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Objectives  Pituitary tumor treatment is hampered by the relative rarity of the disease, absence of a multicenter collaborative platform, and limited translational-clinical research partnerships. Prior studies offer limited insight into the formation of a multicenter consortium. Design  The authors describe the establishment of a multicenter research initiative, Registry of Adenomas of the Pituitary and Related Disorders (RAPID), to encourage quality improvement and research, promote scholarship, and apply innovative solutions in outcomes research. Methods  The challenges encountered during the formation of other research registries were reviewed with those lessons applied to the development of RAPID. Setting/Participants  RAPID was formed by 11 academic U.S. pituitary centers. Results  A Steering Committee, bylaws, data coordination center, and leadership team have been established. Clinical modules with standardized data fields for nonfunctioning adenoma, prolactinoma, acromegaly, Cushings disease, craniopharyngioma, and Rathkes cleft cyst were created using a Health Insurance Portability and Accountability Act-compliant cloud-based platform. Currently, RAPID has received institutional review board approval at all centers, compiled retrospective data and agreements from most centers, and begun prospective data collection at one site. Existing institutional databases are being mapped to one central repository. Conclusion  The RAPID consortium has laid the foundation for a multicenter collaboration to facilitate pituitary tumor and surgical research. We sought to share our experiences so that other groups also contemplating this approach may benefit. Future studies may include outcomes benchmarking, clinically annotated biobank tissue, multicenter outcomes studies, prospective intervention studies, translational research, and health economics studies focused on value-based care questions.

IntroductionWe elicited Vietnamese Americans' perspectives on culturally appropriate recruitment into a new research registry: Collaborative Approach for Asian Americans, Native Hawaiians, and Pacific Islanders (AANHPIs) Research and Education (CARE).MethodsThree focus groups were conducted with 21 Vietnamese Americans. Topics included knowledge about and experiences with research, outreach and recruitment methods for research participation and registry enrollment, and views about research incentives. Focus group transcripts were analyzed thematically.ResultsMean age of participants was 41 years (range 18-73), 57% were male, 86% were non-US born, and 81% had never participated in a research study. Themes that emerged included (1) motivations to participate in research to gain knowledge: for oneself, for family's benefit, and for the Vietnamese American community as a whole; (2) necessity of trustworthy and credible individuals/spokespersons to promote the research initiative; (3) recruitment strategies that are age-specific and culturally appropriate, and (4) importance of monetary incentives.ConclusionFindings from this study will be used to guide recruitment into and engagement with CARE among Vietnamese Americans but are also relevant for other registries aiming to diversify their participants.

STUDY QUESTION What are the current national medically assisted reproduction (MAR) data collection systems across EU Member States, and how can these countries contribute to a unique, cycle-by-cycle registry for the European Monitoring of Medically Assisted Reproduction (EuMAR) project? SUMMARY ANSWER The study identified significant variation in MAR data collection practices across Member States, with differences in data types, collection methods, and reporting requirements; the EuMAR project emerges as an opportunity to enhance data standardization and improve MAR data collection in the EU. WHAT IS KNOWN ALREADY There is a need for new approaches in MAR data collection that include long-term and cross border follow-up. The EuMAR project intends to establish a unified, cycle-by-cycle registry of data on MAR treatments in EU countries, from which accurate cumulative outcomes can be calculated. STUDY DESIGN, SIZE, DURATION This cross-sectional study involved a survey and interviews with stakeholders from 26 EU Member States conducted in 2023 over a period of seven months. PARTICIPANTS/MATERIALS, SETTING, METHODS Representatives from national competent authorities and professional associations involved in MAR data collection in EU countries were invited to complete the survey and interviewed to assess current data flows, information requirements, and their interest in the EuMAR project. MAIN RESULTS AND THE ROLE OF CHANCE Half of the participating countries reported having a national MAR registry with cycle-by-cycle data (n = 13), while 31% reported having a national registry with aggregated data (n = 8) and 19% reported having no national registry (n = 5). Of the countries with a national cycle-by-cycle registry, eight countries collect identifiable data, five countries collect pseudonymized data, and one country collects fully anonymized data. Informed consent is required in 10 countries. The main advantages that participants expected from a European registry like EuMAR were the possibility of obtaining national statistics in the absence of a national registry and improving the calculation of cumulative outcomes. LIMITATIONS, REASONS FOR CAUTION The results of the study are based on self-reported data, which may be subject to bias, however, the validity of the collected information was verified with different means, including follow-up calls for clarifications and sharing final transcript reports. The feasibility of the proposed data flow models will be tested in a pilot study. WIDER IMPLICATIONS OF THE FINDINGS Despite the heterogeneity of data collection practices across EU countries, the results show that stakeholders have high expectations of the benefits that the EuMAR registry can bring, namely the improvement of data consistency, cross-border comparability, and cumulative live birth rates, leading to better information for patients, health care providers and policy makers. STUDY FUNDING/COMPETING INTEREST(S) The EuMAR project was co-founded by ESHRE and the European Commission (101079865—EuMAR–EU4H-2021-PJ2). No competing interests were declared. TRIAL REGISTRATION NUMBER N/A. [ABSTRACT FROM AUTHOR]

Background: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. Methods: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. Discussion: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. Trial registration: ClinicalTrials.gov. Identifier: NCT05889416. Registered 2023-03-23. [ABSTRACT FROM AUTHOR]

Background and hypothesis Advances in organ procurement, surgical techniques, immunosuppression regimens, and prophylactic antibiotic therapies have dramatically improved kidney transplant graft failure. It is unclear how these interventions have affected longer-term graft failure. It is hypothesized that graft failure has improved over the last 20 years. Methods Data on all first kidney transplants from 1995 to 2014 were extracted from the Australia and New Zealand Dialysis and Transplant Registry with follow-up as of 31 December 2021. Primary exposure was transplant era, classified into 5-year intervals. Primary outcome was all-cause 5-year graft failure. Secondary outcomes included all-cause 10-year graft failure and cause-specific graft failure. Kaplan–Meier curves and multivariable Cox proportional hazards regression models were used to assess trends in all-cause graft failure. Fine–Gray subdistribution hazard models verified that changes in death rates were not biasing the Cox proportional hazards regression models. Cumulative incidence functions were used to assess temporal trends in cause-specific graft failure. Results Across 10 871 kidney transplants, there was a shift towards transplanting more recipients aged >45 years old, with more comorbidities, longer dialysis vintage, body mass index >30 kg/m2, and greater human leukocyte antigen mismatches. Donor age has increased but no clear shift in donor source was observed. Compared to 1995–99 (reference), the adjusted hazard ratio for 5-year graft failure was 0.78 (95% CI 0.67–0.91), 0.70 (95% CI 0.59–0.83), and 0.60 (95% CI 0.50–0.73) for 2000–04, 2005–09, and 2010–14, respectively. Ten-year graft failure similarly reduced from 0.83 (95% CI 0.74–0.93) for 2000–04 to 0.78 (95% CI 0.68–0.89) for 2010–14, compared to 1995–99. Conclusion Medium- and long-term all-cause graft failure has improved steadily since 1995–99. Significant reductions in graft failure due to rejection and vascular causes were observed at 5 years, and due to rejection, vascular causes, death, and glomerular disease at 10 years. [ABSTRACT FROM AUTHOR]

In recent years, containerization is becoming more and more popular for deploying applications and services and it has significantly contributed to the expansion of edge computing. The demand for effective and scalable container image management, however, increases as the number of containers deployed grows. One solution is to use a localized Docker registry at the edge, where the images are stored closer to the deployment site. This approach can considerably reduce the latency and bandwidth required to download images from a central registry. In addition, it acts as a proactive caching mechanism by optimizing the download delays and the network traffic. In this paper, we introduce an edge-enabled storage framework that incorporates a localized Docker registry. This framework aims to streamline the storage and distribution of container images, providing improved control, scalability, and optimized capabilities for edge deployment. Four demanding XR applications are employed as use cases to experiment with the proposed solution. [ABSTRACT FROM AUTHOR]

To evaluate the relative effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) versus standard-dose quadrivalent influenza vaccine (QIV-SD) against recurrent hospitalizations and its potential variation in relation to influenza circulation. We did a post-hoc analysis of a pragmatic, open-label, randomized trial of QIV-HD versus QIV-SD performed during the 2021–2022 influenza season among adults aged 65–79 years. Participants were enrolled in October 2021–November, 2021 and followed for outcomes from 14 days postvaccination until 31 May, 2022. We investigated the following outcomes: Hospitalizations for pneumonia or influenza, respiratory hospitalizations, cardio-respiratory hospitalizations, cardiovascular hospitalizations, all-cause hospitalizations, and all-cause death. Outcomes were analysed as recurrent events. Cumulative numbers of events were assessed weekly. Cumulative relative effectiveness estimates were calculated and descriptively compared with influenza circulation. The trial is registered at Clinicaltrials.gov: NCT05048589. Among 12,477 randomly assigned participants, receiving QIV-HD was associated with lower incidence rates of hospitalizations for pneumonia or influenza (10 vs. 33 events, incidence rate ratio [IRR] 0.30 [95% CI, 0.14–0.64]; p 0.002) and all-cause hospitalizations (647 vs. 742 events, IRR 0.87 [95% CI, 0.76–0.99]; p 0.032) compared with QIV-SD. Trends favouring QIV-HD were consistently observed over time including in the period before active influenza transmission; i.e. while the first week with a ≥10% influenza test positivity rate was calendar week 10, 2022, the first statistically significant reduction in hospitalizations for pneumonia or influenza was already observed by calendar week 3, 2022 (5 vs. 15 events, IRR 0.33 [95% CI, 0.11–0.94]; p 0.037). In a post-hoc analysis, QIV-HD was associated with lower incidence rates of hospitalizations for pneumonia or influenza and all-cause hospitalizations compared with QIV-SD, with trends evident independent of influenza circulation levels. Our exploratory results correspond to a number needed to treat of 65 (95% CI 35–840) persons vaccinated with QIV-HD compared with QIV-SD to prevent one additional all-cause hospitalization per season. Further research is needed to confirm these hypothesis-generating findings. [ABSTRACT FROM AUTHOR]

Aims: To assess the level of adherence to glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) treatment using real‐world data and to investigate the sociodemographic and clinical factors associated with discontinuation of GLP‐1RAs. Methods: First‐time users of GLP‐1RAs with type 2 diabetes mellitus (T2DM), aged ≥18 years, in the period 2007 to 2020, were identified using Danish registries, allowing all participants a minimum of 18 months' follow‐up. Adherence to GLP‐1RA therapy (medication possession ratio >0.80) and discontinuation of GLP‐1RA therapy was estimated at 6‐ and 12‐month follow‐ups. Multivariable cause‐specific Cox regression was used to identify sociodemographic and clinical factors associated with risk of discontinuation. Results: In total, 44 343 first‐time users of GLP‐1RAs with T2DM were identified (mean age 58.6 years, 42.7% female, median duration of T2DM 6.8 years, median glycated haemoglobin level 65 mmol/mol). The absolute risk of discontinuing GLP‐1RA treatment within 6 months was 14.2% (95% confidence interval [CI] 13.9–14.6) and 21.2% (95% CI 20.8–21.5) within 12 months. At 6 months, 50.4% were adherent to GLP‐1RA therapy and at 12 months, 48.6% remained adherent. In the multivariable model, younger (<40 years) and older age (>75 years), higher Charlson Comorbidity Index score, lower household income, high school and longer university degree as educational attainment level, and longer diabetes duration were associated with a higher risk of discontinuing GLP‐1RA treatment. Conclusion: Approximately one in five patients discontinued GLP‐1RA therapy within the first 12 months and only half were adherent. Overall, lower socioeconomic status and higher comorbidity burden were associated with higher risk of discontinuing GLP‐1RA treatment. [ABSTRACT FROM AUTHOR]

The American Academy of Dermatology launched DataDerm in 2016 as the clinical data registry platform of American Academy of Dermatology. DataDerm has evolved to be the largest database in the world containing information about dermatology patients, capturing information about their course of disease, associated therapeutic interventions, and health outcomes. As of December 31, 2022, DataDerm contained data from 14.2 million unique patients and 53.5 million unique patient visits, with 415 practices representing 1663 clinicians actively participating in DataDerm in 2022. This article is the fourth in a series of Annual Reports about the status of DataDerm. This year's 2023 Annual Report presents the progress DataDerm has made in conjunction with OM1, the data analytics partner of DataDerm, with a special highlight on the longitudinal care of common dermatologic conditions in the registry and a detailed focus on skin cancer. Furthermore, we review the current status of DataDerm as a robust representation of real world specialty data, reflecting the day-to-day dermatologic care of patients over time. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusions Clinical registries are an important research tool to enhance our understanding of vision loss in the Australian paediatric population. We aim to provide an update on the epidemiology of visual impairment among Western Australian children using registry data analysis, and to highlight the challenges of registry data collection.This is a retrospective study of visual impairment and blindness registrations of children aged 0–16 years in Western Australia from 1996 to 2015. Blindness was defined as visual acuity ≤6/60 in the better‐seeing eye or binocular visual field ≤20° diameter, with all other certifications labelled as visual impairment. Certificates were assessed for primary causes of vision loss by age strata and sex. Registration rate trends were analysed across three discrete registration periods.Of 11 800 certificates issued between 1996 and 2015, 728 certificates (6.2%) were issued to 710 children. Five hundred and twenty‐nine (74.5%) certificates were issued for visual impairment and 181 (25.5%) for blindness. The leading cause of certification was inherited retinal disease (73, 10.3%), followed by cortical visual impairment (57, 8.0%) and albinism (56, 7.9%). The annual registration rate of visual impairment increased from 0.5 to 9.8 per 100 000 person‐years across the study period, whereas blindness rates fell from 2.7 to 1.3.Overall registration rates of paediatric visual impairment in Western Australia are increasing, but these trends should be interpreted with caution given the known limitations of registry data. Enhancements of the registration process could be achieved through digitisation, inclusion of patient outcome data, and incentives for greater practitioner engagement. [ABSTRACT FROM AUTHOR]

Background: Clinical trial registration is critical for research transparency and integrity. Since 2005, the Declaration of Helsinki has required prospective registration of trials before subject recruitment. In Israel, the MyTrial registry was established in 2015 to register interventional trials and became mandatory in 2016 for ethical approval. The study aimed to analyze the registration practices, challenges, and trends in clinical trial registration in Israel using the local registry "MyTrial". Methods: A total of 3,895 clinical trial records from 2011 to December 2022 were retrieved from the MyTrial platform and subjected to descriptive analysis. Results: A significant increase occurred from 2016 to 2021 due to mandated registration, with a peak in 2020 (733 trials) and a decrease in 2022 (462 trials), likely due to COVID-19. Most of the trials included drugs (56%) or medical devices (33%). Geographically, 53% were from central Israel. Only 39% of the patients were registered at both MyTrial and ClinicalTrials.gov. 65% had no blinding. 47% featured unregistered products. 56% had not started recruitment. Since 2016, the number of advanced therapy trials has steadily increased, reaching 19 in 2022. There are gaps between registered trials and official government reports. Conclusion: These findings provide valuable insights into the current landscape of clinical trial registration in Israel and highlight the need for improvements in compliance with prospective registration and adherence to the WHO-ICTRP standards. Significance: What's Known on this Subject: Clinical trial registration has been increasingly recognized as important for research transparency and integrity since requirements were introduced in the 2005 Declaration of Helsinki. [ABSTRACT FROM AUTHOR]

Background: Bladder cancer (BCa) is a significant public health concern. This study aimed to analyze the incidence trends, histological subtypes, and topographical distribution of BCa in Iran over a decade. Methods: This retrospective registry-based study analyzed data on BCa patients diagnosed between March 20, 2006, and March 20, 2015. Following data quality control, age-standardized incidence rates (ASIRs) were calculated for BCa overall, by sex and histological subtype using the new World Health Organization (WHO) standard population. Results: We identified 51,379 BCa cases (81.97% male) with a mean age of 65.10 ± 14.89 years. The overall ASIR was 8.92 per 100,000 (95% CI: 8.84-9.00). While a modest increase in ASIR was observed overall (8.77 in 2006 to 9.64 in 2015) and among males (14.13 in 2006 to 15.95 in 2015) during the study period, males consistently had a significantly higher ASIR compared to females (approximately 4.5:1 ratio). BCa incidence showed a progressive increase across older age groups, particularly those aged 40-44 to 80-84 years. Urothelial cell carcinoma (UCC) was the most prevalent histological type (ASIR: 8.19 to 7.93), followed by adenocarcinoma (AC; ASIR: 0.13 to 0.11). Squamous cell carcinoma (SCC) displayed a decreasing trend (ASIR: 0.11 to 0.06). Both UCC and AC were more frequent in males (approximately 5 and 3 times higher than females, respectively). Malignant neoplasm of the bladder, unspecified, constituted over 95% of BCa topography classifications. Conclusion: This study identified a modest rise in BCa incidence, with male predominance and a higher burden in older adults. Further investigation into potential risk factors contributing to this increase is warranted. [ABSTRACT FROM AUTHOR]

Introduction: Randomised evidence supports the use of partial breast irradiation (PBI) with targeted intraoperative radiotherapy (TARGIT-IORT) for early stage breast cancer, but prospective data from real-world adoption of this technique is also important. The aim of this study was to determine if the outcome reported in TARGIT-A trial could be replicated in large cohort of early stage breast cancer treated with TARGIT-IORT. Methods: This prospective observational study analysed all patients treated with TARGIT-IORT between 2004 and 2021 in a single national cancer institute. TARGIT-IORT during lumpectomy was performed according to the riskadapted TARGIT-A protocol using the Intrabeam® device. We analysed the completeness of follow up, 5-year in-breast-tumour-recurrence (IBTR), long term local recurrence free survival, distant disease-free survival, overall survival and breast-cancer-related survival, using the Kaplan-Meier method. A covariate analysis was performed to investigate risk factors for IBTR. We also analysed high grade toxicity events. Results: The study included 814 patients and the a median follow up was 72 months. The majority of patients (60.3%) received TARGIT-IORT as PBI modality ("exclusive IORT" group); 39.7% received additional EBRT. There was no significant difference between the 5 years IBTR for the whole study population and the "exclusive IORT" cohort (1.6% (95%CI=1.1-2.1%) and 2.5% (95%CI=1.7%- 3.3%) respectively). 5 years overall survival and tumour related survival were >95%. In 21% of patients with recurrence, breast was preserved. Radiotherapy toxicity (CTCAE Grade>2) was very rare (0.9%). Conclusions: This large single institute study found that breast cancer control and survival outcomes with TARGIT-IORT were consistent with TARGIT-A trial results. This "real world" experience confirmed that the randomised evidence showing the value of TARGIT-IORT as partial breast irradiation modality that can be replicated in routine clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of this study was to describe how hip fractures differentially affect male and female patients regarding fracture pattern, hospital course, and postoperative course. Materials and Methods: This retrospective case series was performed in a metropolitan healthcare system involving 2996 hip fracture patients >59 years old who underwent surgical management (eg, intramedullary nail, hemiarthroplasty, percutaneous pinning, etc.). Male patients were matched to female patients using 1:2 nearest neighbor matching on the basis of age and Charlson Comorbidity Index. Outcomes of interest included AO/OTA fracture classification, 30- and 90-day readmission, and 30-day and 1-year mortality rates. Results: The cohort was predominantly female (64.5%). Female patients were more likely to sustain a type 31A fracture compared to males (P =.016). The average CCI was higher for males vs females (3.0 ± 2.5 vs 2.6 ± 2.3, P <.001). Males were more likely to be readmitted at 30 (P <.001) and 90 (P =.015) days after discharge. The 30-day mortality was higher for males vs females (6.6% vs 4.5%, P =.015). Approximately 19.9% of male patients vs 15.1% of females died within a year of surgery (P <.001). The average time to surgery was longer for males vs females (23.8 ± 18.8 vs 22.5 ± 21.9 h, P =.048). Males were more likely to die within a year if they underwent surgery >24 h after admission (P =.029). Discussion: Hip fractures have different implications for male and female patients. With age, the incidence of IT fractures increased in females, while it decreased in males. On average, males with hip fractures are sicker than females, which likely contributes to the longer time to surgery as well as increased readmission and mortality rates seen in males. Conclusions: Male and female hip fracture patients are not similar in baseline health status, fracture pattern, or postoperative morbidity and mortality. Orthogeriatricians and other providers that care for this patient population should be aware of these differences when implementing treatment strategies to optimize the recovery of their patients, and while educating patients and their families about postoperative expectations. [ABSTRACT FROM AUTHOR]

Background: Multidisciplinary discussion (MDD), in which physicians, radiologists, and pathologists communicate and diagnose together, has been reported to improve diagnostic accuracy compared to diagnoses made solely by physicians. However, even among experts, diagnostic concordance of MDD is not always good, and some patients may not receive a specific diagnosis due to insufficient findings. A provisional diagnosis based on the ontology with a diagnostic confidence level has recently been proposed. Additionally, we developed an artificial intelligence model to differentiate idiopathic pulmonary fibrosis (IPF) from other chronic interstitial lung diseases (ILD)s, which needs validation in a broader population. Methods: This prospective nationwide ILD registry has recruited patients with newly diagnosed ILD at the referral respiratory hospitals in Japan and provides rapid MDD diagnoses and treatment recommendations through a central online MDD platform with a 3-year follow-up period. A modified diagnostic ontology is used. If no diagnosis reaches more than 50% certainty, the diagnosis is unclassifiable ILD. If multiple diseases are expected, the diagnosis with a high probability takes precedence. If the confidence levels for the top two possible diagnoses are equal, the diagnosis can be unclassifiable. The registry uses tentative diagnostic criteria for nonspecific interstitial pneumonia with organising pneumonia and smoking-related ILD not otherwise specified as possible new entities. Central MDD diagnosticians review the clinical data, test results, radiology images, and pathological specimens on a dedicated website and conduct MDD diagnoses using online meetings with a cloud-based reporting system. This study aims to (1) provide MDD diagnoses with treatment recommendations; (2) determine the overall ILD rates in Japan; (3) clarify the reasons for unclassifiable ILDs; (4) evaluate possible new disease entities; (5) identify progressive phenotypes and create a clinical prediction model; (6) measure the agreement rate between institutional and central diagnoses in ILD referral and non-referral centres; (7) identify key factors for each specific ILD diagnosis; and (8) create a new disease classification system based on treatment strategies, including the use of antifibrotic drugs. Discussion: This study will provide ILD frequencies, including new entities, using central MDD on dedicated online systems, and develop a machine learning model for ILD diagnosis and prognosis prediction. Trial registration: UMIN-CTR Clinical Trial Registry (UMIN000040678). [ABSTRACT FROM AUTHOR]

Objective: We aimed to compare the results of phase III and IV clinical trials examining drugs to treat multiple sclerosis (MS) registered at ClinicalTrials.gov to those published in peer-reviewed journals. Methods: After identifying trials registered at ClinicalTrials.gov, consecutive searches were conducted in PubMed, EMBASE and Google Scholar for matching publications. Information regarding participants and efficacy and safety results was extracted and compared. The degree of consistency was classified as 'concordant', 'discrepant' or 'not comparable'. The Kaplan–Meier method was used to model time to reporting. Results: In total, 65 trials were appraised. The median time from completion to reporting was shorter for ClinicalTrials.gov (16.4 vs 27.3 months; p = 0.010). Information availability was generally higher in journals except for serious adverse events (SAEs) (86.2% vs 100.0%, p = 0.029) and their description (78.2% vs 100.0%, p < 0.001). However, 45 trials had at least one reporting discrepancy (69.2%). Three studies omitted one or more primary outcomes in the matching journal publication. Regarding safety results, the lowest consistencies were found for causes of death (60.0%) and description of SAEs (27.9%). Conclusion: Consulting both ClinicalTrials.gov and journals increases the accessibility to MS clinical trial results. Some data were frequently missing or disagreed between sources, raising concerns about transparency and generalizability of results. [ABSTRACT FROM AUTHOR]

Introduction: Living liver donation improves survival of end‐stage liver disease (ESLD) patients. Yet, it continues to represent a small proportion of United States (U.S.) liver transplantation with existing racial disparities. We investigated the interplay of donor–recipient relationship and donor race to understand donor subgroups with no significant increase. Methods: We studied 4407 living liver donors in the U.S. from January 1, 2012, to December 31, 2022 (median age = 36 years, and 59% were biologically related to the recipient). We quantified the change in the number of donors per 3‐year increment using negative binomial regression (incidence rate ratio [IRR]), stratified by donor–recipient relationship and race/ethnicity. Results: Among biologically related donors, the observed annual number of White donors increased from 146 to 253, Hispanic donors from 18 to 53, and Black donors decreased from 11 to 10. Among unrelated donors, White donors increased from 65 to 221, Hispanic donors from 4 to 25, and Black donors from 3 to 11. For the IRR of biologically related donors aged <40 and ≥40 years, White donors increased by 18% and 22%; Hispanic donors increased by 25% and 54%; and Black donors did not change. Likewise, the IRR of unrelated donors aged <40 and ≥40 years, White donors increased by 48% and 55%; Hispanic donors increased by 52% and 65%; and Black donors did not change. Conclusions: While biologically related donors represent the majority of donors, unrelated donors have substantially risen in recent years, primarily driven by White donors. Although the rate of unrelated donations increased among Hispanic donors, the absolute number remains very small (≤25 donors/year). Interventions are needed to increase education among Hispanic and Black communities to grow unrelated living liver donations across race/ethnicity. [ABSTRACT FROM AUTHOR]

To provide an overview of the I‐CAH Registry. Following the successful roll‐out of the I‐DSD Registry in the 2000s, it was felt that there was a need for a registry for congenital adrenal hyperplasia (CAH) and this was launched in 2014 as a dedicated module within the original registry. In addition to supporting and promoting research, the I‐CAH Registry acts as an international tool for benchmarking of clinical care and it does this through the collection of standardised data for specific projects. Surveillance of novel therapies in the field of CAH can also be achieved via global collaborations. Its robust governance ensures adherence to the international standards for rare disease registries. Rare disease registries such as the I‐CAH Registry are important tools for all stakeholders involved in the care of people with CAH. [ABSTRACT FROM AUTHOR]

Objective: The impact of sex on outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS) is not fully elucidated. The aim of this study was to analyze the association between sex and outcomes of asymptomatic patients who underwent primary carotid interventions in France. Methods: This nationwide retrospective study was performed using the French National Health Insurance Information System and included asymptomatic patients who underwent primary carotid intervention over a 10-year period (1 January 2013 to 31 August 2023). Symptomatic patients and patients who had peri-operative neurologic events were excluded. The primary endpoints were the occurrence of death and stroke/transient ischaemic attack (TIA) at 30 days, 1 and 5 years after patients' discharge. Results: In total, 115,879 patients were admitted for an index CEA (29.4% women) and 6500 for CAS (29.8% women). In the CEA group, no significant sex-related difference was observed for 30-day mortality; however, women had significantly lower 1-year and 5-year mortality rates compared to men (1.9% vs. 2.6%, p < 0.001 and 7.9% vs. 11.1%, p < 0.001). In the CAS group, women had lower 30-day, 1-year and 5-year mortality (0.6% vs. 1.0%, p = 0.040, 3.8% vs. 4.9%, p = 0.048, and 10.4% vs. 15.0%, p < 0.001). A multivariate analysis showed that sex was not associated with the risk of stroke/TIA and mortality at 30 days (OR 0.84 (95% CI 0.67–1.04) and 1.27 (95% CI 0.98–1.64)). Male sex was associated with a higher risk of 1-year and 5-year mortality (OR 1.24 (95% CI 1.13–1.36) and 1.25 (95% CI 1.18–1.31)), but a lower risk of stroke/TIA than female sex. Conclusions: No significant sex-related difference was observed at 30 days in patients being discharged alive and without peri-operative neurologic events. Male sex was associated with a higher risk of mortality but a lower risk of stroke/TIA at 1 and 5 years. [ABSTRACT FROM AUTHOR]

Background: The aim of this study is to analyze the data collected on lateral incisional hernias (LIH) in the National Incisional Hernia Registry (EVEREG) and assess current practices and outcomes in LIH repair. Methods: A retrospective cohort study was conducted using LIH data recorded over 10 years (2012–2022). Comorbidities, hernia characteristics, short-term complications, and recurrences were studied, along with their association with the type of approach used, either open or laparoscopic, in elective surgery. Results: 1742 LIH cases were studied. According to the EHS classification, these included L1 409 (23.5%), L2 388 (22.3%), L3 565 (32.4%), L4 150 (8.6%) and combined 230 (13.2%). An open approach was performed in 1528 (87.7%) cases and laparoscopic in 214 (12.3%). The median age was 66 ± 12.45 years, with a majority of males, 934 (53.6%). The median body mass index was 29 ± 5.18 kg/m2. The most observed comorbidity was arterial hypertension (957 patients, 55%). A specialist was present in 638 interventions (56%). The 24-month follow-up was 17.9%, and recurrence in those cases was 27.2%, with a higher incidence when there was no specialist present during the intervention, onlay mesh position, and larger defect size. Conclusions: Surgery for LIH is common, although laparoscopic approach remains infrequent. Furthermore, it is associated with a high percentage of recurrences that increases when there is no specialist in abdominal wall surgery present. [ABSTRACT FROM AUTHOR]

Summary: A validation of the GeRi-Score on 120-day mortality, the impact of a pre-operative visit by a geriatrician, and timing of surgery on the outcome was conducted. The score has predictive value for 120-day mortality. No advantage was found for surgery within 24 h or a preoperative geriatric visit. Purpose: Numerous tools predict mortality among patients with hip fractures, but they include many variables, require time-consuming assessment, and are difficult to calculate. The GeRi-Score provides a quick method of pre-operative assessment. The aim of this study is to validate the score in the 120-day follow-up and determine the impact of a pre-operative visit by a geriatrician and timing of surgery on the patient outcome. Methods: A retrospective analysis of the AltersTraumaRegister DGU® from 2017 to 2021 was conducted, including all proximal femur fractures. The patients were divided into low-, moderate-, and high-risk groups based on the GeRi-Score. Mortality was analyzed using logistic regression. To determine the influence of the time to surgery and the preoperative visit by a geriatrician, matching was performed using the exact GeRi-Score, preoperative walking ability, type of fracture, and the time to surgery. Results: The study included 38,570 patients, divided into 12,673 low-risk, 18,338 moderate-risk, and 7,559 high-risk patients. The moderate-risk group had three times the mortality risk of the low-risk group (OR 3.19 (95% CI 2.68–3.79; p<0.001)), while the high-risk group had almost eight times the mortality risk than the low-risk group (OR 7.82 (95% CI 6.51–9.93; p<0.001)). No advantage was found for surgery within the first 24 h across all groups. There was a correlation of a preoperative geriatric visit and mortality showing an increase in the moderate and high-risk group on in-house mortality. Conclusions: The GeRi-Score has predictive value for 120-day mortality. No advantage was found for surgery within 24 h. The analysis did not demonstrate a benefit of the preoperative geriatric visit, but more data are needed. [ABSTRACT FROM AUTHOR]

Introduction: The evolution of disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) has improved patient prognosis. However, more real-world safety/effectiveness data comparing methotrexate (MTX), tofacitinib, tumor necrosis factor inhibitors (TNFi), and non-TNFi biologic DMARDs (bDMARDs) are warranted. Methods: The CorEvitas RA Japan registry was used to identify patients with rheumatologist-diagnosed RA who initiated MTX/tofacitinib/TNFi/non-TNFi bDMARDs. Safety outcomes included incidence of major adverse cardiovascular events (MACE), total cardiovascular disease, total serious infections, total herpes zoster, and total malignancies (excluding non-melanoma skin cancer). Effectiveness outcomes included change from baseline (Δ) in Clinical Disease Activity Index (CDAI) and proportion of patients achieving a minimum clinically important difference (MCID) in CDAI at month 6. Adjusted regression models were fit; marginal means were estimated. Results: Overall, 1972 patients were included in the safety cohort: MTX (N = 298); tofacitinib (N = 253); TNFi (N = 663); non-TNFi (N = 758). Mean follow-up time was 3.8, 2.9, 3.0, and 2.9 years for MTX, tofacitinib, TNFi, and non-TNFi, respectively. Adjusted incidence rates (IRs, patients with events/100 patient-years [95% confidence intervals]) for MACE and total cardiovascular disease, respectively, were numerically lower for MTX (0.34 [0, 0.83]; 0.42 [0, 0.92]) and TNFi (0.09 [0, 0.27]; 0.61 [0.15, 1.07]) versus tofacitinib (0.48 [0, 1.20]; 2.30 [0.38, 4.22]) and non-TNFi (0.77 [0.35, 1.19]; 1.28 [0.73, 1.82]). Serious infections were numerically higher for non-TNFi (4.47 [3.38, 5.56]); herpes zoster was higher for tofacitinib (7.41 [4.52, 10.29]), versus other groups. IRs for malignancies were comparable between groups. Mean ΔCDAI and rates of achieving MCID in CDAI at month 6 were generally greater with tofacitinib versus other groups. Conclusion: Some variations in incidence of safety outcomes were observed between treatments, while certain effectiveness outcomes favored tofacitinib. Sample size variation between groups and low number of safety events limited the analysis. Further studies are warranted to investigate observed differences. ClinicalTrials.gov: NCT05572567. [ABSTRACT FROM AUTHOR]

Purpose: Clinical registries have great potential for quality control of medical procedures regarding the indications, therapeutic processes and results, including their possible complications. This is particularly true when providing patients with severe hearing loss or deafness with a cochlear implant (CI). This treatment represents a lifelong care process that requires continuous quality control over time. On the initiative of the Executive Committee of the German Society of Otorhinolaryngology (Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e.V., DGHNO-KHC), a national German CI registry (Deutsches Cochlear Implant Register, DCIR) was established in January 2022. This article focuses on the first demographic and baseline data of the DCIR. Methods: The DCIR covers the complete therapeutic process from indication, surgery, fitting and lifelong aftercare in CI therapy. By the end of 2022, 75 hospitals in Germany had agreed to contribute to the DCIR. Results: During the year 2022, 63 hospitals actively contributed data to the DCIR. Pseudonymized data from 2,292 CI implantations (2,176 primary implantations, 99 explantations with immediate re-implantations and 17 re-implantations following an earlier explantation) in 2,108 patients were documented. Cochlear implantation was accomplished in 1,807 adults (≥ 18 years) and 301 children (< 18 years). Fourty patients (1,9%) were children < 1 year of age and 55 (2,6%) were patients > 85 years. From the total of 2,292 implantations, 226 (9.9%) were performed as simultaneous bilateral implantations (CI implantation in both ears of 113 patients on the same day of surgery) and 412 implantations (19.1% of 2,162 implantations with data provided on the contralateral ear's hearing status) were in patients with single sided deafness (normal hearing in the contralateral ear). In addition, the reported complications in 2022 were also evaluated. Seven reports (0.4%) of mild to moderate severe facial nerve dysfunctions were documented. No reports of severe or total facial nerve dysfunction (House-Brackmann grade V/VI), meningitis or death related to CI therapy were documented. Conclusion: Although still in the start-up phase, these initial DCIR data already provide an interesting first insight into the demographic structure and baseline data of CI therapy in Germany. The successful implementation of the DCIR represents an important step towards continuous quality control of CI care. [ABSTRACT FROM AUTHOR]

Purpose: High quality data regarding long-term clinical and patient-reported outcomes (PROs) of genital gender-affirming surgery (GGAS) are lacking, and transgender and non-binary (TGNB) community voices have not historically been included in research development. These factors limit the utility of current research for guiding patients, clinicians, payers, and other GGAS stakeholders in decision-making. The Transgender and Non-Binary Surgery (TRANS) Registry has been developed to meet the needs of GGAS stakeholders and address limitations of traditional GGAS research. Methods: Development of the TRANS Registry occurred over several developmental phases beginning in May 2019 to present. Stakeholder engagement was performed throughout these phases, including: determination of key clinical outcomes and PROs, creation and implementation of data collection tools within the electronic health record (EHR), and development of centralized registry infrastructure. Results: The TRANS Registry is a prospective observational registry of individuals seeking vaginoplasty and vulvoplasty. The EHR-enabled infrastructure allows patients and clinicians to contribute longitudinal outcomes data to the TRANS Registry. We describe our community engaged approach to designing the TRANS Registry, including lessons learned, challenges, and future directions. Conclusions: The TRANS Registry is the first multicenter initiative to prospectively track the health of individuals seeking vaginoplasty and vulvoplasty using EHR-enabled methods, engaging TGNB community members and clinicians as partners in the process. This process may be used as a model for registry development in other emerging fields where high-quality longitudinal outcomes data are needed. [ABSTRACT FROM AUTHOR]

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Background It is unclear whether targeted monitoring of acute adrenal insufficiency (AI) related adverse events (AE) such as sick day episodes (SDEs) and hospitalization rate in congenital adrenal hyperplasia (CAH) is associated with a change in the occurrence of these events. Aim Study temporal trends of AI related AE in the I-CAH Registry. Methods In 2022, data on the occurrence of AI-related AE in children aged <18 years with 21-hydroxylase deficiency CAH were compared to data collected in 2019. Results In 2022, a total of 513 children from 38 centers in 21 countries with a median of 8 children (range 1-58) per center had 2470 visits evaluated over a 3-year period (2019-2022). The median SDE per patient year in 2022 was 0 (0-2.5) compared to 0.3 (0-6) in 2019 (P =.01). Despite adjustment for age, CAH phenotype and duration of study period, a difference in SDE rate was still apparent between the 2 cohorts. Of the 38 centers in the 2022 cohort, 21 had also participated in 2019 and a reduction in SDE rate was noted in 13 (62%), an increase was noted in 3 (14%), and in 5 (24%) the rate remained the same. Of the 474 SDEs reported in the 2022 cohort, 103 (22%) led to hospitalization compared to 299 of 1099 SDEs (27%) in the 2019 cohort (P =.02). Conclusion The I-CAH Registry can be used for targeted monitoring of important clinical benchmarks in CAH. However, changes in reported benchmarks need careful interpretation and longer-term monitoring. [ABSTRACT FROM AUTHOR]

Background: Hypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension. The multicenter, single-arm, observational Global Paradise™ System (GPS) registry has been designed to examine the long-term safety and effectiveness of ultrasound RDN (uRDN) with the Paradise System in a large population of patients with hypertension. Methods: The study aims to enroll up to 3000 patients undergoing uRDN in routine clinical practice. Patients will be recruited over a 4-year period and followed for 5 years (at 3, 6, and 12 months after the uRDN procedure and annually thereafter). Standardized home BP measurements will be taken every 3 months with automatic upload to the cloud. Office and ambulatory BP and adverse events will be collected as per routine clinical practice. Quality-of-Life questionnaires will be used to capture patient-reported outcomes. Conclusions: This observational registry will provide real-world information on the safety and effectiveness of uRDN in a large population of patients treated during routine clinical practice, and also allow for a better understanding of responses in prespecified subgroups. The focus on home BP in this registry is expected to improve completeness of long-term follow-up and provide unique insights into BP over time. Global Paradise System registry study design. ABP, ambulatory blood pressure; BP, blood pressure; FU, follow-up; M, month; OBP, office blood pressure. [ABSTRACT FROM AUTHOR]

Objectives: To document the real-world experience with the use of pneumatic pulsatile mechanical circulatory support (MCS) with the PulseCath iVAC2L during high-risk percutaneous coronary interventions (HR-PCIs). Background: The use of MCS in HR-PCIs may reduce the rate of major adverse cardiovascular events (MACEs) at 90 days. The PulseCath iVAC2L is a short-term pulsatile transaortic left ventricular (LV) assist device that has been in use since 2014. The iVAC2L Registry tracks its safety and efficacy in a variety of hospitals worldwide. Methods: The iVAC2L Registry is a multicenter, observational registry that aggregates clinical data from patients treated with the iVAC2L worldwide. A total of 293 consecutive cases were retrospectively collected and analyzed. Estimated rates of in-hospital clinical endpoints were described. All-cause mortality was used as the primary endpoint and other outcomes of interest were used as secondary endpoints. The rates obtained were reported and contextualized. Results: The in-hospital rate of all-cause mortality was 1.0%, MACE was 3.1%. Severe hypotension occurred in 8.9% of patients. Major bleeding and major vascular complications occurred in 1.0% and 2.1%, respectively. Acute myocardial infarction occurred in 0.7% of patients. Cerebrovascular events occurred in 1.4% of patients. Cardiac arrest occurred in 1.7% of patients. A statistically significant improvement in blood pressure was observed with iVAC2L activation. Conclusions: The results of the present study suggest that the iVAC2L is capable of improving hemodynamics with a low rate of adverse events. However, confirmatory studies are needed to validate these findings. [ABSTRACT FROM AUTHOR]

Introduction & objectives: To evaluate whether cardiovascular risk factors and their management differ in primary prevention between adult males and females with type 1 diabetes (T1D) in two European countries in 2020–2022 and sex inequalities in achievement of standards of care in diabetes. Methods: We used 2020–2022 data of patients without a cardiovascular history in the Prospective Diabetes Follow-up registry (DPV) centres, in Germany, and the Société Francophone du Diabète– Cohorte Diabète de Type 1 cohort (SFDT1), in France. Results: We included 2,657 participants from the DPV registry and 1,172 from the SFDT1 study. Body mass indexes were similar in females and males with similar proportions of HbA1c < 7% (DPV: 36.6 vs 33.0%, p = 0.06, respectively; SFDT1: 23.4 vs 25.7%, p = 0.41). Females were less overweight compared to men in DPV (55.4 vs 61.0%, p < 0.01) but not in SFDT1 (48.0 vs 44.9%, p = 0.33) and were less prone to smoke (DPV: 19.7 vs 25.8%, p < 0.01; SFDT1: 21.0 vs 26.0%, p = 0.07). Systolic blood pressure was lower in females than males with a higher rate of antihypertensive therapy in case of hypertension in females in DPV (70.5 vs 63.7%, p = 0.02) but not in SFDT1 (73.3 vs 68.6%, p = 0.64). In the case of microalbuminuria, ACEi-ARB were less often prescribed in women than men in DPV (21.4 vs 37.6%, p < 0.01) but not SFDT1 (73.3 vs 67.5.0%, p = 0.43). In females compared to males, HDL-cholesterol levels were higher; triglycerides were lower in both countries. In those with LDL-cholesterol > 3.4 mmol/L (DPV: 19.9 (females) vs 23.9% (males), p = 0.01; SFDT1 17.0 vs 19.2%, p = 0.43), statin therapy was less often prescribed in females than males in DPV (7.9 vs 17.0%, p < 0.01), SFDT1 (18.2 vs 21.0%, p = 0.42). Conclusion: In both studies, females in primary prevention have a better cardiovascular risk profile than males. We observed a high rate of therapeutic inertia, which might be higher in females for statin treatment and nephroprotection with ACEi-ARB, especially in Germany. Diabetologists should be aware of sex-specific differences in the management of cardiorenal risk factors to develop more personalized prevention strategies. [ABSTRACT FROM AUTHOR]

Aims Methods and results Conclusion We analysed baseline characteristics and guideline‐directed medical therapy (GDMT) use and decisions in the European Society of Cardiology (ESC) Heart Failure (HF) III Registry.Between 1 November 2018 and 31 December 2020, 10 162 patients with acute HF (AHF, 39%, age 70 [62–79], 36% women) or outpatient visit for HF (61%, age 66 [58–75], 33% women), with HF with reduced (HFrEF, 57%), mildly reduced (HFmrEF, 17%) or preserved (HFpEF, 26%) ejection fraction were enrolled from 220 centres in 41 European or ESC‐affiliated countries. With AHF, 97% were hospitalized, 2.2% received intravenous treatment in the emergency department, and 0.9% received intravenous treatment in an outpatient clinic. AHF was seen by most by a general cardiologist (51%) and outpatient HF most by a HF specialist (48%). A majority had been hospitalized for HF before, but 26% of AHF and 6.1% of outpatient HF had de novo HF. Baseline use, initiation and discontinuation of GDMT varied according to AHF versus outpatient HF, de novo versus pre‐existing HF, and by ejection fraction. After the AHF event or outpatient HF visit, use of any renin–angiotensin system inhibitor, angiotensin receptor–neprilysin inhibitor, beta‐blocker, mineralocorticoid receptor antagonist and loop diuretics was 89%, 29%, 92%, 78%, and 85% in HFrEF; 89%, 9.7%, 90%, 64%, and 81% in HFmrEF; and 77%, 3.1%, 80%, 48%, and 80% in HFpEF.Use and initiation of GDMT was high in cardiology centres in Europe, compared to previous reports from cohorts and registries including more primary care and general medicine and regions more local or outside of Europe and ESC‐affiliated countries. [ABSTRACT FROM AUTHOR]

The authors propose the generation of a multi-institutional TBI registry. Barriers to registry implementation include: (1) difficulties in acquiring ethical approval; (2) incomplete clinical data available; (3) lack of information and insufficient technology (IT) support; (4) limited available resources; (5) time constraints involving understaffing yet managing high patient volumes; (6) time constraints associated with entering patient data into the registry tool. The authors detail the current state of affairs on neurotrauma registries worldwide and propose the creation of a multi-institutional, global neurotrauma registries. This private-public partnership will enable appropriate balance among stakeholders while offering care to the largest number of citizens. This initiative will require coordinated efforts involving vetted members of organized neurosurgery. Support from these entities, such as fellowship program creation, provided funding through travel vouchers to LMICs, secured housing and transportation costs in LMI nations, facilitated meetings with global local stakeholders, and promotion of key developments via social media, will accelerate the creation of this global neurotrauma registry. We propose the creation of a global TBI registry, in partnership with large, academic medical centers. Several proposed limitations of registry implementation can be addressed with support from local stakeholders, including government officials and administrative members at key institutions. Several American institutions have well-established global health programs to support this initiative. Further, at Harvard Medical School, the program in Global Surgery and Social Change offers the Paul Farmer Global Surgery Fellowship that trains leaders in policy development and implementation. The fellowship consists of 2 separate tracks: a 2-year research fellow (PGY-5—PGY-6) and 1-year research associate (MD and MBBS, etc.). Funding could be allocated towards creating a year-long fellowship dedicated towards implementing a neurotrauma registry, with this selected scholar granted the resource and connections to network with government officials and healthcare groups in every nation within that jurisdiction. A scholar would be assigned a region of the world with the goal to generate a registry that would later be combined with those generated by peer scholars. In addition, we propose the creation of a fund, controlled by donors, as a funding model. [ABSTRACT FROM AUTHOR]

Background Data monitoring and surveillance systems are the cornerstone for governance and regulation, planning, and policy development for chronic disease care. Our study aims to evaluate health systems capacity for data monitoring and surveillance for kidney care. Methods We leveraged data from the third iteration of the International Society of Nephrology Global Kidney Health Atlas (ISN-GKHA), an international survey of stakeholders (clinicians, policymakers and patient advocates) from 167 countries conducted between July and September 2022. ISN-GKHA contains data on availability and types of kidney registries, the spectrum of their coverage, as well as data on national policies for kidney disease identification. Results Overall, 167 countries responded to the survey, representing 97.4% of the global population. Information systems in forms of registries for dialysis care were available in 63% (n  = 102/162) of countries, followed by kidney transplant registries (58%; n  = 94/162), and registries for non-dialysis chronic kidney disease (19%; n  = 31/162) and acute kidney injury (9%; n  = 14/162). Participation in dialysis registries was mandatory in 57% (n  = 58) of countries; however, in more than half of countries in Africa (58%; n  = 7), Eastern and Central Europe (67%; n  = 10), and South Asia (100%; n  = 2), participation was voluntary. The least-reported performance measures in dialysis registries were hospitalization (36%; n  = 37) and quality of life (24%; n  = 24). Conclusions The variability of health information systems and early identification systems for kidney disease across countries and world regions warrants a global framework for prioritizing the development of these systems. [ABSTRACT FROM AUTHOR]

Summary: The population has aged; there is a greater risk of osteoporosis and hip fracture. We describe the standards of care for hip fractures in various hospitals of Mexico. A total of 1042 subjects participated. The acute mortality was 4.3%. Significance. Hip fracture registries provide a means to compare care and establish improvement processes. Background: The Mexican population has aged; thus, there is a greater risk of osteoporosis, and its main consequence is hip fracture due to fragility. Its incidence is high, and it is expected to increase due to aging in our country. International guidelines provide standardized recommendations for the care of people with hip fractures, while hip fracture registries provide a means to compare care with local, national, and international clinical standards and establish improvement processes. Objective: Describe the standards of care for hip fractures in various hospital centers of the Mexican Social Security Institute. Methods: This was an observational, multicenter, longitudinal, and descriptive study. It included 24 hospital centers in Mexico. Informed consent was obtained. Data were recorded during the hospital stay, epidemiological data, and management, and follow-up was carried out 30 and 120 days after discharge. The information was analyzed using SPSS version 22.0. Results: A total of 1042 subjects aged 79.5 ± 7.6 years participated, mostly women (n = 739; 70.9%) from the community (n = 1,021; 98.0%) and with functional independence (Barthel 80.9 ± 22.2). The transfer time to the emergency room was 4.6 ± 14.6 days. Pertrochanteric hip fracture was the most common (n = 570, 54.7%). The most common type of procedure was dynamic hip screw (DHS) (n = 399; 40.1%). Documented thromboprophylaxis was granted in 91.5% (n = 953) and antibiotic prophylaxis in 53.0% (n = 552) of the patients. The goal of 36 h for the surgical procedure was achieved in 7.6% of the subjects (n = 76), with the most frequent cause being a delay in scheduling (n = 673, 67.6%). The mean time from emergency room to surgery was 7.8 ± 7.0 days. The acute mortality rate was 4.3%. Secondary pharmacologic prevention upon discharge occurred in 64.2% of patients. At 30 days, 370 subjects (37.1%) were lost to follow-up, with a mortality of 3%, while at 120 days, 166 subjects (27.8%) were lost, with a mortality of 2.8%. Conclusion: In the hospital centers where the study was carried out, there are still no standards of care for hip fractures, which makes it necessary to rethink the care for this population group through a strategy focused on meeting those standards. [ABSTRACT FROM AUTHOR]

Background: South Carolina has arguably the most robust Alzheimer's Registry in the United States. For enhanced planning in both clinical practice and research and better utilization of the Registry data, it is important to understand survival after Registry entry. To this end, we conducted exploratory analyses to examine the patterns of longevity/survival in the South Carolina Alzheimer's Disease Registry. Methods: The sample included 42,028 individuals in the South Carolina Alzheimer's Disease Registry (SCADR). Participants were grouped into four cohorts based on their year of diagnosis. Longevity in the Registry (LIR), or the length of survival in the registry, was calculated based on the years of reported diagnosis and death. Results: The median LIR varied between 24 to 36 months depending on the cohort, with 75% of individuals in the three recent cohorts surviving for at least 12 months. Across all cohorts, 25% of the participants survived at least 60 months. The median LIR of females was longer than that of males. Individuals whose race was classified as Asian, American Indian, and other than listed had longer LIR compared to White, African American, and Hispanic individuals. Median LIR was shorter for Registry cases diagnosed at an earlier age (less than 65 years). Conclusion: Our data indicate that significant longevity is to be expected in the SCADR but that there is interesting variability which needs to be explored in subsequent studies. The SCADR is a rich data source prime for use in research studies and analyses. [ABSTRACT FROM AUTHOR]

Genetic testing is the gold standard for diagnosing different epidermolysis bullosa (EB) subtypes; however, testing rates are low. We conducted a pilot study to test feasibility of a novel, home‐based registry that involved patients with EB submitting self‐reported clinical symptoms using secure, online surveys (REDCap) and submitting buccal swabs for exome sequencing of EB‐related genes (GeneDx). In total, 50 EB participants were enrolled, with an average age of 17 years and an average distance of 198 miles from EB specialty centers. All buccal swabs (N = 24) provided sufficient DNA for sequencing without causing mucosal trauma and 80% of participants were found to have pathogenic variants in COL7A1, the gene mutated in DEB. Participants with recessive dystrophic EB (RDEB) reported a higher prevalence of esophageal dilations (65.7% vs. 0%, p =.009) and mitten deformities of the feet (57.1% vs. 0%, p =.047) compared to non‐RDEB participants. [ABSTRACT FROM AUTHOR]

Introduction: The key outcome of joint registries is revision events, which inform clinical practice and identify poor‐performing implants. Registries record revision events and reasons, but accuracy may be limited by a lack of standardized definitions of revision. Our study aims to assess the accuracy and completeness of unicompartmental knee arthroplasty (UKA) revision and indications reported to the New Zealand Joint Registry (NZJR) with independent clinical review. Methods: Case record review of 2272 patients undergoing primary UKA at four large tertiary hospitals between 2000 and 2017 was performed, identifying 158 patients who underwent revision. Detailed review of clinical findings, radiographs and operative data was performed to identify revision cases and the reasons for revision using a standardized protocol. These were compared to NZJR data using chi‐squared and Fisher exact tests. Results: The NZJR recorded 150 (95%) of all UKA revisions. Osteoarthritis progression was the most common reason on the systematic clinical review (35%), however, this was underreported to the registry (8%, P < 0.001). A larger proportion of revisions reported to the registry were for 'pain' (30% of cases vs. 5% on clinical review, P < 0.001). A reason for revision was not reported to the registry for 10% of cases. Conclusion: The NZJR had good capture of UKA revisions, but had significant differences in registry‐reported revision reasons compared to our independent systematic clinical review. These included over‐reporting of 'pain', under‐reporting of osteoarthritis progression, and failing to identify a revision reason. Efforts to improve registry capture of revision reasons for UKA could be addressed through more standardized definitions of revision and tailored revision options for UKA on registry forms. [ABSTRACT FROM AUTHOR]

Background: Early revision for total hip arthroplasty is a serious adverse outcome. There are multiple contributing risk factors for early revision. Risk factors can exist at the level of the surgeon and the level of the institution. The primary research question of this study was to determine the relative contribution of surgeon‐level and hospital‐level variance to rates of early revision (overall and for infection) after primary total hip arthroplasty. Methods: This is a registry‐based study from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Data for the most commonly used stem (Exeter V40) were used to reduce prosthesis variation from the analysis. A mixed effects Cox Model (also known as a frailty model) with crossed random effects for surgeon and hospital was used. Outcomes were early revision (within 2 years) for all causes and for infection. This model allowed for the risk of early revision to be explained by the variability at the surgeon level or hospital level. Results: There were 32 031 procedures performed by 735 surgeons across 250 hospitals between 1 January 2015 and 31 December 2019. Surgeon variability significantly contributed to overall variation in revision for any cause and revision for infection (P < 0.0001). There was no significant contribution of hospital‐level variation to overall revision or for infection. Conclusions: Surgeon‐level factors play a more important role than institution‐level factors in early revision after primary total hip arthroplasty. If surgeons are identified as having a higher risk of revision, there is potential for surgeon‐level practice change to reduce the risk of early revision. [ABSTRACT FROM AUTHOR]

The Chronic Angioedema Registry (CARE) is an international disease registry that aims to improve patient care for recurrent angioedema. It collects data through questionnaires completed by physicians and patients to assess disease control, quality of life, and treatment responses. However, the outcomes may not apply to less severe cases typically seen in primary care or community settings, and the findings may not be generalizable to patients from diverse ethnic backgrounds. The document also lists conflicts of interest for authors involved in the CARE study, who have disclosed financial relationships with pharmaceutical companies and other organizations. The study received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin. [Extracted from the article]

The CARMEN-France registry is a prospective, multicenter registry in France including adult patients with a new diagnosis of immune thrombocytopenia or of autoimmune immune hemolytic anemia (2402 patients included in December 31, 2023). The recording of clinical, biological and treatment data allows detailed epidemiological and pharmacoepidemiological real-world studies. This review summarizes the CARMEN-France registry protocol, gives examples of studies conducted in the registry, and indicates future directions such as inclusion of patient reported outcomes, linkage with the French national health insurance database and linkage with other registries in Europe. [ABSTRACT FROM AUTHOR]

STUDY QUESTION How are ART and IUI regulated, funded, and registered in European countries, and how has the situation changed since 2018? SUMMARY ANSWER Of the 43 countries performing ART and IUI in Europe, and participating in the survey, specific legislation exists in only 39 countries, public funding varies across and sometimes within countries (and is lacking or minimal in four countries), and national registries are in place in 33 countries; only a small number of changes were identified, most of them in the direction of improving accessibility, through increased public financial support and/or opening access to additional subgroups. WHAT IS KNOWN ALREADY The annual reports of the European IVF-Monitoring Consortium (EIM) clearly show the existence of different approaches across Europe regarding accessibility to and efficacy of ART and IUI treatments. In a previous survey, some coherent information was gathered about how those techniques were regulated, funded, and registered in European countries, showing that diversity is the paradigm in this medical field. STUDY DESIGN, SIZE, DURATION A survey was designed using the SurveyMonkey tool consisting of 90 questions covering several domains (legal, funding, and registry) and considering specific details on the situation of third-party donations. New questions widened the scope of the previous survey. Answers refer to the situation of countries on 31 December 2022. PARTICIPANTS/MATERIALS, SETTINGS, METHODS All members of the EIM were invited to participate. The received answers were checked and initial responders were asked to address unclear answers and to provide any additional information considered relevant. Tables resulting from the consolidated data were then sent to members of the Committee of National Representatives of ESHRE, requesting a second check. Conflicting information was clarified by direct contact. MAIN RESULTS AND THE ROLE OF CHANCE Information was received from 43 out of the 45 European countries where ART and IUI are performed. There were 39 countries with specific legislation on ART, and artificial insemination was considered an ART technique in 33 of them. Accessibility is limited to infertile couples only in 8 of the 43 countries. In 5 countries, ART and IUI are permitted also for treatments of single women and all same sex couples, while a total of 33 offer treatment to single women and 19 offer treatment to female couples. Use of donated sperm is allowed in all except 2 countries, oocyte donation is allowed in 38, simultaneous donation of sperm and oocyte is allowed in 32, and embryo donation is allowed in 29 countries. Preimplantation genetic testing (PGT)-M/SR (for monogenetic disorders, structural rearrangements) is not allowed in 3 countries and PGT-A (for aneuploidy) is not allowed in 10; surrogacy is accepted in 15 countries. Except for marital/sexual situation, female age is the most frequently reported limiting criterion for legal access to ART: minimal age is usually set at 18 years and the maximum ranges from 42 to 54 with some countries not using numeric definition. Male maximum age is set in very few countries. Where third-party donors are permitted, age is frequently a limiting criterion (male maximum age ranging from 35 to 50; female maximum age from 30 to 37). Other legal restrictions in third-party donation are the number of children born from the same donor (or, in some countries, the number of families with children from the same donor) and, in 12 countries, there is a maximum number of oocyte donations. How countries deal with the anonymity is diverse: strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), a mixed system (anonymous and non-anonymous donations), and strict non-anonymity. Inquiring about donors' genetic screening showed that most countries have enforced either mandatory or scientific recommendations that exclude the most prevalent genetic diseases, although, again, diversity is evident. Reimbursement/compensation systems exist in more than 30 European countries, with around 10 describing clearly defined maximum amounts considered acceptable. Public funding systems are extremely variable. One country provides no financial assistance to ART/IUI patients and three offer only minimal support. Limits to the provision of funding are defined in the others i.e. age (female maximum age is the most used), existence of previous children, BMI, maximum number of treatments publicly supported, and techniques not entitled for funding. In a few countries reimbursement is linked to a clinical policy. The definitions of the type of expenses covered within an IVF/ICSI cycle, up to which limit, and the proportion of out-of-pocket costs for patients are also extremely dissimilar. National registries of ART are in place in 33 out of the 43 countries contributing to the survey and a registry of donors exists in 19 of them. When comparing with the results of the previous survey, the main changes are: (i) an extension of the beneficiaries of ART techniques (and IUI), evident in nine countries; (ii) public financial support exists now in Albania and Armenia; (iii) in Luxembourg, the only ART centre expanded its on-site activities; (iv) donor-conceived children are entitled to know the donor identity in six countries more than in 2018; and (v) four more countries have set a maximum number of oocyte donations. LIMITATIONS, REASONS FOR CAUTION Although the responses were provided by well-informed and committed individuals and submitted to double checking, no formal validation by official bodies was in place. Therefore, possible inaccuracies cannot be excluded. The results presented are a cross-section in time, and ART and IUI frameworks within European countries undergo continuous modification. Finally, some domains of ART activity were deliberately left out of the scope of this survey. WIDER IMPLICATIONS OF THE FINDINGS Our results offer a detailed updated view of the ART and IUI situation in European countries. It provides extensive answers to many relevant questions related to ART usage at the national level and could be used by institutions and policymakers at both national and European levels. STUDY FUNDING/COMPETING INTEREST(S) The study has no external funding, and all costs were covered by ESHRE. There were no competing interests. [ABSTRACT FROM AUTHOR]

Background: Infertility is a prevalent global condition, and emerging reproductive technologies may enhance its evaluation and treatment. Understanding the current features of randomized clinical trials in infertility is crucial for improving study design and ensuring the translation of results for patient benefits. Objectives: To investigate the primary characteristics of randomized clinical trials related to infertility and areas where require improvement. Materials and methods: We conducted a search on the International Clinical Trials Registry platform for eligible infertility trials between 2003 and 2022. The distribution ratio of various characteristics uploaded by infertility‐related studies on the platform was analyzed and compared according to sex and registration year. Results: Out of the total trials, 85.3% (1,906) included only women, 8.6% (192) included only men, and 6.1% (136) included couples. The majority of retrieved trials followed a parallel arm design (91.0%) and were non‐industry‐funded (92.2%), with a median planned sample size of 131 patients (interquartile range 75–270). Among these trials, 54.5% (1,217) were conducted in Asia. The most common primary purpose of infertility‐related trials was treatment (88.8%), with over half of the investigated interventions focusing on medication (57.9%). Discussion: Asia is the leading region for research, and the drug therapy is still widely used and updated. However, support care for infertile couples has also received some preference. Areas that require improvement and promotion include addressing male infertility and focusing on underserved regions like Africa. The results also highlight deficiencies in trial registration and masking methods, emphasizing the need for better regulation and facilitation of infertility trials in the post‐COVID‐19 era. Conclusion: Based on the current status of infertility RCT studies, greater attention should be paid to infertile men and populations in underdeveloped regions like Africa in future studies, together with a standardized registration and implementation procedures. [ABSTRACT FROM AUTHOR]

Introduction: The pathogenesis and clinical profiles of patients with pulmonary hypertension (PH) associated with interstitial lung disease (ILD-PH) are poorly understood. Whether and to what extent pulmonary arterial hypertension (PAH)-specific therapy improves hemodynamic and outcome in ILD-PH are also unknown. Study Objective: This study aims to clarify the characteristics, clinical course and response to PAH-specific therapy of ILD and/or PH by enrolling three unique subsets: PAH, ILD-PH, and ILD. Methods: The proposed study is a retrospective and prospective, multi-centre, observational cohort study of patients treated at any of three university hospitals in the Hokkaido region of Japan who have any one of the following: PAH; ILD-PH with or without PAH features; or ILD without PH. We aim to enrol 250 patients in total. For the retrospective observation period, data obtained after 1 January 2010, will be analysed, and the prospective observation period will be 1 year. We will compare the clinical data of patients with ILD-PH with those of patients with PAH and those of patients with ILD without PH in the real-world clinical setting. In addition, within the cohort of patients with ILD-PH, we will explore the subset with "ILD-PH with PAH features" and compare the response to PAH-specific therapy with that of PAH. The primary outcome will be the change in pulmonary vascular resistance from first treatment to follow-up in patients with PAH and ILD-PH with PAH features (excluding ILD-PH without PAH feature and ILD-no-PH for the primary outcome). The exploratory outcomes will include analyses of PH-associated biomarkers, right ventricular function and patient-reported outcomes. Results: This is a protocol article and the results will be presented after data collection is completed. Conclusion: The POPLAR study will provide data that help better understand the pathophysiology of ILD-PH and improve the quality of life and outcome of patients with PH and/or ILD. Trial Registration: Japan Registry of Clinical Trials: jRCT1010230018. [ABSTRACT FROM AUTHOR]

Background: Aneurysmal subarachnoid haemorrhage (aSAH) is a life‐threatening disease with high mortality and morbidity. Patients with aSAH in Sweden are cared for at one of six neuro intensive care units (NICU) or at a general intensive care unit (ICU).This study aimed to describe the incidence, length of stay, time in ventilator and mortality for these patients. Methods: This is a retrospective, descriptive study of patients with aSAH, registered in the Swedish Intensive care Registry between 2017 and 2019. The cohort was divided in sub‐cohorts (NICU and general ICU) and regions. Mortality was analysed with logistic regression. Results: A total of 1520 patients with aSAH from five regions were included in the study. Mean age of the patients were 60.6 years and 58% were female. Mortality within 180 days of admission was 30% (n = 456) of which 17% (n = 258) died during intensive care. A majority of the patients were treated at one hospital and in one ICU (70%, n = 1062). More than half of the patients (59%, n = 897) had their first intensive care admission at a hospital with a NICU. Patients in the North region had the lowest median GCS (10) and the highest SAPS3 score (60) when admitted to NICU. Treatment with invasive mechanical ventilation differed significantly between regions; 91% (n = 80) in the region with highest proportion versus 56% (n = 94) in the region with the lowest proportion, as did mortality; 16% (n = 44) versus 8% (n = 23). No differences between regions were found regarding age, sex and length of stay. Conclusions: Patients with aSAH treated in a NICU or in an ICU in Sweden differs in characteristics. The study further showed some differences between regions which might be reduced if there were national consensus and treatment guidelines implemented. [ABSTRACT FROM AUTHOR]

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Aims. Multiple sclerosis treatment strategies are changing in the Czech Republic. According to data from 2013–2021, the proportion of patients starting high-efficacy disease-modifying therapies is increasing. In this survey, we describe the actual data trends in multiple sclerosis (MS) patients beginning their first disease-modifying therapies (DMTs) from 2013 to 2021. The secondary objective was to present the history, data collection, and scientific potential of the Czech National MS registry (ReMuS). Methods. First, using descriptive statistics, we analysed the data for patients starting their first DMTs, either platform (including dimethyl fumarate) or high-efficacy DMTs (HE-DMTs), for each successive year. Second, a detailed description of the history, data collection, completeness, quality optimising procedures, and legal policies of ReMuS is provided. Results. Based on the dataset from December 31, 2021, the total number of monitored patients with MS in ReMuS increased from 9,019 in 2013 (referred from 7 of 15 MS centres) to 12,940 in 2016 (referred from all 15 Czech MS centres) to 17,478 in 2021. In these years, the percentage of patients treated with DMTs in the registry ranged from 76 to 83%, but the proportion of patients treated with HE-DMTs changed from 16.2% in 2013 to 37.1% in 2021. During the follow-up period, a total of 8,491 treatment-naive patients received DMTs. The proportion of patients (all MS phenotypes) starting HE-DMTs increased from 2.1% in 2013 to 18.5% in 2021. Conclusion. Patient registries, including ReMuS, provide an essential quality data source, especially in light of the increasing percentage of patients on HE-DMTs. Although early initiation of HE-DMT can provide considerable benefits, it also carries greater potential risks. Consistent long-term follow-up of patients in real-world clinical practice, which only registries allow, is therefore crucial to evaluate the efficacy and safety of therapeutic strategies, for epidemiological research and to assist decision making by healthcare providers and regulatory bodies. [ABSTRACT FROM AUTHOR]

Background and Aims. There are limited data on real clinical practice in heart failure patients in the Czech Republic. We analysed the clinical parameters from the Moravian Midlands Registry (MMR) and compared them to LCZ696 patients in the Paradigm-HF trial. The Moravian Midlands Registry is a retrospective patient database from two outpatient cardiology centres in the Czech Republic. The Paradigm-HF is a large-scale prospective randomized multicentre trial with more than 8000 individuals with stabilized chronic heart failure. Methods. A retrospective analysis of heart failure with reduced ejection fraction patients from two outpatient cardiology centres in the Czech Republic from October 2016 to December 2019. Results. Patients in the MMR were younger (60.5 ± 10.7 vs 63.8 ± 11.5 years, P<0.05), had a higher body mass index (30.3 ± 5.0 vs 28.1 ± 5.5, P<0.05) and higher serum creatinine level (101.9 ± 36.0 vs 99.9 ± 26.5 µmol/L, P<0.05). MMR patients had lower left ventricular ejection fraction (27.8 ± 6.9 vs 29.6 ± 6.1%, P<0.05). The serum N-terminal pro-B-type natriuretic peptide, [2563.5 (377–3536) vs 1631 (885–3154), was non significantly higher P=0.07]. Pharmacotherapy use differed for mineralocorticoid antagonist (91.4% in MMR vs 54.2% in Paradigm-HF), and digoxin (13.5% vs 29.2%). Beta-blocker use was similar (96.2% vs 93.1%) as was angiotensin-converting enzyme (ACE) inhibitors – (71.2% vs 78.0%) and angiotensin-receptor blockers – ARB (27.9% vs 22.2%). Dosages of the commonly used ACE inhibitors at the screening visit (Paradigm-HF) / before angiotensin receptor-neprilysin inhibitor administration (MMR) differed significantly only for ramipril (7.0 ± 3.1 mg vs 4.8 ± 2.9 mg, P<0.05), dosages of ARB were – losartan (67.1 ± 30.2 vs 39.6 ± 32.0 mg, P=0.09) and valsartan (181.5 ± 71.1 vs 130.9 ± 82.2 mg, P=0.07). There was a substantial difference in device-based therapy (ICD in 60.6%, CRT 25.9% in MMR vs 14.9% and 7.0% in Paradigm-HF). Conclusion. The differences between the groups for the majority of clinical parameters compared were minimal, except for younger age, higher body mass index and serum creatinine level and lower left ventricular ejection fraction and substantially lower dosage of administered ramipril prior to commencing sacubitril/valsartan therapy. There was a higher prevalence of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy (CRT) in the MMR group. [ABSTRACT FROM AUTHOR]

Objective: To describe the background, methodology, and results of the congressionally mandated Department of Veterans Affairs (VA) Traumatic Brain Injury (TBI) Veterans Health Registry. Setting: Veterans Health Administration (VHA) and Veterans Benefit Administration (VBA). Participants: A total of 441 639 Veterans of post-9/11 conflicts who exhibited symptoms associated with TBI and sought care or benefits from the VA between September 2001 and September 2021. Design: Retrospective analysis of VHA and VBA administrative records. Main Measures: (1) VA/Department of Defense Identity Repository to identify Veterans with a deployment to the Southwest Asia theater of operations; (2) the VA TBI Screening and Evaluation Program data; (3) Inpatient and Outpatient Encounter data; and (4) an extract of the VBA Corporate Database to identify Veterans filing benefit claims based on TBI. Results: An unduplicated total of 441 639 post-9/11 Veterans were identified in the Registry via three different pathways to entry: 369 909 Veterans through a positive TBI Screen, 253 177 Veterans receiving healthcare including a TBI diagnosis, and 108 541 Veterans filing TBI disability claims. Among Veterans reporting current TBI symptoms who completed a clinical evaluation, a diagnosis of TBI was confirmed by a TBI specialist in 68.7% of the cases. The TBI severity of confirmed cases was classified as mild in 86.6% of the cases, moderate in 8.3%, and severe in 4.1%. The TBI Registry Veterans were hospitalized 66 503 times and seen 1 521 898 times as outpatients in VHA facilities with diagnoses including TBI. Among Veterans filing TBI disability claims, 67.3% were adjudicated as service-connected. Conclusion: The VA TBI Health Registry has identified over 440 000 Veterans of post-9/11 conflicts who presented to the VA for care or benefits with TBI symptomatology. This large number and the volume of TBI health care and benefits provided over the two decades since 9/11 demonstrate the need for the VA’s strong ongoing focus on screening, evaluation, and rehabilitation of TBI. [ABSTRACT FROM AUTHOR]

Recently, the indication of reverse total shoulder arthroplasty (RTSA) has expanded beyond rotator cuff arthropathy to include treatment of complex acute proximal humeral fracture (PHF). Limited previous studies have compared the long-term clinical and functional outcomes of patients undergoing RTSA for PHF vs. elective indications for degenerative conditions. The purpose of this study was to compare implant survivorship, reasons for revision and functional outcomes in patients undergoing RTSA for acute PHF with those undergoing elective RTSA in a population-based cohort study. Prospectively collected data from the New Zealand Joint Registry from 1999 to 2021 and identified 6862 patients who underwent RTSA. Patients were categorized by preoperative indication, including PHF (10.8%), rotator cuff arthropathy (RCA) (44.5%), osteoarthritis (OA) (34.1%), rheumatoid arthritis (RA) (5.5%), and old traumatic sequelae (5.1%). Revision-free implant survival and functional outcomes (Oxford Shoulder Scores [OSSs] at the 6-month, 5-year, and 10-year follow-ups) were adjusted by age, sex, American Society of Anesthesiologists class, and surgeon experience and compared. Revision-free implant survival at 10 years for RTSA for PHF was 97.3%, compared with 96.1%, 93.7%, 92.8%, and 91.3% for OA, RCA, RA and traumatic sequelae, respectively. When compared with RTSA for PHF, the adjusted risk of revision was significantly higher for traumatic sequelae (hazard ratio = 2.3, P =.023) but not for other elective indications. The most common reason for revision in the PHF group was dislocation or instability (42.9%), which was similar to the OA (47.6%) and traumatic sequelae (33.3%) groups. At 6 months post-surgery, OSSs were significantly lower for the PHF group compared with the RCA, OA, and RA groups (31.1 vs. 35.6, 37.7, and 36.5, respectively, P <.001), and similar to traumatic sequelae (31.7, P =.431). At 5 years, OSSs were only significantly lower for PHF compared with OA (37.4 vs. 41.0, P <.001) and there was no difference between the PHF and other groups. At 10 years, there were no significant differences between groups. RTSA for PHF demonstrated reliable long-term survivorship and functional outcomes compared with elective indications. Despite lower functional outcomes in the early postoperative period for the PHF group, implant survivorship was similar in patients undergoing RTSA for the primary indication of acute PHF compared with RCA, OA, and RA and superior compared to the primary indication of traumatic sequelae. [ABSTRACT FROM AUTHOR]

Background: Limited information is available on the safety and efficacy of cryoballoon ablation (CBA) in elderly patients with atrial fibrillation (AF). Moreover, global utilization of CBA in this population (≥ 80 years old) has not been reported. This study's objectives were to determine the use, efficacy, and safety of CBA to treat octogenarians suffering from AF. Methods: In this sub-analysis of the Cryo Global Registry, 12-month outcomes of treating AF via CBA in octogenarians were compared to patients < 80 years old. Efficacy was evaluated as time to a ≥ 30 s atrial arrhythmia (AA) recurrence. Healthcare utilization was determined via repeat ablations and hospitalizations. Improvement upon disease burden was evaluated through patient reporting of symptoms and the EQ-5D-3L quality of life (QoL) survey. Results: The octogenarian cohort (n = 101) had a higher prevalence of females (51.5% vs 35.7%) and CHA2DS2-VASc scores (4.2 ± 1.3 vs 2.0 ± 1.5) compared to the control cohort (n = 1573, both p < 0.01). Even when adjusting for baseline characteristics and antiarrhythmic drug usage, freedom from AA recurrence at 12 months (80.6% vs 78.9%, HRadj:0.97 [95% CI:0.59–1.58], p = 0.90) was comparable between octogenarians and control, respectively. Similar serious adverse event rates were observed between octogenarians (5.0%) and control (3.2%, p = 0.38). The groups did not differ in healthcare utilization nor reduction of AF-related symptoms from baseline to follow-up, but both experienced an improvement in QoL at 12 months. Conclusions: Despite more age-related comorbidities, CBA is a safe and effective treatment for AF in octogenarians, with efficacy and adverse events rates akin to ablations performed in younger patients. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT02752737 [ABSTRACT FROM AUTHOR]

Introduction: Nowadays, the demand for physical therapy services has grown significantly over the last few decades due to an aging population, a rise in chronic conditions, and increased awareness of the benefits of physical therapy for injury recovery and managing various health issues. Collecting and managing data from physical therapy services is highly significant and beneficial. One of the information management systems that facilitates data collection related to physical therapy services is a physical therapy registry. In this systematic review, we aimed to identify physical therapy registries worldwide and examine the characteristics and data elements of each registry. Methods: PubMed, Scopus, Web of Science, and IEEE databases were searched from inception until March 19, 2023 by using keywords and Medical Subject Headings (MeSH) terms regarding "registries" and "physical therapy." The criteria for inclusion in the study were: (1) studies with the English language; (2) original studies, and online access to the physical therapy registry is available; (3) full‐text available; (4) studies related to the aims of the study, and (5) studies that have sufficient available information regarding the minimum datasets and other characteristics physical therapy registry. The methodological quality of the included studies was independently assessed by two reviewers using the Effective Public Health Practice Project's (EPHPP) quality assessment tool. Results: Sixteen studies were eligible to be included. The findings of this review indicated that the oldest physical therapy registry was established in 1992, while the newest one was established in 2017. The USA has the highest number of physical therapy registries (n = 7). Ten registries were funded by the government, and the data source for most registries was collected in clinics (n = 11). The geographical coverage of 10 registries was national. All registries collected administrative data (such as sociodemographic data, healthcare provider's data, and others) and clinical data (such as diagnosis, type of physical therapy intervention, pain location, comorbidities, and others) through web‐based systems. The data collection method in half of the registries was retrospective (n = 8 out of 16). According to the EPHPP quality assessment tool, 11 studies (73%) were rated as moderate, 3 (20%) as weak, and 1 (7%) as strong. Conclusion: This systematic review found that most developed countries have implemented web‐based physical therapy registries to collect administrative and clinical data at the national level. It is recommended that developing countries design and implement similar registries based on these characteristics and extracted data elements. Additionally, these registries should be designed to enable data sharing and interoperability with other international health information systems. [ABSTRACT FROM AUTHOR]