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.

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: 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 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.

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.

Objectives Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist of items necessary for regulators to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance. Design A three-round Delphi panel. Setting A task within the Coordinating Research and Evidence for Medical Devices project. Participants 101 experts in the medical device community (healthcare professionals, methodologists, registry experts, regulators, and assessors from notified bodies) were invited. Interventions Based on a literature review and expert advice, 27 items relating to the quality of registry data and the analysis of medical device safety and performance were selected. In round 1, participants selected which items were required for a minimum checklist. They could also propose new items. Items selected by ≥70% of participants indicated consensus. Remaining items were discussed in round 2, resulting in a final checklist that was ranked by participants for importance (round 3). Main outcome measures Consensus of items to be included in the minimum checklist. Results 51 experts participated in round 1, achieving consensus on 18 (67%) items and suggesting 12 items. After discussion in round 2, 5 additional items were selected, resulting in a final set of 15 data quality items and 8 data analysis items. The most important items were ‘completeness of procedures’ (data quality) and ‘definition of outcome analyzed’” (quality of analysis). Conclusions Reporting all items from the minimum checklist will facilitate judgment of the utility of registry data to evaluate medical devices during post-market surveillance.

Following the publication of the original article [1], we were notified that the name of the 10 ^th author was incorrectly tagged in the article’s XML. <GivenName>Perla</GivenName> <GivenName>J.</GivenName> <GivenName>Marang-van</GivenName> <Particle>de</Particle> <FamilyName>Mheen</FamilyName> <GivenName>Perla</GivenName> <GivenName>J.</GivenName> <FamilyName>Marang-van de Mheen</FamilyName> The original article has now been corrected.

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: 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.

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.

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.