resulting in more discrepancies between work-as-done and work-as-imagined. Professionals experienced responsibility for delegated tasks, even without formal accountability, and needed to feel qualified and capable as well as complete clear information to accept these tasks. 

Conclusions

Including task delegation in FRAM models improves the understanding of healthcare processes, communication about distribution of responsibilities and thereby development of more effective improvement strategies.

Introduction: Some patients undergoing metabolic bariatric surgery (MBS) may transfer to another hospital for subsequent procedures. Due to legal constraints imposed by privacy regulations on inter-hospital data sharing, limited research has examined the characteristics and outcomes of these patients. This study aimed to identify the frequency and factors associated with hospital transfer using a novel privacy-enhancing approach based on secure multi-party computation (MPC). Methods: All primary and secondary MBS procedures registered in the Dutch Audit for Treatment of Obesity between January 1, 2014, and December 31, 2022, were considered. MPC enabled privacy-preserving linkage of surgeries across different hospitals. Patients undergoing secondary surgery in the same or a different hospital were compared on patient and treatment characteristics and outcomes of primary MBS to investigate associations with hospital transfer. Results: Two thousand three hundred eighty-two patients with data on both primary and secondary MBS were identified. A minority (n = 275; 11.5%) underwent their second procedure elsewhere. At baseline, these patients on average were younger (37.9 vs. 42.5, p < 0.001), less often had hypertension or GERD, and had similar BMI (43.9 vs 43.9, p = 0.89) compared with those who stayed. At secondary surgery, the BMI of patients transferring hospitals on average was lower (39.0 vs. 43.0, p < 0.001), and the indication was more often recurrent weight gain (49.0% vs. 23.0%, p < 0.001). Conclusion: A minority of patients (1 in 9) transferred to a different hospital for secondary MBS. These patients were generally younger and had fewer obesity-related diseases. Although they presented with a lower BMI at the time of secondary surgery, they more frequently sought surgery for recurrent weight gain.

Background: Quality of metabolic bariatric surgery (MBS) care is often monitored by national registries using quality indicators (QIs), but data collection takes up considerable time and costs. QIs are mostly introduced merely based on expert opinion. Therefore, the study’s aim was to systematically evaluate whether all QIs from the Dutch Audit for Treatment of Obesity (DATO) are still relevant and useful to initiate quality improvement initiatives. Methods: Twenty-four QIs were evaluated using hospital data from 2022 to 2023. To test whether QIs measured the same quality of care aspect (parsimony and relevance), correlations of QI pairs were examined using Pearson correlation coefficients. Usefulness to identify improvement opportunities was considered limited when variance is ≤ 0.001 without any outliers identified, indicating that the QI could be retired. Actionability was assessed through line graphs of hospital performance over the years. Results: Eleven QIs were highly correlated to other QIs, particularly the follow-up and weight loss indicators at 2 and 4 years, and therefore lacked added value. The weight loss QIs showed minimal variance and were adjusted by increasing the threshold to achieving ≥ 25% total weight loss. Multiple QIs showed improving trends and thereby their actionability, most pronounced for postoperative complications. The final QI set measured three constructs with good validity: Cronbach’s alpha values 0.53 (safety), 0.70 (treatment effectiveness), and 0.43 (follow-up process). Conclusion: Through a systematic evaluation of the DATO QI set, a smaller set of 13 QIs was shown to capture the same relevant information to improve MBS care.

Purpose: The objective was to investigate the consistency in cumulative revision rates (CRRs) for a selection of total hip arthroplasty cups and stems across national/regional hip arthroplasty registries worldwide. • Methods: Ten cups and ten stems from total hip systems were randomly selected. Two frequently used implants across registries were added, totalling 11 cups and 11 stems. CRRs and 95% CIs were extracted from the latest annual registry reports using these implants. CRRs were pooled for each cup or stem, and differences between cup-stem combinations and between registries were investigated. • Results: CRRs were available for ten cups and eight stems from eight registries, totalling 552,148 cups and 727,447 stems. Follow-up was 1–20 years. The 5-year CRR pooled for all cups was 2.9% (95% CI: 2.3–3.6) and for all stems, 3.0% (95% CI: 2.4–3.8). Homogeneous (consistent) CRRs with respect to both associated implant and country were observed for two cups and three stems. Significant differences in CRR were identified in one cup by associated implant only, in one cup by registry only, and in two cups and four stems for both. Sparse data prevented evaluation of four cups and one stem. • Conclusion: Registries’ annual reports provide a large amount of publicly available information on CRRs of specific implants. These CRRs can be synthesised to improve the assessment of implant performance over time. Our CRR analysis represents a promising approach to detect implants with a consistent low- or high-risk pattern across registries.

Background and purpose — Standardized reporting on methodology and results in clinical RSA research papers facilitates evaluation of quality and interpretation of results. We aimed to assess the extent to which radiostereometric analysis (RSA) and computed tomography-based RSA (CT-RSA) studies adhered to the items of the new RSA reporting guideline from 2024. Methods — A systematic literature search was performed to identify all clinical RSA studies published between January 2012 and February 2024. Studies were eligible for inclu-sion if prosthesis migration over time was assessed. The adherence of studies to each applicable guideline item (full, partial, or no) was assessed. Results — 285 studies were included, most of which assessed prosthesis migration in the hip (n = 161) or knee (n = 99). No study reported on all guideline items. The mean (full or partial) adherence of studies to all (appli-cable) items was 61% (standard deviation [SD] 11). Large variation between the reporting of items was found, ranging from being reported in 1% of the studies to 100%. The least reported items in studies were the mean number and SD of days between surgery and baseline RSA examination (8% of studies), mean number and SD of days between surgery and primary endpoint RSA examination (1%), and consistent-or all-marker method for RSA analysis (3%). Conclusion — Current studies on average reported only 61% of the items from the updated RSA guidelines. Adherence to the guidelines in clinical RSA studies on prosthesis migration should be improved, in order to improve the quality of studies and the interpretation of outcomes on implant migration.

In recent years, the relationship between academia and the fossil fuel industry has become a focal point of intense debate. This concern arises from the fear that corporate funding might skew research activities. A significant development in this area is the adoption of policies by a Dutch university, and discussions in several others, prohibiting research funded by the fossil fuel industry. These policies aim to safeguard academic freedom and integrity. Despite this, there has been little discussion on the myriad challenges, implications, and possible unintended consequences, particularly in the realm of safety-and-security research. As such, this manuscript delves into the complex transition towards a fossil-fuel-free society, examining it through the lenses of safety science and sociotechnical systems. It emphasizes the vital importance of collective responsibility in ensuring systemic safety and security as we navigate towards achieving the sustainable development goals. This journey requires a delicate balance between the objectives of safety and sustainability, along with a deep understanding of the security implications of decreasing our dependence on the fossil fuel industry. The strategy of distancing academic research from fossil fuel industries, commonly seen as a positive step, also demands a nuanced consideration of its broader impacts, including the setting of precedents for addressing other existential and systemic risks. Instead, we argue for the establishment of robust governance structures rooted in restorative justice principles. Such frameworks can facilitate productive dialogue with underrepresented groups, motivate the fossil fuel industry towards sustainable practices, and safeguard the integrity of scholarly research. This approach not only addresses immediate concerns related to fossil fuels but also lays the groundwork for a more inclusive and equitable model of climate risk research, essential for tackling the multifaceted challenges of our era.

Background and purpose — Pooling data on the performance of total knee (TK) implants across registries is only possible if the same TK implant is used across multiple registries and if used in patients with similar characteristics. We assessed to what extent specific TK implants: (i) are used across multiple registries or only in a single registry; and (ii) differ in patient characteristics between registries. Methods — All primary TK implants implanted between January 2020 and December 2021 in the Danish, Dutch, German, and Italian registries were included. We determined the number of registries using a specific TK implant (based on combined femoral-tibial component brand name and fixation/congruency/mobile bearing insert/patella usage). Patient characteristics (age/body mass index [BMI]/sex/ diagnosis osteoarthritis) were compared across registries for TK implants used in ≥ 2 registries ≥ 100 times. Results — 813 different TK implants (577,351 procedures) were used across the 4 registries, of which 53 TK implants (7%) were used in 1 registry (8,000 procedures). 760 different TK implants (569,351 procedures; 99%) were used in ≥ 2 registries of which 47 different TK implants (393,954 procedures; 68%) were used in ≥ 2 registries and ≥ 100 times. Statistically and clinically significant differences in age for the same TK implant across registries were observed for 29 TK implants (62%) and 3 TK implants (6%), respectively; for other characteristics these were for BMI 30 (64%) and 0 (0%) TK implants; for male proportion 23 (49%) and 17 (36%) TK implants; and for diagnosis of osteoarthritis 42 (89%) and 34 (72%) TK implants, respectively. Conclusion — Most specific TK implants and TK procedures were used across multiple registries, but they were often used in patients with different characteristics. This has an impact on comparing implant performances between registries.

Background and purpose — The amount of information publicly available from arthroplasty registries is large but could be used more effectively. This project aims to improve the knowledge concerning existing registries to facilitate access, transparency, harmonization, and reporting. Methods — Within the International Society of Arthroplasty Registries (ISAR) we aimed at developing, testing, adopting, and making publicly available a short, standardized registry description with items considered relevant for stakeholders using a cross-sectional study survey. Items were chosen based on a literature review and expert advice, selected by 9 ISAR working group members, tested iteratively in 3 registries, and commented upon by 4 external experts. All 29 ISAR member registries as of July 2023 were invited to participate in the project. Results — Included items covered general descriptive information regarding registries, information related to governance, outcomes, data quality, data access, and registry production. The template was adopted, completed, and made publicly available by 25 of the 29 registries. Of those, 2/3 were national registries. 23 captured both hip and knee arthroplasties and 10 captured shoulder arthroplasties. Most registries had public reporting of data quality, methods, and results. Data was accessible in all but 2 registries, mainly as aggregated data. Important items relevant to registry quality for researchers to consistently indicate in scientific papers include scope, inclusion criteria, outcomes definitions, coverage/completeness, and validation processes. Conclusion — This ISAR initiative implemented a short, standardized description to facilitate appropriate use of orthopedic registry data worldwide relevant for a diverse group of stakeholders including researchers, industry, public health and regulatory agencies.

Background

Metabolic bariatric surgery (MBS) quality registries monitor various outcomes, enabling the assessment of hospital performance in comparison with national benchmarks. However, if there is considerable between-surgeon outcome variation, surgeon-level feedback may be better suited. The aim of this study was to assess the extent to which patient-, surgeon-, and hospital-level factors contribute to the variation in outcomes after MBS. 

Methods

All primary procedures registered in the Dutch MBS quality registry between 1 January 2020 and 31 December 2023 were included. Outcomes included severe postoperative complications, reoperation, prolonged length of stay (LOS), readmission, textbook outcome, and achieving ≥25% total weight loss within 1 year. Multilevel logistic regression models were built for each outcome, including all available patient characteristics, operating surgeon, and hospital, to determine the variance explained by patient-, surgeon-, and hospital-level factors. 

Results

In total, 30 610 patients were included, operated on by 144 surgeons in 19 hospitals. Hospital-level factors contributed most to the explained variance for all outcomes, ranging from 59.6% for reoperation to 90.3% for prolonged LOS. Surgeon-level factors explained less variance, ranging from 3.2% for prolonged LOS to 28.2% for reoperation. Patient characteristics explained the least, ranging from 4.4% for textbook outcome to 13.1% for severe postoperative complications. 

Conclusion

Variation in outcomes is mostly explained by hospital factors, rather than surgeon factors, supporting hospital-based performance feedback. The results suggest that the pre- and postoperative trajectory and perioperative care may affect MBS outcomes more than patient characteristics or surgical team performance.

Before a high-risk medical device is approved for implantation into patients, there should be evidence not only of its performance and safety with a favourable benefit-risk ratio, but also of its clinical efficacy. Regulatory guidance on study methodologies is lacking, however, so the European Commission funded the CORE–MD project (Coordinating Research and Evidence for Medical Devices) to advise regulators on appropriate designs for clinical trials of high-risk devices. The CORE–MD consortium recommends that evaluation should be planned in four stages. Randomised controlled trials should be performed more often, against active comparators reflecting the best available treatment, or using sham interventions with ethical safeguards. Large trials can be managed efficiently using an electronic database or registry. Non-randomised clinical studies can apply objective performance criteria or other validated patient-relevant outcome measures, with adjustments to minimise bias. Full transparency of results from clinical investigations is essential. Proportionate regulation of breakthrough or orphan devices for independently-defined serious unmet needs may involve approval with less evidence, but on condition of subsequent confirmatory studies. These CORE–MD consensus proposals have been submitted to European Union medical device regulators, to be considered as a basis for more transparent and predictable requirements for clinical evidence. Funding: The CORE–MD project was funded as a Coordination and Support action from the European Union Horizon 2020 research and innovation programme, under grant agreement 965246.

Background and purpose — The safety and performance of hip and knee prostheses can be assessed by ana-lyzing peer-reviewed literature, registry reports, and safety notices published by national competent authorities/regula-tory agencies, or manufacturers. The percentage of hip and knee prostheses with a safety signal published through any of these data sources is unknown. We aimed to assess the frequency of signals identified for a random sample of 10 hip stems, 10 hip cups, and 10 knee implants. Methods — 3 literature libraries were searched to find safety signals defined as information on patterns/occurrences that may alter the device’s benefit–risk profile, reported in peer-reviewed publications for the randomly selected implants. Annual registry reports from 5 national registries were examined to check whether any of the selected implants had outlier performance. The CORE-MD post-market surveillance (PMS) tool was used to collect all related safety notices from 13 competent authority/regulatory agency websites. Manufacturers’ websites were screened for any reported safety information. Results — Safety signals were identified for 21 of the 30 randomly selected implants: 18 identified by registries, 7 by the CORE-MD PMS tool, and 8 based on literature, with 10 implants identified by multiple sources. There was no systematic pattern in timing of publication with a particular source publishing safety signals earlier than other sources. Conclusion — 70% of the randomly selected hip and knee prostheses had ≥ 1 safety signals published, with registries as the source for the majority. No single source identified all 21 implants with signals, which highlights the need for a comprehensive surveillance strategy to aggregate safety signals from multiple sources.