Multiple Registry Research Articles

Socioeconomic status is associated with process times in the emergency department for patients with chest pain.

Emergency department length of stay (EDLOS) is linked to crowding and patient outcomes whereas worse prognosis in low socioeconomic status remains poorly understood. We studied whether income was associated with ED process times among patients with chest pain. This was a registry-based cohort study on 124,980 patients arriving at 14 Swedish EDs between 2015 and 2019 with chest pain as their chief complaint. Individual-level sociodemographic and clinical data were linked from multiple national registries. The associations between disposable income quintiles, whether the time to physician assessment exceeded triage priority recommendations as well as EDLOS were evaluated using crude and multivariable regression models adjusted for age, gender, sociodemographic variables, and ED-management circumstances. Patients with the lowest income were more likely to be assessed by physician later than triage recommendations (crude odds ratio [OR] 1.25 (95% confidence interval [CI] 1.20-1.29) and have an EDLOS exceeding 6h (crude OR 1.22 (95% CI 1.17-1.27). Among patients subsequently diagnosed with major adverse cardiac events, patients with the lowest income were more likely to be assessed by a physician later than triage recommendations, crude OR 1.19 (95% CI 1.02-1.40). In the fully adjusted model, the average EDLOS was 13 min (5.6%) longer among patients in the lowest income quintile, 4:11 [h:min], (95% CI 4:08-4:13), compared to patients in the highest income quintile, 3:58 (95% CI 3:56-4:00). Among ED chest pain patients, low income was associated with longer time to physician than recommended by triage and longer EDLOS. Longer process times may have a negative impact due to crowding in the ED and delay diagnosis and timely treatment of the individual patient.

Edoxaban treatment in atrial fibrillation in routine clinical care: One-year outcomes of the prospective observational ETNA-AF study in South Korean patients.

The real-world outcomes of edoxaban treatment in patients with atrial fibrillation (AF) were analyzed in the ETNA-AF (Edoxaban Treatment in Routine Clinical Practice) study involving data from multiple regional registries. This report addresses effectiveness and safety of edoxaban in the Korean ETNA-AF population. One-year data from 1887 Korean ETNA-AF participants were analyzed according to edoxaban dose and patient age and compared with results of other ETNA-AF registries. Approximately 70% of patients received the recommended doses of edoxaban (60 mg/30 mg); non-recommended 60 mg and 30 mg doses were prescribed to 9.6% and 19.8% of the patients, respectively. The proportions of reference age (<65 years), youngest-old (65-74 years) and middle-old/oldest-old (≥75 years) groups were 21.4%, 40.2%, and 38.4%, respectively. Incidence of major or clinically relevant nonmajor bleeding was similar within dose (0.57%-1.71%) and age subgroups (1.26%-1.63%). Incidence of net clinical outcome, a composite of stroke, systemic embolic event, major bleeding, and all-cause mortality, was also comparable among dose subgroups (1.14%-3.10%) and age subgroups (2.28%-2.78%). The percentage of Korean patients receiving non-recommended 30 mg (19.8%) was over twice that of the European population (8.4%). However, the clinical outcomes were generally similar among different populations included in the ETNA-AF study. The outcomes in the Korean ETNA-AF population are like those in the global ETNA-AF population, with overall low event rates of stroke, major bleeding and all-cause mortality across age and dose subgroups. Edoxaban can be used effectively and safely in specific populations of Korean AF patients, including the elderly.

Oncological and functional outcomes of transoral surgery compared with non-surgical management in small-volume oropharyngeal cancer: a systematic review protocol.

The objective of this systematic review is to investigate oncological and functional outcomes following primary transoral surgery compared with non-surgical management in patients with small-volume (T1-2, N0-2) oropharyngeal cancer. The incidence of oropharyngeal cancer is rising. Transoral surgery was introduced to provide a minimally invasive treatment option for patients with small-volume oropharyngeal cancer and to avoid the morbidity that results from open surgery and the potential acute and late toxicities of chemoradiotherapy. The review will include all studies on adult patients with small-volume oropharyngeal cancer managed by transoral surgery or non-surgical management with radiotherapy and/or chemotherapy. All patients must have undergone treatment with curative intent. Participants who underwent palliative treatment will be excluded. This review will follow the JBI methodology for systematic reviews of effectiveness. Eligible study designs will include randomized controlled trials, quasi-experimental studies, and prospective or retrospective cohort studies. Databases to be searched will include PubMed, Embase, CINAHL, Cochrane CENTRAL, and multiple trial registries from 1972. Titles and abstracts will be reviewed, and full-text articles will be retrieved if they meet the inclusion criteria. All eligible studies will be critically appraised by 2 independent reviewers using the appropriate JBI tools for experimental and observational designs. Where possible, outcome data from studies will be pooled with statistical meta-analysis to compare both oncological and functional outcomes between the two groups. All time to event to data will be converted to a common metric for oncological outcomes. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be followed to assess the certainty of findings. PROSPERO CRD4202235209.

The lifetime health and economic burden of obesity in five European countries: what is the potential impact of prevention?

Estimating the burden of obesity in five European countries (Germany, Greece, the Netherlands, Spain and the UK) and the potential health benefits and changes in health care costs associated with a reduction in body mass index (BMI). A Markov model was used to estimate the long-term burden of obesity. Health states were based on the occurrence of diabetes, ischaemic heart disease and stroke. Multiple registries and literature sources were used to derive the demographic, epidemiological and cost input parameters. For the base-case analyses, the model was run for a starting cohort of healthy obese people with a BMI of 30 and 35 kg/m2 aged 40 years to estimate the lifetime impact of obesity and the impact of a one-unit decrease in BMI. Different scenario and sensitivity analyses were performed. The base-case analyses showed that total lifetime health care costs (for obese people aged 40 and BMI 35 kg/m2 ) ranged from €75 376 in Greece to €343 354 in the Netherlands, with life expectancies ranging from 37.9 years in Germany to 39.7 years in Spain. A one-unit decrease in BMI showed gains in life expectancy ranging from 0.65 to 0.68 year and changes in total health care costs varying from -€1563 to +€4832. The economic burden of obesity is substantial in the five countries. Decreasing BMI results in health gains, reductions in obesity-related health care costs, but an increase in non-obesity related health care costs, which emphasizes the relevance of including all costs in decision making on implementation of preventive interventions.

Surviving critical COVID-19 requiring mechanical ventilation is associated with a high long-term risk of de novo arrhythmic events

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Swedish Research Council Swedish Heart- and Lung Foundation Background The long-term risk of de novo arrhythmic events after severe COVID-19 requiring intensive care is largely unknown, especially after adjusting for multiple risk factors such as co-morbidities and socio-economic factors. Objective The primary objective of this study was to investigate the long-term, co-variate adjusted risk of arrhythmic event after discharge from intensive care unit for critical COVID-19. Methods We performed a nationwide case-control study on patients with severe COVID-19 (cases) treated with mechanical ventilation and discharged alive from an intensive care unit. Each case was matched (age, sex, district of residence) with up to 10 population-based control. The study database from the Swedish ICU register was merged with multiple compulsory national registries. The primary outcome was hospitalizations with the following arrhythmias identified: ventricular tachycardia, atrial fibrillation, any other tachy-arrhythmia, or bradycardia/pacemaker implantation. Hazard ratios were adjusted for co-morbidities, socioeconomic status, level of education, region of birth and disposable income. Average follow-up was 12 months. Results We included 3 023 patients with severe COVID-19 that were treated with mechanical ventilation at a Swedish ICU (March 1, 2020 to June 8, 2021) and were discharged alive. Control subjects (n= 28,463 ) were selected based on matching by age, sex and district of residence. The Hazard ratios for the risk of de novo arrhythmic event post ICU discharge for COVID-19 adjusted for age, gender, all comorbidities, level of education, marital status and income were increased between 13.1 – 21.0 in all four types of arrhythmias (Table 1). Conclusions We report increased risks for major arrhythmic events following severe COVID-19 even after adjusting for cardiovascular risk factors and for socio-economic factors. These data suggest that at least patients with inherit risk factors for developing arrhythmias in need of ICU treatment for COVID-19 should be closely followed-up after discharge.

Fosfomycin for Antibiotic Prophylaxis in Men Undergoing a Transrectal Prostate Biopsy: A Systematic Review and Meta-Analysis.

Background and Objectives: To assess the effects of fosfomycin compared with other antibiotics as a prophylaxis for urinary tract infections (UTIs) in men undergoing transrectal prostate biopsies. Materials and Methods: We searched multiple databases and trial registries without publication language or status restrictions until 4 January 2022. Parallel-group randomized controlled trials (RCTs) and non-randomized studies (NRS) were included. The primary outcomes were febrile UTI, afebrile UTI, and overall UTI. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs. The protocol was registered with PROSPERO (CRD42022302743). Results: We found data on five comparisons; however, this abstract focuses on the primary outcomes of the two most clinically relevant comparisons. Regarding fosfomycin versus fluoroquinolone, five RCTs and four NRSs with a one-month follow-up were included. Based on the RCT evidence, fosfomycin likely resulted in little to no difference in febrile UTIs compared with fluoroquinolone. This difference corresponded to four fewer febrile UTIs per 1000 patients. Fosfomycin likely resulted in little to no difference in afebrile UTIs compared with fluoroquinolone. This difference corresponded to 29 fewer afebrile UTIs per 1000 patients. Fosfomycin likely resulted in little to no difference in overall UTIs compared with fluoroquinolone. This difference corresponded to 35 fewer overall UTIs per 1000 patients. Regarding fosfomycin and fluoroquinolone combined versus fluoroquinolone, two NRSs with a one- to three-month follow-up were included. Based on the NRS evidence, fosfomycin and fluoroquinolone combined may result in little to no difference in febrile UTIs compared with fluoroquinolone. This difference corresponded to 16 fewer febrile UTIs per 1000 patients. Conclusions: Compared with fluoroquinolone, fosfomycin or fosfomycin and fluoroquinolone combined may have a similar prophylactic effect on UTIs after a transrectal prostate biopsy. Given the increasing fluoroquinolone resistance and its ease to use, fosfomycin may be a good option for antibiotic prophylaxis.

PO-03-135 LEFT ATRIAL APPENDAGE OCCLUSION VERSUS STANDARD OF CARE IN PATIENTS WITH ATRIAL FIBRILLATION AND A PRIOR THROMBO-EMBOLIC EVENT DESPITE ORAL ANTICOAGULANT THERAPY: A PROPENSITY SCORE MATCHED COMPARISON

Patients with atrial fibrillation (AF) that suffer from ischemic stroke despite oral anticoagulant (OAC) therapy have a very high risk of recurrent stroke and better prevention strategies are needed. Left atrial appendage occlusion (LAAO) is a promising secondary prevention strategy that may provide mechanical protection. However, evidence showing effectiveness of LAAO in this population is scarce and the current international guidelines only consider LAAO in patients with a contra-indication for OAC. To compare percutaneous LAAO to standard-of-care including continuing/switching OAC therapy for secondary stroke prevention in patients with AF and a prior thrombo-embolic event and/or LAA thrombus under OAC therapy. The STR-OAC LAAO cohort is an international collaboration of multiple LAAO registries (21 participating centers). All patients that underwent percutaneous LAAO because of a thrombo-embolic event and/or LAA thrombus on OAC were included. Propensity score matching with a previously published multi-center dataset of patients continuing/switching OAC therapy after a thrombo-embolic event was performed to compare the occurence of ischemic stroke between groups.Time-to-event analysis was performed with Kaplan-Meier curves and Cox-proportional-hazard regression analyses. A total of 425 patients underwent LAAO between 2010-2021 and were included in the STR-OAC LAAO cohort. Mean age was 72±9 years; 45% was female and mean CHA2DS2-VASc and HAS-BLED score were 4.8±1.5 and 2.8±1.2, respectively. Oral anticoagulation was discontinued after LAAO at discharge or after confirmation of adequate LAA closure at 1-3 months follow-up in most patients, the remaining 30% of patients continued OAC after LAAO as an adjunctive strategy. All LAAO patients were propensity-score matched and included in the primary outcome analysis. During follow up including 1450 patient-years a total of 59 patients experienced ischemic stroke: 1.9% per patient-year in LAAO group versus 9.2% per patient-year in the control group. LAAO was associated with a significantly lower risk of ischemic stroke (HR 0.3, 95%CI [0.2-0.5], p<0.001) compared to standard-of-care. In this propensity-score matched study, LAAO was associated with a lower risk of ischemic stroke compared to standard-of-care in patients with a thrombo-embolic event and/or LAA thrombus despite OAC treatment. Randomized controlled trial data may further confirm the effectiveness of LAAO in this very high-risk population.

Real-world use of natalizumab in Austria: data from the Austrian Multiple Sclerosis Treatment Registry (AMSTR)

IntroductionWith the approval of natalizumab in Europe in 2006, the Austrian Multiple Sclerosis Therapy Registry (AMSTR) was established. Here, we present data from this registry about effectiveness and safety of natalizumab in patients treated up to 14 years.Patients/methodsData retrieved from the AMSTR contained baseline characteristics and biannual documentation of annualised relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score as well as adverse events and reasons for discontinuation on follow-up visits.ResultsA total of 1596 natalizumab patients (71% women, n = 1133) were included in the analysis and the observed treatment duration ranged from 0 to 164 months (13.6 years). The mean ARR was 2.0 (SD = 1.13) at baseline, decreasing to 0.16 after 1 year and 0.01 after 10 years. A total of 325 patients (21.6%) converted to secondary progressive multiple sclerosis (SPMS) during the observational period. Of 1502 patients, 1297 (86.4%) reported no adverse events (AE) during follow-up visits. The most common reported AEs were infections and infusion-related reactions. John Cunningham virus (JCV) seropositivity was the most common specified reason for treatment discontinuation (53.7%, n = 607). There were five confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) with 1 death.ConclusionThe effectiveness of natalizumab in patients with active relapsing–remitting multiple sclerosis (RRMS) could be confirmed in our real-world cohort even after follow-up of up to 14 years, though after year 10, there were less than 100 remaining patients. A low number of AE were reported in this nationwide registry study, establishing Natalizumab’s favourable safety profile during long-term use.

Identifying recurrent breast cancer patients in national health registries using machine learning

Background More than 4500 women are diagnosed with breast cancer each year in Denmark, however, despite adequate treatment 10–30% of patients will experience a recurrence. The Danish Breast Cancer Group (DBCG) stores information on breast cancer recurrence but to improve data completeness automated identification of patients with recurrence is needed. Methods We included patient data from the DBCG, the National Pathology Database, and the National Patient Registry for patients with an invasive breast cancer diagnosis after 1999. In total, relevant features of 79,483 patients with a definitive surgery were extracted. A machine learning (ML) model was trained, using a simplistic encoding scheme of features, on a development sample covering 5333 patients with known recurrence and three times as many non-recurrent women. The model was validated in a validation sample consisting of 1006 patients with unknown recurrence status. Results The ML model identified patients with recurrence with AUC-ROC of 0.93 (95% CI: 0.93–0.94) in the development, and an AUC-ROC of 0.86 (95% CI: 0.83–0.88) in the validation sample. Conclusion An off-the-shelf ML model, trained using the simplistic encoding scheme, could identify recurrence patients across multiple national registries. This approach might potentially enable researchers and clinicians to better and faster identify patients with recurrence and reduce manual patient data interpretation.

PD27-09 PATIENT REPORTED OUTCOMES AFTER RADICAL PROSTATECTOMY OR RADIOTHERAPY FOR PROSTATE CANCER, A REGISTER-BASED NATIONWIDE STUDY

You have accessJournal of UrologyCME1 Apr 2023PD27-09 PATIENT REPORTED OUTCOMES AFTER RADICAL PROSTATECTOMY OR RADIOTHERAPY FOR PROSTATE CANCER, A REGISTER-BASED NATIONWIDE STUDY Oskar Bergengren, Christian Corsini, Stefan Carlsson, Ingela Franck-Lissbrant, Hans Garmo, Marie Hjelm-Eriksson, Per Fransson, Jon Kindblom, David Robinson, Marcus Westerberg, Pär Stattin, and Sigrid Carlsson Oskar BergengrenOskar Bergengren More articles by this author , Christian CorsiniChristian Corsini More articles by this author , Stefan CarlssonStefan Carlsson More articles by this author , Ingela Franck-LissbrantIngela Franck-Lissbrant More articles by this author , Hans GarmoHans Garmo More articles by this author , Marie Hjelm-ErikssonMarie Hjelm-Eriksson More articles by this author , Per FranssonPer Fransson More articles by this author , Jon KindblomJon Kindblom More articles by this author , David RobinsonDavid Robinson More articles by this author , Marcus WesterbergMarcus Westerberg More articles by this author , Pär StattinPär Stattin More articles by this author , and Sigrid CarlssonSigrid Carlsson More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003305.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The two main alternatives for curative treatment of prostate cancer (PCa) are robot assisted radical prostatectomy (RARP) and radiotherapy (RT). We assessed outcomes after RARP and RT by use of Patient Reported Outcomes Measures (PROM) in a large, contemporary population. METHODS: The National Prostate Cancer Register of Sweden (NPCR) includes information on almost all Swedish men with PCa. The PCa Data Base Sweden (PCBaSe) links data to multiple national population-based registries. PROM are distributed to all men scheduled for curative treatment. 12 month PROM were used to evaluate the outcomes erectile dysfunction, urinary symptoms, bowel dysfunction, and quality of life (QoL). Data for all men who completed 12 month PROM in PCBaSe 5.0 aged <75 years, with clinical T1c-T3 or Tx, any Gleason score, preoperative PSA levels <l00 ng/mL, no metastases (N0, Nx. M0 or Mx) who underwent RARP or RT between 1 January 2018 and 31 December 2020 were analyzed (n=4298). Comorbidities were assessed by Charlson Comorbidity Index and a Drug Comorbidity Index. Adjusted odds ratios (OR) for each outcome comparing RT vs RARP (reference) were obtained using logistic regression, adjusting for confounders at date of treatment (age, comorbidities, educational level, civil status, PSA, prostate volume, biopsies with cancer, cT-stage and Gleason score). RESULTS: 2557 men underwent RARP and 1741 men received RT. On average, men who had undergone RT were 4 years older and had more comorbidities. The prevalence of erectile dysfunction was 80% among men who underwent RARP and 82% among RT. 13% of the men were incontinent one year after RARP while only 5% reported incontinence after RT. 17% of men treated with RT and 18% with RARP reported high urinary bother. 34% of men who underwent RT reported urgency to defecate compared to 14% of men treated with RARP. High QoL was reported by 85% of men who underwent RARP and 79% who underwent RT. RT was associated with lower risk of erectile dysfunction (OR 0.57, 95% CI 0.48-0.67), lower risk of urine incontinence (OR 0.24, 95% CI 0.19-0.32), lower urinary bother (OR 0.74, 95% CI 0.61-0.89) but higher risk of bowel related symptoms (OR 2.84 95%, CI: 2.40-3.37). RARP was associated with higher QoL (OR 1.33, 95% CI: 1.11-1.60). CONCLUSIONS: Results from this large, contemporary, and unselected population confirms previous reports on common side-effects after curative treatment for PCa. However, QoL is high regardless of treatment suggesting that factors other than side-effects are the main drivers of QoL. Source of Funding: National Institutes of Health/National Cancer Institute (K22 CA234400) to Dr. Carlsson and Hillevi Fries Research Foudation, Johanna Hagstrand and Sigfrid Linnérs Research Foundation, Nyströms America Scholarship, and the Swedish Society of Medicine to Dr. Bergengren © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e745 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Oskar Bergengren More articles by this author Christian Corsini More articles by this author Stefan Carlsson More articles by this author Ingela Franck-Lissbrant More articles by this author Hans Garmo More articles by this author Marie Hjelm-Eriksson More articles by this author Per Fransson More articles by this author Jon Kindblom More articles by this author David Robinson More articles by this author Marcus Westerberg More articles by this author Pär Stattin More articles by this author Sigrid Carlsson More articles by this author Expand All Advertisement PDF downloadLoading ...

The strengths and complexities of European registries concerning paediatric kidney transplantation health care.

Patient data are increasingly available in (multi)national registries, especially for rare diseases. This study aims to provide an overview of current European registries of paediatric kidney transplantation (PKT) care, their coverage, and their focus. Based on these data, we assess whether the current status is optimal for achieving our common goal: the optimalisation of health care. A list of all PKT centres within the European Union (EU) as well as active PKT registries was compiled using existing literature and the European Platform on Rare Disease Registration. Registry staff members were contacted to obtain information about the parameters collected and the registry design. These data were compared between registries. In total, 109 PKT centres performing PKT surgery were identified in the 27 EU Member States. Currently, five European PKT registries are actively collecting data. In 39% of these centres, no data were registered within any of these five existing international registries. A large variety was observed in the number of patients, centres, and countries involved in the registries. Furthermore, variability existed regarding the inclusion criteria, definitions used, and parameters collected. Collection of perioperative urologic data are currently underrepresented in the registries. Currently, multiple registries are collecting valuable information in the field of PKT, covering the majority of PKT centres in Europe. Due to a large variety in the parameters collected as well as different focuses, data collection is currently fragmented and suboptimal; therefore, the current existing data are incomplete. In addition, a considerable proportion of the transplantation centres do not enter data in any international registry. Combining available information and harmonising future data collection could empower the aim of these registries-namely increasing insights into the strengths and potential of current care and therefore improve healthcare.

Age-specific lymphoma and reticuloendothelial neoplasms incidence rates in children and adolescents in the world.

In order to compare lymphoma and reticuloendothelial neoplasms incidence rate in children and adolescents between Japan and other countries, we extracted information on lymphoma and reticuloendothelial neoplasms incidence in children and adolescents from the third volume of the International Incidence of Childhood Cancer series (IICC-3) (1). The IICC-3 reports the number or incidence rates of cancers diagnosed in childhood and adolescence, from cancer registries (regional or national) worldwide. We analysed incidence rate in four countries in Asia (Japan, China, the Republic of Korea and Thailand), two countries in Africa (Egypt and Uganda), four countries in the Americas (North: The United States of America [USA] and Canada, Latin and Caribbean: Brazil and Colombia), three countries in Europe (the United Kingdom [UK], France and Germany) and two countries in Oceania (Australia and New Zealand). Information from the Republic of Korea, USA, UK, Australia and New Zealand was obtained at the national level, and that from the other countries was extracted from one or multiple regional cancer registries. The years of incidence included in the analyses varied from country to country, ranging from 1990 to 2014, with the shortest being 12 years (Egypt: 1999–2010, UK: 2000–2011) and the longest being 24 years (Japan and China: both 1990–2013). In this study, we compared the lymphoma and reticuloendothelial neoplasms incidence in children and adolescents by age groups 0, 1–4, 5–9, 10–14 and 15–19 years between these countries.

Derivation and validation of predictive indices for cardiac readmission after coronary and valvular surgery – A multicenter study

ObjectiveTo derive and validate models to predict the risk of a cardiac readmission within one year after specific cardiac surgeries using information that is commonly available from hospital electronic medical records. MethodsIn this retrospective cohort study, we derived and externally validated clinical models to predict the likelihood of cardiac readmissions within one-year of isolated CABG, AVR, and combined CABG+AVR in Ontario, Canada, using multiple clinical registries and routinely collected administrative databases. For all adult patients who underwent these procedures, multiple Fine and Gray subdistribution hazard models were derived within a competing-risk framework using the cohort from April 2015 to March 2018 and validated in an independent cohort (April 2018 to March 2020). ResultsFor the model that predicted post-CABG cardiac readmission, the c-statistic was 0.73 in the derivation cohort and 0.70 in the validation cohort at one-year. For the model that predicted post-AVR cardiac readmission, the c-statistic was 0.74 in the derivation and 0.73 in the validation cohort at one-year. For the model that predicted cardiac readmission following CABG+AVR, the c-statistic was 0.70 in the derivation and 0.66 in the validation cohort at one-year. ConclusionsPrediction of one-year cardiac readmission for isolated CABG, AVR, and combined CABG+AVR can be achieved parsimoniously using multidimensional data sources. Model discrimination was better than existing models derived from single and multicenter registries.

International variations in age-specific incidence rates of central nervous system (CNS) neoplasms in children and adolescents.

To compare the incidence rates of central nervous system (CNS) neoplasms in children and adolescents between Japan and other countries, we extracted information on the incidence of CNS and miscellaneous intracranial and intraspinal neoplasms in children and adolescents from the third volume of the International Incidence of Childhood Cancer series (IICC-3) (1). The IICC-3 reports the number or incidence rates of cancers diagnosed in childhood and adolescence, from cancer registries (regional or national) worldwide. We analysed incidence rate in four countries in Asia (Japan, China, the Republic of Korea and Thailand), two countries in Africa (Egypt and Uganda), four countries in the Americas (North: the United States of America [USA] and Canada, Latin and Caribbean: Brazil and Colombia), three countries in Europe (the United Kingdom [UK], France and Germany) and two countries in Oceania (Australia and New Zealand). Information from the Republic of Korea, USA, UK, Australia and New Zealand was obtained at the national level, and that from the other countries was extracted from one or multiple regional cancer registries. The years of incidence included in the analyses varied from country to country, ranging from 1990 to 2014, with the shortest being 12 years (Egypt: 1999–2010, UK: 2000–2011) and the longest being 24 years (Japan and China: both 1990–2013). In this study, the incidence rates of CNS neoplasms in children and adolescents for different age groups (0, 1–4, 5–9, 10–14 and 15–19 years) were compared between the included countries.

COMPARING MODERN UNCEMENTED, HYBRID AND CEMENTED IMPLANT COMBINATIONS IN OLDER PATIENTS UNDERGOING PRIMARY TOTAL HIP ARTHROPLASTY: A NEW ZEALAND JOINT REGISTRY STUDY

Multiple joint registries have reported better implant survival for patients aged &gt;75 years undergoing total hip arthroplasty (THA) with cemented implant combinations when compared to hybrid or uncemented implant combinations. However, there is considerable variation within these broad implant categories, and it has therefore been suggested that specific implant combinations should be compared. We analysed the most common contemporary uncemented (Corail/Pinnacle), hybrid (Exeter V40/Trident) and cemented (Exeter V40/Exeter X3) implant combinations in the New Zealand Joint Registry (NZJR) for patients aged &gt;75 years.All THAs performed using the selected implants in the NZJR for patients aged &gt;75 years between 1999 and 2018 were included. Demographic data, implant type, and outcome data including implant survival, reason for revision, and post-operative Oxford Hip Scores were obtained from the NZJR, and detailed survival analyses were performed. Primary outcome was revision for any reason. Reason for revision, including femoral or acetabular failure, and time to revision were recorded.5427 THAs were included. There were 1105 implantations in the uncemented implant combination group, 3040 in the hybrid implant combination group and 1282 in the cemented implant combination group. Patient reported outcomes were comparable across all groups. Revision rates were comparable between the cemented implant combination (0.31 revisions/100 component years) and the hybrid implant combination (0.40 revisions/100 component years) but were statistically significantly higher in the uncemented implant combination (0.80/100 component years). Femoral-sided revisions were significantly greater in the uncemented implant combination group.The cemented implant and hybrid implant combinations provide equivalent survival and functional outcomes in patients aged over 75 years. Caution is advised if considering use of the uncemented implant combination in this age group, predominantly due to a higher risk of femoral sided revisions. The authors recommend comparison of individual implants rather than broad categories of implants.

A Study on the Enablers and Challenges of Co-Creation for the Digital Common Household Unit Integrated Public Service in Malta

Several public services in Malta operate under the stewardship of different governmental bodies, ministries, or departments. This results in considerable effort in the delivery of public services, especially ones that require the use of multiple registries, such as integrated public services (IPSs). Co-creation and co-production are increasingly being seen by public administrations as an approach toward mitigating issues stemming from such a siloed environment. Indeed, they are seen as a means to improve service provision through the delivery of citizen-centric public services that are more efficient and effective. This paper presents the Malta pilot as part of the inGOV project. The latter aims to develop and deploy a comprehensive IPS holistic framework and ICT mobile tools that will support IPS co-creation and governance. The Malta pilot focuses on modernising the Digital Common Household Unit public service. Improving considerably upon the previous ad hoc solution, the Digital Common Household Unit public service implements an iterative co-creation and co-production approach with the various stakeholders. This paper therefore presents the applied methodology in researching current challenges and enablers to the co-creation and co-production of a digital common household unit public service, with a specific focus on sustainability.

Achieving no evidence of disease activity-3 in highly active multiple sclerosis patients treated with cladribine and monoclonal antibodies.

We aimed to determine the proportion of highly active multiple sclerosis patients under high-efficacy therapies (HETs) achieve no evidence of disease activity-3 (NEDA-3) at 1 and 2 years, and to identify factors associated with failing to meet no evidence of disease activity 3 at 2 years. This retrospective cohort study based on Argentina Multiple Sclerosis patient registry (RelevarEM), includes highly active multiple sclerosis patients who received HETs. In total, 254 (78.51%) achieved NEDA-3 at year 1 and 220 (68.12%) achieved NEDA-3 at year 2. Patients who achieved NEDA-3 at 2 years had a shorter duration of multiple sclerosis (p < 0.01) and a shorter time between first treatment and current treatment (p = 0.01). Early high-efficacy strategy patients reached NEDA-3 more frequently (p < 0.01). Being a naïve patient (odds ratio: 3.78, 95% confidence interval 1.50-9.86, p < 0.01) was an independent predictor to reach NEDA-3 at 2 years. No association was found between type of HETs and NEDA-3 at 2 years when adjusted for potential confounders (odds ratio: 1.73; 95% confidence interval 0.51-6.06, p 0.57). We found a high proportion of patients who achieved NEDA-3 at 1 and 2 years. Early high-efficacy strategy patients had a higher probability of achieving NEDA-3 at 2 years.

Complementary and alternative medicine for long COVID: a systematic review of randomized controlled trials.

Complementary and alternative medicine (CAM) interventions are growing in popularity as possible treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This study aims to review existing published studies on the use of CAM interventions for patients experiencing long COVID through a systematic review. Systematic review of randomized controlled trials (RCTs). A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of CAM for long COVID were included. Methodological quality of each included trial was appraised with the Cochrane 'risk of bias' tool. A qualitative analysis was conducted due to heterogeneity of included studies. A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that CAM interventions could benefit patients with long COVID, especially those suffering from neuropsychiatric disorders, olfactory dysfunction, cognitive impairment, fatigue, breathlessness, and mild-to-moderate lung fibrosis. The main interventions reported were self-administered transcutaneous auricular vagus nerve stimulation, neuro-meditation, dietary supplements, olfactory training, aromatherapy, inspiratory muscle training, concurrent training, and an online breathing and well-being program. CAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on CAM for long COVID are warranted in the future.

Mitral valve TEER in the UK: what you need to know as TEER becomes routinely available in the NHS.

Transcatheter edge-to-edge repair (TEER) was first performed in 2003, and is now established across the developed world as an effective, minimally invasive treatment option for patients with mitral regurgitation (MR). Multiple large registries have established the efficacy of mitral TEER in patients with primary or degenerative MR in whom surgery is considered prohibitive or high risk, while ongoing randomised-controlled trials will determine its role in younger and lower- risk patients. In patients with secondary or functional MR, in whom mitral valve surgery is not routinely recommended, the pivotal COAPT trial showed a profound reduction in both mortality and heart failure hospitalisation in carefully selected patients. NHS England approved the routine commissioning of mitral TEER in 2019, and following a substantial delay, due in large part to the COVID pandemic, the procedure is now widely available across the UK. This review article describes the TEER procedure, currently available devices, the underlying evidence base, and the key facts needed for clinicians to understand who, how, and where to refer patients for consideration of mitral TEER. The emerging role of TEER in patients with severe symptomatic tricuspid regurgitation is also considered.

Towards FAIRification of sensitive and fragmented rare disease patient data: challenges and solutions in European reference network registries

IntroductionRare disease patient data are typically sensitive, present in multiple registries controlled by different custodians, and non-interoperable. Making these data Findable, Accessible, Interoperable, and Reusable (FAIR) for humans and machines at source enables federated discovery and analysis across data custodians. This facilitates accurate diagnosis, optimal clinical management, and personalised treatments. In Europe, twenty-four European Reference Networks (ERNs) work on rare disease registries in different clinical domains. The process and the implementation choices for making data FAIR (‘FAIRification’) differ among ERN registries. For example, registries use different software systems and are subject to different legal regulations. To support the ERNs in making informed decisions and to harmonise FAIRification, the FAIRification steward team was established to work as liaisons between ERNs and researchers from the European Joint Programme on Rare Diseases.ResultsThe FAIRification steward team inventoried the FAIRification challenges of the ERN registries and proposed solutions collectively with involved stakeholders to address them. Ninety-eight FAIRification challenges from 24 ERNs’ registries were collected and categorised into “training” (31), “community” (9), “modelling” (12), “implementation” (26), and “legal” (20). After curating and aggregating highly similar challenges, 41 unique FAIRification challenges remained. The two categories with the most challenges were “training” (15) and “implementation” (9), followed by “community” (7), and then “modelling” (5) and “legal” (5). To address all challenges, eleven types of solutions were proposed. Among them, the provision of guidelines and the organisation of training activities resolved the “training” challenges, which ranged from less-technical “coffee-rounds” to technical workshops, from informal FAIR Games to formal hackathons. Obtaining implementation support from technical experts was the solution type for tackling the “implementation” challenges.ConclusionThis work shows that a dedicated team of FAIR data stewards is an asset for harmonising the various processes of making data FAIR in a large organisation with multiple stakeholders. Additionally, multi-levelled training activities are required to accommodate the diverse needs of the ERNs. Finally, the lessons learned from the experience of the FAIRification steward team described in this paper may help to increase FAIR awareness and provide insights into FAIRification challenges and solutions of rare disease registries.